title-902•Title 902 KAR — Cabinet for Health and Family Services - Department for Public Health
Title 902 KAR — Cabinet for Health and Family Services - Department for Public Health
title-902902 KARRegulation
Chapter 1 Administration
902 KAR 1:400 Administrative conference {#sec-902-kar-1-400 omnilex-key=us-ky-regs-official--title-902--902 KAR 1:400}
Section 1. Notice of Enforcement.
(1) The Department for Public Health (DPH) shall provide the opportunity for an administrative conference to any regulated entity aggrieved by the issuance of a Notice of Enforcement (DFS-214).
(2) The Notice of Enforcement (DFS-214) shall be sent by:
(a) United States first-class mail to the registered permit holder or responsible party's last address on file;
(b) Electronic mail to the registered permit holder or responsible party's last electronic mail address on file; or
(c) Hand delivered or other means, as appropriate.
(3) The notice shall contain:
(a) A description of the proposed action or action taken;
(b) The reasons for the action;
(c) The statutory or regulatory authority for the action; and
(d) The timeline required to submit a Request for Administrative Conference (DFS-212).
(4) Upon receipt of a Notice of Enforcement (DFS-214), the permit holder or responsible party may submit a Request for Administrative Conference (DFS-212) within ten (10) business days to the Department for Public Health or local health department of jurisdiction.
(5) Upon receipt of a request for a conference, the Department for Public Health or local health department of jurisdiction shall schedule an administrative conference and send a Notice of Administrative Conference (DFS-213).
(6) The Notice of Administrative Conference (DFS-213) shall:
(a) Be sent to the permit holder or responsible party who requested a conference at least ten (10) business days prior to the conference; and
(b) Include the date, time, and location of the administrative conference.
Section 2. Administrative Conference.
(1) The administrative conference shall be conducted by a representative of the Department for Public Health.
(2) The permit holder or responsible party may examine any evidence or information in the agency's possession to be used at the administrative conference at least five (5) days prior to the conference.
(3) The permit holder or responsible party may arrange an independent transcription of the administrative conference proceedings at its own expense.
(4) During the administrative conference, the permit holder or responsible party may:
(a) Be represented by counsel; and
(b) Present documentation in his or her favor.
(5) The purpose of the administrative conference is to:
(a) Clarify the issues and positions of the parties; and
(b) Attempt to resolve any dispute over the proposed action or action taken.
Section 3. Administrative Conference Decision.
(1) Within ten (10) business days of the conclusion of the administrative conference, the Department for Public Health representative shall:
(a) Send a written decision to the director of the local health department of jurisdiction; and
(b) Send a written decision to the permit holder or responsible party, with a copy to the appropriate program staff.
(2) The director of the local health department of jurisdiction or appropriate program staff shall forward a copy of the decision to the permit holder or responsible party within five (5) business days.
(3) The decision shall:
(a) Be sent by:
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United States first-class mail to the registered permit holder or responsible party's last address on file; and
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Electronic mail to the registered permit holder or responsible party's last electronic mail address on file; and
(b) Contain the:
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Results of the administrative conference; and
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Permit holder or responsible party's right to appeal pursuant to KRS Chapter 13B.
Section 4. Appeals. The permit holder or responsible party may request a hearing within ten (10) days of receipt of the administrative conference decision by:
(1)
(a) Mailing a request for a hearing to the Division of Public Health Protection and Safety, Department for Public Health, 275 E. Main Street, Mailstop HS1E-A, Frankfort, Kentucky 40621;
(b) Faxing a request for a hearing to 502-564-9523; or
(c) Emailing a request for hearing to environmentalappeals@ky.gov.
(2) Requests for a hearing shall be forwarded by the division to the Office of Administrative Hearings within the Department of Law in accordance with KRS 15.111(2)(g), within two (2) working days of receipt.
Section 5. Nothing in this administrative regulation shall be construed to prevent the Department for Public Health from taking emergency action to protect the public health and safety under the provisions of KRS 13B.125.
Section 6. Material Incorporated by Reference.
(1) The following material is incorporated by reference:
(a) "Request for Administrative Conference (DFS-212)", 5/2026 edition;
(b) "Notice of Administrative Conference (DFS-213)", 5/2026 edition; and
(c) "Notice of Enforcement (DFS-214)", 5/2026 edition.
(2) This material may be inspected, copied or obtained at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621. Office hours are 8 a.m. to 4:30 p.m.
(3) This material is also available online at https://chfs.ky.gov/agencies/dph/dafm/Pages/lhddocuments.aspx .
History
- RELATES TO: KRS 15.111, 211.180, 211.190, 211.210, 211.357, 211.360, 211.760, 211.844, 211.925, 212.210, 212.230, 212.620, 212.627, 217.125, 217.126, 217.809, 217C.040, 217C.050, 219.031, 219.370, 223.070
- STATUTORY AUTHORITY: KRS 13B.170, 211.025
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 13B.170 authorizes an agency to enact administrative hearing procedures by administrative regulation that supplement the provisions of KRS Chapter 13B. KRS 211.025 requires the cabinet to administer all provisions of law relating to public health and to enforce all public health laws and all administrative regulations of the secretary. This administrative regulation establishes the procedures for requesting an administrative conference by the Department for Public Health.
- History: 902 KAR 001:400. 23 Ky.R. 1829; 2521; eff. 11-20-1996; Crt eff. 10-15-2019; 52 Ky.R. 1582, 56; eff. 8-18-2026.
Chapter 2 Communicable Diseases
902 KAR 2:020 Reportable disease surveillance {#sec-902-kar-2-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:020}
Section 1. Definitions.
(1) "Acid fast bacilli" or "AFB" means the mycobacteria that, if stained, retains color even after having been washed in an acid solution and can be detected under a microscope in a stained smear.
(2) "Health facility" is defined by KRS 216B.015(13).
(3) "Health professional" means a professional licensed under KRS Chapters 311 through 314.
(4) "Healthcare-associated infection" or "HAI" means an infection acquired by a person while receiving treatment for a separate condition in a health care setting.
(5) "Kentucky public health advisory" means a notification to health professionals, health facilities, and laboratories subject to this administrative regulation identifying a new health threat that warrants reporting through the procedures of this administrative regulation.
(6) "Medical laboratory" is defined by KRS 333.020(3).
(7) "National Healthcare Safety Network" or "NHSN" means the nation's most widely used healthcare-associated infection (HAI) tracking system as provided to medical facilities by the Centers for Disease Control and Prevention (CDC).
(8) "National reference laboratory" means a laboratory located outside of Kentucky that is contracted by a Kentucky health professional, laboratory, or health facility to provide laboratory testing.
(9) "Novel influenza A virus" means an influenza virus that causes human infection but is different from the seasonal human influenza A virus subtypes and includes viruses predominately of avian and swine origin.
(10) "Nucleic acid amplification test" or "NAAT" means the laboratory test used to target and amplify a single deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) sequence, usually for detecting a microorganism.
(11) "Outbreak" means:
(a) Two (2) or more cases, including HAIs, that are epidemiologically linked or connected by person, place, or time; or
(b) A single case of an HAI or other disease or condition not commonly diagnosed.
(12) "Pharmacist" is defined by KRS 315.010(17).
(13) "Post-exposure prophylaxis" or "PEP" means taking an antiretroviral medicine after being potentially exposed to HIV to prevent becoming infected.
(14) "Pre-exposure prophylaxis" or "PrEP" means daily medicine intended to reduce the chance of getting HIV.
(15) "Select agent" means a biological agent or toxin that could pose a severe threat to public health, plant health, animal product, or plant product as determined by the National Select Agent Registry (NSAR) at www.selectagents.gov.
(16) "Veterinarian" is defined by KRS 321.181(4).
Section 2. Notification Standards.
(1) Health professionals and health facilities.
(a) A health professional or a health facility shall give notification if:
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The health professional or a health facility makes a probable diagnosis of a disease specified in Section 3, 6, 7, 8, 9, 12, 16, 17, 18, or 19 of this administrative regulation; and
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The diagnosis is supported by:
a.
(i) Clinical or laboratory criteria; and
(ii) Case classifications published by the Centers for Disease Control and Prevention at https://ndc.services.cdc.gov/; or
b. A health professional's medical opinion that the disease is present.
(b) A single report by a health facility of a condition diagnosed by a test result from the health facility's laboratory shall constitute notification on behalf of the health facility and its laboratory.
(c) A health facility may designate an individual to report on behalf of the health facility's laboratory, pharmacy, and the health facility's other clinical entities.
(d) Notification shall be given to the Kentucky Department for Public Health or the local health department serving the county in which the patient resides, with the exception of conditions specified in Sections 16 and 17 of this administrative regulation which shall be reported directly to the Kentucky Department of Public Health.
(e) The reporting health professional or health facility shall submit:
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Information required in Section 5(6) of this administrative regulation; and
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Clinical, epidemiologic, and laboratory information pertinent to the disease including sources of specimens submitted for laboratory testing.
(2) Medical Laboratories.
(a) Any laboratory test result that indicates infection with an agent associated with one (1) or more of the diseases or conditions specified in Section 3, 6, 7, 8, 9, 12, 16, 17, 18, or 19 of this administrative regulation shall be reported by the medical laboratory to the Kentucky Department for Public Health or the local health department serving the county in which the patient resides.
(b) The reporting laboratory shall submit the information required in Section 5(6) of this administrative regulation.
(3) National Reference Laboratories.
(a) A test result performed by a national reference laboratory that indicates infection with an agent associated with one (1) or more of the diseases or conditions specified in Section 3, 6, 7, 8, 9, 12, 18, or 19 of this administrative regulation shall be reported by the director of a medical laboratory, a health facility, or the health professional that referred the test to the national reference laboratory to the Kentucky Department for Public Health or the local health department serving the county in which the patient resides.
(b) The report shall include the information required by Section 5(6) of this administrative regulation.
Section 3. Submission of Specimens and Isolates to the Kentucky Department for Public Health Division of Laboratory Services.
(1) A medical laboratory and a national reference laboratory in receipt of diagnostic specimens originating from the Commonwealth of Kentucky shall send direct specimens or pure clinical isolates for diseases established in subsection (5) of this section to the Division of Laboratory Services for primary or confirmatory testing and related studies.
(2) A medical laboratory or national reference laboratory using non-culture techniques to identify bacterial agents of diarrheal disease, such as enzyme immunoassays (EIAs) or molecular assays, shall attempt isolation of the etiologic agent identified. Pure clinical isolates shall be submitted to the Division of Laboratory Services.
(3) If the culture attempts do not produce a clinical isolate, the direct specimen, submitted in the appropriate preservative, shall be sent to the Division of Laboratory Services. A submitting laboratory shall provide the name of the etiologic agent detected by the non-culture technique at the time of specimen submission.
(4) A medical laboratory performing this test shall continue to follow the state's requirement for the submission of appropriate materials to the state public health laboratory.
(5) A medical or national reference laboratory shall submit pure isolates for the following organisms or, if not available, the direct specimen from the following diseases to the Division of Laboratory Services:
(a) Acute flaccid myelitis;
(b) Botulism, with prior approval from the Division of Epidemiology for testing;
(c) Brucella;
(d) Campylobacter;
(e) Candida auris;
(f) Carbapenem-resistant Acinetobacter;
(g) Carbapenem-resistant Enterobacterales;
(h) Carbapenem-resistant Pseudomonas;
(i) Cronobacter ssp, isolated from a sterile specimen site in a patient less than twelve (12) months of age;
(j) Diphtheria;
(k) Hemolytic Uremic Syndrome (HUS) – Post Diarrheal;
(l) Listeria monocytogenes;
(m) Measles;
(n) Mycobacterium tuberculosis (TB);
(o) Neisseria meningitidis, isolated from a sterile specimen site;
(p) Rabies, animal;
(q) Rubella;
(r) Salmonella;
(s) Salmonella typhi (Typhoid fever);
(t) Shiga toxin-producing Escherichia coli (STEC) or verotoxin-producing E.coli (VTEC) including E. coli O1457:H7;
(u) Shigellosis;
(v) Tularemia;
(w) Typhoid fever;
(x) Vancomycin-intermediate Staphylococcus aureus;
(y) Vancomycin-resistant Staphylococcus aureus;
(z) Vibrio species, including those that cause cholera and other disease;
(aa) Zika, with prior approval from the Division of Epidemiology for testing; and
(bb) Clinical samples and isolates necessary for assisting with a public health investigation upon request of the Division of Epidemiology.
(6) All direct specimens or clinical isolates from enteric disease shall be submitted within seventy-two (72) hours from collection.
Section 4. Laboratory Testing and Submission of Specimens to the Division of Laboratory Services for the Identification of M. tuberculosis.
(1) For the identification of M. tuberculosis, a medical laboratory or national reference laboratory shall perform AFB smear and culture, regardless of rapid molecular testing results (NAAT).
(2) Rapid molecular testing shall be performed for the identification of M. tuberculosis on:
(a) Any diagnostic specimen with an AFB smear positive result; or
(b) Any specimen that originates from an individual with clinical or epidemiological evidence suggesting active tuberculosis.
(3) If rapid molecular testing cannot be performed by the medical laboratory or national reference laboratory, the diagnostic specimen shall be sent to the Division of Laboratory Services.
(4) A medical laboratory or national reference laboratory that has a diagnostic specimen test positive for M. tuberculosis by rapid molecular testing shall send the remainder of that specimen to the Division of Laboratory Services.
(5) Any diagnostic specimen found to be positive for M. tuberculosis by rapid molecular testing or culture testing shall be reported in accordance with Section 7 of this administrative regulation.
Section 5. Reporting Classifications and Methods.
(1) Immediate reporting.
(a) A report required by Section 12(1) and (2) of this administrative regulation to be made immediately shall be:
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Made by telephone to the local health department serving the county in which the patient resides; and
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Followed up by electronic or fax submission to the local health department serving the county in which the patient resides within one (1) business day.
(b) Upon receipt of a report for a disease requiring immediate reporting, the local health department shall:
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Notify the Kentucky Department for Public Health by telephone; and
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Assist the department in carrying out a public health response.
(c) Weekend, evening, or holiday immediate notification. If local health department personnel cannot be contacted directly, notification shall be made by telephone using an emergency number provided by the local health department or the Kentucky Department for Public Health.
(d) For the protection of patient confidentiality, a report using the emergency number shall include:
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The name of the condition being reported; and
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A telephone number that can be used by the department to contact the reporting health professional or health facility.
(2) Urgent reporting.
(a) A report made within twenty-four (24) hours as required by Section 6 of this administrative regulation shall be:
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Submitted electronically, by fax, or by telephone to the local health department serving the county in which the patient resides; and
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If submitted by telephone, followed up by electronic or fax submission to the local health department serving the county in which the patient resides within one (1) business day.
(b) Upon receipt of a report for a disease requiring urgent reporting, the local health department shall:
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Notify the Kentucky Department for Public Health; and
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Assist the department in carrying out a public health response.
(c) Weekend, evening, or holiday urgent notification. If local health department personnel cannot be contacted directly, notification shall be made by telephone using an emergency number provided by the local health department or the Kentucky Department for Public Health.
(d) For the protection of patient confidentiality, notification using the emergency number shall include:
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The name of the condition being reported; and
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A telephone number that can be used by the department to contact the reporting health professional or health facility.
(3) Priority reporting.
(a) A report made within one (1) business day as required by Section 7, 11, 12(3), 17(4), or 18 of this administrative regulation shall be:
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Submitted electronically, by fax, or by telephone to the local health department serving the county in which the patient resides; and
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If submitted by telephone, followed up by electronic or fax submission of a report to the local health department serving the county in which the patient resides within one (1) business day.
(b) Upon receipt of a report for a disease requiring priority reporting, a local health department shall:
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Investigate the report and carry out public health protection measures; and
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Notify the Kentucky Department for Public Health of the case by electronic or fax submission within one (1) business day.
(c) The reporting health department may seek assistance in carrying out public health measures from the Kentucky Department for Public Health.
(4) Routine reporting.
(a) A report made within five (5) business days, as required by Section 8, 9, 10, 13(1), 16(1), 17(7), or 20(1) of this administrative regulation, shall be made electronically, by fax, or by mail to the Kentucky Department for Public Health or the local health department serving the county in which the patient resides, except for the conditions specified in Sections 16 and 17 of this administrative regulation which shall be reported directly to the Kentucky Department for Public Health.
(b) Upon receipt of a report of a disease or condition requiring routine reporting, the Kentucky Department for Public Health or the local health department shall:
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Make a record of the report;
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Answer inquiries or render assistance regarding the report if requested by the reporting entity; and
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Forward the report to the Kentucky Department for Public Health by electronic or fax submission of a report, or in writing within five (5) business days.
(5) General reporting. A report made within three (3) months, as required by Section 19 of this administrative regulation, shall be made electronically, by fax, or by mail.
(6) Reporting requirements.
(a) A report submitted by fax or by mail shall be made using one (1) of the following reporting forms:
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EPID 200, Kentucky Reportable Disease Form;
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EPID 250, Kentucky Reportable MDRO Form, to be used for priority reporting;
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EPID 394, Kentucky Reportable Disease Form, Hepatitis Infection in Pregnant Women or Child (HBV – aged two years or less & HCV – aged three years or less);
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EPID 399, Perinatal Hepatitis B Prevention Form for Exposed Infants and/or Hepatitis B Positive Pregnant Mothers;
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Adult HIV Confidential Case Report Form; or
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Pediatric HIV Confidential Case Report Form.
(b) Case reports may be made electronically through the Kentucky Health Information Exchange. Electronic case reports shall include the information required by paragraph (c) of this subsection.
(c) Information to be reported. Except as provided in subsections (1)(d) and (2)(d) of this section, a report required by this administrative regulation shall include:
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Patient name;
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Date of birth;
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Gender;
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Pregnancy status;
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Race;
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Ethnicity;
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Patient address;
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County of residence;
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Patient telephone number;
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Name of the reporting medical provider or facility;
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Address of the reporting medical provider or facility; and
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Telephone number of the reporting medical provider or facility.
(d) A reporting health professional shall submit the information listed in this subsection and Section 2(1)(f) of this administrative regulation.
Section 6. Notifiable Infectious Conditions Requiring Urgent Notification.
(1) Notification of the following pathogens or conditions shall be considered urgent and shall be made within twenty-four (24) hours:
(a) Anthrax;
(b) Botulism;
(c) Brucellosis (multiple cases, temporally or spatially clustered);
(d) Cronobacter ssp, invasive disease in an infant less than twelve (12) months of age;
(e) Diphtheria;
(f) Hepatitis A, acute;
(g) Measles;
(h) Melioidosis;
(i) Meningococcal infections;
(j) Middle East Respiratory Syndrome-associated Coronavirus (MERS-CoV) disease;
(k) Novel influenza A virus infections;
(l) Orthopox virus infection, including:
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Mpox;
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Smallpox; and
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Vaccinia;
(m) Plague;
(n) Poliomyelitis;
(o) Rabies, animal;
(p) Rabies, human;
(q) Rubella;
(r) Severe Acute Respiratory Syndrome-associated Coronavirus (SARS-CoV) disease;
(s) Tularemia;
(t) Viral hemorrhagic fevers due to:
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Crimean-Congo Hemorrhagic Fever virus;
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Ebola virus;
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Lassa virus;
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Lujo virus;
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Marburg virus; or
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New world arenaviruses including:
a. Guanarito virus;
b. Junin virus;
c. Machupo virus; and
d. Sabia virus; and
(u) Yellow fever.
(2)
(a) A laboratory shall report positive test results for Orthopox viral detection using Nucleic Acid Amplification Test (NAAT), including polymerase chain reaction (PCR).
(b) A laboratory may report negative and equivocal test results for Mpox viral detection using NAAT, including PCR.
Section 7. Notifiable Infectious Conditions and Notifiable Non-Infectious Conditions Requiring Priority Notification. Notification of the following diseases or conditions shall be considered priority and shall be made within one (1) business day:
(1) Arboviral diseases, neuroinvasive and non-neuroinvasive, including:
(a) California serogroup virus diseases, including diseases caused by:
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California encephalitis virus;
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Jamestown Canyon virus;
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Keystone virus;
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La Crosse virus;
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Snowshoe hare virus; and
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Trivittatus viruses;
(b) Chikungunya virus disease;
(c) Eastern equine encephalitis virus disease;
(d) Powassan virus disease;
(e) St. Louis encephalitis virus disease;
(f) Venezuelan equine encephalitis disease;
(g) West Nile virus disease;
(h) Western equine encephalitis virus disease; and
(i) Zika virus disease, non-congenital or congenital;
(2) Brucellosis (cases not temporally or spatially clustered);
(3) Campylobacteriosis;
(4) Carbon monoxide poisoning;
(5) Cholera;
(6) COVID-19 associated mortality in a patient who is:
(a) Less than eighteen (18) years of age; or
(b) Pregnant or postpartum (within three (3) months of delivery);
(7) Cryptosporidiosis;
(8) Cyclosporiasis;
(9) Dengue virus infections;
(10) Escherichia coli O157:H7;
(11) Foodborne disease outbreak;
(12) Free-living amoeba infections, including:
(a) Acanthamoeba disease;
(b) Acanthamoeba keratitis;
(c) Balamuthia mandrillaris; and
(d) Naegleria fowleri causing primary amebic meningoencephalitis (PAM);
(13) Giardiasis;
(14) Haemophilus influenzae invasive disease;
(15) Hansen's disease (leprosy);
(16) Hantavirus infection, non-Hantavirus pulmonary syndrome;
(17) Hantavirus pulmonary syndrome (HPS);
(18) Hemolytic uremic syndrome (HUS), post-diarrheal;
(19) Hepatitis B, acute;
(20) Hepatitis B infection in a pregnant woman;
(21) Hepatitis B infection in an infant or a child aged five (5) years or less;
(22) Newborns born to Hepatitis B positive mothers at the time of delivery;
(23) Influenza-associated mortality in a patient who is:
(a) Less than eighteen (18) years of age; or
(b) Pregnant or postpartum (within three (3) months of delivery);
(24) Legionellosis, including Pontiac Fever and extrapulmonary disease;
(25) Leptospirosis;
(26) Listeriosis;
(27) Mumps;
(28) Norovirus outbreak;
(29) Pertussis;
(30) Pesticide-related illness, acute;
(31) Psittacosis;
(32) Q fever;
(33) Respiratory Syncytial Virus (RSV)-associated mortality in a patient who is less than eighteen (18) years of age;
(34) Rubella, congenital syndrome;
(35) Salmonellosis;
(36) Shiga toxin-producing E. coli (STEC);
(37) Shigellosis;
(38) Streptococcal toxic-shock syndrome;
(39) Streptococcus pneumoniae, invasive disease (i.e., invasive pneumococcal disease);
(40) Tetanus;
(41) Toxic-shock syndrome (other than Streptococcal);
(42) Tuberculosis;
(43) Typhoid fever;
(44) Varicella;
(45) Vibriosis; and
(46) Waterborne disease outbreak.
Section 8. Notifiable Infectious Conditions and Notifiable Non-Infectious Conditions Requiring Routine Notification. Notification of the following diseases shall be considered routine and shall be made within five (5) business days:
(1) Acute Flaccid Myelitis;
(2) Alpha-gal syndrome;
(3) Anaplasmosis;
(4) Babesiosis;
(5) Coccidioidomycosis;
(6) Creutzfeldt-Jakob disease;
(7) Ehrlichiosis;
(8) Hepatitis C, acute;
(9) Hepatitis C infection in a pregnant woman;
(10) Hepatitis C infection in an infant or a child aged five (5) years or less;
(11) Newborns born to Hepatitis C positive mothers at the time of delivery;
(12) Histoplasmosis;
(13) Lead poisoning;
(14) Lyme Disease;
(15) Malaria;
(16) Multi-system Inflammatory Syndrome in Children (MIS-C);
(17) Spotted Fever Rickettsiosis (Rocky Mountain Spotted Fever);
(18) Toxoplasmosis; and
(19) Trichinellosis (Trichinosis).
Section 9. Notifiable Infectious Conditions Requiring Routine Notification by Electronic Laboratory Reporting.
(1) Notification of the following shall be considered routine and shall be electronically reported to the Kentucky Department for Public Health through the Kentucky Health Information Exchange within five (5) business days:
(a) Hepatitis B laboratory test results, which shall:
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Be reported as positive or negative; and
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Include the serum bilirubin levels or serum alanine aminotransferase taken within ten (10) days of the test of a patient who has tested positive;
(b) Hepatitis C laboratory test results, which shall:
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Be reported as positive or negative; and
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Include the serum bilirubin levels or serum alanine aminotransferase taken within ten (10) days of the test of a patient who has tested positive; or
(c) Laboratory-confirmed influenza, detected by:
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Reverse transcriptase polymerase chain reaction (RT PCR);
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Nucleic acid detection; or
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Viral culture;
(d) Laboratory-confirmed Respiratory Syncytial Virus (RSV), detected by Nucleic Acid Amplification Test (NAAT), including polymerase chain reaction (PCR);
(e) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2), detected by:
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Nucleic Acid Amplification Test (NAAT), including polymerase chain reaction (PCR); or
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SARS-CoV-2 molecular sequencing; or
(f) Varicella laboratory test results reported as positive for:
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Isolation of varicella virus from a clinical specimen;
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Varicella antigen detected by direct fluorescent antibody test; or
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Varicella-specific nucleic acid detected by polymerase chain reaction (PCR).
(2) Reports made pursuant to this section shall include a diagnosis.
Section 10. Multi-Drug Resistant Organisms and Other Organisms Requiring Routine Notification by Electronic Laboratory Reporting.
(1) Notification of the following diseases shall be considered routine and shall be electronically reported to the Kentucky Department for Public Health through the Kentucky Health Information Exchange within five (5) business days:
(a) Clostridioides (formerly Clostridium) difficile (C. difficile) identified from a positive laboratory test result for C. difficile toxin A or B (includes molecular assays {PCR} or toxin assays) or a toxin-producing organism detected by culture or other laboratory means performed on a stool sample;
(b) Enterobacterales species resistant to ceftazidime, ceftriaxone, or cefotaxime;
(c) Methicillin-resistant Staphylococcus aureus (MRSA), which includes S. aureus cultured from any specimen that tests oxacillin-resistant, cefoxitin-resistant, or methicillin-resistant by standard susceptibility testing methods, or by a laboratory test that is FDA-approved for MRSA detection from isolated colonies. These methods may also include a positive result by any FDA-approved test for MRSA detection; and
(d) Vancomycin-resistant Enterococcus species (VRE), only those identified to the species level, that are resistant to Vancomycin by standard susceptibility testing methods or by results from any FDA-approved test for VRE detection from specific specimen sources.
(2) The report of an organism under this section shall include the:
(a) Date of specimen collection;
(b) Source of specimen;
(c) Susceptibility pattern; and
(d) Name of the ordering health professional.
(3) Upon a test result performed by a medical laboratory that indicates infection with an agent associated with one (1) or more of the diseases or conditions or a multi-drug resistant organism specified in this section, the director of the medical laboratory shall electronically report the result to the Kentucky Department for Public Health through the Kentucky Health Information Exchange within five (5) days.
(4) The report shall include a diagnosis.
Section 11. Multi-drug Resistant Organisms and Other Organisms Requiring Priority Reporting by EPID 250 and by Electronic Laboratory Reporting to the Kentucky Department for Public Health through the Kentucky Health Information Exchange within One (1) Business Day. Notification of the following diseases shall be considered priority:
(1) Candida auris – Detection of Candida auris from any body site using either culture or a culture independent diagnostic test (for example, Polymerase Chain Reaction {PCR});
(2) Carbapenem-resistant – Acinetobacter – Any Acinetobacter species testing resistant to imipenem, meropenem, or doripenem, with minimum inhibitory concentration (MIC) value greater than or equal to eight (8) µg/mL by standard susceptibility testing methods, or by identification of a carbapenemase using a recognized test;
(3) Carbapenem-resistant Enterobacterales (CRE) – Any Enterobacterales species testing resistant to imipenem, meropenem, or doripenem, with MIC value greater than or equal to four (4) µg/mL, or ertapenem with MIC value greater than or equal to two (2) µg/mL, by standard susceptibility testing methods, or by identification of a carbapenemase using a recognized test, including identification of a carbapenemase during screening when a specific organisms is not isolated;
(4) Carbapenem-resistant – Pseudomonas – Any Pseudomonas species testing resistant to imipenem, meropenem, or doripenem, with MIC value greater than or equal to eight (8) µg/mL by standard susceptibility testing methods, or by identification of a carbapenemase using a recognized test, including identification of a carbapenemase during screening when a specific organism is not isolated;
(5) Vancomycin-intermediate Staphylococcus aureus (VISA), which includes S. aureus cultured from any specimen having a MIC of four (4) to eight (8) µg/mL for vancomycin per standard laboratory methods; and
(6) Vancomycin-resistant Staphylococcus aureus (VRSA), which includes S. aureus cultured from any specimen having a MIC of greater than or equal to sixteen (16) µg/mL for vancomycin per standard laboratory methods.
Section 12. Newly Recognized Infectious Agents, HAI Outbreaks, Emerging Pathogens, and Pathogens of Public Health Importance.
(1) The following shall be reported immediately by telephone to the Kentucky Department for Public Health:
(a) A suspected incidence of bioterrorism caused by a biological agent;
(b) Submission of a specimen to the Kentucky Division of Laboratory Services for select agent identification or select agent confirmation testing; or
(c) An outbreak of a disease or condition that resulted in multiple hospitalizations or death.
(2) An unexpected pattern of cases, suspected cases, or deaths that could indicate the following shall be reported immediately by telephone to the local health department in the county where the health professional is practicing or where the facility is located:
(a) A newly-recognized infectious agent;
(b) An outbreak;
(c) An emerging pathogen that may pose a danger to the health of the public;
(d) An epidemic; or
(e) A noninfectious chemical, biological, or radiological agent.
(3) A report of the following shall be considered priority and shall be reported to the local health department in the county where the health professional is practicing or where the facility is located within one (1) business day:
(a) Suspected Staphylococcal or other foodborne intoxication; or
(b) Salmonellosis or other foodborne or waterborne infection.
(4) The local health department shall:
(a) Investigate the outbreak or occurrence;
(b) Carry out public health protection measures to address the disease or condition involved; and
(c) Make medical and environmental recommendations to prevent future similar outbreaks or occurrences.
(5) The local health department may seek assistance from the Kentucky Department for Public Health.
Section 13. Laboratory Surveillance for Antimicrobial Resistance.Upon request by the Kentucky Department for Public Health, a health facility laboratory or a medical laboratory shall report the number of clinical isolates and information regarding the antimicrobial resistance patterns of the clinical isolates at intervals no less frequently than three (3) months for:
(1) Acinetobacter baumannii complex;
(2) Enterobacter cloacae complex;
(3) Enterococcus species;
(4) Escherichia coli;
(5) Klebsiella oxytoca;
(6) Klebsiella pneumoniae;
(7) Pseudomonas aeruginosa;
(8) Staphylococcus aureus; or
(9) An organism specified in a request that includes a justification of its public health importance.
Section 14. Healthcare-Associated Infection and Antimicrobial Use and Resistance Surveillance.
(1) A health facility in Kentucky that participates in Centers for Medicare and Medicaid Services (CMS) reporting programs shall confer rights to the Kentucky Department for Public Health to access health care-associated infection data and antimicrobial use and resistance data reported to NHSN.
(2) The Kentucky Department for Public Health shall preserve patient confidentiality and shall not disclose to the public any patient-level data obtained from any health care facility.
(3) The Kentucky Department for Public Health may issue reports to the public regarding healthcare-associated infections in aggregate data form that:
(a) May identify individual health care facilities; and
(b) Shall comply with methodology developed by the CDC and CMS for national reporting of health care-associated infections.
(4) The Kentucky Department for Public Health may evaluate healthcare-associated infection data for accuracy and completeness.
Section 15. Antimicrobial Use Reporting.
(1) A short-term acute-care, including critical access, hospital in Kentucky that participates in the CMS reporting programs shall report data on facility-wide inpatient antimicrobial use to the Kentucky Department for Public Health, Healthcare-Associated Infection/Antibiotic Resistance (HAI/AR) Prevention Program, on a quarterly basis.
(2) Reporting deadlines shall be two (2) months following the end of a quarter, e.g. for January to March (Quarter 1) the deadline would be May 31.
(3) The HAI/AR Prevention Program shall provide the specifications for data submission.
(4) Hospitals shall include aggregated antimicrobial use and patient day data for all inpatient units (facility-wide inpatient) included in the NHSN Laboratory-identified (LabID) MRSA Bacteremia reporting.
(5)
(a) The antimicrobial use numerator shall be days of therapy (DOTs) as defined by the NHSN Antimicrobial Use and Resistance (AUR) Module, available at https://www.cdc.gov/nhsn/pdfs/pscmanual/11pscaurcurrent.pdf.
(b) Refer to section 1. Antimicrobial Use (AU) Option, subsection Requirements (pages 3-8).
(6) Total DOTs shall be submitted for each of the following antimicrobials:
(a) Azithromycin;
(b) Cefepime;
(c) Ceftazidime;
(d) Ceftriaxone;
(e) Ciprofloxacin;
(f) Clindamycin;
(g) Daptomycin;
(h) Ertapenem;
(i) Imipenem;
(j) Levofloxacin;
(k) Linezolid;
(l) Meropenem;
(m) Piperacillin-tazobactam;
(n) Vancomycin; and
(o) An antimicrobial provided in the specifications for reporting that includes a justification of its public health importance.
(7) Total DOTs for the listed drugs shall include only administrations via the intravenous and digestive tract routes.
(8)
(a) The denominator for antimicrobial use reporting shall be patient days as defined by the NHSN LabID Module available at https://www.cdc.gov/nhsn/pdfs/pscmanual/12pscmdro_cdadcurrent.pdf.
(b) Refer to Appendix 2.
(9) A hospital that reports antimicrobial use data to the NHSN AUR Module shall meet this reporting requirement for a given year through NHSN reporting if the facility reports AUR data for the complete calendar year.
Section 16. Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) Surveillance.
(1) All cases diagnosed in Kentucky shall be submitted to the HIV/AIDS Surveillance Program of the Kentucky Department for Public Health, Division of Epidemiology and Health Planning, or its designee, within five (5) business days of diagnosis on one (1) of the following forms:
(a) Adult HIV Confidential Case Report Form, available at https://www.cdc.gov/hiv.pdf.guidelines/cdc-hiv-adult-case-report-form-2023.pdf; or
(b) Pediatric HIV Confidential Case Report Form, available at https://www.cdc.gov/hiv/pdf/guidelines/cdc-hiv-pediatric-case-report-form-2023.pdf.
(2) Health professionals and medical laboratories shall report:
(a) A positive test result for HIV, including tests with negative or indeterminate results that are part of a diagnostic testing algorithm whose overall interpretation is positive;
(b) All results from an initial false positive test with confirmed negative results;
(c) Results from:
-
Any HIV antibody test;
-
Any HIV antigen test;
-
Any HIV Ribonucleic acid (RNA) or Deoxyribonucleic acid (DNA) test;
-
CD4+ assay including absolute CD4+ cell counts and CD4+%;
-
HIV genetic sequencing; or
-
HIV culture; or
(d) A diagnosis of AIDS that meets the definition of AIDS established within the CDC guidelines.
(3) A negative HIV test, if available, shall be submitted with the report required by subsection (2) (a) or (b) of this section.
(4) Any request for data related to HIV infection or AIDS shall be made to the Department for Public Health, Division of Epidemiology and Health Planning.
(5) A case report for a person with an HIV infection without a diagnosis of AIDS, or HIV infection with a diagnosis of AIDS shall include the information required by Section 5(6)(c) of this administrative regulation, and:
(a) Risk factors as identified by CDC;
(b) Specimens collected;
(c) Date and type of HIV test performed using the format MMDDYYYY;
(d) Results of CD4+ cell counts and CD4+%;
(e) Results of viral load testing;
(f) Results of RNA, DNA, HIV culture, HIV antigen, and HIV antibody, if performed;
(g) Results of TB testing, if available;
(h) Any documented HIV negative test, if available;
(i) History of PrEP or PEP treatment, if available;
(j) Antiretroviral treatment, if available;
(k) HIV status of the person's partner, spouse, or children, as applicable;
(l) Opportunistic infections diagnosed; and
(m) Date of onset of illness.
(6) A report of pregnancy and delivery for a female diagnosed with HIV disease shall include:
(a) All HIV diagnostic testing and results associated with the determination of HIV status of the infant, including tests with negative or indeterminate results that are part of a diagnostic testing algorithm and if final result is negative; and
(b) Any HIV treatment prescribed to an infant.
(7) A report of AIDS shall be made whether or not the patient has been previously reported as having an HIV infection.
(8) If the patient has not been previously reported as having an HIV infection, the AIDS report shall also serve as the report of HIV.
Section 17. Sexually Transmitted Disease (STD).
(1) Notification of a probable diagnosis of an STD as specified in subsection (4) or (7) of this section shall be made.
(2) The report shall provide:
(a) Pregnancy status; and
(b) Clinical, epidemiologic, laboratory, and treatment information pertinent to the disease.
(3) Upon a laboratory test result that indicates infection with an agent associated with one (1) or more of the diseases or conditions specified in subsection (4) or (7) of this section, a medical laboratory shall report to the Kentucky Department for Public Health information required by Section 5(6)(c) of this administrative regulation.
(4) Sexually Transmitted Diseases Requiring Priority Notification. A report of the following shall be considered priority and shall be made within one (1) business day:
(a) Each pregnant female who has tested positive for syphilis regardless of stage; or
(b) Syphilis - primary, secondary, or early latent.
(5) Upon receipt of a report for a disease or condition specified in subsection (4) of this section, a local health department shall:
(a) Investigate the report;
(b) Carry out public health protection measures to address the disease or condition; and
(c) Forward the report to the Kentucky Department for Public Health within one (1) business day.
(6) The local health department may seek assistance from the Kentucky Department for Public Health.
(7) Sexually Transmitted Diseases Requiring Routine Notification. A report of the following shall be considered routine and shall be made within five (5) business days:
(a) Chancroid;
(b) Chlamydia trachomatis infection;
(c) Gonorrhea;
(d) Granuloma inguinale;
(e) Lymphogranuloma venereum; or
(f) Syphilis, other than primary, secondary, early latent, or congenital.
(8) Upon receipt of a report for a disease or condition specified in subsection (7) of this section, a local health department shall:
(a) Make a record of the report using Form EPID 200, Kentucky Reportable Disease Form;
(b) Forward the report to the Kentucky Department for Public Health within five (5) business days; and
(c) Render assistance if requested by the reporting entity or the Kentucky Department for Public Health.
Section 18. Tuberculosis.
(1) A pharmacist shall give notice if two (2) or more of the following medications used for the initial treatment of active tuberculosis are dispensed to an inpatient in a health facility or to an ambulatory patient in a health facility or a pharmacy:
(a) Ethambutol;
(b) Isoniazid;
(c) Pyrazinamide; and
(d) Rifampin or rifabutin.
(2)
(a) A report of tuberculosis shall be considered priority and shall be reported to the local health department serving the county in which the patient resides.
(b) If the local health department cannot be reached, notification shall be given to the Kentucky Department for Public Health.
(3) The report shall include:
(a) Information required in Section 5(6)(c) of this administrative regulation; and
(b) Names of the medications dispensed.
Section 19. Asbestosis, Pneumoconiosis, and Silicosis.
(1) A health professional shall report a diagnosis of the following to the Kentucky Department for Public Health within three (3) months of diagnosis:
(a) Asbestosis;
(b) Pneumoconiosis, including coal worker's pneumoconiosis; or
(c) Silicosis.
(2) A report required under this section shall include the information required in Section 5(6)(c) of this administrative regulation.
Section 20. Reporting of Communicable Diseases in Animals.
(1) A diagnosis in an animal of a condition known to be communicable to humans, except for rabies, shall require routine notification.
(2) A veterinarian shall report the diagnosis within five (5) business days to the local health department serving the county in which the animal is located.
(3) If a laboratory test indicates infection of an animal with an agent associated with a condition known to be communicable to humans, the director of a medical laboratory shall report the result to the local health department serving the county in which the animal is located within five (5) business days.
(4) The local health department receiving the report shall:
(a) Investigate the report;
(b) Carry out public health protection measures for the control of communicable diseases; and
(c) Forward the report to the Kentucky Department for Public Health within five (5) business days.
(5) The local health department may seek assistance from the Kentucky Department for Public Health.
Section 21. Kentucky Public Health Advisory.
(1) If the secretary of the Cabinet for Health and Family Services or the commissioner of the Department for Public Health determines that a disease not presently listed in this administrative regulation requires reporting, the secretary or commissioner shall issue a Kentucky public health advisory.
(2) The Kentucky public health advisory shall include:
(a) Date and time the advisory is issued;
(b) A unique number to identify the advisory;
(c) Names for the disease or condition;
(d) A description of the disease or condition;
(e) Recommendations for health professionals, health facilities, and laboratories; and
(f) Notification requirements including:
-
The notification time interval; and
-
Methods for notification.
(3) The duty to report by health professionals, health facilities, and laboratories pursuant to a Kentucky public health advisory shall begin upon receipt of the advisory and shall remain in effect until the advisory is rescinded by order of the secretary or the commissioner.
Section 22. Penalty. If the cabinet has cause to believe that a physician willfully neglects or refuses to notify the cabinet in accordance with this administrative regulation, pursuant to KRS 214.990(1) the cabinet shall make a referral to the appropriate professional licensing board.
Section 23. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "EPID 200, Kentucky Reportable Disease Form", 7/2024;
(b) "EPID 250, Kentucky Reportable MDRO Form", 7/2024;
(c) "EPID 394, Kentucky Reportable Disease Form, Hepatitis Infection in Pregnant Women or Child (HBV – aged two years or less & HCV – aged three years or less), 7/2024; and
(d) "EPID 399, Perinatal Hepatitis B Prevention Form for Exposed Infants and Hepatitis B Positive Pregnant Mothers", 7/2024.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and available online at https://chfs.ky.gov/agencies/dph/dehp/idb/Pages/default.aspx.
History
- RELATES TO: KRS 214.625(5)(c)5, 214.645, 214.990(1), 215.520, 216B.015, 258.065, 258.990, 311.282, 311.571, 315.010, 321.181(4), 333.020, 333.130
- STATUTORY AUTHORITY: KRS 194A.050, 211.090(3), 211.180(1)(a), 214.010
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180(1)(a) authorizes the cabinet to implement a statewide program for the detection, prevention, and control of communicable diseases, chronic and degenerative diseases, dental diseases and abnormalities, occupational diseases and health hazards peculiar to industry, home accidents and health hazards, animal diseases that are transmissible to humans, and other diseases and health hazards that can be controlled. KRS 214.010 requires every physician and advanced practice registered nurse to notify the local health department of the existence of diseases and conditions designated by administrative regulation of the cabinet. This administrative regulation establishes notification standards and specifies the diseases requiring immediate, urgent, priority, routine, or general notification, in order to facilitate rapid public health action to control diseases and to permit an accurate assessment of the health status of the commonwealth.
- History: CDS-2; 1 Ky.R. 187; eff. 12-11-1974; Am. 2 Ky.R. 464; eff. 4-14-1976; 11 Ky.R. 1518; 1786; eff. 6-4-1985; 16 Ky.R. 663; 1185; eff. 11-29-1989; 21 Ky.R. 128; eff. 8-17-1994; 23 Ky.R. 3119; 3597; 4131; eff. 6-16-1997; 27 Ky.R. 1099; 1489; eff. 12-21-2000; 29 Ky.R. 812; 1273; eff. 10-16-2002; 31 Ky.R. 873; eff. 1-4-2005; 41 Ky.R. 1213; 1674; eff. 2-26-2015; 43 Ky.R. 122, 568; eff, 11-16-2016; 47 Ky.R. 200, 1039; eff. 12-15-2020; 48 Ky.R. 1389; eff. 1-13-2022; 48 Ky.R. 3063; 49 Ky.R 830; eff. 11-15-2022; 51 Ky.R. 795; eff. 2-5-2025.
902 KAR 2:030 Inspections and control procedures {#sec-902-kar-2-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:030}
Section 1. Community Control Procedures.
(1) Inspections. Authorized local health department or Cabinet for Human Resources personnel shall inspect any premises that they have reasonable grounds to believe are in a condition conducive to the spread of any communicable disease.
(2) Control procedures. Local health departments or the Cabinet for Human Resources shall:
(a) Make or cause to be made such investigations as may be necessary for the purpose of securing data regarding clinical diagnosis, reservoir, and time, place and source of infection and contacts.
(b) Establish and maintain quarantine, isolation or other measures as required by law or by administrative regulations of the Cabinet for Human Resources relating to communicable disease control.
(c) Provide, or cause to be provided, for the instruction of persons affected and their attendants in the proper methods of such concurrent and terminal disinfection as may be required by the Cabinet for Human Resources or local board of health having jurisdiction.
(d) Afford all contacts of persons suffering from those diseases for which there is a reliable and approved means of immunization the opportunity to be immunized.
(e) Make inquiry or investigation to see that control measures are being properly observed during the period of communicability.
(f) Introduce such other measures, not inconsistent with law or the administrative regulations of the Cabinet for Human Resources and the local board of health having jurisdiction, as are necessary because of widespread infection or threatened epidemic.
(3) Uncertain diagnosis. Whenever a case of unrecognized illness shall be reported to, or otherwise brought to the attention of the local health department or Cabinet for Human Resources which upon investigation presents symptoms of a communicable disease but in which sufficient time has not elapsed to render a positive diagnosis, the local health department or the Cabinet for Human Resources may establish the control measures applicable in actual cases of the suspected communicable disease, until such time as a positive diagnosis can be established. If the disease proves to be noncommunicable the temporary control measures shall be terminated at once.
Section 2. Control Procedures by Attending Physician.
(1) Isolation by attending physician. It shall be the duty of every physician, immediately upon discovering a case or suspected case of any communicable disease, for which isolation procedures are specified, to secure such isolation of the patient as will minimize the possibility of spread of the disease.
(2) Submission of laboratory specimens. It shall be the duty of each and every physician who shall be in attendance on any person having or reasonably suspected as having any of the diseases specified as reportable, to submit suitable specimens to a laboratory approved by the Cabinet for Human Resources for examination, when such examination is deemed necessary by local health department or Cabinet for Human Resources authorities, for investigation or control of such disease.
Section 3. Isolation of Persons in Institutions. Every institution which provides for care or treatment of the ill shall be provided with at least one (1) isolation ward or room so related to the rest of the building as to make proper isolation therein practicable.
History
- RELATES TO: KRS 211.180, 214.010, 214.020
- STATUTORY AUTHORITY: KRS 195.040, 211.090
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 mandates the Cabinet for Human Resources to implement a statewide program for the detection, prevention and control of communicable diseases. This administrative regulation insures delineation of authority and responsibility for proper investigation and control of communicable diseases throughout the Commonwealth.
- History: 902 KAR 002:030. CDS-3; 1 Ky.R. 187; eff. 12-11-1974; Crt eff. 10-18-2019; Crt eff.5-14-2026.
902 KAR 2:040 Syndromic surveillance {#sec-902-kar-2-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:040}
Section 1. Definitions.
(1) "Admit reason" means the primary reason a patient has presented and is admitted for healthcare.
(2) "Chief complaint" means a concise statement describing the symptoms, problems, health conditions, diagnoses, or other factors that are the reason for the patient encounter.
(3) "Completeness" means the full, detailed data gathered or measured during the patient encounter that is submitted in the correct HL7 messaging segment or position that can be parsed to one of the Centers for Disease Control and Prevention's National Syndromic Surveillance Program (NSSP) Priority 1, Priority 2, or Priority 3 data elements.
(4) "Diagnosis code" means the combination of numbers and letters that reference a certain medical condition, medical procedure, symptom, or disease that is submitted as valid International Classification of Disease-Clinical Modification or Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) codes with the parsed corresponding code description.
(5) "Discharge disposition" means the patient's final destination upon leaving the health facility.
(6) "Encounter" means an interaction between a patient and healthcare provider to provide healthcare service or assess the health status of a patient.
(7) "Facility type" means the type of healthcare services primarily provided by a specific healthcare provider, such as emergency, inpatient, outpatient, urgent care, primary care, or medical specialty.
(8) "Health facility" is defined by KRS 216B.015(13).
(9) "Health professional" means a professional licensed under KRS Chapters 311 through 314.
(10) "HL7 messaging" means the message format that provides a framework for the management, integration, exchange, and retrieval of electronic information across different healthcare systems.
(11) "ICD-CM code" means International Classification of Disease – Clinical Modification that healthcare professionals use to classify and code all diagnoses, symptoms, and procedures for claims processing.
(12) "Kentucky Health Information Exchange" or "KHIE" means the secure network that ensures interoperability among healthcare providers across the commonwealth.
(13) "Medical record number" or "MRN" means the person-level identifier assigned to the patient by the facility that shall:
(a) Not be changed during the encounter; and
(b) Remain consistent across multiple encounters by the same patient at the same facility.
(14) "Patient class" means the level of resources needed to provide healthcare during a given patient encounter, such as direct admit, emergency, inpatient, observation patient, obstetrics, outpatient, preadmit, or recurring patient.
(15) "Patient class code" means the type and manner of admission method that describes the patient interaction with the healthcare facility or provider. Acceptable, valid codes shall be E (emergency), I (inpatient), O (outpatient), B (obstetrics), P (preadmit), or R (recurring patient).
(16) "Syndromic surveillance" means the electronic public health surveillance system that aggregates de-identified healthcare information about patients' demographic information, symptoms, diagnoses, and other healthcare encounter-level data to assess healthcare utilization patterns and trends to identify potential imminent threats to public health in near real-time.
(17) "Systematized Nomenclature of Medicine-Clinical Terms" or "SNOMED-CT" means the standardized, international, multilingual core set of clinical healthcare terminology codes used in electronic health records to supplement ICD-CM diagnosis codes.
(18) "Timeliness" means an initial encounter message level data is submitted and received within forty-eight (48) hours of when the patient encounter occurred.
(19) "Validity" means the use of informative and contextually appropriate free-text strings and proper usage of applicable syndromic surveillance code value sets available within the Centers for Disease Control and Prevention's Public Health Information Network Vocabulary Access and Distribution System (PHIN VADS).
(20) "Visit ID" means the unique numerical identifier assigned by each hospital or healthcare provider to identify each specific patient encounter.
Section 2. Required Reporting. The following data elements shall be reported to the cabinet via KHIE within forty-eight (48) hours of each patient encounter:
(1) Name, which shall be reported separately, in the following format:
(a) First name;
(b) Middle name; and
(c) Last name;
(2) Date of birth in MM/DD/YYYY format with time of birth and age in units;
(3) Gender;
(4) Race;
(5) Ethnicity;
(6) County of residence;
(7) Zip code of residence, except for post office box (P.O. Box) zip codes, which shall not be submitted;
(8) Medical record number (MRN);
(9) MRN assigning authority;
(10) Date and time of the actual patient encounter, which shall not be updated or altered in subsequent HL7 messaging updates for that patient encounter;
(11) Facility identification, including facility type;
(12) Admit reason, including a description with date and time of admission;
(13) Patient type;
(14) Patient class code;
(15) Chief complaint, which shall not include non-chief complaint related information, such as screening questionnaires;
(16) Diagnosis code, which shall be:
(a) A valid ICD-CM code;
(b) A valid SNOMED-CT code with the corresponding diagnosis description and ICD-CM codes; and
(c) Submitted in the diagnosis code field;
(17) Discharge disposition including date and time of discharge;
(18) Death indicator, if applicable, including date and time of death;
(19) Visit ID - A new unique visit ID shall be assigned to the same patient, regardless of transfer status or changes to patient class or patient class code during that patient encounter; and
(20) Pregnancy status, if applicable.
Section 3. Data Submission.
(1) Health professionals and health facilities shall:
(a) Complete the electronic onboarding performed by the Kentucky Health Information Exchange (KHIE);
(b) Work directly with KHIE to establish an active, secure, electronic connection; and
(c) Actively participate with KHIE onboarding staff for ongoing data quality improvement.
(2)
(a) If the active connection required by subsection (1)(b) of this section is lost or an error in connection occurs, the health professional or health facility shall notify KHIE within one (1) business day and:
(b) Any backlog in data submission that results during a lost or errored connection shall be submitted when the connection is re-established.
(3) Syndromic surveillance data shall be submitted in accordance with Centers for Disease Control and Prevention timeliness standards.
(4) Healthcare encounter data submitted shall include all required data elements listed in Section 2 of this administrative regulation. Only required data elements shall be considered during assessments of data quality completeness and validity measures.
(5) Data transmitted to KHIE shall be deidentified and routed to state and national syndromic surveillance platforms on behalf of the submitting healthcare organization.[
History
- RELATES TO: KRS 216B.015, Chapters 311 - 314
- STATUTORY AUTHORITY: KRS 211.180, 214.010
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 requires the Cabinet for Health and Family Services to implement a statewide program for the surveillance, detection, prevention, and control of communicable diseases, chronic diseases, and injuries. KRS 214.010 requires every physician, advanced practice registered nurse, and every head of family to notify the local health department of the existence of diseases and conditions designated by administrative regulation of the cabinet. This administrative regulation ensures that selected individuals and groups who serve as potential sources of certain communicable diseases are under proper medical surveillance in order to prevent outbreaks of these diseases among their contacts.
- History: CDS-4; 1 Ky.R. 188; eff. 12-11-1974; 16 Ky.R. 665; 1187; eff. 11-29-1989; Crt eff. 10-18-2019; 51 Ky.R. 804, 1288; eff. 2-5-2025.
902 KAR 2:050 Control procedures; application {#sec-902-kar-2-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:050}
Section 1. Property. Whenever any private or public property has been implicated as a possible reservoir or possible source of infection of any communicable disease, the local health department or the Cabinet for Human Resources shall take such measures as are necessary to secure adequate cleaning, disinfection, or other control procedures necessary to insure cessation of transmission.
Section 2. Persons. Whenever any person has been implicated as a possible reservoir or possible source of infection of any communicable disease, the local health department or the Cabinet for Human Resources shall employ such measures as are necessary to secure adequate isolation, restriction of employment or other control procedures that may be necessary to insure cessation of transmission of infection.
Section 3. Corpses. Whenever any corpse has been implicated as a possible reservoir or possible source of infection of any communicable disease, the local health department or the Cabinet for Human Resources shall take such measures as are necessary to insure cessation of transmission of infection.
Section 4. Animals. Whenever any wild or domestic animal or animal population has been implicated as a possible reservoir or possible source of infection of any disease which is communicable to humans, the local health department or the Cabinet for Human Resources shall take such measures as are necessary to insure cessation of transmission of infection.
History
- RELATES TO: KRS 211.180, 214.020
- STATUTORY AUTHORITY: KRS 195.040, 211.090
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 mandates the Cabinet for Human Resources to implement a statewide program for the detection, prevention and control of communicable diseases. This regulation insures the application of control procedures necessary to prevent transmission of communicable diseases after the sources of infection are identified.
- History: 902 KAR 002:050. CDS-5; 1 Ky.R. 188; eff. 12-11-1974; Crt eff. 10-18-2019; Crt eff. 5-14-2026.
902 KAR 2:055 Immunization data reporting and exchange {#sec-902-kar-2-055 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:055}
Section 1. Definitions.
(1) "Public health immunization reporting entity" means a:
(a) Health care provider;
(b) Health insurer;
(c) Public or private kindergarten, elementary, or secondary school;
(d) Childcare facility;
(e) Preschool;
(f) Public or private postsecondary educational institution; or
(g) State or local health department.
(2) "Public health interest" means core public health functions of:
(a) Surveillance;
(b) Data collection;
(c) Vaccination;
(d) Vaccination certification;
(e) Prevention of communicable diseases for the protection of the public's health and safety; and
(f) Outbreak investigation.
Section 2. Immunization Reporting.
(1) Kindergartens and public and private elementary and secondary schools shall submit to the local health department in their area immunization results for:
(a) Kindergarten;
(b) Seventh grade;
(c) Eleventh grade; and
(d) Twelfth grade only for the first twelve (12) months after the effective date of this administrative regulation..
(2) The annual survey shall include the number of:
(a) Students in the grade surveyed;
(b) Missing immunization records;
(c) Religious exemptions declinations;
(d) Medical exemptions;
(e) Children who have received age-appropriate immunizations; and
(f) Vaccine-specific exemptions.
(3) All immunization reporting for the annual school survey shall be submitted using an electronic reporting system provided by the Kentucky Department for Public Health.
Section 3. Immunization Data Exchange.
(1) A public health immunization reporting entity may record and exchange immunization data if the person requesting the data provides health related or educational services on behalf of the patient or has a public health interest in accordance with 45 C.F.R. 164.512(b)(i).
(2) Immunization data may be recorded and exchanged electronically via an immunization registry.
(3) Immunization data that may be recorded and exchanged may include:
(a) Patient's name;
(b) Patient's address;
(c) Date of birth;
(d) Sex;
(e) Social Security number;
(f) Medicaid number;
(g) Birth state;
(h) Birth County;
(i) Mother's name;
(j) Mother's maiden name;
(k) Mother's date of birth;
(l) Mother's Social Security number;
(m) Father's name;
(n) Father's date of birth;
(o) Father's Social Security number;
(p) Guardian's name;
(q) Date vaccines were administered;
(r) Vaccine type;
(s) Vaccine lot number;
(t) Vaccine manufacturer;
(u) Vaccine contraindications or adverse reaction indications; and
(v) Vaccine-specific exemptions.
(4) This section shall apply to immunization data regardless of when the immunizations occurred or the medium used to collect and exchange the data.
History
- RELATES TO: KRS 158.035, 158.037, 211.090(3), 45 C.F.R. 164.512(b)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(a) and (e), 214.034, 214.036
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 requires the Cabinet for Health and Family Services to implement a statewide program for the detection, prevention and control of communicable diseases. KRS 214.034 requires public or private primary or secondary schools, day-care centers, certified family child-care homes, or any other licensed facility which cares for children to maintain a current immunization certificate on file for each child in attendance, unless exempted by KRS 214.036. This administrative regulation establishes requirements for reporting immunization results in schools by the public health immunization reporting entity and permits recording and exchange of immunization data.
- History: 30 Ky.R. 1990; Am. 2309; eff. 5-24-2004; 41 Ky.R. 637; 1072; eff. 11-19-2014; 44 Ky.R. 2695; 45 Ky.R. 350; eff. 8-31-2018; Crt eff. 4-23-2025.
902 KAR 2:060 Immunization schedules for attending child day care centers, certified family child care homes, other licensed facilities which care for children, preschool programs, and public and private primary and secondary schools {#sec-902-kar-2-060 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:060}
Section 1. Definitions.
(1) "Advanced practice registered nurse" or "APRN" means a nurse designated to engage in advanced registered nursing as defined in KRS 314.011.
(2) "Advisory Committee on Immunization Practices" or "ACIP" means the United States Department of Health and Human Services (HHS) Committee that makes national immunization recommendations to the Secretary of the HHS, the Assistant Secretary for Health, and the Director of the Centers for Disease Control and Prevention or CDC.
(3) "Child" means a person less than eighteen (18) years of age.
(4) "Commonwealth of Kentucky Parent or Guardian's Declination on Religious Grounds to Required Immunizations" means an original, written, sworn, and notarized statement of a parent or guardian's objection to medical immunization against disease of a child on religious grounds.
(5) "Dose" means a measured quantity of vaccine, specified in the package insert provided by the manufacturer.
(6) "DT" means diphtheria and tetanus toxoids.
(7) "DTaP" means diphtheria and tetanus toxoids and acellular pertussis vaccine.
(8) "DTP" means diphtheria and tetanus toxoids and pertussis vaccine.
(9) "Healthcare provider" means a person licensed under KRS 311.530 to 311.620, 311.840 to 311.862, and a nurse designated to engage in advanced practice registered nursing as defined in KRS 314.011 and 314.042.
(10) "HepA" means hepatitis A vaccine.
(11) "HepB" means hepatitis B vaccine.
(12) "Hib" means Haemophilus influenzae type b conjugate vaccine.
(13) "IPV" means inactivated poliovirus vaccine.
(14) "MenACWY" means serogroups A, C, W, and Y meningococcal conjugate vaccine.
(15) "MMR" means measles, mumps, and rubella virus vaccine.24)
(16) "OPV" means trivalent oral poliovirus vaccine.
(17) "PCV" means pneumococcal conjugate vaccine.
(18) "Pharmacist" means a person licensed under KRS 315.002 to 315.050.
(19) "Physician assistant" means a person licensed under KRS 311.840 to 311.862.
(20) "Td" means tetanus and diphtheria toxoids for adult use.
(21) "Tdap" means tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine.
(22) "Varicella" means varicella vaccine.
(23) "Varicella immunity (non-vaccine)" means:
(a) Diagnosis of varicella disease by a healthcare provider;
(b) Verification of a history of varicella disease by a healthcare provider;
(c) Diagnosis of herpes zoster by a healthcare provider; or
(d) Verification of a history of herpes zoster by a healthcare provider.
Section 2. Immunization Schedules. Except as provided in Section 3 of this administrative regulation:
(1) A current Commonwealth of Kentucky Certificate of Immunization Status shall be required to attend a:
(a) Child day care center, beginning at age three (3) months;
(b) Certified family child care home, beginning at age three (3) months;
(c) Licensed facility that cares for children, beginning at age three (3) months;
(d) Preschool program; or
(e) Public or private primary or secondary school.
(2) A current Commonwealth of Kentucky Certificate of Immunization Status shall be required for a child that is otherwise homeschooled in order to attend one (1) or more in-school classes or to participate in sports or any school-sponsored extra-curricular activities.
(3) A Commonwealth of Kentucky Certificate of Immunization Status of a child shall be considered current for age-appropriate vaccines if the child is:
(a) At least aged three (3) months and less than five (5) months and has received at least:
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One (1) dose of DTaP or DTP;
-
One (1) dose of IPV or OPV;
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One (1) dose of Hib;
-
One (1) dose of HepB; and
-
One (1) dose of PCV;
(b) At least aged five (5) months and less than seven (7) months and has received at least:
-
Two (2) doses of DTaP or DTP or combinations of the two (2) vaccines;
-
Two (2) doses of IPV or OPV or combinations of the two (2) vaccines;
-
Two (2) doses of Hib;
-
Two (2) doses of HepB; and
-
Two (2) doses of PCV;
(c) At least aged seven (7) months and less than twelve (12) months and has received at least:
-
Three (3) doses of DTaP or DTP or combinations or the two (2) vaccines;
-
Two (2) doses of IPV or OPV or combinations of the two (2) vaccines;
-
Two (2) doses of Hib;
-
Two (2) doses of HepB; and
a. Three (3) doses of PCV; or
b. Two (2) doses of PCV if the first dose was received when aged seven (7) months through eleven (11) months;
(d) At least aged twelve (12) months and less than sixteen (16) months and has received at least:
-
Three (3) doses of DTaP or DTP or combinations of the two (2) vaccines;
-
Two (2) doses of IPV or OPV or combinations of the two (2) vaccines;
a. Three (3) doses of Hib;
b. Two (2) doses of Hib if the first dose was received when aged seven (7) months through eleven (11) months;
c. One (1) dose of Hib if the first dose was received when aged twelve (12) months through fourteen (14) months; or
d. One (1) dose of Hib if the first dose was received when aged fifteen (15) months;
-
One (1) dose of HepA;
-
Two (2) doses of HepB; and
a. Four (4) doses of PCV with one (1) dose when aged twelve (12) months through fifteen (15) months;
b. Three (3) doses of PCV if the first dose was received when aged seven (7) months through eleven (11) months, with at least one (1) dose received when aged twelve (12) months through fifteen (15) months; or
c. Two (2) doses of PCV if the first dose was received when aged twelve (12) months through fifteen (15) months;
(e) At least aged sixteen (16) months and less than nineteen (19) months and has received at least:
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Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines;
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Two (2) doses of IPV or OPV or combinations of the two (2) vaccines;
a. Four (4) doses of Hib;
b. Three (3) doses of Hib if the first dose was received before aged twelve (12) months, and the second dose was received when younger than aged fifteen (15) months;
c. Two (2) doses of Hib if the first dose was received when aged twelve (12) months through fourteen (14) months; or
d. One (1) dose of Hib if the first dose was received when aged fifteen (15) months through eighteen (18) months;
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One (1) dose of HepA;
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Two (2) doses of HepB;
a. Four (4) doses of PCV with one (1) dose when aged twelve (12) months through eighteen (18) months;
b. Three (3) doses of PCV if the first dose was received when aged seven (7) months through eleven (11) months, with at least one dose when aged twelve (12) months through eighteen (18) months; or
c. Two (2) doses of PCV if the first dose was received when aged twelve (12) months through eighteen (18) months;
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One (1) dose of MMR; and
a. One (1) dose of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine);
(f) At least aged nineteen (19) months and less than forty-eight (48) months and has received at least:
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Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines;
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Three (3) doses of IPV or OPV or combinations of the two (2) vaccines:
a. Four (4) doses of Hib;
b. Three (3) doses of Hib if the first dose was received before aged twelve (12) months, and the second dose was received when younger than aged fifteen (15) months;
c. Two (2) doses of Hib if the first dose was received when aged twelve (12) months through fourteen (14) months; or
d. One (1) dose of Hib if the first dose was received when aged fifteen (15) months through forty-seven (47) months;
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Two (2) doses of HepA;
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Three (3) doses of HepB;
a. Four (4) doses of PCV with one (1) dose when aged twelve (12) months through fifteen (15) months;
b. Three (3) doses of PCV if the first dose was received when aged seven (7) months through eleven (11) months, with at least one (1) dose when aged twelve (12) months through forty-seven (47) months;
c. Two (2) doses of PCV if the first dose was received when aged twelve (12) months through twenty-three (23) months; or
d. One (1) dose of PCV if the first dose was received when aged twenty-four (24) months through forty-seven (47) months;
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One (1) dose of MMR; and
a. One (1) dose of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine);
(g) At least aged forty-eight (48) months and less than five (5) years and has received at least:
-
Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines;
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Three (3) doses of IPV or OPV or combinations of the two (2) vaccines;
a. Four (4) doses of Hib;
b. Three (3) doses of Hib if the first dose was received before aged twelve (12) months, and the second dose was received when younger than aged fifteen (15) months;
c. Two (2) doses of Hib if the first dose was received when aged twelve (12) months through fourteen (14) months; or
d. One (1) dose of Hib if the first dose was received when aged fifteen (15) months through fifty-nine (59) months;
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Two (2) doses of HepA;
-
Three (3) doses of HepB;
a. Four (4) doses of PCV with one (1) dose when aged twelve (12) months through fifteen (15) months;
b. Three (3) doses of PCV if the first dose was received when aged seven (7) months through eleven (11) months, with at least one (1) dose when aged twelve (12) months through fifty-nine (59) months;
c. Two (2) doses of PCV if the first dose was received when aged twelve (12) months through twenty-three (23) months; or
d. One (1) dose of PCV if the first dose was received when aged twenty-four (24) months through fifty-nine (59) months;
-
Two (2) doses of MMR; and
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine);
(h) At least aged five (5) years and less than seven (7) years and has received at least:
a. Five (5) doses of DTaP or DTP or combinations of the two (2) vaccines; or
b. Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines if the fourth dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
a. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines with the fourth dose received when aged four (4) years through six (6) years and at least six (6) months after the previous dose;
b. Four (4) or more doses of IPV or OPV or combinations of the two (2) vaccines received before age four (4) years and an additional dose received when aged four (4) years through six (6) years and at least six (6) months after the previous dose; or
c. Three (3) doses of IPV or OPV or combinations of the two (2) vaccines if the third dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
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Two (2) doses of HepA;
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Three (3) doses of HepB;
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Two (2) doses of MMR; and
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine);
(i) At least aged seven (7) years and less than eleven (11) years and has received at least:
a. Five (5) doses of DTaP or DTP or combinations of the two (2) vaccines;
b. Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines if the fourth dose was received when aged four (4) years or older and at least six (6) months after the previous dose; or
c. A dose of Td that was preceded by two (2) doses of DTaP, DTP, DT, or Td or combinations of the four (4) vaccines;
a. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines with the fourth dose received when aged four (4) years or older and at least six (6) months after the previous dose;
b. Four (4) or more doses of IPV or OPV or combinations of the two (2) vaccines received before age four (4) years and an additional dose received when aged four (4) years or older and at least six (6) months after the previous dose;
c. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines if the fourth dose was received before August 7, 2009, with all doses separated by at least four (4) weeks; or
d. Three (3) doses of IPV or OPV or combinations of the two (2) vaccines if the third dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
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Two (2) doses of HepA;
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Three (3) doses of HepB;
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Two (2) doses of MMR; and
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine);
(j) At least aged eleven (11) years and less than thirteen (13) years and has received at least:
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One (1) dose of Tdap;
a. Five (5) doses of DTaP or DTP or combinations of the two (2) vaccines;
b. Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines if the fourth dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
c. A dose of Td that was preceded by two (2) doses of DTaP, DTP, DT, or Td or combinations of the four (4) vaccines; or
d. Two (2) doses of Td after the dose of Tdap;
a. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines with the fourth dose received when aged four (4) years and older and at least six (6) months after the previous dose;
b. Four (4) or more doses of IPV or OPV or combinations of the two (2) vaccines received before age four (4) years and an additional dose received when aged four (4) years or older and at least six (6) months after the previous dose;
c. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines if the fourth dose was received before August 7, 2009, with all doses separated by at least four (4) weeks; or
d. Three (3) doses of IPV or OPV or combinations of the two (2) vaccines if the third dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
-
Two (2) doses of HepA;
a. Three (3) doses of HepB; or
b. Two (2) doses of adult HepB approved by the FDA to be used for an alternative schedule for adolescents aged eleven (11) years through fifteen (15) years;
-
Two (2) doses of MMR;
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine); and
- One (1) dose of MenACWY;
(k) At least aged thirteen (13) years and less than sixteen (16) years and has received at least:
-
One (1) dose of Tdap;
a. Five (5) doses of DTaP or DTP or combinations of the two (2) vaccines;
b. Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines if the fourth dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
c. A dose of Td that was preceded by two (2) doses of DTaP, DTP, DT, or Td or combinations of the four (4) vaccines; or
d. Two (2) doses of Td after the dose of Tdap;
a. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines with the fourth dose received when aged four (4) years or older and at least six (6) months after the previous dose;
b. Four (4) or more doses of IPV or OPV or combinations of the two (2) vaccines received before age four (4) years and an additional dose received when aged four (4) years or older and at least six (6) months after the previous dose;
c. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines if the fourth dose was received before August 7, 2009, with all doses separated by at least four (4) weeks; or
d. Three (3) doses of IPV or OPV or combinations of the two (2) vaccines if the third dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
-
Two (2) doses of HepA;
a. Three (3) doses of HepB; or
b. Two (2) doses of adult HepB approved by the FDA to be used for an alternative schedule for adolescents aged eleven (11) through fifteen (15) years;
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Two (2) doses of MMR;
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine); and
- One (1) dose of MenACWY;
(l) At least aged sixteen (16) years or older and has received at least:
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One (1) dose of Tdap;
a. Five (5) doses of DTaP or DTP or combinations of the two (2) vaccines;
b. Four (4) doses of DTaP or DTP or combinations of the two (2) vaccines if the fourth dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
c. A dose of Td that was preceded by two (2) doses of DTaP, DTP, DT, or Td or combinations of the four (4) vaccines; or
d. Two (2) doses of Td after the dose of Tdap;
a. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines with the fourth dose received when aged four (4) years and older and at least six (6) months after the previous dose;
b. Four (4) or more doses of IPV or OPV or combinations of the two (2) vaccines received before age four (4) years and an additional dose received when aged four (4) years or older and at least six (6) months after the previous dose;
c. Four (4) doses of IPV or OPV or combinations of the two (2) vaccines if the fourth dose was received before August 7, 2009, with all doses separated by at least four (4) weeks; or
d. Three (3) doses of IPV or OPV or combinations of the two (2) vaccines if the third dose was received when aged four (4) years or older and at least six (6) months after the previous dose;
-
Two (2) doses of HepA;
a. Three (3) doses of HepB; or
b. Two (2) doses of adult HepB approved by the FDA to be used for an alternative schedule for adolescents aged eleven (11) years through fifteen (15) years;
-
Two (2) doses of MMR;
a. Two (2) doses of Varicella; or
b. A diagnosis or verification from a healthcare provider that the child has varicella immunity (non-vaccine); and
a. Two (2) doses of MenACWY; or
b. One (1) dose of MenACWY if that dose was received at age sixteen (16) years or older.
(4) Immunizations shall be received in accordance with the minimum ages and intervals between doses recommended by the ACIP. Partial, split, half, or fractionated doses or quantities shall not be administered and shall not be counted as a valid dose.
Section 3. Exceptions and Exemptions to the Required Immunization Schedules in Section 2.
(1) If the first two (2) doses of Hib vaccine were meningococcal group B outer membrane protein (PRP-OMP) vaccines, the third dose may be omitted.
(2) A child with a medical contraindication to pertussis vaccine may be given DT in lieu of DTaP or Td in lieu of Tdap.
(3)
(a) If both IPV and OPV were administered as part of a series, a total of four (4) doses shall be administered.
(b) If only OPV was administered, and all doses were received prior to four (4) years of age, one (1) dose of IPV shall be administered when aged four (4) years or older and at least four (4) weeks after the last OPV dose.
(4) A child aged seven (7) years or older may receive one (1) dose of Tdap in the catch-up series if the child is not fully immunized with DTaP vaccine.
(5) A Commonwealth of Kentucky Certificate of Immunization Status marked to designate a medical exemption shall be issued for a child with a temporary or permanent medical contraindication to receiving a vaccine.
(6)
(a) If an immunization is administered but another is objected to on religious grounds, a healthcare provider, pharmacist, local health department, or other licensed healthcare facility administering immunizations:
-
May request that a parent or guardian complete the Commonwealth of Kentucky Parent or Guardian's Declination on Religious Grounds to Required Immunizations form to be submitted upon enrollment in a child care facility or school;
-
Shall issue a Commonwealth of Kentucky Certificate of Immunization Status marked to designate "religious objection" to the requirements of Section 2 of this administrative regulation, in compliance with KRS 214.036; and
-
Shall list administered immunizations on the Commonwealth of Kentucky Certificate of Immunization Status.
(b) An EPID 230A form, Commonwealth of Kentucky Parent or Guardian's Declination on Religious Grounds to Required Immunizations, shall:
-
Be valid for the requirements of Section 2 of this administrative regulation;
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List the immunizations that a parent or guardian objects to being administered to a child based on religious grounds;
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Be an original document written, sworn, and signed before a notary public; and
-
Be submitted at the time of enrollment in a child care facility or school.
(7) A Commonwealth of Kentucky Certificate of Immunization Status marked to designate "Provisional Status" shall:
(a) Be issued for a child who is behind in required immunizations listed in Section 2 of this administrative regulation;
(b) Be issued for a child who has received at least one (1) dose of each of the required vaccines but has not completed all the required immunizations;
(c) Permit a child to attend a child day care center, certified family child care home, licensed facility which cares for children, preschool program, or primary or secondary school until the child reaches the appropriate age or upon passage of the time interval between required doses;
(d) Expire:
-
Fourteen (14) days from the date the next dose is required to be given for school use; or
-
Thirty (30) days from the date the next dose is required to be given for use in a day care center, certified family child-care home, or other licensed facility which cares for children; and
(e) Not be valid for more than one (1) year.
Section 4. Commonwealth of Kentucky Certificate of Immunization Status.
(1) A Commonwealth of Kentucky Certificate of Immunization Status shall be issued by:
(a) A physician licensed in any state;
(b) An advanced practice registered nurse licensed in any state;
(c) A physician assistant licensed in Kentucky;
(d) A pharmacist licensed in Kentucky;
(e) A local health department in Kentucky;
(f) A licensed healthcare facility administering immunizations in Kentucky; or
(g) An authorized user of the Kentucky Immunization Registry.
(2) Signatures on the Commonwealth of Kentucky Certificate of Immunization Status shall:
(a) Contain the printed name;
(b) Be in ink or an electronic signature;
(c) Be dated; and
(d) Be that of:
-
A physician;
-
An advanced practice registered nurse;
-
A physician assistant;
-
A pharmacist;
-
The local health department administrator; or
-
A registered nurse or licensed practical nurse designee of a physician, local health department administrator, or other licensed healthcare facility.
(3) A Commonwealth of Kentucky Certificate of Immunization Status printed from the Kentucky Immunization Registry shall not require a signature.
(4) A healthcare provider, pharmacist, local health department, or other licensed healthcare facility administering immunizations may obtain a blank hard copy of the following from the Cabinet for Health and Family Services:
(a) Commonwealth of Kentucky Certificate of Immunization Status; and
(b) Commonwealth of Kentucky Parent or Guardian's Declination on Religious Grounds to Required Immunizations.
(5) The Commonwealth of Kentucky Certificate of Immunization Status shall:
(a) Be on a hard copy provided by the Cabinet for Health and Family Services; or
(b) Be a copy electronically produced in the size, orientation, and format printed by:
-
A Kentucky medical provider's electronic medical record system;
-
A local health department's electronic medical record system;
-
A Kentucky licensed healthcare facility administering immunizations electronic medical record system; or
-
The Kentucky Immunization Registry.
(6) An electronically produced copy of a Commonwealth of Kentucky Certificate of Immunization Status shall contain at least the following information:
(a) The name of the child;
(b) The birthdate of the child;
(c) The name of the parent or guardian of the child;
(d) The address of the child, including street, city, state, and ZIP Code;
(e) The type(s) of vaccine(s) administered to the child;
(f) The date that each dose of each vaccine was administered;
(g) Certification that the child is current for immunizations until a specified date, including a statement that the certificate shall not be valid after the specified date;
(h) The printed name, ink or electronic signature, and date as described in subsection (2) of this section; and
(i) The name, address, and telephone number of the healthcare provider practice, pharmacy, local health department, or licensed health care facility issuing the certificate.
(7) A signed certificate or a certificate printed from the Kentucky Immunization Registry may be faxed from a medical office to a:
(a) Medical office;
(b) Healthcare facility;
(c) Child care facility;
(d) School; or
(e) State or local health department.
(8) All immunizations required by Section 2 of this administrative regulation and received by a child shall be included on the Commonwealth of Kentucky Certificate of Immunization Status.
(9) All ACIP recommended immunizations a child has received in addition to the immunizations required by Section 2 of this administrative regulation may be included on the Commonwealth of Kentucky Certificate of Immunization Status.
(10) A completed Commonwealth of Kentucky Certificate of Immunization Status shall be:
(a) On file for a child:
- Cared for in a:
a. Child day care center;
b. Certified family child care home; or
c. Licensed facility that cares for children; or
- Enrolled in a:
a. Preschool program;
b. Public or private primary or secondary school; or
c. Preschool program or a public or private primary or secondary school for all in-school classes or to participate in sports or any school sponsored extra-curricular activities if the child is otherwise homeschooled; and
(b) Available for inspection and review by a representative of the Cabinet for Health and Family Services or a representative of a local health department.
Section 5. Out-of-State Certificate of Immunization Status
(1) An Out-of-State Certificate of Immunization Status shall be accepted when completed by an out-of-state physician or advanced practice registered nurse.
(2) The out-of-state certificate shall contain at least the following information:
(a) The name of the child;
(b) The birthdate of the child;
(c) The name of the parent or guardian of the child;
(d) The address of the child, including street, city, state, and ZIP Code;
(e) The type(s) of vaccine(s) administered to the child;
(f) The date that each dose of each vaccine was administered;
(g) All age appropriate immunizations required in Kentucky as identified in Section 2(3) of this administrative regulation;
(h) Certification that the child is current for immunizations until a specified date, including a statement that the certificate shall not be valid after the specified date;
(i) A printed name, ink or electronic signature, and date as described in Section 4(2) of this administrative regulation; and
(j) The name, address, and telephone number of the healthcare provider practice, local health department, or licensed health care facility issuing the certificate.
(3) The Out-of-State Certificate of Immunization Status may be in the size, orientation, and format required by another state.
(4) Immunizations documented on an out-of-state certificate shall be transferred to a hard copy of a Commonwealth of Kentucky Certificate of Immunization Status or shall be documented on an electronically produced Commonwealth of Kentucky Certificate of Immunization Status when one (1) or more immunizations are administered in Kentucky.
Section 6. Review of Immunization Status.
(1) A current Commonwealth of Kentucky Certificate of Immunization Status or an Out-of-State Certificate of Immunization Status for a child shall be provided by a parent or guardian:
(a) Upon enrollment in a:
-
Child day care center;
-
Certified family child care home;
-
Licensed facility that cares for a child; or
-
School at:
a. Kindergarten entry;
b. Seventh grade entry;
c. Eleventh grade entry;
d. Twelfth grade entry for the first twelve (12) months this administrative regulation is effective; and
e. New enrollment at any grade resulting from a transfer to:
(i) Kentucky from another state;
(ii) Kentucky from a country outside the United States; or
(iii) A school from another school within Kentucky;
(b) Upon legal name change; or
(c) At a school required examination pursuant to 702 KAR 1:160.
(2) Upon review of a Commonwealth of Kentucky Certificate of Immunization Status or an Out-of-State Certificate of Immunization Status:
(a) A child whose certificate has exceeded the date for the certificate to be valid shall be recommended to visit the child's medical provider or local health department to receive immunizations required by this administrative regulation; and
(b) An updated and current certificate shall be provided to the:
-
Day care center, certified family child care home, or other licensed facility that cares for children by a parent or guardian within thirty (30) days from when the certificate was found be invalid; or
-
School by a parent or guardian within fourteen (14) days from when the certificate was found to be invalid.
(3) A Commonwealth of Kentucky Certificate of Immunization Status or an Out-of-State Certificate of Immunization Status for a child or group of children shall be reviewed upon request of a local health department as part of controlling an outbreak of a vaccine preventable disease.
Section 7. Effective Date. For all child day cares, certified family child care homes, other licensed facilities which care for children, preschool programs, and public or private primary and secondary schools:
(1) This administrative regulation, except for Section 2, shall become effective for the school year beginning on or after July 1, 2017; and
(2) Section 2 of this administrative regulation shall become effective for the school year beginning on or after July 1, 2018.
Section 8. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) Form "EPID 230, Commonwealth of Kentucky Certificate of Immunization Status", 1/2017; and
(b) Form "EPID 230A, Commonwealth of Kentucky Parent or Guardian's Declination on Religious Grounds to Required Immunizations", 6/2017.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 158.035, 211.090, 211.220, 214.032-214.036
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1)(a), (e), 214.034(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050 requires the secretary for the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.190(3) requires the secretary to promulgate administrative regulations necessary to regulate and control all matters set forth in KRS 211.180. KRS 214.034(1) requires the cabinet to promulgate administrative regulations to establish immunization schedules. This administrative regulation establishes the mandatory immunization schedule for attendance at child day care centers, certified family child care homes, other licensed facilities which care for children, preschool programs, and public and private primary and secondary schools.
- History: CDS-6; 1 Ky.R. 188; Am. 460; eff. 3-12-75; 3 Ky.R. 162; eff. 9-1-76; 785; 4 Ky.R. 114; eff. 8-3-1977; 5 Ky.R. 933; eff. 7-17-1979; 16 Ky.R. 666; 1187; eff. 11-29-1989; 23 Ky.R. 2628; 2997; eff. 1-15-1997; 27 Ky.R. 1351; 2160; eff. 2-1-2001; 29 Ky.R. 1097; 1613; eff. 12-18-2002; 37 Ky.R. 1101; Am. 1442; eff. 12-15-2010; 43 Ky.R. 1454, 1989, 2143; eff. 6-21-2017; Cert. eff. 8-10-2023.
902 KAR 2:065 Immunization requirements for long-term care facilities {#sec-902-kar-2-065 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:065}
Section 1. Definitions.
(1) "Advisory Committee on Immunization Practices" or "ACIP" means the United States Department of Health and Human Services (HHS) Committee that makes national immunization recommendations to the Secretary of HHS, the Assistant Secretary for Health, and the Director of the Centers for Disease Control and Prevention (CDC).
(2) "Department" is defined by KRS 209.550(2).
(3) "Employee" is defined by KRS 209.550(4).
(4) "If vaccine is available" means that a sufficient supply of vaccine has been produced by vaccine manufacturers and is available for purchase and shipment.
(5) "Influenza" means an acute viral infection of the respiratory tract:
(a) Caused by an influenza virus;
(b) Confirmed by:
-
Viral culture;
-
Polymerase chain reaction (PCR);
-
Nucleic acid detection testing; or
-
Rapid influenza diagnostic testing (RIDT); and
(c) Characterized by the sudden onset of a group of signs and symptoms such as fever, headache, myalgia, coryza, sore throat, and a dry cough.
(6) "Influenza-like illness" or "ILI" means, in the absence of a known cause, other than influenza, an illness in which a person experiences:
(a) Fever greater than or equal to 100 degrees Fahrenheit or thirty seven and eight-tenths (37.8) degrees Celsius, as confirmed through oral or equivalent methods;
(b) Cough;
(c) Sore throat; or
(d) Cough and sore throat.
(7) "Influenza vaccine" means a vaccine licensed by the Food and Drug Administration for the prevention of influenza.
(8) "Immunize" means to vaccinate.
(9) "Long-term care facility" is defined by KRS 209.550(6).
(10) "Medically indicated" means a vaccine is recommended by the ACIP for a person:
(a) Who has not been immunized against a disease; and
(b) For whom vaccination is recommended based on:
-
The age of the person;
-
A preexisting medical condition that may cause the person to be at risk; or
-
An occupation of the person that may put others at risk of contracting the disease.
(11) "Outbreak" means two (2) or more cases of influenza, or ILI, occurring in a single long-term care facility during a seventy-two (72) hour period.
(12) "Pneumococcal disease" means a bacterial infection usually involving the lungs producing inflammation caused by Streptococcus pneumoniae, the bacteria commonly referred to as "pneumococcus".
(13) "Pneumococcal vaccine" means a vaccine licensed by the Food and Drug Administration for the prevention of pneumococcus.
Section 2. Vaccine Availability.
(1) If vaccine is available, a long-term care facility shall:
(a) Obtain a sufficient quantity of influenza and pneumococcal vaccine to immunize each employee and resident of a facility for whom the vaccine is medically indicated; or
(b) Enter into an agreement with a local health department or other health care provider to obtain or administer influenza and pneumococcal vaccine to each employee and resident of a facility for whom the vaccine is medically indicated and age-appropriate.
(2) A long-term care facility may charge a third party, a resident, or an employee for the cost of the:
(a) Vaccine; and
(b) Administration of the vaccine.
Section 3. Immunization Schedule for Residents.
(1) A long-term care facility shall have an infection prevention and control plan in compliance with 42 C.F.R. 483.80.
(2) Influenza immunization shall be offered to each resident in compliance with 42. C.F.R. 483.80(d)(1).
(3) Pneumococcal immunization shall be offered to each resident in compliance with 42 C.F.R. 483.80(d)(2).
Section 4. Immunization for Employees.
(1) A long-term care facility shall request that each employee agree to be vaccinated on an annual schedule against influenza when the vaccine is:
(a) Available;
(b) Medically indicated; and
(c) Age-appropriate.
(2) A long-term care facility shall request that each employee agree to be vaccinated against pneumococcal disease if the vaccine is:
(a) Available;
(b) Medically indicated; and
(c) Age-appropriate.
(3) If a long-term care facility is located within a larger facility, such as a hospital, the provisions of this administrative regulation shall apply to every employee of the larger facility who may also work in the long-term care facility on a full-time, part-time, or contractual basis.
Section 5. Health Records.
(1) A long-term care facility shall maintain an immunization health record for each employee and resident that shall document:
(a) The immunization status of the employee or resident for influenza virus and pneumococcal disease;
(b) The date that the employee or resident received counseling on the risks and benefits of the vaccines;
(c) The date the employee or resident was requested to be immunized against influenza virus and pneumococcal disease; and
(d) The date the employee or resident was vaccinated against each disease.
(2) If after being advised of the risks and benefits of the vaccine, an employee, resident, or legal guardian of a resident refuses to be vaccinated, as provided in KRS 209.552(5), a long-term care facility shall document in the health record:
(a) The date each vaccine was offered;
(b) Each vaccine that was not administered; and
(c) The reason each vaccine was refused.
Section 6. Reporting.
(1) Upon recognition of an outbreak of ILI, a long-term care facility shall report the outbreak within twenty four (24) hours, by telephone, facsimile, or e-mail to:
(a) The local health department having jurisdiction; or
(b) The department.
(2) Upon receipt of a report of an outbreak from a long-term care facility, a local health department shall:
(a) Immediately notify the department; and
(b) Assist the department in carrying out a public health response as instructed.
(3) Within one (1) week of reporting an outbreak of ILI, a long-term care facility shall submit a completed EPID 200, Kentucky Reportable Disease Form, incorporated by reference in 902 KAR 2:020, for each affected employee or resident to:
(a) The local health department having jurisdiction; or
(b) The department.
(4) Upon notification of an outbreak of ILI, the local health department having jurisdiction or the department shall contact the long-term care facility to make recommendations for appropriate confirmation of the etiology of illness and intervention.
(5) The department shall maintain a database of confirmed occurrences of influenza occurring in long-term care facilities.
(6) All long-term care facilities shall report the seasonal immunization survey utilizing an electronic reporting system provided by the department.
Section 7. Educational Literature. The department shall provide each licensed long-term care facility with access to the most current vaccine information statements for influenza and pneumococcal disease as published by the CDC.
History
- RELATES TO: KRS 209.550, 209.552, 211.090, 211.180, 214.010, 216.510, 216.515, 216.530, 42 C.F.R. 483.80
- STATUTORY AUTHORITY: KRS 209.554(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 209.554(1) requires the Cabinet for Health and Family Services, Department for Public Health to promulgate administrative regulations to implement provisions of KRS 209.550 to KRS 209.554 relating to immunization of residents and employees of long-term care facilities against influenza and pneumococcal disease. This administrative regulation establishes requirements for long-term care facilities to request that residents and employees agree to be vaccinated against influenza and pneumococcal disease, to provide vaccine for the residents and employees or to make a referral for vaccination, to maintain annual documentation of immunizations, and to report outbreaks of influenza-like illnesses.
- History: 29 Ky.R. 1448; 1818; eff. 1-15-2003; 46 Ky.R. 2334, 2952; eff. 7-29-2020.
902 KAR 2:070 Rabies control {#sec-902-kar-2-070 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:070}
Section 1. Brands and Types of Approved Vaccine. All brands and types of antirabies vaccine approved by the United States Department of Agriculture and administered in accordance with the manufacturers' instructions shall be approved vaccines for the purpose of this administrative regulation.
Section 2. Vaccination Schedule. The vaccination schedule for all dogs, cats, and ferrets shall be as established in this section.
(1)
(a) Except as provided by paragraph (b) of this subsection, all dogs, cats, and ferrets shall be vaccinated against rabies by a veterinarian holding a valid Kentucky license.
(b) An individual permitted under Section 7 of this administrative regulation may vaccinate a dog owned by that individual.
(2) A dog, cat, or ferret initially vaccinated shall be revaccinated one (1) year after the initial vaccination regardless of the type of vaccine used or age of the animal at the time of vaccination.
(3) After the vaccination required by subsection (2) of this section, the period of time required for revaccination shall be dependent upon the type of vaccine administered and the next vaccination due by date as documented on the vaccination certificate.
(4) The current revaccination recommendations of the National Association of State Public Health Veterinarians, Inc. may be utilized in determining expiration dates of vaccines.
Section 3. Vaccination Certificates. A vaccination certificate shall provide the information found on the National Association of State Public Health Veterinarians NASPHV Form 51, Rabies Vaccination Certificate. Certificate information shall either be:
(1) Handwritten on a reproduction of the NASPHV Form51; or
(2) Computer generated.
Section 4. Dogs, Cats, and Ferrets Brought into State.
(1) Each dog, cat, or ferret brought into Kentucky shall be vaccinated in accordance with KRS 258.035.
(2) Reciprocity with other states shall be granted if the vaccine is approved by the U.S. Department of Agriculture and administered by a veterinarian licensed in that state.
Section 5. Animals Suspected of Being Infected by Rabies.
(1) An animal suspected of being infected by rabies shall be quarantined in accordance with KRS 258.085.
(2) An animal ordered for quarantine in accordance with KRS 258.085(1)(a) shall be quarantined in a manner that limits the animal's exposure to humans or other animals.
(3) If a dog, cat, or ferret is ordered to be destroyed and tested for rabies pursuant to KRS 258.085(1)(b), it shall be killed in a manner as to preserve the brain intact. The animal shall not be shot or clubbed in the head. A wild animal suspected of rabies shall be sacrificed and its head submitted to the laboratory immediately.
Section 6. Sending Heads of Ownerless Animals to the Laboratory. If the ownership of a rabies suspect animal is unknown, the expense of forwarding the head of the animal to the laboratory shall be borne by the local health department.
Section 7. Rabies Vaccination Permits for Owners of Dogs.
(1) The Cabinet for Health and Family Services shall issue a permit to an owner of a dog to vaccinate a dog owned by that individual upon satisfactory passage of an examination prescribed by the cabinet.
(2) An individual seeking an initial permit to vaccinate a dog owned by that individual shall:
(a) Register with the state public health veterinarian by September 30;
(b) Attend the instructional course on rabies, epidemiology, laws, and vaccine administration; and
(c) Pass the written examination with a score of seventy (70) percent or higher.
(3) The course required by subsection (2)(b) of this section shall be provided annually in Frankfort at no charge to the participant.
(4) The Cabinet for Health and Family Services shall revoke any permit issued under this administrative regulation upon finding that the permittee had vaccinated a dog not owned by the permittee.
(5)
(a) A permit holder shall renew the permit between January 1 and February 28 each year unless the permit has been suspended, revoked, or cancelled.
(b) A permit shall be renewed by:
-
Returning the Renew Qualified Person Form provided with the certificate of approval to administer a rabies vaccination; or
-
Contacting the state public health veterinarian by phone or email to request renewal.
(c) Failure to renew between January 1 and February 28 of each year shall result in permit cancellation.
(6) Upon transfer of ownership, a dog vaccinated for rabies by a qualified person shall be revaccinated by:
(a) A licensed veterinarian; or
(b) The new owner if that individual is also a qualified person.
Section 8. Local Health Department Operating a Mass Rabies Vaccination Clinic.
(1) A local health department may sponsor a countywide rabies vaccination clinic per year for the purpose of vaccinating dogs, cats, and ferrets.
(2) At least one (1) Kentucky licensed veterinarian shall be available on-site during the rabies clinic to:
(a) Provide the initial vaccine to a dog, cat, or ferret in accordance with Section 2 of this administrative regulation;
(b)
-
Provide a three (3) year vaccine booster to a dog or cat with proof of previous rabies vaccination; and
-
Provide a one (1) year vaccine booster to a ferret with proof of previous rabies vaccination; and
(c) Be available to provide medical care if an adverse vaccine event occurs.
(3) An owner shall not be charged more than ten (10) dollars for each vaccination given.
Section 9. Incorporation by Reference.
(1) The following material is incorporated by reference.
(a) National Association of State Public Health Veterinarians, NASPHV Form51, "Rabies Vaccination Certificate," 2007; and
(b) "Renew Qualified Person Form" 3/2019.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8:00 a.m. to 4:30 p.m., and is available from the Centers for Disease Control and Prevention at https://www.cdc.gov/rabies/resources/publications/.
History
- RELATES TO: KRS 258.005, 258.015, 258.035, 258.043, 258.085, 258.990(1), (2)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180, 258.015, 258.043, 258.075
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 258.075 authorizes the secretary to administer the provisions of KRS 258.005 to 258.087 through the local health departments and to promulgate administrative regulations necessary to effectuate a statewide rabies control program. KRS 258.015 requires the cabinet to approve a vaccination certificate form. KRS 258.043 authorizes a local health department to sponsor a mass rabies immunization clinic and to establish a reasonable fee to be charged to the owner of each dog, cat, or ferret vaccinated to help defray the cost of the clinic. This administrative regulation establishes uniform procedures for the diagnosis, prevention, and control of rabies, and for operating a mass rabies clinic.
- History: 902 KAR 002:070. CDS-7-1; 1 Ky.R. 188; eff. 12-11-74; Am. 5 Ky.R. 262; eff. 11-1-1978; 31 Ky.R. 630; 945; eff. 11-17-2004; 45 Ky.R. 3560, 46 Ky.R. 476; eff. 9-9-2019; Crt eff. 5-14-2026.
902 KAR 2:080 Sexually transmitted diseases {#sec-902-kar-2-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:080}
Section 1. Definitions.
(1) "Certified or Accredited laboratory" means a laboratory that has been:
(a) Issued a laboratory license from the state of Kentucky; or
(b) Evaluated and certified or accredited by one (1) of the following regulatory agencies:
-
The Joint Commission;
-
The College of American Pathologists (CAP);
-
The Centers for Medicare and Medicaid Services (CMS); or
-
The Commission on Office Laboratory Accreditation (COLA).
(2) "Certified or approved serology test" means the Venereal Disease Research Laboratory Slide Test (VDRL) or rapid plasma reagin (RPR) 18 mm circle card test or other Food and Drug Administration (FDA) approved test performed in accordance with the directions of the manufacturer.
(3) "Midlevel health care practitioner" means a health care professional who meets the requirements of KRS 216.925(1).
(4) "Reasonably suspected of being infected with a sexually transmitted disease" means any person named in a controlled interview with a second person infected with an STD, as a sexual contact of that second person within the incubation period for the STD, or who has a laboratory test result consistent with an STD infection.
(5) "Sexually transmitted diseases" or "STD" means syphilis, gonorrhea, chancroid, granuloma inguinale, genital herpes, human immunodeficiency virus (HIV) infection, nongonococcal urethritis, mucopurulent cervicitis, chlamydia trachomatis infections including lymphogranuloma venereum, and human papillomavirus (HPV).
(6) "Sexually transmitted diseases for which a treatment exists to render them noninfectious" means syphilis, gonorrhea, chancroid, granuloma inguinale, nongonococcal urethritis, mucopurulent cervicitis and Chlamydia trachomatis infections including lymphogranuloma venereum.
Section 2. Medical Examination and Treatment of Sexually Transmitted Diseases for Which a Treatment Exists to Render them Noninfectious.
(1) Any person infected with, or reasonably suspected of being infected with, a sexually transmitted disease shall undergo such medical examination as is necessary, including such laboratory testing procedures deemed advisable by the examining physician to reasonably determine the existence or nonexistence of the diagnosed or suspected sexually transmitted disease.
(2) If there is the potential that the person is incubating the disease, he shall undergo such treatment or follow-up as may be determined adequate by the examining physician to render the person noninfectious or to prevent the onset of disease.
(3) This section shall apply only to sexually transmitted diseases as defined by Section 1(4) of this administrative regulation.
Section 3. Investigation and Enforcement.
(1) Only authorized personnel of the Cabinet for Health and Family Services and local health departments assigned to sexually transmitted disease control activities are empowered to carry out the prevention and control provisions set forth in this administrative regulation.
(2) Their duties shall include the investigation of persons known to be or reasonably suspected of being infected with a sexually transmitted disease.
(3) Such authorized personnel are empowered to direct that medical examinations, including laboratory tests, be conducted on persons reasonably suspected of having a sexually transmitted disease.
(4) This section shall apply only to sexually transmitted diseases as defined by Section 1(4) of this administrative regulation.
Section 4. Certified or Accredited Laboratories for Tests.
(1) The laboratory shall hold certification or accreditation for performing tests for syphilis, in compliance with KRS 214.160.
(2) The laboratory shall have as its director a physician licensed to practice medicine in Kentucky or a person who meets the requirements set forth in 902 KAR 11:030, Sections 1(4)(f) or 1(6).
(3) A certified or accredited laboratory shall maintain performance that meets the requirements of the Clinical Laboratory Improvement Amendments (CLIA), 42 U.S.C. 263(a), or the laboratory's certifying or accrediting body regulations for syphilis and other sexually transmitted disease testing.
(4) All certified or accredited laboratories shall fully comply with all state and federal laws, including 42 U.S.C. 263a, and the rules and administrative regulations of the Cabinet for Health and Family Services.
Section 5. Requirements for Reporting STD to Public Health.
(1) Midlevel health care practitioners and physicians shall report STD cases as set forth in 902 KAR 2:020.
(a) Cases shall be reported to the local health department or the Division of Epidemiology, Department for Public Health using the form EPID 200, Kentucky Reportable Disease Form, prepared and furnished by the Cabinet for Health and Family Services or a computer-generated facsimile with the same data fields listed.
(b) Midlevel health care practitioners shall report cases of primary, secondary, early latent, and congenital syphilis not later than twenty-four (24) hours after diagnosis.
(c) Cases of other types of syphilis or other reportable STD shall be reported within five (5) business days after diagnosis.
(2) Hospitals and institutions may conduct their own testing program within the institution or through a licensed medical laboratory.
(a) Hospitals and institutions that conduct their own testing program or contract with a licensed medical laboratory shall report positive test results within twenty-four (24) hours of testing to the attending physician or health care provider and shall report positive test results for primary, secondary, early latent, and congenital syphilis to the local health department or the Division of Epidemiology, Department for Public Health not later than twenty-four (24) hours after being processed by the laboratory.
(b) Positive test results for other types of syphilis and other STD should be reported to the local health department or Division of Epidemiology, Department for Public Health within five (5) business days.
(c) The obligation of hospitals and institutions that may conduct their own testing program within the institution or through a medical laboratory to report positive/reactive STD tests shall not supersede these reporting requirements for physicians or other midlevel health care practitioners.
(d) Reports to the Department for Public Health shall be submitted on the form EPID 240, Report of Positive/Reactive Test for STD, prepared and furnished by the Cabinet for Health and Family Services or a computer-generated facsimile with the same data fields listed.
Section 6. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "EPID 200, Kentucky Reportable Disease Form", edition 5/06; and
(b) "EPID 240, Report of Positive/Reactive Test for STD", edition 1/92.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Laboratory Services, 100 Sower Boulevard Suite 204, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.180, 214.010, 214.160, 214.170, 214.185, 214.420, 42 U.S.C. 263a
- STATUTORY AUTHORITY: KRS 194A.050, 211.090
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 requires the Cabinet for Health and Family Services to implement a statewide program for the detection, prevention and control of communicable diseases and to adopt regulations specifying the information required in and a minimum time period for reporting a sexually transmitted disease. This administrative regulation establishes uniform procedures for the diagnosis, treatment, prevention and control of sexually transmitted diseases (STD).
- History: VD-1-1; 1 Ky.R. 189; eff. 12-11-1974; 4 Ky.R. 334; eff. 5-3-1978; 11 Ky.R. 1918; 12 Ky.R. 343; eff. 8-13-1985; 16 Ky.R. 667; 1188; eff. 11-22-1989; 33 Ky.R. 3295; 34 Ky.R. 35; eff. 8-6-2007; Crt eff. 10-15-2019; Crt eff. 8-12-2026.
902 KAR 2:090 Tuberculosis detection, prevention, and control {#sec-902-kar-2-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:090}
Section 1. Definitions.
(1) "Active tuberculosis" is defined by KRS 215.511(1).
(2) "Child" means an individual under eighteen (18) years of age.
(3) "Exception patient" means an individual with tuberculosis who has been identified by a local health department with jurisdiction as an individual in exceptional or infrequent circumstances.
(4) "Exceptional or infrequent circumstances" means:
(a) Short-term hospitalization is required for:
-
Invasive diagnostic procedures;
-
Respiratory isolation;
-
Management of drug-resistant disease; or
-
Other circumstances that a cabinet physician has determined require hospitalization to detect, prevent, or control tuberculosis; or
(b) Pursuant to KRS 215.560, security measures are required.
(5) "First-time enrollee" means a child who:
(a) Has never attended school in Kentucky; and
(b) Is entering private of public school, entry level through 12th grade, for the first time.
(6) "Isolates" is defined by KRS 215.511(2).
(7) "Tuberculin skin test" means the intradermal injection of five (5) tuberculin units of Purified Protein Derivative (PPD) by the Mantoux technique.
Section 2. Except as provided by KRS 214.036(2), the provisions of this administrative regulation shall not apply to children exempted by KRS 214.036(2).
Section 3.
(1) A reaction to a tuberculin skin test shall be interpreted in accordance with "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children".
(2) If the skin test of a child indicates that treatment is needed, the child shall be treated in accordance with "Treatment of Tuberculosis Infection in Adults and Children".
Section 4.
(1) The department shall authorize a local health department to test first time enrollees in a school within its jurisdiction, if it submits to the department the documentation specified by subsection (2) of this section.
(2) Required documentation.
(a) Documentation of continued transmission of at least two (2) years duration of a multidrug resistance pattern, or more virulent strain, of Mycobacterium tuberculosis; or
(b) Laboratory analysis that documents transmission, whether in consecutive or nonconsecutive years, of a multidrug resistance pattern, or more virulent strain of Mycobacterium tuberculosis; or
(c) A documented outbreak of at least two (2) years duration:
-
With multifamily involvement each year that resulted in at least five (5) cases of tuberculosis per year; and
-
Is two (2) times greater than the national tuberculosis rate per 100,000 population; or
(d) Documentation of a tuberculosis rate per 100,000 that is two (2) times greater than the national tuberculosis rate in each of the last five (5) years.
(3)
(a) A local health department that has been authorized by the Department for Public Health to conduct tuberculin testing of first-time school enrollees may continue to test for an additional year.
(b) If a local health department has submitted documentation that the tuberculin reactor rate in the additional year was at least two (2) times greater than the reactor rate in the previous year, the department shall approve an additional year of testing.
(4) If a local health department has been authorized by the Department for Public Health to conduct tuberculin testing of first-time school enrollees:
(a) The local health department shall notify, in writing, the parent or guardian of a first-time enrollee that a tuberculin skin test is required;
(b) Except as provided by paragraph (c) of this subsection, a first-time enrollee shall be tested for tuberculosis by tuberculin skin test within eighteen (18) months prior to entering school by a licensed or certified health professional authorized to administer the test.
(c) A first-time enrollee who had been tested for tuberculosis by a tuberculin skin test within eighteen (18) months prior to his entering school shall not be required to be retested, if a "Tuberculin Skin Test Certificate", dated and signed by the physician, advanced registered nurse practitioner, or authorized representative of the local health department that administered the test, has been submitted to the local health department with jurisdiction.
(d) If a physician certifies in writing that tuberculin skin testing is medically contraindicated, an enrollee shall receive a chest x-ray, unless documentation is provided of a completed course of prophylaxis or multiple drug treatment for previously diagnosed tuberculosis infection or disease in accordance with "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children".
(e)
-
If an enrollee has not been tested prior to entering school, he shall be permitted to attend class for a period not to exceed thirty (30) days.
-
Before the expiration of thirty (30) days from entering school, proof of having been tested for tuberculosis pursuant to the provisions of this subsection shall be submitted to the local health department with jurisdiction.
-
If the proof required by this subsection is not submitted within thirty (30) days of entering school, the enrollee shall not be permitted to attend school until proof is submitted to the local health department with jurisdiction.
(f) The "Tuberculin Skin Test Certificate" shall include the following information:
-
Complete name of student;
-
Birthdate of student;
-
Address of student;
-
Date test given to student;
-
Type of test;
-
Millimeters of induration at forty-eight (48) hours to seventy-two (72) hours posttesting;
-
Date read;
-
Name of licensed or certified health professional who read the test; and
-
If the provisions of paragraph (c) of this subsection are applicable, the date an x-ray was taken.
(g) A copy of a enrollee's "Tuberculin Skin Test Certificate" shall be transmitted by the local health department with jurisdiction to the enrollee's school.
Section 5. Drug Susceptibility Testing. Drug susceptibility testing shall be conducted to determine the efficacy of prescribed drug therapy for a person with active tuberculosis as provided by this section.
(1) Drug susceptibility testing of initial isolates from clinical specimens obtained from a patient with active tuberculosis shall be performed by a:
(a) Laboratory:
-
Licensed pursuant to KRS 333.030; or
-
Exempted from licensure by KRS 333.040; and
-
Qualified to perform drug susceptibility testing for Mycobacterium tuberculosis; or
(b) The Division of Laboratory Services of the Kentucky Department for Public Health.
(2)
(a) Repeat drug susceptibility testing of a specimen ordered by a physician from a patient who has continued to produce specimens that are culture positive for tuberculosis after three (3) months of treatment shall be made on the latest isolate obtained from the patient.
(b) Testing conducted pursuant to the provisions of this section shall be performed by a laboratory specified by paragraphs (c) and (d) of this section.
(c) A laboratory:
-
Licensed pursuant to KRS 333.030; or
-
Exempted from licensure by KRS 333.040; and
-
Qualified to perform drug susceptibility testing for Mycobacterium tuberculosis.
(d) The Division of Laboratory Services of the Kentucky Department for Public Health.
Section 6.
(1) Within seventy-two (72) hours of the hospitalization of an exception patient, a local health department shall interview an exception patient to determine if the patient is covered by health insurance, including Medicaid.
(2) If the patient is without health coverage, the local health department shall:
(a) Request the Cabinet for Families and Children to evaluate the patient for Medicaid eligibility; and
(b) Assist the Cabinet for Families and Children in efforts to obtain health coverage.
(3) If an exception patient is not covered by health insurance, and is not eligible for health care insurance, reimbursement for tuberculosis inpatient services for the patient shall be made to the provider by the Cabinet for Health Services through the local health department at:
(a) The Medicaid per diem rate; or
(b) Other rate, if approved in advance by the Cabinet for Health Services.
(4) Reimbursement for tuberculosis inpatient services, or for voluntary placement in a half-way house, for an exception patient shall be made by time-limited payment through a contract or memorandum of understanding between the local health department and the admitting facility if the admitting assess a charge.
Section 7. Incorporation by Reference.
(1) The following material is incorporated by reference in this administrative regulation:
(a) "Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children (1994)", American Lung Association; and
(b) "Tuberculin Skin Test Certificate, 12/98", Form EPID 391A.
(2) Material incorporated by reference may be inspected, copied, or obtained at the Office of the Commissioner, Department for Public Health, 275 East Main Street, Frankfort, Kentucky, 40621, 8 a.m. through 4:30 p.m., Monday through Friday.
History
- RELATES TO: KRS 211.180(1)(a), (c), 214.034(2), 215.520(1), (2), (4), (5), (8), (9), 215.560
- STATUTORY AUTHORITY: KRS 194A.050, 211.180(1)(a), (c), 214.034(2), 215.520(1), (2), (4), (5), (8), (9), 215.560
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 215.520 authorizes the Cabinet for Health Services to discharge all duties relating to all matters of tuberculosis control, including: (1) clinical services for either recalcitrant or drug resistant persons with active tuberculosis; (2) the facilitation of tuberculosis programs in cooperation with the Department of Education; (3) the appraisal and provision of services for persons with tuberculosis; and (4) provision of direct assistance to local health departments, and other organizations to assist them in education, prevention, and treatment programs of tuberculosis control. KRS 215.520(2) requires the Cabinet for Health Services to promulgate administrative regulations to implement statutes governing tuberculosis. KRS 211.180(1)(a) requires the Cabinet for Health Services to implement a statewide program for the detection, prevention, and control of communicable diseases. KRS 214.034(2) permits a local health department, with the approval of the Department of Public Health, to require tuberculosis testing of a first-time enrollee in a public or private school within the jurisdiction of the local health department. This administrative regulation establishes: (1) requirements, forms, and procedures for the testing of school children for tuberculosis by a local health department; and (2) testing and treatment of persons diagnosed with tuberculosis.
- History: 10 Ky.R. 258; eff. 8-3-1983; 12 Ky.R. 55; eff. 8-13-1985; 16 Ky.R. 669; eff. 11-29-1989; 21 Ky.R. 577; eff. 9-21-1994; 23 Ky.R. 1463; 2190; 2522; eff. 11-20-1996; 25 Ky.R. 620; 1619; eff. 1-19-1999; Crt eff. 10-15-2019; Crt eff. 8-12-2026.
902 KAR 2:140 Human immunodeficiency virus (HIV) test counseling {#sec-902-kar-2-140 omnilex-key=us-ky-regs-official--title-902--902 KAR 2:140}
Section 1. Before functioning as a counselor in a human immunodeficiency virus (HIV) counseling and testing site under the auspices of the Cabinet for Human Resources, a person shall have completed a training course approved by the Sexually Transmitted Disease Section, Department for Health Services, which includes, but is not limited to, the following:
(1) Medical overview of HIV infection and disease;
(2) Explanation of types of HIV tests and their interpretation;
(3) Review of risk factors for HIV infection and how to prevent infection;
(4) Instruction in counseling approach to a person seeking and/or needing HIV testing;
(5) Instruction and roll play in informing a person of a positive HIV test;
(6) Recognition of need for social services and/or mental health referral, and instruction on how to make these referrals;
(7) Instruction regarding medical care referrals for a person with HIV, including tuberculosis skin testing;
(8) Instruction regarding partner notification services for persons with HIV; and
(9) Training emphasizing the need to assure a complete, coordinated array of care for a person with HIV, and emphasizing the need to view HIV as a chronic disease rather than a rapidly fatal condition.
History
- RELATES TO: KRS 211.180
- STATUTORY AUTHORITY: KRS 194A.050, 211.090
- NECESSITY, FUNCTION, AND CONFORMITY: HB 425, enacted during the 1990 Regular General Assembly, requires that each person providing post-test counseling to persons with positive HIV test results receives specialized training. This administrative regulation is promulgated to comply with HB 425.
- History: 17 Ky.R. 175; eff. 9-13-1990; Crt eff. 11-26-2019; Crt eff. 9-2-2026.
Chapter 4 Maternal and Child Health
902 KAR 4:030 Newborn screening program {#sec-902-kar-4-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:030}
Section 1. Definitions.
(1) "Blood spot testing" means laboratory testing that is performed on newborn infants to detect a wide variety of inherited and congenital disorders and conditions by using a laboratory-authorized filter paper specimen card.
(2) "Critical congenital heart disease" or "CCHD" means an abnormality in the structure or function of the heart that exists at birth and places an infant at significant risk of disability or death if not diagnosed and treated soon after birth.
(3) "Diagnostic echocardiogram" means a test that uses ultrasound to provide an image of the heart that is performed by a technician trained to perform pediatric echocardiograms.
(4) "Laboratory" means the Division of Laboratory Services within the Cabinet for Health and Family Services, Department for Public Health.
(5) "Pediatric cardiologist" means a pediatrician that is board-certified to provide pediatric cardiology care.
(6) "Program" means the Newborn Screening Program for inherited and congenital disorders and conditions operated by the Cabinet for Health and Family Services, Department for Public Health.
(7) "Pulse oximetry testing" means a noninvasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen.
(8) "Submitter" means a hospital, primary care provider, health department, birthing center, laboratory, or midwife submitting an infant's blood specimen for the purpose of newborn screening.
Section 2. Tests for inborn errors of metabolism or other inherited or congenital disorders and conditions for newborn infants as part of newborn screening shall be consistent with the U.S. Department of Health and Human Services' Recommended Uniform Screening Panel and include the following:
(1) 2-Methyl-3-hydroxybutyric aciduria (2M3HBA);
(2) 2-Methylbutyryl-CoA dehydrogenase deficiency (2MBDH);
(3) 3-Methylcrotonyl-CoA carboxylase deficiency (3MCC);
(4) 3-Methylglutaconic aciduria (3MGA);
(5) 3-Hydroxy 3-Methylglutaric aciduria (HMG);
(6) Argininemia (ARG);
(7) Argininosuccinic acidemia (ASA);
(8) Beta-ketothiolase deficiency (BKT);
(9) Biotinidase disorder (BIOT);
(10) Carnitine acylcarnitine translocase deficiency (CACT);
(11) Carnitine palmitolytransferase deficiency I (CPT-I);
(12) Carnitine palmitolytransferase deficiency II (CPT-II);
(13) Carnitine uptake defect (CUD);
(14) Citrullinemia type I (CIT-I);
(15) Citrullinemia type II (CIT-II);
(16) Congenital adrenal hyperplasia (CAH);
(17) Congenital hypothyroidism (CH);
(18) Critical congenital heart disease (CCHD);
(19) Cystic fibrosis (CF);
(20) Ethylmalonic encephalopathy (EE);
(21) Galactosemia (GAL);
(22) Glutaric acidemia type I (GA I);
(23) Glutaric acidemia type II (GA-II);
(24) Glycogen storage disease type II (GSD-II, Pompe Disease);
(25) Guanidinoacetate methyltransferase deficiency (GAMT);
(26) Homocystinuria (HCY);
(27) Hypermethioninemia (MET);
(28) Hyperphenylalinemia (H-PHE);
(29) Isobutyryl-CoA dehydrogenase deficiency (IBG);
(30) Isovaleric acidemia (IVA);
(31) Long-chain hydroxyacyl-CoA dehydrogenase deficiency (LCHAD);
(32) Malonic academia (MAL);
(33) Maple syrup urine disease (MSUD);
(34) Medium-chain acyl-CoA dehydrogenase deficiency (MCAD);
(35) Methylmalonic acidemia (Cbl A,B);
(36) Methylmalonic acidemia (Cbl C,D);
(37) Methylmalonic acidemia mutase deficiency (MUT);
(38) Mucopolysaccharidosis type I (MPS-I, Hurler's Disease);
(39) Mucopolysaccharidosis type II (MPS-II, Hunter's Disease);
(40) Multiple carboxylase deficiency (MCD);
(41) Non-ketotic Hyperglycinemia (NKHG);
(42) Phenylketonuria (PKU);
(43) Propionic acidemia (PA);
(44) Severe combined immunodeficiency (SCID);
(45) Short-chain acyl-CoA dehydrogenase deficiency (SCAD);
(46) Sickle cell disease (Hb S/S);
(47) Sickle cell hemoglobin C disease (Hb S/C);
(48) Sickle cell S Beta Thalassemia (Hb S/Th);
(49) Spinal muscular atrophy (SMA);
(50) Trifunctional protein deficiency (TFP);
(51) Tyrosinemia type I (TYR-I);
(52) Tyrosinemia type II (TYR-II);
(53) Tyrosinemia type III (TYR-III);
(54) Various Hemoglobinopathies (includes Hb E);
(55) Very long-chain acyl-CoA deficiency (VLCAD); and
(56) X-linked adrenoleukodystrophy (X-ALD).
Section 3. Tests for inborn errors of metabolism or other inherited or congenital disorders and conditions for newborn infants as part of newborn screening shall include the following disorder that is not recommended by the U.S. Department of Health and Human Services, but is required by Kentucky law: Krabbe Disease (KD).
Section 4. Submitter Responsibilities.
(1) Except as provided in KRS 214.155(3) and (5), the administrative officer or other person in charge of the hospital or institution caring for newborn infants and the attending primary care provider or midwife shall administer to, or verify administration of tests to, every infant in its care prior to hospital discharge:
(a) A blood spot test to detect inborn errors of metabolism and other inherited and congenital disorders and conditions identified in Sections 2 and 3 of this administrative regulation; and
(b) Pulse oximetry testing to detect critical congenital heart disease.
(2) If a baby is not born in a hospital or institution, the attending primary care provider or midwife shall ensure that both tests required by subsection (1) of this section are:
(a) Administered between twenty-four (24) and forty-eight (48) hours of age;
(b) Acted upon if abnormal; and
(c) Reported to the program by fax or by the cabinet's web-based system.
(3) A capillary blood spot specimen shall be obtained from a newborn infant not requiring an extended stay due to illness or prematurity between twenty-four (24) and forty-eight (48) hours of age.
(4) If the infant is to remain in the hospital due to illness or prematurity, the hospital shall obtain the capillary blood spot specimen from that infant after twenty-four (24) and before seventy-two (72) hours of age.
(5) Except as provided by subsection (6) of this section, the pulse oximetry testing shall be performed when the infant is twenty-four (24) hours of age or older and shall occur prior to discharge.
(6) If the infant is discharged prior to twenty-four (24) hours of age, the blood spot and pulse oximetry testing shall be performed as close to twenty-four (24) hours of age as possible.
(7) If an infant is transferred from the birth hospital to another hospital during the newborn hospital stay, the requirements established in this subsection shall apply.
(a) The sending hospital shall obtain the capillary blood spot specimen for the newborn screening blood test and the pulse oximetry testing for CCHD if the infant is twenty-four (24) hours of age or more when the infant is transferred to another hospital.
(b) The receiving hospital shall ensure the newborn screening blood spot test and the pulse oximetry testing are performed if the infant is less than twenty-four (24) hours of age when the infant is transferred.
(8) If an infant expires before the newborn screening blood spot test and pulse oximetry test have been performed, the program shall be notified within five (5) calendar days.
(9) If the information on the filter paper specimen card obtained by the submitter and sent to the laboratory is incomplete or inadequate, then the submitter, upon request of the program, shall:
(a) Attempt to locate the infant and obtain a complete and adequate specimen within ten (10) days; and
(b) Report to the program a specimen that is unable to be obtained within ten (10) days.
(10) A submitter that is responsible for the collection of the initial blood spot specimen and pulse oximetry testing for newborn screening shall:
(a) Provide to an infant's parent or guardian educational materials regarding newborn screening and pulse oximetry testing;
(b) Designate a newborn screening coordinator and physician responsible for the coordination of the facility's newborn screening compliance by having a newborn screening protocol;
(c) Notify the program of the name of the individuals designated in paragraph (b) of this subsection each year in January and if the designated individual changes; and
(d) Develop a written protocol for tracking newborn screening compliance, which shall:
-
Be submitted to the program each year in January; and
-
Include, at a minimum:
a. A requirement that the name of the primary care provider that will be attending the infant after birth or discharge or, if known, the primary care provider who will be caring for the infant after discharge, shall be placed on the filter paper specimen card sent with the initial blood spot specimen to the laboratory. If the infant is in the neonatal intensive care unit, the name of the attending neonatologist may be placed on the filter specimen card sent with the initial blood spot specimen to the laboratory;
b. Verification that:
(i) Each infant born at that facility has had a specimen obtained for newborn screening and pulse oximetry testing on or before discharge;
(ii) All information on the specimen card has been thoroughly completed; and
(iii) The specimen has been submitted appropriately;
c. A process to ensure that final results of the pulse oximetry screening are entered into the cabinet's web-based system; and
d. A procedure to assure the hospital or facility that identifies that an infant has not had a specimen obtained for newborn screening and pulse oximetry testing prior to discharge shall:
(i) Notify the program;
(ii) Use every reasonable effort to locate the infant;
(iii) Notify the parent or guardian and the primary care provider immediately; and
(iv) Recommend that the infant present to the hospital or primary care provider immediately for a newborn screening blood spot specimen and pulse oximetry testing.
(11) A hospital or facility shall report each written refusal, in accordance with KRS 214.155(5), to the program within five (5) calendar days.
Section 5. Blood Specimen Collection.
(1) A capillary blood spot specimen required by Section 4 of this administrative regulation shall be obtained by a heel stick.
(2) Blood from the heel stick shall be applied directly to the filter paper specimen card.
(3) All circles shall be saturated completely using a drop of blood per circle on a filter paper specimen card.
(4) The specimen collector shall provide information requested by the laboratory on the filter paper specimen card.
(5) The capillary blood spot specimen shall be air dried for three (3) hours and then shall be mailed or sent to the laboratory:
(a) Within twenty-four (24) hours of collection of the specimen; or
(b) The next business day in which mail or delivery service is available.
(6) A submitter sending a blood spot specimen via regular mail services shall send the specimen to the following address: Cabinet for Health and Family Services, Department for Public Health, Division of Laboratory Services, 100 Sower Boulevard, Frankfort, Kentucky 40602.
(7) A submitter sending a blood spot specimen via expedited mail services shall ensure the specimen is sent to the following address: Cabinet for Health and Family Services, Department for Public Health, Division of Laboratory Services, 100 Sower Boulevard, Suite 204, Frankfort, Kentucky 40602.
(8) Specimens processed or tracked under the newborn screening program shall be limited to specimens on infants less than six (6) months of age.
Section 6. Unsatisfactory or Inadequate Blood Specimen.
(1) If a specimen is unsatisfactory or inadequate to produce a valid result, the laboratory shall notify the submitter and the parent on the filter paper specimen card that the newborn screen needs to be repeated as soon as possible.
(2) If a requested repeat specimen has not been received within ten (10) business days from the date the repeat request was issued, the program shall notify the parent by mail of the need for a repeat screening test.
Section 7. Special Circumstances - Blood Transfusion. If a newborn infant requires a blood transfusion, the requirements for newborn screening established in this section shall apply.
(1) The hospital shall obtain a capillary blood spot specimen for newborn screening prior to the infant being transfused, except in an emergency situation.
(2) If the pre-transfusion blood spot specimen was obtained before twenty-four (24) hours of age, or if it was not obtained due to an emergency situation, then the hospital or primary care provider shall use all reasonable efforts to obtain a repeat capillary blood specimen from the transfused infant and submit it to the laboratory according to the following schedule:
(a) Seventy-two (72) hours after the last blood transfusion, rescreen for inborn errors of metabolism and inherited and congenital disorders and conditions listed in Sections 2 and 3 of this administrative regulation; and
(b) Ninety (90) days after the last blood transfusion, rescreen for any disorder that relies on red blood cell analysis such as hemoglobinopathies, galactosemia, and biotinidase deficiency.
Section 8. Reporting Results of Newborn Screening Blood Tests.
(1) Normal Results. Upon receipt of a normal lab result, the laboratory shall send the result to the primary care provider and the submitter.
(2) Abnormal Results.
(a) The laboratory shall report abnormal, presumptive positive, or equivocal results of tests for inborn errors of metabolism, inherited and congenital disorders and conditions to the program.
(b) The submitter and primary care provider shall receive a copy of all abnormal, presumptive positive, and equivocal results.
(c) In addition, a primary care provider shall be notified of an abnormal, presumptive positive, or equivocal result in the manner established in this paragraph.
-
Upon receipt of an abnormal, equivocal, or a presumptive positive lab result, the laboratory shall notify the primary care provider listed on the filter paper specimen card within two (2) business days of the result and the need for follow-up testing.
-
Upon receipt of a presumptive positive lab result, the program shall notify the primary care provider listed on the filter paper specimen card of the result and recommend immediate consultation with a university pediatric specialist.
-
If the program is unable to determine the infant's primary care provider to notify them of an abnormal, presumptive positive, or equivocal result and the need for follow-up, the program shall use every available means to notify the infant's parent.
(d) The Cabinet for Health and Family Services shall share pertinent test results with a state university-based specialty clinic or primary care provider who informs the cabinet they are treating the infant who received the test.
(e) The cabinet may share pertinent test results with the local health department in the infant's county of residence that conducts newborn screening follow-up activities.
(f) A specialty clinic or primary care provider shall report results of diagnostic testing to the program within thirty (30) days or earlier upon request.
(g) If a requested repeat specimen has not been received within ten (10) business days from the date the repeat request was issued, the program shall notify the parent by mail of the need for a repeat screening test.
Section 9. Pulse Oximetry Screening for Critical Congenital Heart Disease. Pulse oximetry screening for critical congenital heart defects required by Section 2 of this administrative regulation shall be consistent with the standard of care according to national recommendations by the American Academy of Pediatrics.
Section 10. Pulse Oximetry Screening Process.
(1) Except as provided by KRS 214.155(3) and subsections (2) and (4) of this section, pulse oximetry testing shall be performed when the infant is between twenty-four (24) and forty-eight (48) hours of age and shall occur no later than the day of discharge.
(2) If the infant is discharged prior to twenty-four (24) hours of age, the blood spot and pulse oximetry testing shall be performed as close to twenty-four (24) hours of age as possible.
(3) An infant in a neonatal intensive care unit shall be screened when medically appropriate after twenty-four (24) hours of age but prior to discharge.
(4) An infant who has been identified with critical congenital heart disease prior to birth or prior to twenty-four (24) hours of age shall be exempt from the pulse oximetry screening process.
(5) Pulse oximetry screening shall be performed by placing pediatric pulse oximetry sensors simultaneously on the infant's right hand and either foot to obtain oxygen saturation results.
(6) If using a single pediatric pulse oximetry sensor, pulse oximetry screening shall be performed on the infant's right hand and either foot, one after the other, to obtain oxygen saturation results.
Section 11. Pulse Oximetry Testing Results.
(1) A passed result shall not require further action if:
(a) The pulse oximetry reading in both extremities is greater than or equal to ninety-five (95) percent; and
(b) The difference between the readings of both the upper and lower extremity is less than or equal to three (3) percent.
(2)
(a) A pending result shall:
- Occur if:
a. The pulse oximetry reading is between ninety (90) and ninety-four (94) percent; or
b. The difference between the readings of both the upper and lower extremity is greater than three (3) percent; and
- Be repeated using the pulse oximetry screening in one (1) hour.
(b) If a repeated pulse oximetry screen is also interpreted as pending, it shall be performed again in one (1) hour.
(c) If the pulse oximetry result on the third screen continues to meet the criteria as pending after three (3) screenings have been performed, it shall be considered failed and the procedures established in subsection (3) of this section shall be followed.
(3) A failed result shall:
(a) Occur if:
-
The initial pulse oximetry reading is less than ninety (90) percent in the upper or lower extremity; or
-
The provisions of subsection (2)(c) of this section apply; and
(b) Require the following actions:
-
The primary care provider shall be notified immediately;
-
The infant shall be evaluated for the cause of the low saturation reading; and
-
If CCHD cannot be ruled out as the cause of the low saturation reading, the attending physician or advanced practice registered nurse shall:
a. Order a diagnostic echocardiogram to be performed without delay;
b. Ensure the diagnostic echocardiogram be interpreted as soon as possible; and
c. If the diagnostic echocardiogram results are abnormal, obtain a consultation with a pediatric cardiologist prior to hospital discharge.
Section 12. Reporting Results of Pulse Oximetry Screening.
(1) Final results of the pulse oximetry screening shall be entered into the cabinet's web-based system.
(2) A failed result shall be immediately reported to the program by fax or by the cabinet's web-based system.
Section 13. Newborn Screening Fees.
(1)
(a) A submitter, other than a midwife, obtaining and sending a blood spot specimen to the laboratory shall be billed a fee of $200 for the initial newborn screening test.
(b) A midwife obtaining and sending a blood spot specimen to the laboratory shall be billed a fee of fifty (50) dollars for the initial newborn screening test.
(2) A submitter obtaining and sending a repeat blood spot specimen to the laboratory shall not be charged an additional fee.
(3) Fees due the Cabinet for Health and Family Services shall be collected through a monthly billing system.
History
- RELATES TO: KRS 194A.050, 211.090, 211.180(1), 214.155
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 214.155
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 214.155 requires the Cabinet for Health and Family Services to operate a newborn screening program for inborn errors of metabolism and other inherited and congenital disorders and conditions, and to establish a schedule of fees to cover the actual costs to the cabinet for the program. This administrative regulation requires that infants be tested for inborn errors of metabolism and other inherited and congenital disorders and conditions as specified in KRS 214.155, and establishes the schedule of fees to cover actual costs of the newborn screening program. The selection of screened conditions is based upon the recommended uniform screening panel as authored by the American College of Medical Genetics and commissioned by the Health Resources and Services Administration, U.S. Department of Health and Human Services.
- History: MCH-3; 1 Ky.R. 640; eff. 4-9-1975; Am. 6 Ky.R. 314; eff. 1-2-1980; 9 Ky.R. 386; 555; eff. 10-6-1982; 11 Ky.R. 652; eff. 11-13-1984; 13 Ky.R. 786; eff. 11-11-1986; 14 Ky.R. 2069; eff. 6-22-1988; 21 Ky.R. 578; eff. 9-21-1994; 32 Ky.R. 2036; 1487; 2274; eff. 6-21-2006; 40 Ky.R. 1484; 2449; eff. 6-6-2014; 41 Ky.R. 1222; eff. 4-3-2015; 42 Ky.R. 1650; eff. 3-4-2016; 45 Ky.R. 3553; eff. 8-19-2019; 47 Ky.R. 209; eff. 12-15-2020; 48 Ky.R. 3071; eff. 9-28-2022; 51 Ky.R. 138, 668; eff. 10-23-2024.
902 KAR 4:035 Cost reimbursement for specialized food products {#sec-902-kar-4-035 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:035}
Section 1. Definitions.
(1) "Amino acid-based elemental formula" is defined by KRS 304.17A-258(1)(c).
(2) "Low-protein modified food" is defined by KRS 304.17A-258(1)(b).
(3) "Patient" means a person with one (1) or more of the metabolic conditions listed in KRS 205.560(1)(c).
(4) "Program" means the Kentucky Metabolic Foods and Formulas program operated by the Cabinet for Health and Family Services, Department for Public Health.
(5) "Specialized food product" means a therapeutic food or formula, supplement, amino acid-based elemental formula, or low-protein modified food product, which is medically indicated for therapeutic treatment.
(6) "Uninsured patient" means a patient who does not meet the criteria to receive Medicaid, K-CHIP, Medicare, or WIC benefits, or whose private insurance coverage is exhausted or denied.
(7) "Vendor" means an individual or entity authorized to fill a prescription for specialized food product for an uninsured patient.
(8) "WIC" is defined by 7 C.F.R. 246.2.
Section 2. Eligibility.
(1) An individual meeting the definition of an uninsured patient shall be eligible to receive approval for financial coverage of a specialized food product by the program.
(2) An uninsured patient seeking financial coverage of a specialized food product shall submit to the program:
(a) Kentucky Metabolic Food and Formula Provision Financial and Release of Information Form; and
(b) Written verification that an application for WIC, Medicaid, Medicare, or K-CHIP was denied, and that private health insurance has been exhausted or denied.
(3) On behalf of an uninsured patient seeking financial coverage of a specialized food product, a licensed or certified healthcare practitioner with prescriptive authority shall submit to the program:
(a)
-
A Kentucky Metabolic Disease Program Physician's Statement of Medical Necessity – Metabolic Disease Therapy form; or
-
A certificate of medical necessity; and
(b) A prescription for the specialized food product.
(4) Eligibility for financial coverage shall be renewed annually by submitting the documentation as required by subsection (2) of this section.
(5) The cost of the formula for a patient who is eligible for WIC shall be covered by the WIC Program in accordance with 7 C.F.R. 246.10(e)(3)(i).
(6) The cost for food and formula for a patient covered by private health insurance shall be paid under the terms of the individual insurance policy, which shall meet or exceed the limit established in KRS 304.17A-258.
Section 3. Cost Reimbursement.
(1) Cost reimbursement shall be made directly to the vendor filling a prescription for a specialized food product.
(2) To receive reimbursement of the actual cost plus twenty (20) percent, a vendor shall submit the following documents to the program:
(a) A prescription for the specialized food product from a licensed or certified healthcare practitioner with prescriptive authority;
(b) A completed Authorization for Services, MFF-100; and
(c) An invoice from the supplier with the patient name, service date, and cost to the vendor.
Section 4. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Kentucky Metabolic Disease Program Physician's Statement of Medical Necessity - Metabolic Disease Therapy", Rev. 2/19;
(b) "Authorization for Services", MFF-100, 2/19; and
(c) "Kentucky Metabolic Food and Formula Provision Financial and Release of Information Form", FRI-100, Rev. 2/19.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Division of Maternal and Child Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 205.560(1)(c), 213.141(2), 304.17A-258, 7 C.F.R. 246.2, 246.10
- STATUTORY AUTHORITY: KRS 194A.050(1), 205.560(1)(c)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 205.560(1)(c) requires the cabinet to cover the cost of products for the treatment of inborn errors of metabolism or genetic, gastrointestinal, and food allergic conditions, consisting of therapeutic food, formulas, supplements, amino acid-based elemental formula, or low-protein modified food products that are medically necessary and administered under the direction of a physician. This administrative regulation establishes the application and cost reimbursement procedures for specialized food products.
- History: 27 Ky.R. 3477; Am. 28 Ky.R. 393; eff. 8-15-2001; 379; 890; eff. 11-16-2005; 45 Ky.R. 3557; eff. 8-19-2019; Crt eff. 7-1-2026.
902 KAR 4:090 Lead poisoning prevention {#sec-902-kar-4-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:090}
Section 1. Definitions. As used in this administrative regulation:
(1) "Board" means the board of health of any county, city-county or district including the Louisville and Jefferson County Board of Health and the Lexington-Fayette Urban-County Board of Health.
(2) "Department" means the department of health of any county, city-county or district health department including the Louisville and Jefferson County Health Department and the Lexington-Fayette Urban-County Health Department.
(3) "Director" means the chief administrative officer of any county, city-county or district health department including the Louisville and Jefferson County Health Department and the Lexington-Fayette Urban-County Health Department.
(4) "Cabinet" means the Cabinet for Human Resources.
(5) "Secretary" means the Secretary for Human Resources or his authorized representative.
(6) "Chewable surface" means surfaces such as windowsills, window frames, door frames, handrails, toys, furniture, food utensils and other appurtenances offering a biting surface to a child or other person.
(7) "Dwelling" means any structure, all or a part of which is designed for human habitation.
(8) "Dwelling unit" means any room or group of rooms or other interior areas of a dwelling designed or used for human habitation.
(9) "Elevated blood lead level" means a confirmed concentration of lead in whole blood of twenty-five (25) micrograms (ug) per deciliter (dl) or greater.
(10) "Exposed surface" means all interior surfaces of a dwelling or dwelling unit and those exterior surfaces of a dwelling or dwelling unit which are readily accessible to children under six (6) years of age, such as stairs, decks, porches, railings, windows, doors and siding. All areas in the vicinity of a dwelling or dwelling unit subject to contamination from flaking or peeling lead based materials shall also be considered an exposed surface.
(11) "Lead based substance" is defined by KRS 211.900(3).
(12) "Owner" means any person who, alone, jointly, or severally with others, has legal title to, charge, care, or control of any dwelling or dwelling unit as owner, agent of the owner, or as executor, administrator, trustee, conservator or guardian of the estate of the owner.
(13) "Occupant" means any person living, sleeping, cooking, eating in or having actual possession of a dwelling unit or rooming unit.
(14) "Surface" means the outermost layer or superficial area of the materials of which a dwelling unit is constructed, excluding paint, plaster or putty of the interior or exterior of a dwelling unit, such as the outermost layer of superficial area of walls, ceilings, floors, stairs, windows, windowsills, window frames, window sashes, doors, door frames, baseboard and woodwork of a dwelling or dwelling unit.
Section 2. Lead Based Paint Health Hazard.
(1) Any lead based substance shall be considered a health hazard to children under six (6) years of age if it:
(a) Exists in or about a dwelling, dwelling unit, household, school or day care facility in which children commonly reside or visit; and
(b) Is determined to be on any surface, exposed surface or chewable surface and contains more than 0.06 percent lead by weight of nonvolatile content or in excess of seven-tenths (0.7) milligrams per square centimeter of surface if tested by radioisotope x-ray fluorescent analyzer.
(2) Any lead based substance found to be a health hazard under subsection (1) of this section shall be corrected within the time period specified by the director in a written order. Failure to correct the health hazard within the specified time period shall result in the appropriate court action against the owner, operator or occupant for noncompliance unless an extension is granted by the director due to undue hardship.
(3) Correction procedures shall be approved by the director and shall include one (1) or more of the following:
(a) Stripping of the surface to the bare underlying materials which do not contain lead at the unsafe levels.
(b) Covering of surfaces that contain lead at unacceptable levels with permanently affixed covering that are:
-
Lead free; and
-
Incapable of being readily chewed through, torn from the surface; pierced or otherwise removed in such a manner as to expose the hazardous surface.
Section 3. Inspections.
(1) If flaking, peeling, chipping, or loose paint, plaster, or structural material is found in or around any building used for housing, specimens of the flaking, chipped or loose paint, plaster or structural material shall be collected to determine whether or not the materials contain lead. In lieu of taking samples, the surface may be tested with an "in situ" analyzer approved by the director.
(2) The chemical determination of the lead content in surface materials may be made by the quantitative measurements of samples of those materials.
(3) The physical determination of the lead content of surface material may be made by nondestructive measurements using radioisotope x-ray fluorescent analyzers (XRF) or other instruments approved by the director.
(4)
(a) If a dangerous level of lead is found in a dwelling, the director may require the examination of:
-
All children under six (6) years of age; and
-
Other children who reside, or recently resided, in the dwelling.
(b) The results of examinations conducted under this subsection shall be reported to the:
-
Director;
-
Affected individual; and
-
His parents or legal guardian.
Section 4. Hazard Abatement.
(1) If the director determines that the presence of lead based substances in any dwelling or dwelling unit or premises creates a health hazard to children under six (6) years of age, he shall issue a written order to the owner, operator or occupant to eliminate the hazard within a time period not to exceed thirty (30) days. Methods for compliance shall be in accordance with Section 2 of this administrative regulation.
(2) Upon completion of the correction procedure, an inspection shall be made by the department to determine if the hazard has been satisfactorily eliminated.
(3) If the dwelling, dwelling unit or premises in which lead based hazardous substances are located is vacated by the occupant who occupied it when the corrective order was issued, the dwelling, dwelling unit or premises shall not be let or occupied by any other person until the corrective order is complied with.
History
- RELATES TO: KRS 211.900, 211.905, 211.994
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.901(5)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.901(6) provides that local boards of health may by the adoption of local administrative regulations establish programs for the prevention, screening, diagnosis and treatment of lead poisoning; if administrative regulations are the same as the provisions of KRS 211.900 to 211.905 and 211.994 and the administrative regulations promulgated by the Secretary for Human Resources pursuant to subsection (5) of KRS 211.901. The function of this administrative regulation is to set forth the criteria that shall be included in local board of health regulations relating to the prevention, screening, diagnosis and treatment of lead poisoning.
- History: 11 Ky.R. 105; 395; eff. 8-7-1984; 18 Ky.R. 1430; 2263; eff. 1-10-1992; Crt eff. 10-15-2019; Crt eff. 7-1-2026.
902 KAR 4:105 Kentucky Lifeline for Moms program implementation {#sec-902-kar-4-105 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:105}
Section 1. Definitions.
(1) "Eligible patient" means any individual who is pregnant or up to twelve (12) months post-pregnancy.
(2) "Health-care provider" is defined by KRS 216.2920(5).
(3) "Lifeline for Moms" means the consultation line, as authorized by KRS 211.123, available for health-care providers to build their capacity to address mental health concerns of patients who are pregnant or up to twelve (12) months post-partum.
(4) "Maternal and infant health collaborative" means the collaborative panel of maternal and infant health-care providers as authorized by KRS 211.122.
Section 2. Program implementation.
(1) A health-care provider who, upon examination of an eligible patient, is concerned that the patient may have a perinatal mood disorder may contact the Kentucky Lifeline for Moms program for assistance in determining the most appropriate course of action in accordance with KRS 211.123(4).
(2) Beginning July 1, 2025, and continuing annually thereafter, the Kentucky Lifeline for Moms program shall provide a report to the maternal and infant health collaborative panel on the following:
(a) The total number of calls received per quarter;
(b) The geographic location by area development district of the caller;
(c) The discipline of the health-care provider who contacted the program; and
(d) The total number of patients served.
History
- RELATES TO: KRS 211.122, 216.2920
- STATUTORY AUTHORITY: KRS 194A.050, 211.123
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.123 establishes the Kentucky Maternal Psychiatric Access Program, also known as the Lifeline for Moms program. This administrative regulation establishes the implementation procedures for the Kentucky Lifeline for Moms program.
- History: 902 KAR 004:105. 51 Ky.R. 1050, 1487; eff. 6-3-2025.
902 KAR 4:110 Abortion information {#sec-902-kar-4-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:110}
Section 1. Definitions.
(1) "Cabinet" is defined by KAR 311.720(3).
(2) "Department" means Department for Public Health.
Section 2. Informational Materials.
(1) The cabinet shall develop and publish the materials identified in this subsection, which shall be offered to pregnant women seeking an abortion at least twenty-four (24) hours in advance of the abortion.
(a) The "Information About Fetal Development" shall provide the information required by KRS 311.725(2)(b).
(b) The "Available Resources for Pregnant Women" shall provide the information required by KRS 311.725(2)(a).
(c) The "Abortion Pill Reversal" shall provide the information required by KRS 311.725(2)(c).
(2) The cabinet shall make available the requested number of materials.
(3) For a paper copy of a publication, the department shall charge the hospital, physician, medical facility, or entity requesting the materials a fee of:
(a) One (1) dollar for a copy of "Available Resources for Pregnant Women";
(b) Three (3) dollars for a copy of "Information About Fetal Development"; and
(c) One (1) dollar for a copy of "Abortion Pill Reversal".
(4) The fee shall be paid by check made payable to the Kentucky State Treasurer.
(5) A free electronic copy of each publication shall be available from the department's Web site.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Abortion Pill Reversal", October 2019;
(b) "Available Resources for Pregnant Women", 2/2020; and
(c) "Information About Fetal Development", 2/8/2020.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.030, 211.090, 211.180, 311.720, 311.725
- STATUTORY AUTHORITY: KRS 194A.050, 311.725
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050 requires the cabinet to adopt administrative regulations necessary to protect and maintain the health, welfare, and personal dignity of the citizens of the Commonwealth. KRS 311.725 requires the secretary of the cabinet to publish printed materials to inform the pregnant woman who is seeking an abortion the probable anatomical and physiological characteristics of the embryo or fetus at appropriate gestational increments, the public and private agencies and services to assist her through pregnancy, childbirth, and while the child is a dependent, the support obligations of the father of the child who is born alive, and the potential ability to reverse the effects of prescription drugs intended to induce abortion. This administrative regulation establishes the requirements for obtaining that information and incorporates by reference the publications required by KRS 311.725(2).
- History: 25 Ky.R. 1291; 1930; 2380; eff. 3-17-1999; 47 Ky.R. 420; eff. 11-19-2020.
902 KAR 4:120 Health Access Nurturing Development Services (HANDS) Program {#sec-902-kar-4-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:120}
Section 1. Definitions.
(1) "Department" means the Department for Public Health or its designated representative.
(2) "Family support worker" means an employee or subcontractor of the local implementing agency who visits participants and performs services.
(3) "Local implementing agency" means a local health department or a contracted agency that agrees to participate as a HANDS provider and employ or contract with staff that meet the qualifications specified in Section 3 of this administrative regulation.
(4) "Participant" means the parent and child enrolled in the HANDS program and receiving HANDS services.
(5) "Tele-service" means a home visitation service provided through video communication with the HANDS provider, parent, and child present in real time.
Section 2. Eligibility Criteria.
(1) In order to receive a service established in Section 4 of this administrative regulation, an individual shall be:
(a) A pregnant individual who is under twenty (20) years old;
(b) A pregnant individual who is at least twenty (20) years old and upon assessment is identified as having one or more risk factors for the pregnancy or the infant;
(c) The child of an individual identified in paragraph (a) or (b) of this subsection who is less than three (3) years of age and assessed for eligibility within ninety (90) days post-birth; or
(d) A father or guardian of a child identified in paragraph (c) of this subsection.
(2) The local implementing agency shall assess an applicant for eligibility. The assessment shall reflect:
(a) The child and parents unique strengths and needs; and
(b) The services appropriate to meet those needs.
(3) All assessments of the child and family shall be:
(a) Conducted in a nondiscriminatory manner;
(b) Selected and administered so as not to be racially or culturally discriminatory; and
(c) Conducted in the native or preferred language of the child or parent.
(4) Parental consent shall be provided to the local implementing agency before an assessment.
(5) The assessment shall:
(a) Be conducted by a family support worker professional who meets the qualifications listed in Section 3(2) of this administrative regulation; and
(b) Result in:
-
Eligibility for HANDS services, in which the family shall be referred for the development of a home visiting plan; or
-
Ineligibility for HANDS services, in which the family shall be provided with community resources, referral information, and general parenting information.
(6) Participation in the HANDS Program is voluntary.
(7) Participation in the HANDS Program shall be discontinued if:
(a) The child dies;
(b) The family elects to withdraw from the program;
(c) The family moves out of state;
(d) Contact with the family is lost; or
(e) The family repeatedly fails to participate in program activities.
Section 3. Provider Qualifications.
(1) A family support worker paraprofessional shall be a:
(a) High school graduate or holder of a general education development credential whois at least eighteen (18) years of age;
(b) Has received department training in:
-
Ongoing assessment of family strengths and needs;
-
Service plan development;
-
Evidence-based home visiting model;
-
Coordination of services; and
-
Evaluation; and
(c) Is supervised by a registered nurse or licensed social worker.
(2) A family support worker professional shall be a:
(a) Licensed nurse who holds a valid Kentucky Board of Nursing license as a registered nurse or advanced practice registered nurse;
(b) Licensed social worker who holds a valid Kentucky Board of Social Work license;
(c) Graduate with a master's degree in human services or closely related field who shall be supervised by a registered nurse or licensed social worker; or
(d) Graduate with a bachelor's degree in early childhood education, human services, or closely related field who shall be supervised by a registered nurse or licensed social worker.
(3) A HANDS supervisor shall be a:
(a) Licensed nurse who holds a valid Kentucky Board of Nursing license as a registered nurse or advanced practice registered nurse; or
(b) Licensed social worker who holds a valid Kentucky Board of Social Work license.
(4) A local implementing agency shall meet the requirements to provide HANDS services if:
(a) It assures that appropriate staff meet the licensure requirements of the department pursuant to subsection (1) or (2) of this section;
(b) It assures supervision by licensed personnel pursuant to subsection (3)(a) or (b) of this section; and
(c) It reports program data from Section 4(1) of this administrative regulation into the online HANDS database no later than the first Sunday of the month following the date of service.
Section 4. Services.
(1) Home visitation may take place in the client's home or another community site if justified in the record. A home visit shall include:
(a) Monitoring the child and family's progress by:
-
Making referrals to community resources;
-
Tracking appointments to ensure they are being kept;
-
Following up on referrals; and
-
Performing periodic evaluations of participant's changing needs;
(b) The preparation and maintenance of case records that document contacts, services needed, reports, and progress;
(c) Consultations with the family on positive pregnancy outcomes, optimal child growth and development, safe and healthy homes, and family decision making and self-sufficiency; and
(d) Crisis assistance.
(2)
(a) Service frequency shall be provided in accordance with the level of need of the parent or family.
(b) The frequency of visitation shall be lessened as the family meets goals agreed to by the provider and the participant.]
Section 5. Appeal Rights.
(1) A local implementing agency shall notify an individual who does not meet criteria for admission or continuation in the program or who has had a service discontinued, in writing, within ten (10) days of the denial or discontinuance.
(2) An individual wishing to appeal an adverse action by the local implementing agency shall notify the department in writing within thirty (30) days of the date of the notice identified in subsection (1) of this section that a hearing is requested.
(3) Notice of an administrative hearing shall be provided in accordance with KRS 13B.050.
(4) The administrative hearing process shall be conducted in accordance with KRS 13B.080 through 13B.160.
Section 6. Tele-service Delivery Methods.
(1)
(a) HANDS home visitation services that are otherwise designated as face-to-face in accordance with this administrative regulation may be provided through tele-service delivery methods with informed parental consent.
(b) These services shall include those listed in Sections 2(5) and 4 of this administrative regulation.
(c) Verbal and written consent shall be provided for each child in a shared household. For example, if the family has twins, verbal and written consent shall be provided for each child.
(2) Tele-service delivery methods shall be reimbursed at the usual and customary rate.
History
- RELATES TO: KRS 13B.080-13B.160, 211.180, 211.689
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.690
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.690 authorizes the Cabinet for Health and Family Services to implement a voluntary statewide home visitation program for the purpose of providing assistance to at-risk parents during the prenatal period until the child's third birthday. This administrative regulation establishes the eligibility criteria, services, provider qualifications, and hearing rights for participants of the Health Access Nurturing Development Services (HANDS) Program.
- History: 27 Ky.R. 1407; Am. 1846; 2162; eff. 2-1-2001; 42 Ky.R. 2982; 43 Ky.R. 210; eff. 8-17-2016; TAm eff. 3-20-2020; Cert. eff. 5-9-2023; 50 Ky.R. 952, 1531; eff. 1-11-2024.
902 KAR 4:150 Enhanced HANDS services in response to declared national or state public health emergency {#sec-902-kar-4-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 4:150}
Section 1. Definitions.
(1) "Declared national or state public health emergency" means a formal declaration by the President of the United States or the Governor of Kentucky of an extraordinary event that is determined to constitute a public health risk through the spread of disease.
(2) "Tele-service" means a home visitation service provided through telephone or video communication with the HANDS provider, parent, and child present in real time.
Section 2. Enhanced Home Visitation Services in Response to a Declared National or State Public Health Emergency.
(1) HANDS services and requirements may be enhanced to allow for tele-service delivery methods if a national or state public health emergency has been declared.
(2)
(a) HANDS home visitation services that are otherwise designated as face-to-face in accordance with 902 KAR 4:120 may be provided through tele-service delivery methods with informed parental consent.
(b) These services shall include those listed in 902 KAR 4:120, Sections 2(4), 2(5), and 4.
(c) Verbal and written consent shall be provided for each child in a shared household. For example, if the family has twins, verbal and written consent shall be provided for each baby.
(3) Tele-service delivery methods shall be reimbursed at the usual and customary rate.
(4) Tele-service delivery methods in the manner established by this section shall only be utilized during a declared national or state public health emergency.
History
- RELATES TO: KRS 13B.080 - 13B.160, 200.700, 211.090, 211.180, 211.689
- STATUTORY AUTHORITY: KRS 194A.050, 211.690
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.690 authorizes the Cabinet for Health and Family Services to implement a voluntary statewide home visitation program for the purpose of providing assistance to at-risk parents. This administrative regulation establishes the provisions for providing home visitation through tele-service delivery methods if a national or state public health emergency has been declared.
- History: 47 Ky.R. 2219; 48 Ky.R. 59; eff. 7-21-2021.
Chapter 7 Public Accommodations
902 KAR 7:010 Hotel and motel code {#sec-902-kar-7-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 7:010}
Section 1. Definitions.
(1) "Employee" means any person working in a hotel.
(2) "Ice dispensing machine" means any self-service or semi self-service machine operated by a mechanism that, upon insertion of a coin, coins, or tokens, or by other devices such as levers or switches, dispenses ice either in bulk or in package form.
(3) "Public restroom" means any facility that provides toilet and hand-washing facilities for the general public.
(4) "Self-service ice storage bin" means a self-service machine or storage bin in which ice is manufactured or stored in bulk form and the ice removed by the hotel guest through use of an ice scoop or other similar device.
(5) "Tempered water" means a water temperature of at least ninety (90) degrees Fahrenheit to a maximum temperature of 110 degrees Fahrenheit.
(6) "Transient" means occupancy of a dwelling unit or a sleeping unit for not more than thirty (30) days.
Section 2. Applicability. For the purposes of this administrative regulation, a hotel shall:
(1) Primarily be transient in nature;
(2) Not include apartments, dormitories, hostels, single or multi-family homes, or vacation rental cabins; and
(3) Consist of three (3) or more rentable units within one (1) location.
Section 3. Application for a Permit.
(1) A person desiring to operate a hotel shall complete and submit form DFS-200, Application for Permit or License, as incorporated by reference in 902 KAR 45:065, to the local or district health department serving the county where the hotel is located.
(2)
(a) Upon receipt of an application, the cabinet shall inspect the hotel to determine compliance with the provisions of this administrative regulation.
(b) If the inspection reveals that the applicable requirements of this administrative regulation have been met, a permit shall be issued to the applicant by the cabinet.
(3) A permit to operate a hotel shall be renewed annually pursuant to KRS 219.021.
(4)
(a) An application for an annual permit to operate a hotel shall be accompanied by a fee of $100.
(b) A late renewal fee of fifty (50) dollars shall be assessed on all annual permit renewals that are postmarked beyond thirty (30) days of the expiration date.
(5) The fee assessed for the inspection of a hotel shall be assessed according to the total number of rooms of the establishment:
(a) One (1) to twenty-five (25) rooms - $150;
(b) Twenty-six (26) to fifty (50) rooms - $175;
(c) Fifty-one (51) to 100 rooms - $200;
(d) 101 to 200 rooms - $225;
(e) 201 to 300 rooms - $250;
(f) 301 to 400 rooms - $275;
(g) 401 to 500 rooms - $300;
(h) 501 to 600 rooms - $325; or
(i) 601 or more rooms - $350.
(6) Payment of Fees. Fees shall be paid to the local health department having juris-diction. Fees received by local health departments shall be deposited in the Kentucky State Treasury. Inspection fees shall be submitted with the application for a permit to operate.
Section 4. Hotel Water Supply and Ice.
(1)
(a) The water supply shall be potable, adequate, and from an approved public supply of a municipality or water district, if available.
(b) If a public water supply of a municipality or a water district is not available, the supply for a hotel shall be developed and approved in accordance with applicable requirements of 401 KAR Chapter 8.
(c) If a public water supply of a municipality or water district subsequently becomes available, connections shall be made to this supply, and the hotel supply shall be discontinued.
(2) Hot and cold or tempered water under pressure shall be provided in all bathrooms and toilet rooms.
(3) Ice used for any purpose shall be:
(a) Made from water that comes from an approved source; and
(b) Used only if it has been manufactured, stored, transported, and handled in a sanitary manner in accordance with the requirements of 401 KAR Chapter 8 and 902 KAR 45:005.
(4)
(a) Self-service ice provided for the hotel guest shall be dispensed through use of ice dispensing machines or prepackaged for individual hotel guests from an approved source in all hotels.
(b) Ice making equipment located in individual rooms shall not be prohibited.
(c) Self-service ice storage bins shall be prohibited.
(5) Ice machines shall be:
(a) Constructed of sanitary, durable, corrosion-resistant material that is easily cleanable;
(b) Located, installed, and operated to prevent contamination of the ice;
(c) Kept clean, free of any mold, rust, debris, or other contaminants;
(d) Maintained in good repair in accordance with the manufacturer's instructions; and
(e) Drained through an air gap.
Section 5. Hotel Sewage and Waste Disposal.
(1) All sewage and waste matter shall be disposed of into a public sewerage system, if available.
(2) If a public sewerage system is not available, disposal shall be made into a private system designed, constructed, and operated in accordance with the requirements of 902 KAR 10:085.
(3) If a public sewerage system subsequently becomes available, connections shall be made to this system, and the hotel sewerage system shall be discontinued.
Section 6. Toilet and Bathing Facilities.
(1) Each hotel shall be provided with adequate and conveniently located toilet and bathing facilities.
(2) Toilet and bathing facilities shall be provided for each sleeping room in accordance with 815 KAR 20:191.
(3) Toilet and bathing fixtures shall be of a sanitary design and readily cleanable.
(4) Toilets and bathing facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair.
(5) Toilet tissue shall be provided.
(6) Easily cleanable receptacles shall be provided for waste materials, and the receptacles in public toilet rooms for women shall be covered.
(7) Public restroom facilities for both sexes shall be provided when required by 815 KAR 20:191.
(8) The doors of all public restrooms shall be self-closing.
(9) Each hotel shall provide adequate, conveniently located hand-washing facilities at each toilet and bathroom and include hand-cleansing soap and approved sanitary towels or other approved hand-drying devices. These facilities shall be kept clean and in good repair.
(10) All plumbing in hotels shall comply with 815 KAR Chapter 20.
Section 7. Storage, Collection and Disposal of Hotel Refuse.
(1) All containers used in guest rooms, lobbies, hallways, and public assembly rooms for storage of refuse shall be constructed of materials that do not leak and do not absorb liquids. These containers shall be thoroughly cleaned on the inside and outside each time they are emptied unless liners are used.
(2) All outside storage containers shall be:
(a) Constructed of materials that do not leak and do not absorb liquids;
(b) Provided with tight fitting lids or covers; and
(c) Kept covered.
(3) Refuse containers shall be adequate for storage of all refuse accumulating on the premises.
(4) All refuse and waste collected at a hotel shall be disposed of in a safe and sanitary manner.
Section 8. General Construction and Room Layout.
(1) All structures used as hotels shall be of permanent, weatherproof construction with sound floors, walls, and ceilings.
(2) All walking, driving, and parking surfaces shall be graded to prevent the pooling of water.
(3) All habitable rooms, bathrooms, and halls shall have adequate lighting, ventilation, and heating as specified in this subsection.
(a) The heating system shall be capable of maintaining a temperature of sixty-eight (68) degrees Fahrenheit.
(b) Natural and artificial lighting for general cleaning purposes and safety of guests shall be at least five (5) foot-candles in guest rooms, stairways, and hallways.
(c) Lighting in reading areas of guest rooms and public meeting rooms shall be thirty (30) foot-candles.
(d) Lighting at bathroom mirrors shall be forty (40) foot-candles.
(4) Sleeping rooms shall have at least one (1) window to the outside air which can be easily opened unless other openings or mechanical devices are used for room ventilation.
(5) Windows that open to the outside air shall have screens to prevent the entry of insects and other vermin, and be maintained in good repair.
(6) All sleeping rooms shall have a door opening directly to the outside or into a hallway leading to the outside.
(7) All sleeping rooms shall be in compliance with KRS 219.111.
Section 9. Soap, Towels, Washcloths, Drinking Glasses, and Ice Containers.
(1) Rooms used for sleeping purposes shall be provided with soap, towels, washcloths, and drinking glasses.
(a) Two (2) clean towels and one (1) clean washcloth of adequate size shall be provided for each occupant.
(b) One (1) multiuse drinking glass or individual single-service cup shall be provided for each occupant.
(2) Ice storage containers, scoops, and drinking glasses, unless they are of the single-service type, shall be smooth, impervious material and designed to facilitate cleaning, and shall be stored, handled, and dispensed in a sanitary manner.
(3) Multiuse drinking glasses and ice containers shall be washed and sanitized according to procedures as set forth in 902 KAR 45:005.
(4) Hotels that do not have adequate and effective facilities for cleaning and sanitizing multiuse drinking glasses and ice containers shall use single-service articles. All single-service articles shall be:
(a) Stored, handled, and dispensed in a sanitary manner;
(b) Used only once; and
(c) Made from nontoxic materials.
(5) Multiuse drinking glasses or single-service containers placed in sleeping rooms shall be individually wrapped or stored on a clean surface in an inverted position.
Section 10. Hotel Beds and Bedding Accessories.
(1) Mattress pads or covers shall be used on all mattresses.
(2) Beds, mattresses, springs, slats, mattress pads, and covers shall be clean and free from vermin.
(3) Each bed shall be provided with two (2) sheets; and one (1) pillow and one (1) pillow case for each occupant.
(4) Sheets and pillow cases shall be kept clean and changed at least once per week or more often if necessary or when there is a new occupant.
(5) All beds shall be supplied with sufficient blankets or coverings to keep the occupant warm.
Section 11. Maintenance of Rooms, Furniture and Accessories. All sleeping rooms, hallways, lobbies, and other facilities shall be kept clean and in good repair. Furniture, drapes, curtains, and shades shall be kept clean and in good repair.
Section 12. Linen Storage. Adequate storage areas, rooms, or cabinets shall be provided for all supplies, linens, and equipment, and shall be kept neat, orderly, clean, and stored away from soiled linens.
Section 13. Vermin Control.
(1) Effective measures shall be taken to control vermin and other pests including their entrance into the hotel.
(2) All exterior areas shall be kept clean and free of debris that could provide rodent harborage or breeding places for flies, mosquitoes, or other pests.
(3) Guest rooms shall not be rented if infested with insects, rodents, or other pests, until the infestation is eliminated.
(4) Any application of pesticides shall be in accordance with 302 KAR Chapter 29.
Section 14. Poisonous and Toxic Materials. The hotel shall only use or store poisonous and toxic materials that are required to maintain sanitary conditions and for sanitization purposes. These materials shall be properly stored and identified and shall be used only in a manner and under conditions as will not constitute a hazard to employees or customers.
Section 15. Hotel Swimming Facilities. Any swimming or bathing facility provided for use by hotel occupants shall be constructed and operated in accordance with 815 KAR 7:120 and 902 KAR 10:120.
Section 16. Hotel Personnel.
(1) A person shall not work in any area of a hotel in any capacity while:
(a) Affected with, or a carrier of, any disease in a communicable form;
(b) Afflicted with boils, infected wounds, or sores; or
(c) Diagnosed with an acute respiratory infection.
(2) If there is a likelihood of a person contaminating bedding and other surfaces with pathogenic organisms, or transmitting disease to other individuals, the hotel manager or person in charge shall follow the procedures established in Section 17 of this administrative regulation.
(3) All employees shall:
(a) Wear clean outer garments;
(b) Maintain a high degree of personal cleanliness;
(c) Conform to hygienic practices while on duty; and
(d) Wash their hands thoroughly in an approved hand-washing facility before starting work, and as often as may be necessary to remove soil and contamination.
(4) All employees shall wash their hands after visiting the toilet, smoking, or eating before returning to work.
Section 17. Procedure when Infection is Suspected.
(1) If the hotel manager or person in charge has reason to suspect that any employee has contracted any disease in communicable form or has become a carrier of a communicable disease, the cabinet shall be notified immediately.
(2) If the cabinet has reasonable cause to suspect the possibility of disease transmission from any hotel employee, the cabinet shall secure a morbidity history of the suspected employee, or make other investigation as may be indicated and take appropriate action in accordance with subsection (3) of this section.
(3) The cabinet may require the following measures:
(a) The immediate exclusion of the employee from the hotel;
(b) Restriction of the employee's services to an area of the establishment where there would be no danger of transmitting disease; or
(c) Require adequate medical and laboratory examinations of the employee, or of other employees.
Section 18. Plan Review of Future Construction.
(1) A person shall not construct, alter, or convert an existing structure into a hotel unless the cabinet has approved the plans and specifications.
(2) The plans and specifications required in subsection (1) of this section shall:
(a) Be submitted to the cabinet; and
(b) Provide the following information:
-
The layout of the hotel;
-
The construction materials that will be used;
-
The fixed equipment; and
-
A plumbing riser diagram.
Section 19. Inspection of Hotels.
(1) At least once every twelve (12) months, the cabinet shall inspect each hotel and shall make additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) When an agent of the cabinet makes an inspection of a hotel, the findings shall be recorded on an official cabinet inspection report form, DFS-314, Hotel - Motel Inspection Form, and a copy provided to the permit holder or operator. The inspection report shall:
(a) Set forth the specific violations found;
(b) Establish a specific period of time for the correction of the violations found; and
(c) State that failure to comply with any notice issued in accordance with the provisions of this administrative regulation can result in suspension of the permit.
(3) If the cabinet or its agent is on notice that a hotel is in violation of another agency's lawful requirement, the permit shall not be renewed until the permit holder demonstrates to the cabinet or its agent that the violation has been corrected.
Section 20. Suspension of Permit.
(1) A hotel permit shall be suspended immediately upon notice to the permit holder if:
(a) The cabinet has reason to believe that an imminent public health hazard exists; or
(b) The permit holder has interfered with agents of the cabinet in the performance of their duties.
(2) If a permit has been suspended, the permit holder may request an administrative hearing in accordance with 902 KAR 1:400.
(3) A permit holder or operator who has failed to comply with any written notice issued under the provisions of this administrative regulation shall be notified in writing that the permit shall be suspended at the end of ten (10) days following service of the notice, unless a written request for a hearing is filed in accordance with 902 KAR 1:400.
Section 21. Reinstatement of Suspended Permits. Any person whose permit has been suspended may, at any time, make application for a reinspection for the purpose of reinstatement of the permit.
Section 22. Revocation of Permits.
(1) For serious or repeated violations of any of the requirements of this administrative regulation or for interference with the agents of the cabinet in the performance of their duties, the permit may be permanently revoked.
(2) Prior to revocation, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit is subject to revocation and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an appeal is filed in accordance with 902 KAR 1:400.
(3) A permit may be suspended for cause pending revocation.
Section 23. Incorporation by Reference.
(1) The "DFS-314, Hotel – Motel Inspection Form", 7/19, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Environmental Management Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.050, 219.011-219.041, 219.111, 219.991(1)
- STATUTORY AUTHORITY: KRS 194A.050(1),(3), 219.021, 219.041
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 194A.050(3) authorizes the secretary of the cabinet to establish a schedule of reasonable fees for permitting and inspection to ensure compliance with program standards administered by the cabinet. KRS 219.021 requires the cabinet to issue permits to operate a hotel and to establish a fee for an annual permit and permit renewal. KRS 219.041 requires the cabinet to adopt a State Hotel Code, which includes the requirements for the issuance, suspension, and revocation of permits to operate; submission of plans for construction and equipment layout; plumbing; lighting; ventilation; water supply; sewage disposal; sanitary standards for operation; and other matters deemed necessary to ensure a safe and sanitary operation of a hotel.
- History: 902 KAR 007:010. 1 Ky.R. 641; eff. 4-9-1975; Am. 16 Ky.R. 936; eff. 1-12-1990; 22 Ky.R. 2355; eff. 8-1-1996; 45 Ky.R. 3560; 46 Ky.R. 979, 1128; eff. 11-1-2019; Crt eff. 5-14-2026.
Chapter 8 Local Health Departments
902 KAR 8:040 Definitions for 902 KAR Chapter 8 {#sec-902-kar-8-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:040}
Section 1. Definitions.
(1) "Above minimum salary" means approval by the department for a minimum salary upon appointment for a specific classification which is higher than the minimum salary established by the Compensation plan or given for additional years of experience above what is required to qualify for the classification.
(2) "Agency" is defined by KRS 211.1751(1).
(3) "Annual Increment" means a yearly salary increase for performance based on annual evaluation as approved by the Board of Health not to exceed five (5) percent of the employee's current salary.
(4) "Appeal" means the right to appear before a hearing officer appointed by the department and be heard on matters of discrimination or disciplinary actions.
(5) "Appointing authority" means the board of health or public health department director authorized under KRS Chapter 212 to make appointments.
(6) "Cabinet" is defined by KRS 211.015(1)(a).
(7) "Certification of eligible applicants" means a list of individuals issued by the Department for Public Health to the agency certifying that the individuals listed meet the established minimum qualifications of the position, passed the required examination, if any, and may be considered for employment.
(8) "Class" means a group of positions similar as to the duties performed; degree of supervision exercised or required; minimum requirements of training, experience, or skill; and other relevant characteristics.
(9) "Classification plan" is defined by KRS 211.175(2).
(10) "Classified service" means employment subject to 902 KAR 8:060 through 902 KAR 8:130 except for:
(a) An employee appointed on a provisional, temporary, or emergency basis as described in 902 KAR 8:080;
(b) An employee appointed as a janitor; or
(c) An employee appointed under 902 KAR 8:080 to work a variable schedule as needed by an agency and whose hours of actual work do not exceed 800 hours per year.
(11) "Compensation plan" is defined by KRS 211.1751(3).
(12) "Compensatory time" means the accumulation of leave time for time worked on an hour-for-hour basis in excess of thirty-seven and one-half (37.5) hours per week subject to KRS Chapter 337 and the Fair Labor Standards Act, 29 U.S.C. 207.
(13) "Continuous open recruitment" means the local health department accepts applications at any time for a designated classification.
(14) "Council" is defined by KRS 211.1751(4).
(15) "Demotion" means a change of an employee from a position in one (1) class to a position in another class having a lower entrance salary and less discretion or responsibility.
(16) "Department" is defined by KRS 211.1751(5).
(17) "Detail to special duty" means the assignment of an employee to a position for not more than twenty-six (26) pay periods to fulfill the responsibilities of an employee on leave or the assumption of additional job duties which are temporary.
(18) "Discipline" means a practice to correct behavior or performance that is below acceptable standards.
(19) "Discrimination" means any administrative decision that violates KRS 344.040.
(20) "Eligible" means an individual whose name appears on a register for a particular class.
(21) "Emergency appointment" means the appointment of a person to a position, for a period not to exceed seven (7) pay periods, if an emergency makes it impractical or impossible to fill the position through standard appointment procedures.
(22) "Excessive absenteeism" means absences from the employee's work station or assigned place of work that cause the irregular attendance with or without approval of the agency; including:
(a) Tardiness;
(b) Leaving early;
(c) Abuse in the use of sick leave;
(d) Excessive unexcused absence that causes repetitive disruption of job performance and responsibilities of the employees and the agency;
(e) Abuse in the use of annual leave;
(f) Violating agency break policy; or
(g) Violation of agency lunch policy.
(23) "Exempt" means an employee in an executive, administrative, or professional position who receives an exemption from the minimum wage and overtime pay requirements under the Fair Labor Standards Act, 29 C.F.R. Part 541, based upon salary level, salary basis, and job duties.
(24) "Full-time employee" means an employee who works at least thirty-seven and one-half (37.5) hours in a work week and is compensated on a salary basis for a standard biweekly pay period.
(25) "In-Range adjustment" means an increase in an employee's salary because the employee's position duties and responsibilities have changed, but not to the extent that would warrant a reclassification.
(26) "Initial probationary period" means a minimum period of six (6) months that an employee is required to serve prior to becoming a regular employee in an agency.
(27) "Insubordination" means the refusal or the ignoring of a request to perform a task or to comply with an order given to the employee by a supervisor under circumstances where:
(a) The employee understands the order or request; and
(b) Refusal to perform is not justified by a reasonable safety concern.
(28) "Local health department" means an agency subject to 902 KAR 8:040 through 902 KAR 8:140.
(29) "Lump sum merit payment" means a single payment made to an employee based on that employee's outstanding job performance.
(30) "Midpoint" means the salary is equidistant between the minimum and maximum rates of salary compensation set for a classification.
(31) "Minimum qualifications" means a comprehensive statement which establishes the minimum background required as to education and experience.
(32) "Minimum salary" means the lowest rate of pay in the salary range for a class of positions.
(33) "Nonexempt" means the employee is required to receive minimum wage and overtime pay benefits under the Fair Labor Standards Act, 29 C.F.R. Part 541.
(34) "Part-time employee" means an employee who works an average of less than 100 hours per month
(35) "Partial year appointment" means the employment of a person to a position that shall contain regularly-scheduled hours, with a break of time not to exceed seven (7) pay periods per year, during which the incumbent remains an employee but is not at work.
(36) "Part-time 100 hour employee" means an employee who works an average of 100 hours per month or more.
(37) "Pay status" means a period of time for which an employee receives pay for:
(a) Time worked;
(b) A holiday; or
(c) Approved accumulated leave of absence, including:
-
Sick leave;
-
Extended sick leave;
-
Vacation, using annual or compensatory leave;
-
Military leave; or
-
Another type of paid leave provided by 902 KAR 8:120.
(38) "Performance evaluation" means a method of appraising each employee on the employee's capability of performing the duties and responsibilities of the job.
(39) "Position description" means a written narrative of responsibilities and duties for an individual employee that:
(a) The employee is expected to assume for a particular position; and
(b) Is in line with the job description for the designated classification.
(40) "Probationary employee" means an employee serving the required initial probationary period following appointment.
(41) "Promotional probationary period" means a period during which an employee is required to demonstrate knowledge of skill in the duties to which the employee has been promoted by actual performance of the duties of the position.
(42) "Reallocated" means the placement of an employee in one position to a newly established class, or to another class due to the employee's current class having been abolished.
(43) "Re-employ" means an employee who was laid off and has been recalled for employment to the same or another position based on needs of the agency. Re-employment rights last for one (1) year.
(44) "Register" means an officially promulgated list of eligible applicants for a job classification.
(45) "Regular status employee" means an employee who has successfully completed a required initial probationary period upon appointment, and any extension, and is subject to 902 KAR Chapter 8.
(46) "Reinstatement" means to return a former employee to a position which the employee held in previous employment.
(47) "Revert" means to return an employee to a previously held position.
(48) "Salary range" means the rate and range of pay established for a classification of positions.
(49) "Variable hour position" means the employee:
(a) Works irregular hours and does not follow a regular schedule for work; and
(b) Is paid per service or paid an hourly rate salary.
History
- RELATES TO: KRS 211.015, 211.170(1), (2), 211.1751, 212.170(4), 212.870, Chapter 337, 29 U.S.C. 207, 29 C.F.R. Part 541
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation establishes definitions for the terms used in 902 KAR Chapter 8.
- History: 19 Ky.R. 2760; 20 Ky.R. 367; 511; eff. 9-3-1993; 21 Ky.R. 580; eff. 9-21-1994; 23 Ky.R. 2192; 25 Ky.R. 566; eff. 8-19-1998; 27 Ky.R. 2250; 2806; eff. 4-9-2001; 37 Ky.R. 1767; 2161; eff. 4-1-2011; 46 Ky.R. 1698; eff. 2-27-2020; Crt eff. 9-2-2026.
902 KAR 8:060 Salary adjustments for local health departments {#sec-902-kar-8-060 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:060}
Section 1. Salary Upon Appointment.
(1) The entrance salary of an employee entering employment shall be at the minimum of the range established for the class to which the employee is appointed, unless otherwise approved by the department, based on the criteria established in subsections (2) and (3) of this section.
(2)
(a) Prior to the start date of a new employee, and upon approval by the department, a new minimum entrance salary may be established by an agency if it is determined that it is not possible to recruit qualified employees for a class of positions at the established entrance salary.
(b) If an appointment is made at the newly established minimum entrance salary, employees of the agency in the same class paid at a lower salary shall have their salaries adjusted to the newly established minimum entrance salary.
(c)
-
If a new minimum entrance salary is established by an agency for a specified class, in addition to the adjustment required by subsection (3) of this section, based on documented recruitment needs, or a new entrance salary is established by a compensation plan change, the department may approve a salary adjustment for employees in the same class.
-
The adjustment shall be a fixed amount provided to each employee in the classification and shall not exceed the amount of increase applied to the newly established minimum.
-
In fixing salaries for this adjustment, an appointing authority shall afford equitable treatment to all employees affected by the adjustment.
(3)
(a) An appointment of an applicant who meets the minimum requirements for a position may be above minimum salary within the salary range applicable to the class, if:
-
The newly appointed employee has previous, relevant experience above the minimum requirements of the job;
-
It is necessary to attract qualified applicants; and
-
The newly appointed employee's hire rate does not exceed the salary of a present employee in the same classification with the comparable years of relevant experience, education, and training.
(b) If the individual possesses qualifications in training and experience in addition to the minimum requirements for the class, the rate of pay may be between the classification minimum and midpoint for appointment.
(c) An employee possessing the same qualifications, in the same class of positions, in the same agency, and who is paid below the entrance salary level as adjusted for the newly appointed employee, shall have his or her salary adjusted to the approved entrance salary level plus five (5) percent.
Section 2. Initial Probationary Salary Adjustment.
(1) The appointing authority shall grant an employee a five (5) percent increase in salary upon successful completion of the required initial employment probationary period as established in 902 KAR 8:080 Section 9(2). The salary adjustment shall take effect the first pay period following completion of the probationary period.
(2) Except as established for in 902 KAR 8:080, Section 3(2)(a), an employee shall not be given an original probationary increment more than once for successful completion of the probationary period in the same classification.
Section 3. In-Range Salary Adjustment.
(1) An appointing authority may request a salary adjustment not to exceed five (5) percent if an employee is assigned permanent job duties and responsibilities that are more complex and difficult than current job duties and grade level, but are less than those indicated through a reclassification.
(2) Only one (1) in-range salary adjustment shall be allowed for an employee per classification.
(3) The appointing authority may request to remove the in-range salary adjustment if the in-range duties are removed. The salary shall be decreased by the equivalent dollar amount of the increase at the time of the in-range adjustment.
Section 4. Reclassification.
(1) A position shall be reclassified if the duties and responsibilities of a position have materially changed.
(2) An agency may request a reclassification of a regular status employee to a different position:
(a) Within the same classification series that has more complex nonsupervisory job duties and responsibilities and has a higher grade level; or
(b) In a different classification series that has the same or higher grade level.
(3) A regular status employee to be reclassified shall:
(a) Meet the minimum requirements of the new classification; and
(b) Have not previously performed the primary duties of the new classification.
(4) An employee who is reclassified with or without probation to a position having a higher pay grade shall receive a salary increase that is the higher of:
(a) Five (5) percent of the employee's current salary;
(b) Three (3) percent for each grade increase to the new position, not to exceed ten (10) percent; or
(c) The minimum salary of the grade assigned to the new position.
(5) A reclassified employee shall serve a probationary period of thirteen (13) pay periods if the reclassification is to a supervisory position or a different classification series within the same grade. If the employee has performed satisfactorily, as determined by the employee's supervisor, the employee shall receive a five (5) percent salary increase at the end of the probationary period.
Section 5. Promotion of an Employee to a Vacant Position.
(1) An employee may be promoted upon the request of an appointing authority if the employee meets the minimum requirements of the vacant position having a higher salary determined by the department to have more extensive and complex job duties and responsibilities.
(2) An employee who is advanced to a higher pay grade through a promotion shall receive a salary increase that is the higher of:
(a) Five (5) percent;
(b) Three (3) percent for each grade increase to the new position not to exceed ten (10) percent; or
(c) The minimum salary of the new position.
(3)
(a) The employee shall serve a promotional probationary period of thirteen (13) pay periods and, except as established in paragraph
(b) of this subsection, shall receive a five (5) percent salary increase following satisfactory completion of the probationary period, as documented by the performance evaluation; or
(c) If the employee was promoted while serving an initial probation, this shall be considered a new initial probation, and the probation timeline shall start again from the date of promotion.
Section 6. Demotion. If an employee is demoted, the appointing authority shall determine the salary in one (1) of the following ways:
(1) If an employee requests a voluntary demotion:
(a)
-
The employee's salary shall be reduced by five (5) percent for one (1) grade; or
-
For multiple grades, three (3) percent for each grade decrease not to exceed ten (10) percent; and
(b) The employee's salary shall be reduced by an additional three (3) percent if the voluntary demotion is to a position that no longer requires supervisory responsibilities;
(2)
(a) If the demotion is due to reorganization by the agency, the employee may retain the salary received prior to demotion. If the employee's salary is not reduced upon demotion and funding is sufficient, the appointing authority shall explain the reason in writing and place the explanation in the employee's personnel files; or
(b) The salary of an employee who is demoted because of a documented disciplinary problem or inability to perform a duty or responsibility required of the position shall be reduced by ten (10) percent of their current salary or to the minimum of the new grade; and
(3) The salary of an employee demoted as a result of documented unsatisfactory performance during the promotional probationary period shall be reduced to the level prior to promotion.
Section 7. Salary Upon Reinstatement of a Former Employee.
(1) A former employee may be reinstated to a position for which the employee was previously employed.
(2) The salary of an employee who is reinstated shall be at the higher of:
(a) The same pay rate the employee had been paid at the termination of service, if the time period between separation and reinstatement does not exceed three (3) years;
(b) The current established minimum entrance salary above the former salary; or
(c) Compensation plan changes.
Section 8. Salary Upon Re-employment.
(1) A former employee may be re-employed to a position for which the employee was previously employed up to one (1) year after separation.
(2) The salary of an employee who is re-employed shall be:
(a) At the same pay rate the employee had been paid at the termination of service, if the period between separation and re-employment does not exceed one (1) year; or
(b) In accordance with Section 6(1) of this administrative regulation if re-employed to a lower classification.
Section 9. Lump Sum Merit Payment.
(1) The appointing authority, with the approval of the department and as established in this section, may award a regular status, full-time, part-time 100 hour, or part-time employee an individual merit lump sum payment.
(2) The appointing authority may grant an individual lump sum merit payment to an employee meeting the eligibility criteria of this section in an amount not to exceed eight (8) percent of the employee's current salary or established minimum of the employee's classification grade during the annual evaluation period of twenty-six (26) pay periods.
(3) A lump sum merit payment may be granted by the appointing authority with the approval of the department, to an employee meeting the following eligibility criteria:
(a) The employee has completed the initial probationary period required on appointment; and
(b)
-
The employee's job performance is consistently above what is normally expected or required by the job duties and responsibilities; or
-
The employee has successfully completed a special project of significant importance to warrant special attention.
(4) The appointing authority shall prepare and submit written documentation to the department that shall substantiate that the employee satisfies the eligibility criteria in this section for the lump sum merit payment to be effective.
(5) The appointing authority shall inform the Board of Health of the number of lump sum merit payments granted during the fiscal year that exceed $2,000 per payment unless the payment is based on the 902 KAR 8:096 annual evaluation.
(6) An agency may grant a one (1) time across the board lump sum payment on a designated payroll during the fiscal year to all regular status employees in recognition of the agency exceeding expectations.
(a) The flat amount per employee shall not exceed $1,500; and
(b) The appointing authority shall receive prior approval from the Board of Health and the department.
Section 10. Detail to Special Duty.
(1) A regular status employee may be detailed to special duty on a temporary basis, not to exceed twenty-six (26) pay periods, to:
(a) Occupy a position and assume the job duties and responsibilities of an employee on an approved leave of absence or an employee who has separated from the agency; or
(b) To undertake a special project assigned by the appointing authority in addition to the employee's regular duties and responsibilities.
(2) An employee who is approved for detail to special duty shall receive a salary increase of five (5) percent during the detail to special duty.
(3) After completion of the special assignment, the employee shall be transferred to the classification or resume normal duties with the employee's salary reduced by an equivalent dollar amount of the increase at the time of the appointment to special duty.
(4) An employee shall be entitled to salary increases provided by the agency during the special assignment.
Section 11. Educational Achievement and Skill Enhancement Pay.
(1) The job-related skill enhancement pay shall be granted to recognize and reward an employee who takes the initiative through his or her own efforts to increase job worth and significantly enhance his or her value to the agency by achieving a higher level of performance through a course of study in the employee's job field.
(2) An agency may elect not to participate in the educational achievement program if sufficient funds are not available.
(3) An employee shall not receive more than one (1) educational achievement salary increase.
(4) An appointing authority may grant a five (5) percent increase to an employee's salary for obtaining a high school diploma, high school equivalency certificate, or a passing score on the GED test:
(a) Outside of work hours; and
(b) While in the employment of the agency.
(5) An appointing authority may grant a five (5) percent increase to an employee's salary for postsecondary education or training if:
(a) The department has determined the employee has completed 260 hours of job-related classroom instruction;
(b) The employee began the course work after becoming an employee of the agency and completed the course work after establishing an increment date;
(c) The employee has completed the course work within five (5) years of the date on which it began;
(d) The course work has not previously been applied toward an educational achievement award;
(e) The agency has not paid for the course work or costs associated with it; and
(f) The employee was not on educational or extended sick leave when the courses were taken.
(6) An appointing authority may grant, with the approval of the department, an employee a lump sum merit payment not to exceed three (3) percent of the employee's grade minimum to an employee that presents a certificate, license, or other evidence of mastering a body of knowledge obtained through a course of study that is directly related to the position held and based on this evidence is identified as an approved program by the department.
(7) The salary adjustment for educational achievement shall not include on-the-job training provided by or required by the agency as part of the assigned job duties and responsibilities.
Section 12. Other Salary Adjustments.
(1)
(a) An agency may submit a request to the department substantiating the need for a specific salary adjustment for a regular status employee in classified service to address:
-
Compensation issues of the agency that negated the ability of the agency to commit available financial resources to salary adjustments based on the most recent compensation plan changes;
-
Special working conditions;
-
After hours adjustment if working hours cannot be adjusted;
-
Internal or external equity issues among individual employees or groups of employees; or
-
Other specific circumstances.
(b) The request shall address:
-
The nature of the salary issue;
-
The consequences of the salary issue;
-
Recommendation of an equitable resolution; and
-
Other pertinent information substantiating the need for the salary adjustment.
(c) The department may undertake a review of the request to determine the validity of the request, the impact on the submitting agency, and the impact on other agencies.
(2)
(a) An agency may grant a one (1) time salary adjustment for all employees during the fiscal year to:
-
Respond to retention and recruitment needs and issues of the agency based on the inability of the agency to attract and maintain a qualified workforce in order to provide services; or
-
Place the agency in a more favorable competitive market and equity position based on an assessment of comparable agencies.
(b) The salary adjustment shall be a set amount given to an employee determined by:
-
Applying an amount not to exceed five (5) percent to the employee's grade minimum;
-
Applying an amount not to exceed five (5) percent to the employee's grade midpoint; or
-
Specifying a fixed hourly amount that would be provided to an employee.
Section 13. Discretionary Salary Increases.
(1) The appointing authority may grant, with the approval of the department, a salary increase not to exceed five (5) percent for a regular status employee or employees who have demonstrated, based on the current performance evaluation, excellent performance and achievement. This increase shall be limited to one (1) increase per evaluation year.
(2) The Board of Health may grant a salary increase for a regular status public health director or administrator who has demonstrated, based on the current performance evaluation, excellent performance and achievement. The increase shall be limited to one (1) increase per evaluation year.
History
- RELATES TO: KRS 211.170(1), (2), 211.1751, 211.1752, 211.1755, 212.170, 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures of the local health department personnel program. This administrative regulation establishes the policies and procedures regarding salary adjustments for local health departments.
- History: 908 KAR 008:060. 19 Ky.R. 2763; 20 Ky.R. 369; 513; eff. 9-3-1993; 21 Ky.R. 582; 1324; eff. 10-19-1994; 22 Ky.R. 1156; eff. 2-12-1996; 24 Ky.R. 2194; 25 Ky.R. 108; 568; eff. 8-19-1998; 27 Ky.R. 2252; 2807; eff. 4-9-2001; 32 Ky.R. 976; 1662; eff. 3-9-2006; 37 Ky.R.1769; 2163; eff. 4-1-2011; 46 Ky.R. 1701; eff. 2-27-2020; 48 Ky.R. 3076; 49 Ky.R. 571; eff. 9-28-2022; 52 Ky.R. 1426, 1816; eff. 7-16-2026.
902 KAR 8:070 Recruitment, examination, and certification of eligible applicants for local health departments {#sec-902-kar-8-070 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:070}
Section 1. Announcement of a Vacant Position.
(1) An agency, prior to announcing a specific vacancy, shall determine whether to recruit for a vacant position on a scheduled basis or on a continuous basis for positions that are difficult to recruit and fill with qualified applicants.
(2) Except as established in 902 KAR 8:090, Sections 1 and 2, and 902 KAR 8:080, Section 3, an agency desiring to fill a vacant position shall announce the vacant position by:
(a) Providing notice of the vacant position within the agency in a manner that affords the ability of current employees to know of the vacancy and procedures for submitting an application;
(b) Providing notice of the vacant position through recruitment resources that are external to the agency; or
(c) A combination of paragraphs (a) and (b) of this subsection.
(3) An announcement shall contain:
(a) The conditions under which an application for potential employment will be received;
(b) The assessment method utilized to select the individual, which may include an interview or demonstration of skills and abilities;
(c) The title and minimum salary or approved salary range of the class of position;
(d) A general statement of the duties to be performed;
(e) The minimum qualifications of education, training, and experience required as stated in the classification plan;
(f) The date, if required, on which an application is to be received in the agency; and
(g) If an agency requires pre-employment drug testing, criminal records information, physical examination, or other special conditions, a statement that they shall be required upon an offer of employment.
(4) The notice of the external recruitment effort shall meet the criteria of subsection (3) of this section and shall be distributed to one (1) or more of the following advertising methods:
(a) Newspapers;
(b) Web site;
(c) Other media viewable by the public;
(d) Employment services offices;
(e) Educational institutions;
(f) Professional and vocational societies; or
(g) Other media, individuals, and organizations as appropriate.
Section 2. Application for Employment Submittal and Review Process.
(1) The agency shall be the custodian of applications.
(2) An applicant shall apply for employment electronically at https://chfs.wd12.myworkdayjobs.com/CHFS.
Section 3. Review of Applications by the Department.
(1) The department shall review and determine the eligibility of an applicant for a position announced by an agency.
(2)
(a) The department shall take one (1) or more of the actions listed in paragraph (b) of this subsection if an applicant, eligible, or appointee:
-
Lacks a specific requirement established for the assessment for the class or position;
-
Is unable to perform the duties of the class;
-
Makes a false statement or misrepresentation in the application;
-
Has used or attempted to use political pressure or bribery to secure an advantage in obtaining the position in the examination or appointment;
-
Has directly or indirectly obtained information regarding the assessment method to which the applicant was not entitled;
-
Has failed to submit a complete application;
-
Has failed to submit the application by the end date established by the agency in a published announcement;
-
Has taken part in the compilation or administration of the interview process;
-
Has submitted an application for an unadvertised position to an agency that is not on continuous open recruitment; or
-
Has failed a background check or drug screen.
(b) Based on one (1) or more of the reasons listed in paragraph (a) of this subsection, the department shall take any of the following actions:
-
Refuse to examine an applicant;
-
Not qualify an applicant;
-
Remove the applicant's name from a register;
-
Refuse to certify an eligible on a register; or
-
Consult with the appointing authority in taking steps to remove a person already appointed.
(3) An applicant or employee who has been convicted of a misdemeanor or felony may be employed, or continue employment, if the appointing authority and the department determine after review that:
(a) The applicant is highly qualified and eligible for appointment;
(b) The misdemeanor or felony conviction will not adversely affect the applicant's job performance;
(c) A specific need exists for the appointment or continuing appointment of this applicant or employee; and
(d) Every determination made is fully supported by written documentation available for public inspection under the provisions of KRS 61.872.
(4) A disqualified applicant shall be promptly notified of the action in writing.
Section 4. Establishment of Registers of Eligible Applicants.
(1) An agency may announce a position on a continuous basis for a position that is difficult to recruit for and fill.
(2) A qualified individual may remain on the register for a period not to exceed six (6) months from the date the individual is determined qualified.
(3) If a vacancy exists in a class of positions for which there is no appropriate register, the department may certify a new register for the class from a previous existing register.
(4) The department may remove the name of an eligible from a register:
(a) For a disqualifying cause established in Section 3(2)(a) of this administrative regulation;
(b) On receipt of a statement from the eligible stating that he or she no longer desires consideration for a position;
(c) If an offer of a probationary appointment to the class for which the register was established has been declined by the eligible;
(d) If the eligible declines an offer of appointment for which the eligible previously indicated acceptance;
(e) If the eligible fails to report for a scheduled interview without valid reason; or
(f) If an eligible has not been offered employment within six (6) months of the application.
(5) If an eligible receives a probationary appointment, the eligible shall be removed from the applicable register unless otherwise requested in writing.
Section 5. Issuance of Certification of Eligible Applicants.
(1) The department shall issue a certification of eligible applicants to an agency in the form of:
(a) A promotional certification of eligible applicants who responded to an announcement provided within an agency;
(b) A regular certification of eligible applicants that responded to an announcement provided to recruitment resources external to the agency; or
(c) A combination of paragraphs (a) and (b) of this subsection.
(2) The certification of eligible applicants shall expire sixty (60) days from the date of issue unless otherwise stated on the certification of eligible applicants.
(3) A regular status employee, placed in a layoff category, shall be considered in filling a vacancy in a classified position for which the employee is qualified in the agency from which the employee was laid off, for up to one (1) year.
(4) A regular status employee in the layoff category shall indicate in writing to the agency that he or she desires reemployment.
(5) If a laid-off regular status employee desires reemployment in a different job classification, the employee shall meet the minimum requirements of the classification.
Section 6. Assessment Method.
(1) An assessment method shall be practical in nature, constructed to reveal the capacity of the applicant for the particular position, as well as general background and related knowledge. An assessment method may be:
(a) A personal interview;
(b) Physical examination;
(c) An evaluation of experience and training;
(d) A demonstration of skill; or
(e) A combination of the methods established in paragraphs (a) through (d) of this subsection, if all applicants for a position are given the same assessment method.
(2) An agency may form an interview committee to evaluate an eligible applicant through a structured interview process.
(3) The interview committee shall structure questions to assess the knowledge, skills, abilities, education, and work experience of the applicants chosen to be interviewed.
(4) The interview questions, criteria for selecting applicants to be interviewed, profiles of interviewed applicants, and results of the interview process shall be maintained by the agency for a period of at least thirteen (13) months after an applicant has been appointed to the vacant position.
Section 7. Incorporation by Reference.
(1) "Application for Employment", form CH-36, January, 2021, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Division of Administration and Financial Management, 275 East Main Street, Frankfort, Kentucky, 40621, Monday through Friday, 8 AM to 4:30 PM.
(3) This material is also available at the agency's website at: https://chfs.wd12.myworkdayjobs.com/CHFS.
History
- RELATES TO: KRS 61.872, 211.170(1), (2), 211.1751, 212.170, 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations that establish policies and procedures for the personnel program for local health departments. This administrative regulation establishes a recruitment program, procedures, and standards for the recruitment, examination, and certification of individuals for potential employment by local health departments.
- History: 902 KAR 008:070. 19 Ky.R. 2765; 20 Ky.R. 371; eff. 9-3-1993; 21 Ky.R. 584; 1053; eff. 9-21-1994; 22 Ky.R. 1159; eff. 2-12-1996; 24 Ky.R. 2197; 25 Ky.R. 110; 570; eff. 8-19-1998; 27 Ky.R. 2254; 2809; eff. 4-9-2001; 32 Ky.R. 981; 1666; eff. 3-9-2006; 37 Ky.R. 1773; 2166; eff. 4-1-2011; 46 Ky.R. 1954, 2450; eff. 3-19-2020; 52 Ky.R. 1429, 1818; eff. 7-16-2026.
902 KAR 8:080 Initial appointment, probationary period, layoffs, performance evaluation, and the resignation of employees of local health departments {#sec-902-kar-8-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:080}
Section 1. Initial Appointments.
(1) The appointing authority of a local health department shall make an initial appointment of an eligible applicant from a certification of eligible applicants issued by the department.
(2) The reemployment of a person shall be an initial appointment if the person:
(a) Was formerly employed by an agency; and
(b) Is receiving retirement benefits from the:
-
Kentucky Public Pensions Authority; or
-
Kentucky Teachers Retirement System.
Section 2. Provisional Appointments.
(1) If there is an urgent reason for filling a position and no appropriate register exists, the appointing authority may submit to the department the name of a person to fill the position pending establishment of a register. If the person's qualifications have been certified by the department as meeting the minimum qualifications, the person may be provisionally appointed to fill the existing vacancy.
(2) A provisional appointment shall not:
(a) Be made until the position has been classified and minimum qualifications established for the class of position; and
(b) Exceed thirteen (13) pay periods from the date of appointment.
(3) Successive provisional appointments of the same person shall not be allowed.
(4) Provisional service immediately prior to initial appointment may be credited, at the request of the appointing authority, toward the required probationary period.
Section 3. Reinstatement.
(1)
(a) For a period of time not to exceed thirty-six (36) months since termination of employment from an agency, a regular-status employee who resigned in good standing or separated without prejudice, shall be eligible for reinstatement to the same position or in a corresponding position within the agency, with the same seniority rights and leave status.
(b) The individual being considered for reinstatement shall be certified by the department as meeting the current minimum qualifications.
(c) The individual being considered for reinstatement shall not be required to serve an initial probationary period if the employee has had a break in service of not more than twelve (12) months.
(d) The accumulated balance of sick leave earned during prior employment with the agency shall be reinstated upon employment, and the period of time of prior employment with the agency shall be used to determine the rate at which the employee earns annual leave.
(2)
(a) If the employee has had a break in service of more than twelve (12) months and the break in service does not exceed thirty-six (36) months, the employee shall serve an initial probationary period and be eligible to receive a probationary increment based on satisfactory performance.
(b) If the employee satisfactorily completes the initial probationary period, the accumulated balance of sick leave earned during prior employment with the agency shall be reinstated and the period of time of prior employment with the agency shall be used to determine the rate at which the employee earns annual leave.
(3) The annual increment date shall be twenty-six (26) pay periods from the effective date of reinstatement.
Section 4. Emergency Appointments.
(1)
(a) If an emergency exists that requires the immediate services of one (1) or more persons and it is not possible to secure a person from an appropriate register, or there is no person qualified for a provisional appointment, the appointing authority may appoint, as established in this section, a person with the approval of the department.
(b) An emergency appointment shall not exceed seven (7) pay periods in duration and shall not be renewable.
(c) The department may make investigations as necessary to determine if an emergency exists.
(2) The appointing authority shall report an emergency appointment to the department, providing the name of the appointee, rate of pay, length of employment, nature of emergency, and duties to be performed. Separation from service of an emergency appointee shall also be reported.
(3) An emergency appointment shall not confer upon the incumbent a privilege or right to promotion, transfer, salary adjustment, or reinstatement to a position under the merit system.
(4) An individual appointed to an emergency position shall be considered in the unclassified service, and continued employment shall be based on the current employment needs of the agency.
Section 5. Temporary Appointment.
(1) The appointing authority may, with the approval of the department, establish a position on a temporary basis for up to nineteen (19) pay periods to accommodate:
(a) Increased work activity of a seasonal nature;
(b) Work study or job training programs;
(c) Special projects; or
(d) Summer employment.
(2) An applicant shall not be appointed to a temporary position unless the applicant meets established minimum requirements.
(3) Continuous appointments to the same temporary position shall not be made.
(4) The period of temporary service shall not constitute a part of the initial employment probationary period.
(5) An individual appointed to a temporary position shall be considered in the unclassified service, and continued employment shall be based on the current employment needs of the agency.
Section 6. Appointment of an Individual to a Variable Hour Position.
(1) An agency, because of special working requirements in meeting programmatic service needs, may establish a position having variable hours of work.
(2) An agency may appoint to a variable hour position an individual who meets the minimum requirements of education and experience established for the position.
(3) The hours of work of the individual shall not exceed 800 hours per year.
(4) An individual appointed to the variable hour position shall be considered in the unclassified service, and continued employment shall be based on the current employment needs of the agency.
(5) The compensation of the individual employed shall be determined by the appointing authority.
Section 7. Partial year Appointment.
(1) An agency may establish a partial year position to accommodate foreseeable seasonal fluctuations in staffing, budgetary, operational, programmatic, or other needs.
(2) An employee in a designated partial year position shall receive the following agency provided benefits:
(a) Health and life insurance benefits provided by the agency for full-time and part-time 100-hour employees;
(b) Sick and annual leave, in accordance with 902 KAR 8:120, Sections 2 and 4, for pay periods the employee actually works;
(c) Enrollment in the Kentucky Employee Retirement System and receipt of appropriate service credit for those pay periods of actual work; and
(d) Service credit for computation of seniority for those pay periods the employee has actually worked.
(3) The employee in a designated partial year position shall be considered a regular-status employee following completion of the initial probationary period in accordance with Section 9 of this administrative regulation.
(4) The employee in a designated partial year position shall:
(a) Work the required number of hours, unless the employee is absent due to illness or needing to provide care for an immediate family member; and
(b) Work at the request of the agency during periods of nonwork to cover during coworker periods of illness, vacation schedules, and other periods of agency demand.
Section 8. Performance Evaluation.
(1) Effective July 1, 2030, all local health departments shall use the performance evaluation system provided in 902 KAR 8:096.
(2) Between July 1, 2026 and July 1, 2030, the appointing authority or designated supervisory staff shall conduct a performance appraisal pursuant to this administrative regulation.
(a) Regular status employee on an annual basis; and
(b) Probationary employee prior to completion of the required probationary period.
(3) An employee who receives a rating of "meets requirements," "exceeds requirements," or "outstanding," shall receive the Board of Health approved annual increment not to exceed five (5) percent of the employee's salary.
(4) An overall rating of "below requirements" or "inadequate" shall require that a new rating of the employee be made within ninety (90) days.
(a) If the employee performance has improved, the appointing authority shall approve the annual increment as approved by the Board of Health.
(b) If employee has not improved or performance deteriorates, the appointing authority shall initiate a disciplinary action.
(c) An employee shall be notified by the appointing authority in writing at least fourteen (14) days prior to the annual increment date if the employee:
-
Is denied an annual increment; or
-
Only receives a portion of the annual increment.
(5) Performance evaluations shall be considered in determining:
(a) An annual and probationary salary advancement;
(b) Requesting and approving a:
-
Promotion;
-
Demotion; or
-
Dismissal; and
(c) The order of separation due to a reduction of work force.
(6) Each agency shall elect, by Board of Health vote, to participate in one (1) of the following employee performance evaluation programs:
(a) The current employee performance evaluation established in this section; or
(b) The evaluation program established in 902 KAR 8:096.
(7) Until July 1, 2030, an agency utilizing the evaluation process established in this section may remain under this section, unless the agency, by vote of the Board of Health, elects to participate in the provisions of 902 KAR 8:096 at the beginning of a subsequent fiscal year.
(8) Prior to July 1, 2030an agency, by vote of the Board of Health, that elects to participate in the employee evaluation program of 902 KAR 8:096, shall notify the department at the beginning of the new fiscal year.
Section 9. Initial Probationary Period.
(1) An employee shall be required to serve a probationary period upon initial employment.
(2) The initial probationary period shall be thirteen (13) pay periods, except as established in subsection (7) of this section.
(3) If the employee has satisfactorily completed the initial probationary period based on a performance evaluation, the appointing authority shall notify the department at least seven (7) days prior to the expiration of the initial probationary period that regular status has been confirmed.
(4) An employee may be separated from the employee's position during the initial probationary period and shall not have the right to appeal, except as established in 902 KAR 8:110, Section 1(3).
(5)
(a) Except as established in paragraph (b) of this subsection, if an employee is to be dismissed during the initial probationary period, the employee shall be notified in writing at least seven (7) calendar days prior to the effective date of dismissal and prior to the expiration of the probationary period.
(b) If the employee commits a serious infraction of agency policy as established in 902 KAR 8:100, Section 4, the employee shall be dismissed in writing immediately without pay.
(6) Unless the appointing authority notifies the employee in writing a minimum of seven (7) calendar days prior to the end of the initial probationary period that the employee is separated, the employee shall be deemed to have served satisfactorily and shall acquire regular status in the classified service.
(7) The initial probationary period may be extended:
(a) For the same length of time as leave granted to cover an absence due to medical reasons causing the employee to be absent from work for twenty (20) days or more during the probationary period;
(b) If the employee, acting with due diligence, has been unable to complete a required job related training course during the probationary period; or
(c) If the appointing authority requires an initial probationary period in excess of thirteen (13) pay periods, not to exceed a total probationary period of twenty-six (26) pay periods, for determination of competency.
(8) An employee whose initial probationary period is extended in accordance with subsection (7)(c) of this section shall be notified of the extension a minimum of seven (7) calendar days prior to the initial probationary period end date.
(9) The employee serving a probationary period may be eligible for promotion to a position in a higher class. If an employee is promoted during a probationary period, the new probationary period shall begin with the date the employee was promoted.
Section 10. Resignations.
(1) An employee who terminates service with an agency shall submit a written resignation or notice of retirement to the appointing authority.
(2) The written resignation or notice of retirement shall be submitted at least fourteen (14) calendar days before the final working day. A copy of an employee's written resignation or notice of retirement shall be filed in the employee's personnel file.
(3) An employee's lump sum payment for accumulated annual leave may be held by an agency until the employee who has resigned, retired, or been dismissed, returns agency credit cards, keys to buildings and automobiles, or other agency property in the possession of the employee.
Section 11. Voluntary and Involuntary Furlough.
(1) An agency may implement a voluntary or involuntary furlough program as part of a layoff plan established in Section 12 of this administrative regulation.
(2) A voluntary or involuntary furlough shall be considered a temporary non disciplinary leave without pay, for a stated period of time if major organizational program and funding changes occur that could result in work reductions of one (1) or more employees of an agency.
(3) A furlough may apply to the entire agency, certain organizational units of the agency, or to one (1) or more employees as the need arises.
(4) A furlough may be for periods of up to twenty-two (22) working days per fiscal year. The furlough may be designated as one (1) continuous period of twenty-two (22) working days or may be discontinuous days or periods, including portions of days.
(5) Employees shall not be paid for days while on furlough. If the furlough is for a continuous period:
(a) An employee's benefits shall not be adversely affected, except for:
-
Retirement contributions shall be based on actual earnings;
-
Holidays that occur during a consecutive furlough period shall not be paid;
-
Annual leave, compensatory time, and sick leave shall not be used; and
-
Medical, dental, life insurance, and flexible spending accounts shall continue to be in effect upon payment of required contributions by the employee; and
(b) Accrual of annual and sick leave, anniversary dates, and seniority shall be treated as if the employee is in pay status for the duration of the furlough.
(6) An employee who is interested in being placed in a voluntary furlough status shall request prior approval from the appointing authority. The request shall include the reason for and the manner in which the employee proposes to use the furlough period that may include:
(a) Shorter work days;
(b) Intermittent days off; or
(c) Consecutive days off.
(7) An appointing authority may direct an employee to be placed in a furlough status instead of a layoff status. The written notice of the required furlough shall:
(a) Be received at least fifteen (15) calendar days prior to the beginning date of furlough;
(b) Include the period of the furlough and if the furlough is continuous or non-continuous;
(c) Include the status of employee benefits; and
(d) State that failure to return to work after the completion of the mandatory furlough may be grounds for disciplinary action, up to and including dismissal from employment.
Section 12. Layoffs.
(1) An agency shall have a Board of Health approved workforce reduction plan on file with the department to lay off an employee in the classified service if necessary because of:
(a) Curtailment of work;
(b) Shortage of funds;
(c) Abolishment of a position;
(d) Modification of service requirements; or
(e) Other material change in the duties or organization of the agency.
(2)
(a) Prior to the notification of an employee that he or she is subject to layoff and prior to the layoff of an employee, the appointing authority shall submit a layoff plan to the department for approval.
(b) The plan shall contain the names of the employees, months of service, and the reasons, in detail, for the layoff and criteria used to select those employees subject to layoff.
(c) Upon written approval of the plan by the department, the employee shall be notified that the employee is subject to layoff and of the:
-
Reason for the layoff;
-
Procedures established for the layoff of employees; and
-
Rights granted employees subject to layoff.
(3) An agency established under KRS 212.040 shall undertake the procedures established in paragraphs (a) through (d) of this subsection, in assisting an employee subject to layoff.
(a) An employee subject to layoff shall be transferred to a vacant position of the same pay grade, level of duties, and responsibilities for which the employee is qualified within the agency.
(b) If a vacancy does not exist for a position of the same pay grade, level of duties, and responsibilities for which the employee is qualified within the agency, the employee shall be notified of all vacant positions within the agency for which the employee is qualified.
(c) The employee shall have the right to be appointed to a vacant position within the agency for which the employee is qualified before another applicant or eligible on a register.
(d) If no position is available to an employee subject to layoff, the employee shall be notified in writing:
-
That the employee is to be laid off effective at least fifteen (15) calendar days after receipt of the notice; and
-
Of the rights and privileges granted laid-off employees.
(4) An agency established under KRS 212.850 shall undertake the following procedures in assisting an employee subject to layoff:
(a) An employee subject to layoff shall be transferred to a vacant position of the same pay grade, level of duties, and responsibilities for which the employee is qualified within the agency. The position shall be located in the same county as the position from which the employee is subject to layoff;
(b) If a vacancy does not exist for a position of the same pay grade, level of duties, and responsibilities for which the employee is qualified within the same county as the position from which the employee is subject to layoff, the employee shall be transferred to a vacant position within the agency for which the employee is qualified. The position shall be located in the same county as the position from which the employee is subject to layoff;
(c)
-
If a position is not available, the employee shall be notified of all vacant positions within the agency for which the employee is qualified.
-
The employee shall have the right to be appointed to a vacant position within the agency for which the employee is qualified.
-
The employee shall have the right to be appointed to a vacant position within the agency for which the employee is qualified before another applicant or eligible on a register; and
(d) If no position is available to an employee subject to layoff, the employee shall be notified in writing:
-
That the employee is to be laid off effective at least fifteen (15) calendar days after receipt of the notice; and
-
Of the rights and privileges granted laid-off employees.
(5) In the same agency, county, and job classification, provisional, temporary, emergency, and probationary employees shall be laid off before regular full-time or regular part-time employees with status. An employee serving a promotional probation shall not be considered a probationary employee for purposes of layoff.
(6) If two (2) or more employees subject to layoff in a layoff plan submitted to the department have the same qualifications, the employee with the lesser seniority shall be laid off first.
(7) An employee who is laid off, upon written request, shall be considered for the class of position from which the employee was laid off and for any class for which the employee is qualified.
(8) For a period of one (1) year, a laid-off employee shall be given priority consideration by the agency before another applicant or eligible except another laid-off employee with greater seniority.
(9) For a period of one (1) year, a laid-off employee shall not be removed from a register unless the employee:
(a) Notifies the agency in writing that the employee no longer desires consideration for a position on a register;
(b) Declines two (2) written offers of appointment to a position of the same classification and salary, and located in the same county or agency, as the position from which the employee was laid off;
(c) Without good cause, fails to report for an interview after being notified in writing at least ten (10) calendar days prior to the date of the interview;
(d) Is unable to perform the duties of the class;
(e) Has been convicted of a job-related misdemeanor; or
(f) Cannot be located by postal authorities at the last address provided by the laid-off employee.
History
- RELATES TO: KRS 211.170(1), (2), 212.040, 212.850, 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation establishes employment categories of permissible appointments, employment probationary periods, and an employee evaluation process.
- History: 902 KAR 008:080. 19 Ky.R. 2768; 20 Ky.R. 373; 514; eff. 9-3-1993; 21 Ky.R. 587; eff. 9-21-1994; 24 Ky.R. 2200; 25 Ky.R. 113; 572; eff. 8-19-1998; 27 Ky.R. 2257; 2811; eff. 4-9-2001; 32 Ky.R. 985; 1437; 1670; eff. 3-9-2006; 37 Ky.R. 1776; 2168; eff. 4-1-2011; 46 Ky.R. 1704; eff. 2-27-2020; 52 Ky.R. 1432, 1820; eff. 7-16-2026.
902 KAR 8:090 Promotion, transfer, and demotion of local health department employees {#sec-902-kar-8-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:090}
Section 1. Promotion.
(1) An employee may be promoted to a higher grade at any time upon the request of an appointing authority if the employee meets the minimum requirements of the position as determined by the department.
(2) The promotion of an employee shall be based upon individual performance, with due consideration for length of service and capability of the individual employee to perform the duties and responsibilities of the new position.
(3) A promoted employee shall serve a probationary period of thirteen (13) pay periods, to determine through performance evaluation, if the employee can satisfactorily perform the duties and responsibilities of the position.
(4) An employee who satisfactorily completes the required promotional probationary period of thirteen (13) pay periods, as documented by the performance evaluation, shall receive a three (3) percent increase in salary.
(5)
(a) A regular status employee may be promoted from a classified position to an unclassified position.
(b) If separated from an unclassified position following promotion, an employee shall revert to the class in which the employee previously held status.
(c) If there is no vacancy in that class, the employee may be reverted to a position for which the employee is qualified and certified by the department, or separated from employment if a position is not available.
(d) Time served in an unclassified position shall count towards years of service and seniority.
(e) The employee shall retain eligibility to earn annual, sick, and compensatory time, if applicable, and also receive agency provided benefits.
(6) If an employee is granted leave for medical reasons in excess of twenty (20) work days during the promotional probationary period, the employee's probationary period shall be extended for the same length of time as the granted leave to cover the absence.
(7) A performance evaluation shall be completed for an employee fourteen (14) calendar days prior to completing the probationary period in order to determine the employee's ability to perform the job duties successfully.
(8) An employee who has been promoted, but fails to successfully complete the probationary period, as documented by the performance evaluation conducted by the appointing authority or designated supervisory staff, shall revert to a position in the former class subject to subsection (9) of this section. Documentation for the unsuccessful completion shall be provided to the employee and the department.
(9) If approved by the appointing authority, a promoted employee may request, during the probationary period, to be reverted to a position in the former class. The employee may revert to a position in a different class if:
(a) There is no vacancy in the former class;
(b) The employee is qualified; and
(c) The employee is determined eligible by the department.
(10) If a regular employee in the classified service is dismissed for cause while serving a promotional probationary period, the employee shall have the right to appeal the dismissal in accordance with 902 KAR 8:110.
Section 2. Transfers.
(1) The appointing authority may, at any time, transfer a regular employee from a position in one (1) organizational subdivision to a position of the same class in another organizational subdivision within an agency.
(2) A transfer of a regular employee from a position in one (1) class to a position in another class within an agency having the same entrance salary may be made only with the approval of the appointing authority and upon determination of eligibility and certification by the department.
(3) An employee of one (1) agency shall not transfer to another agency without prior approval of each appointing authority. If the transfer is approved:
(a) Accumulated annual and sick leave shall be transferred;
(b) Accumulated compensatory leave shall be paid in lump sum by the sending agency; and
(c) The annual increment date shall be retained by the employee.
Section 3. Demotions.
(1) An employee may be demoted for one (1) of the following reasons:
(a) Documented unsatisfactory employee performance during the promotional probationary period;
(b) An employee, with the approval of the appointing authority, voluntarily requests a demotion to a position having a lower salary range and less responsibilities and duties;
(c) A documented disciplinary problem or the inability of an employee to perform a duty or responsibility required of the position; or
(d) Due to a reorganization or reassignment of job duties based on a reorganization plan submitted by an agency and approved by the department.
(2) If a demotion is due to a reorganization of an agency, the plan shall state if a reduction in salary of an employee is to occur.
(3) If an employee is demoted during the initial probationary period, the employee shall continue in the employee's probationary period as if the original appointment had been to the position of the lower class.
(4) The salary of an employee demoted as a result of documented unsatisfactory performance during the promotional probationary period shall be reduced to the level prior to promotion.
History
- RELATES TO: KRS 211.170(1), (2), 211.1751, 211.1755 212.170(4), 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation describes the provisions and requirements for promotions, transfers, and demotions of local health department employees.
- History: 19 Ky.R. 2770; 20 Ky.R. 375; 516; eff. 9-3-1993; 21 Ky.R. 589; eff. 9-21-1994; 22 Ky.R. 2359; 23 Ky.R. 1397; eff. 8-21-1996; 24 Ky.R. 2204; 25 Ky.R. 575; eff. 8-19-1998; 27 Ky.R. 2260; 2814; eff. 4-9-2001; 990; 1673; eff. 3-9-2006; 37 Ky.R. 1781; 2171; eff. 4-1-2011; 46 Ky.R. 1956; eff. 3-19-2020.
902 KAR 8:096 Local health department employee performance evaluation program {#sec-902-kar-8-096 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:096}
Section 1.
(1) Upon Board of Health approval, each agency shall elect to participate in one (1) of the following employee performance evaluation programs:
(a) The evaluation program established in 902 KAR 8:080, Section 8, effective until July 1, 2030; or
(b) The evaluation program established in this administrative regulation.
(2) Between July 1, 2026 and July 1, 2030:
(a) An agency electing to participate in the employee evaluation program pursuant to this administrative regulation shall notify the department prior to the start of each fiscal year; and
(b) An agency electing to participate in the employee evaluation program pursuant to 902 KAR 8:080, Section 8, shall:
-
Notify the department prior to the start of each fiscal year;
-
Remain under the requirements of that administrative regulation unless the agency elects to participate in the provision of this administrative regulation at the start of a subsequent fiscal year; and
-
Not be subject to any provisions of this administrative regulation.
(3) Effective July 1, 2030, all employee performance evaluation programs shall be in accordance with this administrative regulation.
(4) The department shall provide technical assistance and training for appropriate local health department supervisory employees if requested by the agency and upon notification of the board's approval.
Section 2. Purpose of the Employee Performance Evaluation Program.
(1) The purpose of the employee performance evaluation program shall be to establish a uniform process for the evaluation of an employee's performance during a specified time period.
(2) Specific objectives of the program shall include the following:
(a) Increase the efficiency of the agency and employee through the annual planning of job duties, objectives, and performance characteristics, and assisting the employee to improve performance through prior knowledge of the expectations of the supervisor;
(b) Serve as a medium which brings the supervisor and employee together for constructive performance discussion and written documentation;
(c) Serve as a means to determine the level at which an employee is performing;
(d) Recognize performance that meets and exceeds performance standards;
(e) Identify and correct substandard performance;
(f) Assist in determining and recording special talents, skills, and capabilities that might otherwise not be noticed or recognized;
(g) Ensure understanding of duties and standards expected of the employee;
(h) Provide assistance in assigning work and delegating responsibility based on a mutual understanding of the employee's skills and abilities;
(i) Encourage the continued growth and development of employees; and
(j) Serve as a basis to review the employee's performance for granting work related salary adjustments.
Section 3. Designated Employee Performance Evaluations. Employee performance evaluations shall be completed at the following times:
(1) Prior to the completion of the required initial appointment probationary period established in 902 KAR 8:080, Section 9;
(2) At the annual employee performance evaluation in accordance with Section 4 of this administrative regulation;
(3) Prior to completion of the required probationary period following promotion established in 902 KAR 8:090, Section 1(3); or
(4) Following reinstatement of an employee that had a gap of service with an agency of more than one (1) year, but does not exceed three (3) years from date of separation in accordance with 902 KAR 8:080, Section 3(2).
Section 4. Annual Employee Performance Evaluation.
(1) An employee that has gained regular status shall be evaluated by the appointing authority or designated supervisor on an annual basis.
(2)
(a) An employee's established annual increment date shall be the first day of the first pay period after completion of twenty-six (26) pay periods of service during which the employee earned annual and sick leave pursuant to 902 KAR 8:120.
(b) A designated part-time employee's established annual increment date shall be the first day of the first pay period upon completion of twenty-six (26) pay periods of service.
(3) An employee returning to duty from leave without pay shall receive an annual increment when the employee has completed twenty-six (26) pay periods of service since the date the employee last received an annual increment.
(4) An annual increment date shall not change when an employee:
(a) Is in a position that is assigned a new or different salary grade;
(b) Receives a salary adjustment as a result the employee's position being reallocated;
(c) Is transferred;
(d) Receives a demotion;
(e) Is approved for detail to special duty;
(f) Returns from military leave covered under the Employment and Reemployment Rights of Members of the Uniformed Services, 38 U.S.C. 4301 to 4335;
(g) Is reclassified; or
(h) Is promoted.
Section 5. Employee Performance Evaluation Process.
(1) The supervisor shall maintain a record throughout the evaluation period for each employee supervised.
(2) The record shall provide a chronological record of accomplishments or problems of an employee. The records shall include:
(a) Dates;
(b) Details;
(c) Names; and
(d) Any written statements regarding accomplishments or problems.
(3) The purpose of the record shall be to ensure that the evaluations are based on actual activities and performance during the review period and provide documentation necessary for the performance salary adjustment or indicated disciplinary actions necessary in the case of unacceptable performance.
(4) A performance evaluation shall be completed for each regular status employee using the Local Health Department Employee Performance Evaluation form CH-40B.
(5) The CH-40B shall contain documented efforts made during the review period to correct unacceptable performance of the employee.
(6) At the beginning of the review period, the supervisor shall identify and develop an annual, written performance plan that establishes for each employee supervised:
(a) The performance competencies;
(b) Expectations;
(c) Goals; and
(d) Objectives.
(7) The supervisor and employee shall meet to discuss the identified performance competencies, expectations, goals, and objectives, and decide on an individual development plan to assist the employee in performing the job. The annual performance plan shall include:
(a) An annual performance plan period;
(b) Job-related performance competencies, goals, and objectives that are consistent with the employee's position description and relate to the agency's goals and performance competencies. Each performance competency shall describe:
-
Standards or indicators of success; and
-
Measurable results and time frames if applicable; and
(c) Provisions for a minimum of one (1) interim performance plan review during the plan year to discuss performance progress, any deficiencies, and plan updates as necessary.
(8) The supervisor, at the end of the review period, shall rate the performance of an employee on the identified performance competencies, indicating both the level of work performed and examples of the employee's work supporting the rating given on each measure and the final rating the employee will receive.
(9) The supervisor shall identify the performance competencies, goals, expectations, and objectives for the next plan year.
(10) The results of the employee performance evaluation may be submitted to the second line supervisor, if other than the appointing authority, and the appointing authority prior to meeting with the employee.
(11) The supervisor and the employee shall meet to discuss the supervisory ratings, performance competencies, goals, and expectations, objectives identified for the next review period, and the employee's development plan for the next review period. The employee may provide input, examples of work, and a self-evaluation for the supervisor's consideration.
(12) The employee shall have an opportunity to provide comments concerning the rating of the supervisor's evaluation. The comments shall be provided to the supervisor no later than five (5) working days after the supervisor and employee meet to discuss the performance evaluation.
(13) An employee that disagrees with the performance rating conducted by the employee's supervisor may ask for a review with the second line supervisor or appointing authority. If the employee is not satisfied with the response, the employee may submit a grievance through the agency's grievance procedure.
Section 6. Employee Performance Evaluation Competencies.
(1) An employee shall be evaluated on at least the following performance competencies:
(a) Position knowledge;
(b) Communication;
(c) Concern for accuracy;
(d) Service orientation;
(e) Organizational awareness; and
(f) Performance orientation.
(2) A supervisor shall be evaluated on the following competencies in addition to those stated above:
(a) Staff development;
(b) Functional planning; and
(c) Decision making.
(3) In addition to the required competencies established in subsections (1) and (2) of this section, additional competencies may be added to the employee's or supervisor's evaluation that reflects the level of development of the employee, level of responsibility, degree of independence, complexity of duties, and the overall scope of the employee's job duties.
Section 7. Employee Evaluation Rating Factors. The following ratings shall be used by the supervisor to evaluate an employee's job performance for the competencies identified:
Section 8. Overall Performance Rating of the Employee. The supervisor shall provide an overall rating of the employee's performance based on the following levels of performance:
(1) Highly commendable performance rating level for the employee who:
(a) Consistently surpasses skill expectations in execution of the majority of critical job responsibilities and objectives;
(b) Makes exceptional contributions to the overall functioning of a department by demonstrating initiative, flexibility, and creativity in addressing issues or developing systems, procedures, or enhancements for greater efficiencies and effectiveness;
(c) Possesses superior skills and knowledge;
(d) Constantly anticipates or responds quickly to changing situations and departmental needs;
(e) Constantly contributes workable solutions to projects or problems;
(f) Demonstrates work of a superior quality; and
(g) Is a solution-oriented team player who maintains and promotes excellent working relationships.
(2) Proficient and commendable performance rating level for the employee who:
(a) Consistently demonstrates skill in the execution of the majority of critical job responsibilities and objectives;
(b) Makes important contributions to the overall functioning of a department by demonstrating solid performance with respect to productivity and quality;
(c) Possesses strong skills and knowledge; and
(d) Is an excellent team player who maintains and promotes good working relationships.
(3) Effective and competent performance rating level for the employee who:
(a) Competently executes the majority of critical job responsibilities and objectives;
(b) Makes positive contributions to the overall functioning of an agency by demonstrating sufficient performance with respect to productivity and quality of work;
(c) Possesses appropriate level of skills and knowledge;
(d) Maintains and promotes positive working relationships as a team player;
(e) Works positively to influence the work group; and
(f) Adjusts readily to changing situations and work assignments.
(4) Needs development performance rating level for the employee who:
(a) The overall performance to ensure consistent execution of all job responsibilities and objectives needs development;
(b) Demonstrates success in some areas, but guidance in other areas has been needed; and
(c) Demonstrates performance competencies that need further development and consistent application.
(5) Unacceptable performance rating level for the employee whose overall performance indicates that:
(a) Job duties, responsibilities, and objectives have not been consistently met;
(b) Employee's performance requires close monitoring and has not kept pace with job-related requirements; and
(c) Successes have been only occasional or of minimal impact and performance has failed to demonstrate sufficient level of competencies required.
Section 9. Salary or Annual Leave Adjustment for an Employee Based on the Levels of Performance.
(1) An employee who receives an overall rating at the highly commendable or proficient and commendable level, shall be eligible to receive:
(a) The annual increment rate adopted by the Board of Health at the beginning of the fiscal year not to exceed five (5) percent of the employee's salary; and
(b)
-
An additional lump sum payment that was adopted by the Board of Health at the beginning of the fiscal year not to exceed five (5) percent of the employee's salary if adequate documented justification is provided to the department for approval; or
-
An additional one (1) or two (2) days annual leave.
(c) The lump sum payment or annual leave adjustment shall be effective the same date as the annual increment awarded.
(2) An employee who receives a performance rating at the effective and competent level shall be eligible to receive the annual employee performance rate adopted by the Board of Health at the beginning of the fiscal year not to exceed five (5) percent of the employee's salary.
(3)
(a) An employee who receives a rating at the needs development level after appropriate supporting documentation has been made, shall be eligible to receive a salary adjustment equivalent to fifty (50) percent of the annual performance evaluation rate adopted by the Board of Health at the beginning of the fiscal year not to exceed five (5) percent of the employee's salary.
(b) An employee shall be notified by the appointing authority in writing at least seven (7) days prior to the annual increment date if the employee:
-
Is denied an annual increment; or
-
Only receives a portion of the annual increment.
(c) An appointing authority shall require a special evaluation to be conducted no later than 120 days following the annual evaluation to determine if the employee's level of performance has improved.
(d) If the employee's performance has improved to the effective and competent level, the appointing authority shall approve the employee's receipt of the additional fifty (50) percent over the remainder of the evaluation period.
(e) For the employee who shows no improvement in performance or whose performance deteriorates, the appointing authority shall:
-
Remove the salary increment allowed under paragraph (a) of this subsection; and
-
Initiate appropriate disciplinary action in accordance with 902 KAR 8:100.
(4)
(a) For an employee who receives a rating at the unacceptable level, the appointing authority shall not grant a salary increase except as established in paragraph (d) of this subsection.
(b) The appointing authority shall initiate dismissal action if indicated by supporting documentation.
(c) If the supporting documentation does not indicate a dismissal action, the appointing authority shall initiate appropriate disciplinary action followed by a performance re-evaluation to be completed no later than 120 days after the disciplinary action was initiated.
(d) The appointing authority shall provide the employee a salary adjustment equivalent to fifty (50) percent of the annual performance evaluation rate at the needs development performance level if an employee improves the level of performance and satisfactorily meets the performance improvement objectives as determined by the re-evaluation.
(5) The employee performance salary adjustment shall be given to the eligible employee at the beginning of the first pay period following twenty-six (26) pay periods of service during which the employee was in pay status.
Section 10. Special Performance Evaluation. A special performance evaluation may be conducted at any time by the employee's supervisor to gauge the level of performance or to improve performance.
Section 11. Incorporation by Reference.
(1) "Local Health Department Employee Performance Evaluation", CH-40B 5/2019, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Division of Administration and Financial Management, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m., or online at https://www.chfs.ky.gov/agencies/dph/dafm/lhpb/Forms%20for%20HR%20Staff/096EmployeePerformanceEvaluation.pdf.
History
- RELATES TO: KRS 211.090(2), 211.170(1), 211.1751, 212.170(4), 212.870, 38 U.S.C 4301-4335
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures of the personnel program for local health departments. This administrative regulation establishes the requirements and procedures for the evaluation of local health department employee performance.
- History: 902 KAR 008:096. 32 Ky.R. 1029; 1441; 1674; eff. 3-9-2006; 37 Ky.R. 1781; 2172; eff. 4-1-2011; 46 Ky.R. 1958; eff. 3-19-2020; 52 Ky.R. 1437, 1823; eff. 7-16-2026.
902 KAR 8:100 Disciplinary procedures applicable for local health department employees {#sec-902-kar-8-100 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:100}
Section 1. Disciplinary Action.
(1) An appointing authority may discipline an employee for:
(a) Lack of good behavior; or
(b) Unsatisfactory performance of a job duty.
(2) A situation that may warrant disciplinary action shall include:
(a) Inefficiency or incompetency in the performance of a duty;
(b) Negligence in the performance of a duty;
(c) Careless, negligent, or improper use of local health department property or equipment;
(d) Excessive absenteeism;
(e) Habitual pattern of failure to report for duty at the assigned time and place;
(f) Failure to obtain or maintain a current license or certificate or other qualification required by law or rule as a condition of continued employment;
(g) Willful abuse or misappropriation of funds, property, or equipment;
(h) Falsification of an official document relating to or affecting employment;
(i) Disrupting, disturbing, or interfering with management of agency operation;
(j) Abusive behavior towards a patient, coworker, or the public in the performance of a duty;
(k) Insubordination;
(l) Reporting to work under the influence of alcohol or illegal drugs, or partaking of alcohol or illegal drugs on the job;
(m) Sleeping or failure to remain alert during working hours;
(n) Violation of confidential information policies of the agency or assigned program;
(o) Prohibited political activity;
(p) Unauthorized or unreported absence for any period of working without notifying supervisor;
(q) Breach of state law, an agency rule, policy, or directive; or
(r) Performing an unauthorized duty, or performing a duty requiring special training, licensure, or certification, that the employee has not attained.
Section 2. Administering Disciplinary Actions.
(1) A classified employee with regular status shall not be disciplined by the appointing authority except for cause.
(2) Except as provided by subsection (4) of this section, an appointing authority shall apply discipline in a progressive manner, with each disciplinary action more severe, in an effort to correct an employee's performance or behavior problem.
(3) Progressive discipline shall consist of the actions of:
(a) Verbal admonishment;
(b) Written admonishment or warning;
(c) Demotion or suspension; and
(d) Dismissal.
(4) One (1) or more of the disciplinary actions stated in subsection (3) of this section may be bypassed by the appointing authority based on the severity of the performance or behavior problem.
Section 3. Predisciplinary Action Meeting.
(1) Except as provided in Section 5(1) of this administrative regulation, prior to a demotion provided by 902 KAR 8:090, Section 3(1)(c), suspension, or dismissal, a classified regular employee with status shall be notified in writing of the intent of the agency to demote, suspend, or dismiss the employee. The notice shall also include:
(a) The specific reasons for the demotion, suspension, or dismissal including:
-
The statutory, regulatory, or agency policy violation; and
-
The specific action or activity that resulted in the intent to demote, suspend, or dismiss;
(b) The date, time, and place of the action or activity, if known;
(c) The name of each party involved; and
(d) That the employee has the right to appear personally, or with counsel if the employee has retained counsel, to reply to the appointing authority regarding the intent to demote, suspend, or dismiss.
(2) A request to appear to reply to the appointing authority shall be:
(a) In writing; and
(b) Made within two (2) working days of receipt of the notice of intent to demote, suspend, or dismiss.
(3) The meeting shall be held within six (6) working days after receipt of the employee's request to appear before the appointing authority, excluding the day the request is received.
(4) No later than five (5) working days after the employee appears to reply to the intent to demote, suspend, or dismiss, the appointing authority shall determine whether to demote, suspend, or dismiss the employee or to alter, modify, or rescind the intent to demote, suspend, or dismiss. The appointing authority shall notify the employee in writing of the decision.
(5) If the appointing authority decides to demote, suspend, or dismiss, the employee shall be notified in writing of:
(a) The effective date of the demotion, suspension, or dismissal;
(b) The reason for the demotion, suspension, or dismissal, including the:
-
Statutory, regulatory, or agency policy violation; and
-
Specific action or activity that resulted in the demotion, suspension, or dismissal;
(c) The date, time, and place of the action or activity, if known;
(d) The name of each party or witness involved; and
(e) The right to appeal the demotion, suspension, or dismissal in accordance with 902 KAR 8:110.
(6) The appointing authority shall provide the employee with the Request for Appeal form, as incorporated by reference in 902 KAR 8:110.
Section 4. Conditions for Bypassing Progressive Discipline and the Issuance of a Notice of Intent for the Suspension or Dismissal of an Employee.
(1) An appointing authority may issue a notice of intent for the suspension or dismissal of an employee for a serious misconduct infraction.
(2) An example of a misconduct infraction that may be considered serious enough to merit an immediate intent of suspension or dismissal includes:
(a) Threatening, assaulting, fighting with, or harassing a supervisor, another employee, or anyone encountered during the normal course of business;
(b) Stealing or deliberately damaging the property of:
-
The agency;
-
A client;
-
A patient; or
-
Another employee;
(c) Reporting to work under the influence of alcohol, narcotics, or other drugs, unless the drug was prescribed by a physician;
(d) Taking unauthorized leave or failing to show up at work without notifying a supervisor for more than three (3) consecutive work days;
(e) Engaging in a fraudulent activity;
(f) Breach of the employee confidentiality agreement; or
(g) Performing a procedure on a patient or client for which the employee has neither been certified nor has the current credentials to perform.
(3) The employee shall be notified in writing by the appointing authority regarding the intent to suspend or dismiss.
(4) If an employee wishes to reply to a notice, the employee shall:
(a) Request to appear personally before the appointing authority. The request shall be:
-
In writing; and
-
Made within two (2) working days of receipt of the notice; and
(b) File the request with the appointing authority. If a request is mailed by certified mail, return receipt requested, it shall be considered filed on the date it is postmarked.
(5) An employee may be represented by counsel at an appearance before the appointing authority.
(6) The meeting shall be held within six (6) working days after receipt of the employee's request to appear before the appointing authority, excluding the day the request is received.
(7) Within five (5) working days after the employee appears to reply to the intent to suspend or dismiss, the appointing authority shall determine whether to modify, or rescind the intent to suspend or dismiss. The appointing authority shall notify the employee in writing of the decision.
(8) If the appointing authority decides to suspend or dismiss immediately following the meeting, the employee shall be notified in writing of:
(a) The effective date of the suspension or dismissal;
(b) The reason for the suspension or dismissal, including the:
-
Statutory, regulatory, or agency policy violation; and
-
Specific action or activity on which the suspension or dismissal is based;
(c) The date, time, and place of the action or activity, if known;
(d) The name of each party or witness involved; and
(e) The right to appeal the suspension or dismissal in accordance with 902 KAR 8:110.
Section 5. Directive to Vacate Premises.
(1) If an employee has committed a serious misconduct infraction, and there is a need to diffuse a presently dangerous or disruptive situation, or the appointing authority intends to terminate the employee's employment, a director or designee may direct the offending employee to vacate the premises. The appointing authority shall, by the most immediate means, contact the department and relate the action taken.
(2) A pre-termination hearing shall be provided within three (3) working days after removal.
(3) The employee may be placed on leave using accumulated leave or on immediate suspension without pay.
History
- RELATES TO: KRS 211.090(3), 211.170(2), 211.1751, 212.170(4), 212.870, 237.109, 237.115(2)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures of the personnel program for local health departments. This administrative regulation establishes separations and disciplinary procedures applicable to a local health department.
- History: 19 Ky.R. 2771; 20 Ky.R. 376; 517; eff. 9-3-1993; 21 Ky.R. 590; eff. 9-21-1994; 24 Ky.R. 2206; 25 Ky.R. 116; 575; eff. 8-19-1998; 27 Ky.R. 2261; 2815; eff. 9-4-2001; 37 Ky.R. 1787; 2175; eff. 4-1-2011; 46 Ky.R. 1709; eff. 2-27-2020; 48 Ky.R. 3079; 49 Ky.R. 572; eff. 9-28-2022.
902 KAR 8:110 Disciplinary appeal process applicable for local health department employees {#sec-902-kar-8-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:110}
Section 1. Appeals.
(1) An employee with status who is demoted according to 902 KAR 8:090, Section 3(1)(c), suspended, or dismissed shall have the right to appeal the action. The appeal shall be:
(a) In writing, on a form CH-41 "Request for Appeal"; and
(b) Filed with or mailed to the department by certified mail, return receipt requested within fifteen (15) days of the demotion, suspension, or dismissal.
(2) An eligible whose name has been removed from a register for any of the reasons specified in 902 KAR 8:070, Section 4(5)(a) through (i) may appeal the action. The appeal shall be mailed to the department within thirty (30) days after the date on which the notification of removal was mailed to the eligible.
(3) An applicant or employee may appeal within thirty (30) days of the alleged discrimination if he or she believes that they have been discriminated against in a personnel action in violation of KRS 344.040.
(4) An appeal shall be conducted in accordance with Section 2 of this administrative regulation.
Section 2. Hearing Process.
(1) The department shall schedule an administrative hearing upon an appeal to be held within sixty (60) days of receipt of the Request for Appeal. Notice of the hearing and conduct of the proceedings shall be in accordance with the requirements of KRS Chapter 13B.
(2) The hearing shall be conducted by a designated hearing officer.
(3) The hearing officer shall:
(a) Make findings of fact and conclusions of law; and
(b) Issue a recommended order to each party.
(4) Each party shall have fifteen (15) days from the date of the recommended order to file exceptions to the recommendations with the cabinet.
(5) The secretary of the cabinet shall issue a final order in accordance with KRS 13B.120.
Section 3. Incorporation by Reference.
(1) "Request for Appeal", form CH-41, September 2018, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Division of Administration and Financial Management, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 194A.050, 211.170(1), 211.1755, 212.170, 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755 requires the Cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation establishes the disciplinary appeal process for employees.
- History: 19 Ky.R. 2773; eff. 9-3-1993; 21 Ky.R. 592; eff. 9-21-1994; 22 Ky.R. 1163; 1475; eff. 2-12-1996; 25 Ky.R. 2208; 25 Ky.R. 577; eff. 8-19-1998; 37 Ky.R. 1789; 2176; eff. 4-1-2011; 46 Ky.R. 1711; eff. 2-27-2020; Crt eff. 9-2-2026.
902 KAR 8:120 Leave provisions applicable to employees of local health departments {#sec-902-kar-8-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:120}
Section 1. Hours of Work.
(1) The normal work week shall consist of thirty-seven and one-half (37.5) hours per week.
(a) The appointing authority shall establish the hours and days of work for the agency or for specific employees.
(b) The work schedule may be changed by the appointing authority to provide for flexibility in meeting particular work requirements of the agency or specific employees whose schedules may require them to work different hours.
(2) Hours worked in excess of the thirty-seven and one-half (37.5) hours during the established work week shall be:
(a) Approved by the appointing authority; and
(b) Subject to compensatory time and overtime provisions of this administrative regulation.
(3) The standard pay period shall consist of seventy-five (75) hours.
(4) An appointing authority, with department approval, may establish a position having special conditions of employment based on the needs of the agency.
(5) The employee who requests and receives consideration for special conditions shall acknowledge acceptance of the special conditions in writing.
Section 2. Earning of Annual Leave.
(1) Except for a temporary or an emergency employee, a full-time employee shall earn annual leave credit at the following rate:
(2) Annual leave for a full-time employee shall not accrue unless the employee has been in pay status at least thirty-seven and one-half (37.5) hours of the standard pay period. The employee shall be credited with additional leave credit upon the first day of the pay period following the pay period in which the leave was earned.
(3) Except for a temporary or an emergency employee, a part-time employee, who is designated as serving on a part-time 100 hour basis and is in pay status at least twenty-three (23) hours each pay period, shall earn annual leave credit at the following rate:
(4) In computing years of total service for determining the rate of earning annual leave for designated part-time 100 hour employees, only the months the employee was designated as a full-time, part-time 100 hour, or was on educational leave with pay shall be used.
(5) An employee who has retired from a position covered by a state retirement system, is receiving retirement benefits, and returns to an agency, shall not receive credit for months of service prior to retirement.
(6) An employee who has resigned from one (1) agency and returns to another agency as an original appointment shall not receive credit for months of service prior to resignation.
(7) Annual leave shall not accrue unless an employee is working or on authorized leave with pay. Annual leave shall not accrue if an employee is on authorized educational leave with pay.
(8) The maximum amount of annual leave earned by a full-time employee that may be accumulated and carried forward to the next calendar year shall not exceed the following amounts:
(9) The maximum amount of annual leave for a designated part-time 100 hour employee who works an average of 100 hours per month that may be accumulated and carried forward to the next calendar year shall not exceed the following amounts:
(10) Except as provided for in Section 3(9) of this administrative regulation, annual leave earned in excess of that which is allowed to be accumulated shall be converted to sick leave and credited during the first pay period following the end of the calendar year. Annual leave shall not be granted in excess of that earned.
Section 3. Use of Annual Leave Credit.
(1) An employee who has accumulated annual leave credit, upon timely request and subsequent approval of the supervisor, shall be granted leave subject to the operating requirements of the agency.
(2) An employee shall not be charged with annual leave for absence except on a day upon which they would otherwise work and receive pay.
(3) Absence for a fraction or part of a day that is chargeable to annual leave shall be charged in fifteen (15) minute periods.
(4) An employee shall be paid a lump sum for accumulated annual leave, not to exceed the maximum amounts established in Section 2 of this administrative regulation, if separated by proper resignation, layoff, retirement, or change from full-time or part-time 100 hour to part-time. Following payment of annual leave, leave remaining after the payment of the maximum provided in Section 2 of this administrative regulation shall be removed from the balance.
(5)
(a) An employee who has been dismissed for cause shall not be paid for accumulated annual leave.
(b) An appointing authority may withhold payment of accumulated annual leave for an employee who has failed to give proper notice of resignation or retirement, or who has submitted notice of resignation or retirement after receiving an intent to dismiss letter.
(c) Annual leave withheld shall result in a determination that the employee resigned not in good standing.
(6) Upon the death of an employee, the employee's estate shall be entitled to be paid for the unused portion of the employee's accumulated annual leave.
(7) Annual leave shall not be advanced or taken until it is earned.
(8) An absence due to sickness, injury, or disability in excess of accumulated sick leave, may be charged against annual leave if approved by the appointing authority.
(9) An employee who has accumulated annual leave in excess of 275 hours may request payment of an amount of annual leave not to exceed seventy-five (75) hours during the fiscal year of the agency. The requested annual leave payment, if approved by the appointing authority, shall not reduce the employee's balance of annual leave below 275 hours and shall be paid in a manner convenient to the agency.
(10) An appointing authority may require an employee who has a balance of compensatory leave hours to use compensatory leave before the employee's request to use annual leave balance is granted, unless the employee's annual leave balance will exceed the maximum number of hours that may be carried forward pursuant to Section 2(8) and (9) of this administrative regulation.
Section 4. Earning of Sick Leave.
(1) A full-time employee, except for an emergency employee, shall earn sick leave at the rate of three and one-half (3.5) hours per pay period.
(a) An employee shall have worked or been in pay status for at least thirty-seven and one-half (37.5) hours of the seventy-five (75) standard hours in each pay period in order to accumulate sick leave.
(b) The employee shall be credited with sick leave upon the first day of the pay period following the pay period in which the leave was earned.
(2) An employee designated as a part-time 100 hour employee, except for an emergency employee, who is in pay status at least twenty-three (23) hours in a pay period shall earn sick leave at the rate of two and one-tenth (2.1) hours per pay period. A part-time 100 hour employee shall be credited with additional sick leave upon the first day of the pay period following the pay period in which the leave was earned.
(3) A full-time employee completing ten (10) years of total service in full-time status with an agency shall be credited with seventy-five (75) additional hours of sick leave.
(4) An employee designated as a part-time 100 hour employee completing ten (10) years of total service in a part-time 100 status with an agency shall be credited with forty-five (45) additional hours of sick leave.
(5) A full-time employee completing 240 months of total service in a full-time status with one (1) or more agencies shall be credited with an additional seventy-five (75) hours of sick leave.
(6) An employee designated as a part-time 100 hour employee completing 240 months of total service in a part-time 100 status with one (1) or more agencies shall be credited with forty-five (45) additional hours of sick leave.
Section 5. Uses of Sick Leave Credit.
(1) The appointing authority, upon proper request, may grant sick leave with pay to a full-time or designated part-time 100 hour employee with sufficient leave credit, if the employee:
(a) Receives medical, psychiatric, dental, or optical examination or treatment;
(b) Is disabled by sickness or injury;
(c) Is required to provide care for a sick or injured spouse, child, step-child, parent, step-parent, brother, step-brother, sister, step-sister, grandparent, step-grandparent, grandchild, step-grandchild, mother- or father-in-law, or daughter- or son-in-law;
(d) Would jeopardize the health of others at his or her workstation post because of exposure to a contagious disease;
(e) Has lost by death a spouse, child, step-child, parent, step-parent, brother, step-brother, sister, step-sister, grandparent, step-grandparent, grandchild, step-grandchild, mother- or father-in-law, or daughter- or son-in-law; or
(f) Is required to take the employee's spouse, child, step-child, parent, step-parent, brother, step-brother, sister, step sister, grandparent, step-grandparent, grandchild, step-grandchild, mother- or father-in-law, or daughter- or son-in-law for medical, psychiatric, dental, or optical examination or treatment.
(2) Accumulated sick leave may be granted for death in the employee's family, as described in subsection (1) of this section, and shall be limited to three (3) days or a reasonable extension at the discretion of the appointing authority.
(3) An employee shall file a written request for sick leave with or without pay within a reasonable time. An employee shall request advance approval for sick leave for medical, dental, or optical examination and for sick leave without pay.
(4) Except for an unexpected absence from work because of an illness, the employee shall notify the employee's supervisor or other designated person in advance. Failure to do so in a reasonable time period may be cause for denial of the sick leave for the period of absence or for disciplinary action.
(5)
(a) An appointing authority may, for good cause and on notice, require an employee to supply supporting evidence in order to receive sick leave for the days or hours sick leave is requested.
(b) A medical certificate may be required signed by a licensed practitioner and certifying to the incapacity, examination, and treatment during the time for which sick leave was taken.
(c) An appointing authority may grant sick leave if the application is supported by acceptable evidence, but may require confirmation if there is reasonable cause to question the authenticity of the certificate or its contents.
(6) If an employee requests leave in excess of five (5) working days, a statement from the employees' licensed practitioner shall accompany the request for leave. The statement shall contain:
(a) The licensed practitioner's judgment that the employee is incapable of performing the essential duties of the job;
(b) Estimate of the length of time that the employee's illness or disability will last;
(c) Restrictions that render the employee incapable of performing the essential duties of the job; and
(d) Recommendation for special considerations to accommodate the employee once released to return to work.
(7) An appointing authority may place an employee on sick leave with or without pay, if:
(a) The employee's health might jeopardize others;
(b) The employee's health prevents performance of job duties and responsibilities;
(c) The employee fails to produce a satisfactory medical certificate upon request; or
(d) The employee exhibits behavior that disrupts the agency's ability to function in providing services or that might endanger the employee or others.
(8) Absence for a fraction or part of a day that is chargeable to sick leave shall be charged in fifteen (15) minute periods.
(9) An employee who is transferred or otherwise changed from one (1) agency to another shall retain accumulated sick leave in the receiving agency.
(10) A former employee who is reinstated or reemployed shall have his or her previous rate of earning annual leave and unused sick leave balances reinstated upon successful completion of probation, if applicable.
(11) Sick leave may be utilized in cases of absence due to illness or injury for which workers' compensation income benefits are received for lost time to the extent of the differences between these benefits and the employee's regular salary.
Section 6. Family and Medical Leave.
(1) An appointing authority shall comply with the requirements of the Family and Medical Leave Act (FMLA) of 1993, 29 U.S.C. 2601 et seq., Pub.L. 103-3, and the federal regulations implementing the Act, 29 C.F.R. Part 825.
(2) An employee shall qualify for twelve (12) weeks of unpaid family and medical leave if the employee has:
(a) Completed twelve (12) months of service; and
(b) Worked at least 1,250 hours in the twelve (12) months immediately preceding the first day of family and medical leave.
(3) An employee shall be entitled to a maximum of twelve (12) weeks of unpaid family and medical leave for the birth, placement, or adoption of the employee's child.
(4) While an employee is on unpaid family and medical leave, the employer contribution for health and life insurance shall be maintained by the employer.
(5) An employee shall use accrued paid leave concurrently with FMLA leave, except an employee may reserve up to ten (10) days of accumulated sick leave while on FMLA leave. If an employee reserves accumulated sick leave, the remaining FMLA leave will be unpaid.
Section 7. Maternity Leave.
(1) The appointing authority shall grant a maternity leave of absence to an employee because of pregnancy or the adoption of a child. Maternity leave shall not exceed twelve (12) weeks, unless the appointing authority approves additional maternity leave. However, the total leave shall not exceed twenty-six (26) pay periods.
(2) The employee on maternity leave shall use accumulated sick leave credit if available:
(a) For the period of time medically necessary to be absent from work as indicated by the certification of a licensed practitioner; or
(b) For the period of time for placement of a child for adoption with the employee that includes:
-
Counseling sessions;
-
To appear in court;
-
Consult with attorneys or doctors representing the birth parents;
-
Submit to a physical; or
-
Travel to complete adoption.
(c) If sick leave is not available, the employee shall use accumulated annual or compensatory leave if available.
(d) If leave credit is exhausted, the employee shall be placed on leave without pay.
(3) Accumulated annual and compensatory time shall be used for maternity leave that extends beyond the period of absence that is medically necessary for the employee as certified by the employee's medical practitioner.
(4) The employee shall submit a written request for maternity absence, which shall include a statement from a licensed practitioner indicating the expected date of delivery.
(a) The request shall be submitted to the appointing authority as soon as practical to allow for adjustments in the work schedule during the employee's absence.
(b) Additional information from the employee's licensed practitioner may be required if there are complications and the period of absence begins sooner than agreed, extends further than agreed, or requires the use of maternity leave beyond twelve (12) weeks.
Section 8. Workers' Compensation.
(1)
(a) The required medical expense for a service rendered by a hospital or doctor, or for a prescribed medication, shall be paid subject to approval of the claim.
(b) A percentage of the employee's average weekly wage shall be paid if the employee is unable to work for an extended period due to a job-related injury or illness.
(c)
-
Except as provided in subparagraph 2. of this paragraph, compensation shall not be payable for the first seven (7) days of disability.
-
If the disability continues over two (2) weeks, compensation shall be allowed from the first day of disability.
(2) The appointing authority shall offer an employee one (1) of the following options of compensation for an absence due to illness or injury for which workers' compensation benefits are eligible:
(a) Allow employee to accept the workers' compensation benefits directly and use accumulated leave in order to maintain regular full salary; or
(b) Allow employee to use accumulated leave to maintain regular full salary, or a portion thereof, and remit the workers compensation benefits to the agency to reinstate accumulated leave used for the period of time benefits were paid.
(3) The employee shall not receive and retain the benefit of paid leave and workers' compensation income benefits that exceeds his or her regular full salary for the same period of time.
Section 9. Sick Leave Without Pay.
(1) An appointing authority may approve sick leave without pay upon appropriate request of an employee.
(2) An employee shall have used accumulated annual, sick, and compensatory leave credit prior to approved leave without pay.
(3) If an employee approved for leave with pay exhausts accumulated annual, sick, and compensatory leave credit, the employee shall be placed on sick leave without pay, if the total absence does not exceed twenty-six (26) pay periods.
(4) The appointing authority may require periodic statements from a licensed practitioner during the sick leave without pay period attesting to the employee's inability to perform the essential functions of the employee's job duties with or without reasonable accommodation.
Section 10. Return from Sick Leave With or Without Pay.
(1) At the termination of sick leave with pay not exceeding thirteen (13) pay periods, the appointing authority shall return the employee to his or her former position.
(2) At the termination of sick leave with pay exceeding thirteen (13) pay periods, the appointing authority shall return the employee to a position for which he or she is qualified and that resembles his or her former position as closely as circumstances permit. If the employee is unable to perform the essential functions of the position, and there is no other vacant position for which the employee qualifies and is able to perform, the employee may be laid off.
(3) If an employee on approved sick leave without pay for less than twenty-six (26) pay periods has given notice of his or her ability to resume his or her duties, the appointing authority shall return the employee to a position for which he or she is qualified and that resembles his or her former position as closely as circumstances permit. If the employee is unable to perform the essential functions of the position, and there is no other vacant position for which the employee qualifies and is able to perform, the employee may be laid off.
(4) An employee shall be considered to have resigned if the employee:
(a) Has been on continuous sick leave without pay for twenty-six (26) pay periods;
(b) Has been requested by the appointing authority in writing to return to work at least ten (10) days prior to the expiration of sick leave;
(c) Is unable to return to the employee's former position or to a position for which the employee is qualified and that resembles the former position as closely as circumstances permit;
(d) Has been given priority consideration by the appointing authority for a vacant position with the agency, for which the employee qualifies and is capable of performing its essential functions with or without reasonable accommodation; and
(e) The appointing authority has been unable to place the employee in a vacant position.
Section 11. Sharing of Sick Leave.
(1) An employee of the local health department who has accrued a sick leave balance of more than seventy-five (75) hours may, with the approval of the appointing authority, request the transfer of a specified amount of the employee's sick leave balance in excess of seventy-five (75) hours to another named status employee of the local health department who is authorized to receive sick leave.
(2) The appointing authority may approve the amount of sick leave received under this section if:
(a) The employee or a member of his or her immediate family suffers from a medically certified illness, injury, impairment, or physical or psychiatric condition that has caused, or is likely to cause, the employee to go on leave;
(b) The employee's need for absence and use of leave are certified by a licensed practitioner; and
(c) The employee has exhausted his or her accumulated sick leave, annual leave, and compensatory leave balances.
(3) Leave may be transferred from an employee of one (1) agency to an employee within the same agency or may be transferred from an employee of one (1) agency to an employee of another agency. The agency shall maintain records of leave transferred between employees and the utilization of transferred leave.
(4) If an employee is on leave transferred under this section, he or she shall receive the same treatment with respect to salary, wages, and employee benefits.
(5) Salary and wage payments made to an employee while on leave transferred under this section shall be made by the agency employing the person receiving the leave.
(6) Leave transferred under this section which remains unused shall be returned, on a prorated basis, to the employees who transferred the leave if the appointing authority finds that the leave is no longer needed and will not be needed at a future time in connection with the illness or injury for which the leave was transferred to an employee in his or her agency.
(7) An employee shall not intimidate, threaten, coerce, or attempt to intimidate, threaten, or coerce, either directly or indirectly, another employee for the purpose of interfering with the employee's right to voluntarily contribute leave as authorized under this section.
Section 12. Court Leave. An employee shall be entitled to a leave of absence, without loss of pay or time, for each day the employee is subpoenaed by a court to serve as a juror or witness, except in a case where the employee or a member of the employee's family is a party plaintiff. If relieved from duty as a juror or witness during normal working hours, the employee shall return to work. An employee shall retain the fees earned while serving as a potential juror.
Section 13. Military Leave.
(1) Upon request, an employee who is an active member of the United States Army Reserve, the United States Air Force Reserve, the United States Naval Reserve, the United States Marine Corps Reserve, the United States Coast Guard Reserve, the United States Public Health Service Reserve, or the Kentucky National Guard shall be relieved from duty without the loss of pay or time to serve under orders on training duty for a period of up to ten (10) working days, not to exceed seventy-five (75) hours in any one (1) federal fiscal (October 1 to September 30) year. The appointing authority, before granting military leave, may require a copy of the orders requiring the attendance of the employee.
(2) The appointing authority shall grant an employee entering military duty a leave of absence without pay for a period of active duty not to exceed six (6) years. Accumulated annual leave and compensatory leave may be paid in lump sum at the request of the employee, upon being placed on leave.
(3) A part-time 100 or full-time status employee, who is a spouse or a member of the U.S. Armed Forces, including a member of a state National Guard or a Reserve component on federal duty, shall receive one (1) day off, with pay, from work when the member is deployed and one (1) day off, with pay, from work when the member returns.
Section 14. Voting Leave. The appointing authority shall allow each employee four (4) hours paid leave to vote, if requested in advance. The absence shall not be charged against accumulated leave.
Section 15. Special Leave of Absence.
(1) An appointing authority may grant special leave for education, training, or for other circumstances.
(2) Leave may be granted for a period not to exceed twenty-six (26) pay periods.
(3) Leave may be granted without pay if all other leave has been exhausted.
(4) Leave for attendance at a college, university, vocational or business school shall be for training in subjects that:
(a) Relate to the employee's work; and
(b) Will benefit the agency.
Section 16. Administrative Leave for Investigative Purposes.
(1) An appointing authority may place an employee on special leave with pay for investigative purposes pending an investigation of a work-related incident or an allegation of employee misconduct.
(2) Leave shall not exceed thirty (30) working days.
(3) The employee shall be notified in writing by the appointing authority that he or she is being placed on special leave for investigative purposes and the reasons for being placed on leave.
(4) If the investigation reveals no misconduct by the employee:
(a) The employee shall be made whole for the period of the leave; and
(b) Records relating to the investigation shall be purged from agency files.
(5) The appointing authority shall notify the employee, in writing, of the completion of the investigation and the action taken. Notification shall be made to the employee, whether the employee has remained with the agency, or has voluntarily resigned during the interim between being placed on special leave for investigative purposes and the completion of the investigation.
Section 17. Absence Without Leave.
(1) An employee who is absent from duty without prior approval shall report the reason for the absence to the employee's supervisor immediately.
(2) Unauthorized or unreported absence shall:
(a) Be considered absence without leave;
(b) Be treated as leave without pay for an employee covered by the provisions of the Fair Labor Standards Act, 29 U.S.C. Chapter 8; and
(c) Constitute grounds for disciplinary action.
(3) A deduction of pay may be made by the appointing authority for each period of absence.
(4) An employee who has been absent without leave or notice to the supervisor for more than three (3) working days shall be considered to have resigned the employee's position.
Section 18. Holidays.
(1) Agency full-time employees shall be given a 7.5 hours holiday on the following days:
(a) The first day of January and one (1) extra day;
(b) The third Monday in January;
(c) One-half (1/2) day for Good Friday (3.75 hours);
(d) The last Monday in May;
(e) The fourth day of July;
(f) The first Monday in September;
(g) The 11th day of November;
(h) The fourth Thursday in November plus one (1) extra day;
(i) The 25th of December and one (1) extra day;
(j) Presidential election day; and
(k) Holidays issued by Executive Order of the Governor while in effect.
(2) If a day enumerated in subsection (1) of this section falls on a Saturday, the preceding Friday shall be observed as the holiday. If the day enumerated falls on a Sunday, the following Monday shall be observed as the holiday. If an extra day is provided for, it shall be observed as stated by the department.
(3) A full-time employee shall be in pay status on the work day prior to the holiday in order to receive the 7.5 hour holiday benefit.
(4) Full-time exempt employees required to work on a holiday shall accrue compensatory time for the time worked.
Section 19. Absences Due to Adverse Weather.
(1) An employee who chooses not to report to work, or who leaves early, in the event of adverse weather conditions, shall have the absence:
(a) Charged to annual or compensatory leave; or
(b) Taken as leave without pay, if annual and compensatory leave has been exhausted.
(2) An employee who is on prearranged annual, compensatory, or sick leave shall charge leave as originally requested unless the agency closes down. Once the agency closes, all employees are paid other paid leave.
(3) If catastrophic, life-threatening weather conditions occur, such as that created by hurricane, tornado, flood, or blizzard, and it becomes necessary for authorities to order evacuation or shutdown of the place of employment, the following provisions shall apply:
(a) An employee who is required to evacuate or who would report to a location that has been shut down shall not be required to make up the time lost from work during the period officially declared hazardous to life and safety.
(b) An employee who is required to work in an emergency situation shall be compensated pursuant to Section 20 of this administrative regulation.
Section 20. Earning of Compensatory Time.
(1) An employee determined to be exempt under the provisions of the Fair Labor Standards Act, 29 U.S.C. 207, and Kentucky Wage and Labor Law, KRS Chapter 337, authorized by the appointing authority to work in excess of the prescribed thirty-seven and one-half (37.5) hours of duty in one (1) week shall accumulate compensatory time in fifteen (15) minute periods for excess time worked on an hour-for-hour basis. The maximum amount of compensatory time accumulated shall be 200 hours.
(2) An employee shall have the prior approval of the appointing authority or the employee's immediate supervisor before compensatory leave may be earned.
(3) A nonexempt employee authorized by the appointing authority to work in excess of the prescribed thirty-seven and one-half (37.5) hours of duty in one (1) week shall be paid at the employee's current salary for each hour not subject to the provisions of the Fair Labor Standards Act, 29 U.S.C. 207, and Kentucky Wage and Labor Law, KRS Chapter 337.
(4) Any time worked in excess of forty (40) working hours in one (1) week shall be paid overtime at a rate of one and one-half (1 1/2) for each hour exceeding forty (40) working hours. Holiday pay and other types of non-working hours paid are not included in the total number of working hours subject to time and a half overtime pay.
Section 21. Using Accumulated Compensatory Time.
(1) An employee who has accrued compensatory time shall be permitted by the appointing authority to take compensatory time off if practical and upon proper request by the employee.
(2) An employee who has accumulated at least thirty (30) hours of compensatory time may be paid for the accumulated leave by the appointing authority upon written request. If payment is approved by the appointing authority, it shall be at the employee's regular rate of pay and in thirty (30) hour increments.
(3) If an employee has accumulated the maximum amount of compensatory leave, the appointing authority shall pay the employee for at least fifty (50) hours of accumulated compensatory leave at the employee's regular rate of pay and shall reduce the employee's compensatory leave balance accordingly.
(4) Upon separation from service or transfer to another agency, unused compensatory time shall be reimbursed in a lump sum payment to the employee.
(5) Upon the death of an employee, the employee's estate shall be paid for unused accumulated compensatory time.
History
- RELATES TO: KRS 211.170(1), (2), 212.170(4), 212.870, Chapter 337, 29 C.F.R. Part 825,
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2), (3)(a)1
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures of the local health department personnel program. KRS 211.1755(3)(a)1. requires the cabinet to promulgate administrative regulations for local health department personnel leave policies. This administrative regulation establishes work hours, leave, and compensatory time provisions for employees of local health departments.
- History: 19 Ky.R. 2774; 20 Ky.R. 377; eff. 9-3-1993; 21 Ky.R. 593; eff. 9-21-1994; 22 Ky.R. 1164; 1652; eff. 4-5-1996; 24 Ky.R. 2210; 25 Ky.R. 118; 578; eff. 8-19-1998; 27 Ky.R. 2263; 2816; eff. 4-9-2001; 37 Ky.R. 1791; 2177; eff. 4-1-2011; 46 Ky.R. 1963, 2452; eff. 3-19-2020; 48 Ky.R. 3082; 49 Ky.R. 816; eff. 10-26-2022; 52 Ky.R. 1441, 1826; eff. 7-16-2026.
902 KAR 8:130 Participation of local health department employees in political activities {#sec-902-kar-8-130 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:130}
Section 1. Political Activities of Employees. An employee in the classified service shall not:
(1) Serve on or for a political committee, party, or other similar organization;
(2) Serve as a delegate or alternate to a caucus or party convention, but may vote in the selection of:
(a) A delegate to a party convention; and
(b) A person to serve on a precinct committee;
(3) Solicit or handle a political contribution;
(4) Sell or solicit the sale of a ticket or other item for a political party, faction, or candidate; however, an employee may voluntarily purchase the item or a ticket;
(5) Serve as an officer of a political club, as a member or officer of any of its committees, or address a club on a partisan political matter, or be active in organizing it;
(6) Serve in connection with the preparation for, organizing or conducting a political meeting or rally or address a political meeting on a partisan political matter except to vote;
(7) Engage in partisan activity at the polls during a primary, regular, or special election in the position of checker, challenger, or watcher;
(8) Solicit votes and assist voters to mark ballots;
(9) Become a candidate for nomination or election to a federal, state, county, or municipal office, except for a school board district office, which is to be filled in an election in which party candidates are involved or for which compensation is paid;
(10) Solicit another person to become a candidate for nomination or election to an office described above;
(11) Distribute partisan campaign literature or material;
(12) Initiate or circulate a partisan political nominating petition; or
(13) Canvass a district or solicit political support for a party, faction, or candidate, in person or in writing.
History
- RELATES TO: KRS 211.170(1), (2), 212.170(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.1755, 212.170
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation establishes guidelines for employee political activity.
- History: 902 KAR 008:130. 19 Ky.R. 2777; eff. 9-3-1993; 21 Ky.R. 597; eff. 9-21-1994; 24 Ky.R. 2215; 25 Ky.R. 582; eff. 8-19-1998; eff. 6-11-2019; Crt eff. 1-7-2026.
902 KAR 8:140 Appointment of a health officer or a public health department director of a local health department {#sec-902-kar-8-140 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:140}
Section 1. Appointment of Health Officer.
(1) An agency shall appoint a health officer in accordance with the provisions of KRS 212.170, 212.230, or 212.870.
(2) The health officer shall be an unclassified employee and hold office in accordance with KRS 212.170.
(3) The health officer in the unclassified service shall be subject to the following administrative regulations:
(a) 902 KAR 8:060, Salary adjustments for local health departments;
(b) 902 KAR 8:070, Recruitment, examination, and certification of eligible applicants for local health departments;
(c) 902 KAR 8:080, Initial appointment, probationary period, layoffs, performance evaluation, and the resignation of employees of local health departments;
(d) 902 KAR 8:120, Leave provisions applicable to employees of local health departments; and
(e) This administrative regulation.
(4) An individual promoted to the position of health officer shall receive a salary increase, which shall be the greater of the following:
(a) Fifteen (15) percent above current salary;
(b) The minimum of the grade assigned to the health officer; or
(c) Three (3) percent per grade not to exceed midpoint of grade.
Section 2. Appointment of Public Health Department Director.
(1) In the absence of a health officer provided for in this administrative regulation, an agency shall be under the direction of a public health department director who shall meet minimum qualification of education and experience established by the department.
(2) A qualified individual shall be:
(a) Appointed or promoted from an external announcement to the position of public health department director:
(b) Employed in the unclassified service; and
(c) Hold office at the pleasure of both the board of health of the agency and the department.
(3) A public health department director in the unclassified service shall be subject to the following administrative regulations:
(a) 902 KAR 8:060, Salary adjustments for local health departments;
(b) 902 KAR 8:070, Recruitment, examination, and certification of eligible applicants for local health departments;
(c) 902 KAR 8:080, Initial appointment, probationary period, layoffs, performance evaluation, and the resignation of employees of local health departments;
(d) 902 KAR 8:120, Leave provisions applicable to employees of local health departments; and
(e) This administrative regulation.
(4) An individual promoted to the position of public health department director shall receive a salary increase, which shall be the greater of the following:
(a) Fifteen (15) percent above current salary;
(b) The minimum of the grade assigned to the health officer; or
(c) Three (3) percent per grade not to exceed midpoint of grade.
Section 3. Removal of a Health Officer or Public Health Department Director in the Unclassified Service.
(1) A health officer or public health department director removed by the board of health or the department shall be notified in writing, and may, within seven (7) days, make a written request for a pre-termination conference.
(2) If no request for a pre-termination conference is made, the removal shall become effective upon the expiration of seven (7) days.
(3) If a request for a pre-termination conference is made, the pre-termination conference shall be held at the office of the agency within fourteen (14) calendar days after the request is received by the board of health of the agency.
(4) The health officer or public health department director shall not be removed until the pre-termination conference has been held and a decision rendered by the board of health of the agency and the department.
(5) Upon termination of employment, an employee who was promoted to the health officer or public health department director position may:
(a) Revert to the position held prior to promotion; or
(b) Be considered for a vacant position in the agency.
(6) The employee shall have had at least five (5) years of continuous service with the agency prior to the promotion to be considered for reversion.
(7) The reversion shall be subject to the approval of the board of health of the agency.
(8) An employee shall not be reverted to a position in the classified service unless the individual meets the minimum qualifications for the position.
History
- RELATES TO: KRS 211.170(1), (2), 212.170, 212.230, 212.870
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.1755(2), 212.170
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.1755(2) requires the cabinet to promulgate administrative regulations establishing the policies and procedures for the local health department personnel program. This administrative regulation establishes the process for appointing a health officer or public health department director and the provisions of the merit system.
- History: 19 Ky.R. 2778; eff. 9-3-1993; 21 Ky.R. 598; 1055; eff. 9-21-1994; 22 Ky.R. 2360; eff. 8-1-1996; 24 Ky.R. 2216; 25 Ky.R. 123; 583; eff. 8-19-1998; 37 Ky.R. 1796; 2181; eff. 4-1-2011; 46 Ky.R. 1968; eff. 3-19-2020.
902 KAR 8:150 Board of health requirements {#sec-902-kar-8-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:150}
Section 1. Definitions.
(1) "Agency" is defined at KRS 211.1751(1).
(2) "Agency director" means the administrative officer of the agency.
(3) "Board" means a statutorily mandated governing city-county, county, or district board of health created pursuant to KRS 212.020, 212.640, or 212.855, and does not apply to boards of health serving:
(a) A city of the first class created pursuant to KRS 212.350;
(b) An urban county government created pursuant to KRS 212.626; or
(c) An independent district health department created pursuant to KRS 212.780.
(4) "City-county board" means the statutorily mandated governing body of a county that:
(a) Contains a city of the second class;
(b) Is created pursuant to KRS 212.640; and
(c) Is not contained in a district board.
(5) "County board" means the statutorily mandated governing body of a single county health department created pursuant to KRS 212.020, and does not exist in a district.
(6) "District board" means the statutorily mandated governing body of a multicounty agency created pursuant to KRS 212.855.
(7) "Nongoverning board" means a city-county, or county, board of health that is under the governance of a district board.
Section 2. Compliance. The policies and procedures established by governing boards shall be in compliance with KRS 212.230(1)(c).
Section 3. Functions of a Board.
(1) A governing board shall:
(a) Assure that the services provided meet the needs of the local citizenry, to protect and promote public health;
(b) Establish priorities and objectives for:
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Service delivery, considering federal and state disease prevention and health promotion objectives;
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Specific health and safety needs of the community; and
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Resources of the agency.
(c) Assure that financial controls and program evaluation measures are ongoing to facilitate effective and efficient agency services and operations;
(d) Interview and hire an agency director in accordance with 902 KAR 8:040 through 902 KAR 8:140;
(e) Communicate board policies and priorities to the agency director;
(f) Evaluate the performance of the agency director; and
(g) Review information and data provided by the agency director to assess the effectiveness and efficiency of the agency in complying with federal and state public health laws, regulations, and board policies.
(2) A nongoverning board shall:
(a) Maintain a membership on the county public health taxing district board;
(b) Prepare the annual public health tax resolution;
(c) Maintain trusteeship of the county public health tax;
(d) Provide for maintenance and upkeep of the agency building;
(e) Determine the appropriate use of the facility by community groups and other agencies; and
(f) Provide the district board with information regarding specific public health needs and concerns of the city-county or county board.
Section 4. Composition of the Board.
(1) A city-county, county, or district board shall not have an ex officio member, except that an official of a county or a city of the second class may be an ex officio member, if he is a:
(a) County judge executive;
(b) Mayor;
(c) City manager; or
(d) Designee of an official named in paragraph (a), (b) or (c) of this subsection.
(2) The board shall elect a chairman from its membership on an annual basis.
(3) A chairman may serve more than (1) consecutive term.
(4) Each officer shall be a member of the board, except for the board secretary, who may be a member of the board.
(5) The agency director may serve as secretary to the board. An agency director of a district agency may serve as secretary to the district board and as secretary to the nongoverning board within the district; or the agency director may designate an employee to serve as secretary of a city-county or county board.
(6) An employee of an agency shall not serve as a member of the board.
(7) A person shall not serve on a board and receive in excess of $2,000 per year in contract payments, unless approved in writing by the cabinet.
Section 5. Meetings of the Board.
(1) A quorum shall be present in order to conduct business.
(2) A vacant position shall be counted when determining the number to be present for a quorum to exist.
(3) A majority of the quorum is required to approve actions of the board.
(4) A telephone poll vote shall not be permitted on an issue considered by the board.
(5) A member of a board shall not be represented by a proxy at a board meeting, except for a member who is an official of a county or a city of the second class, including a:
(a) County judge executive;
(b) Mayor; or
(c) City manager.
(6) Meetings of a board and its committees shall comply with the Kentucky Open Meetings Law, KRS 61.805 to 61.850.
(7) Meetings of a board shall be held at specific times and places convenient to the public.
(8) The board shall provide a schedule of regular meetings, which shall be made available to the public and published in a local newspaper of general circulation.
(9) Board meetings shall be held in locations accessible to individuals with disabilities.
(10) A qualified interpreter for the deaf and hard of hearing shall be made available upon request to the board chairman or agency director at least ninety-six (96) hours prior to the scheduled meeting.
(11) Matters delegated to an executive committee by the board, shall be specifically set forth in the minutes.
(12) An action of an executive committee shall be confirmed by the board and reflected in the board minutes.
Section 6. Minutes of Board Meetings.
(1) Actions of the board shall be made a part of the minutes.
(2) Minutes shall be signed by the secretary and chairman of the board.
(3) Minutes shall include the following information:
(a) Name of the board;
(b) Date, time, and location of the board meeting;
(c) Listing of board members present and absent;
(d) Acknowledgment of a quorum;
(e) Review and approval or correction of the minutes of the last meeting;
(f) Presentation of old business;
(g) Presentation of new business;
(h) Statement of each motion made, identification of member moving and seconding motion, and tabulation of the vote by the members voting either for or against each motion;
(i) Scheduled date of next meeting; and
(j) Motion to adjourn.
(4) Board minutes shall be available in an alternative format within a reasonable period of time when requested by a member of the public demonstrating need.
(5) A permanent copy of the official minutes shall be maintained and kept on file by the agency.
(6) A signed copy of the minutes of the board shall be submitted to the cabinet within two (2) weeks after the date of the meeting.
Section 7. Conflicts of Interest.
(1) A member of a board shall comply with the KRS 45A.340, Conflicts of interest of public officers and employees.
(2) A board member or a member of his family shall not be considered for a contract, lease or bid for services, in excess of $2000, unless the services are in the best public interest and have the prior approval in writing of the cabinet.
(3) If a board member or a member of his immediate family is considered for approval for a contract, lease, or bid to provide services to the agency, the board member shall:
(a) Leave the board meeting prior to discussion of the contract, lease or bid; and
(b) Not be allowed a vote on the contract, lease or bid.
(4) The board minutes shall reflect the board member was absent from the discussion because of a conflict of interest and was not permitted a vote.
Section 8. Training for Board Members.
(1) A new member appointed to the board shall receive training from the agency director or other appropriate agency representative.
(2) The training shall include discussion or written materials on the following topics:
(a) Statutory responsibilities and functions of the cabinet, agency, and the board;
(b) Board laws, regulations, and local ordinances;
(c) Board members' responsibilities and functions;
(d) Agency services sites and the services provided at these sites;
(e) Agency staff by discipline or profession;
(f) Review of agency medical and environmental services, budget and annual report;
(g) Board minutes for the last calendar year; and
(h) Tour of the agency's main facility or, if feasible, a tour of satellite or remote site.
Section 9. Board Regulations.
(1) Internal board regulations and ordinances shall be indexed and placed in an agency's local board of health policy manual.
(2) New policies shall be placed in the manual no later than thirty (30) days after approval by the board and the cabinet, if applicable.
Section 10. Legal Advice. A board created pursuant to KRS 212.020, 212.640, or 212.855, may employ counsel as needed to act as legal advisor for the board.
History
- RELATES TO: KRS 45A.340, 61.805-61.850, 211.090, 211.170, 211.1751(1), 212.020, 212.120, 212.210, 212.230, 212.245, 212.350, 212.626, 212.640, 212.780, 212.855, 212.860, 212.880
- STATUTORY AUTHORITY: KRS 194A.050, 211.025
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.025, 211.090(3), 211.170, 212.120, and 212.230 together require the Cabinet for Health Services to establish policies and standards of operation for the boards of health for local health departments of Kentucky. This administrative regulation establishes minimum administrative and operational requirements for city-county, county, and district boards of health. This administrative regulation does not apply to the Lexington-Fayette, Louisville-Jefferson or Northern Kentucky Independent District Boards of Health.
- History: 902 KAR 008:150. 28 Ky.R. 763; 1155; 1398; eff. 12-19-2001; 29 Ky.R. 815; 1275; eff. 10-16-2002; eff. 6-11-2019; Crt eff. 1-7-2026.
902 KAR 8:160 Local health department operations requirements {#sec-902-kar-8-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:160}
Section 1. Definitions.
(1) "Agency" is defined by KRS 211.1751(1).
(2) "Animal control officer" is defined by KRS 258.005(7).
(3) "Board" means the statutorily mandated governing body for local health departments in Kentucky.
(4) "Public health department director" means the administrative officer of the agency.
Section 2. Policies and Procedures. Internal policies and procedures for operations established by an agency shall comply with procedures and policies developed by the cabinet, in accordance with KRS 211.170(1), (2), (3), (4), and (6).
Section 3. Conflict of Interests.
(1) An agency employee shall avoid situations that are or appear to be a conflict of interest.
(2) An agency employee shall not:
(a) Sell, recommend, or promote a specific brand of product or equipment that is subject to inspection or evaluation by an agency or its employees;
(b) Recommend or express to the public a preference for health-related professional services or products of an individual or firm;
(c) Be engaged in a business or have financial interests that affect the employee's professional relationship with the agency or cabinet or impair the effectiveness of the employee;
(d) Enter into a contract with or hold an additional full-time or part-time position in another agency unless approved by the cabinet in writing;
(e) Be an owner or part owner of a business that contracts with or is regulated by the agency without prior review by the cabinet; or
(f) Accept appointment or be employed as an animal control officer.
(3) An agency employee shall not conduct the following services for the employee, the employee's spouse, parent, child, brother or sister or the spouse of either of them, grandparent, grandchild, mother or father-in-law, daughter or son-in-law:
(a) Determine eligibility for an agency service;
(b) Issue women, infants, and children food instruments or prescribe food packages; or
(c) Conduct an inspection or monitor compliance with the agency's medical or environmental standards and administrative regulations.
(4) An employee or former employee shall not receive severance pay in cash, benefits, goods, or services.
Section 4. Employee Tuition Assistance.
(1) A public health department director may approve a tuition assistance agreement to specify the terms and conditions for a regular full-time or part-time 100 hour employee to attend a course of study provided by a college or university, correspondence school, vocational school, or other training institution, if the coursework is related to:
(a)
-
The work of the agency; and
-
The employee's current position; or
(b) An agency position to which the employee can reasonably aspire.
(2) The public health department director may approve tuition assistance from the agency budget for a nonrelated course if:
(a) The course is a requirement for a degree or certification program; and
(b) The degree is determined to be necessary to the function and purpose of the agency.
(3) The board may approve a tuition assistance request to be used by a public health department director for the director's course of study.
(4) Restricted funds used for payment of tuition assistance shall receive prior written approval from the funding authority.
(5) An employee approved to receive tuition assistance shall repay to the agency the tuition paid on the employee's behalf if the employee:
(a) Fails to provide the agency, or board, evidence of satisfactory completion of the training within thirty (30) working days after scheduled completion; or
(b) Receives a grade of:
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Less than "C" in an undergraduate course;
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Less than "B" in a graduate course;
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"F" in a pass/fail course;
-
"U" in a satisfactory/unsatisfactory course;
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"I" for incomplete; or
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Fails to complete the training, regardless of cause, without prior approval of the public health department director or board.
(6) The employee shall maintain paid full-time or part-time 100 hour work status for the agency while taking courses.
(7) An employee shall continue employment with the agency for a period of at least one (1) month for each semester hour or equivalent of tuition paid by the agency, after completion of all courses, unless directed by the agency to undertake the course work.
(8) The employee shall repay the agency for educational assistance funds expended on the employee's behalf if the employee resigns, retires, or is dismissed for cause prior to completion of the continued employment provisions of subsection (7) of this section.
(9) The repayment shall be:
(a) Prorated according to the portion of the continued employment provisions of subsection (7) of this section the employee has fulfilled; and
(b) Repaid within six (6) months following resignation, retirement, or dismissal.
(10) The employee may use accumulated annual leave or compensatory time as necessary to attend classes if requested by the employee.
(11) The maximum allowable course hours an employee may take in a semester shall be determined by the public health department director as provided in their internal control manual.
(12) If approved, tuition assistance shall be granted for:
(a) Tuition and routine registration fees;
(b) Laboratory and examination fees; and
(c) Required textbooks.
(13) Tuition assistance shall not be granted for:
(a) Late registration;
(b) Graduation fees;
(c) Parking or transportation;
(d) Records or transcripts;
(e) Supplies;
(f) Assessments; or
(g) Courses taken prior to approval by the agency.
(14) Tuition and fees shall be paid directly to the college or training institution or reimbursed to the employee.
(15) An agency shall maintain records, subject to audit, to ensure the proper administration of the employee tuition assistance program.
Section 5. Educational Leave Program.
(1) The public health department director may approve educational leave for a regular full-time or part-time 100 hour employee.
(2) Educational leave may be approved on a full-time or part-time basis with or without pay as determined by the public health department director.
(3) Educational leave shall be for the purpose of coursework or training related to the current or future duties and responsibilities of the employee.
(4) Payment for educational leave shall come from the agency budget.
(5) Restricted funds used for payment of educational leave shall receive prior written approval from the funding authority.
(6) Educational leave payment shall not be granted for:
(a) Late registration fees;
(b) Graduation fees;
(c) Parking or transportation;
(d) Records or transcripts;
(e) Supplies;
(f) Assessments; or
(g) Courses taken prior to approval by the agency.
(7) To participate in educational leave with pay, the employee shall:
(a) Be a regular full-time or part-time 100 hour employee;
(b) Enroll in an area of study with a clear and direct relationship to the work of the agency;
(c) Be formally accepted by the educational institution; and
(d) Be approved for educational leave by the agency.
(8) An agency approving an employee for educational leave with pay shall:
(a)
-
Place the employee on full-time or part-time educational leave at the employee's regular rate of pay; and
-
Restore the employee to the position the employee formerly held, to a position of like status and pay, or promote the employee to a higher position upon the employee's successful completion of educational leave; or
(b) Cancel the employee's educational leave and restore the employee to the same or like position if the academic standing of the employee falls below the requirement of Section 4(5) of this administrative regulation.
(9) An employee on full-time leave with pay shall be a full-time student as defined by the institution where the employee is enrolled.
(10) After satisfactorily completing the educational leave the employee shall:
(a) Continue employment with the agency:
-
At least one (1) day for each full day of leave used if tuition and other fees are not paid by the agency; or
-
At least one and one-half (1 1/2) days for each full day of leave used if tuition and other fees are paid by the agency; or
(b)
-
If the employee terminates employment with the agency, repay the agency at the rate of 100 percent of the employee's daily pay or an average of the employee's daily pay during leave, multiplied by the number of obligated days remaining; and
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Forfeit all leave rights if the employee accepts public or institutional financial assistance other than that provided by the agency, unless the agency has granted prior approval.
(11) An agency directing an employee to be placed on full-time or part-time educational leave shall:
(a) Pay the following:
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The employee's regular rate of pay;
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Tuition and routine registration fees;
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Required textbooks;
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Laboratory and examination fees;
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Dormitory or housing costs; and
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Transportation costs to and from the school once per semester;
(b) Restore the employee to the position the employee formerly held, to a position of like status and pay, or promote the employee to a higher position, if qualified, following completion of educational leave; and
(c) Cancel the employee's educational leave and restore the employee to the same or like position if the academic standing of the employee falls below the requirement of Section 4(5) of this administrative regulation.
(12) An employee approved for educational leave without pay shall not incur any service obligation to the agency.
(13) An agency shall maintain an educational leave file on each employee requesting or receiving educational leave.
Section 6. Employment of Relatives.
(1) Except as provided in subsections (3) and (4) of this section, an agency shall not employ an individual that is immediately related to the public health department director or to an immediate supervisor.
(2) An individual immediately related to the public health department director or immediate supervisor shall include:
(a) Spouse;
(b) Parent;
(c) Child;
(d) Brother or sister or the spouse of either of them;
(e) Grandparent;
(f) Grandchild;
(g) Mother or father-in-law; or
(h) Daughter or son-in-law.
(3) If a current employee is in a supervisory relationship with an immediate relative, the employee shall be transferred to another site within the agency with the same job duties, or assigned a different supervisor.
(4) The cabinet may approve the employment of an immediate relative in a case determined to be in the public interest and approved by the board.
Section 7. Agency Facility Ownership.
(1) An agency shall not pay rent to the fiscal court if the facility is owned by the fiscal court and was constructed with state funds, agency funds, or local public health tax appropriations.
(2) The agency shall be permitted to remain in the facility owned by the fiscal court rent free for a minimum of twenty (20) years or for the useful life of the facility, whichever is longer.
Section 8. Capital Construction Requirements.
(1) An agency requesting state capital construction funds from the cabinet for new construction, building expansion, or renovation shall:
(a) Submit a letter of request for the project to the cabinet, and if requested, submit one (1) copy of the plans and specifications for the project to the cabinet for review and approval;
(b) Submit one (1) copy of the plans and specifications, if appropriate, to the Department of Housing, Buildings, and Construction to assure compliance with building and safety codes;
(c) Provide written assurance to the cabinet that the facility will be constructed in accordance with approved plans and specifications;
(d) Provide written assurance to the cabinet that a cost overrun or financial commitment above the state grant will be paid by the agency;
(e) Submit architectural and contractor agreements or contracts to the cabinet for review prior to implementation;
(f) Provide written assurance to the cabinet that the agency will be allowed to use the facility for a minimum of twenty (20) years rent free or for the useful life of the facility, whichever is longer;
(g) Provide written documentation to the cabinet that the board has approved the awarding of the architectural and contractor agreements;
(h) Provide quarterly progress reports to the cabinet on the status of the project;
(i) Submit a closing report upon completion or close-out of the project; and
(j) Maintain a comprehensive construction file for the useful life of the building which includes:
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Documents and correspondence relative to the project;
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Written contracts or agreements; and
-
Progress reports, and financial transactions.
(2) An agency's facilities, whether owned or leased by the agency, shall comply with applicable state and local building, fire and safety codes, and ordinances.
(3) Prior to construction or modification of an x-ray room, the plans and specifications for the construction or modification shall be evaluated by a qualified expert. The Radiation Health Branch of the department shall be contacted regarding compliance requirements.
Section 9. Agency Insurance Requirements.
(1) An agency shall maintain current replacement value insurance on:
(a) A building owned by the agency or board; and
(b) On the contents of both owned and leased facilities.
(2) An agency shall maintain:
(a) Public officials' liability insurance for board members;
(b) General liability insurance for agency staff; and
(c) Fiduciary bonding on staff and board members who handle public funds.
(3) Contracted providers shall attest to current liability coverage under the terms of their contract with the agency.
(4) Contractors of capital construction projects shall:
(a) Post bid and performance bonds; and
(b) Carry appropriate liability insurance at levels approved by the board, to cover their contracted responsibilities.
Section 10. Identification of Local Needs.
(1) A local needs assessment that describes the prevailing health status and health needs of the population within the local health department's jurisdiction shall be conducted at least once every five (5) years.
(2) The local needs assessment shall be submitted to the Department for Public Health.
(3) The local needs assessment shall include:
(a) A statement of the health status of the community;
(b) A description of the process used to determine the health status of the community, including stakeholder involvement throughout the local needs assessment;
(c) A summary of the data used to determine the health status of the community, including:
-
Quantitative data;
-
Qualitative data;
-
Community demographic data; and
-
Identification of health inequities; and
(d) An annual evaluation of the progress of evidence-based and promising practice strategies implemented to address the health status of the community.
(4) A community health assessment may be submitted as a local needs assessment if it meets the requirements of this section.
Section 11. Days and Hours of Operation.
(1) An agency shall post the hours of operation near the main entrance to the agency. The posting shall be plainly visible from the outside.
(2) Except in an emergency situation, an agency shall publicize in advance if the agency is to be closed during regular working hours. The notice shall:
(a) Be prominently displayed at the main entrance to the agency;
(b) Indicate where and how staff may be reached; and
(c) Indicate when offices are expected to reopen.
Section 12. Grievance Policies.
(1) An agency shall establish an internal grievance procedure to assure the timely and equitable resolution of a complaint alleging discrimination, unfair, or inappropriate treatment from a member of the public.
(2) In accordance with 7 C.F.R. 246.8, complaints alleging civil rights discrimination for United States Department of Agriculture (USDA) funded programs, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), WIC Farmers Market Nutrition Program, and WIC Breastfeeding Peer Program, shall be referred to or filed with the Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW, Washington, D.C. 20250-9410; by fax: (833) 256-1665 or (202) 690-7442; or by email: program.intake@usda.gov. Complaints filed in accordance with this subsection shall be filed within 180 days of the alleged incident. Only the Secretary of the USDA or the secretary's designee may waive this timeline for cause.
(3) For all other complaints from a member of the public, an agency grievance procedure shall:
(a) Protect the rights of the complainant;
(b) Meet due process requirements;
(c) Assure compliance with applicable federal laws and administrative regulations governing equal opportunity;
(d) Designate an employee to coordinate the grievance process; and
(e) Provide for methods of accepting written, verbal, or anonymous complaints.
(4) A complaint shall be filed within sixty (60) days of the alleged incident.
(5) An agency shall conduct an investigation of the complaint to afford interested or affected parties an opportunity to submit evidence or testimony relevant to the complaint.
(6) A written description of the investigation and a description of the resolution shall be issued and a copy forwarded to the complainant and the agency director no later than forty-five (45) calendar days after receipt of the complaint.
(7) An agency shall maintain files and records relating to complaints filed.
(8) The complainant dissatisfied with the resolution may request reconsideration, within thirty (30) calendar days, by the public health department director or the board.
(9) The complaint shall continue through the agency's grievance process even if the complainant is pursuing other state or federal remedies, unless otherwise advised by legal counsel.
(10) Complaints or grievances regarding employment shall be filed according to the agency's personnel policies.
History
- RELATES TO: KRS 211.1751(1), 212.230, 212.240, 212.245, 212.890, 258.005, 7 C.F.R. 246.8
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.170, 211.180
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of the citizens of the commonwealth; to operate the programs and fulfill the responsibilities vested in the cabinet; or to comply with federal law. KRS 211.170(1) and (3) require the cabinet to establish policies and standards of operation for the local health departments of Kentucky. This administrative regulation establishes minimum administrative and operational requirements for Kentucky's local health departments.
- History: 28 Ky.R. 754; 1157; 1400; eff. 12-19-2001; 37 Ky.R. 3006; 38 Ky.R. 245; eff. 8-17-2011; Cert eff. 6-11-2019; 47 Ky.R. 421; eff. 2-4-2021; 49 Ky.R. 907, 1430; eff. 1-12-2023.
902 KAR 8:165 Local health department accounting and auditing requirements {#sec-902-kar-8-165 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:165}
Section 1. Definitions.
(1) "Auditee" is defined by 2 C.F.R. 200.6.
(2) "GAAP" means generally-accepted accounting principles.
(3) "Government auditing standards" means the standards and guidance for auditors and audit organizations who audit federal, state, and local government programs, outlining the requirements for audit reports, professional qualifications for auditors, and audit organization quality control.
Section 2. Accounting and Auditing Requirements.
(1)
(a) All recording by health departments in the books of account and all financial reporting shall be performed in accordance with:
-
This administrative regulation;
-
Cash or modified accrual accounting procedures as approved by the Department for Public Health;
-
2 C.F.R. Part 200; and
-
GAAP.
(b) If GAAP conflicts with policies established in this administrative regulation, the local health department shall follow policies established in this administrative regulation.
(2) Each local health department shall be audited by a certified public accountant after the close of every fiscal year to assure receipts and expenditures have been properly authorized, recorded, and reported.
(a) The following items shall be audited:
-
Federal, state, and local funds and fees received and expended; and
-
Books, accounts, and other financial documentation, by cost center.
(b) An audit shall be conducted in accordance with:
-
GAAP; and
-
Government auditing standards.
(c) The audit of a local health department expending $750,000 or more in federal funds shall be conducted in accordance with:
-
Paragraph (b) of this subsection; and
-
The provisions of 2 C.F.R. 200.500-200.520.
(d) The following reports shall be provided to the local health department and the Department for Public Health:
-
Auditor's opinion on the financial statements and on the schedule of expenditures of federal awards, as required by 2 C.F.R. 200.515(a);
-
Statement of assets, liabilities, and fund balance;
-
Statement of revenues and expenditures by cost center;
-
Statement of changes in fund balance;
-
Comparative schedule of budgeted to actual operating revenues and expenditures by cost center;
-
Audit adjustments, or a statement that an adjustment is not required;
-
Schedule of expenditures of federal awards, as required by 2 C.F.R. 200.510(b);
-
Report on compliance and on internal control over financial reporting based on an audit of financial statements performed in accordance with government auditing standards;
-
Single audit report on compliance with requirements applicable to each major program and on internal control over compliance in accordance with 2 C.F.R. 200.515(b);
-
Schedule of findings and questioned costs, in accordance with 2 C.F.R. 200.515(d), including the status of an uncorrected finding from a prior audit;
-
A summary of the auditor's results, in accordance with 2 C.F.R. 200.516;
-
Auditee's corrective action plan; and
-
Auditee letter:
a. Describing an internal control or compliance deficiency not a reportable condition; and
b. Referenced in the auditor's report on internal control and compliance.
(3) The reports described in subsection (2)(d) of this section shall be presented as prescribed by the American Institute of Certified Public Accountants Statement of Position 98-3, Audits of States, Local Governments, and Not-for-Profit Organizations Receiving Federal Awards, and subsequent amendments, except that a written auditee letter is required when internal control and compliance deficiencies are determined not to be reportable conditions.
(4) A report shall contain all reportable conditions, with those reportable conditions that are considered material weaknesses being appropriately segregated and identified. Any other matters conveyed to the auditee shall be in writing in the auditee letter, and shall be discussed during the exit conference. Reportable conditions presented as part of the reports shall be well developed and shall consist of the following components, to the extent practicable:
(a) A statement of condition;
(b) The criteria for the reportable condition;
(c) The cause of the condition;
(d) The effect of the condition;
(e) A recommendation for correction; and
(f) Auditee's response and corrective action plan.
(5) If applicable, the audit firm shall report on:
(a) Uncorrected comments reported in the preceding audit;
(b) The status of prior-year questioned costs, whether resolved with the federal grantor or unresolved; and
(c) Questioned costs from the preceding audit and any unresolved questioned costs from prior years.
(6) The audit firm shall report immediately, in writing, to the Commissioner of the Department for Public Health, any fraud, irregularity, illegal act, or indication of an illegal act of the auditee, that comes to its attention during the audit proceedings.
(7) A vendor selected to conduct a local health department audit shall meet criteria provided in the request for proposal instructions provided by the Department for Public Health.
Section 3. Internal Control Procedures.
(1) A local health department shall have written internal control procedures that shall be followed by the local health department. The chief executive officer, senior local health department management official, or other staff shall notify the Department for Public Health immediately if evidence of possible fraud or mismanagement is discovered.
(2) A local health department shall use an automated financial accounting system approved by the Department for Public Health.
(3) Local health departments shall submit all financial reports to the Department for Public Health in accordance with the instructions provided by the department
History
- RELATES TO: 211.180, 212.230, 212.240, 212.245, 212.890, 2 C.F.R. Part 200
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.170(1), (3), (6)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to qualify for federal funds. KRS 211.170(1), (3), and (6) require the cabinet to establish policies and standards of operation for Kentucky's local public health departments. This administrative regulation establishes minimum accounting and auditing requirements for Kentucky's local public health departments.
- History: 902 KAR 008:165. 28 Ky.R. 768; 1160; 1402; eff. 12-19-2001; 45 Ky.R. 1430; eff. 1-23-2019; Crt eff. 7-17-2025.
902 KAR 8:170 Local health department financial management requirements {#sec-902-kar-8-170 omnilex-key=us-ky-regs-official--title-902--902 KAR 8:170}
Section 1. Definitions.
(1) "Core public health program" is defined by KRS 211.185(4).
(2) "Foundational public health program" is defined by KRS 211.185(6).
(3) "Local public health priorities" is defined by KRS 211.185(9).
(4) "Local support" means local health department financial support:
(a) Including:
-
Unrestricted receipts from a local government agency or special district;
-
Receipts from the public health taxing district;
-
Nonfederal receipts from a contract with a board of education; and
-
An unrestricted donation from another source; and
(b) Excluding funds from the Unrestricted and Restricted fund balances.
(5) "Personal service contract" is defined by KRS 45A.690(1)(h).
(6) "Public health department director" means:
(a) The administrative or health officer of a county or district health department;
(b) The administrative assistant of a county health department that does not have a health officer;
(c) The director of a district health department that does not have a health officer;
(d) The district director of health of an independent district department of health; or
(e) The commissioner of an urban-county department of health or of a health department serving a county with a city of the first class.
(7) "Restricted fund" means the portion of a local health department's total fund balance that is limited by the Department for Public Health for a specific program's expenses or other items of expense.
(8) "Unrestricted fund balance" means the portion of a local health department's total fund balance that is not limited by the Department for Public Health for a specific program's expenses or other items of expense.
Section 2. Budgeting Requirements.
(1) Each local health department shall prepare a fiscal year budget in accordance with annual budgeting guidance provided by the Department for Public Health.
(2) The local health department budget narrative shall include an attestation that core and foundational public health programs will be implemented, maintained, or assured in accordance with KRS 211.186.
(3) A description of the local public health priorities, supported by a local needs assessment in accordance with KRS 211.187, to be funded by local tax or unrestricted funds shall be submitted to the Department for Public Health, Office of the Commissioner, for review and approval.
(4) Each local health department shall have a balanced budget in which receipts at least equal expenditures and shall operate within its approved budgets.
(5) Each local health department annual budget shall be approved by both the governing local board of health and the Department for Public Health.
(6)
(a) Each local health department shall be responsible for making budget changes necessitated by:
-
Changes in financial status;
-
Changes in project status; or
-
The addition or deletion of a new project.
(b) Changes shall:
-
Be subject to review and approval by the Department for Public Health; and
-
Require a corresponding change in plans if required by the Department for Public Health.
(7) Actual capital expenditures of local health departments for furniture and equipment, data processing equipment, land, buildings, and vehicles shall not exceed the approved budgeted amount without prior approval by the appropriate governing board of health.
(8) Actual use of a local health department's unrestricted fund balance in excess of the amount included in the approved budget shall be approved by the governing board of health and shall be used solely for the operation and maintenance of local health departments.
(9) An actual deficit in a local health department's financial operations for the fiscal year wherein cash expenditures and payroll related liabilities exceed available cash receipts, including approved use of the unrestricted fund balance, shall not be allowable.
(10)
(a) The Department for Public Health shall notify the local health department in writing if it determines that:
-
A local health department is receiving fewer receipts than are budgeted;
-
A local health department is making expenditures in excess of the approved budget; or,
-
A deficit condition is probable at the end of the fiscal year.
(b) Within fifteen (15) working days of receipt of the notification, the local health department shall inform the Department for Public Health in writing of the reasons that the determination may be in error.
(c) If the reasons and corrective actions listed by the local health department are not sufficient to prevent a deficit condition from occurring at the end of the fiscal year, the Department for Public Health shall direct the local health department to:
-
Institute a hiring freeze on employees;
-
Institute a freeze on meritorious, promotional, or other salary increments;
-
Institute a reduction in contractual and other expenditure categories; or
-
Take other action necessary to correct the deficit situation.
Section 3. Use of Receipts.
(1) A local health department may, with the approval of the Department for Public Health, transfer funds from a restricted to an unrestricted account.
(2) Receipts from any source shall be used:
(a) In accordance with laws, policies, administrative regulations, and contracts governing the use of the receipts; and
(b) Only for the operation and maintenance of the health department for necessary, reasonable, and proper purposes that protect and improve the health of the people of the Commonwealth.
(3) The minimum acceptable level of local support shall be determined annually by the Commissioner of the Department for Public Health.
(4) The state allotment to a local health department shall be adjusted in the following circumstances:
(a) The local health department decreases its budgeted amount of local support below the minimum acceptable level. The state allotment shall be decreased by the same percentage in the year of the decrease.
(b) The local health department receives less local financial support than the required level. The state allotment shall be decreased by the percentage that the actual local support was deficient. The decrease shall apply to the fiscal year following the shortage.
(c) The local health department accumulates an unrestricted fund balance, as of June 30 of a fiscal year, in excess of forty (40) percent of that year's expenditures, or $100,000, whichever is greater. The local health department shall submit, to the Department for Public Health, a written plan of use for the amount of the excess. If approved, the funds shall be placed into a local restricted fund to be used solely as approved.
(5) Fees.
(a)
-
A request from a local health department to change patient fees to either a sliding or nominal fee basis shall be sent to the Department for Public Health for approval.
-
A request shall include documentation of the proposed full amount of the fee, the estimated annual cost of the service, and the estimated net fee income for the service.
-
Charges for medical supplies and equipment may be requested as a percentage of the acquisition cost of the supply or equipment item or may be requested as charges for individual items.
(b) Patient fees charged to self-pay patients shall be on a sliding fee basis approved by the Department for Public Health and be based on the level of income matched with the level of poverty, utilizing the federal poverty guidelines as published annually by the U.S. Department of Health and Human Services, according to the following scale:
-
Above 250 percent of poverty, fee shall be assessed at full charge of service;
-
From 101 to 250 percent of poverty, fee shall be based on a schedule of discounts; and
-
Below 101 percent of poverty, there shall be no fee except as specified in paragraph (c) of this subsection.
(c) A fee up to five (5) dollars may be charged for communicable disease services specified by the Department for Public Health.
(d) The inability to pay the assessed fee shall not be a barrier to services.
(e) A charge shall not be made to school age children at a school-based clinic if requested by the local health department and authorized by the Department for Public Health.
(f) A policy of a local health department that may result in referral of services due to non-payment of fees shall be approved by the Department for Public Health.
(g)
-
A local health department shall bill third-party payors for covered services provided to individuals.
-
If a third-party governmental payor is billed for services rendered to an eligible patient, the regulations of the third-party payor shall be followed for the part of the fee charged directly to the patient.
-
A patient's health insurance carrier shall be billed at 100 percent of charges. A balance not covered by the health insurance carrier shall be charged to the patient, except that the amount charged shall not exceed the amount that a patient without health insurance coverage would be charged, using standard discounts as applied to total charges for services rendered.
(h) A fee, regardless of the source of the fee or the funding of the project, shall be applied to the project that generates the fee, in accordance with income procedures of 2 C.F.R. 200.307(e). A third-party cost reimbursement payment and an interim payment shall be recorded in the same project where the costs were recorded, in proportion to the expenditures of each project that were reimbursed by the third party.
(6) A matching requirement for any source of receipts shall be the sole responsibility of each local health department.
(7) The following policies shall be applied in closing receipt accounts for the local health department fiscal year, July 1 to June 30:
(a) Receipts earned and received during a fiscal year shall be recorded as a receipt of that fiscal year; and
(b) Receipts earned in one (1) fiscal year and received after June 30 of that fiscal year shall be recorded as new fiscal year receipts.
Section 4. Expenditure Policies. Policies and procedures required by 2 C.F.R. 200 Subpart E shall be followed by local health departments for expenditures in projects, regardless of the source of funds for the project. The following policies concerning allowable expenditures and their proper documentation shall be followed by local health departments:
(1) Salaries, wages, benefits, and personnel payments.
(a) Salaries and wages for only those positions specified in administrative regulations for local health departments, 902 KAR 8:060 through 902 KAR 8:090, and 902 KAR 8:140, shall be allowable. The positions and related expenditures shall be included in the approved budget or approved budget revisions of the local health department. Other salary, wage, or bonus payments shall not be allowable, unless specifically approved by the Department for Public Health. Uniform pay dates shall be determined annually by the Department for Public Health.
(b) Expenditures shall be authorized for payment of employer paid fringe benefits required or allowed by policies of the Department for Public Health.
-
Required benefits shall be payments of the single-coverage amount for health insurance and life insurance that are part of the state-negotiated plans.
-
Additional allowed benefits shall be determined by the public health department director and approved by the governing board of health.
-
A part-time employee or a personal services contract employee working less than 100 hours per month shall not be eligible for employer-paid fringe benefits.
-
A payment to or on behalf of an employee for another direct or fringe benefit or other reason shall not be made unless:
a. Specifically allowed by this administrative regulation;
b. Approved by the Department for Public Health; and
c. A disbursement for services of a contract employee or independent contractor shall be made in accordance with the terms of the written contract. A contract payment shall not be made without proper written documentation demonstrating that services have been rendered.
(2) Capital expenditures.
(a) Capital expenditures are allowable for necessary capital equipment, land, and buildings.
-
The equipment in this category shall cost more than $5,000 and have an expected useful life of one (1) year or more.
-
The same purchasing policies apply to capital items as apply to noncapital purchases.
-
Before purchasing land or buildings or contracting for the construction or remodeling of a building, the local health department shall notify the Department for Public Health.
(b) A local health department shall pay a vendor within thirty (30) working days of the receipt of the service or goods, or within thirty (30) working days of the receipt of the invoice or bill from the vendor, whichever is later, unless the local health department and the vendor have agreed in writing to a longer period of time.
(c) A local health department shall not donate anything of value to any individual or entity, unless approved by the Department for Public Health.
Section 5. Travel Policies.
(1) The public health department director shall insure that travel expenses are economical.
(2) A person who travels on official local health department business shall state on the expense voucher the purpose of each trip and shall maintain records to support claims.
(a) A local health department may provide an employee with a credit card to cover travel expenses.
(b) Due care shall be taken to assure that use of a local health department credit card is not abused.
(c) A local health department shall not provide an employee with cash to pay travel expenses. The public health department director responsible for insuring that travel reimbursement conforms to this policy shall disallow, reduce, or strike from an expense voucher any claim contrary to this administrative regulation, and may require written justification for an amount claimed.
(3) With the exceptions cited in this policy, reimbursement shall not be claimed for expenses of a person other than an employee, or other person in the official service of the local health department. Only necessary expenses of official travel shall be reimbursed.
(4) Each day's vicinity travel shall be listed on a separate line on the expense voucher. The employee's supervisor or the public health department director shall monitor vicinity mileage claimed by an employee on travel status.
(5) A travel voucher shall be signed and dated by the employee submitting the claim and by an employee designated in accordance with the local health department's internal control procedures. The public health department director's travel voucher shall be signed by one (1) or more board of health members designated at a board of health meeting to perform the function.
(6) The official work station of an employee shall be:
(a) The street address of the local health department facility;
(b) For a local health department with more than one (1) facility, the facility in which the employee most often works;
(c) Established not for an employee's purposes, but in the best interest of the local health department; and
(d) Designated for a valid purpose.
(7) A standard travel expense voucher or another voucher approved by the Department for Public Health shall be used to claim reimbursement for travel expenses.
(a) Each travel expense voucher shall show the claimant's identifying number, name, address, and official workstation. The travel voucher may be typed, prepared by computer, or legibly prepared in ink.
(b) Receipts shall be submitted with the travel voucher.
(c) If leave interrupts official travel, the travel voucher shall show the dates of leave.
(8) A travel expense shall not be reimbursed unless the travel was authorized in advance by the public health department director or designee.
(9) A local health department employee traveling on local health department business shall use the most economical, standard transportation available and the most direct and usually traveled routes. Expenses added by use of other transportation or routes shall be assumed by the employee.
(10) Local health department-owned vehicles and gasoline credit cards shall be used for local health department business travel if available and feasible.
(a) Mileage payment shall not be claimed by an individual when local health department vehicles are used.
(b) Routine personal use of a local health department vehicle, including commuting use, shall not be an allowable public expenditure.
(c) An assignment of a vehicle to an employee who takes the vehicle home shall be minimal and limited to direct service personnel providing:
-
On-call direct services, or a majority of services in the field; or
-
Substantial direct services on the way to or from the employee's workstation.
(d) If a vehicle is assigned under paragraph (c) of this subsection, some personal commuting mileage may be unavoidable. A local health department shall develop a written policy to address the unavoidable personal mileage. The policy shall conform to current federal and state tax requirements for income and travel and shall be forwarded to the Department for Public Health for review and approval.
(11) Mileage claims for use of privately-owned vehicles shall be disallowed if a local health department vehicle was available and feasible.
(12) An employee on official travel status whose private or agency automobile breaks down may continue in travel status as approved by the public health department director.
(13) An employee on official travel status may be continued on travel status, as approved by the public health department director, if the employee becomes incapacitated due to illness or injury that qualifies as official sick leave. Medical expenses shall not be reimbursable travel costs.
(14) On nonworking days, an employee on official travel status shall forfeit official travel status once the employee returns to his official work station or domicile.
(15) Reimbursement shall not be paid for travel between the employee's residence and official workstation, unless requested to report to work while off duty.
(16) Commercial airline travel shall be coach or tourist class. Additional expense for first-class travel shall not be reimbursed.
(17) Mileage for each in-state trip shall be based on the Department of Transportation's official mileage map or on the Finance and Administration Cabinet's mileage chart if available. Out-of-state mileage shall be based on mileage maps. If point of origin is the claimant's residence, mileage and time shall be paid between the residence and travel destination, or between the work station and travel destination, whichever is shorter.
(18) The cost of renting a car or other special conveyance in lieu of ordinary transportation shall be allowed only with acceptable written justification to the public health department director. Privately-owned aircraft may be used only when it is to the advantage of the local health department as evidenced by a reduction in both travel costs and travel time.
(19) Lodging costs shall be the most economical available.
(a) Facilities providing special government rates or commercial rates shall be used where feasible.
(b) State-owned facilities or local health departments shall be used for meeting rooms and lodging if available, practical, and economical.
(20) A claimant who attaches the hotel's or motel's preprinted, receipted bill shall be reimbursed for the claimant's actual cost of lodging, subject to the following provisions:
(a) Reimbursement at a Kentucky state park shall be at the park's actual rate.
(b) The local health department shall not pay for lodging located within forty (40) miles of a claimant's residence or work station without approval of the public health department director.
(c) Lodging accommodations shared with another person or persons, not a local health department employee, shall be reimbursed at the rate for a single room. Lodging accommodations shared with other local health department employees shall be reimbursed on a pro rata basis.
(21) Mileage reimbursement for official use of privately-owned vehicles shall be at the mileage reimbursement rate determined by the Department for Public Health.
(22) With receipts, actual commercial transportation costs shall be reimbursed.
(23) Reimbursement for use of privately-owned aircraft shall not exceed the cost of air coach fare or the privately-owned vehicle rate, whichever is less.
(24) A claimant using camping vehicles for lodging shall be reimbursed for actual expense plus parking or camping charges. A receipt for parking or camping charges shall be submitted.
(25) Actual parking, bridge, and toll charges shall be reimbursable. Toll receipts shall not be required for in-state travel by a two (2) axle vehicle.
(26) Reasonable expenses shall be allowed for baggage handling, for delivery to or from a common carrier or lodging, and for storage. Charges for overweight baggage shall be allowed if the excess was for official business.
(27) Registration fees required for admittance to meetings shall be allowed. An employee shall not claim meal expenses for meals included in the registration fee. A notation shall be made on the travel voucher that the registration fee included the cost of meals. Reimbursement for registration fees and other job-related training may be claimed as "other expenses" on the travel voucher and charged to the appropriate expenditure accounts. Receipts for job-related fees shall be attached to the travel voucher.
(28) Telephone and fax costs for necessary official business shall be reimbursable.
(29) If justified, other necessary miscellaneous expenses associated with official travel may be allowed by the public health department director. Receipts shall be attached to the travel voucher.
(30) Receipts shall be required for travel expenses over ten (10) dollars except for subsistence expense items.
(31) Subsistence shall include amounts determined to have been spent for meals, taxes, and tips. To be eligible for subsistence for breakfast or lunch while traveling in Kentucky, a claimant's authorized work shall require overnight accommodations at a destination more than forty (40) miles from both work station and home and shall also require absence from the work station and home during mealtime. The claimant shall attach to the travel voucher, either lodging receipts or other credible documentation sufficient for audit.
(32) Local health department employees assigned to attend a function of an organization not under their control may be reimbursed for actual meal costs charged or arranged for by the organization. Receipts for meals shall be attached to the travel voucher.
(33) The local health department may pay for subsistence and related expenses at staff meetings not to exceed four (4) meals per year for an employee. The subsistence expense shall not exceed the department's standard meal reimbursement amount. Travel status shall not be required for staff meeting meals.
(34) Other allowable travel expense reimbursements shall consist of the following:
(a) Expenditures for the actual and reasonable cost of meals provided for district and county board of health members for official board functions, and for meals of guests invited to participate in the official business conducted at these functions;
(b) Travel expenditures of board of health members attending official board of health functions, in accordance with travel policy provisions;
(c) Travel expenditures incurred by board members other than the chairperson if approved by the chairperson or the full board;
(d) Travel expenditures incurred by the chairperson if approved by the vice-chairperson or the full board;
(e) Expenditures for meals and transportation expenses of local health department advisory committee members attending official local health department functions; and
(f) Travel expenses of a person applying for a position that will designate the applicant as the public health department director for the department, or as the medical director subject to the limits applicable to local health department employees, but no more than one (1) round trip for each applicant.
(35) Expenditures shall be authorized for employee morale and welfare items, as defined in 2 C.F.R. 200.437, in an amount not to exceed twenty-five (25) dollars per employee per fiscal year. Receipts shall be kept for all expenditures.
(36) Expenditures shall be allowed for other items necessary for the maintenance and operation of the local health department, if the expenditure is made in accordance with statutes and administrative policies.
(a) The Department for Public Health may require a local health department to provide adequate justification for any expenditure made by the local health department.
(b) If the justification is determined to be inadequate, appropriate corrective action shall be taken by the Department for Public Health.
Section 6. Purchasing Policies.
(1) Each local health department shall develop and follow formal procedures for authorizing purchases made on behalf of the local health department.
(a) These procedures shall be outlined in the local health department's written internal control procedures.
(b) Written purchase orders (service authorizations for independent contractors) and receiving reports or service verifications shall be used except for utility bills and purchase orders not in conformance with standard business practice.
(2) A local health department shall use the following minimum procedures in accordance with 2 C.F.R. 200.322 for purchasing and advertisement for bids:
(a) If an expenditure for a single type of good or service not covered by contract policies is more than $40,000 in a fiscal year, advertisements for bids shall be made in accordance with KRS 424.110-424.150. The Department for Public Health may be contacted for assistance in determining whether an expenditure is for a single type of good or service. The local health department shall:
- Record, in writing, and maintain for department review:
a. Price quotations received; and
b. Reasons and basis for selecting and placing the order, if the lowest price was not selected; and
- Select the lowest or best bid.
(b) If the expenditure for a single type of good or service is $3,000 but not greater than $40,000 in a fiscal year, the local health department shall:
-
Obtain three (3) or more price quotations from qualified sources of supply, if available, in the department's normal trade area; and
-
Record, in writing, and maintain for department review:
a. Price quotations received; and
b. Reason and basis for selecting and placing.
(c) If a single type of good or service purchased is less than $3,000, to the extent practicable, the local health department shall distribute purchases equitably among qualified suppliers. Purchases may be awarded without soliciting competitive quotations.
(d) The requirements for competitive bidding shall not apply to a purchase made under the provisions of a state price contract.
(e) A physician who is the health officer for more than one (1) local health department may purchase supplies and services or technical services on a cooperative purchasing basis, in accordance with the purchasing administrative regulations for local health departments.
(f) A local health department shall not enter into a lease or purchase agreement for nonprofessional services with a local health department employee or a business entity in which a local health department employee owns or controls more than five (5) percent interest, except if determined to be in the best interest of the public and approved in writing by the Department for Public Health.
Section 7. Contracting for Services.
(1) A local health department may contract for a core public health program.
(2) A local health department contracting for a core public health program shall evaluate the ability of the contracting agency to provide the program in accordance with applicable state statutes and administrative regulations.
(3) The contract for a core public health program shall include:
(a) A method for ongoing, comprehensive performance evaluation of the contracted vendor;
(b) Established performance criteria and standards to evaluate the contracted vendor; and
(c) An assurance the local health department will continue core public health programs in accordance with KRS 211.186, if the contracted vendor is no longer able to operate the program, as funds allow.
Section 8. Personal Service Contracts.
(1) A local health department shall not contract with a provider who is disbarred or suspended by a federal funding agency or by a Kentucky licensure board.
(2) This policy applies to personal service contracts for services of a professional or technical nature not available through the local health department merit system.
(3) Services of a professional or technical nature shall be contracted for in writing in accordance with this policy except:
(a) Nonprofessional emergency repair services of skilled tradesmen shall not require written contracts. Nonemergency services of skilled tradesmen shall be procured in accordance with purchasing policies.
(b) Administrative or management services, financial management services, data processing services, or consulting services, or studies shall not be contracted for if these services can be provided to the local health department by the Department for Public Health.
(4) Allowable services.
(a) The service to be contracted for shall be an essential service that is necessary for carrying out public health services.
(b) A local health department may use a personal service contract to substitute for establishing a position in the local health department, with Department for Public Health approval.
(5) A provider shall not be paid more than the standard hourly rate determined by the Personnel Cabinet. In determining acceptable rates of reimbursement, consideration shall be given to:
(a) The type of service to be provided;
(b) The availability of providers;
(c) The duration of services to be performed;
(d) Rates being paid to regular employees for similar services; and
(e) Comparable rates being paid in the area and other parts of the state for similar services.
(6) A personal service contract shall not be entered into with a provider when a conflict of interest, real or apparent, exists.
(a) Conflicts of interest fall into the following categories:
-
Constitutional;
-
Statutory;
-
Common-law; and
-
Department for Public Health policies.
(b) A personal service contract shall not be entered into with a local health department employee or local board of health member, unless authorized in writing by the Department for Public Health, and except for medical or professional services under $10,000.
(c) A county board of health member who is not a member of the district board of health shall not incur a conflict of interest if the district health department contracts for the county board of health member's services.
(d) A contract exceeding $5,000 in a fiscal year shall not be entered into with a professional service corporation that has employees or governing board members as constituents, unless authorized in writing by Department for Public Health.
(7) In drafting a personal service contract, a determination shall be made concerning whether the provider of the service is an "independent contractor".
(a) If it is determined that the individual is not an independent contractor, the local health department shall withhold applicable federal, state, and local taxes and Social Security (FICA), and shall use a standard local health department personal service contract.
(b) If it is determined that the provider is an independent contractor, a standard local health department independent contract shall be used.
(8) A personal service contract:
(a) Shall not exceed one (1) year in duration and shall not contain a clause that indicates the contract is automatically renewable at the end of the fiscal year;
(b) Shall expire on or before June 30 of each fiscal year unless approved by the Department for Public Health; and
(c) May be extended into the new fiscal year by filing a formal contract extension, approved by the Department for Public Health.
(9) Either party shall have the right to terminate a personal service contract at any time upon notice to the other party.
(a) A local health department may add a clause to a contract requiring up to a ninety (90) day notice prior to termination.
(b) Confirmation of termination shall be in writing and a copy of the notice of termination shall be provided to the Department for Public Health.
(10) All local health department personal service contracts and amendments are subject to review by the Department for Public Health.
(a) If the Department for Public Health questions the legality, propriety, necessity, rate of compensation, or description of services, in a personal service contract, the department shall notify the local health department of its concerns.
(b) A personal service contract for which clarification is requested by the Department for Public Health shall be put on hold until a review has been completed.
(11) A personal service contract may be modified at any time, and a proposed change shall be accomplished by formal contract amendment.
Section 9. Disposition of Assets, Surplus, or Excess Property.
(1) If a county withdraws from a district health department, the following policies shall apply to the disposition of surplus receipts, assets, and liabilities:
(a) Program restricted surplus receipts or supplies, inventories, or equipment shall be retained by the district health department except in the case of complete dissolution of the district. If the district is dissolved, program restricted surplus receipts and items shall be equitably distributed to the county or counties proportionate to their taxing district or fiscal court participation in the district;
(b) Unrestricted receipts, supplies, and inventories shall be divided among district and withdrawing county boards of health proportionate to the ratio of local taxing district support provided by each county in the year preceding the withdrawal;
(c) Deficits shall be charged to the district and withdrawing county boards of health according to the ratio of local taxing district or fiscal court support provided by each party in the year preceding the withdrawal;
(d) Equipment purchased by withdrawing county boards of health prior to the organization of the district shall be returned to the board that originally purchased the equipment;
(e) Equipment purchased during the operation of the district shall be divided among the district and the withdrawing boards of health according to the ratio of local taxing district or fiscal court support provided by the withdrawing county boards of health to the total local taxing district or fiscal court support of the district in the year preceding the withdrawal:
-
The net inventoried book value of the equipment shall be used in determining the distribution.
-
The Department for Public Health shall approve the final disposition of equipment.
(f) Buildings owned by the district board of health shall remain the property of the district health department. If total dissolution of a district health department occurs, buildings owned by the district shall be sold according to the policies of the Department for Public Health and the proceeds shall be added to the surplus receipts of the district to be divided according to the procedures listed in this subsection; and
(g) The Department for Public Health shall approve the disposition of assets and liabilities.
(2) A local health department may sell or dispose of any real or personal property including intangible property that is not needed or has become unsuitable for use.
(3) The funding source shall be contacted for the exact requirements. Property purchased with restricted funds may have disposal requirements in addition to or instead of the following requirements:
(a) A written determination as to need or suitability of any property of the local health department shall be made, and shall fully describe the property, its intended use at the time of acquisition, and the reasons why it is in the public interest to dispose of the item;
(b) Surplus or excess property may be transferred, with or without compensation, to another governmental agency, or it may be sold at public auction or by sealed bids. The highest bid shall be accepted. Other methods of disposition of surplus or excess property shall not be allowable;
(c) If a local health department receives no bids for surplus or excess property, either at public auction or by sealed bid, or reasonably determines that the aggregate value of the item is less than $500, the property may be disposed of, consistent with the public interest, in any manner determined appropriate by the local health department. A written description of the property, the method of disposal, and the amount of compensation, if any, shall be made; and
(d) Any compensation resulting from the disposal of surplus or excess property shall be deposited in the local health department's bank account. If the property was purchased with restricted funds, appropriate accounting of the compensation received shall be made as required by 2 C.F.R. Part 200 Subpart E.
Section 10. Bank Accounts and Investments.
(1) Fidelity bonding shall be obtained on local health department employees and board of health members who handle funds of the local health department.
(a) An individual who makes deposits or signs checks or other instruments on local health department checking or investment accounts or certificates shall be bonded.
(b) Employees or board members shall be bonded in an amount sufficient to cover the total amount of funds to which they have access at any one (1) time.
(2) Local health departments may invest and reinvest money subject to their control and jurisdiction in the following investments:
(a) Obligations of the United States and of its agencies and instrumentalities. These investments may be accomplished through repurchase agreements reached with national or state banks chartered in Kentucky, and bonds or certificates of indebtedness of the state of Kentucky and of its agencies and instrumentalities;
(b) A savings and loan association insured by an agency of the government of the United States up to the amount so insured; and
(c) Interest-bearing deposits, or other authorized insurance instruments, in national or state banks chartered in Kentucky and insured by an agency of the government of the United States up to the amount so insured, and in larger amounts if the bank shall pledge as security, obligations as permitted by KRS 41.240(4), having a current quoted market value at least equal to uninsured deposits.
(3) A local health department may hold funds in its local bank account in a federally-insured bank at the minimum level necessary for efficient operations.
(4) Local health department funds shall not be transferred to a public health taxing district account or to an account not reported in the local health department financial statements.
History
- RELATES TO: KRS 41.240(4), 45A.690, 211.180(1), 211.185, 211.186, 211.187, 212.025, 212.120, 212.245(3), (4), 212.890, 424.110-424.150, 2 C.F.R. Part 200
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.170(1), (2), (3), (6)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet; or to comply with federal law. KRS 211.170(1), (2), (3), and (6) require the cabinet to establish policies and standards of operation; supervise financial, personnel, program, administrative and other functions; and allocate, modify, or cancel allotments of state funds for Kentucky's local health departments. This administrative regulation establishes minimum fiscal and financial management requirements for Kentucky's county and district local health departments and for all other classes of local health departments, except if a specific Kentucky revised statute requires a more stringent minimum requirement.
- History: 28 Ky.R. 770; Am. 1162; 1654; eff. 1-14-2002; 29 Ky.R. 1100; 1616; eff. 12-18-2002; 37 Ky.R. 3012; 38 Ky.R. 249; eff. 8-17-2011; 45 Ky.R. 1432, 2098; eff. 1-23-2019; TAm eff. 3-20-2020; 47 Ky.R. 425, 1394; eff. 2-4-2021; TAm eff. 12-6-2021.
Chapter 9 State and Local Confinement Facilities
902 KAR 9:010 Environmental health {#sec-902-kar-9-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 9:010}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 211.920(1).
(2) "Cell" means a room designated to provide sleeping and personal storage facilities for no more than two (2) inmates.
(3) "Confinement housing unit" means a residential structure that:
(a) Is intended for occupancy by inmates of a state confinement facility; and
(b) May include:
-
Wings, levels, or sections containing inmate living areas; and
-
Facilities for:
a. Food preparation, service, and dining;
b. Medical treatment;
c. Physical exercise;
d. Education;
e. Visitation;
f. Storage; or
g. Other functions necessary for the operation and maintenance of the unit.
(4) "Dormitory" means a room designated to provide sleeping and personal storage facilities for three (3) or more inmates.
(5) "Inmate" means any person confined or assigned to residence in a state confinement facility.
(6) "Inmate space" means the living area, as measured in gross square feet of floor space, required for each inmate within a confinement housing unit.
(7) "Living area" means the cell or dormitory to which an inmate is assigned for housing, and includes common areas, personal hygiene facilities, and other areas within a confinement housing unit that are normally accessible to an inmate on a daily basis.
(8) "Personal hygiene facility" means a room or rooms that contain sanitary fixtures such as lavatories, water closets, showers or bathtubs, and other necessary appurtenances for maintaining inmate personal hygiene.
(9) "Tempered water" means a water temperature of at least ninety (90) degrees Fahrenheit to a maximum temperature of 110 degrees Fahrenheit.
Section 2. Sanitary Facilities and Controls.
(1)
(a) The water supply shall be potable, adequate, and from an approved public supply of a municipality or water district, if available.
(b) If not available, the supply shall be developed and approved pursuant to applicable requirements of 401 KAR Chapter 8.
(c) If a public water supply subsequently becomes available, connections shall be made to this supply, and the state confinement facility's supply shall be discontinued.
(2)
(a) All sewage and liquid waste matter shall be disposed of into a public sewer system, if available.
(b) If a public sewer system is not available, disposal shall be made into a private sewage disposal system designed, constructed, and operated pursuant to 902 KAR 10:085.
(c) If an adequate public sewer system subsequently becomes available, connections shall be made to this system, and the state confinement facility's sewage disposal system shall be discontinued.
(3) A drinking fountain or a potable water service fixture with individual single service drinking cups shall be accessible to inmates in their living area pursuant to the requirements of 815 KAR Chapter 20. The use of a common drinking vessel shall be prohibited.
(4) Each confinement housing unit shall include personal hygiene facilities within the unit that contain sanitary fixtures meeting the requirements of 815 KAR Chapter 20 as to design, fixture type, and numbers of fixtures.
(5) All personal hygiene facilities shall be designed and constructed pursuant to the requirements of 815 KAR 7:120. All walls, floors, ceilings, partitions, sanitary fixtures, and appurtenances shall be maintained in a sanitary condition and in good repair.
(6) An adequate supply of clean washcloths, towels, and clothing, and toilet tissue, soap, and similar personal hygiene articles shall be issued to each inmate as necessary to maintain hygiene.
(7) Hot and cold or tempered water shall be supplied to all lavatories, showers, and bathtubs, and all hot or tempered water supply lines to the fixtures shall be protected by temperature and pressure control devices approved for use by 815 KAR Chapter 20 to prevent scalding.
(8) All plumbing shall comply with 815 KAR Chapter 20.
(9) All refuse shall be:
(a) Kept in containers that are:
-
Leak-proof;
-
Non-absorbent;
-
Flame-retardant; and
-
Routinely cleaned; and
(b) Removed from confinement housing units on a daily basis and be disposed of at least weekly or more often if necessary in accordance with 401 KAR Chapter 30.
Section 3. Facilities and Equipment.
(1) Each confinement housing unit shall provide a minimum inmate space of sixty (60) square feet for each inmate housed within that unit.
(2) Each cell and dormitory shall:
(a) Have at least eight (8) foot ceilings;
(b) Contain a bed for each inmate; and
(c) Provide facilities for storage of inmates' personal belongings, including clothing and towels.
(3) All floors, walls, ceilings, and equipment of confinement housing units shall be constructed pursuant to 815 KAR 7:120. All parts of the confinement housing unit and its premises shall be kept in good repair, clean, neat, and free of refuse.
Section 4. Lighting. Each confinement housing unit shall be provided with natural or artificial light sufficient to provide twenty (20) foot candles of light for reading purposes, to permit observation, and for proper cleaning and maintenance. All light fixtures shall be kept in good repair and clean.
Section 5. Heating, Cooling and Ventilation.
(1) All confinement housing units shall be provided with heating, cooling, and ventilation equipment as required by 815 KAR 7:120.
(2) Ventilation, through natural or mechanical means, shall be sufficient to provide fresh air and remove disagreeable odors.
Section 6. Vermin Control.
(1) Effective measures to control the presence of rodents, flies, roaches, and other vermin on the premises shall be utilized. The premises shall be kept in a condition as to prevent the harborage or breeding of vermin.
(2) Openings to the outside shall be protected against the entrance of rodents, insects, and other vermin by tight-fitting, self-closing doors, closed windows, screening, or controlled air currents. Screening material shall not be less than sixteen (16) mesh to one (1) inch.
Section 7. Bedding.
(1) As a minimum, each inmate in a state confinement facility shall be provided with:
(a) An approved flame-retardant and water-repellent mattress and pillow;
(b) A pillowcase;
(c) A sheet or cloth mattress cover; and
(d) A blanket.
(2) If, in the sound discretion of the appropriate person in charge of the state confinement facility, any items listed in this section would constitute a danger or hazard to the inmate confined due to a behavior or mental condition, the items may be withheld.
(3) Mattresses, pillows, blankets, sheets, pillowcases, and mattress covers shall be kept in good repair and clean.
(4) Sheets, pillow cases, and mattress covers, if used without sheets, shall be changed and laundered at least weekly and before being issued to another inmate.
Section 8. Exercise. Adequate space shall be provided within the state confinement facility to allow all inmates an opportunity to obtain physical exercise.
Section 9. Medical Examination Room. Adequate space shall be provided within the state confinement facility to allow for medical examination of inmates.
Section 10. Food Service. All state confinement facilities shall comply with the food service provisions of 902 KAR 45:005. If food for inmates is not prepared by the state confinement facility, food shall be obtained from a commercial food service establishment holding a valid permit from the cabinet.
Section 11. Food Manufacturing. All food manufacturing and processing conducted at state confinement facilities shall be operated pursuant to 902 KAR 45:160.
Section 12. Existing Facilities and Equipment. Facilities and equipment being used by existing state confinement facilities, which do not fully meet the design and construction requirements of this administrative regulation, may be continued in use, if the facility or equipment:
(1) Is in good repair;
(2) Is capable of being maintained in a sanitary condition; and
(3) Does not create a health hazard.
Section 13. Plan Review of Construction. Plans for alteration or new construction of state confinement facilities shall be submitted to the appropriate agencies for approval.
Section 14. Inspection of State Confinement Facilities.
(1) At least once each six (6) months, the cabinet shall inspect each state confinement facility and shall make as many additional inspections and reinspections as are necessary for carrying out the provisions of this administrative regulation.
(2) When an agent of the cabinet makes an inspection of a state confinement facility, the findings shall be recorded on the DFS-316, Confinement Facility Inspection Report, and a copy shall be provided to the warden or superintendent. If a deficiency is found, the inspection report shall:
(a) Set forth the specific deficiencies found;
(b) Identify any variances previously granted;
(c) Establish a specific and reasonable period of time for the correction of the deficiency found; and
(d) State that failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in the initiation of legal action.
Section 15. Enforcement Hearings. For purposes of enforcement, if the warden or superintendent has failed to comply with any written notice or order issued under the provisions of this administrative regulation, they shall be notified in writing that legal action may be instituted against the state confinement facility in accordance with KRS 211.935.
Section 16. Variance Hearings.
(1) A warden or superintendent of a state confinement facility may request in writing that the cabinet consider granting a variance to any provision of this administrative regulation.
(2) A written request for a variance shall include all pertinent information about the facility, the specific provision of the administrative regulation affected, the specific reason for the request, and evidence in support of the request.
(3) Upon receipt of a request for a variance, the cabinet shall review the request and establish a date, time, and location for the convening of an administrative hearing.
(4) The requesting authority shall be notified of the date, time, and location of the hearing within ten (10) working days of the receipt of the request, and at least five (5) working days prior to the date of the hearing.
(5) The hearing officer shall recommend that the variance be granted or denied, and may recommend that legal action be pursued.
(6) A variance shall only be granted upon written determination that the variance will not endanger the health of those confined in the facility or the public health. Any variance so granted may be with or without stipulations or restrictions.
Section 17. Incorporation by Reference.
(1) DFS-316, Confinement Facility Inspection Report, 10/18, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Environmental Management Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.920, 211.925, 211.935, 217.015(20)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.925
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of the individual citizens of the Commonwealth and necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.925 authorizes the cabinet to promulgate administrative regulations and standards relating to the public health or health aspects of the operation of state confinement facilities. This administrative regulation establishes uniform standards of institutional sanitation to safeguard the health of persons confined in state confinement facilities, by providing for the opportunity to pursue adequate personal hygiene for health maintenance, control of the incidence and spread of disease, and maintenance of sanitary living conditions.
- History: 3 Ky.R. 373; eff. 10-6-1976; Am. 10 Ky.R. 179; eff. 8-3-1983; 16 Ky.R. 2063; eff. 5-13-1990; . 2362; eff. 8-1-1996; 45 Ky.R. 3564, 46 Ky.R. 439; eff. 8-19-2019; Crt eff. 4-21-2026.
Chapter 10 Sanitation
902 KAR 10:010 Public Restrooms {#sec-902-kar-10-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:010}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 211.970(2).
(2) "On-site sewage disposal system", "on-site sewage system", or "on-site system" means a system installed on a parcel of land under the control or ownership of a person that accepts sewage for treatment and ultimate disposal under the surface of the ground, including:
(a) A conventional system consisting of a sewage pretreatment unit, distribution devices, and lateral piping within rock-filled trenches or beds;
(b) A modified system consisting of:
-
A conventional system enhanced by shallow trench or bed placement;
-
Artificial drainage systems;
-
Dosing;
-
Alternating lateral fields;
-
Fill soil over the lateral field; or
-
Other necessary modifications to the site, system, or wasteload to overcome site limitations;
(c) An alternative system consisting of:
-
A sewage pretreatment unit;
-
Necessary site modifications;
-
Wasteload modifications; and
-
A subsurface soil treatment and dispersal system using methods and technologies other than a conventional or modified system to overcome site limitations;
(d) A cluster system; and
(e) A holding tank that provides limited pretreatment and storage for off-site disposal where site limitations preclude immediate installation of a subsurface soil treatment and dispersal system or connection to a municipal sewer.
(3) "Person" is defined by KRS 211.970(6).
(4) "Public restroom" means a facility that provides toilet and hand-washing facilities for the general public..
Section 2. General Requirements for Public Restroom Facilities. If public restroom facilities are provided for the accommodation of the public or patrons at public places:
(1) The floors shall be of smooth construction and relatively impervious to water.
(2) The walls and ceilings shall:
(a) Have a smooth washable surface;
(b) Be painted or finished in light color; and
(c) Be maintained in good condition.
(3) All openings shall be effectively screened against flies and other insects.
(4) All doors shall be self-closing.
(5) The plumbing installations shall comply with 815 KAR Chapter 20.
(6) All wastes resulting from toilets, lavatories, or other fixtures shall be disposed of in a public sewer or, in the absence of a public sewer, by a method approved by the Energy and Environment Cabinet or Cabinet for Health and Family Services.
(7) An adequate supply of toilet tissue shall be provided at each restroom facility at all times.
(8) The rooms shall be adequately lighted and ventilated.
(9) If drinking water is provided, it shall be from a source approved by the Energy and Environment Cabinet.
(10) If drinking fountains are provided, they shall be installed in accordance with 815 KAR Chapter 20 and maintained in a sanitary manner.
(11) The use of a common drinking cup is prohibited.
(12) Hand-washing facilities, including running water, soap, and individual cloth or paper towels, or other method for drying hands approved by the cabinet, shall be provided.
(13) The use of a common towel is prohibited.
(14) All trash or refuse shall be kept in nonabsorbent containers and removed from the premises as frequently as necessary to prevent an unsanitary condition from developing. A covered waste container shall be provided in each women's restroom facility.
(15) The rooms, including all fixtures, shall be kept clean, in good repair, and free from dust, dirt, insects, and other contaminating material.
Section 3. Privies.
(1) Outdoor toilets or privies not connected to a public sewerage system or on-site system shall be prohibited within the boundaries of cities of the first or second class as provided by KRS 381.780.
(2) In other areas, if water under pressure is not available, privies may be used for the accommodation of the public or patrons at a public place provided they comply with 902 KAR 10:081, 10:085, and the following requirements:
(a) Construction of privies:
-
The privy shall not be located within 100 feet of any source of water supply;
-
The floor and seat riser shall be constructed of impervious material or tongue and groove lumber, and in a manner to exclude insects and rodents;
-
The seat riser shall be so constructed and bonded with the floor as to prevent seepage through the riser onto the floor and the seat opening shall be elevated at least twenty (20) inches above floor level; and
-
The superstructure of the privy shall be constructed of substantial material fastened solidly to the floor.
(b) Maintenance of privies:
-
The floor, seat, and other fixtures shall be kept in good repair and clean at all times;
-
An adequate supply of toilet tissue shall be provided; and
-
The privy shall be adequately ventilated.
(c) No person shall install a new or replace an existing on-site sewage disposal system if a publicly or privately owned treatment facility capable of treating the pollutants to be discharged is available pursuant to 902 KAR 10:085 Section 13(2)(a),(b) and 401 KAR 5:037 Section 2(5)(b).
History
- RELATES TO: KRS 211.970, 211.990, 381.780
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 318.160
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) requires the cabinet to regulate the sanitation of public restrooms. KRS 318.160 authorizes the cabinet to review all applications for construction, installation, or alteration when a sewage subsoil drainage system or other type of on-site sewage disposal system that does not have a surface discharge is used. This administrative regulation provides standards for public restrooms in order to protect the health of the public.
- History: San-2; 1 Ky.R. 369; eff. 2-5-1975; 18 Ky.R. 1431; 2264; eff. 1-10-1992; Crt eff. 11-18-2019; 47 Ky.R. 1283; eff. 6-16-2021.
902 KAR 10:030 Registered environmental health specialists and sanitarians {#sec-902-kar-10-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:030}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 223.010(1).
(2) "Cabinet representative" means the secretary's designee.
(3) "Committee" means the registered environmental health specialists or sanitarian examining committee established in accordance with KRS 223.020.
(4) "Continuing education unit" or "CEU" means the completion of ten (10) hours of educational courses approved by the committee.
(5) "Secretary" is defined by KRS 223.010(3).
Section 2. Applications for Registration.
(1) An applicant for registration as a registered environmental health specialist or sanitarian shall meet the qualifications listed in KRS 223.030(1).
(2) Applications shall be submitted to the committee for approval on the "Application for Registration", 05/2020, incorporated by reference or available online at https://chfs.ky.gov/agencies/dph/dphps/emb/Pages/sanitarians.aspx.
(3) An application fee of fifty (50) dollars by money order, bank draft, or check made payable to the Kentucky State Treasurer shall accompany each application.
(4) After the committee has approved an application, and all the requirements provided by law are fulfilled, the applicant can be scheduled to take the examination.
Section 3. Examinations.
(1) The committee shall:
(a) Conduct examinations at least four (4) times a year; and
(b) Determine the time and place for the examination.
(2) A score of at least seventy (70) percent shall be a passing score for the examination.
(3) Applicants failing to achieve a passing score may apply to retake the exam by submitting another application and fee.
Section 4. Issuance and Expiration of Certificates of Registration.
(1) Upon successful passing of the examination as outlined in Section 3 of this administrative regulation, the committee shall certify the passing score to the secretary.
(2) The applicant shall be issued a registration card certifying that he or she holds a certificate of registration.
(3) Pursuant to KRS 223.040, an individual who receives an initial certificate of registration shall be under the direct supervision of a qualified registered environmental health specialist or sanitarian until the individual successfully completes an initial public health training program provided by the cabinet. This training shall be offered at least two (2) times per year at no cost to the trainee.
(4) The committee shall assign serial numbers to each certificate of registration.
(5) All registration certificates issued under the provisions of this administrative regulation shall expire on June 30 following the date of issue, unless renewed by payment of a twenty (20) dollar registration fee.
(6) The certification renewal fee shall be paid by money order, bank draft, or check made payable to the Kentucky State Treasurer, or online at the Registered Sanitarian ePayment Web site at https://prd.webapps.chfs.ky.gov/KYRegSan_ePay.
(7) A late renewal fee of twenty (20) dollars will be assessed for all payments not received by July 1.
Section 5. Renewals and CEUs.
(1) All registered environmental health specialists and sanitarians shall receive a written notice of certification renewal at least thirty (30) days prior to the expiration date of their certificate.
(2) Before the renewal of registration can be issued, the registrant shall submit evidence of having completed the required CEUs.
(3) In addition to the public health training required by Section 4(3) of this administrative regulation, individuals achieving initial registered environmental health specialist or sanitarian status in any given fiscal year shall be required to submit evidence of having completed CEUs based on the quarter of the fiscal year in which certification was attained:
(a) July 1 to September 30 – ten (10) CEUs required;
(b) October 1 to December 31 – seven (7) CEUs required;
(c) January 1 to March 31 – five (5) CEUs required; or
(d) April 1 to June 30 – no CEUs required.
(4) An application for CEU approval by the committee shall include the following:
(a) An outline or summary of the course content;
(b) Identity of the instructor or sponsor of the course; and
(c) A letter or certificate of completion from the instructor or sponsor certifying the applicant satisfactorily completed the course; or
(d) Proof of attendance in the form of a copy of the course sign-in sheet or attendee roster.
(5) In-service educational conferences, courses, and seminars sponsored by professional and industrial organizations, or governmental agencies which registrants attend, or where they present, may qualify for CEUs.
(6) CEUs shall not be awarded for classes taught by the registrant or for mandatory employee trainings provided by the registrant's employer that are not related to the fields of environmental or public health, or specifically related to the duties, roles, and responsibilities of a registered environmental health specialist or sanitarian as determined by the committee.
Section 6. Extension for submitting CEUs.
(1) A registrant may submit a written request to the committee for an extension to acquire CEUs until September 30. This written request shall:
(a) Be received by the committee on or before June 30; and
(b) Provide justification for the request.
(2) The committee may grant an extension beyond the September 30 deadline based on extenuating circumstances beyond the control of the registrant.
(3) Registrants shall be notified in writing by the cabinet representative of the committee's decision to grant or deny the September 30 extension.
(4) Failure to submit evidence of completion of the CEUs required in Section 5(3) of this administrative regulation by the September 30 extension deadline shall result in suspension of the certificate of registration in accordance with Section 8 of this administrative regulation.
Section 7. Inactivation of Certificates of Registration.
(1) Persons requesting to have their certificates of registration placed in inactive status shall submit a written request to the committee on or before June 30.
(2) A registered environmental health specialist or sanitarian granted inactive status by the committee shall be notified in writing.
(3) A registered environmental health specialist or sanitarian on inactive status shall be exempt from the CEU requirements specified in Section 5 of this administrative regulation but shall not be exempt from the twenty (20) dollar renewal fee required under Section 4(5) of this administrative regulation.
Section 8. Suspension and Revocation of Certificates of Registration.
(1) Certificates of registration shall be suspended by the committee on July 1 for:
(a) Failure to remit payment for renewal by June 30 in accordance with Section 4 of this administrative regulation;
(b) Failure to submit evidence of completion of CEUs by June 30 in accordance with Section 5 of this administrative regulation; or
(c) Failure to request an extension for CEUs by June 30.
(2) Certificates of registration shall be suspended the next business day following the receipt of the request for an extension in accordance with Section 6 of this administrative registration.
(3) Persons whose certificates of registration have been suspended shall be sent a notice of suspension by the committee.
(4) If employed by the cabinet, a local health department, or a district health department, a copy of the notice of suspension shall be provided to the employer.
(5) A registered environmental health specialist or sanitarian with a suspended certificate of registration shall receive a written notice to appear before the committee at the next regularly scheduled committee meeting to provide justification for:
(a) Failing to remit payment by June 30; or
(b) Failing to submit evidence of completed CEUs by June 30 or by the extension granted by the committee in accordance with Section 6 of this administrative regulation.
(6) Failure to appear before the committee at the next regularly scheduled meeting shall be grounds for the committee to recommend revocation of a certificate of registration to the secretary.
(7) A registered environmental health specialist or sanitarian suspended for failure to remit payment in accordance with Section 4, or CEUs in accordance with Section 5, by June 30, may, at any time before the next regularly scheduled committee meeting, submit payment or evidence of completed CEUs and be returned to active status without having to appear before the committee.
(8) In any action involving the revocation of a certificate of registration, the committee shall refer the matter to the secretary.
(a) Prior to revocation, the committee shall send a notice of revocation to the last known address available to the committee.
(b) The notice of revocation shall include the option for the certificate holder to submit a request for an administrative hearing within ten (10) days of the notice to show cause as to why their certificate should not be revoked.
(9) All administrative hearings shall be conducted in accordance with KRS Chapter 13B
(10) Persons who have their certificate of registration revoked solely for failure to remit renewal payment or submit required CEUs may reapply for registration by submitting an application and fee in accordance with Section 3 of this administrative regulation and by successfully completing the examination.
(11) Upon revocation of a registered environmental health specialist or sanitarian certification by the secretary for causes established in KRS 223.070, the person shall:
(a) Not be eligible to serve as a registered environmental health specialist or sanitarian in the Commonwealth; and
(b) Cease and desist practice.
(12) If employed by the cabinet, a local health department, or a district health department, a copy of the notice of revocation shall be provided to the employer.
Section 9. Expenditure of Funds. Expenditures for examinations, clerical expenses, training and reference materials, including approved home study courses, and for affiliation with any national sanitarian registration organization, may be made out of the trust and agency fund created by KRS 223.050.
Section 10. Material Incorporated by Reference.
(1) "Application for Registration", 05/2020, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8:00 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 194A.050(1), 211.090, 223.010, 223.020, 223.030, 223.040, 223.050, 223.060, 223.070,223.080, 223.990
- STATUTORY AUTHORITY: KRS 223.040, 223.050, 223.055, 223.070
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 223.040, 223.050, 223.055 and 223.070 authorize the Cabinet for Health and Family Services to establish minimum standards and qualifications for registered environmental health specialists and sanitarians. This administrative regulation provides uniform standards for registered environmental health specialists and sanitarians, procedures for processing applications, continuing education requirements, inactive status registration, and establishes fees for examination and registration.
- History: San 6-1; 1 Ky.R. 511; eff. 3-12-1975; 14 Ky.R. 2072; eff. 6-22-1988; 16 Ky.R. 2781; eff. 7-18-1990; 17 Ky.R. 3048; 18 Ky.R. 52; eff. 6-19-1991; 22 Ky.R. 2367; eff. 8-1-1996; Crt eff. 10-2-2019; 47 Ky.R. 425, 1399; eff. 2-4-2021.
902 KAR 10:040 Kentucky youth camps {#sec-902-kar-10-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:040}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 194A.005(1).
(2) "Camp" or "youth camp":
(a) Means an area, parcel, or tract of land, under the control of a person on which facilities are established, maintained, or operated for recreational, educational, or vacation purposes for five (5) or more children to attend no longer than two (2) weeks, either free of charge or for payment of a fee;
(b) Includes a:
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Day camp;
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Primitive or outpost camp; or
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Residential camp; and
(c) Does not include a:
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Camp, campsite, or camping session operated solely for family or adult camping;
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Privately owned camp or campsite intended for the sole use of the owner, their family, or invited guests;
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Weekend or similar overnight troop or trip camping activities conducted by an organized youth troop or association of less than seventy-two (72) hours duration, and not a part of an established youth camp operating session;
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Facility that is operated as an instructional studio or center that provides lessons or other activities for school age children individually or collectively during parents' working hours, before or after school, or during school vacation periods;
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A vacation bible school, bible day school, or similar activity held in a church for school age children individually or collectively during parents' working hours, before or after school, or during school vacation periods; or
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A wilderness camp licensed as a private child caring facility pursuant to 922 KAR 1:460.
(3) "Camp director" means the individual agent of the camp operator on the premises of any youth camp who has the primary responsibility for the administration, operation, and supervision of the camp and its staff.
(4) "Camp operator" means the person that owns a youth camp, whether the camp is operated for profit or not for profit.
(5) "Camper" means a child under eighteen (18) years of age living apart from relatives, parents, or legal guardians, while attending a youth camp.
(6) "Day camp":
(a) Means a camp operated for all or part of the day; and
(b) Does not include:
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Overnight lodging of campers; or
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A camp operating at a facility under a different cabinet license or permit or that is already subject to routine sanitation and safety inspection by the cabinet.
(7) "Disqualifying offense" means, pursuant to KRS 194A.380, a conviction of or a plea of guilty to a:
(a) Criminal offense against a minor;
(b) Sex crime; or
(c) Violent offense.
(8) "Permanent structure" means a building and appurtenances owned or operated by the camp management for living, dining, kitchen, sleeping, toilet, bathing, shelter, tool shed, storage, assembly, infirmary, or stabling purposes, constructed to be immobile and permanent.
(9) "Person" means an individual, firm, partnership, company, corporation, organization, trustee, association, or other public or private entity.
(10) "Primitive or outpost camp" means a portion of the residential camp premises or other site under control of the camp operator that is intended only for occasional use as an overnight tent camping site and has no permanent structure or facility.
(11) "Residential camp" means a camp operated on a permanent campsite with overnight lodging facilities.
(12) "Semipermanent structure" means a building, tent, structure, or trailer, and appurtenances owned or operated by the camp management for sleeping, living, dining, toilet, bathing, kitchen, tool shed, storage, assembly, infirmary, or animal sheltering purposes, that is constructed to be movable, easily disassembled, and not permanent in nature.
Section 2. Permits.
(1) A permit to operate a youth camp issued pursuant to this administrative regulation shall not exempt a child-care facility or program from the licensure required by 922 KAR Chapter 2.
(2) A person shall not operate a youth camp within the Commonwealth of Kentucky without possession of a valid permit issued by the cabinet.
(3) Only a person who complies with the requirements of this administrative regulation shall be entitled to receive and retain a permit.
(4) A permit shall not be transferable from one (1) person to another person or place.
(5) The permit shall be posted or readily available at every camp.
(6) Each permit shall expire on the December 31 following its date of issuance.
Section 3. Application for a Permit.
(1) A person desiring to operate a camp shall complete and submit form DFS-200, Application for a Permit.
(2) A person desiring to operate a day camp shall complete and submit form DFS-200, Application for a Permit, and form DFS-340, Application and Permit to Operate Day Camp Facilities.
(3) Upon receipt of an application, the cabinet shall inspect the camp to determine compliance with the provisions of this administrative regulation. If inspection discloses that the applicable requirements of this administrative regulation have been met, a permit shall be issued to the applicant by the cabinet.
Section 4. Camp Site. The camp site shall be located on land that provides natural drainage. The area on which tents, buildings, or structures are erected, and other areas frequently used for camp activities, shall be drained and shall not be located in a swamp or similar place in which mosquitoes can breed.
Section 5. Camp Facilities.
(1) All camp structures used for human occupancy or assembly, and all electrical, heating, ventilating, air conditioning, plumbing, and lighting systems in those structures shall be designed and constructed pursuant to 815 KAR 7:120, Kentucky Building Code.
(2) All camp food preparation and service facilities shall comply with the provisions of KRS 217.005 – 217.215 and 902 KAR 45:005. If food for campers and staff is not prepared by the camp, food shall be obtained from a commercial food service establishment holding a valid permit from the cabinet.
(3) Floors, walls, ceilings, and attached or freestanding appurtenances, fixtures, and equipment in all permanent and semipermanent structures shall be kept clean and in good repair.
(4) All gas or oil burning heating and cooking facilities used in any camp shall meet applicable state fire codes for installation, operation, and maintenance, in accordance with 815 KAR 7:120.
(5) All structures used as sleeping quarters shall have all outer openings screened or protected to prevent the entry of insects and other vermin.
Section 6. Sleeping Facilities.
(1) A minimum of thirty (30) square feet of floor space shall be provided for each camper in all structures used for sleeping purposes.
(2)
(a) All structures used as sleeping quarters shall be designed to provide a minimum of two (2) feet separation between beds, cots, or sleeping bags on all sides.
(b) Beds, cots, or sleeping bags shall be placed so that the heads of campers are at least six (6) feet apart.
(c) If double-decked beds are used, there shall be not less than twenty-seven (27) inches of separation between the lower mattress and the bottom of the upper bed.
(3)
(a) Mattresses shall be covered in materials that are water repellent, easily cleanable, and meet the federal flammability standards in 16 C.F.R. Part 1632, or shall be encased in a separate mattress cover that meets these requirements.
(b) Each occupied bed or cot shall be provided with one (1) sheet, one (1) pillow, one (1) pillowcase, and one (1) blanket either by the camp or by the individual camper, except that this requirement shall not apply if a camper provides his or her own sleeping bag.
(4)
(a) All articles of bedding provided by the camp shall be kept clean and in good repair.
(b) Linen shall be changed at least once weekly and more often, if necessary, or if there is a new camper occupying the bed or cot.
Section 7. Personal Hygiene Facilities.
(1) Each residential or day camp shall provide personal hygiene facilities consisting of water closets and hand-washing and shower facilities for each sex accommodated, pursuant to the design, construction, and sanitary fixture requirements of the State Plumbing Code, 815 KAR Chapter 20.
(2) Personal hygiene facilities shall have natural and artificial lighting of at least twenty (20) foot-candles.
(3) Personal hygiene facilities shall be located no more than 500 feet from any permanent structure used for human occupancy or assembly.
(4) Hot and cold or tempered water service shall be provided to all lavatories and showers, and approved temperature limited devices meeting State Plumbing Code requirements in 815 KAR Chapter 20 shall be used to prevent delivery of water at a temperature above 120 degrees Fahrenheit.
(5) Lavatories or hand-washing facilities shall be conveniently located to all toilet facilities. Water, hand-cleansing soap, and approved sanitary towels or other approved hand-drying device shall be provided at all lavatories and hand-washing facilities.
(6) All personal hygiene facilities shall be maintained in good repair and shall be kept clean at all times.
(7) Adequate toilet tissue shall be provided at each toilet facility.
(8) Flame retardant, easily cleanable refuse containers shall be provided in all toilet facilities. Covered waste receptacles shall be accessible in each toilet stall designed for females.
(9) All windows used for room ventilation shall be screened and outer openings protected in toilet and personal hygiene facilities.
Section 8. Sewage and Waste Water Disposal.
(1) All sewage and waste water shall be disposed of into a public sewer system if available.
(2) If a public sewer system is not available, disposal shall be made into a private sewage disposal system designed, constructed, and operated pursuant to the requirements of the cabinet in 902 KAR 10:085and the Energy and Environment Cabinet in KAR Title 401;
(3) If a public sewer system subsequently becomes available, connections shall be made to it and the camp sewer system shall be discontinued upon failure of the private system.
Section 9. Water Supply System.
(1) The water supply shall be potable, adequate, and from an approved public supply of a municipality or water district if available.
(2) If a public water supply of a municipality or water district is not available, the supply for the camp shall be developed and approved pursuant to applicable requirements of the Energy and Environment Cabinet in KAR Title 401;
(3) If a public water supply of a municipality or water district subsequently becomes available, connections shall be made to it and the camp supply shall be discontinued.
(4) Adequate drinking fountains meeting State Plumbing Code requirements in 815 KAR Chapter 20 or portable drinking water containers of an approved type shall be used within the camp. Common drinking cups, glasses, and vessels shall be prohibited.
(5) If portable drinking water containers are used, they shall be easily cleanable, kept securely closed and designed so that water is withdrawn from the container only by water tap or faucet and shall be maintained in a sanitary condition.
(6) All ice used shall be from an approved source of water, in accordance with Title 401 KAR and 902 KAR 45:005, and shall be handled and stored in a manner to prevent contamination. If ice is made on the premises of any camp, the ice-making machine shall be of approved construction in accordance with 902 KAR 45:005, and the water shall be of the same bacteriological quality as approved drinking water.
Section 10. Refuse Handling.
(1) The storage, collection, and disposal of refuse shall be conducted to avoid a health hazard, rodent harborage, insect breeding area, accident or fire hazard, or air pollution violation and shall conform to all other requirements of the Energy and Environment Cabinet in KAR Title 401.
(2) All refuse shall be stored in flytight, watertight, rodent proof containers, and containers shall be emptied and cleaned at a frequency necessary to prevent a nuisance.
(3) Container storage that has been approved by the local health department shall be provided and shall be designed and maintained to avoid a nuisance.
(4) All refuse containing garbage shall be collected at least once per week or more often if necessary.
Section 11. Maintenance of Animal Facilities.
(1) Barns, stables, corrals or other structures used to house animals shall be located at least 500 feet from any sleeping, eating, or food preparation area. Tie-rails or hitching posts shall not be located within 200 feet of a dining hall, kitchen, or other place where food is prepared, cooked, or served.
(2) Barns, stables, and corrals shall be located on a well-drained sloping area and situated to prevent contamination of any water supply.
(3)
(a) Manure shall be removed from barns, stalls, and corrals as often as necessary to prevent a fly problem. Fly repellents or other precautions shall be used to prevent these shelters from attracting flies or becoming a breeding place for flies.
(b) Manure disposal shall be handled in a manner that does not create a nuisance or contaminate surface or groundwater.
Section 12. Swimming Facilities and Recreational Water Activities.
(1) A public swimming and bathing facility shall comply with 902 KAR 10:120.
(2) All small craft and boating activities shall be conducted in compliance with requirements of the Tourism, Arts, and Heritage Cabinet, pursuant to 301 KAR Chapter 6..
(3) All swimming and small craft and boating activities shall be under the supervision of a person holding a current American Red Cross Lifeguard Certification or its equivalent at all times.
Section 13. Insect, Rodent and Pest Control.
(1) Grounds, buildings, and structures shall be maintained free of insect and rodent harborage and infestations. Extermination methods and other measures to control insects and rodents shall be pursuant to KAR Title 302.
(2) Camps shall be maintained free of accumulations of debris that can provide rodent harborage or breeding places for other pests.
(3) Storage areas shall be maintained to prevent rodent harborage. Lumber, pipe, and other building materials shall be stored at least one (1) foot above the ground.
Section 14. Camp Director, Records and Reports, Medical Supervision, and First Aid.
(1) The camp operator shall assure that a camp director or an authorized agent is available within the camp boundaries at all times while the camp is in operation.
(2)
(a) Pursuant to KRS 194A.382, the camp operator shall require a prospective employee, contractor, or volunteer to complete the form DPP-156 pursuant to 922 KAR 1:470, Section 3.
(b) The prospective employee, contractor, or volunteer shall submit a letter to the camp operator from the cabinet stating that a background check of child abuse and neglect records maintained by the cabinet has not revealed any findings of substantiated child abuse or neglect prior to the individual's presence at the camp or involvement in any program of the camp. The applicant, contractor, or volunteer shall submit to the camp operator a letter from the cabinet stating that the individual has no findings of substantiated child abuse or neglect found through a background check of child abuse and neglect records maintained by the cabinet prior to the individual's presence at the camp or involvement in any program of the camp.
(3) The requirements of subsection (2) of this section shall be deemed to have been met if the prospective employee, contractor, or volunteer provides to the camp operator documentation of a:
(a) Background check performed pursuant to 922 KAR 2:280 finding no disqualifying offense; or
(b) A state and national criminal background check finding no disqualifying offense.
(4) The documentation required by subsection (2) or (3) of this section shall be kept on camp premises and made available for examination upon request of the cabinet.
(5) Records or personal data, including a medical history, shall be kept on each person attending a camp. Minimum records shall include:
(a) The name, date of birth, and address of each person in the camp;
(b) The name, address, and telephone number of parents or guardians; and
(c) The medical history and dates of hospital admission and discharge,if applicable, of each camper.
(6) Residential camps shall have facilities for isolation of persons suspected of having a communicable disease. Other camps shall provide for the immediate isolation of campers suspected of having a communicable disease.
(7) Adequate first aid supplies and equipment as designated by the available or on call physician, required by subsection (9) of this section, shall be located within the camp. An American Red Cross certificate required by paragraph (a) or (b) of this subsection shall be kept on camp premises and made available for examination upon request of the cabinet.
(a) Residential camps shall have a person holding an American Red Cross Standard First Aid and Personal Safety Certificate or its equivalent on site twenty-four (24) hours a day while the camp is in session.
(b) All other camps shall have a person holding, as a minimum, a first aid course certificate from the American Red Cross or its equivalent on site while camp is in session.
(8) All prescription drugs shall be kept in a locked cabinet or container with the exception of medications for which a patient has documentation from a licensed health care provider that states:
(a) The purpose of the medication;
(b) How the medication is to be administered; and
(c) That the medication may be retained by the patient for immediate use.
(9) A nearby physician or emergency room shall be available or on call for medical emergencies, and the camp shall have access to a telephone with emergency telephone numbers posted. Transportation shall be available at all times for any emergencies.
(10) All serious illnesses and accidents resulting in death or injury, other than minor injuries that require only first aid treatment and that do not involve medical treatment, shall be reported to the cabinet by the next business day on form DFS-309, Kentucky Youth Camp Accident/Illness Report.
Section 15. Safety and Accident Prevention.
(1) All camps shall comply with KRS 227.200 to 227.400 and applicable local fire codes pertaining to fire safety, fuel supply, and fuel connections.
(2) In every camp with an electrical system, the wiring, fixtures, and equipment shall be installed and maintained pursuant to applicable local codes and 815 KAR 7:120.
(3) Protection from natural hazards.
(a) Potential hazards occurring naturally in the environment within the boundaries of the camp shall be plainly marked, and measures and procedures shall be followed to insure the safety of the campers.
(b) Poison plants, such as poison sumac and poison ivy, shall be subject to control and elimination from areas where their presence is hazardous to campers.
(4) Elimination of artificial hazards.
(a) All buildings, grounds, and equipment shall be maintained in a manner to eliminate or minimize the danger from holes, glass, splinters, sharp projections, and other hazardous conditions to protect the safety of all persons residing in or using the facilities at the camp site.
(b) All insecticides, pesticides, and chemical poisons shall be plainly labeled and stored in a locked and secured place.
(c) Gasoline and other highly flammable fluids shall be plainly marked and stored in a locked container or building not occupied by residents of the camp and at a safe distance from sleeping quarters or buildings where people congregate.
Section 16. Plan Review for Future Construction.
(1) Any person contemplating construction, alteration, addition to, or change in the construction of any permanent camp shall, prior to the initiation of any construction, submit plans in triplicate, through the local health department concerned, of any proposed camp, additions, alterations, or change in construction.
(2) The plans shall show:
(a) The name and address of the owner or operator of the camp;
(b) The area and dimension of the site;
(c) The property lines;
(d) A separate floor plan of all buildings and other improvements constructed or to be constructed, including:
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Location and number of personal hygiene facilities; and
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A plumbing riser diagram.
(e) Detailed drawings of sewage disposal facilities, including written specifications;
(f) Detailed drawings of water supply if the source is not public; and
(g) The location and size of water and sewer lines within the camp.
(3) If central food preparation and food service buildings are to be provided, plans and specifications shall be submitted showing the kitchen floor plan, layout, and type of equipment, storage area, restrooms, and dining area pursuant to 902 KAR 45:005.
(4) If artificially constructed swimming pools or beaches are planned, the plans and specifications shall be submitted to the cabinet for review and approval prior to construction pursuant to 902 KAR 10:120.
Section 17. Inspection of Camp.
(1) Each camping season, the cabinet shall inspect each camp at least once prior to the opening of the camp and at least once while the camp is in actual operation. The cabinet shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) If an agent of the cabinet makes an inspection of a camp, findings shall be recorded on an official cabinet inspection report form, DFS-308, Youth Camp Inspection Report, and a copy provided to the permit holder or operator. The inspection report shall:
(a) Set forth any violation found;
(b) Establish a specific and reasonable period of time for the correction of any violation found; and
(c) State that failure to comply with a notice issued pursuant to the provisions of this administrative regulation can result in suspension or revocation of the permit.
Section 18. Suspension of Permit.
(1) If the cabinet has reason to believe that an imminent public health hazard exists, or if the permit holder has interfered with the authorized agents of the cabinet in the performance of their duties, the permit shall be suspended immediately upon notice to the permit holder prior to holding a hearing on form DFS-212, Request for Hearing. The permit holder may request a hearing, which shall be granted as soon as practicable.
(2) Failure to comply with the criminal background check and employment requirements established in KRS 194A.382 shall result in penalties pursuant to KRS 194A.383.
(3)
(a) In all other instances of violation of the provisions of this administrative regulation, the cabinet shall serve upon the holder of the permit a written notice specifying the violation in question and afford the holder a reasonable opportunity to correct it.
(b) If a permit holder or operator has failed to comply with written notice issued under the provisions of this administrative regulation, the permit holder or operator shall be notified in writing that the permit shall be suspended at the end of five (5) business days following service of the notice, unless a written request for a conference is submitted to the cabinet by the permit holder within the five (5) business day period.
(4) All administrative conferences shall be conducted in accordance with 902 KAR 1:400.
Section 19. Reinstatement of Suspended Permits.
(1) A person whose permit has been suspended may apply for reinspection on form DFS-215, Application for Reinstatement of Suspended Permits for the purpose of reinstatement of the permit.
(2) Within five (5) business days following receipt of the written request, including a statement signed by the applicant that in his or her opinion the conditions causing the suspension of the permit have been corrected, the cabinet shall make a reinspection.
(3) If the applicant is found to be in compliance with the requirements of this administrative regulation, the permit shall be reinstated.
Section 20. Revocation of Permits.
(1) For repeated violations of any of the requirements of this administrative regulation, the permit may be permanently revoked after an opportunity for a conference has been provided in accordance with 902 KAR 1:400.
(2) Prior to permanent revocation, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit is subject to revocation and advising that the permit shall be permanently revoked at the end of ten (10) business days following service of the notice, unless a request for a conference is filed with the cabinet by the permit holder, in accordance with 902 KAR 1:400 within the ten (10) business day period.
Section 21. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "DFS-200, Application for a Permit", 6/2018;
(b) "DFS-308, Youth Camp Inspection Report", 6/2018;
(c) "DFS-309, Kentucky Youth Camp Accident/Illness Report", 3/2018; and
(d) "DFS-340, Application and Permit to Operate Day Camp Facilities", 3/2018.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.005(1), 194A.381-383, 217.005-217.215
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1)(c)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) requires the cabinet to enforce administrative regulations promulgated for the regulation and control of the sanitation of public and semipublic recreational areas. This administrative regulation establishes uniform standards for youth camps necessary to insure a safe and sanitary environment to protect the health and safety of children attending camps in this state.
- History: San 7; 1 Ky.R. 642; Am. 1227; eff. 5-14-1975; 5 Ky.R. 933; eff. 7-17-1979; 17 Ky.R. 474; 1372; eff. 9-19-1990; 22 Ky.R. 2369; eff. 8-1-1996; 44 Ky.R. 2277; 45 Ky.R. 100, 351; eff. 8-13-2018; Crt eff. 3-26-2025.
902 KAR 10:081 Construction standards for components of on-site sewage disposal systems {#sec-902-kar-10-081 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:081}
Section 1. Citation of Administrative Regulation. This administrative regulation may be cited as the "Construction standards for components of on-site sewage disposal systems."
Section 2. Definitions. As used in this administrative regulation the following terms shall have the meanings set forth below:
(1) "Approved" means that which has been considered acceptable to the cabinet.
(2) "Cabinet" means the Cabinet for Human Resources and includes its authorized agents.
(3) "Component" means any device used in the construction, installation or alteration of an on-site sewage disposal system which forms an integral part of that system, and is necessary to its proper operation and maintenance. It includes, but is not limited to:
(a) Sewage pretreatment units, holding tanks, grease traps, pump or dosing tanks, and necessary equipment and appurtenances;
(b) Distribution boxes, alternating valves, filters, and similar devices; and
(c) Piping, fittings, valves, and leaching chambers.
(4) "Effluent" means the liquid discharge of a septic tank or other sewage pretreatment unit.
(5) "Gravelless pipe" means large diameter perforated piping designed for use in lateral field trenches without the use of trench rock or gravel fill material. Such pipe includes a mandatory overwrap or encasing of synthetic filter material meeting specific criteria.
(6) "Grease" means fats or oils of animal, vegetable, or mineral origin, separately or in colloidal or dissolved states in combination with soaps, detergents, and/or food particles.
(7) "Grease trap" means a component designed to separate grease and its constituents from the wastewater stream, provide for storage of separated grease, and discharge the remaining wastewater for treatment.
(8) "Lateral field" means the area in which the subsurface soil absorption system is installed and is a general term for the system itself.
(9) "Low pressure pipe system" means an on-site sewage disposal system consisting of a sewage pretreatment unit, a dosing tank with pump(s) or siphon(s), a pressurized supply line, manifold, and lateral lines, and necessary control devices and appurtenances.
(10) "Leaching chamber" means a specially designed component for use in lateral field trenches or beds, with or without the use of trench rock or gravel fill material, which forms an open bottomed chamber or cavern over the subsurface soil absorption surface, and which interlocks with other such chambers to obtain the necessary absorption surface area.
(11) "On-site sewage disposal system" means a complete system installed on a parcel of land, under the control or ownership of any person, which accepts sewage for treatment and ultimate disposal under the surface of the ground. The common terms "on-site sewage system" or "on-site system" also have the same meaning. This definition includes, but is not limited to, the following:
(a) A conventional system consisting of a sewage pretreatment unit(s), distribution box(es), and lateral piping within rock-filled trenches or beds;
(b) A modified system consisting of a conventional system enhanced by shallower trench or bed placement, artificial drainage systems, dosing, alternating lateral fields, fill soil over the lateral field, or other necessary modifications to the site, system or wasteload to overcome site limitations;
(c) An alternative system consisting of a sewage pretreatment unit(s), necessary site modifications, wasteload modifications, and a subsurface soil absorption system using other methods and technologies than a conventional or modified system to overcome site limitations;
(d) Cluster systems which accept effluent from more than one (1) structure's or facility's sewage pretreatment unit(s) and transport the collected effluent through a sewer system to one (1) or more common subsurface soil absorption system(s) of conventional, modified or alternative design; and
(e) A holding tank which provides limited pretreatment and storage for off-site disposal where site limitations preclude immediate installation of a subsurface soil absorption system, or connection to a municipal sewer.
(12) "Person" means any individual, firm, association, organization, partnership, business trust, corporation, company or governmental unit.
(13) "Secretary" means the Secretary for the Cabinet for Human Resources.
(14) "Sewage pretreatment unit" means a watertight sewage treatment structure designed and constructed to receive raw sewage, separate solids from liquids, digest organic matter through a period of retention, and allow clarified effluent to discharge to a subsurface soil absorption system. Such pretreatment units fall into three (3) basic categories:
(a) Septic tanks - which rely predominantly on anaerobic bacterial action for treatment;
(b) Aerobic units - which introduce atmospheric air into the sewage to promote treatment by aerobic bacteria; and
(c) Combination units - which provide treatment through both anaerobic and aerobic bacterial action and/or mechanical filtering, ozonation or ultraviolet irradiation.
(15) "Subsurface soil absorption system" means that portion of an on-site sewage disposal system which accepts effluent from a sewage pretreatment unit(s) for further treatment by microbial, plant and animal life within the soil, as well as treatment by filtration, chemical decomposition and bonding within the soil itself, and consists of:
(a) Devices, components, and piping to transport effluent under pressure or by gravity flow, and distribute the effluent to the soil absorption surfaces;
(b) Trenches, beds, chambers, mounds, lagoons, artificial marshes, etc., separately or in combination, which form or enclose the soil absorption surfaces;
(c) Rock, gravel, or other fill materials required within the system, including barrier materials, and fill soil within or over the system; and
(d) Artificial drainage systems, and other necessary site or soil modifications.
Section 3. Approval Procedures.
(1) All commercial manufacturers and suppliers of materials, components, and equipment designed or intended for use in the construction of on-site sewage disposal systems shall obtain approval of such materials, components, and equipment from the cabinet prior to their sale or use in Kentucky. Such approval shall be based upon conformance to recognized design, materials, construction, and performance standards of the National Sanitation Foundation (NSF), the American Society for Testing and Materials (ASTM), and the standards set forth in this administrative regulation.
(2) Manufacturers, purveyors and suppliers of materials, components, and equipment shall submit the following information, as applicable, to the cabinet in review and consideration in the approval process:
(a) All applicable plans, specifications, process descriptions, and other relevant data.
(b) Supportive test data from independent laboratories, testing firms, NSF, ASTM, and other approved organizations.
(c) Other pertinent information as requested by the cabinet.
(3) New or experimental materials, components, or equipment shall be submitted for approval as outlined in subsection (2) of this section and the following additional requirements and restrictions shall apply:
(a) Those materials, components, or equipment which consist of modifications to existing approved products shall be considered for approval after demonstration, through independent testing of the modifications, that improved performance, service life, or ease of maintenance and operation results.
(b) Those materials, components, or equipment which involve new or experimental technologies relating to design, construction, or operational process shall be considered for approval on a probationary basis. During the probationary period, it shall be the responsibility of the person seeking approval of such product to contract with an independent testing firm to provide monitoring of the performance of the product in its intended usage. Such monitoring of the product shall include documentation of the site conditions where the product is installed, the waste load generated by the user and its constitution, and other parameters deemed necessary by the cabinet. In the event that the product fails to perform in an acceptable manner, it shall be the responsibility of the person seeking its approval to replace the product with another product which is approved by the cabinet for that particular use.
(c) Any materials, components, or equipment which, in the opinion of the cabinet, meet the requirements for approval after careful study and testing, as required, shall be considered to be approved for use in Kentucky for the specific purpose(s) intended. Such approval shall be made in writing to the person requesting same and shall set forth any conditions or restrictions for the use of the product when deemed necessary by the cabinet. Each product, so approved, shall be listed by the cabinet on an "approved listing of materials, components, and equipment," which shall be updated on a timely basis and distributed to local health departments and other interested parties on request.
Section 4. Septic Tank Pretreatment Units.
(1) Precast concrete.
(a) All precast concrete septic tanks shall be designed and constructed so as to provide sufficient rigidity and structural strength to prevent damage due to hydrostatic water pressure and support vertical uniform loading of 150 lb./sq. ft. on the top of the tank.
(b) A minimum and product strength of 4,000 pound per square inch shall be used in the construction of the tank.
(c) The top, bottom, ends and sides of the tank shall have a minimum thickness of two and one-half (2 1/2) inches.
(d) The tank shall be reinforced by using a minimum reinforcing of six (6) inch No. 10 gauge welded steel reinforcing wire lapped at least six (6) inches. Other reinforcing methods may be used provided that such other methods can be demonstrated to the satisfaction of the cabinet to be equal, or superior, to the method described herein.
(e) The tank shall be so designed and constructed that all joints, seams, or other openings shall be watertight in use. Asphalt compounds, neoprene gaskets, or other acceptable sealant materials shall be used to insure watertightness.
(f) At least two (2) manholes shall be provided to permit access for maintenance of the tank. Manholes shall have a minimum dimension of ten (10) inches and a maximum of twenty-four (24) inches measured on the bottom edge of the manhole opening into the tank. Manholes shall be located on each end of the tank over the inlet and outlet structures (baffles or tees). The manhole openings shall be beveled so as to adequately seal and support the manhole cover. The manhole cover shall possess sufficient strength to support a uniform load of 150 lb./sq. ft. without damage to the cover or tank and provide a means for removal (handles).
(g) Cast-in-place baffles, at inlet and outlet ends of the tank have a minimum thickness of two (2) inches and be reinforced in the same manner as the tank. For cast-in-place baffles reinforcing wire into and along the tank side walls a minimum of (6) inches for proper anchorage. For tanks using drop-in baffles, a molded in slot or groove with a minimum one (1) inch penetration into the tank side wall shall be provided to retain the baffle. Such slot or groove shall be slightly tapered to produce a secured "wedge fit" baffle. For bolt-on tee-type baffle structures, stainless steel bolts, washers and nuts shall be used for anchorage. Such bolts shall be cast-in-place in the baffle or tank endwall and securely anchored by attachment to tank or baffle reinforcing material. On those tanks where baffle attachment bolts penetrate through the tank endwall suitable bushings or seals shall be used to render bolt holes watertight. Suitable sealants shall also be used on all baffle edges which contact the tank endwall to prevent short-circuiting of tank contents.
(h) In lieu of concrete baffles, sanitary tees or other baffle devices of corrosion resistant materials (fiberglass, plastic) may be used as long as joints are properly sealed, acceptable attachment methods are used, and the specified dimensions above and below the liquid level of the tank are maintained.
(i) Internal dimensions of the tank shall fall within plus or minus one (1) foot of the proportional ratios of 2:1 to 3:1, the length being approximately two (2) to three (3) times the width. The minimum liquid depth shall be thirty-four (34) inches with maximum depth of fifty-four (54) inches. The inlet and outlet pipe knockouts or holes shall be of sufficient diameter to accept a minimum four (4) inch diameter pipe and shall be so designed as to provide a minimum height difference of three (3) inches for the inlet pipe invert above the outlet pipe invert. Inlet and outlet holes shall be so located on the ends of the tank as to provide a minimum freeboard space of ten (10) inches to one (1) foot between the liquid level and the inside top surface of the tank for scum storage. Both inlet and outlet baffles or tees shall extend above the liquid level of the tank to within at least two (2) inches but not less than one (1) inch of the inside top surface of the tank to contain scum and provide venting space for gases. Baffle designs which extend to the inside top of the tank may be used provided that a slotted vent space of a minimum height of one (1) inch by four (4) inches in width is located at the juncture of the baffle and tank top in the center of the baffle. The inlet tee or baffle shall extend below the liquid level between eight (8) to ten (10) inches, and the outlet baffle or tee shall extend downward to thirty-five (35) to forty (40) percent of the total liquid depth of the tank. When baffles are used, the distance between the outlet baffle and tank endwall shall be between four (4) to six (6) inches, and the distance between the inlet baffle and endwall shall be between six (6) to ten (10) inches.
(j) All tanks offered for sale or use in Kentucky shall bear, by imprint, stencil, or other acceptable means of marking, the manufacturer's name, the serial number assigned to the manufacturer's plans and specifications approved by the cabinet, and the liquid or working capacity of the tank. This imprint, stencil, or other marking shall be located to the right of the knockout or hole made for the outlet pipe on the outlet end of the tank.
(2) Constructed on site. Septic tanks constructed on site of cast-in-place concrete, or concrete block shall be constructed to conform with the requirements in subsection (1) of this section except as follows:
(a) Cast-in-place concrete septic tanks shall have a minimum wall thickness of four (4) inches.
(b) Concrete block septic tanks shall have a minimum wall thickness of at least eight (8) inches when the design volume is less than 1,000 gallons and a minimum wall thickness of at least ten (10) inches when the design volume is 1,000 gallons or more. All septic tanks constructed of block shall be plastered on the inside with a 1:3 mix (one (1) part cement, three (3) parts sand) of portland cement at least three-eighths (3/8) inch thick or the equivalent using other approved waterproofing material, and provided with acceptable reinforcing within all walls.
(c) The bottom and top of the constructed on site septic tank shall be poured reinforced concrete with a minimum thickness of four (4) inches.
(d) For large capacity (5,000 gallons or more) cast-in-place concrete tanks, maximum liquid depth shall be sixty-six (66) inches.
(3) Prefabricated steel. Prefabricated steel septic tanks shall conform to the requirements listed under subsection (1)(a), (e), (f), (h), (i) and (j) of this section, in addition to the following:
(a) All prefabricated steel tanks shall be thoroughly coated on all surfaces with a minimum one-eighth (1/8) inch thick coating of liquid asphalt, mastic compound, plastic waterproofing compound, or liquid cured vinyl. Each such septic tank shall be accompanied on site delivery by a one-half (1/2) pint container of the coating material for use in touchup coating of steel surfaces of the tank exposed through damage in shipping and handling. If such volume is insufficient to repair all damaged areas, additional coating material shall be secured by the installer.
(b) Coated steel baffles shall not be used in prefabricated steel tanks. Sanitary tees of approved plastic, fiberglass, or cast iron shall be required.
(4) Molded plastic, fiberglass. Septic tanks of molded plastic, fiberglass, or other such type of materials shall conform to the requirements listed under subsection (1)(a), (e), (f), (h), (i) and (j) of this section, in addition to the following: baffles, if used in lieu of sanitary tees, shall be molded or formed in place so as to be an integral part of the tank. Glued, riveted, or otherwise mechanically attached baffles are not permitted (solvent welding on plastic tanks and resin bonding on fiberglass are acceptable). Such baffles shall be formed of material equal in thickness and rigidity to the tank wall material.
Section 5. Aerobic Pretreatment Units.
(1) Precast concrete tank. All precast concrete tank aerobic pretreatment units shall comply with the construction requirements of Section 4(1)(a), (b), (c), (d), (e), (f) and (j) of this administrative regulation, in addition to the following:
(a) All cast-in-place baffles, compartment walls, dividers, weirs, and other devices or structural forms shall be a minimum thickness of two (2) inches and be reinforced in the same manner as the tank. Such reinforcing material shall extend into and along the tank side wall a minimum of six (6) inches.
(b) Baffles, compartment walls, dividers, weirs, and other such devices or structural forms that are not cast-in-place or may be of dissimilar materials to the tank shall be of corrosion resistant materials, of sufficient structural strength and anchorage to the tank to prevent damage or dislodgment in normal operation, and where requiring routine maintenance, readily accessible through tank access manholes.
(c) All manholes providing access to mechanical or electrical components, chlorinating or other treatment devices or filters shall be provided with risers extending to grade to allow ready access for maintenance. Covers for such manholes or risers shall be provided with locks or other devices to prevent entry by unauthorized persons. On units which are intended to be installed flush with grade or above grade, which are designed to have an open top, suitable gridding, decking, or other such barriers to entry to the tank shall meet the 150 lb./sq. ft. support strength requirements and shall be so designed and installed to prevent entry to the tank or contact with its contents by unauthorized persons.
(2) Prefabricated steel. All prefabricated steel tank aerobic pretreatment units shall comply with the construction requirements listed in Section 4(1)(a), (e), (f), (j), and (3)(a) of this administrative regulation, subsection (1)(b) and (c) of this section, in addition to the following: coated steel, welded-in-place or mechanically attached baffles, compartment walls, dividers, weirs, and other devices or structural forms shall receive additional corrosion protection materials or coatings when they are exposed directly through splash or immersion on two (2) or more surfaces or sides to tank liquid contents.
(3) Molded plastic, fiberglass. All molded plastic or fiberglass tank aerobic pretreatment units shall comply with the construction requirements listed in Section 4(1)(a), (e), (f) and (j) of this administrative regulation, and subsection (1)(b) and (c) of this section, in addition to the following: baffles, compartment walls, dividers, weirs, and other such devices or structural forms, if cast or molded in place, shall be formed of material equal in thickness and rigidity to the tank material.
(4) Piping, mechanical devices and electrical equipment, filtration devices, and other appurtenances.
(a) All internal or external piping or conduits and fittings necessary to the transport of tank sewage contents between tank compartments, mechanical equipment, or other components of the treatment process involved shall be of Schedule 40 PVC or ABS plastic pipe. Mixing of PVC and ABS or other dissimilar plastic pipe or fittings is prohibited.
(b) Mechanical fittings and connections where used to connect PVC or ABS piping to equipment or components shall be corrosion resistant and of a type, design, and construction compatible for use with the type of pipe involved.
(c) Mechanical aerators, stirrers, diffusers, rotating disks, and other devices used to provide direct exposure of atmospheric air to tank sewage contents shall be constructed of corrosion resistant materials and of sufficient structural strength to withstand normal operating stresses without damage or deformation resulting in system malfunction for the designed service life of the device.
(d) Pumps, electrical motors, or other such devices shall be of sealed or submersible design and construction when subject to submersion, splash, or corrosive atmosphere within the aerobic pretreatment unit. Such pumps, motors, or other such devices shall be properly sized and designed for the intended use and duty cycle.
(e) Filters, chemical feeders, and other such devices shall be constructed of corrosion resistant materials and possess sufficient strength to withstand normal operational stresses without damage or deformation resulting in system malfunction.
(f) Electrical controls, switches, ozone generators, ultraviolet generators, and other such devices relying upon electrical current for operation shall be designed and constructed as to be water and corrosive vapor proof in all portions of the device where electrical current carrying components are located. All such devices shall be properly grounded and otherwise designed, constructed, installed, and operated in accordance with National Electrical Code requirements.
(g) All fasteners, brackets, clips, hangers, or other such devices used in the anchorage, installation, mounting, or attachment of unit components and equipment both internal or external to the aerobic pretreatment tank shall be designed and constructed of materials possessing sufficient strength and corrosion resistance to withstand normal operational stresses without damage or deformation resulting in system malfunction.
(h) All components of aerobic pretreatment units which require routine maintenance shall be installed and located within the unit as to be readily accessible. Such components which require replacement, removal, or dismantling for routine maintenance shall be designed, constructed, and installed so as to facilitate their replacement, removal, or dismantling with simple tools. A maintenance instruction manual using pictures and simple language for identification of unit components, maintenance to be performed, components needing routine replacement, removal or dismantling procedures, maintenance interval, and simple troubleshooting procedures shall be included with all units. Such manual shall be provided to the ultimate operator or user of the unit. When aerobic pretreatment units are to be installed by other persons, rather than the manufacturer or his agents, a detailed installation manual shall be supplied outlining proper installation procedures including hookup to an electrical power source, unit start-up procedures, and necessary adjustments or calibrations to be made to meet manufacturer's operating specifications for effluent quality.
Section 6. Dosing and Holding Tanks.
(1) All dosing and holding tanks shall comply with the general construction requirements listed in Section 4 of this administrative regulation for septic tanks, based upon the type of material used in their construction, in addition to the following:
(a) Access manholes for dosing or holding tanks shall be extended to grade through the use of suitable risers to permit ease of access for maintenance and pumping.
(b) Such manholes in dosing and holding tanks shall provide a minimum opening of eighteen (18) inches by eighteen (18) inches into the tank. Manhole riser lids or covers shall be designed and constructed so as to be watertight and, through the use of locks, locking devices, or other means, prevent access to the tank by unauthorized persons.
(c) All dosing or holding tanks, due to their frequently empty or partially filled condition, shall be designed or installed (using suitable anchoring devices or antiflotation devices) to prevent flotation or vertical shifting due to ground water pressure.
(2) All dosing and holding tank equipment, controls, and appurtenances shall comply, where applicable, with the requirements of Section 5(4)(a), (b), (d), (f), (g) and (h) of this administrative regulation, in addition to the following:
(a) High water alarms, including an audible or visible alarm system within the structure served by the dosing or holding tank, shall be installed in such tanks and calibrated to activate an alarm whenever the tank liquid level reaches eighty-five (85) percent of capacity. Such alarms shall be connected to a separate electrical circuit, and visible systems shall be located in an area of high pedestrian traffic.
(b) When pumps are used for dosing effluent into the lateral field or are used for lifting effluent to a lateral field above the elevation of the dosing tank, electrically operated mercury float switch controls shall be provided to permit automatic operation of such pumps. Manually operated pump controls are not permitted. When pumps are used, they shall be installed in an elevated position in respect to the tank bottom, by placement on stands designed for such purpose, concrete blocks, or through the use of suitable hangers to allow for sludge storage space and prolong service life of the pumps. Elevation distance from the tank bottom shall be a minimum of eight (8) inches.
(c) In lieu of pumps, automatic dosing siphons may be used for lateral field dosing where a suitable downhill gradient exists from the elevation of the siphon to the lateral field.
Section 7. Grease Traps. All grease traps shall comply with the general construction requirements listed in Section 4 of this administrative regulation for septic tanks, based upon the type of material used in their construction, in addition to the following:
(1) Inlet baffle, sanitary tee or baffle device shall extend two (2) to no more than four (4) inches below the liquid level of the trap;
(2) Outlet baffle, sanitary tee or baffle device shall extend downward to eighty (80) percent of the total liquid depth of the trap;
(3) The minimum liquid depth shall be twenty-four (24) inches with a maximum depth of forty-eight (48) inches;
(4) Grease traps are exempted from the 2:1 to 3:1 length to width ratio requirements in Section 4 of this administrative regulation; and
(5) A manhole or manholes shall be provided on each grease trap to allow free access for servicing all areas of the trap. Such manhole(s) shall have a minimum dimension of eighteen (18) inches measured at the bottom edge of the manhole opening into the trap, and manhole risers shall be used to extend the manhole(s) to grade.
Section 8. Distribution Devices.
(1) Precast concrete.
(a) All precast concrete distribution boxes shall be designed and constructed to provide sufficient strength and structural integrity to withstand a vertical uniform load of 150 lb./sq. ft. on the top of the box.
(b) A minimum end product strength of 4,000 pounds per square inch shall be used in the construction of the box and lid.
(c) A minimum wall thickness of one and one-half (1 1/2) inches shall be used in the construction of distribution box bottoms, side walls, and lids and shall be reinforced by a minimum No. 10 gauge six (6) inch by six (6) inch welded steel reinforcing wire, or equivalents, as approved by the cabinet.
(d) Distribution box lids or covers shall meet the requirements of paragraph (a) of this subsection and shall be provided with suitable handles for removal.
(e) Knockouts or holes for inlet and outlet piping shall be of sufficient diameter to accept four (4) inch diameter piping but no more than five (5) inches in diameter at the inside surface of the box.
(f) All distribution devices offered for sale or use in Kentucky shall bear, by imprint, stencil, or other acceptable means of marking, the manufacturer's name and the serial number assigned to the manufacturer's plans and specifications approved by the cabinet. This imprint, stencil, or other marking shall be located on the inlet end of the device. Low pressure pipe manifolds shall meet the identification requirements for plastic piping in Section 9 of this administrative regulation.
(2) Molded plastic and fiberglass. Molded plastic or fiberglass distribution boxes shall be designed and constructed to meet the requirements listed in subsection (1)(a), (d), (e) and (f) of this section.
(3) Equal flow and level type design standards.
(a) Outlet holes or knockouts in equal flow and level boxes shall be spaced a minimum of seven (7) inches on centers to permit access for application of waterproofing sealants around lateral piping and the external surface of the box side wall or endwall. When plastic or neoprene connectors are cast into the box, this requirement may be waived. Outlet holes or knockouts shall be located a minimum distance of six (6) inches on centers, on a single plane, above the inside bottom surface of the box and a minimum of three (3) inches on centers from adjacent side walls in the outlet portion of the box. At the inlet portion of equal flow boxes a minimum distance of eight (8) inches on centers shall be maintained between outlet holes and the side wall or endwall to allow for the placement of a baffle to retard incoming effluent velocity.
(b) Centerline of the inlet hole or knockout shall be a minimum distance of one and one-half (1 1/2) inches to a maximum of three (3) inches above the centerline of the outlets.
(c) All equal flow boxes shall be provided with a baffle on the inlet end of the box. A double flange, molded or cast-in slot, or other acceptable means to retain the baffle in place shall be provided. Baffle material and construction shall be equal to that used in the box itself. Baffles and their mounts or retainers shall be so designed as to provide a passageway for effluent between the box bottom and bottom edge of the baffle of no more than two (2) inches in height. The baffle shall extend to one (1) inch above the top of the inlet.
(d) Equal flow boxes shall be designed so as to provide unobstructed access, on removal of the lid or top, for direct, simultaneous viewing of all outlets to facilitate the performance of "water leveling" procedures during installation.
(4) Hillside or drop box type design standards.
(a) Lateral outlet holes or knockouts shall be located a minimum of two and one-half (2 1/2) inches on centers, on a single plane above the inside bottom surface of the box, and a minimum of three (3) inches on centers from adjacent side walls.
(b) Centerline of the inlet hole or knockout shall be a minimum of five (5) inches above the centerline of the lateral outlets and a minimum of one (1) inch above the centerline of the supply line outlet going to the next box in series.
(c) Hillside or drop boxes shall be designed so as to provide sufficient separation distance (twelve (12) inches or greater recommended) between the inlet side wall and supply line outlet side wall to minimize the risk of short-circuiting of effluent under heavy flow conditions or on steep hillsides where gradient induced flow velocity is created. In lieu of this requirement, box designs offsetting the vertical centerlines of inlets and supply line outlets or other acceptable means, may be employed.
(5) Plastic low pressure pipe manifolds. All plastic pipe, fittings, and connectors used in low pressure pipe supply lines and manifolds shall be of Schedule 40 PVC or ABS construction and materials.
(6) Alternating valves and devices design standards.
(a) Alternating valves and devices shall meet the general design and construction standards listed in subsection (1)(a) and (d) of this section, and if constructed of precast concrete, subsection (1)(b) and (c) of this section as well.
(b) All alternating valves and devices shall be designed and constructed to provide a positive seal to each outlet when in a closed position. The valving device shall be constructed of corrosion resistant materials and of sufficient strength to withstand normal operational stresses without damage or deformation resulting in valve malfunction.
(c) All alternating valves and devices shall be fitted with risers and watertight lids or covers, extending to grade, which will permit unobstructed access for maintenance, inspection, and operation.
Section 9. Piping, Fittings, and Connectors.
(1) Nonperforated pipe - gravity flow usage.
(a) All nonperforated piping used for gravity flow carriage of effluent between septic tanks in series, septic tanks or other pretreatment units and distribution or alternating devices, and for two (2) feet into lateral trenches or beds from distribution devices shall be at least SDR 35 ASTM-D3034 and D3033 for PVC and ASTM-D2751 for ABS. 1,500 lb. crush ASTM-F810 for polyethylene may be used between distribution devices and lateral trenches or beds.
(b) All such nonperforated piping shall be of a minimum internal diameter of four (4) inches, except that such piping used between distribution devices and lateral trenches or beds may be reduced to a minimum internal diameter of two (2) inches with the use of approved reducer coupler fittings.
(c) Each standard section of pipe as supplied by the manufacturer shall be plainly marked, embossed, or engraved showing the manufacturer's name or hallmark, the SDR 35 ASTM D3034, D3033, or D2751, 1,500 lb. crush ASTM-F810 designation, and the type of pipe material (PVC, ABS, or polyethylene).
(2) Nonperforated pipe - pressure usage.
(a) All nonperforated piping used for pressurized carriage of effluent between dosing or pumping and distribution or alternating devices shall be of at least 160 psi PVC or ABS.
(b) 160 psi polyethylene pipe or equivalent may be used in all applications listed above in lieu of PVC or ABS piping, except in the construction of any portion of a low pressure pipe (LPP) system where PVC or ABS pipe shall be required.
(c) Each standard section of pipe as supplied by the manufacturer, or in the case of polyethylene or equivalent piping rolls at not greater than ten (10) foot intervals, shall be plainly marked, embossed, or engraved showing the manufacturer's name or hallmark, the 160 psi designation, and the type of pipe material.
(d) All such pipe used on an individual low pressure pipe (LPP) system installation shall be of the same type of material - mixing of PVC, ABS, polyethylene, or other equivalent piping is prohibited.
(3) Perforated pipe - gravity flow usage.
(a) All perforated pipe used for gravity flow carriage and distribution of effluent within lateral trenches, beds, mounds, or other such applications shall meet 1,500 lb. crush ASTM-F810 standards for rigid piping and ASTM-F405 for corrugated semirigid piping.
(b) Each standard section of pipe as supplied by the manufacturer shall be plainly marked, embossed, or engraved showing the manufacturer's name or hallmark, the type of pipe material, and showing the product meets applicable ASTM standards and a bearing load of 1,500 lbs., per foot. In addition, a painted or other clearly marked line or spot shall be marked on each section to denote the top of the pipe.
(c) All such gravity flow usage perforated pipe shall have a minimum internal diameter of two (2) inches.
(d) On two (2) inch or three (3) inch diameter pipe: if one (1) row of holes is use, it shall be located directly opposite the top marking on the pipe and holes shall be a minimum one-fourth (1/4) inch in diameter; if two (2) rows of holes are used, they shall be one-quarter (1/4) inch to five-sixteenths (5/16) inch in diameter, and evenly spaced and placed within an arc of 120 degrees on the bottom of the pipe. Spacing of holes longitudinally shall be between twelve (12) inches to five (5) feet on centers.
(e) All four (4) inch diameter or greater pipe shall have at least two (2) rows of holes five-sixteenths (5/16) to one-half (1/2) inch in diameter, evenly spaced and placed within an arc of 120 degrees on the bottom of the pipe. If three (3) holes are used, the center row shall be directly opposite the top marking. Spacing of holes longitudinally shall be between three (3) to twelve (12) inches on centers.
(4) Perforated pipe - gravelless pipe design.
(a) All eight (8) and ten (10) inch I.D. corrugated polyethylene pipe used in gravelless pipe lateral fields shall meet the requirements of ASTM F667.
(b) Each standard section of pipe as supplied by the manufacturer shall be plainly marked, embossed, or engraved showing the manufacturer's name or hallmark, the type of pipe material, and showing the product meets ASTM F667. In addition, a painted or other clearly marked line shall be placed on each section to denote the top of the pipe.
(c) All gravelless piping shall be encased, at the point of manufacturer, with a spun bonded nylon filter wrap, or equivalent, meeting or exceeding the performance criteria below:
(d) Gravelless pipe hole placement and diameter shall be as follows: holes shall be cleanly drilled and be placed in two (2) rows spaced 120 degrees apart along the bottom half of the pipe and 120 degrees from the top stripe to either row. Hole size shall be between five-sixteenths (5/16) inch to one-half (1/2) inch in diameter, and holes shall be placed only in corrugation "valleys," not on the crown or in the corrugation sidewall.
(e) All gravelless piping and encasing filter wrap shall be further encased, at the point of manufacture, within a plastic shipping and storage bag of sufficient burst strength, tear resistance and opacity, to prevent physical damage and ultraviolet radiation deterioration of the filter wrap.
(f) The manufacturer shall also make available suitable wide-width plastic tape for sealing of pipe section and fitting joints.
(5) Perforated pipe - pressure usage, low pressure pipe systems (LPP).
(a) Pipe used for pressure carriage and distribution of effluent within lateral trenches, beds, mounds, or other low pressure pipe (LPP) applications shall be of at least 160 psi PVC or ABS construction. Deep hub water line type pipe shall be used.
(b) Pipe shall meet the requirements listed under subsection (2)(c) and (d) of this section.
(c) Minimum pipe internal diameter shall be determined on a case-by-case basis, based upon system size, configuration, and other factors necessary in the design of a low pressure pipe system. In no case shall the internal diameter be less than one (1) inch.
(d) Pipe perforations shall run in a straight line along the bottom of the pipe. Where preperforated pipe is unavailable, perforations shall be hand-drilled, and deburred. Hole diameters and hole spacing shall be determined on a case-by-case basis relative to design requirements of the low pressure pipe system. Hole sizes may range from 5/32 to one-fourth (1/4) inch in diameter, and hole spacing form three (3) to eight (8) feet depending on design requirements.
(6) Fittings and connectors.
(a) Piping elbows, tees, wyes, reducers, end caps, plugs, connectors, and other such fittings shall be designed and constructed for the intended use.
(b) Fittings and connectors shall be formed of materials compatible with the piping to which they are joined and meet the same standards as that piping. Mixing of different pipe and fitting materials except when expressly designed and constructed for such purpose is prohibited.
(c) Joints formed between fittings, connectors, and/or piping shall be rigid and watertight and shall be made by the methods (solvent welding, chemical fusion, mechanical compression, etc.) applicable to the materials joined.
Section 10. Leaching Chambers. All leaching chambers shall comply with the general construction requirements listed in Section 4 of this administrative regulation for septic tanks, based upon the type of material used in their construction, in addition to the following:
(1) Metal leaching chambers are prohibited;
(2) All leaching chambers shall be designed and constructed to support vertical uniform loading of 600 lb./sq.ft. on the top of the chamber without damage or permanent deformation;
(3) All leaching chambers shall be designed and constructed to provide ports, slots, holes or other similar openings on sidewalls to allow air movement and effluent access to lateral field trench or bed sidewall absorption surfaces;
(4) All leaching chambers shall be designed and constructed to be interlocking to allow serial installation of chambers, and be provided with acceptable end plates, caps or other necessary fittings and connectors;
(5) All leaching chambers shall be provided with at least one (1) inspection port of a minimum internal dimension of six (6) inches centrally located in the top of the chamber; and
(6) All such chambers offered for sale or use in Kentucky shall bear, by imprint, stencil, or other acceptable means of marking, the manufacturer's name and the serial number assigned to the manufacturer's plans and specifications approved by the cabinet. This imprint, stencil, or other marking shall be located beside the observation port.
Section 11. Trench Fill and Barrier Material.
(1) Trench fill material.
(a) River gravel or crushed dolomitic limestone shall be used for bedding and trench fill material for conventional gravity flow lateral lines. Foreign matter, dust, and fines shall be removed. Such material shall be of sufficient hardness to attain a three (3) on the Moh's Scale (material hard enough to scratch a copper penny without crumbling or powdering shall be considered acceptable). Such material shall conform to the sizing standards and specifications of the Kentucky Transportation Cabinet for No. 2, No. 23, and No. 4 coarse aggregates, except that other grades may be used if they are in conformance with the general requirements of this paragraph and are acceptable to the cabinet. A size range of three-quarters (3/4) inch to two and one-half (2 1/2) inches in rough diameter shall be used, and material shall be graded for uniformity in size.
(b) Other materials such as blast furnace slag may be considered for usage if such materials can meet or exceed all of the requirements of paragraph (a) of this subsection.
(c) Pea gravel of a minimum one-fourth (1/4) inch diameter shall be used for bedding and trench fill material for low pressure pipe systems. River gravel or crushed limestone may also be used if washed and screened to a uniform size range of three-fourths (3/4) inch to one and one-half (1 1/2) inch.
(d) Graded sands used for the construction of mound systems or filter units shall be sized according to the design requirements of the system or unit involved.
(e) Crushed rock, gravel, pea gravel, sand, or other such materials meeting the requirements of this section for use as trench fill, lateral bedding material, mound fill, or filter material may be used, as applicable, in the construction of curtain, vertical, and underdrain ground water drainage systems.
(2) Trench barrier material.
(a) Straw or synthetic filter fabrics shall be used in all lateral trenches, beds, mounds, subsurface sand filters, or ground water drainage systems to provide a barrier to the entrance of soil backfill into the rock, gravel, pea gravel, or sand fill in such trenches, beds, mounds, filters, or drainage systems.
(b) Other similar materials may be considered for such usage provided that they can be demonstrated to perform in an equivalent manner with the above and do not restrict air movement within the trench, bed, mound, filter, or drainage system.
History
- RELATES TO: KRS 211.350-211.380, 211.990(2)
- STATUTORY AUTHORITY: KRS 194.050, 211.090(3), 211.180(3)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.350 to 211.380 directs the cabinet to regulate the construction, installation, or alteration of on-site sewage disposal systems except for systems with a surface discharge. The purpose of this administrative regulation is to establish minimum component standards including design, construction, and materials specifications for on-site sewage disposal systems in Kentucky in order to protect the public health.
- History: 902 KAR 010:081. 12 Ky.R. 1457; eff. 3-4-1986; 15 Ky.R. 619; eff. 9-21-1988; Crt eff. 4-5-2019; TAm eff. 3-20-2020; Crt eff. 10-13-2025.
902 KAR 10:085 Kentucky on-site sewage disposal systems {#sec-902-kar-10-085 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:085}
Section 1. Definitions.
(1) "Alter" means to make a physical change in the original design, sizing, layout, components, location, or method of operation, individually or in combination, of an existing on-site sewage disposal system, as a result of necessary repair or change in wasteload volume or characteristics.
(2) "Approved" means acceptable to the cabinet for the proposed use.
(3) "Area subject to flooding damage" means an area:
(a) Subject to surface ponding of rainfall runoff one (1) or more times each year for more than seven (7) consecutive days;
(b) In a floodplain or drainageway with visible evidence of stream scouring, pot-holing, or gully or ravine formation; or
(c) Within a karst depression subject to backwater flooding from a subsurface conduit.
(4) "Artificial drainage system" means:
(a) A manmade system of surface ditching or berming to divert surface water run-off;
(b) A curtain or vertical drain for interception and diversion of lateral groundwater flow; or
(c) Underdrain for lowering the level of a high water table.
(5) "Blackwater" means wastewater containing liquid or solid waste generated through use of a urinal, water closet, garbage disposal, or a similar sanitary fixture.
(6) "BOD-5" means five (5) day biochemical oxygen demand.
(7) "Cabinet" is defined by KRS 211.015(1)(a).
(8) "Certified inspector" means an individual certified under the provisions of KRS 211.360.
(9) "Certified installer" means an individual certified under the provisions of KRS 211.357.
(10) "Clay" means a mineral soil separate consisting of particles less than 0.002 mm in equivalent diameter.
(11) "Cluster system" means a system designed to:
(a) Accept effluent from more than one (1) structure's or facility's sewage pretreatment unit; and
(b) Transport the collected effluent through a sewer system to one (1) or more common subsurface soil treatment and dispersal system of conventional, modified, or alternative design.
(12) "Effluent" means the liquid discharge of a septic tank or other sewage pretreatment unit.
(13) "FOG" means fats, oils, and grease.
(14) "Gravelless pipe" means large diameter perforated piping encased in a synthetic filter material and designed for use in a lateral field trench without trench rock or gravel fill material.
(15) "Grease" is defined by KRS 211.970(3).
(16) "Grease trap" is defined by KRS 211.970(4).
(17) "Greywater" or "graywater":
(a) Means wastewater generated by hygiene activities including wastewater from laundry, lavatory sinks, showers, bath tubs, and laundry tubs, but excluding kitchen sinks and food preparation sinks; and
(b) Does not mean or include blackwater.
(18) "Karst" means a type of topography formed over limestone, dolomite, or other soluble rock, by dissolving or solution, and characterized by sinkholes, caves, and underground drainage. Groundwater flow in karst occurs principally in conduits and is turbulent.
(19) "Landscape position" means the location of an area on a site being evaluated for the proposed installation of an on-site sewage disposal system relative to the surrounding topographic relief of the land surface. Landscape positions are defined as:
(a) Hill or ridge top: the relatively level area occupying the summit of a hill or ridge;
(b) Shoulder slope: the transitional area immediately adjacent to the hill or ridge top where the slope begins to increase downward;
(c) Side slope: the slightly to steeply sloping portion of a hillside lying between the shoulder and foot slopes;
(d) Foot slope: the slightly to steeply sloping portion of a hillside near the base or lowest point of elevation;
(e) Toe slope: the lowest point of elevation at the base of a hillside; generally concave in cross-sectional profile;
(f) Terrace, natural: a naturally occurring elevated shelf of level to slightly sloping character adjacent to current or former streams and drainageways;
(g) Terrace, artificial: a manmade elevated shelf or bench created by excavating into a slope or placing fill along the contour;
(h) Flood plain: level to slightly sloping areas adjacent to streams or other bodies of water subject to flooding for extended periods, or other flood-prone areas such as sinkholes or other surface depressions;
(i) Depressions: sinkholes or other areas with a concave or cupped cross-sectional profile and lacking surface drainage outlets;
(j) Drainageway: an area in the landscape with slight to steeply sloping sides that causes accumulation of surface and groundwater and channels it to surface or subsurface drainage outlets;
(k) Convex slope: a sloping area with a humped or upwardly bowed cross-sectional profile that promotes dispersal of surface and groundwater; and
(l) Concave slope: a sloping area with a cupped or downwardly bowed cross-sectional profile that causes accumulation of surface and groundwater.
(20) "Lateral field" means that portion of an on-site sewage treatment and dispersal system that consists of subsurface trenches or beds containing materials, components, or devices for maintaining exposed soil surfaces and a means to distribute effluent to those surfaces.
(21) "Leaching chamber" means a specially designed component for use in lateral fields, which forms an open bottomed chamber or conduit over the soil absorption surface.
(22) "Low pressure pipe system" or "LPP system" means an on-site sewage disposal system consisting of a sewage pretreatment unit, a dosing tank with pump or siphon, a pressurized supply line, manifold, lateral field, and necessary control devices and appurtenances.
(23) "Mottling" means spots or blotches of different colors or hues interspersed with the dominant color of a soil, created by the following three (3) basic processes:
(a) Groundwater saturation of the soil for varying periods of time, causing reducing conditions to occur that chemically bleach or fade soil colorants evidenced by soft concretions or soil color of chroma two (2) or less by Munsell notation;
(b) Parent material weathering evidenced by relic fragments of more durable parent material encapsulated within a mottle of weathering mineral material; or
(c) Mechanical disturbance of soils by cutting, filling, soil compaction, landslide, or other means evidenced in commingling of soil types and destruction of original internal drainage pathways.
(24) "On-site sewage disposal system" or "on-site sewage system" or "on-site system" means a system installed on a parcel of land, under the control or ownership of a person, that accepts sewage for treatment and ultimate disposal under the surface of the ground, including:
(a) A conventional system consisting of a sewage pretreatment unit, distribution devices, and lateral piping within rock-filled trenches or beds;
(b) A modified system consisting of a conventional system enhanced by shallow trench or bed placement, artificial drainage systems, dosing, alternating lateral fields, fill soil over the lateral field, or other necessary modifications to the site, system, or wasteload to overcome site limitations;
(c) An alternative system consisting of a sewage pretreatment unit, necessary site modifications, wasteload modifications, and a subsurface soil treatment and dispersal system using methods and technologies other than a conventional or modified system to overcome site limitations;
(d) A cluster system; and
(e) A holding tank that provides limited pretreatment and storage for off-site disposal where site limitations preclude immediate installation of a subsurface soil treatment and dispersal system or connection to a municipal sewer.
(25) "Overflow piping" means a system composed of a supported, vertically-oriented tee connected to a nonperforated gravity flow plastic pipe that conducts overflow to distribution boxes of the lateral field.
(26) "Parent material" means weathering fragments of bedrock underlying a soil, colluvial or alluvial deposits, loess deposits, or glacial tills from which the soil is being formed.
(27) "Perched water table" means a saturated zone as identified by free water, soft concretions, or soil color of chroma 2 or less overlying an impermeable horizon and generally above the permanent water table.
(28) "Permanent water table" means the zone of soil and parent material saturation by groundwater that remains relatively constant unless acted upon by artificial means of drainage or severe weather conditions. This zone is evidenced by free water or soil colors of black (due to high organic content), grays, blues, or olive greens.
(29) "Permeability test" means a scientific procedure using lysimeters and other instrumentation to determine the saturated hydraulic conductivity of site specific soil horizons.
(30) "Person" is defined by KRS 211.970(6).
(31) "Plastic limit" means the moisture content at which a soil changes from a semisolid to plastic.
(32) "Professional engineer" means an engineer licensed under the provisions of KRS Chapter 322.
(33) "Puddling" means the creation of a thin restrictive horizon atop and within an exposed soil surface by deposition of waterborne silt or clay-sized soil particles.
(34) "Repair area" means an area, either in its natural state or capable of being modified consistent with this administrative regulation, which is reserved for the installation of an additional lateral field and is not covered with permanent structures or impervious materials, consistent with this administrative regulation.
(35)
(a) "Residential septic tank effluent" means the liquid discharge having the constituency and strength typical of liquid discharges from a domestic household septic tank pretreatment unit that is generally considered to have waste strength values equal to or less than the following monthly averages:
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Twenty (20) mg/l of FOG;
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250 mg/l of BOD-5; and
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155 mg/l of TSS.
(b) Monthly average is equal to the sum of measurements taken over thirty (30) consecutive days, with at least six (6) measurements occurring on six (6) separate days, divided by the number of measurements taken during the thirty (30) day period.
(36) "Restrictive horizon" means a soil horizon relatively impervious to the movement of groundwater or effluent and includes:
(a) Mineralogically-cemented soil aggregates such as fragipans or iron pans;
(b) Naturally-formed structureless soils (massive structural grade);
(c) Naturally-formed horizontally structured soil (platy structure);
(d) Claypan, a compact, slowly permeable layer in the subsoil having a much higher clay content than the overlying material from which it is separated by a sharply-defined boundary. Clay pans are usually hard when dry and plastic and sticky when wet; or
(e) Structurally destroyed soils in which mechanical compression forces the plastic limit of the soil to be exceeded, such as traffic pans, plow plans, and compacted fill.
(37) "Rock" means the consolidated or partially consolidated mineral matter or aggregate, including weathered rock not exhibiting soil properties, and exposed at the surface or overlain by soil.
(38) "Sand" means a mineral soil separate consisting of particles between two (2) and 0.05 mm in diameter.
(39) "Seasonal high water table" means the upper level of a zone of soil and parent material saturation over restrictive horizons or the permanent water table.
(40) "Sewage" means blackwater, greywater, or a combination of blackwater and greywater wastes generated in a residential, commercial, institutional, or recreational facility.
(41) "Sewage pretreatment unit" is defined by KRS 211.970(9).
(42) "Silt" means a mineral soil separate consisting of particles between 0.05 mm and 0.002 mm in diameter.
(43) "Sinkhole" means a naturally occurring depression in soil or bedrock:
(a) Formed in a karst area by the removal of earth material from below the land surface;
(b) Circumscribed by a closed topographic contour; and
(c) Lacking a surface drainage outlet.
(44) "Sinkhole sideslope midpoint" means the line of equal elevation along the midpoint between the footslope and the shoulder slope.
(45) "Sinkhole throat" means an outlet for a sinkhole allowing runoff from the drainage basin of the sinkhole to flow directly into the ground.
(46) "Site" means an area or parcel of land, under the control of any person, on which an on-site sewage disposal system serving any structures or facilities is to be located.
(47) "Slope" means the deviation of the surface of the land from true horizontal, measured as the rise or fall in feet and inches from a fixed point to another point 100 feet distant, expressed as a percentage of slope.
(48) "Soil" means the naturally occurring unconsolidated mineral and organic material of the land surface consisting of:
(a) Sand, silt, and clay minerals;
(b) Variable amounts of organic materials; and
(c) Void areas between mineral and organic matter particles.
(49) "Soil absorption" means the movement of effluent into and through interconnected voids within the soil.
(50) "Soil compaction" means permanent damage to, or destruction of, natural soil structural features by mechanical compression or puddling that restricts or prevents natural air and water movement through the soil.
(51) "Soil horizon" means a layer of soil, soil material, rock fragments, and other unconsolidated material approximately parallel to the land surface and differing from adjacent genetically related layers in:
(a) Physical, chemical, and biological properties; or
(b) Characteristics such as:
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Color;
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Structure;
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Texture;
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Consistence; and
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pH.
(52) "Soil map" means a map showing the distribution of soil series or other soil mapping units in relation to the prominent physical and cultural features of the earth's surface.
(53) "Soil morphology" means the physical constitution, particularly the structural properties, of a soil profile as exhibited by the:
(a) Kinds, thickness, and the arrangement of the horizons in the profile; and
(b) Texture, structure, uniformity, and internal soil drainage of each horizon.
(54) "Soil series" means a basic unit of soil classification, consisting of soils that are essentially alike in all major profile characteristics.
(55) "Soil structure" means the combination or arrangement of individual soil particles into definable aggregates, or peds, which are characterized and classified on the basis of size, shape, and degree of distinctness.
(56) "Soil survey" means the systematic examination, description, classification, and mapping of soils in an area.
(57) "Soil tests" means tests and evaluations of soil morphology and land features required to complete a site evaluation for a proposed site.
(58) "Soil texture" means the relative proportions of sand, silt, and clay in a soil and may include particles greater than two (2) mm in diameter, such as gravel, cobblestones, flagstones, and chert.
(59) "Subdivision" means the separation of a parcel or tract of land into two (2) or more parcels or tracts for the purpose of development into residential, commercial, or public building sites.
(60) "Subsoil" means that part of the soil below the A horizon.
(61) "Subsurface soil treatment and dispersal system" means the portion of an on-site sewage disposal system that accepts effluent from a sewage pretreatment unit for further treatment by microbial, plant, and animal life within the soil, as well as treatment by filtration, chemical decomposition, and bonding within the soil, and consists of:
(a) Devices, components, and piping to:
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Transport effluent under pressure or by gravity flow; and
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Distribute the effluent to the soil absorption surfaces;
(b) Trenches, beds, chambers, mounds, lagoons, artificial marshes, separately or in combination, that form or enclose the soil absorption surfaces; and
(c) Rock, gravel, or other fill materials required within the system, including barrier materials, and fill soil within or over the system.
(62) "System replacement area" means a parcel of land under the control of an on-site system owner and reserved for system alteration, expansion, or replacement.
(63) "Textural class" means soil groupings based upon a specified range in texture.
(64) "Topsoil" means the A or Ap horizon as defined in the Soil Survey Manual, 1993, Soil Survey Division Staff, USDA Handbook No. 18, located at the Web site: nrcs.usda.gov/Internet/FSEDOCUMENTS/nrcs142p2050993.
(65) "TSS" means total suspended solids or a measure of solid material, including organic and inorganic, that are suspended or dissolved in wastewater, effluent, or water bodies and related to both specific conductance and turbidity.
(66) "Variance" means a waiver of certain specified requirements of this administrative regulation granted by the cabinet.
Section 2. Site Approval Procedures.
(1) Individual site approval procedures.
(a) A person seeking approval of an individual site for the installation of an on-site sewage disposal system or alteration of an existing lateral field shall submit:
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The required fee; and
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A completed application including a basic site plan drawing showing the:
a. Specific address or location of the site;
b. Site boundary lines and dimensions of the site;
c. Location of:
(i) Existing structures;
(ii) Sewage disposal systems;
(iii) Wells;
(iv) Ponds;
(v) Streams;
(vi) Easements;
(vii) Roads; and
(viii) Drives; and
d. Proposed or existing location of the structure to be served by the system and proposed system location.
(b) A person seeking approval shall establish an appointment time and date for the site evaluation if the person desires to be present during the evaluation.
(c) Property boundaries shall be clearly identified.
(d) If the site evaluation reveals that the applicable requirements of this administrative regulation are met, the area designated for system installation shall be clearly marked by the certified inspector or professional engineer using flags or other suitable, readily observable markers.
(e) The location of the designated area shall be recorded on a property drawing by showing distances to existing set points.
(f) The person seeking approval shall receive a copy of the:
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Site Evaluation Form including the overall evaluation rating;
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Drawing showing the location of the designated lateral field area; and
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Written requirements relative to site limitations.
(g) After the site evaluation has been conducted, a permit to construct, install, or alter an on-site sewage disposal system shall be obtained prior to construction of any portion of that system.
(h) An application for a construction permit shall be submitted and accompanied by a detailed drawing of the proposed system or alteration, including all necessary specifications, and required permit fees.
(i) A permit shall be issued only by a certified inspector and only to a certified installer or homeowner as provided in 902 KAR 10:110 and shall expire one (1) year from date of issuance unless an extension is granted by the cabinet.
(2) Subdivision approval procedures.
(a) A person seeking approval for a subdivision and for all existing subdivisions of record shall follow the procedures for approval established in subsection (1)(a), (b), and (c) of this section. Each individual lot or site shall be evaluated individually.
(b) If a site evaluation reveals that an individual on-site sewage disposal system is unapprovable due to site characteristics, the applicant shall be advised as to alternatives if available.
(c) If a cluster system is proposed, legal documents relative to ownership, operation, and maintenance of the system in perpetuity shall be submitted.
(d) A local health department may adopt more specific requirements for subdivision approval within its jurisdiction if not in conflict with this administrative regulation.
Section 3. Site Evaluation Standards.
(1) A certified inspector or professional engineer shall evaluate each proposed site. Pursuant to subsections (2) through (9) of this section, an official site evaluation form shall be completed classifying each factor as:
(a) SUITABLE (S);
(b) PROVISIONALLY SUITABLE (PS); or
(c) UNSUITABLE (U).
(2) Topography.
(a) Uniform slopes fifteen (15) percent or less shall be considered SUITABLE with respect to topography.
(b) Uniform slopes greater than fifteen (15) percent and up to and including thirty (30) percent shall be considered PROVISIONALLY SUITABLE with respect to topography.
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Slopes within this range may require installation of curtain drains, vertical drains, or other approved drainage methods upslope from the lateral field.
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Usable areas larger than normally required may be needed in this slope range.
(c) Slopes greater than thirty (30) percent shall be considered UNSUITABLE except slopes greater than thirty (30) percent may be classified as PROVISIONALLY SUITABLE if:
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The soil characteristics are classified as either SUITABLE or PROVISIONALLY SUITABLE to a depth of at least thirty (30) inches;
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Surface water run-off is diverted around the lateral field;
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Groundwater or perched water table flow is intercepted and diverted through:
a. Curtain drains;
b. Vertical drains; or
c. Other approved drainage methods; and
- There is sufficient ground area available to install the on-site sewage disposal system with approved modification.
(d) Complex slope patterns and slopes dissected by gullies and ravines shall be considered UNSUITABLE with respect to topography.
(3) Landscape position.
(a) Convex hill or ridge tops, shoulder slopes, and side slopes shall be considered SUITABLE with respect to landscape position.
(b) Convex foot slopes and natural terraces shall be considered PROVISIONALLY SUITABLE with respect to landscape position.
(c) Concave hill or ridge tops, shoulder, side, foot, and toe slopes, drainageways, depressions, and terraces may be considered PROVISIONALLY SUITABLE if:
-
The soil characteristics are classified as either SUITABLE or PROVISIONALLY SUITABLE;
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Surface water run-off is diverted around the lateral field; and
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Groundwater flow is intercepted and diverted through curtain or vertical drains.
(d) If the provisions in paragraph (c) of this subsection cannot be met, the landscape position shall be classified UNSUITABLE.
(e) An area closer than seventy (70) feet to an open sinkhole throat, downslope from the sinkhole sideslope midpoint, or an area subject to flooding damage shall be considered UNSUITABLE with respect to landscape position.
(4) Soil characteristics or morphology.
(a) Backhoe pits may be required for site evaluation.
-
If backhoe pits are not required, at least four (4) soil borings shall be taken in the area to be used for lateral fields.
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Backhoe pits or borings shall be excavated to a depth of forty-two (42) inches or as required to determine the soil characteristics.
(b) Each excavated test hole or pit shall be backfilled to grade upon completion of the soil evaluation.
(c) Soil boring cores or exposed soil horizons in backhoe pits shall be evaluated and a determination made as to the suitability of the soil to treat and disperse effluent. Evaluation of soil characteristics shall be performed according to procedures established by the Soil Survey Manual, 1993, Soil Survey Division Staff, USDA Handbook No. 18, as follows:
- Texture. The texture of the different horizons of soils may be classified into four (4) general groups:
a. SOIL GROUP I - sandy texture soils containing more than seventy (70) percent sand-sized particles in the soil mass. These soils are usually without sufficient clay to be cohesive. The sandy group includes the sand and loamy sand soil textural classes and shall generally be considered SUITABLE with respect to texture.
b. SOIL GROUP II - coarse loamy texture soils containing no more than twenty-seven (27) percent clay-sized particles in the soil mass. They exhibit slight or no stickiness. The coarse loamy group includes sandy loam and loam soil textural classes and shall generally be considered SUITABLE with respect to texture.
c. SOIL GROUP III - fine loamy texture soils containing less than forty (40) percent clay-sized particles in a soil mass. They exhibit slight to moderate stickiness. The fine loamy group includes sandy clay loam, silt, silt loam, clay loam, and silty clay loam textural classes and shall generally be considered PROVISIONALLY SUITABLE with respect to texture.
d. SOIL GROUP IV - clayey texture soils contain forty (40) percent or more clay-sized particles and include sandy clay, silty clay, and clay.
(i) Soil materials with 1:1 kaolinitic or mixed mineralogy clays shall generally be considered PROVISIONALLY SUITABLE as to texture.
(ii) Soil materials with 2:1 clays and montmorillonitic mineralogy shall generally be considered UNSUITABLE as to texture.
(iii) Soil mineralogy information may be obtained from proper soil classification and correlation of the site by soil mapping or by laboratory tests listed in the Soil Survey Laboratory Methods Manual, 1996, National Soil Survey Center, NRCS-USDA, Soil Survey Investigations Report No. 42, located at the Web site: nrcs.usda.gov/Internet/FSEDOCUMENTS/stelprdb1253872.
e. The soil texture shall be estimated by field testing. Laboratory estimation of texture by particle-size analysis may be substituted for field testing if conducted in accordance with approved standard procedures such as those listed in the Soil Survey Laboratory Methods Manual, 1996, National Soil Survey Center, NRCS-USDA, Soil Survey Investigations Report No. 42, at the property owner's expense;
- Structure. The four (4) kinds of soil structure most significant in movement of sewage effluent through soils are:
a. Block-like soil structure - block-like soil structure shall be considered PROVISIONALLY SUITABLE. Some rocks even though weathered, such as shales or creviced or fractured rocks, exhibit block-like structure. Rock shall be considered UNSUITABLE as to structure;
b. Prismatic soil structure - prismatic soil structure is generally considered PROVISIONALLY SUITABLE unless it is associated with fragipans, which shall be considered UNSUITABLE;
c. Platy soil structure - if Group II, III, and IV soils fall out into plate-like sheets, then the soil would have platy structure which shall be considered UNSUITABLE; and
d. Absence of soil structure - soils that are massive or single grain and exhibit no structural aggregates shall be considered UNSUITABLE.
(5) Internal soil drainage.
(a) Internal soil drainage characteristics shall be determined by comparison of moist soil samples collected throughout the soil profile to a minimum depth of forty-two (42) inches to standard Munsell notation soil color charts to establish color hue, value, and chroma with:
-
Observation of soil profile for evidence of chroma 2 or less, with or without mottling, characterized as to abundance and contrast; or
-
Observation of freestanding water table.
(b) Soils exhibiting colors or mottling of greater than chroma 2 with no freestanding water table to a depth of forty-two (42) inches shall be considered SUITABLE with respect to internal drainage if soil texture and structure are classified as either SUITABLE or PROVISIONALLY SUITABLE.
(c) Soils exhibiting colors or mottling of chroma 2 or less or freestanding water table starting at a depth of less than forty-two (42) inches but greater than or equal to twenty-four (24) inches shall be considered PROVISIONALLY SUITABLE with respect to internal drainage if soil texture and structure are classified SUITABLE or PROVISIONALLY SUITABLE.
(d) Soils exhibiting colors or mottling of chroma 2 or less or freestanding water table at a depth of less than twenty-four (24) inches may be classified as PROVISIONALLY SUITABLE, if:
-
Soil texture and structure are classified SUITABLE or PROVISIONALLY SUITABLE; and
-
Curtain drains, vertical drains, or other approved methods are installed to intercept lateral water movement, or to lower and maintain the freestanding water table level to a depth of greater than twenty-four (24) inches.
(e) Soils exhibiting colors or mottling of chroma 2 or less or freestanding water table at a depth of less than twenty-four (24) inches that cannot meet the criteria listed in paragraph (d)1. of this subsection shall be considered UNSUITABLE.
(6) Soil depth.
(a) Presence of bedrock or large flagstones, also known as floaters, shall be determined by probing the site and through direct observation of the soil profile. Soil depth shall be considered the vertical distance from the existing ground surface to:
-
Solid, fractured, or rippable bedrock;
-
Weathered parent material; or
-
Large flagstones that occupy more than thirty (30) percent of the exposed soil profile.
(b) Soil depths forty-two (42) inches or greater shall be considered SUITABLE as to depth.
(c) Soil depths less than forty-two (42) inches, but at least twenty-four (24) inches, shall be considered PROVISIONALLY SUITABLE as to depth.
(d) Soil depths less than twenty-four (24) inches shall be classified UNSUITABLE as to depth.
(e) If special system design and installation modifications can be made to provide at least eighteen (18) inches of undisturbed naturally occurring soil between the bottom of the lateral field, the soils may be reclassified PROVISIONALLY SUITABLE as to depth.
(7) Restrictive horizons.
(a) Soils in which restrictive horizons are at forty-two (42) inches in depth or greater shall be considered SUITABLE.
(b) Soils in which restrictive horizons are at depths less than forty-two (42) inches, but at least twenty-four (24) inches, shall be considered PROVISIONALLY SUITABLE.
(c) Soils in which restrictive horizons are at depths less than twenty-four (24) inches may be classified PROVISIONALLY SUITABLE if special system design and installation modifications can be made to provide at least eighteen (18) inches of undisturbed naturally occurring soil between the bottom of the lateral field and the restrictive horizon.
(d) Soils in which restrictive horizons are at depths less than twenty-four (24) inches, which cannot meet the provisions in paragraph (c) of this subsection, shall be considered UNSUITABLE.
(8) Available space.
(a) Sites that have two (2) times the usable land area required to permit the installation of an approved on-site sewage disposal system, in addition to the land area to be occupied by existing or proposed structures or other natural or manmade features of the site that are not compatible with system installation shall be classified SUITABLE as to available space.
(b) Sites that have the usable land area required to permit the installation of an approved on-site sewage disposal system and the usable land area required to permit the installation of an equivalent approved system, in addition to the land area to be occupied by existing or proposed structures or other natural or manmade features of the site that are not compatible with system installation, shall be classified PROVISIONALLY SUITABLE as to available space.
(c) All other sites shall be classified UNSUITABLE as to available space.
(9) Determination of overall site suitability. The criteria in subsections (2) through (8) of this section shall be SUITABLE, PROVISIONALLY SUITABLE, or UNSUITABLE as indicated. If all criteria are classified the same, that classification shall prevail. If there is a variation in classification of the several criteria, the lowest classification shall determine the overall site classification.
(a) Topography classified as UNSUITABLE may be reclassified PROVISIONALLY SUITABLE under the provisions of subsection (2) of this section.
(b) If the landscape position, soil texture, soil structure, internal drainage, or depth to restrictive horizon is classified as UNSUITABLE and cannot be reclassified as PROVISIONALLY SUITABLE through modification, the overall classification shall be UNSUITABLE regardless of the other criteria unless the provisions of Section 4(6) of this administrative regulation are met.
(c) Soil depth classified as UNSUITABLE may be reclassified as PROVISIONALLY SUITABLE under the provisions of subsection (6)(e) of this section.
Section 4. Site Classification and System Restrictions.
(1) Restrictions shall be placed upon on-site sewage systems approved for use due to site limitations or daily waste load volume. The restrictions shall be determined by the conditions established in subsections (2) through (7) of this section, and the modified or alternative system listed shall be considered as the minimum acceptable.
(2) A site with an overall evaluation rating of SUITABLE, a conventional subsurface soil treatment, and dispersal system twenty four (24) inches deep shall not be permitted without the approval of the local health department or the Department for Public Health.
(3) A site with an overall rating of PROVISIONALLY SUITABLE due to:
(a) Depth to rock, water table, or restrictive horizon.
-
Twenty-four (24) inches but less than forty-two (42) inches - a six (6) to twenty-three (23) inch deep modified conventional trench, or other approved system with a minimum separation distance of eighteen (18) inches between trench bottoms and rock, water table, or restrictive horizon. A minimum separation distance of twelve (12) to eighteen (18) inches between trench bottoms and rock, water table, or restrictive horizon may be considered with additional approved treatment technology.
-
Eighteen (18) inches to less than twenty-four (24) inches:
a. A mound system;
b. Other approved system that maintains a minimum separation distance of eighteen (18) inches between trench bottoms and rock, water table, or restrictive horizon; or
c. Sufficient filling of the area with suitable soil to allow installation of a modified or alternative system after a one (1) year settling period.
- A minimum separation distance of twelve (12) to eighteen (18) inches between trench bottoms and rock, water table, or restrictive horizon may be considered with additional approved treatment technology such as:
a. Peat filter systems;
b. Sand filter systems;
c. Aerobic units;
d. Drip irrigation systems;
e. Two (2) tanks in a series;
f. Dual compartment septic tanks;
g. Approved effluent filters; or
h. Constructed wetlands cells.
- Less than eighteen (18) inches - filling of the area with suitable soil to sufficient depth to allow modified or alternative system installation after a one (1) year settling period. A minimum separation distance of eighteen (18) inches between trench bottoms and rock, water table, or restrictive horizon shall be maintained on a fill and wait system.
(b) Soil texture or structure.
-
Soil Group III - any approved system.
-
Soil Group IV - a conventional trench system modified by the use of additional pretreatment as established in Section 6(2) of this administrative regulation.
a. The system may be required to be modified by:
(i) The use of alternating lateral fields;
(ii) Dosing tank and pump or siphon;
(iii) Dosed alternating lateral fields;
(iv) Dosed automatic alternating lateral fields;
(v) The use of an LPP system;
(vi) By a lagoon and lateral field system; or
(vii) Other systems approved by the cabinet for use in Group IV textured soil.
b. Gravity flow distribution systems in this soil group shall use equal flow distribution boxes only.
(4) If available space for the installation of an approved system is inadequate:
(a) Installation of permanent one and six-tenths (1.6) gallon or less low-volume flush water closets or nonwater carriage toilet devices shall be required; and
(b) As much lateral footage of the most space efficient approved system, but no less than fifty (50) percent of the required minimum lateral footage for that system, discharging into a holding tank that is at least equal in capacity to the required pretreatment unit shall be required.
(5) If a PROVISIONALLY SUITABLE rating was obtained, which may be affected by a combination of site limitations, the on-site system, whether conventional, modified, or alternative, which shall overcome all limitations involved shall be installed.
(6) A site classified as UNSUITABLE may be used for on-site sewage disposal systems if engineering, hydrogeologic, and soil studies indicate to the cabinet that a suitable on-site sewage disposal system can reasonably be expected to function satisfactorily. The site may be reclassified as PROVISIONALLY SUITABLE upon submission to the cabinet of adequate substantiating data to indicate that:
(a) An on-site sewage disposal system may be installed so that the effluent shall receive adequate treatment and proper disposal;
(b) The effluent shall not contaminate any drinking water supply, groundwater, perched water, or surface water;
(c) The effluent shall not be exposed on the ground surface.
(7) A site originally classified as UNSUITABLE due to soils that have been structurally damaged may be upgraded to PROVISIONALLY SUITABLE if:
(a) Structural damage shall be limited to a maximum depth of six (6) inches from the original ground surface;
(b) Trench depth at least six (6) inches deeper than the damaged layer;
(c) Required vertical separation distances to rock, water table, or other restrictive horizons shall be maintained;
(d) Soil rectification shall be performed using one (1) of the following methods:
-
Mechanical renovation with a chisel plow or other similar device if damaged soil is adequately improved by lifting from two (2) inches below the damaged layer; or
-
Removal of damaged soil and replacement with a Group III or better soil with a SUITABLE or PROVISIONALLY SUITABLE structure; and
(e) A certified inspector reevaluates following soil rectification and prior to system installation.
Section 5. Approval of Consultants.
(1) The cabinet may grant limited approval to an eligible individual to perform tentative site evaluations only for proposed subdivisions for which on-site sewage disposal systems are intended.
(a) Individuals eligible for approval as consultants shall include:
-
Professional engineers;
-
Registered architects;
-
Soil scientists;
-
Professional geologists; and
-
Certified inspectors whose certifications have not been suspended or revoked.
(b) The cabinet may require attendance at training seminars and competency testing as a condition of maintaining approved status.
(2) To be eligible for approval as a consultant, the individual shall possess a valid professional registration, license, certificate, or other similar document, issued by the respective profession's registration, licensure, or certification board, agency, committee, or other body recognized by the state of Kentucky.
(3) If suspension or revocation proceedings are initiated by the cabinet in accordance with KRS 211.360(3), the certified individual may request a hearing before the cabinet in accordance with KRS 211.360(4) to present evidence on his behalf as to why the intended action should not be taken.
(4) If the cabinet has suspended or revoked certification for cause, the cabinet shall provide notification to the appropriate professional body with which the person affected is registered, licensed, or certified.
Section 6. System Sizing Standards.
(1) Design waste flows. Daily waste flow volumes for system design and sizing purposes shall be computed for each residential unit, business or commercial facility, or other public facility based upon the design flow per designated flow unit listed in Table 1 multiplied by the number of flow units involved.
(a) If approved permanent nonwater carriage water closet type devices, such as composting, incinerator, or oil carriage toilets, are installed exclusively in a residence, the daily design waste flow unit for that specific residence may be reduced to the amount in Table 1, Column B.
(b) If an approved greywater system is installed so that all greywater is separated from the onsite sewage disposal system and no other greywater type wastes are created, the daily design waste flow for the onsite sewage disposal system for that specific residence may be reduced to the amount in Table 1, Column B.
(c) If a residence meets the criteria of paragraphs (a) and (b) of this subsection, the design daily waste flow for onsite sewage disposal system for that residence may be reduced to the amount in Table 1, Column C.
(d) A daily waste flow unit reduction shall not be granted for installation of nonpermanent flow reduction devices, such as showerheads, showerhead or faucet inserts, suds-saver type automatic washing machines, or other similar devices. Use of water saving devices, such as low-volume flush water closets, may be required by the cabinet if necessary due to site limitations.
(e) An on-site sewage system that receives a design daily waste flow of 2,000 gallons or more shall be designed to provide dosing of the lateral field through the use of dosing tanks and pumps or siphons, or through the installation of an LPP system.
(f) An applicant proposing to use an on-site sewage disposal system for a nonresidential source of sewage shall provide the following information to the cabinet:
-
Data to show the sewage does not contain industrial wastewater;
-
Data to establish the potential sewage strength and to identify chemicals found in the sewage that are not typically found in residential sewage; and
-
A design to provide pretreatment of the sewage to at least residential septic tank effluent quality.
(g) The following businesses or facilities shall not be approved for disposal of waste waters into an on-site sewage disposal system due to the nature of the wastes generated or the high volume of wastewater created:
-
Laundromats, except on an experimental basis as provided under subsection (16) of this section;
-
Car washes;
-
Kill room wastes from livestock slaughterhouses;
-
Embalming wastes from funeral parlors or mortuaries; and
-
Industrial or process wastes from factories.
(2) Residential pretreatment units. A septic tank in a single-family residence on-site sewage disposal system shall meet the minimum working liquid capacities in paragraphs (a) to (c) of this subsection, based on the number of bedrooms involved. An aerobic or other type of approved pretreatment unit shall be sized according to its rated treatment capacity in gallons per day, based upon the design daily waste flow per design unit given in Table 1.
(a) On a Soil Group IV site, additional pretreatment shall be provided by use of one (1) of the following methods:
-
Installation of multiple septic tanks in series. The first tank receiving raw sewage from the residence shall be of the required minimum capacity in Table 2. Additional tanks shall be installed in series as needed to provide a total capacity equal to the required minimum plus an additional fifty (50) percent;
-
Installation of an aerobic pretreatment unit. An aerobic unit that does not include an integral trash or primary settling chamber in its construction shall be provided by the series installation of a minimum 1,000 gallon septic tank to receive raw sewage, with effluent discharging into the aerobic unit;
-
Installation of multiple compartment septic tanks. The first compartment receiving raw sewage from the residence shall be of the required minimum capacity in Table 2. The second compartment shall have a total capacity equal to at least fifty (50) percent of the first compartment; or
-
Permanent installation of effluent filters. The effluent filter shall be a maximum screen size of one-sixteenth (1/16) inch and shall be installed either inside or following a properly-sized septic tank. Access to filters shall be provided to finished grade.
(b) Subsurface flow constructed wetlands on-site sewage disposal systems shall include one (1) of the following pretreatment options:
-
Two (2) septic tanks in series and an approved commercial-sized filter located at the outlet end of the second tank;
-
A two (2) compartment septic tank and an approved commercial-sized filter located at the outlet end of the second compartment; or
-
An aerobic unit and an approved commercial-sized filter installed internally or externally on the outlet pipe.
(c) A pretreatment unit for subsurface flow constructed wetlands shall be sized the same as a pretreatment unit for Group IV textured soil.
(d) If required minimum tank capacities for residential systems exceed 1,000 gallons and larger capacity tanks are unavailable, serial installation of multiple tanks is permitted to obtain the necessary capacity. The first tank in series shall have a minimum capacity of 1,000 gallons.
(3) Commercial and public facility pretreatment units.
(a) Minimum working liquid capacities for a septic tank for a commercial or public facility on-site sewage disposal system shall be determined by multiplying the daily design waste flow per unit times the total number of units, plus an additional fifty (50) percent of that figure for solids storage: (Gallons/unit/day X Number of Units) + 50% = MINIMUM CAPACITY REQUIRED.
(b) Commercial facility system installation shall be subject to procedures and requirements established in subsection (2) of this section relative to:
-
Sites with soils in Soil Group IV;
-
Subsurface flow constructed wetlands;
-
Aerobic and other types of pretreatment units; and
-
Use of multiple tanks in series to obtain required capacity.
(c) An establishment with food preparation or food processing facilities shall install adequately designed and approved pretreatment units to reduce FOG, BOD-5, and TSS to a level typically found in residential septic tank effluent. The applicant shall be required to submit data from comparable facilities to determine the establishment's potential effluent strength.
(d)
-
A commercial or public facility engaged in the manufacture, processing, preparation, or service of food or food products shall use an approved grease trap.
-
Wastewater drain piping from food processing equipment; sinks for washing of food, equipment and utensils; dishwashers; and floor drains in food preparation and processing areas shall be separated from other wastewater piping and shall discharge into a grease trap prior to entrance into an on-site sewage disposal system.
-
Grease trap capacity shall be a minimum of 500 gallons for daily waste flows of 6,000 gallons or less and 1,000 gallons for daily waste flows greater than 6,000 gallons.
-
A grease trap shall be placed outside of the structure and shall be located as close as practicable to the source of the wastewater to prevent separation of grease prior to entry into the grease trap.
(4) Sizing of gravity distribution lateral fields. Gravity distribution lateral fields for an on-site sewage disposal system shall be sized based upon the design daily waste flow for the residence, commercial or public facility involved, as determined from Table 1. The total daily waste flow multiplied by the linear footage requirement per gallon found in Table 3 for the specific site soil characteristics shall determine the minimum linear footage of lateral trench required.
(5) Sizing of LPP distribution lateral fields. LPP distribution lateral fields for on-site sewage disposal systems shall be sized based upon the calculated total design daily waste flow for the residence, commercial, or public facility involved, as determined from Table 1. The total daily waste flow divided by the allowable daily loading rate found in Table 4, for the specific site soil characteristics, shall determine the minimum square footage of absorption area required.
(6) Sizing of gravelless pipe systems.
(a) Gravelless pipe in eight (8) and ten (10) inch internal diameter sizes may be used in lieu of standard lateral trenches for conventional and modified conventional lateral field applications.
(b) Linear footage requirements listed in Table 3 shall apply to gravelless pipe.
(c) Gravelless pipe shall not be permitted in Group IV textured soils.
(7) Sizing of gravity distribution lateral beds. If lateral beds are permitted in lieu of standard two (2) foot wide lateral trenches, the required total length of standard lateral trench shall be calculated from Tables 1 and 3 information. That figure shall be multiplied by the percentage shown on Table 5 for the bed width intended for use. The number of linear feet resulting shall be the amount required for installation for that particular bed width.
(8) Sizing of leaching chamber systems. Leaching chamber systems may be used in lieu of standard lateral trenches. Linear footage requirements for chambers shall be based on nominal internal chamber width as follows:
(a) In trench configuration – for nominal widths of:
-
Fifteen (15) to twenty-one (21) inches, 100 percent of Table 3;
-
Twenty-two (22) to twenty-seven (27) inches, seventy (70) percent of Table 3;
-
Twenty-eight (28) to thirty (30) inches, sixty (60) percent of Table 3;
-
Thirty-one (31) to thirty-six (36) inches, fifty-five (55) percent of Table 3;
-
Thirty-seven (37) to forty-one (41) inches, fifty (50) percent of Table 3; and
-
Forty-two (42) to forty-four (44) inches, forty-five (45) percent of Table 3;
(b) In bed configuration - for chamber widths eighty-five (85) percent of Table 5 linear footage requirements based on total bed width to nearest foot; and
(c) Other chamber designs including those with nominal widths outside the ranges listed in paragraph (a) of this subsection shall be sized on a case-by-case basis to allow for technological advancements.
(9) Sizing of gravity distribution alternate lateral fields or beds. If alternate gravity distribution lateral fields or beds are used, the individual alternate lateral fields or beds shall each contain one-half (1/2) of the total linear footage required for the system and shall be alternated in use on a yearly basis by use of an approved alternating valve or device.
(10) Sizing of dosed gravity distribution automatic alternating lateral fields or beds.
(a) If dosed automatic alternating lateral fields or beds are used, the individual alternating lateral fields or beds shall each contain one-half (1/2) of the total linear footage required for the system.
(b) Dosed automatic alternating lateral field or bed systems shall be designed and operated so as to alternate between lateral fields or beds with doses of effluent, by two (2) or more dosing siphons or pumps controlled by an automatic alternating device or by simultaneous dosing.
(11) Sizing of combination evaporation-absorption lagoon and lateral field systems.
(a) On sites with Group IV soils where a conventional lateral field system or alternative system cannot be installed due to heavy clay soils with poor or no structure conditions, a combination evaporation-absorption lagoon and shallow lateral field system may be considered for installation.
(b) Total daily waste flow shall be determined by using Table 1 and the total square footage of lagoon waste surface area shall be calculated by multiplying the total gallons of waste flow per day by five (5) square feet per gallon.
(c) Effluent entering the lagoon shall have passed through a properly sized pretreatment unit according to the provisions of Table 2 and subsection (3)(a) of this section.
(d) The overflow from the lagoon shall be directed to an approved lateral field according to the provisions of Section 4 of this administrative regulation. Lagoon overflow lateral field size for two (2) foot wide gravel field trenches shall be calculated by multiplying the total daily waste flow in gallons by one-tenth (.10) linear feet per gallon.
(12) Sizing of mound systems.
(a) Mound systems shall be designed and sized based upon the information and criteria given in the United States Environmental Protection Agency publication EPA 625/1-80-012 Design Manual, On-site Wastewater Treatment and Disposal Systems," Chapter 7.2.4 on Mound Systems, located at the Web site: nepis.epa.gov/Exe/ZyPDF.cgi/300043XO.PDF?Dockey=300043XO.PDF, and may require soil permeability testing if necessary.
(b) All mound systems shall use pressure distribution of effluent in the absorption area.
(c) Mound fill material shall be coarse ASTM C-33 sand that meets the following criteria:
-
Less than twenty (20) percent, by weight, greater than two (2) mm in diameter; and
-
Less than five (5) percent, by weight, less than 0.053 mm in diameter.
(d) The design loading or filtration rate shall be one (1.0) gpd/sq.ft. for residential septic tank effluent.
(e) The sand fill material shall not be included in the measurement of the vertical separation distance between the absorption area and a:
-
Restrictive horizon;
-
Rock; or
-
Water table.
(13) Sizing of subsurface flow constructed wetlands systems.
(a) Constructed wetlands cells shall contain a minimum of one and three-tenths (1.3) cubic feet of fill material for each one (1) gallon of total daily waste flow.
(b) Total interior square footage shall be based on one and three-tenths (1.3) cubic feet per one (1) gallon of total daily design wasteflow; if twelve (12) inches of fill material is used, then the square footage equals the cubic footage.
(c) The length to width ratio of the cell shall range between three (3) to one (1) and five (5) to one (1) for gravity flow.
(d) The length to width ratio for pressure distribution shall be determined based on system size and available installation area.
(e) The overflow lateral field footage shall be calculated by using fifty (50) percent of the standard sizing for the chosen type of system, and all approved lateral field types shall be acceptable.
(14) Sizing of drip treatment and disposal systems. Drip treatment and disposal systems shall be:
(a) Designed and sized based upon the information contained in Drip Irrigation Treatment and Disposal System Design Standards;
(b) Installed in a location in which the county or district board of health has adopted an Operation and Maintenance Ordinance; and
(c) Approved for inspection upon receipt of a Declaration of Covenants, Conditions, and Restrictions form completed by the prospective owner and incorporated into the property deed in order to inform future owners.
(15) Sizing of residential greywater waste systems. If greywater is to be separated from the blackwater sewer, the separation shall be accomplished as established in paragraphs (a) through (e) of this subsection.
(a) Greywater shall be separated from the main house sewer.
(b) A residential greywater waste system shall be installed according to the results of the site evaluation of the greywater installation area and:
-
A septic tank is not required for a greywater waste system;
-
A distribution device is not required for the greywater waste system;
-
A twelve (12) inch separation from the bottom of the greywater absorption system to rock, water table, or restrictive horizon is allowed;
-
Cover over the greywater absorption waste system shall prevent ponding or surfacing of greywater;
-
A valve shall be installed to divert greywater back into the onsite sewage disposal system, except in a laundry greywater system;
-
The system shall have 100 percent system replacement area available;
-
The minimum setback distances listed in Table 7 shall apply to the greywater absorption area;
-
The system shall accept domestic type flows with the consistency and strength typical of greywater from domestic households, the source being:
a. Bathing;
b. Showering;
c. Washing clothes; or
d. Laundry sinks;
- The system shall not contain water used to wash materials soiled with:
a. Human excreta;
b. Infectious substances;
c. Cleaning chemicals other than soap;
d. Water softener backwash; or
e. A hazardous household product; and
- Greywater shall not be applied directly to the surface of the ground or above grade without receiving written approval from the Energy and Environment Cabinet.
(c) Sizing of the absorption area shall be based on fifty-five (55) gallons per day per bedroom and the Application Rate in Table 3 to calculate the total area of the bottom of the absorption designs except in a laundry greywater system.
(d) For only a laundry greywater system, the sizing shall be based on fifteen (15) percent of total daily waste flow and the Application Rate in Table 3 to calculate the total area of the bottom of the subsurface absorption designs.
(e) On a new system installation permitting laundry wasteflow separation:
-
For Soil Groups I to III, a fifteen (15) percent reduction in the primary system lateral field requirement shall be allowed; and
-
For Soil Group IV, a system size reduction shall not be allowed.
(16) The cabinet shall size an experimental or alternative system not covered by this administrative regulation, based upon:
(a) Site characteristics;
(b) Effluent characteristics;
(c) Pretreatment processes;
(d) Technology used; and
(e) Other demonstrable factors.
(17) Sizing of dosing tanks. Dosing tanks shall be of sufficient capacity to hold:
(a) Two (2) times the total design daily waste flow calculated from Table 1; or
(b) One (1) times the total design daily waste flow calculated from Table 1 with the requirements established in subparagraphs 1. through 3. of this paragraph
-
Dual alternating pumps shall be utilized and the pumps automatically alternate each pump cycle.
-
Dual pumps shall be controlled with an automatic override so that in the event one (1) pump fails, the other shall automatically take over until the failed pump can be replaced.
-
A pump failure alarm shall be installed so that in the event one (1) pump fails, the alarm is activated and the failed pump shall be replaced as soon as possible.
(18) Use of holding tanks.
(a) A holding tank shall be permitted only:
-
If written official verification is submitted to the cabinet that a municipal sewer system shall be available within a two (2) year period;
-
If a commercial or public facility has a daily wasteflow of less than 200 gallons per day;
-
During a one (1) year waiting period for soil to settle in an area that has been filled with topsoil, in accordance with Section 7(5) of this administrative regulation;
-
To repair an existing septic system if no other means of repair is available;
-
To expand an existing system for a single family residence if no other means of expanding the system is available; or
-
In accordance with Section 4(4)(b) of this administrative regulation.
(b) If a holding tank is permitted:
-
Water closets with flush volume of one and six-tenths (1.6) gallons or less shall be installed;
-
An audible and visible alarm system shall be installed:
a. Within the structure served; or
b. In a high pedestrian traffic area within sight of the structure served;
-
The applicant shall submit with the permit application a copy of a contract with a licensed septic tank cleaning company or other management entity for servicing the holding tank and shall thereafter maintain servicing records available for cabinet inspection; and
-
The local health department may require the owner to post a cash performance bond.
(19) Sizing of holding tanks. Holding tanks shall be sized as established in paragraphs (a) and (b) of this subsection.
(a) Holding tanks installed to repair an existing system, as an addition to a new system, or added to expand an existing system shall be sized the same as the required pretreatment unit.
(b) All other holding tanks shall be sized to hold a minimum seven (7) days wasteflow for the structure served.
Section 7. System Installation Standards.
(1) System layout standards.
(a)
-
A system shall be designed, laid out, and installed in the designated area set aside during the site evaluation, and installation of the system in any other area is prohibited without the written consent of the local health department certified inspector.
-
If the markers used to designate the system area cannot be identified, the certified inspector or professional engineer who conducted the site evaluation shall revisit the property to reestablish the original designated area and confirm that it has not been altered.
-
Layout of the system on the site by the certified installer shall be accomplished by using suitable stakes or markers to locate excavation sites for system components, and shooting of surface grades to establish necessary excavation depths to assure proper elevation "fall" in the system.
-
Lateral trenches or beds shall be laid out to follow parallel to the surface contour lines of the site.
(b)
-
Maximum length for individual lateral trenches or beds for gravity distribution systems shall be no more than 200 feet.
-
Maximum length for individual lateral trenches in LPP systems shall be seventy (70) feet.
(c) Individual lateral lines or beds receiving effluent from an equal flow distribution box shall be of equivalent size within ten (10) percent of the longest line or bed.
(d)
-
Lateral trenches, and leaching chambers two (2) feet wide or less, for gravity distribution systems shall be spaced a minimum of eight (8) feet on centers;
-
Lateral trenches for LPP systems shall be spaced a minimum of five (5) feet on centers;
-
Lateral beds, and leaching chambers greater than two (2) feet wide, for gravity distribution systems shall be spaced a minimum of eight (8) feet from side wall to side wall;
-
Spacing shall be increased two (2) feet on all sites with slopes greater than fifteen (15) percent and up to and including twenty (20) percent; and
-
On slopes greater than twenty (20) percent, each five (5) percent increase in slope, or fraction thereof, shall require an additional spacing of two (2) feet for lateral trenches.
(e) Lateral line spacing in gravity distribution bed systems shall be as established in subparagraphs 1. through 3. of this paragraph.
-
For beds of four (4) to six (6) feet in width, one (1) lateral line shall be placed on the centerline of the bed.
-
For beds of seven (7) to ten (10) feet in width, two (2) lateral lines shall be spaced two and one-half (2 1/2) feet from the side walls.
-
For beds eleven (11) feet and wider, the two (2) lateral lines shall be spaced two and one-half (2 1/2) feet from the side walls, and additional lateral lines shall be installed five (5) feet on centers, or fraction thereof, from the side wall laterals.
(2) Excavation standards.
(a) Only equipment necessary to the installation of an on-site sewage disposal system shall be permitted in the designated area set aside for that system. Equipment shall be operated so as to minimize travel over and soil compaction of the system area.
(b) Excavation of the lateral field, bed, or other subsurface soil absorption system portion of the total system area shall be restricted by the soil moisture conditions of that portion of the area at the intended depth of excavation for all soil texture classes.
-
Soil moisture conditions shall be determined by test excavation to the intended depth of the lateral trenches or beds.
-
A small portion of soil excavated from that depth shall be rolled between the thumb and fingers. If the soil can be rolled into a "wire" shaped form which does not easily crumble, the soil is too wet to work and will compact and seal absorption surfaces. If a "wire" form cannot be rolled and the soil crumbles, excavation can proceed.
(c) Excavation for septic tanks or other pretreatment units, distribution boxes, alternating valves or devices, and all nonperforated piping used to conduct effluent to other components through gravity flow means shall be done only after shooting of grades to assure a positive gradient from the outlet of the pretreatment unit through all components to the distribution box or device. The determinations of grade shall take into account the intended excavation depth from grade of lateral trenches or beds.
(d)
-
Excavations for placement of all components shall be made to the necessary depth for installation and shall be dug level in undisturbed earth.
-
If filling is required to level or raise components to the proper grade, except for lateral trenches or beds, tamped gravel, sand, or compacted soil shall be used for bedding purposes.
-
If installation occurs in stony areas, large stones, flagstones, and boulders shall be removed from the component placement excavations to prevent component damage and the cavities created by their removal shall be filled with tamped gravel, sand, or compacted soil if they are located on the bottom surface of the excavation.
(e)
-
Excavations for lateral trenches or beds shall be made to the depth specified by the site evaluation results.
-
Maximum trench or bed depth from grade for an on-site sewage treatment and dispersal system shall be twenty-four (24) inches.
-
Minimum trench or bed depth for modified gravity and dosed gravity distribution systems shall be six (6) inches from grade.
-
Minimum trench depth for LPP systems shall be six (6) inches from grade.
-
Trench width for LPP systems shall be a minimum of twelve (12) inches.
-
Minimum trench width for gravelless pipe shall be eighteen (18) inches to a maximum of twenty-four (24) inches.
-
Minimum or maximum trench width shall be as per manufacturer's specifications for leaching chambers, but in no instance shall the trench width exceed the chamber width by more than eight (8) inches.
(f) Lateral trench and bed bottom grades shall be as established in Table 6:
(g)
-
Excavations for curtain drains or vertical drains to intercept or lower groundwater tables shall be made to the depth determined by the site evaluation.
-
Curtain drain excavations shall maintain the required depth in all parts upgrade from the lowest lateral line and then be graded to drain to the surface or to a pumped catchment basin.
-
Vertical drain excavations shall encircle the entire soil absorption field area.
-
Pretreatment units may be included within the curtain drained or vertical drained area.
(h)
-
Excavations for distribution leaders or nonperforated pipe from a distribution box on gravity distribution systems shall be made so as to provide a "benched" distribution corridor above the trench or bed bottom.
-
This "benched" corridor shall be bedded in undisturbed earth, and shall be excavated so as to provide a "bench" height of six (6) inches above the elevations of the trench or bed bottoms.
-
Benching of the distribution corridor shall be used to reduce the possibility of "short circuiting" of effluent and effluent ponding around distribution boxes.
(i)
-
Excavation of evaporation/absorption lagoons shall be made to provide uniformly level lagoon bottoms and to provide a wastewater depth below the overflow outlet of four and one-half (4 1/2) feet and a freeboard of two (2) feet.
-
Containment berming, dikes, dams, and liners shall be of Group IV soil texture and installed so as to provide a minimum of eighteen (18) inch separation from the inside wall and bottom of the lagoon to rock and shall be "keyed" into the original soil at least one (1) foot deep and two (2) feet wide at the base.
-
Berms, dikes, or dams shall be constructed on a two (2) feet vertical to one (1) foot horizontal slope.
-
To prevent entrance by unauthorized persons, a lagoon shall be enclosed within a minimum six (6) foot high chain-link fence or equivalent (no climb) open weave designed fence with a locked gate.
(j)
-
Constructed wetlands cell bottoms shall be excavated uniformly level and prepared so that no coarse materials are exposed.
-
Soil berming used for constructed wetlands shall be constructed so that the berming is stable and soil sloughing does not occur.
-
The outside walls shall have a slope of one (1) foot vertical to three (3) feet horizontal.
-
The inside walls shall have a minimum slope of one (1) foot vertical to two (2) feet horizontal.
-
Vegetation shall be established on berming as soon as possible.
(3) Component installation standards.
(a)
-
Septic tanks and other pretreatment units, dosing tanks, and holding tanks shall be installed level.
-
Connections to the unit that conduct sewage or effluent and unit joints or seams shall be watertight.
-
Manufacturer's instructions on installation and piping and electrical connections to the unit, shall be followed by the installer.
-
A unit showing structural damage on delivery or damaged in placement shall be replaced with an undamaged unit.
-
Patching of minor damage that does not affect the structural integrity, watertightness, or function of the unit shall be done under the supervision of the certified inspector.
(b)
-
The certified installer shall provide access to finished grade above the outlet end manhole on each septic tank through the use of suitable manhole risers of a minimum eighteen (18) inches internal dimension to allow removal of the tank manhole lid.
-
The manhole risers shall be provided with tamper-resistant lids or covers. Lids or covers of precast concrete, cast iron, or steel shall be considered tamper-resistant if weighing sixty (60) pounds or more and require a vertical lift for removal.
-
Lids or covers of sheet metal, plastic, or fiberglass shall be attached by bolts or other suitable fastener requiring a tool for removal.
(c) An approved distribution device shall be used in a gravity flow system.
(d)
-
Distribution boxes and alternating valves or devices shall be installed level, and each piping connection shall be rendered watertight.
-
A component showing structural damage on delivery or damaged in placement shall be replaced with an undamaged component.
(e)
-
An equal flow distribution box shall be installed on a stable base to prevent settling.
-
A plastic or fiberglass equal flow or level box shall be securely anchored to a poured concrete base a minimum of four (4) inches thick and extending on all sides of the box side walls at least four (4) inches.
(f) Outlet piping of an equal flow box shall be extended past the inside side wall of the box at least three-fourths (3/4) of an inch but no greater than one (1) inch to allow attachment of water leveling devices.
(g)
-
Approved nonperforated pipe shall be used as leader piping to connect an outlet in a distribution box to each perforated lateral line in the gravity distribution system and shall extend two (2) feet into all trenches or beds before connection to perforated lateral line.
-
The leader piping excavation shall be manually filled with tightly tamped soil.
(h) Leader piping connected to equal flow boxes shall be installed at no greater than one-eighth (1/8) inch per foot slope for the first five (5) feet of run from the box to restrict the flow velocity of effluent.
(i) Lateral lines for conventional gravity distribution trenches or beds shall be laid as established in subparagraphs 1. through 4. of this paragraph.
-
A six (6) inch deep layer of approved trench rock or other fill material shall be carefully placed in the trench or bed to prevent sealing of absorption surfaces from fill impact, and leveled.
-
Lateral piping shall be placed and leveled on the trench fill material in the center of the trench (or properly spaced in beds) and retained in place to prevent movement, while additional trench fill material is added to a point two (2) inches above the top of the top of the lateral piping, for a total of twelve (12) inches of trench fill material.
-
A four (4) inch layer of approved barrier material, whole straw, or a single layer of synthetic filter fabric shall then be placed over the trench fill material to prevent entry of backfill soil fines.
-
Other methods of lateral piping and trench rock placement may be approved by the cabinet upon demonstration of equivalent compliance.
(j) Lateral lines for LPP systems shall be laid as established in subparagraphs 1. through 6. of this paragraph.
-
At the beginning of each trench and at twenty (20) foot intervals thereafter, barrier walls of undisturbed earth or compacted earthfill at least one (1) foot thick shall be placed from sidewall to sidewall of the trench to the level at which lateral piping is to be installed.
-
Six (6) inches of pea gravel or approved alternate trench rock shall be placed in the trench and leveled.
-
Lateral piping shall be laid in place and assembled, or may be preassembled, and leveled.
-
Trench earth barrier walls shall be completed to ground surface and additional pea gravel or other trench fill material carefully placed over the laterals to a height of two (2) inches over the top of the piping.
-
A two (2) inch layer of approved barrier material, whole straw, or a single layer of synthetic filter fabric shall be placed over the pea gravel to prevent entry of backfill soil fines.
-
Other methods of lateral piping and trench rock or pea gravel placement shall be approved by the cabinet upon demonstration of equivalent compliance.
(k) Lateral lines for gravelless pipe systems shall be installed as established in subparagraphs 1. through 7. of this paragraph.
-
Plastic shipping and storage bags shall be removed from pipe, but filter wrap shall not be removed.
-
Gravelless pipe with the top stripe up shall be laid out. Filter wrap shall be rolled back from ends of each section of pipe to allow proper connection of pipe sections and reducer connectors or end caps.
-
Pipe sections shall be joined together with approved connectors, making sure top stripes shall be in direct alignment on both sections to be joined. Joints shall be taped with plastic tape supplied by the pipe manufacturer to seal the joints. Filter wrap ends shall be pulled back over joints and shall tape them together.
-
Offset reducer connectors shall be fitted of size four (4) by eight (8) inches or four (4) by ten (10) inches, to inlet ends of joined pipe sections and located at the four (4) inch inlet at the top of pipe in alignment with top stripes. Joints shall be taped to seal. Filter wrap shall be left loose at this time.
-
End caps shall be fitted on the other end of joined pipe sections. Joints shall be sealed with tape. Filter wrap shall be pulled over the end joint and taped in place.
-
Joined lateral pipe sections shall be laid into trenches with the top stripe directly up. Solid smooth wall header piping shall be connected from distribution box outlets to four (4) inch inlet on offset reducer connector. Header pipe shall be inserted four (4) inches into the connector, and joints shall be sealed with tape. Filter wrap shall be pulled over the end of the reducer cap and around four (4) inches of header piping and shall be taped in place.
-
Each pipe section shall be centered and supported with handfilled soil.
(l) Installation of constructed wetland components shall be as established in subparagraphs 1. through 18. of this paragraph.
-
Cell framing shall be structurally supported by spiking, mortaring, bolting, or other approved means.
-
A liner shall be installed in each cell and shall be watertight after installation.
a. A manufactured liner shall be installed to conform to the shape of the cell, and wrinkles shall be smoothed prior to the placement of fill material.
b. The certified installer shall inspect the installed liner for holes or cuts.
c. If the liner requires perforation to allow piping to pass through, the liner shall be watertight after the piping is installed.
d. A liner shall be protected from sunlight before and after installation.
a. A clay liner may be installed in a second cell application for residential use only if naturally-occurring Group IV textured soil is present.
b. The berming of the clay liner shall be keyed into the original soil by six (6) to twelve (12) inches.
c. The clay liner shall be compacted.
-
Cell fill material shall be installed level, at a uniform depth ranging between twelve (12) and eighteen (18) inches, based on the plant species selected.
-
The cell shall be constructed to provide a water depth equal to the cell fill material depth.
-
Two (2) inches of approved cover material shall be placed over the cell fill material;
-
Inlet and outlet headers shall be located at the bottom, center, or top of the fill material.
-
Inlet and outlet headers shall be located within one (1) foot from the cell end walls for gravity flow.
-
Inlet headers shall be located within three (3) feet from the cell end walls for pressure distribution.
-
If a header is located at an elevation that may cause siphoning of the effluent from a cell, approved antisiphon methods shall be used.
-
If perforated horizontal header piping is used, the header pipe shall be installed level with the holes located one (1) inch from the pipe bottom at the same elevation.
-
If perforated horizontal inlet header piping is used, access to cover material grade shall be provided for clean out.
-
Each header shall be covered with two (2) to four (4) inches of approved cover material.
-
Water level control devices may be installed at the ends of the cells with the design of these devices in compliance with the construction standards of 902 KAR 10:081.
a. At least two (2) access ports of at least four (4) inch diameter pipe shall be installed in each cell.
b. At least one (1) access port shall be located one-third (1/3) of the distance from the inlet end wall to outlet end wall.
c. At least one (1) access port shall be located within six (6) inches of the outlet header.
d. If water level control devices are not used, at least one (1) of the access ports in each cell shall be at least six (6) inches in diameter.
e. Access ports shall have holes located at the same depth as the cell fill material to allow the effluent to enter the access port.
f. Access ports shall be equipped with removable lids or caps.
-
Plants shall be installed and spaced as required for the specific plant species. The permit holder shall be responsible for the installation of suitable wetland plants with hydrophilic plants preferred.
-
The overflow lateral field shall be installed as required for lateral trenches, beds, and components. Required vertical separation distances between overflow lateral trench or bed bottoms and any restrictive horizon, water table, or bedrock, as determined by the site evaluation results, shall be maintained.
(m) Leaching chambers shall be installed according to manufacturer's specification unless the specifications are less restrictive or conflict with 902 KAR Chapter 10, in which case the administrative regulations shall take precedence, except that reduced backfill cover of six (6) inches or more over the leaching chamber shall be allowed.
(n) Effluent piping to an evaporation/absorption lagoon and overflow piping to the lateral field system shall be installed as established in subparagraphs 1. through 3. of this paragraph.
-
Nonperforated gravity flow or pressurized piping shall be laid in an excavated trench into the lagoon and anchored to a poured concrete, three (3) foot square, four (4) inch thick apron. The inlet shall be a tee laid on its side.
-
For overflow piping, the overflow shall be located at the point within the lagoon farthest from the inlet apron. The upper leg of the tee shall be screened, and the lower leg shall extend downward to within three and one-half (3 1/2) feet of the lagoon bottom.
-
Submerged piping into and out of a lagoon shall be provided with suitable water stops or leak collars with a minimum extension of twelve (12) inches on all sides of the pipe.
(4) Curtain and vertical drain installation standards.
(a) Curtain and vertical drains shall be installed as established in subparagraphs 1. through 3. of this paragraph.
-
After excavation and grading of drain trenches to the required depth, slotted plastic drainage pipe with slots around the entire pipe circumference shall be laid in the trench. The pipe shall be bedded in two (2) to four (4) inches of leveled trench rock fill material.
-
After bedding and grading the pipe to drain, approved trench rock fill material for trenches twelve (12) inches or wider, or pea gravel for trenches narrower than twelve (12) inches, shall be added to the trench to a point four (4) inches below grade.
-
Barrier material approved for use in lateral trenches shall be placed over the drain trench fill material.
(b) Vertical drains may be used if more permeable soil horizons exist below a restrictive horizon and shall be installed as established in subparagraphs 1. through 3. of this paragraph.
-
After excavation to the required depth the trenches shall be filled with crushed rock or pea gravel as in curtain drains, pursuant to paragraph (a)2 of this subsection, as applicable.
-
Drainage piping shall be unnecessary in vertical drains because drainage is encouraged downward through the restrictive horizon to more permeable soils.
-
Barrier material approved for use in lateral trenches shall be placed over the drain trench fill material.
(5) Filling, backfilling and finish grading standards.
(a) On a site requiring the placement of fill soil before an on-site sewage disposal system can be installed, the requirements established in subparagraphs 1. through 5. of this paragraph shall apply.
-
Surface vegetation shall be removed and the original soil surface layer shall be tilled to a depth of two (2) inches prior to placement of fill.
-
Soil fill material shall meet or exceed the textural class characteristics of Soil Group III established in Section (3)(4)(c)1. of this administrative regulation and shall not be obtained from a restrictive horizon.
-
Soil fill material shall be placed in the area to be filled by methods acceptable to the cabinet, to prevent stratification and unnecessary soil compaction.
-
Soil fill shall be:
a. Protected by establishing a fast growing ground cover;
b. Allowed to settle for a period of one (1) year; and
c. Reevaluated prior to system installation.
- Depth of soil fill required shall be determined by the site evaluation, based upon minimum separation distances between lateral trench bottoms and restrictive horizons, bedrock, or water tables.
(b)
-
Backfilling around and over septic tanks and other pretreatment units, dosing tanks, holding tanks, distribution boxes, LPP manifolds, alternating valves and devices, and nonperforated effluent piping and distribution leader piping, shall be accomplished by filling and tamping by layers.
-
During filling and tamping, care shall be taken to prevent shifting, tilting, misalignment, or damage to system components, watertight joints, seams, or connections.
-
The location of each component shall be clearly marked by staking or flagging after backfilling and prior to final grading.
(c)
-
If manufacturer's installation instructions require specific backfilling procedures to protect component warranties, prevent damage, or prevent flotation of the component due to ground water pressure, those procedures shall be followed.
-
Soil for backfilling gravelless pipe trenches shall be loose and friable. Soil aggregates, clods, or clumps, used for backfill in contact with pipe and filter wrap shall be no larger than one-half (1/2) inch in any dimension. Large clods or clumps of soil for backfill shall not be used.
-
If soil excavated from trenches is unable to meet the criteria established in this paragraph, suitable backfill soil shall be obtained elsewhere.
(d)
-
Backfilling of lateral trenches or drainage trenches shall be accomplished with minimal compaction of soil fill, and soil fill material shall be left mounded four (4) to six (6) inches above grade over trenches to allow for settling.
-
Backfilling over lateral beds shall be accomplished through the use of lightweight wheeled or crawler type tractors to minimize soil compaction, and soil fill material shall be left mounded four (4) to six (6) inches above grade to allow for settling.
(e) Backfilling shall not be done until after the system has been inspected and approved to that point of construction by a certified inspector.
(f) On sites in which additional fill soil is required over the lateral field due to shallow depth of installation, the procedures established in subparagraphs 1. through 3. of this paragraph shall apply.
-
The requirements of paragraph (a)1 through 3 of this subsection shall apply
-
Fill shall be extended on all sides of the lateral field to a minimum distance of ten (10) feet, except on sloping sites where the fill on each end of the system shall expand outward to a minimum of fifteen (15) feet at the lowest point downslope, and the fill at the downslope side of the system shall be increased to a minimum of fifteen (15) feet beyond the system.
-
Minimum depth of fill shall be as required by the site evaluation, but not less than ten (10) inches of settled soil over the trench rock fill material or top of the gravelless pipe (for leaching chambers six (6) inches minimum) and that depth shall extend over the entire lateral field to a point at least two (2) feet beyond the sidewall of any trench, bed, or chamber, at which point the remainder of the fill may be tapered to original grade out to the minimum distances specified in subparagraph 2 of this paragraph.
(g)
-
Finish grading over the on-site sewage system shall be performed to minimize soil compaction through the use of lightweight equipment.
-
Grading shall be restricted to work necessary to provide positive surface drainage away from the system, especially the lateral field.
-
Final grading over staked or flagged system components shall be accomplished manually or with lightweight equipment, using extreme care to prevent damage to or misalignment of components.
(h) Finish grading work that removes soil from the system area, or that results in that area being used to dispose of excess soil graded from other areas on the site, shall be prohibited.
(i) Finish grading on other areas of the site shall be done in such a manner as to divert surface water run-off from driveways, patios, downspouts, slopes, ditches, gullies, etc., away from the area where the system is installed. If site conditions are such that normal grading procedures cannot divert the run-off, diversion ditches, swales, berms, or other diversion drainage means shall be constructed to divert run-off away from the system.
Section 8. System Setback Restrictions.
(1) Minimum setback distances for installation of on-site sewage disposal systems from structures, water supplies, roads, streams, bodies of water, and other structural or topographic features are listed in Table 7.
(2) Lagoon setback distances shall be measured from the inside berm wall at a point four and one-half (4.5) feet vertically from the lagoon bottom.
Section 9. System Installation Inspection.
(1) Every on-site sewage disposal system installed, constructed, altered, or repaired shall be inspected by a certified inspector.
(2) The inspection sequence performed shall be as established in paragraphs (a) through (g) of this subsection.
(a)
-
The certified installer shall complete an installer's affidavit for every system, recording all grade shot readings of all excavation work and certifying by the certified installer's signature that the work has been performed in compliance with this administrative regulation; or
-
In lieu of the installer's affidavit, the certified installer shall request an initial inspection be performed by a certified inspector.
(b)
-
An initial inspection shall consist of shooting of grades in all excavations to determine compliance with this administrative regulation.
-
For subsurface flow constructed wetland systems, an initial inspection shall be made by a certified inspector to determine compliance with excavation standards.
a. An installer's affidavit in lieu of the initial inspection shall not be accepted.
b. The liner shall be in place in the cell prior to the initial inspection unless special cell preparation is needed prior to placement of the liner.
- All components and the overflow lateral field shall be inspected.
(c)
-
The certified installer shall request an installation inspection be scheduled and completed by a certified inspector before the system is backfilled.
-
To facilitate inspection of lateral fields and constructed wetland system cells, the certified installer shall provide direct access to trench, bed, or cell bottoms to allow accurate shooting of grade and elevation.
-
Direct access shall be provided through the use of ports, piping, or other methods acceptable to the certified inspector and at locations within the lateral field the inspector deems necessary.
(d) The installation inspection shall consist of:
-
Examination of system components, including constructed wetland systems plants, as to type, size or capacity, approved status, materials, and connections;
-
Examination of installation as to proper placement, proper grade, or level;
-
Conduct "water leveling" method on equal flow distribution boxes;
-
Testing of dosing devices, low pressure systems, and alarm systems;
-
Shooting of trench, bed, constructed wetland cell, or lagoon bottom grade and elevation;
-
Examination of installation of lateral lines, trench, and constructed wetland cell fill material depth, trench barrier material, constructed wetland cell cover material depth and placement, and water depth; and
-
Other necessary examinations and checks to determine compliance with this administrative regulation relative to all site and system modifications required.
(e) A constructed wetland system shall not be approved before it is complete, including plant installation.
(f) An approved system shall be backfilled in accordance with this administrative regulation.
- The certified installer shall:
a. Assure proper backfilling;
b. After completion of backfilling, perform or supervise finish grading; and
c. Request a final inspection if additional fill soil is required after completion of finish grading.
- The owner shall, during subsequent occupancy and system usage, protect the system from damage, disruption, or unnecessary surface water drainage.
(g) A system not meeting approval shall be reconstructed as needed to meet compliance requirements.
Section 10. Responsibilities.
(1) The construction, operation, and maintenance of on-site sewage disposal systems, whether conventional, modified, or alternative systems, shall be the responsibility of the owner, developer, certified installer, or user of the system as applicable in the circumstances.
(2) Actions of the cabinet and certified inspectors engaged in the evaluation and determination of measures required to effect compliance with the provisions of this administrative regulation shall in no way be taken as a guarantee that on-site sewage disposal systems approved and permitted shall function in a satisfactory manner for any given period of time, or that such agents or employees assume any liability for damages, consequential or direct, which are caused or may be caused by a malfunction of the systems.
Section 11. Prohibited Practices. The following practices shall be prohibited and their use shall result in immediate voiding of permits or site evaluations:
(1) Use of unapproved system components in lieu of replacement with approved components;
(2) Except as provided in Section 13 of this administrative regulation, use of seepage pits, cesspools, or dry wells;
(3) Use of improperly constructed or designed systems in lieu of redesign or reconstruction;
(4) Placement of lateral field within less than twelve (12) inches of, or below, the upper limits of a restrictive horizon or water table;
(5) Placement of lateral field within less than twelve (12) inches of, or into, bedrock;
(6) Dynamiting, ripping, or otherwise removing bedrock to install a lateral field;
(7) Cutting, filling, or otherwise altering the original grade or soil characteristics of the area upon a site staked or flagged off for system installation, except if the work is a requirement of this administrative regulation;
(8) Allowing use of the area staked or flagged off for system installation as a material or soil stockpile, vehicle or heavy equipment parking area or roadway, or other unauthorized use that may damage or alter the soil or site characteristics; or
(9) Construction of evapotranspiration lagoons in Group I, Group II, or Group III textured soil.
Section 12. Variances.
(1) The owner of a site where an on-site sewage disposal system is proposed to be installed may request, in writing, to the local board of health or its designated agent, a variance to specific portions of this administrative regulation.
(2) A written request shall include:
(a) Pertinent information about the site;
(b) The specific portion of the administrative regulation requested for waiver;
(c) The specific reasons for the request; and
(d) Documented evidence justifying the granting of the variance.
(3) A request shall be acted upon by the local board of health or its designated agent as soon as practicable. A written decision, either denying the variance with reasons for denial, or granting the variance with or without stipulations or restrictions, shall be presented to the applicant within five (5) working days of the decision.
(4) An applicant for a variance may appear with counsel or expert professional witnesses or both before the local board of health or its agent for the purpose of presenting the request or to appeal a decision.
(5) If a hearing is requested, the local board of health or its agent shall:
(a) Set a time and date for the hearing, as soon as practicable; and
(b) Notify the applicant, in writing, within five (5) working days of receipt of the request and at least two (2) days prior to the date of hearing, of the time and date for the hearing.
(6) A decision regarding a variance shall be based upon evidence presented by:
(a) The applicant;
(b) The certified inspector for the site in question; and
(c) Expert professional witnesses.
(7) A decision regarding a variance shall be influenced by:
(a) The requirements of the On-site Sewage Systems Law, KRS 211.350 to 211.380, and related law; and
(b) The presence or absence of reasonable assurance, derived from evidence presented, that the granting of the variance shall not result in the creation of:
-
Groundwater contamination;
-
Effluent surfacing;
-
A public health hazard; or
-
A public health nuisance.
(8) A variance shall not be granted:
(a) To waive of site evaluation or system inspection;
(b) To reduce required system size if a modified or alternative system is able to provide an equivalent system in the available area on the site;
(c) If site or system modification or an alternative system can overcome a site limitation; or
(d) For a practice prohibited by Section 11 of this administrative regulation.
(9) A variance shall be made a permanent record and filed at the local health department in the county where the site is located.
(10) A variance request shall be acted upon and a final decision made by the local board of health or its agent prior to the issuance of a permit to install the proposed on-site sewage disposal system.
Section 13. Exemption.
(1) On-site sewage systems shall be governed by the provisions of KRS 211.355(3) and this section.
(2) The repair or alteration of an on-site sewage treatment system shall be permitted if:
(a) A municipal or public sewage treatment system is not available; and
(b) Repair or alteration is required because of:
-
Malfunction;
-
Damage; or
-
Upgrade.
(3) In the repair or alteration of an on-site sewage system utilizing a seepage pit, an owner shall be permitted to:
(a) Clean;
(b) Service; and
(c) Repair, alter, reconstruct, or replace:
-
Any system component leading to a pit, such as pipes and septic tanks;
-
Pit rings; or
-
Any other component repair that would not require the drilling of a new pit.
(4) With regard to a single-family dwelling only, if a municipal or public sewage treatment system is not available, a seepage pit may be installed as an on-site sewage disposal system in the development of a vacant lot, purchased on or before May 1, 1992, if bona fide construction began by December 25, 1992.
Section 14. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Drip Irrigation Treatment and Disposal System Design Standards", 1/2017; and
(b) Form "DFS-450, Declaration of Covenants, Conditions, and Restrictions", 1/2017.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.050(2), 211.015, 211.350-211.380, 211.990(2), Chapter 322
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1)(d), 211.350, 211.351
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180(1)(d) requires the cabinet to regulate the construction, installation, or alteration of any on-site sewage disposal system, except for a system with a surface discharge, regulated by KRS 224.10-100(19). This administrative regulation establishes uniform standards for on-site sewage disposal systems to assure that the construction, installation, or alteration of an on-site sewage disposal system is performed in such a manner as to protect public health and the environment.
- History: 11 Ky.R. 1556; eff. 5-14-1985; Am. 15 Ky.R. 628; eff. 9-21-1988; 18 Ky.R. 3239; 19 Ky.R. 53; eff. 6-24-1992; 27 Ky.R. 2083; 2618; 29 Ky.R. 441; eff. 8-12-2002; 43 Ky.R. 1462, 1736; eff. 5-5-2017; TAm eff. 3-20-2020; Cert. eff. 8-10-2023.
902 KAR 10:110 Issuance of on-site sewage disposal system permits {#sec-902-kar-10-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:110}
Section 1. Definitions.
(1) "Alter" means to make a physical change in the original design, sizing, layout, components, location, or method of operation, either individually or in any combination of changes, of an existing on-site sewage disposal system, as a result of necessary repair or a change in wasteload volume or wasteload characteristics.
(2) "Approved" is defined by KRS 211.970(1).
(3) "Cabinet" is defined by KRS 211.970(2).
(4) "Certified inspector" means an individual certified under the provisions of KRS 211.360.
(5) "Certified installer" means a specific individual person who has met the requirements for certification contained in KRS 211.357 and 902 KAR 10:140.
(6) "Component" means any device used in the construction, installation or alteration of an on-site sewage disposal system which forms an integral part of that system and has been approved for that specific use by the cabinet.
(7) "Construct" or "install" means the physical assembly of various necessary components and materials into an on-site sewage disposal system and includes all necessary design, site layout, excavation, backfilling, and additional site fill work that may be required to produce a finished on-site system.
(8) "Homeowner" means a specific individual person who actually occupies the single family residence where a proposed new on-site sewage disposal system is intended to serve, or where an existing system that is proposed to be altered serves, or who proposes to construct or have constructed a single family residence for personal use and occupancy where a proposed new on-site system is intended to serve. This term shall not include any person who is a builder or contractor who engages in a business of constructing or rehabilitating residential structures for sale or resale.
(9) "On-site sewage disposal system", "on-site sewage system", or " on-site system" means a system installed on a parcel of land, under the control or ownership of a person, that accepts sewage for treatment and ultimate disposal under the surface of the ground, including:
(a) A conventional system consisting of a sewage pretreatment unit, distribution devices, and lateral piping within rock-filled trenches or beds;
(b) A modified system consisting of:
-
A conventional system enhanced by shallow trench or bed placement;
-
Artificial drainage systems;
-
Dosing;
-
Alternating lateral fields;
-
Fill soil over the lateral field; or
-
Other necessary modifications to the site, system, or wasteload to overcome site limitations;
(c) An alternative system consisting of:
-
A sewage pretreatment unit;
-
Necessary site modifications;
-
Wasteload modifications; and
-
A subsurface soil treatment and dispersal system using methods and technologies other than a conventional or modified system to overcome site limitations;
(d) A cluster system; and
(e) A holding tank that provides limited pretreatment and storage for off-site disposal where site limitations preclude immediate installation of a subsurface soil treatment and dispersal system or connection to a municipal sewer.
(10) "Person" is defined by KRS 211.970(6).
Section 2. Issuance of Permits.
(1) A certified installer or homeowner meeting the requirements of this administrative regulation shall complete and submit to the local health department certified inspector having jurisdiction:
(a) A DFS-307, On-site Sewage Disposal System Construction Application and Permit;
(b) The on-site sewage disposal permit fee of fifty (50) dollars; and
(c) The required fee as established by the local board of health in accordance with KRS 211.355.
(2) The on-site sewage disposal cluster system plan review shall be:
(a) Submitted to the Environmental Management Branch; and
(b) Accompanied by the $600 permit fee payable by check or money order to the Kentucky State Treasurer.
(3) Except as otherwise provided by subsection (4) of this section, permits to construct, install, or alter on-site sewage disposal systems shall be issued only to certified installers.
(4) Permits to construct, install, or alter on-site sewage disposal systems may be issued to homeowners provided:
(a) Application is made for a permit as specified in 902 KAR 10:085, Section 2(1)(g), (h), and (i) prior to construction of any portion of the proposed on-site sewage disposal system;
(b) All work is performed in compliance with 902 KAR 10:081, 902 KAR 10:085, and this administrative regulation;
(c) All work is personally performed by the homeowner, except that necessary excavation and backfilling work may be performed by a certified installer if notification of intent is made at the time of application for a permit, and the certified installer's name and certification number are included on the application;
(d) If local electrical codes require electrically operated components of an on-site sewage disposal system to be connected to electrical service only by a certified or licensed professional electrician, and do not permit homeowner performed work, that work shall also be excepted from the requirements of paragraph (c) of this subsection; and
(e) No person shall be issued more than one (1) homeowner permit to construct or alter an on-site sewage disposal system in any five (5) year period, except in instances of necessary repair or alteration of the originally permitted on-site system.
Section 3. Incorporation by Reference.
(1) DFS-307, "On-site Sewage Disposal System Construction Application and Permit", (10/20) is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.357, 211.360, 211.370, 211.375, 211.380, 211.970, 211.976, 211.990(2)
- STATUTORY AUTHORITY: KRS 211.350, 211.355
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.350 provides that no person, firm, or corporation shall construct, install, alter or cause to be constructed, installed, or altered any on-site sewage disposal system subject to administrative regulation by the cabinet without having first obtained an on-site sewage disposal permit from the local health department. KRS 211.355 authorizes a local board of health to establish a schedule of fees reasonably related to the cost of administering programs including inspections incidental to construction, installation, and alteration of on-site sewage disposal systems, and inspections incidental to maintenance and operation of on-site sewage disposal systems. This administrative regulation establishes the requirements for issuance of permits.
- History: 11 Ky.R. 107; eff. 9-11-84; 13 Ky.R. 540; eff. 10-2-86; 18 Ky.R. 1433; 2265; eff. 1-10-92; Crt eff. 11-18-2019; 47 Ky.R. 1285; eff. 6-16-2021.
902 KAR 10:120 Kentucky public swimming and bathing facility operations {#sec-902-kar-10-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:120}
Section 1. Definitions.
(1) "Alkalinity" or "total alkalinity" means the amount of carbonates or bicarbonate present in water solution as expressed in parts per million (ppm).
(2) "Approved" means that which is acceptable to the cabinet.
(3) "Backwash" means the flow of water through the filter element or media in the reverse direction sufficient to dislodge the accumulated dirt and filter aid and remove them from the filter tank.
(4) "Bather" means a person using a public swimming and bathing facility.
(5) "Cabinet" is defined by KRS 211.015(1)(a).
(6) "Diatomaceous earth (DE) filter" means a filter that utilizes a thin layer of diatomaceous earth as its filter media that will need to be periodically replaced.
(7) "Disinfectant" means an approved chemical compound designed for the destruction of pathogenic organisms in bathing facilities and includes chlorine and bromine.
(8) "Facility operator" means a person or employee of that person who is responsible for the proper operation and maintenance of the facility.
(9) "Filter" means a device that separates solid particles from water by recirculating it through a porous substance.
(10) "Filter aid" means an enhancement to the efficiency of the filter media.
(11) "Filter cycle" means the operating time between cleaning or replacing the filter media or backwash cycles.
(12) "Filter element" means a device within a filter tank designed to entrap solids and conduct water to a manifold, collection header, pipe, or similar conduit.
(13) "Flow meter" means a device that measures the flow of water through piping.
(14) "Holding tank" means a storage vessel to retain water for a spray pad recirculation system.
(15) "Inlet" means a fitting or fixture through which filtered water returns to a pool or spa.
(16) "Main outlet" means an outlet fitting at the deepest point of the horizontal bottom of a pool through which water passes to a recirculating pump or surge tank, and is often referred to as a "main drain".
(17) "Perimeter overflow system" means a channel at normal water level that extends completely around the pool perimeter and is used to remove surface debris, also known as an overflow or scum gutter.
(18) "Play feature" means a structure or feature that is added to a pool for the purpose of entertainment.
(19) "Plunge pool" means a pool or area within a pool designed as the termination point for a water slide or water ride.
(20) "Precoat" means the process of depositing a layer of diatomaceous earth or perlite on the filter element at the start of a filter cycle.
(21) "Public swimming and bathing facility" or "facility" means a natural or artificial body or basin of water that is modified, improved, constructed, or installed for the purpose of swimming or bathing, except for a pool at a private single family residence intended only for the use of the occupant and guests.
(22) "Public swimming and bathing facility enclosure" means an enclosure that surrounds and secures the public swimming and bathing facility which includes decking and pool.
(23) "Readily accessible" means direct access without the necessity of removing any panel, door, or similar obstruction.
(24) "Skimmer" means a device designed to continuously remove surface film and water and return it through the filter.
(25) "Splash pad" means a public swimming and bathing facility that:
(a) Has aquatic play features that spray or drop water for the purpose of wetting people;
(b) Is designed so that there is no accumulation or ponding of water on the ground;[]
(c) Includes both recirculating and non-recirculating water systems; and
(d) Includes splash pads operated by local governments as defined in KRS 211.205.
(26) "Strainer" means a device used to remove hair, lint, leaves, or other coarse material on the suction side of a pump.
(27) "Superchlorinate" means the addition to the public swimming and bathing facility water of an amount of chlorine sufficient to produce a free available chlorine that is at least equal to ten (10) times the amount of combined chlorine plus the required minimum level of free available chlorine in order to oxidize the ammonia and nitrogenous materials which may be dissolved in the facility water.
(28) "Total residual chlorine" means the arithmetical sum of free available chlorine and combined chlorine, which is composed of the following components:
(a) Free available chlorine, which is the amount of chlorine available to inactivate microorganisms and that has not reacted with ammonia, nitrogenous material, and other contaminants in facility water; and
(b) Combined chlorine (also called "chloramine"), which is the amount of chlorine that has reacted and combined with ammonia and other nitrogenous material to form chloro-ammonia compounds.
(29) "Wading pool" means a pool or area within a pool where the water depth is twenty-four (24) inches or less.
Section 2. Submission of Plans, Annual Permit Fee, and Inspection Fees.
(1) Submission of Plans.
(a) All new construction, changes in construction, and equipment shall be in accordance with the requirements set forth in 902 KAR 10:123.
(b) New facilities shall receive final construction approval inspections by the cabinet, and other affected state and local regulatory agencies, prior to placing the facility in operation. It shall be the owner or operator's responsibility to notify the cabinet and other involved agencies of construction completion and call for inspection.
(2) Annual Permit Fee.
(a) An annual permit fee of $110 for all public swimming and bathing facilities shall be:
-
Paid no later than May 1 each year; and
-
Paid to the Kentucky Department for Public Health by check or money order made payable to the Kentucky State Treasurer.
(b) A late payment fee of fifty-five (55) dollars shall be assessed on all annual permits not received by May 1 each year.
(c) Permits shall not be transferable.
(3) A fee shall be required for inspections conducted by the cabinet or the local health department to determine compliance with this administrative regulation for public swimming and bathing facilities.
(4) For public swimming and bathing facilities the annual inspection fee shall be:
(a) Assessed according to the total square footage of the water surface area;
(b) Calculated as established in this paragraph:
-
1,000 square feet or less, the fee shall be ninety-nine (99) dollars;
-
1,001 to 1,500 square feet, the fee shall be $165;
-
1,501 to 2,000 square feet, the fee shall be $220; and
-
2,001 and above, the fee shall be $220 plus fifty-five (55) dollars for each additional 500 square feet of water surface area; and
(c) Include $82.50 for interactive water features.
(5) For splash pads, the annual inspection fee shall be $275 per year.
(6) For spas and hot tubs, the annual inspection fee shall be $165 per year.
(7) The inspection fee required by this section shall be:
(a) Paid to the local health department having jurisdiction by check or money order made payable to the Kentucky State Treasurer;
(b) Deposited in the environmental fee account; and
(c) Sent to the Department for Public Health for deposit with the Kentucky State Treasury.
Section 3. Water Supplies.
(1) Potable water from an approved municipal water system or water district shall be supplied to all public swimming and bathing facilities. If these supplies are not available, a potable water supply meeting the approval of the Energy and Environment Cabinet shall be provided.
(2) The water supply shall be capable of providing:
(a) Sufficient quantities of water under pressure to all water-using fixtures and equipment at the facility; and
(b) Enough water to raise the water level by at least one (1) inch in three (3) hours in:
-
Swimming, diving, or wave pools; and
-
Water slide plunge pools.
Section 4. Sewage and Wastewater Disposal.
(1) Sewage or wastewater generated from the operation of a public swimming and bathing facility shall discharge to a public sanitary sewer.
(2) If a public sanitary sewer is not available, sewage or wastewater shall be discharged to a system which complies with 902 KAR 10:085.
(3) Outdoor deck or surface area drainage water may be discharged directly to storm sewers, natural drainage areas, or to the ground surface without additional treatment. This drainage shall not result in nuisance conditions that create an offensive odor, a stagnant wet area, or an environment that allows for the breeding of insects.
(4) Filter backwash shall be discharged to public sanitary sewers, or if unavailable, to a system approved by the cabinet.
Section 5. Refuse Disposal.
(1) All refuse at a public swimming and bathing facility shall be disposed of in a manner approved by the Energy and Environment Cabinet in KAR Title 401.
(2) An adequate number of refuse containers with tight fitting lids shall be provided at readily accessible locations at all public swimming and bathing facilities.
(3) Refuse containers in women's restrooms shall be kept covered.
(4) Bulk refuse storage areas shall be designed and maintained to prevent rodent harborage.
(5) Bulk refuse containers shall be:
(a) Of approved design and construction;
(b) Kept closed; and
(c) Placed upon an impervious surface within a suitable enclosure to prevent access by animals.
Section 6. Facility Design and Construction.
(1) All public swimming and bathing facilities, and attendant structures, such as bathhouses, dressing rooms, or restrooms shall meet the design, materials, fixture, and construction requirements of 815 KAR 7:120 and 815 KAR Chapter 20.
(2) Bathhouses, restrooms, and drinking fountains shall not be required for the design and construction of splash pads.
Section 7. Facility Water Treatment Systems.
(1) A recirculation system, consisting of pumps, piping, filters, water conditioning, disinfection equipment, and other accessory equipment shall be provided to clarify, chemically balance, and disinfect the water for all swimming and bathing facilities.
(2) The recirculation system shall comply with the requirements set forth in 902 KAR 10:123.
Section 8. Operational Water Quality Standards.
(1) Disinfectant residuals for swimming and diving pools, holding tanks, wading pools, water slides, and wave pools:
(a) Chlorine residual shall be maintained between one (1) and five (5) ppm as free available chlorine.
(b) Bromine residual shall be maintained between two (2) and six (6) ppm as free available disinfectant.
(c) Pools stabilized with cyanuric acid shall meet the following criteria:
-
Be an outdoor facility;
-
Maintain one and five-tenths (1.5) to five (5) ppm free available chlorine residual; and
-
Cyanuric acid concentration not to exceed fifty (50) ppm.
(d) If the presence of chloramines is determined, superchlorination is required, and the chloramine level shall not exceed two-tenths (0.2) ppm.
(2) Disinfectant residuals for spas:
(a) Chlorine residual shall be maintained between two (2) and five (5) ppm as free available chlorine;
(b) Bromine residual shall be maintained between two (2) and six (6) ppm as free available disinfectant; and
(c) If the level of chloramines exceeds two-tenths (0.2) ppm, superchlorination is required. During the superchlorination process and until the time that free chlorine levels return to five (5) ppm or less, the facility shall be closed.
(3) The pH of the facility water shall be maintained in a range of seven and two-tenths (7.2) to seven and eight-tenths (7.8). For corrosive water supplies, the alkalinity level shall be suitably adjusted to allow maintenance of the pH level.
(4) Turbidity. Facility water shall have sufficient clarity at all times so that:
(a) A black disc, six (6) inches in diameter, is readily visible if placed on a white field at the deepest point of the pool; and
(b) The openings of the main outlet grate are clearly visible by an observer on the deck.
(5) Total alkalinity. The alkalinity of the facility water shall not be less than fifty (50) nor more than 180 ppm, as determined by suitable test kits.
(6) Temperature.
(a) The water temperature for indoor swimming and bathing facilities other than spas shall not be less than seventy-six (76) degrees Fahrenheit nor more than eighty-four (84) degrees Fahrenheit. The cabinet may allow variances from the above temperature limits for special use purposes as competition, physical therapy, or instruction of children. Variances may be approved if proof is presented showing that a variance from the temperature requirements is necessary for the special uses stated and that the variance shall not jeopardize public health.
(b) Air temperature at an indoor facility shall be higher than the water temperature, except for spas.
(c) Water temperatures for any facility including spas shall not exceed 104 degrees Fahrenheit.
(d) All facilities with heated water shall have at least one (1) break proof thermometer located within the facility water in a conspicuous location. The thermometer shall be securely mounted to prevent tampering by bathers.
(7) Testing Equipment.
(a) Testing equipment shall be provided at all swimming and bathing facilities, maintained with fresh reagents, and consist of a DPD (Diethyl-P-Phenylene-Diamine) colorimetric test kit used to determine free disinfectant residual, combined disinfectant residual, total alkalinity, and pH of the facility water. Test kits using orthotolidine reagents shall be prohibited.
(b) Test kits shall be used to determine the total residual chlorine either directly or by summation of free chlorine and combined chlorine test results. Chlorine standards shall range from one-tenth (0.1) to five (5.0) ppm.
(c) pH standards shall range from six and eight-tenths (6.8) to eight and four-tenths (8.4).
(d) Both tests shall be accurate to within two-tenths (0.2) units.
(e) Facilities using cyanurates for stabilization shall have a test kit to measure the cyanuric acid concentration. The cyanuric acid test kit shall permit readings up to 100 ppm.
(8) The facility operator shall perform tests for each of the above water quality characteristics before opening and during all hours of operation based on the frequency schedule listed in paragraphs (a) through (c) of this subsection, and record all test results on a daily operational log sheet:
(a) Disinfectant residual, temperature, and pH shall be checked at least three (3) times daily with a greater frequency if bather load or climatic conditions warrant.
(b) Turbidity shall be checked daily, or more often as needed.
(c) The following shall be checked weekly, or more often as needed:
-
Alkalinity; and
-
Cyanuric acid, if used.
(9) All spas shall be completely drained, thoroughly cleaned, and refilled with potable water at least once per week. Cleaners used shall be compatible with facility wall and bottom finishes.
Section 9. General Facility Operation and Maintenance.
(1) All facilities shall be maintained:
(a) Free from sediment and debris; and
(b) In good repair.
(2) Decks shall be kept clean. Indoor decks shall be disinfected at least weekly.
(3) Perimeter overflow and skimmers. The perimeter overflow system or automatic surface skimmers shall be clean and free of leaves or other debris. The strainer baskets for skimmers shall be cleaned daily. The flow through each skimmer shall be adjusted as often as necessary to maintain a vigorous skimming action. The facility water shall be maintained at an elevation so that effective surface skimming is accomplished. The flow returning from the facility shall be balanced or valved so that the majority of flow is returned through the perimeter overflow or skimmer system.
(4) Inlet fittings. Inlets shall be checked frequently to ensure that the rate of flow through each inlet is correct so that a uniform distribution pattern is established.
(5) Bather preparation facilities.
(a) The floors of dressing rooms, shower stalls, and other interior rooms shall be cleaned and disinfected daily.
(b) Toilet rooms and fixtures shall be kept clean, free of dirt and debris, and in good repair.
(c) Floors shall be maintained in a nonslip condition.
(d) Soap dispensers shall be filled and operable.
(e) Adequate supplies of toilet tissue, disposable hand drying towels, or suitable hand drying devices shall be maintained.
(6) Street attire. Street shoes shall not be worn on the facility decks or wet areas of the bather preparation facilities, except for those persons engaged in official duties.
(7) Safety.
(a) All public swimming and bathing facility enclosures shall meet the specifications of Department of Housing, Buildings and Construction. Doors or gates in the facility enclosure shall be kept closed and locked if the facility is closed.
(b) Facility enclosures shall not be required for splash pads.
(8) Electrical systems. Repairs to any electrical system shall be made by an electrician. All repairs shall be in accordance with the National Electrical Code and shall be approved by a certified electrical inspector.
(9) Diving equipment, ladders, hand rails, and other similar equipment, shall be maintained in good repair, be securely anchored, and have a nonslip surface.
(10) Operation of mechanical equipment.
(a) Manufacturers' instructions for operation and maintenance of mechanical and electrical equipment, as well as pump performance curves, shall be kept available at the facility.
(b) Pumps, filters, disinfectant feeders, pH controls, flow indicators, gauges, and all related components of the facility water recirculation system shall be kept in continuous operation twenty-four (24) hours a day.
(c) Recirculation pumps. The pump shall not be throttled on the suction side during normal operation, except for the main drain, and shall be kept in good repair and condition. The flow control valve on the discharge side shall be adjusted as necessary to maintain the design flow rate.
(11) Filtration.
(a) Sand filters.
-
The filter air release valve shall be opened, as necessary, to remove air which collects in the filter and following each backwash.
-
The filter shall be backwashed if the design flow rate can no longer be achieved, or as specified by the filter manufacturer, whichever occurs first.
(b) Diatomaceous earth filters.
-
The dosage of diatomaceous earth precoat shall be at least one and one-half (1 1/2) ounces per square foot of element surface area. Pressure diatomaceous earth filters shall be backwashed if the design flow rate can no longer be achieved or as specified by the filter manufacturer, whichever occurs first. If the recirculation pump stops or is shut off, the filter shall be thoroughly backwashed and the elements shall be precoated before placing the pump back into operation. Vacuum diatomaceous earth filters shall be washed if the design flow rate can no longer be achieved or as specified by the filter manufacturer, whichever occurs first;
-
Following the precoating operation, the initial filter effluent shall be either recirculated through the filter until the filter effluent is clear, or the initial filter effluent shall be discharged to waste until properly clarified water is produced; and
-
If continuous diatomaceous earth feed is required (filter loading rate exceeds one and five-tenths (1.5) gallons per minute per square foot of filter surface area), it shall be applied at a rate of one-half (1/2) to one and one-half (1 1/2) ounces per square foot of surface area per day, or as needed to extend filter cycles.
(12) Hair and lint strainers. Hair and lint strainers shall be cleaned to prevent clogging of the suction line and cavitation. The pump shall be stopped before the strainer is opened. In all cases, the hair strainer basket shall be cleaned during the time the filter is being backwashed.
(13) Flow meters. Flow meters shall be maintained in an accurate operating condition and readily accessible. The glass and the connecting tubes shall be kept clean.
(14) Vacuum and pressure gauges. The lines leading to the gauges shall be bled occasionally to prevent blockage.
(15) Positive displacement feeders.
(a) Positive displacement feeders shall be periodically inspected and serviced;
(b) To minimize sludge accumulation in the unit, the lowest practicable concentration of solution shall be used. If liquid chlorine solution is used, the dilution with water is not critical to the operation of the unit; and
(c) Sludge accumulations shall be cleaned periodically from the unit.
(16) Chlorinated cyanurates. The use of chlorinated cyanurates shall be prohibited.
(17) pH adjustment.
(a) Soda ash or caustic soda may be used to raise the facility water pH.
(b) Caustic soda shall only be used in accordance with the manufacturer's instructions. If caustic soda is intended for use, the cabinet shall be notified in writing. Protective equipment and clothing, including rubber gloves and goggles, shall be available for the handling and use of this chemical.
(c) Sodium bisulfate or muriatic acid may be used to lower pool water pH.
(d) Hydrochloric (muriatic) acid may only be used with proper supervision and care. Protective equipment and clothing, including rubber gloves and goggles, shall be available for handling this chemical.
(e) The cabinet shall be consulted if there are unusual pH problems including corrosion, scaling, or wide fluctuations in pH.
(18) Algae control.
(a) The development of algae shall be eliminated by superchlorinating. The facility shall not be open for use during this treatment. If superchlorination fails to eliminate the algae, the cabinet shall be consulted for further advice.
(b) Treated algae which cling to the bottom and sides of the facility shall be brushed loose and removed by the suction cleaner and filtration system.
(19) Miscellaneous chemicals.
(a) Chemicals other than approved disinfectants shall be used only with the advice and under the supervision of the cabinet.
(b) Chemicals shall be kept covered and stored in the original container, away from flammables and heat, and in a clean, dry, and well-ventilated place that prevents unauthorized access to the chemicals.
(c) The chemicals used in controlling the quality of water shall be used only in accordance with the manufacturer's instructions.
(d) If polyphosphates are used for sequestering iron, the concentration of polyphosphates shall not exceed ten (10) ppm.
(20) Equipment rooms shall comply with the following requirements:
(a) Equipment necessary for facility operation shall be housed in a lighted, ventilated room that affords protection from the weather and prevents unauthorized access.
(b) Suitable space, if not provided in the equipment room, shall be provided for storage of chemicals, tools, equipment, supplies, and records where they may be acquired by the facility operator without leaving the premises. The storage space shall be dry and protected from unauthorized access.
(c) The equipment room and all other storage areas shall be maintained in a clean, uncluttered condition, and shall not be used for storage of materials not essential to operation and maintenance of the facility.
Section 10. Facility Records.
(1) The operator of each facility shall keep a daily record of information regarding operation of the facility on the DFS-352, Swimming Pool Log Sheet. This data shall be kept on file by the operator and submitted to the cabinet as requested. Proper operating records shall be kept showing daily or weekly results, as applicable, for:
(a) Disinfectant residuals;
(b) pH readings, total alkalinity, cyanuric acid level, if applicable; and
(c) Equipment malfunctions.
(2) If two (2) or more facilities are operated on the same site, separate records shall be maintained for each facility.
Section 11. Safety.
(1) Operator. A facility operator shall be responsible for the operation and maintenance of all swimming and bathing facilities. The operator shall be available at all times if the facility is open for use.
(2) Lifeguards shall comply with the requirements set forth in 902 KAR 10:125 Section 2.
(3) Safety equipment shall comply with the requirements set forth in 902 KAR 10:125 Section 3.
Section 12. Spectator and Bather Administrative Regulations.
(1) Management of each facility shall adopt rules for controlling of food, drink, and smoking in the facility and surrounding areas.
(2) Rules governing the use of the facility and instructions to bathers shall be displayed on placards at the entrance to dressing rooms and enforced by the facility operator. Posting of rules and other instructions shall provide that:
(a) Admission to the facility shall be refused to a person:
-
Having any contagious disease or infectious conditions, such as colds, fever, ringworm, foot infections, skin lesions, carbuncles, boils, inflamed eyes, ear discharges, or any other condition that has the appearance of being infectious;
-
Having excessive sunburn, abrasions that have not healed, corn plasters, bunion pads, adhesive tape, rubber bandages, or other bandages of any kind; and
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Under the influence of alcohol, illegal substances, or exhibiting erratic behavior;
(b) Food, drink, gum, tobacco, or vapor producing products shall not be allowed, other than in specially designated and controlled sections of the facility area;
(c) Personal conduct within the facility shall ensure that the safety of self and others is not jeopardized;
(d) Running and boisterous or rough play shall not be permitted, except for supervised water sports;
(e) Spitting, spouting of water, blowing the nose, or otherwise introducing contaminants into the facility water shall not be permitted;
(f) Glass, soap, or other material that creates hazardous conditions or interferes with efficient operation of the facility shall not be permitted in the facility or on the deck;
(g) All apparel worn in the facility shall be clean;
(h) Diving in shallow water shall not be permitted;
(i) Caution shall be exercised in the use of diving boards; and
(j) Service animals may be allowed in the deck area, but shall be excluded from the water.
(3) Due to the nature of splash pads, animals shall be excluded from the splash pad and deck area.
(4) In addition to the requirements of subsection (2) of this section, a caution sign shall be mounted adjacent to all spas and contain the following warnings:
(5) A sign shall be posted in the immediate vicinity of the spa stating the location of the nearest telephone and indicating that emergency telephone numbers are posted at that location.
Section 13. Swimming Suits and Towels Furnished by Management. All swimming suits and towels used by swimmers and maintained for public use shall be cleaned after each use. These items shall be handled in a sanitary manner.
Section 14. Facility Inspection.
(1) Seasonal facilities.
(a) All owners or operators of seasonal facilities, prior to opening to the public, shall certify to the cabinet, in writing, that the facility is in compliance with the requirements of this administrative regulation, except if the cabinet has made an inspection prior to its opening. For seasonal facilities, the cabinet shall make at least two (2) full facility inspections during the operating season. The cabinet may require one (1) of the full facility inspections to be performed prior to a facility's opening.
(b) The facility owner or operator shall be responsible for notifying the cabinet of the proposed opening date.
(2) Continuous operation indoor facilities shall receive a full facility inspection by the cabinet at least once each six (6) months.
(3) Facilities shall be inspected at a minimum of once each thirty (30) day period by the cabinet on a monitoring basis. The monitoring inspection shall consist of:
(a) Disinfectant residual testing and combined disinfectant in ppm;
(b) pH testing;
(c) Total alkalinity testing;
(d) Cyanuric acid testing, if cyanuric acid stabilizers are used;
(e) Turbidity assessment;
(f) Temperature testing, if heated water facility;
(g) Review of operator's daily log;
(h) Visual scanning for algae or debris; and
(i) Other checks as necessary.
(4) The cabinet may make as many additional inspections and reinspections as necessary for the enforcement of this administrative regulation.
(5) If an agent of the cabinet makes an inspection of a public swimming and bathing facility, the findings shall be recorded on the DFS-349, Public Swimming and Bathing Facilities Inspection Report and a copy provided to the facility owner or operator. The inspection report shall:
(a) Set forth any violation observed;
(b) Establish a specific and reasonable period of time for the correction of the violation observed; and
(c) State that failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in closure of the facility.
Section 15. Water Sampling and Testing.
(1) A water sample may be collected from facilities if inspections or monitoring indicates water quality standards are not being maintained, or there is a suspected water borne disease outbreak. These samples shall be submitted to the Division of Laboratory Services in an approved container and by approved sampling procedures for analysis.
(2) Samples shall be collected and analyzed for any of the following or other contaminants:
(a) Total coliform;
(b) E. coli; and
(c) Pseudomonad organisms.
(3) If a sample tests positive for a contaminant, the test shall be repeated within one (1) to seven (7) days.
(4) For a facility, no more than two (2) consecutive samples shall be positive for:
(a) More than two (2) coliform organisms per 100 milliliter (mL);
(b) Pseudomonas organisms; or
(c) E. coli.
(5) Additional samples may be requested to ensure compliance with this administrative regulation.
Section 16. Bacteriological Quality of Facility Water. No more than two (2) consecutive samples shall:
(1) Contain more than 200 bacteria per mL;
(2) Have a positive confirmatory test for coliform organisms in any of the five (5) ten (10) mL portions of a sample or more than two (2) coliform organisms per 100 mL if the membrane filter test is used;
(3) Have a positive confirmatory test for pseudomonas organisms; or
(4) Have a positive test for fecal coliform organisms.
Section 17. Conditions requiring Closure of a Facility and Enforcement Provisions.
(1) The cabinet shall immediately order the closure of a facility and prohibit any person from using the facility by written notice to the facility owner or operator if:
(a) There is an immediate danger to health or safety;
(b) There are violations of the Virginia Graeme Baker Pool and Spa Safety Act, 15 U.S.C. 8001 et seq.;
(c) The water does not conform to the bacteriological standards contained in this administrative regulation;
(d) Turbidity levels of facility water do not meet the requirements of Section 8(4) of this administrative regulation;
(e) The disinfectant residual is outside the range prescribed in this administrative regulation;
(f) The pH is outside the range prescribed by this administrative regulation;
(g) The cyanuric acid level exceeds fifty (50) ppm;
(h) There is no pool operator available;
(i) There has been a fecal accident in the pool;
(j) The owner, operator, an employee, or representative of the owner interferes with duly authorized agents of the cabinet who bear proper identification, in the performance of their duties;
(k) If recirculation systems, filtration systems, or disinfectant systems are not in operation, with exceptions for maintenance and seasonal shut down, or replaced without prior approval; or
(l) If serious or repeated violations of any of the requirements of 902 KAR 10:120 or 902 KAR 10:125 are found.
(2) The notice shall state the reasons prompting the closing of the facility, and a copy of the notice shall be posted conspicuously at the facility by the owner or operator.
(3) Any owner or operator affected by an order may request an administrative conference in accordance with 902 KAR 1:400.
(4) If the conditions rendering closure are abated or further analyses prove to not render closure, the cabinet may authorize reopening the facility.
(5) In all other instances of a violation of the provisions of this administrative regulation the cabinet shall serve upon the owner or operator a written notice specifying the violation in question and afford a reasonable opportunity to correct the violation. An owner or operator who fails to comply with any written notice issued under the provisions of this administrative regulation shall be notified in writing that the facility shall be closed at the end of ten (10) days following service of the notice, unless a written request for a conference pursuant to 902 KAR 1:400 is filed with the cabinet by the owner or operator within the ten (10) day period.
(6) All administrative hearings shall be conducted in accordance with KRS Chapter 13B.
(7) Any person whose facility has been closed may, at any time, make application for a reinspection for the purpose of reopening the facility. Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his or her opinion the conditions causing closure of the facility have been corrected, the cabinet shall make a reinspection. If the facility is found to be in compliance with the requirements of this administrative regulation, the facility shall be reopened.
(8)
(a) For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with the agents of the cabinet in the performance of their duties, the facility may be permanently closed after an opportunity for a conference has been provided in accordance with 902 KAR 1:400.
(b) Prior to the action, the cabinet shall notify the owner or operator, in writing, stating the reasons for which the facility is subject to closure and advising that the facility shall be permanently closed at the end of ten (10) days following service of the notice unless a request for a conference is filed with the cabinet by the owner or operator, within the ten (10) day period.
Section 18. Existing Facilities and Equipment.Existing facilities and equipment being used prior to the effective date of this administrative regulation that do not fully meet the design, construction, and materials requirements of this administrative regulation, may continue to be used if the facilities and equipment:
(1) Are in good repair;
(2) Are capable of being maintained in a sanitary condition;
(3) Meet facility water quality standards; and
(4) Create no health or safety hazard.
Section 19. Effect on Local Administrative Regulations. Compliance with this administrative regulation shall not relieve any person from compliance with any other state or local laws dealing with pool operation and maintenance matters or zoning requirements that may also be applicable.
Section 20. Incorporated by Reference.
(1) The following material is incorporated by reference:
(a) "DFS-349, Public Swimming and Bathing Facilities Inspection Report", 12/2024; and
(b) "DFS-352 Swimming Pool Log Sheet", 5/2021.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and online at https://chfs.ky.gov/agencies/dph/dphps/emb/Pages/pools.aspx.
History
- RELATES TO: KRS Chapter 13B, 211.015, 211.205, 211.990(2), 15 U.S.C. 8003
- STATUTORY AUTHORITY: KRS 194A.050, 211.180(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. KRS 194A.050(2) authorizes the secretary to promulgate regulations to establish a fee schedule for permitting and annual inspection of efforts regarding compliance with program standards administered by the cabinet. KRS 211.180 requires the cabinet to adopt administrative regulations relating to public facilities and their operation and maintenance in a safe and sanitary manner to protect public health and prevent health hazards. This administrative regulation establishes uniform standards for public swimming pools and bathing facilities.
- History: 13 Ky.R. 2177; 14 Ky.R. 214; eff. 8-5-1987; 17 Ky.R. 480; 1377; eff. 9-19-1990; 22 Ky.R. 2378; eff. 8-1-1996; Crt eff. 10-2-2019; TAm eff. 3-20-2020; 48 Ky.R. 638, 1734, 2419, 2735; eff. 7-20-2022; 51 Ky.R. 385, 1151, 1457; eff. 2-13-2025.
902 KAR 10:123 Kentucky public swimming and bathing facilities construction requirements {#sec-902-kar-10-123 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:123}
Section 1. Definitions.
(1) "Accessible" means having access to a fixture, connection, appliance or equipment, even if it is necessary to remove an access panel, door, or similar obstruction.
(2) "Agitation" means the mechanical or manual movement to dislodge the filter aid and dirt from the filter element.
(3) "Air gap" means the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet conveying water or waste to a tank, plumbing fixture, receptor, or other device, and the flood level rim of the receptacle.
(4) "Approved" means that which is acceptable to the cabinet.
(5) "Backwash" means the flow of water through the filter element or media in the reverse direction sufficient to dislodge the accumulated dirt and filter aid and remove them from the filter tank.
(6) "Backwash cycle" means the time required to backwash the filter system thoroughly.
(7) "Backwash rate" means the rate of application of water through a filter during the backwash cycle expressed in gallons per minute per square foot of effective filter area.
(8) "Bather" means a person using a public swimming and bathing facility.
(9) "Cabinet" is defined by KRS 211.015(1)(a).
(10) "Cartridge filter" means a filter that utilizes a porous cartridge as its filter media.
(11) "Diatomaceous earth (DE) filter" means a filter that utilizes a thin layer of diatomaceous earth as its filter media that will need to be periodically replaced.
(12) "Disinfectant" means an approved chemical compound designed for the destruction of pathogenic organisms in bathing facilities and includes chlorine and bromine.
(13) "Equalizer line" means the connection from the skimmer housing to the pool, spa, or hot tub below the weir box that:
(a) Is sized to satisfy pump demand and prevent air lock or loss of prime; and
(b) Contains a float valve assembly and pop-up valve.
(14) "Facility operator" means a person or employee of that person who is responsible for the proper operation and maintenance of the facility.
(15) "Filter" means a device that separates solid particles from water by recirculating it through a porous substance.
(16) "Filtration rate" means the rate of water flow through a filter while in operation.
(17) "Flow meter" means a device that measures the flow of water through piping.
(18) "Head loss" means the total pressure drop between the inlet and the outlet of a component.
(19) "Holding tank" means a storage vessel to retain water for a spray pad recirculation system.
(20) "Hydrojet" means a fitting which blends air and water, creating a high velocity, turbulent stream of air enriched water.
(21) "Inlet" means a fitting or fixture through which filtered water returns to a pool or spa.
(22) "Main outlet" means an outlet fitting at the deepest point of the horizontal bottom of a pool through which water passes to a recirculating pump or surge tank, and is often referred to as a "main drain".
(23) "Modulating valve" means a valve that automatically regulates the flow of water from the main drain through the use of a float ball.
(24) "Perimeter overflow system" means a channel at normal water level that extends completely around the pool perimeter and is used to remove surface debris, also known as an overflow or scum gutter.
(25) "Perlite filter" means a filter that utilizes a thin layer of perlite as its filter media deposited on a septum that needs to be periodically replaced.
(26) "Play feature" means a structure or feature that is added to a pool for the purpose of entertainment.
(27) "Plunge pool" means a pool or area within a pool designed as the termination point for a water slide or water ride.
(28) "Positive shutoff valve" means a valve that completely stops the flow of water.
(29) "Precoat" means the process of depositing a layer of diatomaceous earth or perlite on the filter element at the start of a filter cycle.
(30) "Public swimming and bathing facility" means a natural or artificial body or basin of water that is modified, improved, constructed, or installed for the purpose of swimming or bathing, except for a pool at a private single family residence intended only for the use of the occupant and guests.
(31) "Readily accessible" means direct access without the necessity of removing any panel, door, or similar obstruction.
(32) "Skimmer" means a device designed to continuously remove surface film and water and return it through the filter.
(33) "Splash pad" means an area that:
(a) Has aquatic play features that spray or drop water for the purpose of wetting people;
(b) Is designed so that there is no accumulation or ponding of water on the ground;
(c) Includes both recirculating and non-recirculating water systems; and
(d) Includes splash pads operated by local governments as defined in KRS 211.205.
(34) "State Building Code" means the requirements established in 815 KAR 7:120.
(35) "State Plumbing Code" means the requirements established in 815 KAR Chapter 20.
(36) "Strainer" means a device used to remove hair, lint, leaves, or other coarse material on the suction side of a pump.
(37) "Suction piping" means that portion of the circulation piping located between the facility structure and the inlet side of a pump.
(38) "Surge tank" means a storage vessel within the pool recirculation system used to retain the water displaced by bathers.
(39) "Total discharge head" means the amount of water that a pump will raise water above its center line.
(40) "Total dynamic head" means the arithmetical difference between the total discharge head and total suction head (a vacuum reading is considered as a negative pressure). This value is used to develop the published performance curve.
(41) "Total suction head" means the amount of water that a pump will lift by suction.
(42) "Turnover rate" means the time requirements, in hours or minutes, for the circulation system to filter and recirculate a volume of water equal to the facility volume.
(43) "Wading pool" means a pool or area within a pool where the water depth is twenty- four (24) inches or less.
Section 2. Submission of Plans and Specifications for Approval.
(1) A person shall not construct, alter, or reconstruct a public swimming and bathing facility until approval of detailed plans and specifications, with supporting design data as required in this administrative regulation, is granted in writing by the state or local agency having jurisdiction.
(2) The original plans and five (5) copies shall be submitted to the local health department with payment pursuant to Section 3 of this administrative regulation.
(3) The front page of the plans submitted for review and approval shall contain the:
(a) Name of the swimming and bathing facility;
(b) Location by city and county;
(c) Name and contact information for the facility owner;
(d) Name of the installer; and
(e) Name of the engineer, architect, or person preparing the plans.
(4) Plans submitted by an engineer or architect licensed in the state of Kentucky shall bear the individual's official seal.
(5) Plans and specifications on public swimming and bathing facilities constructed by the state or local government, or for a facility with surface area greater than 1,600 square feet, shall be prepared by an engineer or architect registered in the State of Kentucky.
(6) The plans shall be:
(a) Drawn to scale;
(b) Accompanied by proper specifications to permit a comprehensive review of the plans, including the piping and hydraulic details; and
(c) Include:
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A site plan of the general area with a plan and sectional view of the facility complex with all necessary dimensions;
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A piping diagram showing all appurtenances including treatment facilities in sufficient detail, as well as pertinent elevation data, to permit a hydraulic analysis of the system;
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The specifications on all treatment equipment, including performance ranges of pumps, disinfecting equipment, chemical feeders, filters, strainers, lights, skimmers, suction outlets or return inlets, diving boards, safety equipment, and other related equipment;
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A drawing of the equipment room showing the placement of equipment; and
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Appropriate fees required by Section 3 of this administrative regulation.
(7) One (1) set of approved plans shall be kept at the job site and available for inspection.
(8) Upon completion of recirculation piping system construction and prior to the piping being tested for air pressure at ten (10) pounds per square inch of pressure for fifteen (15) minutes and covered, the owner or builder shall contact the cabinet for an inspection.
(9) Upon completion of construction, a notarized statement certifying the facility was constructed in accordance with the approved plans and this administrative regulation shall be submitted to the cabinet.
(10) The facility shall not be used before receiving a final inspection and written approval from the cabinet, as well as any other affected state and local regulatory agencies. It shall be the owner or operator's responsibility to notify the cabinet and other involved agencies of construction completion and call for inspection.
(11) Unless construction is begun within one (1) year from the date of approval, the approval shall expire. Extension of approval may be considered upon written request to the cabinet.
(12) A change in location, construction, design, materials, or equipment shall not be made to approved plans or the facility without the written approval of the cabinet.
Section 3. Fees for Plan Review and Construction Inspection.
(1) A fee shall be required for all plan reviews and construction inspections by the cabinet or the local health department to determine compliance with this administrative regulation.
(2) The fee for plan review shall be calculated as follows:
(a) Swimming and bathing facility plan review for gutter pools, the fee shall be $346.50;
(b) Swimming and bathing facility plan review for skimmer pools, the fee shall be $173.25; and
(c) Swimming and bathing facility plan review for minor reconstruction, the fee shall be $115.50.
(3) The fee required shall include $82.50 for interactive water features.
(4) The fee for swimming and bathing facility construction inspection shall be calculated as follows:
(a) Pre-renovation evaluation/consultation, the fee shall be $231.00;
(b) Rough-in construction inspection, the fee shall be $115.50; and
(c) Final construction inspection, the fee shall be $173.25.
(5) The plan review and construction inspection fees required by this section shall be paid to the Kentucky Department for Public Health by check or money order made payable to the Kentucky State Treasurer.
Section 4. Water Supplies.
(1) Potable water from an approved municipal water system or water district shall be supplied to all public swimming and bathing facilities. If these supplies are not available, a potable water supply meeting the approval of the Energy and Environment Cabinet shall be provided.
(2) The water supply shall be capable of providing:
(a) Sufficient quantities of water under pressure to all water-using fixtures and equipment at the facility; and
(b) Enough water to raise the water level by at least one (1) inch in three (3) hours in:
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Swimming, diving, or wave pools; and
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Water slide plunge pools.
Section 5. Sewage and Wastewater Disposal.
(1) Sewage or wastewater generated from the operation of a public swimming and bathing facility shall discharge to a public sanitary sewer.
(2) If a public sanitary sewer is not available, sewage or wastewater shall be discharged to a system that complies with 902 KAR 10:085.
(3) Outdoor deck or surface area drainage water may be discharged directly to storm sewers, natural drainage areas, or to the ground surface without additional treatment. This drainage shall not result in nuisance conditions that create an offensive odor, a stagnant wet area, or an environment that allows for the breeding of insects.
(4) Filter backwash shall be discharged to public sanitary sewers, or if unavailable, to a system approved by the cabinet.
Section 6. Facility Design and Construction.
(1) All public swimming and bathing facilities, and attendant structures, such as bathhouses, dressing rooms, or restrooms, except for beach areas at bathing beaches, shall meet the design, materials, fixture, and construction requirements of 815 KAR 7:120 and 815 KAR Chapter 20.
(2) Depth markings and lane lines.
(a) On all facilities other than beaches, the depth of the water shall be marked plainly at or above the water surface on the vertical wall of the facility, if possible, and on the edge of the deck next to the facility. Depth markers shall be placed at the following locations:
-
At the points of maximum and minimum depths;
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At the point of change of slope between deep and shallow portions or transition point;
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At intermediate two (2) feet increments of water depth; and
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If the facility is designed for diving, at appropriate points to denote the water depths in the diving area.
(b) Depth markers shall be spaced so that the distance between adjacent markers is not greater than twenty-five (25) feet as measured peripherally.
(c) Depth markers shall be in Arabic numerals at least four (4) inches high and of a color contrasting with the background. If depth markers cannot be placed on the vertical walls at or above the water level, other means shall be used, so that markings shall be plainly visible to persons in the facility.
(d) Lane lines or other markings on the bottom of the facility shall be a minimum of ten (10) inches in width and be of a contrasting color.
(3) A safety line supported by buoys shall be provided across the section of the pool where the break between the shallow and deep water occurs (five (5) feet) except if the pool is being used for organized activities or during operation as a wave pool. The line shall be placed one (1) foot toward the shallow end from where the break occurs.
(4) The hydrojet auxiliary air or water pump for a spa shall be controlled by an on-off switch with a fifteen (15) minute timer located and labeled at least five (5) feet away from the spa.
(5) All facilities shall provide an emergency automatic pump shut off located adjacent to the telephone.
Section 7. Facility Water Treatment Systems.
(1)
(a) A recirculation system, consisting of pumps, piping, filters, water conditioning, disinfection equipment, and other accessory equipment shall be provided to clarify, chemically balance, and disinfect the water for all swimming and bathing facilities, except bathing beaches.
(b) All system components, including piping, shall bear the NSF International (NSF) potable water (NSF-pw) mark.
(c) All pool equipment systems shall be certified to NSF or American National Standards Institute (ANSI) 50 standards by an ANSI accredited certification body.
(d) Pumps greater than seven and five-tenths (7.5) horse power that are not required to meet NSF testing standards shall be considered on a case-by-case basis.
(2) Pumping equipment.
(a) The recirculation pump and motor shall deliver the flow necessary to obtain the turnover required in the table in paragraph (b) of this subsection. A valve for flow control and a flow meter shall be provided in the recirculation pump discharge piping.
(b) The turnover rate shall be:
(c) Higher flow rates may be necessary in pools with skimmers so that each skimmer shall have a minimum flow rate of thirty (30) gallons per minute.
(d) The pump shall be of sufficient capacity to provide a minimum backwash rate of fifteen (15) gallons per square foot of filter area per minute in sand filter systems.
(e) The pump or pumps shall supply the required recirculation rate of flow to obtain the turnover rate required at a total dynamic head of at least:
-
Fifty (50) feet for all vacuum filters;
-
Seventy (70) feet for pressure sand or cartridge filters; or
-
Eighty (80) feet for pressure diatomaceous earth filters and perlite filters.
(f) If the pump is located at an elevation higher than the facility water line, it shall be self-priming.
(g) If vacuum filters are used, a vacuum limit control shall be provided on the pump suction line. The vacuum limit switch shall be set for a maximum vacuum of eighteen (18) inches of mercury.
(h) A compound vacuum-pressure gauge or vacuum gauge shall be installed on the suction side of the pump.
(i) A pressure gauge shall be installed on the pump discharge line adjacent to the pump.
(j) Valves shall be installed to allow the flow to be shut off during cleaning, switching baskets, or inspection of hair and lint strainers.
(k) A hair or lint strainer with openings no more than one-eighth (1/8) inch is required except for pumps that are used with vacuum filter systems.
(3) Water heaters shall be installed at all indoor swimming and bathing facilities, and shall comply with the following:
(a) A water heater piping system shall be equipped with a bypass. A valve shall be provided at the bypass and on the influent and effluent heater piping. The influent and effluent heater piping shall be metallic and installed in accordance with heater manufacturer's recommendations;
(b) A heating coil, pipe, or steam hose shall not be installed in any swimming and bathing facility;
(c) Thermometers shall be provided in the piping to check the temperature of the water returning from the facility and the temperature of the blended water returning to the facility;
(d) An automatic temperature limiting device with thermostatic control that prevents the introduction of water in excess of 100 degrees Fahrenheit to swimming and diving pools and in excess of 104 degrees Fahrenheit for spas shall be provided and shall be accessible only to the facility operator;
(e) A pressure relief valve shall be provided and shall be piped to within six (6) inches of the floor;
(f) Venting of gas or other fuel burning water heaters shall be provided in accordance with the State Building Code;
(g) Heaters for indoor swimming and diving pools shall be capable of maintaining an overall pool water temperature between seventy-six (76) degrees Fahrenheit and eighty-four (84) degrees Fahrenheit;
(h) Combustion and ventilation air shall be provided for fuel burning water heaters in accordance with manufacturer recommendations or the State Building Code;
(i) Heaters for indoor swimming and diving pools shall be sized on a basis of 150 British Thermal Units per hour input per square foot of pool water surface area; and
(j) All heaters shall meet the latest standards of applicable recognized testing agencies.
(4) A flow meter shall be:
(a) Located so that the rate of recirculation may be easily read;
(b) Installed on a straight length of pipe at a distance of at least ten (10) pipe diameters downstream, and five (5) pipe diameters upstream from any valve, elbow, or other source of turbulence, except for those specifically designed without separation parameters; and
(c) Installed on each recirculation system, splash pad feature, waterslide, any other type of spray feature, and on multiple filtration units, except at government-owned, non-recirculating splash pads.
(5) Vacuum cleaning system.
(a) A vacuum cleaning system shall be:
-
Provided for all facilities except beaches; and
-
Capable of reaching all parts of the facility bottom.
(b) A vacuum system that utilizes the attachment of a vacuum hose to the suction piping through the skimmer may be provided.
(c)
- If the vacuum cleaning system is an integral part of the facility recirculation system, a wall fitting shall be provided:
a. Eight (8) to twelve (12) inches below the normal water level; and
b. With a cap or plug that is not removable by bathers.
- Piping from this connection shall be:
a. To the suction side of the pump ahead of the hair and lint strainer;
b. At least one and one-half (1.5) inches in diameter; and
c. Equipped with a control valve near the junction with the pump suction line.
- The size of the vacuum hose shall be at least one and one-half (1.5) inches in diameter and be of sufficient strength to prevent collapsing and allow adequate flow for proper cleaning.
(d) Automatic vacuum systems may be used to supplement the built-in vacuum system provided they are capable of removing all debris from the facility bottom.
(e) Vacuum systems shall only be used if the facility is closed to bathers.
(6) Piping, skimmer, and overflow system.
(a) Piping shall comply with the material specifications listed in the Kentucky State Plumbing Code for potable water.
(b) All piping, valves, and fittings shall be color coded, suitably labeled, or marked to denote its purpose within the facility water treatment system.
(c) The piping shall be designed to carry the required quantities of water at velocities not exceeding five (5) feet per second in suction piping and ten (10) feet per second in pressure piping.
(d) Gravity piping shall be sized so that the head loss in piping, fittings, and valves does not exceed the difference in water levels between the facility and the maximum operating level in the surge or filter tank.
(e) The following waste lines shall be provided with six (6) inch air gaps at their points of discharge to the waste pump or sewer:
-
Main outlet bypass or other connections to waste;
-
Surge tank drain and overflow lines;
-
Pump discharge to waste lines; and
-
Gutter bypass to waste lines.
(7) Inlets.
(a) Each inlet shall be directionally adjustable.
(b) The velocity of flow through any inlet orifice shall be in the range of five (5) to twenty (20) feet per second, except that facilities equipped with skimmers shall have a velocity of flow in the range of ten (10) to twenty (20) feet per second.
(c) Inlets shall be located and directed to produce uniform circulation of water to facilitate the maintenance of a uniform disinfectant residual throughout the entire facility without the existence of dead spots.
(d) Inlets in facilities with skimmers shall be twelve (12) inches below the midpoint on the skimmer throat.
(e) Inlets in facilities with a prefabricated perimeter overflow system shall be eight (8) inches or more below the lip of the gutter.
(f) Inlets shall be placed completely around the pool with each serving a linear distance of not more than fifteen (15) feet on center. The pipe serving the inlets shall form a loop completely around the pool, with no reduction in loop pipe sizing.
(g) The number of inlets shall be determined by dividing the perimeter of the pool measured in feet, by fifteen (15). Any fraction thereof may represent one (1) additional inlet.
(h) Pools greater than forty-five (45) feet wide shall be equipped with floor inlets in a grid pattern located no more than seven and five-tenths (7.5) feet from a wall and no more than fifteen (15) feet apart. The grid shall form a continuous loop with no reduction in loop pipe sizing.
(i) A minimum of two (2) inlets is required on all pools, holding tanks, and bathing facilities, regardless of size.
(j) At least one (1) inlet shall be located in each recessed stairwell or other space if water circulation may be impaired.
(k) Prefabricated perimeter overflow systems shall be approved on a case-by-case basis by the cabinet.
(8) Outlets.
(a) All facilities, including holding tanks, shall be provided with a minimum of two (2) main outlets at the deepest horizontal point plumbed in parallel to permit the facility to be completely and easily drained.
(b) Openings and grates shall:
-
Conform to 15 U.S.C. 8003;
-
Be covered by a proper grating that is not removable by bathers;
-
Be at least four (4) times the area of the main outlet pipe;
-
Have sufficient area so that the maximum velocity of the water passing through the grate does not exceed one and one-half (1.5) feet per second at maximum flow; and
-
Have a maximum grate opening width of one-fourth (1/4) inch.
(c) Additional outlets shall be provided in all facilities where the width of the facility is more than sixty (60) feet. In these cases, outlets shall be spaced not more than thirty (30) feet apart, nor more than fifteen (15) feet from side walls, and shall be connected in parallel, not series.
(d) A hydrostatic relief valve may be provided for in-ground swimming and diving pools. Subsurface drainage, if provided, shall not be directly connected to a sanitary sewer.
(e) Main outlet piping shall be sized for water removal at a rate of at least 100 percent of the design recirculation flow rate and at velocities specified in subsection (6)(c) of this section. It shall function as a part of the recirculation system. The piping system shall be valved to permit adjustment of flow through it.
(9) Perimeter overflow systems.
(a) Swimming and bathing facilities with a water surface area greater than 1,600 square feet shall have a continuous perimeter overflow system.
(b) A perimeter overflow system shall:
-
Extend completely around the facility;
-
Permit inspection, cleaning, and repair;
-
Be designed so that no ponding or retention of water occurs within any portion of the system;
-
Be designed to prevent entrapment of bathers or the passage of small children into an enclosed chamber;
-
Have an overflow lip which is rounded, provides a good handhold, and is level within two-tenths (0.2) inch;
-
Provide for the rapid removal of all water and debris skimmed from the pool's surface;
-
Be designed for removal of water from the pool's upper surface at a rate equal to 100 percent of the design turnover flow rate;
-
Discharge to the recirculation system;
-
Be provided with a minimum of two (2) outlet pipes that shall not allow the overflow channel to become flooded if the facility is in normal use;
-
Require additional outlet pipes provided at one (1) per 150 lineal feet of perimeter overflow system or fraction thereof; and
-
Have drain gratings with surface area at least equal to two (2) times the area of the outlet pipe.
(10) All facilities that have perimeter overflow systems shall have a net surge capacity of at least one (1.0) gallon per square foot of water surface area. Surge capacity shall be provided either in a vacuum filter tank, surge tank, or a combination of these. Main drain piping shall terminate eighteen (18) inches above the surge tank floor and be equipped with a modulating valve and a positive shutoff valve. Surge capacity for a diatomaceous earth (DE) filter is measured eighteen (18) inches above the filter media and the bottom of the gutter pipe.
(11) Skimmers are permitted on facilities whose width does not exceed thirty (30) feet and whose water surface area is 1,600 square feet or less. If skimmers are used, the following shall be met:
(a) At least one (1) skimmer shall be provided for each 500 square feet of water surface area or fraction thereof with a minimum of two (2) skimmers provided, except for spas, holding tanks, or wading pools with a water surface area of 144 square feet or less, which shall require a minimum of one (1) skimmer.
(b) Skimmers shall be located to minimize interference with each other.
(c) The rate of flow per skimmer shall not be less than thirty (30) gallons per minute, and all skimmers shall be capable of handling at least eighty (80) percent of required flow rate.
(d) Surface skimmer piping shall have a separate valve in the equipment room to permit adjustment of flow.
(e) Each skimmer shall be provided with an equalizer line at least one and one-half (1.5) inches in diameter, located at least one (1) foot below the lowest overflow level of the skimmer, and be provided with a self-closing valve and cover that conforms to 15 U.S.C. 8003.
(f) All overflow water shall pass through a basket that may be removed without the use of tools.
(g) All pools not equipped with a perimeter overflow system shall have a smoothly contoured handhold coping not over two and one-half (2.5) inches thick for the outer two (2) inches or an equivalent approved handhold. The handhold shall be no more than nine (9) inches above the normal water line.
(12) All facilities shall be equipped for the addition of make-up water from a potable water source pursuant to the following:
(a) Discharge through an air gap of at least six (6) inches to a surge tank or a vacuum filter tank. If make-up water is added directly to the facility, the fill-spout shall be located under or immediately adjacent to a ladder rail, grab rail, or lifeguard platform. If added to a surge tank or vacuum filter tank, the six (6) inch air gap shall be measured above the top lip of the tank; and
(b) Through piping with vacuum breaker, antisiphon, or other protection as specified by the State Plumbing Code.
(13) Filtration.
(a) Filters shall comply with the following:
- Pressure filters shall have:
a. Pressure gauges;
b. An observable free fall, or a sight glass installed on the backwash discharge line; and
c. A manual air-relief valve at the high point;
-
The filter backwash disposal facility shall have sufficient capacity to prevent flooding during the backwash cycle;
-
All filters shall be designed so that they may be completely drained. Filters shall be drained through a six (6) inch air gap to a pump or sanitary sewer; and
-
Filter media shall be listed as NSF approved.
(b) Each facility shall have separate filtration and treatment systems.
(c) Filter equipment and treatment systems shall operate continuously twenty-four (24) hours per day, except if the facility is closed for repairs or at the end of the swimming season.
(d) Rapid sand or gravity sand filters shall be designed for a filter rate not to exceed three (3) gallons per minute per square foot of bed area at time of maximum head loss with sufficient area to meet the design rate of flow required by the prescribed turnover.
(e) At least eighteen (18) inches of freeboard shall be provided between the upper surface of the filter media and the lowest portion of the pipes or drains that serve as overflows during backwashing.
(f) The filter system shall be designed with necessary valves and piping to permit filtering to the pool.
(g) High rate sand filters. The design filtration rate shall be a minimum of five (5) gallons per minute per square foot of filter area. The maximum design filtration rate shall be the lesser of fifteen (15) gallons per minute per square foot of filter area or seventy-five (75) percent of the NSF listed filtration rate. The backwash rate shall be fifteen (15) gallons per minute per square foot of filter area.
(h) Diatomaceous earth filters shall comply with the following requirements:
-
The design filtration rate shall not exceed one and one-half (1.5) gallons per minute per square foot of filter area on diatomaceous earth filters, except that the rate of filtration may be increased to two (2) gallons per minute per square foot of filter area if continuous feeding of diatomaceous earth is employed;
-
A precoat pot shall be provided on the pump suction line for pressure diatomaceous earth systems. All diatomaceous earth filter systems shall have piping arranged to allow recycling of the filter effluent during precoating;
-
If equipment is provided for the continuous feeding of diatomaceous earth to the filter influent, the equipment shall have a capacity to feed at least one and one-half (1.5) ounces of this material per square foot of filter area per day;
-
Overflow piping on vacuum diatomaceous earth filters shall be provided on the filter tank to discharge overflow water;
-
All filters shall be equipped for cleaning by one (1) or more of the following methods:
a. Backwashing;
b. Air-pump assist backwashing;
c. Spray wash;
d. Water pressure to wash vacuum filter; or
e. Agitation; and
- Perlite may be used in filters listed by NSF for perlite, but it may not be substituted for diatomaceous earth without NSF listing.
(i) Vacuum sand filters shall comply with the following requirements:
-
The design filtration rate shall be seventy-five (75) percent of that listed by NSF or fifteen (15) gallons per minute, whichever is lesser. The backwash rate shall be at fifteen (15) gallons per minute per square foot of filter area; and
-
Overflow piping shall be provided in order to drain overflow water.
(j) Cartridge filters shall comply with the following requirements:
-
Cartridge filters shall not be used on facilities with a capacity larger than 80,000 gallons;
-
Cartridge filters shall only be used on indoor pools;
-
The design filtration rate shall not exceed fifteen hundredths (0.15) gallons per minute per square foot of filter surface area; and
-
A clean duplicate set of cartridges shall be maintained at the facility.
(14) Disinfectant and chemical feeders.
(a) The minimum chemical feed equipment required at any facility shall include a unit for feed of a disinfectant and a unit for feed of a chemical for pH control.
(b) Equipment capacity.
- Equipment for supplying chlorine or compounds of chlorine shall be of sufficient capacity to feed the chlorine at a rate of:
a. Eight (8) ppm or two and seven-tenths (2.7) pounds per day chlorine gas or its equivalent for each 10,000 gallons of pool volume for outdoor facilities; or
b. Three (3) ppm or one (1) pound per day for chlorine gas or its equivalent for each 10,000 gallons of pool volume for indoor facilities based on the turnover rates specified in subsection (2)(b) of this section.
-
The equipment for supplying chlorine shall not be controlled by a day-date clock.
-
The injection point for chlorine shall be placed on the discharge side of the pump and downstream of the flow meter unless the chlorine injection point is located within the surge tank.
-
Pot feeders for supplying bromochlorodimethylhydantoin sticks shall contain at least five tenths (0.50) a pound of bromochlorodimethylhydantoin per thousand gallons of facility capacity, or fraction thereof. The feeder shall have a method of feed rate adjustment.
-
Supplemental NSF listed ultraviolet (UV) light disinfection systems:
a. Shall be:
(i) Provided on all splash pads with a recirculating water system;
(ii) Installed on a bypass line; and
(iii) Equipped with a flow indicator; and
b. May be used on other facilities as supplemental disinfection.
-
Ozone may be used as a supplement to chlorination or bromination. Ozonation equipment shall be considered by the cabinet on a case-by-case basis.
-
More than one (1) gram per day of ozone per ten (10) gallons per minute of flow rate shall not be allowed. The ambient air ozone concentration shall be less than five hundredths (.05) ppm at all times either in the vicinity of the ozonator or at the pool water surface.
(c) If positive displacement pumps, or hypochlorinators, are used to inject the disinfectant solution into the recirculation line, they shall be of variable flow type and shall be of sufficient capacity to feed the amount of disinfectant required by paragraph (b)1 of this subsection. If calcium hypochlorite is used, the concentration of calcium hypochlorite in the solution shall not exceed five (5) percent. The solution container shall have a minimum capacity equal to the volume of solution required per day at the feed rate required in paragraph (b)1 of this subsection.
(d) Gas chlorinators shall only be used in a pre-existing facility and shall comply with applicable sections of 29 C.F.R. 1910.119.
(e) pH control feeders. All facilities shall install a chemical feeder of positive displacement type for the purpose of applying chemicals to maintain pH of facility water within the range of seven and two-tenths (7.2) to seven and eight-tenths (7.8). A solution tank of adequate capacity shall be provided.
Section 8. Operational Water Quality Standards. Operational water quality shall comply with 902 KAR 10:120.
Section 9. Equipment Rooms. Equipment rooms shall comply with the following requirements:
(1) Equipment necessary for facility operation shall be housed in a lighted, ventilated room that affords protection from the weather, prevents unauthorized access, has ceilings of at least seven (7) feet in height, and is of sufficient size for operation and inspection.
(2) The equipment room floor shall slope toward drains and shall have a nonslip finish.
(3) A hose bib with a vacuum breaker shall be installed in the equipment room.
(4) Suitable space, if not provided in the equipment room, shall be provided for storage of chemicals, tools, equipment, supplies, and records where they may be acquired by the facility operator without leaving the premises. The storage space shall be dry and protected from unauthorized access.
(5) The equipment room and all other storage areas shall be maintained in a clean, uncluttered condition, and shall not be used for storage of materials not essential to operation and maintenance of the facility.
Section 10. Telephones.
(1) All facilities shall have a non-pay landline telephone, or Voice over Internet Protocol (VoIP) telephone, continuously connected to a power source and operational at all times, capable of direct dialing 911 without going through a switchboard located on the deck that is readily accessible and conspicuously located. A cordless telephone shall be prohibited.
(2) All facilities utilizing VoIP telephones shall only use fixed VoIP services.
(3) Instructions for dialing shall be posted if necessary.
(4) The address of the facility and the telephone number of the police department, fire department, emergency medical service, or a hospital shall be posted in a conspicuous place near the telephone.
Section 11. Existing Facilities and Equipment.
(1) Existing facilities and equipment being used prior to the effective date of this administrative regulation that do not fully meet the design, construction, and materials requirements of this administrative regulation, may continue to be used if the facilities and equipment:
(a) Are in good repair;
(b) Are capable of being maintained in a sanitary condition;
(c) Meet facility water quality standards; and
(d) Create no health or safety hazard.
(2) If existing equipment, components, piping, or fittings involved in the facility water treatment system are replaced to effect repairs, the replacement equipment, components, piping, or fittings shall meet the requirements of this administrative regulation. If replacement occurs, it shall be the owner's or operator's responsibility to notify the cabinet as to what was replaced and what was used for a replacement.
Section 12. Effect on Local Administrative Regulations. Compliance with this administrative regulation shall not relieve any person from compliance with any other state or local laws dealing with pool operation and maintenance matters or zoning requirements that may also be applicable.
Section 13. Variances for Construction Requirements.
(1) All facilities shall be constructed or remodeled in compliance with the provisions of this administrative regulation, except that an applicant may request a variance if the cabinet determines that the variance shall not seriously affect the safe and healthful operation of the facility.
(2) Before granting a variance, the cabinet shall require documentation from the applicant that the requested variance shall comply with the basic intent of this administrative regulation and that a safety or health hazard shall not be created if the variance is granted.
History
- RELATES TO: KRS 211.015, 211.090, 211.205, 211.210, 211.220, 211.990(2), 29 C.F.R. 1910.119, 15 U.S.C. 8003
- STATUTORY AUTHORITY: KRS 194A.050, 211.180
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.180 requires the cabinet to adopt administrative regulations relating to public facilities and their operation and maintenance in a safe and sanitary manner to protect public health and prevent health hazards. This administrative regulation establishes uniform standards for construction of public swimming pools and bathing facilities.
- History: 51 Ky.R. 441, 1163, 1468; eff. 2-13-2025.
902 KAR 10:125 Kentucky public swimming and bathing facility safety requirements {#sec-902-kar-10-125 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:125}
Section 1. Definitions.
(1) "Bather" means a person using a public swimming and bathing facility.
(2) "Bather load" means all bathers within the public swimming and bathing facility enclosure.
(3) "Cabinet" is defined by KRS 211.015(1)(a).
(4) "Class A" is defined by KRS 211.203(1)(a).
(5) "Class B" is defined by KRS 211.203(1)(b).
(6) "Play feature" means a structure or feature that is added to a pool for the purpose of entertainment.
(7) "Public swimming and bathing facility" or "facility" means a natural or artificial body or basin of water that is modified, improved, constructed, or installed for the purpose of swimming or bathing, except for a pool at a private single-family residence intended only for the use of the occupant and guests.
(8) "Public swimming and bathing facility enclosure" means an enclosure that surrounds and secures the public swimming and bathing facility that includes decking and pool.
(9) "Readily accessible" means direct access without the necessity of removing any panel, door, or similar obstruction.
(10) "Splash pad" means a public swimming and bathing facility that:
(a) Has aquatic play features that spray or drop water for the purpose of wetting people;
(b) Is designed so that there is no accumulation or ponding of water on the ground;
(c) Includes both recirculating and non-recirculating water systems; and
(d) Includes splash pads operated by local governments as defined in KRS 211.205.
(11) "Third-party compliance specialist":
(a) Means a person who is a representative of an incorporated organization that provides lifeguard training and pool safety analysis; and
(b) Does not include:
-
A representative of state and local governments; and
-
An associate of the establishment seeking use of an alternative lifeguard plan.
Section 2. Lifeguards.
(1) Class A and Class B pools that meet the criteria specified in KRS 211.203(2)(a) shall have lifeguards on duty at a rate of one (1) per 100 bathers.
(2) All Class A pools over 2,000 square feet shall have a minimum of one (1) lifeguard on duty at all times the pool is open to bathers.
(3) Additional lifeguards shall be provided at a rate of:
(a) One (1) per 2,000 square feet or major fraction more than half thereof according to the following table:
(b) One (1) per 100 bathers according to the following table:
(4) All Class A and B pools using number of bathers for the lifeguard application rate shall:
(a) Establish a method for tracking bathers entering the facility;
(b) Continuously monitor fluctuating bather load and staff lifeguards accordingly; and
(c) Upon inspection, provide accurate bather load logs to the cabinet.
(5) In accordance with KRS 211.203(4), a swimming coach or instructor may count as a required lifeguard. The swimming coach or instructor shall comply with the requirements of subsection (10)(a) of this section if acting as a required lifeguard.
(6) All facilities that are not required to provide lifeguards shall post and enforce the following rules at all entrance points: "No Lifeguard on Duty" and "A person shall not enter the facility area alone or swim alone."
(7) In accordance with KRS 211.203(2), if a lifeguard is not on duty, features such as induced waves, slides, diving boards, platforms, climbing walls, or other similar features shall not be used. These features shall be either roped off or otherwise blocked for usage, and signage shall clearly indicate that the features shall not be used.
(8) Splash pads shall not be required to provide lifeguards.
(9) A facility may submit an alternative lifeguard staffing plan that:
(a) Has been certified by an independent third-party compliance specialist who witnessed the initial testing to ensure the plan is sufficient to protect patrons;
(b) Designates the number of lifeguards necessary to ensure each lifeguard is capable of viewing the entire area of the assigned zone of patron surveillance;
(c) Ensures the lifeguard is able to reach the farthest extent of the assigned zone of patron surveillance within twenty (20) seconds; and
(d) Includes the following:
-
A description of study methods and calculations used to determine lifeguard zones and placement;
-
Methods and frequency of testing that shall be performed to ensure the plan protects patrons;
-
A complete layout of the pool surface diagrammed with lifeguard placement and assigned zone of surveillance; and
-
A minimum baseline of lifeguards required for safe operation;
(e) The alternative lifeguard staffing plan shall be:
-
On file with the Public Safety Branch within the Department for Public Health;
-
Submitted to the local health department of jurisdiction; and
-
Resubmitted if there is a change in:
a. The shape or size of the swimming pool;
b. The surrounding areas that may obstruct the lifeguard's view of the bottom of the pool; or
c. Ownership of the facility.
(10) Lifeguards shall comply with the following:
(a) Lifeguards, including coaches or instructors serving as lifeguards as described in KRS 211.203(4), shall have a current lifesaving certificate. Current training as a lifesaver or water safety instructor shall be an American Red Cross or equivalent training and include an in-water training component. The certificate of competency shall be onsite and available for inspection upon request;
(b) Lifeguards shall be dressed in swimming attire; and
(c) Lifeguards assigned to the supervision of the facility shall not be subject to duties that may:
-
Distract their attention from proper observation of persons in the facility area; or
-
Prevent immediate assistance to persons in distress in the water.
Section 3. Safety Equipment.
(1) One (1) unit consisting of the following lifesaving equipment shall be provided for 2,000 square feet of water surface area and an additional unit for each additional 2,000 square feet or major fraction more than half thereof:
(a) A U.S. Coast Guard approved ring buoy no more than twenty (20) inches in diameter with a three-sixteenths (3/16) inch rope attached that measures one and one-half (1 1/2) times the maximum pool width;
(b) Rescue tubes that may be used if lifeguards are present; and
(c) A shepherd's hook securely attached to a one (1) piece pole not less than twelve (12) feet in length.
(2) One (1) backboard with head immobilizer and at least three (3) straps for back and neck injuries shall be provided per facility.
(3) All facilities shall be equipped with a minimum of one (1) standard twenty-four (24) unit first aid kit or its equivalent that is kept filled and ready for use. Additional units shall be provided for each additional 2,000 square feet of facility area or major fraction more than half thereof.
(4) Spas with less than 144 square feet of water surface areas shall be exempt from the requirements of subsection (1) and (2) of this section.
(5) Splash pads shall be exempt from the requirements of subsection (1) through (3) of this section.
(6) Lifesaving equipment shall be mounted in conspicuous places at lifeguard chairs or other readily accessible locations. Its function shall be plainly marked, and this equipment shall be kept in repair and ready condition. Bathers or other persons shall not be permitted to tamper with, use for any purpose other than its intended use, or remove this equipment from its established location.
(7) The hydrojet auxiliary air or water pump for a spa shall be controlled by an on-off switch with a fifteen (15) minute timer located and labeled at least five (5) feet away from the spa.
(8) All facilities shall provide an emergency automatic pump shut off readily accessible by facility staff.
Section 4. Emergency Telephones.
(1) All facilities shall have a non-pay landline or Voice over Internet Protocol (VoIP) telephone, continuously connected to a power source and operational at all times, capable of direct dialing 911 without going through a switchboard, and located on the deck in a conspicuous, readily accessible location. A cordless telephone shall be prohibited. Instructions for dialing shall be posted if necessary.
(2) All facilities utilizing VoIP telephones shall only use fixed VoIP services. Non-fixed VoIP services shall be prohibited.
(3) The address of the facility and the telephone number of the police department, fire department, emergency medical service, or a hospital shall be posted in a conspicuous place near the telephone.
Section 5. Reporting Requirements. All drownings, near drownings, and injuries requiring hospitalization shall be immediately reported to the local health department and the Department for Public Health on form DFS-354, Kentucky Public Swimming and Bathing Facilities Drowning and Injury Report.
Section 6. Existing Facilities and Equipment. Existing facilities and equipment being used prior to the effective date of this administrative regulation that do not fully meet the design, construction, and materials requirements of this administrative regulation, may continue to be used if the facilities and equipment:
(1) Are in good repair;
(2) Are capable of being maintained in a sanitary condition; and
(3) Create no health or safety hazard.
Section 7. Variances.
(1) A facility submitting an alternative lifeguard staffing plan pursuant to Section 2(9) of this administrative regulation may submit a request for a variance to the safety equipment requirements of Section 3 of this administrative regulation to the Environmental Management Branch in the Department for Public Health.
(2) The variance requested shall not affect the safe and healthful operation of the facility.
(3) Before granting a variance, the cabinet shall require documentation from the applicant that the requested variance shall comply with the basic intent of Section 3 of this administrative regulation and that a safety or health hazard shall not be created if the variance is granted.
Section 8. Incorporated by Reference.
(1) The "DFS-354, Kentucky Public Swimming and Bathing Facilities Drowning and Injury Report", 3/2024, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and online at https://chfs.ky.gov/agencies/dph/dphps/emb/Pages/pools.aspx.
History
- RELATES TO: KRS 211.015, 211.205
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 211.203
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.180 requires the cabinet to adopt administrative regulations relating to public facilities, and their operation and maintenance in a safe and sanitary manner to protect public health and prevent health hazards. This administrative regulation establishes uniform safety standards for public swimming pools and bathing facilities.
- History: 51 Ky.R. 448, 1170, 1474; eff. 2-13-2025.
902 KAR 10:127 Kentucky public beach requirements {#sec-902-kar-10-127 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:127}
Section 1. Definitions.
(1) "Approved" means that which is acceptable to the cabinet.
(2) "Bather" means a person using a public beach.
(3) "Cabinet" is defined by KRS 211.015(1)(a).
(4) "Facility" means a public beach as defined in subsection (6) of this section.
(5) "Facility operator" means a person or employee of that person who is responsible for the proper operation and maintenance of the facility.
(6) "Public beach" means a natural body of water that is modified or improved for the purpose of swimming or bathing.
(7) "Readily accessible" means direct access without the necessity of removing any panel, door, or similar obstruction.
(8) "State Plumbing Code" means the requirements established in 815 KAR Chapter 20.
(9) "Turbidity" means the state or quality of being clouded or opaque with suspended matter.
Section 2. Submission of Plans and Specifications for Approval.
(1) A person shall not construct, alter, or reconstruct a public beach until approval of detailed plans and specifications, with supporting design data as required in this administrative regulation, is granted in writing by the state or local agency having jurisdiction.
(2) The original plans and five (5) copies shall be submitted to the local health department with payment pursuant to Section 3 of this administrative regulation.
(3) The front page of the plans submitted for review and approval shall contain the:
(a) Name of the public beach;
(b) Location by city and county;
(c) Name and contact information for the facility owner;
(d) Name of the installer; and
(e) Name of the engineer, architect, or person preparing the plans.
(4) Plans shall be submitted by an engineer or architect licensed in the state of Kentucky and bear the individual's official seal.
(5) The plans shall be:
(a) Drawn to scale;
(b) Accompanied by proper specifications to permit a comprehensive review of the plans; and
(c) Include:
-
A site plan of the general area with a sectional view of the facility complex with all necessary dimensions;
-
A diagram showing all appurtenances in sufficient detail, as well as pertinent elevation data, water depths, and slope of the beach below the water line;
-
Indication of the placement of sand or gravel for the beach area; and
-
The fees required by Section 3 of this administrative regulation.
(6) One (1) set of approved plans shall be kept at the job site and available for inspection.
(7) Prior to the issuance of plan and construction approval, the cabinet shall conduct a sanitary survey of the proposed beach. This survey shall include an evaluation of the physical, chemical, and bacteriological characteristics of the public beach area and the watershed.
(8) Upon completion of construction, a notarized statement certifying the facility was constructed in accordance with the approved plans and this administrative regulation shall be submitted to the cabinet.
(9) The facility shall not be used before receiving a final inspection and written approval from the cabinet.
(10) Unless construction is begun within one (1) year from the date of approval, the approval shall expire. Extension of approval may be considered upon written request to the cabinet.
(11) A change in location, construction, design, materials, or equipment shall not be made to approved plans or the facility without the written approval of the cabinet.
Section 3. Plan Review and Construction Inspection Fees.
(1) A fee shall be required for all plan reviews and construction inspections by the cabinet or the local health department.
(2) The fee for plan review shall be calculated as follows:
(a) Public beach plan review, the fee shall be $346.50; and
(b) Include $82.50 for interactive water features or inflatable water features.
(3) The fee for public beach construction inspection shall be calculated as follows:
(a) Pre-construction survey or pre-renovation evaluation, the fee shall be $231;
(b) Rough-in construction inspection, the fee shall be $115.50; and
(c) Final construction inspection, the fee shall be $173.25.
Section 4. Permit and Inspection Fees.
(1) An annual permit fee of $110 for all public beaches shall be:
(a) Paid no later than May 1 each year; and
(b) Paid to the Kentucky Department for Public Health by check or money order made payable to the Kentucky State Treasurer.
(2) Permits shall be nontransferable from one (1) person to another.
(3) Fees for Inspections.
(a) For all public beaches, the annual inspection fee shall be:
-
Assessed according to the linear footage of beach front;
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Calculated as established in this paragraph:
a. 149 or less linear feet, the fee shall be ninety-nine (99) dollars;
b. 150 to 200 linear feet, the fee shall be $192.50; and
c. 201 and above, the fee shall be $192.50 plus fifty-five (55) dollars for each additional fifty (50) linear feet; and
(b) Include $82.50 for interactive or inflatable water features.
(4) A late payment fee of fifty-five (55) dollars shall be assessed on all annual permits not received by May 1 each year.
(5) The inspection fee required by this section shall be:
(a) Paid to the local health department having jurisdiction by check or money order made payable to the Kentucky State Treasurer;
(b) Deposited in the environmental fee account; and
(c) Sent to the Department for Public Health for deposit with the Kentucky State Treasury.
Section 5. Water Quality and Sanitary Requirements for Public Beaches.
(1) Physical quality. The following characteristics shall not be present in the beach area or watershed:
(a) Sludge deposits, solid refuse, floating waste solids, oils, grease, and scum; or
(b) Hazardous substances being discharged into public beach water or watershed.
(2) The beach or watershed used for recreational purposes shall not have been used as part of a municipal sewage system, including a sewage overflow reservoir.
(3) Bacteriological quality. The bacteriological quality of water at public beaches shall comply with the following criteria:
(a) It shall meet the requirements of 401 KAR 10:031. Satisfactory bacteriological results shall be obtained before approval for construction is considered; and
(b) There shall not be any sanitary or combined sewer discharges or other raw or partially treated sewage discharges to the public beach area or immediate watershed.
(4) Chemical quality. There shall not be any discharges of chemical substances, other than disinfecting agents, capable of creating toxic reactions, or irritations to the skin or mucous membranes of a bather.
Section 6. Water Supplies at Public Beaches.
(1) Potable water from an approved municipal water system or water district shall be supplied to all public beaches. If these supplies are not available, a potable water supply meeting the approval of the Energy and Environment Cabinet shall be provided.
(2) The water supply shall be capable of providing sufficient quantities of water under pressure to all water-using fixtures and equipment at the facility.
Section 7. Sewage and Wastewater Disposal.
(1) All sewage and waste water shall be disposed of into a public sewer system if available.
(2) If a public sewer system is not available, disposal shall be made into a private sewage disposal system designed, constructed, and operated pursuant to the requirements of the cabinet in 902 KAR 10:085 and the Energy and Environment Cabinet in KAR Title 401.
(3) If a public sewer system subsequently becomes available, connections shall be made to it and the use of the facility's private sewage disposal system shall be discontinued.
Section 8. Refuse Disposal.
(1) All refuse at a public swimming and bathing beach shall be disposed of in a manner approved by the Energy and Environment Cabinet in KAR Title 401.
(2) An adequate number of refuse containers with tight fitting lids shall be provided at readily accessible locations at all public beaches.
(3) Refuse containers in women's restrooms shall be kept covered.
(4) Bulk refuse storage areas shall be designed and maintained to prevent rodent harborage.
(5) Bulk refuse containers shall be:
(a) Of approved design and construction;
(b) Kept closed; and
(c) Placed upon an impervious surface within a suitable enclosure to prevent access by animals.
Section 9. Facility Design and Construction.
(1) Attendant structures, such as bathhouses, dressing rooms, or restrooms, shall meet the design, materials, fixture, and construction requirements of 815 KAR 7:120 and 815 KAR Chapter 20.
(2)
(a) The wading and swimming areas at beaches where the water is less than five (5) feet deep shall be separated from swimming and diving areas by lines securely anchored and buoyed.
(b) Safe limits of swimming shall be marked by buoys, poles, or other markers located not over 100 feet apart and visible to bathers from a distance of at least 100 feet.
(c) Lettering on markers shall be maintained in good repair.
(d) Within these limits of safe swimming there shall not be any boating, underwater obstructions, or other hazards that may be dangerous or cause injury to swimmers.
(e) Signs shall be provided on the beach describing these markers and stating that they indicate the limits of safe bathing.
(f) The bottom of the swimming area shall consist of sand or gravel and be of a uniform slope.
(3) The water surrounding any floats or inflatable features where diving is permitted shall be at least nine (9) and one-half (1/2) feet deep.
Section 10. General Facility Operation and Maintenance.
(1) All facilities shall be maintained in good repair and free of debris.
(2) Bather preparation facilities. Each beach facility shall provide one (1) or more central bath houses containing the necessary toilet and other plumbing fixtures as designated in paragraphs (a) through (e) of this subsection.
(a) Toilet facilities shall be provided for females at a ratio of three (3) for 500 linear feet of beach.
(b) Toilet facilities shall be provided for males at a ratio of one (1) for 500 linear feet of beach.
(c) Urinal facilities shall be provided for males at a ratio of two (2) for 500 linear feet of beach.
(d) Lavatories shall be provided for each sex accommodated at a ratio of two (2) for 500 linear feet of beach.
(e) For each additional 500 linear feet of beach one (1) additional toilet and lavatory shall be provided for female and male restrooms and one (1) additional urinal for male restrooms.
(3) A bath house shall be conveniently located within 500 feet of the beach area to be served.
(4) All plumbing installations shall meet the State Plumbing Code, 815 KAR Chapter 20.
(5) A room containing sanitary facilities shall have:
(a) Every opening to the outer air effectively screened and a self-closing entry door;
(b) Natural or artificial lighting;
(c) Hot and cold or tempered water under pressure furnished at every lavatory and sink; and
(d) Cold water furnished to every toilet and urinal.
(6) Floors, walls, ceilings, attached or freestanding fixtures, and equipment shall be easily cleanable and in good repair. Floors shall be maintained in a nonslip condition.
(7) An adequate supply of toilet tissue, soap, and disposable hand drying towels or suitable hand drying devices shall be provided and maintained.
(8) Refuse containers shall be placed in all restrooms.
(9) Diving boards or platforms, ladders, hand rails, docks, and other similar equipment, shall be maintained in good repair, be securely anchored, and have a nonslip surface.
(10) Maintenance of bathing beaches.
(a) Beach areas shall be maintained free of litter and water borne debris. Beverage containers of glass or metal containers with detachable pull tabs shall be prohibited.
(b) A layer of sand or gravel of sufficient depth to prevent the creation of mud holes or slicks and to reduce shallow water turbidity shall be maintained on all beach areas and shall extend beneath the water of all wading and swimming areas.
(c) Wading, swimming, and diving areas shall be examined by the facility operator on a routine basis and immediately after high water conditions for floating or sunken debris, obstructions at diving areas, and high-water turbidity, which may present safety hazards to bathers.
Section 11. Personnel.
(1) Operator. A facility operator shall be responsible for the operation and maintenance of the facility. The operator shall be available at all times if the facility is open for use.
(2) Lifeguards.
(a) Lifeguards shall be provided at all bathing beaches that allow bathers seventeen (17) years of age or younger without a responsible adult at a rate of one (1) per 100 linear feet of beach front or major fraction more than half thereof. Public beaches that do not provide lifeguards shall post the following warnings: "No lifeguard on duty. Swim at your own risk. A person seventeen (17) years of age or younger shall not swim without a responsible adult present.".
(b) A public beach that has an inflatable water attraction shall have a minimum of one (1) lifeguard per attraction, with additional lifeguards provided to ensure all areas surrounding the attraction are clearly visible at all times.
(3) Lifeguards shall comply with the following:
(a) Lifeguards shall have a current lifesaving certificate. Current training as a lifesaver or water safety instructor by the American Red Cross or equivalent shall satisfy this requirement. The certificate of competency shall be prominently posted;
(b) Lifeguards shall be dressed in swimming attire; and
(c) Lifeguards assigned to the supervision of the facility shall not be subject to duties that may:
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Distract their attention from proper observation of persons in the facility area; or
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Prevent immediate assistance to persons in distress in the water.
Section 12. Safety Equipment.
(1) One (1) unit of life saving equipment consisting of the following shall be provided per facility:
(a) A U.S. Coast Guard approved ring buoy no more than twenty (20) inches in diameter with a three-sixteenths (3/16) inch rope attached;
(b) A shepherd's hook securely attached to a one (1) piece pole not less than twelve (12) feet in length;
(c) One (1) backboard with head immobilizer and at least three (3) straps, for back and neck injuries;
(d) One (1) lifeboat outfitted to meet state water safety administrative regulations;
(e) A torpedo shaped buoy; and
(f) A minimum of one (1) standard twenty-four (24) unit first aid kit or its equivalent that is kept filled and ready for use.
(2) Lifesaving equipment shall be mounted in a conspicuous place at the most centrally located readily accessible location. Its function shall be plainly marked, and this equipment shall be kept in good repair and ready condition. Bathers or other persons shall not be permitted to tamper with, use for any purpose other than its intended use, or remove this equipment from its established location.
(3) Telephones.
(a) All facilities shall have a non-pay landline or Voice over Internet Protocol (VoIP) telephone, continuously connected to a power source and operational at all times, capable of direct dialing 911 without going through a switchboard, and located in a conspicuous, readily accessible location. A cordless telephone shall be prohibited. Instructions for dialing shall be posted if necessary.
(b) A two (2) way radio communication system to a manned telephone system may be substituted at an isolated beach facility.
(c) All facilities utilizing VoIP telephones shall only use fixed VoIP services. Non-fixed VoIP services shall be prohibited.
(d) The address of the facility and the telephone number of the police department, fire department, emergency medical service, or a hospital shall be posted in a conspicuous place near the telephone.
(4) All drownings, near drownings, and injuries requiring hospitalization shall be immediately reported by next business day to the local health department and the Department for Public Health on form DFS-354, Kentucky Public Swimming and Bathing Facilities Drowning and Injury Report, incorporated by reference in 902 KAR 10:125.
Section 13. Spectator and Bather Administrative Regulations.
(1) Management of each facility shall adopt rules for controlling of food, drink, and smoking in the facility and surrounding areas.
(2) Rules governing the use of the facility and instructions to bathers shall be displayed on placards at the entrance to dressing rooms and enforced by the facility operator. Posting of rules and other instructions shall provide that:
(a) Admission to the facility shall be refused to a person:
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Having any contagious disease or infectious conditions, such as colds, fever, ringworm, foot infections, skin lesions, carbuncles, boils, inflamed eyes, ear discharges, or any other condition that has the appearance of being infectious;
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Having excessive sunburn, abrasions that have not healed, corn plasters, bunion pads, adhesive tape, rubber bandages, or other bandages of any kind; and
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Under the influence of alcohol, illegal substances, or exhibiting erratic behavior;
(b) Food, drink, gum, tobacco, or vapor producing products shall not be allowed, other than in specially designated and controlled sections of the facility area;
(c) Glass, soap, or other material that creates hazardous conditions shall not be permitted in the beach area or in the water;
(d) Beverage containers of glass or metal containers with detachable pull tabs shall not be permitted in the beach area or in the water;
(e) Diving in areas other than designated diving areas shall not be permitted; and
(f) Caution shall be exercised in the use of diving boards, floating platforms, and inflatable attractions.
Section 14. Facility Inspection.
(1) Inspections.
(a) All owners or operators, prior to opening to the public, shall certify to the cabinet in writing, that the facility is in compliance with the requirements of this administrative regulation, except if the cabinet has made an inspection prior to its opening. The cabinet shall make at least two (2) full facility inspections during the operating season. The cabinet may require one (1) of the full facility inspections to be performed prior to a facility's opening.
(b) The facility owner or operator shall be responsible for notifying the cabinet of the proposed opening date.
(2) New facilities shall receive final construction approval inspections by the cabinet, and other affected state and local regulatory agencies, prior to placing the facility in operation. It shall be the owner or operator's responsibility to notify the cabinet and other involved agencies of construction completion and call for inspection.
(3) The cabinet may make as many additional inspections and reinspections as necessary for the enforcement of this administrative regulation.
(4) If an agent of the cabinet makes an inspection of a public swimming and bathing facility, the findings shall be recorded on the DFS-350, Public Beach Inspection Report, and a copy provided to the facility owner or operator. The inspection report shall:
(a) Set forth any violation observed;
(b) Establish a specific and reasonable period of time for the correction of the violation observed; and
(c) State that failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in closure of the facility.
Section 15. Water Sampling and Testing.
(1) Beaches shall comply with the requirements of Section 5 of this administrative regulation prior to opening for the season and during the operating season.
(2) Beaches shall be monitored once each month or anytime immediately after periods of heavy rainfall. Monitoring inspections for beaches shall include general sanitation, bacteriological water sampling, and safety checks as necessary. Results shall be made available to the cabinet upon inspection.
(3) Additional samples may be requested to ensure compliance with this administrative regulation.
Section 16. Conditions requiring Closure of a Facility and Enforcement Provisions.
(1) The cabinet shall immediately order the closure of a facility and prohibit any person from using the facility by written notice to the facility owner or operator if:
(a) There is an immediate danger to health or safety;
(b) The water does not conform to the bacteriological standards contained in this administrative regulation;
(c) An environmental survey of the area shows evidence of sewage, other pollutants, or toxic materials being discharged to waters tributary to a beach;
(d) The owner, operator, an employee, or representative of the owner interferes with duly authorized agents of the cabinet who bear proper identification, in the performance of their duties; and
(e) If serious or repeated violations of any of the requirements of this administrative regulation are found.
(2) The notice shall state the reasons prompting the closing of the facility, and a copy of the notice shall be posted conspicuously at the facility by the owner or operator.
(3) Any owner or operator affected by an order may request an administrative conference in accordance with 902 KAR 1:400.
(4) If the conditions rendering closure are abated or further analyses prove to not render closure, the cabinet may authorize reopening the facility.
(5) If a source of sewage, pollution, or toxic material discovered as a result of an environmental survey is eliminated, the cabinet may authorize the reopening of a beach.
(6) In all other instances of a violation of the provisions of this administrative regulation, or for the nonpayment of fees, the cabinet shall serve upon the owner or operator a written notice specifying the violation in question and afford a reasonable opportunity to correct the violation. An owner or operator who fails to comply with any written notice issued under the provisions of this administrative regulation shall be notified in writing that the facility shall be closed at the end of ten (10) days following service of the notice, unless a written request for a conference pursuant to 902 KAR 1:400 is filed with the cabinet by the owner or operator within the ten (10) day period.
(7) All administrative hearings shall be conducted in accordance with KRS Chapter 13B.
(8) Any person whose facility has been closed may, at any time, make application for a reinspection for the purpose of reopening the facility. Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his or her opinion the conditions causing closure of the facility have been corrected, the cabinet shall make a reinspection. If the facility is found to be in compliance with the requirements of this administrative regulation, the facility shall be reopened.
(9)
(a) For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with the agents of the cabinet in the performance of their duties, the facility may be permanently closed after an opportunity for a conference has been provided in accordance with 902 KAR 1:400.
(b) Prior to the action, the cabinet shall notify the owner or operator, in writing, stating the reasons for which the facility is subject to closure and advising that the facility shall be permanently closed at the end of ten (10) days following service of the notice unless a request for a conference is filed with the cabinet by the owner or operator, within the ten (10) day period.
Section 17. Existing Facilities and Equipment. Existing facilities and equipment being used prior to the effective date of this administrative regulation that do not fully meet the design, construction, and materials requirements of this administrative regulation, may continue to be used if the facilities and equipment:
(1) Are in good repair;
(2) Are capable of being maintained in a sanitary condition;
(3) Meet facility water quality standards; and
(4) Create no health or safety hazard.
Section 18. Effect on Local Administrative Regulations. Compliance with this administrative regulation shall not relieve any person from compliance with any other state or local laws dealing with beach operation and maintenance matters or zoning requirements that may also be applicable.
Section 19. Variances for Construction Requirements.
(1) All facilities shall be constructed or remodeled in compliance with the provisions of this administrative regulation, except that an applicant may request a variance if the cabinet determines that the variance shall not seriously affect the safe and healthful operation of the facility.
(2) Before granting a variance, the cabinet shall require documentation from the applicant that the requested variance shall comply with the basic intent of this administrative regulation and that a safety or health hazard shall not be created if the variance is granted.
Section 20. Incorporated by Reference.
(1) The "DFS-350 Public Beach Inspection Report", 3/2024, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and online at https://chfs.ky.gov/agencies/dph/dphps/emb/Pages/pools.aspx.
History
- RELATES TO: KRS 211.015, 211.090, 211.210, 211.220, 211.990(2)
- STATUTORY AUTHORITY: KRS 194A.050, 211.180
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.180 requires the cabinet to adopt administrative regulations relating to public facilities and their operation and maintenance in a safe and sanitary manner to protect public health and prevent health hazards. This administrative regulation establishes uniform requirements for public swimming and bathing beaches.
- History: 51 Ky.R. 152, 1174, 1476; eff. 2-13-2025.
902 KAR 10:140 On-site sewage disposal system installer certification program standards {#sec-902-kar-10-140 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:140}
Section 1. Definitions.
(1) "Approved" is defined by KRS 211.970(1).
(2) "Cabinet" is defined by KRS 211.015(1)(a).
(3) "Certification level" means the level of technical skills and knowledge attained by an installer as categorized below:
(a) "Provisional" or "Probationary level" means the certification entry level for an installer as specified in KRS 211.357(2) and Section 2(3) of this administrative regulation;
(b) "Full level" means the certification level attained by an installer as specified in KRS 211.357(2) and Section 2(4) of this administrative regulation;
(c) "Advanced level" means the certification level attained by an installer as specified in Section 2(5) of this administrative regulation; and
(d) "Master level" means the certification level attained by an installer as specified in Section 2(6) of this administrative regulation.
(4) "Certified inspector" means a person employed by the cabinet or by a local health department who has met the requirements for certification contained in KRS 211.360.
(5) "Certified installer" means a specific individual person who has met the requirements for certification contained in KRS 211.357 and the certification maintenance requirements contained in this administrative regulation.
(6) "Competency" means an acceptable level of professional conduct, workmanship, and technical knowledge in the design and installation of on-site sewage disposal systems.
(7) "On-site sewage disposal system", "on-site sewage system", or "on-site system" means a complete system installed on a parcel of land, under the control or ownership of any person, that accepts sewage for treatment and ultimate disposal under the surface of the ground, including:
(a) A conventional system consisting of a sewage pretreatment unit or units, distribution devices, and lateral piping within rock-filled trenches or beds;
(b) A modified system consisting of a conventional system enhanced by shallower trench or bed placement, artificial drainage systems, dosing, alternating lateral fields, fill soil over the lateral field, or other necessary modifications to the site, system, or wasteload to overcome site limitations;
(c) An alternative system consisting of a sewage pretreatment unit or units, necessary site modifications, wasteload modifications, and a subsurface soil treatment and dispersal system using other methods and technologies than a conventional or modified system to overcome site limitations;
(d) A cluster system; and
(e) A holding tank that provides limited pretreatment and storage for off-site disposal where site limitations preclude immediate installation of a subsurface soil treatment and dispersal system, or connection to a municipal sewer.
(8) "Person" is defined by KRS 211.970(6).
Section 2. Application for Certification.
(1) A person shall not offer services to construct, install, alter, or repair on-site sewage disposal systems without:
(a) Meeting the application requirement of this administrative regulation; and
(b) Obtaining a valid certification card from the cabinet.
(2) Certification shall be:
(a) Nontransferable from one (1) person to another;
(b) Valid statewide subject to the provisions of KRS 211.357 and this administrative regulation; and
(c) Renewed annually by submitting to the Environmental Management Branch a certification fee of forty-five (45) dollars by check or money order made payable to the Kentucky State Treasurer.
(3)
(a) A person seeking provisional or probationary level certification shall:
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Be of legal age to conduct business in Kentucky;
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Have sufficient skills and knowledge of administrative regulations and construction techniques to pass a minimum competency examination;
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Submit a completed DFS-303, Application for Certification or Registration, incorporated by reference in 902 KAR 45:065, to the local health department;
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Provide proof of liability insurance; and
-
Pay the test registration fee of twenty-five (25) dollars by check or money order made payable to the local health department.
(b) A passing score of at least seventy (70) percent shall be achieved on the exam.
(c) An individual failing to achieve a passing score may retake the exam by re-registering and submitting another registration fee.
(d) An individual who passes the exam shall submit to the Environmental Management Branch a forty-five (45) dollar certification fee by check or money order made payable to the Kentucky State Treasurer.
(4) A person seeking full level certification shall:
(a) Have continuously maintained provisional or probationary level status in good standing;
(b) Meet the requirements as specified in KRS 211.357(2);
(c) Submit the documentation required in subsection (3)(a)3. and 4. of this section; and
(d) Maintain requirements for certification as specified in Section 4 of this administrative regulation.
(5) A person seeking advanced level certification shall:
(a) Have continuously maintained full level status in good standing;
(b) Submit the documentation required in subsection (3)(a)3. and 4. of this section;
(c) Complete the necessary training workshops with passing scores on workshop tests to obtain advanced level certification as required by the cabinet; and
(d) Maintain requirements for certification as specified in Section 4 of this administrative regulation.
(6) A person seeking master level certification shall:
(a) Have continuously maintained advanced level status in good standing;
(b) Submit the documentation required in subsection (3)(a)3. and 4. of this section;
(c)
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Installed a minimum of two (2) systems as specified in Section 3(4) of this administrative regulation; and
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Submit written verification of passed inspection from a certified inspector employed by the local health department having jurisdiction; and
(d) Maintain requirements for certification as specified in Section 4 of this administrative regulation.
(7) A certified installer advancing to the next level certification shall submit the documentation required by subsections (4), (5), and (6) of this section, and to the Environmental Management Branch a certification fee of forty-five (45) dollars by check or money order made payable to the Kentucky State Treasurer.
Section 3. Certification Level Standards. Certification level standards shall be limited to on-site systems that utilize only the following:
(1) Provisional or probationary certification level is limited to residential, on-site systems utilizing:
(a) Gravity distribution;
(b) Rock-filled trenches or beds;
(c) Leaching chamber trenches or beds; or
(d) Evaporation-absorption lagoons.
(2) Full certification level is able to install residential, commercial, industrial, or public facility systems utilizing:
(a)
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Dosed systems;
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Fill and wait systems;
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Leaching chambers at grade; or
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Constructed wetlands; and
(b) Provisional or probationary certification level system listings.
(3) Advanced certification level is able to install residential, commercial, industrial, or public facility systems utilizing:
(a)
-
Low pressure pipe systems;
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Mounds;
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Drip irrigation;
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Advanced treatment;
-
Experimental technology; or
-
Cluster systems; and
(b) Provisional, probationary, and full certification level system listings.
(4) Master certification level is able to install residential, commercial, industrial, or public facility systems utilizing provisional, probationary, full, and advanced certification level system listings.
Section 4. Maintenance of Certification.
(1) Each person holding a valid certification under KRS 211.357 shall be required to:
(a) Attend training workshops offered by the cabinet to maintain certification and improve competency based on the level of certification attained;
(b) Maintain and submit proof of liability insurance annually to the local health department; and
(c) Annually pay the certification fee as required by Section 2(3)(d) of this administrative regulation.
(2) An installer whose certification has expired shall:
(a) Comply with subsection (1) of this section;
(b) Submit proof of completion of continuing education units; and
(c) Receive a renewal certification card prior to installing an on-site sewage system.
(3)
(a) For provisional, probationary, full, and advanced certification levels, a minimum of two (2) training workshops for a total of six (6) approved continuing education units per year with passing scores on workshop tests shall meet certification maintenance requirements.
(b) For master certification level, a minimum of two (2) training workshops for a total of six (6) approved continuing education units every two (2) years with passing scores on workshop tests shall meet certification maintenance requirements.
(4) Attendance at workshops, seminars, or conferences not sponsored by the cabinet may be substituted on a one (1) for one (1) basis to meet certification maintenance requirements at the determination of the cabinet. Requests for consideration of other training for substitution shall be based upon the following:
(a) Submission of a copy of the training agenda, speaker or presenter biographies, and course outlines; and
(b) Submission of proof of attendance and results of any testing or other performance measurement with verification by the training sponsor.
(5) Upon receipt of a request for training substitution the cabinet shall compare that training for equivalency with similar training it provides. If equivalency is demonstrated, the cabinet shall accept that training for substitution as specified in subsection (4) of this section.
(6) Any person failing to meet certification maintenance requirements shall be subject to administration action under Section 7 of this administrative regulation and KRS 211.357(4).
Section 5. Training.
(1) The cabinet shall develop and implement a series of training workshops for certified installers in the areas of on-site sewage disposal system design, technology, application, and function.
(2) Training workshops shall be conducted throughout the state at frequencies, times, and locations necessary to provide all certified installers a reasonable opportunity to attend a number of workshops sufficient to maintain certification.
(3) A schedule of training workshops, including dates, times, location, and topics shall be prepared and made available to all certified installers to notify them of training opportunities and allow for scheduling attendance.
(4) A series of training courses shall be developed including instructor and student manuals, and other audiovisual and written materials.
(5) The cabinet may charge a reasonable fee at each training workshop to support program costs.
(6) The cabinet shall establish, through grants or contracts, a training staff composed of local health department fully certified inspectors to conduct training workshops on a regional basis. These local instructors shall serve as supplemental staff to the cabinet and act under the direct supervision of the cabinet.
(7) Training workshops for staff and supplemental staff instructors shall be conducted to assure uniformity of training for certified installers.
(8) The cabinet may contract with other governmental agencies, private consultants, or professional organizations for specialized instructor services.
Section 6. Materials and Equipment.
(1) Each training course shall be developed into a training materials packet consisting of the following:
(a) Course outline;
(b) Instructor script;
(c) Trainee guide;
(d) Audiovisual materials;
(e) Trainee worksheets and reference sheets;
(f) Test;
(g) Instructor comment sheet; and
(h) Trainee comment sheet.
(2) A complete training materials packet, in hardcopy or digital format shall be provided to each instructor for each course.
(3) A training material packet, excluding subsection (1)(b), (d), and (g) of this section, shall be provided to each trainee for each course.
(4) Sufficient stocks of instructor and trainee material packets shall be maintained for each course to meet demand.
(5) Audiovisual equipment shall be available to each instructor.
Section 7. Enforcement.
(1) Failure of any certified installer to comply with the requirements of KRS 211.350, 211.357(4) and (5), 902 KAR 10:081, 902 KAR 10:085, or this administrative regulation shall result in administrative action being taken.
(2) A minimum six (6) months probationary period shall be assigned to any certified installer who:
(a) Fails final inspection on any two (2) consecutive systems that require follow-up inspections before approval is granted;
(b) Backfills any system before final inspection is conducted and approval to backfill is given;
(c) Fails final inspection on any system that results in reconstruction of the system before approval can be given;
(d) Fails to place, cause to be placed, or fails to supervise placement of any required additional fill soil over an installed system;
(e) Fails to call for final inspection of any system;
(f) Fails to be present on the site anytime work is being performed on the system under construction;
(g) Fails to provide name, certification number, and notification of intent on application of permit when performing excavation and backfilling work on permitted homeowner installations; or
(h) Performs work on any system outside of the designated certification level.
(3) Probation may be assigned to a certified installer by the cabinet or by the certified inspector having local jurisdiction. Terms of the probationary period shall stipulate any restrictions, requirements, or additional training determined necessary to correct performance.
(4) For other violations, the provisions of KRS 211.357(4) and (5) relating to suspension or revocation of certification shall apply.
(5) In all instances of administrative action being taken for probation, suspension, or revocation, a certified installer shall have the right to request an administrative conference. The request shall be submitted in writing on form DFS-212 - Request for Conference, incorporated by reference in 902 KAR 1:400, to the local health department having jurisdiction or to the cabinet. All administrative conferences shall be conducted pursuant to 902 KAR 1:400.
(6) If immediate legal action is necessary to prevent the creation or continuance of a health hazard, damage to the environment, or compel compliance with KRS 211.350(5), (7), (8), and (9), 211.357(4) and (5), or administrative regulations pursuant to those statutes, the cabinet or local health department concerned may maintain, in its own name, injunctive action against any person engaged in the construction, installation, or alteration of an on-site sewage disposal system.
(7) The cabinet shall be notified within two (2) business days of any administrative action taken by a local health department against any certified installer, so that other local health departments can be alerted to that installer's status.
History
- RELATES TO: KRS 211.015, 211.360, 211.375, 211.970, 211.990(2)
- STATUTORY AUTHORITY: KRS Chapter 13B, 211.350, 211.357
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.350 requires the cabinet to regulate the construction, installation, or alteration of on-site sewage disposal systems except for systems with a surface discharge. KRS 211.357 requires the cabinet to establish a program of certification for installers of on-site sewage disposal systems. This administrative regulation establishes the certification program including competency testing, training, continuing education, and enforcement procedures relative to maintenance of an acceptable standard of competency for installers.
- History: 18 Ky.R. 579; 1888; eff. 1-10-1992; 22 Ky.R. 2392; eff. 8-1-1996; Crt eff. 11-18-2019; 47 Ky.R. 1288, 1970; eff. 6-16-2021; 48 Ky.R. 3088; 49 Ky.R. 575; eff. 9-28-2022.
902 KAR 10:150 Domestic septage disposal site approval procedures {#sec-902-kar-10-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:150}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 211.970(2).
(2) "Certified Inspector" means a specific individual who has met the requirements for certification contained in KRS 211.360.
(3) "Deep incorporation" means land application by subsurface injection, trench disposal, or a furrow-placement-cover operation.
(4) "Domestic septage" means liquid or solid material removed from a septic tank, holding tank, portable toilet, Type III marine sanitation device, or similar treatment works that receives only domestic sewage. Domestic septage shall not include:
(a) Liquid or solid material removed from a septic tank that contains commercial wastewater or industrial wastewater processes;
(b) Similar treatment works that receives commercial or industrial wastewater processes or individual wastewater processes; or
(c) Grease removed from a grease trap at a restaurant or similar grease producing business.
(5) "Grease" is defined by KRS 211.970(3).
(6) "Land application" means:
(a) The spraying or spreading, while the vehicle is in motion, of domestic septage or domestic septage mixed with grease at a ratio of three (3) parts domestic septage to one (1) part grease onto the land surface;
(b) The injection of domestic septage below the land surface; or
(c) The incorporation of domestic septage into the soil.
(7) "Operator" means a person operating or owning a domestic septage disposal, treatment, or recycling site, including their authorized agents.
(8) "Restrictive horizon" means a soil horizon that is relatively impervious to the downward movement of water, grease, domestic septage, or mixture because of its cemented, compacted or structural condition.
(9) "Shallow incorporation" means land application by surface spreading followed by plowing, disking, or harrowing.
(10) "Surface disposal site" means an area of land that is used for domestic septage disposal.
(11) "Tank" is defined by KRS 211.970(12).
(12) "Water table" means the zone of soil saturation by groundwater.
Section 2. Application for Site Evaluation.
(1)
(a) Form DFS-345, Application for Site Evaluation and Permit to Operate a Disposal Site, incorporated by reference in 902 KAR 10:160, shall be submitted by the owner or operator to the local health department for any site that is to be used as a domestic septage disposal site.
(b) A farm that properly disposes of less than 2,000 gallons of its own domestic septage per year shall not be required to be permitted. The farm shall be registered with the local health department.
(2) The disposal area where domestic septage is to be applied shall meet the requirements in Section 4 of this administrative regulation.
(3) The following documents shall accompany the application:
(a) A plat or recording in the local county clerk's office, an original and current 7.5 minute U. S. Geological Survey Quadrangle topographical map with proposed site boundaries clearly marked, or dimensioned site plan showing:
-
Number of acres and site boundaries;
-
Structures and other facilities;
-
Proposed disposal area;
-
Setback distances for features on the site and adjacent to the site as listed in Section 4, Table 8, of this administrative regulation;
-
North and prevailing wind direction; and
-
Access roads and other features outside of the boundaries of the site that may have an impact on site approval.
(b) Proposed operations plan including:
-
Methods and equipment for application, treatment, recycling, or storage;
-
Land usage and the nitrogen requirement for the crop or vegetation;
-
Application rate;
-
Monitoring program for vector and pathogen reduction;
-
State and federal endangered species impact statement, if applicable; and
-
Other information determined as necessary by the cabinet.
Section 3. Site Evaluation Fee.
(1) An evaluation fee shall be required for the cost of conducting a site evaluation by the local health department.
(2) In accordance with KRS 211.355, the site evaluation fee shall be established by the local board of health having jurisdiction.
Section 4. Site Approval Procedures.
(1) A certified inspector shall evaluate each proposed site based on the factors listed in Tables 1 through 8 of this section. An official site evaluation form shall be completed classifying each factor using the following rating method:
(a) An "A" rating means that the site is acceptable for that site factor.
(b) An "M" rating means the site factor is acceptable with modification or restriction to the site or disposal method.
-
M1 - Upslope surface water diversion required.
-
M2 - Shallow placement of domestic septage shall maintain a minimum separation distance of eighteen (18) inches between the domestic septage and a water table or bedrock. Lined wetland cells, storage, or treatment facilities may be excluded from this requirement;
-
M3 - Shallow placement of domestic septage shall be required to maintain a minimum separation distance of eighteen (18) inches between the domestic septage and a restrictive horizon.
-
M4 - Acceptable if a curtain drain is installed to lower the water table to a level of eighteen (18) inches below the domestic septage application.
(c) A "U" rating means the site factor is not acceptable. Reclamation site areas with "U" ratings may be acceptable for disposal sites if the disposal activity will not contaminate the groundwater or create a public health nuisance.
(2) Topography.
(3) Landscape position.
(4) Soil texture. Soil texture shall be classified as follows:
(a) Soil Group I. Sandy texture soils containing more than the seventy (70) percent sand-sized particles including the sand and loamy sand soil textural classes;
(b) Soil Group II. Coarse loamy texture soils containing more than thirty (30) percent clay-sized particles including sandy loam and loam soil texture classes;
(c) Soil Group III. Fine loamy soils containing less than forty (40) percent clay-sized particles and not more than thirty (30) percent sand-sized particles including sandy clay loam, silt loam, clay loam, and silty lay loam textural classes; and
(d) Soil Group IV. Clay texture soils containing forty (40) percent or more clay-sized particles including sandy clay, silty clay, and clay.
(5) Depth to a restrictive horizon.
(6) Depth to a water table.
(7) Soil depth.
(8) Available space. The disposal site area shall be a minimum of one (1) acre (43,560 sq. ft.) after application of the setback distance requirements.
(9) Backhoe pits or a soil probe truck shall be used to determine soil characteristics and as necessary, soil samples shall be randomly spaced and taken to a depth of forty-two (42) inches unless limited by site conditions. The owner or operator shall provide the backhoe or soil probe truck.
Section 5. Appeal Procedures.
(1) An administrative conference shall be provided, pursuant to 902 KAR 1:400, at the request of the owner or operator if a site has been disapproved.
(2) The request for an administrative conference shall be made in writing on Form DFS-212, Request for Conference, incorporated by reference in 902 KAR 1:400.
History
- RELATES TO: KRS 211.355, 211.360, 211.970, 211.974, 211.976, 211.981
- STATUTORY AUTHORITY: KRS 194A.050(1) 211.980
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.980 requires the secretary to promulgate administrative regulations relating to approval of domestic septage treatment, land application, and surface disposal sites. This administrative regulation establishes the approval process for domestic septage disposal sites.
- History: 21 Ky.R. 806; 1326; eff. 10-19-94; 22 Ky.R. 2394; eff. 8-1-96; Crt eff. 11-18-2019; 47 Ky.R. 1292, 1973; eff. 6-16-2021; Crt eff. 9-2-2026.
902 KAR 10:160 Domestic septage disposal site operation {#sec-902-kar-10-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:160}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 211.970(2).
(2) "Certified inspector" means a specific individual who has met the requirements for certification contained in KRS 211.360.
(3) "Deep incorporation" means land application by subsurface injection, trench disposal, or a furrow-placement-cover operation.
(4) "Domestic septage" means liquid or solid material removed from a septic tank, holding tank, portable toilet, Type III marine sanitation device, or similar treatment works that receives only domestic sewage. Domestic septage shall not include:
(a) Liquid or solid material removed from a septic tank that contains commercial wastewater or industrial wastewater processes;
(b) Similar treatment works that receives commercial or industrial wastewater processes; or
(c) Grease removed from a grease trap at a restaurant or similar grease producing business.
(5) "Grease" is defined by KRS 211.970(3).
(6) "Land application" means:
(a) The spraying or spreading, while the vehicle is in motion, of domestic septage mixed with grease at a ratio of three (3) parts domestic septage to one (1) part grease onto the land surface;
(b) The injection of domestic septage below the land surface; or
(c) The incorporation of domestic septage into the soil.
(7) "Operator" means a person owning, operating, or controlling a septic tank domestic septage servicing business or a person operating or owning a domestic septage disposal, treatment, or recycling site, including their employees or agents.
(8) "pH" means the logarithm of the reciprocal of the hydrogen ion concentration.
(9) "Reclamation" means the approved reclaiming of strip mine and construction sites for the disposal of domestic septage.
(10) "Shallow incorporation" means land application by surface spreading followed by plowing, disking, or harrowing.
(11) "Surface disposal site" means an area of land that is used for domestic septage disposal.
Section 2. Application for Permit to Operate.
(1)
(a) A person shall not construct or operate a site for domestic septage disposal or domestic septage mixed with grease at a ratio of three (3) parts domestic septage to one (1) part grease without having first obtained a permit from the cabinet.
(b) A farm owner shall not be required to be permitted as a disposal site if that farm properly disposes of less than 2,000 gallons of its own domestic septage per year. The farm shall be registered with the local health department and the disposal of its own domestic septage on the farm shall not contaminate the groundwater or surface water or create a public health nuisance.
(2) Form DFS-200, Application for Permit or License, incorporated by reference in 902 KAR 45:065, and form DFS-345, Application for Site Evaluation and Permit to Operate a Disposal Site, (12/18), shall be submitted to the local health department for the initial application.
(3) The disposal area where domestic septage is to be applied shall meet the requirements of 902 KAR 10:150.
(4) The following documents shall be submitted with the initial application or any time changes to the operation or process occur:
(a) A plat or recording in the local county clerk's office, an original and current 7.5 minute U.S. Geological Survey Quadrangle topographical map with proposed site boundaries clearly marked, or dimensioned site plan showing:
-
Number of acres and site boundaries;
-
Structures and other facilities;
-
Approved disposal area;
-
Setback distances of features on and adjacent to the site;
-
North and prevailing wind direction; and
-
Access roads and other features outside of the boundaries of the site.
(b) Proposed operations plan including:
-
Methods and equipment for application or storage;
-
Land usage and the nitrogen requirement for the crop or vegetation;
-
Application rate; and
-
Pathogen reduction and vector control plan.
(5)
(a) A certification statement shall be submitted to the local health department certified inspector with the initial permit application and annually thereafter.
(b) This statement shall read: "I certify, under penalty of law, that pathogen reduction and the vector attraction reduction requirements have been met, and no changes to the operation or process, as submitted in the original application, have occurred as per 902 KAR 10:150. This determination has been made under my direction and supervision in accordance with the system designed to ensure that qualified personnel properly gather and evaluate the information used to determine that the requirements have been met."
(6) A permit to operate shall be issued after the owner or operator meets the requirements of this administrative regulation and 902 KAR 10:150.
(7) The permit shall expire March 1 of each year.
Section 3. Permit and Inspection Fees.
(1) An annual permit fee of $187 is assessed for each permitted site to cover the costs of reviewing documentation and conducting inspections by the local health department.
(2) Fees shall be made payable to the local health department.
Section 4. Business Requirements.
(1) The operator of a domestic septage disposal site shall:
(a) Refuse to accept any type of waste for which the site is not approved.
(b) Maintain the site, facilities, and equipment in a safe and sanitary condition.
(c) Direct and manage the unloading and application of domestic septage to the site during the hours of operation.
(d) Notify service vehicle operators if the site is closed during normal working hours.
(e) Notify the local health department certified inspector immediately of any person who discharges prohibited waste.
(f) Submit a written closure plan to the local health department prior to thirty (30) days of closure.
(2) The owner of a disposal site shall:
(a) Provide written notification to the subsequent owner prior to the sale that the land was used as a domestic septage disposal site.
(b) Maintain a list of the vehicle license numbers, disposal method, location, and total number of gallons of domestic septage or domestic septage mixed with grease received, retain these records for five (5) years, and make these records available to the cabinet during normal business hours.
Section 5. Approved Methods of Domestic Septage Disposal.
(1) Domestic septage storage facilities capable of holding three (3) times the storage capacity of the largest pump truck, or at least 4,000 gallons, shall be provided at the disposal site.
(2) Unless previously added, sufficient alkali shall be applied to each application method of domestic septage or domestic septage mixed with grease to raise the pH to twelve (12) for thirty (30) minutes to control odors and vectors.
(3) Surface application and shallow incorporation.
(a) Equipment used for surface application shall have a spray bar, splash plate, or other device to evenly distribute the domestic septage while the equipment is in motion. The device shall be:
-
Designed to direct the contents away from the vehicle; and
-
Rinsed prior to it leaving the site.
(b) The domestic septage shall be surface spread uniformly to prevent ponding.
(c) The site shall have a well-established and maintained sod covering or approved vegetation unless the domestic septage application is used to establish a vegetative cover in reclamation.
(d) Domestic septage on sites using shallow incorporation shall be incorporated into the soil within six (6) hours.
(e) Incorporation of domestic septage shall follow the contour of the site to minimize erosion and runoff.
(4) Deep incorporation.
(a) Deep incorporation of domestic septage shall follow the contour of the site to minimize soil erosion and runoff.
(b) If approved, trenches shall be a maximum of two (2) feet deep and two (2) to ten (10) feet wide. Actual configuration of the width and linear dimensions may be restricted by topography and soil conditions.
-
The excavated soil from the trench or bed shall be placed on the uphill side to control the movement of surface water into the trench or bed.
-
An additional application of alkali may be required.
-
The trench shall be covered with a minimum of one (1) foot of soil when it reaches its holding capacity and has dewatered sufficiently.
-
Trenching of grease alone is prohibited.
Section 6. Experimental Disposal Methods. The following disposal methods shall be considered experimental and, if it is determined that they are likely to have an adverse environmental impact, the cabinet shall submit the application for review by the Energy and Environment Cabinet:
(1) Lagoon;
(2) Wetlands;
(3) In-vessel composting;
(4) Static pile composting;
(5) Windrow composting;
(6) Recycling; and
(7) Other, similar proposed methods.
Section 7. Domestic Septage Disposal Site Maintenance.
(1) Sites shall be maintained to prevent the creation of a public health hazard or degrading conditions to the environment.
(2) The DFS-234, Permit to Operate (12/18), shall be posted at the entrance of the disposal site.
(3) A plot plan shall be posted at the site showing the following information:
(a) Division of site by approved application methods; and
(b) Number of gallons of domestic septage applied.
(4) Access roads shall be maintained to minimize dust and rutting.
(5) Surface application shall not be applied during or immediately after inclement weather or a hard freeze.
(6) Warning signs, fencing, or barriers shall be required to prevent unauthorized entry into the disposal area.
Section 8. Inspection Procedures.
(1) At least one (1) time every calendar year the local health department certified inspector shall inspect:
(a) Vehicles;
(b) Equipment;
(c) Domestic septage storage facilities used at the site; and
(d) The domestic septage disposal site.
(2) The cabinet shall have the right of access to inspect vehicles, equipment, domestic septage storage locations, and the domestic septage disposal sites during normal hours of operation. The right of access at all times shall not be denied if there is a potential imminent health hazard.
(3) The findings shall be recorded on Form DFS-315, Inspection Report, (1/19), and a copy of the inspection report shall be provided to the owner or operator.
(4) If a violation is found, the inspection report shall:
(a) Set forth the specific violation;
(b) Set a time period for correcting the violation; and
(c) State that failure to comply with any notice issued pursuant to KRS 211.970 to 211.981 and this administrative regulation may result in initiation of the enforcement proceedings in Section 9 of this administrative regulation and KRS 211.995.
Section 9. Administrative Enforcement Procedures.
(1) A permit may be suspended or revoked upon evidence that the operator:
(a) Knowingly violates the provisions of KRS 211.970 to 211.981 or this administrative regulation;
(b) Accepts prohibited wastes;
(c) Practices fraud or deception in applying for a permit;
(d) Fails to pay required fees;
(e) Is incompetent to operate a domestic septage disposal site; or
(f) Interferes with the cabinet in the performance of its duties.
(2) An administrative conference shall be provided, after request by the operator, if:
(a) A permit is denied, suspended, or revoked; or
(b) An inspection indicates failure to comply with the requirements of KRS 211.970 to 211.981 or this administrative regulation.
(3) The request for an administrative conference shall be made in writing on Form DFS-212, Request for Conference, incorporated by reference in 902 KAR 1:400.
(4) Service of process and proof of service shall comply with KRS 211.220.
(5) An injunction may be obtained by the cabinet or local health department if immediate action is necessary to prevent the creation or continuance of a health hazard, damage to the environment, or to compel compliance with KRS 211.970 to 211.981 and this administrative regulation.
Section 10. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "DFS-234, Permit to Operate a Disposal Site", (12/18);
(b) "DFS-315, Inspection Report", (1/19); and
(c) "DFS-345, Application for Site Evaluation and Permit to Operate a Disposal Site", (12/18).
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.220, 211.360, 211.970, 211.972, 211.974, 211.976, 211.981, 211.995
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.980,
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.980 authorizes the secretary to promulgate administrative regulations relating to vehicle tank and equipment requirements; conduct of business; approval of disposal or treatment sites and methods; domestic septage treatment, land application, and surface disposal sites; inspection and administrative enforcement procedures, including suspension or revocation of licensing; injunctive action; and any other matters deemed necessary to protect public health and the environment. This administrative regulation establishes the requirements for issuing a permit to operate a domestic septage storage or disposal site, the procedures for operating a domestic septage storage or disposal site, and the inspection process of treatment or disposal sites.
- History: 21 Ky.R. 810; 1330; eff. 10-19-94; 22 Ky.R. 2399; eff. 8-1-96; Crt eff. 11-18-2019; 47 Ky.R. 1295, 1975; eff. 6-16-2021.
902 KAR 10:170 Septic tank servicing {#sec-902-kar-10-170 omnilex-key=us-ky-regs-official--title-902--902 KAR 10:170}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 211.970(2).
(2) "Domestic septage" means liquid or solid material removed from a septic tank, holding tank, portable toilet, Type III marine sanitation device, or similar treatment works that receives only domestic sewage. Domestic septage shall not include:
(a) Liquid or solid material removed from a septic tank that contains commercial wastewater or industrial wastewater processes;
(b) Similar treatment works that receives commercial or industrial wastewater processes or individual wastewater processes; or
(c) Grease removed from a grease trap at a restaurant or similar grease producing business.
(3) "Domestic sewage" means waste and wastewater from humans or household operations that is discharged to, or otherwise enters a wastewater treatment works.
(4) "Grease" is defined by KRS 211.970(3).
(5) "Operator" means a person owning, operating, or controlling a septic tank servicing business, including their employees or agents.
(6) "Pathogen" means disease-causing organisms.
(7) "Site" is defined by KRS 211.970(11).
(8) "Tank" is defined by KRS 211.970(12).
(9) "Vector attraction" means the characteristics of domestic septage that attract rodents, flies, mosquitoes, or other organisms capable of transporting infectious agents.
Section 2. Licensing and Fees for Septic Tank Servicing.
(1) An annual application for a business license to service or maintain septic tanks, holding tanks, seepage pits, portable toilets, Type III marine sanitation devices, or similar treatment works that receive domestic sewage, grease traps, or domestic septage mixed with grease, shall be:
(a) Submitted to the cabinet on DFS-306 Application for a License (1/19); and
(b) Accompanied by:
-
A business license fee of $150; and
-
A vehicle license fee of fifty (50) dollars for each vehicle; and
(c) Accompanied by a surety bond in the amount of $5,000.
(2) The business license fee established in subparagraph (1)(b)1. of this section shall be paid by check or money order made payable to the Kentucky State Treasurer and mailed to the Kentucky Department for Public Health, 275 East Main Street, Mailstop HS1C-D, Frankfort, Kentucky 40621.
(3) The vehicle license fee established in subparagraph (1)(b)2. of this section shall be made payable to the local health department having jurisdiction.
(4) Applications shall be made to the cabinet prior to March 1 of each year.
(5) A late renewal fee $100 shall be assessed on all annual license renewal applications not received by April 1 each year.
Section 3. Conduct of Business. A septic tank service operator shall:
(1) Not dispose of domestic septage or domestic septage mixed with grease unless approved by the cabinet at a permitted site, treatment facility, or registered farm that properly disposes less than 2,000 gallons of its own domestic septage per year.
(2) Register a farm that properly disposes less than 2,000 gallons of its own domestic septage or domestic septage mixed with grease per year with the local health department.
(3) Not apply additional domestic septage or domestic septage mixed with grease to any disposal site if the annual application rate has been reached during a 365-day period.
(4) Verify in writing that the vector attraction reduction and pathogen reduction requirements have been met if disposing of domestic septage or domestic septage mixed with grease.
(5) Maintain setback distances from features as required in 902 KAR 10:150, Section 4 (8), Table 8.
(6) Not dispose of domestic septage or domestic septage mixed with grease during adverse weather or if the site is snow covered or frozen.
(7) Provide an adequate storage facility capable of holding three (3) times the storage capacity of the largest pump truck, during adverse weather, wet site conditions, or if the disposal site is not accessible.
(8) Maintain written authorization from the land owner or facility operator to use the site to dispose of domestic septage or domestic septage mixed with grease. The authorization shall be maintained in each licensed vehicle and at the business office.
(9) Remove all domestic septage from the tank being serviced.
(10) Not use chemicals or biological cleaners, starters, or other agents as part of the service unless the material has been approved by the cabinet. An additive may be approved if it can be demonstrated that the product has a positive benefit and no adverse effect on the operation and performance of an on-site sewage disposal system.
(11) Re-cover access openings and leave the property in a safe and sanitary condition.
(12) Notify the owner of any damage to the sewage treatment or disposal system found during the servicing operation.
(13) Provide the customer an invoice containing the following minimum information:
(a) Customer's name;
(b) Location of service;
(c) Date of service;
(d) Amount of domestic septage and grease from grease traps removed in gallons;
(e) Vehicle license number;
(f) Name and address of servicing business;
(g) Printed and signed name of individual vehicle operator; and
(h) Name and location of approved disposal site, registered farm, landfill, or treatment facility.
(14) Retain copies of customer invoices and other records pertaining to the business operation for five (5) years and make available upon request by the cabinet during normal business hours.
(15) Maintain the following information if domestic septage or domestic septage mixed with grease has been applied to an approved site:
(a) Location by street address, descriptive location, or latitude and longitude of each site where domestic septage or domestic septage mixed with grease has been applied;
(b) The number of acres in each site;
(c) The date and time of application of the domestic septage or domestic septage mixed with grease;
(d) Application rate, in gallons, per acre per 365-day period of domestic septage or domestic septage mixed with grease;
(e) The following certification statement: "I certify, under penalty of law, that the pathogen reduction and vector attraction reduction requirements have been met. This determination has been made under my direction and supervision in accordance with the system designed to ensure that qualified personnel properly gather and evaluate the information used to determine that the pathogen requirements and vector attraction reduction requirements have been met.";
(f) A description of how the pathogen and vector attraction reduction requirements have been met; and
(g) Name and location of wastewater treatment facility or landfill used to dispose of the domestic septage or domestic septage mixed with grease.
(16) Submit a statement of compliance in accordance with KRS 211.979 and this administrative regulation prior to transportation or disposal of domestic septage or domestic septage mixed with grease within the borders of the Commonwealth.
(17) Provide employees with necessary personal protective equipment suitable for the work being performed, such as gloves, clothing, and respiratory masks.
Section 4. Grease Disposal.
(1) Grease traps serviced at restaurants, residential, or institutional food preparation may be mixed at a ratio of three (3) parts domestic septage to one (1) part grease and disposed at approved disposal sites.
(2) Grease alone may be discharged into a publicly owned wastewater treatment works that will accept grease pumpings.
(3) Grease may be dewatered and disposed at a landfill that will accept grease pumpings.
(4) Grease alone shall not be land applied.
Section 5. Vehicle, Tank, and Equipment Requirements.
(1) All vehicles, tanks, towable tank trailers, and equipment used in the pumping, transporting, treatment, or disposal of domestic septage or grease traps shall be maintained in safe and sanitary condition.
(2) Tanks used in the pumping or transporting of domestic septage shall meet the following additional requirements:
(a) Tanks shall be leak-proof, constructed of, or coated with, a corrosion resistant material, and securely attached to the vehicle chassis;
(b) Discharge openings shall be constructed so the tank completely drains and the discharge stream is not obstructed by any part of the vehicle or equipment, except for splash plates, spray bars, or similar devices; and
(c) Valves at the tank inlet and outlet shall be water-tight and fitted with caps or plugs for use during transport or storage.
(3) Pumps, valves, and hoses shall be maintained to prevent leakage and meet the following requirements:
(a) Pumps shall be self-priming and maintained to prevent backflow;
(b) Connections or openings shall be water-tight and fitted with caps or plugs when the pumping system is not in use;
(c) Pulleys, chains, belts, or flexible shafts shall have guards to prevent injury; and
(d) Hoses shall have leak-proof connectors, caps, or plugs unless stored in leak-proof compartments.
(4) The license for each vehicle shall be visible in accordance with KRS 211.978(2).
(5) The vehicle license number shall be nontransferable from one vehicle to another.
Section 6. Inspection Procedures.
(1) At least one (1) time every calendar year the cabinet shall inspect:
(a) Vehicles;
(b) Equipment; and
(c) The domestic septage storage locations.
(2) The cabinet shall have the right of access to inspect vehicles, equipment, and domestic septage storage locations during normal hours of operation. The right of access shall not be denied if there is an imminent health hazard.
(3) The findings shall be recorded on form DFS-315, Inspection Report, (1/19), incorporated by reference in 902 KAR 10:160,, and a copy of the inspection report provided to the owner or operator.
(4) If a violation is found, the inspection report shall:
(a) Set forth the specific violation;
(b) Set a time period for correcting the violation; and
(c) State that failure to comply with any notice issued pursuant to KRS 211.970 to 211.981 and this administrative regulation may result in initiation of the enforcement proceedings in Section 7 of this administrative regulation and KRS 211.995.
Section 7. Administrative Enforcement Procedures.
(1) A license may be suspended or revoked if the operator:
(a) Violates the provisions of KRS 211.970 to 211.981 or this administrative regulation;
(b) Practices fraud or deception in applying for a license;
(c) Fails to pay required fees or maintain bonding requirements; or
(d) Interferes with the cabinet in the performance of its duties.
(2) An administrative conference shall be provided, after request by the operator, if:
(a) A license is denied, suspended, or revoked; or
(b) An inspection indicates repeated violations or failure to comply with the requirements of KRS 211.970 to 211.981 or this administrative regulation.
(3) The request for an administrative conference shall be made in writing on Form DFS-212, Request for Conference, incorporated by reference in 902 KAR 1:400.
(4) An injunction may be obtained by the cabinet or local health department if immediate legal action is necessary to prevent the creation or continuance of a health hazard, damage to the environment, or to compel compliance with KRS 211.970 to 211.981 or this administrative regulation.
Section 8. Incorporation by Reference.
(1) The "DFS-306, Application for a License", (1/19) is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.970, 211.972, 211.974, 211.978, 211.979, 211.981, 211.995
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.976, 211.978, 211.979, 211.980
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.980 authorizes the secretary to promulgate administrative regulations relating to vehicle tank and equipment requirements; conduct of business; approval of disposal or treatment sites and methods; inspection and administrative enforcement procedures, including suspension or revocation of licensing; injunctive action; and any other matters deemed necessary to protect public health and the environment. This administrative regulation establishes the requirements for a septic tank service operator, the disposal of grease; vehicle, tank and equipment operations; licensing; inspection procedures; and enforcement actions.
- History: 21 Ky.R. 813; 1333; eff. 10-19-94; 22 Ky.R. 2403; eff. 8-1-96; Crt eff. 11-18-2019; 47 Ky.R. 1299, 1978; eff. 6-16-2021; Crt eff. 9-2-2026.
Chapter 11 Medical Laboratories
902 KAR 11:010 Application for licensure; fee {#sec-902-kar-11-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:010}
Section 1. Licenses.
(1) Except as otherwise provided by KRS 333.040 no person shall operate any medical laboratory in this Commonwealth without first obtaining the appropriate license.
(2) Applications for licensure shall be filed with the Cabinet for Human Resources, Office of Inspector General, Division for Licensing and Regulation, Frankfort, Kentucky 40621, and shall be accompanied by a fee of $155.
(3) Applicants for licenses shall, as a condition to licensure, be in compliance with 902 KAR Chapter 11.
(4) Licenses shall expire on December 31 following the date of issuance.
(5) Licenses may be renewed upon payment of eighty (80) dollars.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194A.050, 333.070
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human Resources to license and regulate medical laboratories in Kentucky including applications for licenses and the setting of reasonable license fees. This administrative regulation establishes application procedures for licensure and establishes reasonable licensure fees.
- History: 3 Ky.R. 197; 747; eff. 5-4-1977; 9 Ky.R. 498; eff. 11-3-1982; 14 Ky.R. 2073; eff. 8-3-1988; 17 Ky.R. 129; eff. 9-13-1990; 20 Ky.R. 2179; eff. 3-14-1994; eff. 3-22-2019; Crt eff. 12-29-2025.
902 KAR 11:020 Reports and standards of health and safety {#sec-902-kar-11-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:020}
Section 1. Reporting of Information Concerning Operations. The medical laboratory director shall submit to the cabinet reports of operation as the cabinet may require.
Section 2. Medical Laboratory Space, Facilities, and Personnel Health. Conditions in the medical laboratory shall be adequate to ensure proper performance of services within the laboratory. The following requirements shall be met:
(1) Workbench space within the laboratory shall be ample, well-lighted, and situated to facilitate the use of necessary sinks, water, gas, suction, and electrical outlets.
(2) Work areas shall be arranged to minimize problems in transportation and communication.
(3) The laboratory shall be properly ventilated.
(4) Volatile chemicals and inflammable solvents shall be properly stored in areas where they are unlikely to ignite.
(5) Temperature and humidity within the laboratory shall be controlled within the limits required for proper performance of tests and operation of instruments affected by these variations.
(6) Fire precautions and occupational safety rules shall be posted and observed to avoid physical, chemical, and biological hazards.
(7) Appropriate sterilization and disinfection techniques shall be used for tests performed on potentially contaminated material. Pipettes, Petri dishes, and other disposable items shall be appropriately discarded immediately after use. Each sterilizing cycle shall contain a recording thermometer or other device indicating the point of proper sterilization. Records of temperature readings shall be kept at least two (2) years. Proper operation of the autoclave shall be checked monthly with viable spores or appropriate indicator.
Section 3. Provisions for Acceptance by National Licensing or other Accrediting Bodies. With the exception of 902 KAR 11:030 and Section 1 of this administrative regulation, medical laboratories inspected and certified pursuant to 42 USC 263a, Public Health Service Act, and medical laboratories which have been inspected and accredited by the commission on inspection and accreditation of the College of American Pathologists or by any other national accreditation body approved by the cabinet, shall be deemed to meet all of the requirements for licensure, if the standards applied by the commission or body in determining accreditation of the medical laboratory are equal to, or more stringent than, the provisions of KRS Chapter 333 and the rules and regulations issued pursuant to KRS Chapter 333; and there is adequate provision for assuring the standards continue to be met by the laboratory.
Section 4. Compliance with State, Federal, and Local Laws. All medical laboratories shall comply with any other applicable state, federal, and local laws and regulations.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 directs that the Cabinet for Human Resources may require medical laboratory directors to submit reports concerning selected test results and medical laboratory operations. KRS Chapter 333 authorizes the Secretary for Human Resources to adopt rules and regulations to effectuate the provisions of KRS Chapter 333, including standards of construction of medical laboratories, sanitary conditions within the medical laboratory and its surroundings, and licensure of medical laboratories. This administrative regulation sets out the contents of the required reports, standards of health and safety for medical laboratories, and a provision relating to licensure.
- History: 3 Ky.R. 197; 748; eff. 5-4-1977; 20 Ky.R. 2180; eff. 3-14-1994; eff. 3-22-2019; Crt eff 12-29-2025.
902 KAR 11:030 Personnel standards {#sec-902-kar-11-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:030}
Section 1. Medical Laboratory Director.
(1) A medical laboratory director shall, in addition to the responsibilities specified in KRS Chapter 333, be responsible for the following:
(a) Technical and scientific operation of the laboratory;
(b) Performance of tests made in the laboratory;
(c) Reporting of findings of laboratory tests; and
(d) Employment of qualified laboratory personnel and their in-service training.
(2) The director may serve the laboratory on a full-time or regular part-time basis.
(a) A director may not serve more than three (3) medical laboratories on a regular part-time basis, unless the director provides for an associate, qualified according to the standards in subsection (4) of this section, in each additional laboratory to serve as assistant director in each laboratory.
(b) An assistant director shall not serve more than three (3) laboratories.
(3) Commensurate with the laboratory workload, the director shall spend adequate time in the laboratory to effectively direct and supervise its technical operation. The director shall be available for personal or telephone consultation. If the director is to be continuously absent from the laboratory for more than one (1) month, the director shall make arrangements for a qualified substitute director.
(4) To qualify as a medical laboratory director, a person shall meet one (1) of the following requirements:
(a) Is a physician certified in anatomical or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, or possessing qualifications equivalent to those required for the certification.
(b) Is a physician certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one (1) of the laboratory specialties.
(c) Is a physician certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or any other national accrediting board in one (1) of the laboratory specialties.
(d) Is a physician certified by the American Society of Cytology to practice cytopathology or possessing qualifications which are equivalent to those required for certification.
(e) Is a physician who, subsequent to graduation, has two (2) years of experience in a medical laboratory approved by the cabinet.
(f) Holds an earned doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject; and
-
Is certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or any other national accrediting board acceptable to the cabinet in one (1) of the laboratory specialties; or
-
Subsequent to graduation has two (2) years' full-time experience in one (1) of the laboratory specialties.
(5) A dentist certified by the American Board of Oral Pathology or possessing qualifications equivalent to those required for certification may serve as director of a medical laboratory specializing in the area of oral pathology only.
(6) An individual responsible for the direction of a medical laboratory for twelve (12) months between January 1, 1968, and May 4, 1977, may continue to serve as a medical laboratory director if one (1) of the following requirements is met:
(a) Holds a master's degree from an accredited institution with a chemical, physical, or biological science as a major subject and, subsequent to graduation, has four (4) years of pertinent full-time laboratory experience.
(b) Holds a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject, and subsequent to graduation, has six (6) years of pertinent full-time medical laboratory experience.
(c) Has achieved a satisfactory grade through an examination approved by the cabinet.
Section 2. Medical Laboratory Supervisors.
(1) Each medical laboratory shall have a general supervisor and a technical supervisor. A general supervisor may be a technical supervisor in those specialties in which requirements of competency are met as provided in 902 KAR Chapter 11.
(2) The general supervisor shall be present on the laboratory premises during all hours in which tests are being performed.
(3) The technical supervisor shall spend adequate time in the laboratory to supervise the technical performance of the staff in the specialty and shall be available for personal or telephone consultation.
(4) Emergency procedures implemented outside regularly scheduled hours of duty may proceed without the general supervisor being on the premises if the technologist performing the tests is qualified to do so. The supervisor who is responsible for the result of the work shall review the tests during the next duty period, and a record shall be maintained reflecting the actual review.
(5) To qualify as a general supervisor, a person shall meet one (1) of the following requirements:
(a) Is a physician, or has earned a doctoral degree from an accredited institution with a major in one (1) of the chemical, physical, or biological sciences and, subsequent to graduation, has two (2) years of experience in one (1) of the laboratory specialties in a medical laboratory approved by the cabinet.
(b) Holds a master's degree from an accredited institution with a major in one (1) of the chemical, physical, or biological sciences and, subsequent to graduation, has three (3) years of pertinent full-time laboratory experience of which two (2) years have been spent working in the designated laboratory specialty in a medical laboratory approved by the cabinet.
(c) Is qualified as a medical laboratory technologist pursuant to Section 3 of this administrative regulation and, subsequent to the date of qualifying as a medical laboratory technologist, has four (4) years of pertinent full-time laboratory experience of which two (2) years have been spent working on the designated laboratory specialty in a medical laboratory approved by the cabinet.
(6) To qualify as a technical supervisor, the person shall meet competency requirements provided in 902 KAR Chapter 11.
(7) To serve as general supervisor of medical laboratory personnel specializing in the area of diagnostic cytology, a person shall qualify as a cytotechnologist pursuant to Section 3 of this administrative regulation and, subsequent to the qualification, have four (4) years of full-time experience as a cytotechnologist in a laboratory directed or supervised by a pathologist or other physician recognized as a specialist in diagnostic cytology within the preceding ten (10) years.
(8) A person not meeting the training and experience requirements of subsection (5)(a),(b), and (c) of this section may qualify as a medical laboratory general supervisor if the person:
(a) Was performing the duties of a medical laboratory general supervisor anytime between January 1, 1968, and May 4, 1977; and
(b) Has fifteen (15) years of pertinent full-time medical laboratory experience. A minimum of thirty (30) semester hours of credit from an approved school of medical technology or toward a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject shall be considered equivalent to two (2) years of experience. Additional education shall be equated to the rate of fifteen (15) hours of credit for one (1) year of experience.
(9) An individual serving as a medical laboratory supervisor in Kentucky for a period of one (1) year prior to May 4, 1977, may continue to supervise the laboratory unless otherwise exempted in subsections (5), (6), (7), and (8) of this section. The cabinet may require, in the interest of the health, safety, and welfare of the people of this state and as a condition to issuance of an original or renewal license, the individual to satisfactorily demonstrate the ability to perform medical laboratory examinations and supervise a medical laboratory.
Section 3. Medical Laboratory Technologists and Cytotechnologists.
(1) Medical laboratory technologists and cytotechnologists shall be in sufficient number to adequately supervise the work of technicians or trainees.
(2) An individual qualifying as a medical laboratory technologist shall:
(a) Perform tests requiring the exercise of independent judgment and responsibility with minimal supervision by the director or supervisors only in those specialties or subspecialties in which the technologists are qualified by education, training, and experience.
(b) Perform tests only under the direct supervision of the laboratory supervisor or qualified technologist in those specialties in which the medical laboratory technologist is not qualified by education, training, or experience.
(3) To qualify as a medical laboratory technologist, a person shall meet one (1) of the following requirements:
(a) Earn a bachelor's degree in medical technology from an accredited university or college.
(b) Successfully complete three (3) years of academic study (a minimum of ninety (90) semester hours or equivalent) in an accredited college or university which meet the specific requirements for entrance into a school of medical technology accredited by an accrediting agency approved by the cabinet and successfully complete completed a course of training of twelve (12) months in a school of medical technology.
(c) Earn a bachelor's degree in one (1) of the chemical, physical, or biological sciences, with an additional one (1) year of pertinent full-time laboratory experience or training in the specialty or subspecialty in which the individual performs.
(d) Successfully complete three (3) years (a minimum of ninety (90) semester hours or equivalent) in an accredited college or university with the following distribution of courses:
-
For those whose training was completed prior to September 15, 1963, the course work shall include twenty-four (24) semester hours in chemistry and biology courses of which six (6) semester hours are in inorganic chemistry, and three (3) semester hours are in other chemistry courses, and twelve (12) semester hours are in biology courses pertinent to the medical sciences; or
-
For those whose training was completed after September 14, 1963, the course work shall include sixteen (16) semester hours in chemistry courses which include six (6) semester hours in inorganic chemistry acceptable toward a major in chemistry, sixteen (16) semester hours in biology courses which are pertinent to the medical sciences and are acceptable toward a major in biology, and three (3) semester hours of mathematics; and
-
Has experience or training covering several fields of medical laboratory work of one (1) year and of a quality to provide education and training in medical technology equivalent to that described in paragraphs (a) and (b) of this subsection.
(e) A person not meeting the training and experience requirements defined in paragraphs (a), (b), (c), or (d) of this subsection may qualify as a medical laboratory technologist if the person:
-
Was performing the duties of a medical laboratory technologist any time between January 1, 1968, and May 4, 1977; and
-
Had ten (10) years of pertinent medical laboratory experience prior to May 4, 1977. A minimum of thirty (30) semester hours of credit from an approved school of medical technology or toward a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject shall be considered equivalent to two (2) years of experience. Additional education shall be equated to the rate of fifteen (15) hours of credit for one (1) year of experience.
(f) Has achieved a satisfactory grade in a proficiency examination approved by the cabinet. After December 31, 1978, initial qualification as a technologist shall be in accordance with the requirements of paragraphs (a), (b), (c), or (d) of this subsection.
(4) To qualify as a medical laboratory cytotechnologist, a person shall meet one (1) of the following requirements:
(a) Successfully complete two (2) years in an accredited college or university with twelve (12) semester hours in science, eight (8) hours of which are in biology; and
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Complete twelve (12) months of training in a school of cytotechnology accredited by an accrediting agency approved by the cabinet; or
-
Has received six (6) months of formal training in a school of cytotechnology accredited by an accrediting agency approved by the cabinet and six (6) months of full-time experience in cytotechnology in a laboratory acceptable to the pathologist who directed the formal six (6) months of training.
(b) Has, prior to May 4, 1977:
-
Graduated from high school;
-
Completed six (6) months of training in cytotechnology in a laboratory directed by a pathologist or other physician recognized as a specialist in cytotechnology; and
-
Completed two (2) years of full-time supervised experience in cytotechnology.
(c) Has achieved a satisfactory grade in a proficiency examination approved by the cabinet. After December 31, 1978, initial qualification as a cytotechnologist shall be in accordance with the requirements of paragraphs (a) or (b) of this subsection.
(5) An individual qualifying as a cytotechnologist solely under subsection (4) of this section may supervise technicians and trainees only in the specialty of cytology.
(6) An individual serving as a laboratory technologist or cytotechnologist in Kentucky for a period of one (1) year prior to May 4, 1977, may continue to serve the laboratory in a capacity unless otherwise exempted in subsections (3) and (4) of this section. The cabinet may require, in the interest of the health, safety, and welfare of the people of this state and as a condition to issuance of an original or renewal license, the individual to satisfactorily demonstrate the ability to perform medical laboratory functions under supervision.
Section 4. Medical Laboratory Technicians and Trainees.
(1) Medical laboratory technicians shall:
(a) Perform only medical laboratory procedures which require a degree of skill commensurate with their education, training, and technical abilities, and which involve limited exercise of independent judgment.
(b) Perform procedures only in the presence of a qualified medical laboratory technologist, supervisor, or director.
(2) A medical laboratory technician trainee shall perform only repetitive procedures which require a minimal exercise of independent judgment. These procedures shall be performed only under the personal and direct supervision of a qualified supervisor or technologist.
(3) To qualify as a medical laboratory technician, a person shall meet one (1) of the following requirements:
(a) Successfully complete sixty (60) semester hours of academic credit, including chemistry and biology, and a structured curriculum in medical laboratory techniques at an accredited institution, or possess an associate degree based on a course of study including those subjects from an accredited institution.
(b) Be a high school graduate or equivalent and have completed one (1) year in a technician training program in a school accredited by an accrediting agency approved by the cabinet.
(c) Be a high school graduate or equivalent and have two (2) years of pertinent full-time laboratory experience as a technician trainee in a medical laboratory approved by the cabinet.
(d) Be a high school graduate or equivalent, have successfully completed an official military medical laboratory procedures course of fifty (50) weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician).
(e) A person not meeting the training and experience requirements defined in paragraphs (a), (b), (c), or (d) of this subsection may qualify as a medical laboratory technician if the person:
-
Was performing the duties of a medical laboratory technician any time between January 1, 1968, and May 4, 1977; and
-
Had five (5) years of pertinent medical laboratory experience prior to May 4, 1977.
(f) An individual serving as a laboratory technician in Kentucky for a period of one (1) year prior to May 4, 1977, may continue to serve the laboratory unless otherwise exempted in paragraphs (a), (b), (c), (d), and (e) of this subsection. The cabinet may require, in the interest of the health, safety, and welfare of the people of the state and as a condition to the issuance of an original or renewal license, the individual to satisfactorily demonstrate the ability to perform medical laboratory functions under supervision.
(g) Has achieved a satisfactory grade in a proficiency examination approved by the cabinet. After December 31, 1978, initial certification as a technician shall be in accordance with paragraphs (a), (b), (c), or (d) of this subsection.
Section 5. Personnel Policies. Each laboratory shall create and maintain written personnel policies, practices, and procedures that support sound laboratory practice. Work assignments shall be consistent with qualifications. The laboratory shall maintain written employment records which include:
(1) A resume of each employee's initial and continued training, experience, duties, and date or dates of employment.
(2) Evidence of adequate health supervision of employees, including results of preemployment physical examinations, including chest X-rays, immunization records, and records of all illnesses and accidents occurring on duty.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human Resources to license and regulate medical laboratories in Kentucky, including the setting of qualifications for medical laboratory personnel. This administrative regulation establishes personnel standards for medical laboratory directors, supervisors, technologists, and technicians.
- History: 3 Ky.R. 198; eff. 5-4-1977; 20 Ky.R. 2181; 2637; eff. 3-14-1994; eff. 3-22-2019; Crt eff. 12-29-2025.
902 KAR 11:035 Proficiency test procedures {#sec-902-kar-11-035 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:035}
Section 1. Definitions.
(1) "Reference laboratory" means a laboratory designated by the cabinet to authenticate the identification, content, or titer of samples and other materials used in proficiency testing.
(2) "Referee laboratory" means a laboratory designated by the cabinet to examine specimens or other materials for proficiency testing using the time schedule allowed for licensed laboratories and under conditions similar to those under which licensed laboratories examine materials.
Section 2. Proficiency Testing; Procedures, Samples, Test Conditions. Applicants and licensees shall be subject to a proficiency testing program approved by the cabinet, to aid in assessing the competency of laboratory staff and the adequacy and quality of facilities, equipment, reagents, working conditions, and procedures. Testing may be carried out during on-site inspections by the cabinet or by submittal to laboratories of samples for examination. In conducting testing, the following rules shall apply:
(1) The laboratory shall be tested only in those procedures or specialties of procedures for which a license application, original or renewal, has been filed with the cabinet, or for which the cabinet has issued a license.
(2) Samples shall be examined by regularly assigned personnel using the laboratory's routine methods.
(3) Samples to be tested may be provided prior to, during, or subsequent to inspections.
(4) Time allowed for testing of samples shall be the time required under conditions of normal laboratory operations, as determined by the cabinet.
(5) Laboratory personnel shall enter the date and time of receipt of samples, results of tests, and other information required by the cabinet, on forms provided or required by the cabinet.
Section 3. Proficiency Testing; Reference Laboratories and Referee Laboratories. Samples identical to those submitted to the applicant or licensee laboratory shall be submitted to reference or referee laboratories designated by the cabinet.
Section 4. Proficiency Testing; Reporting of Test Scores.
(1) If laboratory reports reflect a lack of proficiency, the cabinet may recommend corrective measures, consultation, or training in an appropriate laboratory and may, upon written request of the laboratory director, furnish the laboratory with additional samples after corrective measures have been taken.
(2) Results reflecting a lack of proficiency may constitute a basis for denial, revocation, suspension, or limitation of the laboratory license, as provided by KRS 333.190(3).
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human Resources to periodically inspect medical laboratories in Kentucky and to withhold the issuance of a license to the medical laboratory until the cabinet determines that the laboratory is adequately staffed and equipped to operate in conformity with the requirements of KRS Chapter 333 and the administrative regulations promulgated thereunder. KRS Chapter 333 directs the Secretary for Human Resources to adopt rules and regulations to effectuate the purposes of KRS Chapter 333 including the licensure of medical laboratories, standards of performance in the examination of specimens, and the operation by the cabinet of a medical laboratory evaluation program. This administrative regulation describes the proficiency test program which shall be employed by the cabinet to evaluate the work of medical laboratories.
- History: 3 Ky.R. 201; eff. 5-4-1977; 20 Ky.R. 2184; eff. 3-14-1994; eff. 3-22-2019; Crt. eff 12-29-2025.
902 KAR 11:040 Specialty test procedure {#sec-902-kar-11-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:040}
Section 1. Tests Performed. The medical laboratory shall perform only those laboratory procedures and tests that are within the specialties and subspecialties the laboratory director or supervisor is qualified. The following standards shall apply:
(1) A laboratory may perform anatomical and clinical laboratory procedures and tests in all specialties if the laboratory director or a supervisor is a physician certified in both anatomical and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possesses qualifications equivalent to those required for certification.
(2) Unless otherwise exempted in subsection (1) of this section, a laboratory may perform tests in the specialty of:
(a) Microbiology, including the subspecialties of bacteriology, virology, mycology, and parasitology if the director or a supervisor is a physician or holds an earned doctoral or master's degree in microbiology from an accredited institution and, subsequent to graduation, had two (2) years of experience in clinical microbiology.
(b) Serology if the director or a supervisor is a physician or holds an earned doctoral or master's degree in biology, chemistry, immunology, or microbiology from an accredited institution and, subsequent to graduation, had two (2) years of experience in serology.
(c) Hematology, including gross and microscopic examination of the blood, if the director or a supervisor holds a master's or bachelor's degree in biology, immunology, microbiology, chemistry, or medical technology from an accredited institution and, subsequent to graduation, had two (2) years of experience in hematology.
(d) Immunohematology if the director or a supervisor is a physician with two (2) years of experience in immunohematology subsequent to graduation.
(e) Clinical chemistry if the director or a supervisor is a physician or holds an earned doctoral or master's degree in chemistry from an accredited institution and, subsequent to graduation, had two (2) years of experience in clinical chemistry approved by the cabinet.
(f) Radiobioassay if the director or a supervisor is a physician or holds an earned doctoral, master's, or bachelor's degree in chemistry, physics, biology, or medical technology from an accredited institution and, subsequent to graduation, had two (2) years of experience in radiobioassay approved by the cabinet.
(g) Tissue pathology, limited to skin pathology, if the director or a supervisor is a physician certified in dermato-pathology by the American Board of Dermatology or possesses qualifications equivalent to those required for certification.
(h) Diagnostic cytology if the director or a supervisor is a physician who is certified by the American Society of Cytology to practice cytopathology or possesses qualifications equivalent to those required for certification. The laboratory shall be qualified to perform the tests only on that anatomic site for which the director or supervisor is certified.
(i) Oral pathology if the director or supervisor is a dentist or physician who is certified in oral pathology by the American Board of Oral Pathology or possesses qualifications equivalent to those required for certification.
(3) Unless otherwise exempted in subsections (1) and (2)(d) of this section, a laboratory may perform tests in the immunohematology subspecialties of ABO grouping and Rh typing, antibody detection, identification, and titering if the director or a supervisor holds a master's or bachelor's degree in biology, immunology, microbiology, chemistry, or medical technology from an accredited institution and, subsequent to graduation, has two (2) years of experience in immunohematology.
(4) A laboratory may perform tests in the specialty of tissue pathology if the director or a supervisor is a physician who is certified in anatomical pathology by the American Board of Pathology or possesses qualifications equivalent to those required for certification.
Section 2. Special Exceptions.
(1) Unless otherwise exempted in Section 1(2)(a), (b), (c), (e), or (f) of this administrative regulation, if an individual qualifies as a medical laboratory director by reason of having served as director of a medical laboratory for twelve (12) months between January 1, 1968, and May 4, 1977, having attained a bachelor's degree from an accredited institution with a chemical, physical, or biological science as a major subject, and, subsequent to graduation, had six (6) years of pertinent full-time medical laboratory experience, the laboratory may perform tests in the specialty of:
(a) Microbiology if the director holds a bachelor's degree in a biological science and, subsequent to graduation, had four (4) years of experience in microbiology.
(b) Hematology if the director holds a bachelor's degree in biology, immunology, or microbiology from an accredited institution and, subsequent to graduation, had four (4) years of experience in hematology.
(c) Serology if the director holds a bachelor's degree in biology, chemistry, immunology, or microbiology and, subsequent to graduation, had four (4) years of experience in serology.
(d) Radiobioassay if the director, subsequent to graduation, had one (1) year of experience in radiobioassay.
(e) Clinical chemistry if the director holds a bachelor's degree in a chemical science or its equivalent and, subsequent to graduation, had four (4) years of experience in clinical chemistry.
(2) The laboratory may perform tests in the subspecialties of blood grouping and Rh typing, antibody detection, identification, and titering if the director holds a bachelor's degree in biology, immunology or microbiology from an accredited institution and, subsequent to graduation, had four (4) years of experience in immunohematology.
(3) The laboratory may perform tests in any of the specialties or subspecialties mentioned in subsections (1) and (2) of this section if the director holds a bachelor's degree in medical technology and, subsequent to graduation, had the designated years of specialized experience.
Section 3. Special Qualification by Examination. Unless otherwise exempted in Sections 1 and 2 of this administrative regulation, if an individual qualifies as a medical laboratory director by reason of having served as director of a medical laboratory for twelve (12) months between January 1, 1968, and May 4, 1977, and has achieved a satisfactory grade through an examination approved by the cabinet, the laboratory may perform tests in the laboratory specialties the director achieved a satisfactory grade in an examination approved by the cabinet.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human Resources to issue licenses to medical laboratories in Kentucky, and directs that licenses be issued only for the performance of those medical laboratory procedures which the particular laboratory, by virtue of the educational and experience background of its laboratory personnel, is competent to perform. The cabinet is authorized to adopt reasonable rules and regulations to effectuate the purposes and provisions of KRS Chapter 333. This administrative regulation establishes standards for determining the specialty of test procedures for which a laboratory may be licensed.
- History: 3 Ky.R. 202; eff. 5-4-1977; 20 Ky.R. 2186; 2640; eff. 3-14-1994; eff. 3-22-2019; Crt eff. 12-29-2025.
902 KAR 11:045 Test and specimen records {#sec-902-kar-11-045 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:045}
Section 1. Records of Observations. Records of observations shall be made by the medical laboratory concurrently with the performance of each step in the examination of specimens.
(1) The records shall reflect the actual results of all control procedures.
(2) Pursuant to KRS 333.180(1), all pertinent laboratory records shall be made available to inspection, examination, and copying as the cabinet may direct.
(3) All records shall be retained for a period of at least two (2) years after the date of submittal of the report, except as otherwise prescribed by law.
Section 2. Specimen Records. Daily accession records shall be maintained containing the following information:
(1) Laboratory number of the specimen or other means of identification;
(2) Name and other identification of the person from whom the specimen was taken, if available;
(3) Name of the licensed physician or other person or laboratory submitting the specimen;
(4) Date the specimen was collected by the physician or other authorized person, if available;
(5) Date the specimen was received in the laboratory;
(6) Condition of unsatisfactory specimens and packages if received (e.g., broken, leaked, hemolyzed, or turbid);
(7) Type of test performed;
(8) Result of the laboratory test; and
(9) Date the test was completed.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 requires medical laboratories in Kentucky to keep records involving medical laboratory services and copies of reports of laboratory tests for the period of time and in a manner prescribed by administrative regulation. KRS Chapter 333 authorizes the Secretary for Human Resources to adopt rules and regulations to effectuate the purposes and provisions of the chapter. This administrative regulation describes the contents of test and specimen records to be maintained by the medical laboratories.
- History: 3 Ky.R. 203; eff. 5-4-1977; 20 Ky.R. 2188; eff. 3-14-1994; eff. 3-22-2019; Crt eff 12-29-2025.
902 KAR 11:050 Equipment, methods, and samples {#sec-902-kar-11-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 11:050}
Section 1. Quality Control; General Practices. Each medical laboratory shall establish a quality control program covering all types of analyses performed by the laboratory for verification and assessment of accuracy, measurement of precision, and detection of error. The program shall provide for the following:
(1) Preventive maintenance, periodic inspection, and testing for proper operation of equipment and instruments as may be appropriate; validation of methods; evaluation of reagents; surveillance of results; and remedial action to be taken in response to detected defects.
(2) Adequacy of facilities, equipment, instruments, and methods for performance of the procedures or categories of procedures for which a license application is filed or granted; proper lighting for accuracy and precision; monitoring of temperature-controlled spaces and equipment, including water baths, incubators, sterilizers, and refrigerators, to ensure proper performance; evaluation of analytical measuring devices, such as photometers and radioactivity counting equipment, with respect to all critical operating characteristics.
(3) Labeling of all reagents and solutions to indicate identity and, if significant, titer, strength or concentration, recommended storage requirements, preparation or expiration date, and other pertinent information; assure that material of substandard reactivity or deteriorated materials are not used.
(4) The availability at all times, in the immediate bench area in which staff is engaged in examining specimens and performing related procedure within a category (e.g., clinical chemistry, hematology, and pathology) of current laboratory manuals or other complete written descriptions and instructions relating to:
(a) The analytical methods to be used by the staff, properly designated and dated to reflect the most recent supervisory reviews;
(b) Reagents;
(c) Control and calibration procedures; and
(d) Pertinent literature references. Textbooks may be used as supplements to the written descriptions but may not be used in lieu thereof.
(5) Written approval by the director or supervisor of all changes in laboratory procedures.
(6) Maintenance and availability to laboratory personnel and to the cabinet of records, reflecting dates and, if appropriate, the nature of inspection, validation, remedial action, monitoring, evaluation, and changes and dates of changes in laboratory procedures.
(7) Solicitation designed to provide for the collection, preservation, and transportation of specimens sufficiently stable to provide accurate and precise test results suitable for clinical interpretation.
Section 2. Quality Control for Particular Specialties and Subspecialties. In addition to the quality control provisions required under Section 1 of this administrative regulation, each medical laboratory shall provide for additional controls which pertain to the particular specialties and subspecialties in which the laboratory is involved. In establishing the controls, the following rules shall apply:
(1) If the laboratory performs tests in the specialty of microbiology, chemical and biological solutions, reagents, and antisera shall be tested and inspected each day of use for reactivity and deterioration.
(a) If the laboratory performs tests in the subspecialties of bacteriology and mycology, staining materials shall be tested for intended reactivity by application to smears of microorganisms with predictable staining characteristics; and each batch of medium shall be tested before, or concurrently with, use with selected organisms to confirm required growth, characteristics, selectivity, enrichment, and biochemical response.
(b) If the laboratory performs tests in the subspecialty of parasitology, a reference collection of slides, photographs, or gross specimens of identified parasites shall be available and used in the laboratory for appropriate comparison with diagnostic specimens; and a calibrated ocular micrometer shall be used for determining the size of ova and parasites, if size is a critical factor.
(c) If the laboratory performs tests in the subspecialty of virology, systems for the isolation of viruses and reagents for the identification of viruses shall be available to cover the entire range of viruses which are etiologically related to clinical diseases for which services are offered; records shall be maintained which reflect the systems used and the reactions observed; in tests for the identification of viruses, controls shall be employed which identify erroneous results; and if sero-diagnostic tests for virus diseases are performed, requirements for quality control as specified for serology shall apply.
(2) If the laboratory performs tests in the specialty of serology, the following controls shall be established:
(a) Serologic tests on unknown specimens shall be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels.
(b) Controls for all test components (antigens, complement, erythrocyte indicator systems, etc.) shall be employed to ensure reactivity and uniform dosage.
(c) Test results shall not be reported unless the predetermined reactivity pattern of the controls is obtained.
(d) Equipment, glassware, reagents, controls, and techniques for tests for syphilis shall conform to those recommended in the "Manual of Tests for Syphilis", American Public Health Association, 1990, incorporated by reference, or to any subsequent revisions. A copy of the "Manual of Tests for Syphilis" may be inspected or obtained at the Office of the Commissioner for Health Services, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. until 4:30 p.m.
(3) If the laboratory performs tests in the specialty of clinical chemistry:
(a) Each instrument or other device shall be recalibrated or rechecked at least once on each day of use. Records which document the routine precision of each method, automated or manual, and its recalibration schedule shall be maintained and available to laboratory personnel and the cabinet; at least one (1) standard and one (1) reference sample (control) shall be included each day of testing unknown specimens; and control limits for standards and reference samples shall be recorded and displayed and shall include the course of action to be instituted if the results are outside the acceptable limits.
(b) Screening or qualitative chemical urinalysis shall be checked daily by use of suitable reference samples.
(4) If the laboratory performs tests in the specialty of immunohematology:
(a) ABO grouping shall be performed by testing unknown red cells with anti-A and anti-B grouping serums licensed under Part 73, Title 42, Code of Federal Regulations, or possessing equivalent potency, using the technique for which the serum is specifically designed to be effective; for confirmation of ABO grouping the unknown serum shall be tested with known A1 and B red cells.
(b) The Rho(D) type shall be determined by testing unknown red cells with anti-Rho (anti-D) typing serum licensed under 42 CFR Part 73, or possessing equivalent potency using the technique for which the serum is specifically designed to be effective; anti-Rho' (CD), anti-Rho" (DE) and anti-Rhorh'rh" (CDE) serums licensed pursuant to 42 CFR Part 73, or possessing an equivalent potency, may be used for typing donor blood; all Rho negative donor and patient cells shall be tested for the Rho variant (Du); a control system of patient's cells suspended in his own serum or in albumin shall be employed if the test is performed in a protein medium.
(c) The potency and reliability of reagents (antisera, known test cells, and antiglobulin - Coombs serum) used for ABO grouping, Rh typing, antibody detection, and compatibility determinations shall be tested for reactivity on each day of use and if a new lot of reagents is used.
(5) If the laboratory performs tests in the specialty of hematology, instruments and other devices used in hematological examination of specimens shall be recalibrated, retested, or reinspected, as may be appropriate, each day of use; each procedure shall be rechecked each day of use with two (2) levels of controls; tests such as the one (1) stage prothrombin time test shall be run in duplicate unless the laboratory can demonstrate that low frequency of random error or high precision makes the testing unnecessary; standard deviation, coefficient of variation, or other statistical estimates of precision shall be determined by random replicate testing of specimens; and the accuracy and precision of blood cell counts, hematocrit, and hemoglobin measurements shall be tested each day of use.
(6) If the laboratory performs tests in the specialties of exfoliative cytology, histopathology, or oral pathology, the following controls shall be established:
(a) If the laboratory performs tests in the specialty of exfoliative cytology, the laboratory director or supervisor qualified in cytology shall rescreen for proper staining and correct interpretation at least a ten (10) percent random sample of gynecological smears which have been interpreted to be in one (1) of the benign categories by personnel not possessing director or supervisor qualifications; all gynecological smears interpreted to be in the "suspicious" or positive categories by screeners shall be confirmed by the laboratory director or qualified supervisor and the report shall be signed by a physician qualified in pathology or cytology; all nongynecological cytological preparations, positive or negative, shall be reviewed by a director or supervisor qualified in cytology; nonmanual methods shall provide quality control similar to that in other nonmanual laboratory procedures; and all smears shall be retained for not less than five (5) years from date of examination.
(b) If the laboratory performs tests in the specialties of histopathology and oral pathology, all special stains shall be controlled for intended reactivity by use of positive slides; stained slides shall be retained for not less than two (2) years from date of examination, and blocks shall be retained for not less than one (1) year from the date of examination; and remnants of tissue specimens shall be retained in a fixative solution until those portions submitted for microscopy have been examined and a diagnosis made by a pathologist.
(7) If the laboratory performs tests in the specialty of radiobioassay, the counting equipment shall be checked for stability at least once each day of use, with radioactive standards or reference sources; reference samples with known activity and within expected levels of normal samples shall be processed in replicate quarterly; for each method, records which document the routine precision and the recalibration schedule shall be maintained and be available to the staff and the cabinet.
History
- RELATES TO: KRS Chapter 333
- STATUTORY AUTHORITY: KRS 194.050
- NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 directs that all medical laboratories in Kentucky shall establish a quality control program acceptable to the Cabinet for Human Resources, and authorizes the cabinet to adopt reasonable rules and regulations to effectuate the purposes of KRS Chapter 333, including standards of performance in the examination of specimens. This administrative regulation is to ensure accuracy of test results by control of medical laboratory equipment, methods, and samples.
- History: 3 Ky.R. 204; eff. 5-4-1977; 20 Ky.R. 2189; eff. 3-14-1994; eff. 3-22-2019; Crt eff. 12-29-2025.
Chapter 15 Mobile Homes and Recreational Vehicles Parks; Facilities Standards
902 KAR 15:010 Manufactured and mobile home communities {#sec-902-kar-15-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 15:010}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 219.320(2).
(2) "Community street" means the paved portion of a roadway between curbs or, if not paved, the surfaced area separating lots.
(3) "Flood plain" means the area in a watershed that is subject to flooding at least one (1) time every 100 years.
(4) "Footer" means that part of a manufactured or mobile home lot that supports the foundation for the placement of a manufactured or mobile home and appurtenant structures or additions.
(5) "Foundation" means the substructure placed on a footer for supporting a manufactured home or mobile home.
Section 2. Application for a Permit.
(1) A person desiring to operate a manufactured or mobile home community shall complete and submit Form DFS-200, Application for a Permit, incorporated by reference in 902 KAR 10:040, to the local or district health department serving the county in which the community is located.
(2)
(a) Upon receipt of an initial Application for a Permit, the cabinet shall inspect the manufactured or mobile home community to determine compliance with the provisions of this administrative regulation and KRS 219.310 through 219.410.
(b) If the inspection reveals compliance with this administrative regulation, a permit shall be issued to the applicant by the cabinet.
(3) The Application for a Permit to operate a manufactured or mobile home community shall be accompanied by:
(a) An application fee of $150; and
(b) The inspection fee required by subsection (6) of this section.
(4) A permit to operate a manufactured or mobile home community shall be:
(a) Nontransferable from one (1) person to another; and
(b) Renewed annually by June 30 each year.
(5) A late renewal fee of seventy-five (75) dollars shall be assessed on all permit renewal applications not received or postmarked on or before July 31 each year.
(6) The fee assessed for the inspection of a manufactured or mobile home community shall be assessed according to the total number of spaces in the community:
(a) Two (2) to ten (10) spaces - $150;
(b) Eleven (11) to fifty (50) spaces - $225;
(c) Fifty-one (51) to 100 spaces - $300;
(d) 101 to 200 spaces - $375;
(e) 201 to 300 spaces - $450;
(f) 301 to 400 spaces - $525;
(g) 401 to 500 spaces - $600; or
(h) 501 or more spaces - $675.
Section 3. Submission of Construction Plan.
(1) A person desiring to construct or alter a manufactured or mobile home community shall complete and submit a notarized Form DFS-317, Application for a Permit to Construct or Alter a Mobile Home Park or Recreational Vehicle Park, to the local or district health department serving the county in which the community is located.
(2) Each application for a permit to construct or alter a manufactured or mobile home community shall be accompanied by:
(a) A complete plan, drawn to scale, submitted in triplicate, of the proposed community or alteration; and
(b) An application for plan review fee of seventy (70) dollars.
(3) If the community is located within a flood plain, the plan shall be submitted in quadruplicate.
(4) The plan shall show existing and proposed facilities including:
(a) The area and dimensions of the tract of land being developed;
(b) The number, location, and size of all manufactured or mobile home lots;
(c) The area within each manufactured or mobile home lot intended for location of a manufactured or mobile home and setback distances;
(d) The location and width of roadways, driveways, and walkways;
(e) The number, location, and size of all off-street automobile parking spaces;
(f) The location of each community street lighting and electrical system;
(g) A detailed drawing of the water supply, if the source is other than public;
(h) A detailed drawing of the sewage disposal facilities, including specifications;
(i) A detailed drawing of the refuse storage facilities;
(j) The location and size of water and sewer lines, and riser pipes;
(k) The size and location of playground areas within the community, if provided; and
(l) A separate floor plan of each building and other improvement constructed or to be constructed within the manufactured or mobile home community, including a plumbing riser diagram.
Section 4. Location and General Layout Standards.
(1) Every manufactured or mobile home and manufactured or mobile home community shall be located on a well-drained area. Each site shall be graded to prevent the accumulation of storm or other waters.
(2) If the location is in an area at high risk for flooding as determined by the National Flood Insurance Program, the applicant shall:
(a) Submit an engineering study to the cabinet; and
(b) Maintain flood insurance for the site.
(3) Each manufactured or mobile home or lot shall be numbered and displayed in a systematic order.
(4) Each manufactured or mobile home lot shall:
(a) Contain at least 4,000 square feet; and
(b) Be sized to ensure that spacing and setback requirements are met for any manufactured or mobile home placed on that lot.
(5) Manufactured or mobile homes shall be separated from each other and from other permanent buildings by at least fifteen (15) feet.
(6) A manufactured or mobile home shall be located at least twenty-five (25) feet from a community property boundary line abutting upon a public street or highway, and at least ten (10) feet from other community property boundary lines.
(7) There shall be at least twenty (20) feet between an individual manufactured or mobile home and the adjoining surface of a community street, or common parking area or other common areas.
(8) If a community provides a playground area, the area shall be easily accessible to all community residents and shall be fenced or otherwise rendered free of traffic hazards.
(9) Each lot shall abut a community street.
(a) The minimum width for a two (2) way community street with no parking shall be eighteen (18) feet.
(b) The minimum width for a two (2) way community street with one (1) side parking shall be twenty-seven (27) feet.
(c) The minimum width for a two (2) way community street with both sides parking shall be thirty-six (36) feet.
(d) The minimum width for a one (1) way community street with no parking shall be fourteen (14) feet.
(e) The minimum width for a one (1) way community street with one (1) side parking shall be twenty-three (23) feet.
(f) The minimum width for a one (1) way community street with both sides parking shall be thirty-two (32) feet.
(10) Each community street, driveway, and walkway shall be:
(a) Of gravel, asphalt, or concrete construction;
(b) Maintained in good condition;
(c) Drained so as not to allow water to pond or accumulate;
(d) Relatively free of dust; and
(e) Free of holes.
(11) The installation area of the manufactured or mobile home shall be suitable for placement of a manufactured or mobile home foundation, in compliance with site preparation and installation requirements of 815 KAR Chapter 25.
Section 5. Lighting within Community. A minimum equivalent to a 100 watt high pressure sodium light or light emitting diode equivalent, shall be provided at the community entrances, intersections, and at intervals of 200 feet within the community.
Section 6. Community Water Supply.
(1)
(a) The water supply shall be potable, adequate for the size of the community, and, if available, from a public supply of a municipality or water district in compliance with 401 KAR Chapter 8.
(b) If a public water supply of a municipality or a water district is not available, the supply for the community shall be developed and approved in accordance with the applicable requirements of 401 KAR Chapter 8.
(c) If a public water supply of a municipality or water district subsequently becomes available, connections shall be made to it and the community supply shall be discontinued.
(2) The water supply shall be capable of supplying at least 150 gallons per day per manufactured or mobile home lot.
(3) A physical connection shall not be made between an approved public water supply and unapproved water supply.
(4) Water distribution lines and connections shall comply with 815 KAR Chapter 20.
Section 7. Community Sewage and Waste Disposal.
(1)
(a) Sewage and waste matter shall be disposed of into a municipal sewer system, if available.
(b) If a municipal sewer system is not available, disposal shall be made into a private sewage disposal system designed, constructed, and operated in accordance with the requirements of 815 KAR Chapter 20 and 902 KAR Chapter 10.
(c) If a municipal sewer system subsequently becomes available, connections shall be made to it and the private sewer system shall be discontinued.
(2) The sewer outlet shall be capped while not in use.
(3) Manufactured or mobile home community sewer system connections shall comply with 815 KAR Chapter 20.
Section 8. Storage, Collection, and Disposal of Community Refuse.
(1) The permit holder shall be responsible for storage and disposal of refuse in common containers.
(2) The storage, collection, and disposal of refuse in the community area shall not create:
(a) A health, safety, or fire hazard;
(b) Rodent harborage;
(c) Insect breeding area;
(d) Air pollution; or
(e) Other public or private nuisance.
(3) Refuse shall be stored in insect-proof, watertight, rodent-proof common containers, which shall be located near each manufactured or mobile home lot. Common containers shall be provided in sufficient number and capacity to properly store all refuse deposited by community residents.
(4) A common container storage location shall be provided, designed, and maintained so as not to create a nuisance.
(5) Refuse shall be collected at least once a week or more often, if necessary.
(a) If suitable collection service is not available from municipal or private agencies, the owner or operator of the community shall provide this service.
(b) All refuse shall be collected and transported in covered, leak-proof containers or vehicles.
(6) Refuse collected at a community shall be disposed in a safe and sanitary manner approved in accordance with 401 KAR Chapter 47.
(7) Open burning shall be prohibited in a manufactured or mobile home community.
Section 9. Insect, Rodent, and Vegetative Nuisance Control within the Community.
(1) Grounds, buildings, and structures shall be maintained free of insect and rodent harborage and infestation. Approved extermination methods and other measures to control insects and rodents shall be used.
(2) Communities shall be maintained free of accumulations of debris that could provide rodent harborage or breeding places for flies, mosquitoes, and other pests.
(3) Storage areas shall be maintained to prevent rodent harborage. Lumber, pipe, and other building materials shall be stored at least one (1) foot above the ground.
(4) Within forty-five (45) days of placement, each manufactured or mobile home shall have underpinning of vinyl, metal, masonry, or pressure-treated lumber.
(5)
(a) A community shall be maintained to prevent the growth of ragweed, poison ivy, poison oak, poison sumac, and other noxious weeds considered detrimental to health.
(b) A community shall be free of heavy vegetative growth of any description.
(c) Pesticide application for the control of vegetative growth shall be in accordance with 302 KAR Chapter 28.
Section 10. Community Electrical Distribution Systems. Every community shall contain an electrical system consisting of wiring, fixtures, equipment, and appurtenances installed and maintained pursuant to the requirements of 815 KAR Chapter 7.
Section 11. Community Fire Protection. Each community shall comply with fire safety codes applicable to manufactured or mobile home communities, including:
(1) Spacing and setback requirements for attached or unattached accessory buildings or structures;
(2) State Fire Marshal requirements established in 815 KAR Chapter 10; and
(3) Local fire codes regarding fuel supply storage and fuel connections.
Section 12. Community Maintenance and Registration of Occupants. The person to whom a permit to operate a community is issued shall:
(1) Maintain the community, the community's facilities, and equipment in good repair and in a clean and sanitary condition;
(2) Notify community occupants of relevant provisions of this administrative regulation, including occupants' duties and responsibilities;
(3)
(a) Assign proper orientation and location of each community home; and
(b) Assure proper installation and set up of each manufactured or mobile home, in compliance with the provisions established in KRS 227.570(2) and 815 KAR Chapter 25; and
(4) Maintain a register containing the names of community occupants, to be made available to a person authorized to inspect the community.
Section 13. Communities Holding a Valid Operation Permit and Constructed Prior to December 18, 2002.
(1) A community with a valid operating permit issued between January 12, 1973 and December 18, 2002 shall be eligible for a permit to continue operation if it meets:
(a) The requirements of the 1973 administrative regulations; or
(b) The site plan approved by the cabinet at the time of permit issuance.
(2) A manufactured or mobile home community with a valid operating permit, constructed on or before January 12, 1973, shall be eligible for a permit to continue operation if:
(a) The community does not meet the design and construction requirements of this administrative regulation; but
(b)
-
Community facilities are capable of being maintained in a safe and sanitary manner, in compliance with this administrative regulation; and
-
The community does not present a public health nuisance.
(3) A manufactured or mobile home community with a valid operating permit, constructed on or before January 1, 1956, shall be eligible for a permit to continue operation if:
(a) The community does not meet the design and construction requirements of this administrative regulation; but
(b)
-
Community facilities are capable of being maintained in a safe and sanitary manner, in compliance with this administrative regulation; and
-
The community does not present a public health nuisance.
(4) A manufactured or mobile home currently in place at a community shall be allowed to continue to be situated on that lot. If the home is removed, it shall be replaced only by a home:
(a) The same size as the home being removed; or
(b) That preserves the set back and spacing requirements in effect at the time the community was constructed. A setback from an interior street shall be the maximum achievable for the replacement home.
Section 14. Inspection of Communities.
(1) At least once every twelve (12) months, the cabinet shall inspect each community and shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2)
(a) A cabinet inspector shall record the inspection findings on the DFS-318, Mobile Home and Recreational Vehicle Park Inspection Report; and
(b) Provide a copy of the report to the permit holder or the permit holder's designee.
(3) The findings shall:
(a) State the specific violations if found;
(b) Establish a specific and reasonable period of time for the correction of violations if found; and
(c) State that failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in suspension or revocation of the permit.
Section 15. Suspension, Reinstatement, and Revocation of Permits. In addition to penalties established in KRS 219.991(2), the cabinet may suspend or revoke a permit, in accordance with KRS 219.380(2).
(1) The cabinet shall, upon notice to the permit holder, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists; or
(b) The holder or an employee has interfered with the cabinet in the performance of the cabinet's duties.
(2) In all other instances of violation of the provisions of this administrative regulation the cabinet shall:
(a) Serve on the permit holder or the permit holder's designee, a written notice stating the violation; and
(b) Afford the holder a reasonable opportunity for correction.
(3) The cabinet shall notify, in writing, a permit holder who fails to comply with a written notice issued under the provisions of this section that the permit shall be suspended at the end of ten (10) days following service of the notice.
(4) A person whose permit has been suspended may, at any time, submit Form DFS-215, Application for Reinstatement, incorporated by reference in 902 KAR 45:005, for the purpose of reinstatement of the permit.
(5) A permit shall be permanently revoked for:
(a) Serious or repeated violations of a requirement of this administrative regulation; or
(b) Interference with an agent of the cabinet in the performance of his or her duties.
(6) Prior to the action, the cabinet shall notify the permit holder or the permit holder's designee, in writing, stating the reasons for which the permit is subject to revocation and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice.
(7) If the cabinet or the cabinet's agent is on notice that a manufactured or mobile home community is in violation of another agency's lawful requirement, the permit shall not be renewed until the permit holder or the permit holder's designee demonstrates to the cabinet or its agent that the violation has been corrected.
Section 16. Appeals. A permit holder, a permit holder's designee, or an applicant aggrieved by a decision of the cabinet may request an appeal pursuant to 902 KAR 1:400.
Section 17. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) DFS-317, "Application for a Permit to Construct or Alter a Mobile Home Park or Recreational Vehicle Park," Rev 10-18; and
(b) DFS-318, "Mobile Home and Recreational Vehicle Park Inspection Report," 10-18.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40602, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 219.310-219.410, 219.991(2), 227.570(2)
- STATUTORY AUTHORITY: KRS 194A.050(1), 219.340, 219.360
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 219.340(1) requires the cabinet to establish a schedule of fees that shall be paid for a permit to operate a manufactured or mobile home community. KRS 219.360 authorizes the cabinet to issue a permit for the new construction or alteration of a manufactured or mobile home community. This administrative regulation establishes standards for community construction and layout, sanitary standards for operation, the permitting and inspection fee schedule, and other matters necessary to insure a safe and sanitary manufactured or mobile home community operation.
- History: 902 KAR 015:010. MRP-1; 1 Ky.R. 369; eff. 2-5-1975; Am. 17 Ky.R. 496; 1392; eff. 9-19-1990; 22 Ky.R. 2415; eff. 8-1-1996; 28 Ky.R. 1234; 1659; eff. 1-14-2002; 29 Ky.R. 1107; 1622; eff. 12-18-2002; 45 Ky.R. 3281, 46 Ky.R. 46, 478; eff. 9-9-2019; TAm eff. 3-20-2020; Crt eff. 5-14-2026.
902 KAR 15:020 Recreational vehicles {#sec-902-kar-15-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 15:020}
Section 1. Definitions.
(1) "Community street" means the paved portion of a roadway between curbs or, if not paved, the surfaced area separating sites.
(2) "Exempt recreational vehicle community" means a recreational vehicle community operated in accordance with KRS 219.410.
(3) "Floodplain" means the area in a watershed that is subject to flooding at least one (1) time every 100 years.
(4) "Recreational vehicle parking area" means that portion of the space used to park the recreational vehicle and towing vehicle, if any.
(5) "Self-contained recreational vehicle community" means a community in which all recreational vehicle spaces are designed with water and sewer riser pipe connections that permit the parking of only self-contained recreational vehicles.
(6) "Sewer riser pipe" means that portion of the sewer lateral that extends vertically to the ground elevation and terminates at each recreational vehicle space.
(7) "Seasonal" means a consecutive period of time not to exceed ninety (90) days within a calendar year.
(8) "Special Event" is a nonroutine activity within a community not to exceed fourteen (14) consecutive days in a calendar year.
(9) "Special Event Camping" is camping that is in conjunction with a special event.
(10) "Temporary" means a period of time not to exceed fourteen (14) days within a calendar year.
Section 2. Submission of Construction Plan.
(1) In accordance with KRS 219.350, each Application for a Permit, DFS-317, to construct or alter a recreational vehicle community shall be submitted to the local health department.
(2) Except as established in subsection (3) of this section, each Application for a Permit, DFS-317, shall be accompanied by a complete plan, drawn to scale, and submitted in triplicate, of the proposed community or alteration.
(3) If the community is located within a floodplain, the plan shall be submitted in quadruplicate.
(4) The plans shall show all existing and proposed facilities including:
(a) The size of the area and general dimensions of the tract of land being developed;
(b) The number, location, and size of all recreational vehicle spaces;
(c) The area within the space planned for location of the recreational vehicle including setback distances where applicable;
(d) The location and width of roadways, driveways, and walkways;
(e) The number, location, and size of all off-street automobile parking spaces;
(f) The location of the exterior area lights and the exterior electrical distribution system;
(g) Detailed drawings of water supply if source is other than public;
(h) Detailed drawings of sanitary station and watering station;
(i) Detailed drawings of sewage disposal facilities, including written specifications;
(j) Detailed drawings of refuse storage facilities;
(k) The location and size of water and sewer lines and riser pipes;
(l) Size and location of playground area within the community, if provided; and
(m) A separate floor plan of all service buildings and other improvements constructed or to be constructed within the recreational vehicle community, including a plumbing riser diagram.
(5) The cabinet shall provide written response to the application within thirty (30) business days.
(a) If the construction plans are not approved, the cabinet shall give the reason in writing to the person submitting the construction plans.
(b) Plans may be revised in response to written cabinet deficiencies and resubmitted for another review following the procedure established in this section.
Section 3. Location and General Layout Standards.
(1) The recreational vehicle community shall be located on a well drained area, not in a floodplain. Each site shall be graded to prevent the accumulation of storm or other waters.
(2) If the location is in an area at high risk for flooding, the applicant shall:
(a) Submit an engineering study to the cabinet; and
(b) Maintain flood insurance for the site.
(3) The area of the recreational vehicle community shall be large enough to accommodate the designated number of recreational vehicle spaces, necessary streets and roadways, and parking areas for motor vehicles.
(4) Each recreational vehicle space shall be numbered and displayed in some systematic order.
(5) Each recreational vehicle space shall contain a minimum of 1,500 square feet and adequate square footage to accommodate the maximum size recreational vehicle.
(6) Recreational vehicles shall be separated from each other and from other structures by at least fifteen (15) feet.
(7) A recreational vehicle shall be located at least twenty-five (25) feet from a public street or highway right-of-way and at least ten (10) feet from other community property boundary lines.
(8) Each parking area shall be provided with safe and convenient vehicular access from abutting public or community streets or roads to each recreational vehicle space. Alignment and gradient shall be properly adapted to topography.
(9) Access to recreational vehicle parking areas shall be designed to minimize congestion and hazards at each entrance or exit and allow free movement of traffic on adjacent streets. All traffic into or out of the parking areas shall be through these entrances and exits.
(10) Each space shall abut upon a community street.
(a) For a two (2) way community street, the minimum width shall be eighteen (18) feet; and
(b) For a one (1) way community street, the minimum width shall be twelve (12) feet.
(11) Community streets, driveways, and recreational vehicle parking areas shall be of all-weather construction, maintained in good condition, have natural drainage, be relatively free of dust, and be maintained free of holes.
(12) Each parking area shall provide sufficient parking and maneuvering space so that the parking, loading or maneuvering of recreational vehicles incidental to parking shall not necessitate the use of a public street, sidewalk or right-of-way, or private ground not part of the parking area.
(13) If a community provides a playground area, the area shall be easily accessible to all community residents and shall be fenced or otherwise rendered free of traffic hazards.
Section 4. Lighting within the Community. A minimum equivalent to a 175 watt metal halide type light shall be provided at community entrances, intersections, service buildings, sanitary stations, and other areas within the community as necessary.
Section 5. Community Water Supply.
(1) The water supply shall be potable, adequate, and from an approved public supply of a municipality or water district, if available.
(a) If a public water supply of a municipality or a water district is not available, the supply for the community shall be developed and approved pursuant to 401 KAR Chapter 8.
(b) If a public water supply of a municipality or water district subsequently becomes available, connections shall be made to it and the community supply provided for in paragraph (a) of this subsection shall be discontinued.
(2) The water supply shall be capable of supplying a minimum of fifty (50) gallons per day per recreational vehicle space.
(3) Except as provided in subsection (4) of this section, each recreational vehicle community shall have at least one (1) easily accessible watering station for filling recreational vehicle water storage tanks.
(a) There shall be one (1) watering station for each fifty (50) recreational vehicle spaces or fraction thereof.
(b) Each watering station shall be protected against backflow, back-siphonage, and other means of contamination.
(c) A watering station shall be separated from a sanitary station by at least fifty (50) feet.
(4) In lieu of a watering station, individual water connections may be provided at each recreational vehicle space. Riser pipes provided for individual water-service connections shall be located and constructed to prevent damage by the parking of recreational vehicles.
(5) Water distribution lines and connections in the service buildings, sanitary stations, water stations, and at recreational vehicle spaces shall comply with KRS Chapter 318, Plumbers and Plumbing, and 815 KAR Chapter 20.
Section 6. Community Sewage and Waste Disposal.
(1) All sewage and waste matter shall be disposed of into a public sewer system, if available.
(a) If a public sewer system is not available, disposal shall be made into a private system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5.
(b) If a public sewer system provided for in paragraph (a) of this subsection subsequently becomes available, connections shall be made to it and the community sewer system shall be discontinued.
(2) Except for self-contained recreational vehicle communities, each community shall provide at least one (1) sanitary station.
(a) If more than seventy-five (75) recreational vehicle spaces without sewer riser pipes are provided, additional sanitary stations shall be required at the ratio of one (1) station for each seventy-five (75) recreational vehicle spaces without sewer riser pipes or fraction thereof.
(b) A sanitary station shall:
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Consist of at least a trapped four (4) inch sewer riser pipe connected to the community sanitary sewer system; and
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Be surrounded at the inlet end by a concrete apron sloped to the drain.
(c) The riser shall be provided with a suitable hinged cover, and the area around the station shall be sloped to drain the surface water away.
(d) A water outlet shall be included to permit sanitary maintenance of the station and be marked in three (3) inch block letters in a contrasting color: "This Water for Flushing and Cleaning Purposes Only."
(e) The water outlet hose shall be reel or tower mounted to insure sanitary storage when not in use.
(f) A vacuum breaker shall be installed at the highest point on the reel or tower mounting.
(3) If facilities for individual sewer riser pipes are provided, the following requirements shall apply:
(a) The sewer riser pipe shall have at least a four (4) inch diameter and shall be located on the recreational vehicle space so that the sewer riser pipe to the recreational vehicle drain outlet shall approximate a vertical position; and
(b) Provision shall be made for capping the sewer riser pipe when a recreational vehicle does not occupy the space. Surface drainage shall be diverted away from the riser.
(4) Sewer system connections in recreational vehicle communities shall comply with KRS Chapter 318, Plumbers and Plumbing, and 815 KAR Chapter 20.
Section 7. Storage, Collection, and Disposal of Community Refuse.
(1) The storage, collection, and disposal of refuse in the community area shall be conducted to not create a health, safety, or fire hazard; rodent harborage; insect breeding area; or cause air pollution.
(2) Refuse shall be stored in flytight, watertight, rodent proof common containers. Common containers shall be provided at the ratio of one (1) container per two (2) recreational vehicle spaces and in additional numbers as may be necessary to properly store refuse.
(3) Refuse collection stands shall be provided for refuse containers with less than thirty-five (35) gallons capacity. Stands shall be designed to prevent containers from being tipped, to minimize spillage and container deterioration, and to facilitate cleaning around them.
(4) Refuse containing garbage shall be collected at least once a week or more often if necessary.
(a) If suitable collection service is not available from a municipal or private agency, the owner or operator of the community shall provide this service.
(b) Refuse shall be collected and transported in covered, leak-proof containers or vehicles.
(5) Refuse and waste collected at a community shall be disposed in a safe and sanitary manner in accordance with 401 KAR Chapter 47.
Section 8. Community Service Buildings.
(1) Except for self-contained recreational vehicle communities, each community shall provide one (1) or more central service buildings containing the necessary toilet and other plumbing fixtures specified by the State Plumbing Code, 815 KAR Chapter 20.
(2) A service building shall be conveniently located within a radius of approximately 500 feet of the spaces to be served. A variance shall be granted by the cabinet if topography or other geographical conditions warrant.
(3) A service building shall be constructed and maintained pursuant to the requirements of the State Building Code, 815 KAR 7:120.
(4) A room containing sanitary or laundry facilities shall have:
(a) Every opening to the outer air effectively screened and each door provided with a spring or other self-closing device;
(b) Illumination levels maintained as follows:
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General visual tasks: ten (10) foot-candles;
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Laundry room work area: forty (40) foot-candles; and
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Toilet room, in front of mirrors: forty (40) foot-candles;
(c) Hot and cold water furnished to every lavatory, sink, shower, and laundry fixture, and cold water furnished to every water closet and urinal;
(d) Walls, floors, ceilings, attached or freestanding fixtures, and equipment maintained in good repair and sanitary. Surfaces shall not consist of carpeting or material that is not smooth and easily cleanable;
(e) Refuse stored in easily cleanable containers;
(f) Sanitary towels or a mechanical hand drying device located adjacent to the lavatories; and
(g) A covered waste receptacle for each toilet room stall used by women.
Section 9. Insect, Rodent, Pest, and Pet Control within the Community.
(1) Grounds, buildings, and structures shall be maintained free of insect and rodent harborage and infestation. Approved extermination methods and other measures to control insects and rodents shall be used.
(2) Communities shall be maintained free of accumulations of debris that could provide rodent harborage or breeding places for flies, mosquitoes, or other pests.
(3) Storage areas shall be maintained to prevent rodent harborage. Lumber, pipe, and other building materials shall be stored at least one (1) foot above the ground.
(4) If the potential for insect and rodent infestation exists, all exterior openings in or beneath a structure shall be appropriately screened with wire mesh or other suitable materials.
(5) The growth of brush, weeds, and grass shall be controlled to prevent harborage of ticks, chiggers, and noxious insects within the area used for the parking of recreational vehicles.
(6) Communities shall be maintained to prevent the growth of ragweed, poison ivy, poison oak, poison sumac, and other noxious weeds considered detrimental to health. Open areas shall be maintained free of heavy undergrowth.
(7) An owner or person in charge of a dog, cat, or other pet shall not permit the animal to run at large or to create a nuisance within the limits of the community.
Section 10. Community Electrical Distribution Systems. Every community shall contain an electrical system consisting of wiring, fixtures, equipment, and appurtenances installed and maintained pursuant to the requirements of the Public Protection Cabinet.
Section 11. Community Fire Protection. Each community shall comply with applicable rules and administrative regulations of the State Fire Marshal and applicable local fire codes pertaining to Standards of Safety, 815 KAR 10:060, fuel supply storage, and fuel connections.
Section 12. Community Maintenance and Registration of Occupants and Vehicles.
(1) The permit holder shall maintain the community, its facilities, and equipment in good repair and in a clean and sanitary condition.
(2) Every permittee shall maintain a register showing the following:
(a) The names and permanent addresses of all recreational vehicle occupants;
(b) The make, model, and license number of the recreational vehicle or the tow vehicle; and
(c) The dates of arrival and departure of the recreational vehicle or its occupants.
(3) The register shall be available to an authorized person inspecting the recreational vehicle parking area.
(4) An owner or operator of a self-contained recreational vehicle community shall not permit the parking of a dependent recreational vehicle within the self-contained recreational vehicle community.
(5) An owner or operator of a recreational vehicle community shall not construct, install, or attach, or permit the construction, installation, or attachment of a lean-to, deck, addition, or other permanent or semipermanent structure upon a recreational vehicle or recreational vehicle space, except that a collapsible awning or screened enclosure mounted upon or transported with the recreational vehicle may be permitted.
Section 13. Communities Constructed prior to June 16, 1973. A recreational vehicle community in existence on June 16, 1973, shall be eligible for a permit to operate notwithstanding that the community does not fully meet the design and construction requirements of this administrative regulation, if:
(1) The cabinet determines that the community can be operated in a safe and sanitary manner pursuant to the operational requirements of this administrative regulation; and
(2) The community has a service building, sanitary station, safe water supply, adequate sewage, and solid waste disposal, and does not create a nuisance.
Section 14. Special Event Camping. A recreational community shall notify the local health department of the intention to operate at least twenty (20) days prior to each special event.
Section 15. Inspection of Communities.
(1) At least once every twelve (12) months, the cabinet shall inspect each community and shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) Special event camping communities shall be inspected and reinspected daily or with sufficient frequency to ensure enforcement of this administrative regulation and to protect public health.
(3) An inspector shall record inspection findings on an official cabinet report form, DFS 318, Mobile Home and Recreational Vehicle Park Inspection Report, and shall provide the permit holder or operator with a copy. The inspection report shall:
(a) Set forth the specific violations if found;
(b) Establish a specific and reasonable period of time for the correction of the violations found; and
(c) State that failure to comply with a notice issued pursuant to the provisions of this administrative regulation shall subject the permit to consideration for suspension or revocation of the permit.
Section 16. Suspension of Permits.
(1) The cabinet shall address penalties, including permit suspension and revocation, in accordance with KRS 219.380(2) and 219.991(2).
(2) The cabinet shall, upon notice to the permit holder, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists; or
(b) The holder or an employee has interfered with the cabinet in the performance of its duties.
(3) In all other instances of violation of the provisions of this administrative regulation, the cabinet shall:
(a) Serve on the permit holder or his designee a written notice specifying the violation; and
(b) Afford the holder a reasonable opportunity for correction.
(4) The cabinet shall notify, in writing, the permit holder or operator who fails to comply with a written notice issued under the provisions of this section, that the permit shall be suspended at the end of ten (10) days following service of the notice.
Section 17. Reinstatement of Suspended Permits.
(1) A person whose permit has been suspended may make application for a reinspection for the purpose of reinstatement of the permit.
(2) Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his opinion the conditions causing suspension of the permit have been corrected, the cabinet shall make a reinspection.
(3) If the applicant is found to be in compliance with the requirements of this administrative regulation, the permit shall be reinstated.
Section 18. Revocation of Permits.
(1) A permit shall be permanently revoked for:
(a) Serious or repeated violations of a requirement of this administrative regulation; or
(b) Interference with an agent of the cabinet in the performance of his duties.
(2) Prior to the action, the cabinet shall notify the permit holder or his designee, in writing, stating the reasons for which the permit is subject to revocation and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice.
Section 19. Permit Renewal.
(1) A permit to operate a recreational vehicle community shall be renewed annually, in the month of July. A permit fee shall be assessed pursuant to 902 KAR 45:120, Section 2(2).
(2) Exempt recreational vehicle communities shall register with the cabinet or its agents. Required information for registration shall be the:
(a) Name of community;
(b) Name of owner; and
(c) Dates the recreational community will be operation.
(3) If the cabinet or its agent is on notice that a recreational vehicle community is in violation of another agency's lawful requirement, the permit shall not be renewed until the permit holder or his designee demonstrates to the cabinet or its agent that the violation has been corrected.
Section 20. Appeals.
(1) A permit holder, his designee, or an applicant aggrieved by a decision of the cabinet may request a conference or administrative hearing. The request shall be submitted within ten (10) days of receipt of a written notice of:
(a) A violation;
(b) Suspension or revocation of a permit;
(c) Denial to renew a permit; or
(d) Denial of an initial application.
(2) Conference hearings.
(a) A conference hearing shall be conducted in accordance with 902 KAR 1:400, Administrative hearings, with the following exceptions:
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The conference hearing shall be less formal than an administrative hearing;
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The matter at issue shall be discussed before a representative of the Department for Public Health; and
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Participants in the discussion shall be:
a. An agent of the cabinet; and
b. The permit holder, his designee, or the applicant.
(b) A request for a conference hearing shall be:
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In writing; and
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Submitted or addressed to the cabinet's agent at the local health department that issued or gave notice of the violation, suspension, or revocation.
(c) A permit holder, his designee, or an applicant who does not agree with the conference report issued after the conference hearing may appeal by requesting an administrative hearing.
(3) Administrative hearing.
(a) A request for an administrative hearing shall indicate waiver of the right to request a conference hearing.
(b) The administrative hearing shall be conducted in accordance with 902 KAR 1:400, Administrative hearings.
(c) A request for an administrative hearing shall be:
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In writing;
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Submitted or addressed to the Commissioner, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621; and
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Accompanied by a copy of the notice of violation, notice to suspend or revoke, letter denying an application, or the conference hearing report.
Section 21. Exceptions. Exempt recreational vehicle communities as defined in KRS 219.410 shall not be subject to this administrative regulation unless indicated otherwise within this administrative regulation.
Section 22. Variance. The owner of a site where special event camping or campground is proposed to be installed may request, in writing, from the local board of health or its designated agent, a variance to the requirements included within this administrative regulation.
(1) A written request for variance shall include:
(a) Pertinent information about the site including a detailed site plan;
(b) The specific portion of the administrative regulation requested for waiver;
(c) The specific reasons for the request; and
(d) Documents, drawings, specifications, and other evidence of compliance with this administrative regulation through alternative means that support the granting of the variance.
(2) A request for variance shall be acted upon by the local board of health or its designated agent within ten (10) business days of receipt of the request.
(a) A written decision on the request shall be presented to the applicant within five (5) business days of the decision.
(b)
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The variance may be granted with stipulations.
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If the variance is granted with stipulations, the stipulations shall be included in the decision notice.
(3) An applicant for a variance may appear before the local board of health or it's agent for the purpose of presenting the request or to appeal a decision.
(4) If a hearing on the variance request or decision is requested, the local board of health or it's agent shall:
(a) Set a time and date for the hearing within ten (10) business days of the request; and
(b) Notify the applicant, in writing, within five (5) business days of receipt of the request and at least two (2) days prior to the date of hearing, of the time and date for the hearing.
(5) A decision regarding a variance shall be based upon evidence presented by:
(a) The applicant; and
(b) The local health department representative; or
(c) An expert professional witness.
(6) A decision regarding a variance shall be considered in accordance with:
(a) The requirements of 902 KAR 15:020, KRS 219.310 to 219.410 and related laws; and
(b) The presence or absence of reasonable assurance, derived from evidence presented, that the granting of the variance shall not result in the creation of:
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A public health hazard; or
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A public health nuisance.
Section 23. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Application for a Permit", DFS-317, May 1991; and
(b) "Mobile Home and Recreational Vehicle Park Inspection Report", DFS-318, September 1996.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 211.180(1)(c), 219.310-219.410, 219.991(2), Chapter 318
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.090 requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary for compliance with KRS 211.180. KRS 211.180(1) requires the secretary to promulgate administrative regulations to provide a safe and sanitary environment for recreational areas designated public and semipublic. This administrative regulation establishes standards for community construction and layout, sanitary standards for operation, and other matters necessary to insure a safe and sanitary recreational vehicle community operation.
- History: 902 KAR 015:020. MRP-2; 1 Ky.R. 371; eff. 2-5-1975; 17 Ky.R. 500; 9-19-1990; 22 Ky.R. 2418; eff. 8-1-1996; 29 Ky.R. 1110; 1625; eff. 12-18-2002; 38 Ky.R. 343; 924; eff. 11-10-2011; Crt eff. 10-18-2019; Crt eff. 5-14-2026.
Chapter 18 WIC Program
902 KAR 18:011 Definitions for 902 KAR Chapter 18 {#sec-902-kar-18-011 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:011}
Section 1. Definitions.
(1) "Above-50-percent vendor" is defined by 7 C.F.R. 246.2.
(2) "Alcohol" is defined by KRS 241.010(1).
(3) "Alcoholic beverage" is defined by KRS 241.010(2).
(4) "Approved product listing" or "APL" means an electronic list or file identifying the food items approved by the state WIC agency pursuant to 902 KAR Chapter 18 for purchase with WIC food instruments by food category and subcategory.
(5) "Authorized supplemental food" is defined by 7 C.F.R. 246.2.
(6) "Cash-value voucher" is defined by 7 C.F.R. 246.2.
(7) "Competent professional authority" means a person authorized to determine eligibility and certify persons for the WIC program.
(8) "Class" means food sale classification.
(9) "Compliance buy" is defined by 7 C.F.R. 246.2.
(10) "Contract price" means the price for a WIC food item negotiated between the state WIC agency and the vendor.
(11) "Dual participation" is defined by 7 C.F.R. 246.2.
(12) Electronic Benefit Transfer" (EBT) is defined by 7 C.F.R. 246.2.
(13) "Electronic WIC benefits" or "eWIC" means a technology that allows WIC participants to obtain food benefits by using a method that permits electronic access at authorized participating WIC vendors.
(14) "Exempt infant formula" is defined by 7 C.F.R. 246.2.
(15) "FNS" means Food and Nutrition Services.
(16) "Food instrument" is defined by 7 C.F.R. 246.2.
(17) "Good letter with exceptions" means a written notification letter that:
(a) An investigation has been conducted;
(b) A violation occurred; and
(c) No sanction was applied due to lack of pattern of incidence.
(18) "High risk vendor" means a vendor having a high probability of noncompliance with KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18.
(19) "Integrated" means a commercial system that fully incorporates eWIC functionality into an existing electronic cash register (ECR) system.
(20) "Inventory audit" is defined by 7 C.F.R. 246.2.
(21) "Investigation" means a method used by the state WIC agency to detect a WIC program violation.
(22) "Local agency" is defined by 7 C.F.R. 246.2.
(23) "Low variance" means the redemption of the same type of food item at the same price or within a narrow price range.
(24) "Not to exceed" or "NTE" means:
(a) FNS-approved cost containment methodology with WIC authorized vendors subject to price limitations; and
(b) The maximum amount that Kentucky will pay for a specific food item identified by its UPC code.
(25) "Participant" is defined by 7 C.F.R. 246.2.
(26) "Participant violation" means an intentional, knowing act of a participant that violates KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18.
(27) "PIN" means a unique four (4) digit personal identification number designated by the WIC participant.
(28) "Point of sale" or "POS" means the combination of hardware and software that enables a vendor to accept payment for WIC food transactions.
(29) "POS device" means a dedicated point of sale terminal that is used for eWIC food transactions.
(30) "Positive buy" means a compliance buy, onsite review, or online WIC transaction review that provides evidence that a violation of the vendor agreement or KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18 has occurred.
(31) "Price look up" or "PLU" means a four (4) or five (5) digit identifier used to identify individual and bulk produce.
(32) "Proxy" is defined by 7 C.F.R. 246.2.
(33) "Routine monitoring" is defined by 7 C.F.R. 246.2.
(34) "Rural" means any area not defined as urban.
(35) "Shelf price" means the price displayed on the food item, shelf, or display case where the food item is available for purchase.
(36) "SNAP" means the Supplemental Nutrition Assistance Program, formerly known as the Food Stamp Program.
(37) "Staple food items" means meat, poultry, fish, bread, breadstuff, cereals, vegetables, fruit, vegetable and fruit juices, and dairy products, excluding items, such as coffee, tea, cocoa, carbonated and uncarbonated beverages, condiments, and spices.
(38) "State WIC agency" means the Cabinet for Health and Family Services or its designated representative.
(39) "Systematic review" means a review of electronic WIC transactions by the state WIC agency or its representatives to monitor systematic violations of the program.
(40) "Trafficking" means the redemption or exchange of WIC food instruments for cash, firearms, ammunition, explosives, or controlled substances as defined by 21 U.S.C. 802(6).
(41) "Unauthorized food" means foods not authorized by the state or local agency for issuance to a particular participant.
(42) "Unique customer" means the number of unduplicated WIC households that have one (1) or more transactions at a specific authorized WIC vendor during a specified time period.
(43) "UPC" or "Universal product code" means a unique barcode consisting of numerical- digits used for tracking inventory in retail stores.
(44) "Urban" means a metropolitan area as defined by the U.S. Office of Management and Budget (OMB) Bulletin No. 23-01 available at https://www.whitehouse.gov/wp-content/uploads/2023/07/OMB-Bulletin-23-01.pdf.
(45) "Vendor" is defined by 7 C.F.R. 246.2.
(46) "Vendor authorization" is defined by 7 C.F.R. 246.2.
(47) "Vendor overcharge" is defined by 7 C.F.R. 246.2.
(48) "Vendor peer group system" is defined by 7 C.F.R. 246.2.
(49) "Vendor violation" is defined by 7 C.F.R. 246.2.
(50) "WIC agency" means a local health department or agency contracted with the state to deliver WIC services.
(51) "WIC benefits" means a voucher, check, Electronic Benefits Transfer card (EBT), coupon, or document that is used by a participant to obtain supplemental foods.
(52) "WIC-eligible nutritionals" is defined by 7 C.F.R. 246.2.
(53) "WIC program" or "WIC" means the Special Supplemental Nutrition Program for Women, Infants and Children authorized by Section 17 of the Child Nutrition Act of 1966, 42 U.S.C. 1786, and administered pursuant to 42 U.S.C. 1786 and 7 C.F.R. Part 246.
(54) "Written communication" means a letter or email correspondence that can be retrieved and tracked for timeline compliance.
History
- RELATES TO: KRS 194A.050, 194A.505, 241.010, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes definitions for the terms used in 902 KAR Chapter 18.
- History: 902 KAR 018:011. 40 Ky.R. 493; 827; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1585, 34; eff. 8-18-2026.
902 KAR 18:021 Eligibility, certification periods, and time frames for processing applicants {#sec-902-kar-18-021 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:021}
Section 1. Eligibility. To be certified as eligible to participate in the WIC program, a person shall:
(1) Be categorically eligible as:
(a) A pregnant woman;
(b) A postpartum woman, up to six (6) months after termination of pregnancy;
(c) A breastfeeding woman, up to the infant's first birthday;
(d) An infant, birth to one (1) year of age; or
(e) A child, one (1) to five (5) years of age;
(2) Provide proof of residence in the Commonwealth of Kentucky, such as a utility bill, driver's license, or Supplemental Nutrition Assistance Program (SNAP) identification card;
(3) Provide proof of identity as defined by 7 C.F.R. 246.7(c), such as a driver's license, medical card, birth certificate, or photo identification;
(4) Provide proof of household income, such as the most recent paystub, tax form (W-2), or medical card, and meet the following income criteria:
(a) Receive Kentucky Transitional Assistance Program (KTAP), SNAP, or Medicaid;
(b) A pregnant woman or infant in the household receives Medicaid;
(c) A member of the household receives Medicaid; or
(d) The household income is at or below 185 percent of the federal poverty level;
(5) Meet the required nutritional risk data at certification:
(a) Height or length and weight measurements shall be performed and documented, or referral data performed by a health care provider collected within sixty (60) days of the date of certification; and
(b) Hematological tests shall be performed and documented, or referral data performed by a health care provider collected within ninety (90) days of the date of certification; and
(6) Meet one (1) of the following nutritional risk criteria:
(a) A detrimental or abnormal nutritional condition detectable by biochemical or anthropometric measurements, such as:
-
Anemia;
-
Underweight;
-
Overweight;
-
Abnormal pattern of weight gain in a pregnant woman;
-
Low birth weight in an infant; or
-
Stunting in an infant or child; or
(b) A documented nutritionally related medical condition, such as:
-
Clinical signs of nutritional deficiency;
-
Metabolic disorder;
-
Pre-eclampsia in a pregnant woman;
-
Failure to thrive in an infant;
-
Chronic infection;
-
Alcohol or drug abuse or mental retardation in a woman;
-
Lead poisoning;
-
History in a pregnant woman of a high risk pregnancy or an associated factor, such as:
a. Smoking;
b. Conception before sixteen (16) months postpartum;
c. History of low birth weight, premature birth, or neonatal loss;
d. Adolescent pregnancy; or
e. Current multiple pregnancy;
-
Congenital malformation in an infant or child;
-
An infant born to a woman with:
a. A history of alcohol abuse;
b. A history of drug abuse; or
c. Mental retardation;
- A dietary deficiency that impairs or endangers health, such as an inadequate dietary pattern as assessed by:
a. A twenty-four (24) hour dietary recall;
b. Dietary history; or
c. Food frequency checklist; or
- A condition that predisposes a person to an inadequate nutritional pattern or nutritionally related medical condition, such as homelessness or migrancy.
Section 2. Certification Periods. WIC program benefits shall be based upon certifications established in accordance with the time frames established in this section.
(1) A pregnant woman shall be certified for the duration of her pregnancy and for up to six (6) weeks postpartum.
(2) A postpartum woman shall be certified for up to six (6) months postpartum.
(3) A breastfeeding woman shall be certified up to the infant's first birthday or when the woman ceases breastfeeding, whichever occurs first.
(4) An infant shall be certified up to the infant's first birthday. The local WIC agency shall ensure that the infant receives the required health and nutrition assessments pursuant to 7 C.F.R. 246.11(e)(3).
(5) A child shall be certified at intervals of approximately twelve (12) months, up until the child reaches their fifth birthday. The local WIC agency shall ensure that the child receives the required health and nutrition assessments in accordance with 7 C.F.R. 246.11(e)(3).
Section 3. Priority System. Vacancies in the WIC program shall be filled as they occur unless maximum participation has been reached. If maximum participation has been reached, vacancies shall be filled by a priority system based upon the nutritional risk of the patient.
Section 4. Time Frames for Processing Applicants.
(1) Pregnant women, infants, and migrant farmworkers and their families shall be screened and notified of WIC program eligibility or ineligibility within ten (10) days of application.
(2) All other applicants shall be screened and notified of WIC program eligibility or ineligibility within twenty (20) days of application. WIC benefits shall be provided when participants are notified of certification.
(3) In accordance with 7 C.F.R. 246.7(f)(2)(iii)(A), the state agency may provide an extension of the notification period to a maximum of fifteen (15) days for those local agencies that make a written request, including a justification of the need for an extension.
Section 5. Nutrition Education.
(1) Nutrition education shall be made available to the participant or the participant's parent or guardian and shall relate to the participant's nutritional needs, household situation, and cultural preferences.
(2) Tobacco, drug, and other substance abuse information shall be provided to each participant or the participant's parent or guardian.
(3) Breastfeeding information, including the benefits of breastfeeding, shall be provided to each pregnant participant, unless contraindicated.
History
- RELATES TO: KRS 194A.050, 7 C.F.R. Part 246, 278.6
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the application and participation process for participants of the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:021. 40 Ky.R. 496; 828; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1588, 36; eff. 8-18-2026.
902 KAR 18:031 Participant violations {#sec-902-kar-18-031 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:031}
Section 1. Participant Violation of the Program.
(1) The state WIC agency or a local agency shall issue a written warning for the following suspected acts for which a complaint is received concerning a participant:
(a) Purchasing unauthorized foods;
(b) Redeeming WIC benefits at an unauthorized store;
(c) Making a verbal offer to sell or exchange supplemental food or WIC food instruments with another individual, group, or vendor;
(d) Returning supplemental foods to a vendor for cash;
(e) Posting WIC foods, benefits, or eWIC cards for sale in print or online, or allowing someone else to do so; or
(f) Posting a WIC-issued breast pump for sale in print or online, or allowing someone else to do so.
(2) The state WIC agency or a local agency shall take the following specified actions for an intentional act of violation by a participant:
(a) Redeeming a food instrument before the first day to use or after the last date of use:
-
First offense: written warning;
-
Second offense: monthly pickup of food instruments; and
-
Third or subsequent offense:
a. One (1) month suspension; and
b. Reinstatement of two (2) or three (3) month issuance shall be at the discretion of the competent professional authority;
(b) Redeeming a food instrument that has previously been reported to the local agency as being lost or stolen and has been replaced:
-
First offense: written warning; and
-
Second and subsequent offenses: claim issued to recoup the WIC benefits that have been redeemed;
(c) Purchasing unauthorized food:
-
First offense: written warning; and
-
Second and all subsequent offenses: one (1) month suspension from the WIC program;
(d) Redeeming WIC benefits at an unauthorized store:
-
First offense: written warning; and
-
Second and all subsequent offenses: one (1) month suspension from the WIC program;
(e) Verbal abuse or threatening physical abuse of clinic or vendor staff:
-
First offense: written warning; and
-
Second and all subsequent offenses: one (1) month suspension from the WIC program;
(f) Physical abuse of clinic or vendor staff, first and all subsequent offenses; three (3) month suspension from the WIC program;
(g) Exchanging or selling supplemental food or a WIC food instrument with another individual, group, or vendor, first and all subsequent offenses; three (3) month suspension from the WIC program;
(h) Exchanging supplemental food or a WIC food instrument for credit, nonfood items, or supplemental food in excess of WIC benefits prescribed, first and all subsequent offenses: three (3) month suspension from the WIC program;
(i) Posting possible WIC-issued foods, benefits, or food instruments for sale in print, online, or allowing another person to do so:
-
First offense: written warning; and
-
Second offense: Three (3) month suspension;
(j) Dual participation in more than one (1) WIC program or participation in both the WIC program and the Commodities Supplemental Food Program:
-
First offense: written warning and immediate termination from one (1) of the WIC programs. The continuing WIC agency shall be chosen based upon the participant's residence or services; and
-
Second and all subsequent offenses: one (1) year disqualification from the WIC program and a claim to recoup WIC benefits previously redeemed;
(k) Knowingly and deliberately making a false or misleading statement or misrepresenting, concealing, or withholding a fact in order to obtain program benefits:
-
First offense: three (3) month disqualification from the WIC program and a claim issued to recoup the WIC benefits redeemed; and
-
Second and all subsequent offenses: one (1) year disqualification from the WIC program and a claim issued to recoup the WIC benefits redeemed; or
(l) Exchanging or selling supplemental foods, WIC benefits, or food instruments or allowing another person to do so:
-
First offense: three (3) month suspension from the WIC program; and
-
Second and all subsequent offenses: One (1) year disqualification from the WIC program and a claim issued to recoup the WIC benefits redeemed.
(3) Mandatory disqualification. Except as provided in subsections (4) and (5) of this section, a participant shall be disqualified from the WIC program for one (1) year if the state WIC or local WIC agency assesses:
(a) A claim of $200 or more; or
(b) A second or subsequent claim of any dollar amount.
(4) A mandatory disqualification shall not be imposed if, within thirty (30) days of receipt of the claim letter demanding repayment:
(a) Full restitution is made;
(b) A repayment schedule is agreed on; or
(c) The state WIC or local WIC agency approves the designation of a proxy if the participant is an infant, child, or under age eighteen (18).
(5) A participant may reapply to participate in the WIC program before the end of a mandatory disqualification period when:
(a) Full restitution is made;
(b) A repayment schedule is agreed upon; or
(c) The state WIC or local WIC agency approves the designation of a proxy if the participant is an infant, child, or under age eighteen (18).
(6) The amount of a claim shall be determined by the value of the WIC benefits redeemed. If the claim is not paid, the participant shall be denied application to the WIC program for the number of months of benefits which were used to calculate the claim amount.
(7) A participant with a pattern of violations of the WIC program shall be referred to the Office of the Inspector General for prosecution under KRS 194A.505.
(8) Activities prohibited by KRS 194A.505 apply to participants, vendors, and agency personnel. Penalties in KRS 194A.990 apply to participants, vendors, and agency personnel who have violated KRS 194A.505.
History
- RELATES TO: KRS 194A.050, 194A.505, 194A.990, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the sanction schedule for participants who violate the participation requirements of the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:031. 40 Ky.R. 497; 829; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1590, 37; eff. 8-18-2026.
902 KAR 18:040 Fair hearing procedures for participants {#sec-902-kar-18-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:040}
Section 1. Fair Hearing Procedures.
(1) In accordance with 7 C.F.R. 246.9, a local agency shall inform an individual in writing of the right to a fair hearing and the method by which a hearing may be requested if the person is:
(a) Determined to be ineligible for the program;
(b) Disqualified or suspended during a certification period; or
(c) Issued a claim.
(2)
(a) A person shall request a fair hearing by contacting the state WIC agency within sixty (60) days from the date the person receives the adverse action letter by hand delivery, electronic mail, or certified mail.
(b) Requests for a hearing shall be forwarded by the cabinet to the Office of Administrative Hearings within the Department of Law in accordance with KRS 15.111(2)(g), within two (2) working days of receipt.
(c) The hearing shall be accessible to the appellant and shall be conducted as soon as practical. Notice of the hearing shall be given to all involved parties at least twenty (20) days in advance of the date set for the hearing unless otherwise required by 7 C.F.R. 246.9.
(d) The Office of Attorney General hearing official shall provide the person with at least twenty (20) days advanced written notice of the time and place of the hearing.
(3) The request for a hearing shall not be denied or dismissed unless:
(a) The request is not received within the time limit established by subsection (2)(a) of this section;
(b) The request is withdrawn in writing by the appellant or a representative of the appellant;
(c) The appellant or representative fails, without good cause, to appear at the scheduled hearing; or
(d) The appellant has been denied participation by a previous hearing and cannot provide evidence that circumstances relevant to the WIC program eligibility have changed in a way that would justify a hearing.
(4) The state or local agency shall refer complaints that allege discrimination based on race, color, national origin, sex, handicap, or age to the Secretary of Agriculture or the Director of the Office of Equal Opportunity.
(5) The hearing shall be conducted in accordance with KRS Chapter 13B.
(6) Decisions of the hearing official shall be based upon the application of KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18 as related to the facts of the case as established in the hearing record.
(7)
(a) Participants who appeal the termination of benefits within the fifteen (15) day advance adverse action notice period provided by 7 C.F.R. 246.7 shall continue to receive WIC program benefits until the hearing officer reaches a decision or the certification period expires, whichever occurs first.
(b) WIC program benefits shall not be provided or continued with a filed appeal in the following situations:
-
Applicants who are denied benefits at initial certification;
-
Participants whose certification periods have expired; or
-
Participants who become categorically ineligible.
(c) If the hearing officer's recommended order concerns disqualification and is in favor of the state WIC agency, as soon as administratively feasible any continued benefits shall be terminated.
(d) If the decision regarding repayment of the benefits by the appellant is in favor of the state WIC agency, efforts to collect the claim shall be resumed, even during pendency of an appeal of a fair hearing decision.
(8) The appellant may appeal a hearing officer's decision by filing exceptions to the recommended order with the Cabinet for Health and Family Services, Office of the Secretary, 275 East Main Street, 5W-A, Frankfort, Kentucky 40621.
(9) Each party in the hearing shall have fifteen (15) days from the date the recommended order is mailed within which to file exceptions to the recommended order with the cabinet.
(10) A party may file a response to an opposing party's exceptions. The response shall be filed within twenty-five (25) days from the date the recommended order is mailed.
(11) Exceptions and responses to exceptions shall be considered filed on the date they are received by the cabinet.
(12) Any party aggrieved by the decision of the Cabinet for Health and Family Services, Office of the Secretary may seek judicial review of the decision by filing a petition in the circuit court of the county where the petitioner resides. Judicial review shall be in accordance with KRS 13B.140, 13B.150, and 13B.160.
(13) In accordance with 7 C.F.R. 246.8, complaints alleging civil rights discrimination for United States Department of Agriculture (USDA) funded programs, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), WIC Farmers Market Nutrition Program, and WIC Breastfeeding Peer Program, shall be filed with the USDA, Director, Office of Adjudication and Compliance, 1400 Independence Avenue, SW., Washington, DC 20250-9410, or call (800) 795-3272 (voice) or (202) 720-6382 (TTY).
History
- RELATES TO: KRS 15.111, 194A.050, 194A.505, 194A.990, 205.231, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 205.231, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the fair hearing procedures for participants for the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:040. 40 Ky.R. 499; 830; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1593, 38; eff. 8-18-2026.
902 KAR 18:050 Vendor authorization criteria {#sec-902-kar-18-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:050}
Section 1. Vendor Authorization Criteria.
(1) Only a vendor authorized by the state WIC agency pursuant to 902 KAR Chapter 18 shall redeem a food instrument.
(2) Each store operated by a business entity shall be authorized separately from other stores operated by the business entity.
(3) Each store shall have a single, fixed location and redeem the WIC food instruments and provide the WIC foods within the walls of the establishment.
(4) A vendor authorized as a pharmacy shall only redeem food instruments for exempt infant formulas and WIC-eligible nutritionals.
(5) Vendors shall be authorized in sufficient numbers and with distribution adequate to ensure:
(a) Participant convenience and access; and
(b) Effective management of vendor review by the cabinet.
(6) In order to be an authorized WIC vendor, a vendor shall:
(a) Complete the application process established in 7 C.F.R. 246.4, meet authorization criteria, and be approved by the WIC state agency pursuant to 902 KAR Chapter 18;
(b) Provide business information requested by the state WIC agency;
(c) Stock, at all times, minimum inventory in accordance with the Minimum Stock Requirements established in the Kentucky WIC Vendor Agreement.
-
Expired foods shall not count towards meeting the minimum stock requirement.
-
A pharmacy shall supply exempt formula or WIC-eligible nutritionals within forty-eight (48) hours of request;
(d) Obtain infant formula only from the listing of Kentucky WIC Authorized Formula Suppliers;
(e) Except for a pharmacy, be in compliance with the Kentucky Food Code, 902 KAR 45:005, and have a valid retail food establishment or retail food store permit in the current owner's name;
(f) Except for a pharmacy, be an authorized SNAP retailer;
(g) Have competitive prices with other authorized WIC vendors in the area ;
(h) Post the current prices of WIC approved foods on each individual product, on the shelf directly in front of the product, or on the refrigerated display case where the items are located. A cost plus ten (10) percent store shall post the final price on the individual product on the shelf, or on the refrigerated display case where the items are located;
(i) Be in compliance with the other Food and Nutrition Service programs or the Medicaid program, including:
-
Not be disqualified or withdrawn by the United States Department of Agriculture from participation in another Food Nutrition Service program or the Medicaid program;
-
Not be denied application to participate in SNAP or Medicaid;
-
Not be currently paying a civil money penalty to SNAP or Medicaid; or
-
Not have been assessed a civil money penalty by SNAP or Medicaid, and the disqualification period that would otherwise have been imposed has not expired;
(j) Request authorization for a business whose primary purpose is to be a retail grocery.
-
Except for a pharmacy, a direct distribution outlet or wholesale food establishment shall not be eligible.
-
A vendor that derives more than fifty (50) percent of annual food sales revenue from the sale of food items that are purchased with WIC food instruments shall not be eligible.
-
A retail grocery shall:
a. Have a separate and distinct grocery department in a stationary location that stocks staple food items in addition to WIC approved foods; and
b. Have fifteen (15) percent of gross sales in nontaxable food sales;
(k) Be registered with the Secretary of State and be in good standing, if a corporation or partnership;
(l) Except for a farmers' market, be open for business year round at least eight (8) hours per day, six (6) days per week;
(m) Be accessible to monitoring by state and federal officials without prior notice;
(n) Not be indebted to the WIC program for an unpaid claim or a civil money penalty against a store owned or previously owned by the applying owners; and
(o) Have the capability to accept WIC program benefits electronically. A store shall have the use of an internet cable or a currently Food and Nutrition Services certified system to accept online WIC EBT.
(7) The WIC program shall not authorize a vendor applicant if, during the last six (6) years, an applicant, current owner, officer, or manager has been convicted of or had a civil judgment for:
(a) Fraud;
(b) Antitrust violation;
(c) Embezzlement, theft, or forgery;
(d) Bribery;
(e) Falsification or destruction of records;
(f) Making false statements or claims;
(g) Receiving stolen property;
(h) Obstruction of justice; or
(i) Another act reflecting on the business integrity and reputation of the applicant, such as removal from other federal or state programs.
(8) The WIC program shall not authorize a store that has attempted to circumvent a period of disqualification from the program, including a store that has undergone a sale or changes of operation if the transaction involved the following parties:
(a) The seller or transferor is an owner, operator, or manager currently suspended, sanctioned, has outstanding monetary claims, or disqualified from WIC, SNAP, or Medicaid; or
(b) The buyer or transferee is related to the seller by marriage or consanguinity within the fourth degree, or was a manager or employee of the seller when the sanction, suspension, outstanding monetary claim, or disqualification was issued or the violation occurred.
(9) A contract shall not be entered into with a vendor if the contract would cause a conflict of interest, real or apparent.
(10) The WIC program shall terminate a vendor contract if the vendor or vendor's employee provided false information in connection with the vendor application.
(11) An authorized WIC vendor shall send appropriate employees (owner, manager, or head cashier) to attend state WIC agency required training.
(12) If an applying vendor does not meet the criteria upon review by the state WIC agency:
(a)
-
The applying vendor shall be notified in writing; and
-
After two (2) reviews, the applying vendor shall not apply for the program for at least sixty (60) days from the date of denial;
(b) After three (3) reviews, the applying vendor shall not apply for at least 120 days from the date of the denial; and
(c) Each subsequent denial shall result in an additional sixty (60) day waiting period.
(13) A person aggrieved by a decision of the cabinet may file a written request for a hearing with the cabinet within fifteen (15) days after receipt of notice of the adverse action. The hearing shall be conducted in accordance with KRS Chapter 13B.
History
- RELATES TO: KRS 194A.050, 194A.505, 194A.990, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802.
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the vendor authorization criteria for the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:050. 40 Ky.R. 501; 832; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1595, 39; eff. 8-18-2026.
902 KAR 18:061 Vendor violations and sanctions {#sec-902-kar-18-061 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:061}
Section 1. Vendor Violations and Sanctions.
(1) In addition to any criminal penalty imposed pursuant to KRS 194A.990, the cabinet shall impose one (1) or more of the following civil sanctions for established violations committed by a vendor or his or her employee or agent:
(a) Failure of a vendor to meet the authorization criteria in 902 KAR 18:050:
-
First occurrence: a sixty (60) day disqualification or non-renewal;
-
Second occurrence: a ninety (90) day disqualification or non-renewal; or
-
Third and subsequent occurrences: a 120 day disqualification or non-renewal;
(b) Failure of a vendor to pay a claim. The state WIC agency shall request payment by:
-
Written communication to the vendor requesting payment by a stated date;
-
If payment is not received by the stated date, the state WIC agency shall contact the vendor by either email or telephone, reminding vendor of payment due;
-
If payment is not received within fifteen (15) days of the stated date, the state WIC agency shall send a second letter by certified mail, return receipt requested, of past due claim; and
-
If payment is not received by the deadline stated in the second letter, then the following disqualification shall be issued:
a. First occurrence: a six (6) month disqualification; or
b. Second occurrence and subsequent occurrences: a one (1) year disqualification from the WIC program;
(c) Failure of a vendor to return the POS device (if applicable). The state WIC agency shall request return of the POS device (if applicable) by:
-
Written communication to the vendor requesting return of the POS device (if applicable) within seven (7) days of disqualification or termination;
-
If the POS device (if applicable) is not received, the state WIC agency shall contact the vendor by either email or telephone, reminding the vendor that the POS device (if applicable) is due; and
-
If the POS device (if applicable) is not returned within seven (7) days of the effective date of termination or disqualification, then an additional six (6) month disqualification shall be issued;
(d) Store personnel requesting the PIN: two (2) positive buys out of three (3) shall result in a one (1) year disqualification;
(e) Using the integrated or WIC POS device Cash-Value Benefits (CVB) functionality to provide non-produce food item(s): two (2) positive buys out of three (3) shall result in a one (1) year disqualification from the WIC program;
(f) Providing free merchandise exclusively to WIC participants as an incentive to redeem WIC benefits: one (1) positive buy out of three (3) shall result in a six (6) month disqualification;
(g) Public notice by a WIC vendor of providing free merchandise exclusively to participants as an incentive to redeem WIC benefits: one (1) occurrence shall result in a six (6) month disqualification;
(h) Conviction of trafficking in WIC benefits or selling a firearm, ammunition, an explosive, or controlled substance, as defined by 21 U.S.C. 802, in exchange for a food instrument: one (1) positive buy shall result in a permanent disqualification;
(i) Trafficking in WIC benefits or selling a firearm, ammunition, an explosive, or controlled substance, as defined by 21 U.S.C. 802, in exchange for a food instrument: one (1) positive buy shall result in a six (6) year disqualification;
(j) Sale of alcohol or alcoholic beverage or tobacco product in exchange for a food instrument: one (1) positive buy shall result in a three (3) year disqualification;
(k) Claiming reimbursement for the sale of an amount of a specific supplemental food item, that exceeds the vendor's documented inventory of that supplemental food item for:
-
An inventory audit for a thirty (30) day period, that results in more WIC sales than the documented inventory, shall result in a three (3) year disqualification;
-
An inventory audit for a ninety (90) day period, that results in more WIC sales than the documented inventory, shall result in a three (3) year disqualification; or
-
An inventory audit for a 180-day period, that results in more WIC sales than the documented inventory, shall result in a three (3) year disqualification;
(l) Charging a participant more for supplemental food than a non-WIC customer is charged or the current shelf price:
- Two (2) positive compliance buys out of three (3) shall result in a three (3) year disqualification if:
a. The vendor has exhibited a prior pattern of overcharging based upon routine monitoring visits that have resulted in two (2) letters for price discrepancies; or
b. The vendor has exhibited a pattern of two (2) out of four (4) quarters of low variance in the prior federal fiscal year;
- The state WIC agency shall:
a. Require a vendor that has received two (2) letters for price discrepancies during the federal fiscal year to receive training provided by the state WIC agency; and
b. Notify a vendor that has exhibited a pattern of low variance for two (2) or more quarters during the federal fiscal year; and
- Three (3) positive compliance buys out of three (3) shall result in a three (3) year disqualification for a vendor that does not meet the conditions in subparagraph 1. of this paragraph;
(m) Receiving, transacting, or redeeming food instruments outside of authorized channels, including the use of an unauthorized vendor or unauthorized person: two (2) positive buys out of three (3) shall result in a three (3) year disqualification;
(n) Charging for supplemental food not received by the participant, such as charging for one (1) food item or more listed on the WIC benefits but not purchased by the WIC participant: three (3) positive buys out of three (3) shall result in a three (3) year disqualification;
(o) Providing credit, an IOU, a rain check, a due bill, or a store credit, or providing a nonfood item other than cash, alcohol, tobacco, firearms, ammunition, explosives, or controlled substances, as defined by 21 U.S.C. 802, in exchange for a food instrument: two (2) positive buys out of three (3) shall result in a three (3) year disqualification;
(p) Providing an unauthorized food item or items in exchange for a food instrument: three (3) positive buys out of four (4) shall result in a one (1) year disqualification;
(q) Charging for supplemental food provided in excess of those listed on the food instrument: three (3) positive buys out of four (4) shall result in a one (1) year disqualification;
(r) A vendor that has been disqualified from the SNAP shall be disqualified from the WIC program for the same length of time as the SNAP disqualification; or
(s) A vendor that has been assessed a civil money penalty by SNAP, as established in 7 C.F.R. 278.6, shall be disqualified from the WIC program for the same length of time for which the vendor would have been disqualified from SNAP unless the WIC program determines that disqualification would result in inadequate participant access, in which case a penalty shall not be assessed.
(2) If multiple vendor violations are found during an investigation, the length of the disqualification shall be determined by the most serious violation.
(3) A vendor who has previously received two (2) or more of the mandatory sanctions established in subsection (1)(h) through (q) of this section, and that receives another sanction for a violation established in subsection (1)(h) through (q) of this section, shall have the third and all subsequent sanctions be doubled. A civil monetary penalty shall not be assessed for a third or subsequent sanction.
(4) Disqualified vendors. Even if the decision is later overturned, a disqualified vendor shall not be entitled to receive compensation for revenues lost as a result of a disqualification.
Section 2. Vendor Notification
(1) Except for violations established in Section 1(1)(a) through (c), (f) through (j), (r), and (s) of this administrative regulation, the state WIC agency shall notify a vendor in writing if an investigation reveals a potential initial violation.
(2) The vendor shall be notified before another violation is documented unless the state WIC agency determines that notifying the vendor would compromise the investigation.
(a) The notification determination shall be made on a case-by-case basis based on this administrative regulation.
(b) A notification of a potential initial violation shall not be issued if:
-
The vendor is identified as a high-risk vendor in accordance with 902 KAR 18:090;
-
One (1) or more of the same type of violation occurred within the same federal fiscal year or prior federal fiscal year and the vendor has received prior notification; and
-
Sending a notification letter would divulge the identity of the investigator.
History
- RELATES TO: 194A.050, 194A.505, 194A.990, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the vendor violations and sanctions for the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:061. 40 Ky.R. 503; 832; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1597, 40; eff. 8-18-2026.
902 KAR 18:071 Participant access determination and civil money penalty {#sec-902-kar-18-071 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:071}
Section 1. Participant Access Determination.
(1) Except for a violation established in 902 KAR 18:061, Section 1(1)(h) and (i), prior to disqualifying a vendor for a violation established in 902 KAR 18:061, the state WIC agency shall determine if disqualification of the vendor will result in inadequate participant access.
(2) Mileage shall be measured by automobile odometer or geomapping.
(3) The determination and documentation of adequate participant access shall be made based on if the sanctioned vendor
(a) Is located within:
-
A metropolitan area, as defined by the U.S. Office of Management and Budget (OMB) Bulletin No. 23-01, and there is another authorized vendor located within two (2) miles of the sanctioned vendor; or
-
A nonmetropolitan area and there is another authorized vendor located within seven (7) miles of the sanctioned vendor;
(b) Has redeemed food instruments for WIC nutritionals or exempt infant formula within thirty (30) days preceding the date of the letter issuing the notice of disqualification, and there is another authorized vendor within the designated mileage as established in paragraph (a) of this subsection that can supply the products which were previously redeemed; or
(c) Has redeemed food instruments from a minimum number of unique customers within thirty (30) days preceding the date of the letter issuing the notice of disqualification.
-
The minimum number of unique customers shall be calculated according to the vendor peer group system.
-
If a sanctioned vendor meets the criteria for unique customers, the state WIC agency shall determine if:
a. Conditions exist that would allow travel using public transportation to another authorized WIC vendor within the designated mileage in paragraph (a)1. of this subsection;
b. Crosswalks exist across multilane highways or railroad tracks if another authorized WIC vendor is located in a metropolitan area; or
c. An impassable mountain or an unbridged river would prevent travel if another authorized WIC vendor is located in a non-metropolitan area.
(4) If the WIC program determines there is adequate participant access, retailers shall be afforded the opportunity to submit written documentation providing evidence of the impact of the adverse action on WIC participants.
(5) If inadequate participant access is determined pursuant to subsection (3) of this section, a civil money penalty shall be assessed for a violation established in 902 KAR 18:061. The civil money penalty shall be calculated in accordance with 7 C.F.R. 246.12(l)(1)(x).
(6) The written documentation shall be received by the state WIC agency within fifteen (15) days from the date of receipt of the state WIC agency notification of disqualification. If the written documentation is not received within fifteen (15) days, further consideration shall not be given to participant access.
(7) Upon receipt and the review of the documentation, the WIC program shall send, within thirty (30) days, a written summary of the participant access review to the vendor. The vendor may then request a hearing. The hearing shall be in accordance with 902 KAR 18:081.
Section 2. Civil Money Penalty.
(1) The WIC program may negotiate an installment plan for the collection of a civil money penalty if requested by the vendor in writing prior to the payment due date.
(2) A vendor that fails to pay, partially pay, or timely pay a civil money penalty within the required time frame shall be disqualified for the length of time corresponding to the most serious violation.
History
- RELATES TO: 194A.050, 194A.505, 194A.990, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorize grants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes procedures for WIC vendor disqualification including the participant access determination and civil money penalty.
- History: 902 KAR 018:071. 40 Ky.R. 505; 834; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1600, 42; eff. 8-18-2026.
902 KAR 18:081 Local agency fair hearing and vendor administrative review process {#sec-902-kar-18-081 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:081}
Section 1. Local Agency.
(1) A local agency may request a fair hearing for:
(a) Denial of a local agency's application;
(b) Disqualification of a local agency; or
(c) Any other adverse action that affects a local agency's participation.
(2) The following state WIC agency actions shall not be subject to administrative review via a fair hearing:
(a) Expiration of the local agency's agreement; and
(b) Denial of a local agency's application if the state WIC agency has issued a request for bid and followed finance procurement procedures.
(3) The following shall be the effective dates of adverse actions against local agencies:
(a) Denial of local agency applications shall be effective immediately;
(b) Adverse actions in subsection (1)(b) and (c) of this section shall be effective no later than sixty (60) days after the date of the notice of adverse action is served by hand delivery or certified mail receipt; and
(c) Adverse actions that are appealed shall be effective the date that the local agency receives the fair hearing decision.
(4) A local agency may file a request for a fair hearing by electronic mail, hand delivery, or certified mail with the state WIC agency within fifteen (15) days after receipt of notice of the adverse action.
Section 2. Vendor Right to an Administrative Review.
(1) In accordance with 7 C.F.R. 246.18, a vendor aggrieved by a qualifying adverse action may request an administrative review for:
(a) Denial of authorization based on the vendor authorization criteria found in 902 KAR 18:050;
(b) Termination of an agreement;
(c) Disqualification in accordance with 902 KAR 18:061; or
(d) Imposition of a fine or civil money penalty in lieu of a disqualification in accordance with 902 KAR 18:071.
(2) In accordance with 7 C.F.R. 246.18, the following state WIC agency actions shall not be subject to administrative review under this section:
(a) The validity or appropriateness of the vendor selection criteria for minimum variety and quantity of supplemental foods, business integrity, and current SNAP disqualification or civil money penalty for hardship;
(b) The validity or appropriateness of the selection criteria for competitive price, including vendor peer group system criteria and the criteria used to identify vendors that are above-50-percent vendors;
(c) The validity or appropriateness of the participant access criteria and the state WIC agency's participant access determinations;
(d) The determination to include or exclude an infant formula manufacturer, wholesaler, distributor, or retailer from the list of entities where infant formula can be purchased;
(e) The validity or appropriateness of the prohibition of incentive items;
(f) The determination not to notify a vendor in writing if an investigation reveals an initial violation for which a pattern of violations shall be established in order to impose a sanction;
(g) The determination that a vendor did not have a policy and program in effect to prevent trafficking and that the ownership of the vendor was not aware of, did not approve of, and was not involved in the conduct of the violation;
(h) The expiration or non-renewal of a vendor's agreement;
(i) Disputes regarding food instrument payments and vendor claims; or
(j) Disqualification of a vendor as a result of disqualification from the SNAP.
(3) A vendor may file a request for an administrative review by electronic mail, hand delivery, or certified mail with the state WIC agency within fifteen (15) days after receipt of notice of the adverse action.
Section 3. Fair Hearing or Administrative Review.
(1) Requests for a fair hearing or an administrative review shall be forwarded by the cabinet to the Office of Administrative Hearings within the Department of Law in accordance with KRS 15.111(2)(g), within two (2) working days of receipt.
(2) The fair hearing or an administrative review shall be conducted in accordance with KRS Chapter 13B, except as established in this administrative regulation.
(3) The hearing or administrative official shall provide notice of the time and place of the fair hearing or administrative review within fifteen (15) days of a request.
(4) A request for a fair hearing or administrative review may be dismissed if:
(a) The request is not received within the time limit established by this administrative regulation;
(b) The request is withdrawn in writing by the appellant or a representative of the appellant; or
(c) The appellant or representative fails, without good cause, to appear at the scheduled fair hearing or administrative review.
(5) To protect the identity of the state WIC agency investigators, cross examinations of these witnesses shall be conducted behind a protective screen or other device in accordance with 7 C.F.R. 246.18(b)(5).
(6)
(a) In accordance with 7 C.F.R. 246.18(b)(9), the fair hearing or administrative review official shall issue a written recommended order no later than ninety (90) days after the cabinet receives the request for the fair hearing or administrative review, which shall include:
-
The findings of fact;
-
Conclusions of law; and
-
Recommended disposition, including recommended penalties, if any, in accordance with KRS 13B.110.
(b) In accordance with 7 C.F.R. 246.18(b)(8), decisions of the fair hearing or administrative review official shall be based on KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18, and the facts of the case as established in the official record as established in KRS 13B.130.
(c) An official shall not reduce or modify sanctions that are established by KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18.
(7) Exceptions to the official's recommended order shall be filed with or mailed to Cabinet for Health and Family Services, Office of the Secretary, 275 East Main Street, 5W-A, Frankfort, Kentucky 40621.
(8) Each party shall have fifteen (15) days from the date the recommended order is mailed within which to file exceptions to the recommended order, as provided in KRS 13B.110.
(9) A party may file a response to an opposing party's exceptions. The response shall be filed within twenty-five (25) days from the date the recommended order is mailed.
(10) Exceptions and responses to exceptions shall be considered filed on the date they are received by the cabinet.
(11) Appealing an action shall not relieve an appellant from the responsibility of continued compliance with KRS Chapter 194A, 42 U.S.C. 1786, 7 C.F.R. Part 246, 7 C.F.R. 278.6, or 902 KAR Chapter 18.
(12) The final order shall be issued in accordance with KRS 13B.120.
(13) In accordance with 7 C.F.R. 246.18(e), the state WIC agency shall make denials of authorization and disqualifications imposed under 902 KAR 18:061 effective on the date of receipt of the notice of adverse action.
Section 4. In accordance with KRS 13B.140, any party aggrieved by the final order may seek judicial review of the decision. Judicial review shall be requested by filing a petition within thirty (30) days of receipt of final order notice in the Franklin Circuit Court or the circuit court of the county in which the party resides or operates a business.
History
- RELATES TO: KRS 15.111, 194A.050, 194A.505, 194A.990, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246, authorizegrants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the local agency right to a fair hearing and the vendor right to an administrative review in regard to the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:081. 40 Ky.R. 507; 834; eff. 10-16-13; Crt eff. 4-13-2020; 52 Ky.R. 1603, 42; eff. 8-18-2026.
902 KAR 18:090 High risk criteria {#sec-902-kar-18-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 18:090}
Section 1. High Risk Criteria. In accordance with 7 C.F.R. 246.12, high-risk vendors shall be identified at least once each federal fiscal year. The criteria and points established in this section shall be assessed.
(1) A vendor with low variance shall be assessed one (1) point per quarter.
(2) A vendor that redeemed six (6) or more gallons of milk in a single transaction, occurring in thirty (30) or more transactions a quarter, shall be assessed five (5) points per quarter.
(3) A vendor with full package redemptions in one (1) transaction occurring in twenty (20) or more transactions per quarter shall be assessed five (5) points per quarter.
(4) A vendor with a lack of inventory shall be assessed five (5) points per occurrence during a monitoring visit.
(5) A vendor with prices for transactions greater than or equal to ninety (90) percent and above the NTE shall be assessed five (5) points per quarter.
(6) A vendor that has redeemed more than $10,000 in transactions per federal fiscal year from out of its contracted local WIC agency shall receive one (1) point per federal fiscal year.
(7) A vendor that received a Good Letter with Exceptions shall be assessed five (5) points per letter.
Section 2. High Risk Referrals. A vendor assessed thirty (30) points or more per federal fiscal year shall be referred to a federal agency, state agency, or local law enforcement agency for an investigation.
History
- RELATES TO: KRS 194A.050, 194A.505, 194A.990, 205.231, 7 C.F.R. Part 246, 278.6, 21 U.S.C. 802
- STATUTORY AUTHORITY: KRS 194A.050, 205.231, 211.180, 7 C.F.R. Part 246, 42 U.S.C. 1786
- NECESSITY, FUNCTION, AND CONFORMITY: 42 U.S.C. 1786 and 7 C.F.R. Part 246 authorizegrants for state operation of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations as necessary to qualify for the receipt of federal funds. KRS 211.180(1)(e) and (f) authorize the cabinet to promulgate administrative regulations for the health of expectant mothers, infants, and preschoolers, and the improvement of health through better nutrition. This administrative regulation establishes the high-risk criteria for contracted vendors with the Kentucky Special Supplemental Nutrition Program for Women, Infants and Children (WIC).
- History: 902 KAR 018:090. 40 Ky.R. 509; 835; eff. 10-16-2013; Crt eff. 4-13-2020; 52 Ky.R. 1605, 44; eff. 8-18-2026.
Chapter 19 Health Provider Surveillance Data
902 KAR 19:010 Kentucky Birth Surveillance Registry {#sec-902-kar-19-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 19:010}
Section 1. Definitions.
(1) "Agent" means an entity with which the department may:
(a) Contract pursuant to carrying out the duties of the registry; and
(b) Designate to act on the behalf of the registry to edit or analyze data from hospitals.
(2) "Cabinet" is defined by KRS 211.651(1).
(3) "Coding and transmission specifications" means the required data elements and codes to be included on the UB-04 CMS 1450 Form.
(4) "Department" is defined by KRS 211.651(3).
(5) "Free-standing birthing center" means a non-hospital affiliated alternative birthing center licensed under the provisions of KRS Chapter 216B.
(6) "Hospital" means an acute care hospital licensed under the provisions of KRS Chapter 216B.
(7) "Hospitalization" means the inpatient medical episode identified by a patient's birth, admission date, length of stay and discharge date, and further identified by a provider-assigned patient control number unique to that inpatient episode.
(8) "ICD-10 Code" means the International Classification of Diseases, Tenth Revision, Clinical Modification system used by physicians and other health care providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care.
(9) "Laboratory" means a medical laboratory licensed under KRS Chapter 333.
(10) "Medical record" means the patient's actual medical record maintained by a hospital's or free-standing birth center's medical record department or by a laboratory.
(11) "Record" means documentation in UB-04 data format, in paper or electronic submission, of:
(a) A hospitalization;
(b) An outpatient visit; or
(c) A laboratory result.
(12) "Registry" means the Kentucky Birth Surveillance Registry.
(13) "UB-04 data" means the standard claim format used by birthing centers, hospitals and laboratory providers to transmit a healthcare claim.
Section 2. Data Collection.
(1) Hospitalization records. A hospital shall document, in the UB-04 data format, each inpatient hospitalization of a child up to age five (5) years who is diagnosed with a congenital birth anomaly or high-risk condition, as defined by the department in accordance with KRS 211.660(2), and included in Section 5 of this administration regulation. Each hospital shall provide to the registry the data specified in Section 6 of this administrative regulation.
(2) Outpatient and laboratory records.
(a) In accordance with KRS 211.660(3)(b), a laboratory shall maintain medical records for each child up to the age of five (5) years who has a primary diagnosis or laboratory test result indicating a congenital anomaly or high-risk condition, as defined by the department and included in Section 5 of this administrative regulation.
(b) A laboratory, and a hospital voluntarily maintaining an outpatient list as described at KRS 211.660(3)(a), shall provide the data specified in Section 6 of this administrative regulation.
(3) Access to medical records. A hospital, free-standing birthing center, or laboratory shall provide an agent of the department access to the medical record of:
(a) Patients meeting the criteria in subsections (1) or (2) of this section;
(b) An infant who dies before his or her first birthday;
(c) Any stillborn child; and
(d) Maternal prenatal medical records for a patient meeting the criteria in:
-
Subsections (1) or (2) of this section; and
-
Paragraphs (b) and (c) of this subsection.
(4) Maternal prenatal medical records shall be used to assist in determining the possible causes of congenital anomalies, stillbirths, and high risk conditions, and aid in the development of prevention strategies to reduce their incidence as authorized by KRS 211.655.
Section 3. Data Finalization and Submission.
(1) Submission of final data. Data shall be final for purposes of submission to the registry as soon as a record is sufficiently final that the provider could submit it to a payor for billing purposes, whether or not the record has actually been submitted to a payor.
(a) Finalized data shall not be withheld from submission to the registry on grounds that it remains subject to adjudication by a payor; and
(b) Data on a hospitalization shall not be submitted to the registry before the patient is discharged.
(2) Data editing.
(a) If the registry identifies a record as incomplete or invalid, the submitting hospital shall submit a corrected copy within thirty (30) days of notification.
(b) The date of notification shall be the date postmarked on the registry's mailed notice of required correction.
(c) Resubmission shall be by either electronic transmission or mailing.
(3) Transmission of records.
(a) Data submitted to the registry shall be uniformly completed and formatted according to coding and transmission specifications;
(b) Hospitals, free-standing birthing centers, and laboratories that have the capacity shall submit data on computer-readable electronic media;
(c) Hospitals, free-standing birthing centers, and laboratories shall provide backup security against accidental erasure or loss of the data until any incomplete or inaccurate records identified by the registry have been corrected and resubmitted; and
(d) Data submitted by mail shall be by certified mail or other traceable carrier, such as United Parcel Service, and be postmarked on or before the due date.
Section 4. Data Submission Timetable. Quarterly submission. A hospital, free-standing birthing center, or laboratory shall submit data at least once for each calendar quarter. A quarterly submission shall contain data from records of patients which became final during that quarter, as specified in Section 3(1) of this administrative regulation. The data shall be submitted to the registry not later than forty-five (45) days after the last day of that quarter.
(1) If the 45th day falls on a weekend or holiday, the submission due date shall become the next following working day.
(2) Outpatient data shall be submitted directly to the registry within thirty (30) days of the written request.
(3) A hospital, free-standing birthing center, or laboratory shall, within thirty (30) days of receipt of a written request from the registry, submit a medical records report for specified ICD-10 codes for a designated quarter.
Section 5. Required Reporting Conditions. Hospitals, free-standing birthing centers, and laboratories shall submit to the registry the following information with respect to all patients up to the age of five (5) years, diagnosed with the following ICD-10 codes:
(1) All congenital anomalies codes Q00-Q99, and all subcategories;
(2) Metabolic storage disorder codes D80-D82, E70-E72, E74-E83, E88, and all subcategories;
(3) Teratogens (noxious influences) codes P04.0-P04.9, and all subcategories;
(4) Zika virus disease code A92.5; and
(5) Any additional condition necessary for public health surveillance.
Section 6. Required Data Elements.
(1) UB-04 data. Hospitals and free-standing birthing centers shall ensure that each copy of UB-04 data submitted to the registry contains the following data elements:
(2) Outpatient and laboratory data. A laboratory and a hospital voluntarily maintaining a list of outpatients, in accordance with KRS 211.660(3)(a), shall ensure that the data submitted to the registry includes the following data elements: patient name, patient address, birth date, sex, principal diagnosis, other diagnoses, and reporting source.
Section 7. Incorporation by Reference.
(1) "UB-04 CMS 1450 Form", 03-01-2007, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Birth Surveillance Registry, Division of Maternal and Child Health, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.050, 211.180, 211.651, 211.655, 211.660, 211.670, Chapter 216B
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.660(6)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.660(1) requires the department to establish the Kentucky Birth Surveillance Registry based on the need to provide information on the incidence, prevalence, and trends of congenital anomalies, stillbirths and high risk conditions; provide information as to possible causes; and develop preventive strategies to reduce their incidence and the secondary complications associated with them. KRS 211.660(6) authorizes the department to implement the provisions of KRS 211.651 to 211.670 through the promulgation of administrative regulations. This administrative regulation establishes uniform procedures for collection of data for the registry.
- History: 902 KAR 019:010. 22 Ky.R. 1185; Am. 1480; 1604; eff. 3-7-96; 29 Ky.R. 574; 966; eff. 10-16-2002; 45 Ky.R. 2777, 3182; eff. 5-31-2019; Crt eff. 1-8-2026.
Chapter 20 Health Services and Facilities
902 KAR 20:008 License procedures and fee schedule {#sec-902-kar-20-008 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:008}
Section 1. Definitions.
(1) "Adverse action" means action taken by the Cabinet for Health and Family Services, Office of Inspector General to deny, suspend, or revoke a health facility's or health service's license to operate.
(2) "Cabinet" is defined by KRS 216B.015(6).
(3) "Deemed hospital" means a hospital that has had its accreditation accepted by the Office of Inspector General pursuant to KRS 216B.185(1) as evidence that the hospital demonstrates compliance with the licensure requirements of KRS Chapter 216B.
(4) "Health facility" is defined by KRS 216B.015(13).
(5) "Health services" is defined by KRS 216B.015(14).
(6) "Inspector General" means the Inspector General of the Cabinet for Health and Family Services or designee.
(7) "Significant financial interest" means lawful ownership of a health facility or health service, whether by share, contribution, or otherwise in an amount equal to or greater than twenty-five (25) percent of total ownership of the health facility or health service.
(8) "Variance" means the written approval of the Inspector General authorizing a health facility to depart from a required facility specification, upon meeting the conditions established in Sections 4 and 5 of this administrative regulation.
Section 2. Licenses.
(1) Any person or entity, in order to lawfully operate a health facility or health service, shall first obtain a provisional license.
(2) A license required by KRS 216B.105(1), including a provisional license, shall be conspicuously posted in a public area of the health facility.
(3) An applicant for provisional licensure or annual renewal of licensure as a health facility or health service shall complete and submit to the Office of the Inspector General the appropriate application as follows:
(a) Application for License to Operate a Health Facility or Health Service;
(b) Application for License to Operate a Chemical Dependency Treatment Service, Group Home, Psychiatric Residential Treatment Facility, or Residential Hospice Facility;
(c) Application for License to Operate a Hospital;
(d) Application for License to Operate a Home Health Agency, Non-residential Hospice, or Private Duty Nursing Agency;
(e) Application for License to Operate a Renal Dialysis Facility, Freestanding or Mobile Technology, or Hospital-owned Pain Management Clinic;
(f) Application for License to Operate a Long Term Care Facility; or
(g) Application for License to Operate a Family Care Home.
(4) Provisional License. Upon receipt of an application for a license and appropriate licensure fee as established in Section 3 of this administrative regulation, the Office of Inspector General shall:
(a) Review the application for completeness, including documentation related to:
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Ownership;
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Personnel;
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Operations and administrative policies;
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The type of services to be provided applicable to the license requested; and
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if appropriate, plans and specifications for construction or renovation; and
(b) Return the application and accompanying licensure fee if:
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An individual having a significant financial interest in the health facility or health service has had, within the seven (7) year period prior to the application date, a significant financial interest in a facility or service that was licensed or certified by the cabinet, and the license or certificate to operate was denied, suspended, revoked, or voluntarily relinquished as the result of an investigation or adverse action that placed patients, residents, or clients at risk of death or serious harm; or
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The cabinet finds that the applicant misrepresented or submitted false information on the application.
(5) If an application is determined complete and no statutory or regulatory deficiencies are identified, the Office of Inspector General shall issue a provisional license to remain in effect until:
(a) Completion of the on-site inspection established in subsection (7) of this section; and
(b) Verification of compliance with each statute and administrative regulation applicable to the license requested.
(6)
(a) Upon receipt of a provisional license, the licensee shall begin providing health services as designated on the licensure application.
(b) If a provisional licensee does not begin providing services within ten (10) business days after receipt of the provisional license, the licensee shall provide written notification to the cabinet of the following:
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The reason the licensee has not yet begun providing services; and
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The anticipated date the licensee will begin operating.
(c) The licensee shall notify the cabinet within three (3) business days after the licensee begins providing services.
(7)
(a) Within three (3) months from the effective date of a provisional license, the Office of Inspector General shall conduct an unannounced, on-site inspection of the health facility or health service to verify compliance with each statute and administrative regulation applicable to the license requested.
(b) If the Office of Inspector General identifies a statutory or regulatory violation or multiple violations during the provisional licensure period, the health facility or health service shall be subject to the correction process established in subsection (13) of this section.
(8) A provisional license shall expire on the date the Office of Inspector General grants approval of or denies a license following the inspection described in subsection (7) of this section.
(9) If a provisional licensee receives notice from the Office of Inspector General that a license is denied, the licensee shall cease providing services immediately.
(10) Written notice denying a license shall explain the reason for the denial, including:
(a) Substantial failure, as described by KRS 216B.105(2), to comply with the provisions of KRS Chapter 216B or any administrative regulation applicable to the regular license;
(b) Substandard care that places patients, residents, or clients at risk of death or serious harm; or
(c) Denial of access to the Office of Inspector General as described in subsection (12) of this section.
(11) The effective date of the license shall be backdated to the issuance date of the provisional license and be subject to annual renewal within one (1) year from the effective date.
(12) Licensure inspections.
(a) Except for a health facility subject to KRS 216.530, a licensure inspection may be unannounced.
(b)
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A representative of the Office of Inspector General shall have access to the health facility pursuant to KRS 216B.042(2).
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An applicant for licensure or a current licensee shall not deny access to a representative of the Office of Inspector General, after proper identification, to make an inspection for determining compliance with the requirements of each applicable administrative regulation for which the health facility or health service is licensed under 902 KAR Chapter 20 or 906 KAR Chapter 1.
a. Denial of access, including any effort to delay, interfere with, or obstruct an effort by a representative of the Office of Inspector General to enter the health facility or health service, or deny access to records relevant to the inspection, unless deemed confidential by 42 U.S.C. 299b-22(a), shall result in disciplinary action, including denial, revocation, modification, or suspension of the license of the health facility or health service.
b. Denial, revocation, modification, or suspension of a health facility's or health service's license shall be subject to appeal pursuant to KRS 216B.105.
(c) An inspection of a health facility or health service licensed under 902 KAR Chapter 20 or 906 KAR Chapter 1 shall comply as follows:
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The inspection shall be made at any time during the licensee's hours of operation;
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The inspection shall be limited to ensure compliance with the standards set forth in 902 KAR Chapter 20, 906 KAR Chapter 1, KRS Chapter 216, or KRS Chapter 216B; and
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The inspection of a health facility or health service based on a complaint or a follow-up visit shall not limit the scope of the inspection to the basis of the complaint or the implementation of a plan of correction.
(13) Violations.
(a) The Office of Inspector General shall notify a health facility or health service in writing of a regulatory violation identified during an inspection.
(b) The health facility or health service shall submit to the Office of Inspector General, within ten (10) days of the notice, a written plan for the correction of the regulatory violation.
- The plan shall be signed by the health facility's or health service's administrator, the licensee, or a person designated by the licensee and shall specify:
a. The date by which the violation shall be corrected;
b. The specific measures to be utilized to correct the violation; and
c. The specific measures to be utilized to ensure the violation will not recur.
- The Office of Inspector General shall review the plan and notify the health facility or health service in writing of the decision to:
a. Accept the plan;
b. Not accept the plan; or
c. Deny, suspend, or revoke the license for a substantial regulatory violation in accordance with KRS 216B.105(2).
- The notice specified in subparagraph 2.b. of this paragraph shall:
a. State the specific reasons the plan is unacceptable; and
b. Require an amended plan of correction within ten (10) days of receipt of the notice.
- The Office of Inspector General shall review the amended plan of correction and notify the health facility or health service in writing of the decision to:
a. Accept the plan;
b. Deny, suspend, or revoke the license for a substantial regulatory violation in accordance with KRS 216B.105(2); or
c. Require the health facility or health service to submit an acceptable plan of correction.
- A health facility or health service that fails to submit an acceptable amended plan of correction may be notified that the license will be denied, suspended, or revoked in accordance with KRS 216B.105(2).
(14) A license shall:
(a) Expire one (1) year from the effective date, unless otherwise expressly provided in the license certificate; and
(b) Be renewed in the form of a validation letter if the licensee:
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Submits a completed licensure application;
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Pays the prescribed fee;
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Has no pending adverse action; and
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Unless exempted, has responded to requests from the cabinet for:
a. Annual utilization surveys; and
b. Requests for information regarding health services provided.
(15) Except for a Level I psychiatric residential treatment facility licensed pursuant to the exception established in 902 KAR 20:320, Section 3(2), more than one (1) license shall not be issued or renewed for a particular licensure category at a specific location.
(16) Written notice shall be filed with the Office of Inspector General within thirty (30) calendar days of the effective date of a change of ownership. A change of ownership for a license shall:
(a) Be deemed to occur if more than twenty-five (25) percent of an existing health facility or health service or equity or voting rights of a legal entity is purchased, leased, or otherwise acquired by one (1) or more persons or legal entity from another; and
(b) Not require the issuance of a provisional license.
(17) The licensee shall fully disclose to the cabinet the name, mailing address, email address, and phone number, or a change in the name, mailing address, email address, or phone number of:
(a) Each person or legal entity having an ownership interest in the health facility or health service; and
(b)
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Each officer or director if organized as a corporation, limited liability company, or other legal entity; or
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Each partner if organized as a partnership.
(18) An individual, shareholder, partner, member, or legal entity shall not acquire a significant financial interest in any licensed health facility or health service if that individual, shareholder, partner, member, or legal entity previously held a significant financial interest in a licensed facility that had its license or certificate to operate denied, suspended, revoked, or voluntarily relinquished, within the preceding seven (7) years, as the result of an investigation or adverse action that placed patients, residents, or clients at risk of death or serious harm.
(19) An unannounced inspection shall be conducted:
(a) In response to a relevant complaint or allegation; and
(b) According to procedures established in subsection (12) of this section.
(20) A licensee that does not have a pending adverse action, but fails to submit a completed licensure application annually shall cease operating the health facility or health service unless:
(a) The items required under subsection (14)(b) of this section have been tendered; and
(b) The Office of Inspector General has provided the health facility or health service with a notice granting temporary authority to operate pending submission of the application.
(21) Credentialing and Re-credentialing. A licensed health facility or health service that is required by KRS 216B.155(2) to assess the credentials of health care professionals applying for privileges shall use Form KAPER-1, Part B, incorporated by reference in 806 KAR 17:480.
(22) Licensure exemptions.
(a) A facility shall be exempt from licensure if it meets the criteria established by KRS 216B.020(2) or (3).
(b) A federally certified rural health clinic or a federally qualified health center that provides services to patients with behavioral health or psychiatric conditions, including substance use disorders, shall:
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Be exempt from licensure in accordance with KRS 216B.020(2) and (3); and
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Not be subject to licensure in a separate category under 902 KAR Chapter 20 or 908 KAR Chapter 1.
Section 3. Fee Schedule.
(1)
(a) Fees for review of plans and specifications for construction or renovation of health facilities shall be as follows:
(b) A request for review of plans and specifications shall be submitted on the Program Review Fee – Worksheet Health Facility Identification form, accompanied by payment described in paragraph (a) of this subsection.
(2) Initial and Annual fees. The initial and annual licensure fee for health facilities and services shall be as follows:
(3) Change in status of a licensed health facility.
(a) Name change or change of facility administrator. If a health facility changes the name of the facility as set forth on its license or the facility administrator changes, the licensee shall notify the Office of Inspector General of the facility's new name or new administrator within ten (10) calendar days of the effective date of the name change or administrator change.
(b) Change of location.
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If a health facility or one (1) of its extensions or satellites changes location and certificate of need approval is not required prior to relocation, the licensee shall notify the Office of Inspector General of the new location within ten (10) calendar days of the effective date of the change.
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The Office of Inspector General shall conduct an on-site inspection for a change of location if the facility is one (1) of the following levels of care:
a. Freestanding birth center;
b. Alzheimer's nursing home;
c. Ambulatory surgical center;
d. Chemical dependency treatment service;
e. Group home;
f. Non-deemed hospital;
g. Intermediate care facility;
h. Intermediate care facility for individuals with an intellectual or developmental disability (ICF/IID);
i. Nursing facility;
j. Nursing home;
k. Personal care home;
l. Psychiatric residential treatment facility;
m. Renal dialysis facility;
n. Residential hospice facility;
o. Outpatient health care clinic; or
p. Abortion facility.
(4)
(a) Failure to renew a license by the annual renewal date shall result in a late penalty equal to twenty (20) percent of the renewal fee or twenty-five (25) dollars, whichever amount is greater.
(b) Continual failure to submit a completed and accurate renewal application or fee by the date specified by the cabinet may result in an enforcement action.
Section 4. Existing Facilities With Waivers.
(1) The Inspector General shall deem an existing health facility to be in compliance with a facility specification requirement, even though the health facility does not meet fully the applicable requirement, if:
(a) The Inspector General has previously granted, to the health facility, a waiver for the requirement;
(b) The health facility is licensed by the cabinet;
(c) The health facility is in good standing; and
(d) The waived requirement does not adversely affect the health, safety, or welfare of a resident or patient.
(2) If the Inspector General determines that the waived requirement has adversely affected patient or resident health, safety or welfare, then:
(a) The Inspector General shall notify the health facility of the findings and the need to comply with the applicable administrative regulations; and
(b) The health facility shall submit a written plan to ensure compliance, pursuant to Section 2(13)(b) of this administrative regulation.
Section 5. Variances.
(1) The Inspector General may grant a health facility a variance from a facility specification requirement if the facility establishes that the variance will:
(a) Improve the health, safety, or welfare of a resident or patient; or
(b) Promote the same degree of health, safety, or welfare of a resident or patient as would prevail without the variance.
(2) A health facility shall submit a request for a variance, in writing, to the Office of Inspector General. The request shall include:
(a) All pertinent information about the facility;
(b) The specific provision of the administrative regulation affected;
(c) The specific reason for the request; and
(d) Evidence in support of the request.
(3) The Inspector General shall review and approve or deny the request for variance. The Inspector General may request additional information from the health facility as is necessary to render a decision. A variance may be granted with or without a stipulation or restriction.
(4) The Inspector General shall revoke a variance previously granted if the Inspector General determines the variance has not:
(a) Improved the health, safety, or welfare of a patient or resident; or
(b) Promoted the same degree of health, safety, or welfare of a patient or resident that would prevail without the variance.
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The Inspector General shall notify the health facility of a decision to revoke a variance and the need to comply with the applicable regulatory requirement.
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The health facility shall submit a written plan to ensure compliance, pursuant to Section 2(13)(b) of this administrative regulation.
Section 6. Variance Hearings.
(1)
(a) A health facility dissatisfied with a decision to deny, modify, or revoke a variance or a request for a variance may file a written request for a hearing with the Secretary of the Cabinet for Health and Family Services.
(b) The request shall be received by the secretary within twenty (20) days of the date the health facility receives notice of the decision to deny, modify, or revoke the variance or request for a variance.
(2) An administrative hearing shall be conducted in accordance with KRS Chapter 13B.
Section 7. Adverse Action Procedures.
(1) A health facility or health service that has received a preliminary order to close or other notice of adverse action:
(a) Shall receive a duplicate license from the Office of Inspector General indicating that the health facility or health service has an adverse action pending;
(b) Shall post the duplicate license in place of the original license;
(c) Shall be subject to periodic inspections by the inspecting agency to investigate complaints and ensure patient safety; and
(d) May continue to operate under duplicate license pending completion of the adverse action process, if patients and residents are not subjected to risk of death or serious harm.
(2) Until all appeals pursuant to KRS 216B.105 of the pending adverse action have been exhausted, the health facility or health service shall not have its:
(a) License renewed; or
(b) Duplicate license replaced.
Section 8. Denial and Revocation.
(1) The cabinet shall deny or revoke a license if it finds that:
(a) In accordance with KRS 216B.105(2), there has been a substantial failure by the health facility or health service to comply with the provisions of:
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KRS Chapter 216B; or
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The administrative regulations applicable to the health facility's or health service's license;
(b) The health facility or health service fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by Section 2(13) of this administrative regulation;
(c) The health facility or health service fails to comply with the annual renewal process described by Section 2(14) of this administrative regulation; or
(d) The health facility or health service denies access to the Office of Inspector General pursuant to Section 2(12)(b) of this administrative regulation.
(2) The denial or revocation of a health facility's or health service's license shall be issued pursuant to KRS 216B.105(2).
(3) Notice of the denial or revocation shall set forth the particular reasons for the action.
(4) In accordance with KRS 216B.105(2), the denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee, within the thirty (30) day period, files a request in writing for a hearing with the cabinet.
(5) Pursuant to KRS 216B.050, the cabinet may compel obedience to its lawful orders.
Section 9. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) Form OIG 001, "Application for License to Operate a Health Facility or Health Service", July 2018;
(b) Form OIG 002, "Application for License to Operate a Chemical Dependency Treatment Service, Group Home, Psychiatric Residential Treatment Facility, or Residential Hospice Facility", January 2017;
(c) Form OIG 003, "Application for License to Operate a Hospital", January 2017;
(d) Form OIG 004, "Application for License to Operate a Home Health Agency, Non-Residential Hospice, or Private Duty Nursing Agency", January 2017;
(e) Form OIG 005, "Application for License to Operate a Renal Dialysis Facility, Freestanding or Mobile Technology, or Hospital-owned Pain Management Clinic", July 2018;
(f) Form OIG 006, "Application for License to Operate a Long Term Care Facility", January 2017;
(g) Form OIG 007, "Application for License to Operate a Family Care Home", January 2017; and
(h) Form OIG PR-1, "Program Review Fee – Worksheet Health Facility Identification Form", June 2014.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of the Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 216.2925, 216.530, 216B.010, 216B.015, 216B.020(2)(c), (3), 216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.185, 216B.990
- STATUTORY AUTHORITY: KRS 216.530(1), 216B.042(1)(a)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1)(a) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function and to establish reasonable application fees for licenses. This administrative regulation establishes the fee schedule and requirements for obtaining a license to operate a health facility or health service, and establishes the procedure for obtaining a variance.
- History: 902 KAR 020:008. 8 Ky.R. 218; 493; eff. 2-1-1982; 9 Ky.R. 61; eff. 8-11-1982; 745; eff. 1-6-1983; 1055; eff. 4-6-1983; 1325; eff. 7-6-1983; 11 Ky.R. 465; 730; eff. 12-11-1984; 13 Ky.R. 1131; eff. 2-10-1987; 14 Ky.R. 1870; 2031; eff. 4-14-1988; 17 Ky.R. 133; eff. 9-13-1990; 3536; eff. 7-17-1991; 23 Ky.R. 3624; 4135; eff. 6-16-1997; 24 Ky.R. 1786; 2378; eff. 5-18-1998; 27 Ky.R. 3166; 28 Ky.R. 90; eff. 7-16-2001; 29 Ky.R. 1896; 2471; eff. 4-11-2003; 30 Ky.R. 434; 868; eff. 10-15-2003; 41 Ky.R. 194; 809; eff. 12-17-2014; 43 Ky.R. 801, 1421, 15669; eff. 3-31-2017; 45 Ky.R. 474, 1022; eff. 11-2-2018; Crt eff. 9-3-2025.
902 KAR 20:009 Facility specifications; hospitals {#sec-902-kar-20-009 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:009}
Section 1. Definitions.
(1) "License" means an authorization issued by the Cabinet for Health and Family Services for the purpose of operating a hospital facility.
(2) "Licensure agency" means the of Inspector General, Cabinet for Health and Family Services.
(3) "Relocatable unit" means a structure that is not on wheels and which is built in such a manner that it may be relocated at any time.
(4) "Transportable unit" means any pre-manufactured structure, trailer, or self-propelled unit, equipped with a chassis or on wheels.
Section 2. Preparation and Approval of Plans and Specifications. After receiving a certificate of need, if required, and before beginning new construction or renovation, or making a change in function of a facility, the following procedures shall be followed:
(1) The licensee or applicant shall complete the planning and design requirements established in Chapter 1.5, Sections 1.1 through 2.3.3.2, of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, published by the Facility Guidelines Institute and the American Institute of Architects, Academy of Architecture for Health.
(2) The licensee or applicant shall submit a functional program for each project to the licensure agency. The functional program shall meet the requirements established in Chapter 1.2, Sections 2.1 through 2.3.2, of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition.
(3) architectural, mechanical, and electrical drawings shall bear the seal of an architect or engineer registered in the Commonwealth of Kentucky.
(4) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(5) Plans and specifications must be submitted to and approved by the licensure agency prior to commencement of new construction, renovation, or a change in function of a facility.
(6) Plans and specifications must be approved by the Office of Housing, Buildings and Construction. Appropriate local building permits shall be obtained prior to commencement of new construction or renovation.
(7) The architect or engineer of record shall provide evidence that facilities where sources of radiation are used or stored shall comply with the requirements of the Radiation Health Branch, Division of Public Health Protection and Safety, Department for Public Health, Cabinet for Health and Family Services.
Section 3. Submission of Plans and Specifications for Hospitals.
(1) First stage, schematic plans.
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical patient room layouts scaled (one-half (1/2) inch = one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking, and orientation shall be shown in a plot plan.
(b) If the project is an addition, or is otherwise related to existing buildings on the site, plans shall show the facilities and general arrangement of those buildings.
(2) Second stage, design development plans. Design development plans shall include the following:
(a) Architectural.
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Plans of basement, floors, and roof showing space assignment, sizes, and outlines of fixed and movable equipment;
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Elevations and typical sections;
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Plot plan showing roads, parking, and sidewalks; and
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Areas and bed capacities by floors.
(b) Mechanical.
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Single line layout of duct and piping systems;
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Riser diagrams for multistory construction; and
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Scale layout of boilers and major associated equipment and central heating, cooling, and ventilating units.
(c) Electrical.
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Plans showing space assignment, size, and outline of transformers, main switch, switchboards, generator sets and other fixed equipment; and
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Simple riser diagram for multistory building construction, showing arrangement of feeders, subfeeders, bus work, load centers, and branch circuit panels.
(d) Outline specifications.
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General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls; duct and piping systems; and dietary, laundry, sterilizing, and other special equipment; and
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General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage, contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following disciplines of the work: architectural, structural, mechanical, and electrical. Drawings shall include the following:
- Architectural drawings.
a. Approach plan showing new topography, newly established levels and grades, existing structures on the site, new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor, and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Layout of typical and special rooms indicating fixed equipment and major items of movable equipment. Equipment not included in the construction contract shall be so indicated; and
h. Conveying systems. Details of construction, machine and control spaces necessary, size and type of equipment, and utility requirements for the following:
(i) Dumbwaiters: electric, hand, or hydraulic;
(ii) Elevators: freight, passenger, or patient;
(iii) Loading dock devices; and
(iv) Pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings; and
c. Details of special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems:
(i) Radiators and steam heated equipment such as sterilizers, warmers, and steam tables;
(ii) Heating and steam mains and branches with pipe sizes;
(iii) Diagram of heating and steam risers with pipe sizes;
(iv) Sizes, types, and capacities of boilers, furnaces, hot water heaters with stokers, oil burners, or gas burners;
(v) Pumps, tanks, boiler breeching, and piping and boiler room accessories;
(vi) Air-conditioning systems with required equipment, water and refrigerant piping, and ducts;
(vii) Supply and exhaust ventilation systems with heating/cooling connections and piping; and
(viii) Air quantities for room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems:
(i) Size and elevation of street sewer, house sewer, house drains, street water main, and water service into the building;
(ii) Location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment;
(iii) Size and location of hot, cold, and circulating branches, and risers from the service entrance, and tanks;
(iv) Riser diagram for plumbing stacks with vents, water risers, and fixture connections;
(v) Gas, oxygen, and vacuum systems;
(vi) Standpipe and sprinkler systems where required; and
(vii) Fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment, and diagram of feeders and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits; and
g. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe type, size capacity workmanship, finish and other characteristics of materials and equipment. Specifications shall include:
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Cover or title sheet;
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Index; and
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Detailed description of materials and workmanship for each class of work.
(c) Access to work. Representatives of the appropriate state agencies shall have access at reasonable times to the work and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances, and Administrative Regulations.
(1) General. Nothing stated herein shall relieve the license or applicant from compliance with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions.
(2) The following requirements shall apply if applicable:
(a) Safety pursuant to 815 KAR 10:060;
(b) Plumbing pursuant to 815 KAR Chapter 20.;
(c) Air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010;
(d) Elevators pursuant to 815 KAR 4:010; and
(e) Making buildings and facilities accessible to and usable by the physically handicapped pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
Section 5. Existing Facility Requirements. Licensure requirements for the structural specifications, plant requirements, and maintenance of a licensed hospital's physical structure which existed before the effective date of this regulation, and hospital construction and renovation plans approved by the licensure agency before the effective date of this regulation shall meet the requirements in Sections 6 through 33 of this administrative regulation.
Section 6. Nursing Unit.
(1) Patient rooms. Each patient room shall meet the following requirements:
(a) Maximum room capacity shall be four (4) patients.
(b) Minimum room area exclusive of toilet rooms, closets, lockers, wardrobes, and vestibules shall be 100 square feet in a one (1) bed room and eighty (80) square feet per bed in a multibed room.
(c) A multibed room shall be designed to permit no more than two (2) beds side by side parallel to the window wall with not less than a four (4) foot space provided between beds, and at least a three (3) foot space between the side of a bed and the nearest wall, fixed cabinet, or heating/cooling element. A minimum of four (4) feet is required between the foot of a bed and the opposite wall, or foot of the opposite bed in a multibed room.
(d) Window. A patient room shall have windows operable without the use of tools and shall have sills not more than three (3) feet above the floor. The window area shall be at least eight (8) percent of the patient room floor area.
(e) Nurses' calling system. See Section 32(7) of this administrative regulation.
(f) Lavatory. In a single or a two (2) bed room with private toilet room, the lavatory may be located in the toilet room. If two (2) patient rooms share a common toilet, a lavatory shall be provided in each patient room.
(g) Wardrobe or closet for each patient. Minimum clear dimensions shall be eight (8) inches deep by one (1) foot and eight (8) inches wide with full length hanging space, clothes rod and shelf.
(h) Cubicle curtains or equivalent built-in devices shall be provided to furnish complete privacy for each patient in multibed rooms.
(i) No patient room shall be located more than 120 feet from the nurses' station, the clean workroom, and the soiled workroom. No room shall be used as a patient room if the access is through another patient's room. At least sixty (60) percent of the beds in a nursing unit shall be located in rooms designed for one (1) or two (2) beds.
(2) Service areas in each nursing unit. The size of each service area shall depend on the number and types of beds within the unit and shall include:
(a) Nurses' station for charting, doctors' charting, communications, and storage for supplies and nurses' personal effects.
(b) Clean workroom or clean holding area. The clean workroom shall contain a work counter, hand-washing lavatory or sink, and storage facilities. The clean holding room shall be part of a system for storage and distribution of clean and sterile supplies and shall be similar to the clean workroom except that the work counter and hand-washing facilities may be omitted.
(c) Soiled workroom or soiled holding room.
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A soiled workroom shall contain a clinical sink or equivalent flushing rim fixture, sink equipped for hand washing, work counter, waste receptacle, and linen receptacle.
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A soiled holding room shall be part of a system for collection and disposal of soiled materials and shall be similar to the soiled workroom except that the clinical sink and work counter may be omitted.
(d) Lounge and toilet rooms for staff including lockers for storage of personal effects. These rooms may serve more than one (1) nursing unit.
(e) Multipurpose room for conferences, demonstrations, and consultation. This room may serve more than one (1) nursing unit.
(f) Examination and treatment room. The examination and treatment room shall have a minimum floor area of 120 square feet with a minimum dimension of ten (10) feet. This room may serve more than one (1) nursing unit. The examination and treatment room may be eliminated if all patient rooms are single-bed rooms. The room shall contain a lavatory or sink equipped for hand washing, a work counter, storage facilities, and an examination table. The emergency treatment room may be used for this purpose, if it is conveniently located on the same floor as the patient rooms.
(g) Medicine area. Provision shall be made for convenient and prompt twenty-four (24) hour distribution of medicine to patients. This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.
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If used, a medicine preparation room or unit shall be under the nursing staff's visual control and shall contain a work counter, refrigerator, and locked storage for biologicals and drugs.
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A medicine dispensing unit may be located at the nurses' station, in the clean workroom, or in an alcove or other space under direct control of the nursing or pharmacy staff.
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A controlled substances locker must be under double lock.
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A hand-washing facility shall be provided in the medicine area.
(h) Clean linen storage. An enclosed storage space or a designated area within the clean workroom shall be provided for storage of clean linen. If a closed cart system is used, storage may be in an alcove.
(i) Nourishment station. The nourishment state shall contain a sink equipped for hand washing, equipment for serving between scheduled meals, refrigerator, storage cabinets, and a self-dispensing ice maker. A nourishment station may serve more than one (1) nursing unit on the same floor.
(j) Patients' bathing facilities. Bathing facilities shall include at least one (1) shower stall or one (1) bathtub for each twelve (12) patients not individually served. At least one (1) bathing facility on each patient floor shall have space for a wheelchair patient and an assisting attendant. At least one (1) sitz bath shall be provided in post partum units.
(k) Stretcher and wheelchair parking area or alcove. The stretcher and wheelchair parking area or alcove may serve more than one (1) nursing unit on the same floor.
(l) Janitor's closet. A janitor's closet shall be provided for storage of housekeeping supplies and equipment. The closet shall have a floor receptor or service sink. The closet may serve more than one (1) nursing unit on the same floor.
(m) Equipment storage room. The equipment storage room shall have sufficient space for equipment. The equipment storage room may serve more than one (1) nursing unit on the same floor.
(n) Emergency equipment storage. Space for emergency equipment shall be located in close proximity to the nurses' station and out of traffic. The emergency equipment storage space may serve more than one (1) nursing unit on the same floor.
(3) Patient toilet rooms. A toilet room shall be directly accessible from each patient room without going through the general corridor. One (1) toilet room may serve two (2) patient rooms, but not more than four (4) beds. The lavatory may be omitted from the toilet room if a lavatory is provided in each patient room.
(4) Isolation room. An isolation room shall be provided which shall have:
(a) One (1) patient per room;
(b) A separate toilet room, with direct entry from the patient bed area, with bath or shower, and lavatory; and
(c) Facilities outside and immediately adjacent to the patient room for maintaining aseptic conditions.
Section 7. Intensive Care Unit. Hospitals that have intensive care units shall meet the following requirements:
(1) Patient rooms. A Cardiac intensive care patient shall be placed in a single-bed room. A medical or surgical intensive care patient may be housed in a single-bed room or in a multibed room. At least one (1) single-bed room shall be provided in each medical or surgical care unit. Beds shall be arranged to permit direct visual observation by nursing staff. Each patient room shall meet the following requirements:
(a) Clearance between beds in a multibed room shall not be less than seven (7) feet with a minimum of three (3) feet to the side of beds and at least four (4) feet from the foot of the beds. A single-bed room or cubicle shall have a minimum clear area of 120 square feet with a minimum dimension of ten (10) feet.
(b) View panels shall be provided in the doors and walls for nursing staff observation of patients. A means shall be provided to obstruct the view panels when the patient requires visual privacy. Glazing for view panels shall be safety glass, wire glass or clear plastic unless wire glass is required for fire safety purposes.
(c) An I.V. solution support shall be provided for each patient and shall be positioned to prevent the suspension of the solution directly over the patient.
(d) A lavatory equipped for hand washing shall be provided in each private patient room. In multibed rooms there shall be at least one (1) lavatory for each six (6) beds.
(e) Nurses' calling system. See Section 32(7) of this administrative regulation.
(f) Each cardiac intensive care patient shall be provided a toilet facility which is directly accessible from the bed area.
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A water closet shall have sufficient clearance around it to facilitate its use by a patient needing assistance.
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A portable water closet is permitted within the patient room. If a portable unit is used, facilities for servicing and storing the unit shall be located convenient to the cardiac care unit.
(g) Each room shall have a window or each bed shall have visual access to a window. one (1) window may serve more than one (1) patient by use of vision panels in partitions. The window sill height shall not exceed three (3) feet above the floor.
(2) Service areas. The size and location of each service area shall depend upon the number of beds to be served. One (1) service area may serve two (2) or more intensive care units. The following service areas shall be located in or be readily available to each intensive care unit:
(a) Nurses' station. The nurses' station shall be located to permit direct visual observation of each patient served.
(b) Hand-washing facilities. Hand-washing facilities shall be located convenient to the nurses' station and medicine area.
(c) Charting facilities. Charting facilities shall be separated from the monitoring service.
(d) Staff's toilet room. The toilet room shall contain a water closet and lavatory equipped for hand washing.
(e) Closets. Individual closets or compartments for the safekeeping of coats and personal effects belonging to the nursing staff shall be located at or near the nurses' station.
(f) Clean workroom or a system for storage and distribution of clean and sterile supplies. The clean workroom shall contain a work counter, hand-washing facility, and storage facilities.
(g) Soiled workroom or soiled holding room.
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A soiled workroom shall contain a clinical sink or equivalent flushing rim fixture, sink equipped for hand washing, work counter, waste receptacle, and soiled linen receptacles.
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A soiled holding room shall be part of a system for collection and disposal of soiled materials and shall be similar to the soiled workroom except that the clinical sink and work counter may be omitted.
(h) Facilities for washing or flushing bedpans. Facilities for washing or flushing bedpans shall be provided within the unit.
(i) Medicine area. Provision shall be made for convenient and prompt twenty-four (24) hour distribution of medicine to patients. This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.
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A medicine preparation room or unit shall be under the nursing staff's visual control and shall contain a work counter, refrigerator, and locked storage for biologicals and drugs. A medicine preparation room shall contain a minimum floor area of fifty (50) square feet.
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A medicine dispensing unit may be located at the nurses' station, in the clean workroom, or in an alcove or other space under direct control of the nursing or pharmacy staff.
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Controlled substances shall be under double lock and a hand-washing facility shall be provided.
(j) Clean linen storage. A separate closet or designated area within the clean workroom shall be provided for clean linen storage. If a closed cart system is used, storage may be in an alcove.
(k) Nourishment station. The nourishment station shall contain a sink equipped for hand washing, equipment for serving between- scheduled meals, refrigerator, storage cabinets, and a self-dispensing ice maker to provide ice for patient service and treatment.
(l) Emergency equipment storage. Space shall be provided for a crash cart and other necessary emergency equipment.
(m) Equipment storage room. Space shall be provided for necessary equipment.
(n) Patient storage facilities. Individual lockers shall be provided for the storage of a patient's clothing and personal effects. The lockers may be located outside the intensive care unit. Lockers shall be of a size to permit hanging of full length garments.
(o) Waiting room. A separate waiting room shall be provided for the intensive care unit. A toilet room, public telephone, and seating accommodations for long waiting periods shall be provided.
Section 8. Obstetrical Suite.
(1) General. If an obstetrical suite is included in the functional program, it shall be located and arranged to preclude unrelated traffic through the suite. The number of delivery rooms, labor rooms, recovery beds, and the size of the service areas shall depend upon the estimated obstetrical workload.
(2) Delivery room. Each room shall have a minimum clear floor area of 300 square feet exclusive of fixed and movable cabinets and shelves. The room shall have a minimum dimension of sixteen (16) feet.
(3) Labor room. Each room shall be a single-bed or two (2) bed room with a minimum clear area of 100 square feet per bed.
(a) Labor beds shall be provided at the rate of two (2) for each delivery room.
(b) Each labor room shall contain a lavatory equipped for hand washing and have direct access to a toilet room. One (1) toilet room may serve two (2) labor rooms.
(c) The labor room shall be arranged so that the door is visible from a nurses' work station and shall be directly accessible to facilities for medication, hand washing, charting, and storage for supplies and equipment.
(d) At least one (1) shower shall be provided for use by labor room patients.
(e) Controls shall be located outside of the wet area for use by nursing staff.
(4) Recovery room. The recovery room shall contain not less than two (2) beds, charting facilities located to permit staff surveillance of all beds, facilities for medicine dispensing, hand washing facilities, clinical sink with bedpan flushing device, and storage for equipment and supplies. The recovery room may be omitted in hospitals with an annual birth rate of less than 1,500.
(5) Service areas. The service areas in each obstetrical suite shall include:
(a) Control station located to permit visual surveillance of all traffic which enters the obstetrical suite.
(b) Supervisor's office or station.
(c) Sterilizing equipment conveniently located to serve delivery rooms.
(d) Drug distribution station for storage and preparation of medication for patients. The drug distribution station shall contain a work counter, storage facilities, and a sink equipped for hand washing. Controlled substances shall be under double lock.
(e) Scrub facilities. Two (2) scrub stations shall be provided near the entrance to each delivery room. Two (2) scrub stations may serve two (2) delivery rooms if the scrub stations are located adjacent to the entrance to each delivery room.
(f) Soiled workroom for the exclusive use of the obstetrical suite staff or a soiled holding area that is part of a system used for the collection and disposal of soiled materials.
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A soiled workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand washing, waste receptacle, and linen receptacle.
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A soiled holding room shall be similar to the soiled workroom except that the clinical sink may be omitted.
(g) Clean workroom or clean supply room.
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A clean workroom is required if clean materials are assembled within the obstetrical suite prior to use. A clean workroom shall contain a work counter, sink equipped for hand washing, and space for clean and sterile supplies.
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A clean supply room shall be provided if the facility utilizes a central system for the cleanup, distribution of clean and sterile supplies, and central storage.
(h) Anesthesia workroom. A workroom for cleaning, testing and storage of anesthesia equipment shall contain a work counter and sink.
(i) Anesthesia storage facilities.
(j) Medical gas supply with storage space for reserve medical gas cylinders shall be provided.
(k) Equipment storage room for equipment used in the obstetrical suite.
(l) Staff clothing change areas.
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Appropriate areas shall be provided for male and female personnel working within the obstetrical suite.
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Each area shall contain lockers, showers, toilets, lavatories equipped for hand washing and space for putting on scrub suits and boots.
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Each area shall be arranged to provide a one (1) way traffic pattern, so that personnel entering from outside the obstetrical suite can shower, change and go directly into the obstetrical suite.
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Space for removal of scrub suits and boots in the change area shall be designed so that personnel using it will avoid physical contact with clean personnel.
(m) Lounge and toilet facilities for obstetrical staff. A nurses' toilet room shall be provided near the labor rooms and recovery rooms.
(n) Janitor's closet. A closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the obstetrical suite.
(o) Stretcher storage area. This area shall be out of the direct line of traffic.
Section 9. Newborn Nursery Unit.
(1) General. Each nursery shall provide:
(a) One (1) Lavatory for hand washing for each eight (8) infants;
(b) Emergency nurses' call system;
(c) Oxygen;
(d) Isolation nursery; and
(e) Glazed observation windows to permit viewing of infants from public areas, from workrooms, and between adjacent nurseries.
(2) Nursery. Each room shall contain not more than eight (8) bassinets, or up to sixteen (16) bassinets if the extra bassinets are of the isolation type. The room shall have a minimum area of twenty-four (24) square feet per regular bassinet and forty (40) square feet per isolation type bassinet. No nursery shall open directly into another nursery.
(3) Workroom. Each nursery shall be served by a connecting workroom. It shall contain gowning facilities at the entrance for staff and housekeeping personnel, work space with counter, refrigerator, lavatory or sinks equipped for hand washing, and storage. One (1) workroom may serve a number of full-term nurseries if required services are convenient to each.
(4) Examination and treatment room. The examination and treatment room shall contain a work counter, storage, and lavatory equipped for hand washing.
(5) Continuing care nursery. If a continuing care nursery is provided, each nursery shall have a minimum area of forty (40) square feet per bassinet. The continuing care nursery shall have its own workroom including lavatory. A work area within the continuing care nursery may be used for the workroom, but this area shall be in addition to the required bassinet area.
(6) Formula room. This room shall be used solely for preparing the infant formula and shall have no direct access to the nursery or workroom. The formula room may be located elsewhere in the hospital. The following shall be provided unless commercially prepared formula is used:
(a) Work counter with built-in sink with gooseneck-type spout and knee or foot control;
(b) Lavatory;
(c) Hot plate;
(d) Refrigerator;
(e) Sterilizer; and
(f) Bottle washer.
(7) If commercially prepared formula is to be used or other modifications are proposed in formula preparation and processing, the formula room shall include such space and equipment as necessary to accommodate formula processing, handling, and storage requirements.
(8) Janitor's closet. A closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the newborn nursery unit.
Section 10. Pediatric Unit. If provided as a separate unit, the pediatric unit shall include:
(1) Patient rooms. Each pediatric patient room shall conform to the same requirements as Section 6(1)(b) and (c) of this administrative regulation except that a patient room used for cribs shall contain at least sixty (60) square feet of clear area for each crib and shall have no more than six (6) cribs in a room.
(2) Nursery. Each nursery serving pediatric patients shall contain no more than eight (8) bassinets. The minimum clear floor area per bassinet shall be forty (40) square feet. Each room shall contain a lavatory equipped for hand washing, nurses' emergency calling system and glazed view windows for observation of infants from public areas and the workroom.
(3) Nursery workroom. Each nursery shall be served by a connecting workroom. The workroom shall contain gowning facilities at the entrance for staff and housekeeping personnel, work space with counter, storage facilities, and a lavatory or sink equipped for hand washing. One (1) workroom may serve more than one (1) nursery.
(4) The examination and treatment room for a nursery may be located in a separate room or a designated part of the workroom. The examination and treatment room shall contain a work counter, storage facilities, and a lavatory equipped for hand washing.
(5) Service areas. The service areas shall conform to the requirements in Section 6(2) of this administrative regulation and shall meet the following additional conditions:
(a) Multipurpose or individual room shall be provided for dining, educational, and play purposes. A total floor area of twenty (20) square feet per pediatric patient based on fifty (50) percent of the total number of pediatric patients shall be provided. Special provisions shall be made to minimize impact noise transmission through the floor of the multipurpose room to occupied space below.
(b) Space for preparation and storage of infant formula shall be provided in the unit or in a convenient location nearby.
(c) A toilet room shall be provided for each sex, with a minimum ratio of one (1) toilet for each eight (8) beds excluding bassinets.
(d) Storage closets or cabinets for toys and for educational and recreational equipment shall be provided.
(e) Storage space shall be provided for replacement of cribs and adult beds to provide flexibility for interchange of patient accommodations.
Section 11. Psychiatric Unit. If included as a separate unit, the psychiatric unit shall be designed as other nursing units except that care shall be taken to provide for patients needing close supervision to prevent the patient's escape, suicide, or hiding. The unit shall contain:
(1) Patient room.
(a) Each patient room shall meet the following requirements:
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Minimum floor area of 100 square feet in a one (1) bed room and eighty (80) square feet per patient in a multibed room; and
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Maximum of two (2) patients per room.
(b) Patient toilet room. A toilet room shall be directly accessible from each patient room without going through the general corridor. One (1) toilet room may serve two (2) patient rooms.
(c) Lavatory. A lavatory shall be provided in each patient room. If the patient room is served by its own private toilet room, the lavatory may be located in the toilet room.
(d) Window.
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Sill height shall not be higher than three (3) feet above the floor.
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Windows in a psychiatric unit shall be security windows or a type that can only be opened by keys or tools that are under the control of staff. The degree of security required shall be as determined by the program, but operation of the sashes shall be restricted to prevent escape or suicide.
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Safety glazing or other appropriate security features shall be incorporated if glass fragments may create a hazard.
(e) A nurses' calling system is not required. If a call system is included, provisions shall be made to permit removal of call buttons or use of blank plates as appropriate.
(f) The visual privacy provided each patient shall isolate patients from one another but not from observation by staff.
(g) Bedpan flushing devices may be omitted from patient room toilets.
(2) Service areas. Service areas shall conform to the requirements in Section 6(2) of this administrative regulation and shall meet the following additional conditions:
(a) Provide separate space for occupational therapy at the rate of fifteen (15) square feet per patient and a minimum area of 400 square feet.
(b) Provide a minimum of two (2) separate social spaces, one (1) appropriate for noisy activities and the other for quiet activities. The combined area shall be a minimum of thirty (30) square feet per patient or a minimum of 120 square feet for each of the two (2) spaces, whichever is greater. This space may be shared by dining activities.
(c) Provide storage for recreational and occupational therapy equipment.
(d) Provide storage for patients' belongings.
(e) Provide bathtubs or showers at the rate of one (1) for each four (4) beds which are not individually served. At least one (1) bathing facility shall have space for a wheelchair patient and an assisting attendant.
(3) Seclusion room. A seclusion room shall be provided for a patient requiring security and protection from himself or others.
(a) The room shall be located in a manner affording direct supervision of the patient by the nursing staff.
(b) The room shall be a single room and shall be constructed to minimize the possibility of a patient's hiding, escape, injury, or suicide.
(c) There shall be a minimum of one (1) seclusion room for every twenty-four (24) beds.
(d) Ground fault interrupters for electrical circuits and tamper-proof screws shall be used.
(e) Doors shall swing outward and shall have provisions for staff observation while maintaining privacy from the public and other patients.
Section 12. Surgical Suite.
(1) General. If a surgical suite is included in the functional program, the surgical suite shall be located and arranged to preclude unrelated traffic through the suite. The number of operating rooms and recovery beds, including the size of the service areas, shall be based on the expected surgical workload.
(2) Operating room. Each operating room shall have a minimum clear floor area of 360 square feet, exclusive of fixed and movable cabinets and shelves, with a minimum dimension of eighteen (18) feet. Storage space for splints and traction equipment shall be provided for rooms equipped for orthopedic surgery. At least two (2) x-ray film illuminators or a monitor for displaying at least two (2) films or images simultaneously shall be provided in each operating room.
(3) Room for surgical cystoscopy and other endoscopic procedures. The procedure room shall have a minimum clear area of 250 square feet, exclusive of fixed and movable cabinets and shelves, with a minimum dimension of fifteen (15) feet. Facilities shall be provided for the disposal of liquid wastes.
(4) Recovery room. A room shall be provided for post anesthesia recovery of surgical patients and shall contain a drug distribution station, hand-washing facilities, charting facilities, clinical sink, and storage space for supplies and equipment. The design shall provide for a minimum three (3) foot clearance to each side of the recovery bed.
(5) Medical preparation and holding area. A room shall be provided for medical preparation of patients and holding prior to surgery. The room shall contain a drug distribution station, hand-washing facilities, and charting facilities. The design shall provide for a minimum three (3) foot clearance to each side of the bed. This area may be eliminated if the medical preparation of a patient prior to surgery is done in the patient room.
(6) Service areas in each surgical suite. The service areas shall include:
(a) A control station located to permit visual surveillance of traffic that enters the surgical suite;
(b) Sterilizing facilities with high speed autoclaves located near the operating room;
(c) A drug distribution station for storage and preparation of medication for patients. The station shall contain a work counter, storage facilities, and a sink equipped for hand washing. Controlled substances shall be under double lock;
(d) Two (2) scrub stations near the entrance to each operating room or two (2) scrub stations for two (2) operating rooms if the scrub stations are located adjacent to the entrance to each operating room;
(e)
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A soiled workroom for the exclusive use of the surgical suite staff that contains a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand washing, waste receptacle, and linen receptacle; or
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A soiled holding area that is part of a system used for the collection and disposal of soiled materials and that is similar to a soiled workroom except that the clinical sink and work counter may be omitted;
(f)
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If clean materials are assembled within the surgical suite prior to use, a clean workroom that contains a work counter, sink equipped for hand washing, and storage space for clean and sterile supplies; or
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If the facility utilizes a central system for the cleanup, distribution of clean and sterile supplies, and central storage, a clean supply room;
(g) Anesthesia workroom for cleaning, testing, and storage of anesthesia equipment that contains a work counter and sink;
(h) Anesthesia storage facilities;
(i) Medical gas supply with storage space for reserve medical gas cylinders shall be provided;
(j) Storage room for equipment and supplies used in the surgical suite;
(k) Staff clothing change areas for male and female personnel working within the surgical suite that:
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Contain lockers, showers, toilets, lavatories equipped for hand washing and space for putting on scrub suits and boots; and
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Are arranged to provide a one (1) way traffic pattern so that personnel entering from outside the surgical suite can shower, change, and go directly into the surgical suite;
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Are designed so that personnel using it for removal of scrub suits and boots will avoid physical contact with clean personnel;
(l) If the functional program includes outpatient surgical services:
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An outpatient surgery change area for an outpatient to change for street clothing into a hospital gown, with a waiting room lockers, toilets, and clothing change or gowning area with a traffic pattern similar to that of the staff clothing change area; and
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A separate recovery area for outpatients;
(m) In facilities with two (2) or more operating rooms unless a separate room for medical preparation of patients is provided as called for under Section 12(5) of this administrative regulation, a patient's holding area that:
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Is a room or alcove to accommodate stretcher patients waiting for surgery; and
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Is under the visual control of the surgical suite control station;
(n) Stretcher storage areas out of the direct line of traffic;
(o) Lounge and toilet facilities for surgical staff that are located to permit use without leaving the surgical suite and include a toilet room near the recovery rooms; and
(p) A janitor's closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment for exclusive use in the surgical suite.
Section 13. Outpatient and Emergency Suite.
(1) General. Facilities for emergency and outpatient clinic care shall be provided if included in the functional program.
(2) Emergency patient care services. The extent of the emergency services to be provided in the hospital shall depend upon the community needs and the availability of other organized programs for emergency care within the community. The facilities shall be located to prevent outpatients from traversing inpatient areas and shall include the areas described in paragraphs (a) through (n) of this subsection.
(a) Entrance at grade level which is sheltered from the weather and has convenient access for ambulances and wheelchairs.
(b) Reception and control area located near the entrance, waiting area, and treatment room.
(c) Public waiting area with toilet facilities, public telephone, and drinking fountain.
(d) Examination and treatment room. Hand-washing facilities shall be provided in each room. Each room shall have a minimum floor area of 120 square feet with a minimum dimension of ten (10) feet.
(e) Emergency room for minor surgical procedures. The minor surgical procedures room shall contain a hand-washing facility and shall have a minimum floor area of 240 square feet. The minimum dimension shall be fifteen (15) feet.
(f) Clean workroom. The clean workroom shall contain a work counter, sink equipped for hand washing, and storage space for clean and sterile supplies.
(g) Soiled workroom. The soiled workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand washing, waste receptacle, and linen receptacle.
(h) Drug distribution station for storage and preparation of medication. The drug distribution station shall contain a work counter, storage facilities, and sink equipped for hand washing. Controlled substances shall be under double lock.
(i) Nurses' station for nurses' charting, doctors' charting, communications and storage for supplies and nurses' personal effects.
(j) Staff toilet room.
(k) Patient's toilet room located convenient to the treatment room.
(l) Wheelchair and stretcher alcove located convenient to the entrance to the department.
(m) Janitor's closet. The janitor's closet shall contain a floor receptor or service sink with storage space for housekeeping supplies and equipment for exclusive use in the emergency department.
(n) Equipment storage room.
(3) Outpatient department. If outpatient services are provided, the extent of the administrative, clinical, and diagnostic facilities provided shall depend on the estimated patient load as described in the functional program. Outpatient facilities shall provide for the privacy and dignity of the patient during interview, examination, and treatment. Facilities shall be located so that outpatients do not traverse inpatient areas and shall include the areas described in paragraphs (a) through (s) of this subsection.
(a) Entrance at grade level which is sheltered from weather and able to accommodate wheelchair access.
(b) Reception and control area located near the entrance and waiting area.
(c) Wheelchair storage out of the line of direct traffic.
(d) Public waiting area with toilet facilities, public telephone, and drinking fountain.
(e) Interview space for private interviews relating to social service, credit and admissions.
(f) General or individual office for business transaction, records, administrative, and professional staff.
(g) Multipurpose room for conferences, meetings, and health education purposes. The multipurpose room shall be equipped for the use of visual aids.
(h) General purpose examination room for medical, obstetrical, and similar examinations. Each room shall have a minimum floor area of eighty (80) square feet, excluding such spaces as the vestibule, toilet, closet, and work counter. An examination table shall be placed to provide at least thirty (30) inches clearance to each side and at the foot of the table. A lavatory or sink equipped for hand washing shall be provided in each room.
(i) Special purpose examination rooms. Room sizes for special clinics shall be determined by the types of equipment used but shall be not less than eighty (80) square feet. A lavatory or sink equipped for hand washing shall be provided in each room.
(j) Observation room for handling of isolation, suspect, or disturbed patients. The observation room shall be located convenient to the nurses' station to permit close observation of patients. In facilities having 15,000 or less annual outpatients, a separate room shall not be required if an examination room is modified to accommodate this function.
(k) Patient toilet facilities.
(l) Nurses' station for nurses' charting, doctors' charting, communications, and storage for supplies and nurses' personal effects.
(m) Staff toilet room located convenient to the nurses' station.
(n) Clean workroom. The clean workroom shall contain a work counter, sink equipped for hand washing, and storage space for clean and sterile supplies.
(o) Soiled workroom. The soiled workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand washing, waste receptacle, and linen receptacle.
(p) Drug distribution station for storage and preparation of medication. The drug distribution station shall contain a work counter, sink equipped for hand washing, and storage facilities. Controlled substances shall be under double lock.
(q) Wheelchair and stretcher alcove located convenient to the entrance to the department.
(r) Janitor's closet. The janitor's closet shall contain a floor receptor or service sink with storage space for housekeeping supplies and equipment for exclusive use in the outpatient department.
(s) Equipment storage room.
Section 14. Radiology Suite. The radiology suite shall contain the following:
(1) Radiographic room;
(2) Film processing facilities;
(3) Viewing and administrative area;
(4) Film storage facilities;
(5) Toilet room with hand-washing facility, which shall be accessible from each fluoroscopy room without entering the general corridor area;
(6) Dressing area for ambulatory patients with convenient access to toilets;
(7) Waiting room or alcove for ambulatory patients;
(8) Holding area for stretcher patients, which shall be located out of the direct line of normal traffic; and
(9) Hand-washing facilities in each radiographic room unless the room is used only for routine diagnostic screening.
Section 15. Laboratory Suite. Facilities shall be provided for the following and the size of the areas including equipment shall depend on the patient workload:
(1) Hematology;
(2) Clinical chemistry with acid-shower and eye washing facility provided nearby;
(3) Urinalysis with specimen toilet and hand-washing facility provided nearby;
(4) Cytology;
(5) Bacteriology;
(6) Waiting area for ambulatory patients;
(7) Administrative support areas;
(8) Blood storage facilities;
(9) Blood specimen collection area with a work counter, hand-washing facilities, and space for patient seating;
(10) Glass-washing and sterilizing facilities; and
(11) Recording and filing facilities.
Section 16. Physical Therapy Suite. If a physical therapy suite is addressed in the functional program, the following items shall be provided:
(1) Office space;
(2) Waiting space;
(3) Treatment areas for thermotherapy, diathermy, ultrasonics, and hydrotherapy with:
(a) Cubicle curtains around each individual treatment area for privacy purposes;
(b) Hand-washing facilities, but one (1) lavatory or sink may serve more than one (1) treatment cubicle; and
(c) Facilities for collection of wet and soiled linen or other material;
(4) Exercise area;
(5) Storage for clean linen, supplies, and equipment;
(6) Patient dressing areas, showers, lockers, and toilet rooms;
(7) Janitor's closet with floor receptor or service sink and storage space for housekeeping supplies and equipment; and
(8) Wheelchair and stretcher storage area.
Section 17. Morgue and Autopsy.
(1) If autopsies are performed within the hospital, the following shall be provided:
(a) Refrigerated facilities for body-holding.
(b) Autopsy room that contains the following:
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Work counter with sink equipped for hand washing;
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Storage space for supplies, equipment, and specimens;
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Autopsy table;
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Clothing change area with shower, toilet, and lockers; and
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A janitor's closet containing a floor receptor or service sink with storage for housekeeping supplies and equipment for exclusive use in this area.
(2) If autopsies will be performed outside the hospital, only a well-ventilated body-holding room shall be provided.
Section 18. Pharmacy or Drug Room. An adequate supply of drugs and other medicinal agents shall be available at all times to meet the requirements of the hospital. Drugs shall be stored in a safe manner and shall be kept properly labeled and accessible. Controlled substances and other dangerous or poisonous drugs shall be handled in a safe manner to protect against unauthorized use. Controlled substances shall be under double lock. There shall be adequate refrigeration for biologicals and drugs which require refrigeration. The existing laws, rules, and administrative regulations governing drugs and poisons shall be complied with.
Section 19. Dietary Department. Food service facilities shall be designed and equipped to meet the requirements of the functional program. If a commercial service will be used, dietary areas and equipment shall be designed to accommodate the requirements for sanitary storage, processing, and handling. If on-site conventional food preparation is used, the department shall include the following facilities:
(1) Control station for the receiving of food supplies;
(2) Food preparation facilities. Conventional food preparation systems shall have space and equipment for food preparation, cooking, and baking. Convenience food service systems or systems using contractual commissary services shall have space and equipment for thawing, portioning, cooking, and baking;
(3) Hand-washing facilities located conveniently accessible in the food preparation area;
(4) Patient meal service facilities required for tray assembly and distribution;
(5) Dishwashing space:
(a) With commercial-type dishwashing equipment that is located in a room or alcove separate from the food preparation and serving area;
(b) With space provided for receiving, scraping, sorting, and stacking soiled dishware and tableware prior to cleanup;
(c) That is designed to allow clean dishware and tableware to be removed at a different location than the one used for the soiled dishware and tableware; and
(d) With a conveniently-located hand-washing lavatory;
(6) Pot-washing facilities;
(7) Refrigerated storage to accommodate a three (3) day minimum supply;
(8) Dry storage to accommodate a three (3) day minimum supply;
(9) Storage areas and sanitizing facilities for cans, carts, and mobile tray conveyors;
(10) Waste storage facilities located in a separate room easily accessible to the outside for direct pickup or disposal;
(11) Dining space for ambulatory patients, staff, and visitors;
(12) Offices or desk spaces for dieticians or the dietary service manager;
(13) Conveniently-located toilets with hand-washing facilities for use by the dietary staff; and
(14) Janitor's closet located within the department that contains a floor receptor or service sink with storage for housekeeping supplies and equipment to be used exclusively in this area.
Section 20. Administrative and Public Areas. The following shall be provided:
(1) Lobby that includes:
(a) Storage space for wheelchairs;
(b) Reception and information counter or desk;
(c) Waiting space; and
(d) Public toilet facilities designed for use by the physically handicapped.
(2) Interview space for private interviews relating to social services, credit, and admissions;
(3) Director of nurses' office;
(4) Staff toilet rooms;
(5) Medical library facilities;
(6) General or individual offices for business transactions, medical and financial records, administrative, and professional staff use;
(7) Administrator's office;
(8) Multipurpose room for conferences, meetings, and health education purposes, including provisions for showing visual aids; and
(9) Storage for office equipment and supplies.
Section 21. Medical Records Unit. This unit shall include:
(1) Medical records administrator or technician office or space;
(2) Active record storage area;
(3) Record review and dictating room; and
(4) Work area for sorting, recording, or microfilming.
Section 22. Central Medical and Surgical Supply Department. The following areas shall be permanently separated from each other:
(1) Receiving and decontamination room. The room shall contain work space and equipment for cleaning medical and surgical equipment and for the disposal or processing of unclean material. Hand-washing facilities shall be provided.
(2) Clean workroom. This room shall be divided into work space, clean storage area, and sterilizing and sanitizing facilities. Hand-washing facilities shall be provided.
(3) Storage area for clean supplies and sterile supplies. The storage area may be in a designated area in the clean workroom.
(4) Equipment storage.
(5) Cart storage, if this type of system is utilized.
(6) Janitor's closet. The janitor's closet shall contain a floor receptor or service sink with storage space for housekeeping supplies and equipment to be utilized exclusively in this department.
Section 23. Central Stores. The following shall be provided:
(1) Off-street unloading facilities;
(2) Control station for receiving supplies; and
(3) General storage rooms which are adequate in size to meet the needs of the facility.
Section 24. Laundry. On-site processing and off-site processing.
(1) If linen is to be processed in the hospital, the following shall be provided:
(a) Soiled linen receiving, holding and sorting room with hand-washing facilities;
(b) Laundry processing room with hand-washing facilities and commercial-type equipment which can process seven (7) days of linen needs within a regularly scheduled work week;
(c) Storage for laundry supplies;
(d) Clean linen inspection and mending room;
(e) Clean linen storage, issuing and holding room or area;
(f) Janitor's closet that contains a floor receptor or service sink with storage space for housekeeping supplies and equipment to be utilized exclusively in this department; and
(g) Cart storage and cart sanitizing facilities.
(2) Arrangement of equipment and procedures shall permit an orderly work flow with a minimum of cross traffic to maintain separation of clean and soiled operations.
(3) If linen is to be processed off the hospital site, the following shall be provided:
(a) Soiled linen holding room with a hand-washing facility conveniently accessible; and
(b) Clean linen receiving, holding, inspection, and storage room.
Section 25. Employee Facilities.
(1) Female locker room. This room shall have lounge space, lockers for personal effects, and a separate toilet room. The area shall be designed for use by the physically handicapped. Shower facilities may be appropriate depending on the size of the facility.
(2) Male locker room. This room shall have lockers and a separate toilet room. The area shall be designed for use by the physically handicapped. Shower facilities may be appropriate depending on the size of the facility.
Section 26. Engineering Service and Equipment Areas. The following shall be provided:
(1) Room or separate buildings for boilers, mechanical equipment and electrical equipment;
(2) Engineer's office;
(3) Maintenance shop;
(4) Storage room for building maintenance supplies;
(5) Storage room for central housekeeping equipment and supplies;
(6) Office and administrative support space for the person in charge of central housekeeping; and
(7) Yard equipment storage.
Section 27. Waste Processing Services.
(1) The following shall be provided:
(a) Space and facilities shall be provided for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, removal, or by a combination of these techniques; and
(b) A gas, electric, or oil-fired incinerator for the complete destruction of pathological and infectious waste, which includes dressing and material from open wounds, laboratory specimens, and all waste material from isolation patient rooms;
(2) Waste tissue and contaminated combustible solids shall be rendered safe by sterilization or incineration.
(3) Culture plates, tubes, sputum cups, contaminated sponges, and swabs shall be sterilized before they are washed or discarded.
(4) Unpreserved tissue specimens from surgical or necropsy material shall be disposed of by incineration.
Section 28. Details and Finishes. details and finishes shall meet the following requirements:
(1) Details.
(a) Doors to patient toilet rooms and other rooms needing access for wheelchairs shall have a minimum width of two (2) feet and ten (10) inches.
(b) doors to patient-room toilets and patient-room bathrooms shall swing outward or be equipped with hardware that will permit access in an emergency.
(c) If required by the functional program, suitable hardware shall be provided on doors to patient toilet rooms in psychiatric nursing units so that access to these rooms can be controlled by the nursing staff.
(d) Windows and outer doors which may be frequently left in an open position shall be provided with screens.
(e) Thresholds and expansion joint covers shall be made flush with the floor surface to facilitate use by wheelchairs and carts.
(f) lavatories and sinks shall be equipped with blade handles which shall have a minimum of sixteen (16) inches clearance to each side of the centerline of the fixture.
(g) Towel dispensers or other hand-drying equipment shall be provided at lavatories and sinks equipped for hand washing, except scrub sinks.
(h) Grab bars shall be provided at patient toilets, showers, tubs, and sitz baths. The bars shall have one and one-half (1 1/2) inches clearance to walls and shall be of sufficient strength and anchorage to sustain a concentrated load of 250 pounds for a period of five (5) minutes.
(i) Recessed soap dishes shall be provided at showers and bathtubs.
(j) Mirrors shall not be installed at hand-washing fixtures in food preparation areas, nurseries, clean and sterile supply rooms, or scrub sink areas.
(k) Radiation protection requirements of facilities where sources of radiation are used or stored shall be approved by the Radiation Health Branch, Division of Public Health Protection and Safety, Department for Public Health, Cabinet for Health and Family Services.
(l) Ceiling heights shall be as follows:
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Boiler room ceiling height shall be at least two (2) feet and six (6) inches above the main boiler header and connecting piping with a minimum height of nine (9) feet.
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Ceiling height of corridors, storage rooms, patient toilet rooms, and other minor rooms shall be at least seven (7) feet and six (6) inches.
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Radiographic, operating, and delivery rooms, and other rooms containing ceiling-mounted equipment or ceiling-mounted surgical light fixtures shall have a height as required to accommodate the equipment or fixtures.
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Ceilings of other rooms shall be at least eight (8) feet.
(m) Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over patient bed areas, delivery suites, operating suites, or nurseries unless special provisions are made to minimize transmission of noise.
(n) Boiler rooms, laundries, food preparation areas, and other rooms containing heat-producing equipment shall be insulated and ventilated to prevent any floor surface from exceeding a temperature of ten (10) degrees Fahrenheit above the ambient room temperature.
(o) Noise reduction criteria. Partition, floor, and ceiling construction in patient areas shall comply with Table 1, Section 33(1) of this administrative regulation.
(2) Finishes.
(a) Floor materials shall be easily cleanable and shall have wear resistance appropriate for the location involved. Floors in areas used for food preparation or food assembly shall be water-resistant and grease-proof. Joints in tile and similar material in food preparation areas shall be resistant to food acids. In areas subject to frequent wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet shall have a nonslip finish.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable, and in the immediate area of plumbing fixtures the finish shall be smooth and moisture-resistant. Finish, trim, and floor and wall construction in dietary and food preparation areas shall be free of spaces that may harbor rodents and insects.
(d) Wall bases in kitchens, operating rooms, delivery rooms, and other areas subject to frequent wet cleaning methods shall be made integral and coved with the floor, tightly sealed within the wall, and constructed without voids that may harbor harmful bacteria.
(e) Ceilings shall be cleanable. Ceilings in surgical, delivery, nursery, and isolation rooms shall be readily washable and without crevices that may retain dirt particles. Surgical, delivery, nursery, and isolation rooms and dietary and food preparation areas shall have a finished ceiling covering overhead piping and ductwork. Finished ceilings may be omitted in mechanical and equipment spaces, shops, general storage areas, and similar spaces, unless required for fire-resistive purposes.
(f) Acoustical type ceilings shall be provided for corridors in patient areas, nurses' stations, labor rooms, dayrooms, recreation rooms, dining areas, and waiting areas.
(g) Ceilings of patient rooms in psychiatric nursing units shall be of monolithic or bonded construction.
Section 29. Elevators. Hospitals having bedrooms, dining rooms, recreation areas, operating rooms, delivery rooms, diagnostic, or therapy areas, located on other than the main entrance floor, shall have elevators.
(1) Number of elevators.
(a) At least one (1) hospital-type elevator shall be installed if one (1) to fifty-nine (59) patient beds are located on any floor other than the main entrance floor.
(b) At least two (2) hospital-type elevators shall be installed if sixty (60) to 200 patient beds are located on floors other than the main entrance floor, or if the major inpatient services are located on a floor other than those containing patient beds.
(c) At least three (3) hospital-type elevators shall be installed if 201 to 350 patient beds are located on floors other than the main entrance floor, or if the inpatient services are located on a floor other than those containing patient beds.
(d) If a hospital has more than 350 beds, the number of elevators shall be determined from a study of the hospital plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Cars of hospital-type elevators shall have inside dimensions that will accommodate a hospital bed and attendant and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep. The car door shall have a minimum clear opening of at least three (3) feet and eight (8) inches.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
(4) Operation. Elevators, except freight elevators, shall be equipped with a two (2) way special service switch to permit cars to bypass landing button calls and be dispatched directly to any floor.
Section 30. Construction.
(1) Design. Every building and every portion thereof shall be designed and constructed to sustain dead and live loads in accordance with accepted engineering practices and standards, including seismic forces if applicable.
(2) Foundations. Foundations shall rest on natural solid bearing if a satisfactory bearing is available at reasonable depths. Proper soil-bearing values shall be established in accordance with recognized standards. If solid bearing is not encountered at practical depths, the structure shall be supported on driven piles, augured piles, poured caissons, or an equivalent designed to support the intended load without detrimental settlement, except that one (1) story buildings may rest on a fill designed by a soils engineer. If engineered fill is used, site preparation and placement of fill shall be done under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the compacted fill operation and a certification of compliance with the job specifications. Footings shall extend to a depth not less than one (1) foot below the estimated frost line.
(3) Natural disasters. Special provisions shall be made in the design of buildings in geographic areas where local experience reflects loss of life or extensive damage to buildings resulting from tornadoes or floods.
Section 31. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect or engineer shall obtain from the contractor, certification in writing that mechanical systems have been tested and that the installation and performance of these systems conform with the final plans and specifications.
(2) Incinerators. The design and installation shall comply with the applicable state regulations for control of air contaminants for incinerators.
(3) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) shall be provided and the combined capacity of the boilers shall be able to supply 150 percent of the normal requirements for systems and equipment in the facility.
(b) Boiler accessories. Boiler feed pumps, condensate return pumps, fuel oil pumps, and circulation pumps shall be connected and installed to provide normal and standby service.
(c) Valves. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends, except that vacuum condensate returns need not be valved at each piece of equipment.
(4) Thermal and acoustical installation.
(a) Insulation shall be provided on the following within the building:
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Boilers, smoke breeching, and stacks;
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Steam supply and condensate return piping;
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Hot water piping above 120 degrees Fahrenheit at hot water heaters, generators, and converters;
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Chilled water, refrigerant, other process piping, and equipment operating with fluid temperatures below ambient dew point;
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Water supply and drainage piping on which condensation may occur;
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Air ducts and casings with outside surface temperature below ambient dew point or temperature above eighty (80) degrees Fahrenheit; and
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Other piping, ducts, and equipment as necessary to maintain the efficiency of the system.
(b) Insulation on cold surfaces shall include an exterior vapor barrier.
(c) Duct linings shall not be used in systems supplying operating rooms, delivery rooms, recovery rooms, nurseries, isolation rooms of intensive care units unless terminal filters of at least ninety (90) percent efficiency are installed downstream of the lining.
(5) Air-conditioning, heating, and ventilation systems.
(a) Temperatures and humidities.
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The designed capacity of the systems shall provide the following temperatures and humidities in the areas noted below:
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For other areas occupied by inpatients, the indoor winter design temperature shall be seventy-five (75) degrees Fahrenheit. For all other occupied areas, the indoor winter design temperature shall be seventy-two (72) degrees Fahrenheit.
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For all other occupied areas, the indoor summer design temperature shall be seventy-five (75) degrees Fahrenheit.
(b) Ventilation system details. Air-supply and air-exhaust systems shall be mechanically operated. Fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates as shown on Table 2, Section 33(2) of this administrative regulation shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates.
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Outdoor air intakes shall be located as far as practical but not less than twenty-five (25) feet from exhaust outlets of ventilation systems, combustion equipment stacks, medical surgical vacuum systems, plumbing vent stacks, or from areas which may collect vehicular or other noxious fumes. The bottom of outside air intakes serving central air systems shall be located as high as practical but not less than six (6) feet above ground level or, if installed above the roof, three (3) feet above roof level.
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The ventilation systems shall be designed and balanced in accordance with the pressure relationship as shown in Table 2, Section 33(2) of this administrative regulation.
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Air supplied to operating rooms, delivery rooms, nurseries, and other sensitive areas shall be delivered at or near the ceiling of the area served and return/exhaust air shall be removed near floor level. At least two (2) return/exhaust outlets shall be provided in each operating room and delivery room.
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Room supply, return, and exhaust outlets shall be located not less than three (3) feet above finished floor.
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Isolation rooms and intensive care rooms may be ventilated by induction units if the induction units contain only a reheat coil and if only the primary air from a central system passes through the reheat coil.
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Central ventilation or air-conditioning systems shall be equipped with filters having minimum efficiencies as listed below:
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If two (2) filter beds are required in central ventilation and air-conditioning equipment, Filter Bed No. 1 shall be located upstream of the air-conditioning equipment and Filter Bed No. 2 shall be located downstream of the supply fan, any recirculating spray water system, or water reservoir type humidifiers. If only one (1) filter bed is required, it shall be located upstream of the air-conditioning equipment unless an additional prefilter is employed. In this case, the prefilter shall be located upstream of the equipment and the main filter may be located further downstream.
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Filter efficiencies as listed above shall be average atmospheric dust spot efficiencies tested in accordance with the "American Society of Heating, Refrigerating, and Air-Conditioning Engineers" (ASHRAE) Standard in effect at the time the hospital is constructed.
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Filter frames shall be durable and carefully dimensioned, and shall provide an airtight fit with the enclosing ductwork. Joints between filter segments and the enclosing ductwork shall be gasketed or sealed to provide a positive seal against air leakage.
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A manometer or its equivalent shall be installed across each filter bed serving sensitive areas or central air systems.
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Ducts which penetrate construction intended for x-ray or other ray protection shall not impair the effectiveness of the protection.
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Laboratories shall be provided with outdoor air at a rate of two (2) air changes per hour. If this ventilation rate does not provide the air required to ventilate fume hoods and safety cabinets, additional outdoor air shall be provided. A filter with ninety (90) percent minimum efficiency shall be installed in the air supply system at its entrance to the media transfer room.
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Laboratory hoods for general use shall have a minimum average face velocity of seventy-five (75) feet per minute. Hoods in which infectious or highly radioactive materials are processed shall have a face velocity of 100 feet per minute and each hood shall have an independent exhaust system with the fan installed at the discharge point of the system. Hoods used for processing infectious materials shall be equipped with a means of disinfection.
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Duct systems serving hoods in which highly radioactive materials and strong oxidizing agents are used shall be constructed of stainless steel for a minimum distance of ten (10) feet from the hood and shall be equipped with washdown facilities.
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Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and reasonable temperatures in the rooms and in adjoining areas.
(6) Plumbing systems. Plumbing systems shall be designed and installed in accordance with the applicable state plumbing regulations.
(a) Plumbing fixtures.
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The material used for plumbing fixtures shall be of nonabsorptive acid-resistant material.
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Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum of five (5) inches above the rim of the fixture. Fixtures used by medical and nursing staff and lavatories used by patients and food handlers shall be equipped with valves which can be operated without the use of hands. If blade handles are used for this purpose, they shall not exceed four and one-half (4 1/2) inches in length, except that handles on scrub sinks and clinical sinks shall be not less than six (6) inches long.
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Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
(b) Water supply systems.
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Systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.
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Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
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A backflow preventer or vacuum breaker shall be installed on hose bibbs, laboratory sinks, janitors' sinks, bedpan flushing attachments, autopsy tables, and other fixtures to which hoses or tubing can be attached.
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Flush valves installed on plumbing fixtures shall be of a quiet operating type.
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Bedpan flushing devices shall be provided in each patient toilet room and in the soiled workrooms located in the patient nursing units.
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An auxiliary water supply shall be available to provide potable water in case of emergencies.
(c) Hot water heating systems.
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The hot water heating equipment shall have a sufficient capacity to supply water at the temperature and amounts indicated below:
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Storage tanks shall be fabricated from corrosive-resistant metal or be lined with noncorrosive material.
(d) Drainage systems.
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Drain lines from sinks in which acid wastes may be poured shall be fabricated from an acid-resistant material.
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Piping over operating and delivery rooms, nurseries, food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage or condensation from necessary overhead piping systems.
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Floor drains shall not be installed in operating and delivery rooms. Flushing rim type floor drains may be installed in cystoscopic operating rooms.
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Building sewers shall discharge into a community sewerage system. If a community sewerage system is not available, a facility providing sewage treatment shall be installed which conforms to applicable local and state administrative regulations.
(7) Nonflammable medical gas systems. Installations shall be in accordance with the requirements of the National Fire Protection Association (NFPA) 99, Health Care Facilities and the NFPA 99C, Gas and Vacuum Systems incorporated by reference in 815 KAR 7:120 as part of the Kentucky Building Code. The number, type, and location of outlets shall be as follows:
Section 32. Electrical Requirements.
(1) General.
(a) Equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. Materials shall be listed as complying with applicable standards of Underwriters' Laboratories, Inc., or other similarly established standards.
(b) Electrical installations and systems shall be tested to show that the equipment is installed and operates as planned or specified. A written record of performance tests on special electrical systems and equipment shall be supplied to the owner. These tests shall show compliance with the governing codes and shall include conductive floors, isolated power centers, grounding continuity, and alarm systems.
(2) Switchboard and power panels. Circuit breakers or fusible switches that provide disconnecting means and overcurrent protection for conductors connected to switchboards and panel boards shall be enclosed or guarded to provide a dead front type of assembly. The main switchboard shall be located in a separate enclosure accessible only to authorized persons. The switchboard shall be convenient for use, readily accessible for maintenance, clear of traffic lanes, and in a dry ventilated space devoid of corrosive fumes or gases. Overload devices shall be suitable for operating properly in the ambient temperature conditions.
(3) Panel boards. Lighting and appliance panel boards shall be located on the same floor as the circuits they serve.
(4) Lighting.
(a) Spaces occupied by people, machinery, or equipment within buildings, and the approaches thereto, and parking lots shall have lighting.
(b) Patient bedrooms shall have general lighting and night lighting. A reading light shall be provided for each patient. Flexible light arms shall be mechanically operated to prevent the bulb from coming in contact with the bed linen. Patients' reading lights and other fixed lights not switched at the door shall have switch controls located convenient to the luminaire. A fixed type night light, mounted at approximately sixteen (16) inches above the floor, shall be provided in each patient room. Switches for control of lighting in patient areas shall be of the quiet operating type.
(c) Operating and delivery rooms shall have general lighting in addition to local lighting provided by special lighting units at the surgical and obstetrical tables. Each fixed special lighting unit at the tables, except portable units, shall be connected to an independent circuit.
(d) Nursing unit corridors shall have general illumination with provisions for reduction of light levels at night. Refer to Table 3, Section 33(3) of this administrative regulation.
(5) Receptacles.
(a) Anesthetizing locations. Each operating, delivery, and emergency room shall have at least three (3) receptacles. In locations where mobile x-ray is used, an additional outlet distinctively marked for x-ray use shall be provided.
(b) Bedroom. Each patient bedroom shall have duplex receptacles as follows:
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One (1) on each side of the head of the bed;
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One (1) for the television, if used; and
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One (1) on another wall.
(c) Receptacles in pediatric and psychiatric units shall be of the safety type or shall be protected by five (5) milliampere ground fault interrupters.
(d) Nurseries. Each bassinet shall have a minimum of one (1) duplex receptacle. Additional receptacles shall be provided in special care nurseries, dependent on the types of equipment which will be used to provide medical care.
(e) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart and within twenty-five (25) feet of ends of corridors. Receptacles in corridors of pediatric and psychiatric units shall be of the safety type or shall be protected by five (5) milliampere ground fault interrupters.
(6) Equipment installation in special areas.
(a) Installation in anesthetizing locations. Electrical equipment, devices, receptacles, and wiring shall be in accordance with NFPA 99, Health Care Facilities and the NFPA 99C, Gas and Vacuum Systems as adopted by the State Fire Marshal's Office for hospitals.
(b) Facilities where sources of radiation are used or stored shall conform to applicable state regulations for radiation protection.
(c) Equipment for displaying images. At least two (2) x-ray illuminators or a monitor for displaying at least two (2) films or images simultaneously shall be installed in each operating room, emergency treatment room, and viewing room in the radiology department.
(7) Nurses' calling system.
(a) General.
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In general patient areas, each room shall be served by at least one (1) calling station and each bed shall be provided with a call button.
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Two (2) call buttons serving adjacent beds may be served by one (1) calling station.
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Calls shall register at an annunciator panel at the nurses' station and shall actuate a visible signal in the corridor at the patient room door, in the clean workroom, soiled workroom, the nourishment station, and the nurses' lounge of the nursing unit.
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In multicorridor nursing units, additional visible signals shall be installed at corridor intersections.
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In rooms containing two (2) or more calling stations, indicating lights shall be provided at each station.
-
Nurses' calling systems that provide two (2) way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operating.
(b) Patient emergency.
-
A nurses' call emergency button shall be provided for patient use at each patient's toilet, bath, sitz bath, and shower room on the nursing unit floors.
-
Call buttons shall be usable by a patient lying on the floor, and the inclusion of a pull cord shall satisfy this requirement.
(c) Intensive care. In areas where patients are under constant surveillance, the nurses' calling system may be limited to a bedside station that will actuate a signal that can be readily seen by the nurse.
(d) Staff emergency. An emergency calling station, which may be used by staff to summon assistance, shall be provided in each operating, delivery, recovery, emergency treatment, and intensive care room, in nurseries, and in supervised nursing units for psychiatric patients.
(8) Fire alarm and fire detection systems. The design and installation of fire alarm and fire detection systems shall be approved by the State Fire Marshal's Office.
(9) Emergency electrical.
(a) General. To provide electricity during interruption of the normal electric supply, an emergency source of electricity shall be provided and connected to circuits for lighting and power as set forth in paragraph (d) below.
(b) Sources. The source of this emergency electric service shall be as follows:
-
An emergency generating set if the normal service is supplied by one (1) or more central station transmission lines; or
-
An emergency generating set or a central station transmission line if the normal electric supply is generated on the premises.
(c) Emergency generating set.
-
The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system.
-
Generator sets shall be self-sufficient insofar as possible, without dependency on public utilities that may be subject to cutoff or outages.
-
A system of prime movers which is ordinarily used to operate other equipment and alternately used to operate the emergency generators shall be permitted provided that the:
a. Number and arrangement of the prime movers are such that when one (1) is out of service, due to breakdown or for routine maintenance, the remaining prime movers can operate the required emergency generators; and
b. Connection time requirements as listed in paragraph (e) of this subsection are met.
-
The emergency generator set shall be of sufficient kilowatt capacity to supply the lighting and power load demands of the emergency electrical system.
-
The power factor rating of the generator shall be not less than eighty (80) percent.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting:
a. Exits and necessary ways of approach thereto, including exterior of exits, exit doorways, stairways, and corridors;
b. Surgical, obstetrical, and emergency room operating lights;
c. Nursery, laboratory, recovery room, intensive care areas, nursing station, medication preparation area, and labor rooms;
d. Generator set location, switch-gear location, mechanical room, and boiler room;
e. Elevator cabs; and
f. Night light in patient rooms.
- Equipment essential to life safety and for protection of important equipment or vital materials:
a. Nurses' calling system;
b. Paging or speaker systems, if intended for issuing instructions during emergency conditions with alarms required for medical gas systems;
c. Fire pump and jockey pump, if installed;
d. Pump for central suction system;
e. Sewerage or sump lift pump, if installed;
f. Blood bank refrigerator; and
g. Selected receptacles in:
(i) Infant nurseries;
(ii) Medicine dispensing areas;
(iii) Cardiac catheterization laboratories;
(iv) Angiographic laboratories;
(v) Labor, operating, delivery, and recovery rooms;
(vi) Dialysis units;
(vii) Intensive care units;
(viii) Emergency treatment rooms;
(ix) Basic laboratory functions; and
(x) Nurses' stations.
h. Duplex receptacles in patient corridors and at least one (1) duplex receptacle located on the patient headwall in each patient room.
i. Elevator service that will reach every patient floor. Manual throw over facilities shall be provided to allow temporary operation of any elevator for the release of persons who may be trapped between floors.
j. Ventilation of operating and delivery rooms.
k. Equipment necessary for maintaining telephone service.
- Heating. Equipment for heating operating, delivery, labor, recovery, intensive care, and general patient rooms, except that service for heating of general patient rooms will not be required under either of the following conditions:
a. The design temperature is higher than twenty (20) degrees Fahrenheit, based on the Median of Extremes as shown in the current edition of the "ASHRAE Handbook- Fundamentals".
b. The hospital is supplied by two (2) or more electrical services supplied from separate generating sources, or a utility distribution network having multiple power input sources and arranged to provide mechanical and electrical separation, so that a fault between the hospital and generating sources will not likely cause an interruption of the hospital service feeders.
(e) Details.
- The emergency electrical system shall be controlled so that, after interruption of the normal electric power supply, the generator shall be brought to full voltage and frequency and shall be connected within ten (10) seconds through one (1) or more primary automatic transfer switches to
a. Emergency lighting systems;
b. Alarm systems;
c. Blood banks;
d. Nurses' calling systems;
e. Equipment necessary for maintaining telephone service;
f. Pump for central suction system; and
g. Task illumination and receptacles in:
(i) Operating areas;
(ii) Delivery areas;
(iii) Emergency areas;
(iv) Intensive care nursing areas;
(v) Nurseries;
(vi) Patient rooms; and
(vii) Patient corridors.
-
Other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching.
-
Receptacles connected to the emergency system shall be distinctively marked for identification.
-
Storage-battery-powered lights, provided to augment the emergency lighting or for continuity of lighting during the interim of transfer switching immediately following an interruption of the normal service supply, shall not be used as a substitute for the requirement of a generator.
-
If stored fuel is required for emergency generator operation, the storage capacity shall be sufficient to supply for at least twenty-four (24) hours of continuous operation.
Section 33. Tables.
Section 34. New Construction and Renovation Facility Requirements.
(1) Unless otherwise required by this section, effective June 1, 2008, hospital plans submitted for approval to the licensing agency:
(a) Shall be compliant with the standards established in chapters 1.6 and 2.1 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition; and
(b) Shall not be required to comply with requirements established in other chapters of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, as referenced in Chapter 2.1.
(2) Hospital plans submitted for approval to the licensing agency after the effective date of this regulation and prior to June 1, 2008 may meet either the requirements established in this section or in Sections 6 through33 of this administrative regulation.
(3) An endoscopy suite shall comply with requirements established in Chapter 3.9, Sections 2.3 through 3.5 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition including requirements established in other chapters of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, as referenced in Chapter 3.9, Sections 2.3 through 3.5.
(4) A psychiatric nursing unit patient room shall comply with the requirements established in Chapter 2.3, Sections 2.1 through 2.1.1.6 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, as referenced in Chapter 2.1, Section 3.8.2 Health Care Facilities", 2006 edition.
(5) Psychiatric nursing unit support areas shall comply with requirements established in Chapter 2.3, Sections 2.6.1 through 2.9.4 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition.
(6) A seclusion treatment room in a psychiatric nursing unit shall comply with requirements established in Chapter 2.3, Sections 2.2.1 through 2.2.1.5 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, as referenced in Chapter 2.1, Section 3.8.3 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition.
(7) A child psychiatric unit shall comply with requirements established in Chapter 2.3, Sections 2.3 through 2.3.3 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition.
(8) A geriatric, Alzheimer's, or other dementia unit shall comply with requirements established in Chapter 2.3, Sections 2.4 through 2.4.2.3 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition.
(9) Outpatient surgery and post-anesthetic care provided in the surgical suite of the hospital, in a separate unit of the hospital, or in a separate facility licensed as part of the hospital, shall comply with the requirements established in Chapter 3.7, Sections 1.1 through 2.3.1 and Sections 2.3.1.2 through 6.4.1 of the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition. Class A operating rooms shall not be allowed.
(10) When directed by the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, to "see" another section of the Guidelines, a hospital shall comply with the language of the section to which it has been referred by the word "see" if the section is incorporated by reference in Section 35 of this administrative regulation.
(11) Notwithstanding the version of a referenced code or standard in the "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, a hospital shall meet the version of the code or standard adopted by the state authority having jurisdiction.
(12) Outpatient services licensed as part of the hospital shall comply with requirements established in this administrative regulation and shall be provided in the main hospital building or in buildings on the premises or contiguous to the premises of the hospital.
(13) A patient room shall have a window with a sill that is not more than three (3) feet above the floor and not less in area than eight (8) percent of the total floor area of the room.
(14) Transportable or relocatable units utilized by the applicant or licensee shall:
(a) Comply with requirements established in this section; and
(b) Be accessible to the facility by a covered walkway that:
-
Ensures a patient is protected from the outside elements; and
-
Provides access to a patient in a wheelchair or on a stretcher.
(15) Prior to completion of construction or renovation, the licensee or applicant shall obtain a letter from the engineer of record or contractor certifying that new or modified mechanical and electrical systems have been tested and that the installation and performance of these systems conform with the final plans and specifications.
Section 35. Incorporation by Reference.
(1) The following sections of "Guidelines for Design and Construction of Health Care Facilities", 2006 edition, are incorporated by reference:
(a) Chapter 1.2, Sections 2.1 through 2.3.2;
(b) Chapter 1.5, Sections 1.1 through 2.3.3.2;
(c) Chapter 1.6;
(d) Chapter 2.1;
(e) Chapter 2.3, Sections 2.1 through 2.1.1.6;
(f) Chapter 2.3, Sections 2.2.1 through 2.2.1.5;
(g) Chapter 2.3, Sections 2.3 through 2.3.3;
(h) Chapter 2.3, Sections 2.4 through 2.4.2.3;
(i) Chapter 2.3, Sections 2.6.1 through 2.9.4;
(j) Chapter 3.7, Sections 1.1 through 2.3.1;
(k) Chapter 3.7, Sections 2.3.1.2 through 6.4.1; and
(l) Chapter 3.9, Sections 2.3 through 3.5.
(2) This material may be inspected, copied, or obtained subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Fifth Floor East, Frankfort, Kentucky 40621, Monday through Friday, 8:00 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Kentucky Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of licensure of health facilities. This administrative regulation establishes licensure requirements for plan submission and the structural specifications and plant requirements for new construction, renovation, and maintenance of hospital facilities.
- History: 902 KAR 020:009. 8 Ky.R. 580; eff. 2-1-1982; 16 Ky.R. 939; eff. 1-12-1990; 34 Ky.R. 410; 1005; 1439; eff. 12-12-2007; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 20:012 Hospital examination services {#sec-902-kar-20-012 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:012}
Section 1. Definition - Hospitals, General. Establishments with organized medical staffs with permanent facilities that include inpatient beds and medical services, including physician services and continuous nursing services, to provide diagnosis and treatment for patients who have a variety of medical conditions, both surgical and nonsurgical.
Section 2. Examination Services for Victims of Sexual Offenses.
(1) Hospitals offering emergency services shall provide for the examination of reported victims of sexual offenses as defined by KRS 510.010 to 510.140.
(2) The hospital shall develop procedures to be followed in the examination of reported victims of sexual offenses. The procedures shall include but need not be limited to the following:
(a) Twenty-four (24) hour on-call responsibility of the medical staff of physicians;
(b) The gathering and handling of physical evidence in accordance with the procedures of the Kentucky State Police Central Crime Laboratory;
(c) Obtaining appropriate patient consent for examination (a minor may consent to examination);
(d) Informing the victim of available services for treatment of venereal disease, pregnancy, and other medical and psychiatric problems.
(3) The hospital shall, upon the examination of a reported victim and the consent of the reported victim, submit to the Office of the Attorney General a completed examination verification form supplied by the Office of the Attorney General which includes the following:
(a) Physician signature attesting to the performance of the examination and collection of evidence;
(b) Hospital verification that appropriate law enforcement agencies have been notified of the reported sexual offense; and
(c) Hospital verification that proper confidentiality releases have been obtained.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.400, 216B.990(1), (2), 510.010-510.140
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides for a licensure requirement for the services to be provided by hospitals.
- History: 902 KAR 020:012. 8 Ky.R. 36; 150; eff. 8-5-1981; 16 Ky.R. 957; eff. 1-12-1990; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 20:016 Hospitals; operations and services {#sec-902-kar-20-016 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:016}
Section 1. Definitions.
(1) "Accredited record technician" means an individual who:
(a) Has graduated from a program for medical record technicians that is accredited by the Council on Medical Education of the American Medical Association and the American Health Information Management Association; and
(b) Is certified as an accredited record technician by the American Health Information Management Association.
(2) "Governing authority" means the individual, agency, partnership, or corporation in which the ultimate responsibility and authority for the conduct of the health facility is vested.
(3) "Long-term acute inpatient hospital services" means acute inpatient services provided to patients whose average inpatient stay is greater than twenty-five (25) days.
(4) "Organ procurement agency" means a federally designated organization that coordinates and performs activities to encourage the donation of organs or tissues for transplantation.
(5) "Protective device" means a device designed to protect a person from falling, and may include:
(a) Side rails;
(b) A safety vest; or
(c) A safety belt.
(6) "Psychiatric unit" means a department of a general acute care hospital consisting of eight (8) or more psychiatric beds organized for the purpose of providing psychiatric services.
(7) "Registered health information administrator" means an individual who has obtained professional certification from the American Health Information Management Association.
(8) "Registered or registry-eligible dietician" means an individual who is licensed as a dietician in accordance with KRS Chapter 310.
(9) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a patient or the movement of a portion of a patient's body.
Section 2. Requirements to Provide Services. A facility shall not be licensed as or hold itself out to be a hospital unless it provides:
(1) The full range of services required by Section 4 of this administrative regulation; and
(2) Treatment for a variety of illnesses.
Section 3. Administration and Operation.
(1) Governing authority licensee.
(a) The hospital shall have a recognized governing authority that has overall responsibility for:
-
The management and operation of the hospital; and
-
Compliance with federal, state, and local law pertaining to its operation.
(b) The governing authority shall:
-
Appoint an administrator whose qualifications, responsibilities, authority, and accountability shall be defined in writing and approved by the governing authority; and
-
Designate a mechanism for the annual performance review of the administrator.
(2) Administrator.
(a) The administrator shall:
-
Act as the chief executive officer;
-
Be responsible for the management of the hospital; and
-
Act as the liaison between the governing authority and the medical staff.
(b) The administrator shall keep the governing authority fully informed of the conduct of the hospital through:
-
Reports; and
-
Attendance at meetings of the governing authority.
(c) The administrator shall:
-
Develop an organizational structure including lines of authority, responsibility, and communication; and
-
Organize the day-to-day functions of the hospital through appropriate departmentalization and delegation of duties.
(d) The administrator shall establish formal means of accountability on the part of each subordinate to whom the administrator has assigned duties.
(e) The administrator shall:
-
Hold interdepartmental and departmental meetings as appropriate;
-
Attend or be represented at the meetings on a regular basis; and
-
Report to each department and to the governing authority the pertinent activities of the hospital.
(3) Administrative records.
(a) The hospital shall establish administrative records that reflect and guide the administrative operations of the hospital, including:
-
Minutes of the governing authority;
-
Financial records;
-
Personnel records; and
-
Employee health records.
(b) A hospital shall have discretion as to the form or content of any administrative record it establishes.
(c) The hospital shall maintain a:
-
Patient admission register;
-
Discharge register;
-
Birth register, if applicable; and
-
Surgical register, if applicable.
(d) Licensure inspection reports and plans of correction shall be made available to the general public upon request.
(4) Policies. The hospital shall have written policies and procedures governing all aspects of the operation of the facility and the services provided, including:
(a) A written description of the organizational structure of the facility that includes the lines of authority, responsibility, and communication, and departmental organization;
(b) The admission procedure to assure that a patient is admitted to the hospital in accordance with medical staff policy;
(c) Any constraint imposed on admissions by a limitation of:
-
Services;
-
Physical facilities;
-
Staff coverage; or
-
Other relevant factor;
(d) Financial requirements for patients on admission;
(e) Emergency admissions;
(f) Requirements for informed consent by patient, parent, guardian, or legal representative for diagnostic or treatment procedures;
(g) Effective procedures for tracking incidents, including transfusion reactions, drug reactions, and medication errors that may occur in the facility. A hospital shall have discretion as to its process, and the procedures shall encourage statistical analysis to inform process improvement activities;
(h) Procedures for meeting the requirements of KRS Chapter 214 and 902 KAR 2:020, including the reporting of:
-
Notifiable infectious conditions;
-
Notifiable non-infectious conditions;
-
Multi-drug resistant organisms;
-
Other reportable disease surveillance; and
-
Electronic laboratory reporting;
(i) Use of restraints and a mechanism for monitoring and controlling the use of restraints;
(j) The internal transfer of a patient from one (1) level or type of care to another, if applicable;
(k) The discharge and termination of services;
(l) An organ procurement for transplant protocol developed by the medical staff in consultation with the organ procurement agency;
(m) Policies that assure the reporting of cases of abuse, neglect, or exploitation of adults and children to the cabinet pursuant to KRS Chapters 209 and 620, including evidence that all allegations of abuse, neglect, or exploitation are thoroughly investigated internally to prevent further potential abuse while the investigation is in progress; and
(n) Policies that assure compliance with KRS 216B.165.
(5) Patient identification. The hospital shall have a system for identifying each patient from the time of admission to discharge. For example, an identification bracelet imprinted with the following:
(a) Name of patient;
(b) Hospital identification number;
(c) Date of admission; and
(d) Name of attending medical staff member.
(6) Discharge planning.
(a) The hospital shall have a discharge planning program to assure continuity of care for a patient who is:
-
Transferred to another health care facility; or
-
Discharged to the home.
(b) The professional staff of the facility involved in the patient's care during hospitalization shall participate in discharge planning of the patient whose illness requires a level of care outside the scope of the general hospital.
(c) The hospital shall:
-
Coordinate the discharge of the patient with the patient and the person or agency responsible for the postdischarge care of the patient;
-
Provide pertinent information concerning postdischarge needs to the responsible person or agency, including the full range of qualified providers or appropriate support organizations in the community available to provide post-acute care services; and
-
Comply with the requirements established in KRS 216B.230 to 216B.239, which include providing each patient or the patient's legal guardian, if applicable, with at least one (1) opportunity to designate a lay caregiver.
(7) Transfer procedures and agreements.
(a) The hospital shall have a written patient transfer procedure and agreement with at least one (1) of each type of other health care facility able to provide a level of inpatient care not provided by the hospital.
(b) A hospital that does not have a transfer agreement in effect, but has documented a good faith effort to enter into an agreement, shall be in compliance with paragraph (a) of this subsection.
(c) A transfer procedure and agreement shall:
-
Specify the responsibilities each institution assumes in the transfer of a patient; and
-
Establish the hospital's responsibility for:
a. Notifying the receiving entity promptly of the impending transfer of a patient; and
b. Arranging for appropriate and safe transportation.
(d) If a patient is transferred to another health care facility or to the care of a home health agency:
- A transfer form containing the following information shall accompany the patient or be sent immediately to the other health care facility or home health agency:
a. Attending medical staff member's instructions for continuing care;
b. Current summary of the patient's medical record;
c. Information as to special supplies or equipment needed for patient care; and
d. Pertinent social information on the patient and family; and
- A copy of the patient's signed discharge summary shall be forwarded to the health care facility or home health agency within thirty (30) days of the patient's discharge.
(e) If a patient is transferred to another licensed level of care within the same facility:
- The history and physical examination report shall:
a. Be transferred to the other licensed level of care within the same hospital pursuant to KRS 216B.175(3); and
b. Serve to meet the history and physical examination requirement for the licensed level of care to which the patient has been transferred; and
- The complete medical record or a current summary of the record shall be transferred with the patient.
(8) Medical staff.
(a) The hospital shall have a medical staff organized under bylaws approved by the governing authority.
(b) The medical staff shall be responsible:
-
To the governing authority for the quality of medical care provided to the patients; and
-
For the ethical and professional practice of its members.
(c) The organized medical staff shall be composed of doctors of medicine or doctors of osteopathy.
(d) At the discretion of the hospital, the governing body may elect to include the following practitioners as eligible for appointment to the medical staff to provide only those services authorized within the practitioner's respective scope of practice:
-
A licensed practitioner described in 42 U.S.C. 1395x(r)(2) – (5); or
-
A licensed practitioner described in 42 U.S.C. 1395u(b)(18)(C).
(e) The governing body of a hospital shall not be required to open eligibility for medical staff appointment to any licensed practitioner in addition to doctors of medicine or doctors of osteopathy.
(f) The medical staff shall develop and adopt policies or bylaws, subject to the approval of the governing authority that address the following:
-
Qualifications for medical staff membership, including licensure to practice in Kentucky in accordance with authorized scope of practice, except for graduate doctors of medicine or doctors of osteopathy in their first year of hospital training;
a. Responsibilities and duties of each category of medical staff membership the medical staff may choose to create, for example, active, associate, or courtesy;
b. Clinical privileges that may be possessed by medical staff members and allied health professionals;
c. Procedures for granting and withdrawing medical staff membership and clinical privileges; and
d. Procedures for reviewing credentials;
-
A mechanism for appeal of decisions adversely affecting medical staff membership or clinical privileges;
-
A method for the selection of officers of the medical staff;
-
Policy regarding the frequency of and attendance at meetings of the medical staff;
-
Authority to appoint committees to address areas of operation or clinical focus, which may include the following:
a. Executive committee;
b. Credentials committee;
c. Medical audit committee;
d. Medical records committee;
e. Infection control committee;
f. Tissue committee;
g. Pharmacy and therapeutics committee;
h. Utilization review committee; or
i. Quality assurance committee; and
- A policy requiring a member of the medical staff to sign a verbal order for diagnostic testing or treatment:
a. As soon as possible after the order was given; or
b. If the patient was discharged prior to the order being authenticated, within thirty (30) days of the patient's discharge.
(g) All licensed practitioners appointed to the medical staff shall:
-
Be privileged in accordance with and function under the policies or bylaws required by paragraph (f) of this subsection; and
-
Comply with the hospital infection control and employee health policies.
(9) Personnel. The hospital shall:
(a) Employ a sufficient number of qualified personnel to provide effective patient care and other related services;
(b) Have written personnel policies and procedures available to hospital personnel;
(c) Have a written job description for each position subject to review and revision as necessary;
(d) Have an employee health program for the mutual protection of employees and patients, including provisions for preemployment medical examination and follow-up medical examination no less than every three (3) years thereafter for staff who serve patients;
(e) Have a tuberculosis infection control program;
(f) Comply with the tuberculosis testing requirements established for health care workers in 902 KAR 20:205; and
(g) Maintain the following information in each employee's personnel record:
-
Name, address, Social Security number;
-
Health record;
-
Evidence of current registration, certification, or licensure;
-
Record of training and experience; and
-
Record of performance evaluation.
(10) Physical and sanitary environment.
(a) The condition of the physical plant and the overall hospital environment shall be maintained in such a manner that the safety and well-being of patients, personnel, and visitors are assured.
(b) A person shall be designated responsible for services and for the establishment of practices and procedures in each of the following areas:
-
Plant maintenance;
-
Laundry operations; and
-
Housekeeping.
(c) There shall be an infection control program charged with responsibility for investigating, controlling, and preventing infections in the hospital. A multidisciplinary infection control committee shall have oversight of the program. The program shall:
- Be directed by:
a. A certified infection control preventionist; or
b. An infection preventionist that has education or specialized training and experience necessary to be certified within two (2) years of employment;
- Have assigned administrative and professional staff to perform:
a. Infection control surveillance;
b. Investigation of cases and outbreaks;
c. Infection control training;
d. Reporting of diseases; and
e. Infection control collaborations with employee health services;
-
Receive every report of an infection incident discovered by an employee; and
-
Develop written infection control policies consistent with the Centers for Disease Control and Prevention guidelines.
(d) The infection control policies shall address the:
- Prevention of disease transmission to and from patients, visitors, and employees, including:
a. Universal blood and body fluid precautions;
b. Precautions for infections that can be transmitted by the airborne route;
c. Work restrictions, including return to work policies for employees with infectious diseases;
d. Policies for vaccinating health care personnel or documenting immunity status for:
(i) Hepatitis B;
(ii) Influenza;
(iii) Measles;
(iv) Mumps;
(v) Rubella;
(vi) Pertussis; and
(vii) Varicella;
e. Policies for vaccinating health care personnel to prevent meningococcal disease, typhoid fever, or polio for personnel who have certain health conditions or are at risk for work-related exposure;
f. Handwashing and hand hygiene;
g. Antimicrobial stewardship; and
h. Reporting, investigating, and controlling outbreaks of healthcare-associated infections;
-
Use of environmental cultures. Culture testing results shall be recorded and reported to the Infection Control Committee; and
-
Cleaning, disinfection, and sterilization methods used for equipment and the environment.
(e) The hospital shall provide in-service education programs on the cause, effect, transmission, prevention, and elimination of infections.
(f) The hospital buildings, equipment, and surroundings shall be kept in a condition of good repair, neat, clean, and free from accumulations of dirt, rubbish, and foul, stale, or musty odors.
-
An adequate number of housekeeping and maintenance personnel shall be provided.
-
A written housekeeping procedure shall be:
a. Established for the cleaning of each area; and
b. Made available to personnel.
-
Equipment and supplies shall be provided for cleaning of all surfaces. The equipment shall be maintained in a safe, sanitary condition.
-
Hazardous cleaning solutions, compounds, and substances shall be:
a. Labeled;
b. Stored in closed metal containers; and
c. Kept separate from other cleaning materials.
-
The facility shall be kept free from insects, rodents, and their nesting places, and entrances to their nesting places shall be eliminated.
-
Garbage and trash shall be:
a. Stored in areas separate from those used for preparation and storage of food; and
b. Removed from the premises regularly.
- Trash containers shall be cleaned on a regular basis.
(g) Sharp wastes.
- Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be:
a. Segregated from other wastes; and
b. Placed in puncture resistant containers immediately after use.
-
A needle or other contaminated sharp shall not be purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
-
A sharp waste container shall be:
a. Incinerated on or off site; or
b. Rendered nonhazardous.
- Nondisposable sharps, such as large-bore needles or scissors, shall be placed in a puncture resistant container for transport to the Central Medical and Surgical Supply Department, in accordance with 902 KAR 20:009, Section 22.
(h) Disposable waste.
- Disposable waste shall be:
a. Placed in a suitable bag or closed container to prevent leakage or spillage; and
b. Handled, stored, and disposed of to minimize direct exposure of personnel to waste materials.
-
The hospital shall establish specific written policies regarding handling and disposal of waste material.
-
The wastes identified in this subparagraph shall receive special handling.
a. Microbiology laboratory waste including a viral or bacterial culture, contaminated swab, or a specimen container or test tube used for microbiologic purposes shall be incinerated, autoclaved, or otherwise rendered nonhazardous.
b. Pathological waste including a tissue specimen from a surgical or necropsy procedure shall be incinerated.
- Blood, blood specimens, used blood tubes, or blood products shall be:
a. Disposed of by incineration;
b. Autoclaved before disposal; or
c. Carefully poured down a drain connected to a sanitary sewer, subject to limitations in subparagraph 5. of this paragraph.
-
Wastes conveyed to a sanitary sewer shall comply with applicable federal, state, and local pretreatment law, including 40 C.F.R. Part 403 and relevant local ordinances.
-
An incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 and 401 KAR 61:010.
(i) The hospital shall have available at all times a quantity of linen essential to the proper care and comfort of patients.
-
Linens shall be handled, stored, and processed to control the spread of infection.
-
Clean linen and clothing shall be stored in a clean, dry, dust-free area designated exclusively for this purpose.
-
An uncovered mobile cart may be used to distribute a daily supply of linen in patient care areas.
-
Soiled linen and clothing shall be placed in a suitable bag or closed container to prevent leakage or spillage, and there shall be minimal handling of soiled linen to prevent generating further aerosols.
-
Soiled linen shall be stored in an area separate from clean linen.
(11) Medical and other patient records.
(a) The hospital shall have a medical records service with administrative responsibility for medical records.
(b) A medical record shall be maintained in accordance with accepted professional principles for every patient admitted to the hospital or receiving outpatient services.
- The medical records service shall:
a. Be directed by:
(i) A registered health information administrator on a full-time, part-time, or consultative basis; or
(ii) An accredited record technician on a full-time or part-time basis; and
b. Have available a sufficient number of regularly assigned employees so that medical record services may be provided as needed.
- Medical records shall be retained for at least:
a. Six (6) years from date of discharge; or
b. If a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
-
A provision shall be made for written designation of the specific location for storage of medical records if the hospital ceases to operate because of disaster or for any other reason.
-
The hospital shall be responsible for safeguarding the record and its informational content against loss, defacement, and tampering.
-
Particular attention shall be given to protection from damage by fire or water.
(c) A system of identification and filing to assure the prompt location of a patient's medical record shall be maintained in accordance with the requirements of this paragraph.
-
Index cards, if used, shall bear at least the patient's full name, birth date, and medical record number.
-
There shall be a system for coordinating the inpatient and outpatient medical records of a patient whose admission is a result of, or related to, outpatient services.
-
Clinical information pertaining to inpatient and outpatient services shall be centralized in the patient's medical record.
-
A hospital using automated data processing shall keep patient indices electronically or reproduced on paper and kept in books.
(d) Ownership.
-
Medical records shall be the property of the hospital.
-
The original medical record shall not be removed from the facility except by court order or subpoena.
-
Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established by paragraph (e) of this subsection.
(e) Confidentiality and Security: Use and Disclosure.
-
The hospital shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
-
The hospital may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
-
A hospital may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(f) Medical record contents shall be pertinent, current, and include the following:
-
Identification data and signed consent forms, including name and address of next of kin, and of the person or agency responsible for patient;
-
Date of admission, name of attending medical staff member, and allied health professional in accordance with subsection (8)(d)2. of this section;
-
Chief complaint;
-
Medical history including present illness, travel history, occupational history, past history, family history, and physical examination results;
-
Report of special examinations or procedures, which may include consultations, clinical laboratory tests, x-ray interpretations, or EKG interpretations;
-
Provisional diagnosis or reason for admission;
-
Orders for diet, diagnostic tests, therapeutic procedures, and medications, including patient limitations, signed and dated by the medical staff member or other ordering personnel acting within the limits of his or her statutory scope of practice;
-
Medical, surgical, or dental treatment notes and reports, signed and dated by a physician, dentist, licensed practitioner, or other ordering personnel acting within the limits of his or her statutory scope of practice if applicable, including records of all medication administered to the patient;
-
Complete surgical record signed by the attending surgeon or oral surgeon, including the:
a. Anesthesia record signed by the anesthesiologist or an advanced practice registered nurse who is a certified registered nurse anesthetist;
b. Preoperative physical examination and diagnosis;
c. Description of operative procedures and findings;
d. Postoperative diagnosis; and
e. Tissue diagnosis by qualified pathologist on tissue surgically removed;
-
Patient care plan that addresses the comprehensive care needs of the patient, including the coordination of the facility's service departments that have impact on patient care;
-
Nurses' observations and progress notes of a physician, dentist, licensed practitioner, or other ordering personnel acting within the practitioner's statutory scope of practice;
-
Record of temperature, blood pressure, pulse, and respiration;
-
Final diagnosis using terminology in the current version of the International Classification of Diseases or the American Psychiatric Association's Diagnostic and Statistical Manual, if applicable;
-
Discharge summary, including:
a. Condition of patient on discharge; and
b. Date of discharge; and
- In case of death:
a. Autopsy findings, if performed; and
b. An indication that the patient has been evaluated for organ donation in accordance with hospital protocol.
(g) Records shall be indexed according to disease, operation, and attending medical staff member using a recognized indexing system.
- The disease and operative indices shall:
a. Use recognized nomenclature;
b. Include each specific disease diagnosed and each operative procedure performed; and
c. Include essential data on each patient having that particular condition.
-
The attending medical staff index shall include all patients attended or seen in consultation by each medical staff member.
-
Indexing shall be current, within six (6) months following discharge of the patient.
(12) Organ donation.
(a) The hospital shall establish and maintain a written protocol regarding organ procurement for transplant in consultation with an organ procurement agency.
(b) If a patient has died or death is imminent, the patient's attending physician shall determine, in accordance with the hospital's protocol, whether the patient is a potential organ or tissue donor.
(c) The hospital protocol shall include:
-
Criteria developed in consultation with the organ procurement agency for identifying potential donors;
-
Procedures for obtaining consent for organ donation;
-
Procedures for the hospital administrator or the administrator's designee to notify the organ procurement agency of a potential organ donor; and
-
Procedures by which the patient's attending physician or designee shall document in the patient's medical record:
a. If the patient is a potential donor, that the organ procurement agency has been notified; or
b. The contraindications to donation.
(d) A patient with impending or declared brain death or cardiopulmonary death, as determined pursuant to KRS 446.400, shall not be a potential donor if contraindications are identified and documented in the patient's medical record.
Section 4. Provision of Services.
(1) Medical staff services.
(a) Medical care provided in the hospital shall be under the direction of a medical staff member in accordance with staff privileges granted by the governing authority.
(b) An attending medical staff member shall assume responsibility for diagnosis and care of his or her patient with respect to any medical or psychiatric problem that is present on admission or develops during hospitalization, subject to this paragraph:
- If a patient is admitted by a practitioner identified in 42 C.F.R. 482.12(c)(4):
a. The patient shall be under the care of the practitioner for any condition that is specifically within the scope of practice of the practitioner as that scope is defined by the medical staff and permitted by state law; and
b. A doctor of medicine or doctor of osteopathy shall be responsible for care of the patient for any condition beyond the scope of the admitting practitioner's license.
a. Except as provided by clause b. of this subparagraph, if a patient is admitted by a licensed practitioner identified at 42 U.S.C. 1395u(b)(18)(C), a doctor of medicine or doctor of osteopathy shall be responsible for diagnosis and care of the patient.
b. If a non-Medicare patient is admitted by a certified nurse midwife, the patient shall be under the care of the certified nurse midwife for all services within that professional's scope of practice.
(c) Other qualified personnel may:
-
Complete medical histories;
-
Perform physical examinations; or
-
Record findings and compiler discharge summaries in accordance with the:
a. Practitioner's scope of practice; and
b. Hospital's protocols and bylaws.
(d) A complete history and physical examination shall be conducted according to the requirements of KRS 216B.175(2).
- The history and physical examination shall include:
a. A description of the patient's chief complaint and the major reason for hospitalization;
b. A history of the patient's:
(i) Present illness;
(ii) Past illnesses;
(iii) Surgeries;
(iv) Medications;
(v) Allergies;
(vi) Social history;
(vii) Occupational history;
(viii) Travel history; and
(ix) Immunizations;
c. A review of the patient's anatomical systems and level of function at the time of the exam;
d. The patient's vital signs; and
e. A general observation of the patient's:
(i) Alertness;
(ii) Debilities; and
(iii) Emotional behavior.
- The results of the history and physical examination shall be:
a. Recorded;
b. Reviewed for accuracy; and
c. Signed by the practitioner conducting the examination.
(e) The attending medical staff member shall:
-
State his or her final diagnosis;
-
Assure that the discharge summary is completed; and
-
Sign the records within thirty (30) calendar days following the patient's discharge.
(f) Physician services shall be available twenty-four (24) hours a day on at least an on-call basis.
(g) There shall be sufficient medical staff coverage for all clinical services of the hospital, in keeping with their size and scope of activity.
(2) Nursing service.
(a) The hospital shall have a nursing department organized to meet the nursing care needs of the patients and maintain established standards of nursing practice.
(b) A registered nurse with a bachelor of science degree in nursing shall serve as director of the nursing department.
(c) There shall be a registered nurse on duty at all times.
-
There shall be registered nurse supervision and staff nursing personnel for each service or nursing unit to insure the immediate availability of a registered nurse for all patients on a twenty-four (24) hour basis.
-
There shall be other nursing personnel in sufficient numbers to provide nursing care not requiring the service of a registered nurse.
-
There shall be additional registered nurses for surgical, obstetrical, emergency, and other services of the hospital, in keeping with their size and scope of activity.
-
Persons not employed by the hospital who render special duty nursing services in the hospital shall be under the supervision of the nursing supervisor of the department or service concerned.
(d) The hospital shall have written nursing care procedures and written nursing care plans for patients.
(e) Patient care shall be carried out in accordance with:
-
Attending medical staff member's orders;
-
Nursing process; and
-
Nursing care procedures.
(f) The nurse shall evaluate the patient using standard nursing procedure.
(g) A registered nurse shall assign staff and evaluate the nursing care of each patient in accordance with the patient's need and the nursing staff available.
(h) Nursing notes shall be:
-
Written and signed on each shift by nursing staff rendering care to patients;
-
Descriptive of the nursing care given; and
-
Include information and observations of significance that contribute to the continuity of patient care.
(i) A medication shall be administered only by a:
-
Registered nurse;
-
Physician;
-
Dentist;
-
Physician's assistant;
-
Advanced practice registered nurse;
-
Licensed practical nurse under the supervision of a registered nurse;
-
Paramedic acting within his or her statutory scope of practice and in accordance with the hospital's operating policies and procedures; or
-
Nurse extern in accordance with 201 KAR 20:400.
(j) Except in a circumstance that requires a verbal order, a medication, diagnostic test, or treatment shall not be given without a written order signed by a physician, dentist, licensed practitioner, or other ordering personnel acting within his or her statutory scope of practice.
(k) A verbal order for a medication shall be:
-
Given only to a licensed practical or registered nurse, paramedic, or pharmacist; and
-
Signed by a member of the medical staff or other ordering practitioner as soon as possible after the order was given, or if the patient was discharged prior to the order being authenticated, within thirty (30) calendar days of the patient's discharge.
(l) A verbal order for a diagnostic test or treatment order may be given to a licensed practitioner acting within his or her statutory scope of practice and the hospital's protocols.
(m) A person receiving a verbal order for medication, a diagnostic test, or treatment shall, at the time the order is received:
-
Immediately transcribe the order;
-
Repeat the order to the person issuing the order; and
-
Annotate the order on the patient's medical record, as repeated and verified.
(n) A patient restraint or protective device, other than bed rails, shall not be used except:
-
In an emergency until the attending medical staff member can be contacted; or
-
Upon a written or telephone order of the attending medical staff member.
(o) If a patient restraint is necessary, the least restrictive form of protective device shall be used that affords the patient the greatest possible degree of mobility and protection.
(p) A locking restraint shall not be used under any circumstances.
(q) Meetings of the nursing staff and other nursing personnel shall be held at least monthly to discuss patient care, nursing service problems, infection control, employee health policies, and administrative policies.
(r) Written minutes of all meetings shall be kept.
(3) Dietary services.
(a) The hospital shall have a dietary department organized, directed, and staffed to provide quality food service and optimal nutritional care.
(b) The dietary department shall be directed on a full-time basis by an individual who by education, or specialized training and experience, shall be knowledgeable in food service management.
(c) The dietary service shall have at least one (1) registered or registry-eligible dietician working full-time, part-time, or on a consultative basis to supervise the nutritional aspects of patient care.
(d) Sufficient additional personnel shall be employed to perform assigned duties to meet the dietary needs of all patients.
(e) The dietary department shall have current written policies and procedures for food storage, handling, and preparation.
(f) Written dietary policy and procedure shall be available to dietary personnel.
(g) An in-service training program that includes the proper handling of food, safety, and personal grooming shall be given at least quarterly for new dietary employees.
(h) Menus shall be planned, written, and rotated to avoid repetition.
(i) Nutritional needs shall be met in accordance with:
-
Recommended dietary allowances of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences; and
-
The medical staff member's orders.
(j) Each meal shall correspond with the posted menu.
(k) If a change is necessary, substitution shall provide equal nutritive value and the change shall be recorded on the menu.
(l) Each menu shall be kept on file for thirty (30) calendar days.
(m) Every diet, regular or therapeutic, shall be prescribed in writing, dated, and signed by the attending medical staff member or other ordering personnel acting within his or her statutory scope of practice.
(n) Information on the diet order shall be specific and complete and include:
-
The title of the diet;
-
Modifications in specific nutrients stating the amount to be allowed in the diet; and
-
Specific problems that may affect the diet or eating habits.
(o) Food shall be:
-
Prepared by methods that conserve nutritive value, flavor, and appearance;
-
Served at the proper temperatures; and
-
Prepared in a form such as cut, chopped, or ground to meet individual needs.
(p) If a patient refuses foods served, a nutritious substitution shall be offered.
(q) At least three (3) meals or their equivalent shall be served daily with not more than a fifteen (15) hour span between a substantial evening meal and a breakfast unless otherwise directed by the attending medical staff member.
(r) Meals shall be served at regular times with between-meal or bedtime snacks of nourishing quality offered.
(s) There shall be at least a three (3) day supply of food available in the facility at all times to prepare well-balanced palatable meals for all patients.
(t) There shall be an identification system for patient trays and methods used to assure that each patient receives the appropriate diet as ordered.
(u) The hospital shall comply with all applicable provisions of 902 KAR 45:005, the Kentucky food code.
(4) Laboratory services.
(a) The hospital shall have a well-organized, adequately supervised laboratory with the necessary space, facilities, and equipment to perform services commensurate with the hospital's needs for its patients.
(b) Anatomical pathology services and blood bank services shall be available in the hospital or by arrangement with other facilities.
- Clinical laboratory. Basic clinical laboratory services necessary for routine examinations shall be available regardless of the size, scope, and nature of the hospital.
a. Equipment necessary to perform the basic tests shall be provided by the hospital.
b. Equipment shall be in good working order, routinely checked, and precise in terms of calibration.
c. Provision shall be made to carry out adequate clinical laboratory examinations including chemistry, microbiology, hematology, immunology, and immunohematology.
d. Services may be provided through arrangement with another licensed hospital that has the appropriate laboratory facilities, or with an independent laboratory licensed pursuant to 42 C.F.R. Part 493, KRS 333.030, and relevant administrative regulations.
e. The original report from a test performed by an outside laboratory shall be contained in the patient's medical record.
f. Laboratory facilities and services shall be available at all times.
g. Emergency laboratory services shall be available twenty-four (24) hours a day, seven (7) days a week, including holidays, in the hospital or through arrangement as specified in clause d. of this subparagraph.
h. The conditions, procedures, and availability of a service performed by an outside laboratory shall be in writing and available in the hospital.
i. There shall be a clinical laboratory director and a sufficient number of supervisors, technologists, and technicians to perform promptly and proficiently the tests requested of the laboratory.
j. The laboratory shall not perform a procedure or test outside the scope of training of the laboratory personnel.
k. Laboratory services shall be under the direction of a:
(i) Pathologist;
(ii) Doctor of medicine or osteopathy with training and experience in clinical laboratory services; or
(iii) Laboratory specialist with a doctoral degree in physical, chemical, or biological sciences, and training and experience in clinical laboratory services.
l. A report of each laboratory service provided shall be filed with the patient's medical record.
(i) A duplicate copy shall be kept in the department.
(ii) Each request for a laboratory test shall be ordered and signed by qualified personnel in accordance with his or her scope of practice and the hospital's protocols and bylaws.
- Anatomical pathology. Anatomical pathology services shall be provided as indicated by the needs of the hospital, either in the hospital or under arrangement as specified in subparagraph 1.d. of this paragraph.
a. Anatomical pathology services shall be under the direct supervision of a pathologist full-time, part-time, or on a consultative basis.
b. If the supervision is provided on a consultative basis, the hospital shall provide for at least monthly consultative visits by a pathologist.
c. The pathologist shall participate in staff, departmental, and clinicopathologic conference.
d. The pathologist shall be responsible for establishing the qualifications of staff and in-service training.
e. Except for exclusions listed in written policies of the medical staff, tissues removed at surgery shall be examined macroscopically, and if necessary, microscopically by the pathologist.
f. A list of tissues that do not routinely require microscopic examination shall be developed in writing by the pathologist or designated physician with the approval of the medical staff.
g. A tissue file shall be maintained in the hospital.
h. In the absence of a pathologist, there shall be an established plan for sending tissue to a pathologist outside the hospital if examination is required.
i. A signed report of a tissue examination shall be filed promptly with the patient's medical record.
j. A duplicate copy shall be kept in the department.
k. Each report of a macroscopic or microscopic examination performed shall be signed by the pathologist.
l. Examination results shall be filed promptly in the patient's medical record.
m. The medical staff member requesting the examination shall be notified promptly.
n. A duplicate copy of each examination report shall be filed in the laboratory in a manner that permits ready identification and accessibility.
-
The laboratory shall meet the proficiency testing and quality control provisions in accordance with the certification requirements of 42 C.F.R. Part 493.
-
Blood bank. Facilities for procurement, safekeeping, and transfusion of blood and blood products shall be provided or shall be readily available.
a. The hospital shall maintain proper blood storage facilities under adequate control and supervision of the pathologist or other authorized physician.
b. For emergency situations, the hospital shall:
(i) Maintain at least a minimum blood supply in the hospital at all times; and
(ii) Be able to obtain blood quickly from community blood banks or institutions.
c. If the hospital provides donor services, the hospital shall have an up-to-date list of donors and equipment necessary to obtain blood.
d. If the hospital utilizes outside blood banks, there shall be a written agreement governing the procurement, transfer, and availability of blood products between the hospital and donor center.
e. There shall be a provision for:
(i) Prompt blood typing and cross-matching; and
(ii) Laboratory investigation of transfusion reactions, either through the hospital or by arrangement with others on a continuous basis, under the supervision of a physician.
f. Blood storage facilities in the hospital shall have an adequate alarm system, which shall be:
(i) Regularly inspected and tested; and
(ii) Safe and adequate. Inspections of the alarm system shall be documented.
g. Records shall be kept on file indicating the receipt and disposition of blood provided to patients in the hospital.
h. A committee of the medical staff, or its equivalent, shall:
(i) Review transfusions of blood or blood derivatives; and
(ii) Make recommendations concerning policies governing transfusion practices.
i. Samples of each unit of blood used at the hospital shall be retained for further testing if there was an adverse reaction.
j. Blood not retained that has exceeded its expiration date shall be disposed of promptly.
k. The review committee shall:
(i) Investigate each transfusion reaction occurring in the hospital; and
(ii) Make recommendations to the medical staff regarding improvement in transfusion procedure.
(5) Pharmaceutical services.
(a) The hospital shall have adequate provisions for the handling, storing, recording, and distribution of pharmaceuticals in accordance with state and federal law.
(b) A hospital that maintains a pharmacy for compounding and dispensing of drugs shall provide pharmaceutical services under the supervision of a registered pharmacist on a full-time or part-time basis, according to the size and demands of the hospital.
(c) The pharmacist shall be responsible for supervising and coordinating the activities of the pharmacy department.
(d) Additional personnel competent in their respective duties shall be provided in keeping with the size and activity of the department.
(e) A hospital that does not maintain a pharmacy shall have a drug room utilized only for the storage and distribution of drugs, drug supplies, and equipment.
-
Prescription medications shall be dispensed by a registered pharmacist elsewhere.
-
The drug room shall be operated under the supervision of a pharmacist employed at least on a consultative basis.
(f) The consulting pharmacist shall assist in drawing up correct procedures and directions for the distribution of drugs.
(g) The consulting pharmacist shall visit the hospital on a regularly scheduled basis in the course of his or her duties.
(h) The drug room shall be kept locked and the key shall be in the possession of a responsible person on the premises designated by the administrator.
(i) Records shall be kept of the transactions of the pharmacy or drug room and correlated with other hospital records if indicated.
(j) The pharmacy shall establish and maintain a system of records and bookkeeping in accordance with accounting procedures and policies of the hospital for:
-
Maintaining adequate control over the requisitioning and dispensing of drugs and drug supplies; and
-
Charging patients for drugs and pharmaceutical supplies.
(k) A record of the stock on hand and of the dispensing of every controlled substance shall be maintained to ensure that the disposition of any particular item may be readily traced.
(l) The medical staff in cooperation with the pharmacist and other disciplines, as necessary, shall develop policies and procedures that govern the safe administration of drugs, including:
-
The administration of medications only upon the order of an individual who has been assigned clinical privileges or who is an authorized member of the house staff;
-
Review of the original order or a direct copy by the pharmacist dispensing the drugs;
-
The establishment and enforcement of automatic stop orders;
-
Proper accounting for, and disposition of, unused medications or special prescriptions returned to the pharmacy if:
a. The patient is discharged; or
b. The medication or prescription does not meet requirements for sterility or labeling;
-
Emergency pharmaceutical services; and
-
Reporting adverse medication reactions to the:
a. Appropriate committee of the medical staff; and
b. Food and Drug Administration MedWatch Program.
(m) Therapeutic ingredients of medications dispensed shall be favorably evaluated in the:
-
United States Pharmacopoeia;
-
National Formulary; or
-
United States Homeopath-Pharmacopoeia; Other necessary medication shall be approved for use by the appropriate committee of the medical staff.
(n) A pharmacist shall be responsible for determining specifications and choosing acceptable sources for drugs with approval of the appropriate committee of the medical staff.
(o) There shall be available a formulary or list of drugs accepted for use in the hospital, developed and amended as necessary by the appropriate committee of the medical staff.
(6) Radiology services.
(a) The hospital shall have:
-
Diagnostic radiology facilities currently licensed or registered pursuant to KRS 211.842 to 211.852;
-
At least one (1) fixed diagnostic x-ray unit capable of general x-ray procedures;
-
A radiologist on at least a consulting basis to:
a. Function as medical director of the department; and
b. Interpret films requiring specialized knowledge for accurate reading; and
- Personnel adequate to supervise and conduct services, including one (1) certified radiation operator who shall be on duty or on call at all times.
(b) There shall be written policies and procedures governing radiologic services and administrative routines that support sound radiologic practices.
(c) Signed reports shall be filed in the patient's record and duplicate copies kept in the department.
(d) Radiologic services shall be performed only upon the written order of qualified personnel in accordance with the:
-
Professional's scope of practice; and
-
Hospital's protocols and bylaws.
(e) The written order shall contain a concise statement of the reason for the service or examination.
(f) Reports of interpretations shall be written or dictated and signed by the radiologist.
(g) Only an individual licensed pursuant to 201 KAR Chapter 46 and KRS Chapter 311B, under the direction of medical staff members, if necessary, shall use any x-ray apparatus or material. Uses include application, administration, and removal of:
-
Radioactive elements;
-
Disintegration products; and
-
Radioactive isotopes.
(h) An individual licensed pursuant to 201 KAR Chapter 46 and KRS Chapter 311B, under the direction of a physician, may administer medications allowed within:
-
The professional's scope of practice; and
-
Context of radiological services and procedures being performed.
(i) The radiology department shall be free of hazards for patients and personnel.
(j) Proper safety precautions shall be maintained against:
-
Fire and explosion hazards;
-
Electrical hazards; and
-
Radiation hazards.
(7) Physical restoration or rehabilitation service.
(a) If the hospital provides rehabilitation, work hardening, physical therapy, occupational therapy, audiology, or speech-language pathology services, the services shall be organized and staffed to insure the health and safety of patients.
(b) A hospital that provides physical restoration or rehabilitation services shall provide individualized techniques intended to:
-
Achieve maximum physical function normal to the patient; and
-
Prevent unnecessary debilitation and immobilization.
(c) The hospital shall develop written policies and procedures for each rehabilitation service provided.
(d) The hospital shall designate a member of the medical staff to coordinate restorative services provided to patients in accordance with their needs.
(e) Therapeutic equipment shall be:
-
Adequate to meet the needs of the service; and
-
In good condition.
(f) Therapy services shall be provided only upon written orders of qualified personnel in accordance with the practitioner's scope of practice and according to the hospital's protocols and bylaws.
(g) Therapy services shall be provided by or under the supervision of a licensed therapist, on a full-time, part-time, or consultative basis.
(h) The hospital shall maintain a complete therapy record for each patient provided physical therapy services.
(i) The report shall be:
-
Signed by the therapist who prepared the report; and
-
Maintained in the patient's medical record.
(8) Emergency services.
(a) A hospital shall develop written procedures for emergency patient care, including a requirement for:
-
Each patient requesting emergency care to be evaluated by a registered nurse;
-
At least one (1) registered nurse on duty to perform patient evaluation; and
-
A physician to be on call.
(b) A patient who presents at the hospital for emergency services shall be triaged by a registered nurse or paramedic acting:
-
Within his or her scope of practice; and
-
In accordance with the hospital's formal operating policies and procedures.
(c) The medical staff of a hospital within an organized emergency department shall establish and maintain a manual of policy and procedures for emergency and nursing care provided in the emergency room.
(d) The emergency service shall be under the direction of a licensed physician.
(e) Medical staff members shall be available at all times for the emergency service, either on duty or on call.
(f) Current schedules and telephone numbers shall be posted in the emergency room.
(g) Nursing personnel shall be assigned to or designated to cover the emergency service at all times.
(h) Facilities shall be provided to assure prompt diagnosis and emergency treatment.
(i) A specific area of the hospital shall be utilized for patients requiring emergency care on arrival.
(j) The emergency area shall be:
-
Located in close proximity to an exterior entrance of the facility; and
-
Independent of the operating room suite.
(k) Diagnostic and treatment equipment, drugs, and supplies shall be:
-
Readily available for the provision of emergency services; and
-
Adequate in terms of the scope of services provided.
(l) Adequate medical records shall be:
-
Kept on every patient seen in the emergency room, under the supervision of the Medical Record Service; and
-
If appropriate, integrated with inpatient and outpatient records.
(m) Emergency room records shall include at least:
- A log listing the patient visits to the emergency room in chronological order, including:
a. Patient identification;
b. Means of arrival;
c. Person transporting patient; and
d. Time of arrival;
-
History of present complaint and physical findings;
-
Laboratory and x-ray reports, if applicable;
-
Diagnosis;
-
Treatment ordered and details of treatment provided;
-
Patient disposition;
-
Record of referrals;
-
Instructions to the patient or family for those not admitted to the hospital; and
-
Signatures of attending medical staff member, and nurse if applicable.
(9) Outpatient services.
(a) A hospital with an organized outpatient department shall have written policies and procedures relating to the staff, functions of service, and outpatient medical records.
(b) The outpatient department shall be organized in sections or clinics, the number of which shall depend on the:
-
Size and degree of departmentalization of the medical staff;
-
Available facilities; and
-
Needs of the patients the outpatient department serves.
(c) The outpatient department shall have appropriate cooperative arrangements and communications with community agencies, which may include:
-
Home health agencies;
-
The local health department;
-
Social and welfare agencies; and
-
Other outpatient departments.
(d) Each service offered by the outpatient department shall be under the direction of a:
-
Physician who shall be a member of the medical staff; or
-
Licensed healthcare practitioner qualified by education, experience, and specialized training related to the specific type of service under the practitioner's direction if the hospital has a separate director for each outpatient service.
(e) A registered nurse shall be responsible for the nursing services of the outpatient department.
(f) The number and type of other personnel employed shall be determined by the:
-
Volume and type of services provided; and
-
Type of patient served in the outpatient department.
(g) Necessary laboratory and other diagnostic tests shall be available through:
-
The hospital;
-
A laboratory in another licensed hospital; or
-
A laboratory licensed pursuant to KRS 333.030.
(h) Medical records shall be maintained and if appropriate, coordinated with other hospital medical records.
(i) The outpatient medical record shall be filed in a location that insures ready accessibility to the:
-
Medical staff members;
-
Nurses; and
-
Other personnel of the outpatient department.
(j) Information in the medical record shall be complete and sufficiently detailed relative to the patient's:
-
History;
-
Physical examination;
-
Laboratory and other diagnostic tests;
-
Diagnosis; and
-
Treatment.
(10) Surgery services.
(a) A hospital in which surgery is performed shall have an operating room and a recovery room supervised by a registered nurse qualified by training, experience, and ability to direct surgical nursing care.
(b) Sufficient surgical equipment, including suction facilities and instruments in good repair, shall be provided to assure safe and aseptic treatment of surgical cases.
(c) If flammable anesthetics are used, precautions shall be taken to eliminate hazards of explosions, including:
-
Use of shoes with conductive soles; and
-
Prohibition of garments or other items of silk, wool, or synthetic fibers that accumulate static electricity.
(d) There shall be effective policies and procedures regarding:
-
Surgical staff privileges;
-
Functions of the service;
-
Evaluation of the surgical patient; and
-
Surgical smoke safety and control. The smoke evacuation policy shall be available to staff in all areas where surgical smoke is generated.
(e)
- In accordance with KRS 216B.153, a hospital that utilizes an energy-generating device shall make use of a smoke evacuation system:
a. That effectively captures and neutralizes surgical smoke at the site of origin and before the smoke can make ocular contact or contact with the respiratory tract of the occupants of the room; and
b. During any surgical procedure that is likely to produce surgical smoke.
- The cabinet shall impose fines in accordance with KRS 216B.990(8) for each violation of noncompliance with KRS 216B.153 only if the violation has not been remedied after the hospital has had an opportunity to correct the violation through the filing of a plan of correction in accordance with 902 KAR 20:008, Section 2(13).
(f) Surgical privileges shall be delineated for each member of the medical staff performing surgery in accordance with the competencies of each staff member.
(g) A roster of medical staff specifying the surgical privileges of each shall be maintained.
(h) Except in emergency, a surgical operation or other hazardous procedure shall be performed only on written consent of the patient or the patient's legal representative.
(i) The operating room register shall:
-
Be complete and up to date; and
-
Include the following:
a. Patient's name;
b. Hospital room number;
c. Preoperative and postoperative diagnosis;
d. Complications, if any;
e. Names of:
(i) Surgeon;
(ii) First assistant;
(iii) Anesthesiologist or an advanced practice registered nurse who is a certified registered nurse anesthetist; and
(iv) Scrub and circulating nurse;
f. Operation performed; and
g. Type of anesthesia.
(j) There shall be a complete history and physical workup in the chart of each patient prior to surgery.
(k) If the history and workup has been transcribed, but not yet recorded in the patient's chart, there shall be a statement to that effect and an admission note by the attending medical staff member in the chart.
(l) The chart shall:
-
Accompany the patient to the operating suite; and
-
Be returned to the patient's floor or room after the operation.
(m) An operative report describing the techniques and findings shall be:
-
Written or dictated immediately following surgery; and
-
Signed by the surgeon.
(n) Tissues removed by surgery shall be:
-
Placed in suitable solutions;
-
Properly labeled; and
-
Submitted to the pathologist for macroscopic and, if necessary, microscopic examination.
(o) An infection of a clean surgical case shall be recorded and reported to the Infection Control Program. The program shall investigate according to established procedures for investigation and review of surgical site infections.
(p) Rules and policies related to the operating rooms shall be available and posted.
(11) Anesthesia services.
(a) A hospital that provides surgical or obstetrical services shall have anesthesia services available.
(b) Anesthesia services shall be organized under written policies and procedures regarding:
-
Staff privileges;
-
The administration of anesthetics; and
-
The maintenance of safety controls.
(c) A physician member of the medical staff shall be the medical director of anesthesia services.
(d) If possible, the director shall be a physician specializing in anesthesiology.
(e) If anesthetics are not administered by an anesthesiologist, the medical staff shall designate an advanced practice registered nurse who is a certified registered nurse anesthetist qualified to administer anesthetics.
(f) A qualified medical staff member or licensed practitioner functioning within their scope of practice shall perform a preanesthetic physical examination for every patient requiring anesthesia services.
(g) The following shall be recorded within forty-eight (48) hours of surgery:
-
Findings of the preanesthetic physical examination;
-
An anesthetic record on a special form; and
-
A postanesthetic follow-up, with findings recorded by the:
a. Anesthesiologist; or
b. Advanced practice registered nurse who is a certified registered nurse anesthetist.
(h) The postanesthetic follow-up note shall:
- Be written:
a. Upon discharge from the postanesthesia recovery area; or
b. Within three (3) to twenty-four (24) hours after the procedure requiring anesthesia; and
- Include:
a. Blood pressure and pulse measurements;
b. Presence or absence of the swallowing reflex and cyanosis;
c. Postoperative abnormalities or complications; and
d. The patient's general condition.
(12) Obstetrics service.
(a) A hospital providing obstetrical care shall have:
-
Adequate space;
-
Necessary equipment and supplies; and
-
A sufficient number of nursing personnel to:
a. Assure safe and aseptic treatment of mothers and newborns; and
b. Provide protection from infection and cross-infection.
(b) The obstetrics service shall be under the:
-
Medical direction of a physician; and
-
Supervision of a registered nurse qualified by training, experience, and ability to direct effective obstetrical and newborn nursing care.
(c) If a hospital has an obstetrical caseload that does not justify a separate nursing staff, the hospital's obstetrical nurses shall be designated and oriented to the specific needs of obstetrical patients.
(d) A registered nurse shall be on duty in the labor and delivery unit if a patient is in the unit.
(e) Each obstetrics patient shall be kept under close observation by professional personnel during the period of recovery after delivery, whether in the delivery room or in a recovery area, until the patient is transferred to the maternity unit.
(f) An on-call schedule or other suitable arrangement shall be provided to ensure that a physician who is experienced in obstetrics is readily available for consultation and for an obstetrical emergency.
(g) Patients in labor shall be cared for in adequately equipped labor rooms.
(h) An adequate supply of prophylaxis for the prevention of infant blindness shall be kept on hand and administered within thirty (30) minutes after delivery.
(i) The hospital shall comply with the provisions of KRS 214.155 and 902 KAR 4:030 in administering tests for inborn errors of metabolism and other inherited and congenital disorders.
(j) The hospital shall have a method and procedure for the positive associative identification of the mother and infant.
(k) The identifiers shall be placed on mother and newborn in the delivery room at the time of birth and shall remain in place during the entire period of hospitalization.
(l) An up-to-date register book of deliveries shall be maintained containing the following information:
-
Infant's full name, sex, date, time of birth, and weight;
-
Mother's full name, including maiden name, address, birthplace, and age at time of this birth;
-
Father's full name, birthplace, and age at time of this birth; and
-
Full name of attending physician or nurse midwife.
(m) Each hospital providing maternity service shall provide a nursery not used for any other purpose.
(n) Specific routines for daily care of infants and their environment shall be prepared in writing and posted in the nursery workroom.
(o) A policy shall be established for:
-
A delivery occurring outside the delivery room; and
-
A patient with an infectious disease.
(p) Written policies and procedures shall be developed to cover alternative use of obstetrical beds.
(q) The hospital shall comply with the provisions of KRS 214.175 by participating in surveys conducted by the cabinet for the purpose of determining the prevalence of alcohol or other substance abuse among pregnant women and newborn infants.
(r) The hospital shall comply with the provisions of KRS 216.2970 by providing an auditory screening for all newborn infants.
(13) Pediatric services.
(a) A hospital providing pediatric care shall have proper facilities for the care of children apart from the newborn and maternity nursing services.
(b) If there is not a separate area permanently designated as the pediatric unit, there shall be an area within an adult care unit for pediatric patient care.
(c) There shall be available beds and other equipment that are appropriate in size for pediatric patients.
(d) There shall be proper facilities and procedures for the isolation of children with infectious, contagious, or communicable conditions.
(e) At least one (1) patient room shall be available for isolation use.
(f) A physician with pediatric experience shall be on call at all times for the care of pediatric patients.
(g) Pediatric nursing care shall be under the supervision of a registered nurse qualified by training, experience, and ability to direct effective pediatric nursing.
(h) Nursing personnel assigned to pediatric service shall be oriented to the special care of children.
(i) Policies shall be established to cover conditions under which parents may stay with small children or "room-in" with their hospitalized child for moral support and assistance with care.
(14) Psychiatric services. A hospital with a psychiatric unit shall:
(a) Designate the location and number of beds to be licensed as psychiatric beds; and
(b) Meet the requirements of 902 KAR 20:180.
(15) Chemical dependency treatment services. A hospital providing chemical dependency treatment services shall:
(a) Meet the requirements of 902 KAR 20:160, Sections 3 and 4; and
(b) Designate the location and number of beds to be used for chemical dependency treatment services.
(16) Medical library.
(a) The hospital shall maintain appropriate medical library services according to the professional and technical needs of hospital personnel.
(b) The medical library shall be in a location accessible to the professional staff.
(c) If printed resources are used, the library collection shall be organized.
(d) The library collection may be composed of digital references, which shall be on line or accessible on a computer.
Section 5. Long-term Acute Inpatient Hospital Services.
(1) A hospital licensed pursuant to this administrative regulation and seeking to qualify for available Title XVIII Medicare reimbursement may provide long-term acute inpatient hospital services pursuant to applicable federal law and in accordance with this section.
(2) The area of the hospital designated to provide long-term acute inpatient hospital services shall provide services in compliance with:
(a) This administrative regulation; and
(b) 42 C.F.R. 412.22.
(3) A hospital wishing to provide long-term acute inpatient hospital services shall request authorization from the Office of Inspector General, Cabinet for Health and Family Services.
(4) The Office of Inspector General shall conduct a survey to determine if the requirements of this section are met and notify the hospital of the survey results by letter.
Section 6. Optional Designations. A hospital shall be designated as a:
(1) Primary stroke center if the hospital meets the criteria established in KRS 216B.0425(2); or
(2) SANE-ready hospital if the hospital meets the criteria established in KRS 216B.401(1).
Section 7. Off-campus, Kentucky Hospital-Owned Freestanding Emergency Department (FSED).
(1) A hospital licensed pursuant to this administrative regulation may provide off-campus emergency services in a hospital-owned FSED. For purposes of this section, "off-campus" shall mean a location:
(a) Off the campus of the parent hospital that owns the FSED; and
(b) At least thirty-five (35) miles from an existing hospital that is:
-
Licensed pursuant to this administrative regulation; and
-
Designated as a sole community hospital pursuant to 42 C.F.R. 412.92.
(2) If a Kentucky-licensed hospital owns and operates an ambulatory care clinic licensed under 902 KAR 20:073 prior to July 15, 2018, or holds a certificate of need for an ambulatory care clinic that is not licensed by that date, the hospital shall notify the cabinet no later than ninety (90) days from the effective date of this administrative regulation of the clinic's scope of operations. The hospital's notification shall inform the cabinet whether the clinic will:
(a) Operate as an FSED, in which case the facility shall:
-
Provide emergency services in accordance with Section 4(8) of this administrative regulation;
-
Be designated as provider-based pursuant to 42 C.F.R. 413.65;
-
Not be required to obtain a new certificate of need; and
-
Obtain a separate license under 902 KAR Chapter 20 for any existing service provided under the ambulatory care clinic license and covered under Section IV of the State Health Plan without being subject to a separate certificate of need; or
(b) Provide services that are limited to treatment for minor injury or illness, in which case the clinic shall not hold itself out to the public as an emergency treatment center or use similar terminology that expresses or implies that emergency medical service is offered at the clinic. This paragraph shall not prohibit the clinic from holding itself out to the public as an urgent treatment center.
(3) A Kentucky-licensed hospital that seeks to establish an FSED under circumstances not covered under subsection (2)(a) of this section shall obtain a certificate of need.
(4) An FSED shall:
(a) Be owned by an accredited Kentucky hospital licensed under this administrative regulation;
(b) Be included under the same license and accreditation as the parent hospital;
(c) Meet the requirements of and be certified by the Centers for Medicare and Medicaid Services as a provider-based entity under 42 C.F.R. 413.65;
(d) Pay a fee in the amount of $1,000 for the FSED location at the time of annual renewal of the hospital's license;
(e) Operate twenty-four (24) hours per day, seven (7) days per week;
(f) Comply with the provisions of Section 4(8) of this administrative regulation governing emergency services;
(g) Be under the direction of a licensed physician who is a member of the parent hospital's organized medical staff;
(h) Ensure that nursing personnel are assigned to or designated to cover the emergency service at all times;
(i) Comply with the Emergency Medical Treatment and Labor Act (42 U.S.C. 1395dd) and 42 C.F.R. 489.24;
(j) Have facilities sufficient to assure prompt diagnosis, treatment, and stabilization of injuries and trauma;
(k) Have a written patient transportation agreement with a local emergency medical services (EMS) provider; and
(l) Maintain compliance with applicable federal, state, and local laws.
(5) An FSED shall cease to operate under this administrative regulation if the:
(a) Cabinet finds that there has been substantial failure by the facility to comply with the provisions of KRS Chapter 216B or this administrative regulation; and
(b) Facility fails to submit and implement an acceptable plan of correction or amended plan of correction in accordance with 902 KAR 20:008, Section 2(13).
(6) If an FSED receives notice to cease operations in accordance with subsection (5) of this section, the parent hospital may file a request in writing for a hearing pursuant to KRS 216B.105.
History
- RELATES TO: KRS 198B.260, Chapter 209, 211.842-211.852, Chapter 214, 216.2970, 216B.010, 216B.015, 216B.040, 216B.042, 216B.0425(2), 216B.045, 216B.050, 216B.055, 216B.075, 216B.085, 216B.105-216B.125, 216B.140-216B.175, 216B.185, 216B.190, 216B.230-216B.239, 216B.250, 216B.400-216B.402, 216B.990, Chapter 310, 311.560, 311.992, Chapter 311B, 314.011(8), 314.042(8), 333.030, 446.400, Chapter 620, 29 C.F.R. 1910.1030(d)(2)(vii), 40 C.F.R. Part 403, 42 C.F.R. Part 405, 412.22, 412.92, 413.65, 482.12(c), 489.24, Part 493, 45 C.F.R. Part 160, Part 164, 42 U.S.C. 1320d-2—1320d-8, 1395u(b)(18)(C), 1395x(r)(2)-(5), 1395dd
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes the minimum licensure requirements for the operation of hospitals and the basic services provided by hospitals.
- History: 8 Ky.R. 596; eff. 2-1-1982; 9 Ky.R. 1327; eff. 7-6-1983; 11 Ky.R. 467; eff. 10-9-1984; 1173; 1311; eff. 6-4-1985; 13 Ky.R. 331; 645; eff. 10-2-1986; 1282; eff. 2-10-1987; 15 Ky.R. 1157; 1583; eff. 1-18-1989; 18 Ky.R. 2027; 2565; eff. 3-7-1992; 19 Ky.R. 2506; 20 Ky.R. 121; eff. 8-6-1993; 21 Ky.R. 599; 1335; eff. 10-19-1994; 23 Ky.R. 2296; 3040; eff. 4-16-1997; 24 Ky.R. 969; 1268; eff. 11-19-1997; 25 Ky.R. 1714; 2380; eff. 4-21-1999; 27 Ky.R. 1920; 2820; eff. 4-9-2001; 29 Ky.R. 188; 716; eff. 8-21-2002; TAm eff. 3-11-2011; 44 Ky.R. 1415, 2054; 45 Ky.R. 355; eff. 8-31-2018; 48 Ky.R. 2285, 2993; eff. 8-25-2022.
902 KAR 20:018 Operation and services; End Stage Renal Disease (ESRD) facilities {#sec-902-kar-20-018 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:018}
Section 1. Definitions.
(1) "Administrator" means an individual who:
(a) Holds a baccalaureate degree or its equivalent;
(b) Has at least one (1) year of experience working in an ESRD unit; and
(c) Is responsible for the management of the ESRD facility.
(2) "Charge nurse" means a nurse responsible for each shift who:
(a) Is licensed to practice as a:
-
Registered nurse under KRS 314.041; or
-
Licensed practical nurse under KRS 314.051 and works under the supervision of a registered nurse; and
(b) Has at least twelve (12) months experience in providing nursing care, including three (3) months of experience in providing nursing care to patients on maintenance dialysis.
(3) "Dialysis technician" means a person credentialed by the Board of Nursing as a dialysis technician.
(4) "End Stage Renal Disease" or "ESRD" means a medical condition in which a person's kidneys cease functioning on a permanent basis leading to the need for long-term dialysis or a kidney transplant to maintain life.
(5) "ESRD facility" means a facility or entity that provides outpatient maintenance dialysis services, home dialysis training and support, or both.
(6) "Medical director" means a Kentucky-licensed physician who:
(a) Is board-certified in internal medicine or pediatrics;
(b) Has completed a board-approved training program in nephrology; and
(c)
-
Has at least twelve (12) months of experience providing care to patients receiving dialysis; or
-
If the physician does not meet the requirements of paragraphs (a) through (c) of this subsection, has received approval in accordance with 42 C.F.R. 494.140(a)(2) to direct an ESRD facility.
(7) "Qualified dietician" means an individual who:
(a) Is licensed pursuant to KRS 310.021; and
(b) Has a minimum of one (1) year professional work experience in clinical nutrition as a registered dietitian.
(8) "Qualified medical record technician" means an individual who:
(a) Has graduated from a program for medical record technicians that is accredited by the Council on Medical Education of the American Medical Association and the American Medical Record Association; and
(b) Is certified as an accredited record technician by the American Medical Record Association.
(9) "Qualified registered nurse manager" means a nurse manager responsible for nursing services who:
(a) Is licensed to practice as a registered nurse under KRS 314.041;
(b) Is a full-time employee of the ESRD facility; and
(c) Has at least:
-
Twelve (12) months of experience in clinical nursing; and
-
Six (6) months of experience in providing nursing care to patients on maintenance dialysis.
(10) "Qualified social worker" means a clinical social worker licensed and practicing in accordance with KRS 335.100.
(11) "Renal transplantation center" means a hospital unit approved to provide kidney transplants and other medical and surgical specialty services required for the care of the ESRD transplant patients, including inpatient dialysis provided directly or under arrangement.
(12) "Self-care dialysis training" means a program to train an ESRD patient or the patient's helper, or both, to perform dialysis.
Section 2. Requirement for Service. An ESRD facility shall not be licensed or relicensed as an ESRD facility unless the facility meets the requirements of this administrative regulation.
Section 3. Administration and Operation.
(1) Licensee.
(a) The licensee shall be legally responsible for the operation of the ESRD facility and for compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the facility.
(b) The licensee shall develop and enforce written policies for the administration and operation of the ESRD facility. Policies shall include:
-
Personnel practices and procedures;
-
Job descriptions for each level of personnel, including authority and responsibilities for each classification;
-
Qualifications for medical staff membership;
-
Medical care practices and procedures;
-
Prevention and control of hepatitis, peritonitis, and other infections, including appropriate procedures for:
a. Surveillance and reporting of infections;
b. Housekeeping;
c. Handling and disposal of waste and contaminants;
d. Sterilization and disinfection; and
e. Sterilization and maintenance of equipment; and
- Procedures to be followed in an emergency, including fire, natural disaster, and equipment failure.
(2) Administrator. An ESRD facility shall have an administrator responsible for the management of the facility, including enforcement of written policies and protection of patients' rights.
(3) An ESRD facility shall:
(a) Demonstrate compliance with the requirements of 42 C.F.R. 494.1 through 494.180, except for an ESRD facility that is state-licensed only; and
(b) Maintain regularly scheduled hours during which dialysis services shall be available.
(4) Emergency coverage.
(a) An ESRD facility's governing body shall ensure that the facility shall provide each patient and facility staff member with written instructions for obtaining emergency medical care.
(b) An ESRD facility shall have available at the nursing station, a roster with:
-
The names of physicians who may be called for emergencies;
-
When the physicians may be called; and
-
How the physicians may be reached.
(c) An ESRD facility shall have an agreement with a hospital that can provide the following services twenty-four (24) hours per day, seven (7) days per week:
-
Inpatient care;
-
Routine and emergency dialysis;
-
Other hospital services; and
-
Emergency medical care.
(d) The agreement shall:
-
Ensure that hospital services shall be available to the ESRD facility's patients as needed; and
-
Include reasonable assurances that each patient from the ESRD facility shall be accepted and treated in an emergency.
(5) Personnel. An adequate number of personnel shall be present to meet the needs of patients at all times, including emergency situations.
(a) Medical staff. An ESRD facility shall have an organized medical staff responsible for the:
-
Quality of all medical care provided to patients in the facility; and
-
Ethical and professional practices of the facility's staff.
(b)
-
There shall be a medical director responsible for supervising the staff of the ESRD facility.
-
The medical director shall be a full- or part-time staff member.
-
In the medical director's absence, a physician meeting the qualifications of a medical director or a physician who has received approval in accordance with 42 C.F.R. 494.140(a)(2) to direct an ESRD facility shall be in the unit or immediately available while a patient is being dialyzed.
(c)
- The ESRD facility shall employ:
a. At least one (1) full-time qualified registered nurse manager responsible for nursing services; and
b. A charge nurse responsible for each shift.
- If a patient is undergoing dialysis, a qualified registered nurse manager or charge nurse shall be on duty to supervise patient care.
(d) The ESRD facility shall employ the following ancillary personnel directly or by contract:
-
A qualified dietician;
-
A qualified medical records technician; and
-
A qualified social worker.
(6) Incident and accident reports.
(a) An ESRD facility shall submit an incident report to the cabinet no later than three (3) days after a reportable event as established by paragraph (c) of this subsection.
(b) An ESRD facility shall retain a copy of the incident report for inspection by the cabinet.
(c) A reportable event shall include:
-
An incident requiring emergency treatment or hospitalization;
-
A cleaning agent left in a machine that is subsequently used on a patient;
-
Contamination of the water supply;
-
Development of infection or communicable disease; or
-
An accident or other event having a direct or immediate bearing on the health, safety, or security of a patient or staff member.
Section 4. Services.
(1)
(a) Except as established in paragraph (b) of this subsection, each patient shall be admitted under the medical authority and supervision of the medical director.
(b) In the absence of the medical director, a physician meeting the qualifications of a medical director or a physician who has received approval in accordance with 42 C.F.R. 494.140(a)(2) to direct an ESRD facility shall be responsible for patient admissions and supervision.
(2) Laboratory services.
(a) An ESRD facility shall have access to laboratory facilities and services (except tissue pathology and histocompatibility) to meet the needs of each ESRD patient.
(b) The laboratory that provides services shall be:
-
Located in a licensed hospital; or
-
Licensed in accordance with KRS Chapter 333.
(3) Medical records.
(a) An ESRD facility shall maintain complete, accurate, and accessible records for each patient, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility.
(b) Organization. The supervisor of medical records shall be responsible for the proper documentation, completion, and preservation of the records.
(c) Indexing. Medical records shall be properly indexed and systematically filed.
(d) Ownership.
-
Medical records shall be the property of the ESRD facility.
-
The original medical record shall not be removed from the facility, except by court order or subpoena.
-
Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established by paragraph (e) of this subsection.
(e) Confidentiality and security; use and disclosure.
-
The ESRD facility shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
-
The facility may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
(f) Content. A complete medical record shall be prepared for each patient admitted to the ESRD facility and include the:
-
Name and address of the person or agency responsible for the patient, if applicable;
-
Patient identification information, including the patient's:
a. Name;
b. Address;
c. Date of birth;
d. Gender; and
e. Marital status;
-
Date of admission;
-
Date of transfer to renal transplantation center, if applicable;
-
Referring and attending physicians' names;
-
History and physical examination record prior to the initial treatment;
-
Treatment plans;
-
Records of special examinations, consultations, and clinical, laboratory, and x-ray services;
-
Doctors' orders, dated and signed;
-
Nurses' notes;
-
Dialysis chart including pulse, respiration, and blood pressure;
-
Social evaluation and plan developed by the social worker; and
-
Orders for medication and treatment written in ink and signed by the prescribing practitioner acting within the scope of practice; and
-
A record of each medication administered, including:
a. Date and time of administration;
b. Type of medication administered;
c. Amount of medication administered;
d. Method of administration;
e. Name of the prescribing practitioner; and
f. Name of the person who administered the medication.
(g) Retention of records. Medical records shall be retained for at least six (6) years from the date of the patient's discharge, transfer, or death.
(4) Pharmaceutical services.
(a) An ESRD facility shall have provisions for promptly obtaining prescribed drugs and biologicals from a licensed pharmacy.
(b) The ESRD facility shall provide appropriate methods and procedures for storage, control, and administering of drugs and biologicals.
(c) A medication shall be administered by one (1) of the following practitioners acting within the individual's professional scope of practice:
-
A physician;
-
A physician's assistant;
-
An advanced nurse registered practitioner;
-
A registered nurse;
-
A licensed practical nurse; or
-
A dialysis technician.
(5) Social services. The ESRD facility shall have a qualified social worker responsible for:
(a) Evaluation of each patient's psychosocial needs;
(b) Participating in the ESRD facility's interdisciplinary team review of patient progress and recommending any changes, if needed, in treatment based on the patient's current psychosocial needs;
(c) Providing casework, counseling services, and referrals for other social services to assist the patient in achieving and sustaining an appropriate psychosocial status as measured by a standardized mental and physical assessment tool chosen by the social worker;
(d) Referrals for vocational rehabilitation services; and
(e) Identifying community social agencies and other resources and assisting patients and their families to utilize those resources.
(6) Dietetic services.
(a) The nutritional needs of each patient shall be evaluated by the:
-
Attending physician; and
-
Qualified dietician.
(b) The dietician, in consultation with the attending physician, shall be responsible for:
-
Assessing the nutritional status of each patient;
-
Recommending therapeutic diets;
-
Counseling patients and their families on prescribed diets; and
-
Monitoring adherence and response to diets.
(7) Self-care dialysis support services.
(a) An ESRD facility that offers self-care dialysis training shall make the following services available, directly or through an agreement or arrangement with another ESRD facility, upon completion of patient training:
-
Monitoring the patient's home adaptation, including visits to the patient's home by ESRD facility personnel in accordance with the patient's plan of care;
-
Patient consultation as needed with a member of the ESRD facility's interdisciplinary team (a qualified social worker or qualified dietician);
-
A recordkeeping system to assure continuity of care;
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Installation and maintenance of dialysis equipment;
-
Testing and appropriate treatment of the dialysis water;
-
Ordering of supplies as needed; and
-
Infection control, including hepatitis and peritonitis.
(b) A self-care and home dialysis training nurse shall:
-
Be a registered nurse licensed in accordance with KRS 314.041; and
-
Have at least twelve (12) months of experience in clinical nursing care and at least three (3) months of experience in the specific modality for which the nurse will provide self-care training.
(8) Dialysis services in a Medicare-certified nursing facility. A Medicare-certified ESRD facility or entity may provide dialysis services to a long-term care resident within a designated area of a Medicare-certified nursing facility as established in paragraphs (a) through (d) of this subsection.
(a)
-
Prior to providing dialysis in the nursing facility, the ESRD facility or entity shall submit a Form CMS-3427 to the cabinet, completing Section 22 and all other applicable fields.
-
Form CMS-3427 is available for download from the Centers for Medicare and Medicaid Services (CMS) Web site at: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-3427.
(b)
-
The ESRD facility or entity shall comply with the guidance established in the CMS State Operations Manual (SOM), chapter 2, section 2271A Dialysis in Nursing Homes.
-
The SOM, Chapter 2, section 2271A is available for download from the CMS Web site at: https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/som107c02.pdf.
(c)
-
The ESRD facility shall enter into a written agreement with each Medicare-certified nursing facility for which the ESRD facility will provide dialysis services.
-
The written agreement shall state the responsibilities of the ESRD facility and the nursing facility regarding the care of the resident before, during, and after dialysis treatments.
(d) The ESRD facility shall be responsible for the safe delivery of dialysis to the nursing facility resident, including:
-
Review of ESRD staff qualifications, training, and competency evaluation; and
-
Monitoring of all ESRD personnel who:
a. Administer dialysis treatments in the nursing facility; and
b. Provide on-site supervision of dialysis treatments.
Section 5. Physical Environment.
(1) Building and equipment.
(a)
-
An ESRD facility shall implement and maintain a program to ensure that all equipment shall be maintained and operated in accordance with the manufacturer's recommendations.
-
There shall be a program of preventive maintenance of equipment used in dialysis and related procedures in the ESRD facility.
(b)
-
Water used for dialysis purposes shall be analyzed periodically and treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques.
-
Records of test results and equipment maintenance shall be maintained at the ESRD facility.
(2) Infection control.
(a) The licensee shall provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the ESRD unit and any adjacent hospital or other public areas pursuant to 42 C.F.R. 494.30.
(b) An ESRD facility using a central-batch delivery system shall provide, on the premises or through affiliation agreements, sufficient individual delivery systems for the treatment of any patient requiring special dialysis solutions.
(3) Contamination prevention.
(a) An ESRD facility shall use appropriate techniques to prevent cross contamination between the unit and adjacent hospital or public areas including:
-
Food service areas;
-
Laundry;
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Disposal of solid waste and blood-contaminated equipment; and
-
Disposal of contaminants into sewage systems.
(b) An ESRD facility shall maintain procedures, in accordance with applicable law and accepted public health procedures for the:
-
Handling, storage, and disposal of potential infectious waste; and
-
Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Section 6. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "End Stage Renal Disease Application and Survey and Certification Report", Form CMS-3427, February 2022; and
(b) "CMS State Operations Manual (SOM), Chapter 2, Section 2271A, Dialysis in Nursing Homes", September 2018.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of the Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 216B.010, 216B.015, 216B.040, 216B.042, 216B.045, 216B.050, 216B.055, 216B.075, 216B.085, 216B.105-216B.125, 216B.990(1), (2), 310.021, 314.041, 314.051, Chapter 333, 335.100, 42 C.F.R. 494.1 – 494.180, 45 C.F.R. Part 160, Part 164, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the cabinet to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensing standards and procedures to ensure safe, adequate, and efficient health services and health facilities. This administrative regulation establishes the minimum licensure requirements for the operation of and services provided by End Stage Renal Disease (ESRD) facilities.
- History: 8 Ky.R. 219; eff. 11-5-1981; 12 Ky.R. 62; eff. 8-13-1985; 18 Ky.R. 811; eff. 10-16-1991; 23 Ky.R. 199; eff. 8-21-1996; 2859; eff. 2-19-1997; 28 Ky.R. 1697; 2040; eff. 3-14-2002; Cert eff. 1-11-2019; 48 Ky.R. 2123, 49 Ky.R. 63; eff. 8-25-2022; 49 Ky.R. 2166; eff. 9-27-2023.
902 KAR 20:031 Facility specifications; personal care homes {#sec-902-kar-20-031 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:031}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the board for the purpose of operating a personal care home and offering personal care service.
(3) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Human Resources Cabinet.
Section 2. Preparation and Approval of Plans and Specifications. After receiving certificate of need from the board, the following procedures shall be followed:
(1) Before construction is begun for the erection of new buildings or alterations to existing buildings or any changes in facilities, for a personal care facility, the licensee or applicant shall submit plans in the detail specified in Section 3 of this administrative regulation to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear either the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) All such plans and specifications must be approved by the licensure agency prior to commencement of construction of new buildings or alterations of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications must be approved by the Department of Housing, Buildings and Construction, and appropriate local building permits shall be obtained prior to commencement of construction.
Section 3. Submission of Plans and Specifications.
(1) First stage; schematic plans (required only if facility exceeds 100 beds).
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical resident room layouts (scaled one-fourth (1/4) inch = one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(b) If the project is an addition, or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangements of those buildings.
(2) Second stage; preliminary plans. Preliminary sketch plans shall include the following:
(a) Architectural: plans of basement and floors.
(b) Outline specifications.
-
General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering;
-
Description of the air-conditioning, heating, and ventilation systems and their controls, duct and piping systems; and dietary, laundry, and other special equipment;
-
General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage; contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Equipment. Location of all fixed equipment. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems. Details of construction, machine and control spaces necessary, size and type of equipment, and utility requirements for the following: dumbwaiters: electric, hand, hydraulic; elevators: freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems: radiators and steam heated equipment, such as warmers and steam tables; heating and steam mains and branches with pipe sizes; diagram of heating and steam risers with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heaters with stokers, oil burners, or gas burners; pumps, tanks, boiler breeching, and piping, and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems. Size and elevation of: street sewer, house sewer, house drains, street water main, and water service into the building. Location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment. Size and location of hot, cold, and circulating branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections. Standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for residents' beds and rest rooms; duty station, door signal light and wiring diagrams (this is optional but required in all higher levels of care);
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits;
g. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
-
Cover or title sheet;
-
Index;
-
Sections describing materials and workmanship in detail for each class of work;
-
General conditions, which must contain the following requirements: Access to the work. Representatives of the appropriate state agencies will have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances and Administrative Regulations.
(1) This section may be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended.
(b) Requirements for plumbing pursuant to 815 KAR 20:010-190, as amended.
(c) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010.
(d) Requirements for elevators pursuant to 815 KAR 4:010.
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(4) Prior to occupancy, the facility shall have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code before relicensure is granted by the licensure agency.
Section 5. Facility Requirements and Special Conditions.
(1) Facilities shall be available to the public, staff, and residents who may be physically handicapped with special attention given to ramps, drinking fountain height, mirrors, etc.
(2) At least sixty-six (66) percent of the beds in the facility shall be located in rooms designed for one (1) or two (2) beds.
(3) Access to the facility shall be by means of a paved or gravel roadway which shall be available for use by traffic prior to a license being issued to a facility for occupancy.
Section 6. Resident Unit. The following shall be included:
(1) Resident rooms. Each room shall meet the following requirements:
(a) Maximum room capacity: four (4) residents.
(b) Resident rooms shall be designed to permit not less than a three (3) foot space between beds, and at least a three (3) foot space between the side of the bed and the nearest wall, fixed cabinet, or heating/cooling unit. Beds shall be at least thirty-six (36) inches wide. A minimum of three (3) feet is required between the foot of the bed and opposite wall or foot of opposite bed in multibed rooms.
(c) Windows. All resident rooms shall have windows opening to the outside. The sill shall not be higher than three (3) feet above the floor and shall be above grade. Window area shall be at least eight (8) percent of resident room floor area.
(d) Lavatory. In single and two (2) bed rooms with a private toilet room, the lavatory may be located in the toilet room. Where two (2) residents' rooms share a common toilet, a lavatory shall be provided in each resident room.
(e) Wardrobe or closet for each resident. Minimum clear dimensions: one (1) foot and ten (10) inches deep by one (1) foot and eight (8) inches wide with full length hanging space; provide clothes rod and shelf.
(f) In multibed rooms a method of assuring visual privacy for each resident shall be provided.
(2) Resident toilet and bathing areas for existing facilities.
(a) Where a centralized bathing area is used, the facility shall provide for each sex on every floor the following: one (1) shower stall or one (1) bathtub for each twelve (12) residents or major fraction thereof is required. One (1) shower stall shall be designed for wheelchair use.
(b) Where a centralized toilet area is used, the facility shall provide for each sex on every floor the following: one (1) toilet for each eight (8) residents or fraction thereof and one (1) lavatory for each sixteen (16) residents or fraction thereof is required. Toilets must be separated by a permanent partition and at least one (1) toilet for each sex must be designed for wheelchair use.
(c) The centralized bathing and centralized toilet area may be combined into one (1) location provided provision is made for the privacy of sexes.
(d) Grab bars or patient lift with a safety device shall be provided at all tubs. Grab bars shall be provided at all shower stalls and toilets.
(3) Service areas for each floor. The size and location of each service area will depend on the maximum number of residents the floor was designed for and shall include:
(a) Duty station. An adequate centralized area must be provided for charting and other required administrative functions.
(b) Staff lounge area. The area shall have personal storage space and a toilet room for staff.
(c) Visitors toilet room. The home shall provide a toilet room for visitors. The staff toilet room may serve as the visitors toilet room if marked and accessible.
(d) Medication area, with sink, refrigerator, locked storage and facilities for preparation of medication. Controlled substances locker must be under double lock.
(e) Clean linen storage. Enclosed storage area.
(f) Janitor's closet. Storage of housekeeping supplies and equipment. Floor receptor or service sink.
(4) Residents' dining, TV viewing, and recreation areas.
(a) The total areas set aside for these purposes shall be not less than thirty (30) square feet per bed for the first fifty (50) beds and twenty (20) square feet per bed for all beds in excess of fifty (50).
(b) Storage shall be provided for recreational equipment and supplies (such as wall cabinets or closets).
Section 7. Dietary Department. If a commercial service will be used or meals will be provided by an adjacent hospital, dietary areas and equipment shall be designed to accommodate the requirements for sanitary, efficient and safe storage, processing, and handling, otherwise the following shall be provided:
(1) Food preparation center. Provide a lavatory but do not provide a mirror.
(2) Food serving facilities to accommodate residents and staff.
(3) Dishwashing and pot-washing facilities. Dish and utensil washing equipment will be used that will result in sanitized serviceware and will prevent recontamination.
(4) Refrigerated storage shall accommodate a three (3) day supply minimum.
(5) Dry storage shall accommodate a three (3) day supply minimum.
(6) Food carts. If the home uses food carts, space shall be provided in the kitchen or in a separate storage area for the cleaning and storage of food carts.
(7) Janitor's closet. Storage for housekeeping supplies and equipment; floor receptor or service sink.
(8) A toilet room conveniently accessible to the dietary department. If a toilet room is built in this department, it must have two (2) door separation from food preparation area or dining areas.
Section 8. Administration Department. Sufficient space shall be allotted for administrative operations. The areas may include: an administrator's office, business office, information center, admitting and medical records.
Section 9. Laundry. The following shall be included:
(1) Soiled linen room.
(2) Clean linen room.
(3) Lavatory. Accessible from soiled, clean, and processing rooms.
(4) Laundry processing room and storage for laundry supplies (need not be provided if laundry is processed outside the facility).
Section 10. Storage and Service Areas. The following shall be included:
(1) Sufficient storage space shall be provided.
(2) Engineering service and equipment areas. The following shall be provided where applicable:
(a) Boiler room;
(b) Mechanical and electrical equipment room(s) (can be combined with boiler room);
(c) Storage room for housekeeping equipment (need not be provided if space is available in janitor's closets or elsewhere);
(d) Refuse area, for holding trash prior to disposal, shall be located convenient to service entrance.
Section 11. Details and Finishes. A high degree of safety for the occupants in minimizing the incidence of accidents shall be provided. Hazards such as sharp corners shall be avoided. All details and finishes shall meet the following requirements:
(1) Details.
(a) Handrails shall be provided on both sides of corridors used by residents in personal care with a clear distance of one and one-half (1 1/2) inches between handrail and wall.
(b) All doors opening onto corridors shall be swing-type except elevator doors. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
(c) All doors to resident room toilet rooms shall swing outward or shall be equipped with hardware which will permit access in any emergency.
(d) Thresholds and expansion joint covers, if used, shall be flush with the floor.
(e) Grab bars and accessories in toilet, shower, and bathrooms shall have sufficient strength and anchorage to sustain a load of 250 pounds for five (5) minutes.
(f) Lavatories intended for use by residents shall be installed to permit wheelchairs to slide under.
(g) Mirrors shall be arranged for convenient use by residents in wheelchairs as well as by residents in standing position.
(h) Towel rack or dispensers shall be provided at all lavatories and sinks used for hand-washing.
(i) Ceiling heights.
-
Boiler room. Not less than two (2) feet and six (6) inches above the main boiler header and connecting piping with adequate headroom under piping for maintenance and access;
-
Corridors, storage rooms, residents' toilet room, and other minor rooms. Not less than seven (7) feet and six (6) inches;
-
All other rooms. Not less than eight (8) feet.
(j) Boiler room, food preparation centers, and laundries shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of eighty-five (85) degrees Fahrenheit.
(k) Noise reduction criteria. The ceilings of the following areas shall be designed to reduce noise transmission:
-
Corridors in resident areas;
-
Work areas such as utility rooms;
-
Lobbies and recreation areas.
(l) Special attention shall be given to sound transmission from boiler rooms, mechanical rooms, and kitchen, to resident bedroom areas.
(2) Finishes.
(a) Floors generally shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchen and related spaces shall be waterproof and grease-proof. In all areas where floors are subject to wetting, they shall have a nonslip finish.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable and in the immediate area of plumbing fixtures, the finish shall be moisture-proof. Wall bases in dietary areas shall be free of spaces that can harbor insects.
(d) Ceilings generally shall be washable or easily cleanable. This requirement does not apply to boiler rooms, mechanical and building equipment rooms, shops and similar spaces.
Section 12. Elevators. Elevators shall conform with 815 KAR 4:010. Elevators, where required. All facilities where either resident beds or residential facilities such as recreation, resident dining or therapy rooms are located on other than the first floor, shall have electric or electrohydraulic elevators as follows:
(1) Number of elevators. All homes with resident beds or residential facilities located on any floor other than the first floor shall have at least one (1) hospital-type elevator and such additional elevators as determined by the licensure agency from a study of the facility plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Cars of hospital-type elevators shall have inside dimensions that will accommodate a resident's bed and attendants and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep; car doors shall have a clear opening of not less than three (3) feet and eight (8) inches. Cars of all other required elevators shall have a clear opening of not less than three (3) feet.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
Section 13. Construction. Foundations shall rest on natural solid ground if a satisfactory soil is available at reasonable depths. Proper soil bearing values shall be established in accordance with recognized standards. If solid ground is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement.
Section 14. Mechanical Requirements.
(1) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) must be provided; the combined capacity of the boilers, based upon the published Steel Boiler Institute or Institute of Boiler and Radiator Manufacturer's net rating, must be able to supply 150 percent of the normal requirements of all systems and equipment.
(b) The design and installation of boilers in personal care homes shall comply with 815 KAR 15:010 through 060.
(2) Temperature and ventilating systems.
(a) Temperature. A minimum temperature of seventy-two (72) degrees Fahrenheit shall be provided for in occupied areas in winter conditions. A maximum temperature of eighty-five (85) degrees Fahrenheit shall be provided for in occupied areas in summer conditions.
(b) Ventilation systems details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at or near the point of discharge from the building. The ventilation rates shown in Table 1, Section 16 of this administrative regulation, shall not be considered as precluding the use of higher ventilation rates if they are required to meet design conditions.
-
Outdoor ventilation air-intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five (25) feet from the exhausts from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight (8) feet above the ground level or, if installed through the roof, three (3) feet above roof level.
-
The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas shown in Table 1, Section 16 of this administrative regulation.
-
Room supply air inlets, recirculation, and exhaust air outlets shall be located not less than three (3) inches above the floor.
-
Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate rooms such as bathrooms, toilet rooms, or janitor's closets which open directly on corridors.
(3) Plumbing and other piping systems. Lavatories in resident rooms shall have the water supply spout mounted so that its discharge point is a minimum distance of five (5) inches above the rim of the fixture. Fixtures used in the dietary area, soiled workroom and clean workroom shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall be at a distance from the centerline of the sink to be operational.
(4) Water supply systems.
(a) System shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.
(b) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
(c) Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior barrier.
(d) Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitor's sinks and bedpan flushing attachments.
(e) Hot water distribution systems shall be arranged to provide hot water at each fixture at all times.
(f) Piping over food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of, or condensation from necessary overhead piping systems.
(5) Hot water heaters and tanks.
(a) The hot water heating equipment shall have sufficient capacity to supply the water at the temperature and amounts indicated below:
(b) Storage tank(s) shall be provided and shall be fabricated of corrosion-resistant metal, or have noncorrosive lining.
(6) Plumbing approval. Prior to final approval of the plans and specifications by the licensure agency, the plumbing plans and specifications must be approved by the Division of Plumbing, Department of Housing, Buildings and Construction.
Section 15. Electrical Requirements.
(1) General. Electrical requirements of the Kentucky Building Code shall apply where applicable.
(2) The wiring in each home shall be inspected by a certified electrical inspector and a certificate of approval shall be issued, to the facility, prior to occupancy; however, the wiring in existing buildings shall be approved by a certified electrical inspector only when the building has not been previously so approved for health care occupancy or where the State Fire Marshal finds that a hazardous condition exists.
(3) Switchboard and power panels. All breakers and switches shall be indexed.
(4) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have electric lighting.
(b) Residents' bedrooms shall have general lighting. A reading light shall be provided for each resident when appropriate. Residents' reading lights and other fixed lights not switched at the door shall have switch controls convenient for use at the luminaire. Night lights shall be provided in each resident's room.
(c) Lighting levels for the facility shall comply with the requirements in Table 2, Section 16 of this administrative regulation.
(5) Receptacles (convenience outlets).
(a) Bedroom. Each resident bedroom shall have duplex receptacles as follows: one (1) each side of the head of each bed (for parallel adjacent beds, only one (1) receptacle is required between beds); receptacles for luminairies, television and motorized beds, if used, and one (1) receptacle on another wall.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of ends of corridors.
(6) Emergency electric service.
(a) General.
-
To provide electricity during an interruption of the normal electric supply that could affect the care or safety of the occupants, an emergency generating set shall be provided and connected to certain circuits for lighting and power for a continuous period up to four (4) hours.
-
When the home is supplied by at least two (2) dedicated and separate utility service feeders, an emergency generating set is not required.
(b) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto, including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors;
b. Medication preparation areas;
c. Switch-gear location and boiler room;
d. Elevator (if required for emergency).
- Equipment, essential to life safety and for protection of important or vital materials: sewage or sump lift pump, if installed.
(c) Details. The emergency system shall be so controlled that after interruption of the normal electric power supply, the electric source is brought to full voltage and frequency and connected to all emergency lighting, all alarms, and equipment.
Section 16. Tables.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides for the licensure requirements for the facility specifications for the construction, alteration and maintenance of personal care homes.
- History: 902 KAR 020:031. 8 Ky.R. 222; eff. 11-5-1981; 16 Ky.R. 966; eff. 1-12-1990; Crt eff. 4-30-2019; TAm eff. 3-20-2020; Crt eff. 2-17-2026.
902 KAR 20:036 Operation and services; personal care homes {#sec-902-kar-20-036 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:036}
Section 1. Definitions.
(1) "Activities of daily living" or "ADL" is defined by KRS 194A.700(1).
(2) "Administrator" means an individual who:
(a)
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Has a license to practice long-term care administration pursuant to KRS 216A.080; or
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Has a high school diploma, a general equivalency diploma (GED), or qualifying documentation from a comparable educational entity; and
(b) Is age twenty-one (21) or older.
(3) "Ambulatory" is defined by KRS 216.597(2)(b) as having the same meaning as "ambulatory" as defined by KRS 194A.700(2).
(4) "Certified nutritionist" means a health care professional who is certified pursuant to KRS 310.031.
(5) "Instrumental activities of daily living" or "IADL" is defined by KRS 194A.700(15).
(6) "Licensed dietician" means a health care professional who is licensed pursuant to KRS 310.021.
(7) "Mobile nonambulatory" means unable to walk without assistance, but able to move from place to place with the use of a device including walkers, crutches, wheelchairs, or other assistive medical devices and includes the ability to:
(a) Self exit the building; and
(b) Transfer independently or with minimal assistance from bed-to-chair.
(8) "Nonambulatory" means unable to walk without assistance.
(9) "Nonmobile" means unable to move from place to place.
(10) "Nurse" is defined by KRS 314.011(3).
(11) "Personal care home" or "PCH" is defined by KRS 216.597(1)(b).
(12) "Qualified mental health professional" or "QMHP" is defined by KRS 202A.011(12).
(13) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a portion of a patient's body.
(14) "Serious mental illness" or "SMI" means a mental illness or disorder (but not a primary diagnosis of Alzheimer's disease or dementia), that is described in the Diagnostic and Statistical Manual of Mental Disorders (DSM), 5th Edition, or the DSM currently in use, that impairs or impedes functioning in one (1) or more major areas of living and is unlikely to improve without treatment, services, or supports.
(15) "Specialized personal care home" or "SPCH" is defined by KRS 216.597(1)(c).
(16) "Temporary condition" is defined by KRS 194A.700(26) in accordance with KRS 216.597(4).
(17) "PRN" is defined as medications administrated as needed.
Section 2. Licensure Application and On-site Visits.
(1) Upon approval of certificate of need followed by approval of plans and specifications submitted in accordance with 902 KAR 20:031, an applicant for a provisional license as a PCH or SPCH shall submit the following to the Office of Inspector General:
(a) A completed Application for License to Operate a Long Term Care Facility incorporated by reference in 902 KAR 20:008, Section 9(1)(f) accompanied by the licensure fee established by 902 KAR 20:008, Section 3(2)(q);
(b) Proof of approval by the State Fire Marshal's office; and
(c) A copy of the applicant's compliance history for any other care facility the applicant operates, including a copy of all enforcement actions issued by the regulatory agency against the care facility, such as violations, fines, or negative action against the facility's license during the seven (7) year period prior to application for a provisional license.
(2) A licensed PCH or SPCH shall comply with the annual renewal process established by 902 KAR 20:008, Section 2(14)(b).
(3) On-site inspections shall be conducted in accordance with the survey intervals established by KRS 216.597(7)(c).
(4) Nothing in this administrative regulation shall prevent the cabinet from:
(a) Conducting an investigation related to a complaint; or
(b) Making an on-site survey of a PCH or SPCH more often, if necessary.
(5) A PCH or SPCH shall comply with the:
(a) Inspection requirements of 902 KAR 20:008, Section 2(12)(b) and (c);
(b) Procedures for correcting violations established by 902 KAR 20:008, Section 2(13); and
(c) Civil monetary penalties established by KRS 216.555 through 216.567.
Section 3. Scope of Operations and Services.
(1) A resident in a PCH or SPCH shall:
(a) Be admitted in accordance with KRS 216.765;
(b) Be ambulatory or mobile nonambulatory, unless the facility elects to provide services in accordance with KRS 216.597(4) to a resident who is deemed to have a temporary condition;
(c) Be able to manage most of the activities of daily living; and
(d) Have care needs that do not exceed the capability of the PCH or SPCH.
(2) An individual who is nonambulatory or nonmobile shall not be eligible for residence in a PCH or SPCH pursuant to KRS 216.597(3).
Section 4. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for:
(a) The operation of the PCH or SPCH;
(b) Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the facility;
(c) The development and implementation of policies related to administration and operation of the facility;
(d) If the licensee is a SPCH, the development and implementation of written transition procedures to ensure cooperation with an individual or entity that assists with transitioning residents with an SMI to community living arrangements; and
(e) If the licensee is an SPCH, access to confidential and secure telehealth services unless access is impossible to provide due to a lack of:
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Broadband service; or
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An appropriate physical space for residents.
(2) Administrator.
(a) The administrator shall:
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Be responsible for the day-to-day operation of the PCH or SPCH; and
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Designate one (1) or more staff to act on behalf of the administrator or to perform the administrator's responsibilities in the administrator's absence.
(b) Each SPCH shall ensure that the administrator completes the mental illness or intellectual disability training workshop established by 921 KAR 2:015, Section 14, within six (6) months of hire and every two (2) years thereafter.
(3) Admission.
(a) A PCH or SPCH shall not care for or be responsible for the care of more residents than the capacity indicated on the license.
(b) Upon admission, a PCH or SPCH shall provide the resident and a responsible member of the resident's family or other designated representative with written information regarding the facility's policies, including:
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Services offered and charges;
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The right to arrange for additional services under direct contract or arrangement with an outside party pursuant to KRS 216.597(5) if allowed by the policies of the PCH or SPCH;
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The right to visitation with family and friends, subject to visiting rules and hours established by the facility; and
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Meal services.
(c) Prior to admission, each resident shall have a complete medical examination in accordance with KRS 216.765.
(d) Upon admission, a PCH or SPCH shall complete the SMI Screening Form for each new or returning resident.
(4) Patient rights. Patient rights shall be provided for pursuant to KRS 216.510 through 216.525.
(5) Adult protection. PCHs and SPCHs shall have written policies that ensure the reporting of allegations of abuse, neglect, or exploitation of adults pursuant to KRS 209.030, including evidence that all allegations of abuse, neglect, or exploitation shall be thoroughly investigated internally to prevent further potential abuse while the investigation is in progress.
(6) Emergency evacuation. Each PCH and SPCH shall have a written policy in accordance with KRS 216.597(6)(c) that describes how priority will be given to assist a resident during an emergency if evacuation of the facility is necessary and the resident requires hands-on assistance from another person to walk, transfer, or move from place to place with or without an assistive device.
(7) Nursing tasks. If nursing tasks are delegated, each PCH or SPCH shall have a written policy regarding the supervision of unlicensed personnel performing delegated tasks, including how the facility ensures compliance with the supervision requirements of 201 KAR 20:400, Section 4.
(8) Transfer and discharge.
(a) PCHs and SPCHs shall:
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Comply with the requirements of 900 KAR 2:050 upon transferring or discharging a resident; and
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Have written transfer procedures and agreements for the transfer of residents to a higher intensity level of care, if indicated.
(b) A PCH or SPCH that does not have a transfer agreement in effect, but has attempted in good faith to enter into an agreement shall be considered to be in compliance with the requirements of paragraph (a)2. of this subsection.
(c) The transfer procedures and agreements shall:
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State the responsibilities each party assumes in the transfer of residents;
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Establish responsibility for notifying the other party of an impending transfer; and
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Arrange for safe transportation and transfer of files.
(d) The administrator shall initiate a transfer through the resident's physician or appropriate agencies if the resident's condition is not within the scope of services of the PCH or SPCH.
(e) PCH or SPCH resident records.
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If a resident transfers to another health care facility, a current summary of the resident's medical record shall accompany the resident.
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If a resident transfers to another level of care within the same facility, a copy of the resident's record or current summary of the resident's medical record shall accompany the resident.
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If a resident transitions into a community living setting, a current summary of, or a copy of the resident's records shall be provided to the resident and the resident's guardian.
(9) Tuberculosis Testing.
(a) All employees of a PCH or SPCH shall be screened and tested for tuberculosis in accordance with 902 KAR 20:205.
(b) Residents of a PCH or SPCH shall be screened and tested in accordance with 902 KAR 20:200.
(10) Personnel.
(a) In accordance with KRS 216.532, a PCH or SPCH shall not employ or be operated by an individual who is listed on the nurse aide and home health aide abuse registry established by 906 KAR 1:100.
(b) In accordance with KRS 209.032, a PCH or SPCH shall not employ or be operated by an individual who is listed on the caregiver misconduct registry established by 922 KAR 5:120.
(c) A PCH or SPCH shall obtain a criminal record check on each applicant for initial employment in accordance with KRS 216.789 and 216.793.
(d) Current employee records shall be maintained on each staff member and contain:
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Name and address;
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Verification of all training and experience, including evidence of current licensure, registration, or certification, if applicable;
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Employee health records;
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Annual performance evaluations; and
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Documentation of compliance with the background check requirements of paragraphs (a) through (c) of this subsection.
(e) Each employee shall be of an age in conformity with state laws.
(f) An employee who contracts a communicable or an infectious disease shall:
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Be immediately excluded from work; and
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Remain off work until cleared as noninfectious by a health care practitioner acting within the practitioner's scope of practice.
(g) Each dietary staff member shall wear a hair net.
(h) In-service training.
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Each PCH or SPCH employee shall receive orientation and annual in-service training that corresponds with the staff member's job duties.
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Documentation of orientation and in-service training shall be maintained in the employee's record and shall include:
a. Name of the individual or individuals who provided the training;
b. Date and number of hours the training was given; and
c. A summary of the training program's content.
- In-service training shall include:
a. Policies regarding the responsibilities of specific job duties;
b. Services provided by the facility;
c. Recordkeeping procedures;
d. Procedures for the reporting of cases of adult abuse, neglect, or exploitation pursuant to KRS 209.030;
e. Resident rights established by KRS 216.510 through 216.525;
f. Adult learning principles and methods for assisting residents to achieve maximum abilities in ADLs and IADLs;
g. Procedures for the proper application of emergency manual restraints;
h. Procedures for maintaining a clean, healthful, and pleasant environment;
i. The aging process;
j. The emotional problems of illness;
k. Use of medication; and
l. Therapeutic diets.
- Each SPCH shall ensure that at least one (1) direct care staff member in addition to the administrator completes the mental illness or intellectual disability training workshop established by 921 KAR 2:015, Section 14, within six (6) months of hire and every two (2) years thereafter. An SPCH shall employ at least one (1) direct care staff member who has received the training.
(i) Staffing requirements.
- The number of personnel required shall be based on:
a. The number of patients; and
b. Amount and kind of personal care, health care, and supervision needed to meet the needs of the residents.
- The administrator shall designate one (1) or more staff members to be responsible for:
a. Recordkeeping;
b. Basic health and health related services; and
c. Activity services.
- Each PCH or SPCH shall have a full-time staff member who shall be:
a. Responsible for the total food service operation of the facility; and
b. On duty a minimum of thirty-five (35) hours each week.
- In accordance with KRS 216.597(6)(a) and (b):
a. Staffing in a PCH or SPCH shall be sufficient in number and qualifications to meet the twenty-four (24) hour scheduled needs of each resident; and
b. At least one (1) staff member shall be awake and on-site at all times at each licensed facility.
(11) Medical records.
(a) The PCH or SPCH administrator or staff member in charge of medical records shall ensure that a complete medical record is kept for each resident with all entries current, dated, and signed.
(b) Each record shall include:
- Identification information, including:
a. Resident's name;
b. Social Security, Medicare, and Medical Assistance identification number (if appropriate);
c. Marital status;
d. Birthdate;
e. Age;
f. Sex;
g. Home address;
h. Religion and personal clergyman, if any (with consent of the resident);
i. Attending physician, health care practitioner acting within the practitioner's scope of practice, QMHP, dentist, and podiatrist, if any, and address and phone number for each;
j. Next of kin or responsible person, address, and telephone number;
k. Date of admission and discharge;
l. If the resident is discharged, transferred, or transitioned to a community living arrangement, a copy of the summary of resident's records; and
m. Monthly recording of the resident's weight;
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If admitted from another facility, a discharge summary or transfer summary;
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Admitting medical evaluation;
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Report by the physician or health care practitioner acting within the practitioner's scope of practice, documenting completion of an annual medical evaluation of each resident;
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Physician, health care practitioner, or QMHP progress notes indicating any changes in the resident's condition, documented at the time of each visit by the physician, health care practitioner, QMHP, or consultant;
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Orders for medication or therapeutic services;
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Nurses' or staff notes indicating any changes in the resident's condition as changes occur;
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Documentation of any accident, injury, illness, medication error, or drug reaction impacting the resident;
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Documentation of social services, dental, laboratory, x-ray, or reports from consultants or therapists if the resident receives any of these services;
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Medication and treatment sheets, including all medications, treatments, and special procedures performed for that resident, with the date and time of each service documented and initialed by the individual rendering treatment or administering medication;
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Documentation of the use of an emergency manual restraint for that resident, including justification for why the procedure was used;
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Documentation of the resident's discharge, transfer, or transition destination, if applicable;
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Copy of a completed SMI Screening Form for each PCH or SPCH resident; and
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Monthly documentation of ADL and IADL skills instruction provided to, or made available and refused by, the resident if the resident is an SPCH resident who is transitioning to living independently in the community pursuant to 908 KAR 2:065.
(12) Retention of records. After death or discharge, the completed medical record shall be placed in an inactive file and retained for at least six (6) years.
Section 5. Provision of Services.
(1) Basic health and health related services.
(a) A PCH or SPCH shall provide basic health and health related services, including:
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Supervision and monitoring of the resident to ensure that the resident's health care needs are met;
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Supervision of self-administration of medications;
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Storage and control of medications; and
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Arranging for therapeutic services ordered by the resident's health care practitioner, if the services are not available in the facility.
(b) For a PCH or SPCH, the administrator or staff person designated by the administrator shall, relating to the provision of basic health and health-related services:
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Be responsible for obtaining medical care promptly in response to an accident, injury, or acute illness of any resident; and
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Document any accident, injury, illness, incident, medication error, or drug reaction in the resident's medical record.
(c) Medications or therapeutic services shall not be administered or provided to any resident, except on the order of a licensed physician or other health care practitioner as authorized under the practitioner's scope of practice.
(d) Administration of all medications and delivery of therapeutic services shall be recorded in the resident's medical record.
(e) If an order is received by telephone, the order shall be:
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Recorded in the resident's medical record; and
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Signed by the physician or other health care practitioner as authorized under the practitioner's scope of practice within fourteen (14) days.
(f)
- The administrator or staff person designated by the administrator shall make a written report of any incident or accident involving a:
a. Resident,including a medication error or drug reaction;
b. Visitor; or
c. Staff member.
- The report shall:
a. Identify any staff member who might have been witness to the incident; and
b. Be filed in an incident file.
(g)
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Controlled substances and medication administration. A PCH or SPCH shall not keep any controlled substances or other habit forming drugs, hypodermic needles, or syringes except under the specific direction of a prescribing practitioner.
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Controlled substances shall be kept under double lock, for example stored in a locked box in a locked cabinet, and keys or access codes to the locked box and locked cabinet shall be accessible to designated staff only.
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There shall be a controlled substances bound record book with numbered pages that includes:
a. Name of the resident;
b. Date, time, kind, dosage, and method of administration of each controlled substance;
c. Name of the practitioner who prescribed the medications; and
d. Name of the:
(i) Nurse who administered the controlled substance; or
(ii) Staff member who provided assistance with or supervised self-administration by a resident whose medical record includes a written determination from a health care practitioner that the resident is able to safely self-administer a controlled substance with assistance or under supervision.
- A staff member with access to controlled substances shall be responsible for maintaining a recorded and signed:
a. Schedule II controlled substances count daily; and
b. Schedule III, IV, and V controlled substances count at least one (1) time per week.
- All expired or unused controlled substances shall be disposed of, or destroyed in accordance with 21 C.F.R. Part 1317 no later than thirty (30) days:
a. After expiration of the medication; or
b. From the date the medication was discontinued.
- If controlled substances are destroyed on-site:
a. The method of destruction shall render the drug unavailable and unusable;
b. The administrator or staff person designated by the administrator shall be responsible for destroying the controlled substances with at least one (1) witness present; and
c. A readily retrievable record of the destroyed controlled substances shall be maintained for a minimum of eighteen (18) months from the date of destruction and contain the:
(i) Date of destruction;
(ii) Resident name;
(iii) Drug name;
(iv) Drug strength;
(v) Quantity;
(vi) Method of destruction;
(vii) Name of the person responsible for the destruction; and
(viii) Name of the witness.
- A PCH or SPCH that stores and administers controlled substances in an emergency medication kit (EMK) shall comply with the:
a. Requirement for licensed personnel established by 201 KAR 2:370, Section 2(4)(i);
b. Requirements for storage and administration established by 902 KAR 55:070, Section 2(2), (5), and (7) through (9); and
c. Limitation on the number and quantity of medications established by 902 KAR 55:070, Section 2(6).
(h) All resident medications shall be plainly labeled with the:
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Resident's name;
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Name of the drug;
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Strength;
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Name of the pharmacy;
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Prescription number;
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Date;
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Prescriber's name; and
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Caution statements and directions for use, unless a modified unit dose drug distribution system is used.
(i)
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All medicines kept by the PCH or SPCH shall be kept in a locked place.
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The nurse or administrator or staff person designated by the administrator shall be responsible for administering or supervising the self-administration of medication.
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The administrator or staff person designated by the administrator shall:
a. Be responsible for supervising the self-administration of medication;
b. Ensure that all medications requiring refrigeration are kept in a separate locked box in the refrigerator in the medication area; and
c. Ensure that drugs for external use are stored separately from those administered by mouth and injection.
(j)
- A PCH or SPCH that stores and administers non-controlled substances in an EMK shall comply with the:
a. Requirement for licensed personnel established by 201 KAR 2:370, Section 2(4)(i); and
b. Limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(4)(b).
- A PCH or SPCH that stores and administers non-controlled substances from a long-term care facility (LTCF) drug stock shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(5)(b).
(k)
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If a resident manifests persistent behavior that might require psychiatric treatment, the PCH or SPCH shall notify the resident's physician or health care practitioner acting within the practitioner's scope of practice to evaluate and direct the resident's care.
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If the resident's condition does not improve, making continued stay in a PCH or SPCH unfeasible, the physician or health care practitioner shall initiate transfer of the resident to an appropriate facility as soon as possible.
(l) Use of restraints.
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Chemical and physical restraints shall not be used, except as authorized by KRS 216.515(6).
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Restraints that require a lock and key shall not be used.
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Emergency use of a manual restraint shall be applied only by appropriately trained personnel if:
a. A resident poses an imminent risk of physical harm to self or others; and
b. The emergency manual restraint is the least restrictive intervention to achieve safety.
- Restraints shall not be used as:
a. Punishment;
b. Discipline;
c. Convenience for staff; or
d. Retaliation.
(m) Each resident shall have an annual medical evaluation by a physician or health care practitioner acting within the practitioner's scope of practice.
(n) Communicable diseases. If a resident or prospective resident is suspected or confirmed as having a communicable disease for which a reasonable probability of disease transmission exists in the PCH or SPCH, the administrator or staff person designated by the administrator shall:
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Contact a physician; and
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Ensure that appropriate measures are taken to treat the resident with the communicable disease and prevent the disease from spreading.
(2) Residential care services. A PCH or SPCH shall provide residential care services to all residents, including:
(a) Room accommodations;
(b) Housekeeping and maintenance services; and
(c) Dietary services.
(3) A PCH or SPCH shall meet the following requirements relating to the provisions of residential care services:
(a) Room accommodations.
- A PCH or SPCH shall provide each resident with:
a. A bed that is at least thirty-six (36) inches wide;
b. A clean, comfortable mattress with a support mechanism;
c. A mattress cover;
d. Two (2) sheets and a pillow; and
e. Bed covering to keep the resident comfortable.
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Each bed shall be placed so that a resident does not experience discomfort because of proximity to a radiator, heat outlet, or exposure to a draft.
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Except for married couples or domestic partners, there shall be separate sleeping quarters for males and females.
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A PCH or SPCH shall provide:
a. Window coverings;
b. Bedside tables with reading lamps, if appropriate;
c. Comfortable chairs;
d. A chest or dresser with a mirror for each resident; and
e. A night light.
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A resident shall not be housed in a room, detached building, or other enclosure that has not previously been inspected and approved for residential use by the Office of Inspector General and the Department of Housing, Buildings and Construction.
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Basement rooms shall not be used for sleeping rooms for residents.
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Residents may have personal items and furniture, if feasible.
(b) Housekeeping and maintenance services.
- A PCH or SPCH shall:
a. Maintain a clean and safe facility free of unpleasant odors; and
b. Ensure that odors are eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
- A PCH or SPCH shall:
a. Have available at all times, a quantity of clean linen essential to the proper care and comfort of residents;
b. Ensure that soiled clothing and linens receive immediate attention and shall not be allowed to accumulate;
c. Ensure that clothing or bedding used by one (1) resident shall not be used by another resident unless laundered or dry cleaned;
d. Ensure that each resident's personal clothing and bed linens shall be laundered as often as is necessary;
e. Maintain responsibility for laundering each resident's personal clothing unless the resident or the resident's family accepts this responsibility;
f. Provide laundry equipment for each resident who is capable of, and chooses to launder his or her personal clothing; and
g. Label or mark each resident's personal clothing if laundered by the facility for return to the correct resident.
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Safety. The condition of the overall environment shall be maintained to ensure the safety and well-being of residents, personnel, and visitors.
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Maintenance. The premises shall be well kept and in good repair as established in clauses a. through d. of this subparagraph.
a. The facility shall ensure that the grounds are well kept and the exterior of the building, including the sidewalk, steps, porches, ramps, and fences, are in good repair.
b. The interior of the building, including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures, shall be in good repair. Windows and doors shall be screened.
c. Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly.
d. A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. Care shall be taken to use the least toxic and least flammable insecticides and rodenticides. The compounds shall be stored under lock if stored by the facility.
(c) Dietary services.
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Dining area. A dining area shall be available for the residents.
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Therapeutic diets. If the facility provides therapeutic diets and the staff member responsible for food services is not a licensed dietitian or certified nutritionist, the responsible staff person shall consult with a licensed dietician or certified nutritionist.
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Menu planning.
a. Menus shall be planned in writing and rotated to avoid repetition.
b. A PCH or SPCH shall meet the nutrition needs of residents in accordance with physician's orders.
c. Except as established in clause e. of this subparagraph, meals shall correspond with the posted menu.
d. Menus shall be planned and posted one (1) week in advance.
e. If changes in the menu are necessary:
(i) Substitutions shall provide equal nutritive value;
(ii) The changes shall be recorded on the menu; and
(iii) Menus shall be kept on file for at least thirty (30) days.
- Food preparation and storage.
a. There shall be at least a three (3) day supply of food to prepare well-balanced, palatable meals.
b. Food shall be prepared with consideration for any individual dietary requirement.
c. Modified diets, nutrient concentrates, and supplements shall be given only on the written order of a physician.
d. At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the evening meal and breakfast.
e. Between-meal snacks, including an evening snack before bedtime, shall be offered to all residents.
f. Adjustments shall be made if medically contraindicated.
g. Food shall be:
(i) Prepared by methods that conserve nutritive value, flavor, and appearance; and
(ii) Served at the proper temperature and in a form to meet individual needs.
h. A file of tested recipes, adjusted to appropriate yield, shall be maintained.
i. Food shall be cut, chopped, or ground to meet individual needs.
j. If a resident refuses food served, substitutes shall be offered.
k. All opened containers or leftover food items shall be covered and dated when refrigerated.
l. Ice water shall be readily available to the residents at all times.
m. Food services shall be provided in accordance with 902 KAR 45:005.
(4) Personal care services. All PCHs and SPCHs shall provide services to assist residents with activities of daily living to achieve and maintain good personal hygiene, including assistance as needed with:
(a) Bathing. The facility shall provide soap, clean towels, and wash cloths for each resident and ensure that toilet articles such as towels, brushes, and combs are not used in common;
(b) Shaving;
(c) Cleaning and trimming of fingernails and toenails;
(d) Cleaning of the mouth and teeth to maintain good oral hygiene and care of the lips to prevent dryness and cracking. The facility shall provide all residents with tooth brushes, a dentifrice, and denture containers, if applicable; and
(e) Washing and grooming.
(5) Activity services.
(a) All PCHs and SPCHs shall provide social and recreational activities to:
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Stimulate physical and mental abilities to the fullest extent;
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Encourage and develop a sense of usefulness and self-respect;
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Prevent, inhibit, or correct the development of symptoms of physical and mental regression; and
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Provide sufficient variety to meet the needs of each resident.
(b) All PCHs and SPCHs shall meet the requirements established in subparagraphs 1. through 8. of this paragraph relating to the provision of activity services.
- Staff. The administrator:
a. Shall designate a staff member to be responsible for the activity program; and
b. May accept services from a volunteer group to assist with carrying out the activity program.
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There shall be a planned activity period each day.
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The schedule shall be current and posted.
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The activity program shall be planned for group and individual activities, both within and outside of the facility.
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The staff member responsible for the activity program shall maintain a current list of residents in which precautions are documented regarding if a resident's condition might restrict or modify the resident's participation in the program.
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A living or recreation room and outdoor recreational space shall be provided for residents and their guests.
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The facility shall provide supplies and equipment for the activity program.
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Reading materials, radios, games, and TV sets shall be provided for the residents.
(c) An SPCH shall collaborate with the agency or team that is working with residents transitioning to community living pursuant to 908 KAR 2:065 to offer basic instruction in ADLs and IADLs to each resident who is identified as working to transition to independent community living pursuant to 908 KAR 2:065. ADL and IADL skills training shall include instruction that is integrated into the normal rhythms of life.
(6) For purposes of subsection (5)(c) of this section:
(a) "Basic instruction" in ADLs and IADLs shall have the same meaning as "assistance with" ADLs and IADLs;
(b) An SPCH shall not be responsible for selecting which residents receive basic instruction in ADLs and IADLs; and
(c) An SPCH shall not be responsible for ensuring that a resident has mastered each task defined as an ADL or IADL.
Section 6. Mental Illness or Intellectual Disability (MI/ID) Supplement Program Certification.
(1) Office of Inspector General staff shall visit a personal care home to certify eligibility to participate in the MI/ID Supplement Program established by 921 KAR 2:015, Section 13.
(2) A personal care home's initial MI/ID Supplement Program certification inspection:
(a) May be separate from an unannounced inspection conducted in accordance with KRS 216.530; and
(b) Shall be in effect until the next licensure survey conducted in accordance with KRS 216.597(7)(c)2.
(3) During an MI/ID Supplement Program inspection, Office of Inspector General staff shall:
(a) Observe and interview residents and staff; and
(b) Review records to ensure that the facility:
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Maintains documentation of staff completion of the training required by 921 KAR 2:015, Section 14(1) through (4); and
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Complies with clauses a. and b. of this subparagraph.
a. The staff person who attended the one (1) day MI/ID training workshop shall share information obtained from the workshop with all other direct care staff through annual in-service training or orientation pursuant to Section 4(10)(h)3.f. of this administrative regulation.
b. If medication is administered to residents, administration shall be done by a nurse, administrator, or staff person designated by the administrator, shall demonstrate a knowledge of psychotropic drug side effects.
(4) Office of Inspector General staff shall review the facility's documentation of MI/ID training prior to performing a record review during the MI/ID Supplement Program inspection process.
(5) If at least thirty-five (35) percent of the resident population meets the criteria established by 921 KAR 2:015, Section 13(1)(c)2. on the day of the visit, a personal care home shall be deemed to have an ongoing qualifying percentage in the MI/ID Supplement Program effective with the month of request for certification in the program.
(6) Office of Inspector General staff shall provide the Department for Community Based Services with a completed STS-4, Mental Illness or Intellectual Disability (MI/ID) Supplement Certification Survey, incorporated by reference in 921 KAR 2:015, Section 17(1)(d), within fifteen (15) working days of an:
(a) Initial survey; or
(b) Inspection conducted in accordance with KRS 216.530 and 216.597(7)(c)2.
(7) The Office of Inspector General shall provide the Department for Community Based Services with a copy of a Type A citation issued to a specialized personal care home that participates in the MI/ID Supplement Program by the fifth working day of month following the month the citation was issued.
Section 7. Denial and Revocation.
(1) In addition to the reasons for denial or revocation of a license in accordance with 902 KAR 20:008, Section 8, the cabinet shall deny or revoke a PCH or SPCH license in accordance with KRS 216.597(7)(a) if:
(a) There has been a substantial failure by the facility to comply with the provisions of:
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KRS 216.510 through 216.597, or 216.789; or
-
This administrative regulation;
(b) The facility allows, aids, or abets the commission of any illegal act in the provision of services;
(c) The facility performs any act detrimental to the health, safety, or welfare of a resident;
(d) The facility obtains licensure by fraud or misrepresentation, including a false statement of a material in fact in:
-
The Application for Licensure to Operate an Assisted Living Community, incorporated by reference in 902 KAR 20:480; or
-
Any records required by this administrative regulation;
(e) The facility denies a representative of the cabinet access to any part of the facility's books, records, files, employees, or residents;
(f) The facility interferes with or impedes the performance of the duties and responsibilities of the long-term care ombudsman;
(g) The facility interferes with or impedes a representative of the cabinet in the enforcement of this administrative regulation or fails to fully cooperate with a survey or investigation by the cabinet;
(h) The facility destroys or makes unavailable any records or other evidence relating to the facility's compliance with this administrative regulation;
(i) The facility refuses to initiate a background check or otherwise fails to comply with the requirements of KRS 216.789;
(j) The facility fails to timely pay any fines assessed by the cabinet;
(k) The facility violates any applicable building or safety codes as determined by the building code or safety code enforcement authority with jurisdiction;
(l) There have been repeated incidents in the facility of personnel performing services beyond their competency level;
(m) The facility continues to operate beyond the scope of the facility's license after the timeframe established for correction of the violation; or
(n) An individual with a significant financial interest in the facility:
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Is convicted of a felony or gross misdemeanor that relates to the operation of the facility or directly affects resident safety or care; or
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Had the application returned in accordance with 902 KAR 20:008, Section 2(4)(b).
(2) The cabinet shall follow the notification requirements of 902 KAR 20:008, Section 8(2) and (3) for denial or revocation.
(3) In accordance with KRS 216B.105(2), the denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee files a request in writing for a hearing with the cabinet within thirty (30) days after the date of the notice.
Section 8. Material Incorporated by Reference.
(1) The form, "SMI Screening Form", August 2019, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m., or it may be viewed on the Office of Inspector General's Web site at https://chfs.ky.gov/agencies/os/oig/dhc/pages/ltc.aspx.
History
- RELATES TO: KRS 194A.700(1), (2), (15), (26), 194A.705(2)(c), 202A.011(12), 209.030, 209.032, 216.510 – 216.525, 216.530, 216.532, 216.555 - 216.597, 216.765, 216.785-216.793, 216A.080, 216B.010,216B.040, 216B.042, 216B.045-216B.130, 216B.990, 310.021, 310.031, 314.011(3), 21 C.F.R. Part 1317
- STATUTORY AUTHORITY: KRS 216B.042, 216.597(7)(a)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 216.597(7)(a) requires the cabinet to promulgate administrative regulations related to licensure and relicensure of personal care homes (PCHs) and specialized personal care homes (SPHCs). This administrative regulation establishes minimum licensure requirements for the operation of and services provided by personal care homes, including specialized personal care homes.
- History: 8 Ky.R. 227; eff. 11-5-1981; 11 Ky.R. 819; eff. 12-11-1984; 13 Ky.R. 351; eff. 9-4-1986; 18 Ky.R. 815; eff. 10-16-1991; 24 Ky.R. 190; eff. 8-20-1997; 25 Ky.R. 1232; eff. 1-19-1999; Cert eff. 4-30-2019; 46 Ky. R. 3286; 47 Ky.R. 484, 1132; eff. 7-29-2020; 50 Ky.R. 1576; 51 Ky.R. 51; eff. 7-30-2024.
902 KAR 20:041 Operation and services; family care homes {#sec-902-kar-20-041 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:041}
Section 1. Definitions.
(1) "Ambulatory" means able to walk without assistance.
(2) "Home" means a family care home.
(3) "Impaired capacity for self care" means mental or physical limitation which decreases the ability to function in a normal adult manner and requires supervision, assistance, or the use of prescription medicines to normalize daily living.
(4) "Licensee" means the operator of the family care home.
(5) "Mobile nonambulatory" means unable to walk without assistance, but able to move from place to place, and self exit the building, with the use of a device such as a walker, crutches, or wheelchair and capable of independent bed-to-chair transfer.
(6) "Protective environment" means an environment in which basic health care needs, personal care needs, nutritional needs and safety are insured for the resident who is not capable of providing these services in an effective manner.
(7) "Resident" means a person who is admitted to a family care home for the purpose of receiving personal care and assistance.
Section 2. Scope of Operations and Services. A family care home shall provide twenty-four (24) hour supervision and personal care services in residential accommodations for a resident who because of impaired capacity for self care, elects to have or requires a protective environment but does not have an illness, injury, or disability for which constant medical care or skilled nursing services are required. A resident shall be ambulatory or mobile nonambulatory and able to manage most of the activities of daily living.
Section 3. Operation and Management.
(1) The licensee shall be legally responsible for the operation of the home and for compliance with federal, state and local laws and regulations pertaining to the operation of the home.
(2) The licensee shall be a mature literate adult, at least eighteen (18) years of age, who has knowledge and understanding of adults who require supervision and personal care services.
(3) The licensee shall be directly responsible for the twenty-four (24) hour daily operation of the home and for delegating that responsibility to another similarly qualified individual if a temporary absence is necessary. The name of the individual to whom the responsibility may be delegated shall be in writing and provided to the representative of the Division of Licensing and Regulation inspecting the home.
(4) An employee of the home who contracts an infectious disease shall not appear for work until the infectious disease can no longer be transmitted.
(5) The licensee shall attend at least one (1) training program for family care home operators per year if offered or approved by the Cabinet for Health Services.
(6) The home shall have no more than three (3) residents who are not related to the operator within the third degree of consanguinity.
(7) The licensee shall provide opportunities for a resident to become involved in community activities and activities within the home. A resident in cooperation with the licensee and family shall be allowed to use areas of the home, other than his bedroom, such as living rooms, kitchen, dining areas, and recreation areas for entertainment, recreation, and visitation.
(8) The licensee shall maintain a record, located on the premises and available for inspection which contains the following information typed or in ink about each resident:
(a) Resident name and sex.
(b) Marital status.
(c) Birthdate and age.
(d) Religion and personal clergyman, if any, with consent of resident.
(e) Attending physician and dentist, if any; address and phone number for each.
(f) Next of kin or responsible person or agency, address and telephone number.
(g) Date of admission and discharge.
(h) Other relevant information including physician visits or assessment reports.
(i) Amount charged per week or month as compensation for care.
(9) The licensee shall make arrangements with other health agencies and facilities for residents who, at some time, may require a transfer to a different level of care.
(10) The licensee shall have phone numbers of a hospital, an ambulance service, fire department, and a physician for emergencies posted by the telephone in large legible print if phone service is available in the area.
(11) The licensee shall have a written procedure for providing or obtaining emergency services.
(12) The licensee shall:
(a) Make a written report of an accident involving a resident, an incident involving a resident's health, welfare or safety, and the death of a resident;
(b) Send the original, within seven (7) days of the incident, to the Cabinet for Health Services, Office of the Inspector General, Division for Licensing and Regulation, 275 East Main Street, Frankfort, Kentucky 40621; and
(c) Retain one (1) file copy.
(13) The licensee shall provide for patient rights pursuant to KRS 216.510 to 216.525.
(14) A resident shall be at least eighteen (18) years of age.
(15)
(a) A representative of the Division for Licensing and Regulation shall visit the home of the applicant for initial licensure.
(b) A representative of the Department for Social Services shall:
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Visit the home of the applicant upon notification by the Division of Licensing and Regulation; and
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Provide the division information relating to its prelicensure assessment of the applicant.
(16) An initial license shall be denied and an existing license shall be revoked if the applicant for licensure or the licensee has been convicted of a crime that has a bearing upon the applicant's suitability to operate a family care home, unless the applicant shows that:
(a) The crime occurred more than five (5) years ago; and
(b) The applicant has been sufficiently rehabilitated.
(17) An initial license shall be denied and an existing license shall be revoked if the applicant for licensure or the licensee:
(a) Has failed to assure that nutrition, medication, or treatment of an individual under his care is in accordance with acceptable professional practice;
(b) Has aided, abetted, sanctioned, condoned or participated in the commission of an illegal act involving an individual under his care; or
(c) Has had a license to operate a facility or service suspended or revoked during the three (3) years immediately proceeding an application for licensure.
(18) The licensee shall comply with KRS 216.532.
(19) The licensee shall report all cases of abuse, neglect, or exploitation of an adult pursuant to KRS 209.030(2) and (3).
Section 4. Services.
(1) Basic health and health related services.
(a) A family care home shall, through continuous supervision and monitoring, assure that a resident's health care needs are met by:
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Supervising self-administration of medication;
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Monitoring storage and control of medication; and
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Arranging for necessary therapeutic or physician services.
(b) A licensee shall not knowingly admit a person who has a communicable disease which is reportable to the health department, except a noninfectious tuberculosis patient under continuing medical supervision for his tuberculosis disease.
(c) If a resident is suspected of having a communicable disease that would endanger the health and welfare of another resident, the licensee shall assure that a physician is contacted and that medically appropriate measures are taken on behalf of that resident and the other residents in the home.
(d) The licensee shall show evidence that a resident has obtained a physical examination by a physician within three (3) months prior to admission to the home. If admitted from another health care facility, a discharge summary or transfer form shall be in the resident's record which includes a medical history, record of physical examination and diagnosis.
(e) The licensee shall obtain the services of a physician in case of accident or acute illness of a resident.
(f) A prescription medication administered to a resident shall be noted in writing, with the date, time and dosage, and signed by the person administering the medication.
(g) Medication shall not be administered to a resident except on the written order of a physician or other practitioner acting within the limits of his statutory scope of practice. If medication requires administration by a licensed person, an arrangement shall be made to procure the services of a person licensed to administer medication.
(h) A medication kept in the home shall be kept in a locked cabinet.
(i) Self-administration of a prescription medication shall be allowed only upon the written instruction of the attending physician or other practitioner acting within the limits of his statutory scope of practice.
(j) A resident admitted or retained for care shall not require because of illness, injury or disease, a degree of care exceeding the skill of the operator to provide.
(2) Personal care services.
(a) A resident in a family care home shall be assisted to achieve and maintain good personal hygiene by providing assistance as required by individual needs with:
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Washing and bathing of the body to maintain clean skin and freedom from offensive odors with the following items provided for each resident and not used by others: soap, clean towels and wash cloths, brushes and combs and other appropriate toilet articles.
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Shaving.
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Cleaning of the mouth and teeth to maintain good oral hygiene as well as care of the lips to prevent dryness and cracking. A resident shall be provided with a toothbrush, dentifrice, and denture container, if applicable.
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Washing, grooming and cutting of hair.
(b) The home shall provide each resident with a bureau or cupboard for storage of personal belongings.
(c) The home shall provide each resident with a bed equipped with substantial springs, a clean comfortable mattress, two (2) sheets, a pillow, and bed covering as required for resident's health and comfort.
(d) A resident shall be allowed rest periods in his own bed if he desires.
(3) Dietary services.
(a) Food shall be prepared with consideration for individual dietary requirements and appetites.
(b) The menu shall be planned in writing and rotated to avoid repetition. A written record shall be kept of foods served, including food offered as snacks.
(c) Nutritional needs shall be met in accordance with the current recommended dietary allowances of the Food and Nutrition Board of the National Research Council and adjusted for age, sex, and activity in accordance with physician's orders.
(d) Food returned from residents' dishes shall be discarded at the conclusion of the meal and not served again in any form.
(e) Therapeutic diets. A special diet or dietary restriction shall be medically prescribed.
(f) At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the evening meal and breakfast. A snack shall be provided if desired or requested by a patient, except if it conflicts with a special diet prescribed by a licensed physician.
(g) Food shall be stored above the floor so as to be protected from dust, flies, vermin, or other forms of contamination.
(h) Each refrigerator shall have a complete seal, be clean, free of odors, and kept at a temperature below forty-five (45) degrees Fahrenheit. A thermometer shall be placed in each refrigerator and freezer.
(i) Food showing evidence of spoilage or infestation shall be disposed of immediately upon detection.
(4) Housekeeping and sanitation. Each family care home shall:
(a) Maintain a clean, uncluttered and safe facility with screens on doors and windows;
(b) Eliminate odors at their source by prompt and thorough cleaning of commodes, and other obvious sources;
(c) Maintain the premises so as to prevent infestation by rodents and insects;
(d) Change bed linens as often as necessary to provide a clean bed at all times. A mattress pad or other protective covering (excluding paper) shall be used on mattresses;
(e) Give soiled clothing and linens immediate attention and not allow them to accumulate. Clothing or bedding used by one (1) patient shall not be used by another until it has been laundered or dry cleaned;
(f) Have appropriate toilet facilities which dispose of wastes in a sanitary manner into a public system where available, or if none is available, disposal shall be made into a private system designed, constructed and operated in accordance with the requirements of the cabinet; except if a public sewerage system subsequently becomes available, connections shall be made to that system and any other sewerage system shall be discontinued. An outside toilet shall be allowed if local county health department approves; and
(g) Collect and dispose of all garbage, refuse, trash, and litter in compliance with applicable state and local laws and administrative regulations. A garbage container shall be made of metal or other impervious material and shall be water tight and rodent proof and shall have tight-fitting covers.
Section 5. Accommodations. Each family care home shall:
(1) Be safe and of substantial construction and comply with applicable state and local laws relating to location, zoning, plumbing, and sanitation.
(2) Be adequately lighted by natural or artificial light including each hall, stairway, entryway, patient area, kitchen, and bathroom.
(3) Have a water supply of a safe, sanitary quality approved by the local health department or other qualified laboratory or agency.
(4) Have an ample supply of hot and cold running water available at all times for general use. The water temperature at a tap used by a resident shall not exceed 110 degrees Fahrenheit.
(5) Have appropriate sanitary toilet and bathing facilities conveniently available for resident use with no less than one (1) toilet and lavatory per six (6) persons residing in the home.
(6) Have adequate ventilation in areas used by residents. A toilet room shall be vented to the outside, if there is no window. There shall be an exterior window in each resident room, which can be opened.
(7) A bed occupied by a resident shall be placed so that the resident shall not experience discomfort due to proximity to a radiator, heat outlet, or exposure to drafts.
(8) Not use "bunk" beds.
(9) Have beds that are no less than thirty-three (33) inches wide and six (6) feet long.
(10) Not house a resident in a room or detached building or other enclosure that has not been previously inspected and approved for resident use, or in a basement not constructed for sleeping quarters. An approved basement shall have an outside door.
(11) Not be located in a house trailer or motor home.
(12) Provide a heating system which can maintain an even temperature of at least seventy-two (72) degrees Fahrenheit in resident occupied areas under winter conditions and a maximum temperature of eighty-five (85) degrees under summer conditions.
(13) Have telephone service, if available in the area, accessible to the residents.
(14) If the home accepts a resident who uses a wheelchair, insure that the resident is able to exit the building without assistance (i.e., ramps, rails, etc.).
(15) Have a three (3) day supply of food on hand at all times.
Section 6. Safety. Each home shall take appropriate precautions to insure the safety of the residents and visitors by having:
(1) Exterior grounds including sidewalks, steps, porches, ramps, and fences in good repair;
(2) The home's interior including walls, ceilings, floors, floor coverings, steps, windows, window coverings, doors, plumbing, and electrical fixtures in good repair;
(3) A fire control and evacuation plan;
(4) An adequate number of ABC-rated fire extinguishers located throughout the home with a minimum of one (1) per floor or level of the residence;
(5) A person in charge thoroughly oriented in the evacuation of the residents in the event of a fire;
(6) Firearms and ammunition locked in a cabinet, drawer, or closet with the key not accessible to residents. Firearms shall not be loaded; and
(7) At least two (2) functioning smoke detectors in the home, one of which shall be in each resident bedroom or in a hall adjacent to the resident bedroom.
History
- RELATES TO: KRS 209.030(1)- (3), 216.510-216.525, 216.532, 216B.010, 216B.015, 216B.030, 216B.105, 216B.990, 311.560(4), 314.011(8), 314.042(8), 320.210(2)
- STATUTORY AUTHORITY: KRS 209.030(1), 216B.010, 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Cabinet for Health Services regulate health facilities and health services. This administrative regulation provides for the licensure requirements for the operation of family care homes.
- History: 902 KAR 020:041. 8 Ky.R. 232; eff. 11-5-1981; 11 Ky.R. 1183; eff. 3-12-1985; 18 Ky.R. 820; eff. 10-16-1991; 23 Ky.R. 2863; eff. 2-19-1997; 25 Ky.R. 1722; 2165; eff. 3-17-1999; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:046 Facility specifications; nursing homes {#sec-902-kar-20-046 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:046}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the board for the purpose of operating a nursing home facility.
(3) "Licensure Agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Preparation and Approval of Plans and Specifications.
(1) Before alterations are begun to existing buildings or any change in existing nursing home facilities, the licensee or applicant shall submit plans to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear either the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) All such plans and specifications must be approved by the licensure agency prior to commencement of alteration of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications must be approved by the Department of Housing, Buildings and Construction and appropriate local building permits shall be obtained prior to commencement of any alteration.
Section 3. Submission of Plans and Specifications.
(1) First stage, schematic plans.
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical patient room layouts (scaled one-fourth (1/4) inch to one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(b) If the project is an addition or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangements of those buildings.
(2) Second stage, preliminary plans. Preliminary sketch plans shall include the following:
(a) Architectural: plans of basement and floors.
(b) Outline specifications.
-
General description of the alteration, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls, duct and piping systems; and dietary, laundry, sterilizing, and other special equipment;
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General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage. Contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems. Details of construction, machine and control space necessary, size and type of equipment, and utility requirements for the following: dumbwaiters - electric, hand, hydraulic; elevators - freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems. Radiators and steam heated equipment, such as sterilizers, warmers, and steam tables; heating and steam mains and branches with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heater with stokers; oil burners, or gas burners; pumps, tanks, boiler breeching, and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping, and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems. Size and elevation of: street sewer, house sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold and circulating branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections; gas, oxygen, and vacuum systems; standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electrical service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits;
g. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
-
Cover or title sheet;
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Index;
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Sections describing materials and workmanship in detail for each class of work;
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Access to the work. Representatives of the appropriate state agencies shall have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances and Administrative Regulations.
(1) This section be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended;
(b) Requirements for plumbing pursuant to 815 KAR 20:010 to 20:190, as amended;
(c) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010;
(d) Requirements for elevators pursuant to 815 KAR 4:010; and
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(4) Prior to occupancy, facility must have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code before relicensure is granted by the licensure agency.
Section 5. Facility Requirements and Special Conditions.
(1) Independent facilities with a capacity of fifty (50) beds or less present special problems. The sizes of the various departments will depend upon the requirements of the facilities. Some functions allotted separate spaces or rooms in these general standards may be combined provided that the resulting plan will not compromise the standards of safety and of medical and nursing practices and the social needs of patients. In other respects, the general standards set forth herein, including the area requirements, shall apply.
(2) Facilities shall be available to the public, staff, and patients who may be physically handicapped with special attention given to ramps, drinking fountain height, mirrors, etc.
(3) The number of beds in a nursing unit shall not exceed sixty (60) unless additional services are provided, as deemed necessary by the state agency. At least two (2) rooms per nursing unit shall be designed for single person occupancy (one (1) bed) and shall have private toilet rooms with bath. At least sixty (60) percent of the beds shall be located in rooms designed for one (1) or two (2) beds.
Section 6. Nursing Unit.
(1) Patient rooms. Each patient room shall meet the following requirements:
(a) Maximum room capacity: four (4) patients;
(b) Patient rooms shall be designed to permit no more than two (2) beds side by side parallel to the window wall. Not less than a four (4) foot space shall be provided between beds, and at least a three (3) foot space between the side of a bed and the nearest wall, fixed cabinet, or heating/cooling element. A minimum of four (4) feet is required between foot of bed and opposite wall, or foot of opposite bed in multibed rooms;
(c) Window. All patient rooms must have windows opening to the outside. Sill shall not be higher than three (3) feet above the floor and shall be above grade. Window area to be at least eight (8) percent of patient room floor area;
(d) Lavatory. In single and two (2) bed rooms with private toilet room, the lavatory may be located in the toilet room. Where two (2) patient rooms share a common toilet, a lavatory shall be provided in each patient room;
(e) Wardrobe or closet for each patient. Minimum clear dimensions: one (1) foot deep by one (1) foot and eight (8) inches wide with full length hanging space clothes rod and shelf;
(f) Cubicle curtains, or equivalent built-in devices for complete privacy for each patient in each multibed room and in tub, shower and toilet rooms;
(g) No patient room shall be located more than 120 feet from the nurses' station, the clean workroom, and the soiled workroom. No room shall be used as a patient room where the access is through another patient's room.
(2) Patient toilet rooms.
(a) A toilet room shall be directly accessible from each patient room and from each central bathing area without going through the general corridor. One (1) toilet room may serve two (2) patient rooms but not more than four (4) beds. The minimum dimensions of any room containing only a toilet shall be three (3) feet by five (5) feet;
(b) Toilets must be easily usable by wheelchair patients. Grab bars shall be provided at all toilets;
(c) At least one (1) toilet for each sex shall be provided for training purposes and access by wheelchairs. It shall be accessible from the nursing corridor, may be part of the bathing area and shall have a minimum size, of five (5) feet by six (6) feet;
(d) Doors to toilet rooms shall have a minimum width of two (2) feet and ten (10) inches to admit a wheelchair.
(3) Service areas in each nursing unit. The size of each service area will depend on the number and types of beds within the unit and shall include:
(a) Nurses' station for nurses' charting, doctors' charting, communications, and storage for supplies and nurses' personal effects;
(b) Staff lounge area. The area shall have personal storage space and a toilet room for staff;
(c) Visitors toilet room. The facility shall provide a toilet room for visitors. The staff toilet room may serve as the visitors toilet room if marked and accessible;
(d) Clean workroom for storage and assembly of supplies for nursing procedures containing work counter, sink, and small sterilizer;
(e) Soiled workroom containing clinical sink, work counter with two (2) compartment sink, waste receptacles, and soiled linen receptacles;
(f) Medicine room adjacent to nurses' station with sink, refrigerator, locked storage, and facilities for preparation and dispensing of medication. (May be designated area within clean workroom if a self-contained cabinet is provided.) The controlled substances locker must be under double lock and wired to warning light at nurses' station;
(g) Clean linen storage with enclosed storage space (may be a designated area within the clean workroom);
(h) Nourishment station with storage space, sink, hot plate and refrigerator for serving between-meal nourishments (may serve more than one (1) nursing unit on the same floor);
(i) Equipment storage room for storage of IV stands, inhalators, air mattresses, walkers, and similar bulky equipment;
(j) Patient baths. One (1) shower stall or one (1) bathtub required for each fifteen (15) beds not individually served. There shall be at least one (1) free standing bathtub in each bathroom. Grab bars or patient lift with a safety device shall be provided at all bathing fixtures. Each bathtub or shower enclosure in central bathing facilities shall provide space for the private use of bathing fixture, for dressing, and for a wheelchair and attendant. Showers in central bathing facilities shall not be less than four (4) feet square, without curbs, and designed to permit use from a wheelchair. Soap dishes in showers and bathrooms shall be recessed;
(k) Stretcher and wheelchair parking area or alcove;
(l) Janitor's closet for storage of housekeeping supplies and equipment. Floor receptor or service sink;
(m) Bedpan washing facilities. Bedpan washing attachments are recommended for each patient room toilet. It will be acceptable, however, to have separate bedpan washing closets in each nursing unit, provided that they are so located that bedpans need not be carried through lobbies, dining and recreation areas, or day rooms.
(4) Special purposes room(s) for consultation, examination and treatment, and therapeutic and nursing procedures. (May serve more than one (1) nursing unit on the same floor.) These rooms shall include a lavatory, storage space, and space for a treatment table and have a minimum floor area of nine (9) feet by eleven (11) feet.
(5) Patients' dining, TV viewing and recreation areas.
(a) The total areas set aside for these purposes shall be not less than thirty (30) square feet per bed for the first fifty (50) beds and twenty (20) square feet per bed for all beds in excess of fifty (50). Additional space shall be provided for outpatients if they participate in a day care program.
(b) Storage shall be provided for recreational equipment and supplies (e.g., wall cabinet and closets).
Section 7. Therapy Units.
(1) If the facility has a physical therapy unit the following shall be provided (depending on the program):
(a) Office (may also serve for occupational therapy office);
(b) Exercise and treatment areas with sink or lavatory and cubicle curtains around treatment areas;
(c) Hydrotherapy areas with cubicle curtains around treatment areas;
(d) Storage for supplies and equipment; and
(e) Toilet rooms located for convenient access by physical therapy patients (may also serve occupational therapy patients).
(2) If the facility has an occupational therapy unit it shall include:
(a) Office space (may be shared with physical therapy office);
(b) Therapy area with sink or lavatory;
(c) Storage for supplies and equipment;
(d) Toilet room (Not required if other toilet facilities are convenient).
(3) Personal care room with space for shampoo sink and barber chair (not required in facility of less than twenty-five (25) beds).
Section 8. Dietary Department. If a commercial service will be used or meals will be provided by an adjacent hospital, dietary areas and equipment shall be designed to accommodate the requirements for sanitary storage, processing, and handling, otherwise the following shall be provided:
(1) Food preparation center with a lavatory but no mirror;
(2) Food serving facilities to accommodate patients and staff;
(3) Dishwashing room with commercial-type dishwashing equipment and a lavatory;
(4) Pot-washing facilities;
(5) Refrigerated storage to accommodate three (3) day supply;
(6) Dry storage to accommodate three (3) day supply;
(7) Cart cleaning facilities;
(8) Cart storage area;
(9) Waste disposal facilities;
(10) Can-washing facilities;
(11) Staff dining facilities;
(12) Patient dining facilities;
(13) Dietician's office (may be omitted in facilities with less than 100 beds if desk space is provided in kitchen);
(14) Janitor's closet with storage for housekeeping supplies and equipment, floor receptor or service sink; and
(15) Toilet room which is conveniently accessible to dietary staff with a two (2) door separation from food preparation area or dining area.
Section 9. Administration Department. The facility shall have adequate administrative, public, and staff facilities (e.g., offices, lobby, toilet facilities) to accommodate the needs of the public, patients, and staff without interfering with the provision of medical care services.
Section 10. Laundry. The following shall be included:
(1) Soiled linen room;
(2) Clean linen and mending room;
(3) Linen cart storage;
(4) Lavatories accessible from soiled, clean, and processing rooms;
(5) Laundry processing room with commercial type equipment sufficient to take care of seven (7) days' needs within the workweek;
(6) Janitor's closet with storage for housekeeping supplies and equipment, floor receptor or service sink; and
(7) Storage for laundry supplies. (Subsections (5), (6), and (7) of this section need not be provided if laundry is processed outside the facility.)
Section 11. Storage and Service Areas.
(1) Central storage room(s) with at least ten (10) square feet per bed for first fifty (50) beds; and five (5) square feet per bed for all beds over fifty (50), to be concentrated in one (1) area.
(2) Locker rooms with toilets, and lavatories for staff and volunteers and rest space for females.
(3) Engineering service and equipment areas. The following shall be provided:
(a) Boiler room;
(b) Engineers' office (may be omitted in facilities of less than 100 beds);
(c) Mechanical and electrical equipment room(s) (can be combined with boiler room);
(d) Maintenance shop(s). At least one (1) room shall be provided (can be combined with boiler room in nursing homes of less than fifty (50) beds);
(e) Storage room for building maintenance supplies and paint storage;
(f) Storage room for housekeeping equipment (need not be provided if space is available in janitor's closets or elsewhere);
(g) Toilet and shower rooms (may be omitted in nursing homes of less than 100 beds);
(h) Incinerator space. If the facility has an incinerator, it shall be in a separate room, in a designated area within the boiler room, or outdoors;
(i) Refuse room for holding trash prior to disposal located convenient to service entrance; and
(j) Yard equipment storage room for yard maintenance equipment and supplies.
Section 12. Details and Finishes. The facility shall be designed for maximum safety for the occupants to minimize the incidence of accidents. Hazards such as sharp corners shall be avoided. All details and finishes shall meet the following requirements:
(1) Details.
(a) Doors to patient toilet rooms and other rooms needing access for wheelchairs shall have a minimum width of two (2) feet and ten (10) inches.
(b) Such items as drinking fountains, telephone booths and vending machines shall be located so that they do not project into the required width of exit corridors.
(c) Handrails shall be provided on both sides of corridors used by patients in facilities with a clear distance of one and one-half (1 1/2) inches between handrail and wall.
(d) All doors to patient-room toilet rooms and patient-room bathrooms shall swing outward or shall be equipped with hardware which will permit access in any emergency.
(e) All doors opening onto corridors shall be swing-type except elevator doors. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
(f) Thresholds and expansion joint covers, if used, shall be flush with the floor.
(g) Grab bars and accessories in patient toilet, shower, and bathrooms shall have sufficient strength and anchorage to sustain a load of 250 pounds for five (5) minutes.
(h) Lavatories intended for use by patients shall be installed to permit wheelchairs to slide under.
(i) The location and arrangement of lavatories and sinks with blade handles intended for hand-washing purposes shall provide sixteen (16) inches clearance each side of center line of fixture.
(j) Mirrors shall be arranged for convenient use by patients in wheelchairs as well as by patients in standing position.
(k) Towel dispensers shall be provided at all lavatories and sinks used for hand-washing.
(l) If linen and refuse chutes are used, they shall be designed as follows:
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Minimum diameter of gravity-type chutes shall be two (2) feet;
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Chutes shall extend at least four (4) feet above the roof and shall be covered by a metal skylight glazed with thin plain glass or plastic.
(m) Ceiling heights.
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The boiler room ceiling shall not be less than two (2) feet six (6) inches above the main boiler header and connecting piping with nine (9) feet headroom under piping for maintenance and access;
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Corridors, storage rooms, patients' toilet room, and other minor rooms shall not be less than seven (7) feet and six (6) inches;
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Ceilings in all other rooms shall not be less than eight (8) feet.
(n) Boiler room, food preparation centers, and laundries shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of eighty-five (85) degrees Fahrenheit.
(o) Noise reduction criteria. Provision shall be made to minimize sound transmission in:
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Corridors in patient areas;
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Nurses' stations;
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Utility rooms;
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Floor pantries; and
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Lobbies and recreation areas.
(p) Special attention shall be given to sound transmission from boiler rooms, mechanical rooms, and kitchen, to patient bedroom areas.
(2) Finishes.
(a) Floors generally shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchen and related spaces shall be waterproof and grease-proof. In all areas where floors are subject to wetting, they shall have a nonslip finish. Carpeting is not permitted in the following areas: kitchen, dishwashing room, soiled utility room, janitor's closet, soiled linen rooms, storage room, bathrooms, public toilet rooms, patient toilet rooms, hydrotherapy rooms, treatment rooms, and any other room where the floor is subject to repeated wetting or soiling.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable, and in the immediate area of plumbing fixtures, the finish shall be moisture-proof. Wall bases in dietary areas shall be free of spaces that can harbor insects.
(d) Ceilings generally shall be washable or easily cleanable. This requirement does not apply to boiler rooms, mechanical and building equipment rooms, shops and similar spaces.
Section 13. Elevators. All facilities where either patient beds or inpatient facilities such as diagnostic, recreation, patient dining or therapy rooms are located on other than the first floor, shall have electric or electrohydraulic elevators as follows:
(1) Number of elevators. All facilities with patient beds or residential facilities located on any floor other than the first floor shall have at least one (1) hospital-type elevator and such additional elevators as determined by the licensure agency from a study of the facility plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Elevator cars and platforms shall be constructed of noncombustible material, except that fire-retardant-treated material may be used if all exterior surfaces of the cars are covered with metal. Cars of hospital-type elevators shall have inside dimensions that will accommodate a patient's bed and attendants and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep. Car doors shall have a clear opening of not less than three (3) feet and eight (8) inches. Cars of all other required elevators shall have a clear opening of not less than three (3) feet.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
Section 14. Foundations. Foundations shall rest on natural solid ground if a satisfactory soil is available at reasonable depths. Proper soil bearing values shall be established in accordance with recognized standards. If solid ground is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement.
Section 15. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect and/or engineer shall obtain certification from the contractor that all mechanical systems have been tested and that the installation and performance of these systems conform to the requirements of the plans and specifications.
(2) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) must be provided. The combined capacity of the boilers, based upon the published Steel Boiler Institute of Boiler and Radiator Manufacture's net rating, must be able to supply 150 percent of the normal requirements of all systems and equipment.
(b) Covering. Boiler and smoke breeching, all steam supply piping and high pressure steam return piping, and hot water space heating supply and return piping shall be insulated.
(3) Temperatures and ventilating systems.
(a) Temperatures. A minimum temperature of seventy-two (72) degrees Fahrenheit shall be provided for in all occupied areas in winter conditions. A maximum temperature of eighty-five (85) degrees Fahrenheit shall be provided for in occupied areas in summer conditions.
(b) Ventilation system details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates shown in Section 17, Table 1 of this administrative regulation, shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates if they are required to meet design conditions.
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Outdoor ventilation air-intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five (25) feet from the exhausts from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight (8) feet above the ground level or, if installed through the roof, three (3) feet above roof level.
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The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas shown in Section 17, Table 1 of this administrative regulation.
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Room supply air inlets, recirculation, and exhaust air outlets installed in nonsensitive areas shall be located not less than three (3) inches above the floor.
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Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate bathrooms, toilet rooms, or janitor's closets opening directly into corridors.
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Filters. Central systems shall be provided with filters rated at eighty (80) percent efficiency based upon the National Bureau of Standards Dust Spot Method with Atmospheric Dust.
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A manometer shall be installed across each filter bed serving central air systems.
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The air from dining areas may be used to ventilate the food preparation areas only after it has been passed through a filter with eighty (80) percent efficiency.
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Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and required temperatures in the facility.
(4) Plumbing and other piping systems.
(a) Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five (5) inches above the rim of the fixture. All fixtures used by medical and nursing staff, and all lavatories used by patients and food handlers shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall be at a distance from the center line of the sink to be operational.
(b) Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
(5) Water supply system.
(a) Systems shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.
(b) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
(c) Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.
(d) Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitor's sinks and bedpan flushing attachments.
(e) Flush valves installed on plumbing fixtures shall be of a quiet operating type, equipped with silencers.
(f) Bedpan flushing devices shall be provided.
(g) Hot water distribution systems shall be arranged to provide hot water at each fixture at all times.
(h) Plumbing fixtures which require hot water and which are intended for patient use shall be supplied with water which is controlled to provide a maximum water temperature of 110 degrees Fahrenheit at the fixture.
(i) Piping over food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of, or condensation from, necessary overhead piping systems.
(6) Hot water heaters and tanks.
(a) The hot water heating equipment shall have sufficient capacity to supply the water at the temperature and amounts indicated below:
(b) Storage tank(s) shall be provided and shall be fabricated of corrosion-resistant metal, or have noncorrosive lining.
(7) Plumbing approval. Prior to final approval of the plans and specifications by the licensure agency, the plumbing plans and specifications must be approved by the Division of Plumbing, Department of Housing, Buildings and Construction.
Section 16. Electrical Requirements.
(1) Electrical requirements of the Kentucky Building Code shall apply where applicable.
(2) The wiring in each facility shall be inspected by a certified electrical inspector and a certificate of approval shall be issued to the facility, prior to occupancy. However, the wiring in existing buildings shall be approved by a certified electrical inspector only when the building has not been previously so approved for health care occupancy or where the State Fire Marshal finds that a hazardous condition exists.
(3) Switchboard and power panels. All breakers and switches shall be indexed.
(4) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have electric lighting.
(b) Patients' bedrooms shall have general lighting and night lighting. A reading light shall be provided for each patient. A fixed receptacle type night light mounted approximately sixteen (16) inches above the floor, shall be provided in each patient room. Patients' reading lights and other fixed lights not switched at the door shall have switch controls convenient for use at the luminaire. All switches for control of light in patient areas shall be of the quiet operating type.
(c) Lighting levels for the facility shall comply with the requirements of Section 17, Table 2 of this administrative regulation.
(5) Receptacles. Convenience outlets.
(a) Bedroom. Each patient bedroom shall have duplex receptacles on each side of the head of each bed (for parallel adjacent beds, only one (1) receptacle is required between the beds), receptacles for luminairies, television and motorized beds, if used, and one (1) receptacle on another wall.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of ends of corridors.
(6) Nurses' calling system. A nurses' calling station shall be installed at each patient bed and in each patient toilet, bath, and shower room. The nurses' call in toilet, bath, or shower rooms shall be an emergency call. All calls shall register at the nurses' station and shall actuate a visible signal in the corridor at the patients' door, in the clean workroom, soiled workroom, and nourishment station of the nursing unit. Nurses' call systems which provide two (2) way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operative.
(7) Emergency electric service.
(a) General. To provide electricity during an interruption of the normal electric supply that could affect the nursing care, treatment, or safety of the occupants, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) Sources. The source of this emergency electric service shall be as follows:
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An emergency generating set, when the normal service is supplied by one (1) or more central station transmission lines;
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An emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
(c) Emergency generating set.
-
The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electric system. The emergency generator set shall be sufficient kilowatt capacity to supply all electrical connections itemized in paragraph (d) of this subsection.
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In facilities constructed prior to the effective date of this administrative regulation which are supplied by at least two (2) dedicated and separate utility service feeders, an emergency generating set is not required.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto, including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors;
b. Dining and recreation rooms;
c. Nursing station and medication preparation area;
d. Generator set location, switch-gear location, and boiler room;
e. Elevator; and
f. Night lights in patient rooms.
- Equipment. Essential to life safety and for protection of important or vital materials:
a. Nurses' calling system;
b. Alarm system including fire alarm actuated at manual stations, water flow alarm devices of sprinkler system if electrically operated, fire detecting and smoke detecting systems, paging or speaker systems if intended for issuing instructions during emergency conditions, and alarms required for nonflammable medical gas systems, if installed;
c. Fire pump, if installed;
d. Sewerage or sump lift pump, if installed;
e. At least one (1) duplex receptacle in each patient room;
f. One (1) elevator, where elevators are used for vertical transportation of patients. Provide manual switch-over to operate other elevators;
g. Equipment such as burners and pumps necessary for operation of one (1) or more boilers and their necessary auxiliaries and controls, required for heating and sterilization; and
h. Equipment necessary for maintaining telephone service.
- Heating. Where electricity is the only source of power normally used for space heating, the emergency service shall provide for heating of patient rooms. Emergency heating of patient rooms will not be required in areas where the facility is supplied by at least two (2) utility service feeders, each supplied by separate generating sources or a network distribution system fed by two (2) or more generators, with the facility feeders so routed, connected, and protected that a fault any place between the generators and the facility will not likely cause an interruption of more than one (1) of the facility service feeders.
(e) Details. The emergency system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting, all alarms, nurses' call, equipment necessary for maintaining telephone service, and receptacles in patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification. Storage battery powered lights shall not be used as a substitute for the requirement of a generator. Where fuel is normally stored on the site, the storage capacity shall be sufficient for twenty-four (24) hour operation of required emergency electric services. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.
Section 17. Tables.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides licensure requirements for structural specifications for the alteration and maintenance of existing nursing home facilities.
- History: 902 KAR 020:046. 8 Ky.R. 391; eff. 1-6-1982; Am. 16 Ky.R. 972; eff. 1-12-1990; crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:048 Operation and services; nursing homes {#sec-902-kar-20-048 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:048}
Section 1. Definitions.
(1) "Activities of daily living" is defined by KRS 194A.700(1).
(2) "Administrator" means a person who has a license to practice long-term care administration pursuant to KRS 216A.080.
(3) "Licensed dietitian" means a health care professional who is licensed pursuant to KRS 310.021.
(4) "Nursing home" means an establishment located in a permanent building that has resident beds and provides:
(a) Medical services; and
(b) Continuous nursing services.
(5) "PRN medications" means medications administered as needed.
(6) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a portion of a resident's body.
Section 2. Administration and Operation.
(1) Licensee. The licensee shall:
(a) Be legally responsible for:
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The operation of the facility; and
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Compliance with federal, state and local laws, and administrative regulations pertaining to the operation of the facility; and
(b) Contract for professional and supportive services not available in the facility as dictated by the needs of each resident.
(2) All facilities shall have an administrator who shall:
(a) Be responsible for the day-to-day operation of the facility; and
(b) Designate one (1) or more staff to act on behalf of the administrator or to perform the administrator's responsibilities in the administrator's absence.
(3) Administrative records.
(a) The facility shall maintain a resident registry that documents the:
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Name of each resident;
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Date of admission; and
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Date of discharge.
(b) The facility shall maintain a record of written recommendations or comments from consultants regarding the program and its development on a per visit basis.
(c) The facility shall maintain menu and food purchase records.
(d)
- The administrator or administrator's designee shall make a written report of any incident or accident involving a:
a. Resident,including a medication error or drug reaction;
b. Visitor; or
c. Staff member.
- The report shall:
a. Identify any staff member who witnessed the incident; and
b. Be filed in an incident file.
(4) Policies. The facility shall have written policies and procedures that govern all services provided by the facility. The policies shall:
(a) Address resident care and services, including physician, nursing, pharmaceutical, and residential services;
(b) Require the reporting of cases of abuse, neglect, or exploitation of adults pursuant to KRS 209.030, including evidence that all allegations of abuse, neglect, or exploitation shall be thoroughly investigated internally to prevent further potential abuse while the investigation is in progress;
(c) Prohibit the use of chemical and physical restraints, except as authorized by KRS 216.515(6); and
(d) Specify in a step-by-step manner the actions that shall be taken by staff if a resident is lost, unaccounted for, or on other unauthorized absence.
(5) Resident rights shall be provided for pursuant to KRS 216.510 to 216.525.
(6) Admission.
(a) A resident in a nursing home shall:
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Be admitted only upon the referral of a physician;
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Have a medical condition that requires:
a. Medical services;
b. Continuous nursing services; and
c. Residential care, but not inpatient hospital services; and
- Not have care needs that exceed the capability of the facility.
(b)
- Upon admission, the facility shall obtain the:
a. Resident's medical diagnosis;
b. Physician's orders for the care of the resident; and
c. Transfer form.
- Within forty-eight (48) hours after admission, the facility shall obtain a medical evaluation from the resident's physician including:
a. Current medical findings;
b. Medical history; and
c. Physical examination.
- The medical evaluation may be a copy of the discharge summary or history and physical report from a hospital or nursing facility, if done within five (5) days prior to admission.
(c) Upon admission, the facility shall provide the resident and a responsible member of the resident's family or other designated representative with written information regarding the facility's policies, including:
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Services offered and charges;
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Visitation rights during serious illness;
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Visiting hours; and
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Type of diets offered.
(d) The facility shall maintain a system for:
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Identifying each resident's personal property; and
-
Safekeeping valuables, including assurance that each resident's clothing and other property is reserved for the resident's own use.
(7) Discharge planning. The facility shall have a discharge planning program to ensure the continuity of care for residents who are:
(a) Transferred to another health care facility; or
(b) Discharged to the home.
(8) Transfer and discharge.
(a) The facility shall:
-
Comply with the requirements of 900 KAR 2:050 upon transferring or discharging a resident; and
-
Have written transfer procedures and agreements for the transfer of a resident to a higher intensity level of care, if indicated.
(b) A facility that does not have a transfer agreement in effect, but has attempted in good faith to enter into an agreement shall be considered to be in compliance with the requirements of paragraph (a)2. of this subsection.
(c) The transfer procedures and agreements shall:
-
Specify the responsibilities each party assumes in the transfer of residents;
-
Establish responsibility for notifying the other party of an impending transfer; and
-
Arrange for appropriate and safe transportation of the resident and resident's files.
(d) Except in cases of emergency, the administrator shall:
-
Initiate a transfer through the resident's physician if the resident's condition exceeds the scope of services of the facility; or
-
Contract for services from another community resource to meet a resident's needs.
(e) If a resident's condition improves and the resident may be served in a less restrictive environment, the facility shall offer assistance in making arrangements for the resident to be transferred to a lower intensity level of care.
(f) Except in an emergency, the resident, resident's responsible family member,or guardian, if any, and the attending physician shall be consulted in advance of the transfer or discharge.
(g) If a resident transfers to another level of care, the complete medical record or a current summary of the resident's medical record shall accompany the resident.
(h) If the resident is transferred to another health care facility or home to receive home health services, a transfer form shall:
-
Accompany the resident; and
-
Include the following:
a. Physician's orders (if available);
b. Current information regarding the resident's diagnosis with a history of any health conditions that require special care;
c. A summary of prior treatment, special supplies, or equipment needed for the resident's care; and
d. Pertinent social information on the resident and resident's family.
(9) Tuberculosis testing.
(a) All employees of a nursing home shall be screened and tested for tuberculosis in accordance with the provisions of 902 KAR 20:205.
(b) Residents of a nursing home shall be screened and tested in accordance with 902 KAR 20:200.
(10) Personnel.
(a) In accordance with KRS 216.532, a nursing home shall not employ or be operated by an individual who is listed on the nurse aide and home health aide abuse registry established by 906 KAR 1:100.
(b) In accordance with KRS 209.032, a nursing home shall not employ or be operated by an individual who is listed on the vulnerable adult maltreatment registry established by 922 KAR 5:120.
(c) A nursing home shall obtain a criminal record check on each applicant for initial employment in accordance with KRS 216.789 and 216.793.
(d) A nursing home may participate in the Kentucky National Background Check Program established by 906 KAR 1:190 to satisfy the background check requirements of paragraphs (a) through (c) of this subsection.
(e) A written job description shall be developed for each category of personnel, including:
-
Qualifications;
-
Lines of authority; and
-
Specific duty assignments.
(f) Current employee records shall be maintained on each staff member and contain:
-
Name and address;
-
Verification of training and experience, including evidence of current licensure, registration, or certification, if applicable;
-
Employee health records;
-
Annual performance evaluations; and
-
Documentation of compliance with the background check requirements of paragraphs (a) through (c) of this subsection.
(g) Staffing requirements.
-
Staffing in the facility shall be sufficient in number and qualifications to meet the personal care, nursing care, supervision, and other needs of each resident on a twenty-four (24) hour basis.
-
A responsible staff member shall be on-site and awake at all times to ensure prompt, appropriate action in cases of injury, illness, fire, or other emergencies.
-
The use of volunteers shall not be included in the minimum staffing requirements of this paragraph.
(h) The facility shall have a director of nursing who:
-
Is a registered nurse and works full time during the day; and
-
Devotes full time to the nursing services of the facility.
(i) If the director of nursing has administrative responsibility for the facility, there shall be an assistant director of nursing to ensure that there is the equivalent of a full-time director of nursing.
(j) The director of nursing shall:
-
Be trained or experienced in areas of nursing service, administration, rehabilitation nursing, psychiatric, or geriatric nursing;
-
Be responsible fordeveloping and maintaining:
a. Nursing service objectives;
b. Standards of nursing practice;
c. Nursing procedure manuals; and
d. Written job descriptions for each level of nursing personnel;
-
Recommend to the administrator the number and levels of nursing personnel to be employed;
-
Participate in staff recruitment and selection or recommend termination, if necessary;
-
Assign and supervise all levels of nursing personnel;
-
Participate in planning and budgeting for nursing care;
-
Participate in the development and implementation of resident care policies;
-
Coordinate nursing services with other resident care services;
-
Plan and conduct orientation programs for new nursing personnel and annual in-service education for all nursing personnel;
-
Participate in the screening of prospective residents in terms of required nursing services;
-
Ensure that a written monthly assessment of the resident's general condition is completed;
-
Ensure that a nursing care plan is:
a. Established for each resident; and
b. Reviewed and modified as necessary;
-
Ensure that all nurses and unlicensed staff are assigned duties consistent with their training and experience; and
-
Ensure that a monthly review of each resident's medications is completed and notify the resident's physician if changes are appropriate.
(k) Supervising nurse.
-
The facility shall have a full-time registered nurse who provides or supervises nursing care.
-
The supervising nurse:
a. May be the director of nursing or the assistant director of nursing;
b. Shall be trained or experienced in the areas of:
(i) Nursing administration and supervision;
(ii) Rehabilitative nursing;
(iii) Psychiatric nursing; or
(iv) Geriatric nursing;
c. Shall make daily rounds to all nursing units that perform functions that include:
(i) Visiting each resident; and
(ii) Reviewing medical records, medication cards, resident care plans, and staff assignments; and
d. If possible, shall accompany the physician during visits with residents.
(l) Charge nurse.
-
There shall be at least one (1) registered nurse or licensed practical nurse on duty at all times who shall be responsible for the nursing care of residents.
-
If a licensed practical nurse is on duty, a registered nurse shall be on call.
(m) Pharmacist. The facility shall retain a licensed pharmacist on a full-time, part-time, or consultant basis to direct pharmaceutical services.
(n) Therapists.
- If the facility provides rehabilitative services beyond rehabilitative nursing care, directly or through contract, the services shall be provided or supervised by qualified therapists that include, depending on the service, licensed:
a. Physical therapists;
b. Speech-language pathologists; or
c. Occupational therapists.
- If supervision is less than full time, it shall be:
a. Provided on a planned basis; and
b. Frequent enough, in relation to the therapist's training and experience, to ensure sufficient review of individual treatment plans and progress.
- In a facility with an organized rehabilitation service using a multidisciplinary team approach to meet all of a resident's needs and if all rehabilitative services are administered under the direct supervision of a physician qualified in physical medicine who determines the goals and limits of the therapists' work and prescribes modalities and frequency of therapy, persons with qualifications other than licensed therapists may be assigned duties appropriate to their training and experience.
(o) Dietary. Each facility shall have a full-time staff person designated by the administrator who shall be:
-
Responsible for the total food service operation of the facility; and
-
On duty a minimum of thirty-five (35) hours each week.
(p) Each facility shall designate one (1) or more staff who shall be responsible for:
-
Maintaining medical records;
-
Arranging for social services; and
-
Developing and implementing the activities program and therapeutic recreation.
(q) The facility shall ensure that supportive personnel, consultants, assistants, and volunteers are supervised and function within the policies and procedures of the facility.
(r) An employee who contracts a communicable or infectious disease shall:
-
Be immediately excluded from work; and
-
Remain off work until cleared as noninfectious by a health care practitioner acting within the practitioner's scope of practice.
(s) In-service training.
-
Each facility employee shall receive orientation and annual in-service training that corresponds with the staff member's job duties.
-
Documentation of orientation and in-service training shall be maintained in the employee's record and shall include:
a. Policies regarding the responsibilities of specific job duties;
b. Services provided by the facility;
c. Emergency and disaster procedures;
d. Procedures for the reporting of cases of adult abuse, neglect, or exploitation pursuant to KRS 209.030;
e. Residents rights established by KRS 216.510 to 216.525; and
f. Other training and ongoing education that correspond with the duties of the staff person's respective job.
(11) Medical records.
(a) The facility administrator or staff member in charge of medical records shall ensurethat a complete medical record is kept for each resident with all entries current, dated, and signed.
(b) Each record shall include:
- Identification information, including:
a. Resident's name;
b. Address;
c. Social Security, Medicare, and Medical Assistance identification number, if appropriate;
d. Name, address, and telephone number of the referral agency;
e. Name and telephone number of the resident's physician or health care practitioner;
f. Name, address, and telephone number of the resident's responsible family member, guardian, or other responsible person; and
g. Date of admission;
-
Admitting medical evaluation as required by subsection (6)(b) of this section;
-
Dated and signed orders for medication, diet, or therapeutic services;
-
Physician's progress notes indicating any changes in the resident's condition, documented at the time of each visit;
-
Findings and recommendations of consultants;
-
A medication sheet that includes the date, time given, name of each medication dosage, name of the prescribing physician or practitioner as authorized by the scope of practice, and name of nurse or certified medication aide who administered the medication;
-
Nurse's notes indicating any changes in the resident's condition, including:
a. A response to medications or treatments;
b. Mode and frequency of PRN medications administered;
c. Condition necessitating administration of PRN medication;
d. Reaction following PRN medication;
e. Visits from the physician and phone calls to the physician;
f. Medically prescribed diets; and
g. Preventive maintenance or rehabilitative nursing measures;
-
Written assessment of the resident's monthly general condition;
-
Documentation of dental, laboratory, and x-ray services (if applicable);
-
Changes in the resident's response to the activity and therapeutic recreation program; and
-
A discharge summary, signed and dated by the attending physician within one (1) month of discharge from the facility.
(12) Retention of records. After death or discharge, the completed medical record shall be placed in an inactive file and retained for at least six (6) years.
(13) Confidentiality and Security: Use and Disclosure.
(a) The facility shall maintain the confidentiality and security of resident records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, and as provided by applicable federal or state law.
(b) The facility may use and disclose resident records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
(c) The facility may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
Section 3. Provision of Services.
(1) Physician services.
(a) The health care of each resident shall be under the supervision of a physician who, based on an evaluation of the resident's immediate and long-term needs, prescribes a planned regimen of medical care that covers:
-
Indicated medications;
-
Treatments;
-
Rehabilitative services;
-
Diet;
-
Special procedures recommended for the health and safety of the resident;
-
Activities;
-
Plans for continuing care; and
-
Discharge.
(b)
-
Each resident shall be evaluated by a physician at least one (1) time every thirty (30) days for the first sixty (60) days following admission.
-
After the 60th day following admission, the physician shall evaluate the resident every sixty (60) days unless justified and documented by the attending physician in the resident's medical record.
-
There shall be evidence in the resident's medical record of the physician's visits at appropriate intervals.
(c) There shall be evidence in the resident's medical record that the attending physician has made arrangements for the medical care of the resident in the physician's absence.
(d)
-
The facility shall have an arrangement with one (1) or more physicians who shall be available to furnish necessary medical care in case of an emergency if the physician responsible for the care of the resident is not immediately available.
-
A schedule listing the names and telephone numbers of physicians and the specific days each is on call shall be posted in each nursing station.
-
There shall be established procedures for emergency situations that:
a. Address immediate care of the resident;
b. Persons to be notified; and
c. Reports to be prepared.
(2) Nursing services.
(a) There shall be twenty-four (24) hour nursing services with a sufficient number of nursing personnel on duty at all times to meet the total needs of residents.
(b) Nursing personnel shall include registered nurses, licensed practical nurses, and unlicensed staff members.
(c) The amount of nursing time available for resident care shall be exclusive of non-nursing duties.
(d) Sufficient nursing time shall be available to ensure that each resident:
-
Receives treatments, medication, and diets as prescribed;
-
Receives proper care to prevent decubiti and is kept comfortable, clean, and well-groomed;
-
Is protected from accident or injury by the adoption of indicated safety measures; and
-
Is treated with kindness and respect.
(3) Rehabilitative nursing care.
(a) There shall be an active program of rehabilitative nursing care that helps each resident achieve and maintain the resident's highest level of self-care and independence.
(b) Rehabilitative nursing care initiated in a hospital shall be continued immediately upon admission to the facility.
(c) Nursing personnel shall:
-
Be taught rehabilitative nursing measures; and
-
Provide rehabilitative nursing care to residents daily, such as:
a. Maintaining good body alignment and proper positioning of bedfast residents;
b. Encouraging and assisting bedfast residents to change positions at least every two (2) hours, day and night, to stimulate circulation and prevent decubiti and deformities;
c. Making every effort to keep residents active and out of bed for reasonable periods of time, except if contraindicated by physician's orders;
d. Encouraging residents to achieve independence in activities of daily living by teaching self-care, transfer, and ambulation activities;
e. Assisting residents to adjust to their disabilities, to use their prosthetic devices, and to redirect their interests if necessary; and
f. Assisting residents to carry out prescribed physical therapy exercises between visits of the physical therapist.
(4) Dietary supervision.
(a) Nursing personnel shall ensure that each resident is served a diet as prescribed.
(b) A resident in need of help eating shall be assisted promptly upon receipt of meals.
(c) Food and fluid intake shall be observed and deviations from normal shall be reported to the charge nurse.
(d) Persistent unresolved problems shall be reported to the physician.
(5) Nursing care plan.
(a) There shall be a written nursing care plan for each resident based on the:
-
Nature of illness;
-
Treatment prescribed;
-
Long and short term goals; and
-
Other pertinent information.
(b) The nursing care plan shall:
-
Be a personalized, daily plan for the resident;
-
Indicate the resident's nursing care needs, including:
a. How the nursing care can best be accomplished for the resident;
b. The resident's preferences;
c. Methods and approaches that are most successful; and
d. Any modifications that are necessary to ensure best results;
-
Be available for use by all nursing personnel; and;
-
Be reviewed and revised as needed.
(c) Relevant nursing information from a resident's nursing care plan shall be included with other medical information if the resident is transferred.
(6) Specialized rehabilitative services.
(a) Rehabilitative services shall:
-
Be provided upon written order of the physician;
-
Indicate the anticipated goals; and
-
Prescribe specific modalities to be used, including frequency of physical, speech, or occupational therapy services.
(b) Therapy services include:
-
Physical therapy;
-
Speech therapy; and
-
Occupational therapy.
(c) Therapists shall collaborate with the facility's medical and nursing staff in developing the resident's total plan of care.
(d) Commonly used ambulation and therapeutic equipment necessary for services shall be available, including:
-
Parallel bars;
-
Hand rails;
-
Wheelchairs;
-
Walkers;
-
Walkerettes;
-
Crutches; and
-
Canes.
(e) Therapists shall advise the administrator concerning the purchase, rental, storage, and maintenance of equipment and supplies.
(7) Personal care services. Personal care services shall includeassistance with:
(a) Bathing;
(b) Shaving;
(c) Cleaning and trimming of fingernails and toenails;
(d) Cleaning of the mouth and teeth; and
(e) Washing, grooming, and cutting of hair.
(8) Pharmaceutical services.
(a) The facility shall provide pharmaceutical services, including procedures that ensure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to meet the needs of each resident.
(b) The facility shall employ or obtain the services of a licensed pharmacist who shall:
-
Provide consultation on all aspects of the provision of pharmacy services in the facility;
-
Establish a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation;
-
Determine that drug records are in order; and
-
Ensure that an account of all controlled drugs is maintained and reconciled.
(c) If the facility does not have a pharmacy department, it shall ensure that prescribed drugs and biologicals may be obtained from a community or institutional pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy pursuant to KRS 315.035.
(d) If the facility does not have a pharmacy department, but maintains a supply of drugs,the consultant pharmacist shall:
-
Be responsible for the control of all bulk drugs;
-
Maintain records of the receipt and disposition of bulk drugs; and
-
Dispense drugs from the drug supply, properly label them, and make them available to appropriate licensed nursing personnel.
(e) A facility that stores and administers non-controlled substances in an emergency medication kit (EMK) shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(4)(b).
(f) A facility that stores and administers non-controlled substances from a long-term care facility drug stock shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(5)(a).
(9) Medication services.
(a) Medication administered to a resident shall be ordered in writing by the prescribing:
-
Physician; or
-
Health care practitioner as authorized by the scope of practice.
(b) If an order is received by telephone, the order shall be:
-
Recorded in the resident's medical record; and
-
Signed by the physician or other health care practitioner as authorized under the practitioner's scope of practice within fourteen (14) days.
(c) If an order for medication does not include a specific time limit or a specific number of dosages, the facility shall notify the physician or prescribing practitioner that the medication will be stopped at a certain date unless the medication order is continued.
(d) A registered nurse or pharmacist shall review each resident's medication profile at least monthly.
(e) The prescribing physician or other prescribing practitioner shall review the resident's medication profile at least every two (2) months.
(f) The facility shall release medications to a resident who is discharged upon written authorization of the physician or prescribing practitioner.
(10) Administration of medications.
(a) A licensed health professional may:
-
Administer medications as authorized under the professional's scope of practice; or
-
Delegate medication administration tasks in accordance with paragraph (b) of this subsection.
(b) A facility may allow an unlicensed staff person to administer medication in accordance with KRS 194A.705(2)(c) and 201 KAR 20:700 as follows:
-
Medication administration is delegated to the unlicensed staff person by an available nurse;
-
If administration of oral or topical medication is delegated, the unlicensed staff person shall have a:
a. Certified medication aide (CMA) I credential from a training and skills competency evaluation program approved by the Kentucky Board of Nursing (KBN); or
b. Kentucky medication aide credential from the Kentucky Community and Technical College System; and
- If administration of a preloaded insulin injection is delegated, the unlicensed staff person shall have a CMA II credential from a training and skills competency evaluation program approved by KBN.
(c) An intramuscular injection shall be administered by a licensed nurse or physician.
(d) If an intravenous injection is necessary, the injection shall be administered by a licensed physician or registered nurse.
(e) Each medication administered shall be recorded in the resident's medical record.
(f) The nursing station shall have readily available items necessary for the proper administration of medications.
(g) The facility shall ensure that medication cards or another appropriate system is used and checked against the orders of a physician or practitioner acting under the scope of practice.
(h) A medication that is prescribed for one (1) resident shall not be administered to any other resident.
(i) A resident shall not be allowed to self-administer a medication except:
-
On special order of the resident's physician or prescribing practitioner; or
-
In a predischarge program under the supervision of a licensed nurse.
(j) The facility shall ensure that a medication error or drug reaction is:
-
Immediately reported to the resident's physician or practitioner; and
-
Documented in the resident's medical record and in an incident report.
(k) All resident medications shall be plainly labeled with the:
-
Resident's name;
-
Name of the drug;
-
Strength;
-
Name of the pharmacy;
-
Prescription number;
-
Date;
-
Prescriber's name; and
-
Caution statements and directions for use, unless a modified unit dose distribution system is used.
(l) All medications kept by the facility shall be:
-
Stored in their original containers; and
-
Kept in a locked place.
(m) The facility shall ensure that:
-
All medications requiring refrigeration are kept in a separate locked box of adequate size in the refrigerator in the medication area;
-
Drugs for external use are stored separately from those administered by mouth and injection;
-
Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels are returned to the issuing pharmacist or pharmacy for relabeling or disposal;
-
Containers with no labels are appropriately destroyed;
-
Cabinets are well-lighted and of sufficient size to permit storage without crowding; and
-
Expired medications and medications no longer in use are disposed of or destroyed appropriately.
(11) Controlled substances.
(a) Controlled substances shall be kept under double lock, for example in a locked box in a locked cabinet, and keys or access to the locked box and locked cabinet shall be accessible to designated staff only.
(b) A nurse may delegate administration of a regularly scheduled controlled substance to a CMA if the medication has been prescribed and labeled in a container for a specific resident.
(c) For a controlled substance ordered on a PRN basis, a nurse may delegate administration to a CMA if:
-
The medication has been prescribed and labeled in a container for a specific resident;
-
The nurse assesses the resident, in person or virtually, prior to administration of the PRN controlled substance;
-
The nurse assesses the resident, in person or virtually, following the administration of the PRN controlled substance; and
-
The nurse documents administration of the PRN controlled substance by a CMA in the resident's record.
(d) There shall be a controlled substances bound record book with numbered pages that includes:
-
The name of the resident;
-
Date, time, kind, dosage, and method of administration of each controlled substance;
-
Name of the physician or practitioner who prescribed the medications; and
-
Name of the:
a. Nurse or CMA who administered the controlled substance; or
b. Staff member who supervised the self-administration.
(e) A staff member with access to controlled substances shall be responsible for maintaining a recorded and signed:
-
Schedule II controlled substances count daily; and
-
Schedule III, IV, and V controlled substances count at least one (1) time per week.
(f) All expired or unused controlled substances shall be disposed of, or destroyed in accordance with 21 C.F.R. Part 1317 no later than thirty (30) days:
-
After expiration of the medication; or
-
From the date the medication was discontinued.
(g) If controlled substances are destroyed on-site:
-
The method of destruction shall render the drug unavailable and unusable;
-
The administrator or staff person designated by the administrator shall be responsible for destroying the controlled substances with at least one (1) witness present; and
-
A readily retrievable record of the destroyed controlled substances shall be maintained for a minimum of eighteen (18) months from the date of destruction and contain the:
a. Date of destruction;
b. Resident name;
c. Drug name;
d. Drug strength;
e. Quantity;
f. Method of destruction;
g. Name of the person responsible for the destruction; and
h. Name of the witness.
(h) A facility that stores and administers controlled substances in an emergency medication kit (EMK) shall comply with the:
-
Requirements for storage and administration established by 902 KAR 55:070, Section 2(2), (5), and (7) through (9); and
-
Limitation on the number and quantity of medications established by 902 KAR 55:070, Section 2(6).
(12) Use of restraints.
(a) Chemical and physical restraints shall not be used, except as authorized by KRS 216.515(6).
(b) Restraints that require lock and key shall not be used.
(c) Emergency use of a restraint shall be applied only by appropriately trained personnel if:
-
A resident poses an imminent risk of harm to self or others; and
-
The emergency restraint is the least restrictive intervention to achieve safety.
(d) Restraints shall not be used as:
-
Punishment;
-
Discipline;
-
A convenience for staff; or
-
Retaliation.
(13) Infection control.
(a) There shall be written infection control policies that address:
-
The prevention of disease transmission; and
-
Cleaning, disinfection, and sterilization methods used for equipment and the environment.
(b) The facility shall provide in-service education programs on the cause, effect, transmission, prevention, and elimination of infections for all personnel responsible for direct care.
(14) Sharp wastes.
(a) Sharp wastes shall be segregated from other wastes and placed in puncture-resistant containers immediately after use.
(b) A needle or other contaminated sharp shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Centers for Disease Control and Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
(c) A sharp waste container shall be incinerated on or off-site, or be rendered nonhazardous.
(d) Any nondisposable sharps shall be placed in a hard walled container for transport to a processing area for decontamination.
(15) Disposable waste.
(a) Disposable waste shall be:
-
Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
-
Handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
(b) The facility shall establish specific written policies regarding handling and disposal of all waste material.
(16) Infectious or communicable diseases.
(a) An individual infected with one (1) of the following diseases shall not be admitted to the facility:
-
Anthrax;
-
Campylobacteriosis;
-
Cholera;
-
Diphtheria;
-
Hepatitis A;
-
Measles;
-
Pertussis;
-
Plague;
-
Poliomyelitis;
-
Rabies (human);
-
Rubella;
-
Salmonellosis;
-
Shigellosis;
-
Typhoid fever;
-
Yersiniosis;
-
Brucellosis;
-
Giardiasis;
-
Leprosy;
-
Psittacosis;
-
Q fever;
-
Tularemia; or
-
Typhus.
(b) A facility may admit a noninfectious tuberculosis resident in accordance with 902 KAR 20:200, Section 4 or Section 8(5).
(c) A resident with symptoms or an abnormal chest x-ray consistent with tuberculosis shall be isolated and evaluated in accordance with 902 KAR 20:200, Section 6(4).
(d) If a resident is suspected of having a communicable disease that would endanger the health and welfare of other residents, the administrator or administrator's designee shall:
-
Contact a physician; and
-
Ensure that appropriate measures are taken on behalf of the resident, other residents, and staff.
(17) Laboratory, radiology, and other diagnostic services.
(a) Laboratory services.
- The facility shall provide or obtain laboratory services to meet the needs of its residents from a laboratory that is:
a. Part of a hospital; or
b. Licensed in accordance with KRS 333.030.
-
The facility shall provide or obtain laboratory services if ordered by a physician or other health care practitioner acting within the practitioner's scope of practice.
-
The facility shall:
a. Assist the resident in making transportation arrangements to and from the source of service, if applicable; and
b. File in the resident's record a copy of each laboratory report with the:
(i) Date of the service; and
(ii) Name and address of the testing laboratory.
(b) Radiology and other diagnostic services. The facility shall:
-
Provide or obtain radiology and other diagnostic services if ordered by a physician or other health care practitioner acting within the practitioner's scope of practice;
-
Assist the resident in making transportation arrangements to and from the source of service, if applicable; and
-
File in the resident's record a copy of the signed and dated report of x-ray and other diagnostic services.
(18) Dental services.
(a) The facility shall assist residents in obtaining regular and emergency dental care.
(b) A dentist shall:
-
Provide consultation;
-
Participate in in-service education;
-
Recommend policies concerning oral hygiene; and
-
Be available in case of emergency.
(c) If necessary, the facility shall arrange for the resident to be transported to the dentist's office.
(d) Nursing personnel shall assist the resident with carrying out the dentist's recommendations.
(19) Social services.
(a) The facility shall provide social services to:
-
Meet the medically-related social service needs of each resident;
-
Meet the physical, mental, and psycho-social well-being of each resident; and
-
Assist each resident in attaining or maintaining the highest practicable level of functioning.
(b) Upon admission, the facility shall evaluate a resident's need for social services.
(c) If the resident appears eligible for financial assistance necessary to remain in the facility, the facility shall make a referral for a full evaluation of need.
(d) The facility shall take appropriate action to obtain any needed social services to help resolve issues related to a resident's:
-
Illness;
-
Response to treatment; or
-
Adjustment to care in the facility.
(e) The facility shall consider factors such as a resident's home situation, financial resources, community resources, and information related to the resident's medical and nursing care needs in any decisions regarding discharge from the facility.
(f) The staff member responsible for coordinating social services shall:
-
Participate in clinical staff conferences;
-
Confer with the attending physician and nurses during the resident's stay in the facility; and
-
Include signed social service summaries in the resident's medical record.
(20) Resident activities.
(a) The facility shall provide activities as an adjunct to the active treatment program.
(b) Activities shall:
-
Be suited to the needs and interests of residents; and
-
Encourage restoration of self-care and resumption of normal activities.
(c) The activity leader shall usecommunity, social, and recreational opportunities to the fullest extent possible.
(d) Residents shall be encouraged, but not forced to participate in activities.
(e) The facility shall provide suitable activities for residents who are unable to leave their rooms.
(f) The facility shall permit, and assist if needed, residents[ who are able and wish to attend religious services.
(g) The facility shall honor a resident's request to see their clergymen or church leader and provide space for privacy during visits.
(h) The facility shall ensure that visiting hours are established in accordance with KRS 216.537 and 216.540.
(i) The facility shall make available a variety of supplies and equipment adequate to satisfy the individual interests of residents, such as:
-
Books and magazines;
-
Daily newspapers;
-
Games;
-
Stationery;
-
Radio and television; and
-
Craft and hobby supplies.
(21) Transportation.
(a) If transportation of residents is provided by the facility to community agencies or other activities, the following shall apply:
-
Special provision shall be made for each resident who uses a wheelchair.
-
An escort or assistant to the driver shall accompany a resident or residents, if necessary, to help ensure safety during transport.
(b) The facility shall arrange for appropriate transportation in case of a medical emergency.
(22) Dietary services.
(a) The facility shall provide or contract for food services to meet the dietary needs of the residents, including:
-
Modified diets; or
-
Dietary restrictions as prescribed by the attending physician.
(b)
-
If a facility contracts for food services with an outside food management company, the company shall provide a licensed dietitianon a full-time, part-time, or consultant basis to the facility.
-
The licensed dietitianshall make recommendations to the facility's medical and nursing staff on dietetic policies affecting resident care.
-
The food management company shall comply with the dietary services requirements of this subsection.
(c) If the facility provides therapeutic diets and the staff member responsible for the food services is not a licensed dietitian, the responsible staff person shall consult with a licensed dietitian[].
(d) The facility shall:
-
Have sufficient number of food service personnel;
-
Ensure that the food service staff schedules are posted; and
-
If any food service personnel are assigned duties outside the dietary department, the duties shall not interfere with the sanitation, safety, or time required for regular dietary assignments.
(e) Menu planning.
-
Menus shall be planned, written, and rotated to avoid repetition.
-
The facility shall meet the nutrition needs of residents in accordance with a physician's orders.
-
Except as established in subparagraph 5. of this paragraph, meals shall correspond with the posted menu.
-
Menus shall be planned and posted one (1) week in advance.
-
If changes in the menu are necessary:
a. Substitutions shall provide equal nutritive value;
b. The changes shall be recorded on the menu; and
c. Menus shall be kept on file for at least thirty (30) days.
- Food preparation and storage.
a. There shall be at least a three (3) day supply of food to prepare well balanced, palatable meals.
b. A record of food purchased for preparation shall be on file for thirty (30) days.
c. Food shall be prepared with consideration for any individual dietary requirement.
d. Modified diets, nutrient concentrates, and supplements shall be given only on the written orders of a:
(i) Physician;
(ii) Advanced practice registered nurse; or
(iii) Physician assistant.
e. At least three (3) meals per day shall be served with not more than a fourteen (14) hour span between the substantial evening meal and breakfast.
f. Between-meal snacks and beverages, including an evening snack before bedtime, shall be available at all times for each resident, unless medically contraindicated as documented by a physician in the resident's record.
g. Foods shall be:
(i) Prepared by methods that conserve nutritive value, flavor, and appearance; and
(ii) Served at the proper temperature and in a form to meet individual needs.
h. A file of tested recipes, adjusted to appropriate yield, shall be maintained.
i. Food shall be cut, chopped, or ground to meet individual needs.
j. If a resident refuses foods served, nutritional substitutions shall be offered.
k. All opened containers or left over food items shall be covered and dated when refrigerated.
- Serving of food.
a. If a resident cannot be served in the dining room, trays shall:
(i) Be provided for bedfast residents; and
(ii) Rest on firm supports such as overbed tables.
b. Sturdy tray stands of proper height shall be provided for residents able to be out of bed.
c. Direct care staff shall be responsible for correctly positioning a resident to eat meals served on a tray.
d. A resident who requires help with eating shall be assisted within a reasonable length of time.
e. The facility shall provide adaptive feeding equipment if needed by a resident.
f. Food services shall be provided in accordance with 902 KAR 45:005.
(23) Housekeeping and maintenance services.
(a) The facility shall:
-
Maintain a clean and safe facility free of unpleasant odors; and
-
Ensure that odors are eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
(b) The facility shall:
-
Have available at all times an adequate supply of clean linen essential to the proper care and comfort of residents;
-
Ensure that soiled clothing and linens receive immediate attention and not be allowed to accumulate;
-
Ensure that clothing and linens used by one (1) resident shall not be used by another resident unless it has been laundered or dry cleaned; and
-
Ensure that soiled clothing and linens shall be:
a. Placed in washable or disposable containers;
b. Transported in a sanitary manner; and
c. Stored in separate, well-ventilated areas in a manner to prevent contamination and odors.
(c) Equipment or areas used to transport or store soiled linen shall not be used for handling or storing of clean linen.
(d) Soiled linen shall be sorted and laundered in the soiled linen room in the laundry area.
(e) Hand-washing facilities with hot and cold water, soap dispenser, and paper towels shall be provided in the laundry area.
(f) Clean linen shall be sorted, dried, ironed, folded, transported, stored, and distributed in a sanitary manner.
(g) Clean linen shall be stored in clean linen closets on each floor, close to the nurses' station.
(h) Personal laundry shall be:
-
Collected, transported, sorted, washed, and dried in a sanitary manner separate from bed linens;
-
Laundered as often as necessary;
-
The responsibility of the facility unless the resident or resident's family accepts this responsibility; and
-
Marked or labeled to identify the resident so that it may bereturned to the correct resident.
(24) Maintenance. The premises shall be well kept and in good repair as established in this subsection.
(a) The facility shall ensure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences are in good repair.
(b) The interior of the building, including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures, shall be in good repair. Windows and doors shall be screened.
(c) Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly.
(d) A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(25) Room accommodations.
(a) A facility shall provide each resident with:
-
A bed that is at least thirty-six (36) inches wide;
-
A clean, comfortable mattress with a support mechanism;
-
A mattress cover;
-
Two (2) sheets and a pillow; and
-
Bed covering to keep the resident comfortable.
(b) Each bed shall be placed so that a resident does not experience discomfort because of proximity to a radiator, heat outlet, or exposure to drafts.
(c) The facility shall provide:
-
Window coverings;
-
Bedside tables with reading lamps,if appropriate;
-
Comfortable chairs;
-
A chest or dresser with a mirror for each resident;
-
A night light; and
-
Storage space for clothing and other possessions.
(d) A resident shall not be housed in a room, detached building, or other enclosure that has not been previously inspected and approved for residential use by the Office of Inspector General and the Department of Housing, Buildings and Construction.
(e) Basement rooms shall not be used for sleeping rooms for residents.
(f) Residents may have personal items and furniture, if feasible.
(26) Living and dining area.
(a) Each living room or lounge area and recreation area shall have an adequate number of:
-
Reading lamps; and
-
Tables and chairs or settees of sound construction and satisfactory design.
(b) Dining room furnishings shall be adequate in number, well constructed, and of satisfactory design for the residents.
History
- RELATES TO: KRS 194A.700(1), 194A.705(2)(c), 209.030, 209.032, 216.510-216.525, 216.532, 216.537, 216.540, 216.789, 216.793, 216A.080, 310.021, 310.031, 315.035, 333.030, 21 C.F.R. Part 1317, 29 C.F.R. 1910.1030(d)(2)(vii), 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of and services provided by nursing homes.
- History: 8 Ky.R. 398; 892; eff. 4-7-1982; 11 Ky.R. 824; eff. 12-11-1984; 13 Ky.R. 356; eff. 9-4-1986; 1142; eff. 2-10-1987; 16 Ky.R. 2486; 17 Ky.R. 67; eff. 7-18-1990; 1582; eff. 12-18-1990; 24 Ky.R. 2226; 25 Ky.R. 321; eff. 8-17-1998; TAm eff. 3-11-2011; Cert eff. 4-30-2019; TAm eff. 3-20-2020; 50 Ky.R. 1385, 2063; eff. 6-18-2024.
902 KAR 20:051 Operation and services; intermediate care {#sec-902-kar-20-051 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:051}
Section 1. Definitions.
(1) "Activities of daily living" means activities of self-help (e.g., being able to feed, bathe and/or dress oneself), communication (e.g., being able to place phone calls, write letters and understanding instructions) and socialization (e.g., being able to shop, being considerate of others, working with others and participating in activities).
(2) "Administrator" means a person who is licensed as a nursing home administrator pursuant to KRS 216A.080.
(3) "Facility" means an intermediate care facility.
(4) "License" means an authorization issued by the cabinet for the purpose of operating an intermediate care facility and offering intermediate care services.
(5) "PRN medications" means medications administered as needed.
(6) "Qualified dietician" or "nutritionist" means:
(a) A person who has a bachelor of science degree in foods and nutrition, food service management, institutional management or related services and has successfully completed a dietetic internship or coordinated undergraduate program accredited by the American Dietetic Association (ADA) and is a member of the ADA or is registered as a dietician by ADA; or
(b) A person who has a master's degree in nutrition and is a member of ADA or is eligible for registration by ADA; or
(c) A person who has a bachelor of science degree in home economics and three (3) years of work experience with a registered dietician.
(7) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a patient or the movement of a portion of a patient's body.
Section 2. Scope of Operations and Services. Intermediate care facilities are establishments with permanent facilities including inpatient beds. Services provided include twenty-four (24) hour supervision of patients, services including physician, nursing, pharmaceutical, personal care, activities and residential services. Patients in an intermediate care facility must have a physical or mental condition that requires intermittent nursing services along with continuous supervision of the activities of daily living.
Section 3. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for the facility and for compliance with federal, state and local laws and regulations pertaining to the operation of the facility.
(2) Administrator.
(a) All facilities shall have an administrator who is responsible for the operation of the facility and who shall delegate such responsibility in his absence. The administrator shall not be the nursing services supervisor in a facility with more than sixty (60) beds.
(b) The licensee shall contract for professional and supportive services not available in the facility as dictated by the needs of the patient. The contract shall be in writing.
(3) Administrative records.
(a) The facility shall maintain a bound, permanent, chronological patient registry showing date of admission, name of patient, and date of discharge.
(b) The facility shall require and maintain written recommendations or comments from consultants regarding the program and its development on a per visit basis.
(c) Menu and food purchase records shall be maintained.
(d) A written report of any incident or accident involving a patient (including medication errors or drug reactions), visitor or staff shall be made and signed by the administrator or nursing service supervisor, and any staff member who witnessed the incident. The report shall be filed in an incident file.
(4) Policies. The facility shall establish written policies and procedures that govern all services provided by the facility. The written policies shall include:
(a) Patient care and services to include physician, nursing, pharmaceutical (including medication stop orders policy), and residential services.
(b) Adult and child protection. The facility shall have written policies which assure the reporting of cases of abuse, neglect or exploitation of adults and children pursuant to KRS Chapters 209 and 620.
(c) Use of restraints. The facility shall have a written policy that addresses the use of restraints and a mechanism for monitoring and controlling their use.
(d) Missing patient procedures. The facility shall have a written procedure to specify in a step-by-step manner the actions which shall be taken by staff when a patient is determined to be lost, unaccounted for or on other unauthorized absence.
(5) Patient rights. Patient rights shall be provided for pursuant to KRS 216.510 to 216.525.
(6) Admission.
(a) Patients shall be admitted only upon the referral of a physician. The facility shall admit only persons who have a physical or mental condition which requires intermittent nursing services and continuous supervision of activities of daily living. The facility shall not admit persons whose care needs exceed the capability of the facility.
(b) Upon admission the facility shall obtain the patient's medical diagnosis, physician's orders for the care of the patient and the transfer form. Within seventy-two (72) hours after admission the facility shall obtain a medical evaluation from the patient's physician including current medical findings, medical history and physical examination. The medical evaluation may be a copy of the discharge summary or history and physical report from a hospital or long-term facility if done within fourteen (14) days prior to admission.
(c) Before admission the patient and a responsible member of his family or committee shall be informed in writing of the established policies of the facility including fees, reimbursement, visitation rights during serious illness, visiting hours, type of diets offered and services rendered.
(d) The facility shall provide and maintain a system for identifying each patient's personal property and facilities for safekeeping of his declared valuables. Each patient's clothing and other property shall be reserved for his own use.
(7) Discharge planning. The facility shall have a discharge planning program to assure the continuity of care for patients being transferred to another health care facility or being discharged to the home.
(8) Transfer and discharge. The facility shall comply with the requirements of 900 KAR 2:050 when transferring or discharging residents.
(a) The facility shall have written transfer procedures and agreements for the transfer of patients to other health care facilities which can provide a level of inpatient care not provided by the facility. Any facility which does not have a transfer agreement in effect but which documents a good faith attempt to enter into such an agreement shall be considered to be in compliance with the licensure requirement. The transfer procedures and agreements shall specify the responsibilities each institution assumes in the transfer of patients and establish responsibility for notifying the other institution promptly of the impending transfer of a patient and arrange for appropriate and safe transportation.
(b) When the patient's condition exceeds the scope of services of the facility, the patient, upon physician's orders (except in cases of emergency), shall be transferred promptly to a hospital or a skilled nursing facility, or services shall be contracted for from another community resource.
(c) When changes and progress occur which would enable the patient to function in a less structured and restrictive environment, and the less restrictive environment cannot be offered at the facility, the facility shall offer assistance in making arrangements for patients to be transferred to facilities providing appropriate services.
(d) Except in an emergency, the patient, his next of kin, or guardian, if any, and the attending physician shall be consulted in advance of the transfer or discharge of any patient.
(e) When a transfer is to another level of care within the same facility, the complete medical record or a current summary thereof shall be transferred with the patient.
(f) If the patient is transferred to another health care facility or home to be cared for by a home health agency, a transfer form shall accompany the patient. The transfer form shall include at least: physician's orders (if available), current information relative to diagnosis with history of problems requiring special care, a summary of the course of prior treatment, special supplies or equipment needed for patient care, and pertinent social information on the patient and his family.
(9) Tuberculosis testing. All employees and patients shall be tested for tuberculosis in accordance with the provisions of 902 KAR 20:200, Tuberculosis testing in long term care facilities.
(10) Personnel.
(a) Job descriptions. Written job descriptions shall be developed for each category of personnel, to include qualifications, lines of authority and specific duty assignments.
(b) Employee records. Current employee records shall be maintained and shall include a resume of each employee's training and experience, evidence of current licensure or registration where required by law, health records, records of in-service training and ongoing education, and the employee's name, address and Social Security number.
(c) Staffing requirements.
-
The facility shall have adequate personnel to meet the needs of the patients on a twenty-four (24) hour basis. The number and classification of personnel required shall be based on the number of patients and the amount and kind of personal care, nursing care, supervision and program needed to meet the needs of the patients as determined by medical orders and by services required by this administrative regulation.
-
When the staff to patient ratio does not meet the needs of the patients, the Division for Licensing and Regulation shall determine and inform the administrator in writing how many additional personnel are to be added and of what job classification and shall give the basis for this determination.
-
A responsible staff member shall be on duty and awake at all times to assure prompt, appropriate action in cases of injury, illness, fire or other emergencies.
-
Volunteers shall not be counted to make up minimum staffing requirements.
-
Supervision of nursing services shall be by a registered nurse or licensed practical nurse employed on the day shift seven (7) days per week. The supervisor shall have training in rehabilitative nursing. When a licensed practical nurse serves as the supervisor, consultation shall be provided by a registered nurse at regular intervals, not less than four (4) hours weekly. The responsibilities of the nursing services supervisor shall include:
a. Developing and maintaining nursing service objectives, standards of nursing practice, nursing procedure manuals, and written job descriptions for each level of nursing personnel.
b. Recommending to the administrator the number and levels of nursing personnel to be employed, participating in their recruitment and selection and recommending termination of employment when necessary.
c. Assigning and supervising all levels of nursing care.
d. Participating in planning and budgeting for nursing care.
e. Participating in the development and implementation of patient care policies.
f. Coordinating nursing services with other patient care services.
g. Participating in the screening of prospective patients in terms of required nursing services and nursing skills available.
h. Assuring that a written monthly assessment of the patient's general condition is completed.
i. Assuring that the establishment, review and modification of nursing care plans for each patient is done by licensed nursing personnel.
j. Assuring that all medications are administered by licensed personnel or by other personnel who have completed a state-approved training program.
k. Assuring that a monthly review of each patient's medications is completed and notifying the physician when changes are appropriate.
-
The facility shall employ a licensed pharmacist on a full-time, part-time or consultant basis to direct pharmaceutical services.
-
Each facility shall have a full-time person designated by the administrator, responsible for the total food service operation of the facility and on duty a minimum of thirty-five (35) hours each week.
-
Each facility shall designate a person for the following areas who will be responsible for:
a. Medical records;
b. Arranging for social services; and
c. Developing and implementing the activities program and therapeutic recreation.
- Supportive personnel, consultants, assistants and volunteers shall be supervised and shall function within the policies and procedures of the facility.
(d) Health requirements. No employee contracting an infectious disease shall appear at work until the infectious disease can no longer be transmitted.
(e) Orientation program. The facility shall conduct an orientation program for all new employees to include review of all facility policies (that relate to the duties of their respective jobs), services and emergency and disaster procedures.
(f) In-service training.
-
All employees shall receive in-service training and ongoing education to correspond with the duties of their respective jobs.
-
All nursing personnel shall receive in-service or continuing education programs at least quarterly.
(11) Medical records.
(a) The facility shall develop and maintain a system of records retention and filing to insure completeness and prompt location of each patient's record. The records shall be held confidential. The records shall be in ink or typed and shall be legible. Each entry shall be dated and signed. Each record shall include:
-
Identification data including the patient's name, address and Social Security number (if available); name, address and telephone number of referral agency; name and telephone number of personal physician; name, address and telephone number of next of kin or other responsible person; and date of admission.
-
Admitting medical evaluation by a physician including current medical findings, medical history, physical examination and diagnosis. (The medical evaluation may be a copy of the discharge summary or history and physical report from a hospital, skilled nursing facility if done within fourteen (14) days prior to admission.)
-
Dated and signed orders for medication, diet, and therapeutic services.
-
Physician's progress notes describing significant changes in the patient's condition, written at the time of each visit.
-
Findings and recommendations of consultants.
-
A medication sheet which contains the date, time given, name of each medication dosage, name of prescribing physician, advanced practice registered nurse, therapeutically-certified optometrist, or physician assistant, and name of person who administered the medication.
-
Nurse's notes indicating changes in patient's condition, actions, responses, attitudes, appetite, etc. Nursing personnel shall make notation of response to medications, response to treatments, mode and frequency of PRN medications administered, condition necessitating administration of PRN medication, reaction following PRN medication, visits by physician and phone calls to the physician, medically prescribed diets and preventive, maintenance or rehabilitative nursing measures.
-
Written assessment of the patient's monthly general condition.
-
Reports of dental, laboratory and x-ray services (if applicable).
-
Changes in patient's response to the activity and therapeutic recreation program.
-
A discharge summary, signed and dated by the attending physician within one (1) month of discharge from the facility.
(b) Retention of records. After patient's death or discharge the completed medical record shall be placed in an inactive file and retained for five (5) years or, in case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
Section 4. Provision of Services.
(1) General requirements.
(a) Patient care equipment. There shall be a sufficient quantity of patient care equipment of satisfactory design and in good condition to carry out established patient care procedures. The equipment shall include:
-
Wheelchairs with brakes;
-
Walkers;
-
Bedside rails;
-
Bedpans and urinals (permanent or disposable);
-
Emesis basins and wash basins (permanent or disposable);
-
Footstools;
-
Bedside commodes;
-
Foot cradles;
-
Foot boards;
-
Under-the-mattress bed boards;
-
Trapeze frames;
-
Transfer board; and
-
An autoclave for sterilization of nursing equipment and supplies or an equivalent alternate method of sterilization.
(b) Infection control and communicable diseases.
- There shall be written infection control policies, which are consistent with the Centers for Disease Control guidelines including:
a. Policies which address the prevention of disease transmission to and from patients, visitors and employees, including:
(i) Universal blood and body fluid precautions;
(ii) Precautions for infections which can be transmitted by the airborne route; and
(iii) Work restrictions for employees with infectious diseases.
b. Policies which address the cleaning, disinfection, and sterilization methods used for equipment and the environment.
-
The facility shall provide in-service education programs on the cause, effect, transmission, prevention and elimination of infections for all personnel responsible for direct patient care.
-
Sharp wastes.
a. Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other wastes and placed in puncture resistant containers immediately after use.
b. Needles shall not be recapped by hand, purposely bent or broken, or otherwise manipulated by hand.
c. The containers of sharp wastes shall either be incinerated on or off site, or be rendered nonhazardous by a technology of equal or superior efficacy, which is approved by both the Cabinet for Health Services and the Natural Resources and Environmental Protection Cabinet.
- Disposable waste.
a. All disposable waste shall be placed in suitable bags or closed containers so as to prevent leakage or spillage, and shall be handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
b. The facility shall establish specific written policies regarding handling and disposal of all wastes.
c. The following wastes shall be disposed of by incineration, autoclaved before disposal, or carefully poured down a drain connected to a sanitary sewer: blood, blood specimens, used blood tubes, or blood products.
d. Any wastes conveyed to a sanitary sewer shall comply with applicable federal, state, and local pretreatment regulations.
-
Patients infected with the following diseases shall not be admitted to the facility unless the patient's attending physician certifies in writing that the condition of the patient is not communicable to others in the long-term care environment: anthrax, campylobacteriosis, cholera, diphtheria, hepatitis A, measles, pertussis, plague, poliomyelitis, rabies (human), rubella, salmonellosis, shigellosis, typhoid fever, yersiniosis, brucellosis, giardiasis, leprosy, psittacosis, Q fever, tularemia, and typhus. If an attending physician is in doubt regarding the communicability of a patient's condition, he may contact the Department for Health Services.
-
A facility may admit a noninfectious tuberculosis patient under continuing medical supervision for his tuberculosis disease.
-
Patients with active tuberculosis may be admitted to the facility whose isolation facilities and procedures have been specifically approved by the cabinet.
-
If, after admission, a patient is suspected of having a communicable disease that would endanger the health and welfare of other patients the administrator shall assure that a physician is contacted and that appropriate measures are taken on behalf of the patient with the communicable disease and the other patients.
(c) Use of restraints.
-
No restraints shall be used except as permitted by KRS 216.515(6).
-
Restraints that require lock and key shall not be used.
-
Restraints shall be applied only by appropriately trained personnel.
-
Restraints shall not be used as a punishment, as discipline, as a convenience for the staff, or as a mechanism to produce regression.
(2) Physician services. All patients shall be under the medical supervision of a licensed physician. These services shall include:
(a) Physician's visit for medical evaluation as often as necessary and in no case less often than every sixty (60) days, unless justified and documented by the attending physician in the patient's medical report.
(b) Physician services for medical emergencies available on a twenty-four (24) hour, seven (7) days-a-week basis.
(3) Nursing services. Nursing services shall include:
(a) The establishment of a nursing care plan for each patient. Each plan shall be reviewed and modified as necessary, or at least quarterly. Each plan shall include goals and nursing care needs;
(b) Rehabilitative nursing care to achieve and maintain the highest degree of function, self-care and independence. Rehabilitative measures shall be practiced on a twenty-four (24) hour, seven (7) day week basis. Those procedures requiring medical approval shall be ordered by the attending physician. Rehabilitative measures shall include:
-
Positioning and turning. Nursing personnel shall encourage and assist patients in maintaining good body alignment while standing, sitting, or lying in bed.
-
Exercises. Nursing personnel shall assist patients in maintaining maximum joint range of motion or active range of motion.
-
Bowel and bladder training. Nursing personnel shall make every effort to train incontinent patients to gain bowel and bladder control.
-
Training in activities of daily living. Nursing personnel shall encourage and when necessary teach patients to function at their maximum level in appropriate activities of daily living for as long as, and to the degree that, they are able.
-
Ambulation. Nursing personnel shall assist and encourage patients with daily ambulation unless otherwise ordered by the physician.
(c) Administration of medications including oral, rectal, hypodermic, and intramuscular;
(d) Written monthly assessment of the patient's general condition by licensed nursing personnel;
(e) Treatments such as: enemas, irrigations, catheterizations, applications of dressings or bandages, supervision of special diets;
(f) The recording of any changes, as they occur, in the patient's condition, actions, responses, attitudes, appetite, etc.
(g) Implementing a regular program to prevent decubiti with emphasis on the following:
-
Procedures to maintain cleanliness of the patient, his clothes and linens shall be followed each time the bed or the clothing is soiled. Rubber, plastic, or other type of linen protectors shall be properly cleaned and completely covered to prevent direct contact with the patient.
-
Special effort shall be made to assist the patient in being up and out of bed as much as his condition permits, unless medically contraindicated. If the patient cannot move himself, he shall have his position changed as often as necessary but not less than every two (2) hours.
(4) Pharmaceutical services.
(a) The facility shall provide appropriate methods and procedures for obtaining, dispensing, and administering drugs and biologicals, developed with the advice of a licensed pharmacist or a pharmaceutical advisory committee which includes one (1) or more licensed pharmacists.
(b) If the facility has a pharmacy department, a licensed pharmacist shall be employed to administer the pharmacy department.
(c) If the facility does not have a pharmacy department, it shall have provision for promptly obtaining prescribed drugs and biologicals from a community or institutional pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy, pursuant to KRS 315.035.
(d) An emergency medication kit approved by the facility's professional personnel shall be kept readily available. The facility shall maintain a record of what drugs are in the kit and document how the drugs are used.
(e) Medication requirement and services.
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All medications administered to patients shall be ordered in writing by the prescribing physician, advanced practice registered nurse as authorized in KRS 314.011(8) and 314.042(8), therapeutically-certified optometrist in the practice of optometry as defined in KRS 320.210(2), or physician assistant as authorized in KRS 311.560(3) and (4). Oral orders shall be given only to a licensed nurse or pharmacist, immediately reduced to writing, and signed. Medications not specifically limited as to time or number of doses, when ordered, shall be automatically stopped in accordance with the facility's written policy on stop orders. A registered nurse or the pharmacist shall review each patient's medical profile monthly. Medications shall be reviewed at least quarterly by the attending or staff physician. The patient's attending physician shall be notified of stop order policies and contacted promptly for renewal of such orders so that continuity of the patient's therapeutic regimen is not interrupted. Medications shall be released to patients on discharge or visits only after being labeled appropriately and on the written authorization of the physician.
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Administration of medications. All medications shall be administered by licensed nurses or personnel who have completed a state-approved training program, from a state approved training provider. Each dose administered shall be recorded in the medical record. Intramuscular injections shall be administered by a licensed nurse or a physician. If intravenous injections are necessary they shall be administered by a licensed physician or registered nurse.
a. The nursing station shall have items required for the proper administration of medications.
b. Medications prescribed for one (1) patient shall not be administered to any other patient.
c. Self-administration of medications by patients shall not be permitted except on special order of the patient's physician and a predischarge program under the supervision of a licensed nurse.
d. Medication errors and drug reactions shall be immediately reported to the patient's physician and pharmacist and an entry thereof made in the patient's medical record as well as on an incident report.
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The facility shall provide up-to-date medication reference texts for use by the nursing staff (e.g., Physician's Desk Reference).
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Labeling and storing medications. All medications shall be plainly labeled with the patient's name, the name of the drug, strength, name of pharmacy, prescription number, date, physician name, caution statements and directions for use except where accepted modified unit dose systems conforming to federal and state laws are used. The medications of each patient shall be kept and stored in their original containers and transferring between containers shall be prohibited. All medicines kept by the facility shall be kept in a locked place and the persons in charge shall be responsible for giving the medicines and keeping them under lock and key. Medications requiring refrigeration shall be kept in a separate locked box of adequate size in the refrigerator in the medication area. Drugs for external use shall be stored separately from those administered by mouth and injection. Provisions shall also be made for the locked separate storage of medications of deceased and discharged patients until such medication is surrendered or destroyed in accordance with federal and state laws and regulations.
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Controlled substances. Controlled substances shall be kept under double lock (e.g., in a locked box in a locked cabinet). There shall be a controlled substances record, in which is recorded the name of the patient; the date, time, kind, dosage, balance remaining and method of administration of all controlled substances; the name of the physician who prescribed the medications; and the name of the nurse who administered it, or staff who supervised the self-administration. In addition, there shall be a recorded and signed Schedule II controlled substances count daily, and Schedule III, IV and V controlled substances count once per week by those persons who have access to controlled substances. All controlled substances which are left over after the discharge or death of the patient shall be destroyed in accordance with 21 CFR 1307.21.
(5) Personal care services.
(a) All facilities shall provide services to assist patients to achieve and maintain good personal hygiene including the level of assistance necessary with:
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Bathing of the body to maintain clean skin and freedom from offensive odors. In addition to assistance with bathing, the facility shall provide soap, clean towels, and wash cloths for each patient. Toilet articles such as brushes and combs shall not be used in common.
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Shaving.
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Cleaning and trimming of fingernails and toenails.
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Cleaning of the mouth and teeth to maintain good oral hygiene as well as care of the lips to prevent dryness and cracking. All patients shall be provided with tooth brushes, a dentifrice, and denture containers, when applicable.
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Washing, grooming, and cutting of hair.
(b) The staff shall encourage and assist the patients to dress in their own street clothing (unless otherwise indicated by the physician).
(6) Dental services. The facility shall assist patients in obtaining dental services. Conditions necessitating dental services shall be noted and such dental procedures and services provided shall be recorded in the patient's record.
(7) Social services. The facility shall provide or arrange for social services as needed by the patient.
(a) Social services shall be integrated with other elements of the plan of care.
(b) A plan for such care shall be recorded in the patient's record and periodically evaluated in conjunction with the patient's total plan of care.
(c) Social services records shall be maintained as an integral part of case record maintained on each patient.
(8) Activities and therapeutic recreation.
(a) All facilities shall provide a program to stimulate physical and mental abilities to the fullest extent, to encourage and develop a sense of usefulness and self respect and to prevent, inhibit or correct the development of symptoms of physical and mental regression due to illness or old age. The program shall provide sufficient variety to meet the needs of the various types of patients in the facility. When possible, the patient shall be included in the planning of activities.
(b) All facilities shall meet the following program requirements:
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Staff. A person designated by the administrator shall be responsible for the program.
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A program shall be developed for each patient and shall be incorporated in the patient's plan of care and revised according to the patient's needs. Changes in his response to the program shall be recorded in the medical record.
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There shall be a planned and supervised activity period each day. The schedule shall be current and posted.
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The program shall be planned for group and individual activities, both within and outside of the facility, weather permitting.
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The person responsible for activities shall maintain a current list of patients on which precautions are noted regarding a patient's condition that might restrict or modify his participation in the program.
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A living or recreation room and outdoor recreational space shall be provided for patients and their guests.
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The facility shall provide supplies and equipment for the activities program.
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Reading materials, radios, games and TV sets shall be provided for the patients.
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The program may include religious activities for each patient if it is the desire of the patient to participate. Requests from a patient to be seen by a clergyman shall be acted upon as soon as possible, and an area of private consultation shall be made available.
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The facility shall allow the patient to leave the facility to visit, shop, attend church, or other social activities provided this does not endanger his health or safety.
(9) Transportation.
(a) If transportation of patients is provided by the facility to community agencies or other activities, the following shall apply:
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Special provision shall be made for patients who use wheelchairs.
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An escort or assistant to the driver shall be provided in transporting patients to and from the facility if necessary for the patient's safety.
(b) The facility shall arrange for appropriate transportation in case of medical emergencies.
(10) Residential care services. All facilities shall provide residential care services to all patients including: room accommodations, housekeeping and maintenance services, and dietary services. All facilities shall meet the following requirements relating to the provision of residential care services.
(a) Room accommodations.
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Each patient shall be provided a standard size bed at least thirty-six (36) inches wide, equipped with substantial springs, a clean comfortable mattress, a mattress cover, two (2) sheets and a pillow, and such bed covering as is required to keep the patients comfortable. Rubber or other impervious sheets shall be placed over the mattress cover whenever necessary. Beds occupied by patients shall be placed so that no patient may experience discomfort because of proximity to radiators, heat outlets, or by exposure to drafts.
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The facility shall provide window coverings, bedside tables with reading lamps (if appropriate), comfortable chairs, chest or dressers with mirrors, a night light, and storage space for clothing and other possessions.
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Patients shall not be housed in unapproved rooms or unapproved detached buildings.
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Basement rooms shall not be used for sleeping rooms for patients.
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Patients may have personal items and furniture when it is physically feasible.
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There shall be a sufficient number of tables provided that can be rolled over a patient's bed or be placed next to a bed to serve patients who cannot eat in the dining room.
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Each living room or lounge area and recreation area shall have an adequate number of reading lamps, and tables and chairs or settees of sound construction and satisfactory design.
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Dining room furnishings shall be adequate in number, well constructed and of satisfactory design for the patients.
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Each patient shall be permitted to have his own radio and television set in his room unless it interferes with or is disturbing to other patients.
(b) Housekeeping and maintenance services.
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The facility shall maintain a clean and safe facility free of unpleasant odors. Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans and other obvious sources.
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An adequate supply of clean linen shall be on hand at all times. Soiled clothing and linens shall receive immediate attention and shall not be allowed to accumulate. Clothing or bedding used by one (1) patient shall not be used by another until it has been laundered or dry cleaned.
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Soiled linen shall be placed in washable or disposable containers, transported in a sanitary manner and stored in separate, well-ventilated areas in a manner to prevent contamination and odors. Equipment or areas used to transport or store soiled linen shall not be used for handling or storing of clean linen.
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Soiled linen shall be sorted and laundered in the soiled linen room in the laundry area. Hand-washing facilities with hot and cold water, soap dispenser and paper towels shall be provided in the laundry area.
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Clean linen shall be sorted, dried, ironed, folded, transported, stored and distributed in a sanitary manner.
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Clean linen shall be stored in clean linen closets on each floor, close to the nurses' station.
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Personal laundry of patients or staff shall be collected, transported, sorted, washed and dried in a sanitary manner, separate from bed linens.
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Patients' personal clothing shall be laundered by the facility as often as is necessary. Patients' personal clothing shall be laundered by the facility unless the patient or the patient's family accepts this responsibility. Patients capable of laundering their own personal clothing and wishing to do so may, instead, be provided the facilities to do so. Patient's personal clothing laundered by the facility shall be marked to identify the patient-owner and returned to the correct patient.
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Maintenance. The premises shall be well kept and in good repair. Requirements shall include:
a. The facility shall insure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps and fences are in good repair.
b. The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing and electrical fixtures shall be in good repair. Windows and doors shall be screened.
c. Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly.
d. A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(c) Dietary services. The facility shall provide or contract for food service to meet the dietary needs of the patients including modified diets or dietary restrictions as prescribed by the attending physician. When a facility contracts for food service with an outside food management company, the company shall provide a qualified dietician on a full-time, part-time or consultant basis to the facility. The qualified dietician shall have continuing liaison with the medical and nursing staff of the facility for recommendations on dietetic policies affecting patient care. The company shall comply with all of the appropriate requirements for dietary services in this administrative regulation.
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Therapeutic diets. If the designated person responsible for food service is not a qualified dietician or nutritionist, consultation by a qualified dietician or qualified nutritionist shall be provided.
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Dietary staffing. There shall be sufficient food service personnel employed and their working hours, schedules of hours, on duty and days off shall be posted. If any food service personnel are assigned duties outside the dietary department, the duties shall not interfere with the sanitation, safety or time required for regular dietary assignments.
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Menu planning.
a. Menus shall be planned, written and rotated to avoid repetition. Nutrition needs shall be met in accordance with the current recommended dietary allowances of the Food and Nutrition Board of the National Research Council adjusted for age, sex and activity, and in accordance with physician's orders.
b. Meals shall correspond with the posted menu. Menus must be planned and posted one (1) week in advance. When changes in the menu are necessary, substitutions shall provide equal nutritive value and the changes shall be recorded on the menu and kept on file for thirty (30) days.
c. The daily menu shall include daily diet for all modified diets served within the facility based on an approved diet manual. The diet manual shall be a current manual with copies available in the dietary department, that has the approval of the professional staff of the facility. The diet manual shall indicate nutritional deficiencies of any diet. The dietician shall correlate and integrate the dietary aspects of the patient care with the patient and patient's chart through such methods as patient instruction, recording diet histories and participation in rounds and conferences.
- Food preparation and storage.
a. There shall be at least a three (3) day supply of food to prepare well balanced palatable meals.
b. Food shall be prepared with consideration for any individual dietary requirement. Modified diets, nutrient concentrates and supplements shall be given only on the written orders of a physician, advanced practice registered nurse as authorized in KRS 314.011(8) and 314.042(8), or physician assistant as authorized in KRS 311.560(3) and (4).
c. At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the substantial evening meal and breakfast. Between-meal snacks to include an evening snack before bedtime shall be offered to all patients. Adjustments shall be made when medically indicated.
d. Foods shall be prepared by methods that conserve nutritive value, flavor and appearance and shall be attractively served at the proper temperatures, and in a form to meet the individual needs. A file of tested recipes, adjusted to appropriate yield shall be maintained. Food shall be cut, chopped or ground to meet individual needs. If a patient refuses foods served, nutritional substitutions shall be offered.
e. All opened containers or leftover food items shall be covered and dated when refrigerated.
- Serving of food. When a patient cannot be served in the dining room, trays shall be provided for bedfast patients and shall rest on firm supports such as overbed tables. Sturdy tray stands of proper height shall be provided for patients able to be out of bed.
a. Correct positioning of the patient to receive his tray shall be the responsibility of the direct patient care staff. Patients requiring help in eating shall be assisted.
b. Adaptive self-help devices shall be provided to contribute to the patient's independence in eating.
- Sanitation. All facilities shall comply with all applicable provisions of KRS 219.011 to KRS 219.081 and 902 KAR 45:005.
Section 5. Separability. If any clause, sentence, paragraph, section or part of these administrative regulations shall be adjudged by any court of competent jurisdiction to be invalid, the judgment shall not affect, impair or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph, section or part thereof, directly involved in the controversy in which the judgment was rendered.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105, 311.560(3), (4), 314.011(8), 314.042(8), 320.210(2), EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Cabinet for Health Services regulate health facilities and health services. This administrative regulation establishes licensure requirements for the operation of and services provided by intermediate care facilities. Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Office of Inspector General and its programs under the Cabinet for Health Services.
- History: 902 KAR 020:051. 8 Ky.R. 406; 900; eff. 4-7-1982; 11 Ky.R. 832; eff. 12-11-1984; 13 Ky.R. 365; eff. 9-4-1986; 1151; eff. 2-10-1987; 16 Ky.R. 2496; 17 Ky.R. 76; eff. 7-18-1990; 1590; eff. 12-18-1990; 24 Ky.R. 2233; 25 Ky.R. 328; eff. 8-17-1998; TAm eff. 3-11-2011; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:056 Facility specifications; intermediate care {#sec-902-kar-20-056 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:056}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the Board for the purpose of operating an intermediate care facility.
(3) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Preparation and Approval of Plans and Specifications. After receiving certificate of need approval from the board, the following procedures shall be followed:
(1) Before construction is begun for the erection of new buildings or alterations to existing buildings or any change in facilities for an intermediate care facility, the licensee or applicant shall submit plans in the detail specified in Section 3 of this administrative regulation to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear either the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) All such plans and specifications must be approved by the licensure agency prior to commencement of construction of new buildings or alterations of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications must be approved by the Department of Housing, Buildings and Construction, and appropriate local building permits shall be obtained prior to commencement of construction.
Section 3. Submission of Plans and Specifications.
(1) First stage. Schematic plans.
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical patient room layouts (scaled one-fourth (1/4) inch = one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(b) If the project is an addition, or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangements of those buildings.
(2) Second stage. Preliminary plans: preliminary sketch plans shall include the following:
(a) Architectural: plans of basement and floors.
(b) Outline specifications.
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General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls, duct and piping systems; and dietary, laundry, and other special equipment;
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General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage. Contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Equipment. Location of all fixed equipment. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems. Details of construction, machine and control spaces necessary, size and type of equipment, and utility requirements for the following: dumbwaiters: electric, hand, hydraulic; elevators: freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems: radiators and steam heated equipment, such as warmers and steam tables; heating and steam mains and branches with pipe sizes; diagram of heating and steam risers with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heaters with stokers, oil burners, or gas burners; pumps, tanks, boiler breeching, and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems: size and elevation of: street sewer, house sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold and circulating branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections; oxygen and vacuum systems; standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits (with schedule of feeder breakers or switches);
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
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Cover or title sheet;
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Index;
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Sections describing materials and workmanship in detail for each class of work.
(c) Access to the work. Representatives of the appropriate state agencies shall have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances and Administrative Regulations.
(1) This section may be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority.
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended.
(b) Requirements for plumbing pursuant to 815 KAR 20:010 through 191, as amended.
(c) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010.
(d) Requirements for elevators pursuant to 803 KAR 4:010.
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(4) Prior to occupancy, facility must have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code, before relicensure is granted by the licensure agency.
Section 5. Facility Requirements and Special Conditions.
(1) Independent facilities with a capacity of fifty (50) beds or less present special problems. The sizes of the various departments shall depend upon the requirements of the facilities. Some functions allotted separate spaces or rooms in these general standards may be combined provided that the resulting plan will not compromise the standard of safety and of medical and nursing practices and the social needs of patients. Otherwise, the general standards set forth herein, including the area requirements, shall apply.
(2) Facilities shall be available to the public, staff, and patients who may be physically handicapped with special attention given to ramps, drinking fountain height, mirrors, etc.
(3) The number of beds in a nursing unit shall not exceed sixty (60) unless additional services are provided, as deemed necessary by the board. At least sixty-six (66) percent of the beds shall be located in rooms designed for one (1) or two (2) beds unless health program needs indicate otherwise in intermediate care mentally retarded/developmentally disabled facilities.
(4) Access to the facility shall be by means of a paved or gravel roadway which shall be available for use by traffic prior to a license being issued to the facility for occupancy.
Section 6. Nursing Unit.
(1) Patient rooms. Each patient room shall meet the following requirements:
(a) Maximum room capacity: four (4) patients.
(b) Patient rooms shall be designed to permit not less than a four (4) foot space between beds, and at least three (3) foot space between the side of a bed and the nearest wall, fixed cabinet, or heating/cooling element. A minimum of four (4) feet is required between foot of bed and opposite wall, or foot of opposite bed in multibed rooms.
(c) Window. All patient rooms must have windows opening to the outside. The sill shall not be higher than three (3) feet above the floor and shall be above grade. Window area shall be at least eight (8) percent of patient room floor area.
(d) Lavatory. In single and two (2) bed rooms with a private toilet room, the lavatory may be located in the toilet room. Where two (2) patient rooms share a common toilet, a lavatory shall be provided in each patient room;
(e) Wardrobe or closet for each patient. Minimum clear dimensions shall be one (1) foot and ten (10) inches deep by one (1) foot and eight (8) inches wide with full length hanging space with a clothes rod and shelf.
(f) Cubicle curtains, or equivalent built-in devices shall be provided for complete privacy for each patient in each multibed patient room and in tub, shower and toilet rooms.
(g) No patient room shall be located more than 120 feet from the nurses' station, the clean workroom, and the soiled workroom. No room shall be used as a patient room where the access is through another patient's room.
(2) Patient toilet rooms:
(a) Where a centralized toilet area is used, the facility shall provide for each sex on every floor the following: one (1) toilet for each eight (8) residents or major fraction thereof and one (1) lavatory for each sixteen (16) residents or major fraction thereof. Toilets must be separated by a permanent partition and at least one (1) toilet for each sex must be designed for wheelchair use.
(b) Grab bars shall be provided at all toilets. At least one (1) toilet shall be easily usable by wheelchair patients.
(c) Doors to toilet rooms shall have a minimum width of two (2) feet and ten (10) inches to admit wheelchair.
(3) Service areas in each nursing unit. The size of each service area will depend on the number and types of beds within the unit and shall include:
(a) Nurses' station. For nurses' charting, doctors' charting, communications, and storage for supplies and nurses' personal effects.
(b) Staff lounge area with personal storage space and a toilet room for staff.
(c) Visitors toilet room. The facility shall provide a toilet for visitors. The staff toilet room may serve as the visitors toilet room if marked and accessible.
(d) Clean workroom for storage and assembly of supplies for nursing procedures with a work counter and sink.
(e) Soiled workroom with a clinical sink, work counter with two (2) compartment sink, waste receptacles, and soiled linen receptacles.
(f) Medication area adjacent to nurses' station with sink, refrigerator, locked storage, and facilities for preparation and dispensing of medication. (May be designated area within clean workroom if a self-contained cabinet is provided.) The controlled substances locker must be under double lock.
(g) Clean linen storage with enclosed storage space. (May be designated area within the clean workroom.)
(h) Equipment storage room for storage of IV stands, inhalators, air mattresses, walkers, and similar bulky equipment.
(i) Patient baths. One (1) shower stall or one (1) bathtub shall be required for each twelve (12) beds not individually served. There shall be at least one (1) free standing bathtub in each bathroom. Grab bars or patient lift with a safety device shall be provided at all tubs. Grab bars shall be provided at all shower stalls. Each bathtub or shower enclosure in central bathing facilities shall provide space for private use, for dressing and for a wheelchair and attendant. At least one (1) shower in the central bathing facilities shall not be less than four (4) feet square, without curbs, and designed to permit use from a wheelchair. Soap dishes in showers and bathrooms shall be recessed.
(j) Janitor's closet for storage of housekeeping supplies and equipment with floor receptor or service sink.
(k) Bedpan washing facilities on each floor and located so that bedpans need not be carried through lobbies and dining areas.
(4) Patients' dining, TV viewing and recreation areas:
(a) The total areas set aside for these purposes shall be not less than thirty (30) square feet per bed for the first fifty (50) beds and twenty (20) square feet per bed for all beds in excess of fifty (50). Additional space shall be provided for outpatients if they participate in a day care program.
(b) Storage shall be provided for recreational equipment and supplies. (Such as wall cabinets or closets.)
(c) The areas set aside for these purposes must be readily accessible to wheelchair patients and shall be of sufficient size to accommodate equipment and permit unobstructed movement of wheelchair patients and personnel responsible for instructing and supervising patients.
Section 7. Dietary Department. If a commercial service will be used or meals will be provided by an adjacent hospital, dietary areas and equipment shall be designed to accommodate the requirements for sanitary, efficient, and safe storage, processing, and handling, otherwise the following shall be provided:
(1) Food preparation center with a lavatory but no mirror.
(2) Food serving facilities to accommodate patient and staff.
(3) Dishwashing and pot-washing facilities. Dish and utensil washing equipment shall be used that will result in sanitized serviceware and will prevent recontamination.
(4) Refrigerated storage which can accommodate a three (3) day supply minimum.
(5) Dry storage which can accommodate a three (3) day supply minimum.
(6) Food carts. If the facility uses food carts, space shall be provided in the kitchen or in a separate storage area for the cleaning and storage of food carts.
(7) Janitor's closet for storage for housekeeping supplies and equipment with a floor receptor or service sink.
(8) A toilet room conveniently accessible to the dietary department. If a toilet room is built within the dietary department it must have a two (2) door separation from food preparation area or dining areas.
Section 8. Administration Department. The facility shall have adequate administrative, public, and staff facilities (e.g., offices, lobby, toilet facilities) to accommodate the needs of the public, patients, and staff without interfering with the provision of medical care services.
Section 9. Laundry. The following shall be included:
(1) Soiled linen room;
(2) Clean linen room;
(3) Lavatory accessible from soiled, clean, and processing rooms;
(4) Laundry processing room, and storage for laundry supplies. (Need not be provided if laundry is processed outside the facility.);
(5) Janitor's closet with storage for housekeeping supplies and equipment and floor receptor or service sink.
Section 10. Storage and Service Areas. The following shall be included:
(1) Sufficient storage space for general storage requirements.
(2) Engineering service and equipment areas. The following shall be provided where applicable:
(a) Boiler room;
(b) Mechanical and electrical equipment room(s) (can be combined with boiler room);
(c) Storage room for housekeeping equipment (need not be provided if space is available in janitor's closets or elsewhere);
(d) Refuse area for holding trash prior to disposal which is located convenient to service entrance.
Section 11. Details and Finishes. A high degree of safety for the occupants to minimize the incidence of accidents shall be provided. Hazards such as sharp corners shall be avoided. All details and finishes shall meet the following requirements:
(1) Details.
(a) Handrails shall be provided on both sides of corridors used by patients in intermediate care facilities with a clear distance of one and one-half (1 1/2) inches between handrail and wall.
(b) All doors to patient-room toilet rooms and patient-room bathrooms shall swing outward or shall be equipped with hardware which will permit access in any emergency.
(c) All doors opening onto corridors shall be swing-type except elevator doors. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
(d) Thresholds and expansion joint covers, if used, shall be flush with the floor.
(e) Grab bars and accessories in patient toilet rooms, shower rooms, and bathrooms shall have sufficient strength and anchorage to sustain a load of 250 pounds for five (5) minutes.
(f) Lavatories intended for use by patients shall be installed to permit wheelchairs to slide under.
(g) Mirrors shall be arranged for convenient use by patients in wheelchairs as well as by patients in standing position.
(h) Towel rack or dispenser shall be provided at all lavatories and sinks used for hand-washing.
(i) Ceiling heights.
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Boiler room. Not less than two (2) feet and six (6) inches above the main boiler header and connecting piping with adequate headroom under piping for maintenance and access;
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Corridors, storage rooms, patients' toilet rooms, and other minor rooms. Not less than seven (7) feet and six (6) inches;
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All other rooms. Not less than eight (8) feet.
(j) Boiler room, food preparation centers, and laundries shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of eighty-five (85) degrees Fahrenheit.
(k) Noise reduction criteria. The ceilings of the following areas shall be designed to reduce noise transmission:
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Corridors in patient areas;
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Nurses' stations;
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Work areas, such as utility rooms;
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Lobbies and recreation areas.
(l) Special attention shall be given to sound transmission from boiler rooms, mechanical rooms, and kitchen, to patient bedroom areas.
(2) Finishes.
(a) Floors generally shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchen and related spaces shall be waterproof and grease-proof. In all areas where floors are subject to wetting, they shall have a nonslip finish.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable and in the immediate area of plumbing fixtures, the finish shall be moisture-proof. Wall bases in dietary areas shall be free of spaces that can harbor insects.
(d) Ceilings generally shall be washable or easily cleanable. This requirement does not apply to boiler rooms, mechanical and building equipment rooms, shops and similar spaces.
Section 12. Elevators. Elevators shall conform with 815 KAR 4:010. Elevators, where required. All facilities where either patient beds or inpatient facilities such as diagnostic, recreation, patient dining or therapy rooms are located on other than the first floor, shall have electric or electrohydraulic elevators as follows:
(1) Number of elevators. All facilities with either patient beds or inpatient facilities located on any floor other than the first floor shall have at least one (1) hospital-type elevator and such additional elevators as determined by the licensure agency from a study of the facility plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Cars of hospital-type elevators shall have inside dimensions that will accommodate a patient's bed and attendants and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep; car doors shall have a clear opening of not less than three (3) feet and eight (8) inches. Cars of all other required elevators shall have a clear opening of not less than three (3) feet.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
Section 13. Construction. Foundations shall rest on natural solid ground if a satisfactory soil is available at reasonable depths. Proper soil bearing values shall be established in accordance with recognized standards. If solid ground is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement.
Section 14. Mechanical Requirements.
(1) Steam and hot water systems.
(a) Boilers. If boilers are used a minimum of two (2) must be provided; the combined capacity of the boilers, based upon the published Steel Boiler Institute or Institute of Boiler and Radiator Manufacturer's net rating, must be able to supply 150 percent of the normal requirements of all systems and equipment.
(b) The design and installation of boilers in the facility shall comply with 815 KAR 15:010 through 060.
(2) Temperature and ventilating systems.
(a) Temperatures. A minimum temperature of seventy-two (72) degrees Fahrenheit shall be provided for in occupied areas in winter conditions. A maximum temperature of eighty-five (85) degrees Fahrenheit shall be provided for in occupied areas in summer conditions.
(b) Ventilation systems details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at or near the point of discharge from the building. The ventilation rates shown in Table 1, Section 16 of this administrative regulation, shall not be considered as precluding the use of higher ventilation rates if they are required to meet design conditions.
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Outdoor ventilation air-intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five (25) feet from the exhausts from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight (8) feet above the ground level or if installed through the roof, three (3) feet above roof level.
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The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas shown in Table 1, Section 16 of this administrative regulation.
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Room supply air inlets, recirculation, and exhaust air outlets shall be located not less than three (3) inches above the floor.
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Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate rooms such as bathrooms, toilet rooms, or janitor's closets which open directly on corridors.
(3) Plumbing and other piping systems.
(a) Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five (5) inches above the rim of the fixture. All fixtures used by medical and nursing staff, and all lavatories used by patients and food handlers shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall be at a distance from the center line of the sink to be operational.
(b) Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
(4) Water supply system:
(a) Systems shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.
(b) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
(c) Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.
(d) Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitor's sinks and bedpan flushing attachments.
(e) Hot water distribution systems shall be arranged to provide hot water at each fixture at all times.
(f) Piping over food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of, or condensation from, necessary overhead piping systems.
(5) Hot water heaters and tanks.
(a) The hot water heating equipment shall have sufficient capacity to supply the water at the temperature and amounts indicated below:
(b) Storage tank(s) shall be provided and shall be fabricated of corrosion-resistant metal, or have noncorrosive lining.
(6) Plumbing approval. Prior to final approval of the plans and specifications by the licensure agency, the plumbing plans and specifications must be approved by the Division of Plumbing, Department of Housing, Buildings and Construction.
Section 15. Electrical Requirements.
(1) General. Electrical requirements of the Kentucky Building Code shall apply where applicable.
(2) The wiring in each facility shall be inspected by a certified electrical inspector and a certificate of approval shall be issued to the facility, prior to occupancy; however, the wiring in existing buildings shall be approved by a certified electrical inspector only when the building has not been previously so approved for health care occupancy or where the State Fire Marshal finds that a hazardous condition exists.
(3) Switchboard and power panels. All breakers and switches shall be indexed.
(4) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have electric lighting.
(b) Patients' bedrooms shall have general lighting. A reading light shall be provided for each patient when appropriate. Patients' reading lights and other fixed lights not switched at the door shall have switch controls convenient for use at the luminaire. Fixed type night lights shall be provided in each patient's room.
(c) Lighting levels for the facility shall comply with the requirements of Table 2, Section 16 of this administrative regulation.
(5) Receptacles (convenience outlets).
(a) Bedroom. Each patient bedroom shall have duplex receptacles as follows: one (1) each side of the head of each bed (for parallel adjacent beds, only one (1) receptacle is required between the beds), receptacles for luminairies, television and motorized beds, if used, and one (1) receptacle on another wall.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of ends of corridors.
(6) Nurses' calling system. A nurses' visible signal calling station shall be installed at each patient bed and in each patient toilet, bath, and shower room. The nurses' call in toilet, bath, or shower room, shall be an emergency call. All calls shall register at the nurses' station and shall actuate a visible signal in the corridor at the patient's door, in the clean workroom, and the soiled workroom of the nursing unit.
(7) Emergency electric service.
(a) General. To provide electricity during an interruption of the normal electric supply that could affect the nursing care, treatment, or safety of the occupants, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) Sources. The source of this emergency electric service shall be an emergency generating set, when normal service is supplied by one (1) or more central station transmission lines.
(c) Emergency generating set.
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The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system. The emergency generator set shall be sufficient kilowatt capacity to supply all lighting and power load demands of the emergency system. The power factor rating of the generator shall be not less than eighty (80) percent.
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When the facility is supplied by at least two (2) dedicated and separate utility service feeders, an emergency generating set is not required.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto, including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors;
b. Dining and recreation rooms;
c. Nursing station and medication preparation area;
d. Generator set location, switch-gear location, and boiler room;
e. Elevator (if required for emergency).
- Equipment. Essential to life safety and for protection of important or vital materials:
a. Nurses' calling system;
b. Sewage or sump lift pump, if installed;
c. At least one (1) duplex receptacle in each patient room;
d. Equipment such as burners and pumps necessary for operation of one (1) or more boilers and their necessary auxiliaries and controls, required for heating and sterilization;
e. Details. The emergency system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting, all alarms, nurses' call, and receptacles in patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification. Storage-battery-powered lights shall not be used as a substitute for the requirement of a generator. Where fuel is normally stored on the site, the storage capacity shall be sufficient for twenty-four (24) hour operation of required emergency electric services. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.
f. Emergency heating. Where electricity is the only source of power normally used for space heating, an alternate emergency heating system for the heating of corridors will be required. Emergency heating of corridors will not be required in areas where the facility is supplied by at least two (2) utility service feeders, each supplied by separate generating sources or a network distribution system fed by two (2) or more generators, with the facility feeders so routed, connected, and protected so that a fault any place between the generators and the facility will not be likely to cause an interruption of more than one (1) of the intermediate care facility's service feeders. If there is written plan for the transfer of patients within a reasonable time to other facilities with which the intermediate care facility has written transfer agreements, the above alternate emergency heating system will not be required.
Section 16. Appendix.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides licensure requirements for facility specifications for the construction, alteration and maintenance of intermediate care facilities.
- History: 902 KAR 020:056. 8 Ky.R. 234; eff. 11-5-1981; 16 Ky.R. 982; eff. 1-12-1990; Crt eff. 4-30-2019; TAm eff. 3-20-2020; Crt eff. 2-17-2016.
902 KAR 20:066 Operation and services; adult day health care programs {#sec-902-kar-20-066 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:066}
Section 1. Definitions.
(1) "Administrator" means a person who:
(a) Has a minimum of two (2) years college, or equivalent training with at least two (2) years of clinical experience, a degree, or a license in a health related profession; or
(b) Is licensed as a nursing home administrator pursuant to KRS 216A.080.
(2) "Licensed practical nurse" means a person who is licensed pursuant to KRS 314.011(9).
(3) "Nursing services" means the delivery of medication, or treatment by a registered nurse or a licensed practical nurse supervised by a registered nurse, consistent with KRS Chapter 314 scope of practice provisions and the Kentucky Board of Nursing scope of practice determination guidelines.
(4) "Occupational therapist" means a person who is currently licensed pursuant to KRS Chapter 319A.
(5) "Personal care services" means services to help patients achieve and maintain good personal hygiene including assistance with:
(a) Bathing;
(b) Shaving;
(c) Cleaning and trimming of fingernails and toenails;
(d) Cleaning of the mouth and teeth; and
(e) Washing, grooming, and cutting of hair.
(6) "Program" means an adult day health care program as established in KRS 216B.0441(1).
(7) "Physical therapist" means a person who is currently licensed by the Kentucky Board of Physical Therapy.
(8) "Registered nurse" means a person who is currently licensed pursuant to KRS 314.011(5).
(9) "Speech-language pathologist" means a person who is currently licensed by the Kentucky Board of Speech-Language Pathology and Audiology.
Section 2. Administration and Operation.
(1) Licensee.
(a) The licensee shall be legally responsible for the operation of the program and for compliance with federal, state, and local laws pertaining to the operation of the program.
(b) The licensee shall ensure policies, consistent with state or local laws, for the administration and operation of the program are established in writing and enforced including:
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A description of services provided by the program;
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A procedure for providing first aid and making arrangements for medical care with a physician or hospital in case of accidents or medical emergencies;
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A procedure for transporting patients to a physician or hospital in case of an accident or a medical emergency;
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Procedures for admission, evaluation of patient's needs, and discharge;
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A procedure which assures the reporting of abuse, neglect, or exploitation of adults and children to the Cabinet for Families and Children pursuant to KRS Chapters 209 and 620;
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A policy to ensure that a patient of the program is protected and accounted for while in the care of the program;
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An infection control policy, which is consistent with the Centers for Disease Control guidelines, to include policies which address the prevention of disease transmission to and from patients, visitors, and employees including:
a. Blood and body fluid precautions;
b. Precautions for infections which can be transmitted by the airborne route; and
c. Work restrictions for employees with infectious diseases;
- Guidelines for the storage and administration of medications that include:
a. A provision to ensure that medicines kept by the program shall be labeled with the patient's name, name of the drug, strength of the drug, name of the dispensing pharmacy, prescription number, date, physician's name, caution statements, and directions for use;
b. A provision to ensure that medicines requiring refrigeration are kept in a refrigerator;
c. A provision that medications kept by the program are kept under lock;
d. A provision to ensure that controlled substances are kept under double lock (e.g., a locked box in a locked cabinet); and
e. A provision to ensure that there is a controlled substances record, in which is recorded the name of the patient, the date, time, kind, dosage, balance remaining, and method of administration of controlled substances; the name of the physician who prescribed the controlled substance; and the name of the nurse who administered the controlled substance, or staff who supervised the self-administration of the controlled substance;
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A program providing nursing services pursuant to Section 4 of this administrative regulation shall have provisions for promptly and conveniently obtaining prescribed drugs and biologicals from a community or institutional pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy, pursuant to KRS 315.035; and
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A written policy to ensure that a child who attends the program:
a. Is free from physical, verbal, and sexual abuse and neglect;
b. Has age appropriate programming and activities; and
c. Is kept segregated from adult patients except for meals and special events.
(2) Administrator. A program shall have an administrator who shall be responsible for the operation of the facility and shall delegate such responsibility in his absence.
(3) A patient shall be evaluated upon admission to determine his program needs. A care plan shall be developed for the patient.
(4) Personnel.
(a) The program shall employ or have access to a sufficient number of qualified personnel as may be required to provide the services required by this administrative regulation and indicated by the need of the program's patients.
(b) Written job descriptions and standards of qualifications shall be developed for each category of personnel. Job descriptions shall include necessary qualifications, lines of authority, and specific duty assignments. Job descriptions shall be reviewed annually and revised as necessary.
(c) Current employee records shall be maintained and shall include a resume of an employee's training and experience, evidence of current licensure or registration if required by law, health records and evaluation of performance, along with an employee's name, address, and Social Security number.
(d) Supportive personnel, assistants and volunteers shall be supervised and shall function within the policies and procedures of the program.
(e) An employee shall have a test for tuberculosis prior to or within the first week of employment and annually thereafter. An employee contracting an infectious disease shall not appear at work until the infectious disease can no longer be transmitted.
(f) The program shall conduct an orientation for new employees.
(g) A planned in-service training program shall be provided to employees covering policies and procedures pertinent to their roles within the program.
(h) The administrator shall attend educational programs appropriate to the responsibilities of the position and arrange for other professional personnel to attend appropriate educational programs on supervision and subjects related to personal care, activities, nutrition, and other pertinent subjects.
(i) Staffing. The administrator shall designate the person who shall be primarily responsible for the coordination and provision of a dietary and activity service.
(j) An employee of the program who has direct patient care responsibilities shall have current cardiopulmonary resuscitation (CPR) certification from either the American Heart Association or the American Red Cross.
(5) Patient's records.
(a) The facility shall maintain an individual record for a patient and shall develop a system of identification and filing to ensure prompt location of the patient's record. Records shall be treated with confidentiality, shall be in ink or typed, and shall be legible. The record shall include the:
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Patient's name, address, and Social Security number (if available);
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Name, address, and telephone number of a referral agency;
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Name and telephone number of personal physician;
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Patient's history and physical examination report;
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Patient's medication and food allergies;
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Name, telephone number, and address of next of kin or other responsible person; and
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Date of admission and discharge.
(b) A progress record shall be maintained stating goals for a patient and shall indicate changes in the patient's condition, behavior, responses, attitude, appetite, and other changes as noted by staff, and shall include a discharge summary. An entry in the record shall be signed and dated.
(c) If the patient has been referred on orders of a physician, the record shall contain a dated and signed medical summary and care plan including orders for special diet, contraindications for specific types of activities, and other special procedures required for the safety and well-being of the patient.
(d) A consultant involved in the program shall make a written report of his findings and recommendations at the time of his visit to be included in the patient's record.
(e) If a medication shall be administered to a patient during the period of time he is in the program, a medication sheet shall be maintained which contains the date, time given, name of medication, dosage, name of prescribing physician, and by whom administered.
(f) A full written report of an incident or accident involving a patient or employee shall be made and signed by the administrator or his designee and shall include the names of any witnesses.
(g) A record shall be retained for a minimum of five (5) years or, in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
(h) A telephone order from a physician or another individual acting within his scope of practice shall be countersigned within thirty (30) days.
(i) If nursing services are provided pursuant to Section 4 of this administrative regulation, the record shall indicate a description of the nursing service provided, the date the service was provided, and pertinent information relating to the delivery of the service.
(6) Registry. The program shall maintain a permanent, chronological patient registry book showing date of admission, name of patient, and date of discharge.
(7) Equipment and supplies. The program shall have equipment and supplies of sufficient quality and quantity to meet patients' needs.
Section 3. Health services.
(1) Health care services shall include:
(a) Supervision and monitoring of the patients to assure that health care needs are being met including supervision of self-administration of medications;
(b) Providing first aid and making arrangements for medical care with a physician or hospital in case of accidents or medical emergencies; and
(c) Arranging for the transportation of a patient to a physician's office or hospital in case of accidents or medical emergencies.
(2) Medical therapeutic services such as physical therapy or speech therapy shall be administered upon written order of the physician and shall be provided by a physical therapist or a speech-language pathologist or under the supervision of a physical therapist or a speech-language pathologist.
(3) Occupational therapy shall be provided by an occupational therapist or under the supervision of an occupational therapist.
(4) A patient receiving medical therapeutic services or occupational therapy shall be ensured privacy and dignity.
Section 4. Nursing Services.
(1) A program that provides nursing services shall obtain a license to provide nursing services pursuant to subsection (5) of this section.
(2) Nursing services administered to patients by a registered nurse or licensed practical nurse supervised by a registered nurse shall be ordered in writing by the patient's physician or another licensed professional acting within his scope of practice.
(3) If an order for treatment or medication is received by telephone it shall be given to a registered nurse or licensed practical nurse and immediately reduced to writing.
(4) Nursing services, other than the delivery of oral medications, shall be provided in a treatment room.
(5) Special licensing provisions for a program providing nursing services:
(a) A program currently licensed by the cabinet may complete a revised form OIG 144 indicating that nursing services shall be provided.
(b) The Office of the Inspector General may conduct a survey as defined in 902 KAR 20:008 to ensure the requirements for providing nursing services are met.
(c) The program shall be issued an amended license reflecting the authority to provide nursing services.
(d) A program that is applying for an initial license shall indicate on the form OIG 144 that nursing services shall be provided and the initial license issued by the Office of the Inspector General shall reflect the authority to provide nursing services.
(6) A program licensed as of September 1, 2000 that applies for an amended license to provide nursing services shall not be required to comply with Section 6(10) or (11) of this administrative regulation, prior to September 1, 2001.
Section 5. Other Services.
(1) Self-care training. The program shall provide a training program for self-care to assist a patient to gain independent living status.
(2) Personal care. Personal care services shall be provided.
(3) Activity program.
(a) The program shall include a balanced activity program for all ages served. A patient shall choose and plan, if feasible, a variety of activities that the patient desires, and the involvement of the staff shall be advisory. There shall be a written activity program with activities planned to fill patient needs with a sufficient variety for choice including:
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Recreation and physical exercise;
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Diversion, games, music, and crafts;
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Intellectual and educational stimulation, current events, and educational films; and
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Participation in planning menus and preparation of food.
(b) Activities shall be group or individually oriented aimed at participation at all levels of capability.
(c) A specific period of the day shall be set aside for rest. There shall be appropriate accommodations for rest.
(4) Transportation. If transportation of the patient to or from the program is provided by the program:
(a) A special provision shall be made for a patient who uses a wheelchair; and
(b) An escort or assistant to the driver shall be provided if necessary.
(5) Dietary services.
(a) Food service and preparation.
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The program shall offer one (1) or more hot meals providing no less than one-third (1/3) of the daily nutritional requirements per meal.
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Foods shall be prepared by appropriate methods to conserve their nutritive value and enhance their flavor and appearance.
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Nutritional needs shall be met in accordance with the current Recommended Dietary Allowance of the Food and Nutrition Board of the National Research Council, adjusted for age, sex, and activity and in accordance with physician's orders.
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Food shall be cut, chopped, or ground to meet individual needs.
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Effective equipment shall be provided and procedures established to maintain food at proper temperature during service.
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A patient requiring help in eating shall be assisted.
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Adaptive self-help devices shall be provided if required in such a manner as to contribute to the patient's independence in eating.
(b) Maintenance of sanitary condition.
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The dietary department shall comply with all applicable provisions of KRS 219.011 to KRS 219.081 and 902 KAR 45:005. If the program contracts for food service, the catering service shall comply with the applicable requirements of 902 KAR 45:005 and the applicable requirements of this administrative regulation.
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Perishable foods shall be refrigerated at the appropriate temperature and in an orderly and sanitary manner. Leftover food items shall be covered and dated if refrigerated.
Section 6. Facility Requirements.
(1) The facility shall be maintained in a safe and clean manner, free from offensive odors, safety hazards, and accumulations of dirt, rubbish and dust.
(2) A deodorizer shall not be used to conceal an odor caused by unsanitary conditions or poor housekeeping practices.
(3) The grounds shall be kept free from refuse and litter. Areas around buildings, sidewalks, gardens, and patios shall be kept clear of dense undergrowth.
(4) The facility shall be maintained free from insects and rodents.
(5) Open windows and doors shall be screened.
(6) Nests and entrances for insects and rodents shall be eliminated.
(7) Waste disposal.
(a) Sharp waste.
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Sharp waste, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other waste and placed in puncture resistant containers immediately after use.
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A needle or other contaminated sharp instrument shall not be purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Occupational Safety and Health Administration guidelines established in 29 CFR 1910.1030(d)(2)(vii).
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The containers of sharp waste shall be incinerated on or off site, or be rendered nonhazardous.
(b) Disposable waste.
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Disposable waste shall be placed in suitable bags or closed containers to prevent leakage or spillage, and shall be handled, stored, and disposed of minimizing direct exposure of personnel to waste materials.
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The program shall establish specific written policies regarding handling and disposal of waste.
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The following waste shall be disposed of by incineration, or be autoclaved before disposal, or be carefully poured down a drain connected to a sanitary sewer:
a. Blood;
b. Blood specimens;
c. Blood products; or
d. Used blood tubes.
(8) There shall be adequate space in the facility to provide for patient needs and comfort.
(9) The facility shall have space to allow a patient who has become ill to rest in comfort and privacy.
(10) A program that provides nursing services shall have a treatment room.
(a) The treatment room shall have a minimum floor area of 120 square feet.
(b) The treatment room shall contain:
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A lavatory or sink equipped for hand washing;
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A work counter;
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Storage facilities for storage and distribution of clean and sterile supplies; and
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Adequate furnishings to safely and comfortably provide nursing services.
(11) A program that provides nursing services shall have a workroom or closet that contains:
(a) A sink equipped for hand washing;
(b) A waste receptacle; and
(c) A linen receptacle for the collection of soiled linen.
Section 7. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) Kentucky Board of Nursing Scope of Practice Determination Guidelines, April 1995 edition; and
(b) Form OIG 144, Application for a License to Operate a Health Facility or Service, February 2001 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of the Inspector General, 275 East Main Street, Fifth Floor East, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.0441, 216B.0443(1), 216B.990
- STATUTORY AUTHORITY: KRS 216B.042, 216B.0441, 216B.0443(1), 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Health Services regulate health facilities and health services. KRS 216B.0441 and 216B.0443(1) mandate that the Cabinet for Health Services establish licensure requirements for adult day health care programs. This administrative regulation provides for the licensure requirements for the operation of adult day health care programs and the services to be provided by adult day health care programs.
- History: 902 KAR 020:066. 8 Ky.R. 240; eff. 11-5-1981; 11 Ky.R. 476; eff. 10-9-1984; 18 Ky.R. 1233; eff. 11-25-1991; 27 Ky.R. 2905; eff. 6-8-2001; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:074 Operation and services; outpatient health care center {#sec-902-kar-20-074 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:074}
Section 1. Definitions.
(1) "Campus" means the physical area on which the licensee's main administrative building, other areas and structures are located as well as that physical area located, immediately adjacent to and within 250 yards of the main administrative building.
(2) "Main provider" means a licensed acute care hospital under which an outpatient health care center functions as a subordinate and integral part, and which is under the same name, ownership, and control as the outpatient health care center.
(3) "Outpatient health care center" or "center" means a licensed health care facility that is designated in the Certificate of Need State Health Plan as a primary care center with outpatient diagnostic and surgical services, and which is certified by the Centers for Medicare and Medicaid Services under 42 C.F.R. 413.65 as a provider-based institution, with permanent facilities on a single campus that is operated under the supervision of an organized medical staff and is comprised of service components for the provision of primary care, ambulatory surgery, twenty-four (24) hour emergency care, and radiological and magnetic resonance imaging "MRI".
Section 2. Services. The center shall provide component services that include primary care services, 24-hour emergency services, diagnostic imaging including MRI, and ambulatory surgery services on a single campus that is located in a county that has no hospital, that has a population of 60,000 or more persons and that also is a medically-underserved area as determined by the Secretary of the Federal Department for Health and Human Services.
(1) A primary care component shall include the following services, which shall be provided in the center or shall be arranged through other providers with which the center has linkage agreements in accordance with Section 7 of this administrative regulation:
(a) Basic health care services to patients of all ages during normal hours of operation;
(b) A variety of preventative, diagnostic, and therapeutic services of sufficiently broad scope to provide for the usual and expected needs of patients in all age groups;
(c) Coordinated services for all other health components in this administrative regulation; and
(d) Services established in Section 8(1) of this administrative regulation.
(2) An ambulatory surgical care component shall include:
(a) Ambulatory surgical services that, in the professional judgment of the surgeon and the facility's medical director, may be safely performed in the outpatient setting on a patient whose recovery under normal circumstances shall not require inpatient care, observation-hold, or convalescence in excess of twenty-three (23) hours;
(b) Follow-up care and services as necessary for a surgical patient's recovery; and
(c) Services established in Section 8(4) of this administrative regulation.
(3) An emergency medical services component shall include:
(a) Twenty-four (24) hour emergency medical treatment by a board certified or board eligible emergency room physician seven (7) days per week;
(b) A specific area for emergency treatment that shall be located adjacent to an exterior entrance and is immediately accessible to emergency transport vehicles;
(c) Facilities sufficient to assure prompt diagnosis, treatment, and stabilization of injuries and trauma; and
(d) Services established in Section 8(2) of this administrative regulation.
(4) A diagnostic imaging and MRI component shall include:
(a) Radiologic and magnetic resonance imaging with permanent, fixed-site equipment licensed or registered pursuant to KRS 211.842 to 211.852 and 900 KAR 6:050, but shall not include any services for which a separate certificate of need is required;
(b) Radiologic and imaging services shall be provided in accordance with protocols established by the center, which shall include a concise statement of the reason for the service; and
(c) Services established in Section 8(3) of this administrative regulation.
Section 3. Administration and Operations.
(1) The licensee shall:
(a) Be legally responsible for the center and for compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the center;
(b) Appoint a full-time administrator of the center whose qualifications, responsibilities, authority, and accountability shall be defined in writing and approved by the hospital governing authority; and
(c) Be responsible for and assure compliance with this administrative regulation, and make immediately available for public inspection at the center all licensure and complaint inspection reports and plans of correction pertaining to the last three (3) year survey period.
(2) The administrator shall:
(a) Be responsible for the daily operations of the center and shall delegate that responsibility in his absence;
(b) Assure the establishment and implementation of written policies and procedures covering all aspects of the center's operation and, if appropriate, shall be consistent with the policies and procedures of the main provider;
(c) Serve as liaison between the center, its medical staff, and the main provider;
(d) Hold at least quarterly, component and departmental staff meetings that shall include a discussion of administrative and patient care standards;
(e) Ensure that a sufficient number of trained staff are available to meet the needs of all persons who receive services in the center; and
(f) Appoint a licensed physician to serve as medical director who shall direct and coordinate all medical services and oversee implementation of patient care standards and policies, who may serve as the licensed physician in charge as established in Section 5(1)(a)1 of this administrative regulation.
Section 4. Policies and Procedures.
(1) Development of policies and procedures. The administrator shall assure development or adoption and implementation of the following policies and procedures:
(a) Administrative standards and policies covering all aspects of the center's operation and specific to each component part, including at least the following:
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A description of organizational structure, staffing, and allocation of responsibility and accountability within each component part;
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A description of referral linkages with inpatient facilities and other providers;
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A description of the component services provided by the center;
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Policies and procedures for the guidance and control of personnel performance and quality assurance;
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Policies and procedures for creation and maintenance of administrative and patient care records and reports;
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Policies for expense and accrual-based revenue accounting system following generally-accepted accounting procedures;
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Policies and procedures governing the use of aseptic techniques in all areas of the center;
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Policies and procedures for sterilization of equipment and supplies;
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Policies and procedures for disposal of patient waste and other potentially-infectious materials; and
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Policies and procedures for granting and withdrawal of medical staff surgical privileges and privileges for the administration of anesthetics.
(b) Patient care policies and standards, which shall be developed by staff physicians and other qualified professional staff, for all medical aspects of the center including:
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Written protocols for standing orders, rules of practice, and medical directives applying to each of the component services, which shall be signed by the administrator and staff physician;
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Patient care policies and standards for patients held in the center's holding-observation area;
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Patient care policies and standards for primary care services;
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Patient care policies and standards for emergency medical services;
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Patient care policies and standards for ambulatory surgical services; and
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Patient care policies and standards for diagnostic imaging and magnetic resonance imaging services; and
(c) Patient rights policies which shall be developed and assure that each patient is:
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Informed of the patient's rights and facility responsibilities, including procedures for handling patient grievances;
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Informed of services available at the center and any charges not covered under Medicare, Medicaid, or other third-party payor arrangements;
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Informed of his medical condition, unless medically contraindicated and documented in the medical record, and is afforded the opportunity to participate in the planning of medical treatment, the right to refuse treatment, and informed consent;
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Encouraged and assisted to understand and exercise patient rights and the right to make grievances and receive a response to a grievance;
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Assured confidentiality in treatment, care, and records, and is afforded the opportunity to approve or refuse release of records to any individual not involved in his care except as required by Kentucky law or third-party payment contract; and
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Treated with consideration, respect, and full recognition of his dignity and individuality, including privacy in treatment, and in the care of his personal health needs.
(2) Accessibility of policies and procedures. Written policies and procedures shall be maintained in the facility in a readily-accessible electronic format or a written manual that is available and conveniently accessible to all staff employed in the component service.
Section 5. Personnel and Qualifications.
(1) Personnel. The center shall have sufficient trained personnel to meet the needs of each patient who presents for treatment at the center, which shall include:
(a) At a minimum, a core center provider team to coordinate services for the component services, composed of at least one (1) licensed physician in charge, who may also serve as the center's medical director and the physician in charge of emergency medicine; one (1) full-time registered nurse, who shall provide services within the scope of practice; and other nursing personnel, aides, and technicians as required to meet the needs of the patients, as follows:
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A licensed physician shall be in charge in the center twenty-four (24) hours a day, seven (7) days a week, who shall be a physician in active practice and who shall be responsible for all medical aspects of the center's operation. The licensed physician in charge may provide direct medical services in accordance with KRS Chapter 311.
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The center shall employ or have contractual or other linkage agreements with other physicians as necessary to meet the surgical needs of the center's patients, and who shall be qualified to practice general medicine (e.g., general practitioner, family practitioner, obstetrician/gynecologist, pediatrician, and internist), and who shall hold at least courtesy staff privileges at one (1) or more hospitals with which the center has a formal transfer agreement.
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The registered nurse shall provide nursing services within the scope of practice pursuant to KRS Chapter 314.
(b) At a minimum, a core ambulatory surgery component provider team composed of one (1) licensed physician in charge; other licensed physicians, dentists, or podiatrists, as necessary to meet the surgical needs of the center's patients; an anesthesiologist or nurse anesthetist; a full-time registered nurse; and other nursing personnel, aides, and technicians as required to meet the needs of the patients, as follows:
- A licensed physician shall be in charge of the ambulatory surgery component, and may also serve as the center's medical director. This physician shall be in active practice and shall either:
a. Have surgical privileges at the provider-based hospital or one (1) or more hospitals with which the center has a formal transfer agreement; or
b. Be a board-certified anesthesiologist in active practice and be employed full time by the center or have a contract to work full time at the center.
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Surgical procedures shall be performed by physicians who are legally authorized to perform these procedures and have been granted privileges by the center through its medical staff or governing body.
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The ambulatory surgery registered nurse shall be employed full-time and shall provide services within the scope of practice pursuant to KRS Chapter 314.
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Other nursing personnel, aides, and technicians shall be employed to meet the needs of the patients. A registered nurse shall be available during the surgical procedure and if a patient is in recovery for patient care in the operating or post-anesthesia recovery room.
(c) At a minimum, the emergency medical component shall be composed of a licensed physician, board certified in emergency medicine or board eligible, who shall serve as director of emergency medicine; at least one (1) full-time registered nurse; and other physicians and medical staff who shall be available or on duty at all times for the emergency service, as follows:
- A licensed physician shall be present in the center twenty-four (24) hours a day, seven (7) days a week, shall serve as director of emergency services and may also serve as the center's medical director. The director of emergency medicine shall assure creation and implementation of patient care policies, and assure at least the following:
a. Each patient presenting for or requesting care shall be evaluated by a qualified physician or registered nurse;
b. Qualified medical personnel shall be available to treat a patient presenting for or requesting emergency care;
c. At least one (1) physician shall be available on-site at all times to treat a patient;
d. Establishment and maintenance of a manual of policies and procedures for emergency and nursing care provided in the emergency room;
e. Nursing personnel shall be assigned to or available to cover the emergency service at all times; and
f. Diagnostic and treatment equipment, drugs, and supplies shall be readily available for the provision of emergency services and shall be adequate in terms of the scope of services provided.
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Physicians employed by or under contract with the center to provide emergency medical treatment shall be board certified in emergency medicine or board eligible.
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Other nursing personnel, aides, and technicians shall be available in the emergency department to meet the needs of the patients who present for treatment.
(2) Center staffing and qualifications. In addition to the core service component staff requirements, the center shall employ sufficient numbers of qualified administrative and medical personnel to provide prompt and effective patient care and services, and shall assure at least the following:
(a) A written job description for each position, which shall be reviewed and revised by the administrator as necessary;
(b) An employee health program for mutual protection of employees and patients, including provisions for preemployment and periodic health examination;
(c) A tuberculosis skin test of each staff member, which shall be implemented according to the following requirements be documented in the employee's personnel record and which shall:
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A test shall be initiated on each new staff member before or during the first week of employment. The results shall be documented in the employee's personnel record within the first month of employment, unless the employee documents a prior skin test of ten (10) or more millimeters of induration, or is currently receiving or has completed nine (9) months of therapy for latent tuberculosis infection (LTBI) or a course of multiple-drug chemotherapy for tuberculosis;
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There shall be a two (2) step skin testing for a new employee regardless of age whose initial test shows less than ten (10) millimeters of induration, unless the employee can document that he has had a tuberculosis skin test within one (1) year prior to his current employment;
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A staff member who has never had a skin test result of ten (10) or more millimeters induration shall be skin tested annually, on or before the anniversary of the last skin test;
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A staff member who has a skin test result of ten (10) or more millimeters induration on initial employment or annual testing shall receive a chest x-ray unless:
a. A chest x-ray within the previous two (2) months showed no evidence of tuberculosis; or
b. The individual can document the previous completion of a course of prophylactic treatment with Isoniazid. The employee shall be advised of the symptoms of the disease and instructed to report to his employer and to seek medical attention promptly if symptoms persist;
- The following shall be reported by the center administrator to the local health department having jurisdiction immediately upon becoming known:
a. Names of staff who convert from a skin test of less than ten (10) to a skin test of ten (10) millimeters or more induration at the time of employment; and
b. Chest x-rays suspicious for tuberculosis;
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A staff member whose skin test status changes on annual testing from less than ten (10) to ten (10) or more millimeters of induration shall be considered to be recently infected with Mycobacterium tuberculosis. A recently-infected person who has no sign or symptom of tuberculosis disease on chest x-ray or medical history shall receive preventative therapy with Isoniazid for six (6) months, unless medically contraindicated, as determined by a licensed physician. Medication shall be administered only upon the written order of a physician or other ordering personnel acting within their statutory scope of practice. If an individual is unable to take Isoniazid therapy, the individual shall be advised of the clinical symptoms of the disease, and shall have an interval medical history and a chest x-ray taken and evaluated for tuberculosis every six (6) months during the two (2) years following conversation, for a total of five (5) x-rays; and
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A staff member who documents completion of preventive treatment with Isoniazid shall be exempt from further screening requirements; and
(d) An employee file, which shall include at least the following information for each employee:
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Name, address, Social Security number;
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Evidence of current professional registration, certification, or licensure;
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Complete record of training, experience, and in-service;
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Records of performance evaluation;
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Records of incidents and accidents in which the employee was involved; and
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Documentation of current tuberculin screening.
(3) Personnel in-service training. Center personnel shall participate in quarterly in-service training programs relating to their respective job duties and activities, which shall include at least the following:
(a) Job orientation for new personnel and recurring in-service training, including a requirement that each staff member shall be knowledgeable of the center's policies;
(b) Quarterly in-service training for all staff emphasizing professional competence, quality assurance, policy development; and the physical, nutritional, environmental, and social components necessary for effective health care;
(c) Quarterly in-service training pertaining to medical documentation and maintenance of medical records;
(d) Reporting, identifying, and preventing abuse and neglect of children and adults; and
(e) Maintaining privacy and confidentiality of patient-specific information and records.
Section 6. Medical Records.
(1) Maintenance of records. The center or the main provider shall maintain a medical record at the center for each patient to include at least the following:
(a) Medical and social history, including data from other providers;
(b) Description of each medical visit or contact, including identification of the condition or reason for the visit or contact, assessment performed, medical diagnosis, services provided, medications and treatments prescribed, and disposition;
(c) Reports of all laboratory, x-ray, and other test findings;
(d) Documentation pertaining to a patient referred to the center for treatment, including the reason for the referral, to whom the patient was referred, and information obtained from the referral source;
(e) Physicians' orders, nurses' notes, and surgical and medical consent forms;
(f) History and physical examination record prior to surgery;
(g) For surgical patients, the complete medical record signed by the operating surgeon, including anesthesia record, preoperative diagnosis, operative procedures and findings, postoperative diagnosis and, if required, tissue diagnosis by a pathologist on specimens surgically removed;
(h) Charts, including records of temperature, pulse, respiration, and blood pressure; and
(i) Discharge summary completed at the time of discharge which includes condition on discharge and post-treatment instructions to the patient;
(2) Confidentiality. Confidentiality of patient records shall be maintained at all times;
(3) Transfer of records. The center shall establish systematic procedures to assist in continuity of care if the patient moves to another provider of care, and the center shall, upon proper release, transfer medical records or an abstract, if requested;
(4) Attending signature. The attending physician shall complete and sign the medical record of each patient as soon as practicable after discharge, but not to exceed ten (10) days; and
(5) Retention of records. Medical records shall be maintained by the center for a period of five (5) years following the last treatment, assessment, or visit made by the patient.
Section 7. Linkage Agreements. The center shall have linkages through written agreements.
(1) Linkage agreements. Linkage agreements shall be established with other providers of other levels of care which may be medically indicated to supplement the services available in the center and shall include:
(a) Hospitals;
(b) Emergency medical transportation services in the service area;
(c) In-patient care facilities; and
(d) Other agreements as necessary.
(2) Inpatient agreements. Linkage agreements with inpatient care facilities shall incorporate provisions for:
(a) Appropriate referral and acceptance of patients from the center;
(b) Provisions for appropriate coordination of discharge planning with center staff; and
(c) Provisions for the center to receive a copy of the discharge summary for each patient referred to the center.
(3) Transfer agreements. The written transfer agreements shall include designation of responsibility for:
(a) Transfer of information;
(b) Provision of transportation;
(c) Sharing of services, equipment, and personnel;
(d) Provision of total care or portions thereof in relation to facility and agency capability; and
(e) Patient record confidentiality.
Section 8. Provision of Services. The center shall provide the following component services on its campus:
(1) Primary care component. The center shall provide at least the following services during scheduled hours of operation that reasonably accommodate various segments of the population:
(a) Medical diagnostic and treatment services of sufficiently broad scope to accommodate the basic health needs of all age groups;
(b) Preventive health services of sufficiently broad scope to provide for the usual and expected health needs of persons in all age groups;
(c) Educational offerings in the appropriate use of health services, preventive health services, and health maintenance;
(d) Chronic illness management;
(e) Laboratory, x-ray, and treatment services shall be provided directly or arranged through other providers; and
(f) Supplemental services may also be provided for pharmacy, dentistry, optometry, nutrition, and counseling.
(2) Emergency services component. The center shall have written policies for operation of the emergency component and shall assure the following:
(a) A patient presenting for or requesting emergency care shall be evaluated and triaged by a registered nurse or emergency department physician in accordance with the center's formal operating policies and procedures;
(b) The physician, in conjunction with the administrator and other medical staff, shall establish and maintain policies and procedures for emergency and nursing care, which shall assure that:
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Emergency services shall at all times be under the direction of a licensed physician;
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Sufficient medical staff shall be available and on site at all times to perform emergency medical care in accordance with accepted standards of practice; and
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Current medical staff schedules and telephone numbers shall be posted in the emergency treatment area;
(c) Sufficient nursing and medical personnel shall be assigned to or designated to cover the provision of emergency services at all times;
(d) Appropriate facilities shall be provided to assure prompt diagnosis and emergency treatment for patients requiring emergency care on arrival;
(e) Adequate diagnostic and treatment equipment, drugs, and supplies shall be readily available for the provision of emergency services;
(f) Adequate medical records shall be kept for each patient seen in the emergency department, which shall include at least:
- A log listing the patient visits to the emergency department in chronological order, including:
a. Patient identification;
b. Means of arrival;
c. Person transporting patient;
d. Time of arrival;
e. History of present complaint and physical findings;
f. Laboratory and x-ray reports, if applicable;
g. Diagnosis;
h. Treatment ordered and details of treatment provided;
i. Patient disposition; and
j. Record of referrals.
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Instructions to the patient or family for those not admitted to the center; and
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Signatures of attending medical staff member, and nurse if applicable.
(3) Diagnostic imaging and MRI services. The center shall have written policies for the operation of the component and shall assure the following:
(a) The center shall have diagnostic radiology facilities currently licensed or registered pursuant to KRS 211.842 to 211.852, the Kentucky Radiation Control Act of 1978;
(b) The center shall employ or contract with a radiologist on at least a consulting basis to:
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Function as the director of the department; and
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Interpret films requiring specialized knowledge for accurate reading;
(c) The center shall employ and have on duty sufficient personnel to supervise and conduct services, including one (1) certified radiation operator who shall be on duty or on call at all times;
(d) Written policies and procedures governing radiologic services and administrative routines that support sound radiologic practices;
(e) Signed reports shall be filed in the patient's record, and duplicate copies kept in the department;
(f) Radiologic services shall be performed only upon written order of qualified personnel in accordance with their scope of practice and the center's protocols and bylaws, and the order shall contain a concise statement of the reason for the service or examination;
(g) Reports of interpretations shall be written or dictated and signed by the radiologist;
(h) Only a certified radiation operator, under the direction of medical staff, if necessary, shall use any x-ray apparatus or material. Uses shall include application, administration, and removal of radioactive elements, disintegration products, and radioactive isotopes. A certified radiation operator under the direction of a physician may administer medications allowed within his professional scope of practice and the context of radiological services and procedures being performed; and
(i) The radiology department shall be free of hazards for patients and personnel. Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards, and radiation hazards.
(4) Ambulatory surgical component services. The center shall have written policies for the operation of the component and shall assure the following:
(a) The patient or the patient's legal representative shall sign a written informed consent prior to all surgical operations;
(b) A medical history and physical evaluation shall be performed and entered into the medical record no more than thirty (30) days prior to surgery on a patient;
(c) Pertinent preoperative diagnostic studies and laboratory tests shall be performed and made a part of the medical record prior to surgery. The preoperative diagnosis shall be recorded in the medical record;
(d) A patient shall be examined by a physician immediately prior to surgery to evaluate the risk of anesthesia and of the procedure to be performed, taking into account site of service, the invasive nature of the procedure, and the need for extended postoperative recovery time or monitoring;
(e) The center shall employ a registered nurse who shall serve as operating room supervisor;
(f) A registered nurse shall be available to circulate in the operating room at all times.
(g) A list of physicians with surgical privileges at the center and the privileges assigned to each by the medical staff shall be on file;
(h) The operating room shall have an up-to-date operating room register;
(i) The operating room shall have medically-appropriate supplies and equipment available at all times to meet the needs of the patients, including the following:
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Oxygen;
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Mechanical ventilator assistance equipment including airways, manual breathing bag, and ventilator;
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Cardiac defibrillator,
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Cardiac monitoring equipment,
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Tracheostomy set,
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Laryngoscopes,
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Endotracheal tubes,
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Suction equipment; and
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Emergency medical equipment and supplies specified by the medical staff;
(j) The operating room shall have on hand, or make arrangements for obtaining, an adequate supply of blood in a timely manner to meet the needs of each patient;
(k) Operating room administrative regulations shall be posted;
(l) Physicians' orders shall be in writing and signed by the physician;
(m) Except for cases requiring only local infiltration anesthetics, a physician qualified to administer anesthesia, a dentist qualified to administer anesthesia, or a registered nurse anesthetist acting under the direction of the operating surgeon shall administer the anesthetics and shall remain present during the surgical procedure and until the patient is discharged to home or observation;
(n) The patient's attending physician shall be responsible for assuring that tissue removed during surgery is delivered to the center's pathologist and that an examination and report is made on the tissue, if required by the center's written policies;
(o) Voluntary interruption of pregnancy. The center shall comply with the applicable Kentucky statutes, including KRS 311.710 to 311.810;
(p) The center shall have written surgery policies and protocols that shall include:
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Infection control policies addressing the use of aseptic techniques and procedures for surgical patients;
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Protocols for sterilization of surgical equipment and supplies;
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Protocols for disposal of patient waste and other potentially-infectious materials;
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Protocol for obtaining pathological examination of tissues removed during surgery; and
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Policies for granting and withdrawing surgical privileges and privileges for the administration of anesthetics.
(q) The center shall have the following postanesthesia recovery services:
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At least one (1) postanesthesia recovery unit;
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Adequate staff available in the recovery unit so that no patient is left alone at any time;
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At least one (1) licensed physician shall be present until all surgical patients are discharged;
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A registered nurse shall be present in the recovery unit while a patient is recovering from anesthesia;
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A registered nurse shall be available to the recovery unit at all times;
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A person staffing the postanesthesia recovery unit shall be adequately trained in all aspects of postoperative and postanesthetic care; and
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The recovery unit nurse shall record a nursing note on the patient, noting the following:
a. Postoperative abnormalities or complications;
b. Pulse;
c. Respiration;
d. Blood pressure;
e. Presence or absence of swallowing reflex;
f. Cyanosis; and
g. The general condition of the patient.
(r) The ambulatory surgery component shall assure the following equipment is available to the operating area:
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Suction machine;
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Stethoscope;
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Sphygmomanometer;
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Emergency crash cart;
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Necessary drugs; and
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Oxygen.
(s) The surgical center shall provide suitable accommodations for its patients, including:
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Adequate floor space, furnishings, bed linens, and utensils, equipment, and supplies reasonably required for the proper care and comfort of patients accommodated;
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Holding-observation and convalescent accommodations within the following limitations:
a. Holding-observation and convalescent accommodations shall not exceed twenty-three (23) hours postadmission for medical observation, recuperation, or convalescence in anticipation of discharge to the patient's home;
b. The decision to hold a patient shall be the responsibility of a physician on the medical staff of the center, who shall document the reason for and duration of the hold in the patient's medical record and shall date and sign the entry; and
c. A physician or registered nurse shall be on duty at the center, if a patient is held in the center's accommodations beyond regularly scheduled hours.
(5) Physical and sanitary environment.
(a) The condition of the physical plant and the overall environment shall be maintained in such a manner that the safety and well-being of patients, personnel, and visitors are assured.
(b) There shall be an infection control committee charged with the responsibility of investigating, controlling, and preventing infections. This committee shall develop written infection control policies that are consistent with Centers for Disease Control guidelines and include:
- Prevention of disease transmission to and from patients, visitors, and employees, including:
a. Universal blood and body fluid precautions;
b. Precautions against airborne transmittal of infections; and
c. Work restrictions for employees with infectious diseases;
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Use of environmental cultures. Culture testing results shall be recorded and reported to the Infection Control Committee; and
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Cleaning, disinfection, and sterilization methods used for equipment and the environment.
(c) The center shall provide in-service education programs on the cause, effect, transmission, prevention, and elimination of infections.
(d) The center's buildings, equipment, and surroundings shall be kept in a condition of good repair, neat, clean, free from accumulation of dirt, rubbish, and foul, stale, or musty odors.
(e) Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in closed metal containers, and kept separate from other cleaning materials.
(f) The facility shall be kept free from insects and rodents, and their nesting places, and entrances shall be eliminated.
(g) Garbage and trash:
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Shall be stored in areas separate from those used for preparation and storage of food;
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Shall be removed from the premises regularly; and
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Containers shall be cleaned on a regular basis.
(h) Sharp wastes:
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Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other wastes and placed in puncture-resistant containers immediately after use.
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A needle or other contaminated sharp shall not be purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
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A sharp waste container shall be incinerated or shall be rendered nonhazardous.
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Nondisposable sharps, such as large-bore needles or scissors, shall be placed in a puncture-resistant container for transport to the Central Medical and Surgical Supply Department in accordance with 902 KAR 20:009, Section 22.
(i) Disposable waste:
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Disposable waste shall be placed in a suitable bag or closed container so as to prevent leakage or spillage, and shall be handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
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The center shall establish specific written policies regarding handling and disposal of waste material.
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The following wastes shall receive special handling:
a. Microbiology laboratory waste including a viral or bacterial culture, contaminated swab, or a specimen container or test tube used for microbiologic purposes shall be incinerated, autoclaved, or otherwise rendered nonhazardous; and
b. Pathological waste including a tissue specimen from a surgical or necropsy procedure shall be incinerated.
(6) Utilization review and medical audit. In order to determine the appropriateness of the services delivered, the center shall establish procedures for the medical audit and utilization review of services provided in the center. The center may use professional capabilities and assistance obtainable from other agencies and sources. There shall be a written plan for utilization review developed by the center including frequency of review and composition of the body conducting the review.
History
- RELATES TO: KRS 194A.030(1), 211.842-211.852, 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.176, 216B.177, 216B.990, Chapter 311, Chapter 314, 29 C.F.R. 1910.1030(d)(2)(vii), 42 C.F.R. 413.65, 42 U.S.C. 1320d-2
- STATUTORY AUTHORITY: KRS 194A.050(1), 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.105 and 216B.042 require the Cabinet for Health and Family Services to license and regulate health care facilities and health care services. This administrative regulation provides licensure requirements for the operation of and services provided by outpatient health care centers.
- History: 902 KAR 020:074. 32 Ky.R. 2407; 33 Ky.R. 814; 1083; eff. 10-13-2006; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:078 Operations and services; group homes {#sec-902-kar-20-078 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:078}
Section 1. Definitions.
(1) "Developmental disability" means a severe chronic disability which is attributable to a mental or physical impairment or combination of mental and physical impairments manifested before the person attains the age of twenty-two (22) and is likely to continue indefinitely. This disability results in substantial limitations in areas of major life activity including self-care, receptive and expressive language, learning, mobility, capacity for independent living and economic sufficiency and requires individually planned and coordinated services of a lifelong or extended duration.
(2) "Mental retardation" means a significantly subaverage general intellectual functioning existing concurrently with deficiencies in adaptive behavior which is first manifested during the developmental period.
(3) "Normalization principle" means the utilization of means which are as culturally normative as possible in order to establish and maintain personal behavior and characteristics which are as culturally normative as possible.
(4) "Qualified mental retardation or developmental disability professional" means:
(a) A physician with specialized training or one (1) year of experience in treating persons with mental retardation or developmental disabilities;
(b) A psychologist with a doctoral or master's degree from an accredited program with specialized training or one (1) year of experience in treating persons with mental retardation or developmental disabilities;
(c) An educator with at least a bachelor's degree in education and with specialized training or one (1) year of experience in working with persons with mental retardation or developmental disabilities;
(d) A social worker with at least a bachelor's degree from an accredited program and with specialized training or one (1) year of experience working with persons having mental retardation or developmental disabilities, or a field other than social work and at least three (3) years of social work experience under the supervision of a qualified social worker;
(e) A licensed physical therapist or an occupational therapist who is a graduate of a program of physical or occupational therapy approved by the Council on Medical Education of the American Medical Association and who has specialized training or one (1) year of experience in treating persons with mental retardation or developmental disabilities;
(f) A speech pathologist or audiologist who has been granted a certificate of clinical competence by the American Speech and Hearing Association or who has completed the equivalent educational and experimental requirements for such a certificate and has specialized training or one (1) year of experience in training persons with mental retardation or developmental disabilities;
(g) A registered nurse who has specialized training or one (1) year of experience in treating persons with mental retardation or developmental disabilities;
(h) A therapeutic recreation specialist who is a graduate of an accredited program and licensed or registered by the state if required; or
(i) A rehabilitation counselor who is certified by the commission on Rehabilitation Counselor Certification.
Section 2. Scope of Operations. A group home shall provide a homelike environment and specialized services in accordance with individualized habilitation plans to not less than four (4) nor more than eight (8) persons with mental retardation or developmental disabilities, at a location not adjacent to or part of a mental health or mental retardation institution.
Section 3. Administration and Operations.
(1) Licensee. The licensee shall be legally responsible for the group home and for compliance with federal, state and local laws and regulations pertaining to the operation of the home.
(2) Manager. The group home shall have a manager who is responsible for the full-time operation of the home and for implementing programs as delineated. The manager shall be at least twenty-one (21) years of age and a high school graduate or equivalent.
(3) In the absence of the manager, responsibility shall be delegated to a similarly qualified staff person, to be on site when a resident is present.
(4) Advisory board. Each group home shall have a specific group of individuals, organized as an advisory board, who shall establish policies concerning the operation of the group home and the welfare of the individuals residing in the home. The advisory board shall meet at least quarterly. The advisory board shall be composed of at least three (3) members and shall include representatives from each of the following groups:
(a) Mental retardation or developmental disability representative from regional mental health and mental retardation board;
(b) A parent or guardian of an individual with mental retardation or developmental disability or a consumer advocate knowledgeable of the needs of group home residents; and
(c) A qualified mental retardation or developmental disability professional.
(5) Policies. The licensee shall develop, with the input of the advisory board:
(a) A written outline of the objectives and goals it is striving to achieve. The outline shall be available for public distribution; and
(b) A written policy to include description of procedures for:
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Current routine operations;
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Protection of resident rights;
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Protection of resident financial interests; and
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Reporting of cases of abuse, neglect or exploitation of an adult or child pursuant to KRS Chapters 209 and 620.
(6) The licensee shall incorporate the normalization principle into its objectives and shall implement programs consistent with this principle.
(7) The licensee shall establish a job description for group home personnel and shall delegate necessary authority for the daily management of the group home program.
(8) The licensee shall conduct an annual program evaluation.
(9) The way residents are represented to the public shall be appropriate to the purposes and programs of the group home and shall not emphasize mental retardation or deviancy.
(10) The advisory board shall appoint a services committee which shall be responsible for:
(a) Decisions pertaining to resident admissions, transfers and discharges.
(b) Assuring that a comprehensive habilitation plan is established for each resident on an individual basis.
(11) The services committee shall:
(a) Be composed of the manager and two (2) other persons, both of whom shall be qualified mental retardation and developmental disability professionals.
(b) Determine eligibility for admission based on areas of comparable need for programming. If the chronological age span of the program participants exceeds five (5) years for individuals twelve (12) years or younger, ten (10) years for individuals aged thirteen (13) to eighteen (18), and twenty (20) years for individuals eighteen (18) years and older, written justification demonstrating the appropriateness of the program shall be a part of the individual habilitation plan.
(12) Upon admission a resident shall be free from communicable disease which is reportable to the health department, except a noninfectious tuberculosis patient under continuing medical supervision for tuberculosis. Thirty (30) days prior to or within fourteen (14) days after admission, a resident shall have a physical examination.
(13) The services committee shall assure that the following information is a part of each resident's record:
(a) Persons to contact in case of emergency;
(b) Next of kin;
(c) Legal competency status and presence or absence of committee; and
(d) Financial resources.
Section 4. Personnel.
(1) The group home shall employ an adequate number of supervisory and direct care personnel and establish an on-call procedure to assure that the home has staff present when a resident is present.
(2) Volunteers may be utilized but not substituted for the employment of full- or part-time staff.
(3) The group home shall provide an employee orientation program to include:
(a) History of retardation;
(b) Normalization principle;
(c) Habilitation planning techniques; and
(d) Basic first aid.
(4) A regular in-service program for the entire staff shall be conducted at least four (4) times a year. Volunteers may participate in the program.
Section 5. Services.
(1) Within thirty (30) days after admission to the facility the services committee shall establish a comprehensive habilitation plan for each resident. The resident's habilitation plan shall be reviewed at least every ninety (90) days. In all cases, whether children or adults, the resident or resident's representatives shall participate in the development of the comprehensive habilitation plan.
(a) The plan shall address the following:
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Sensorimotor needs;
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Communicative needs;
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Social needs;
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Emotional needs;
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Educational needs; and
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Vocational training needs.
(b) The individual habilitation plan shall outline the responsible parties for meeting each of the above listed needs.
(c) Each resident's habilitation plan shall be maintained as an integral part of the resident's records.
(2) Availability of services. The licensee shall assure that a comprehensive array of services is available as needed by each resident of the group home. These services shall be obtained from agencies through a written agreement. The following components shall be available:
(a) Medical services, including emergency medical services and an annual physical examination. For women this examination shall include gynecological services.
(b) Dental services to include at least two (2) visits annually.
(c) Psychological and psychiatric services, to be available as needed according to the resident's habilitation plan.
(d) Physical therapy.
(e) Social services, to include individual, group and family counseling as appropriate, according to individual needs.
(f) Occupational rehabilitative services, to include vocational counseling, planning and training as appropriate, according to individual needs.
(g) Speech therapy and audiology services, as needed.
(h) Public education for school age persons in accordance with 20 USC 1400.
(i) Recreational opportunities to provide the resident with adequate physical fitness and constructive leisure time activities.
Section 6. Physical Standards. The ultimate aim of the environment and design for a group home shall be to foster those skills necessary for maximum independence of the resident and enhance the resident's ability to cope with his or her environment. To this end the following shall be required:
(1) Location.
(a) Group homes may be located in urban, suburban or rural settings, but shall not be isolated from the mainstream of their community, and shall be in an area zoned for residential use where applicable. The residence shall have the style and appearance of neighborhood houses.
(b) The group home shall be located within thirty (30) minutes driving time of resident's day program locations, medical and other professional services; and the usual array of essential merchants: groceries, clothing stores, drug stores, etc. The home shall be located within sixty (60) minutes driving time of a hospital.
(c) Group homes shall not be located in house trailers or motor homes.
(2) Resident accommodations.
(a) The residence shall house no less than four (4) nor more than eight (8) residents.
(b) Other than residents, a person other than the residence's staff and the staff's immediate family shall not reside in the home.
(c) A bedroom shall contain no more than two (2) beds with a minimum of sixty (60) square feet in single rooms and eighty (80) square feet in multiple rooms. A bed shall be no less than thirty-three (33) inches wide and six (6) feet long. Bunk beds shall not be used.
(d) A bed occupied by a resident shall be placed so that the resident shall not experience discomfort because of proximity to a radiator, heat outlet, or exposure to drafts. Each resident shall have his or her own bed equipped with substantial springs, a clean comfortable mattress, two (2) sheets and a pillow, and bed covering as required for the resident's health and comfort.
(e) Closet space and drawer space shall be provided for personal belongings.
(f) A resident shall not be housed in a room, a detached building or other enclosure which has not been previously inspected and approved for resident use, or in a basement not constructed for sleeping quarters. An approved basement shall have an outside door.
(g) Appropriate sanitary toilet and bathing facilities shall be conveniently available for resident use with one (1) toilet, lavatory and shower or tub for each six (6) persons residing in the home, including residents and staff.
(h) Adequate ventilation in resident use areas shall be maintained. Each resident bedroom shall have an exterior screened window, which can be opened.
(i) If a private source of water is used, the group home shall annually obtain written certification from an appropriate agency that the supply is safe and sanitary. An ample supply of hot and cold running water shall be available at all times.
(j) The group home shall have adequate lighting by natural or artificial means in each hall, stairway, entryway, vestibule, resident area, kitchen, and bathroom.
(k) A heating system which can maintain an even temperature of seventy-two (72) degrees Fahrenheit in resident used areas shall be provided.
(l) Adequate common living areas shall be provided in the group home. This shall include separate living, recreational and eating areas, each large enough to accommodate residents and their visitors.
(m) Adequate laundry facilities shall be available in the home or a conveniently located laundromat may be used.
(n) Telephone service shall be provided to the residents. This service shall be accessible to the residents and shall afford a degree of privacy.
(o) Resident staff living quarters. Resident staff living quarters shall provide privacy. Resident staff includes managers.
(3) General requirements.
(a) The facility shall conform to the National Fire Protection Association 101, Life Safety Code adopted by the Kentucky Department of Housing, Buildings and Construction relative to group homes.
(b) The group home shall conform to requirements for plumbing pursuant to 815 KAR 20:010 to 20:191, as amended.
(c) The group home shall conform to requirements for making buildings and facilities accessible to and usable by persons with disabilities.
(d) The group home shall comply with applicable state and local laws relating to sanitation, including insect and rodent control.
Section 7. Resident Care and Safety.
(1) Dietary.
(a) The group home shall provide at least three (3) meals per day with not more than a fifteen (15) hour span between the substantial evening meal and breakfast. One (1) or more of these meals may be provided outside the group home depending upon the resident's habilitation plan, but all meals are the financial responsibility of the group home.
(b) Nutrition needs shall be met in accordance with the current recommended dietary allowances of the Food and Nutrition Board of the National Research Council and in accordance with resident dietary restrictions.
(c) A written record shall be kept of foods served.
(d) Food shall be stored off the floor in such a manner as to be protected from dust, insects, rodents, birds, or other forms of contamination. Food showing evidence of spoilage or infestation shall be disposed of immediately upon detection.
(e) Each refrigerator shall have a complete seal, be clean, free of odor, and kept at a temperature of forty-five (45) degrees Fahrenheit or below. A thermometer that is easily readable shall be placed in each refrigerator and freezer.
(2) Housekeeping and sanitation.
(a) The facility shall be kept in good repair, clean, uncluttered and sanitary at all times. Floors, walls, ceilings, lighting fixtures, storage areas and equipment shall be kept clean and in good repair. Windows and doors shall be screened.
(b) The facility shall collect and dispose of all garbage, refuse, trash, and litter in compliance with applicable state and local laws and administrative regulations. Garbage containers shall be made of metal or other impervious material, approved by the fire marshal, that will not emit harmful vapors upon exposure to extreme heat, and shall be water tight and rodent proof and shall have tight-fitting lids.
(3) Emergency procedures.
(a) Each group home shall have a fire control and evacuation plan to be practiced at least quarterly with all staff and residents participating.
(b) An on-duty staff member shall be designated to be in charge of evacuation of residents in the event of a fire or other natural disaster.
(c) Phone numbers of a hospital, an ambulance service, the fire department, and a physician for emergencies shall be posted by each telephone in large legible print.
(d) A report on an accident requiring medical treatment of a resident shall be written and one (1) copy kept on file and made available to the advisory board within seven (7) days of the incident. The original shall be sent to the Cabinet for Health Services, Division for Licensing and Regulation, 275 East Main Street, Frankfort, Kentucky.
(e) An incident report for a minor accident shall be written, kept on file and made available upon request.
(4) Medications.
(a) A prescription medication administered to a resident shall be noted in writing, with the date, time and dosage, and signed by the person administering the medication. A medication shall be plainly labeled with the patient's name, the name of the drug, strength, name of pharmacy, prescription number, date, physician name, caution statement and directions for use.
(b) Medication shall not be administered to a resident except on the written order of a physician or other practitioner acting within his statutory scope of practice. If medication requires administration by a licensed person, an arrangement shall be made to procure the services of a person licensed to administer medication.
(c) A medication in the home shall be kept in a locked cabinet. A controlled substance shall be kept under double lock (e.g., in a locked box in a locked cabinet). There shall be a controlled substance record in which is recorded the name of the patient; the date, time, kind, dosage, balance remaining and method of administration of a controlled substance; the name of the physician who prescribed the medication; and the name of the nurse who administered it, or staff who supervised the self-administration.
(d) Self-administration of prescription medication shall be allowed only upon the written instruction of the attending physician or other practitioner acting within his statutory scope of practice.
(e) Each resident who requires prescription medication shall receive regular evaluation of his response to the medication, including appropriate monitoring and laboratory assessment.
(f) The group home shall comply with federal and state law and regulation relating to the procurement, storage, dispensing, administration and disposal of drugs.
(5) Restraints. Physical or chemical restraint shall not be used.
Section 8. Resident Rights.
(1) Staff shall recognize a resident's rights for:
(a) Treatment which preserves his feelings of self-worth and dignity;
(b) Visitation;
(c) Privacy; and
(d) Freedom of worship.
(2) Staff shall not open resident correspondence, except as authorized by the resident or his legal guardian or committee.
(3) A resident shall be:
(a) Free from physical punishment;
(b) Appropriately dressed;
(c) Supplied with:
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Clean washcloth and towel;
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Toothbrush;
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Hair brush and comb;
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Other toilet articles; and
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Bureau or cupboard for storage of personal belongings.
(d) Allowed rest periods in his own bed;
(e) Allowed free movement within the group home, with access to all common areas; and
(f) Allowed access to the community at large.
History
- RELATES TO: KRS 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.990, 311.560(4), 314.011(8), 320.210(2)
- STATUTORY AUTHORITY: KRS 216B.010, 216B.040, 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Kentucky Cabinet for Health Services to regulate health facilities and health services. This administrative regulation establishes licensure requirements for group homes.
- History: 902 KAR 020:078. 8 Ky.R. 414; eff. 1-6-1982; 16 Ky.R. 994; eff. 1-12-1990; 23 Ky.R. 2866; eff. 2-19-1997; 25 Ky.R. 1725; 2571; eff. 5-19-1999; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:081 Operations and services; home health agencies {#sec-902-kar-20-081 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:081}
Section 1. Definitions.
(1) "Coordination agreement" means an agreement to coordinate health care services within the service area of the agency.
(2) "Home health agency" is defined by KRS 216.935(4).
(3) "Home health aide" is defined by KRS 216.935(3).
(4) "Home health aide services" is defined by KRS 216.935(5).
(5) "Medical social worker" means an individual who:
(a) Has a baccalaureate degree in social work, psychology, sociology, or other field related to social work;
(b) Has at least one (1) year of social work experience in a health care setting; and
(c) Is licensed by the Kentucky Board of Social Work.
(6) "Occupational therapist" is defined by KRS 319A.010(3).
(7) "Physical therapist" is defined by KRS 327.010(2).
(8) "Qualified medical social worker" means an individual who:
(a) Has a master's degree from a school of social work accredited by the Council on Social Work Education;
(b) Has social work experience in a hospital, outpatient clinic, medical rehabilitation, medical care, or mental health program; and
(c) Is licensed by the Kentucky Board of Social Work.
(9) "Speech-language pathologist" is defined by KRS 334A.020(3).
Section 2. Scope. A home health agency shall provide part-time or intermittent health and health related services to a patient in his or her place of residence, either singly or in combination as required by a plan of care prescribed by a licensed physician, advanced practice registered nurse, or physician assistant.
Section 3. Administration and Operation.
(1) The licensee shall be legally responsible for:
(a) The operation of the home health agency; and
(b) Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the service.
(2) The licensee shall establish policies for the administration and operation of the service. The policies shall include the following:
(a) Acceptance of patients. The policy shall assure that the acceptance of patients is based on medical, nursing, and social information provided by the:
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Physician, advanced practice registered nurse, or physician assistant responsible for the patient's care;
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Institutional personnel; and
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Staff of the home health agency.
(b) Establishment and review of the plan of care. The policy shall assure that services and items provided are specified under a plan of care:
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Established, signed, and reviewed by the physician, advanced practice registered nurse, or physician assistant who is responsible for the care of the patient; and
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Developed by the physician, advanced practice registered nurse, or physician assistant and appropriate professional staff acting within the limits of his or her statutory scope of practice.
(3) Home health services shall be available to the total population regardless of age, sex, and ethnic background.
(4)
(a) The status of each patient and the plan of care shall be reviewed at such intervals as the severity of the patient's illness requires but no less frequently than every two (2) months, with a maximum of sixty (60) days, by home health agency staff and the physician, advanced practice registered nurse, or physician assistant.
(b) Verbal authorization to change the plan of care shall be:
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Put in writing, signed, and dated with the date of receipt by the registered nurse or other appropriate professional staff responsible for furnishing or supervising the order services; and
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Signed by the physician, advanced practice registered nurse, or physician assistant within thirty (30) days after the verbal order is issued.
(5) Clinical records.
(a) The home health agency shall maintain a clinical record for each patient that:
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Covers the services the agency provides directly and those provided through arrangements with another agency; and
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Contains pertinent past and current medical, nursing, and social information, including the plan of care.
(b) Ownership.
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Medical records shall be the property of the home health agency.
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The original medical record shall not be removed except by court order.
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Copies of medical records or portions thereof may be used and disclosed in accordance with the requirements established in this administrative regulation.
(c) Confidentiality and Security: Use and Disclosure.
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The agency shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
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The home health agency may use and disclose clinical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
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An agency may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(6) Original drug orders and changes in orders. The following shall be signed by the physician or other prescribing practitioner acting within the statutory scope of his or her license and incorporated in the patient record maintained by the agency:
(a) The original drug order; and
(b) Changes in orders for the administration of drugs subject to federal and state controlled substance acts, and other legend drugs.
(7) Verbal authorization for an original order for drugs or a change order shall be reviewed and signed by the same prescribing practitioner within thirty (30) days after the order is issued.
(8) Evaluation.
(a) The agency shall have procedures that provide for a systematic evaluation of the agency's program at least once every two (2) years.
(b) The agency staff shall conduct the evaluation.
(c) The program evaluation shall include measures to determine whether the policies established are followed, including:
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A review of patient records on a sample basis to determine that services are being used appropriately and the extent to which the needs of the patients the agency serves are being met both quantitatively and qualitatively; and
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A mechanism for reviewing overall management aspects of the agency's services to assure economy and efficiency of operations.
(9) Planning. Each agency shall develop and annually review a long range plan which includes:
(a) Assessment of needs for services in the service area of the agency;
(b) Identification of agency's role in meeting those needs;
(c) Staff expansion for a two (2) year period;
(d) Establishment of goals and objectives; and
(e) Coordination of volunteer services, community education, and community development activities if these services are provided by the agency.
(10) Subdivision operating as home health agency.
(a) If a subdivision of an agency, including the home care department of a hospital or the nursing division of a health department, applies for a license, the subdivision shall:
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Be licensed as a home health agency; and
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Maintain records of the subdivision's activities, ensuring that expenditures attributable to the services provided are identifiable.
(b) The parent organization shall determine who:
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Signs each coordination agreement and other official documents; and
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Receives and disburses funds.
Section 4. Personnel; Supervision and Training.
(1) Personnel policies. The agency shall have written policies available to staff concerning qualifications, responsibilities, and conditions of employment for each type of personnel (including whether licensure is required by state law). The policies shall cover:
(a) Wage scales, hours of work, vacation, and sick leave;
(b) A plan for a preemployment medical examination and follow-up medical examination no less than every three (3) years thereafter for agency staff who serve patients in their place of residence;
(c) Annual tuberculin screening conducted pursuant to 902 KAR 20:205;
(d) Plans for orientation and for on-the-job training;
(e) Annual evaluation of employee performance;
(f) Job descriptions for each category of health personnel which are specific to the type of activity each may carry out;
(g) Pre-employment abuse registry checks conducted pursuant to KRS 216.937 and KRS 209.032; and
(h) Pre-employment criminal background checks in which the agency shall not employ an individual in a position that involves providing direct services if the individual has been convicted of a:
- Felony offense related to:
a. Theft;
b. Abuse, possession, or sale of illegal drugs;
c. Abuse, neglect, or exploitation of a child or an adult; or
d. A sexual crime; or
- Misdemeanor offense related to abuse, neglect, or exploitation of an adult.
(2) Agency supervision. The home health agency shall designate a physician, registered nurse, or physician assistant to supervise the agency's performance in providing home health services in accordance with the:
(a) Orders of the physician, advanced practice registered nurse, or physician assistant responsible for the care of the patient; and
(b) Plan of care established by the physician, advanced practice registered nurse, or physician assistant.
(3) Supervision of therapy services.
(a) If the services of aides or other personnel providing supplementary services are utilized in providing home health services, the staff shall be trained and supervised by a qualified practitioner responsible for the delivery or supervision of services within the practitioner's scope of licensure.
(b) If supervision is less than full-time, the supervision shall:
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Be provided on a planned basis; and
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Assure adequate review of each individual plan of care and progress.
(4) Supervision of home health aides.
(a) A registered nurse shall provide direct supervision as described in this subsection and be readily available at other times by telephone.
(b) The supervisor shall evaluate the home health aide closely to ensure the aide's competence in providing care, including the aide's ability to:
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Carry out assigned duties;
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Relate well to the patient; and
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Work effectively as a member of a team of health workers.
(c) If the patient receives skilled nursing care or another skilled service, the registered nurse or a qualified practitioner responsible for the delivery or supervision of services within the practitioner's scope of licensure shall make a supervisory visit to the patient's residence at least every two (2) weeks when the aide is:
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Present to observe and assist; or
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Absent to assess relationships and determine whether goals are being met.
(d) If home health aide services are provided to a patient who is not receiving skilled nursing care or another skilled service, the registered nurse shall make a supervisory visit to the patient's residence at least every sixty (60) days and the supervisory visit shall occur while the home health aide is providing patient care.
(5) Training of home health aides.
(a) The home health agency shall ensure that each home health aide successfully completes an aide training and competency evaluation program, including training in:
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Methods of assisting patients to achieve maximum self-reliance;
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Principles of nutrition and meal preparation;
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The aging process and the emotional problems of illness;
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Procedures for maintaining a clean, healthful, and pleasant environment;
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Awareness of changes in the patient's condition that should be reported;
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Work of the agency and the health team; and
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Ethics, confidentiality, and recordkeeping.
(b)
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In addition to the training and competency evaluation program required by paragraph (a) of this subsection and within ninety (90) days from the most recent effective date of this administrative regulation, a home health aide who provides care to a patient that exhibits symptoms of Alzheimer's disease or other dementia shall complete at least six (6) hours of initial training and three (3) hours of annual training in dementia care pursuant to the requirements established by KRS 216.9375(3).
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In accordance with KRS 216.9375(2), a home health aide shall successfully complete the initial training in dementia care prior to providing services to a patient that exhibits symptoms of Alzheimer's disease or other dementia.
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Pursuant to KRS 216.9375(6), a home health aide who has a lapse of twenty-four (24) months or more providing care to a patient that exhibits symptoms of Alzheimer's disease or other dementia shall complete the six (6) hours of initial training within sixty (60) days of resuming the delivery of care to a patient that exhibits symptoms of Alzheimer's disease or other dementia.
(c) A home health agency shall:
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Obtain cabinet approval of the agency's dementia care training curriculum in accordance with the process established by 910 KAR 4:010;
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Provide a certificate of completion pursuant to KRS 216.9375(4) to each home health aide who successfully completes the initial and annual dementia care training; and
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Maintain documentation of successful completion of dementia care training for each home health aide in accordance with KRS 216.9375(5).
(d) The cabinet shall impose fines in accordance with KRS 216.9375(9) and (10).
(e) A home health agency's appeal of any decision regarding a fine shall be conducted in accordance with KRS Chapter 13B.
Section 5. Provision of Services.
(1) The home health agency shall provide:
(a) Part-time or intermittent skilled nursing services; and
(b) Other services for restoring, maintaining, and promoting health or rehabilitation with minimum disruption of daily living, including:
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At least one (1) other therapeutic service (physical, speech, or occupational therapy);
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Medical social services; or
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Home health aide services.
(2) Services shall be available five (5) days a week with back-up arrangements for weekend and emergency services.
(3) In addition to the services described in subsection (1) of this section, the agency may provide:
(a) Medical supplies; or
(b) Equipment services.
(4) The following conditions shall be met for the provision of therapeutic and medical social services:
(a) Physical, speech, or occupational therapy. An agency that provides or arranges for physical, speech, or occupational therapy directly or under a contractual arrangement shall provide the service in accordance with a physician, advanced practice registered nurse, or physician assistant's written order by or under the supervision of a therapist defined by Section 1(6), (7), or (9) of this administrative regulation.
(b) Respiratory therapy. An agency that provides or arranges for respiratory therapy directly or under a contractual arrangement shall provide the service in accordance with a physician, advanced practice registered nurse, or physician assistant's written order by or under the supervision of a licensed nurse with experience and training in the field of respiratory therapy.
(c) Medical social services. An agency that provides or arranges for medical social services directly or under a contractual arrangement shall provide the service in accordance with a physician, advanced practice registered nurse, or physician assistant's written order by a medical social worker or a qualified medical social worker as defined by Section 1(5) or (8) of this administrative regulation.
(5) Home health aide services. A visit by a home health aide for the provision of personal care and other related health services shall be:
(a) Ordered by a physician, advanced practice registered nurse, or physician assistant; and
(b) Included in a plan of care approved by the physician, advanced practice registered nurse, or physician assistant.
(6) Services arranged with another provider. A home health agency that makes arrangements for the provision of home health services by another agency shall establish a written agreement that:
(a) Identifies each service provided under the agreement;
(b) Ensures that the services shall be provided within the scope and limitations set forth in the plan of care;
(c) Allows for services to be altered only upon the specific order of the initiating home health agency as the result of a change made by the physician, advanced practice registered nurse, or physician assistant in the patient's plan of care;
(d) Describes how the contracted personnel shall be supervised;
(e) Requires contract personnel to record progress notes and observations in the home health agency records for purposes of planning and evaluating patient care;
(f) Assures that the contract agency's staff and services meet the requirements established in this administrative regulation for personnel qualifications, functions, supervision, orientation, and training; and
(g) Specifies the period of time the written agreement shall be in effect and how frequently the agreement shall be reviewed.
(7) Service agreements with other health care facilities. A home health agency shall establish a coordination agreement defined by Section 1(1) of this administrative regulation with health care providers in the agency's service area including hospitals and long-term care facilities.
History
- RELATES TO: KRS Chapter 13B, 209.032, 216.935, 216.937, 216.9375, 216B.010-216B.130, 216B.990, 311.840(3), 314.011(8), 314.042(8), 319A.010(3), 327.010(2), 334A.020(3), 45 C.F.R. Part 160, 164, 42 U.S.C. 1320d-1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1), 216.9375(11)(a)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 216.9375(11)(a) requires the cabinet to promulgate administrative regulations to implement, monitor, and enforce compliance with dementia-specific training requirements for home health aides. This administrative regulation establishes the minimum licensure requirements for the operation of and services provided by home health agencies.
- History: 8 Ky.R. 243; eff. 11-5-1981; 16 Ky.R. 998; eff. 1-12-1990; 25 Ky.R. 623; 1071; 1364; eff. 12-16-1998; 43 Ky.R. 1311; 1782; 1955; eff. 6-2-2017; 48 Ky.R. 1399; eff. 2-10-2022.
902 KAR 20:086 Operation and services; intermediate care facilities for individuals with intellectual disabilities {#sec-902-kar-20-086 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:086}
Section 1. Definitions.
(1) "Active treatment" means the delivery of resident-specific specialized and generic training, treatment, health services, and related services directed toward the:
(a) Acquisition of behaviors necessary for the resident to function with as much self-determination and independence as possible; and
(b) Prevention or deceleration of regression or loss of current optimal functional status.
(2) "Administrator" means a person who has a license to practice long-term care administration pursuant to KRS 216A.080.
(3) "Aversive stimuli" means things or events that the resident finds unpleasant or painful that are used to immediately discourage undesired behavior.
(4) "Developmental disability" is defined by 45 C.F.R. 1325.3.
(5) "Developmental nursing services" means treatment of an individual's needs by designing interventions to modify the rate or direction of the individual's development in the areas of:
(a) Self-help skills;
(b) Personal hygiene; and
(c) Sex education.
(6) "Intellectual disability" is defined by 34 C.F.R. 300.8(c)(6).
(7) "Interdisciplinary team" means the group of people assembled by the facility who represent the professions, disciplines, or service areas that are relevant to:
(a) Identify the resident's needs; and
(b) Make recommendations for:
-
The resident's individual program plan; and
-
Services designed to meet the resident's needs.
(8) "Normalization principle" means making available to all people with disabilities patterns of life and conditions of everyday living that are as close as possible to the regular circumstances and ways of life or society.
(9) "Qualified social worker" means a person who:
(a) Meets the requirements of 42 C.F.R. 483.430(b)(5)(vi); or
(b) Has a bachelor's degree in a field other than social work and at least three (3) years of social work experience under the supervision of a social worker who meets the requirements of 42 C.F.R. 483.430(b)(vi).
(10) "Qualified intellectual disability professional (QIDP)" is defined by 42 C.F.R. 483.430(a).
(11) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a portion of an individual's body.
(12) "Seclusion" means the involuntary separation of a resident from other residents and the placement of the resident alone in an area from which the resident is prevented from leaving.
(13) "Time-out" means a procedure that involves removing an individual from a reinforcing situation for a period of time if the individual engages in a specified inappropriate behavior.
Section 2. Scope of Operation and Services.
(1) An ICF/IID shall provide services for all age groups on a twenty-four (24) hour basis, seven (7) days per week in an establishment located in a permanent building with resident beds for individuals with intellectual disabilities or related conditions who require developmental nursing services and a planned program of active treatment.
(2) The facility shall provide programs as indicated by a resident's individual program plan to maximize the resident's mental, physical, and social development in accordance with the normalization principle.
(3) The facility shall comply with the facility specification requirements of 902 KAR 20:056.
Section 3. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for:
(a) The operation of the facility; and
(b) Compliance with federal, state and local laws, and administrative regulations pertaining to the operation of the facility.
(2) Administrator. All facilities shall have an administrator who shall:
(a) Be responsible for the day-to-day operation of the facility;
(b) Designate one (1) or more staff to act on behalf of the administrator or to perform the administrator's responsibilities in the administrator's absence; and
(c) Not be the nursing services supervisor.
(3) Contracted services. The licensee shall contract for professional and supportive services not available in the facility based on the needs of each resident.
(4) Administrative records.
(a) The facility shall maintain a resident registry that documents the:
-
Name of each resident;
-
Date of admission; and
-
Date of discharge.
(b) The facility shall maintain written recommendations or comments from consultants regarding the active treatment program and its development on a per visit basis.
(c) The facility shall maintain menu and food purchase records.
(d)
- The administrator or administrator's designee shall make a written report of any incident or accident involving a:
a. Resident,including a medication error or drug reaction;
b. Visitor; or
c. Staff member.
- The report shall:
a. Identify any staff member who witnessed the incident; and
b. Be filed in an incident file.
(5) Policies. The facility shall have written policies and procedures that govern all services provided by the facility. The policies shall:
(a) Address resident services, including medical, nursing, habilitation, pharmaceutical, and residential services;
(b) Require the reporting of cases of abuse, neglect, or exploitation of adults or children pursuant to KRS 209.030 or 620.030, including evidence that all allegations of abuse, neglect, or exploitation shall be thoroughly investigated internally to prevent further potential abuse while the investigation is in process;
(c) Ensure that residents are:
-
Free from unnecessary drugs and physical restraints; and
-
Provided active treatment to reduce dependency on drugs and physical restraints; and
(d) Include in a step-by-step manner the actions that shall be taken by staff if a resident is lost, unaccounted for, or on other unauthorized absence.
(6) Resident rights. Resident rights shall be provided for pursuant to KRS 216.510 to 216.525.
(7) Admission.
(a) A resident of an ICF/IID shall:
-
Be admitted only upon the referral of a physician; and
-
Have a condition that requires developmental nursing services and a planned program of active treatment.
(b) The interdisciplinary team shall consist of:
-
A physician;
-
A psychologist;
-
A registered nurse;
-
A qualified social worker; and
-
Other professionals, at least one (1) of whom is a QIDP.
(c) Prior to admission, the interdisciplinary team shall:
-
Conduct a comprehensive evaluation of the individual no less than ninety (90) days before the date of admission;
-
Assess the individual's physical, emotional, social, and cognitive status; and
-
Determine the need for services, including a review of all available programs of care, treatment, and training.
(d) Admission decisions shall be made in accordance with 42 C.F.R. 483.440.
(e) Upon admission, the facility shall provide the resident and a responsible family member or guardian, if applicable, with written information regarding the facility's policies, including:
-
Services offered and charges;
-
Visitation rights during serious illness;
-
Visiting hours; and
-
Type of diets offered.
(f) The facility shall maintain a system for:
-
Identifying each resident's personal property; and
-
Safekeeping valuables, including ensuring that each resident's clothing and other property shall be reserved for the resident's own use.
(8) Discharge planning.
(a) The facility shall have a discharge planning program, which begins at admission and is an integral part of each individual's treatment plan, thatidentifies other settings and support services that may enable a resident to live in a less restrictive environment.
(b) If a resident is to be transferred or discharged, the facility shall comply with requirements of 42 C.F.R. 483.440(b)(4) and (5).
(9) Transfer procedures and agreements.
(a) The facility shall have written transfer procedures and agreements for the transfer of a resident to a higher intensity level of care, if indicated.
(b) A facility that does not have a transfer agreement in effect, but has attempted in good faith to enter into an agreement shall be considered to be in compliance with the requirements of paragraph (a) of this subsection.
(c) The facility's transfer procedures and agreements shall:
-
State the responsibilities of each party in the transfer of a resident;
-
Establish responsibility for notifying the other party of an impending transfer; and
-
Arrange for appropriate and safe transportation of the resident and resident's files.
(d) Except in cases of emergency, the administrator shall:
-
Initiate a transfer through the resident's physician if the resident's condition exceeds the scope of services of the facility; or
-
Contract for services from another community resource to meet the resident's needs.
(e) If a resident's condition improves and the resident may be served in a less restrictive environment, the facility shall offer assistance in making arrangements for the resident to be transferred to a lower intensity level of care.
(f) Except in an emergency, the resident, resident's responsible family member, or guardian, if any, and the attending physician shall be consulted in advance of the transfer or discharge.
(g) If a resident transfers to another level of care, the complete medical record or a current summary of the resident's medical record shall accompany the resident.
(h) If the resident is transferred to another health care facility or other community resource, a transfer form shall:
-
Accompany the resident;
-
Include the following:
a. Physician's orders,if available;
b. Current information regarding the resident's diagnosis with a history of any health conditions that require special care;
c. A summary of prior treatment, special supplies, or equipment needed for the resident's care; and
d. Pertinent social information on the resident and resident's family.
(10) Medical records.
(a) The facility shall maintain a record for each resident that includes documentation of:
-
Planning and continuous evaluation of the resident's habilitation program, including evidence of the resident's progress; and
-
Protecting the resident's rights.
(b) Each entry in a resident's record shall be legible, dated, and signed.
(c) Each record shall include:
- Identifying information, including:
a. Resident's name;
b. Date of admission;
c. Birth date and place of birth;
d. Citizenship status;
e. Marital status;
f. Social Security number;
g. Father's name and birthplace;
h. Mother's maiden name and birthplace;
i. Parents' marital status;
j. Address of parents, guardian, or responsible family member, if applicable; and
k. Sex, race, height, weight, color of hair, color of eyes, identifying marks, and recent photograph;
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Reason for admission or referral;
-
Type and legal status of admission;
-
Legal competency status;
-
Language spoken or understood;
-
Sources of support, including Social Security, veterans' benefits, or insurance;
-
Religious affiliation, if any;
-
Documentation of the preadmission evaluation; and
-
Documentation of assessments and any other previous evaluations.
(d) Within thirty (30) days after admission, the facility shall enter the following in the resident's record:
-
A report of assessments or reassessments performed by the interdisciplinary team to supplement the preadmission evaluation;
-
The resident's specific developmental and behavioral management needs; and
-
A comprehensive functional assessment and individual program plan developed by the interdisciplinary team.
(e) The facility shall enter the following information in a resident's record:
-
A written report of any accident, seizure, or illness, and treatment services provided;
-
Documentation of immunizations;
-
Documentation of the use of any restraint on the resident, including an explanation of and authorization for the restraint;
-
Documentation of the interdisciplinary team's annual review and evaluation of the resident's individual program plan, developmental progress, and status;
-
Observations regarding the resident's response to the individual program plan used to evaluate its effectiveness;
-
A record of significant behavior incidents;
-
Documentation of family visits and contacts;
-
Documentation of any incident in which the resident is lost, unaccounted for, or on other unauthorized absence;
-
Correspondence pertaining to the resident;
-
Updates as needed to the information initially recorded at the time of admission; and
-
A record of any applicable authorizations or consent.
(f) The facility shall enter a discharge summary in the resident's record at the time of discharge.
(11) Confidentiality and Security: Use and Disclosure.
(a) The facility shall maintain the confidentiality and security of resident records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, and as provided by applicable federal or state law.
(b) The facility may use and disclose resident records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, 45 C.F.R. Parts 160 and 164, and as established in this administrative regulation, if applicable.
(c) The facility may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(12) Personnel.
(a) In accordance with KRS 216.532, an ICF/IID shall not employ or be operated by an individual who is listed on the nurse aide and home health aide abuse registry established by 906 KAR 1:100.
(b) In accordance with KRS 209.032, an ICF/IID shall not employ or be operated by an individual who is listed on the Vulnerable Adult Maltreatment Registry established by 922 KAR 5:120.
(c) An ICF/IID shall obtain a criminal record check on each applicant for initial employment in accordance with KRS 216.789 and 216.793.
(d) An ICF/IID may participate in the Kentucky National Background Check Program established by 906 KAR 1:190 to satisfy the background check requirements of paragraphs (a) through (c) of this subsection.
(e) A written job description shall be developed for each category of personnel, including:
-
Qualifications;
-
Lines of authority; and
-
Specific duty assignments.
(f) Current employee records shall be maintained on each staff member and contain:
-
Name and address;
-
Verification of training and experience, including evidence of current licensure,registration, or certification, if applicable;
-
Employee health records;
-
Annual performance evaluations; and
-
Documentation of compliance with the background check requirements of paragraphs (a) through (c) of this subsection.
(13) Staffing requirements.
(a) Staffing in the facility shall be sufficient in number and qualifications to meet the personal care, nursing care, supervision, and other needs of each resident on a twenty-four (24) hour basis.
(b) The licensee shall have a QIPD who is responsible for:
-
Supervising the delivery of each resident's individual program plan;
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Supervising the delivery of training and habilitation services;
-
Integrating the various aspects of the facility's program;
-
Recording each resident's progress; and
-
Initiating review of each individual program plan for necessary changes.
(c) Each residential living unit shall maintain direct care staff-to-resident ratios in accordance with 42 C.F.R. 483.430(d).
(d) A responsible staff member shall be on duty and awake at all times to assure prompt, appropriate action in case of injury, illness, fire, or other emergency.
(e) The use of volunteers shall not be:
-
Included in the minimum staffing requirements of this subsection; or
-
Relied upon to perform direct care services for the facility.
(14) Nurse staffing.
(a) The facility shall have a registered nurse or licensed practical nurse during the day shift, seven (7) days per week to supervise nursing services.
(b) The supervising nurse shall have training and experience in the field of intellectual and developmental disabilities.
(c) If a licensed practical nurse serves as the supervisor, a registered nurse shall provide consultation at regular intervals, not less than four (4) hours weekly.
(d) The supervising nurse's responsibilities shall include developing and maintaining:
-
Nursing service objectives;
-
Standards of nursing practice;
-
Nursing procedure manuals; and
-
A written job description for each level of nursing personnel.
(e) Nursing service personnel at all levels of experience and competence shall:
-
Be assigned responsibilities in accordance with their qualifications;
-
Delegate tasks as authorized under the nurse's scope of practice;
-
Provide appropriate professional nursing supervision; and
-
Participate in the development and implementation of resident care policies.
(15) Each facility shall retain a licensed pharmacist on a full-time, part-time, or consultant basis to direct pharmaceutical services.
(16) Each facility shall have a full-time staff person designated by the administrator who shall be:
(a) Responsible for the total food service operation of the facility; and
(b) On duty a minimum of thirty-five (35) hours each week.
(17) Each facility shall ensure that supportive personnel, consultants, assistants, and volunteers shall be supervised and shall function within the policies and procedures of the facility.
(18) An employee who contracts a communicable or infectious disease shall:
(a) Be immediately excluded from work; and
(b) Remain off work until cleared as noninfectious by a health care practitioner acting within the practitioner's scope of practice.
(19) All employees of an ICF/IID shall be screened and tested for tuberculosis in accordance with the provisions of 902 KAR 20:205.
(20) In-service training.
(a) Each facility shall have a staff training program adequate for the size and nature of the facility with a staff person who is assigned responsibility for staff development and training.
(b) The training program shall include:
-
Orientation to acquaint each new employee with the philosophy, organization, program, practices, and goals of the facility;
-
Follow-up training for any employee who has not achieved the desired level of competence;
-
Continuing in-service training held at least annually for all employees to update and improve their skills; and
-
Supervisory and management training for each employee who is in, or a candidate for, a supervisory position.
Section 4. Provision of Services.
(1) The interdisciplinary team shall ensure that:
(a) The health needs of each resident are met; and
(b) Each resident shall have an individual program plan developed in accordance with the requirements of 42 C.F.R. 483.440(c) through (f).
(2) Infection control.
(a) There shall be written infection control policies that address:
- The prevention of disease transmission, including:
a. Universal blood and body fluid precautions;
b. Precautions for infections that can be transmitted by the airborne route; and
c. Work restrictions for employees with infectious diseases; and
- Cleaning, disinfection, and sterilization methods used for equipment and the environment.
(b) The facility shall provide in-service education programs on the cause, effect, transmission, prevention, and elimination of infections for all personnel responsible for direct care.
(c) Sharp wastes.
-
Sharp wastes shall be segregated from other wastes and placed in puncture-resistant containers immediately after use.
-
A needle or other contaminated sharp shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as allowed by the Centers for Disease Control and Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
-
A sharp waste container shall be incinerated on or off-site, or be rendered nonhazardous.
-
Any non-disposable sharps be placed in a hard walled container for transport to a processing area for decontamination.
(d) Disposable waste.
- All disposable waste shall be:
a. Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
b. Handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
- The facility shall establish specific written policies regarding handling and disposal of all waste material.
(e) Infectious or communicable diseases. An individual infected with one (1) of the following diseases shall not be admitted to the facility:
-
Anthrax;
-
Campylobacteriosis;
-
Cholera;
-
Diphtheria;
-
Hepatitis A;
-
Measles;
-
Pertussis;
-
Plague;
-
Poliomyelitis;
-
Rabies (human);
-
Rubella;
-
Salmonellosis;
-
Shigellosis;
-
Typhoid fever;
-
Yersiniosis;
-
Brucellosis;
-
Giardiasis;
-
Leprosy;
-
Psittacosis;
-
Q fever;
-
Tularemia; or
-
Typhus.
(f) A facility may admit a noninfectious tuberculosis resident. A noninfectious admittance shall be in accordance with 902 KAR 20:200, Section 4 or Section 8(5).
(g) A resident with symptoms or an abnormal chest x-ray consistent with tuberculosis shall be isolated and evaluated in accordance with 902 KAR 20:200, Section 6(4).
(3) Resident behavior and facility practices.
(a) Each facility shall develop and implement written policies and procedures for the management of conduct between staff and clients in accordance with 42 C.F.R. 483.450(a).
(b) The facility shall:
-
Develop and implement written policies and procedures that govern the management of inappropriate resident behavior in accordance with 42 C.F.R. 483.450(b); and
-
Not allow corporal punishment or seclusion of a resident.
(c) Chemical and physical restraints shall not be used, except as authorized by KRS 216.515(6).
(d) Restraints that require lock and key shall not be used.
(e) Emergency use of a restraint shall be applied only by appropriately trained personnel if:
-
A resident poses an imminent risk of harm to self or others; and
-
The emergency restraint is the least restrictive intervention to achieve safely.
(f) A restraint shall not be used as:
-
Punishment;
-
Discipline;
-
Convenience for staff; or
-
Retaliation..
(g) An order for physical restraint shall:
-
Be by a physician or other licensed health care practitioner who is acting within the scope of practice and trained in the use of emergency safety interventions;
-
Be carried out by trained staff;
-
Be the least restrictive safety intervention that is most likely to be effective in resolving the emergency safety situation based on consultation with staff; and
-
Not be in effect longer than twelve (12) hours.
(h) Appropriately trained staff shall check a resident placed in a physical restraint at least every thirty (30) minutes and document each check.
(i) A resident who is in a physical restraint shall be given an opportunity for motion and exercise for a period of not less than ten (10) minutes during each two (2) hours of restraint.
(j) A mechanical device used for physical restraint shall be designed and used in a way that:
-
Avoids physical injury; and
-
Results in the least possible physical discomfort.
(k) A mechanical support used as a protective device shall be designed and applied:
-
Under the supervision of a qualified professional trained in the use of emergency safety interventions; and
-
In accordance with principles of good body alignment, concern for circulation, and allowance for change of position.
(l) Behavior modification programs involving the use of aversive stimuli or time-out devices shall be:
-
Reviewed and approved by the facility's human rights committee or a QIPD in order to ensure that residents are not unnecessarily restricted;
-
Conducted only with the consent of the affected resident's parents, responsible family member, or guardian; and
-
Described in written plans that are kept on file in the facility.
(m) A physical restraint used as a time-out device may be applied only:
-
During a behavior modification exercise; and
-
In the presence of the trainer.
(n) A time-out device or aversive stimuli shall:
-
Not be used for longer than one (1) hour; and
-
Be used only during a behavior modification program under the supervision of the trainer.
(4) Medical supervision of residents.
(a) Each facility shall maintain policies and procedures to ensure that each resident shall be under the medical supervision of a physician.
(b) The facility shall allow the resident, resident's responsible family member, or guardian to have a choice of physicians.
(c) The physician shall visit each resident at least every sixty (60) days or as often as necessary, unless documented by the attending physician.
(d) No less than ninety (90) days prior to the date of admission, each resident shall have a complete medical evaluation to assess the resident'ssocial, physical, emotional, and cognitive status.
(e) After admission, each resident shall have a medical evaluation at least annually.
(f) The facility shall have formal arrangements to ensure that a physician or health care practitioner acting within the scope of practice shall be available to provide necessary medical care in case of medical emergency.
(5) Health services.
(a) Health services shall includethe establishment of a nursing care plan that:
-
Is part of the total habilitation program for each resident;
-
Shall be reviewed and modified as necessary, but no less than quarterly; and
-
Shall include goals and nursing care needs.
(b) Nursing care shall help enable each resident achieve and maintain the highest degree of function, self-care, and independence, including:
-
Positioning and turning in which nursing personnel shall encourage and assist residents in maintaining good body alignment while standing, sitting, or lying in bed to prevent decubiti;
-
Exercises in which nursing personnel shall assist residents in maintaining maximum range of motion;
-
Bowel and bladder training in which nursing personnel shall make every effort to train incontinent residents to gain bowel and bladder control;
-
Training in habits of personal hygiene, family life, and sex education that includes family planning and venereal disease counseling;
-
Ambulation in which nursing personnel shall assist and encourage residents with daily ambulation unless otherwise ordered by the physician; and
-
Administration of medications and appropriate treatment.
(c) A written monthly assessment of the resident's general condition with any changes in the resident's condition, actions, responses, attitudes, or appetite shall be recorded in the resident's record by licensed personnel.
(6) Pharmaceutical services.
(a) The facility shall provide pharmaceutical services, including procedures that ensure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals to meet the needs of each resident.
(b) The facility shall employ or obtain the services of a licensed pharmacist who shall:
-
Provide consultation on all aspects of the provision of pharmacy services in the facility;
-
Establish a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation;
-
Determine that drug records are in order; and
-
Ensure that an account of all controlled drugs shall be maintained and reconciled.
(c) If the facility does not have a pharmacy department, it shall ensure that prescribed drugs and biologicals may be obtained from a community or institutional pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy pursuant to KRS 315.035.
(d) If the facility does not have a pharmacy department, but maintains a supply of drugs, the consultant pharmacist shall:
-
Be responsible for the control of all bulk drugs;
-
Maintain records of the receipt and disposition of bulk drugs; and
-
Dispense drugs from the drug supply, properly label them, and make them available to appropriate licensed nursing personnel.
(e) A facility that stores and administers non-controlled substances in an emergency medication kit (EMK) shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(4)(b).
(f) A facility that stores and administers non-controlled substances from a long-term care facility drug stock shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(5)(a).
(7) Medication services.
(a) Medication administered to a resident shall be ordered in writing by the prescribing:
-
Physician; or
-
Health care practitioner as authorized by the scope of practice.
(b) If an order is received by telephone, the order shall be:
-
Recorded in the resident's medical record; and
-
Signed by the physician or other health care practitioner as authorized under the practitioner's scope of practice within fourteen (14) days.
(c) If an order for medication does not include a specific time limit or a specific number of dosages, the facility shall notify the physician or prescribing practitioner that the medication will be stopped at a certain date unless the medication order is continued.
(d) A registered nurse or pharmacist shall review the resident's medication profile at least monthly.
(e) The prescribing physician or other prescribing practitioner shall review the resident's medication profile at least every two (2) months.
(f) The facility shall release medications to a resident who is discharged upon written authorization of the physician or prescribing practitioner.
(8) Administration of medications.
(a) A licensed health professional:
-
Shall only administer medications as authorized under the professional's scope of practice; or
-
May delegate medication administration tasks. Delegation shall be in accordance with paragraph (b) of this subsection.
(b) A facility may allow an unlicensed staff person to administer medication. Medication given by an unlicensed staff person shall be administered in accordance with KRS 194A.705(2)(c) and 201 KAR 20:700 as follows:
-
Medication administration shall be delegated to the unlicensed staff person by an available nurse;
-
If administration of oral or topical medication is delegated, the unlicensed staff person shall have a:
a. Certified medication aide (CMA) I credential from a training and skills competency evaluation program approved by the Kentucky Board of Nursing (KBN); or
b. Kentucky medication aide (KMA) credential from the Kentucky Community and Technical College System (KCTCS); and
- If administration of a preloaded insulin injection is delegated, the unlicensed staff person shall have a CMA II credential from a training and skills competency evaluation program approved by KBN.
(c) Each medication administered shall be recorded in the resident's medical record.
(d) An intramuscular injection shall be administered by a licensed nurse or physician.
(e) If an intravenous injection is necessary, the injection shall be administered by a licensed physician or registered nurse.
(f) The nursing station shall have readily available items necessary for the proper administration of medication.
(g) A medication that is prescribed for one (1) resident shall not be administered to any other resident.
(h) A resident shall not be allowed to self-administer a medication except:
-
On special order of the resident's physician or prescribing practitioner; or
-
In a predischarge program under the supervision of a licensed nurse as a part of the resident's treatment plan.
(i) The facility shall ensure that a medication error or drug reaction shall be:
-
Immediately reported to the resident's physician or practitioner; and
-
Documented in the resident's medical record and in an incident report.
(j) All resident medications shall be plainly labeled with the:
-
Resident's name;
-
Name of the drug;
-
Strength;
-
Name of the pharmacy;
-
Prescription number;
-
Date;
-
Prescriber's name; and
-
Caution statements and directions for use, unless a modified unit dose distribution system is used.
(k) All medications kept by the facility shall be:
-
Stored in their original containers; and
-
Kept in a locked place.
(l) The facility shall ensure that:
-
All medications requiring refrigeration shall be kept in a separate locked box of adequate size in the refrigerator in the medication area;
-
Drugs for external use shall be stored separately from those administered by mouth injection; and
-
Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the issuing pharmacist or pharmacy for relabeling or disposal.
(9) Controlled substances.
(a) Controlled substances shall be kept under double lock, for example in a locked box in a locked cabinet, and keys or access to the locked box and locked cabinet shall be accessible to designated staff only.
(b) A nurse may delegate administration of a regularly scheduled controlled substance to a CMA if the medication has been prescribed and labeled in a container for a specific resident.
(c) For a controlled substance ordered on a PRN basis, a nurse may delegate administration to a CMA if:
-
The medication has been prescribed and labeled in a container for a specific resident;
-
The nurse assesses the resident, in person or virtually, prior to administration of the PRN controlled substance;
-
The nurse assesses the resident, in person or virtually, following the administration of the PRN controlled substance; and
-
The nurse documents administration of the PRN controlled substance by a CMA in the resident's record.
(d) There shall be a controlled substances bound record book with numbered pages that includes:
-
The name of the resident;
-
Date, time, kind, dosage, and method of administration of each controlled substance;
-
Name of the physician or practitioner who prescribed the medications; and
-
Name of the:
a. Nurse or CMA who administered the controlled substance;or
b. Staff member who supervised the self-administration.
(e) A staff member with access to controlled substances shall be responsible for maintaining a recorded and signed:
-
Schedule II controlled substances count daily; and
-
Schedule III, IV, and V controlled substances count at least one (1) time per week.
(f) All expired or unused controlled substances shall be disposed of or destroyed in accordance with 21 C.F.R. Part 1317 no later than thirty (30) days:
-
After expiration of the medication; or
-
From the date the medication was discontinued.
(g) If controlled substances are destroyed on-site:
-
The method of destruction shall render the drug unavailable and unusable;
-
The administrator or staff person designated by the administrator shall be responsible for destroying the controlled substances with at least one (1) witness present; and
-
A readily retrievable record of the destroyed controlled substances shall be maintained for a minimum of eighteen (18) months from the date of destruction and contain the:
a. Date of destruction;
b. Resident name;
c. Drug name;
d. Drug strength;
e. Quantity;
f. Method of destruction;
g. Name of the person responsible for the destruction; and
h. Name of the witness.
(h) A facility that stores and administers controlled substances in an EMK shall comply with the:
-
Requirements for storage and administration established by 902 KAR 55:070, Section 2(2), (5), and (7) through (9); and
-
Limitation on the number and quantity of medications established by 902 KAR 55:070, Section 2(6).
(10) Personal care services.
(a) Each resident shall receive training in personal skills essential for privacy and independence, including:
- Bathing in which the facility shall:
a. Provide soap, clean towels, and wash cloths for each resident; and
b. Ensure that toilet articles such as brushes and combs shall not be used in common;
-
Personal hygiene;
-
Dental hygiene;
-
Dressing;
-
Grooming;
-
Self-feeding; and
-
Communication of basic needs..
(b) If a resident does not eliminate appropriately and independently, the facility shall:
-
Provide a toilet training program; and
-
Document the resident's progress.
(c) A resident who is incontinent shall be bathed or cleaned immediately upon voiding or soiling and all soiled items shall be changed.
(d) The staff shall train and if necessary, assist a resident with dressing.
(11) Dental services.
(a) The facility shall provide or make arrangements for dental services, comprehensive dental diagnostic services, and comprehensive dental treatment in accordance with 42 C.F.R. 483.460(e) through (g).
(b) The facility shall maintain documentation of dental services in accordance with 42 C.F.R. 483.460(h).
(c) A dental professional shall participate, as appropriate, on the facility's interdisciplinary team.
(d) A dentist shall be responsible for ensuring that direct care staff shall be instructed in the proper use of oral hygiene methods for residents.
(12) Social services.
(a) The facility shall provide social services directly or by contract to residents and their families, including:
-
Evaluation and counseling with referral to, and use of, other planning for community placement; and
-
Discharge and follow up services rendered by or under the supervision of a qualified social worker.
(b) A facility's social worker shall be under the supervision of a:
-
Qualified social worker; or
-
QIDP.
(c) Social services shall be integrated with other elements of the individual program plan.
(d) A plan for social services shall be recorded in the resident's record and evaluated in conjunction with resident's individual program plan.
(13) Recreation services. The facility shall:
(a) Coordinate recreational services with other services and programs that are provided to each resident;
(b) Provide recreation equipment and supplies in a quantity and variety that shall be sufficient to carry out the stated objectives of the activities programs;
(c) Maintain in the resident's record a review conducted at least annually of each resident's recreational interests, including a determination of the extent and level of the resident'sparticipation in the recreation program; and
(d) Have enough qualified staff who meet the requirements of 42 C.F.R. 483.430(b)(5)(viii) and support personnel available to carry out the various recreation services.
(14) Speech-language pathology and audiology services. The facility shall provide speech-language pathology and audiology services:
(a) By an individual who meets the requirements of 42 C.F.R. 483.430(b)(5)(vii); and
(b) As needed to maximize the communication skills of each resident in need of services.
(15) Occupational therapy.
(a) The facility shall provide occupational therapy by or under the supervision of an occupational therapist who meets the requirements of 42 C.F.R. 483.430(b)(5)(i) to meet a resident's need for services.
(b) The occupational therapist or occupational therapy assistant shall provide services in accordance with the individual program plan designed by the interdisciplinary team.
(16) Physical therapy.
(a) The facility shall provide physical therapy by or under the supervision of a licensed physical therapist who meets the requirements of 42 C.F.R. 483.430(b)(5)(iii) to meet a resident's need for services.
(b) The physical therapist or physical therapy assistant shall provide services in accordance with the individual program plan designed by the interdisciplinary team.
(17) Psychological services.
(a) The facility shall provide psychological services as needed by a psychologist who meets the requirements of 42 C.F.R. 483.430(b)(5)(v).
(b) The psychologist shall participate in evaluation of each resident, individual treatment, and consultation and training of direct care staff as a member of the interdisciplinary team.
(18) Transportation.
(a) If transportation of residents is provided by the facility to community agencies or other activities, the provisions established in subparagraphs 1. and 2. of this paragraph shall apply.
-
Special provision shall be made for each resident who uses a wheelchair.
-
An escort or assistant to the driver shall accompany a resident or residents, if necessary, to help ensure safety during transport.
(b) The facility shall arrange for appropriate transportation in case of a medical emergency.
(19) Residential care services.
(a) All facilities shall provide residential care services to all residents including:
-
Room accommodations;
-
Housekeeping and maintenances services; and
-
Dietary services.
(b) Room accommodations.
- The facility shall provide each resident with:
a. A bed that is at least thirty-six (36) inches wide;
b. A clean, comfortable mattress with a support mechanism;
c. A mattress cover;
d. Two (2) sheets and a pillow; and
e. Bed covering to keep the resident comfortable.
-
Each bed shall be placed so that a resident does not experience discomfort because of proximity to a radiator, heat outlet, or exposure to drafts.
-
The facility shall provide:
a. Window coverings;
b. Bedside tables with reading lamps,if appropriate;
c. Comfortable chairs;
d. A chest or dresser with a mirror for each resident;
e. A night light; and
f. Storage space for clothing and other possessions.
-
A resident shall not be housed in a room, detached building, or other enclosure that has not been previously inspected and approved for residential use by the Office of Inspector General and the Department for Housing, Building, and Construction.
-
Basement rooms shall not be used for sleeping rooms for residents.
-
Residents may have personal items and furniture, if feasible.
-
Each living room or lounge area shall have an adequate number of:
a. Reading lamps; and
b. Tables and chairs or settees of sound construction and satisfactory design.
- Dining room furnishings shall be adequate in number, well-constructed, and of satisfactory design for the residents.
(c) Housekeeping and maintenance services.
- The facility shall:
a. Maintain a clean and safe facility free of unpleasant odors; and
b. Ensure that odors are eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
- The facility shall:
a. Have available at all times, an adequate supply of clean linen essential to the proper care and comfort of residents;
b. Ensure that soiled clothing and linens shall receive immediate attention and shall not be allowed to accumulate;
c. Ensure that clothing and linens used by one (1) resident shall not be used by another unless it has been laundered or dry cleaned; and
d. Ensure that soiled clothing and linens shall be:
(i) Placed in washable or disposable containers;
(ii) Transported in a sanitary manner; and
(iii) Stored in separate, well-ventilated areas in a manner to prevent contamination and odors.
-
Equipment or areas used to transport or store soiled linen shall not be used for handling or storing of clean linen.
-
Soiled linen shall be sorted and laundered in the soiled linen room in the laundry area.
-
Handwashing facilities with hot and cold water, soap dispenser, and paper towels shall be provided in the laundry area.
-
Clean linen shall be sorted, dried, ironed, folded, transported, stored, and distributed in a sanitary manner.
-
Clean linen shall be stored in clean linen closets on each floor, close to the nurses' station.
-
Personal laundry shall be:
a. Collected, transported, sorted, washed, and dried in a sanitary manner separate from bed linens;
b. Laundered as often as necessary;
c. Laundered by the facility unless the resident or the resident's family accepts this responsibility; and
d. Marked or labeled to identify the resident so that it may be returned to the correct resident.
(20) Maintenance. The premises shall be well kept and in good repair as established in paragraphs (a) through (d) of this subsection.
(a) The facility shall ensure that the grounds are well kept and the exterior of the building, including the sidewalks, wide walks, steps, porches, ramps, and fences are in good repair.
(b) The interior of the building, including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures shall be in good repair. Windows and doors shall be screened.
(c) Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly.
(d) A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(21) Dietary services.
(a) The facility shall provide or contract for food services to meet the dietary needs of the residents, including:
-
Modified diets; or
-
Dietary restrictions as prescribed by the attending physician.
(b)
-
If a facility contracts for food services with an outside food management company, the company shall provide a licensed dietitian on a full-time, part-time, or consultant basis to the facility.
-
The licensed dietitian shall make recommendations to the medical and nursing staff on dietetic policies affecting resident care.
-
The food management company shall comply with the dietary services requirements of this subsection.
(c) If the facility provides therapeutic diets and the staff member responsible for the food services is not a licensed dietitian, the responsible staff person shall consult with a licensed dietitian.
(d) The facility shall:
-
Have a sufficient number of food service personnel;
-
Ensure that the food service staff schedules shall be posted; and
-
If any food service personnel are assigned duties outside the dietary department, the duties shall not interfere with the sanitation, safety, or time required from regular dietary assignments.
(e) Menu planning.
-
Menus shall be planned, written, and rotated to avoid repetition.
-
The facility shall meet the nutrition needs of residents in accordance with a physician's orders.
-
Except as established in subparagraph 5. of this paragraph, meals shall correspond with the posted menu.
-
Menus shall be planned and posted one (1) week in advance.
-
If changes in the menu are necessary;
a. Substitutions shall provide equal nutritive value;
b. The changes shall be recorded on the menu; and
c. Menus shall be kept on file for at least thirty (30) days.
(f) Food preparation and storage.
-
There shall be at least a three (3) day supply of food to prepare well-balanced, palatable meals.
-
Food shall be prepared with consideration for any individual dietary requirement.
-
Modified diets, nutrient concentrates, and supplements shall be given only on the written orders of a:
a. Physician;
b. Advanced practice registered nurse; or
c. Physical assistant.
-
At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the evening meal and breakfast.
-
Between-meal snacks and beverages, including an evening snack before bedtime, shall be available at all times for each resident, unless medically contraindicated as documented by a physician in the resident's record.
-
Foods shall be:
a. Prepared by methods that conserve nutritive value, flavor, and appearance; and
b. Served at the proper temperature and in a form to meet individual needs.
-
A file of tested recipes, adjusted to appropriate yield shall be maintained.
-
Food shall be cut, chopped, or ground to meet individual needs.
-
If a resident refuses the food served, nutritious substitutions shall be offered.
-
All opened containers or leftover food items shall be covered and dated when refrigerated.
(g) Serving of food.
- If a resident cannot be served in the dining room, trays shall:
a. Be provided; and
b. Rest on firm supports.
-
Sturdy tray stands of proper height shall be provided for residents able to be out of bed.
-
Direct care staff shall be responsible for correctly positioning a resident to eat meals served on a tray.
-
A resident in need of help eating shall be assisted promptly upon receipt of meals.
-
The facility shall provide adaptive feeding equipment if needed by a resident.
-
Food services shall be provided in accordance with 902 KAR 45:005.902 KAR 20:086
History
- RELATES TO: KRS 194A.705(2)(c), 209.030, 209.032, 216.510 – 216.525, 216.532, 216.789, 216.793, 216A.080, 310.031, 315.035, 620.030, 21 C.F.R. Part 1317, 29 C.F.R. 1910.1030(d)(2)(vii), 34 C.F.R. 300.8(c)(6), 42 C.F.R. 483.400 – 483.480, 45 C.F.R. 1325.3, Parts 160, 164, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation and services provided by intermediate care facilities for individuals with intellectual disabilities (ICF/IID).
- History: 8 Ky.R. 606; eff. 2-1-1982; 11 Ky.R. 1186; 1421; eff. 6-4-1985; 13 Ky.R. 1292; eff. 2-10-1987; 16 Ky.R. 2504; 17 Ky.R. 84; eff. 7-18-1990; 1598; eff. 12-18-1990; Cert eff. 4-30-2019; 50 Ky.R. 1396, 2074; eff. 6-18-2024.
902 KAR 20:091 Facilities specifications, operation and services; community mental health center {#sec-902-kar-20-091 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:091}
Section 1. Definitions.
(1) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy, or a medical officer of the government of the United States while engaged in the performance of official duties, who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc. or the American Osteopathic Board of Neurology and Psychiatry;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A psychiatric nurse as defined by subsection (22) of this section;
(h) A physician assistant licensed under KRS 311.840 to 311.862;
(i) A marriage and family therapist licensed and practicing in accordance with KRS 335.300;
(j) A professional clinical counselor licensed and practicing in accordance with KRS 335.500; or
(k) A licensed professional art therapist as defined by KRS 309.130(2).
(2) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapist associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4); or
(f) Licensed professional art therapist associate as defined by KRS 309.130(3).
(3) "Center" means a community mental health center.
(4) "Certified alcohol and drug counselor" is defined by KRS 309.080(2).
(5) "Certified prevention specialist" means an individual who is currently certified as a certified prevention specialist by the Kentucky Certification Board for Prevention Professionals.
(6) "Client" means an individual described by KRS 210.410(2).
(7) "Community mental health center" means a program established pursuant to KRS Chapter 210.
(8) "Community support associate" means a paraprofessional who meets the application, training, and supervision requirements of 908 KAR 2:250.
(9) "Crisis stabilization unit" means a community-based facility operated by or under contract with a center to provide emergency services as described in Section 8 of this administrative regulation to clients who require overnight stays.
(10) "Designated regional service area" means the geographical area to be served by the community mental health center.
(11) "Licensed assistant behavior analyst" is defined by KRS 319C.010(7).
(12) "Licensed behavior analyst" is defined by KRS 319C.010(6).
(13) "Licensed clinical alcohol and drug counselor" is defined by KRS 309.080(4).
(14) "Licensed clinical alcohol and drug counselor associate" is defined by KRS 309.080(5).
(15) "Licensee" means the governing body legally responsible for the community mental health center.
(16) "Mechanical restraint" means any device attached or adjacent to a client's body that he or she cannot easily remove that restricts freedom of movement or normal access to his or her body.
(17) "Mental health associate" means an individual who meets the mental health associate requirements established in the Community Mental Health Center Behavioral Health Services Manual incorporated by reference in 907 KAR 1:044, Section 13.
(18) "Patient" means a client, as described by KRS 210.410(2), or any other individual who seeks primary care services from a community mental health center.
(19) "Peer support specialist" means a paraprofessional who meets the application, training, examination, and supervision requirements of 908 KAR 2:220, 908 KAR 2:230, or 908 KAR 2:240.
(20) "Plan of care" means a written plan that delineates the services to be provided to a client, and includes the short- and long-term goals of the plan.
(21) "Professional equivalent" means an individual who meets the professional equivalent requirements established in the Community Mental Health Center Behavioral Health Services Manual incorporated by reference in 907 KAR 1:044, Section 13.
(22) "Psychiatric nurse" means a registered nurse who:
(a) Has a master's of science degree in nursing with a specialty in psychiatric or mental health nursing;
(b) Is a graduate of a four (4) year educational program with a bachelor of science degree in nursing and a minimum of one (1) year of experience in a mental health setting;
(c) Is a graduate of a three (3) year educational program with two (2) years of experience in a mental health setting; or
(d) Is a graduate of a two (2) year educational program with an associate degree in nursing and three (3) years of experience in a mental health setting.
(23) "Time out" means a treatment intervention that separates a client from others in a nonsecure area for a time-limited period to permit the client time to regain control over his or her behavior.
Section 2. Scope of Operation and Services.
(1) A community mental health center:
(a) Shall provide a comprehensive range of accessible and coordinated behavioral health (mental health and substance abuse services) and services for individuals with an intellectual or developmental disability, including direct or indirect services to the population of a designated regional service area, as required by KRS 210.370 to 210.480; and
(b) May provide primary care services:
-
As permitted by KRS 210.410; and
-
In accordance with the requirements established in Section 7 of this administrative regulation.
(2) A center's services, including primary care services if provided, shall be available to the client population described by KRS 210.410(2).
Section 3. Administration and Operation.
(1) Licensee.
(a) The licensee shall be legally responsible for:
-
The center;
-
The establishment of administrative policy; and
-
Compliance with federal, state, and local law pertaining to the operation of the center.
(b) To obtain or renew a license to operate a center, the licensee shall comply with the requirements of this administrative regulation and the requirements of relevant statutes and administrative regulations.
(2) Executive director. The licensee shall designate an executive director, qualified by training and experience, who shall be responsible for:
(a) The total program of the center and its affiliates in accordance with the center's written policies; and
(b) Evaluation of the program as it relates to the client's needs.
(3) Policies. The licensee shall establish written policies for the administration and operation of the center, which shall be available to staff and which shall include:
(a) A description of the organizational structure specifying the:
-
Responsibility, function, and interrelations of each organizational unit; and
-
Lines of administrative and clinical authority;
(b) The appropriate method and procedure for storage, dispensing, and administering of a drug or biological agent;
(c) Client grievance procedure;
(d) Confidentiality and use of client records in accordance with federal, state, and local statutes and regulations, including subsection (4) of this section; and
(e) Personnel policy, including:
-
A job description and qualifications for each personnel category;
-
Wage scale, hours of work, vacation and sick leave;
-
A plan for orientation of personnel to the policies and objectives of the center, on-the-job training, if necessary, and ongoing in-service training programs related to the employee's job activities; and
-
Annual evaluation of employee performance.
(4) Client records. A client record shall be maintained for each individual receiving services.
(a) Each entry shall be current, dated, signed, and indexed according to the service received.
(b) Ownership.
-
Client records shall be the property of the center.
-
The original client record shall not be removed from the center except by court order or subpoena.
-
Copies of a client record or portions of the record may be used and disclosed as established by paragraph (d) of this subsection.
(c) A client record shall be retained for at least six (6) years or, in the case of a minor, three (3) years after the client reaches the age of majority, whichever is longer.
(d) Confidentiality and security: use and disclosure.
-
The center shall maintain the confidentiality and security of client records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by Subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law, including 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
-
The center may use and disclose client records. Use and disclosure shall be as established or required by:
a. HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164; or
b. 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
- A center may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320-8, and 45 C.F.R. Parts 160 and 164, or 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(e) Each client record shall contain:
-
An identification sheet;
-
Information on the purpose for seeking a service;
-
A history of findings and treatments rendered;
-
Screening information pertaining to the problem;
-
Staff notes on services provided;
-
Pertinent medical, psychiatric, and social information;
-
Disposition;
-
Assigned status;
-
Assigned personnel; and
-
A termination summary recapitulating findings and events during treatment, clinical impressions, and condition on termination.
Section 4. Staff Requirements.
(1) A community mental health center shall employ the following full-time personnel:
(a) An executive director as required by Section 3(2) of this administrative regulation who:
-
May serve in a dual role as the center's program director;
-
Shall meet the education requirements established by the center's governing board for the executive director, or have a master's degree in business administration or a human services field or a bachelor's degree in a human services field, including:
a. Social work;
b. Sociology;
c. Psychology;
d. Guidance and counseling;
e. Education;
f. Religion;
g. Business administration;
h. Criminal justice;
i. Public administration;
j. Child care administration;
k. Christian education;
l. Divinity;
m. Pastoral counseling;
n. Nursing;
o. Public health; or
p. Another human service field related to working with children with severe emotional disabilities or clients with severe mental illness; and
a. Shall have two (2) years of prior supervisory experience in a human services program for an executive director with a master's degree;
b. Shall have a minimum of two (2) years of prior experience in a human services program plus two (2) years of prior supervisory experience in a human services program for an executive director with a bachelor's degree; or
c. Shall meet the experience requirements established by the center's governing board for the executive director;
(b) A program director who:
- Shall be a:
a. Psychiatrist;
b. Certified psychologist with autonomous functioning, licensed psychological practitioner, or licensed psychologist;
c. Psychiatric nurse;
d. Licensed professional clinical counselor;
e. Licensed marriage and family therapist; or
f. Licensed clinical social worker or certified social worker;
-
May serve as the executive director; and
-
Shall be responsible for maintenance of the center's therapeutic milieu;
(c) A medical director who shall:
-
Be a board certified or board eligible psychiatrist licensed in the state of Kentucky;
-
Be responsible for treatment planning; and
-
Supervise and coordinate the provision of psychiatric services by the center;
(d) A licensed psychologist or licensed psychological practitioner pursuant to KRS 319.050, 319.056, or 319.064;
(e) A sufficient number of personnel to provide services as described in Section 5 of this administrative regulation; and
(f) A records librarian or a designated staff person who shall assure that client records are maintained and that information is immediately retrievable.
(2) Background checks.
(a) The executive director and all personnel of a center shall:
-
Have a criminal record check performed upon initial hire through the Administrative Office of the Courts or the Kentucky State Police;
-
Not have a criminal conviction or plea of guilty to a:
a. Sex crime as specified in KRS 17.500;
b. Violent crime as specified in KRS 439.3401;
c. Criminal offense against a minor as specified in KRS 17.500; or
d. Class A felony; and
- Not be listed on the following:
a. Central registry established by 922 KAR 1:470;
b. Nurse aide or home health aide abuse registry established by 906 KAR 1:100; or
c. Caregiver misconduct registry established by 922 KAR 5:120.
(b) A center may use the Kentucky national background check program established by 906 KAR 1:190 to satisfy the background check requirements of paragraph (a) of this subsection.
(c) A center shall perform annual criminal record and registry checks as described in paragraph (a) of this subsection on a random sample of at least fifteen (15) percent of all personnel who have not been subject to the annual background check during the previous three (3) year period.
(d) A center may use the Kentucky national background check program established by 906 KAR 1:190 to satisfy the annual background check requirements of paragraph (c) of this subsection upon implementation of the continuous assessment service, also referred to as rap back.
Section 5. Services.
(1) The center shall provide services in the designated regional service area directly or through contract.
(2) Direct services. The center shall provide services as described in subsection (4) of this section and offer a sufficiently wide range of treatment to meet client needs, which may include behavioral health services described in subsection (5) of this section.
(3) Plan of care.
(a) Each client receiving direct treatment under the auspices of a community mental health center shall have an individual plan of care signed by an independently licensed behavioral health professional.
(b) A medical service, including a change of medication, a diet restriction, or a restriction on physical activity shall be ordered by a physician or other ordering practitioner acting within the limits of his or her statutory scope of practice.
(4) The center shall provide:
(a) Partial hospitalization or psychosocial rehabilitation services pursuant to KRS 210.410(1)(c). A psychiatrist shall be present on a regularly scheduled basis to provide consultant services to staff;
(b)
-
Inpatient services pursuant to KRS 210.410(1)(a) through affiliation with a licensed hospital for a person requiring full-time inpatient care; or
-
If the center does not have an affiliation contract in effect, documentation of a good faith effort to enter into an affiliation contract;
(c) Outpatient services pursuant to KRS 210.410(1)(b) on a regularly scheduled basis with arrangements made for a nonscheduled visit during a time of increased stress or crisis. The outpatient service shall provide diagnosis and evaluation of a psychiatric problem and a referral to other services or agencies as indicated by the client's needs;
(d) Emergency services pursuant to KRS 210.410(1)(d) for the immediate evaluation and care of a person in a crisis situation on a twenty-four (24) hour a day, seven (7) day a week basis. All components of the emergency service shall be coordinated into a unified program that enables a client receiving an emergency service to be readily transferred to another service of the center as client needs dictate; and
(e) Consultation and education services pursuant to KRS 210.410(1)(e) for individuals, community agencies, and groups to increase the visibility, identifiability, and accessibility of the center and to promote services for intellectual disabilities and mental health disorders, substance use disorders, or co-occurring disorders.
(5) Rehabilitative mental health and substance use services, which may be provided by a center in accordance with a plan of care, include the following:
(a) Screening that shall be provided by a behavioral health professional, behavioral health professional under clinical supervision, professional equivalent, mental health associate, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice to determine the:
-
Likelihood that an individual has a mental health, substance use, or co-occurring disorder; and
-
Need for an assessment;
(b) Assessment that shall:
- Be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, professional equivalent, mental health associate, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice who gathers information and engages in a process with the client, thereby enabling the professional to:
a. Establish the presence or absence of a mental health, substance use, or co-occurring disorder;
b. Determine the client's readiness for change;
c. Identify the client's strengths or problem areas that may affect the treatment and recovery processes; and
d. Engage the client in developing an appropriate treatment relationship;
-
Establish or rule out the existence of a clinical disorder or service need;
-
Include working with the client to develop a plan of care if a clinical disorder or service need is assessed; and
-
Not include psychological or psychiatric evaluations or assessments;
(c) Psychological testing that shall:
-
Be performed by a licensed psychologist, licensed psychological associate, licensed psychological practitioner, or an individual who meets the requirements of KRS Chapter 319 related to the necessary credentials to perform psychological testing; and
-
Include a psychodiagnostic assessment of personality, psychopathology, emotionality, or intellectual disabilities, and interpretation and written report of testing results;
(d) Crisis intervention that:
-
Shall be a therapeutic intervention for the purpose of immediately reducing or eliminating the risk of physical or emotional harm to the client or another individual;
-
Shall consist of clinical intervention and support services necessary to provide:
a. Integrated crisis response;
b. Crisis stabilization interventions; or
c. Crisis prevention activities;
- Shall be provided:
a. On-site at the center;
b. As an immediate relief to the presenting problem or threat; and
c. In a face-to-face, one-on-one encounter;
-
May be provided as a telehealth consultation;
-
May include:
a. Verbal de-escalation;
b. Risk assessment; or
c. Cognitive therapy;
- Shall be provided by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate;
e. Certified alcohol and drug counselor;
f. Licensed clinical alcohol and drug counselor; or
g. Licensed clinical alcohol and drug counselor associate;
-
Shall be followed by a referral to non-crisis services, if applicable; and
-
May include:
a. Further service prevention planning, including:
(i) Lethal means reduction for suicide risk; or
(ii) Substance use disorder relapse prevention; or
b. Verbal de-escalation, risk assessment, or cognitive therapy;
(e) Mobile crisis services that shall:
-
Be available twenty-four (24) hours a day, seven (7) days a week, every day of the year;
-
Be provided for a duration of less than twenty-four (24) hours;
-
Not be an overnight service;
-
Be a multi-disciplinary team based intervention that ensures access to acute mental health and substance use services and supports to:
a. Reduce symptoms or harm; or
b. Safely transition an individual in an acute crisis to the appropriate, least restrictive level of care;
- Involve all services and supports necessary to provide:
a. Integrated crisis prevention;
b. Assessment and disposition;
c. Intervention;
d. Continuity of care recommendations; and
e. Follow-up services;
- Be provided face-to-face in a home or community setting by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate;
e. Certified alcohol and drug counselor;
f. Licensed clinical alcohol and drug counselor; or
g. Licensed clinical alcohol and drug counselor associate; and
- Ensure access to a board certified or board-eligible psychiatrist twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(f) Day treatment that shall:
- Be a nonresidential, intensive treatment program designed for youth who:
a. Have a substance use disorder, mental health disorder, or co-occurring disorder;
b. Are under twenty-one (21) years of age; and
c. Are at high risk of out-of-home placement due to a behavioral health issue;
-
Consist of an organized, behavioral health program of treatment and rehabilitative services for substance use disorder, mental health disorder, or a co-occurring disorder;
-
Have unified policies and procedures that address:
a. The program's philosophy;
b. Admission and discharge criteria;
c. Admission and discharge process;
d. Staff training; and
e. Integrated case planning;
- Include the following:
a. Individual outpatient therapy, family outpatient therapy, or group outpatient therapy;
b. Behavior management and social skill training;
c. Independent living skills that correlate to the age and development stage of the client; and
d. Services designed to explore and link with community resources before discharge and to assist the client and family with transition to community services after discharge;
- Be provided as follows:
a. In collaboration with the education services of the local education authority including those provided through 20 U.S.C. 1400 et seq. (Individuals with Disabilities Education Act) or 29 U.S.C. 701 et seq. (Section 504 of the Rehabilitation Act);
b. On school days and during scheduled school breaks;
c. In coordination with the child's individual educational plan or Section 504 plan if the child has an individual educational plan or Section 504 plan;
d. By personnel that includes the following practicing within his or her scope of practice:
(i) Behavioral health professional;
(ii) Behavioral health professional under clinical supervision;
(iii) Professional equivalent;
(iv) Mental health associate;
(v) Certified alcohol and drug counselor;
(vi) Licensed clinical alcohol and drug counselor;
(vii) Licensed clinical alcohol and drug counselor associate; or
(viii) Peer support specialist; and
e. According to a linkage agreement with the local education authority that specifies the responsibilities of the local education authority and the day treatment provider; and
- Not include a therapeutic clinical service that is included in a child's individualized education plan;
(g) Peer support that shall:
-
Be provided by a peer support specialist;
-
Be structured and scheduled nonclinical therapeutic activity with a client or group of clients;
-
Promote socialization, recovery, self-advocacy, preservation, and enhancement of community living skills; and
-
Be identified in the client's plan of care;
(h) Intensive outpatient program services that shall:
-
Offer a multi-modal, multi-disciplinary structured outpatient treatment program that is more intensive than individual outpatient therapy, group outpatient therapy, or family outpatient therapy;
-
Be provided at least three (3) hours per day at least three (3) days per week;
-
Include the following:
a. Individual outpatient therapy;
b. Group outpatient therapy;
c. Family outpatient therapy unless contraindicated;
d. Crisis intervention; or
e. Psycho-education during which the client or client's family member shall be:
(i) Provided with knowledge regarding the client's diagnosis, the causes of the condition, and the reasons why a particular treatment might be effective for reducing symptoms; and
(ii) Taught how to cope with the client's diagnosis or condition in a successful manner;
- Include a treatment plan that shall:
a. Be individualized; and
b. Focus on stabilization and transition to a lower level of care;
- Be provided by the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate; or
e. Certified alcohol and drug counselor;
-
Include access to a board-certified or board-eligible psychiatrist for consultation;
-
Include access to a psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring; and
-
Be provided in a setting with a minimum client-to-staff ratio of ten (10) clients to one (1) staff person;
(i) Individual outpatient therapy that shall:
- Be provided to promote the:
a. Health and well-being of the client; or
b. Recovery from a substance related disorder;
-
Consist of a face-to-face therapeutic intervention with the client provided in accordance with the client's plan of care, which may be provided as a telehealth consultation;
-
Be aimed at:
a. Reducing adverse symptoms;
b. Reducing or eliminating the presenting problem of the client; and
c. Improving functioning;
-
Not exceed three (3) hours per day; and
-
Be provided by the following personnel practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Licensed behavior analyst;
d. Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
e. Professional equivalent;
f. Mental health associate;
g. Certified alcohol and drug counselor;
h. Licensed clinical alcohol and drug counselor; or
i. Licensed clinical alcohol and drug counselor associate;
(j) Group outpatient therapy that shall:
- Be provided to promote the:
a. Health and well-being of the client; or
b. Recovery from a substance related disorder;
-
Consist of a face-to-face behavioral health therapeutic intervention provided in accordance with the client's plan of care, and which may be provided as a telehealth consultation;
-
Excluding multi-family group therapy, be provided in a group setting of nonrelated individuals, not to exceed twelve (12) individuals in size. For group outpatient therapy, a nonrelated individual means any individual who is not a:
a. Spouse;
b. Significant other;
c. Parent or person with custodial control;
d. Child;
e. Sibling;
f. Stepparent;
g. Stepchild;
h. Step-brother;
i. Step-sister;
j. Father-in-law;
k. Mother-in-law;
l. Son-in-law;
m. Daughter-in-law;
n. Brother-in-law;
o. Sister-in-law;
p. Grandparent; or
q. Grandchild;
-
Focus on the psychological needs of the client as evidenced in the client's plan of care;
-
Center on goals including building and maintaining healthy relationships, personal goals setting, and the exercise of personal judgment;
-
Not include:
a. Physical exercise;
b. A recreational activity;
c. An educational activity; or
d. A social activity;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130;
-
Ensure that the group has a deliberate focus and defined course of treatment;
-
Ensure that the subject of group outpatient therapy shall be related to each client participating in the group; and
-
Be provided by one (1) or more of the following personnel practicing within his or her scope of practice, and who shall maintain individual notes regarding each client within the group in the client's record:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Licensed behavior analyst;
d. Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
e. Professional equivalent;
f. Mental health associate;
g. Certified alcohol and drug counselor;
h. Licensed clinical alcohol and drug counselor; or
i. Licensed clinical alcohol and drug counselor associate;
(k) Family outpatient therapy that shall:
-
Consist of a face-to-face behavioral health therapeutic intervention, which may be provided as a telehealth consultation, and shall be provided through scheduled therapeutic visits between the therapist, the client unless the corresponding current procedural terminology code establishes that the recipient is not present, and at least one (1) member of the client's family;
-
Address issues interfering with the relational functioning of the family;
-
Seek to improve interpersonal relationships within the client's home environment;
-
Be provided to promote the health and well-being of the client or recovery from a substance use disorder;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130; and
-
Be provided by the following personnel practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate;
e. Certified alcohol and drug counselor;
f. Licensed clinical alcohol and drug counselor; or
g. Licensed clinical alcohol and drug counselor associate;
(l) Collateral outpatient therapy that shall consist of a face-to-face behavioral health consultation on behalf of a client under the age of twenty-one (21) and may be provided as a telehealth consultation:
- With a:
a. Parent;
b. Caregiver;
c. Person who has custodial control;
d. Household member;
e. Legal representative;
f. School staff person; or
g. Treating professional;
- Provided by the following personnel practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Licensed behavior analyst;
d. Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
e. Professional equivalent;
f. Mental health associate;
g. Certified alcohol and drug counselor;
h. Licensed clinical alcohol and drug counselor; or
i. Licensed clinical alcohol and drug counselor; and
- Provided upon the written consent of a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21). Documentation of written consent shall be signed and maintained in the client's record;
(m) Service planning that shall be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, professional equivalent, or mental health associate to:
-
Assist a client in creating an individualized plan for services needed for maximum reduction of the effects of a mental health disorder;
-
Restore a client's functional level to the client's best possible functional level; and
-
Develop a service plan that:
a. Shall be directed by the client; and
b. May include:
(i) A mental health advance directive being filed with a local hospital;
(ii) A crisis plan; or
(iii) A relapse prevention strategy or plan;
(n) Screening, brief intervention, and referral to treatment for substance use disorders that shall:
-
Be an evidence-based early intervention approach for an individual with non-dependent substance use prior to the need for more extensive or specialized treatment;
-
Consist of:
a. Using a standardized screening tool to assess the individual for risky substance use behavior;
b. Engaging a client who demonstrates risky substance use behavior in a short conversation, providing feedback and advice; and
c. Referring the client to therapy or other services that address substance use if the client is determined to need additional services; and
- Be provided by the following personnel practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate;
e. Certified alcohol and drug counselor;
f. Licensed clinical alcohol and drug counselor;
g. Licensed clinical alcohol and drug counselor associate; or
h. Certified prevention specialist;
(o) Assertive community treatment for mental health disorders that shall:
- Include:
a. Assessment;
b. Treatment planning;
c. Case management;
d. Psychiatric services;
e. Medication prescribing and monitoring;
f. Individual and group therapy;
g. Peer support;
h. Mobile crisis services;
i. Mental health consultation;
j. Family support; and
k. Basic living skills;
- Be provided by a multidisciplinary team of at least four (4) professionals, including:
a. A psychiatrist;
b. A nurse;
c. A case manager;
d. A peer support specialist; and
e. Any other behavioral health professional, behavioral health professional under clinical supervision, professional equivalent, or mental health associate; and
- Have adequate staffing to ensure that no caseload size exceeds ten (10) participants per team member;
(p) Comprehensive community support services that shall:
-
Consist of activities needed to allow an individual with a mental health disorder to live with maximum independence in the community through the use of skills training as identified in the client's treatment plan;
-
Consist of using a variety of psychiatric rehabilitation techniques to:
a. Improve daily living skills;
b. Improve self-monitoring of symptoms and side effects;
c. Improve emotional regulation skills;
d. Improve crisis coping skills; and
e. Develop and enhance interpersonal skills; and
- Be provided by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Community support associate;
d. Licensed behavior analyst;
e. Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
f. Professional equivalent; or
g. Mental health associate;
(q) Therapeutic rehabilitation program for an adult with a severe mental illness or child with a severe emotional disability that shall:
-
Include services designed to maximize the reduction of mental illness or emotional disability and restoration of the client's functional level to the individual's best possible functioning;
-
Establish the client's own rehabilitative goals within the person-centered plan of care;
-
Be delivered using a variety of psychiatric rehabilitation techniques focused on:
a. Improving daily living skills;
b. Self-monitoring of symptoms and side effects;
c. Emotional regulation skills;
d. Crisis coping skills; and
e. Interpersonal skills; and
- Be provided individually or in a group by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Peer support specialist;
d. Professional equivalent; or
e. Mental health associate;
(r) Partial hospitalization that shall:
- Be provided by the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Professional equivalent;
d. Mental health associate; or
e. Certified alcohol and drug counselor;
-
Be a short-term (average of four (4) to six (6) weeks), less than twenty-four (24) hour, intensive treatment program for an individual who is experiencing significant impairment to daily functioning due to substance use disorder, mental health disorder, or co-occurring disorder;
-
Be provided to an adult or a child;
-
Ensure that admission criteria for partial hospitalization is based on an inability to adequately treat the individual through community-based therapies or intensive outpatient services;
-
Consist of individual outpatient therapy, group outpatient therapy, family outpatient therapy, or medication prescribing and monitoring;
-
Typically be provided for at least four (4) hours per day and focused on one (1) primary presenting problem, which may include substance use, sexual reactivity, or another problem; and
-
Include the following personnel for the purpose of providing medical care if necessary:
a. An advanced practice registered nurse;
b. A physician assistant or physician available on site; and
c. A board-certified or board-eligible psychiatrist available for consultation;
(s) Residential treatment services for substance use disorders as described in Section 6 of this administrative regulation;
(t) Targeted case management services that shall:
- Include services to one (1) or more of the following target groups:
a. An adult or a child with substance use disorder;
b. An adult or child with co-occurring mental health or substance use disorder and chronic or complex physical health issues;
c. A child with a severe emotional disability; or
d. An adult with severe mental illness;
-
Be provided by a case manager who meets the requirements of 908 KAR 2:260; and
-
Include the following assistance:
a. Comprehensive assessment and reassessment of client needs to determine the need for medical, educational, social, or other services. The reassessment shall be conducted annually or more often if needed based on changes in the client's condition;
b. Development of a specific care plan that shall be based on information collected during the assessment and revised if needed upon reassessment;
c. Referral and related activities, which may include:
(i) Scheduling appointments for the client to help the individual obtain needed services; or
(ii) Activities that help link the client with medical, social, educational providers, or other programs and services that address identified needs and achieve goals specified in the care plan;
d. Monitoring, which shall be face-to-face and occur no less than once every three (3) months to determine that:
(i) Services are furnished according to the client's care plan;
(ii) Services in the care plan are adequate; and
(iii) Changes in the needs or status of the client are reflected in the care plan; and
e. Contacts with the client, family members, service providers, or others are conducted as frequently as needed to help the client:
(i) Access services;
(ii) Identify needs and supports to assist the client in obtaining services; and
(iii) Identify changes in the client's needs; or
(u) Pregnant women substance use prevention services or substance use case management services.
(6) Quality assurance and utilization review.
(a) The center shall have an on-going, written quality assurance and utilization review program that:
-
Includes effective mechanisms for reviewing and evaluating client care and, if applicable, patient care in order to identify problems or opportunities to improve care;
-
Provides for appropriate responses to findings;
-
Assigns responsibility for monitoring and evaluating client and, if applicable, patient care;
-
Delineates the scope of care provided by the center;
-
Identifies the aspects of care that the center provides;
-
Identifies indicators and appropriate clinical criteria that can be used to monitor these aspects of care;
-
Collects and organizes data for each indicator;
-
Contains written procedures for taking appropriate corrective action;
-
Assesses the effectiveness of the actions taken to correct problems and documents the improvement in care; and
-
Communicates relevant information to other individuals, departments, or services as to the quality assurance program.
(b) The need for continuing services shall be evaluated immediately upon a change in a client's service needs or a change in the client's condition to ensure that proper arrangements have been made for:
-
Discharge;
-
Transfer; or
-
Referral to another service provider, if appropriate.
(7) Medications.
(a)
-
If a center uses electronic prescribing, the center shall maintain a paper copy of each prescription.
-
If a center does not use electronic prescribing, the center shall document each prescription on a form designated specifically for medications.
(b) Documentation of the prescription shall be kept in the client record.
(c) Blood or another laboratory test or examination shall be performed in accordance with accepted medical practice.
(d) Drug supplies shall be stored under proper sanitary, temperature, light, and moisture conditions.
(e) Medication kept by the center shall be properly labeled.
(f) A medication shall be stored in the originally received container unless transferred to another container by a pharmacist or another person licensed to transfer the medication.
(g) Medication kept in the center shall be kept in a locked cabinet.
-
A controlled substance shall be kept under double lock (e.g., in a locked box in a locked cabinet).
-
There shall be a controlled substances record, in which is recorded:
a. The name of the patient;
b. The date, time, dosage, balance remaining, and method of administration of each controlled substance;
c. The name of the prescribing physician or other ordering practitioner acting within the limits of his statutory scope of practice; and
d. The name of the nurse who administered it, or staff who supervised the self-administration.
- Except for medication to be self-administered in a crisis stabilization unit, access to the locked cabinet shall be restricted to a designated medication nurse or other authorized personnel. Medication to be self-administered in a crisis stabilization unit shall be made available to the patient at the time of administration.
Section 6. Residential Treatment Services for Substance Use Disorders.
(1) If a center licensed under this administrative regulation provides residential services to clients with a substance use disorder, the center shall obtain separate licensure as a residential alcohol and other drug abuse treatment program pursuant to 908 KAR 1:370.
(2) In addition to meeting the requirements of 908 KAR 1:370 for residential treatment programs, a center that provides residential services for substance use disorders shall:
(a) Provide intensive treatment and skills building in a structured and supportive environment;
(b) Assist the client in abstaining from alcohol or substance use and in entering alcohol or drug addiction recovery;
(c) Provide services in a twenty-four (24) hour a day, live-in facility that offers a planned and structured regimen of care aimed at treating individuals with addiction or co-occurring mental health and substance use disorders;
(d) Assist the client in making necessary changes to enable the individual to live drug- or alcohol-free;
(e) Provide services under the medical direction of a physician; and
(f) Provide continuous nursing services in which a registered nurse shall be:
-
On-site during traditional first shift hours, Monday through Friday;
-
Continuously available by phone after hours; and
-
On-site as needed in follow-up to telephone consultation after hours.
Section 7. Primary Care Services.
(1) Basic services. The center may provide a variety of preventive, medical diagnostic, laboratory, x-ray, treatment, and therapeutic (physical, occupational, and speech therapy) services by appropriately licensed or certified health professionals to meet the usual physical health care needs of:
(a) The center's clients as described by KRS 210.410(2) to help ensure continuity of care; and
(b) Other individuals seeking primary care services from the center.
(2) Referrals. If a center provides primary care services to its clients, the center shall provide appropriate referrals for clients who require services that are above the level of basic primary care services not provided by the center.
(3) Policies.
(a) Administrative policies. A center that provides primary care services shall have written administrative policies in addition to the requirement established in Section 3(3) of this administrative regulation, including:
-
A description of organizational structure for the delivery of primary care services, which may include therapeutic services, staffing, and allocation of responsibility and accountability;
-
A description of referral linkages with inpatient facilities and other providers;
-
Policies and procedures for the guidance and control of personnel performances;
-
A description of primary care and therapeutic services directly provided by the center, which may include the provision of services in a home- or community-based setting;
-
A description of the administrative and patient health records and reports; and
-
A policy to specify the provision of emergency medical services.
(b) Patient care policies.
-
Patient care policies shall be developed by the center's medical director required by subsection (4)(b) of this section and other professional staff for all medical aspects of the center's program, including written protocols for standing orders, rules of practice, and medical directives that apply to services provided by the center.
-
The protocols shall be signed by the medical director.
-
A system shall be established to ensure that, if feasible, the patient shall be always cared for by the same health professional or health team, to assure continuity of care.
(c) Patient rights policies. The center shall adopt written policies regarding the rights and responsibilities of patients. These patient rights policies shall assure that each patient shall be:
-
Informed of these rights and of all rules and requirements of 902 KAR Chapter 20 governing patient conduct and responsibilities, including a procedure for allowing the patient to voice a grievance or recommend changes in policies and services. Upon the patient's request, a grievance or recommendation shall be conveyed within a reasonable time to a decision making level within the organization with the authority to take corrective action;
-
Informed of services available at the center;
-
Informed of his or her medical condition, unless medically contraindicated as documented in his or her health record;
-
Afforded the opportunity to participate in the planning of his or her medical treatment and to refuse to participate in experimental research;
-
Encouraged and assisted to understand and exercise his or her patient rights;
-
Assured confidential treatment of his or her records and shall be afforded the opportunity to approve or refuse release of the records to any individual not involved in the patient's care, except as required by applicable law or third-party payment contract; and
-
Treated with consideration, respect, and full recognition of his or her dignity and individuality, including privacy in treatment and in the care of his or her personal health needs.
(4) Personnel.
(a) Primary care provider team. Each center that provides primary care services shall be staffed with at least:
-
One (1) full-time advanced practice registered nurse or physician assistant;
-
One (1) physician who:
a. Except in extraordinary circumstances as documented in the center's records, shall be present no less than once in every two (2) week period to provide medical direction, medical care services, consultation, and supervision; and
b. Shall be available through direct telecommunication for consultation, assistance with medical emergencies, or patient referral. If a center is staffed with a full-time physician who provides medical care services on-site, the requirement for at least one (1) full-time advanced practice registered nurse or physician assistant shall be waived; and
- Core staff of appropriately licensed or certified health professionals as necessary to carry out services provided.
(b) Medical Director. A medical director responsible for oversight of a center's primary care services shall:
-
Be a licensed physician;
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Be responsible for all physical health aspects of the center;
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Provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311; and
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If the medical director responsible for the physical health aspects of the center is not a board certified or board eligible psychiatrist licensed in Kentucky, coordinate care and treatment decisions with the center's psychiatrist for all primary care services delivered to the center's clients.
(c) Physicians. A physician employed by or under contract with the center to perform services as described in paragraph (a)2 of this subsection shall be:
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Qualified to practice general medicine, including as a general practitioner, family practitioner, obstetrician – gynecologist, pediatrician, or internist; and
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A member of the medical staff or hold courtesy staff privileges at one (1) or more hospitals with which the center has a formal transfer agreement.
(d) In-service training.
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All center personnel who provide primary care services shall participate in ongoing in-service training programs relating to their respective job activities.
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The training programs shall include:
a. Thorough job orientation for new personnel;
b. Regular in-service training emphasizing professional competence and the human relationship necessary for effective health care; and
c. On-the-job training, if necessary.
(5)
(a) The confidentiality and retention of client records shall be maintained in accordance with Section 3(4) of this administrative regulation.
(b) The center shall maintain a health record for each patient. The health record shall include:
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The patient's medical and social history, including data obtained from other providers;
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A description of each primary care visit or contact, including the condition or reason necessitating the visit or contact, assessment, diagnosis, services provided, medications and treatments prescribed, and disposition made;
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Reports of all laboratory, x-ray, and other test findings; and
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Documentation of all referrals made, including the reason for the referral, to whom the patient was referred, and any information obtained from the referral source.
(c) Transfer of records. The center shall:
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Establish systematic procedures to assist in continuity of care if the patient moves to another source of care; and
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Upon proper release, transfer health records or an abstract if requested.
(6) Linkage agreements.
(a) The center shall have linkages through written agreements with providers of other levels of care that may be medically indicated to supplement the services available in the center. These linkages shall include:
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Hospitals; and
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Emergency medical transportation services in the service area.
(b) Linkage agreements with inpatient care facilities shall incorporate provisions for:
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Appropriate referral and acceptance of patients from the center;
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Appropriate coordination of discharge planning with center staff; and
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The discharge summary for each patient referred to be requested by the center.
(c) The written transfer agreements shall include designation of responsibility for:
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Transfer of information;
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Provision of transportation;
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Sharing of services, equipment, and personnel;
-
Provision of total care or portions thereof in relation to center and agency capability; and
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Patient record confidentiality pursuant to all applicable federal and state law.
(d) A linkage agreement shall not be required to transfer health records to any other treating health care facility or provider.
(7) Quality assurance program. The center shall have an ongoing, written quality assurance program established in accordance with Section 5(6)(a) of this administrative regulation.
Section 8. Crisis Stabilization.
(1) Emergency services provided in a crisis stabilization unit shall include the following:
(a) A mental status evaluation and physical health questionnaire of the client upon admission;
(b) A treatment planning process;
(c) Procedure for crisis intervention; and
(d) Discharge and aftercare planning processes.
(2) A program shall have a written policy concerning the operation of a crisis stabilization unit including:
(a) Staffing.
- At least one (1) direct-care staff member shall be assigned direct-care responsibility for:
a. Every four (4) clients during normal waking hours; and
b. Every six (6) clients during normal sleeping hours;
- Administrative oversight of the program shall be provided by a staff member who shall be:
a. A person licensed or certified to provide mental health services independent of clinical supervision;
b. A qualified mental health professional as defined in KRS 202A.011(12); or
c. A person qualified to be program director under Section 4(1)(b) of this administrative regulation; and
- The center shall provide a training program for direct care staff pertaining to the care of a client in a crisis stabilization unit.
(b) Criteria to assure that each client in a crisis stabilization program shall be:
-
In either one (1) of two (2) separate programs, child or adult, separated by physical location. A children's program may serve a resident up to age twenty-one (21) if it is more developmentally appropriate for that resident;
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In need of short-term behavior management and at risk of placement in a higher level of care;
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Able to take care of his own personal needs, if an adult;
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Medically able to participate in services; and
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Served in the least restrictive environment available in the community.
(c) Referrals for physical health services to include diagnosis, treatment, and consultation for acute or chronic illnesses occurring during the client's stay in the crisis stabilization unit or for problems identified during the admission assessment.
(d) Rights of a crisis stabilization client, to include:
-
A description of the client's rights and the means by which these rights are protected and exercised.
-
At the point of admission, the program shall provide the statement of rights and responsibilities to the:
a. Client; and
b. In addition to the client, client's parents, guardian, or other legal representative if the client is a minor or incapacitated.
- The statement shall:
a. Be written in language that is understandable;
b. Be read to the client or if the client is a minor, client's parents, guardian, or other legal representative if requested or if either cannot read; and
c. Cover the following:
(i) The right to treatment, regardless of race, religion, or ethnicity;
(ii) The right to recognition and respect of personal dignity in the provision of all treatment and care;
(iii) The right to be provided treatment and care in the least restrictive environment possible;
(iv) The right to an individualized plan of care;
(v) The right of the client, including the client's parents or guardian if the client is a minor, to participate in treatment planning;
(vi) The nature of care, procedures, and treatment provided;
(vii) The right to an explanation of risks, side effects, and benefits of all medications and treatment procedures used; and
(viii) The right, to the extent permitted by law, to refuse the specific medications or treatment procedures and the responsibility of the facility if the client refuses treatment, to seek appropriate legal alternatives or orders of involuntary treatment, or, in accordance with professional standards, to terminate the relationship with the client upon reasonable notice.
-
The statement of rights and responsibilities shall be posted in appropriate areas of the facility.
-
The written policies and procedures concerning client rights shall assure and protect the client's personal privacy within the constraints of his or her plan of care, including:
a. Visitation by family or significant others in a suitable area of the facility; and
b. Telephone communications with family or significant others at a reasonable frequency.
-
If a privacy right is limited, a full explanation shall be given to the client or the client's parent or guardian if the client is a minor. A limitation to a privacy right shall be documented in the client's record.
-
Information shall be provided to the client, or the client's parent or guardian if the client is a minor, regarding the use and disposition of a product of special observation and audio visual techniques, which may include the following:
a. One (1) way vision mirror;
b. Audio recording;
c. Video tape recording;
d. Television;
e. Movie; or
f. Photograph.
a. Written policy and procedure developed in consultation with professional and direct-care staff shall provide for behavior management of a child client, including the use of a time-out room.
b. Behavior management techniques shall be explained fully to each client and the client's parent, or guardian, or other legal representative if the client is a child or otherwise incapacitated.
-
The facility shall prohibit cruel and unusual behavioral management measures, including corporal punishment, the use of a seclusion room, and mechanical restraint.
-
Written policy shall prohibit a client from administering a disciplinary measure upon another client and shall prohibit a person other than professional or direct-care staff from administering a disciplinary measure to a child client.
(e) If therapeutic holds are used as a safe behavioral management technique, the facility shall have a policy that shall describe:
-
Criteria for appropriate use of therapeutic holds;
-
Documentation requirements; and
-
The requirement for completion of a training course approved by the Department for Behavioral Health, Developmental and Intellectual Disabilities prior to using therapeutic holds.
(f) The requirement that a licensed psychiatrist shall be available to evaluate, provide treatment and participate in treatment planning on a regular basis.
(g) The procedure for proper management of pharmaceuticals, consistent with the requirements of Section 5(7) of this administrative regulation.
(h) Except for a program accredited by the Joint Commission or the Commission on Accreditation of Rehabilitation Facilities, general procedures that address the following:
-
Procedures to be followed by staff in the event of a medical emergency of a client;
-
Proper nutrition;
-
Emergency preparedness;
-
Security; and
-
School attendance for children.
(3) Facility requirements for a crisis stabilization unit. A living unit shall be located within a single building and shall include:
(a) Bedrooms.
-
More than four (4) clients shall not sleep in a bedroom.
-
A bedroom shall be equipped with a bed for each client.
-
A bed shall:
a. Be at least thirty-six (36) inches wide and at least five (5) feet in length;
b. Be long and wide enough to accommodate the client's size;
c. Have a mattress cover, two (2) sheets, a pillow, and bed covering as is required to keep the client comfortable;
d. Be equipped with a support mechanism and a clean mattress; and
e. Be placed so that a client shall not experience discomfort because of proximity to a radiator or heat outlet, or exposure to a draft.
-
There shall be separate sleeping quarters for males and females.
-
A client shall not be housed in a room, a detached building, or other enclosure that has not previously been inspected and approved for residential use by the licensure agency and the Department of Housing, Buildings and Construction.
(b) Bathrooms.
- For every eight (8) residents, each living unit shall have at least one (1):
a. Wash basin with hot and cold water;
b. Flush toilet; and
c. Bath or shower with hot and cold water.
- If separate toilet and bathing facilities are not provided, males and females shall not be permitted to use those facilities at the same time.
(c) Living area.
-
The living area shall provide comfortable seating for all clients housed within the living unit.
-
Each living unit shall be equipped with a:
a. Working sink; and
b. Stove and refrigerator, unless a kitchen is directly available within the same building as the living unit.
- A living unit shall house a maximum of sixteen (16) clients.
Section 9. Facility Specifications.
(1) A facility housing a community mental health center or a crisis stabilization unit shall be a general purpose building of safe and substantial construction and shall be in compliance with applicable state and local laws relating to zoning, construction, plumbing, safety, and sanitation. The following shall apply if relevant and as adopted by the respective agency authority:
(a) Requirements for fire safety pursuant to 815 KAR 10:060; and
(b) Requirements for making a building or facility accessible to and usable by an individual with disabilities, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(2) Prior to occupancy, the facility shall have final approval from appropriate agencies.
(3) A facility shall be currently approved by the Department of Housing, Buildings and Construction in accordance with 815 KAR 10:060, before relicensure is granted by the licensure agency.
History
- RELATES TO: KRS 17.500, 198B.260, 202A.011(4), 202B.010(6), 205.6313, 210.370, 210.410, 210.450, 216B.010, 216B.015, 216B.030, 216B.105, 216B.990, 222.211, 309.080, 309.130, 311.560, 314.011(8), 314.042(8), 319.056, 319.064, 319C.010, 320.210(2), 335.080, 335.100, 335.300, 335.500, 439.3401, 645.020(5), 42 C.F.R. Part 2, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 – 1320d-8, 42 U.S.C. 290ee-3
- STATUTORY AUTHORITY: KRS 210.450(1), 216B.010, 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 require the Kentucky Cabinet for Health and Family Services to regulate health facilities and services. KRS 210.450(1) requires the secretary to promulgate administrative regulations to establish standards for qualification of personnel, quality of professional service, and personnel management operations. This administrative regulation establishes licensure requirements for the operation and services, and facility specifications of a community mental health center. In addition, this administrative regulation establishes standards for community mental health centers that elect to provide primary care services pursuant to KRS 210.410 and KRS 205.6313.
- History: 8 Ky.R. 418; eff. 1-6-1982; 16 Ky.R. 1001; eff. 1-12-1990; 24 Ky.R. 1788; 2378; eff. 5-18-1998; 25 Ky.R. 2469; 2916; 26 Ky.R. 394; eff. 8-16-1999; 32 Ky.R. 2157; 33 Ky.R. 117; eff., 7-24-2006; 43 Ky.R. 1057, 1752; eff. 5-5-2017; Cert eff. 2-19-2024
902 KAR 20:101 Facility specifications; ambulatory surgical center {#sec-902-kar-20-101 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:101}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the Board for the purpose of operating an ambulatory surgical center and offering ambulatory surgical services.
(3) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Preparation and Approval of Plans and Specifications. After receiving a certificate of need from the board, the following procedures shall be followed:
(1) Before construction is begun for the erection of new buildings or alterations to existing buildings or any change in facilities, the licensee or applicant shall submit plans in the detail specified in Section 3 to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear either the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) All such plans and specifications shall be approved by the licensure agency prior to commencement of construction of new buildings or alterations of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications shall be approved by the Department of Housing, Buildings and Construction, and appropriate local building permits shall be obtained prior to commencement of construction.
Section 3. Submission of Plans and Specifications.
(1) First stage; schematic plans. Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include the typical patient room layouts (scaled one-fourth (1/4) inch equals one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(2) Second stage; preliminary plans.
(a) Architectural: plans of basement and floors.
(b) Outline specifications.
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General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls, duct and piping systems; and dietary, laundry, sterilizing and other special equipment;
-
General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage; contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Equipment; location of all fixed equipment. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems; details of construction, machine and control spaces necessary, size and type of equipment, and utility requirements, for the following: dumbwaiters: electric, hand, hydraulic; elevators: freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems; radiators and steam heated equipment, such as sterilizers, warmers, and steam tables; heating and steam mains and branches with pipe sizes; diagram of heating and steam risers with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heaters with stokers, oil burners, or gas burners; pumps, tanks, boiler breeching, and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping, and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems; size and elevation of: street sewer, house sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold and circulating branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections; gas, oxygen, and vacuum systems; standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeder and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Fire alarm system with stations, signal devices, control board, and wiring diagrams;
g. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits;
h. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
-
Cover or title sheet;
-
Index;
-
Sections describing materials and workmanship in detail for each class of work.
(c) Access to the work. Representatives of the appropriate state agencies shall have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances and Regulations.
(1) This section may be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended.
(b) Requirements for plumbing pursuant to 815 KAR 20:010 through 190, as amended.
(c) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010.
(d) Requirements for elevators pursuant to 803 KAR 4:010.
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(f) Requirements for radiation protection in x-ray and gamma ray installations pursuant to 902 KAR Chapter 100.
(4) Prior to occupancy, the facility shall have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code, before relicensure is granted by the licensure agency.
Section 5. General Facility Requirements and Special Conditions.
(1) All ambulatory surgical center facilities shall contain at least all the elements described herein, or the narrative program shall indicate the manner in which the needed services are to be provided and identify appropriate modifications or deletions in space and equipment requirements. Each element provided in the ambulatory surgical center facility must meet the construction requirements outlined herein as a minimum, with the understanding that in many instances the elements will need to be expanded to fulfill the program requirements.
(2) A narrative program for each project shall be provided by the sponsor which describes the functional space requirements, staffing patterns, departmental relationships, and other basic information relating to the fulfillment of the objectives of the facility.
(3) The extent (number and types of rooms) of the diagnostic, clinical, and administrative facilities to be provided shall be determined by the services contemplated and the estimated patient load as described in the narrative program.
(4) The planning of ambulatory surgical center facilities shall provide for the privacy and dignity of the patient during interview, examination, and treatment.
(5) Facilities shall be available and accessible to the public, staff, and patients who may be physically handicapped. Special attention shall be given to ramps, drinking fountain height, mirrors, and other items deemed necessary for the physically handicapped.
(6) The facility shall have adequate administrative, public, and staff facilities (e.g., offices, lobby, toilet facilities) to accommodate the needs of the public, patients, and staff without interfering with the provision of medical care services.
Section 6. Clinical Facilities.
(1) General purpose examination room(s) to be used for medical examinations shall have a minimum clear floor area of eighty (80) square feet, excluding such other spaces as vestibule, toilet, closet, and work counter (whether fixed or movable). Arrangement shall permit at least thirty (30) inches of clear space at each side and at foot of examination table. Provide lavatory or sink with handwashing facility and counter or shelf space for writing.
(2) Facilities for charting and for clinical records (nurses' station(s)). Provide counter space, temporary storage, and communication device; these may be located in each examination room and each treatment room.
(3) Drug distribution station. If the facility is to maintain a medication preparation room for the proper storage of drugs and biologicals, it shall be so located as to be under the nursing staff's visual control. It shall contain a work counter, refrigerator, and locked storage for drugs and biologicals.
Section 7. Medical Records Unit. This unit shall include:
(1) Active record storage area;
(2) Record review and dictating room;
(3) Work area for sorting, recording, or microfilming;
(4) Inactive record storage area. (May be omitted if microfilming is used.)
Section 8. Diagnostic Facilities.
(1) Radiology suite. If the facility provides radiology directly it shall provide equipment for diagnostic purposes but may also include therapeutic equipment. The suite shall contain:
(a) Radiographic room(s);
(b) Film processing facilities;
(c) Viewing and administration area(s);
(d) Film storage facilities;
(e) Toilet room which is directly accessible from each fluoroscopy room without entering the general corridor area;
(f) Dressing area(s) with convenient access to public toilets.
(2) Laboratory facilities. Facilities shall be provided directly within the ambulatory surgical center or through a contract arrangement with a nearby hospital or laboratory service for hematology, clinical chemistry, urinalysis, cytology, and bacteriology. If these facilities are provided through such a contract, then at least the following shall be provided:
(a) Laboratory work counter(s) with sink, gas and electric service;
(b) Lavatory(ies) with handwashing facility;
(c) Storage cabinet(s) or closet(s);
(d) Specimen collection facilities. Urine collection rooms shall be equipped with a water closet and lavatory. Blood collection facilities shall have space for a chair and work counter.
Section 9. Janitor's Closet(s). This room shall contain a sink and storage for housekeeping supplies and equipment. Provide at least one (1) janitor's closet per floor.
Section 10. Surgical Suite.
(1) General. The suite shall be located to prevent through-traffic.
(2) Operating rooms. Each room shall have a minimum clear floor area of 240 square feet, with a minimum dimension of fifteen (15) feet.
(3) Recovery facilities. A separate room with charting space, medication storage and preparation space, and clinical sink is required.
(4) Service areas in each surgical suite. The size of each service area will depend on the surgical workload and shall include:
(a) Surgical supervisor station;
(b) Sterilizing facilities; near operating room with high-speed autoclave;
(c) Facilities for storage and preparation of medication;
(d) Scrub-up facilities; adjacent to operating rooms;
(e) Soiled workroom. Shall contain counter, clinical sink, waste receptacles, and soiled linen receptacles;
(f) Storage for sterile and unsterile supplies (may be in clean workroom);
(g) Anesthesia workroom for cleaning and storage of equipment;
(h) Storage room for anesthetic agents;
(i) Nitrous oxide and oxygen facilities (provide storage room if these services are not piped in);
(j) Clean workroom for storage and assembly of supplies; shall contain counter and sink;
(k) Equipment storage room for surgical and monitoring equipment;
(l) Janitor's closet. Floor receptor or service sink and storage for housekeeping supplies and equipment;
(m) Clothing change areas, lockers, and toilet rooms for doctors, nurses, orderlies, and other personnel;
(n) Holding area (for patients) in facilities with two (2) or more operating rooms;
(o) Stretcher alcove.
Section 11. Central Medical and Surgical Supply Department. The following areas shall be separated from each other:
(1) Receiving and cleanup room. Space for cleaning equipment and disposing or processing of unclean articles shall be provided.
(2) Clean workroom. This room shall be divided into work space, clean storage area, sterilizing facilities, and storage area for sterile supplies.
(3) Unsterile supply storage area. May be located in an area other than this department.
Section 12. Engineering Service and Equipment Areas. The following shall be provided:
(1) Room(s) for boilers, mechanical equipment, and electrical equipment.
(2) Refuse storage room. This shall be located convenient to service entrance.
(3) Waste processing services:
(a) Provide space and facilities for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, or removal, or by a combination of these techniques.
(b) If provided, the incinerator shall be in a separate room, in a designated area within the boiler room, or placed outdoors.
Section 13. Details and Finishes. All details and finishes shall meet the following requirements:
(1) Details.
(a) Corridors inside surgical suite shall be eight (8) feet minimum width.
(b) All doors to toilets which may be used by patients shall be equipped with hardware which will permit access in any emergency.
(c) The minimum width of doors for patient access to examination rooms shall be three (3) feet. Minimum width of doors to all rooms needing access for beds or stretchers shall be three (3) feet and eight (8) inches.
(d) Thresholds and expansion joint covers shall be made flush with the floor surface to facilitate use of wheelchairs and carts.
(e) The location and arrangement of handwashing facilities shall permit their proper use and operation. Particular care shall be given to the clearances required for blade-type operating handles.
(f) Paper towel dispensers and waste receptacles shall be provided at all lavatories and sinks used for hand washing.
(g) Ceiling heights:
-
Boiler rooms: Not less than two (2) feet and six (6) inches above the main boiler header and connecting piping.
-
Radiographic and other rooms containing ceiling mounted equipment and including those having ceiling mounted surgical light fixtures shall have a height of not less than nine (9) feet.
-
All other rooms shall have ceilings not less than eight (8) feet high except that ceilings in corridors, storage rooms, toilet rooms, and other minor rooms may be not less than seven (7) feet and eight (8) inches. Tracks, rails, pipes, etc., located in the path of normal traffic, shall be not less than six (6) feet and eight (8) inches above the floor.
(h) Rooms containing heat producing equipment (such as boiler or heater rooms) shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature ten (10) degrees Fahrenheit above the ambient room temperature.
(2) Finishes.
(a) Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. In all areas subject to frequent wet cleaning, floor materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet, as shower and bath areas and certain work areas, shall have a nonslip surface.
(b) Wall finishes shall be washable and, in the immediate area of plumbing fixtures, shall be smooth, moisture resistant, and easily cleaned.
(c) Wall bases in areas used for surgical procedures, and other areas subject to frequent wet cleaning shall be made integral and coved with the floor, tightly sealed within the wall, and constructed without voids that can harbor insects.
(d) Floor and wall penetrations by pipes, ducts, conduits, etc., shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed.
(e) Acoustical ceilings shall be provided in corridors, multipurpose rooms, and waiting areas.
(f) Ceilings in operating suites shall be washable.
Section 14. Construction. Foundations shall rest on natural solid bearing if a satisfactory soil is available at reasonable depths. Proper soil-bearing values shall be established in accordance with recognized standards. If solid bearing is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement, except that one (1) story buildings may rest on a fill designed by a soils engineer. When engineered fill is used, site preparation and placement of fill shall be done under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the grading operation and a certification of compliance with the job specifications. All footings shall extend to a depth not less than one (1) foot below the estimated maximum frost line.
Section 15. Elevators.
(1) General. Elevators shall be required where examination or treatment rooms or diagnostic services are located on other than the main entrance floor.
(2) Cars and platforms. Cars shall have a minimum inside floor dimension of not less than five (5) feet. The car door shall have a clear opening of not less than three (3) feet.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
Section 16. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect and/or engineer shall obtain from the contractor certification that all mechanical systems have been tested and that the installation and performance of these systems conform to the requirements of the plans and specifications.
(2) Steam and hot water systems.
(a) Boiler accessories. Boiler feed pumps, condensate return pumps, fuel oil pumps, and circulating pumps shall be connected and installed to provide standby service when any pump breaks down.
(b) Valves. Supply and return mains and risers of space heating and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return end.
(3) Air-conditioning, heating and ventilating systems.
(a) Temperatures and humidities:
-
The systems shall be designed to provide the temperatures and humidities shown below:
-
For all other occupied areas, a minimum temperature of seventy-five (75) degrees Fahrenheit shall be provided at winter design conditions.
(b) Ventilation system details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates shown in Table 1, Section 18 of this administrative regulation, shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates if they are required to meet design conditions.
-
Outdoor ventilation air intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five (25) feet from the exhaust from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight (8) feet above the ground level or, if installed through the roof, three (3) feet above roof level.
-
The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas as shown in Table 1, Section 18 of this administrative regulation.
-
All air supplied to sensitive areas such as operating rooms shall be delivered at or near the ceiling of the area served, and all air exhausted from the area shall be removed near floor level. At least two (2) exhaust outlets shall be used in all operating rooms. Exhaust outlets shall be located not less than three (3) inches above the floor.
-
Room supply air inlets, recirculation, and exhaust air outlets installed in nonsensitive areas shall be located not less than three (3) inches above the floor.
-
Filters.
a. The ventilation systems serving sensitive areas such as operating rooms, recovery rooms, and laboratory sterile rooms, shall be equipped with a minimum of two (2) filter beds. Filter bed No. 1 shall be located upstream of the conditioning equipment and shall have a minimum efficiency of thirty (30) percent. Filter bed No. 2 shall be located downstream of the conditioning equipment and shall have a minimum efficiency of ninety (90) percent.
b. Central systems serving other than sensitive areas shall be provided with a filter or filters rated at a minimum of twenty-five (25) percent efficiency.
c. The above filter efficiencies shall be warranted by the manufacturer and shall be based on the National Bureau of Standards Dust Spot Test Method with Atmospheric Dust.
-
Acoustical lining materials shall not be used in the interior of duct systems serving sensitive areas such as operating rooms and recovery rooms.
-
Cold-air ducts shall be insulated wherever necessary to maintain the efficiency of the system or to minimize condensation problems.
-
The ventilation system for anesthesia storage rooms shall conform to the requirements of NFPA Standard No. 56A as adopted by the State Fire Marshal's Office for ambulatory surgical center facilities.
-
Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and reasonable temperatures in the rooms and in adjoining areas.
(4) Plumbing fixtures.
(a) The material used for plumbing fixtures shall be of nonabsorptive acid-resistant material.
(b) Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five (5) inches above the rim of the fixture. All fixtures used by medical and nursing staff shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose they shall not exceed four and one-half (4 1/2) inches in length, except that handles on scrub sinks and clinical sinks shall be not less than six (6) inches long.
(c) Hot, cold, and chilled water piping, and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.
(d) Hot water distribution systems shall be arranged to provide hot water at each fixture at all times.
(5) Hot water heaters and tanks.
(a) The hot water heating equipment shall have a sufficient capacity to supply water at the temperature and amounts indicated below:
(b) Storage tank(s) shall be provided and shall be fabricated of noncorrosive metal or lined with noncorrosive material.
(6) Drainage systems.
(a) Drain lines from sinks in which acid wastes may be poured shall be fabricated from an acid-resistant material.
(b) Piping over operating and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of necessary overhead piping systems.
(c) Floor drains shall not be installed in operating rooms.
(d) Building sewers shall discharge into a community sewage system. Where such a system is not available, a facility providing sewage treatment which conforms to applicable local and state regulations is required.
(7) Nonflammable medical gas systems. Nonflammable medical gas system installations shall be in accordance with the requirements of NFPA Standard No. 56F as adopted by the State Fire Marshal's Office for ambulatory surgical center facilities.
Section 17. Electrical Requirements.
(1) General. All material including equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. All materials shall be listed as complying with applicable standards of Underwriters' Laboratories, Inc., or other similarly established standards. The essential electrical systems shall be designed in accordance with NFPA Publication Nos. 70 and 76-A as they relate to hospital facilities.
(2) Switchboard and power panels. All breakers and switches shall be indexed.
(3) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have electric lighting.
(b) Operating rooms shall have general lighting for the room in addition to local lighting provided by special lighting units at the surgical tables. Each special lighting unit for local lighting at tables shall be connected to an independent circuit.
(4) Receptacles (convenience outlets). Anesthetizing locations: Each operating room shall have at least three (3) receptacles of the interchangeable type as defined in NFPA Standard No. 56A as adopted by the State Fire Marshal's Office for ambulatory surgical center facilities. In locations where mobile x-ray is used, an additional receptacle, distinctively marked for x-ray use, shall be fed by an independent ungrounded circuit.
(5) Equipment installation in special areas.
(a) Installation in hazardous areas. In areas where flammable anesthetic agents are used, such as operating and anesthesia induction rooms, and rooms for storage of flammable gases, all electrical equipment and devices including receptacles, wiring and conductive flooring installations shall comply with NFPA Standard No. 56A as adopted by the State Fire Marshal's Office for ambulatory surgical center facilities.
(b) X-ray film illuminator. Viewing panels shall be installed in each operating room and in the x-ray viewing room.
(6) Nurses' calling system. An emergency nurses' calling station shall be provided for nurses' use in each operating room and recovery room.
(7) Emergency electric service.
(a) General. To provide electricity during an interruption of the normal electric supply that could affect the medical care, treatment, or safety of the occupants, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) Sources. The source of this emergency electric service shall be as follows:
-
An emergency generating set, when the normal service is supplied by one (1) or more central station transmission lines.
-
An emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
(c) Emergency generating set. The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system. Exception: A system of prime movers which are ordinarily used to operate the emergency generator(s) will be permitted provided that the number and arrangement of the prime movers is such that when one (1) of them is out of service (due to breakdown or for routine maintenance), the remaining prime mover(s) can operate the required emergency generator(s) and provided that the connection time requirements described in paragraph (e) of this subsection are met. The emergency generator set shall be of sufficient kilowatt capacity to supply all lighting and power load demands of the emergency system. The power factor rating of the generator shall be not less than eighty (80) percent.
(d) Emergency electrical connections. Emergency electrical service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors.
b. Surgical room operating lights.
c. Laboratory, recovery room, nursing station and medication preparation areas.
d. Generator set location, switch-gear location, and boiler room.
- Equipment essential to life safety and for protection of important equipment or vital materials.
a. Nurses' calling system;
b. Alarm system including fire alarm actuated at manual stations, water flow alarm devices of sprinkler system if electrically operated, fire detection systems, paging or speaker systems if intended for issuing instructions during emergency conditions, and alarms required for nonflammable medical gas systems, if installed;
c. Fire pump, if installed;
d. Pump for central suction system;
e. Sewage or sump lift pump, if installed;
f. Receptacles for blood bank refrigerator;
g. Receptacles in operating and recovery rooms except those for x-ray;
h. One (1) elevator, where elevators are used to transport patients to operating rooms;
i. Equipment such as burners and pumps necessary for operation of one (1) or more boilers and their necessary auxiliaries and controls, required for heating of operating rooms, recovery rooms and sterilization;
j. Ventilation of operating and recovery rooms;
k. Equipment necessary for maintaining telephone service.
- Heating. Where electricity is the only source of power normally used for space heating, the emergency service shall provide for heating of operating and recovery room.
(e) Details. The emergency electrical system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting, all alarms, blood banks, nurses' call, equipment necessary for maintaining telephone service, pump for central suction system, and receptacles in operating and recovery rooms. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Where fuel is normally stored on the site, the storage capacity shall be sufficient for twenty-four (24) hour operation. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.
Section 18. Tables.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides licensure requirements for facility specifications for construction, alteration and maintenance of ambulatory surgical centers.
- History: 902 KAR 020:101. 8 Ky.R. 245; eff. 11-5-1982; 1174; eff. 6-2-1982; 16 Ky.R. 1003; eff. 1-12-1990; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:106 Operation and services; ambulatory surgical center {#sec-902-kar-20-106 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:106}
Section 1. Definitions.
(1) "Admission" means the time after completion of the registration process and at the first instance of rendering medical care to the patient on the day of the scheduled procedure as a part, or in anticipation, of a surgery.
(2) "Ambulatory surgical center" means a public or private institution that is:
(a) Hospital-based or freestanding;
(b) Operated under the supervision of an organized medical staff; and
(c) Established, equipped, and operated primarily for the purpose of providing surgical services to patients not requiring hospitalization and whose recovery under normal circumstances is not expected to require inpatient care.
(3) "Cabinet" is defined by KRS 216B.015(6).
(4) "Center" means an ambulatory surgical center.
(5) "Licensee" means a person or business entity that has been issued and holds a valid ambulatory surgical center license from the cabinet.
Section 2. Administration and Operation.
(1) Licensee.
(a) The licensee shall be legally responsible for operation of the center and for compliance with federal, state, and local laws and administrative regulations pertaining to operation of the center.
(b) The licensee shall develop written policies for the administration and operation of the center.
(c) Medical staff shall approve medical policies that include the following:
-
Personnel practices and procedures that shall be readily available to personnel;
-
Job descriptions for each level of personnel, including the authority, responsibilities, and actual work to be performed in each classification;
-
Written infection control measures governing the use of aseptic techniques and procedures in all areas of the center;
-
Sterilization of supplies;
-
Disposal of patient waste and other potentially infectious materials;
-
Examination by a pathologist of tissues removed during surgery, including the identification of tissues that require examination and tissues that are exempted by the medical staff team from examination ;
-
Procedures for consultation with other physicians, dentists, or podiatrists based on a patient's medical needs;
-
A list of surgical procedures performed in the center;
-
The center's privileging process, including the granting and withdrawal of medical staff surgical privileges, and privileges for the administration of anesthetics;
-
Arrangement for transportation of patients who require hospital care;
-
A surgical smoke safety and control policy that shall be available to staff in all areas where surgical smoke is generated; and
-
Policies that assure compliance with KRS 216B.165.
(2) Personnel and administration.
(a) Administrator. The center shall have:
-
An administrator responsible for the daily operation of the center; and
-
A similarly qualified staff person for delegation of responsibilities in the administrator's absence.
(b) Current employee records shall be maintained and include:
-
A resume of the employee's training and experience;
-
Evidence of current licensure or registration, if required; and
-
Evaluation of the employee's performance, including a report of any adverse incident involving the employee.
(c) Medical staff requirements. The center shall have an organized medical staff responsible for:
-
The quality of medical care provided in the center;
-
Oversight of the ethical and professional practices of its members; and
-
Developing the center's medical care policies.
(d) Surgical procedures shall be performed by professionally qualified physicians, dentists, or podiatrists who:
-
Are legally authorized under their scope of practice to perform the procedures; and
-
Have been granted clinical privileges by the center's medical staff or governing body.
(e) Pharmaceutical, radiology, or laboratory services provided directly by the center or through an agreement with another entity shall be provided under the direction of a licensed pharmacist, a physician specializing as a radiologist, or a physician specializing as a pathologist, respectively, on a full-time, part-time, or regular consultative basis.
(f) The center shall employ registered nurses on a full-time basis for patient care in the operating and postanesthesia recovery rooms.
(g) The center shall employ other nursing personnel, aides, and technicians as necessary to meet the needs of the patients served by the center, including personnel responsible for supervision, indexing, and filing of medical records.
(3) A center shall not retain a patient longer than twenty-four (24) hours from the time of admission to discharge.
(4) The center shall not provide obstetric deliveries.
(5) Physician coverage. A physician or a practitioner that performs surgical procedures shall be present in the center until all patients have been discharged and have left the center.
(6) The center shall have a physician on the medical staff with admitting privileges at a nearby hospital who is responsible for admitting patients in need of inpatient care.
(7) Medical records.
(a) Content. The center shall maintain a complete, comprehensive, accurate, and legible medical record for each patient. The record shall include the following information:
-
Name and address of the person or agency responsible for the patient;
-
Patient identification data, including the patient's:
a. Name;
b. Address;
c. Age;
d. Sex; and
e. Marital status;
-
Date of admission and discharge;
-
Name of the referring and attending physician, dentist, or podiatrist;
-
A medical history and physical evaluation that was performed and entered into the medical record no more than thirty (30) days prior to surgery;
-
A surgical consent form that has been signed by the patient or the patient's legal representative prior to the surgical procedure;
-
All preoperative diagnostic studies and laboratory tests;
-
Special examinations, such as consultations, clinical, laboratory, and x-ray;
-
Nurses' notes;
-
Complete medical record signed by the operating surgeon, including:
a. Anesthesia record;
b. Preoperative diagnosis:
c. Operative procedures and findings;
d. Postoperative diagnosis;
e. Condition of patient upon discharge;
f. Postoperative instructions; and
g. If required, tissue diagnosis by a pathologist on specimens surgically removed;
-
Charts including records of temperature, pulse, respiration, and blood pressure; and
-
Medication record including:
a. Name of medication;
b. Dosage;
c. Date and time of administration;
d. Method of administration;
e. Name of prescribing physician, dentist, or podiatrist;
f. Name of person who administered the medication; and
g. Any allergies or abnormal drug reaction.
(b) Indexing. The center shall have a system of identification and filing to assure ready access to a patient's record by authorized personnel.
(c) Ownership.
-
Medical records shall be the property of the center.
-
The original medical record shall not be removed from the center except by court order or subpoena.
-
Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established by paragraph (d) of this subsection.
(d) Confidentiality and Security: Use and Disclosure.
-
The center shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
-
The center may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
-
A center may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(e) Medical records shall be made available if requested for inspection by a duly authorized representative of the cabinet.
(f) The attending physician, dentist, or podiatrist shall complete and sign a patient's medical record as soon as practicable after discharge, but not to exceed ten (10) days.
(g)
- Orders for medication and treatment shall be dated, timed, and signed by the:
a. Prescribing physician, dentist, or podiatrist; or
b. Health care practitioner who receives the verbal order.
-
A verbal order shall be followed by a written order and signed by the prescribing physician, dentist, or podiatrist within forty-eight (48) hours, except that a prescription for a Schedule II drug shall be signed immediately.
-
A record of medication administered to the patient shall be included in the record and signed by the health care professional administering the medication.
(h) Retention of records. Medical records shall be retained for at least:
-
Six (6) years from the date of discharge; or
-
If a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
(8) Bedrails shall be available for patients in the admitting and recovery units.
Section 3. Sanitary Environment. The center shall provide a sanitary environment to avoid sources and transmission of infection.
(1) An infection control committee composed of members of the medical and nursing staff shall be established and charged with responsibility for investigating, controlling, and preventing infections in the center.
(2) Nondisposable sterile supplies shall be reprocessed if the integrity of the pack has not been maintained.
(3) The center shall:
(a) Have suitable equipment for rapid and routine sterilization of supplies, utensils, and equipment; and
(b) Maintain a sterile storage area for the equipment to be kept in a clean, convenient, and orderly manner.
(4) Continuing education shall be provided to all center personnel on the cause, effect, transmission, prevention, and elimination of infections.
Section 4. Surgical Services.
(1) The center shall operate exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed twenty-four (24) hours following admission.
(2) The center shall have at least one (1) operating room.
(3) A patient shall be examined:
(a) By a physician, dentist, or podiatrist acting within the professional's scope of practice; and
(b) Immediately prior to surgery to evaluate risks pertaining to:
-
Anesthesia; and
-
The procedure to be performed.
(4) A registered nurse shall:
(a) Be available to circulate at all times; and
(b) Supervise each operating room .
(5) The center shall have on file a list of all physicians, dentists, and podiatrists who have been granted surgical privileges by the center's medical staff or governing body, including the scope of the privileges granted to each practitioner.
(6) The center shall maintain a complete and up-to-date operating room register.
(7) The following equipment shall be available in the center:
(a) Oxygen;
(b) Mechanical ventilatory assistance equipment including airways, manual breathing bag, and ventilator;
(c) Cardiac defibrillator;
(d) Cardiac monitoring equipment;
(e) Tracheostomy set;
(f) Laryngoscopes and endotracheal tubes;
(g) Suction equipment; and
(h) Emergency medical equipment and supplies specified by the medical staff.
(8)
(a) In accordance with KRS 216B.153, a center that utilizes an energy-generating device shall make use of a smoke evacuation system:
-
That effectively captures and neutralizes surgical smoke at the site of origin and before the smoke can make ocular contact or contact with the respiratory tract of the occupants of the room; and
-
During any surgical procedure that is likely to produce surgical smoke.
(b) The cabinet shall impose fines in accordance with KRS 216B.990(8) for each violation of noncompliance with KRS 216B.153 only if the violation has not been remedied after the center has had an opportunity to correct the violation through the filing of a plan of correction in accordance with 902 KAR 20:008, Section 2(13).
(9) The center shall have arrangements for obtaining an adequate supply of blood in a timely manner to meet the center's needs.
(10) A physician's, dentist's, or podiatrist's orders shall be in writing and signed by the physician, dentist, or podiatrist.
(11) Except for cases requiring only local infiltration anesthetics, a physician anesthesiologist, a physician qualified to administer anesthesia, a dentist qualified to administer anesthesia, or a certified registered nurse anesthetist shall administer the anesthetics and remain present during the surgical procedures and until the patient is fully recovered from the anesthetics.
(12)
(a) The physician, dentist, or podiatrist in charge of the patient shall be responsible for seeing that tissue removed during surgery is delivered to the center's pathologist.
(b) The pathologist's report on any tissue removed during surgery shall be included in the patient's medical record unless the center's medical staff have adopted a written policy exempting certain types of removed tissue from examination.
(13) Voluntary interruption of pregnancies. An ambulatory surgical center shall comply with the applicable Kentucky statutes concerning the voluntary interruption of pregnancies, including KRS 311.710 to 311.810.
Section 5. Postanesthesia Recovery Services.
(1) The center shall have at least one (1) postanesthesia recovery unit.
(2) There shall be adequate staff available in the recovery unit so that no patient is left alone at any time.
(3) A registered nurse shall be present in the recovery unit during the time that a patient is recovering from anesthesia.
(4) A registered nurse shall be available to the recovery unit at all times.
(5) A registered nurse or health care professional staffing the postanesthesia recovery unit shall be adequately trained in all aspects of postoperative and postanesthetic care.
(6) The recovery unit nurse shall record a nursing note on each patient to document the following:
(a) Postoperative abnormalities or complications;
(b) Pulse;
(c) Respiration;
(d) Blood pressure;
(e) Presence or absence of swallowing reflex;
(f) Cyanosis; and
(g) The general condition of the patient.
(7) Available equipment shall include the following:
(a) Suction machine;
(b) Stethoscope;
(c) Sphygmomanometer;
(d) Emergency crash cart;
(e) Necessary drugs; and
(f) Oxygen.
(8)
(a) The center shall provide suitable accommodations for its patients.
(b) There shall be adequate floor space, furnishings, bed linens, and other utensils, equipment and supplies reasonably required for the proper care of the patients.
Section 6. Pharmaceutical Services.
(1) The center shall have a licensed pharmacy or have arrangements for promptly obtaining prescribed drugs and biologicals from a pharmacy.
(2)
(a) The center shall have appropriate methods and procedures for the storage, control, and administration of drugs and biologicals developed with the advice of a licensed pharmacist.
(b) The pharmacist shall properly label drugs for individual patients.
(3) Licensed medical or nursing personnel shall administer medications in accordance with the established standards of practice set forth for:
(a) Podiatrists licensed in accordance with KRS 311.400;
(b) Physicians licensed in accordance with KRS 311.571;
(c) Dentists licensed in accordance with KRS 313.030;
(d) Dental specialists defined by KRS 313.010(9); or
(e) Nurses licensed in accordance with KRS 314.041, 314.042, or 314.051.
(4) Controlled substances.
(a) Controlled substances shall be kept under double lock (i.e., in a locked box in a locked cabinet). There shall be a controlled substances record that includes the:
-
Name of the patient;
-
Date and time;
-
Kind of controlled substance;
-
Dosage and method of administration of the controlled substance;
-
Name of the physician or practitioner who prescribed the controlled substance; and
-
Name of the nurse who administered the controlled substance.
(b) In addition to the requirements established in paragraph (a) of this subsection, there shall be a recorded and signed:
-
Schedule II controlled substances count daily conducted by a member of the nursing staff; and
-
Schedule III, IV, and V controlled substances count once per week by a member of the nursing staff.
Section 7. Radiology Services.
(1) The center shall provide radiology services directly through an:
(a) Agreement with a licensed hospital; or
(b) Independent radiology service.
(2) The radiology service shall have a current license or registration pursuant to KRS 211.842 to 211.852.
(3) If radiology services are provided directly by the center:
(a) The radiology department shall be free of hazards for patients and personnel. Proper safety precautions shall be maintained against:
-
Fire and explosion hazards;
-
Electrical hazards; and
-
Radiation hazards;
(b) A physician specializing in radiology shall supervise the department and interpret films that require specialized knowledge for accurate reading;
(c) Signed reports shall be promptly entered into the medical record and duplicate copies kept in the department; and
(d) Orders for radiology procedures shall be made by a physician, dentist, or podiatrist.
Section 8. Laboratory Services.
(1) The center shall provide laboratory services directly through:
(a) Its own licensed laboratory;
(b) An agreement with a laboratory in a licensed hospital; or
(c) An agreement with a licensed laboratory nearby.
(2) The medical laboratory providing services to the center shall be licensed pursuant to KRS 333.030, unless it is a part of a licensed hospital.
(3) Laboratory examinations shall be made only upon the request of a physician, dentist, or podiatrist.
(4)
(a) The laboratory shall provide tissue pathology and diagnostic cytology examinations.
(b) Tissues removed from a patient during surgery shall be examined by a physician specializing in pathology if required by the center's written policies.
(5) Laboratory and tissue pathology reports shall be signed and entered into the medical record.
Section 9. Utilization Review.
(1) The center shall have in effect a plan for utilization review of the center's services on at least a quarterly basis by a committee of physicians, dentists, or podiatrists who have no financial interest in the center.
(2) Reviews shall be made of the center's admissions and professional services, including utilization of surgical services and tissue reports.
History
- RELATES TO: KRS 211.842-211.852, 216B.015, 216B.042, 216B.153, 216B.165, 216B.990(1), (2), (8), 311.400, 311.571, 311.710-311.810, 313.010(9), 313.030, 314.041, 314.042, 314.051, 333.030, 45 C.F.R. Part 160, Part 164, 42 U.S.C. 1320d-2—1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1)(a) and (c) require the cabinet to promulgate administrative regulations necessary for the proper administration of the licensure function and to establish licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes the licensure requirements for the operation and services of ambulatory surgical centers.
- History: 8 Ky.R. 251; eff. 11-5-1981; 12 Ky.R. 611; eff. 12-10-1985; 18 Ky.R. 824; eff. 10-16-1991; 32 Ky.R. 1152; 1400; eff. 3-2-2006; 35 Ky.R. 1919; 2443; eff. 6-5-2009; Crt eff. 4-30-2019; 48 Ky.R. 2298, 3005; eff. 8-25-2022.
902 KAR 20:111 Medically managed intensive inpatient withdrawal management {#sec-902-kar-20-111 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:111}
Section 1. Definitions.
(1) "Chemical dependency treatment program" means a freestanding or hospital-based facility licensed in accordance with 902 KAR 20:160.
(2) "Hospital" means a:
(a) General acute care hospital licensed in accordance with 902 KAR 20:009 and 902 KAR 20:016; or
(b) Psychiatric hospital licensed in accordance with 902 KAR 20:170 and 902 KAR 20:180.
Section 2. Services.
(1) Medically managed intensive inpatient services shall:
(a) Be delivered twenty-four (24) hours a day in a permanent facility that is a:
-
Chemical dependency treatment program; or
-
Hospital;
(b) Offer medically directed withdrawal management and treatment designed to alleviate acute emotional, behavioral, cognitive, or biomedical distress resulting from, or co-occurring with a patient's use of alcohol or other drugs;
(c) Be provided by a team of interdisciplinary staff under the direction of a licensed physician;
(d) Be provided in accordance with:
-
Physician-approved policies and physician-monitored procedures; or
-
Clinical protocols; and
(e) Include:
-
Availability of specialized clinical consultation, medical evaluation, and supervision for biomedical, emotional, behavioral, and cognitive problems;
-
Ability to arrange for appropriate laboratory and toxicology tests, including human immunodeficiency virus (HIV), hepatitis, and other tests for communicable diseases;
-
Affiliation with other levels of care; and
-
Availability of emergency life support and treatment, either directly or through transfer of the patient to another:
a. Service within the facility; or
b. Health facility equipped to provide emergency care.
(2) Services shall be provided only to patients who meet the:
(a) Diagnostic criteria for substance intoxication or withdrawal disorder as established by the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) for alcohol, tobacco, and other drug use; and
(b) Dimensional criteria for medically managed intensive inpatient services as established in the most recent version of The American Society of Addiction Medicine (ASAM) Criteria.
Section 3. Staff Requirements and Responsibilities.
(1) Physician.
(a) There shall be at least one (1) physician who is:
-
Licensed to practice medicine under KRS Chapter 311; and
-
Responsible for diagnosis, treatment, and treatment plan decisions in collaboration with the patient, including:
a. Whether or not to admit the patient;
b. Whether or not to continue the patient in care; and
c. When to transfer or discharge the patient.
(b) If a facility is managing acute opioid withdrawal, there shall be at least one (1) physician with a waiver under 21 U.S.C. Section 823(g)(2) to prescribe drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, as indicated.
(c) The physician shall:
-
Assess the patient within twenty-four (24) hours of admission, or earlier if indicated; and
-
Provide on-site monitoring, medical services, and patient evaluation daily.
(2) Nurse.
(a) There shall be at least one (1) full-time registered nurse.
(b) If the registered nurse is not on duty, a licensed practical nurse shall be responsible for on-site nursing care and a registered nurse shall be on call.
(c) Twenty-four (24) hour nursing services shall include:
-
A comprehensive nursing assessment, conducted at the time of admission; and
-
Monitoring of the patient's progress, which may occur hourly if needed.
(3) Clinical staff. Clinical staff shall:
(a) Be trained and competent to provide physician-directed care and treatment;
(b) Be able to obtain and interpret information regarding the needs of the patients; and
(c) Provide counseling services if authorized under the scope of the clinician's professional license.
(4) There shall be at least one (1) staff person on duty at all times who is trained in cardiopulmonary resuscitation.
Section 4. Medication. A notation shall be made in the patient's record of all medications administered in accordance with physician orders, including:
(1) Date;
(2) Time;
(3) Dosage;
(4) Frequency of administration; and
(5) Name of the individual administering each dose.
Section 5. Therapies. Therapies shall include daily clinical services to assess and address the needs of each patient, including:
(1) Medical services as needed, including stabilization of the patient;
(2) Withdrawal rating scale tables and flow sheets that include tabulation of vital signs, if needed;
(3) Withdrawal support;
(4) A range of cognitive, behavioral, medical, mental health, and other therapy as needed to enhance the patient's understanding of:
(a) Addiction;
(b) Completion of the withdrawal management process; and
(c) Referral to an appropriate level of care for continuing treatment;
(5) Interdisciplinary individualized assessment and treatment;
(6) Health education services; and
(7) Services to family members or significant others.
Section 6. Assessment and Treatment Plan.
(1) Assessment and treatment planning shall include:
(a) An individualized treatment plan developed in collaboration with the patient within twenty-four (24) hours of admission, including:
-
Problem identification in dimensions two (2) through six (6) of the most recent version of The ASAM Criteria;
-
Development of treatment goals and measurable treatment objectives; and
-
Activities designed to meet the treatment objectives and management of withdrawal syndrome;
(b) Daily assessment of:
-
Progress during withdrawal management; and
-
Any treatment changes;
(c) Transfer and discharge planning, beginning at the point of admission; and
(d) Referral and linkage arrangements for:
-
Counseling;
-
Medical care;
-
Medication assisted treatment, as indicated;
-
Psychiatric care; and
-
Continuing care.
(2) Physician and nurse progress notes shall:
(a) Be maintained in the patient record;
(b) Reflect implementation of the treatment plan;
(c) Document the client's response to treatment; and
(d) Include each amendment of the treatment plan.
Section 7. Discharge Criteria.
(1) A patient shall continue to receive medically managed intensive inpatient withdrawal management until the patient's acute withdrawal signs and symptoms are sufficiently resolved so that the patient can safely transition into continuing services or transfer to a less intensive level of care.
(2) A patient's discharge summary shall be completed within twenty-four (24) hours of discharge and include:
(a) The course and progress of the patient with regard to the treatment plan;
(b) General observations of the patient's condition initially, during treatment, and at discharge; and
(c) Recommendations and arrangements for further treatment.
History
- RELATES TO: KRS 216B.015(13), Chapter 311, 21 U.S.C. Section 823(g)(2)
- STATUTORY AUTHORITY: KRS 216B.042, 222.211(1)(c)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 222.211(1)(c) requires the cabinet to be responsible for assuring that withdrawal management services are provided on a twenty-four (24) hour basis in or near population centers that meet the immediate medical and physical needs of persons intoxicated from the use of alcohol or drugs, or both, including necessary diagnostic and referral services. This administrative regulation establishes standards for medically managed intensive inpatient withdrawal management provided by a chemical dependency treatment program or hospital.
- History: 902 KAR 020:111. 8 Ky.R. 254; eff. 11-5-1981; Am. 10 Ky.R. 37; eff. 8-3-1983; 18 Ky.R. 827; eff. 10-16-1991; 45 Ky.R. 2781, 3416; eff. 7-19-2019; Crt eff. 5-14-2026.
902 KAR 20:140 Operation and services; hospice {#sec-902-kar-20-140 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:140}
Section 1. Definitions.
(1) "Administrator" means a person who has:
(a) Served as a hospice administrator under a state approved hospice program; or
(b) A bachelor of arts or bachelor of science degree in a health care, human services, or administrative curriculum; or
(c) Equivalent administrative work experience in a health care facility.
(2) "Bereavement" means the period of time during which a person experiences, responds emotionally, and adjusts to the loss by death of another person.
(3) "Palliative care" means care directed at reducing or abating pain and other troubling symptoms of the disease process in order to achieve relief of distress.
(4) "Supplemental service" is a hospice service provided under the health care facility's existing license.
(5) "Terminally ill" means a person who is experiencing a fatal condition for which therapeutic strategies directed toward care and control are no longer effective.
(6) "Volunteer" means a person who contributes time and talent to the hospice program without economic remuneration.
Section 2. Scope of Operation and Services. A hospice is a centrally administered program of palliative and supportive services, including skilled nursing services, intended to meet the physical, psychological, social, and spiritual needs of a terminally ill person and his family on a twenty-four (24) hour, seven (7) day- a-week, on-call basis. Services are provided in the home or in an inpatient health care facility as a supplemental service by a medically supervised, interdisciplinary team of professional and lay personnel during the final stages of illness, at death, and through bereavement.
Section 3. Administration and Organization.
(1) A hospice program shall seek licensure to operate as:
(a) A freestanding hospice; or
(b) A hospice operated by a hospital, long term care facility, home health agency, or health maintenance organization, or other licensed health care facility or service.
(2) The licensee shall be legally responsible for the operation of the hospice and for compliance with federal, state, and local law pertaining to the operation of the service.
(3) The licensee shall have permanent facilities for the administration of the program and storage of the patient records.
(4) The licensee shall establish policies for the administration and operation of the service. The policies shall include:
(a) Acceptance of patients;
(b) Development of a plan of care through the interdisciplinary team;
(c) Quality care audits for direct service;
(d) Personnel policy and procedure to include:
-
A description of each personnel position;
-
Wage and salary range for each position;
-
A description of the lines of authority;
-
Personnel benefits;
-
Evaluation and grievance procedure; and
-
Orientation and training program information; and
(e) Use of volunteers, volunteer selection criteria, training, and roles in the hospice program.
(5) Contracted services. If a hospice contracts for services, the contract shall be in writing and shall:
(a) Designate clearly the services to be provided;
(b) Describe how the personnel under contract will provide the service and how they will be supervised;
(c) Require hospice staff to provide training, to participate in personnel, about hospice care; and
(d) Describe the process of coordination for medical recordkeeping, patient evaluation and care planning.
(6) Contracted services with health care facilities.
(a) A contract between a hospice and an inpatient service provider or a health facility, as defined at KRS 216B.015(10), shall:
-
Comply with the requirements established in subsection (5) of this section; and
-
Specify that the hospice maintain professional, financial, and administrative responsibility for planning, coordinating, and prescribing hospice services and care on behalf of the hospice patient and his family.
(b) For a contract with an inpatient service provider, the hospice shall:
-
Provide the service provider a copy of the patient's plan of care;
-
Specify the inpatient services to be furnished; and
-
Require that the inpatient provider agree to the designation of services.
(c) A hospice shall not charge a fee for a service provided directly by the hospice care team which is duplicative of a contractual service provided by a health care facility to the individual or his family.
(7) Medical records.
(a) A medical record shall be maintained for each individual who is accepted as a hospice patient. The medical record shall include:
-
Written referral from the attending physician of the patient to the hospice program;
-
Medical history;
-
Social and psychological information on patient and family;
-
Doctors' orders;
-
The approved care plan; and
-
Documentation of medical services provided.
(b) A medical record shall be kept confidential and shall be retained for a minimum of five (5) years, or in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longer.
(8) Personnel. The hospice shall have:
(a) A medical director who is a licensed physician, available on at least a consultative basis, and who shall:
-
Direct medical aspects of the hospice care program; and
-
Participate in the development of medical policy and procedure.
(b) An administrator who shall:
-
Direct the daily operation of the hospice; and
-
Implement policies and procedures for activities and services, whether provided by hospice personnel or by contract.
(c) A patient-care coordinator who is a registered nurse who shall be:
-
Available on a full or part-time basis; and
-
Knowledgeable of home-based skilled nursing services for the terminally ill.
Section 4. Services.
(1) The hospice program shall provide palliative and supportive services including skilled nursing services to meet the physical, psychological, social, and spiritual needs of a terminally ill person and his family. Hospice services shall:
(a) Be available on a twenty-four (24) hour, seven (7) day a week, on-call basis;
(b) Be provided by an interdisciplinary team which shall include:
-
The patient;
-
The patient's family, if willing to participate;
-
The medical director;
-
A nurse;
-
A social worker; and
-
The following team members, on an optional basis:
a. The patient's attending physician;
b. Other staff physicians;
c. A representative of the clergy if the patient so chooses; and
d. A volunteer.
(2) A patient may be admitted to a hospice program only upon referral from a physician and upon the request of the patient and family. The patient's attending physician shall be responsible for the direct medical care of the patient's illness.
(3) The hospice shall provide the following services directly:
(a) Coordination of the medical aspects of the hospice program;
(b) Assessment of physical, psychological, spiritual, social, and economic needs of the patient and his family;
(c) Development and coordination of a care plan which includes the delineation of responsibilities of each team member and provides for regularly scheduled team meetings for planning, evaluation, and individual case management;
(d) Patient counseling and bereavement counseling of the family; and
(e) Education and training services for staff, volunteers, and family members.
(4) Skilled nursing services shall be provided directly or through contract as indicated by the patient's needs.
(5) The following services shall be provided directly, through contract, or through referral, as indicated by the patient and family needs:
(a) Nutrition;
(b) Homemaker and home health aide;
(c) Physical therapy;
(d) Occupational therapy; and
(e) Speech therapy.
(6) The hospice shall:
(a) Follow up on a patient referral to determine if the service was provided; and
(b) Make an appropriate entry into the patient's medical record for each service provided on a referral basis.
(7) The patient's plan of care shall be reviewed by the attending physician in consultation with agency professional personnel at such intervals as the severity of the patient's illness requires, but in all cases, at least once every two (2) months. Verbal authorization to change the plan of care shall be reviewed and signed by the attending physician within twenty-one (21) days after the order is issued.
(8) An original order for a drug and a change in an order for a drug shall be signed by the physician and made a part of the patient's medical record. Verbal authorization by the physician to change a drug order shall be reviewed and signed by the physician within twenty-one (21) days after the order is issued.
History
- RELATES TO: KRS 216B.010, 216B.015, 216B.042, 216B.105, 216B.155-216B.170, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health Services to regulate health facilities and health services. This administrative regulation establishes licensure requirements for hospice operation and services.
- History: 902 KAR 020:140. 8 Ky.R. 255; 908; eff. 4-7-1982; 15 Ky.R. 2451; eff. 8-5-1989; 25 Ky.R. 2676; 26 Ky.R. 63; eff. 8-18-1999; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:150 Freestanding Birthing Centers {#sec-902-kar-20-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:150}
Section 1. Definitions.
(1) "Cabinet" means the Cabinet for Health and Family Services.
(2) "Freestanding birthing center" (FSBC or center) is defined in KRS 216B.198.
(3) "Low risk" means a normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth including criteria recognized by the Commission for the Accreditation of Birth Centers (CABC).
Section 2. Scope of Operations and Services. Freestanding birthing centers shall be establishments with permanent facilities, which provide prenatal care to low risk childbearing women. A freestanding birthing center shall provide a homelike environment for pregnancy and childbirth and:
(1) Shall include labor and delivery; and
(2) May include prenatal and postpartum care related to medically uncomplicated pregnancies.
Section 3. Administration and Operation.
(1) Licensee.
(a) The licensee shall be responsible for the management and operation of the center and for compliance with federal, state, and local laws and regulations pertaining to its operation.
(b) The licensee shall appoint an administrator whose qualifications, responsibilities, authority, and accountability shall be defined in writing.
(c) .Each center shall be accredited and show proof of accreditation by the Commission for the Accreditation of Birth Centers.
(d) The center shall obtain and maintain professional medical malpractice insurance, in accordance with KRS 304.5-070.
(e) Requirement for Service. A center shall not be licensed or relicensed as a center, unless the facility meets the requirements of this administrative regulation.
(f) Facilities that have four (4) beds or fewer shall be exempt from Certificate of Need requirements.
(g) Licensed facilities shall follow general licensure and fee requirements, in accordance with 902 KAR 20:008.
(2) Administrator.
(a) The administrator shall be responsible for the daily management and operation of the center.
(b) In the absence of the administrator, responsibility shall be delegated to a similarly qualified staff person.
(3) Administrative records and reports.
(a) Administrative reports shall be established, maintained, and utilized as necessary to guide the operation, measure productivity, and reflect the program of the center. These reports shall include financial records and reports, personnel records, inspection reports, and other pertinent reports made in the regular course of business.
(b) Licensure inspection reports and plans of correction shall be made available at the center to the public upon request.
(4) Policies.
(a) Administrative policies. The licensee shall adopt written administrative policies covering all aspects of the center's operation, and shall include:
-
A description of the organizational structure, staffing, and allocation of responsibility and accountability;
-
A description of referral linkages with providers and inpatient facilities;
-
Policies and procedures for the guidance and control of personnel performances;
-
A description of services included in the center's program;
-
A description of the administrative and patient care records and reports;
-
A policy approved by the medical director to specify emergency medical procedures;
-
A policy approved by the medical director, which fully identifies the criteria that would exclude a patient from the center's program; and
-
A policy approved by the medical director, which fully identifies the criteria that would preclude management of newborns at the center.
(b) Patients' rights policies. The licensee shall adopt written policies regarding the rights and responsibilities of patients.
- These policies shall assure that each patient is:
a. Informed of these rights and of all rules and administrative regulations governing patient conduct and responsibilities, including a procedure for handling patient grievances;
b. Fully informed of the services and treatment offered at the center and of related charges, separately identifying those charges not covered by third party payor arrangements;
c. Encouraged and assisted to:
(i) Understand and exercise patient rights;
(ii) Voice grievances; and
(iii) Recommend changes in policies and services;
d. Assured confidential treatment of the patient's records and afforded the opportunity to approve or refuse release of these records to any individual not involved in the patient's care, except as required by law or third party payment contract; and
e. Treated with consideration, respect, and full recognition of the patient's dignity, individuality, and privacy in treatment.
- Upon the patient's request, grievances and recommendations shall be conveyed within a reasonable time to an appropriate decision making level within the organization, which has the authority to take corrective action.
(5) Staffing.
(a) The center shall have a staff that includes:
-
A medical director;
-
At least one (1) Licensed Certified Professional Midwife (LCPM) or Advanced Practice Registered Nurse designated certified nurse-midwife licensed under KRS 314;
-
Two (2) people certified in the Neonatal Resuscitation Program (NRP), which shall include at minimum two (2) licensed midwives or a licensed midwife and an NRP certified assistant ; and
-
Other staff or ancillary personnel necessary to provide the services essential to the center's operation.
(b) Staffing schedules, time worked schedules, and on-call records shall be maintained for three (3) years and shall be available in the center at all times during that period.
(c)
- Medical director.
a. The center shall have a medical director who is a licensed physician and who meets the statutory requirements delineated in KRS 216B.198(3)(a) .
b.
(i) The medical director position shall not be vacant for a time period in excess of ninety (90) days.
(ii) If the birth center is unable to fill the vacancy within ninety (90) days, the birth center may submit a written request for an extension to the Inspector General. The Inspector General may grant an extension of up to ninety (90) days after considering all relevant factors, included those listed in Section 8(5). The birth center may file an appeal pursuant to Section 5.
-
In the interim absence of a medical director, a Certified Nurse Midwife (APRN CNM) licensed by KRS 314.042 may temporarily fulfill the duties of the medical director, within their scope of practice.
-
Licensed Certified Professional Midwife (LCPM) or Advanced Practice Registered Nurse designated certified nurse midwife (APRN CNM) -.
a. Midwife services shall be provided within the respective scope of practice pursuant to KRS Chapter 314 and 201 KAR Chapter 20.
b. There shall be written policies of the birthing center:
(i) Developed by the medical director and licensed midwives; and
(ii) Approved by the medical director.
c. These policies shall be reviewed annuallyand revised, signed, and dated as necessary.
(6) In-service training. The licensee shall provide proof of ongoing in-service training programsrequired by their respective professional licensure boards .
(7) Personnel.
(a) The licensee shall establish personnel policies for the center. These policies shall be reviewed, revised, and approved on an annual basis.
(b) There shall be an individual personnel record for each person employed by the center, which shall include the following. Evidence of:
-
Compliance with 902 KAR 20:205;
-
Education, training, and experience of the individual, along with a copy of the current license or certification credentials, if applicable; and
-
Completion of new employeeorientation about the center's personnel policies and emergency medical procedures during the first week of employment.
(8) Medical records. The center shall maintain a medical record for pregnant women and mothers and shall include at least the following:
(a) Prenatal history, including any physical or health problems;
(b) Past medical, menstrual, obstetric, contraceptive, and immunization history, including progress of current pregnancy;
(c) Complete initial physical examination, including:
-
Blood pressure, weight, and height measurements; and
-
Examination of skin, eyes, teeth, throat, neck, thyroid, breasts, heart, lungs, abdomen, height of fundus, fetal position and auscultation, fetal heart sounds, edema; and
-
Determination of gestational age;
(d) Initial laboratory tests, including:
-
Hemoglobin or hematocrit and white blood count;
-
Serologic tests for syphilis and rubella antibody titer;
-
Blood type;
-
Rh factors and screen for Rh and irregular antibodies; and
-
Gonorrhea culture;
(e) Nutritional assessment;
(f) High risk identification and referral;
(g) Records of subsequent visits with recorded:
-
Weight and blood pressure;
-
Height of fundus;
-
Abdominal findings on palpation;
-
Rate and location of fetal heart tones;
-
Estimation of gestational age;
-
Edema;
-
Unusual signs;
-
Symptoms of quickening;
-
Follow-up hemoglobin or hematocrit; and
-
Rh and irregular antibody screen for Rh negative unsensitized women;
(h) Physical examination including:
-
Temperature, pulse, respiration, and blood pressure measurements;
-
Presentation position;
-
Engagement; and
-
Recording of time of ruptured membranes ;
(i) Progress of labor, monitoring of contractions and fetal heart rate, dilation, effacement, station, urinary output, medications, complications, and action taken;
(j) Delivery time, newborn's Apgar score, laceration, placenta delivery time, medications given, abnormalities, and any complications and actions taken;
(k) Puerperium-time records, including postpartum blood pressure, respirations, pulse, temperature, urine output, breastfeeding status, appropriate RhD immune globin administration at the center, and record of follow-up assessment within seventy-two (72) hours; and
(l) A four (4) to six (6) week follow-up examination, including record of weight, blood pressure, breast, abdominal, and appropriate cervico vaginal cytologic study.
(9)
(a) A health report of the newborn shall be maintained and shall include the following:
-
Duration of ruptured membranes;
-
Maternal antenatal blood serology, rubella titer, blood type, Rh factors and if indicated, a Coombs Test;
-
Description of the progress of labor and delivery, including complications, if any;
-
Condition of the newborn infant, including the Apgar score, resuscitation, time of sustained respirations, if indicated, details of physical abnormalities, pathological states observed, and treatments given before transfer to higher level of care;
-
Any abnormalities of placenta and cord vessels;
-
Date and hour of birth, birth weight, sex, and period of gestation;
-
Written verification of eye prophylaxis or documentation of refusal based on religious belief with parent signature;
-
Report of initial physical examination, including any abnormalities;
-
Discharge-physical examination including weight, head circumference and body length, unless previously recorded, recommendations and designation of responsible care provider for care upon discharge;
-
Progress notes describing feedings, voiding, stools passage, body temperature, medication administration; and
-
Newborn screening in accordance with KRS 214.155 and 902 KAR 4:030, documentation of parental refusal for religious reasons, including parent signature in record, notations of abnormal respiratory rate, dyspnea, color, cyanosis, periodic pallor, lethargy, vomiting, condition of eyes, umbilical cord, and other relevant factors as indicated by the condition of the newborn.
(b) If postnatal care is not provided at the FSBC, the FSBC shall document the coordination of postnatal care with qualified staff. Postnatal care coordination is expected to be in place within forty-eight (48) hours.
(10) Patient records of mother and newborn shall be maintained at the center for five (5) years, or in case of a minor mother, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
(11) An up-to-date register of all deliveries shall be maintained and contain the following information:
(a) Infant's full name, sex, date, time of birth, and weight;
(b) Mother's full name, including maiden name, address, birthplace, and age at time of the birth;
(c) Father's full name, birthplace, and age at time of the birth, if provided; and
(d) Full name of provider.
(12) A certificate of birth shall be filed in accordance with KRS Chapter 213 and 901 KAR Chapter 5.
Section 4. Provision of Services.
(1) Medical services.Perinatal services shall be available twenty-four (24) hours a day, seven (7) days a week, on an on-call basis.
(2) Staffing.
(a) A licensed midwife or physician and a member of the FSBC clinical staff shall be on duty at all times if a patient is laboring in the center. A member of the center's clinical staff shall be present at all times if a patient is at the center. The clinical staff member shall have at least one (1) year of perinatal experience.
(b) The center shall ensure that a mechanism is in place to receive calls twenty-four (24) hours a day, seven (7) days a week, to alert the on-call staff. Telephone numbers of emergency services and staff shall be posted by all telephones in large legible print.
(3) Radiology services. A signed and dated report of any radiology examination shall be entered into the patient's record.
(4) Drug distribution.
(a) There shall be a list approved by the medical director of all drugs and biologicals, including intravenous solutions that are retained for use in the center.
(b) The list of drugs and biologicals shall include the identity of center staff authorized to administer the drugs, biologicals, and intravenous solutions. Oxytocic drugs shall not be used to induce or augment labor.
(c) Drugs and biologicals shall be administered only by persons legally authorized.
(d) A medication shall only be administered by a:
-
Registered nurse;
-
Physician;
-
Physician Assistant;
-
Advanced Practice Registered Nurse;
-
Licensed Practical Nurse under the supervision of a registered nurse; or
-
Licensed Certified Professional Midwife;
(e) Drugs and biologicals shall be stored in a locked cabinet and, if refrigeration is necessary, they shall be stored in a locked container in a refrigerator.
Section 5. Licensure Inspections.
(1) Except for a health facility subject to KRS 216.530, a licensure inspection may be unannounced.
(2)
(a) A representative of the Office of Inspector General shall have access to the health facility pursuant to KRS 216B.042(2).
(b) An applicant for licensure or a current licensee shall not deny access to a representative of the Office of Inspector General, after proper identification, for inspection to determine compliance with 902 KAR Chapter 20 or 906 KAR Chapter 1.
(c)
- Denial of access to the following shall result in disciplinary action, including denial, revocation, modification, or suspension of the license of the health facility or health service:
a. Any effort to delay, interfere with, or obstruct an effort by a representative of the Office of Inspector General to enter the health facility or health service; or
b. Denial of access to records relevant to the inspection, unless deemed confidential by 42 U.S.C. 299b-22(a) .
- Denial, revocation, modification, or suspension of a health facility's or health service's license shall be subject to appeal pursuant to KRS 216B.105.
(3) An inspection of a health facility or health service licensed under 902 KAR Chapter 20 or 906 KAR Chapter 1 shall comply as follows:
(a) The inspection shall be made at any time during the licensee's hours of operation;
(b) The inspection shall be limited to ensure compliance with the standards set forth in 902 KAR Chapter 20, 906 KAR Chapter 1, KRS Chapter 216, or KRS Chapter 216B; and
(c) The inspection of a health facility or health service based on a complaint or a follow-up visit shall not limit the scope of the inspection to the basis of the complaint or the implementation of a plan of correction.
Section 6. Compliance with Building Codes, Ordinances and Regulations.
(1) The licensee shall comply with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdiction.
(2) The following requirements shall apply, if applicable and as adopted by the respective agency authority. Requirements for:
(a) Safety, pursuant to 815 KAR 10:060;
(b) Plumbing, pursuant to 815 KAR 20:010 through 191; and
(c) Making buildings and facilities accessible to and usable by a person with a disability, pursuant to KRS 198B.260 and 815 KAR Chapter 7.
(3) The facility shall be currently approved by the Fire Marshal's Office, in accordance with the Life Safety Code, before licensing or relicensure is granted by the licensing agency.
(4) All facilities shall receive any necessary approval from appropriate agencies prior to occupancy and licensure.
Section 7. Clinical Facilities.
(1) Patientrooms. Each patient room shall be private, with a minimum clear floor area of 120 square feet, excluding fixed and movable cabinets and shelves and with a minimum dimension of fifteen (15) feet.
(2) Each private patient room shall be equipped with the following:
(a) Adequate lighting, including a spotlight suitable for use during delivery;
(b) Resuscitation equipment for mother and infant;
(c) Oxygen with a selection of mask sizes; and
(d) Suction equipment for mother and newborn.
(3) The service areas for the birthing room shall include:
(a) Proper sterilization equipment used for the sterilization of birth instruments ;
(b) A lavatory or a sink for handwashing shall be included in every patient's room. ;
(c) A separate and enclosed area dedicated only for storage and distribution of clean supply materials; and
(d) A separate and enclosed area dedicated only for the collection and disposal of soiled materials.
(4) Physical and sanitary environment.
(a) The condition of the physical plant and the overall center environment shall be maintained so that the safety and well being of patients, personnel, and visitors are assured.
(b) A person or persons shall be designated as responsible for each of the following areas:
-
Plant maintenance;
-
Housekeeping; and
-
Laundry operations, if applicable.
(c) The center shall develop written infection control policies and procedures to minimize and control possibilities of infection, which shall include:
-
The sterilization of supplies;
-
Policies for the protection of patients from employees who have a communicable disease; and
-
Infection control measures, including birth room cleaning and waste disposal.
(d) The center building, equipment, and surroundings shall be kept in a condition of good repair, neat, clean, free from all accumulations of dirt and rubbish, and free from foul, stale or musty odors.
-
Written housekeeping procedures shall be established for cleaning of all areas and copies shall be made available to personnel.
-
Equipment and supplies shall be provided for cleaning of all surfaces. This equipment shall be maintained in a safe, sanitary condition.
-
Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in proper containers, and kept separate from other cleaning materials.
(e) The center shall have available at all times a quantity of linen essential to the proper care and comfort of patients.
-
Linens shall be handled, stored, and processed so as to control the spread of infection.
-
Clean linen and clothing shall be stored in a separate and enclosed, clean, dry, dust-free areas designated exclusively for this purpose.
-
Soiled linen and clothing shall be placed in suitable bags or closed containers and stored in a separate and enclosed area designated exclusively for this purpose.
(f) The center shall have an emergency source of lighting for exam, labor, and birthing rooms to protect the health and safety of the pregnant woman or mother if the normal supply is interrupted.
(g) The center shall establish a written policy for the handling and disposal of waste materials. Any incinerator used shall be in compliance with 401 KAR 59:020 or 401 KAR 61:010, as applicable.
Section 8. Transfer and Transport Agreements.
(1) As required by KRS 216B.198, a center shall enter into a written agreement with a licensedhospital that provides obstetrics services and a local, Kentucky-licensed Class I ambulance service for the transport and treatment of a patient with unforeseen complications related to labor and delivery.
(2) Each written agreement shall be filed with the cabinet pursuant to KRS 216B.198 within ten (10) business days of finalization.
(3) A transfer agreement between the center and a licensed hospital shall:
(a) Be a legally binding contractual document;
(b) Be signed by individuals authorized to execute the agreement on behalf of the center and hospital, who shall certify they have this authority;
(c) Require transfer of a patient, if deemed medically necessary by the provider attending to the patient;
(d) Identify responsibilities of the center in which the center shall, at a minimum:
-
At the time of transfer, provide the hospital with complete and accurate information regarding the patient being transferred to the hospital;
-
Notify the hospital of the impending transfer of a patient;
-
At the time of transfer, provide the hospital with copies of relevant portions of the patient's clinical record;
-
Transfer with the patient, the patient's medical records, demographic information, insurance information, and other information deemed necessary or otherwise required by law to facilitate the provision of medical care when the patient arrives at the hospital; and
-
Arrange for the immediate transfer of the patient's personal effects, including a document listing of the effects; and
(e) Identify responsibilities of the hospital in which the hospital shall, at a minimum:
-
Provide prompt and appropriate evaluation and treatment of a patient transferred to the hospital pursuant to the transfer agreement;
-
Accept responsibility for the patient's care when the patient is received by the hospital;
-
Direct charges performed by the hospital to the patient or patient's third-party payer; and
-
Acknowledge receipt of the patient's personal effects in writing signed by an authorized representative of the hospital and deliver the receipt to the facility.
(4) A transport agreement between the center and a Kentucky-licensed Class I ambulance service capable of responding immediately to a call for emergency transport shall:
(a) Be with an ambulance service located:
-
In the same or contiguous county as the center; or
-
No further than five (5) miles or ten (10) minutes normal driving time from the center;
(b) Be signed by individuals authorized to execute the agreement on behalf of the center and ambulance service, who shall certify they have this authority; and
(c) Identify responsibilities of the ambulance service in which the ambulance service shall agree, at a minimum to:
-
Provide services in accordance with all federal and state laws and administrative regulations applicable to emergency service entities;
-
Require all responding medical personnel to familiarize themselves with the floor plan of the facility to minimize the time required to locate the patient in the facility and exit the facility with the patient as expeditiously as possible;
-
Acknowledge the existence of, and its familiarity with, the terms of the transfer agreement between the facility and an acute care hospital; and
-
Transport the patient to the hospital that is party to the transfer agreement, unless otherwise directed by the patient.
(5) A licensed facility applying for a renewal license or an applicant for a provisional license may submit a request in writing for extensions of time to comply with the agreement requirements to the cabinet's Office of Inspector General in accordance with the provisions of this subsection.
(a) Any request shall:
-
Be in writing;
-
Contain a certification under oath that the party seeking the extension of time has exhausted all reasonable efforts to obtain an agreement for a continuous ninety (90) business day period prior to the request; and
-
Contain a detailed description of the efforts taken to secure the agreements.
(b) In deciding to grant or deny the request for an extension of time, the Inspector General shall consider all relevant factors under the circumstances, including at a minimum:
-
Whether the facility or applicant made, and continues to make, a good faith effort to obtain a transfer or transport agreement;
-
Whether the facility or applicant can provide the same level of patient care and safety through alternative health services during any extension period; and
-
Regulatory compliance history at the facility and at any other health care facility owned, in whole or in part, by the applicant or any other individual or entity having an ownership interest with the facility.
(c) If the request is granted, the extension of time shall be effective for a time-period of ninety (90) business days from the date of issuance.
(d) If the request is granted for a transfer agreement, the transport agreement shall not be required to comply with subsection (4)(c)3. and 4. of this section for the duration of the extension of time.
(e) The inspector general may rescind a previously granted extension of time at any time upon determining that the applicant or facility has not met, or is not meeting, the conditions of paragraph (b) of this subsection.
(f) If at the end of the ninety (90) day extension, the center is unable to secure an agreement with a hospital or ambulance provider, the Inspector General shall determine if a waiver will be granted by considering all relevant factors including those listed in Section 8(5).
(g) If a request for an extension or waiver is denied, an applicant or licensee shall have ten (10) business days to submit a written request for reconsideration to the inspector general, whose decision shall be final. The licensee or applicant for provisional license may appeal a denial in accordance with Section 5 of this administrative regulation.
History
- RELATES TO: KRS 211.848,214.155,KRS 216.530, 216B.010-216B.130, 216B.990(1), (2), 216B.198, 304.5-070, 42 U.S.C. 299b-22(a)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.198
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements necessary for the proper administration of the licensure function forhealth facilities and health services. KRS 216B.198 requires the cabinet to promulgate administrative regulations establishing requirements relating to freestanding birthing centers. This administrative regulation establishes licensure requirements for the operation,services, and facility specifications of freestanding birthing centers.
- History: 902 KAR 020:150. 9 Ky.R. 95; eff. 8-11-1982; 16 Ky.R. 1012; eff. 1-12-1990; Crt eff. 4-30-2019; 52 Ky.R. 1052, 1713; 53 Ky.R. 44; eff. 8-27-2026.
902 KAR 20:160 Chemical dependency treatment services and facility specifications {#sec-902-kar-20-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:160}
Section 1. Definitions.
(1) "Aftercare" means the process of providing continued services following primary chemical dependency treatment to support and increase gains made during treatment.
(2) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy, or a medical officer of the government of the United States while engaged in the performance of official duties, who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc. or the American Osteopathic Board of Neurology and Psychiatry;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A physician assistant as defined by KRS 311.840(3);
(h) A licensed marriage and family therapist as defined by KRS 335.300(2);
(i) A licensed professional clinical counselor as defined by KRS 335.500(3); or
(j) A licensed professional art therapist as defined by KRS 309.130(2).
(3) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapy associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4); or
(f) Licensed professional art therapist associate as defined by KRS 309.130(3).
(4) "Certified alcohol and drug counselor" is defined by KRS 309.080(2).
(5) "Governing authority" means the individual, agency, partnership, or corporation that directs and establishes policy concerning the management and operation of a chemical dependency treatment program.
(6) "Interdisciplinary team" means a group of at least four (4) professionals, including a physician, registered nurse, certified chemical dependency counselor, and a person with a master's degree in psychology, social work, or counseling.
(7) "Licensed clinical alcohol and drug counselor" is defined by KRS 309.080(4).
(8) "Licensed clinical alcohol and drug counselor associate" is defined by KRS 309.080(5).
(9) "Peer support specialist" means a paraprofessional who:
(a) Is a registered alcohol and drug peer support specialist in accordance with KRS 309.0831; or
(b)
-
Meets the application, training, examination, and supervision requirements of 908 KAR 2:220, 908 KAR 2:230, or 908 KAR 2:240; and
-
Works under the supervision of one (1) of the following:
a. Physician;
b. Psychiatrist;
c. Licensed psychologist;
d. Licensed psychological practitioner;
e. Licensed psychological associate;
f. Licensed clinical social worker;
g. Licensed marriage and family therapist;
h. Licensed professional clinical counselor;
i. Certified social worker;
j. Licensed marriage and family therapy associate;
k. Licensed professional counselor associate;
l. Licensed professional art therapist;
m. Licensed professional art therapist associate;
n. Advanced practice registered nurse;
o. Physician assistant;
p. Certified alcohol and drug counselor; or
q. Licensed clinical alcohol and drug counselor.
(10) "Restraint" means a physical or mechanical device used to restrict the movement of the patient or a portion of the patient's body.
(11) "Substance use disorder" is defined by KRS 222.005(12).
(12) "Targeted case manager" means an individual who meets the requirements for a targeted case manager established by 908 KAR 2:260.
Section 2. Scope of Operation and Services.
(1) A chemical dependency treatment service shall have a structured inpatient program to provide medical, social, diagnostic, and treatment services to individuals with substance use disorder.
(2) Chemical dependency treatment services shall:
(a) Have a duration of less than thirty (30) days;
(b) Be hospital based or freestanding;
(c) Have eight (8) or more patient beds;
(d) Be under the medical direction of a physician; and
(e) Provide continuous nursing services.
(3) If a chemical dependency treatment program provides outpatient behavioral health services, as established in Section 5 of this administrative regulation, for individuals with a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis:
(a) The outpatient behavioral health services shall be provided:
-
On a separate floor, in a separate wing, or in a separate building on the campus of the chemical dependency treatment program's inpatient facility; or
-
At an extension off the campus of the chemical dependency treatment program's inpatient facility;
(b) The chemical dependency treatment program shall pay a fee in the amount of $250 per off-campus extension providing outpatient behavioral health services, submitted to the Office of Inspector General at the time of:
-
Initial licensure, if applicable;
-
The addition of a new extension to the chemical dependency treatment program's license; and
-
Renewal;
(c) Each off-campus extension or on-campus program of outpatient behavioral health services shall be listed on the chemical dependency treatment program's license;
(d) An off-campus extension or a separate building on the campus of the chemical dependency treatment program's inpatient facility where outpatient behavioral health services are provided shall comply with the physical environment requirements of Section 8 of this administrative regulation and be approved by the State Fire Marshal's office prior to:
-
Initial licensure;
-
The addition of the extension or on-campus program of outpatient behavioral health services in a separate building; or
-
A change of location;
(e) The program shall employ directly or by contract a sufficient number of personnel to provide outpatient behavioral health services;
(f) The outpatient behavioral health services program shall have a program director who:
-
May also serve as the chemical dependency treatment program's treatment director described in Section 3(10) of this administrative regulation; and
-
Shall be a:
a. Psychiatrist;
b. Physician;
c. Licensed psychologist or certified psychologist with autonomous functioning;
d. Licensed psychological practitioner;
e. Psychiatric nurse;
f. Advanced practice registered nurse;
g. Licensed professional clinical counselor;
h. Licensed marriage and family therapist;
i. Licensed professional art therapist;
j. Licensed behavioral analyst; or
k. Licensed clinical social worker; and
(g) Unless an extension of time is granted pursuant to subsection (4) of this section, the outpatient program shall become accredited by one (1) of the following within one (1) year of adding outpatient behavioral health services to the chemical dependency treatment program's license:
-
The Joint Commission;
-
The Commission on Accreditation of Rehabilitation Facilities;
-
The Council on Accreditation; or
-
A nationally recognized accreditation organization.
(4)
(a) If a chemical dependency treatment services outpatient program has not obtained accreditation within the one (1) year timeframe required by subsection (3)(g) of this section, the program may request a one (1) time only extension to complete the accreditation process.
(b) A request for extension shall:
-
Be submitted in writing to the Office of Inspector General at least sixty (60) days prior to expiration of the one (1) year deadline described in subsection (3)(g) of this section;
-
Include evidence that the program initiated the process of becoming accredited within sixty (60) days of adding outpatient behavioral health services to the program's license and is continuing its efforts to obtain accreditation; and
-
Include an estimated timeframe by which approval of accreditation is anticipated.
(5) A program shall cease providing outpatient behavioral health services if the program fails to:
(a) Become accredited in accordance with subsection (3)(g) of this section;
(b) Request an extension in accordance with subsection (4) of this section, if accreditation has not been obtained; or
(c) Maintain accreditation.
(6) Proof of accreditation shall be provided to the Office of Inspector General upon receiving accreditation and at the time of annual renewal.
Section 3. Administration and Operation.
(1) The licensee shall be responsible for compliance with federal, state, and local laws and administrative regulations pertaining to the operation of chemical dependency treatment programs.
(2)
(a) The governing authority shall appoint a program administrator who shall have a:
-
Bachelor's degree in a health or human services field;
-
Bachelor's degree in another field supplemented with one (1) year of work experience in the field of chemical dependency; or
-
High school diploma and four (4) years of experience in the field of chemical dependency.
(b) The governing authority shall establish, in writing:
-
Program goals and objectives; and
-
An evaluation plan for annual assessment of the attainment of the goals and objectives.
(3) Program administrator.
(a) The program administrator shall:
-
Be responsible for the daily management of the facility; and
-
Serve as the liaison between the governing authority and staff members.
(b) The program administrator shall keep the governing authority informed of the operations of the facility through reports and attendance at meetings of the governing authority.
(4) Administrative records and reports.
(a) A medication error, drug reaction, accident, or other incident involving a patient, visitor, or staff member shall be documented in writing, signed by the program administrator and any witness to the event, and placed in an incident file.
(b) Licensure inspection reports, plans of correction, and program evaluations shall be available to the public, upon request, at the facility.
(5) Policies.
(a) Administrative policies. The program shall have a written administrative policy to cover each aspect of the facility's operation, including:
-
A description of the organizational structure, staffing, and allocation of responsibility and accountability;
-
A description of referral linkages with other facilities and providers;
-
A description of the services included in the program, including outpatient behavioral health services if provided;
-
An expense and revenue accounting system following generally accepted accounting procedures;
-
A volunteer program; and
-
Program evaluation and quality assurance review.
(b) Patient care policy. A written patient care policy shall be developed and shall include a description of:
-
Actions to be taken if a patient is lost, unaccounted for, or otherwise absent without authorization;
-
Provisions for patient visitation and use of telephones;
-
Provision of emergency medical services; and
-
Patient admission and discharge criteria, including the categories of individuals accepted and not accepted by the program.
(c) Patient rights policy. A written policy shall be developed and maintained to enhance patient dignity and to protect human rights. The policy shall assure that each patient or client receiving outpatient behavioral health services shall be:
-
Informed of rules and regulations governing patient conduct and responsibilities, including the procedure for handling grievances;
-
Informed, prior to admission for rehabilitation or receipt of outpatient behavioral health services, of services available and charges for treatment, including charges not covered under Medicare, Medicaid, or other third-party payor;
-
Encouraged and assisted to:
a. Understand and exercise patient rights;
b. Voice grievances; and
c. Recommend changes in policies and services. Upon request by a patient, a grievance or recommendation shall be conveyed to that body within the organization with authority to take corrective action;
-
Presented with the opportunity to participate in the planning of his or her treatment;
-
Informed of the right to refuse to participate in experimental research;
-
Assured confidential treatment of records and presented with the opportunity to approve or refuse release of records to any individual not involved in his or her care, except as required by Kentucky law or third party payment contract; and
-
Treated with consideration, respect, and recognition of personal dignity and individuality, including privacy in treatment and personal health needs.
(6) Personnel.
(a) The governing authority shall:
-
Establish a personnel policy; and
-
Review the personnel policy at least one (1) time annually and update the policy as needed.
(b) There shall be a personnel record for each person employed by the chemical dependency treatment inpatient facility and, if applicable, the outpatient behavioral health services program, which shall include evidence:
-
Of the results of a tuberculosis test, performed either prior to or within the first week of employment and annually thereafter;
-
Of education, training, and experience, and a copy of current license or certification credentials, if applicable;
-
That the employee received orientation to the facility's written policies within the first week of employment; and
-
Of regular in-service training that corresponds with job duties and includes a list of training and dates completed.
(7) Staffing requirements.
(a) The chemical dependency treatment program shall have personnel sufficient to meet patient needs at the inpatient facility on a twenty-four (24) hour basis.
(b) The number and classification of personnel required shall be based on the number of patients and the individual treatment plans.
(8) Medical director. The chemical dependency treatment program's inpatient facility shall have a medical director who shall:
(a) Be a physician licensed in accordance with KRS 311.571;
(b) Be responsible for the medical aspect of the program; and
(c) Have duties that shall include:
-
Patient admission;
-
Approval of patient treatment plans;
-
Participation in the quality assurance review; and
-
Provision of medical services, personally or by a designated physician, either in-house or on-call, on a twenty-four (24) hour basis.
(9) Interdisciplinary team. The chemical dependency treatment program shall have an interdisciplinary team responsible for:
(a) Developing individual treatment plans;
(b) Developing aftercare plans; and
(c) Conducting quality assurance reviews.
(10) Treatment director. The chemical dependency treatment program shall have a full time treatment director responsible for:
(a) Coordinating the interdisciplinary team in developing individual treatment plans;
(b) Initiating a periodic review of each patient's treatment plan;
(c) Supervising the maintenance of patient records; and
(d) Coordinating the interdisciplinary team in developing an aftercare plan for each patient to provide continuity of care.
(11) Nursing services within the chemical dependency treatment program's inpatient facility.
(a) Nursing services shall be available on a twenty-four (24) hour basis.
(b) The program shall have at least one (1) full-time registered nurse.
(c) If a registered nurse is not on duty, a licensed practical nurse shall be responsible for the nursing care of patients and a registered nurse shall be on call.
(12) Medical supervision. A physician, or registered nurse under the direction of a physician, shall supervise:
(a) Implementation of the medical aspects of the treatment plan; and
(b) All staff directly involved in patient medical care.
(13) In-service training.
(a) All personnel of the chemical dependency treatment program's inpatient facility or, if applicable, the outpatient behavioral health services program shall participate in ongoing in-service training specific to the employee's job activities.
(b) Training shall include:
-
Thorough job orientation for new personnel; and
-
Regular in-service training emphasizing professional competence and the human relationship necessary for effective health care.
(14) Patient records of the chemical dependency treatment program's inpatient facility.
(a)
-
An individual record shall be maintained for each patient.
-
Each entry shall be signed and dated by the person making the entry.
(b) At the time of admission, the following information shall be entered into the patient's record:
-
Name, date of admission, birth date and place, marital status, and Social Security number;
-
Person to contact in case of emergency;
-
Next of kin; and
-
Type and place of employment.
(c) The record shall contain documentation of medical services provided during detoxification and rehabilitation, including the results of physical examinations.
(d)
-
The record shall contain the patient's treatment plan establishing goals and objectives for the individual during treatment.
-
The record shall also contain documentation of how the plan was implemented and of patient progress in meeting the goals and objectives established in the treatment plan.
(e) The record shall contain notation of medication administered, stating the date, time, dosage, and frequency of administration and the name of the person administering each dose.
(f) The record shall contain a discharge summary and a plan for aftercare.
(g) The discharge summary shall be entered in the patient's record within seven (7) days after discharge and shall include:
-
The course and progress of the patient with regard to the individual treatment plan;
-
General observations of the patient's condition initially, during treatment, and at discharge; and
-
The recommendations and arrangements for further treatment, including prescribed medications and aftercare.
(h) If the patient is referred to another service provider after discharge, and if the patient executes a written release, a copy of the discharge summary shall be sent to the provider with the patient's permission.
(i) After a patient's death or discharge, the completed record shall be placed in an inactive file and be retained for at least the longer of:
-
Six (6) years; or
-
If a minor, three (3) years after the patient reaches the age of majority pursuant to KRS 2.015.
(15) Confidentiality and Security: Use and Disclosure.
(a) The chemical dependency treatment program shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, including the security requirements mandated by 45 C.F.R. Part 164, Subparts A and C, or as provided by applicable federal or state law, including 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(b) The chemical dependency treatment program may use and disclose medical records. Use and disclosure shall be as established or required by:
-
HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164; or
-
42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(c) This administrative regulation shall not be construed to prohibit the chemical dependency treatment program from establishing higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, or 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(16) Linkage agreements.
(a) The program shall have linkages through written agreements with providers of other levels of care that could be medically indicated to supplement the services available in the program.
(b) Linkages shall include a hospital and an emergency medical transportation service in the area.
(17) Quality assurance. The program shall have a quality assurance program that includes an effective mechanism for reviewing and evaluating patient care on a regular basis by the interdisciplinary team.
(18) Medications.
(a) A prescription or nonprescription medication administered to a patient shall be noted in the patient's records with the date, time, and dosage, and signed by the person administering the medication.
(b) Each prescription medication shall be plainly labeled with the:
-
Patient's name;
-
Name of the drug;
-
Strength;
-
Name of pharmacy;
-
Date;
-
Physician name;
-
Caution statement; and
-
Directions for use.
(c)
-
A prescription or nonprescription medication shall not be administered to a patient except on the written order of a physician or other practitioner acting within his or her statutory scope of practice.
-
A medication shall be administered by licensed personnel.
(d)
-
Medication shall be kept in a locked storage area, which shall be well lighted and of sufficient size to permit storage without crowding.
-
Medication requiring refrigeration shall be kept in a separate locked box in a refrigerator.
-
Medication for external use shall be stored separately from medication administered by mouth or injection.
(e) A medication error or drug reaction shall be reported immediately to the medical director and treatment coordinator and an entry shall be made in the patient's record.
(f) An emergency medical kit, with contents approved by a physician, shall be:
-
Maintained at the facility; and
-
Inspected after use or at least monthly to remove deteriorated and outdated drugs and to ensure completeness of content.
(19) Restraints. Requirements for the use of restraints shall be met pursuant to KRS 202A.241 and 908 KAR 3:010, Section 9.
(20) Activities schedule. A daily schedule of program activities shall be posted in the chemical dependency treatment program's inpatient facility.
Section 4. Provision of Services.
(1) Withdrawal management services. A chemical dependency treatment program's inpatient facility shall:
(a) Provide intensive inpatient withdrawal services pursuant to the requirements of 902 KAR 20:111 and the service criteria in the most recent version of The American Society of Addiction Medicine (ASAM) Criteria relating to the appropriate level of care for the patient. Services shall be provided directly or through another licensed provider for a patient who meets the:
-
Diagnostic criteria for substance intoxication or withdrawal disorder as established by the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) for alcohol, tobacco, and other drug use; and
-
Dimensional criteria for medically monitored intensive inpatient services or medically managed intensive inpatient services in accordance with the most recent version of The ASAM Criteria;
(b) Meet the service criteria established by the most recent version of The ASAM Criteria for ASAM level of care 3.7, medically monitored withdrawal management services, if providing that level of care, including:
-
A planned and structured regimen of twenty-four (24) hour professionally directed evaluation, observation, medical monitoring, and addiction treatment;
-
Twenty-four (24) hour nursing care;
-
Twenty-four (24) hour access to a physician; and
-
Twenty-four (24) hour access to a psychiatrist; and
(c) Meet the service criteria established by the most recent version of The ASAM Criteria for ASAM level of care 4.0, medically managed withdrawal management services, if providing that level of care, including:
-
A planned and structured regimen of twenty-four (24) hour professionally directed evaluation, observation, medical monitoring, and addiction treatment;
-
Twenty-four (24) hour nursing care;
-
Twenty-four (24) hour physician care; and
-
Twenty-four (24) hour access to a psychiatrist.
(2) High intensity residential services. A chemical treatment dependency program may provide clinically managed high intensity residential services. If a chemical dependency treatment program provides this level of care, it shall comply with the requirements of 908 KAR 1:372, Section 2, in addition to the requirements of this administrative regulation.
(3) Rehabilitation. A chemical dependency treatment program's inpatient facility shall provide:
(a) Medical services as needed, under the supervision of a physician;
(b) Scheduled individual, group, and family counseling;
(c) Psychological testing and evaluation as needed;
(d) Education of the patient on the subject of chemical dependency and related lifestyle issues, including nutrition and communication skills;
(e) Recreational activities with facilities and equipment, consistent with the patient's needs and the therapeutic program;
(f) Referral to other rehabilitative or community service agencies providing services not available through the program; and
(g) Aftercare services provided directly or through arrangement with another agency.
(4) Physical examinations. Within ten (10) days prior to, or three (3) days after, admission to the chemical dependency treatment program's inpatient facility for rehabilitation, a patient shall have a physical examination with tests ordered by a physician.
(5) Psychosocial history.
(a) A patient in a chemical dependency treatment program's inpatient facility shall have a psychosocial history and assessment interview within seventy-two (72) hours after admission for rehabilitation.
(b) The following data shall be collected and recorded in the patient record:
-
History of alcohol and drug use;
-
A determination of current emotional state;
-
Vocational history;
-
Familial relationships; and
-
Educational background.
(6) Treatment plan.
(a) The interdisciplinary team, with the participation of the patient, shall develop an individual treatment plan within four (4) days after admission to the chemical dependency treatment program's inpatient facility for rehabilitation, based on the patient's medical evaluation and psychosocial history and assessment.
(b) The treatment plan shall:
-
Specify the services required for meeting the patient's needs;
-
Identify goals necessary for the patient to achieve, maintain, or reestablish physical health and adaptive capabilities;
-
Establish goals with both long-term and short-term objectives and the anticipated time expected to meet these goals; and
-
Identify the location and frequency of treatment procedures, including referrals for a required service not provided by the program.
(7) The treatment plan shall be reviewed and updated at least weekly for the duration of the inpatient treatment.
(8)
(a) The patient's family or significant others shall be involved in the treatment process, if approved by the patient.
(b) An attempt to involve family members or significant others shall be reported in the patient's medical record.
(9) Aftercare plan.
(a)
- A written aftercare plan shall be developed prior to completion of treatment in the chemical dependency treatment program's inpatient facility by the:
a. Interdisciplinary team;
b. Patient; and
c. With the patient's permission, patient's family or significant others.
- The aftercare plan shall be designed to establish continued contact for the support of the patient.
(b) The aftercare plan shall include methods and procedures to meet patient needs through direct contact or with assistance from other community human services organizations.
(c) If aftercare services are provided directly, review and update of the aftercare plan shall be conducted with the frequency of review determined by the:
-
Interdisciplinary team;
-
Patient; and
-
With the patient's permission, patient's family or significant others.
(d) If the patient is referred to another agency for aftercare services, follow-up shall be conducted to determine if services are being provided.
Section 5. Provision of Outpatient Behavioral Health Services, Plan of Care, and Client Records.
(1) Pursuant to Section 2(3) of this administrative regulation, a chemical dependency treatment program may provide one (1) or more of the following outpatient behavioral health services for individuals with a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis:
(a) Screening, which shall be provided face-to-face or via telehealth by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate to determine the:
-
Likelihood that an individual has a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis; and
-
Need for an assessment;
(b) Assessment, which shall:
- Be provided face-to-face or via telehealth by a behavioral health professional, behavioral health professional under clinical supervision, a certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate who gathers information and engages in a process with the client, thereby enabling the professional to:
a. Establish the presence or absence of a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis;
b. Determine the client's readiness for change;
c. Identify the client's strengths or problem areas that could affect the treatment and recovery processes; and
d. Engage the client in developing an appropriate treatment relationship;
-
Establish or rule out the existence of a clinical disorder or service need;
-
Include working with the client to develop a plan of care if a clinical disorder or service need is assessed; and
-
Not include psychological or psychiatric evaluations or assessments;
(c) Psychological testing, which shall:
-
Be performed face-to-face or via telehealth by a licensed psychologist, licensed psychological associate, or licensed psychological practitioner; and
-
Include a psychodiagnostic assessment of personality, psychopathology, emotionality, or intellectual disabilities, and interpretation and written report of testing results;
(d) Crisis intervention, which:
-
Shall be a therapeutic intervention for the purpose of immediately reducing or eliminating the risk of physical or emotional harm to the client or another individual;
-
Shall consist of clinical intervention and support services necessary to provide integrated crisis response, crisis stabilization interventions, or crisis prevention activities;
-
Shall be provided:
a. As an immediate relief to the presenting problem or threat; and
b. In a face-to-face, one (1) on one (1) encounter or as a comparable service provided via telehealth;
- Shall be provided by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate;
-
Shall be followed by a referral to noncrisis services, if applicable; and
-
May include:
a. Further service prevention planning, including:
(i) Lethal means reduction for suicide risk; or
(ii) Substance use disorder relapse prevention; or
b. Verbal de-escalation, risk assessment, or cognitive therapy;
(e) Mobile crisis services, which shall:
-
Be available twenty-four (24) hours a day, seven (7) days a week, every day of the year;
-
Be provided for a duration of less than twenty-four (24) hours;
-
Not be an overnight service;
-
Be a multi-disciplinary team based intervention performed face-to-face or via telehealth that ensures access to acute substance use services and supports to:
a. Reduce symptoms or harm; or
b. Safely transition an individual in an acute crisis to appropriate, least restrictive level of care;
- Involve all services and supports necessary to provide:
a. Integrated crisis prevention;
b. Assessment and disposition;
c. Intervention;
d. Continuity of care recommendations; and
e. Follow-up services;
- Be provided in a home or community setting by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate; and
- Ensure access to a board certified or board-eligible psychiatrist twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(f) Day treatment, which shall:
- Be a nonresidential, intensive treatment program designed for children who:
a. Have a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis;
b. Are under twenty-one (21) years of age; and
c. Are at high risk of out-of-home placement due to a behavioral health issue;
-
Consist of an organized, behavioral health program of treatment and rehabilitative services for substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis;
-
Have unified policies and procedures that address the organization's philosophy, admission and discharge criteria, admission and discharge process, staff training, and integrated case planning;
-
Include:
a. Individual outpatient therapy, family outpatient therapy, or group outpatient therapy;
b. Behavior management and social skill training;
c. Independent living skills that correlate to the age and development stage of the client; and
d. Services designed to explore and link with community resources before discharge and to assist the client and family with transition to community services after discharge;
- Be provided:
a. Face-to-face or via telehealth;
b. In collaboration with the education services of the local education authority including those provided through 20 U.S.C. 1400 et seq. (Individuals with Disabilities Education Act) or 29 U.S.C. 701 et seq. (Section 504 of the Rehabilitation Act);
c. On school days and during scheduled breaks;
d. In coordination with the child's individual educational plan or Section 504 plan if the child has an individual educational plan or Section 504 plan;
e. By personnel that includes a behavioral health professional, a behavioral health professional under clinical supervision, a certified alcohol and drug counselor, a licensed clinical alcohol and drug counselor, a licensed clinical alcohol and drug counselor associate, or a peer support specialist; and
f. According to a linkage agreement with the local education authority that specifies the responsibilities of the local education authority and the day treatment provider; and
- Not include a therapeutic clinical service that is included in a child's individualized education plan;
(g) Peer support, which shall:
-
Be provided by a peer support specialist;
-
Be structured and scheduled nonclinical therapeutic activity with a client or group of clients;
-
Promote socialization, recovery, self-advocacy, preservation, and enhancement of community living skills;
-
Be identified in the client's plan of care developed through a person-centered planning process; and
-
Be provided face-to-face or via telehealth;
(h) Intensive outpatient program services, which shall:
-
Offer a multi-modal, multi-disciplinary structured outpatient treatment program that is more intensive than individual outpatient therapy, group outpatient therapy, or family outpatient therapy;
-
Be provided at least:
a. Three (3) hours per day at least three (3) days per week for adults; or
b. Six (6) hours per week for adolescents;
- Include:
a. Individual outpatient therapy;
b. Group outpatient therapy;
c. Family outpatient therapy unless contraindicated;
d. Crisis intervention; or
e. Psycho-education during which the client or client's family member shall be:
(i) Provided with knowledge regarding the client's diagnosis, the causes of the condition, and the reasons why a particular treatment might be effective for reducing symptoms; and
(ii) Taught how to cope with the client's diagnosis or condition in a successful manner;
- Include a treatment plan, which shall:
a. Be individualized; and
b. Focus on stabilization and transition to a lower level of care;
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate;
-
Include access to a board-certified or board-eligible psychiatrist for consultation;
-
Include access to a psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring;
-
Be provided in a setting with a minimum client-to-staff ratio of ten (10) clients to one (1) staff person; and
-
Be provided face-to-face or via telehealth;
(i) Individual outpatient therapy, which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
- Consist of:
a. A face-to-face encounter or telehealth consultation with the client; and
b. A behavioral health therapeutic intervention provided in accordance with the client's plan of care;
- Be aimed at:
a. Reducing adverse symptoms;
b. Reducing or eliminating the presenting problem of the client; and
c. Improving functioning;
-
Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time with the client is medically necessary in accordance with 907 KAR 3:130; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate;
(j) Group outpatient therapy, which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
-
Consist of a face-to-face behavioral health therapeutic intervention or telehealth consultation provided in accordance with the client's plan of care;
-
Excluding multi-family group therapy, be provided in a group setting of nonrelated individuals, not to exceed twelve (12) individuals in size. For group outpatient therapy, a nonrelated individual means any individual who is not a spouse, significant other, parent or person with custodial control, child, sibling, stepparent, stepchild, step-brother, step-sister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild;
-
Focus on the psychological needs of the client as evidenced in the client's plan of care;
-
Center on goals including building and maintaining healthy relationships, personal goals setting, and the exercise of personal judgment;
-
Not include physical exercise, a recreational activity, an educational activity, or a social activity;
-
Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time is medically necessary in accordance with 907 KAR 3:130;
-
Ensure that the group has a deliberate focus and defined course of treatment;
-
Ensure that the subject of group outpatient therapy shall be related to each client participating in the group; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate who shall maintain individual notes regarding each client within the group in the client's record;
(k) Family outpatient therapy, which shall:
-
Consist of a behavioral health therapeutic intervention provided face-to-face or via telehealth through scheduled therapeutic visits between the therapist, at least one (1) member of the client's family, and the client unless the client's presence is not required in his or her plan of care;
-
Address issues interfering with the relational functioning of the family;
-
Seek to improve interpersonal relationships within the client's home environment;
-
Be provided to promote the health and wellbeing of the client or recovery from a substance use disorder;
-
Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time is medically necessary in accordance with 907 KAR 3:130; and
-
Be provided by a behavioral health professional, a behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate;
(l) Collateral outpatient therapy, which shall consist of a face-to-face or telehealth behavioral health consultation:
-
With a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21), household member, legal representative, school personnel, or treating professional;
-
Provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate; and
-
Provided upon the written consent of a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21). Documentation of written consent shall be signed and maintained in the client's record;
(m) Screening, brief intervention, and referral to treatment for substance use disorders, which shall:
-
Be provided face-to-face or via telehealth;
-
Be an evidence-based early intervention approach for an individual with non-dependent substance use prior to the need for more extensive or specialized treatment;
-
Consist of:
a. Using a standardized screening tool to assess the individual for risky substance use behavior;
b. Engaging a client who demonstrates risky substance use behavior in a short conversation, providing feedback and advice; and
c. Referring the client to therapy or other services that address substance use if the client is determined to need additional services; and
- Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate;
(n) Targeted case management services, which shall:
- Include services to an:
a. Adult or a child with substance use disorder; or
b. Adult or child with co-occurring mental health or substance use disorder and chronic or complex physical health issues;
-
Be provided by a targeted case manager; and
-
Include the following assistance:
a. Comprehensive assessment and reassessment of client needs to determine the need for medical, educational, social, or other services. The reassessment shall be conducted annually or more often if needed based on changes in the client's condition;
b. Development of a specific care plan that shall be based on information collected during the assessment and revised if needed upon reassessment;
c. Referral and related activities, which may include:
(i) Scheduling appointments for the client to help the individual obtain needed services; or
(ii) Activities that help link the client with medical, social, educational providers, or other programs and services that address identified needs and achieve goals specified in the care plan;
d. Monitoring, which shall be face-to-face or via telehealth and occur no less than once every three (3) months to determine that:
(i) Services are furnished according to the client's care plan;
(ii) Services in the care plan are adequate; and
(iii) Changes in the needs or status of the client are reflected in the care plan; and
e. Contacts with the client, family members, service providers, or others are conducted as frequently as needed to help the client:
(i) Access services;
(ii) Identify needs and supports to assist the client in obtaining services; and
(iii) Identify changes in the client's needs;
(o) Service planning, which shall be provided face-to-face or via telehealth by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate, any of which shall be of the client's choosing to:
-
Assist the client in creating an individualized plan for services and developing measurable goals and objectives needed for maximum reduction of the effects of a substance use disorder or co-occurring disorder;
-
Restore the client's functional level to the client's best possible functional level; and
-
Develop a service plan, which:
a. Shall be directed and signed by the client; and
b. May include:
(i) A mental health advance directive being filed with a local hospital;
(ii) A crisis plan; or
(iii) A relapse prevention strategy or plan;
(p) Medication assisted treatment with behavioral health therapy, which shall:
-
Exclude methadone-based treatment restricted to licensure in accordance with 908 KAR 1:370 and 908 KAR 1:374;
-
Require an advanced practice registered nurse, a physician, or a physician assistant who prescribes FDA-approved drugs for the treatment of opioid addiction in adult patients to:
a. Document in the patient's record whether or not the patient is compliant with prescribed dosing as evidenced by the results of:
(i) A KASPER report released to the practitioner pursuant to KRS 218A.202(7)(e); and
(ii) Drug testing; and
b. Comply with the prescribing and dispensing standards in 201 KAR 9:270 or 201 KAR 20:065 for FDA-approved drugs used for the treatment of opioid addiction;
-
Be co-located within the same practicing site as the prescribing provider or conducted via telehealth; and
-
Include individual and group outpatient therapy as a service and document monitoring of compliance with recommended non-medication therapies; or
(q) Ambulatory withdrawal management services, which shall be:
- Provided face-to-face to patients who meet the:
a. Diagnostic criteria for substance intoxication or withdrawal disorder as established by the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (DSM); and
b. Dimensional criteria for outpatient withdrawal management as established in the most recent version of The ASAM Criteria;
-
Provided in regularly scheduled sessions; and
-
Delivered in accordance with clinical protocols established for ambulatory withdrawal management in the most recent version of The ASAM Criteria.
(2) Plan of care.
(a) Each client receiving outpatient behavioral health services from a chemical dependency treatment program shall have an individual plan of care signed by a behavioral health professional.
(b) A plan of care shall:
-
Describe the services to be provided to the client, including the frequency of services;
-
Contain measurable goals for the client to achieve, including the expected date of achievement for each goal;
-
Describe the client's functional abilities and limitations or diagnosis listed in the current edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders;
-
Specify each staff member assigned to work with the client;
-
Identify methods of involving the client's family or significant others if indicated;
-
Establish criteria to be met for termination of treatment;
-
Include any referrals necessary for services not provided directly by the chemical dependency treatment program; and
-
State the date scheduled for review of the plan.
(c) The client shall participate to the maximum extent feasible in the development of his or her plan of care, and the participation shall be documented in the client's record.
(d)
-
The initial plan of care shall be developed through multidisciplinary team conferences at least thirty (30) days following the first ten (10) days of treatment.
-
The plan of care for individuals receiving intensive outpatient program services shall be reviewed every thirty (30) days thereafter and updated every sixty (60) days or earlier if clinically indicated.
-
Except for intensive outpatient program services, the plan of care for individuals receiving any other outpatient behavioral health service established in subsection (1) of this section shall be reviewed and updated every six (6) months or earlier if clinically indicated.
-
The plan of care and each review and update shall be signed by the participants in the multidisciplinary team conference that developed it.
(3) Client Records.
(a) A client record shall be maintained for each individual receiving outpatient behavioral health services.
(b) Each entry shall be current, dated, signed, and indexed according to the service received.
(c) Each client record shall contain:
-
An identification sheet, including the client's name, address, age, gender, marital status, expected source of payment, and referral source;
-
Information on the purpose for seeking a service;
-
If applicable, consent of appropriate family members or guardians for admission, evaluation, and treatment;
-
Screening information pertaining to the mental health or substance use disorder;
-
If applicable, a psychosocial history;
-
If applicable, staff notes on services provided;
-
If applicable, the client's plan of care;
-
If applicable, disposition;
-
If applicable, assigned status;
-
If applicable, assigned therapists; and
-
If applicable, a termination study restating findings and events during treatment, clinical impressions, and condition on termination.
Section 6. Compliance with Building Codes, Ordinances, and Regulations; Chemical Dependency Treatment Program's Inpatient Facility.
(1) The provisions of this administrative regulation shall not relieve the licensee from compliance with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdictions.
(2) The following shall apply:
(a) Requirements for safety pursuant to the National Fire Protection Association 101, Life Safety Code, incorporated by reference in 815 KAR 10:060 and adopted by the Kentucky Department of Housing, Buildings and Construction;
(b) Requirements for plumbing pursuant to 815 KAR 20:010 through 815 KAR 20:195; and
(c) Requirements for making buildings and facilities accessible to and usable by persons with disabilities.
(3) The facility shall be approved by the Fire Marshal's Office before a license or license renewal is granted.
(4) The facility shall receive necessary approval from appropriate agencies prior to occupancy and licensure.
(5) Physical and sanitary environment.
(a) The physical plant and overall facility environment shall be maintained to protect the safety and well-being of patients, personnel, and visitors.
(b) A person shall be designated responsible for services and for the establishment of practices and procedures for:
-
Plant maintenance;
-
Laundry operations either on site or off site; and
-
Housekeeping.
(c) The facility buildings, equipment, and surroundings shall be kept in good repair, neat, clean, free from accumulation of dirt and rubbish, and free from foul, stale, or musty odors.
-
An adequate number of housekeeping and maintenance personnel shall be provided.
-
Written housekeeping procedures shall be established for each area, and copies shall be available to personnel.
-
Equipment and supplies shall be provided for cleaning surfaces. The equipment shall be maintained in a safe, sanitary condition.
-
A hazardous cleaning solution, compound, or substance shall be labeled, stored in an approved container, and kept separate from nonhazardous cleaning materials.
-
The facility shall be free from insects, rodents, and their harborage.
-
Garbage and trash shall be stored in closed containers in an area separate from an area used for the preparation or storage of food.
-
The garbage and trash area shall be cleaned regularly and shall be in good repair.
(d) The facility shall have available at all times a quantity of linen essential to the proper care and comfort of residents.
-
Clean linen and clothing shall be stored in clean, dry, dust-free areas designated exclusively for this purpose.
-
Soiled linen and clothing shall be placed in suitable bags or closed containers and stored in a separate area ventilated to the exterior of the building.
Section 7. Chemical Dependency Treatment Program's Inpatient Facility Requirements and Special Conditions.
(1) Patient rooms. Each patient room shall meet the requirements established in this subsection.
(a) The maximum room capacity shall be six (6) patients.
(b) The minimum room area, exclusive of toilet room, closet, locker, wardrobe, or vestibule, shall be:
-
100 square feet for a one (1) bed room; and
-
Eighty (80) square feet per bed for multibed rooms.
(c)
-
Partitions, cubicle curtains, or placement of furniture shall be used to provide privacy in a multiperson room.
-
Ample closet and drawer space shall be provided for the storage of each patient's personal property.
(d) The placement of a patient in a multibed room shall be appropriate to the age and program needs of the patient.
(2) Lavatory.
(a) In a single or multibed room with a private toilet room, the lavatory may be located in the toilet room.
(b) If two (2) or more patients share a common toilet, a lavatory shall be provided in each patient room.
(3) Centralized toilet area.
(a) If a centralized toilet area is used, the facility shall provide, for each gender on each floor, at least one (1) toilet for each eight (8) residents or a major fraction thereof.
(b) Toilets shall be separated by a permanent partition and at least one (1) toilet for each gender shall be designed for wheelchair use.
(4) Patient baths.
(a) There shall be at least one (1) shower stall or one (1) bathtub for each fifteen (15) patients not individually served.
(b) Each bathtub or shower shall provide space for the private use of the fixture and for dressing.
(5) The patient shall be encouraged to take responsibility for maintaining his or her own living quarters and for other day-to-day housekeeping activities of the program, as appropriate to his or her clinical status.
(6) Dietary service.
(a) The facility shall have a dietary department, organized, directed, and staffed to provide quality food service and optimal nutritional care.
-
The dietary service shall be directed on a full-time basis by an individual who, by education or specialized training and experience, is knowledgeable in food service management.
-
The dietary service shall have at least one (1) dietician licensed pursuant to KRS 310.021 to supervise the nutritional aspects of patient care and to approve menus on at least a consultative basis.
-
If food service personnel are assigned a duty outside the dietary department, the duty shall not interfere with the sanitation, safety, or time required for regular dietary assignments.
(b)
-
A menu shall be planned, written, and rotated to avoid repetition.
-
Nutritional needs shall be met in accordance with:
a. Recommended dietary allowances of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences; and
b. Physician orders, if applicable.
(c)
-
A meal served shall correspond with the posted menu.
-
If a change in the menu is necessary;
a. Substitution shall provide equal nutritive value; and
b. The change shall be recorded on the menu.
- A menu shall be kept on file for at least thirty (30) days.
(d) Food shall be:
-
Prepared by methods that conserve nutritive value, flavor, and appearance; and
-
Served at the proper temperature.
(e)
-
At least three (3) meals shall be served daily with not more than a fifteen (15) hour span between a substantial evening meal and breakfast.
-
Each meal shall be served at a regular time and a nourishing between-meal or bedtime snack shall be offered.
(f) Food services shall be provided in accordance with 902 KAR 45:005.
Section 8. Physical environment of an off-campus extension or separate building on the campus of the chemical dependency treatment program's inpatient facility where outpatient behavioral health services are provided.
(1) Accessibility. The off-campus extension or separate building on the campus of the chemical dependency treatment program's inpatient facility shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and 815 KAR 7:120.
(2) Physical location and overall environment.
(a) The program shall:
-
Comply with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdictions;
-
Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;
-
Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day;
-
Have a reception and waiting area;
-
Provide a restroom; and
-
Have an administrative area.
(b) The condition of the physical location and the overall environment shall be maintained in a manner that assures the safety and well-being of clients, personnel, and visitors.
(3) Prior to occupancy, the facility shall have final approval from appropriate agencies.
History
- RELATES TO: KRS 2.015, 198B.260, 202A.241, 205.559(1), 210.005, 216B.010, 216B.015, 216B.105, 216B.990, 218A.202, 222.005, 309.080, 309.0831, 309.130, 310.021, 311.560, 311.571, 311.840 – 311.862, 314.011(8), 314.042, 319.050, 319.056, 319.064, 319C.010, 320.210(2), 335.080, 335.100, 335.300, 335.500, 42 C.F.R. Part 2, 45 C.F.R. 160, 164, 20 U.S.C. 1400, 29 U.S.C. 701, 42 U.S.C. 290ee-3, 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1), 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 require the Cabinet for Health and Family Services to regulate health facilities and health services. This administrative regulation establishes licensure requirements for the operation, services, and facility specifications of chemical dependency treatment programs, including programs that elect to provide outpatient behavioral health services for individuals with a substance use disorder or co-occurring disorder in which substance use disorder is the primary diagnosis.
- History: 9 Ky.R. 1078; Am. 10 Ky.R. 38; eff. 8-3-1983; 11 Ky.R. 478; eff. 10-9-1984; 18 Ky.R. 828; eff. 10-16-1991; 23 Ky.R. 2870; eff. 2-19-1997; 25 Ky.R. 2967; 26 Ky.R. 763; eff. 10-20-1999; 41 Ky.R. 2374; 42 Ky.R. 377; 690; eff. 9-16-2015; 47 Ky.R. 1103, 1749, 1980; eff. 6-16-2021.
902 KAR 20:170 Facility specifications; psychiatric hospitals {#sec-902-kar-20-170 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:170}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the board for the purpose of operating a psychiatric hospital facility.
(3) "Licensure agency" means the Division for Licensing and Regulation in the office of the Inspector General, Cabinet for Human Resources.
Section 2. Preparation and Approval of Plans and Specifications. After receiving a certificate of need from the board, plans and specifications shall be submitted to the licensure agency and required approvals shall be obtained pursuant to the requirements of 902 KAR 20:009, Sections 2 and 3.
Section 3. Compliance with Building Codes, Ordinances and Regulations.
(1) This section of this administrative regulation may be administered independently from other sections of this administrative regulation.
(2) Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements of the Kentucky Building Code pursuant to 815 KAR 7:010 through 815 KAR 7:060;
(b) Requirements for safety pursuant to 815 KAR 10:020, as amended;
(c) Requirements for plumbing pursuant to 815 KAR 20:010 through 20:191, as amended;
(d) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010;
(e) Requirements for elevators pursuant to 815 KAR 4:010;
(f) Requirements for making buildings and facilities accessible to and usable by the physically handicapped pursuant to KRS 198B.260 and administrative regulations promulgated thereunder;
(g) Review of x-ray installation, construction and modification plans pursuant to 902 KAR 100:160;
(h) Food Service Establishment Act (KRS 219.011 to 219.081) and State Food Service Code (902 KAR 45:005), as amended; and
(i) Requirements for boilers pursuant to 815 KAR 15:010 through 815 KAR 15:070.
(4) Prior to occupancy the facility shall have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office before relicensure is granted by the licensing agency.
Section 4. Facility Requirements and Special Conditions.
(1) A copy of the narrative program as submitted in the certificate of need application for each project shall be provided to the licensure agency by the sponsor which describes the functional space requirements, staffing patterns, departmental relationships, and other basic information relating to the fulfillment of the objectives of the facility.
(2) The extent (number and types of rooms) of the diagnostic, clinical, and administrative facilities to be provided shall be determined by the services to be provided and the estimated patient load as described in the narrative program.
Section 5. Nursing Unit.
(1) Patient room. Each patient room shall meet the following requirements:
(a) Minimum floor area of 100 square feet in one (1) bed rooms and eighty (80) square feet per patient in multibed rooms with a maximum of two (2) patients per room.
(b) Patient toilet rooms. A toilet room shall be directly accessible from each patient room without going through the general corridor. One (1) toilet room may serve two (2) patient rooms.
(c) Lavatory. A lavatory shall be provided in each patient room. If the patient room is served by its own private toilet room the lavatory may be located in the toilet room.
(d) Window. Sill height shall not be higher than three (3) feet above the floor. Windows in psychiatric units shall be of security type or a type that can only be opened by keys or tools that are under the control of staff. Degree of security required shall be as determined by the program. Operation of the sash shall be restricted to inhibit possible tendency for escape or suicide. Where glass fragments may create a hazard, safety glazing and/or other appropriate security features shall be incorporated.
(e) If a nurses' call system is included, provisions shall be made to permit removal of call buttons and/or use of blank plates as appropriate.
(f) Visual privacy shall be provided to each patient as needed which isolates patients from one another but not from observation by staff.
(g) No patient room shall be located more than 120 feet from the nurses' station.
(h) No room shall be used as a patient room where the access is through another patient's room.
(2) Service areas. Each nursing unit shall include:
(a) A separate space for occupational therapy at the rate of fifteen (15) square feet per patient and a minimum area of 400 square feet. This space may be outside the nursing unit.
(b) A minimum of two (2) separate social spaces, one (1) appropriate for noisy activities and the other for quiet activities shall be provided. The combined area shall not be less than thirty (30) square feet per patient or not less than 120 square feet for each of the two (2) spaces, whichever is greater. This space may be shared by dining activities and may be outside of the nursing unit.
(c) Storage for patients' belongings.
(d) Bathing facilities. Bathtubs or showers shall be provided at the rate of one (1) for each four (4) beds which are not individually served. At least one (1) bathing facility shall have space for a wheelchair patient with an assisting attendant.
(e) Nurses' station for charting, communications, and storage for supplies with a sink equipped for handwashing.
(f) Clean workroom or clean holding area. There shall be a clean workroom with a work counter, handwashing and storage facilities or a clean holding room which is part of a central system for storage and distribution of clean and sterile supplies.
(g) Soiled workroom or soiled holding room. There shall be a soiled workroom with a clinical sink or equivalent flushing rim fixture, sink equipped for handwashing, work counter, waste receptacle, and linen receptacle or a soiled holding room which is a part of a central system for collection and disposal of soiled materials.
(h) Medicine area. Provision shall be made for twenty-four (24) hour distribution of medicine to patients. This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system. If a medicine preparation room or unit is used it shall be under the nursing staff's visual control and contain a work counter, refrigerator, and locked storage for biologicals and drugs. If a medicine dispensing unit is used it may be located at the nurses' station, in the clean workroom, or in an alcove or other space under direct control of the nursing or pharmacy staff. The controlled substances locker must have a double lock.
(i) Clean linen storage in an enclosed space (may be a designated area within the clean workroom). If a closed cart system is used, storage may be in an alcove.
(3) Seclusion room(s). A seclusion room shall be provided for patients requiring security and protection from either himself or others. The room shall be located in a manner affording direct observation of the patient by the nursing staff. It shall be a single room and be constructed to minimize the patient's hiding, escape, injury or suicide. There shall be a minimum of one (1) seclusion room for every twenty-four (24) beds. The seclusion room(s) is intended for short term occupancies by patients who may have become violent or suicidal. Therefore, special fixtures, hardware, etc., including ground fault interrupters for electrical circuits and tamper proof screws, shall be used. Doors shall have provisions for staff observation while maintaining privacy from public and other patients.
Section 6. Outpatient Services. Outpatient department. If outpatient services are provided outpatient facilities shall provide for the privacy and dignity of the patient during interview, examination, and treatment. Facilities shall be located so that outpatients do not transverse areas being used by inpatients.
Section 7. Laboratory Facilities. Facilities for laboratory services shall be provided directly within the psychiatric hospital or through a contract with a hospital or laboratory service for hematology, clinical chemistry, urinalysis, cytology, and bacteriology. If the psychiatric hospital has a full medical laboratory providing these services it shall comply with the applicable requirements of 902 KAR 20:009 concerning laboratories. If these services are provided through a contract, the following shall be provided in the psychiatric hospital:
(1) Laboratory work counter(s) with sink, gas and electric service;
(2) Lavatory(ies) with handwashing facility;
(3) Storage cabinet(s) or closet(s); and
(4) Specimen collection facilities. Urine collection rooms shall be equipped with a water closet and lavatory. Blood collection facilities shall have space for a chair and work counter.
Section 8. Pharmacy or Drug Room. There shall be adequate facilities for the safe storage and handling of pharmaceuticals including double locking of controlled substances and refrigeration for biologicals and drugs which require refrigeration.
Section 9. Other Medical Services. If the psychiatric hospital provides radiologic, physical therapy, surgical services or other medical services not addressed by this administrative regulation the facility shall comply with the applicable requirements of 902 KAR 20:009, Facility specifications, hospitals.
Section 10. Dietary Department. Food service facilities shall be designed and equipped for sanitary storage, processing, and handling of food. The facilities shall include refrigerated storage and dry storage to accommodate a three (3) day minimum supply and dining space for ambulatory patients, staff and visitors.
Section 11. Administrative and Public Areas. The facility shall have adequate administrative, public, and staff facilities (e.g., offices, lobby, toilet facilities) to accommodate the needs of the public, patients, and staff without interfering with the provision of medical care services.
Section 12. Medical Records Unit. This unit shall include adequate space for record storage, record review and dictating, record sorting and recording.
Section 13. Laundry.
(1) The arrangement of facilities and equipment shall assure an orderly work flow with a minimum of cross traffic that might mix clean and soiled operations.
(2) If linen is to be processed in the hospital, the following shall be provided:
(a) Soiled linen receiving, holding, and sorting room with handwashing facilities;
(b) Laundry processing room with commercial-type equipment which can process seven (7) days of linen needs within a regularly scheduled work week. Handwashing facilities shall be provided;
(c) Clean linen storage, inspection, and issuing room or area; and
(d) Cart storage and cart sanitizing facilities.
(3) If linen is to be processed off the hospital site there shall be a soiled linen holding room with a handwashing facility conveniently accessible and a room or rooms for receiving, inspection and storage of clean linen.
Section 14. Waste Processing Services. Space and facilities shall be provided for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, removal, or by a combination of these techniques.
Section 15. Details and Finishes. All details and finishes shall meet the following requirements:
(1) Doors to patient toilet rooms and other rooms needing access for wheelchairs shall have a minimum width of two (2) feet and ten (10) inches.
(2) All doors to patient-room toilets and patient-room bathrooms shall swing outward or be equipped with hardware that will permit access in an emergency.
(3) Grab bars provided at patients' toilets, showers, or tubs shall have one and one-half (1 1/2) inches clearance to walls and shall be of sufficient strength and anchorage to sustain a concentrated load of 250 pounds for a period of five (5) minutes.
(4) Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over patient bed areas unless special provisions are made to minimize such noise.
(5) Rooms containing heat-producing equipment such as boiler rooms, laundries, and food preparation areas shall be insulated and ventilated to prevent any floor surface from exceeding a temperature of ten (10) degrees Fahrenheit above the ambient room temperature.
(6) Noise reduction criteria. Partition, floor, and ceiling construction in patient areas shall comply with Section 19, Table 1 of this administrative regulation.
(7) Floors that are subject to traffic while wet, such as shower and bath areas shall have a nonslip finish.
Section 16. Elevators.
(1) Number of elevators. All hospitals having patients' facilities, such as patient rooms, dining rooms or recreation areas, or diagnostic or therapy areas, located other than on the main entrance floor shall have elevators.
(a) At least one (1) hospital-type elevator shall be installed where one (1) to fifty-nine (59) patient beds are located on any floor other than the main entrance floor.
(b) At least two (2) hospital-type elevators shall be installed where sixty (60) to 200 patient beds are located on floors other than the main entrance floor, or where the major inpatient services are located on a floor other than those containing patient beds.
(c) At least three (3) hospital-type elevators shall be installed where 201 to 350 patient beds are located on floors other than the main entrance floor, or where the inpatient services are located on a floor other than those containing patient beds.
(d) For hospitals with more than 350 beds the number of elevators shall be determined from a study of the hospital plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Cars of hospital elevators shall have inside dimensions that will accommodate a hospital bed and attendant and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep. The car door shall have a minimum clear opening of not less than three (3) feet and eight (8) inches.
Section 17. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect and/or engineer shall obtain from the contractor certification in writing that all mechanical systems have been tested and that the installation and performance of these systems conform with the final plans and specifications.
(2) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) shall be provided and the combined capacity of the boilers, based upon the published Steel Boiler Institute or Institute of Boiler and Radiation Manufacturer's net rating, must be able to supply 150 percent of the normal requirements for all systems and equipment in the facility.
(b) Boiler accessories. Boiler feed pumps, condensate return pumps, fuel oil pumps, and circulation pumps shall be connected and installed to provide normal and standby service.
(3) Air-conditioning, heating and ventilation systems.
(a) Temperatures. For all areas occupied by inpatients, the indoor winter design temperature shall be seventy-two (72) degrees Fahrenheit and the indoor summer design temperature shall be seventy-five (75) degrees Fahrenheit.
(b) Ventilation system details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates as shown in Section 19, Table 2 of this administrative regulation, shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates.
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Outdoor air intakes shall be located as far as practical but not less than twenty-five (25) feet from exhaust outlets of ventilation systems, combustion equipment stacks, plumbing vent stacks, or from areas which may collect vehicular or other noxious fumes. The bottom of outside air intakes serving central air systems shall be located as high as practical but not less than six (6) feet above ground level or if installed above the roof, three (3) feet above roof level.
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The ventilation systems shall be designed and balanced in accordance with the pressure relationships as shown in Section 19, Table 2 of this administrative regulation.
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All room supply, return and exhaust outlets shall be located not less than three (3) inches above the finished floor.
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Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate rooms such as bathrooms, toilet rooms, or janitor's closets which open directly on corridors.
(4) Plumbing systems.
(a) Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum of five (5) inches above the rim of the fixture. All fixtures in medical and nursing staff work areas and all lavatories used by food handlers shall be equipped with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall not exceed four and one-half (4 1/2) inches in length, except that handles on scrub sinks and clinical sinks shall be not less than six (6) inches long. These special fixtures are not required on lavatories in patient rooms or patient toilet rooms.
(b) Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
(c) Hot water heating systems. The hot water heating equipment shall have a sufficient capacity to supply water at the temperature and amounts indicated below:
Section 18. Electrical Requirements.
(1) General. All material including equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. All materials shall be listed as complying with applicable standards of Underwriters' Laboratories, Inc., or other similarly established standards.
(2) Panel boards. Lighting and appliance panel boards shall be located on the same floor as the circuits they serve.
(3) Lighting. Patients' bedrooms shall have general lighting and night lighting. A reading light shall be available for each patient. Patients' reading lights and other fixed lights not switched at the door shall have switch controls located convenient to the luminaire. A fixed type night light shall be provided in each patient room.
(4) Receptacles (convenience outlets).
(a) Patient room. Each patient room shall have duplex receptacles as follows: one (1) on each side of the head of the bed; and one (1) on another wall. Receptacles shall be of the safety type or shall be protected by five (5) milliampere ground fault interrupters.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart and within twenty-five (25) feet of ends of corridors. Receptacles shall be of the safety type or shall be protected by five (5) milliampere ground fault interrupters.
(5) Nurses' emergency calling system. An emergency calling system, which may be used by nurses to summon assistance, shall be provided in each nursing unit.
(6) Emergency electrical.
(a) To provide electricity during interruption of the normal electric supply, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) The source of this emergency electric service shall be as follows:
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An emergency generating set, when the normal service is supplied by one (1) or more central station transmission lines.
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An emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
(c) Emergency generating set. The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system. Generator sets shall be self-sufficient insofar as possible without dependency on public utilities that may be subject to cutoff or outages. Exception: A system of prime movers which are ordinarily used to operate other equipment and alternately used to operate the emergency generator(s) will be permitted provided that the number and arrangement of the prime movers are such that when one (1) of them is out of service (due to breakdown or for routine maintenance), the remaining prime mover(s) can operate the required emergency generator(s) and provided that the connection time requirements as listed in Section 19 of this administrative regulation are met. The emergency generator set shall be of sufficient kilowatt capacity to supply all lighting and power load demands of the emergency electrical system. The power factor rating of the generator shall be not less than eighty (80) percent.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto including exterior of exits, exit doorways, stairways, and corridors.
b. Nursing station and medication preparation areas.
c. Generator set location, switch-gear location, mechanical room and boiler room;
d. Elevator cabs.
e. Night light in patient rooms.
f. Dining and recreational areas, occupational therapy and physical therapy.
- Equipment. Essential to life safety and for protection of important equipment or vital materials:
a. Nurses' calling system.
b. Paging or speaker systems, if intended for issuing instructions during emergency conditions.
c. Fire pump and jockey pump, if installed.
d. Sewerage or sump lift pump, if installed.
e. Selected receptacles at the nurses' stations; medicine dispensing area; and basic laboratory functions, if provided.
f. Duplex receptacles in patient corridors.
g. Equipment necessary for maintaining telephone service.
- Heating. Equipment for heating patient rooms; except that service for heating of patient rooms will not be required if:
a. The hospital is supplied by two (2) or more electrical services supplied from separate generating sources, or a utility distribution network having multiple power input sources and arranged to provide mechanical and electrical separation; so that a fault between the hospital and generating sources will not likely cause an interruption of the hospital service feeders;
b. The hospital has an alternate emergency heating system for the heating of corridors; or
c. The hospital has a written plan approved by the licensure agency for the transfer of patients within a reasonable time to other facilities.
(e) Details. The emergency electrical system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and it must be connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting systems; alarms systems; nurses' calling systems; equipment necessary for maintaining telephone service; and task illumination and receptacles in patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification. Storage-battery-powered lights, provided to augment the emergency lighting or for continuity of lighting during the interim of transfer switching immediately following an interruption of the normal service supply, shall not be used as a substitute for the requirement of a generator. Where stored fuel is required for emergency generator operation, the storage capacity shall be sufficient for not less than twenty-four (24) hours of continuous operation.
Section 19. Tables.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides the licensure requirements for the structural specifications and physical plant requirements for new construction, alteration and maintenance of psychiatric hospital facilities. Psychiatric hospital facilities licensed prior to the effective date of this administrative regulation shall meet the facility specifications in force on the date of their most recent licensure inspection.
- History: 900 KAR 020:170. 9 Ky.R. 1350; eff. 7-6-1983; 16 Ky.R. 1018; eff. 1-12-1990; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:180 Psychiatric hospitals; operation and services {#sec-902-kar-20-180 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:180}
Section 1. Definitions.
(1) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy or a medical officer of the government of the United States while engaged in the performance of official duties who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A physician assistant licensed under KRS 311.840 to 311.862;
(h) A marriage and family therapist licensed and practicing in accordance with KRS 335.300;
(i) A professional clinical counselor licensed and practicing in accordance with KRS 335.500; or
(j) A licensed professional art therapist as defined by KRS 309.130(2).
(2) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapist associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4); or
(f) Licensed professional art therapist associate as defined by KRS 309.130(3).
(3) "Cabinet" means the Cabinet for Health and Family Services.
(4) "Certified alcohol and drug counselor" is defined by KRS 309.080(2).
(5) "Chemical restraint" means the use of a drug that:
(a) Is administered to manage a patient's behavior in a way that reduces the safety risk to the patient or others;
(b) Has the temporary effect of restricting the patient's freedom of movement; and
(c) Is not a standard treatment for the patient's medical or psychiatric condition.
(6) "Child with a severe emotional disability" is defined by KRS 200.503(3).
(7) "Community support associate" means a paraprofessional who meets the application, training, and supervision requirements of 908 KAR 2:250.
(8) "Governing authority" means the individual, agency, partnership, or corporation in which the ultimate responsibility and authority for the conduct of the hospital is vested.
(9) "Licensed assistant behavior analyst" is defined by KRS 319C.010(7).
(10) "Licensed behavior analyst" is defined by KRS 319C.010(6).
(11) "Licensed clinical alcohol and drug counselor" is defined by KRS 309.080(4).
(12) "Licensed clinical alcohol and drug counselor associate" is defined by KRS 309.080(5).
(13) "Mechanical restraint" means any device attached or adjacent to a patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to his or her body.
(14) "Peer support specialist" means a paraprofessional who meets the application, training, examination, and supervision requirements of 908 KAR 2:220, 908 KAR 2:230, or 908 KAR 2:240.
(15) "Personal restraint" means the application of physical force without the use of any device for the purpose of restraining the free movement of a patient's body, except for briefly holding a patient, without undue force, in order to calm or comfort him or her or holding a patient's hand to safely escort him or her from one (1) area to another.
(16) "Professional staff" means psychiatrists and other physicians, psychologists, psychiatric nurses and other nurses, social workers, and other professionals with special education or experience in the care of persons with mental illness and who are involved in the diagnosis and treatment of patients with mental illness.
(17) "Psychiatric unit" means a department of a critical access hospital with a maximum of ten (10) psychiatric beds or general acute care hospital consisting of eight (8) or more psychiatric beds organized for the purpose of providing psychiatric services.
(18) "Seclusion" means the involuntary confinement of a patient alone in a room or in an area from which the patient is physically prevented from leaving.
(19) "Severe mental illness" means the conditions defined by KRS 210.005(2) and (3).
Section 2. Applicability.
(1)
(a) A general acute care hospital or a critical access hospital with a psychiatric unit shall:
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Designate the location and number of beds for which licensure is sought;
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Meet the requirements of 902 KAR 20:016; and
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Meet the requirements of this administrative regulation.
(b) A facility requesting licensure exclusively as a psychiatric hospital shall be subject to the requirements of this administrative regulation.
(2) A facility shall not be licensed as, or be called, a psychiatric hospital unless the facility:
(a) Provides the full range of services required by Section 5 of this administrative regulation; and
(b) Provides for the treatment of a variety of mental illnesses.
(3) A psychiatric hospital and a general acute care hospital or critical access hospital with a psychiatric unit that has a mean daily census of patients whose primary diagnosis is chemical dependency exceeding ten (10) percent of the licensed bed capacity shall:
(a) Apply for a certificate of need in order to convert the necessary number of beds to chemical dependency services;
(b) Meet the licensure requirements established in 902 KAR 20:160; and
(c) Report the mean daily census in the Annual Hospital Utilization Report.
(4) If a psychiatric hospital or a general acute care hospital or a critical access hospital with a psychiatric unit provides outpatient behavioral health services as described in Section 6 of this administrative regulation:
(a) The outpatient behavioral health services shall be provided:
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On a separate floor, in a separate wing, or in a separate building on the hospital's campus; or
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At an extension off the campus of the hospital;
(b) The hospital shall pay a fee in the amount of $250 per off-campus extension providing outpatient behavioral health services, submitted to the Office of Inspector General at the time of:
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Initial licensure, if applicable;
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The addition of a new outpatient behavioral health services extension to the hospital's license; and
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Renewal;
(c) Each off-campus extension or on-campus program of outpatient behavioral health services shall:
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Be listed on the hospital's license;
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Have a program director who shall be a:
a. Psychiatrist;
b. Physician;
c. Certified or licensed psychologist;
d. Licensed psychological practitioner;
e. Psychiatric nurse;
f. Advanced practice registered nurse;
g. Licensed professional clinical counselor;
h. Licensed marriage and family therapist;
i. Licensed professional art therapist;
j. Licensed board certified behavioral analyst; or
k. Licensed clinical social worker; and
- Employ directly or by contract a sufficient number of personnel to provide outpatient behavioral health services; and
(d) An off-campus extension or a separate building on the campus of the hospital where outpatient behavioral health services are provided shall comply with the physical environment requirements of Section 7 of this administrative regulation and be approved by the State Fire Marshal's office prior to:
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Initial licensure;
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The addition of the extension or on-campus program of outpatient behavioral health services in a separate building; or
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A change of location.
Section 3. Administration and Operation.
(1) General requirements. A psychiatric hospital and a general acute care hospital or critical access hospital with a psychiatric unit shall comply with:
(a) This section;
(b) 902 KAR 20:016, Section 3; and
(c) KRS Chapters 202A and 202B.
(2) Professional staff. A facility requesting licensure exclusively as a psychiatric hospital shall comply with the following staffing requirements rather than those in 902 KAR 20:016, Section 3(8):
(a) The psychiatric hospital shall have a professional staff:
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Organized under bylaws approved by the governing authority;
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Responsible to the governing authority for the quality of clinical care provided to patients;
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Responsible for the ethical conduct and professional practice of its members; and
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Responsible for developing and adopting bylaws, subject to the approval of the governing authority, which shall:
a. Require that a licensed physician be responsible for admission, diagnosis, all medical care and treatment, and discharge;
b. State the necessary qualifications for professional staff membership;
c. Define and describe the responsibilities and duties of each category of professional staff, such as whether staff is active, associate, courtesy, consulting, or honorary;
d. Delineate the clinical privileges of staff members;
e. Establish a procedure for granting and withdrawing staff privileges, including credentials review;
f. Provide a mechanism for appeal of decisions regarding staff membership and privileges;
g. Provide a method for the selection of officers of the professional staff;
h. Establish requirements regarding the frequency of, and attendance at, general staff and department or service meetings of the professional staff;
i. Provide for the appointment of standing and special committees, which may include the following:
(i) Executive committee;
(ii) Credential committee;
(iii) Medicaid audit committee;
(iv) Medical records committee;
(v) Infections control committee;
(vi) Pharmacy and therapeutic committee;
(vii) Utilization review committee;
(viii) Quality assurance committee; and
(ix) Behavioral health committee;
j. Establish the composition and organization of the standing and special committees, and assure that the committees' minutes and reports shall be part of the permanent records of the hospital; and
k. Establish a policy requiring a physician, or other member of the professional staff permitted to order diagnostic testing and treatment, to sign telephone orders for diagnostic testing and treatment within seventy-two (72) hours of the time the order was given.
(b) A psychiatric hospital shall develop a process of appointment to the professional staff which shall ensure that the individual requesting staff membership is appropriately licensed, certified, registered, or experienced, and qualified for the privileges and responsibilities sought.
(3) Background checks.
(a) All personnel of a state-owned and operated psychiatric hospital and all personnel of a privately operated psychiatric center under contract with the Department for Behavioral Health, Developmental and Intellectual Disabilities who are hired after the effective date of this administrative regulation and have duties that involve or may involve one-on-one contact with a patient or client shall:
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Have a criminal record check performed upon initial hire through the Administrative Office of the Courts or the Kentucky State Police;
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Not have a criminal conviction, or plea of guilty, to a:
a. Sex crime as specified in KRS 17.500;
b. Violent crime as specified in KRS 439.3401;
c. Criminal offense against a minor as specified in KRS 17.500; or
d. Class A felony; and
- Not be listed on the following:
a. Central registry established by 922 KAR 1:470;
b. Nurse aide or home health aide abuse registry established by 906 KAR 1:100; or
c. Caregiver misconduct registry required by KRS 209.032 and established by 922 KAR 5:120.
(b) A state-owned and operated psychiatric hospital, or a privately operated psychiatric center under contract with the Department for Behavioral Health, Developmental and Intellectual Disabilities, may use Kentucky's national background check system established by 906 KAR 1:190 to satisfy the background check requirements of paragraph (a) of this subsection.
(c) A state-owned and operated psychiatric hospital and a privately operated psychiatric center under contract with the Department for Behavioral Health, Developmental and Intellectual Disabilities shall perform annual criminal record and registry checks as described in paragraph (a) of this subsection on a random sample of at least fifteen (15) percent of all personnel.
(4) Policies for psychiatric hospitals and general acute care hospitals or critical access hospitals with a psychiatric unit.
(a) Written admission and discharge policies shall be consistent with the requirements of KRS Chapters 202A and 202B.
(b) Written policies pertaining to patient rights and the use of restraints and seclusion shall be consistent with KRS Chapters 202A and 202B.
(c) Written policies concerning the use of special treatment procedures as described in Section 4(3) of this administrative regulation shall specify the qualifications required for professional staff using special treatment procedures.
(5) Patient rights. A psychiatric hospital and a general acute care hospital or critical access hospital with a psychiatric unit shall assure that patient rights are provided for pursuant to KRS Chapters 202A and 202B.
(6) Medical records.
(a) Ownership.
-
Medical records shall be the property of the hospital.
-
The original medical record shall not be removed from the facility except by court order or subpoena.
-
Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established in this administrative regulation.
(b) Confidentiality and security: use and disclosure.
-
The psychiatric hospital and general acute care hospital or critical access hospital with a psychiatric unit shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law, including 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
-
The psychiatric hospital and general acute care hospital or critical access hospital with a psychiatric unit may use and disclose medical records. Use and disclosure shall be as established or required by:
a. HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164; or
b. 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
- This administrative regulation shall not be construed to forbid the hospital from establishing higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(c) Patient information. The medical record shall contain:
-
Appropriate court order or consent of patient, authorized family member or guardian for admission, evaluation, and treatment;
-
A provisional or admitting diagnosis which includes a physical diagnosis, if applicable, and a diagnosis of mental health disorder, substance use disorder, or co-occurring disorder;
-
Results of the psychiatric evaluation;
-
A complete social history;
-
An individualized comprehensive treatment plan;
-
Progress notes, dated and signed by physician, nurse, social worker, psychologist, or other individuals involved in treatment of patient. Progress notes shall document services and treatments provided and the patient's progress in response to the services and treatments;
-
A record of the patient's weight;
-
Special clinical justification for the use of special treatment procedures described in Section 4(3) of this administrative regulation;
-
A discharge summary which includes a:
a. Recapitulation of the patient's hospitalization and recommendations from appropriate services concerning follow-up or after care; and
b. Brief summary of the patient's condition on discharge;
-
If a patient dies, a summation statement in the form of a discharge summary, including events leading to the death, signed by the attending physician; and
-
If an autopsy is performed, a provisional anatomic diagnosis shall be included in the patient's record within seventy-two (72) hours with the complete summary and pathology report, including cause of death, recorded within three (3) months.
Section 4. Patient Management.
(1) Assessment. A psychiatric hospital and a general acute care hospital or critical access hospital with a psychiatric unit shall be responsible for conducting a complete assessment of each patient.
(a) A provisional or admitting diagnosis, which includes the diagnosis of physical diseases, if applicable, and the psychiatric diagnosis, shall be made for each patient at the time of admission.
(b) A history and physical examination shall be conducted according to the requirements of KRS 216B.175(2).
- The history and physical examination shall include:
a. A description of the patient's chief complaint, the major reason for hospitalization;
b. A history of the patient's:
(i) Present illness;
(ii) Past illnesses;
(iii) Surgeries;
(iv) Medications;
(v) Allergies;
(vi) Social history; and
(vii) Immunizations;
c. A review of the patient's anatomical systems and level of function at the time of the exam;
d. A patient's vital signs; and
e. A general observation of the patient's:
(i) Alertness;
(ii) Debilities; and
(iii) Emotional behavior.
- The results of the history and physical examination shall be recorded, reviewed for accuracy, and signed by the practitioner conducting the examination.
(c) A psychiatric evaluation for each patient shall:
-
Be completed within seventy-two (72) hours of admission; and
-
Include the following:
a. A medical history;
b. A record of mental status;
c. Details regarding onset of illness and circumstances leading to admission;
d. A description of attitudes and behavior;
e. An estimate of intellectual functioning, memory functioning, and orientation; and
f. An inventory of the patient's assets in a descriptive, not interpretative, fashion.
(d) A social assessment of each patient shall be recorded.
(e) An activities assessment of each patient shall be prepared and shall include information relating to the patient's current skills, talents, aptitudes, and interest.
(f)
-
If appropriate, nutritional, vocational, and legal assessments shall be conducted.
-
The legal assessment shall be used to determine the extent to which the patient's legal status will influence progress in treatment.
(2) Treatment plans.
(a) Each patient shall have a written individualized treatment plan that is based on assessments of the patient's clinical needs and approved by the patient's attending physician.
(b) Overall development and implementation of the treatment plan shall be assigned to appropriate members of the professional staff.
(c) Within seventy-two (72) hours following admission, a designated member of the professional staff shall develop an initial treatment plan that is based on an assessment of the patient's:
-
Presenting problems;
-
Physical health;
-
Emotional and behavioral status; and
-
Other relevant factors.
(d) Appropriate therapeutic efforts shall begin before a master treatment plan is finalized. A master treatment plan shall:
-
Be developed by a multidisciplinary team within ten (10) days for any patient remaining in treatment beyond the initial evaluation;
-
Be based on a comprehensive assessment of the patient's needs;
-
Include a substantiated diagnosis;
-
Include short-term and long-range treatment needs;
-
Address the specific treatment modalities required to meet the patient's needs;
-
Include referrals for services not provided directly by the facility;
-
Contain specific and measurable goals for the patient to achieve;
-
Describe the services, activities, and programs to be provided to the patient;
-
Specify staff members assigned to work with the patient and the time and frequency for each treatment procedure;
-
Specify criteria to be met for termination of treatment;
-
Include participation by the patient to the maximum extent feasible in the development of the patient's treatment plan and document patient participation in the patient's record;
-
Include a specific plan for involving the patient's family or significant others in development of the treatment plan if indicated; and
-
Be reviewed and updated through multidisciplinary case conferences as frequently as clinically indicated and in accordance with the following:
a. The review and update shall be completed:
(i) No later than thirty (30) days following the first ten (10) days of treatment; and
(ii) Every sixty (60) days thereafter for the first year of treatment; and
b. Following one (1) year of continuous treatment, the review and update may be conducted at three (3) month intervals.
(3) Special treatment procedures.
(a) Special documentation shall be included in the patient's medical record concerning the use of chemical, personal, or mechanical restraints or seclusion.
(b) The documentation shall include:
-
The written order of a physician, advanced practice registered nurse, or physician's assistant;
-
Justification for the use of the restraint or seclusion;
-
The required consent forms;
-
A description of procedures employed to protect the patient's safety and rights; and
-
A description of the procedure used.
(c) The use of chemical, personal, or mechanical restraints and seclusion shall be governed by the following:
- Restraint or seclusion shall be used only to prevent:
a. A patient from injuring himself, herself, or others; or
b. Serious disruption of the therapeutic program;
-
A written, time-limited order from a physician, advanced practice registered nurse, or physician assistant shall be required for the use of restraint or seclusion;
-
The head of the medical staff shall give written approval when restraint or seclusion is utilized for longer than twenty-four (24) hours;
-
PRN orders shall not be used to authorize the use of restraint or seclusion;
-
The head of the medical staff or his or her designee shall:
a. Review daily all uses of restraint or seclusion; and
b. Investigate unusual or possibly unwarranted patterns of utilization;
-
Restraint or seclusion shall not be used in a manner that causes undue physical discomfort, harm, or pain to the patient;
a. Appropriate attention shall be paid every fifteen (15) minutes to a patient in restraint or seclusion, including attention in regard to regular meals, bathing, and use of the toilet; and
b. Staff shall document in the patient's record that the attention was given to the patient.
(d) Locking mechanical restraints may be used pursuant to subparagraph 5 of this paragraph if the cabinet has previously found that the facility has instituted policies which comply with the provisions of paragraph (c) of this subsection and the following requirements:
- Keys. A facility's direct care nursing staff shall:
a. Have in their possession at least two (2) keys to a locking restraint so that the restraint can be removed immediately in the case of an emergency;
b. Have a plan which designates nursing staff responsible for the keys; and
c. Follow written policy which explains how the keys are to be used.
- An order for a locking mechanical restraint shall be time-limited as follows:
a. Four (4) hours for adults eighteen (18) years of age or older up to a maximum of twenty-four (24) hours, during which time the continued need for the restraint shall be evaluated at fifteen (15) minute intervals until the maximum time is reached;
b. Two (2) hours for children and adolescents ages nine (9) to seventeen (17) up to a maximum of twenty-four (24) hours, during which time the continued need for the restraint shall be evaluated at fifteen (15) minute intervals until the maximum time is reached;
c. One (1) hour for patients under the age of nine (9) up to a maximum of twenty-four (24) hours, during which time the continued need for the restraint shall be evaluated at fifteen (15) minute intervals until the maximum time is reached; and
d. Orders pursuant to this paragraph shall specify the restraint type and criteria for release in the patient's medical record.
a. If, after twenty-four (24) hours, a patient still appears to need restraint, the patient shall receive a face-to-face reassessment by a licensed physician.
b. If the physician determines that continued restraint is necessary, the physician shall write a time-limited order according to the time frames set out in subparagraph 2 of this paragraph;
-
A facility may reinstitute the use of a restraint that has been discontinued if the time frame limited order for the restraint has not expired; and
-
A facility found to be in compliance with this section may use locking mechanical restraints only under the following circumstances:
a. For the transport of forensic or other impulsively violent patients;
b. For the crisis situation stabilization of forensic and other impulsively violent patients;
c. To prevent a patient who has demonstrated the ability to escape from a nonlocking mechanical restraint on one (1) or more occasions; or
d. For a patient requiring ambulatory restraints as approved by a behavioral health management team.
Section 5. Provision of Services.
(1) Psychiatric and general medical services.
(a) Psychiatric services shall be under the supervision of a clinical director, service chief, or equivalent, who is qualified as follows to provide the leadership required for an intensive treatment program:
-
The clinical director, or equivalent, shall be certified by the American Board of Psychiatry and Neurology, or shall meet the training and experience requirements for examination by the board.
-
If the psychiatrist in charge of the clinical program is not board certified, there shall be evidence that consultation is given to the clinical program on a continuing basis by a psychiatrist certified by the American Board of Psychiatry and Neurology.
(b) General medical services provided in the psychiatric hospital or general acute care hospital or a critical access hospital with a psychiatric unit shall be under the direction of a physician member of the professional staff in accordance with staff privileges granted by the governing authority.
a. The attending physician shall assume full responsibility for diagnosis and care of his or her patient.
b. Services provided by a physician assistant or advanced practice registered nurse shall be provided within the practitioner's scope of practice and the hospital's protocols and bylaws.
a. Incidental medical services necessary for the care and support of patients shall be provided by in-house staff or through agreement with outside resources.
b. If a patient's condition requires services not available in the hospital, the patient, on physician's orders, shall be transferred promptly to an appropriate level of care.
c. A physician's order is not necessary in the case of an emergency.
- There shall be a written plan delineating the manner in which emergency services are provided by the hospital or through clearly defined arrangements with another facility. The plan shall clearly specify the following:
a. The arrangement the hospital has made to assure that the patient being transferred for emergency services to a nonpsychiatric facility will continue to receive further evaluation or treatment of the psychiatric problem, as needed;
b. The policy for referring a patient in need of continued psychiatric care after emergency services back to the referring facility; and
c. The policy for notifying a patient's family of an emergency and arrangements that have been made for referring or transferring the patient to another facility for emergency service.
(c) Physician services shall be available twenty-four (24) hours a day on at least an on-call basis.
(d) There shall be sufficient physician staff coverage for all psychiatric and medical services of the hospital, in keeping with their size and scope of activity.
(e) The attending physician shall state the final diagnosis, complete the discharge summary, and sign the records within fifteen (15) days following the patient's discharge.
(2) Nursing services.
(a) The hospital shall have a nursing department organized to meet the nursing care needs of the patients and maintain established standards of nursing practice.
(b) The psychiatric nursing service shall be under the direction of a registered nurse who:
-
Has a master's degree in psychiatric or mental health nursing, or its equivalent, from a school of nursing accredited by the National League for Nursing; or
-
Has a baccalaureate degree in nursing with two (2) years' experience in nursing administration or supervision and experience in psychiatric nursing.
(c) There shall be a registered nurse on duty twenty-four (24) hours a day.
(d) There shall be an adequate number of registered nurses, licensed practical nurses, and other nursing personnel to provide the nursing care necessary under each patient's active treatment program.
(e) There shall be continuing in-service and staff development programs to prepare nursing personnel for active participation in interdisciplinary meetings affecting the planning or implementation of nursing care plans for patients.
(3) Psychological services.
(a) The hospital shall provide psychological services to meet the needs of patients.
(b) Psychological services shall be provided under the direction of a licensed psychologist.
(c) There shall be an adequate number of psychologists, consultants, and supporting personnel to:
-
Assist in essential diagnostic formulations;
-
Participate in program development;
-
Participate in the evaluation of program effectiveness; and
-
Participate in training activities and in therapeutic interventions.
(4) Therapeutic activities.
(a) The hospital shall provide a therapeutic activities program that shall:
-
Be appropriate to the needs and interests of the patients; and
-
Directed toward restoring and maintaining optimal levels of physical and psychosocial functioning.
(b) The number of qualified therapists, support personnel, and consultants shall be adequate to provide comprehensive therapeutic activities, including occupational, recreational, and physical therapy, consistent with each patient's active treatment program.
(5) Pharmaceutical services. The hospital shall comply with requirements of 902 KAR 20:016, Section 4(5), and the following requirements:
(a) Medication shall be administered by one (1) of the following:
-
Registered nurse;
-
Physician;
-
Dentist;
-
Physician assistant; or
-
Advanced practice registered nurse, except in the case of a licensed practical nurse under the supervision of a registered nurse.
(b)
- Medication shall be given only by written order signed within seventy-two (72) hours by one (1) of the following:
a. Physician;
b. Dentist;
c. Advanced practice registered nurse;
d. Therapeutically-certified optometrist; or
e. Physician assistant.
- A telephone order for medication shall be given to only a:
a. Licensed practical nurse;
b. Registered nurse; or
c. Pharmacist.
- A telephone order may be given to a licensed physical, occupational, speech, or respiratory therapist in accordance with the therapist's scope of practice and the hospital's protocol.
(6) Laboratory services. A hospital shall comply with 902 KAR 20:016, Section 4(4), concerning the provision of laboratory and pathology services.
(7) Social services.
(a) A hospital shall provide social services to meet the need of the patients.
(b) There shall be a director of social services who has a master's degree from an accredited school of social work.
(c) There shall be an adequate number of social workers, consultants, and other assistants or case aides to perform the following functions:
-
Secure information about a patient's development and current life situation in order to provide psychosocial data for diagnosis and treatment planning and for direct therapeutic services to a patient, patient group, or family;
-
Identify or develop community resources including family or foster care programs;
-
Participate in interdisciplinary conferences and meetings concerning diagnostic formulation, treatment planning and progress reviews; and
-
Participate in discharge planning, arrange for follow-up care, and develop a mechanism for exchange of appropriate information with a source outside the hospital.
(8) Dietary services. A hospital shall comply with 902 KAR 20:016, Section 4(3), pertaining to the provision of dietary services, and requirements contained in this subsection.
(a) Dietary service personnel who have personal contact with the patients shall be made aware that emotional factors may cause patients to change their food habits and shall inform appropriate members of the professional staff of any change.
(b) Meals shall be provided in central dining areas for ambulatory patients.
(9) Radiology services.
(a) If radiology services are provided within the facility, the hospital shall comply with 902 KAR 20:016, Section 4(6), concerning the provision of radiology services.
(b)
-
If radiology services are not provided within the facility, the hospital shall have an arrangement with an outside source.
-
The arrangement shall be outlined in a written plan.
-
The outside radiology service shall have a current license or registration pursuant to KRS 211.842 to 211.852 and relevant administrative regulations.
(10) Other services. If surgery, anesthesia, physical therapy or outpatient services are provided within the facility, the hospital shall comply with the applicable sections of 902 KAR 20:016.
(11) Chemical dependency treatment services. A psychiatric hospital providing chemical dependency treatment services shall meet the requirements of 902 KAR 20:160, Sections 3 and 4, and shall designate the location and number of beds to be used for this purpose.
Section 6. Outpatient behavioral health services.
(1) A psychiatric hospital or general acute care or critical access hospital with a psychiatric unit may provide one (1) or more of the following outpatient behavioral health services on the campus of the hospital if provided on a separate floor, in a separate wing, in a separate building on the hospital's campus, or at an off-site extension location:
(a) Screening which shall be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice to determine the:
-
Likelihood that an individual has a mental health, substance use, or co-occurring disorder; and
-
Need for an assessment;
(b) Assessment which shall:
- Be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, a certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice who gathers information and engages in a process with the client, thereby enabling the professional to:
a. Establish the presence or absence of a mental health, substance use, or co-occurring disorder;
b. Determine the client's readiness for change;
c. Identify the client's strengths or problem areas which may affect the treatment and recovery processes; and
d. Engage the client in developing an appropriate treatment relationship;
-
Establish or rule out the existence of a clinical disorder or service need;
-
Include working with the client to develop a plan of care if a clinical disorder or service need is assessed; and
-
Not include psychological or psychiatric evaluations or assessments;
(c) Psychological testing which shall:
-
Be performed by a licensed psychologist, licensed psychological associate, or licensed psychological practitioner; and
-
Include a psychodiagnostic assessment of personality, psychopathology, emotionality, or intellectual disabilities and interpretation and written report of testing results;
(d) Crisis intervention which:
-
Shall be a therapeutic intervention for the purpose of immediately reducing or eliminating the risk of physical or emotional harm to the client or another individual;
-
Shall consist of clinical intervention and support services necessary to provide integrated crisis response, crisis stabilization interventions, or crisis prevention activities;
-
Shall be provided:
a. On-site at the facility;
b. As an immediate relief to the presenting problem or threat; and
c. In a face-to-face, one (1) on one (1) encounter;
-
May include verbal de-escalation, risk assessment, or cognitive therapy;
-
Shall be provided by one (1) or more of the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate;
-
Shall be followed by a referral to noncrisis services, if applicable; and
-
May include:
a. Further service prevention planning, including:
(i) Lethal means reduction for suicide risk; or
(ii) Substance use disorder relapse prevention; or
b. Verbal de-escalation, risk assessment, or cognitive therapy;
(e) Mobile crisis services which shall:
-
Be available twenty-four (24) hours a day, seven (7) days a week, every day of the year;
-
Be provided for a duration of less than twenty-four (24) hours;
-
Not be an overnight service; and
-
Be a multi-disciplinary team based intervention that ensures access to acute mental health and substance use services and supports to:
a. Reduce symptoms or harm; or
b. Safely transition an individual in an acute crisis to the appropriate, least restrictive level of care;
- Involve all services and supports necessary to provide:
a. Integrated crisis prevention;
b. Assessment and disposition;
c. Intervention;
d. Continuity of care recommendations; and
e. Follow-up services;
- Be provided face-to-face in a home or community setting by one (1) or more of the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate; and
- Ensure access to a board certified or board-eligible psychiatrist twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(f) Day treatment which shall:
- Be a nonresidential, intensive treatment program designed for children who:
a. Have a substance use disorder, mental health disorder, or co-occurring disorder;
b. Are under twenty-one (21) years of age; and
c. Are at high risk of out-of-home placement due to a behavioral health issue;
-
Consist of an organized behavioral health program of treatment and rehabilitative services for substance use disorder, mental health disorder, or a co-occurring disorder;
-
Have unified policies and procedures that address the organization's philosophy, admission and discharge criteria, admission and discharge process, staff training, and integrated case planning;
-
Include the following:
a. Individual outpatient therapy, family outpatient therapy, or group outpatient therapy;
b. Behavior management and social skill training;
c. Independent living skills that correlate to the age and development stage of the client; and
d. Services designed to explore and link with community resources before discharge and to assist the client and family with transition to community services after discharge;
- Be provided as follows:
a. In collaboration with the education services of the local education authority including those provided through 20 U.S.C. 1400 et seq. (Individuals with Disabilities Education Act) or 29 U.S.C. 701 et seq. (Section 504 of the Rehabilitation Act);
b. On school days and during scheduled school breaks;
c. In coordination with the child's individual educational plan or Section 504 plan if the child has an individual educational plan or Section 504 plan;
d. By personnel that includes a behavioral health professional, a behavioral health professional under clinical supervision, a certified alcohol and drug counselor, a licensed clinical alcohol and drug counselor, a licensed clinical alcohol and drug counselor associate, or a peer support specialist practicing within his or her scope of practice; and
e. According to a linkage agreement with the local education authority that specifies the responsibilities of the local education authority and the day treatment provider; and
- Not include a therapeutic clinical service that is included in a child's individualized education plan;
(g) Peer support which shall:
-
Be provided by a peer support specialist;
-
Be structured and scheduled nonclinical therapeutic activity with a client or group of clients;
-
Promote socialization, recovery, self-advocacy, preservation, and enhancement of community living skills; and
-
Be identified in the client's plan of care;
(h) Intensive outpatient program services which shall:
-
Offer a multi-modal, multi-disciplinary structured outpatient treatment program that is more intensive than individual outpatient therapy, group outpatient therapy, or family outpatient therapy;
-
Be provided at least three (3) hours per day at least three (3) days per week;
-
Include the following:
a. Individual outpatient therapy;
b. Group outpatient therapy;
c. Family outpatient therapy unless contraindicated;
d. Crisis intervention; or
e. Psycho-education during which the client or client's family member shall be:
(i) Provided with knowledge regarding the client's diagnosis, the causes of the condition, and the reasons why a particular treatment might be effective for reducing symptoms; and
(ii) Taught how to cope with the client's diagnosis or condition in a successful manner;
- Include a treatment plan which shall:
a. Be individualized; and
b. Focus on stabilization and transition to a lower level of care;
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
-
Include access to a board-certified or board-eligible psychiatrist for consultation;
-
Include access to a psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring; and
-
Be provided in a setting with a minimum client-to-staff ratio of ten (10) clients to one (1) staff person;
(i) Individual outpatient therapy which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
- Consist of:
a. A face-to-face encounter with the client; and
b. A behavioral health therapeutic intervention provided in accordance with the client's plan of care;
- Be aimed at:
a. Reducing adverse symptoms;
b. Reducing or eliminating the presenting problem of the client; and
c. Improving functioning;
-
Not exceed three (3) hours per day; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
(j) Group outpatient therapy which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
-
Consist of a face-to-face behavioral health therapeutic intervention provided in accordance with the client's plan of care;
-
Excluding multi-family group therapy, be provided in a group setting of nonrelated individuals, not to exceed twelve (12) individuals in size. For group outpatient therapy, a nonrelated individual means any individual who is not a spouse, significant other, parent or person with custodial control, child, sibling, stepparent, stepchild, step-brother, step-sister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild;
-
Focus on the psychological needs of the client as evidenced in the client's plan of care;
-
Center on goals including building and maintaining healthy relationships, personal goals setting, and the exercise of personal judgment;
-
Not include physical exercise, a recreational activity, an educational activity, or a social activity;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130;
-
Ensure that the group has a deliberate focus and defined course of treatment;
-
Ensure that the subject of group outpatient therapy shall be related to each client participating in the group; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice who shall maintain individual notes regarding each client within the group in the client's record;
(k) Family outpatient therapy which shall:
-
Consist of a face-to-face behavioral health therapeutic intervention provided through scheduled therapeutic visits between the therapist, at least one (1) member of the client's family, and the client unless the client's presence is not required in his or her plan of care;
-
Address issues interfering with the relational functioning of the family;
-
Seek to improve interpersonal relationships within the client's home environment;
-
Be provided to promote the health and wellbeing of the client or recovery from a substance use disorder;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130; and
-
Be provided by a behavioral health professional, a behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
(l) Collateral outpatient therapy which shall consist of a face-to-face behavioral health consultation on behalf of a client under the age of twenty-one (21):
-
With a parent, caregiver, person who has custodial control, household member, legal representative, school personnel, or treating professional;
-
Provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice; and
-
Provided upon the written consent of a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21). Documentation of written consent shall be signed and maintained in the client's record;
(m) Service planning which shall be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, or licensed assistant behavior analyst working under the supervision of a licensed behavior analyst to:
-
Assist a client in creating an individualized plan for services needed for maximum reduction of the effects of a mental health disorder;
-
Restore a client's functional level to the client's best possible functional level; and
-
Develop a service plan which:
a. Shall be directed by the client; and
b. May include:
(i) A mental health advance directive being filed with a local hospital;
(ii) A crisis plan; or
(iii) A relapse prevention strategy or plan;
(n) Screening, brief intervention, and referral to treatment for substance use disorders which shall:
-
Be an evidence-based early intervention approach for an individual with non-dependent substance use prior to the need for more extensive or specialized treatment;
-
Consist of:
a. Using a standardized screening tool to assess the individual for risky substance use behavior;
b. Engaging a client who demonstrates risky substance use behavior in a short conversation, providing feedback and advice; and
c. Referring the client to therapy or other services that address substance use if the client is determined to need additional services; and
- Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
(o) Assertive community treatment for mental health disorders which shall:
-
Include assessment, treatment planning, case management, psychiatric services, medication prescribing and monitoring, individual and group therapy, peer support, mobile crisis services, mental health consultation, family support, and basic living skills;
-
Be provided by a multidisciplinary team of at least four (4) professionals, including a psychiatrist, nurse, case manager, peer support specialist and any other behavioral health professional or behavioral health professional under clinical supervision; and
-
Have adequate staffing to ensure that no caseload size exceeds ten (10) participants per team member;
(p) Comprehensive community support services which shall:
-
Consist of activities needed to allow an individual with a mental health disorder to live with maximum independence in the community through the use of skills training as identified in the client's treatment plan;
-
Consist of using a variety of psychiatric rehabilitation techniques to:
a. Improve daily living skills;
b. Improve self-monitoring of symptoms and side effects;
c. Improve emotional regulation skills;
d. Improve crisis coping skills;
e. Develop and enhance interpersonal skills; and
f. Be provided by a;
(i) Behavioral health professional;
(ii) Behavioral health professional under clinical supervision;
(iii) Community support associate;
(iv) Licensed behavior analyst; or
(v) Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
(q) Therapeutic rehabilitation program for an adult with a severe mental illness or child with a severe emotional disability which shall:
-
Include services designed to maximize the reduction of mental illness or emotional disability and restoration of the client's functional level to the individual's best possible functioning;
-
Establish the client's own rehabilitative goals within the person-centered plan of care;
-
Be delivered using a variety of psychiatric rehabilitation techniques focused on:
a. Improving daily living skills;
b. Self-monitoring of symptoms and side effects;
c. Emotional regulation skills;
d. Crisis coping skills; and
e. Interpersonal skills; and
- Be provided individually or in a group by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision; or
c. Peer support specialist;
(r) Targeted case management services which shall:
- Include services to one (1) or more of the following target groups:
a. An adult or a child with substance use disorder;
b. An adult or child with co-occurring mental health or substance use disorder and chronic or complex physical health issues;
c. A child with a severe emotional disability; or
d. An adult with severe mental illness;
-
Be provided by a case manager as described in subsection (2), (3), or (4) of this section; and
-
Include the following assistance:
a. Comprehensive assessment and reassessment of client needs to determine the need for medical, educational, social, or other services. The reassessment shall be conducted annually or more often if needed based on changes in the client's condition;
b. Development of a specific care plan which shall be based on information collected during the assessment and revised if needed upon reassessment;
c. Referral and related activities, which may include:
(i) Scheduling appointments for the client to help the individual obtain needed services; or
(ii) Activities that help link the client with medical, social, or educational providers or other programs and services which address identified needs and achieve goals specified in the care plan;
d. Monitoring which shall be face-to-face and occur no less than once every three (3) months to determine that:
(i) Services are furnished according to the client's care plan;
(ii) Services in the care plan are adequate; and
(iii) Changes in the needs or status of the client are reflected in the care plan; and
e. Contacts with the client, family members, service providers, or others are conducted as frequently as needed to help the client:
(i) Access services;
(ii) Identify needs and supports to assist the client in obtaining services; and
(iii) Identify changes in the client's needs; or
(s) Partial hospitalization which shall:
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, professional equivalent, mental health associate, or certified alcohol and drug counselor;
-
Be a short-term (average of four (4) to six (6) weeks), less than twenty-four (24)-hour, intensive treatment program for an individual who is experiencing significant impairment to daily functioning due to substance use disorder, mental health disorder, or co-occurring disorder;
-
Be provided to an adult or a child;
-
Ensure that admission criteria for partial hospitalization is based on an inability to adequately treat the individual through community-based therapies or intensive outpatient services;
-
Consist of individual outpatient therapy, group outpatient therapy, family outpatient therapy, or medication management;
-
Typically be provided for at least four (4) hours per day and focused on one (1) primary presenting problem, which may include substance use, sexual reactivity, or another problem; and
-
Include the following personnel for the purpose of providing medical care, if necessary:
a. An advanced practice registered nurse;
b. A physician assistant or physician available on site; and
c. A board-certified or board-eligible psychiatrist available for consultation.
(2) A case manager who provides targeted case management services pursuant to subsection (1)(r) of this section to clients with a substance use disorder shall:
(a) Be a certified alcohol and drug counselor, meet the grandfather requirements of 907 KAR 15:040, Section 4(1)(a)3, or have a bachelor's degree in a human services field, including:
-
Psychology;
-
Sociology;
-
Social work;
-
Family studies;
-
Human services;
-
Counseling;
-
Nursing;
-
Behavioral analysis;
-
Public health;
-
Special education;
-
Gerontology;
-
Recreational therapy;
-
Education;
-
Occupational therapy;
-
Physical therapy;
-
Speech-language pathology;
-
Rehabilitation counseling; or
-
Faith-based education;
(b)
-
Have a minimum of one (1) year of full-time employment working directly with adolescents or adults in a human service setting after completion of a bachelor's degree as described in paragraph (a) of this subsection; or
-
Have a master's degree in a human services field as described in paragraph (a) of this subsection;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) Be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least two (2) times per month with at least one (1) of the contacts on an individual, in person basis.
(3) A case manager who provides targeted case management services pursuant to subsection (1)(r) of this section to clients with a mental health or substance use disorder and chronic or complex physical health issues shall:
(a) Meet the requirements of subsection (2)(a) of this section;
(b)
-
After completion of a bachelor's degree, have a minimum of five (5) years of experience providing service coordination or referring clients with complex behavioral health needs and co-occurring disorders or multi-agency involvement to community based services; or
-
After completion of a master's degree in a human services field as described in subsection (2)(a) of this section, have a minimum of two (2) years of experience providing service coordination or referring clients with complex behavioral health needs and co-occurring disorders or multi-agency involvement to community based services;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) For a bachelor's level case manager, be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least three (3) times per month with at least two (2) of the contacts on an individual, in person basis.
(4) A case manager who provides targeted case management services pursuant to subsection (1)(r) of this section to children with a severe emotional disability or clients with a severe mental illness shall:
(a) Meet the requirements of subsection (2)(a) of this section;
(b)
-
Have a minimum of one (1) year of full-time employment working directly with individuals with behavioral health needs after completion of a bachelor's degree in a behavioral science field as described in subsection (2)(a) of this section; or
-
Have a master's degree in a human services field as described in subsection (2)(a) of this section;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) Be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least two (2) times per month with at least one (1) of the contacts on an individual, in person basis.
(5) Plan of care.
(a) Each client receiving outpatient behavioral health services from a psychiatric hospital or general acute care or critical access hospital with a psychiatric unit shall have an individual plan of care signed by a behavioral health professional.
(b) A plan of care shall:
-
Describe the services to be provided to the client, including the frequency of services;
-
Contain measurable goals for the client to achieve, including the expected date of achievement for each goal;
-
Describe the client's functional abilities and limitations or diagnosis listed in the current edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders;
-
Specify each staff member assigned to work with the client;
-
Identify methods of involving the client's family or significant others if indicated;
-
Specify criteria to be met for termination of treatment;
-
Include any referrals necessary for services not provided directly by the chemical dependency treatment program; and
-
State the date scheduled for review of the plan.
(c) The client shall participate to the maximum extent feasible in the development of his or her plan of care, and the participation shall be documented in the client's record.
(d)
-
The initial plan of care shall be developed through multidisciplinary team conferences at least thirty (30) days following the first ten (10) days of treatment.
-
The plan of care for individuals receiving intensive outpatient program services shall be reviewed every thirty (30) days thereafter and updated every sixty (60) days or earlier if clinically indicated.
-
Except for intensive outpatient program services, the plan of care for individuals receiving any other outpatient behavioral health service described in subsection (1) of this section shall be reviewed and updated every six (6) months or earlier if clinically indicated.
-
The plan of care and each review and update shall be signed by the participants in the multidisciplinary team conference that developed it.
(6) Client Records.
(a) A client record shall be maintained for each individual receiving outpatient behavioral health services.
(b) Each entry shall be current, dated, signed, and indexed according to the service received.
(c) Each client record shall contain:
-
An identification sheet, including the client's name, address, age, gender, marital status, expected source of payment, and referral source;
-
Information on the purpose for seeking a service;
-
If applicable, consent of appropriate family members or guardians for admission, evaluation, and treatment;
-
Screening information pertaining to the mental health or substance use disorder;
-
If applicable, a psychosocial history;
-
If applicable, staff notes on services provided;
-
If applicable, the client's plan of care;
-
If applicable, disposition;
-
If applicable, assigned status;
-
If applicable, assigned therapists; and
-
If applicable, a termination study recapitulating findings and events during treatment, clinical impressions, and condition on termination.
Section 7. Physical environment of an off-campus extension or separate building on the campus of the hospital where outpatient behavioral health services are provided.
(1) Accessibility. The off-campus extension or separate building on the campus of the hospital shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and 815 KAR 7:120.
(2) Physical location and overall environment.
(a) The program shall:
-
Comply with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions;
-
Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;
-
Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day;
-
Have a reception and waiting area;
-
Provide a restroom; and
-
Have an administrative area.
(b) The condition of the physical location and the overall environment shall be maintained in such a manner that the safety and well-being of clients, personnel, and visitors are assured.
(3) Prior to occupancy, the facility shall have final approval from appropriate agencies.
History
- RELATES TO: KRS 17.500, 198B.260, 200.503, 202A, 202B, 209.032, 210.005, 211.842-211.852, 216.380(7) and (8), 216B.010-216B.131, 216B.175, 216B.990, 309.080, 309.130, 311.560, 311.571, 311.840 – 311.862, 314.011(8), 314.042, 319.050, 319.056, 319.064, 319C.010, 320.240(14), 335.080, 335.100, 335.300, 335.500, 439.3401, 42 C.F.R. Part 2, 45 C.F.R. 160, 164, 20 U.S.C. 1400, 29 U.S.C. 701, 42 U.S.C. 290ee-3, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042, 216B.175(4)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations to govern health facilities and health services. KRS 216B.175(4) requires the cabinet to promulgate administrative regulations to establish requirements for the history and physical examination performed in an acute or psychiatric hospital. This administrative regulation establishes minimum licensure requirements for the operation and services of psychiatric hospitals and for the provision of psychiatric services in general acute care hospitals or critical access hospitals which have a psychiatric unit. In addition, this administrative regulation establishes requirements for psychiatric hospitals and general acute care hospitals or critical access hospitals that have a psychiatric unit and elect to provide outpatient behavioral health services.
- History: 10 Ky.R. 260; eff. 8-3-1983; Am. 16 Ky.R. 1024; eff. 1-12-1990; 23 Ky.R. 2305; 3049; eff. 2-19-1997; 24 Ky.R. 1962; 2401; 25 Ky.R. 333; eff. 8-17-1998; 27 Ky.R. 1929; 2472; eff. 3-6-2001; TAm eff. 3-11-2011; 42 Ky.R. 2129; eff. 2-5-2016; Cert. eff. 12-14-2022.
902 KAR 20:200 Tuberculosis (TB) testing for residents in long-term care settings {#sec-902-kar-20-200 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:200}
Section 1. Definitions.
(1) "Air changes per hour" or "ACH" means the air change rate expressed as the number of air exchange units per hour.
(2) "Airborne Infection Isolation (AII) room" means a room, formerly called a negative pressure isolation room, which is designed to maintain AII and is a single-occupancy patient-care room used to isolate persons with suspected or confirmed infectious TB disease.
(3) "BAMT conversion" means a change in the BAMT test result, on serial testing, from negative to positive over a two (2) year period.
(4) "Blood Assay for Mycobacterium tuberculosis" or "BAMT" means a diagnostic blood test that:
(a) Assesses for the presence of infection with M. tuberculosis;
(b) Reports results as positive, negative, indeterminate, or borderline; and
(c) Includes interferon-gamma (IFN- ɣ) release assays (IGRA).
(5) "Boosting" or the "booster phenomenon" means if nonspecific or remote sensitivity to tuberculin purified protein derivative (PPD) in the skin test wanes or disappears over time, subsequent tuberculin skin tests (TSTs) may restore the sensitivity.
(6) "Directly observed preventive therapy" or "DOPT" means the DOT for treatment of LTBI.
(7) "Directly observed therapy" or "DOT" means an adherence-enhancing strategy:
(a) In which a health care worker or other trained person watches a patient swallow each dose of medication; and
(b) That is the standard care for all patients with TB disease and is a preferred option for patients treated for latent TB infection (LTBI).
(8) "Extrapulmonary tuberculosis" means TB disease in any part of the body other than the lungs (e.g., kidney, spine, or lymph nodes), and may include the presence of pulmonary TB or other infectious TB diseases.
(9) "Health care workers" or "HCWs" means all paid and unpaid persons working in health care settings who have the potential for exposure to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air, and shall include:
(a) Physicians;
(b) Physician assistants;
(c) Nurses;
(d) Medical assistants;
(e) Nursing assistants or nurse aides;
(f) Therapists;
(g) Technicians;
(h) Emergency medical service personnel;
(i) Dental personnel;
(j) Pharmacists;
(k) Laboratory personnel;
(l) Autopsy personnel;
(m) Students and trainees;
(n) Contractual and community-based physicians and other healthcare professionals and staff not employed by the health care facility; and
(o) Persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that may be transmitted to and from health care workers and patients or residents.
(10) "Induration" means a firm area in the skin that develops as a reaction to injected tuberculin antigen if a person has tuberculosis infection and that is measured in accordance with Section 2(2) of this administrative regulation.
(11) "Infectious tuberculosis" means pulmonary, laryngeal, endobroncheal, or tracheal TB disease or a draining TB skin lesion that has the potential to cause transmission of tuberculosis to other persons.
(12) "Latent TB infection" or "LTBI" means infection with M. tuberculosis without symptoms or signs of disease having been manifested.
(13) "Long-term care setting" means a nursing facility, intermediate care facility, nursing home, Alzheimer's nursing home, personal care home, or intermediate care facility for individuals with an intellectual disability.
(14) "Multidrug-resistant tuberculosis" or "MDR TB" means TB disease caused by M. tuberculosis organisms that are resistant to at least isoniazid (INH) and rifampin.
(15) "Nucleic Acid Amplification" or "NAA" means a laboratory method used to target and amplify a single deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) sequence usually for detecting and identifying a microorganism.
(16) "Polymerase chain reaction" or "PCR" means a system for in vitro amplification of DNA or RNA that can be used for diagnosis of infections.
(17) "Staggered tuberculosis testing" means the testing of a resident in or before the same month as the anniversary date of the resident's admission, or testing in or before the birth month of the resident so that all residents do not have tuberculosis testing in the same month.
(18) "TST conversion" means a change in the result of a test for M. tuberculosis infection in which the condition is interpreted as having progressed from uninfected to infected in accordance with Section 2(4) of this administrative regulation.
(19) "Tuberculin skin test" or "TST" means a diagnostic aid for finding M. tuberculosis infection that:
(a) Is performed by using the intradermal (Mantoux) technique using five (5) tuberculin units of purified protein derivative (PPD); and
(b) Has its results read forty-eight (48) to seventy-two (72) hours after injection and recorded in millimeters of induration.
(20) "Tuberculosis (TB) disease" means a condition caused by infection with a member of the M. tuberculosis complex that meets the descriptions established in Section 2(3) of this administrative regulation.
(21) "Tuberculosis risk assessment" means an initial and ongoing evaluation of the risk for LTBI or active TB disease in a particular resident and is performed in accordance with the provisions established in Sections 3, 7, 8, and 11 of this administrative regulation.
(22) "Two-step TST" or "two-step testing" means a series of two (2) TSTs administered seven (7) to twenty-one (21) days apart and used for the baseline skin testing of persons who will receive serial TSTs, including health care workers and residents of long-term care settings to reduce the likelihood of mistaking a boosted reaction for a new infection.
Section 2. Tuberculosis Testing Requirements for TSTs.
(1) Two-step testing shall be used to distinguish new infections from boosted reactions in infection-control surveillance programs.
(2)
(a) A TST shall be performed by:
-
A physician;
-
An advanced practice registered nurse;
-
A physician assistant;
-
A registered nurse; or
-
A pharmacist.
(b) A licensed practical nurse under the supervision of a registered nurse may perform a TST.
(3) Induration Measurements.
(a) The diameter of the firm area shall be measured transversely (i.e., perpendicularly) to the long axis of the forearm to the nearest millimeter to gauge the degree of reaction, and the result shall be recorded in millimeters.
(b) The diameter of the firm area shall not be measured along the long axis of the forearm.
(c) A reaction of ten (10) millimeters or more of induration, if the TST result is interpreted as positive, shall be considered highly indicative of tuberculosis infection in a health care setting.
(d) A reaction of five (5) millimeters to nine (9) millimeters of induration may be significant in certain individuals with risk factors described in Section 3(3) of this administrative regulation for rapid progression to active tuberculosis disease if infected.
(4) Tuberculosis (TB) disease.
(a) A person shall be diagnosed as having tuberculosis (TB) disease if the infection has progressed to causing clinical (manifesting signs or symptoms) or subclinical (early stage of disease in which signs or symptoms are not present but other indications of disease activity are present, including radiographic abnormalities) illness.
-
Tuberculosis that is found in the lungs shall be called pulmonary TB and may be infectious.
-
Extrapulmonary disease (occurring at a body site outside the lungs) may be infectious in rare circumstances.
(b) If the only clinical finding is specific chest radiographic abnormalities, the condition is termed "inactive TB" and shall be differentiated from active TB disease, which is accompanied by symptoms or other indications of disease activity, including the ability to culture reproducing TB organisms from respiratory secretions or specific chest radiographic finding.
(5)
(a) A TST conversion shall have occurred if the size of the measured TST induration increases by ten (10) millimeters or more during a two (2) year period in a resident with a:
-
Documented baseline two-step TST result measured as zero (0); or
-
Previous follow-up screening TST result with induration measured as one (1) millimeter to nine (9) millimeters and interpreted as negative during serial testing.
(b) A TST conversion shall be presumptive evidence of new M. tuberculosis infection and poses an increased risk for progression to TB disease.
Section 3. TB Risk Assessment and Tuberculin Skin Tests or BAMTs for Residents.
(1) Risk Assessment.
(a) To perform a risk assessment, a questionnaire shall be used and the following factors shall be assessed:
-
The clinical symptoms of active TB disease;
-
Events and behaviors that increase the risk for exposure to M. tuberculosis and the risk of acquiring LTBI; and
-
Medical risk factors that increase the risk for a resident with LTBI to develop active TB disease.
(b) A TB Risk Assessment questionnaire may be obtained from the Kentucky Department for Public Health (published online at: http://chfs.ky.gov/dph/epi/tb.htm) or from a national medical or public health organization, including the American Academy of Pediatrics or the Centers for Disease Control and Prevention.
(c) TB Risk Assessment questions shall be on a facility-approved form or incorporated into the long-term care setting's medical forms or into forms or other features of the long-term care setting's electronic medical record systems.
(2) Exclusion of Residents from Tuberculin Skin Tests or BAMTs on Admission. A TST or BAMT shall not be required on admission if the resident, resident's guardian, resident's health care surrogate, or resident's responsible party provided medical documentation for one (1) of the following as part of a TB Risk Assessment:
(a) A prior TST of ten (10) or more millimeters of induration if the TST result was interpreted as positive;
(b) A prior TST of five (5) millimeters to nine (9) millimeters of induration if the resident has a medical reason as described in subsection (3) of this section for his or her TST result to be interpreted as positive;
(c) A positive BAMT;
(d) A TST conversion;
(e) A BAMT conversion;
(f) The resident is currently receiving or has completed treatment for LTBI with one (1) of the treatment regimens recommended by the Centers for Disease Control and Prevention;
(g) The resident has completed a course of multiple-drug therapy for active TB disease recommended by the Centers for Disease Control and Prevention; or
(h) The resident has had a TST or BAMT within three (3) months prior to admission and has previously been in a serial testing program at another medical facility, long-term care setting, or other health care setting.
(3) A medical reason for a resident's TST result of five (5) millimeters to nine (9) millimeters of induration to be interpreted as positive may include:
(a) HIV-infection;
(b) Immunosuppression from disease or medications;
(c) Fibrotic changes on a chest radiograph consistent with previous TB disease: or
(d) Recent contact with a person who has active TB disease.
(4) TB Risk Assessments and Tuberculin Skin Tests or BAMTs on Admission.
(a) A baseline TB Risk Assessment and a TST or BAMT, if not excluded pursuant to subsection (2) of this section, shall be initiated on each new resident before or during the first week of admission. The results shall be documented in the resident's medical record or electronic medical record within the first two (2) weeks of admission.
(b) A TB Risk Assessment required by paragraph (a) of this subsection and other sections of this administrative regulation shall be performed by:
-
A physician;
-
An advanced practice registered nurse;
-
A physician assistant;
-
A registered nurse; or
-
A pharmacist.
(c) A licensed practical nurse under the supervision of a registered nurse may perform the TB Risk Assessment.
(d) An initial or first-step TST result of ten (10) millimeters or more of induration may be interpreted as positive for a new resident.
(e) An initial or first-step TST result on admission of five (5) to nine (9) millimeters of induration may be interpreted as positive for a resident who has a medical reason as described in subsection (3) of this section for the TST result to be interpreted as positive.
(5)
(a) A two-step baseline TST shall be required on admission for each resident aged fourteen (14) years and older whose initial or first-step TST on admission is interpreted as negative.
(b) The second-step test shall be initiated seven (7) to twenty-one (21) days after the first test.
-
A TST result of five (5) millimeters to nine (9) millimeters of induration may be interpreted as positive on the second step TST for a resident who has a medical reason as described in subsection (3) of this section for the TST result to be interpreted as positive.
-
If a resident aged fourteen (14) years and older does not have a medical reason as identified in subsection (3) of this section and the resident's initial or first-step TST performed in accordance with subsection (4)(a) of this section shows less than ten (10) millimeters of induration and a second step TST shows more than ten (10) millimeters of induration, the TST shall be interpreted as positive.
-
The initial TST shall count as the second-step TST if the resident aged fourteen (14) years and older provided medical documentation that he or she has had a one-step TST interpreted as negative within one (1) year prior to initial testing upon admission to the long-term care setting.
(6) A BAMT may be used in place of, but not in addition to, a TST and:
(a) If a BAMT is performed before or during the first week of admission and the result is positive or negative, only one (1) BAMT test result shall be required; and
(b) A second BAMT shall be performed if the BAMT result is borderline, indeterminate, or invalid.
Section 4. Admission of Patients under Treatment for Pulmonary Tuberculosis Disease or Other Infectious Tuberculosis Diseases.
(1) A long-term care setting as described in Section 1(13) of this administrative regulation shall not admit a person under medical treatment for suspected or confirmed pulmonary tuberculosis disease or other suspected or confirmed infectious tuberculosis diseases caused by either non-MDR TB or MDR-TB unless the person is declared noninfectious by a licensed physician, advanced practice registered nurse, or physician assistant in conjunction with the local and state health departments.
(2)
(a) A long-term care setting as described in Section 1(13) of this administrative regulation shall not admit a person under medical treatment for suspected or confirmed extrapulmonary tuberculosis disease caused by non-MDR TB or MDR TB, unless the person is declared noninfectious by a licensed physician, advanced practice registered nurse, or physician assistant in conjunction with the local and state health departments.
(b) Documentation of noninfectious status shall include clinical, radiographic, and laboratory evidence that concurrent pulmonary TB disease or other infectious TB disease has been excluded.
Section 5. Medical Record or Electronic Medical Record Documentation for Residents.
(1) The TB Risk Assessment shall be documented in the resident's medical record or electronic medical record by recording the date of the assessment and the results.
(2) The TST result of each resident shall be documented in the resident's medical record or electronic medical record by recording the date of measurement, millimeters of induration, and interpretation of the results of all TSTs.
(3) The medical record shall be labeled inside or the electronic medical record shall be labeled with the notation "TST Positive" for each resident with a reaction of:
(a) Ten (10) millimeters or more of induration if the TST result was interpreted as positive; or
(b) Five (5) millimeters to nine (9) millimeters of induration if the resident has a medical reason as described in Section 3(3) of this administrative regulation for the TST result to be interpreted as positive.
(4)
(a) If performed, the BAMT result of each resident shall be documented in the resident's medical record or electronic medical record by recording the date and result as positive, negative, borderline, or indeterminate.
(b) If a resident has a positive BAMT, his or her medical record shall be labeled inside or electronic medical record shall be labeled with the notation "BAMT Positive."
Section 6. Medical Evaluations, Chest X-rays, and Monitoring of Residents with a Positive TST, a Positive BAMT, a TST Conversion, or a BAMT Conversion.
(1) At the time of admission or annual testing, a resident shall have a medical evaluation, including an HIV test unless the resident, resident's guardian, resident's health care surrogate, or resident's responsible party opts out of HIV testing, if the resident is found to have a:
(a) TST result of ten (10) millimeters or more induration if the TST result is interpreted as positive;
(b) TST result of five (5) millimeters to nine (9) millimeters of induration if the resident has a medical reason as described in Section 3(3) of this administrative regulation for the TST result to be interpreted as positive;
(c) Positive BAMT;
(d) TST conversion; or
(e) BAMT conversion.
(2) A chest x-ray shall be performed as part of the medical evaluation required by subsection (1) of this section unless a chest x-ray performed within the previous two (2) months showed no evidence of tuberculosis disease.
(3)
(a) A resident with no clinical evidence of active TB disease upon evaluation by a licensed physician, advanced practice registered nurse, or physician assistant, and a negative chest x-ray shall be offered treatment for LTBI unless there is a medical contraindication.
(b) A resident who refuses treatment for LTBI, or a resident whose guardian, health care surrogate, or responsible party refuses on behalf of the resident treatment for LTBI, or a resident who has a medical contraindication shall be monitored according to the requirements in Section 7 of this administrative regulation.
(4) A resident with symptoms or an abnormal chest x-ray consistent with TB disease shall be:
(a) Isolated in an AII room or transferred within eight (8) hours of facility staff being aware of a suspected TB diagnosis to a facility with an AII room; and
(b) Evaluated for active tuberculosis disease as established in this paragraph.
-
Three (3) sputum specimens collected eight (8) to twenty-four (24) hours apart with at least one (1) being an early morning specimen shall be submitted to a hospital laboratory or a state or national reference laboratory for tuberculosis culture, AFB smear, and NAA or PCR tests.
-
Multi-drug antituberculosis treatment shall be administered by DOT for suspected or active tuberculosis disease.
(5) Individuals under treatment for suspected or confirmed pulmonary tuberculosis disease or other suspected or confirmed infectious tuberculosis diseases may be readmitted to the long-term care setting in accordance with the requirements of Section 4 of this administrative regulation.
Section 7. Monitoring of Residents with a Positive TST, a Positive BAMT, a TST Conversion, or a BAMT Conversion.
(1) A resident shall be monitored for development of pulmonary symptoms, including cough, sputum production, and chest pain, if the resident has:
(a) A TST result with ten (10) or more millimeters of induration;
(b) A TST result of five (5) millimeters to nine (9) millimeters of induration if the resident has a medical reason as described in Section 3(3) of this administrative regulation for his or her TST result to be interpreted as positive;
(c) A positive BAMT;
(d) A TST conversion; or
(e) A BAMT conversion.
(2) If pulmonary symptoms, including cough, sputum production, and chest pain develop and persist for three (3) weeks or longer:
(a) The resident shall have a medical evaluation; and
(b) A chest x-ray shall be taken.
(3) A resident with symptoms or an abnormal chest x-ray consistent with TB disease shall be:
(a) Isolated in an AII room; or
(b) Transferred within eight (8) hours of facility staff being aware of a suspected TB diagnosis to a facility with an AII room.
(4) Three (3) sputum specimens collected eight (8) to twenty-four (24) hours apart with at least one (1) being an early morning specimen shall be submitted to a hospital laboratory or national reference laboratory for tuberculosis culture, AFB smear, and NAA or PCR tests.
(5) Multi-drug antituberculosis treatment shall be administered by DOT for suspected or active tuberculosis disease.
(6) Individuals under treatment for suspected or confirmed pulmonary tuberculosis disease or other suspected or confirmed infectious tuberculosis diseases may be readmitted to the long-term setting in accordance with the requirements of Section 3 of this administrative regulation.
(7)
(a) A resident with a positive TST or a positive BAMT on admission who stays eleven (11) months or longer in the long-term care setting shall have an annual TB Risk Assessment in or before the same month as the anniversary date of his or her last TB Risk Assessment.
(b) The resident shall not be required to submit to an annual TST or BAMT.
(8) A resident with a TST conversion or a BAMT conversion shall:
(a) Be educated about and advised of the clinical symptoms of active TB disease;
(b) Have an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years following TST conversion or BAMT conversion followed thereafter by an annual TB Risk Assessment in or before the same month as the anniversary date of his or her last TB Risk Assessment; and
(c) Not be required to submit to an annual TST or BAMT.
Section 8. Monitoring of Residents with a Negative TST or a Negative BAMT who are Residents for Eleven (11) Months or Longer.
(1) A long-term care setting shall use staggered tuberculosis testing to assure that all residents are not tested in the same month. Staggered testing shall be performed monthly, quarterly, or semiannually.
(2) An annual TB Risk Assessment and a TST or BAMT shall be required in or before the same month as the anniversary date of the resident's last TB Risk Assessment and TST or BAMT.
(3)
(a) If pulmonary symptoms, including cough, sputum production, and chest pain, develop and persist for three (3) weeks or longer:
-
The resident shall have a medical evaluation;
-
The TST or BAMT shall be repeated; and
-
A chest x-ray shall be taken.
(b) A resident with signs or symptoms or an abnormal chest x-ray, consistent with TB disease, shall be:
a. Isolated in an AII room; or
b. Transferred within eight (8) hours of facility staff being aware of a suspected TB diagnosis to a facility with an AII room; and
- Evaluated for active tuberculosis disease as provided in this subparagraph.
a. Three (3) sputum specimens, collected eight (8) to twenty-four (24) hours apart with at least one (1) being an early morning specimen, shall be submitted to a hospital laboratory or a state or national reference laboratory for tuberculosis culture, AFB smear, and NAA tests or PCR tests.
b. Multi-drug antituberculosis treatment shall be administered by DOT for suspected or active tuberculosis disease.
(4) Individuals under treatment for suspected or confirmed pulmonary tuberculosis disease or other suspected or confirmed infectious tuberculosis diseases may be readmitted to the long-term care setting in accordance with the requirements of Section 4 of this administrative regulation.
(5) Individuals evaluated for suspected infectious TB disease of the lungs, airways, or larynx in which active TB disease is considered unlikely after medical evaluation and TB laboratory testing may be readmitted to the long-term care setting if the individual is declared noninfectious for TB by a licensed physician, advanced practice registered nurse, or physician assistant in conjunction with the local and state health departments.
Section 9. Responsibility for Screening and Monitoring Requirements: Residents.
(1) A long-term care setting's administrator or administrator's designee shall be responsible for ensuring that all TB Risk Assessments, TSTs, BAMTs, chest x-rays, and sputum specimen submissions for residents comply with Section 2 through Section 8 of this administrative regulation.
(2) If a long-term care setting does not employ licensed professional staff with the technical training to carry out the screening and monitoring requirements for residents, the administrator shall arrange for training or professional assistance from the local health department or from a licensed medical provider.
(3) TSTs with the date of measurement and millimeters of induration, interpretation of the results, date performed, and reported results of all BAMTs, chest x-rays, sputum specimen AFB smears, TB cultures, TB-related NAA tests, and TB-related PCR tests for a resident shall be:
(a) Recorded as a permanent part of the resident's medical record or electronic medical record; and
(b) Summarized on the resident's transfer form if an inter-facility transfer occurs.
Section 10. Reporting to Local Health Departments.
(1) A long-term care setting's administrator or the administrator's designee shall report a resident identified with one (1) of the following to the local health department having jurisdiction within one (1) business day upon becoming known:
(a) A TST conversion or BAMT conversion on serial testing or identified in a contact investigation;
(b) A chest x-ray which is suspicious for TB disease;
(c) A sputum smear positive for acid-fast bacilli;
(d) A rapid laboratory test positive for Mycobacterium tuberculosis DNA or RNA, such as Mycobacterium tuberculosis positive NAA tests or PCR tests;
(e) Sputum cultures positive for Mycobacterium tuberculosis; or
(f) The initiation of multi-drug antituberculosis treatment for a resident.
(2) A long-term care setting's administrator or the administrator's designee shall report a resident identified with one (1) of the following to the local health department having jurisdiction within five (5) business days upon becoming known:
(a) A TST of ten (10) millimeters or more induration at the time of admission if the TST result was interpreted as positive;
(b) A TST result of five (5) millimeters to nine (9) millimeters of induration at the time of admission for a resident who has a medical reason as described in Section 3(3) of this administrative regulation for his or her TST result to be interpreted as positive; or
(c) A positive BAMT at the time of admission.
Section 11. Treatment for LTBI in Residents.
(1) A resident with a TST conversion or a BAMT conversion with no clinical evidence of active TB disease upon evaluation by a licensed physician, advanced practice registered nurse, or physician assistant and a negative chest x-ray shall be considered to be recently infected with Mycobacterium tuberculosis.
(2) A recently infected person as described in subsection (1) of this section shall have:
(a) A medical evaluation;
(b) An HIV test unless the resident, resident's guardian, resident's health care surrogate, or resident's responsible party opts out of HIV testing; and
(c) A chest x-ray.
(3)
(a) A resident who meets the criteria in subsection (1) of this section and who has no signs or symptoms of tuberculosis disease by medical evaluation or on chest x-ray shall be offered treatment for LTBI, in collaboration with the local health department, unless medically contraindicated as determined by a licensed physician, advanced practice registered nurse, or physician assistant.
(b) Medications shall be:
-
Administered to residents upon the written order of a physician or other licensed medical provider acting within his or her statutory scope of practice; and
-
Given by DOPT.
(4) If a resident, resident's guardian, resident's health care surrogate, or resident's responsible party refuses treatment of the resident for LTBI after a TST conversion or a BAMT conversion or has a medical contraindication:
(a) The individual shall be educated about and advised of the clinical symptoms of active TB disease;
(b) The resident shall have a TB Risk Assessment which includes an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years following TST conversion or BAMT conversion, followed thereafter by an annual TB Risk Assessment in or before the same month as the anniversary date of the resident's last TB Risk Assessment;
(c) The resident shall not be required to submit to an annual TST or BAMT; and
(d) Documentation that the resident, resident's guardian, resident's heath care surrogate, or resident's responsible party was educated and advised of the clinical symptoms of active TB shall be documented in the resident's medical record or electronic medical record.
(5) A resident who has a TST result of ten (10) millimeters or more induration, if the TST result is interpreted as positive, or has a positive BAMT at the time of admission shall be offered treatment for LTBI, unless medically contraindicated.
(6) A resident who has a TST result of five (5) millimeters to nine (9) millimeters of induration at the time of admission and who has a medical reason as described in Section 3(3) in this administrative regulation for his or her TST result to be interpreted as positive shall be offered treatment for LTBI, unless medically contraindicated.
(7) If a resident, resident's guardian, resident's health care surrogate, or resident's responsible party refuses treatment on behalf of the resident for LTBI detected upon admission:
(a) The individual shall be educated about and advised of the clinical symptoms of active TB disease;
(b) The resident shall have a TB Risk Assessment that includes an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years following admission, followed thereafter by an annual TB Risk Assessment in or before the same month as the anniversary date of the resident's last TB Risk Assessment; and
(c) The resident shall not be required to submit to an annual TST or BAMT.
(8) Documentation that the resident, resident's guardian, resident's health care surrogate, or resident's responsible party was educated about and advised of the clinical symptoms of active TB shall be documented in the resident's medical record or electronic medical record.
(9)
(a) A resident who stays eleven (11) months or longer in the long-term care setting and who provided medical documentation for completion of treatment for LTBI with one (1) of the treatment regimens recommended by the Centers for Disease Control and Prevention shall not be required to submit to an annual TST or BAMT.
(b) The resident, resident's guardian, resident's health care surrogate, or resident's responsible party shall receive education on the clinical symptoms of active TB disease during a TB Risk Assessment annually in or before the same month as the anniversary date of the resident's last TB Risk Assessment and any other monitoring in accordance with Section 6 through Section 9 of this administrative regulation.
Section 12. Compliance Date. All health care settings or health facilities subject to the tuberculosis testing requirements of this administrative regulation shall demonstrate compliance no later than 180 days after the effective date of this administrative regulation.
Section 13. Supersede. If any requirement stated in another administrative regulation within 902 KAR Chapter 20 contradicts a requirement stated in this administrative regulation, the requirement stated in this administrative regulation shall supersede the requirement stated elsewhere within 902 KAR Chapter 20.
History
- RELATES TO: KRS 215.520-215.600, 216B.010-216B.131, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to establish licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 215.590 requires a health service or health facility licensed pursuant to KRS Chapter 216B or KRS Chapter 333 to report knowledge of a person who has active tuberculosis to the local health department. This administrative regulation establishes requirements for tuberculosis (TB) testing of residents in the following long-term care settings: nursing facilities, intermediate care facilities, nursing homes, Alzheimer's nursing homes, personal care homes, and intermediate care facilities for individuals with an intellectual disability (ICF/IID). These procedures are necessary to minimize the transmission of infectious tuberculosis among the staff and residents in long-term care settings.
- History: 11 Ky.R. 914; eff. 12-11-1984; Am. 12 Ky.R. 65; eff. 8-13-1985; 13 Ky.R. 1302; eff. 2-10-1987; 18 Ky.R. 1443; eff. 1-10-1992; 42 Ky.R. 1403; 2369; eff. 3-4-2016; Cert. eff. 12-14-2022.
902 KAR 20:205 Tuberculosis (TB) testing for health care workers {#sec-902-kar-20-205 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:205}
Section 1. Definitions.
(1) "Air changes per hour" or "ACH" means the air change rate expressed as the number of air exchange units per hour.
(2) "Airborne Infection Isolation (AII) room" means a room, formerly called a negative pressure isolation room, which is designed to maintain AII and is a single-occupancy patient-care room used to isolate persons with suspected or confirmed infectious TB disease.
(3) "BAMT conversion" means a change in the BAMT test result, on serial testing, from negative to positive over a two (2) year period.
(4) "Blood Assay for Mycobacterium tuberculosis" or "BAMT" means a diagnostic blood test that:
(a) Assesses for the presence of infection with M. tuberculosis;
(b) Reports results as positive, negative, indeterminate, or borderline; and
(c) Includes interferon-gamma (IFN-ɣ) release assays (IGRA).
(5) "Boosting" or the "booster phenomenon" means if nonspecific or remote sensitivity to tuberculin purified protein derivative (PPD) in the skin test wanes or disappears over time, subsequent tuberculin skin tests (TSTs) may restore the sensitivity.
(6) "Extrapulmonary tuberculosis" means TB disease in any part of the body other than the lungs (e.g., kidney, spine, or lymph nodes), and may include the presence of pulmonary TB or other infectious TB diseases.
(7) "Health care setting" or "health facility" means the following settings:
(a) Abortion facility;
(b) Adult day health program;
(c) Alzheimer's nursing home;
(d) Ambulatory care clinic;
(e) Ambulatory surgical center;
(f) Blood establishment;
(g) Chemical dependency treatment service;
(h) Community mental health center;
(i) Comprehensive physical rehabilitation hospital;
(j) Critical access hospital;
(k) Family care home;
(l) Freestanding birth center;
(m) Group home;
(n) Home health agency;
(o) Hospice program;
(p) Hospital;
(q) Intermediate care facility;
(r) Intermediate care facility for individuals with an intellectual disability (ICF/IID);
(s) Limited services clinic;
(t) Medical laboratory;
(u) Mobile health service;
(v) Network;
(w) Nursing facility;
(x) Nursing home;
(y) Nursing pool;
(z) Outpatient health care center;
(aa) Pain management facility;
(bb) Personal care home;
(cc) Prescribed pediatric extended care facility;
(dd) Psychiatric hospital;
(ee) Primary care center;
(ff) Private duty nursing agency;
(gg) Level I or Level II psychiatric residential treatment facility;
(hh) Rehabilitation agency;
(ii) Renal dialysis facility;
(jj) Residential hospice facility;
(kk) Rural health clinic;
(ll) Special health clinic;
(mm) Specialty intermediate care clinic;
(nn) Specialized medical technology service; or
(oo) Behavioral health services organization.
(8) "Health care workers" or "HCWs" means all paid and unpaid persons working in health care settings who have the potential for exposure to infectious materials, including body substances, contaminated medical supplies and equipment, contaminated environmental surfaces, or contaminated air, and shall include:
(a) Physicians;
(b) Physician assistants;
(c) Nurses;
(d) Medical assistants;
(e) Nursing assistants or nurse aides;
(f) Therapists;
(g) Technicians;
(h) Emergency medical service personnel;
(i) Dental personnel;
(j) Pharmacists;
(k) Laboratory personnel;
(l) Autopsy personnel;
(m) Students and trainees;
(n) Contractual and community-based physicians and other healthcare professionals and staff not employed by the health care facility; and
(o) Persons (e.g., clerical, dietary, housekeeping, laundry, security, maintenance, billing, and volunteers) not directly involved in patient care but potentially exposed to infectious agents that may be transmitted to and from health care workers and patients or residents.
(9) "Induration" means a firm area in the skin that develops as a reaction to injected tuberculin antigen if a person has tuberculosis infection and that is measured in accordance with Section 3(2) of this administrative regulation.
(10) "Infectious tuberculosis" means pulmonary, laryngeal, endobroncheal, or tracheal TB disease or a draining TB skin lesion that has the potential to cause transmission of tuberculosis to other persons.
(11) "Latent TB infection" or "LTBI" means infection with M. tuberculosis without symptoms or signs of disease having been manifested.
(12) "Multidrug-resistant tuberculosis" or "MDR TB" means TB disease caused by M. tuberculosis organisms that are resistant to at least isoniazid (INH) and rifampin.
(13) "Nucleic Acid Amplification" or "NAA" means a laboratory method used to target and amplify a single deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) sequence usually for detecting and identifying a microorganism.
(14) "Polymerase chain reaction" or "PCR" means a system for in vitro amplification of DNA or RNA that can be used for diagnosis of infections.
(15) "Staggered tuberculosis testing" means the testing of a health care worker in or before the same month as the anniversary date of his or her date of initial employment, or testing in or before the worker's birth month so that all health care workers do not have tuberculosis testing in the same month.
(16) "TST conversion" means a change in the result of a test for M. tuberculosis infection in which the condition is interpreted as having progressed from uninfected to infected in accordance with Section 3(4) of this administrative regulation.
(17) "Tuberculin Skin Test" or "TST" means a diagnostic aid for finding M. tuberculosis infection that:
(a) Is performed by using the intradermal (Mantoux) technique using five (5) tuberculin units of purified protein derivative (PPD); and
(b) Has results read forty-eight (48) to seventy-two (72) hours after injection and recorded in millimeters of induration.
(18) "Tuberculosis (TB) disease" means a condition caused by infection with a member of the M. tuberculosis complex that meets the descriptions established in Section 3(3) of this administrative regulation.
(19) "Tuberculosis Risk Assessment" means an initial and ongoing evaluation of the risk for LTBI or active TB disease in a particular health care worker and is performed in accordance with the provisions established in Sections 4, 5, 7, and 11 of this administrative regulation.
(20) "Two-step TST" or "two-step testing" means a series of two (2) TSTs administered seven (7) to twenty one (21) days apart and used for the baseline skin testing of persons who will receive serial TSTs, including health care workers and residents of long-term care settings, to reduce the likelihood of mistaking a boosted reaction for a new infection.
Section 2. TB Infection Control Program.
(1) Each health facility shall have a written TB infection control plan that is part of an overall infection control program.
(2) The TB infection control plan shall be designed to control M. tuberculosis transmission through early detection, isolation, diagnosis, and treatment of persons with active TB disease.
(3) A hierarchy of control measures shall be used, including:
(a) Administrative controls;
(b) Environmental controls; and
(c) Respiratory protection.
(4) A TB infection control plan shall include a listing of the job series of health care workers or another standardized method to describe which health care workers shall be included in the facility TB screening program.
(5) At a minimum, a health care worker shall be included in the TB screening program if the worker:
(a) Has duties that involve face‑to-face contact with patients with suspected or confirmed active TB disease, including transport staff;
(b) Has the potential for exposure to M. tuberculosis through air space shared with persons with suspected or confirmed active TB disease of the respiratory system;
(c) Has duties that involve the processing of laboratory specimens for TB testing or TB cultures;
(d) Has duties that have the potential for exposure to the environment of care of persons with suspected or confirmed active TB disease; or
(e) Performs other tasks or procedures which may generate infectious aerosol droplet nuclei in which the worker has or may have exposure to TB disease.
(6) A facility may voluntarily include additional or all health care workers in the TB screening program based upon:
(a) TB incidence (local or regional);
(b) Other TB risk factors;
(c) Changes in the epidemiology of TB (local or regional);
(d) Patient safety strategies;
(e) Risk management strategies; or
(f) Any other factors.
Section 3. Tuberculosis Testing Requirements for TSTs.
(1) Two-step testing shall be used to distinguish new infections from boosted reactions in infection-control surveillance programs.
(2)
(a) A TST shall be performed by:
-
A physician;
-
An advanced practice registered nurse;
-
A physician assistant;
-
A registered nurse; or
-
A pharmacist.
(b) A licensed practical nurse under the supervision of a registered nurse may perform a TST.
(3) Induration Measurements.
(a) The diameter of the firm area shall be measured transversely (i.e., perpendicularly) to the long axis of the forearm to the nearest millimeter to gauge the degree of reaction, and the result shall be recorded in millimeters.
(b) The diameter of the firm area shall not be measured along the long axis of the forearm.
(c) A reaction of ten (10) millimeters or more of induration, if the TST result is interpreted as positive, shall be considered highly indicative of tuberculosis infection in a health care setting.
(d) A reaction of five (5) millimeters to nine (9) millimeters of induration may be significant in certain individuals with risk factors described in Section 4(3) of this administrative regulation for rapid progression to active tuberculosis disease if infected.
(4) Tuberculosis (TB) disease.
(a) A person shall be diagnosed as having tuberculosis (TB) disease if the infection has progressed to causing clinical (manifesting signs or symptoms) or subclinical (early stage of disease in which signs or symptoms are not present, but other indications of disease activity are present, including radiographic abnormalities) illness.
-
Tuberculosis that is found in the lungs shall be called pulmonary TB and may be infectious.
-
Extrapulmonary disease (occurring at a body site outside the lungs) may be infectious in rare circumstances.
(b) If the only clinical finding is specific chest radiographic abnormalities, the condition is termed "inactive TB" and shall be differentiated from active TB disease, which is accompanied by symptoms or other indications of disease activity, including the ability to culture reproducing TB organisms from respiratory secretions or a specific chest radiographic finding.
(5)
(a) A TST conversion shall have occurred if the size of the measured TST induration increases by ten (10) millimeters or more during a two (2) year period in a health care worker with a:
-
Documented baseline two-step TST result measured as zero (0); or
-
Previous follow-up screening TST result with induration measured as one (1) millimeter to nine (9) millimeters and interpreted as negative during serial testing.
(b) A TST conversion shall be presumptive evidence of new M. tuberculosis infection and poses an increased risk for progression to TB disease.
Section 4. TB Risk Assessment and Tuberculin Skin Tests or BAMTs for Health Care Workers on Initial Employment.
(1) Risk Assessment.
(a) To perform a TB Risk Assessment, a questionnaire shall be used and the following factors shall be assessed:
-
The clinical symptoms of active TB disease;
-
Events and behaviors that increase the risk for exposure to M. tuberculosis and the risk of acquiring LTBI; and
-
Medical risk factors that increase the risk for a health care worker with LTBI to develop active TB disease.
(b) A TB Risk Assessment questionnaire may be obtained from the Kentucky Department for Public Health (published online at http://chfs.ky.gov/dph/epi/tb.htm) or from a national medical or public health organization, including the American Academy of Pediatrics or the Centers for Disease Control and Prevention.
(c) TB Risk Assessment questions shall be on a facility-approved form or incorporated into the facility's medical history forms or into forms or other features of the facility's electronic medical record systems.
(2) Exclusion of Health Care Workers from Tuberculin Skin Tests or BAMTs Upon Initial Employment in a Health Facility. A TST or BAMT shall not be required at the time of initial employment if the health care worker provided medical documentation for one (1) of the following as part of a TB Risk Assessment:
(a) A prior TST of ten (10) millimeters or more of induration if the TST result was interpreted as positive;
(b) A prior TST of five (5) millimeters to nine (9) millimeters of induration if the health care worker has a medical reason as described in subsection (3) of this section for his or her TST result to be interpreted as positive;
(c) A positive BAMT;
(d) A TST conversion;
(e) A BAMT conversion;
(f) Current receipt or completion of treatment for LTBI with one (1) of the treatment regimens recommended by the Centers for Disease Control and Prevention;
(g) Completion of a course of multiple-drug therapy for active TB disease recommended by the Centers for Disease Control and Prevention; or
(h) A TST or BAMT within three (3) months prior to initial employment at the facility and previous participation in a serial testing program at another medical facility or health care setting.
(3) A medical reason for a health care worker's TST result of five (5) millimeters to nine (9) millimeters of induration to be interpreted as positive may include:
(a) HIV-infection;
(b) Immunosuppression from disease or medications;
(c) Fibrotic changes on a chest radiograph consistent with previous TB disease; or
(d) Recent contact with a person who has active TB disease.
(4) TB Risk Assessments and Tuberculin Skin Tests or BAMTs for Health Care Workers upon Initial Employment in a Health Facility.
(a) A baseline TB Risk Assessment, and a TST or BAMT if not excluded pursuant to subsection (2) of this section, shall be initiated on each new health care worker before or during the first week of employment. The results shall be documented in the health care worker's medical record or electronic medical record within the first month of employment.
(b)
- A TB Risk Assessment required by paragraph (a) of this subsection and other sections shall be performed by:
a. A physician;
b. An advanced practice registered nurse;
c. A physician assistant;
d. A registered nurse, or
e. A pharmacist.
- A licensed practical nurse under the supervision of a registered nurse may perform the TB Risk Assessment.
(c) An initial or first-step TST result of ten (10) millimeters or more of induration may be interpreted as positive for a new health care worker.
(d) An initial or first-step TST result of five (5) millimeters to nine (9) millimeters of induration may be interpreted as positive for a new health care worker who has a medical reason as described in subsection (3) of this section for the TST result to be interpreted as positive.
(5)
(a) A two-step baseline TST shall be required for a health care worker aged fourteen (14) years and older whose initial or first-step TST, initiated before or during the first week of employment pursuant to subsection (4)(a) of this section, is interpreted as negative.
(b) The second step-test shall be initiated seven (7) to twenty-one (21) days after the first test.
-
A TST result of five (5) millimeters to nine (9) millimeters of induration may be interpreted as positive on the second step TST for a health care worker who has a medical reason as described in subsection (3) of this section for the TST result to be interpreted as positive.
-
If a health care worker aged fourteen (14) years and older does not have a medical reason as identified in subsection (3) of this section and the worker's initial or first-step TST shows less than ten (10) millimeters of induration and a second-step TST shows ten (10) millimeters or more of induration, the TST shall be interpreted as positive.
-
The initial TST shall count as the second-step TST if the health care worker aged fourteen (14) years and older provided medical documentation that he or she has had a one-step TST interpreted as negative within one (1) year prior to initial testing at the time of initial employment.
(6) A BAMT may be used in place of, but not in addition to, a TST, and:
(a) If a BAMT is performed before or during the first week of employment and the result is positive or negative, only one (1) BAMT test result shall be required; and
(b) A second BAMT shall be performed if the BAMT result is borderline, indeterminate, or invalid.
Section 5. Annual TB Risk Assessments and Annual Tuberculin Skin Tests or BAMTs for Health Care Workers.
(1) A health care worker shall have an annual TB risk assessment and annual education about the signs and symptoms of active TB disease.
(2) A health care worker included in the TB screening program, as determined by the health facility's TB infection control plan, shall also have annual TB testing.
(3) The requirements established in this subsection shall apply during annual TB testing.
(a) A health care setting shall use staggered tuberculosis testing to assure that all health care workers are not tested in the same month. Staggered testing shall be performed monthly, quarterly, or semiannually.
(b) A health care worker who has worked eleven (11) months or more in the facility and who has never had a TST interpreted as positive, or has never had a positive BAMT, shall have a TB Risk Assessment and a TST or BAMT annually in or before the same month as the anniversary date of his or her last TB Risk Assessment and TST or BAMT.
(c) A health care worker who has worked eleven (11) months or more in the facility and who has had a previous TST interpreted as positive, or a previously positive BAMT, shall:
-
Have an annual TB Risk Assessment in or before the same month as the anniversary date of his or her last TB Risk Assessment; and
-
Not be required to submit to an annual TST or BAMT.
Section 6. Medical Record or Electronic Medical Record Documentation for Health Care Workers.
(1) The TB Risk Assessment shall be documented in each health care worker's medical record or electronic medical record by recording the date of the assessment and the results.
(2) The TST result of each health care worker shall be documented in the worker's medical record or electronic medical record by recording the date of measurement, millimeters of induration, and interpretation of the results for each TST performed.
(3) The medical record shall be labeled inside or the electronic medical record shall be labeled with the notation "TST Positive" for each health care worker with a reaction of:
(a) Ten (10) millimeters or more of induration if the TST result was interpreted as positive; or
(b) Five (5) millimeters to nine (9) millimeters of induration if the health care worker has a medical reason as described in Section 4(3) of this administrative regulation for the TST result to be interpreted as positive.
(4)
(a) If performed, the BAMT result for each health care worker shall be documented in the worker's medical record or electronic medical record by recording the date and result as positive, negative, borderline, or indeterminate.
(b) If a health care worker has a positive BAMT, the worker's medical record shall be labeled inside or the electronic medical record shall be labeled with the notation "BAMT Positive."
Section 7. Medical Evaluations, Chest X-rays, and Monitoring of Health Care Workers with a Positive TST, a Positive BAMT, a TST Conversion, or a BAMT Conversion.
(1) At the time of initial employment testing or annual testing, a health care worker shall have a medical evaluation, including an HIV test unless the health care worker opts out of HIV testing, if the health care worker is found to have a:
(a) TST result of ten (10) millimeters or more induration if the TST result is interpreted as positive;
(b) TST result of five (5) millimeters to nine (9) millimeters of induration if the health care worker has a medical reason as described in Section 4(3) of this administrative regulation for the TST result to be interpreted as positive;
(c) Positive BAMT;
(d) TST conversion; or
(e) BAMT conversion.
(2) A chest x-ray shall be performed as part of the medical evaluation required by subsection (1) of this section unless a chest x-ray performed within the previous two (2) months showed no evidence of tuberculosis disease.
(3)
(a) A health care worker with no clinical evidence of active TB disease, upon evaluation by a licensed physician, advanced practice registered nurse, or physician assistant and a negative chest x-ray, shall be offered treatment for LTBI unless medically contraindicated.
(b) A health care worker who refuses treatment for LTBI or who has a medical contraindication shall be monitored according to the requirements established in this paragraph.
- A health care worker who has a positive TST or a positive BAMT at the time of initial employment and works eleven (11) months or longer in the health facility shall:
a. Have an annual TB Risk Assessment in or before the same month as the anniversary date of his or her last TB Risk Assessment; and
b. Not be subject to an annual TST or BAMT.
- A health care worker with a documented TST conversion or a BAMT conversion shall:
a. Be educated about and advised of the clinical symptoms of active TB disease;
b. Have an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years after conversion, followed by an annual TB Risk Assessment in or before the same month as the anniversary date of the worker's last TB Risk Assessment; and
c. Not be subject to an annual TST or BAMT.
- A health care worker with a positive TST, a positive BAMT, a TST conversion, or a BAMT Conversion shall be:
a. Educated about and advised of the clinical symptoms of active TB disease; and
b. Instructed to report to his or her facility supervisor and seek medical attention promptly if symptoms persist for three (3) weeks or longer.
(4) Documentation that the health care worker was educated and advised of the clinical symptoms of active TB disease shall be included in the health care worker's medical record or electronic medical record.
Section 8. Medical Evaluations, Chest X-rays, Laboratory Tests, Treatment, and Monitoring of Health Care Workers with Suspected TB Disease or Active TB Disease.
(1) A health care worker with signs or symptoms or an abnormal chest x-ray, consistent with TB disease, shall:
(a) Be immediately excluded from work;
(b) Be isolated in an AII room, referred to a facility with an AII room, or placed in home isolation in collaboration with the local health department;
(c) Be evaluated for active tuberculosis disease and, if needed, treated with multi-drug TB therapy as recommended by the Centers for Disease Control and Prevention; and
(d) Remain off work until cleared as being noninfectious for TB by a licensed physician, advanced practice registered nurse, or physician assistant in conjunction with the local and state health departments.
(2) A health care worker under treatment for suspected or confirmed pulmonary tuberculosis disease, suspected or confirmed extrapulmonary tuberculosis disease, or other suspected or confirmed infectious tuberculosis diseases caused by either non-MDR TB or MDR-TB may return to work in the facility, as recommended by the Centers for Disease Control and Prevention, after being declared noninfectious by a licensed physician, advanced practice registered nurse, or physician assistant in conjunction with the local and state health departments.
Section 9. Responsibility for Screening and Monitoring Requirements: Health Care Workers.
(1) A facility's administrator or administrator's designee shall be responsible for ensuring that all TB Risk Assessments, TSTs, BAMTs, chest x-rays, and sputum specimen submissions for health care workers comply with the requirements of Section 3 through Section 8 of this administrative regulation.
(2) If a facility does not employ licensed professional staff with the technical training to carry out the screening and monitoring requirements, the administrator shall arrange for training or professional assistance from the local health department or from a licensed medical provider.
(3)
(a) A TST with the date of measurement and millimeters of induration, interpretation of the results, the date performed, reported results of all BAMTs, chest x-rays, sputum specimen AFB smears, TB cultures, TB-related NAA tests, and TB-related PCR tests for a health care worker shall be recorded as a permanent part of the worker's medical record or electronic medical record.
(b) Copies of the health care worker's medical record or electronic medical record shall be provided to the worker upon request if the worker transfers to another health facility.
Section 10. Reporting to Local Health Departments.
(1) A health facility's administrator or the administrator's designee shall report a health care worker identified with one (1) of the following to the local health department having jurisdiction within one (1) business day of becoming known:
(a) A TST conversion or BAMT conversion on serial testing or identified in a contact investigation;
(b) A chest x-ray which is suspicious for TB disease;
(c) A sputum smear positive for acid-fast bacilli;
(d) A rapid laboratory test positive for Mycobacterium tuberculosis DNA or RNA, such as Mycobacterium tuberculosis positive NAA tests or PCR tests;
(e) A sputum culture positive for Mycobacterium tuberculosis; or
(f) The initiation of multi-drug antituberculosis treatment for active TB disease in a health care worker.
(2) A health facility's administrator or the administrator's designee shall report a health care worker identified with one (1) of the following to the local health department having jurisdiction within five (5) business days of becoming known:
(a) A TST of ten (10) millimeters or more induration at the time of initial employment at the facility if the TST result was interpreted as positive;
(b) A TST result of five (5) or more millimeters of induration for a health care worker at the time of initial employment who has a medical reason as described in Section 4(3) of this administrative regulation for the TST result to be interpreted as positive; or
(c) A positive BAMT at the time of initial employment.
Section 11. Treatment for LTBI.
(1) A health care worker with a TST conversion or a BAMT conversion with no clinical evidence of active TB disease upon evaluation by a licensed physician, advanced practice registered nurse, or physician assistant and a negative chest x-ray shall be considered to be recently infected with Mycobacterium tuberculosis.
(2) A recently infected person as described in subsection (1) of this section shall have:
(a) A medical evaluation;
(b) An HIV test unless the individual opts out of HIV testing; and
(c) A chest x-ray.
(3) An individual who meets the criteria listed in subsection (1) of this section and who has no signs or symptoms of tuberculosis disease by medical evaluation or on chest x-ray shall be offered treatment for LTBI, in collaboration with the local health department, unless medically contraindicated as determined by a licensed physician, advanced practice registered nurse, or physician assistant.
(4)
(a) If a health care worker refuses treatment for LTBI after a TST conversion or a BAMT conversion or has a medical contraindication, the worker shall:
-
Be educated about, and advised of, the clinical symptoms of active TB disease;
-
Have a TB Risk Assessment, which includes an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years following TST conversion or BAMT conversion, followed thereafter by an annual TB Risk Assessment in or before the same month as the anniversary date of his or her last TB Risk Assessment; and
-
Not be required to submit to an annual TST or BAMT.
(b) Documentation that the health care worker was educated and advised of the clinical symptoms of active TB disease shall be included in the health care worker's medical record or electronic medical record.
(5) A health care worker who has a TST result of ten (10) millimeters or more induration, if the TST result is interpreted as positive, or a positive BAMT at the time of initial employment shall be offered treatment for LTBI, unless medically contraindicated.
(6) A health care worker who has a TST result of five (5) millimeters to nine (9) millimeters of induration upon initial employment and who has a medical reason as described in Section 4(3) of this administrative regulation for the TST result to be interpreted as positive shall be offered treatment for LTBI, unless medically contraindicated.
(7) If a health care worker refuses treatment for LTBI detected at the time of initial employment in the facility or has a medical contraindication, the worker shall:
(a) Be educated about and advised of the clinical symptoms of active TB disease;
(b) Have a TB Risk Assessment that includes an interval medical history for clinical symptoms of active TB disease every six (6) months during the first two (2) years after the date of initial employment in the facility, followed thereafter by an annual TB Risk Assessment in or before the same month as the anniversary date of the worker's last TB Risk Assessment; and
(c) Not be required to submit to an annual TST or BAMT.
(8) Documentation that the health care worker was educated about and advised of the clinical symptoms of active TB disease shall be included in the health care worker's medical record or electronic medical record.
(9) A health care worker who works eleven (11) months or longer in the facility and who provided medical documentation that he or she has completed treatment for LTBI with one (1) of the treatment regimens recommended by the Centers for Disease Control and Prevention shall:
(a) Not be required to submit to an annual TST or BAMT; and
(b) Receive education on the clinical symptoms of active TB disease during a TB Risk Assessment annually in or before the same month as the anniversary date of his or her last TB Risk Assessment.
Section 12. Compliance Date. All health care settings or health facilities subject to the tuberculosis testing requirements of this administrative regulation shall demonstrate compliance no later than 180 days after the effective date of this administrative regulation.
Section 13. Supersede. If any requirement stated in another administrative regulation within 902 KAR Chapter 20 contradicts a requirement stated in this administrative regulation, the requirement stated in this administrative regulation shall supersede the requirement stated elsewhere within 902 KAR Chapter 20.
History
- RELATES TO: KRS 215.520-215.600, 216B.010-216B.131, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to establish licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 215.590 requires a health service or health facility licensed pursuant to KRS Chapter 216B or KRS Chapter 333 to report knowledge of a person who has active tuberculosis to the local health department. This administrative regulation establishes requirements for tuberculosis (TB) testing of health care workers in health facilities or settings licensed under KRS Chapter 216B or KRS Chapter 333. These procedures are necessary to minimize the transmission of infectious tuberculosis disease among staff and patients or residents of health facilities.
- History: 42 Ky.R. 1422; 2219; 2370; eff. 3-4-2016; Cert. eff. 12-14-2022.
902 KAR 20:230 Comprehensive physical rehabilitation hospital; facility specifications {#sec-902-kar-20-230 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:230}
Section 1. Definitions.
(1) "Certificate of need" means an authorization by the Commission for Health Economics Control in Kentucky to proceed to acquire, to establish, to offer, to substantially change the bed capacity, or to substantially change a health service pursuant to KRS Chapter 216B.
(2) "Facility" means a comprehensive physical rehabilitation hospital.
(3) "License" means an authorization issued by the Commission for the purpose of operating a hospital facility.
(4) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Preparation and Approval of Plans and Specifications. After receiving a certificate of need, the following procedures shall be followed:
(1) Before construction is begun for the erection of new buildings or alterations to existing buildings or any change in a facility, the licensee or applicant shall submit plans to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) All such plans and specifications must be approved by the licensure agency prior to commencement of construction of new buildings or alterations of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted, together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications must be approved by the Department of Housing, Buildings and Construction. Appropriate local building permits shall be obtained prior to commencement of construction.
Section 3. Submission of Plans and Specifications for Facilities.
(1) First stage, schematic plans.
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical patient room layouts scaled (one-half (1/2) inch = one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(b) If the project is an addition, or is otherwise related to existing buildings on the site, plans shall show the existing facilities and general arrangements of those buildings.
(2) Second stage, preliminary plans. Preliminary sketch plans shall include the following:
(a) Architectural.
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Plans of basement, floors and roof showing space assignment, sizes, and outline of fixed and movable equipment;
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All elevators and typical sections;
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Plot plan showing roads, parking, and sidewalks;
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Areas and bed capacities by floors.
(b) Mechanical.
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Single line layout of all duct and piping systems;
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Riser diagrams for multistory construction;
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Scale layout of boilers and major associated equipment and central heating, cooling, and ventilating units.
(c) Electrical.
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Plans showing space assignments, sizes and outlines of fixed equipment such as transformers, main switch and switchboards, and generator sets;
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Simple riser diagram for multistory building construction, showing arrangement of feeders, subfeeders, bus work, load centers, and branch circuit panels.
(d) Outline specifications.
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General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls; duct and piping systems; and dietary, laundry, sterilizing and other special equipment;
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General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3) Third stage, contract documents.
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor, and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems. Details of construction, machine and control spaces necessary, size and type of equipment, and utility requirements for the following: dumbwaiters: electric, hand, hydraulic; elevators: freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-conditioning systems. Radiators and steam heated equipment such as sterilizers, warmers, and steam tables; heating and steam mains and branches with pipe sizes; diagram of heating and steam risers with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heaters with stokers, oil burners, or gas burners; pumps, tanks, boiler breeching, and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerator piping, and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems - size and elevation of: street sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and water service with connection to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold and circulating branches, and risers from the service entrance, and tanks; riser diagram for all plumbing stacks with vents, water risers, and fixture connections; gas, oxygen, and vacuum systems; standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets and circuits;
d. Telephone layout showing service entrance telephone switchboard, strip boxes, telephone outlets and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits;
g. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
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Cover or title sheet;
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Index;
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Sections describing materials and workmanship in detail for each class of work.
(c) Access to the work. Representatives of the appropriate state agencies shall have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 4. Compliance with Building Codes, Ordinances and Regulations.
(1) This section may be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended;
(b) Requirements for plumbing pursuant to 815 KAR 20:010-191, as amended;
(c) Requirements for air contaminants for incinerators pursuant to 401 KAR 59:020 and 401 KAR 61:010;
(d) Requirements for elevators pursuant to 815 KAR 4:010;
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(4) Prior to occupancy the facility shall have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code before relicensure is granted by the licensing agency.
Section 5. Facility Requirements and Special Conditions.
(1) A copy of the narrative program as submitted in the Certificate of Need application for each project shall be provided by the sponsor which describes the functional space requirements, staffing patterns, departmental relationships, and other basic information relating to the fulfillment of the objectives of the facility.
(2) The extent (number and types of rooms) of the diagnostic, clinical, and administrative facilities to be provided shall be determined by the services contemplated and the estimated patient load as described in the narrative program.
(3) Facilities shall be available to the public, staff, and patients who may be physically handicapped with special attention given to ramps, drinking fountain height, and mirrors.
Section 6. Nursing Unit.
(1) Patient rooms. Each patient room shall meet the following requirements:
(a) Maximum room capacity shall be four (4) patients.
(b) Minimum room areas exclusive of toilet rooms, closets, lockers, wardrobes, or vestibules shall be 125 square feet in one (1) bed rooms and 100 square feet per bed in multibed rooms.
(c) Multibed rooms shall be designed to permit no more than two (2) beds side by side parallel to the window wall with not less than a four (4) foot space provided between beds, and at least a three (3) foot space between the side of a bed and the nearest wall, fixed cabinet, or heating/cooling element. A minimum of four (4) feet is required between foot of bed and opposite wall, or foot of the opposite bed in multibed rooms.
(d) Window. All patient rooms must have windows operable without the use of tools and shall have sills not more than three (3) feet above the floor. Window area shall be at least eight (8) percent of patient room floor area.
(e) Nurses' calling system. See Section 34(7) of this administrative regulation.
(f) Lavatory. In single and two (2) bed rooms with private toilet room, the lavatory may be located in the toilet room. Where two (2) patient rooms share a common toilet, a lavatory shall be provided in each patient room.
(g) Wardrobe or closet for each patient. Minimum clear dimensions shall be one (1) foot ten (10) inches by one (1) foot and eight (8) inches with full length hanging space, clothes rod and shelf.
(h) Cubicle curtains, or equivalent built-in devices shall be provided to furnish complete privacy for each patient at any one time in multibed rooms. Design for privacy shall not restrict patient access to the toilet, lavatory, or room entrance.
(i) No patient room shall be located more than 120 feet from the nurses' station, the clean workroom and the soiled workroom. No room shall be used as a patient room where the access is through another patient's room. At least sixty (60) percent of the beds in the nursing unit shall be located in rooms designed for one (1) or two (2) beds.
(2) Service areas in each nursing unit. The size and disposition of each service area will depend on the number of beds and types of disabilities to be served. Although identifiable spaces are required for each of the indicated functions, consideration will be given to multiple-use design solutions which provide equal, though unspecified, areas. Certain service areas may be arranged and located to serve more than one (1) nursing unit, but at least one (1) such service area shall be provided on each nursing floor unless noted otherwise. Service areas shall include:
(a) Administrative center or nurses' station for charting, doctors' charting, communications, and storage for supplies and nurses' personal effects.
(b) Clean workroom or clean holding area. The clean workroom shall contain a work counter, hand-washing and storage facilities. The clean holding room shall be part of a system for storage and distribution of clean and sterile supplies and shall be similar to the clean workroom except that the work counter and hand-washing facilities may be omitted.
(c) Soiled workroom or soiled holding room. The soiled workroom shall contain a clinical sink or equivalent flushing rim fixture, sink equipped for hand washing, work counter, waste receptacle, and linen receptacle. A soiled holding room shall be part of a system for collection and disposal of soiled materials and shall be similar to the soiled workroom except that the clinical sink and work counter may be omitted.
(d) Lounge and toilet room(s) for staff including lockers for storage of personal effects readily accessible. (May serve more than one (1) nursing unit.)
(e) Multipurpose room for conferences, demonstrations and consultation. (May serve more than one (1) nursing unit.)
(f) Medicine area. Provision shall be made for convenient and prompt twenty-four (24) hour distribution of medicine to patients. This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system. If used, a medicine preparation room or unit shall be under the nursing staff's visual control and a work counter, refrigerator, and locked storage for biologicals and drugs. A medicine dispensing unit may be located at the nurses' station, in the clean workroom, or in an alcove or other space under direct control of the nursing or pharmacy staff. The controlled substances locker must be under double lock. A hand-washing facility shall be provided.
(g) Clean linen storage. There shall be an enclosed storage space for clean linen. This area may be designated within the clean workroom. If a closed cart system is used, storage may be in an alcove.
(h) Nourishment station. This shall contain a sink equipped for hand-washing equipment for serving between scheduled meals, refrigerator, storage cabinets, and ice making-dispenser units to provide patient service and treatment. (May serve more than one (1) nursing unit on the same floor.)
(i) Stretcher and wheelchair parking area or alcove. This shall be located out of the path of normal traffic. (May serve more than one (1) nursing unit on the same floor.)
(j) Janitor's closet for storage of housekeeping supplies and equipment with a floor receptor or service sink. (May serve more than one (1) nursing unit on the same floor.)
(k) Equipment storage room with sufficient space for equipment such as I.V. stands, inhalators, air mattresses, and walkers. (May serve more than one (1) nursing unit on the same floor.)
(l) Emergency equipment storage. Space for equipment such as crash carts shall be provided and be under direct control of the nursing staff in close proximity to the nurses' station and out of traffic. (May serve more than one (1) nursing unit on the same floor.)
(3) Patients' bathing facilities. There shall be at least one (1) shower stall or one (1) bathtub for each twelve (12) beds not individually served. Each tub or shower shall be in an individual room or privacy enclosure which provides space for the private use of the bathing fixture, for drying and dressing, and for a wheelchair and an assisting attendant. Showers and central bathing facilities shall be at least four (4) feet square without curbs, and designed to permit use by a wheelchair patient.
(4) Patient toilet rooms.
(a) The minimum dimensions of a room containing only a water closet shall be five (5) feet by six (6) feet. Additional space shall be provided if a lavatory is located within the same room. The configuration of patient toilet rooms must provide for side transfers.
(b) A toilet room shall be directly accessible from each patient room without going through the general corridor. One (1) toilet room may serve two (2) patient rooms, but not more than four (4) beds. (The lavatory may be omitted from the toilet room if one is provided in each patient room.)
(c) Doors to toilet rooms shall have a minimum width of two (2) feet ten (10) inches to admit a wheelchair.
(5) Isolation room. If provided for in the program narrative, isolation room(s) shall be required for those prone to infections as well as those suffering from infections. Each isolation room shall have:
(a) Only one (1) patient per room;
(b) Separate toilet room with bath or shower and lavatory for the exclusive use of the patient allowing for direct entry from the patient bed area; and
(c) Facilities outside and immediately adjacent to the patient room for maintaining aseptic conditions.
Section 7. Outpatient Suite.
(1) General. Facilities for outpatient clinic care shall be provided if included in the narrative plan.
(2) Outpatient department. If outpatient services are provided, the extent of the administrative, clinical and diagnostic facilities to be provided will depend on the estimated patient load as described in the program narrative. The planning of outpatient facilities shall provide for the privacy and dignity of the patient during interview, examination, and treatment. Facilities shall be located so that outpatients do not traverse inpatient areas and the following shall be provided:
(a) Entrance at grade level which is sheltered from weather and able to accommodate wheelchair access.
(b) Reception and control area located near the entrance and waiting area(s).
(c) Wheelchair storage out of the line of direct traffic.
(d) Public waiting area with toilet facilities, public telephone and drinking fountain.
(e) Interview space(s) for private interviews relating to social service, credit and admissions.
(f) General purpose examination room(s) for medical examinations. Each room shall have a minimum floor area of eighty (80) square feet, excluding such spaces as vestibule, toilet, closet and work counter. Examination table shall be placed to provide at least thirty (30) inches clearance to each side and at the foot of the table. A lavatory or sink equipped for hand washing shall be provided in each room.
(g) Patient toilet facilities shall be provided. The number required will depend on the actual patient load of the department.
(h) Nurses' station for nurses' charting, doctors' charting, communications and storage for supplies and nurses' personal effects.
(i) Staff toilet room located convenient to the nurses' station.
(j) Clean workroom. It shall contain a work counter, sink equipped for hand washing, and storage space for clean and sterile supplies.
(k) Soiled workroom. It shall contain a clinical sink or equivalent flushing type fixture, work counter, sink equipped for hand washing, waste receptacle and linen receptacle.
(l) Drug distribution station for storage and preparation of medication. It shall contain a work counter, sink equipped for hand washing, and storage facilities. Controlled substances shall be under double lock.
(m) Wheelchair and stretcher alcove located convenient to the entrance to the department.
(n) Janitor's closet. It shall contain a floor receptor or service sink with storage space for housekeeping supplies and equipment for exclusive use in the outpatient department.
(o) Equipment storage room.
Section 8. Radiology Suite. If the facility provides diagnostic radiology services directly, then the suite shall contain the following:
(1) Radiographic room(s);
(2) Film processing facilities;
(3) Viewing and administrative area(s);
(4) Film storage facilities;
(5) Toilet room with hand-washing facility. It shall be located directly accessible from each fluoroscopy room without entering the general corridor area;
(6) Dressing area(s) for ambulatory patients with convenient access to toilets;
(7) Waiting room or alcove for ambulatory patients;
(8) Holding area for stretcher patients. It shall be located out of the direct line of normal traffic; and
(9) Hand-washing facilities shall be provided in each radiographic room unless the room is used only for routine diagnostic screening such as for chest x-rays.
Section 9. Laboratory Suite. Facilities shall be provided directly or through an effective contract arrangement with a nearby hospital for laboratory service for the following:
(1) Hematology;
(2) Clinical chemistry. An acid-shower and eyewashing facility shall be provided nearby;
(3) Urinalysis. A specimen toilet with hand-washing facility shall be provided nearby;
(4) Cytology;
(5) Bacteriology;
(6) Waiting area for ambulatory patients;
(7) Administrative support areas;
(8) Blood storage facilities;
(9) Blood specimen collection area. It shall contain work counter, hand-washing facilities, and space for patient seating;
(10) Glass-washing and sterilizing facilities; and
(11) Recording and filing facilities.
Section 10. Physical Therapy Suite. Each rehabilitation facility shall provide physical therapy services; however, the physical therapy area can be shared with the occupational therapy services, if called for in the program narrative. Each physical therapy suite shall contain the following items:
(1) Office space;
(2) Waiting space;
(3) Treatment area(s) for thermotherapy, diathermy, ultrasonics, hydrotherapy, etc. Cubicle curtains around each individual treatment area shall be provided for privacy purposes. Hand-washing facilities shall be provided but one (1) lavatory or sink may serve more than one (1) treatment cubicle. Facilities for collection of wet and soiled linen or other material shall be provided;
(4) Exercise area(s);
(5) Storage for clean linen, supplies, and equipment;
(6) Patients' dressing areas, showers, lockers and toilet rooms;
(7) Janitor's closet with floor receptor or service sink and storage space for housekeeping supplies and equipment; and
(8) Wheelchair and stretcher storage area. (Items contained in subsections (1), (2), (5), (7) and (8) of this section may be planned and arranged for shared use by occupational therapy patients and staff if the approved narrative program reflects this sharing concept.)
Section 11. Occupational Therapy Suite. Each rehabilitation facility shall provide occupational therapy services; however, the occupational therapy area can be shared with the physical therapy services, if called for in the program narrative. The following shall be provided:
(1) Office space;
(2) Waiting space;
(3) Work areas and counters suitable for wheelchair access;
(4) Hand-wash facilities;
(5) Storage for supplies and equipment.
Section 12. Social Work Suite. Each rehabilitation facility shall contain a social work suite. The following shall be provided:
(1) Office space(s) for staff.
(2) Office space for private interviewing and counseling for all family members.
Section 13. Psychological Services Suite. Each rehabilitation facility shall contain a psychological service suite. The following shall be provided:
(1) Office(s).
(2) Workspace for testing, evaluation, and counseling.
Section 14. Speech and Language Therapy Suite. Each rehabilitation facility shall contain a speech and language therapy suite. The following shall be provided:
(1) Office(s) for therapists.
(2) Space for evaluation and treatment.
(3) Space for equipment and storage.
Section 15. Area for Teaching Activities of Daily Living (should be combined with rehabilitative engineering function, as needed).
(1) An area for teaching activities shall be provided.
(2) It shall include a bedroom, bath, kitchen, and space for stairs.
Section 16. Prosthetics and Orthotics Service. Depending on the needs of those served and the stated institutional goals, the facility shall provide or make arrangements for the following:
(1) Work space for technician(s).
(2) Space for evaluation and fittings (with a provision for privacy).
(3) Space for equipment, supplies, and storage.
Section 17. Vocational Therapy Services. Depending upon the needs of those served and the stated institutional goals, the facility shall provide or make arrangements for the following:
(1) Office(s).
(2) Workspace for vocational services activities such as evaluation (prevocational and vocational).
(3) Training.
(4) Counseling and placement.
Section 18. Respiratory Therapy Services. Depending upon the needs of those served and the stated institution goals, the facility shall provide or make arrangements for the following:
(1) Storage for equipment and supplies.
(2) Space and utilities for cleaning and sanitizing equipment.
(3) Service facilities for calibrating, adjusting, servicing, and minor repairs and equipment.
(4) Respiratory services shall be conveniently accessible on a twenty-four (24) hour basis to the facility.
(5) If respiratory services such as testing and demonstration for outpatients are part of the program, additional facilities and equipment shall be provided as necessary for appropriate function of the service, including but not limited to:
(a) Patient waiting area with provision for wheelchairs.
(b) Reception and control station.
(c) Patient toilets and hand-washing facilities.
(d) Room(s) for patient education and demonstration.
Section 19. Pharmacy Suite. If required by program, the size and type of services to be provided in the pharmacy will depend upon the type of drug distribution system to be used and whether the facility proposes to provide, purchase, or share pharmacy services. This shall be explained in the narrative program. Provision shall be made for the following functional areas:
(1) Dispensing area with hand-washing facility.
(2) Editing or order review area.
(3) Area for compounding.
Section 20. Dietary Department. Food facilities shall be designed and equipped to meet requirements of the narrative program. If a commercial service will be used, dietary areas and equipment shall be designed to accommodate the requirements for sanitary storage, processing, and handling. The department shall include the following facilities unless acceptable commercially prepared dietary services, meals, and or disposables are to be used:
(1) Control station for the receiving of food supplies.
(2) Food preparation facilities. Conventional food preparation systems require space and equipment for preparing, cooking, and baking. Convenience food service systems such as frozen prepared meals, bulk packages entrees, and individual package portions, or systems using contractual commissary services require space and equipment for thawing, portioning, cooking and/or baking.
(3) Hand-washing facility(ies) located conveniently accessible in the food preparation area.
(4) Patients' meals service facilities. Examples are those required for tray assembly and distribution.
(5) Dishwashing space. It shall be located in a room or alcove separate from the food preparation and serving area. Commercial-type dishwashing equipment shall be provided. Space shall also be provided for receiving, scraping, sorting and stacking of soiled dishware and tableware prior to cleanup. The area shall be designed to allow clean dishware and tableware to be removed at a different location than the one used for the soiled dishware and tableware. A hand-washing lavatory shall be conveniently located.
(6) Pot-washing facilities.
(7) Refrigerated storage to accommodate a three (3) day minimum supply.
(8) Dry storage to accommodate a three (3) day minimum supply.
(9) Storage areas and sanitizing facilities for cans, carts and mobile tray conveyors.
(10) Waste storage facilities shall be located in a separate room easily accessible to the outside for direct pickup or disposal.
(11) Dining space for ambulatory patients, staff and visitors.
(12) Office(s) or desk spaces for dieticians or the dietary service manager.
(13) Toilets with hand-washing facilities for use by the dietary staff shall be immediately available.
(14) Janitor's closet located within the department. It shall contain a floor receptor or service sink with storage for housekeeping supplies and equipment to be used exclusively in this area.
Section 21. Patient's Dining, Recreation, and Day Spaces. The following areas shall be provided and may be in separate or adjoining spaces:
(1) Inpatients and residents. A total of twenty-five (25) square feet per bed.
(2) Outpatients. A total of twenty (20) square feet per person when dining is a part of their day care program. (If dining is not part of the program, provide at least ten (10) square feet per person for recreation and day spaces.)
(3) Storage. Storage spaces shall be provided for recreational equipment and supplies.
Section 22. Administrative and Public Areas. The following shall be provided:
(1) Lobby. It shall include:
(a) Storage space for wheelchairs;
(b) Reception and information counter or desk;
(c) Waiting space(s); and
(d) Public toilet facilities designed for use by the physically handicapped.
(2) Interview space(s) for private interviews relating to social services, credit, and admissions.
(3) Director of nurses' office.
(4) Staff toilet rooms.
(5) Medical library facilities.
(6) General or individual office(s) for business transactions, medical and financial records, administrative and professional staffs use.
(7) Administrator's office.
(8) Multipurpose room(s) for conferences, meetings, and health education purposes including provisions for showing visual aids.
(9) Storage for office equipment and supplies.
Section 23. Medical Records Unit. This unit shall include:
(1) Medical records administrator/technician office or space;
(2) Active record storage area;
(3) Record review and dictating room; and
(4) Work area for sorting, recording, and microfilming.
Section 24. Sterilizing Facilities. A system for the sterilization of equipment and supplies shall be provided. Storage area for clean supplies and sterile supplies shall be provided.
Section 25. Central Stores. The following shall be provided:
(1) Off-street unloading facilities.
(2) Control station for receiving supplies.
(3) General storage rooms which are adequate in size to meet the needs of the facility.
Section 26. Laundry. On-site processing and off-site processing.
(1) If linen is to be processed on the site, the following shall be provided:
(a) Soiled linen receiving, holding, and sorting room with hand-washing facilities.
(b) Laundry processing room with commercial-type equipment which can process seven (7) days of linen needs within a regularly scheduled work week. Hand-washing facilities shall be provided.
(c) Storage for laundry supplies.
(d) Clean linen inspection and mending room.
(e) Clean linen storage, issuing, and holding room or area.
(f) Janitor's closet. It shall contain a floor receptor or service sink with storage space for housekeeping supplies and equipment to be utilized exclusively in this department.
(g) Cart storage and cart sanitizing facilities.
(h) Arrangement of equipment and procedures shall be in a manner to permit an orderly work flow with a minimum of cross traffic that might mix clean and soiled operations.
(2) If linen is to be processed off the site, the following shall be provided:
(a) Soiled linen holding room with a hand-washing facility conveniently accessible.
(b) Clean linen receiving, holding, inspection and storage room(s).
Section 27. Employees' Facilities.
(1) Female locker room. This room shall have lounge space, lockers for personal effects and a separate toilet room. The area shall be designed for use by the physically handicapped. In some cases shower facilities may be appropriate depending on the size of the facility.
(2) Male locker room. This room shall have lockers and a separate toilet room. The area shall be designed for use by the physically handicapped. In some cases shower facilities may be appropriate depending on the size of the facility.
Section 28. Engineering Service and Equipment Areas. The following shall be provided:
(1) Room(s) or separate building(s) for boilers, mechanical equipment and electrical equipment;
(2) Engineer's office;
(3) Maintenance shop;
(4) Storage room for building maintenance supplies;
(5) Storage room for central housekeeping equipment and supplies;
(6) Office and administrative support space for person(s) in charge of central housekeeping; and
(7) Yard equipment storage.
Section 29. Waste Processing Services. Rehabilitation facilities which are part of an acute care hospital may share waste processing. Freestanding facilities shall provide the following:
(1) Storage and disposal. Space and facilities shall be provided for the sanitary storage and disposal of waste by incineration, mechanical destruction, compaction, containerization, removal or by a combination of these techniques.
(2) Incinerator. A gas, electric, or oil-fired incinerator shall be provided for the complete destruction of pathological and infectious waste. Infectious waste includes, but is not limited to, waste materials from isolation rooms, dressings and material from open wounds and laboratory specimens. The incinerator may be shared by two (2) or more institutions located on a common "campus."
(a) The incinerator capacity required will vary with the type and quantity of waste to be processed. If approved by local authorities and described in the functional program, items of small mass such as dressings, isolation room waste, laboratory specimens, may be sterilized on site by autoclaving or rendered safe by other acceptable procedure and disposed of in municipal landfill or incinerator. Waste tissue and contaminated combustible solids shall be rendered safe by such methods as sterilization or incineration. Culture plates, tubes, sputum cups, contaminated sponges, swabs and the like shall be sterilized before they are washed and discarded.
(b) Consideration shall be given to the recovery of waste heat from on-site incinerators which are used to dispose of large amounts of waste materials.
Section 30. Details and Finishes.
(1) Details.
(a) All doors to patient-room toilets and patient-room bathrooms shall swing outward or be equipped with hardware that will permit access in an emergency.
(b) Windows and outer doors which may be frequently left in an open position shall be provided with insect screens.
(c) Thresholds and expansion joint covers shall be made flush with the floor surface to facilitate use by wheelchairs and carts and shall be constructed to resist passage of smoke.
(d) The location and arrangements of lavatories and sinks equipped with blade handles for hand-washing purposes shall provide a minimum of sixteen (16) inches clearance to each side of the centerline of the fixture.
(e) Provisions for hand drying shall be included at all hand-washing facilities except scrub sinks. These shall be single use, separate paper or cloth units enclosed in such a way as to provide protection against dust or soil and insure single unit dispensing. Hot air dryers are permitted provided that installation is such as to minimize contamination by recirculated air.
(f) Grab bars shall be provided at all patients' toilets, showers, and tubs. The bars shall have one and one-half (1 1/2) inches clearance to walls and shall be of sufficient strength and anchorage to sustain a concentrated load of 250 pounds for a period of five (5) minutes.
(g) Handrails shall be provided on both sides of corridors used by patients. A clear distance of one and one-half (1 1/2) inches shall be provided between the handrail and the wall, and the top of the rail shall be about thirty-two (32) inches above the floor, except for special care areas such as those serving children.
(h) Ends of handrails and grab bars shall be constructed to prevent snagging the clothes of patients.
(i) Location and arrangement of hand-washing facilities shall permit their proper use and operation. Particular care should be given to clearance required for blade-type operating handles. Lavatories intended for use by handicapped patients shall be installed to permit wheelchairs to slide under them.
(j) Recessed soap dishes shall be provided at all showers and bathtubs.
(k) Mirrors shall be arranged for convenient use by patients in wheelchairs as well as by patients in a standing position.
(l) Protection requirements of x-ray and gamma-ray installations shall be approved by the Radiation and Product Safety Branch, Office of Consumer Health Protection, Department for Health Services, Cabinet for Human Resources.
(m) The minimum ceiling height shall be eight (8) feet, with the following exceptions:
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Boiler rooms shall have ceiling clearances not less than two (2) feet six (6) inches above the main boiler header and connecting piping.
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Radiographic, and other rooms containing ceiling-mounted equipment or ceiling-mounted light fixtures shall have sufficient height to accommodate the equipment or fixtures and their normal movement.
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Ceiling and corridors, storage rooms, and toilet rooms shall be not less than seven (7) feet eight (8) inches. Ceilings in small minor spaces which are normally unoccupied may be reduced to seven (7) feet.
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Suspended tracks, rails, and pipes located in the path of traffic for patients in beds and/or stretchers, including service areas for inpatients shall be not less than seven (7) feet above the floor.
(n) Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over patient bed areas, unless special provisions are made to minimize such noise.
(o) Rooms containing heat-producing equipment such as boiler rooms, laundries, and food preparation areas shall be insulated and ventilated to prevent any floor surface from exceeding a temperature of ten (10) degrees Fahrenheit above the ambient room temperature.
(p) Noise reduction criteria. Partition, floor, and ceiling construction in patient areas shall comply with Table 1, Section 35 of this administrative regulation.
(2) Finishes.
(a) Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. Floors in areas used for food preparation or food assembly shall be water-resistant and grease-proof. Joints in tile and similar material in such areas shall be resistant to food acids. In all areas subject to frequent wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet, such as shower and bath areas, kitchens and similar work areas, shall have a nonslip finish.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable; and in the immediate area of plumbing fixtures, the finish shall be smooth and moisture-resistant. Finish, trim, and floor and wall construction in dietary and food preparation areas shall be free from spaces that can harbor rodents and insects.
(d) Wall bases in kitchens, and other areas subject to frequent wet cleaning methods shall be made integral and coved with the floor, tightly sealed within the wall, and constructed without voids that can harbor harmful bacteria.
(e) Ceilings throughout the facility shall be easily cleanable. Ceilings in dietary and food preparation areas shall have a finished ceiling covering all overhead piping and ductwork. Finished ceilings may be omitted in mechanical and equipment spaces, shops, general storage areas and similar spaces, unless required for fire-resistive purposes.
(f) Acoustical type ceilings shall be provided for corridors in patient areas, nurses' stations, dayrooms, recreation rooms, dining areas, and waiting areas.
Section 31. Elevators. General. All buildings having patients' facilities, such as bedrooms, dining rooms or recreation areas, or critical services, such as diagnostic or therapy areas, located on other than the main entrance floor shall have elevators.
(1) Number of elevators.
(a) At least one (1) hospital-type elevator shall be installed where one (1) to fifty-nine (59) patient beds are located on any floor other than the main entrance floor.
(b) At least two (2) hospital-type elevators shall be installed where sixty (60) to 200 patient beds are located on floors other than the main entrance floor, or where the major inpatient services are located on a floor other than those containing patient beds.
(c) At least three (3) hospital-type elevators shall be installed where 201 to 350 patient beds are located on floors other than the main entrance floor, or where the inpatient services are located on a floor other than those containing patient beds.
(d) For facilities with more than 350 beds number of elevators shall be determined from a study of the facility plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Cars of hospital-type elevators shall have inside dimensions that will accommodate a hospital bed and attendant and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep. The car door shall have a minimum clear opening of not less than three (3) feet and eight (8) inches.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
(4) Operation. Elevators, except freight elevators, shall be equipped with a two (2) way special service switch to permit cars to bypass all landing button calls and be dispatched directly to any floor.
Section 32. Construction.
(1) Design. Every building and every portion thereof shall be designed and constructed to sustain all dead and live loads in accordance with accepted engineering practices and standards, including seismic forces when applicable.
(2) Foundations. Foundations shall rest on natural solid bearing, if a satisfactory bearing is available at reasonable depths. Proper soil-bearing values shall be established in accordance with recognized standards. If solid bearing is not encountered at practical depths, the structure shall be supported on driven piles, augured piles, poured caissons or equivalent designed to support the intended load without detrimental settlement, except that one (1) story buildings may rest on a fill designed by a soils engineer. When engineered fill is used, site preparation and placement of fill shall be done under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the compacted fill operation and certification of compliance with the job specifications. All footings shall extend to a depth not less than one (1) foot below the estimated frost line.
(3) Natural disasters. Special provisions shall be made in the design of buildings in geographic areas where local experience reflects loss of life or extensive damage to buildings resulting from tornadoes, floods, earthquakes, etc.
Section 33. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect and/or engineer shall obtain from the contractor certification in writing that all mechanical systems have been tested and that the installation and performance of these systems conform with the final plans and specifications.
(2) Incinerators. The design and installation shall comply with the current Kentucky standards for control of air contaminants for incinerators regulations as applicable to hospitals.
(3) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) shall be provided and the combined capacity of the boilers, based upon the published Steel Boiler Institute or Institute of Boiler and Radiation Manufacturer's net rating, must be able to supply 150 percent of the normal requirements for all systems and equipment in the facility.
(b) Boiler accessories. Boiler feed pumps, condensate return pumps, fuel oil pumps, and circulation pumps shall be connected and installed to provide normal and standby service.
(c) Valves. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends except that vacuum condensate returns need not be valved at each piece of equipment.
(4) Thermal and acoustical installation.
(a) Insulation shall be provided on the following within the building:
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Boilers, smoke breeching, and stacks;
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Steam supply and condensate return piping;
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Hot water piping above 120 degrees Fahrenheit at all hot water heaters, generators and converters;
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Chilled water, refrigerant, other process piping and equipment operating with fluid temperatures below ambient dew point;
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Water supply and drainage piping on which condensation may occur;
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Air ducts and casings with outside surface temperature below ambient dew point or temperature above eighty (80) degrees Fahrenheit; and
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Other piping, ducts, and equipment as necessary to maintain the efficiency of the system.
(b) Insulation on cold surfaces shall include an exterior vapor barrier.
(5) Air-conditioning, heating and ventilation systems.
(a) Temperatures for areas occupied by inpatients, the indoor winter design temperature shall be seventy-five (75) degrees Fahrenheit. For all other occupied areas, the indoor winter design temperature shall be seventy-two (72) degrees Fahrenheit. For all other occupied areas, the indoor summer design temperature shall be seventy-five (75) degrees Fahrenheit.
(b) Ventilation system details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates as shown on Table 2, Section 35 of this administrative regulation, shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates.
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Outdoor air intakes shall be located as far as practical but not less than twenty-five (25) feet from exhaust outlets of ventilation systems, combustion equipment stacks, medical surgical vacuum systems, plumbing vent stacks, or from areas which may collect vehicular and other noxious fumes. Plumbing and vacuum vents that terminate above the level of the top of the air intake may be located as close as ten (10) feet. The bottom of outside air intakes serving central air systems shall be located as high as practical but not less than six (6) feet above ground level or if installed above the roof, three (3) feet above roof level.
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The ventilation systems shall be designed and balanced in accordance with the pressure relationship as shown in Table 2, Section 35 of this administrative regulation.
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Where two (2) filter beds are required in central ventilation and air-conditioning equipment, Filter Bed No. 1 shall be located upstream of the air-conditioning equipment and Filter Bed No. 2 shall be located downstream of the supply fan, any recirculating spray water system, and water reservoir type humidifiers. Where only one (1) filter bed is required, it shall be located upstream of the air-conditioning equipment unless an additional prefilter is employed. In this case, the prefilter shall be located upstream of the equipment and the main filter may be located further downstream.
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All room supply, return and exhaust outlets shall be located not less than three (3) inches AFF.
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All central ventilation or air-conditioning systems shall be equipped with filters having minimum efficiencies as listed below:
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All filter efficiencies as listed above shall be average atmospheric dust spot efficiencies tested in accordance with ASHRAE Standard 52-76.
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Filter frames shall be durable and carefully dimensioned, and shall provide an airtight fit with the enclosing ductwork. All joints between filter segments and the enclosing ductwork shall be gasketed or sealed to provide a positive seal against air leakages.
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A manometer or its equivalent shall be installed across each filter bed in central air systems.
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Ducts which penetrate construction intended for x-ray or other ray protection shall not impair the effectiveness of the protection.
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Laboratories shall be provided with outdoor air at a rate of two (2) air changes per hour. If this ventilation rate does not provide the air required to ventilate fume hoods and safety cabinets, additional outdoor air shall be provided. A filter with ninety (90) percent minimum efficiency shall be installed in the air supply system at its entrance to the media transfer room.
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Laboratory hoods for general use shall have a minimum average face velocity of seventy-five (75) feet per minute. Hoods in which infections or highly radioactive materials are processed shall have a face velocity of 100 feet per minute and each hood shall have an independent exhaust system with the fan installed at the discharge point of the system. Hoods used for processing infectious materials shall be equipped with a means of disinfection.
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Duct systems serving hoods in which highly radioactive materials and strong oxidizing agents are used shall be constructed of stainless steel for a minimum of ten (10) feet from the hood and shall be equipped with washdown facilities.
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Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and reasonable temperatures in the rooms and in adjoining areas.
(6) Plumbing systems. All plumbing systems shall be designed and installed in accordance with the requirements of the current Kentucky plumbing standards administrative regulations applicable to hospitals.
(a) Plumbing fixtures.
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The material used for plumbing fixtures shall be of nonabsorptive acid-resistant material.
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Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum of five (5) inches above the rim of the fixture. All fixtures used by medical and nursing staff and all lavatories used by patients and food handlers shall be equipped with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall not exceed four and one-half (4 1/2) inches in length, except that handles on scrub sinks and clinical sinks shall be not less than six (6) inches long.
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Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
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Shower bases and tubs shall provide nonslip surfaces for patients.
(b) Water supply systems.
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Systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.
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Each water service main, branch main, riser and branch to a group fixture shall be valved. Stop valves shall be provided at each fixture.
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Backflow preventers (vacuum breakers) shall be installed on hose bibbs, laboratory sinks, janitors' sinks, bedpan flushing attachments, and all other fixtures to which hoses or tubing can be attached.
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Flush valves installed on plumbing fixtures shall be of a quiet operating type.
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Bedpan flushing devices shall be provided in each patient toilet room and in the soiled workrooms located in the patient nursing units.
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An auxiliary water supply shall be available to provide potable water in case of emergencies.
(c) Hot water heating systems.
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The hot water heating equipment shall have a sufficient capacity to supply water at the temperature and amounts indicated below:
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Storage tank(s) shall be fabricated or corrosive-resistant metal or be lined with noncorrosive material.
(d) Drainage systems.
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Drain lines from sinks in which acid wastes may be poured shall be fabricated from an acid-resistant material.
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Piping over food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage or condensation from necessary overhead piping systems.
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Building sewers shall discharge into a community sewerage system. Where such a system is not available, a facility providing sewage treatment shall be installed which conforms to all applicable local and state administrative regulations.
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Nonflammable medical gas systems. If used, nonflammable medical gas systems installations shall be in accordance with the requirements of NFPA Standard 56A and 56F.
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At least two (2) patient rooms in each nursing unit and the examination/treatment rooms shall have oxygen and vacuum outlets.
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In patient rooms with oxygen and vacuum outlets, one (1) set of those outlets may serve two (2) beds.
Section 34. Electrical Requirements.
(1) General.
(a) All material including equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. All materials shall be listed as complying with applicable standards of Underwriters' Laboratories, Inc., or other similarly established standards.
(b) All electrical installations and systems shall be tested to show that the equipment is installed and operates as planned or specified. A written record of performance tests on special electrical systems and equipment shall be supplied to the owner.
(2) Switchboard and power panels. Circuit breakers or fusible switches that provide disconnecting means and overcurrent protection for conductors connected to switchboards and panel boards shall be enclosed or guarded to provide a dead-front type of assembly. The main switchboard shall be located in a separate enclosure accessible only to authorized persons. The switchboard shall be convenient for use, readily accessible for maintenance, clear of traffic lanes, and in a dry ventilated space devoid of corrosive fumes or gases. Overload devices shall be suitable for operating properly in the ambient temperature conditions.
(3) Panel boards. Lighting and appliance panel boards shall be located on the same floor as the circuits they serve.
(4) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have lighting.
(b) Patients' bedrooms shall have general lighting and night lighting. A reading light shall be provided for each patient. Flexible light arms shall be mechanically operated to prevent the bulb from coming in contact with the bed linen. Patients' reading lights and other fixed lights not switched at the door shall have switch controls located convenient to the luminaire. A fixed type night light, mounted at approximately sixteen (16) inches above the floor, shall be provided in each patient room. All switches for control of lighting in patient areas shall be of the quiet operating type. Switches in patients' rooms shall be installed not more than forty-eight (48) inches above the floor to be reached from a wheelchair.
(c) Nursing unit corridors shall have general illumination with provisions for reduction of light levels at night. Refer to Table 3, Section 35 of this administrative regulation.
(5) Receptacles (convenience outlets).
(a) Bedroom. Each patient bedroom shall have duplex receptacles as follows: one (1) on each side of the head of the bed; one (1) for the television, if used; and one (1) on another wall. Receptacles for general use shall be located convenient for use from a wheelchair.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart and within twenty-five (25) feet of ends of corridors.
(6) Equipment installation in special areas.
(a) X-ray and gamma-ray installations. X-ray stationary installations and mobile equipment shall conform to the current Kentucky standards for radiographic and radioisotope equipment and use administrative regulations applicable to hospitals.
(b) X-ray film illuminator units. At least two (2) units shall be installed in the x-ray viewing room.
(c) The electrical circuit(s) to fixed or portable equipment in hydrotherapy units shall be provided with five (5) milliampere ground fault interrupters.
(7) Nurses' calling system.
(a) General. In general patient areas, each room shall be served by at least one (1) calling station and each bed shall be provided with a call button. Two (2) call buttons serving adjacent beds may be served by one (1) calling station. Calls shall register at an annunciator panel at the nurses' station and shall actuate a visible signal in the corridor at the patient room door, in the clean workroom, the soiled workroom, the nourishment station, and the nurses' lounge of the nursing unit. In multicorridor nursing units, additional visible signals shall be installed at corridor intersections. In rooms containing two (2) or more calling stations, indicating lights shall be provided at each station. Nurses' calling systems which provide two (2) way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operating.
(b) Patients' emergency. A nurses' call emergency button shall be provided for patients' use at each patient's toilet, bath, and shower room on the nursing unit floors. Such buttons shall be usable by a collapsed patient lying on the floor; inclusion of a pull cord will satisfy this requirement.
(8) Fire alarms and fire detection systems. The design and installation of these systems must be approved by the State Fire Marshal's Office.
(9) Emergency electrical.
(a) General. To provide electricity during interruption of the normal electric supply, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) Sources. The source of this emergency electric service shall be as follows:
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An emergency generating set, when the normal service is supplied by one (1) or more central station transmission lines.
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An emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
(c) Emergency generating set. The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system. Generator sets shall be self-sufficient insofar as possible without dependency on public utilities that may be subject to cutoff or outages. Exception: a system of prime movers which are ordinarily used to operate other equipment and alternately used to operate the emergency generator(s) will be permitted provided that the number and arrangement of the prime movers are such that when one (1) of them is out of service (due to breakdown or for routine maintenance), the remaining prime mover(s) can operate the required emergency generator(s) and provided that the connection time requirements as listed in Section 34(9)(e) of this administrative regulation are met. The emergency generator set shall be of sufficient kilowatt capacity to supply all lighting and power load demands of the emergency electrical system. The power factor rating of the generator shall be not less than eighty (80) percent.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto, including exterior of exits, exit doorways, stairways, and corridors.
b. Laboratory, nursing station, medication preparation dispensing area.
c. Generator set location, switch-gear location, mechanical room and boiler room.
d. Elevator cabs.
e. Night light in patient rooms.
- Equipment. Essential to life safety and for protection of important equipment or vital materials:
a. Nurses' calling system.
b. Paging or speaker systems, if intended for issuing instructions during emergency conditions. Alarms required for medical gas systems.
c. Fire pump and jockey pump, if installed.
d. Pump for central suction system.
e. Sewerage or sump lift pump, if installed.
f. Blood bank refrigerator.
g. Duplex receptacles in patient corridors, and at least one (1) duplex receptacle located on the patient headwall in each patient room.
h. Elevator service that will reach every patient floor. Manual throw over facilities shall be provided to allow temporary operation of any elevator for the release of persons who may be trapped between floors.
i. Equipment necessary for maintaining telephone service.
- Heating. Equipment for heating general patient rooms; except that service for heating of those rooms will not be required under either of the following conditions:
a. The design temperature is higher than twenty (20) degrees Fahrenheit, based on the Median of Extremes as shown in the current edition of the ASHRAE Handbook of Fundamentals.
b. The facility is supplied by two (2) or more electrical services supplied from separate generating sources, or a utility distribution network having multiple power light sources and arranged to provide mechanical and electrical separation, so that a fault between the facility and generating sources will not likely cause an interruption of the facility service feeders.
(e) Details. The emergency electrical system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and it must be connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting systems; alarms systems; blood banks; nurses' calling systems; equipment necessary for maintaining telephone service; pump for central suction system; and task illumination and receptacles in patient rooms and patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification. Storage-battery-powered lights, provided to augment the emergency lighting or for continuity of lighting during the interim of transfer switching immediately following an interruption of the normal service supply, shall not be used as a substitute for the requirement of a generator. Where stored fuel is required for emergency generator operation, the storage capacity shall be sufficient for not less than twenty-four (24) hours of continuous operation.
Section 35. Table 1 - Sound Transmission Limitations for Rehabilitation Facilities. Table 2 - Pressure Relationships and Ventilation of Certain Rehabilitation Areas. Table 3 - Lighting Levels for Rehabilitation Facilities.
History
- RELATES TO: KRS 216B.010-216B.131, 216B.990
- STATUTORY AUTHORITY: KRS 216B.040-216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.040 and 216B.105(3) mandate that the Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides the licensure requirements for the structural specifications and physical plant requirements for new construction and alteration and maintenance of comprehensive physical rehabilitation hospitals. Comprehensive physical rehabilitation hospitals licensed prior to the effective date of this administrative regulation shall meet the structural specifications in force on the date of their most recent licensure inspection.
- History: 902 KAR 020:230. 14 Ky.R. 92; 439; eff. 9-10-1987; 18 Ky.R. 830; eff. 10-16-1991; Crt eff. 4-30-2019; Crt eff. 2-17-2026.
902 KAR 20:240 Comprehensive physical rehabilitation hospital services {#sec-902-kar-20-240 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:240}
Section 1. Definitions.
(1) "Dietician" is defined at KRS 310.005(3).
(2) "Full-time equivalent" (FTE) means:
(a) One (1) employee working thirty-seven and five-tenths (37.5) hours per week; or
(b) More than one (1) part-time employee whose combined working hours total thirty-seven and five-tenths (37.5) hours per week.
(3) "Governing authority" means the individual, agency, partnership, or corporation that directs and establishes policy concerning the management and operation of a comprehensive physical rehabilitation program.
(4) "Institution" means a freestanding specialty hospital or a general hospital based unit providing inpatient comprehensive physical rehabilitation services.
(5) "Medical staff" means an organized body of physicians, and dentists if applicable, appointed by the governing authority. Members of the medical staff shall be licensed to practice medicine or dentistry in Kentucky, except for graduate physicians in the first year of facility training.
(6) "Nutritionist" is defined at KRS 310.005(4).
(7) "Protective device" means a device designed to protect a person from falling, including a side rail, safety vest, or safety belt.
(8) "Registered Health Information Administrator" means a person certified as a registered records administrator by the American Health Information Management Association.
(9) "Registered Health Information Technician" means a person certified as an Accredited Record Technician by the American Health Information Management Association.
(10) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a patient or the movement of a portion of a patient's body.
Section 2. Administration and Operation.
(1) Governing authority.
(a) The licensee shall be responsible for compliance with federal, state, and local law pertaining to comprehensive physical rehabilitation programs.
(b) The governing authority shall appoint an administrator whose qualifications, responsibilities, authority and accountability are defined in writing and approved by the governing authority, and shall designate a mechanism for the periodic performance review of the administrator.
(2) Administrator. The administrator shall:
(a) Be responsible for daily management of the institution;
(b) Provide a liaison between the governing authority and the medical staff;
(c) Attend meetings of the governing authority;
(d) Report to the governing authority concerning the conduct of the institution;
(e) Hold departmental and interdepartmental meetings on a regular basis;
(f) Attend or be represented at departmental and interdepartmental meetings; and
(g) Present to the departments a report of pertinent activities of the institution.
(3) Administrative records and reports.
(a) Administrative reports shall be established, maintained and utilized as necessary to guide the operation, measure productivity and reflect the programs of the institution. An administrative report shall include:
-
Minutes of the governing authority and staff meetings;
-
Financial records and reports;
-
Incident investigation reports; and
-
Other pertinent reports prepared in the regular course of business.
(b) The institution shall maintain a patient admission and discharge register.
(c) Licensure inspection reports and plans of correction shall be made available to the general public upon request.
(4) Policies. The institution shall have written documents on file governing the operation of the institution and the services provided, including:
(a) A mission statement of the comprehensive physical rehabilitation service;
(b) A program narrative which describes in detail the rehabilitation conditions for which the institution provides services, the delivery of these services, and the goals and treatment;
(c) A description of the organizational structure of the facility, including lines of authority, responsibility, and communication;
(d) An admission policy to assure patient admission is in accordance with medical staff protocol;
(e) A list of constraints imposed on admissions by limitation of service, physical facilities, staff coverage, or other relevant factors;
(f) The financial requirements for a patient to be admitted;
(g) The requirement for an informed consent by patient, parent, guardian or legal representative for diagnostic or treatment procedure;
(h) A procedure for:
-
Recording an accident involving a patient, visitor, or staff member;
-
Recording an incident of drug reaction or medication error; and
-
Reporting in writing through the appropriate committees;
(i) A policy for the use of restraints and a mechanism for monitoring and controlling their use;
(j) A policy for patient discharge and termination of services; and
(k) A policy describing the use of volunteers in program activities.
(5) Patient identification. The institution shall identify each patient from time of admission to time of discharge with an identification bracelet imprinted with the name of the patient, and the date of admission.
(6) Discharge planning.
(a) The discharge decision and plan shall be established with the participation of the patient, if possible, or a significant other person. Discharge planning shall begin early in the treatment phase. Each professional practitioner involved with the patient shall participate in formulating the discharge plan, including professionals from agencies outside the institution who have been or will be involved in the patient's care, if possible.
(b) A discharge authorization and summary shall be prepared for each patient who has been discharged or transferred from the institution to a supportive service. The summary shall contain:
-
The reason for referral;
-
The diagnosis;
-
The rehabilitation problem;
-
The services provided;
-
The results of services provided;
-
Any referral action recommended; and
-
Procedures and activities for patient and family to assist the patient to maintain or improve postdischarge functioning and to increase independence.
(c) The family, appropriate staff members, the referring source, and community agencies proposed to work with the patient, shall receive advance notice of the discharge decision and plan.
(7) Patient follow-up.
(a) The institution shall establish a procedure for patient follow-up.
(b) Follow-up shall be conducted after the patient is:
-
Discharged from the institution;
-
Transferred to a supportive service; or
-
Placed in an inactive status.
(8) Transfer procedures and agreements.
(a) The institution shall have written patient transfer procedures and agreements with other health care facilities which provide a level of inpatient care not provided by the institution. Transfer procedures and agreements shall include:
-
Written procedures insuring prompt notification to the receiving facility;
-
Accommodation for safe and appropriate transfer; and
-
Specification of staff responsibilities during transfer.
(b) If a patient is transferred to another health care facility, a transfer form shall accompany the patient. The transfer form shall include:
-
The attending physician's instructions for continuing care;
-
A current summary of the patient's medical record;
-
Information concerning special supplies or equipment needed for the patient's care; and
-
Pertinent social information concerning the patient the patient's and family.
(c) A copy of the patient's signed discharge summary shall be forwarded to the receiving health care facility within thirty (30) days following the patient's discharge.
(9) Medical staff.
(a) The facility shall have a medical staff organized under bylaws approved by the governing authority. The medical staff shall be responsible to the governing authority for the quality of medical care provided and for the ethical and professional practice of its members.
(b) The medical staff shall develop and adopt policies or bylaws which shall be approved by the governing authority. The policies or bylaws shall:
-
Establish the qualifications for medical staff membership, including professional licensure, except for graduate physicians in their first year of hospital training;
-
Define and describe the responsibilities and duties of each category of medical staff, including each person who is designated active, associate, or courtesy;
-
Delineate the clinical privileges of staff members and allied health professionals;
-
Establish a procedure for granting and withdrawing staff privileges and credentials;
-
Provide a mechanism for appeal of decisions regarding staff membership and privileges;
-
Provide a method for the selection of officers of the medical staff;
-
Establish requirements regarding the frequency of, and attendance at, general staff and department or service meetings of the medical staff;
-
Provide for the appointment of standing and special committees and establish requirements for:
a. Composition and organization;
b. Frequency of and attendance at meetings; and
c. Maintenance of minutes and reports in the permanent hospital records:
- Standing and special committees may include:
a. An executive committee;
b. A credentials committee;
c. A medical audit committee;
d. A medical records committee:
e. An infection control committee:
f. A tissue committee;
g. A pharmacy and therapeutics committee;
h. A utilization review committee; and
i. A quality assurance committee; and
- Establish a policy requiring a member of the medical staff to sign the written documentation of a verbal order for diagnostic testing or treatment:
a. As soon as possible after the order is given; or
b. Within thirty (30) days of the patient's discharge if the patient is discharged prior to the order being authenticated.
(10) Director of rehabilitation. The director of rehabilitation shall:
(a) Be a licensed physician who has completed a one (1) year facility internship and has two (2) years of training or experience in medical management of inpatients requiring rehabilitation services; and
(b) Provide services:
-
On a full-time basis for a freestanding specialty hospital;
-
At least twenty (20) hours per week for a general hospital based unit with twenty (20) or more beds; or
-
At least ten (10) hours per week for a general hospital-based unit with less than twenty (20) beds.
(11) Quality assurance and review.
(a) The quality and appropriateness of major clinical functions shall be monitored and evaluated utilizing:
-
Objective criteria that reflects current knowledge and clinical experience; and
-
Information about identified aspects of rehabilitation care that is collected on a routine basis;
(b) Information from the quality assurance and review shall be:
-
Reviewed and assessed on a periodic basis; and
-
Utilized to improve clinical operations and patient care.
(c) The effectiveness of action taken to improve patient care shall be evaluated.
(d) Findings and conclusions regarding the following shall be documented and reported to the administrator and appropriate committees:
-
Monitoring and evaluation;
-
Problem-solving activity;
-
Activity for the improvement of patient care; and
-
The impact of actions taken.
(e) The quality and appropriateness of patient rehabilitation services provided by an outside source shall be monitored and evaluated, and identified problems resolved.
(12) Personnel.
(a) The institution shall employ qualified personnel sufficient to provide effective patient care and related services and shall make available to all employees written personnel policies and procedures.
(b) There shall be a written job description for each position which shall assure that an employee is appropriately classified and licensed for the position in which he is employed.
(c) There shall be an employee health program that includes preemployment and periodic health examinations.
(d) Each staff member shall be tested for tuberculosis, as follows:
- The skin test status of each staff member shall be documented in the employee's personnel record.
a. A new staff member shall undergo a skin test before or during the first week of employment.
b. The results shall be documented in the employee's personnel record within the first month of employment.
c. A skin test shall not be required at the time of initial employment if the employee:
(i) Documents a prior skin test of ten (10) or more millimeters of induration; or
(ii) If the employee is currently receiving or has completed six (6) months of prophylactic therapy or a course of multiple-drug chemotherapy for tuberculosis.
d. A two (2) step skin test is required for a new employee over age forty-five (45) whose initial test shows less than ten (10) millimeters of induration, unless he can document that he has had a tuberculosis skin test within one (1) year prior to his current employment. An employee who has never had a skin test of ten (10) or more millimeters induration shall be skin tested annually, on or before the anniversary of his last skin test.
- An employee whose initial or annual skin test results in ten (10) or more millimeters induration shall receive a chest x-ray, unless:
a. A chest x-ray within the previous two (2) months showed no evidence of tuberculosis; or
b. The employee can document the previous completion of a course of prophylactic treatment with isoniazid. An employee whose initial skin test shows ten (10) or more millimeters of induration shall be advised of the symptoms of the disease and instructed to report to his employer and seek medical attention promptly.
a. The director of rehabilitation shall be responsible for ensuring that skin tests and chest x-rays are done in accordance with subparagraphs 1 and 2 of this paragraph.
b. Skin testing dates and results and chest x-ray reports shall be recorded as a permanent part of the employee's personnel record.
- The administrator shall report to the local health department, immediately upon discovery, the name of an employee whose:
a. Skin test results are ten (10) millimeters or more induration at the time of employment;
b. Skin test results change from less than ten (10) millimeters induration to more than ten (10) millimeters; or
c. Chest x-rays are suspicious for tuberculosis.
- Prophylaxis of a person with recent infection but no disease.
a. A resident or staff member whose skin test status changes upon annual testing from less than ten (10) to ten (10) or more millimeters of induration shall be considered to be recently infected with Mycobacterium tuberculosis.
b. A recently infected person who has no sign or symptom of tuberculosis disease upon chest x-ray or medical history shall be given preventive therapy with isoniazid for six (6) months unless medically contraindicated by a licensed physician.
c. Medications shall be administered to patients only upon the written order of a physician or other practitioner acting within his statutory scope of practice.
d. If an infected person is unable to take isoniazid therapy, the person shall be advised of the clinical symptoms of the disease, and shall have an interval medical history and a chest x-ray taken and evaluated for tuberculosis disease every six (6) months during the two (2) years following conversion, for a total of five (5) chest x-rays.
- A staff member who documents completion of preventive treatment with isoniazid shall be exempt from further screening requirements.
(e) A current personnel record shall be maintained for each employee which shall include the following:
-
Name, address, and Social Security number;
-
Health records;
-
Evidence of current registration, certification or licensure;
-
Records of training and experience;
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Records of performance evaluation;
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Evidence of completion of an orientation to the facility's written policies initiated within the first month of employment; and
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Evidence of regular in-service training which corresponds with job duties and includes a list of training and dates completed.
(13) Physical and sanitary environment.
(a) The physical plant and premises shall be maintained to promote the safety and well-being of patients, personnel and visitors.
(b) A person shall be designated to be in charge of services and shall be responsible for the establishment of policies and procedures for plant maintenance, laundry, and housekeeping.
(c) The institution's buildings, equipment and surroundings shall be in good repair and shall be neat, clean, free from accumulations of dirt and rubbish, and free from foul, stale, or musty odors.
(d) The institution shall be free of insects and rodents.
(e) Garbage receptacles and trash cans shall be kept clean and shall be stored away from areas used for preparation and storage of food and the contents shall be regularly removed from the premises.
(f) Hazardous cleaning solutions, compounds, and substances shall be labeled, stored in closed containers and shall not be stored with nonhazardous items.
(g) The institution shall have a supply of clean linen available at all times for the proper care and comfort of patients.
-
Linens shall be handled, stored and processed to prevent the spread of infection.
-
Clean linen and clothing shall be stored in clean, dry, dust-free areas.
-
Soiled linen and clothing shall be placed in suitable bags or closed containers and stored in separate areas.
(h)
-
Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures shall be segregated from other wastes and placed in puncture resistant containers immediately after use.
-
A needle or other contaminated sharp shall not be purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
-
A sharp waste container shall be incinerated on or off site, or shall be rendered nonhazardous.
-
Nondisposable sharps, such as large-bore needles or scissors, shall be placed in a puncture resistant container for transport to the Central Medical and Surgical Supply Department, in accordance with 902 KAR 20:009, Section 22.
(14) Patient medical records.
(a) The institution shall have a health information management service that is responsible for the integrity and confidentiality of a patient's medical records. A medical record shall be maintained, in accordance with accepted professional principles, for each patient admitted to the facility or receiving outpatient services.
(b) The health information management service shall be under the direction of a Registered Health Information Administrator, either on a full-time, part-time, or consultative basis, or by a Registered Health Information Technician on a full-time basis and shall have available a sufficient number of regularly-assigned employees to insure that records are stored and retrieved efficiently.
(c) Medical records shall be retained for a minimum of five (5) years from date of discharge or, in the case of a minor, three (3) years after the patient reaches age eighteen (18).
(d) The facility shall designate a location and maintain medical records there in the event the facility ceases to operate for any reason.
(e) Medical record contents shall be pertinent and current and shall include the following:
-
Identification data and signed consent forms, including name and address of next of kin and of person or agency responsible for patient;
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Date of admission, name of attending medical staff member, and allied health professional responsible for the provision of therapy services;
-
Chief complaint;
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Medical history including present illness, past history, family history, and physical examination results;
-
Report of special examinations or procedures performed and results;
-
Provisional diagnosis or reason for admission;
-
Orders for diet, diagnostic tests, therapeutic procedures, and medications, including patient limitations, signed and dated by the medical staff member or other ordering personnel acting within the limits of his statutory scope of practice if applicable, including records of all medication administered to the patient;
-
Complete surgical record signed by attending surgeon or oral surgeon, to include anesthesia record signed by anesthesiologist or anesthetist, preoperative physical examination and diagnosis, description of operative procedures and findings, postoperative diagnosis, and tissue diagnosis by qualified pathologist on tissue surgically removed;
-
Patient care plan which addresses the comprehensive care needs of the patient, to include the coordination of the facility's service departments that impact patient care;
-
Nurses' observations and progress notes of a physician, dentist, or other ordering personnel acting within his statutory scope of practice;
-
Record of temperature, blood pressure, pulse, and respiration;
-
Final diagnosis using terminology in the current version of the International Classification of Diseases or the American Psychiatric Association's Diagnostic and Statistical Manual, as applicable; and
-
Discharge summary, including condition of patient on discharge and date of discharge.
(f) Records shall be indexed according to disease, operation, and attending medical staff member. Any recognized indexing system may be used.
- The disease and operative indices shall:
a. Use recognized nomenclature;
b. Include each specific disease diagnosed and each operative procedure performed; and
c. Include essential data on each patient having that particular condition.
-
The attending medical staff index shall include all patients attended or seen for consultation by each medical staff member.
-
Indexing shall be current, within six (6) months following discharge of the patient.
(g) Medical record review.
-
The institution shall regularly review and evaluate records maintenance and retention policies and shall propose improvements if necessary and appropriate.
-
The institution shall establish and maintain a medical records committee, which shall include a representative from each service department and which shall report to the administrator. The committee shall:
a. Review at least quarterly a sampling of records to measure their adequacy and compliance with established record maintenance policies and procedures; and
b. Review at least annually the medical records policies and procedures and make recommendations for consideration by the administrator.
(h) A statement of professional judgment and a report of services to an individual shall be signed by the person qualified by professional competency and official position. The medical record shall record that services recommended and planned were received by the patient at the time stated.
(i) Clinical information shall be recorded as soon as practicable, but no later than forty-eight (48) hours after the event.
(j) Discharge summaries shall be recorded within thirty (30) days of discharge.
(k) A completed medical record shall include:
-
Name, address and next of kin;
-
The name and address of the personal representative, conservator, guardian, or representative payee, if one has been appointed for the person served;
-
Pertinent history, diagnosis of disability, rehabilitation problem, goals, and prognosis;
-
Reports from referring sources;
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Reports of service referrals;
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Reports from outside consultation, and from laboratory, radiology, orthotic and prosthetic services;
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Designation of the case manager for the patient, unless there is a written policy identifying who is responsible for the plan management of specified groups;
-
Evidence of the patient's participation in devising his own plan;
-
Evaluation reports from each service;
-
Reports of staff conferences;
-
The patient's total treatment plan;
-
Treatment plans from each service;
-
Signed and dated service and progress reports from each service;
-
Correspondence pertinent to the person being served;
-
A signed and dated authorization from the patient, his parent or guardian, if information or photographs have been released or used;
-
Discharge report; and
-
Follow-up reports.
Section 3. Provision of Services.
(1) General requirements.
(a) A medication or treatment shall not be given without a written or verbal order signed by a physician, dentist, or other ordering practitioner acting within his statutory scope of practice.
(b) A verbal order for a medication shall be given only to a licensed practical or registered nurse, paramedic, or pharmacist and shall be signed by a member of the medical staff or other ordering practitioner:
-
As soon as possible after the order is given; or
-
Within thirty (30) days of the patient's discharge if the patient is discharged prior to the order being authenticated.
(c) A verbal order for a diagnostic test or treatment order may be given to a licensed practitioner acting within his statutory scope of practice and the institutions' protocols.
(d) At the time received, verbal orders from medications, diagnostic tests, and treatments shall be:
-
Immediately transcribed by the person receiving the order;
-
Repeated back to the person requesting the order to ensure accuracy; and
-
Annotated on the patient's medical record by the person receiving the order as repeated and verified.
(e) Medications shall be administered by a physician, registered nurse, dentist, or a licensed practical nurse under the supervision of a registered nurse, advanced practice registered nurse, physician's assistant, or a paramedic acting within his scope of practice.
(f) A restraint or protective device, other than bed rails and wheelchair safety belts shall not be used, except in an emergency until the attending medical staff member can be contacted, or upon written or telephone orders of the attending medical staff member. If restraint is necessary, it shall be the least restrictive protective device which affords the patient the greatest possible degree of mobility and protection. A locking restraint shall not be used under any circumstances.
(g) Patient physical. A physician shall conduct a physical examination and determine whether the patient can benefit from a rehabilitation program through the use of therapies provided by the institution within twenty-four (24) hours after admission.
(h) Psychosocial history. Each patient shall have a history and assessment interview within seventy-two (72) hours after admission. The following resultant data shall be entered on the patient record:
-
A determination of current emotional state;
-
Vocational history;
-
Familial relationships;
-
Educational background;
-
Social support system; and
-
A determination of whether the patient can benefit from a rehabilitation program through the use of therapies provided by the institution.
(i) Basic cardiopulmonary resuscitation shall be available within the institution twenty-four (24) hours a day, seven (7) days a week.
(2) Staffing requirements.
(a) The program shall have personnel adequate to meet the needs of patients on a twenty-four (24) hour basis. The number and classification of personnel required shall be based on the number of patients and the individual treatment plans. If the staff to patient ratio does not meet the needs of the patients, the Office of Inspector General shall determine and inform the program administrator in writing how many additional personnel are to be added and of what job classification, and shall give the basis for this determination.
(b) The staffing ratio of therapists and pathologists to patients shall be equal to or greater than one (1) full-time equivalent for every three (3) patients. Only licensed or certified therapists or speech and language pathologists in the areas of physical therapy, occupational therapy, speech and language pathology, or psychology shall be utilized in the computation of this ratio. Certified or licensed assistants shall not be utilized in the computation of this ratio. The staffing for the facility shall be utilized in the computation of the ratio.
(c) There shall be no more than one (1) aide or assistant for each licensed or certified therapist or speech and language pathologist on staff.
(3) Medical staff services.
(a) Medical care provided in the institution shall be under the direction of the medical director or a medical staff member in accordance with staff privileges granted by the governing authority.
(b) Physician services shall be available twenty-four (24) hours a day on at least an on-call basis.
(c) There shall be sufficient medical staff coverage for services provided in the institution in keeping with the size of the institution, the scope of services provided and the types of patients admitted to the facility.
(d) An individual rehabilitation program plan shall be developed for each patient under the supervision of a physician. The attending physician shall attend and actively participate in conferences concerning those served.
(e) The attending physician shall complete the discharge summary and sign the records within thirty (30) days of discharge.
(f) The physician responsible for the patient's rehabilitation program shall have specialized training or experience in rehabilitation.
(g) There shall be direct individual contact by a physician on any day there is an active interdisciplinary treatment program.
(4) Nursing services.
(a) Nursing services shall be directed toward prevention of complications of disability, restoration of optimal functioning, and adaptation to an altered lifestyle.
-
The institution shall have a nursing department organized to provide basic nursing services and rehabilitation nursing services. A registered nurse with training and experience in rehabilitative nursing shall serve as director of the nursing department.
-
A registered nurse shall be on duty at all times.
a. Nursing staff for each nursing unit shall be supervised by a registered nurse in order to insure immediate availability of a registered nurse with rehabilitation experience on a twenty-four (24) hour basis.
b. Other nursing personnel shall be present in sufficient numbers to provide nursing care not requiring the services of a registered nurse.
c. Nursing care shall be documented on each shift by staff members rendering care to patients. This documentation shall describe the nursing care provided and shall include information and observations significant to the continuity of patient care.
(b) Rehabilitation nursing services shall include physical and psychosocial assessment of the following:
-
Body systems related to the patient's physical rehabilitation nursing needs, with special emphasis on skin integrity, bowel and bladder function, and respiratory and circulatory systems function;
-
Self-care skills development;
-
Interpersonal relationships;
-
Adaptation mechanisms and patterns used to manage stress; and
-
Sleep and rest patterns.
(c) Nursing services shall include the following interventions:
-
Health maintenance and discharge teaching;
-
Prevention of the complications of immobility;
-
Physical care including hygiene, skin care, physical transfer from one place to another, positioning, and bowel and bladder care;
-
Psychosocial care including socialization, adaptation to an altered lifestyle; and
-
Reinforcement of the multidisciplinary treatment plan.
(d) A nurse shall collaborate with the patient, family, and other disciplines and agencies in discharge planning and teaching.
(e) Rehabilitation shall monitor the degree of achievement of individualized nursing patient care goals.
(5) Multidisciplinary team. A multidisciplinary team shall develop individual treatment plans and discharge plans and shall conduct quality assurance reviews. The multidisciplinary team shall include a physician, rehabilitation nurse, social worker or psychologist, and a therapist involved in the patient's care.
(6) Case manager.
(a) A single case manager shall be designated for each patient served. The provision of services by the institution to each patient shall be organized through the patient's case manager. The case manager shall:
-
Assume responsibility for the patient during the course of treatment;
-
Coordinate the treatment plan; and
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Cultivate the patient's participation in the program.
(b) If more than one (1) major program is being provided simultaneously, there shall be only one (1) case manager. If the patient's plan changes sequentially from one (1) program area to another, a new case manager may be assigned.
(c) The patient's case manager shall evaluate regularly the appropriateness of the treatment plan in relation to the progress of the patient toward the attainment of stated goals. The case manager shall assure that:
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The patient is adequately oriented;
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The plan proceeds in an orderly, purposeful, and timely manner; and
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The discharge decision and arrangements for follow-up are properly made.
(7) Treatment plan.
(a) The multidisciplinary team, with the participation of the patient shall, within seven (7) days after admission for rehabilitation, develop an individual treatment plan based on the patient's medical evaluation and psychosocial history and assessment, which shall be reviewed at least biweekly. The treatment plan shall include:
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An assessment of the biological, social and psychological needs of the patient, performed by qualified health care professionals;
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A description of the patient's capacities, strengths, disabilities, and weaknesses;
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Identification of the patient's rehabilitation goals stated in functional, performance and behavioral objectives relative to the performance of life tasks and capabilities, with criteria for termination of treatment or discharge from the program;
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Participation of the patient and his family, to the extent possible;
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Physician input relative to both the general medical and rehabilitation medical needs of the patient;
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Discharge planning addressed as part of goal setting as early as possible in the rehabilitation process;
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Time intervals at which treatment or service outcomes will be reviewed;
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Anticipated time frames for accomplishment of the individual's specified goals;
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The measures to be used to assess the effects of treatment or services; and
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The person responsible for implementation of the plan.
(b) The institution shall obtain and retain a signed consent form if applicable.
(c) The institution shall adopt a procedure to protect against release of a patient to an unauthorized individual if a patient is unable to represent his own interests.
(8) Therapeutic services.
(a) The institution shall provide allied services directly or under contract. Skilled therapy shall be provided to a patient at an intensity appropriate to the disability and to the patient's ability to tolerate treatment, at least three (3) hours per person per day, and at least five (5) times per week, or, if the patient's medical condition limits participation, an equivalent amount of combined therapy, medical, nursing, and other professional care that shall be provided.
(b) Occupational therapy services shall be provided by or under the supervision of an individual certified by the American Occupational Therapy Association as an occupational therapist. Services shall include:
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Assessment and treatment of functional performance; independent living skills; prevocational or work adjustment skills; educational, play or leisure and social skills.
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Assessment and treatment of performance components; neuromuscular, sensori-integrative, cognitive and psychosocial skills.
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Therapeutic interventions, adaptations and prevention.
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Individualized evaluations of past and current performance, achieved through observation of individual or group tasks, standardized tests, record review, interviews, or activity histories.
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Assessment of architectural barriers in home and workplace, and recommendation for equipment, adaptations, and different arrangements.
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Treatment goals, achieved by modalities and techniques which include:
a. Task oriented activities; simulation or actual practice of work, self-care, home management, leisure and social skills and their components, creative media, games, computers and other equipment;
b. Prevocational training;
c. Sensorimotor activities;
d. Patient and family education and counseling;
e. Design, fabrication and application of orthotic devices;
f. Guidance in use of adaptive equipment and prosthetic devices;
g. Adaptation to physical and social environment, and use of therapeutic milieu;
h. Joint protection and body mechanics;
i. Positioning;
j. Work simplification and energy conservation; and
k. Cognitive remediation.
- Occupational therapy services that monitor the extent to which goals are met relative to assessing and increasing the patient's functional ability in daily living skills.
(c) Physical therapy services shall be provided by or under the supervision of a licensed physical therapist employed on a full-time basis by a freestanding specialty hospital, or at least twenty (20) hours per week for a general hospital based unit.
- Services shall include the following:
a. An initial physical therapy evaluation and assessment of the patient prior to the provision of services;
b. Development of treatment goals and plans in accord with the initial evaluation findings, with treatment aimed at preventing or reducing disability or pain and restoring lost function; and
c. Therapeutic interventions which focus on posture, locomotion, strength, endurance, balance, coordination, joint mobility, flexibility, and restoring loss of function.
- Physical therapy services shall monitor the extent to which services have met therapeutic goals relative to the initial and all subsequent examinations, and the degree to which improvement occurs relative to the identified movement dysfunction or reduction of pain associated with movement.
(d) Psychological services shall be provided by or under the supervision of a licensed psychologist.
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Assessment areas shall include psychological, vocational, and neuropsychological functioning.
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Interventions include individual and group psychotherapy; family consultation and therapy; and design of specialized psychological intervention programs including behavior modification, behavioral treatment regimens for chronic pain, and biofeedback and relaxation procedures.
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Psychological services shall monitor the cognitive and emotional adaptation of the patient and family to the patient's disability.
(e) Speech-language services shall be provided by or under the supervision of a licensed speech-language pathologist certified in clinical competency by the American Speech-Language-Hearing Association. Services shall include the following:
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Screening to identify individuals who require further evaluation to determine the presence or absence of a communicative disorder;
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Speech and language competency evaluation resulting in the pathologist's plan, direction, and conduct of habilitative, rehabilitative, and counseling programs to improve language, voice, cognitive linguistic skills, articulation, fluency, and adjustment to hearing loss, and an assessment and provision of alternative and augmentative communicative devices;
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A plan for discharge and provision for the patient's understanding of communication abilities and prognosis; and
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Monitoring of services for effectiveness of actions taken to improve communication skills of patients.
(9) The institution shall provide the following services directly or through a contractual arrangement with other providers, as needed, in accordance with the institution's program narrative:
(a) Social work services shall be provided by an individual with a masters degree in social work from a curriculum accredited by the Council for Social Work Education.
- The scope of rehabilitation social services shall include the following areas related to work assessment and interventions to facilitate rehabilitation:
a. Assessment of the personal coping history and current psychosocial adaptation to the disability;
b. Assessment of immediate and extended family and other support persons relative to increasing support networks; and
c. Assessment of housing, living arrangements, and stability and source of income relative to facilitating discharge plans.
- Intervention strategies, aimed at increasing effectiveness of coping, strengthening informal support systems, and facilitating continuity of care, shall include at least the following:
a. Discharge planning;
b. Casework with individual patients;
c. Family counseling and therapy;
d. Group work focused on both education and therapy; and
e. Community service linkage referrals.
- Social work services shall monitor the achievement of goals relative to discharge planning activities designed to meet the basic sustenance, shelter, and comfort needs of patients and their families.
(b) Audiology services shall be provided by or under the supervision of a licensed audiologist who is certified by the American Speech-Language-Hearing Association. The audiologist shall direct and conduct required aural habilitation and rehabilitation programs after determination of the patient's range, nature, and degree of auditory and vestibular function using instrumentation such as audiometers, electroacoustic emittance equipment, brain stem evoked response equipment, and electronystagmographic equipment. Programs shall include:
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Hearing aid and assistive listening device selection and orientation;
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Counseling, guidance and auditory training; and
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Speech reading.
(c) Vocational and vocational rehabilitation services shall provide assessment and evaluation of the patient's or client's need for services to enable return to productive activity through the use of testing, counseling, and other service-related activities. Identified needs are met either directly or through referral. Services shall include:
-
Evaluation and assessment focusing on maximizing the independent, productive functioning of the individual;
-
Comprehensive services to include at least the following areas:
a. Physical and intellectual capacity evaluation;
b. Interest and attitudes;
c. Emotional and social adjustment;
d. Work skills and capabilities;
e. Vocational potential and objectives; and
f. Job analysis;
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The use of instruments, equipment and methods, under supervision of a qualified therapist;
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Preparation of a written report, with interpretation and recommendations, to be shared with the individual and referral source; and
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Monitoring the degree to which appropriate work skills are achieved; the improvement in independent functioning relative to work skill capability; and, the achievement of vocational objectives.
(d) Prosthetic or orthotic services.
- Prosthetic and orthotic services shall be provided by a specialist who is qualified to manage the orthotic or prosthetic needs of a patient by:
a. Performing an examination;
b. Participating in the prescribing of specialized equipment;
c. Designing and fitting specialized equipment; and
d. Following up to ensure that the equipment is properly functioning and fitting.
- Monitoring of prosthetic or orthotic services shall include:
a. Documented evidence of communication with the prescribing physician; and
b. Patient satisfaction with the function and fit of the equipment.
(e) Therapeutic recreation services shall be provided by or under the supervision of a therapeutic recreation specialist or an occupational therapist. The services may be provided in conjunction with occupational therapy services. Services shall include the following:
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Assessment of the patient's leisure or social or recreational abilities, deficiencies, interests, barriers, life experiences, needs, and potential;
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Treatments designed to improve social, emotional, cognitive and physical functional behaviors as a necessary prerequisite to future leisure or social involvement;
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Leisure education designed to help the patient acquire knowledge, skills and attitudes needed for independent leisure or social involvement, community adjustment, responsible decision-making, and use of free time; and
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Monitoring which measures the extent to which goals are achieved relative to the use of leisure time and socialization skills.
(f) Pharmaceutical services. The institution shall provide for handling, storing, recording, and distributing pharmaceuticals in accordance with state and federal law. A supply of medicinal agents adequate to meet institutional needs shall be available on site. They shall be stored in a safe manner and kept properly labeled and accessible. Controlled substances and other dangerous or poisonous drugs shall be handled in a safe manner to protect against their unauthorized use. Controlled substances shall be under double lock. There shall be adequate refrigeration for biologicals and drugs which require refrigeration.
- An institution which maintains a pharmacy for the compounding and dispensing of drugs shall provide pharmaceutical services under the supervision of a registered pharmacist on a full-time or part-time basis, according to the size and demands of the program.
a. The pharmacist shall be responsible for supervising and coordinating the activities of the pharmacy department.
b. Additional personnel competent in their respective duties shall be provided in keeping with the size and activity of the department.
- An institution not maintaining a pharmacy shall have a drug room utilized only for the storage and distribution of drugs, drug supplies and equipment. Prescription medications shall not be dispensed in this area. The drug room shall be operated under the supervision of a pharmacist employed at least on a consultative basis.
a. The consulting pharmacist shall assist in establishing procedures for the distribution of drugs, and shall visit the institution on a regular schedule.
b. The drug room shall be kept locked and the key shall be in the possession of a responsible person on the premises, as designated by the administrator.
c. A record shall be kept of each transaction of the pharmacy or drug room and shall be correlated with other institution records if indicated.
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The pharmacist shall establish and maintain a system of records and bookkeeping, in accordance with policies of the institution, for maintaining control over requisitioning and dispensing of drugs and drug supplies, and for charging patients for drugs and pharmaceutical supplies.
-
A record of the stock on hand and of the dispensing of all controlled substances shall be maintained in such a manner that the disposition of any particular item may be readily traced.
-
The medical staff in cooperation with the pharmacist and other disciplines, as necessary, shall develop policies and procedures that govern the safe administration of drugs, including:
a. The administration of medications only upon the order of an individual who has been assigned medical clinical privileges or who is an authorized member of the house medical staff;
b. Review of the ordering practitioner's original order, or a direct copy, by the pharmacist dispensing the drugs;
c. The establishment and enforcement of automatic stop orders;
d. Proper accounting for and disposition of unused medications or special prescriptions returned to the pharmacy as a result of the patient being discharged, or if such medications or prescriptions do not meet requirements for sterility or labeling;
e. Provision for emergency pharmaceutical services; and
f. Provision for reporting adverse medication reactions to the appropriate committee of the medical staff.
- Therapeutic ingredients of medications dispensed shall be included in the United States Pharmacopeia- National Formulary (USP-NF), the United States Pharmacopeia-Drug Information (USP_DI), or the American Dental Association (ADA) Guide to Dental Therapeutics except for those drugs and biologicals unfavorably evaluated in the ADA Guide to Dental Therapeutics, or shall be approved for use by the appropriate committee of the medical staff.
a. A pharmacist shall be responsible for determining specifications and choosing acceptable sources for all drugs, with approval of the appropriate committee of the medical staff.
b. There shall be available a formulary or list of drugs accepted for use in the institution which shall be developed and amended at regular intervals by the appropriate committee of the medical staff.
(g) Radiology services.
- The institution shall provide diagnostic radiology services directly or through arrangements with a radiology service that has a current license or registration pursuant to KRS 211.842 to 211.850 and associated administrative regulations. If the institution provides radiology services directly, the institution shall have:
a. A radiologist, on at least a consulting basis, to function as medical director of the department and to interpret films that require specialized knowledge for accurate reading; and
b. Personnel adequate to supervise and conduct the services.
-
Written policies and procedures governing radiologic services shall be in accordance with 902 KAR 100:115.
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The radiology department shall be free of hazards for patients and personnel. Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards and radiation hazards.
(h) Laboratory services. The institution shall provide laboratory services directly or through arrangements with a licensed facility which has the appropriate laboratory facilities, or with an independent laboratory licensed pursuant to KRS 333.030 and associated administrative regulations.
- Laboratory facilities and services shall be available at all times.
a. Emergency laboratory services shall be available twenty-four (24) hours a day, seven (7) days a week, including holidays, either in the institution or through a contractual arrangement as specified in subsection (10) of this section.
b. The conditions, procedures, and availability of services provided by an outside laboratory shall be in writing and available in the institution.
- Dated reports of laboratory services provided shall be filed with the patient's medical record and duplicate copies shall be kept in the department.
a. The original report from work performed by an outside laboratory shall be filed in the patient's medical record.
b. The laboratory report shall have the name of the technologist who performed the test.
c. A request for a laboratory test shall be ordered and signed by an ordering practitioner acting within his statutory scope of practice.
- If laboratory services are provided directly, there shall be a basic clinical laboratory which provides services necessary for routine examinations.
a. Equipment necessary to perform the basic tests shall be provided by the facility.
b. Equipment shall be in good working order, routinely checked, and precisely calibrated.
c. Clinical laboratory examinations shall include chemistry, microbiology, hematology, serology, and clinical microscopy.
d. There shall be a clinical laboratory director and a sufficient number of supervisors, technologists and technicians to perform promptly and proficiently the tests requested of the laboratory. Laboratory services shall be under the direction of a pathologist on a full-time, part-time, or a consultative basis. The laboratory shall not perform procedures and tests which are outside the scope of training of the laboratory personnel.
(i) Dietary services.
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The institution shall provide dietary services directly or by contract.
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The dietary service shall be organized, directed and staffed to provide quality food service and optimal nutritional care.
a. The dietary department shall be directed on a full-time basis by an individual who by education or specialized training and experience is knowledgeable in food service management.
b. The dietary service shall have at least one (1) dietician or nutritionist, either full time, part time, or on a consultative basis, to supervise the nutritional aspects of patient care.
c. Sufficient additional personnel shall be employed to perform assigned duties to meet the dietary needs of all patients.
d. The dietary department shall have available for all dietary personnel current written policies and procedures for food storage, handling, and preparation.
e. An in-service training program, which shall include the proper handling of food, safety and personal grooming, shall be given at least quarterly for new dietary employees.
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Menus shall be planned, written and rotated to avoid repetition. Nutritional needs shall be met in accordance with recommended dietary allowances of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences and in accordance with the medical staff member's orders.
-
Meals shall correspond with the posted menu. If changes in menu are necessary, substitutions shall provide equal nutritive value and the changes shall be recorded on the menu. Menus shall be kept on file for thirty (30) days.
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Each diet, regular or therapeutic, shall be prescribed in writing, dated, and signed by the attending medical staff member or other ordering practitioner acting within his statutory scope of practice. Ordering information shall be specific and complete and shall include the title of the diet, modifications in specific nutrients stating the amount to be allowed in the diet, and specific problems that may affect diet or eating habits.
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Food shall be:
a. Prepared by methods that conserve nutritive value, flavor, and appearance;
b. Served at the proper temperature; and
c. Served in a form to meet individual patient needs, including cut, chopped, or ground.
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If a patient refuses foods served, nutritious substitutions shall be offered.
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At least three (3) meals or their equivalent shall be served daily with not more than a fifteen (15) hour span between a substantial evening meal and breakfast, unless otherwise directed by the attending medical staff member. Meals shall be served at regular times. Between-meal or bedtime snacks of nourishing quality shall be offered.
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The dietary service shall comply with KRS 217.015 to 217.045 and 902 KAR 45:005.
(10) If a service is provided under contract, the contract shall:
(a) Require that the service is in accordance with the plan of care approved by the physician responsible for the patient's care, except in the case of an adverse reaction to a specific treatment.
(b) Specify the geographical area in which the service is to be furnished;
(c) Provide that personnel and services contracted for meet the same requirements as those which would be applicable if the personnel and services were furnished directly;
(d) Provide that personnel will participate in conferences required to coordinate the care of an individual patient, as needed;
(e) Provide for the preparation of treatment records, with progress notes and observations, and their prompt incorporation into the clinical records of the institution; and
(f) Specify the period of time the contract is to be in effect and the manner of termination or renewal.
(11) Outpatient services.
(a) An institution which has an organized outpatient department shall have written policies and procedures relating to the staff, functions of service, and outpatient medical records.
(b) The outpatient department shall be organized in sections or clinics, the number of which shall depend upon the size and degree of departmentalization of the medical staff, the available facilities, patient needs, and the program narrative.
(c) The outpatient department shall have appropriate cooperative arrangements and communications with community agencies such as home health agencies, the local health department, social and welfare agencies, and other outpatient departments.
(d) Services offered by the outpatient department shall be under the direction of a physician who is a member of the medical staff.
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A registered nurse shall be responsible for the nursing services of the department.
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The number and type of other personnel employed shall be determined by the volume and type of services provided and type of patient served in the outpatient department.
(e) Necessary laboratory and other diagnostic tests shall be available either through the facility or a laboratory in a licensed facility or a laboratory licensed pursuant to KRS 333.030 and associated administrative regulations.
(f) Medical case records shall be maintained and, if appropriate, coordinated with other institution case records.
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The outpatient medical record shall be filed in a location which ensures ready accessibility to the medical staff members, nurses, and other personnel of the outpatient department.
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Information in the medical record shall be complete and sufficiently detailed relative to the patient's history, physical examination, laboratory and other diagnostic tests, diagnosis, and treatment to facilitate continuity of care.
History
- RELATES TO: KRS 194A.030(1), 216B.010, 216B.015, 216B.040, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to establish administrative regulations for proper administration of the health care facility licensure function. This administrative regulation establishes minimum licensure requirements for inpatient comprehensive physical rehabilitation services, including rehabilitation services in hospital-based rehabilitation units.
- History: 902 KAR 020:240. 14 Ky.R. 105; 452; eff. 9-10-1987; 18 Ky.R. 852; eff. 10-16-1991; 25 Ky.R. 2971; 26 Ky.R. 1161; eff. 12-15-1999; 33 Ky.R. 1159; 1849; 2306; eff. 3-1-2007; TAm eff. 3-11-2011; Crt eff. 4-30-2019; TAm eff. 3-20-2020; Crt eff. 2-17-2026.
902 KAR 20:260 Hospital-owned pain management clinics {#sec-902-kar-20-260 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:260}
Section 1. Definitions.
(1) "Diagnostic services" means services that are performed to ascertain and assess an individual's physical health condition.
(2) "License" means an authorization issued by the cabinet for the purpose of operating a hospital-owned pain management clinic.
(3) "Unencumbered license" means a prescriber's license that has not been restricted by the state professional licensing board due to an administrative sanction or criminal conviction relating to a controlled substance.
Section 2. Scope of Operations and Services. A Kentucky-licensed hospital that is excluded from the definition of pain management facility pursuant to KRS 218A.175(1)(b) shall obtain separate licensure under this administrative regulation for any outpatient clinic owned and operated by the hospital if:
(1) The majority of the patients of the practitioners at the clinic are provided treatment for pain that includes the use of controlled substances; and
(2) The clinic is located off-campus.
Section 3. Administration Requirements.
(1) Administration.
(a) A hospital that owns and operates a pain management clinic shall be legally responsible for the clinic's compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the facility, including the Drug Abuse Prevention and Control Act (21 U.S.C. 801 to 971 et. seq.), KRS Chapter 218A, 902 KAR Chapter 20, and 902 KAR Chapter 55.
(b) A licensee shall establish lines of authority and designate an administrator who shall be principally responsible for the daily operation of the clinic.
(2) Policies. A clinic shall establish and follow written administrative policies covering all aspects of operation, including:
(a) A description of organizational structure, staffing, and allocation of responsibility and accountability;
(b) A description of linkages with inpatient facilities and other providers;
(c) Policies and procedures for the guidance and control of personnel performances;
(d) A written program narrative describing in detail the:
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Services offered:
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Methods and protocols for service delivery;
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Qualifications of personnel involved in the delivery of the services; and
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Goals of the services;
(e) A description of the administrative and patient care records and reports;
(f) Procedures to be followed if an individual seeks or is in need of care and treatment that is beyond the scope of services offered by clinic, which may include:
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Advising the individual to seek services elsewhere;
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Making a referral on behalf of the individual; or
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Contacting emergency medical services; and
(g) Procedures to be followed if the clinic performs any functions related to the storage, handling, and administration of drugs and biologicals.
(3) Patient care policies. The clinic's medical director shall develop patient care policies in collaboration with a group of the clinic's other professionals to address all medical aspects of the clinic's program, including:
(a) A description of the services the clinic provides directly and those provided through agreement;
(b) Guidelines for the medical management of health problems, which include the conditions requiring medical consultation or patient referral;
(c) Guidelines for the maintenance of medical records in accordance with subsection (6) of this section; and
(d) Procedures for review and evaluation of the services provided by the clinic at least annually.
(4) Personnel.
(a) Medical director. A clinic's medical director:
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Shall meet the requirements of Section 6(3) and (4) of this administrative regulation;
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Shall provide direct services, supervision, and consultation to the clinic's staff;
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Shall participate with a group made up of clinic professionals, including at least one (1) nurse, in the development of:
a. Execution and periodic review of the clinic's written policies and services as described in subsection (3) of this section; and
b. Written program narrative describing in detail:
(i) Each service offered;
(ii) Methods and protocols for service delivery;
(iii) Qualifications of personnel involved in the delivery of the services; and
(iv) Goals of each service;
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Shall periodically review the clinic's patient records, provide medical orders, and provide medical care services to patients of the clinic; and
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May serve as both the clinic's administrator and medical director.
(b) The clinic shall:
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Employ, directly or by contract, a sufficient number of qualified personnel (e.g., physicians, nurses, therapists, or technicians) to provide effective patient care and all other related services; and
-
Maintain written personnel policies that are made available to all employees.
(c) There shall be a written job description for each position that shall be reviewed and revised as necessary.
(d) Current personnel records shall be maintained for each employee and include the following:
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Name, address, and Social Security number;
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Evidence of current registration, certification, or licensure of personnel;
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Records of training and experience; and
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Records of performance evaluation.
(5) In-service training. All personnel shall participate in annual in-service training programs relating to their respective job activities, including thorough job orientation for new employees.
(6) Medical records.
(a) The clinic shall maintain accurate, readily accessible, and complete medical records, which contain at least the following:
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Medical or social history relevant to the services provided, including data obtainable from other providers;
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Name of the patient, referring practitioner, if any, and practitioner's orders for special diagnostic services;
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Date and description of each medical visit or contact, to include condition or reason necessitating visit or contact, assessment, diagnosis, services provided, names of personnel who provided the services, medications and treatments prescribed, and disposition made;
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Reports of all physical examinations and laboratory and other test findings relevant to the services provided; and
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Documentation of all referrals made, including reason for referral, to whom patient was referred, and any information obtained from referral source.
(b) Medical records shall be the property of the clinic.
(c) The original medical record shall not be removed from the clinic except in compliance with a court order or subpoena.
(d) Copies of a medical record or portions of the record may be used and disclosed, in accordance with this administrative regulation.
(e) Confidentiality/Security; Use and Disclosure.
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The clinic shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
-
The clinic may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
-
This administrative regulation shall not be construed to forbid the clinic from establishing higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(f) Transfer of records. The clinic shall:
-
Establish systematic procedures to assist in continuity of care if the patient moves to another source of care; and
-
Upon proper release, transfer medical records or an abstract if requested.
(g) Retention of records. After the patient's death or discharge, the complete medical record shall be placed in an inactive file and retained for:
-
Six (6) years; or
-
If a minor, three (3) years after the patient reaches the age of majority under state law, whichever is longer.
(h) The clinic shall:
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Make provisions for the written designation of a specific location for the storage of medical records if the clinic ceases to operate because of disaster or for any other reason; and
-
Safeguard the record and its content against loss, defacement, and tampering.
(7) Kentucky Health Information Exchange (KHIE).
(a) A clinic shall participate in the KHIE pursuant to the requirements of 900 KAR 9:010.
(b) If a clinic has not implemented a certified electronic health record, the clinic may meet the requirement of paragraph (a) of this subsection by participating in the direct secure messaging service provided by KHIE.
(8) Quality assurance program.
(a) Each clinic shall have an ongoing quality assurance program that:
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Monitors and evaluates the quality and appropriateness of patient care;
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Evaluates methods to improve patient care;
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Identifies and corrects deficiencies within the clinic;
-
Alerts the designated physician or prescribing practitioner to identify and resolve recurring problems; and
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Provides for opportunities to improve the clinic's performance and to enhance and improve the quality of care provided to patients.
(b) The medical director shall ensure that the quality assurance program includes the following components:
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The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients;
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The identification of trends or patterns of incidents;
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The development and implementation of measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients; and
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The documentation of these functions and periodic review no less than quarterly of this information by the designated physician or prescribing practitioner.
Section 4. Provision of Services.
(1) Equipment used for direct patient care by a clinic shall comply with the following:
(a) The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative and properly calibrated;
(b) All personnel engaged in the operation of equipment shall have adequate training and be currently licensed, registered, or certified in accordance with applicable state statutes and administrative regulations; and
(c) There shall be a written training plan for the adequate training of personnel in the safe and proper usage of the equipment.
(2) Diagnostic services shall be performed in accordance with the clinic's protocol.
(3) Diagnostic services shall be provided under the supervision of a physician who is qualified by advanced training and experience in the use of the specific technique utilized for diagnostic purposes.
(4) Physical examination services shall be nonabusive and provided in a manner that ensures the greatest amount of safety and security for the patient.
(5) Personnel performing a physical examination shall:
(a) Have adequate training and be currently licensed, registered, or certified in accordance with applicable Kentucky statutes and administrative regulations; and
(b) Be limited by the relevant scope of practice of state licensure.
(6) At least one (1) physician and one (1) advanced practice registered nurse, licensed practical nurse, or registered nurse shall be on duty in the clinic during all hours the facility is operational.
Section 5. Physical environment.
(1) Accessibility. The clinic shall meet requirements for making buildings and facilities accessible to and usable by persons with a disability pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(2) Fire safety. An initial license to operate a clinic or a new license to operate a clinic upon approval of a change of location shall not be issued before the clinic obtains approval from the State Fire Marshal's office.
(3) Housekeeping and maintenance services.
(a) Housekeeping.
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The clinic shall maintain a clean and safe facility free of unpleasant odors.
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Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
(b) Maintenance. The premises shall be well kept and in good repair. Requirements shall include:
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The clinic shall ensure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences, is in good repair;
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The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures shall be in good repair. Windows and doors that can be opened for ventilation shall be screened;
-
Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly; and
-
A pest control program shall be in operation in the clinic. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(4) The clinic shall develop written infection control policies that are consistent with Centers for Disease Control guidelines and include the:
(a) Prevention of disease transmission to and from patients, visitors, and employees, including:
-
Universal blood and body fluid precautions;
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Precautions against airborne transmittal of infections;
-
Work restrictions for employees with infectious diseases; and
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Cleaning, disinfection, and sterilization methods used for equipment and the environment; and
(b) Provision of in-service education programs annually on the cause, effect, transmission, prevention, and elimination of infections.
(5) Hazardous cleaning solutions, compounds, and substances shall be:
(a) Labeled;
(b) Stored in closed metal containers;
(c) Kept separate from other cleaning materials; and
(d) Kept in a locked storage area apart from the exam room.
(6) The facility shall be kept free from insects and rodents and their nesting places.
(7) Garbage and trash:
(a) Shall be removed from the premises regularly; and
(b) Containers shall be cleaned daily.
(8) A clinic shall establish and maintain a written policy for the handling and disposal of wastes, including any infectious, pathological, or contaminated wastes, which shall include the requirements established in this subsection.
(a) Sharp wastes, including broken glass, scalpel blades, and hypodermic needles, shall be segregated from other wastes and placed in puncture-resistant containers immediately after use.
(b) A needle or other contaminated sharp waste shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal except as permitted by the Centers for Disease Control and the Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
(c) A sharp waste container shall be incinerated on or off-site or rendered nonhazardous.
(d) Any nondisposable sharp waste shall be placed in a hard walled container for transport to a processing area for decontamination.
(9)
(a) Disposable waste shall be:
-
Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
-
Handled, stored, and disposed of in a way that minimizes direct exposure of personnel or patients to waste materials.
(b) The clinic shall establish specific written policies regarding handling and disposal of waste material.
(10) A licensee owned or operated incinerator used for the disposal of waste shall be in compliance with all applicable Kentucky statutes and administrative regulations.
Section 6. Standards for prescribing and dispensing controlled substances.
(1) All licensed prescribers of a clinic authorized to prescribe or dispense controlled substances shall comply with the professional standards relating to the prescribing and dispensing of controlled substances established by their professional licensing boards, including 201 KAR 9:260 and 201 KAR 20:057.
(2) A representative from the Office of Inspector General shall review the clinic's records, including the clinic's patient records, to verify facility compliance with administrative regulations promulgated by professional licensing boards pursuant to KRS 218A.205 that establish standards for licensees authorized to prescribe or dispense controlled substances.
(3) A clinic shall not contract with or employ a physician or prescribing practitioner:
(a) Whose Drug Enforcement Administration number has ever been revoked;
(b) Whose application for a license to prescribe, dispense, or administer a controlled substance has been denied by any jurisdiction;
(c) Who has had any disciplinary limitation placed on his or her license by:
-
The Kentucky Board of Medical Licensure;
-
The Kentucky Board of Nursing;
-
The Kentucky Board of Dentistry;
-
The Kentucky Board of Optometric Examiners;
-
The State Board of Podiatry;
-
Any other board that licenses or regulates a person who is entitled to prescribe or dispense controlled substances to humans; or
-
A licensing board of another state if the disciplinary action resulted from illegal or improper prescribing or dispensing of controlled substances; or
(d) Who has been convicted of or pleaded guilty or nolo contendere to, regardless of adjudication, an offense that constitutes a felony for receipt of illicit and diverted drugs, including a controlled substance listed as Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule V in this state or the United States.
(4) The clinic's medical director shall:
(a) Be board certified and have a full, active, and unencumbered license to practice medicine in the commonwealth issued under KRS Chapter 311;
(b) Be physically present practicing medicine in the clinic for at least fifty (50) percent of the time that patients are present in the clinic;
(c) Within ten (10) days after the clinic hires a prescriber of controlled substances or ten (10) days after termination of a prescriber of controlled substances, notify the cabinet in writing and report the name of the prescriber; and
(d) Meet one (1) of the following:
-
Hold a current subspecialty certification in pain management by a member board of the American Board of Medical Specialties, or hold a current certificate of added qualification in pain management by the American Osteopathic Association Bureau of Osteopathic Specialists;
-
Hold a current subspecialty certification in hospice and palliative medicine by a member board of the American Board of Medical Specialties or hold a current certificate of added qualification in hospice and palliative medicine by the American Osteopathic Association Bureau of Osteopathic Specialists;
-
Hold a current board certification by the American Board of Pain Medicine;
-
Hold a current board certification by the American Board of Interventional Pain Physicians; or
-
Have completed a fellowship in pain management or an accredited residency program that included a rotation of at least five (5) months in pain management.
(5) The clinic shall, within ten (10) calendar days after termination of the medical director, notify the cabinet of the identity of the individual designated as medical director, including the identity of any interim medical director until a permanent director is secured for the clinic.
(6) Each licensed physician who prescribes or dispenses a controlled substance to a patient in the clinic as part of his or her employment agreement with the clinic shall successfully complete a minimum of ten (10) hours of Category I continuing medical education in pain management during each registration period throughout his or her employment agreement with the clinic.
Section 7. Denial and Revocation.
(1) The cabinet shall deny a clinic's application, incorporated by reference in 902 KAR 20:008, Section 9(1)(e), if:
(a) The clinic has been discontinued from participation in the Medicaid Program due to fraud or abuse of the program;
(b) An administrative sanction or criminal conviction relating to controlled substances has been imposed on the clinic or any individual under contract or employed directly by the clinic for an act or omission done within the scope of the clinic's license or the individual's employment; or
(c) The applicant fails, after the initial inspection, to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13).
(2) If, during the initial inspection of the clinic, the cabinet has probable cause to believe that a physician or other prescriber practicing at the facility may be engaged in the improper, inappropriate, or illegal prescribing or dispensing of a controlled substance, the cabinet shall:
(a) Refer the physician or other prescriber practicing at the clinic to the appropriate professional licensing board and appropriate law enforcement agency; and
(b) Withhold issuing a license to the clinic pending resolution of any investigation into the matter by a licensing board or law enforcement agency, and resolution of the appeals process, if applicable.
(3) The cabinet shall revoke a clinic's license if it finds that:
(a) In accordance with KRS 216B.105(2), there has been a substantial failure by the clinic to comply with the provisions of this administrative regulation;
(b) An administrative sanction or criminal conviction relating to controlled substances is imposed on the clinic or any individual employed by the clinic for an act or omission done within the scope of the clinic's license or the individual's employment;
(c) The clinic fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13); or
(d) The clinic is terminated from participation in the Medicaid program pursuant to 907 KAR 1:671.
(4)
(a) The denial or revocation of a clinic's license shall be mailed to the applicant or licensee by certified mail, return receipt requested, or by personal service.
(b) Notice of the denial or revocation shall set forth the particular reasons for the action.
(5) The denial or revocation shall become final and conclusive thirty (30) days after notice is given unless the applicant or licensee, within the thirty (30) day period, files a request in writing for a hearing with the cabinet.
(6) Urgent action to suspend a license.
(a) The cabinet shall take urgent action to suspend a clinic's license if the cabinet has probable cause to believe that:
-
The continued operation of the clinic would constitute a danger to the health, welfare, or safety of the facility's patients; or
-
A physician or other prescriber practicing at the clinic may be engaged in the improper or inappropriate prescribing or dispensing of a controlled substance.
(b)
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The clinic shall be served with notice of the hearing on the urgent suspension to be held no sooner than twenty (20) days from the delivery of the notice.
-
Notice of the urgent suspension shall set forth the particular reasons for the action.
(c) If the cabinet issues an urgent suspension of the clinic's license pursuant to paragraph (a)2. of this subsection, the cabinet shall refer the physician or other prescriber practicing at the clinic to the appropriate professional licensing board and appropriate law enforcement agency.
(7) Notice of a hearing on an urgent suspension shall be served on the clinic by certified mail, return receipt requested, or by personal service.
(8)
(a) Within five (5) working days of completion of the hearing, the cabinet's hearing officer shall render a written decision affirming, modifying, or revoking the urgent suspension.
(b) The urgent suspension shall be affirmed if there is substantial evidence of an immediate danger to the public health, safety, or welfare.
(9) The decision rendered under subsection (8) of this section shall be a final order of the agency on the matter, and any party aggrieved by the decision may appeal to circuit court.
(10) If the cabinet issues an urgent suspension, the cabinet shall take action to revoke the clinic's license pursuant to subsection (3) of this section if:
(a) The clinic fails to attend the expedited hearing;
(b) The decision rendered under subsection (8) of this section affirms that there is substantial evidence of an immediate danger to the public health, safety, or welfare; or
(c) Referral to a professional licensing board and law enforcement agency in accordance with subsection (6)(c) of this section results in an administrative sanction or criminal conviction relating to controlled substances against a physician or prescribing practitioner employed by, or under contract with, the clinic.
(11) Pursuant to KRS 216B.050, the cabinet may compel obedience to its lawful orders.
History
- RELATES TO: KRS 198B.260, 216B.010-216B.131, 216B.990, 218A.175, 218A.205, 311, 314, 29 C.F.R. 1910.1030(d)(2)(viii), 45 C.F.R. 160, 164, 21 U.S.C. 801 – 971, 42 U.S.C. 1320d-2 - 1320d-8
- STATUTORY AUTHORITY: KRS 13A.100, 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 require the Cabinet for Health and Family Services to promulgate administrative regulations governing health facilities and health services. This administrative regulation establishes the minimum licensure requirements for the operation of a pain management clinic if the clinic's primary practice component is the treatment of pain using controlled substances, and the clinic is located off the campus of the hospital that has majority ownership interest.
- History: 14 Ky.R. 1718; 1923; 2033; eff. 4-14-1988; 18 Ky.R. 866; eff. 10-16-1991; TAm eff. 12-10-2012; 42 Ky.R. 962; 1805; 2139; eff. 2-5-2016; 45 Ky.R. 479, 1026; eff. 11-2-2018; Crt eff. 5-19-2025.
902 KAR 20:275 Freestanding or mobile technology {#sec-902-kar-20-275 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:275}
Section 1. Definitions.
(1) "License" means an authorization issued by the cabinet for the purpose of operating a freestanding or mobile technology unit.
(2) "Magnetic resonance imaging" or "MRI" means a diagnostic imaging modality that utilizes magnetic resonance, an interaction between atoms and electromagnetic fields, to project images of internal body structures.
(3) "Positron emission tomography scanning" or "PET scanning" means a procedure that allows the study of metabolic processes, such as oxygen consumption and utilization of glucose and fatty acids, by capturing images of cellular activity or metabolism by tracking the movement of radioactive tracers throughout the body.
Section 2. Scope of Operations. In accordance with KRS 216B.020(3)(c) and (f), a freestanding or mobile technology unit that provides diagnostic or therapeutic equipment or procedures, i.e., MRI, PET scanning, cardiac catheterization, or megavoltage radiation therapy services, shall be licensed by the cabinet.
Section 3. Administration.
(1) Licensee.
(a) The licensee shall be legally responsible for:
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All activities of the licensed freestanding or mobile technology unit; and
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Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the freestanding or mobile technology unit.
(b) The licensee shall:
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Establish lines of authority; and
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Designate an administrator who shall be principally responsible for the daily operation of the freestanding or mobile technology unit.
(2) Policies and procedures.
(a) The licensee shall develop and implement policies and procedures that address:
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Care, treatment, procedures, services, and qualifications of personnel involved in the delivery of services; and
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The operation of equipment.
(b) The policies and procedures shall be revised as needed to accurately reflect actual operations.
(c) The licensee shall establish a time period for review of all policies and procedures.
(d) The policies and procedures shall be accessible either by hard copy or electronically.
(3) Personnel.
(a) The licensee shall employ a sufficient number of qualified staff to operate equipment in a manner that safely and effectively meets the needs and condition of the patients.
(b) Staffing numbers and training shall:
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Meet the recommendations of the equipment manufacturers;
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Adhere to current professional organizational standards; and
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Comply with all local, state, and federal laws.
(c) Additional staff members shall be provided if the licensee or cabinet determines that the staff on duty is inadequate to effectively and safely operate the equipment.
(d) Each staff member operating or maintaining equipment shall be assigned duties and responsibilities in accordance with the individual's capability.
(e) Assigned duties shall be:
-
In writing; and
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Reviewed on an annual basis by the staff member and supervisor.
(f) A medical director:
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Shall be a physician who is responsible for the quality of medical equipment services provided to patients; and
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May serve as the administrator as described by subsection (1)(b) of this section.
(4) Personnel records. The licensee shall maintain current personnel records for each employee that shall contain the following:
(a) Name, address, and Social Security number;
(b) Evidence of current registration, certification, or professional licensure;
(c) Documentation of training and experience;
(d) Performance evaluations; and
(e) Record of pre-employment and regular health exams related to employment.
(5) In-service training. Staff shall attend training programs relating to their respective job activities. The training programs shall include:
(a) Thorough job orientation for new employees; and
(b) In-service training programs, emphasizing competence and professionalism necessary for effective health care.
(6) Health assessment. All staff members who have contact with patients shall:
(a) Within twelve (12) months prior to initial patient contact, have a health assessment; and
(b) Comply with the tuberculosis (TB) testing requirements established in 902 KAR 20:205.
(7) Medical records.
(a) The licensee shall maintain medical records that contain the following:
-
Medical and social history relevant to each service provided, including data obtained from other providers;
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Physician's orders if an order is required for a specific diagnostic service;
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Description of each medical visit or contact, including a description of the:
a. Condition or reason for the visit or contact;
b. Assessment;
c. Diagnosis;
d. Services provided;
e. If applicable, medications and treatments prescribed; and
f. Disposition made;
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Reports of all physical examinations, laboratory, x-ray, and other test findings related to each service provided; and
-
Documentation of all referrals made, including reason for referral and to whom patient was referred.
(b) Ownership.
-
Medical records shall be the property of the freestanding or mobile technology unit.
-
The original medical record shall not be removed except by court order.
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Copies of a medical record or portions of the record may be used and disclosed, in accordance with the requirements established in this subsection.
(c) Confidentiality and security: use and disclosure.
-
The freestanding or mobile technology unit shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
-
The freestanding or mobile technology unit may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
-
This administrative regulation shall not forbid the freestanding or mobile technology unit from establishing higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(d) Transfer of records. The licensee shall:
-
Establish procedures to assist in continuity of care if the patient moves to another source of care; and
-
Upon proper release, transfer medical records or an abstract, if requested.
(e) Retention of records. After the patient's death or discharge, the completed medical record shall be placed in an inactive file and retained for:
-
Six (6) years; or
-
If a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
(f) Radiology records shall be retained in accordance with 42 U.S.C. 263b(f)(1)(G).
(g) A specific location shall be designated by the licensee for the maintenance and storage of the unit's medical records.
(h) The licensee shall ensure safe storage of medical records if the unit ceases to operate because of disaster or for any other reason.
(i) The licensee shall safeguard the record and its content against loss, defacement, and tampering.
Section 4. Reporting; Incidents and Accidents.
(1) A record of each incident or accident occurring in the equipment location area involving patients or staff members shall be retained for a period of two (2) years from the date of the incident or accident.
(2) A serious incident, accident, or medical condition as established in subsection (3) of this section and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Office of Inspector General within ten (10) days of the occurrence.
(3) A serious incident, accident, or medical condition shall include any of the following:
(a) Major permanent loss of function;
(b) A procedure on the wrong patient or wrong body part;
(c) Fractures of major limbs or joints;
(d) Severe burns, lacerations, or hematomas; and
(e) Actual or suspected abuse or mistreatment of patients.
(4) Reports made to the Office of Inspector General shall contain:
(a) Facility name;
(b) Patient age and sex;
(c) Date of incident or accident;
(d) Location;
(e) Extent or type of injury; and
(f) Means of treatment, e.g., hospitalization.
(5) A significant medication error or significant adverse medication reaction as established in subsection (6) of this section that requires intervention shall be reported immediately to the:
(a) Patient, next-of-kin, or responsible party;
(b) Prescriber;
(c) Supervising staff member; and
(d) Administrator.
(6) A significant medication error or significant adverse medication reaction shall include any event that is unintended and undesirable, including an unexpected effect of a prescribed medication or of a medication error that:
(a) Requires discontinuing a medication or modifying the dose;
(b) Requires hospitalization;
(c) Results in disability;
(d) Requires treatment with a prescription medication;
(e) Results in cognitive deterioration or impairment;
(f) Is life-threatening; or
(g) Results in death.
(7) Changes in the patient's condition, to the extent that a major cardiac event or other serious health concern is evident, shall be reported immediately to the:
(a) Attending physician;
(b) Next-of-kin or responsible party; and
(c) On-site manager.
Section 5. Provision of Services.
(1) Care, treatment, procedures, or services shall be provided, given, or performed effectively and safely in accordance with an order from a physician or other licensed health care practitioner acting within his or her scope of practice.
(2) Precautions shall be taken for a patient who:
(a) Has a special condition, such as pacemaker, pregnancy, or Alzheimer's disease; or
(b) May be susceptible to deleterious effects as a result of the treatment.
(3) If a patient or potential patient has a communicable disease, a physician or other licensedhealth care practitioner acting within his or her scope of practice shall ensure that:
(a) Adequate care is provided to prevent the spread of the disease; and
(b) The staff members are adequately trained and qualified to:
-
Manage the patient; or
-
Transfer the patient to an appropriate facility, if necessary.
(4) If the licensee engages a source to provide services normally provided by the staff, e.g., staffing, training, equipment maintenance, there shall be a written agreement with the source that describes:
(a) How and when the services are to be provided;
(b) The exact services to be provided; and
(c) A statement that these services are to be provided by qualified individuals.
(5) A current listing of all types of treatment and procedures offered shall be available.
(6) Anesthesia services. After the administration of a general anesthetic, a patient shall be attended by a physician until the patient may be safely placed under post-operative or procedure supervision by the nursing staff who shall then attend the patient until:
(a) The patient has regained full consciousness; or
(b) The effects of the anesthetic have sufficiently subsided for the patient to be able to summon aid if needed.
(7) Laboratory services.
(a) If required in connection with the treatment or procedure performed, laboratory services shall be provided directly or through an arrangement with a licensed laboratory.
(b) Laboratory supplies shall not be expired.
(8) Megavoltage radiation therapy services. A licensee that provides megavoltage radiation therapy services shall comply with the requirements of this subsection.
(a) Sufficient personnel shall be present to supervise and perform the services provided by the facility, including at least one (1):
-
Certified radiation operator; or
-
Physician with specialized training and experience to perform the scope of radiation therapy services provided.
(b) The licensee shall be currently licensed or registered pursuant to KRS 211.842 to 211.852.
(c) There shall be written policies and procedures governing radiologic services and administrative routines that support sound radiologic practices.
(d) Reports of interpretations shall be written or dictated and signed by the radiologist or physician.
(e) The use of all x-ray apparatus shall be limited to certified radiation operators or physicians.
(f) Only a certified radiation operator or physician may apply or remove radium element, its disintegration products, and radioactive isotopes.
(g) Proper safety precautions shall be maintained against fire, explosion, electrical, and radiation hazards.
(9) Adverse conditions.
(a) If a patient experiences any adverse condition or complication during or after the performance of the treatment or procedure, the patient shall remain at the equipment location until the condition or complication is eliminated, as determined by the physician, and the patient is stabilized.
(b) A patient who requires care beyond the capability of the equipment or staff shall be transferred to an appropriate facility.
(10) Patient instruction. Written instructions, if applicable, shall be issued to each patient upon discharge, including:
(a) Signs and symptoms of possible complications;
(b) Telephone number of the location of the equipment, the attending physician, or other knowledgeable professional staff member, if any complication occurs or questions arise;
(c) An emergency telephone number if any complication occurs;
(d) Limitations regarding activities or foods; and
(e) Date for follow-up or return visit, if applicable.
Section 6. Rights and Assurances.
(1) The licensee shall develop and post in a conspicuous place in a public area a grievance or complaint procedure to be exercised on behalf of the patients, including the address and phone number of the Office of Inspector General.
(2) Care, treatment, procedures, and services provided, and the charges for each shall be delineated in writing.
(3) Patients shall be made aware of all charges and services, as verified by the signature of the patient or responsible party.
(4) Storage shall be provided to protect a patient's personal belongings.
(5) Patient rights shall be guaranteed, prominently displayed, and the patient shall be informed of these rights, including:
(a) The care, treatment, procedures, and services to be provided;
(b) Informed consent for care, treatment, procedures, and services;
(c) Respect for the patient's property;
(d) Freedom from mental and physical abuse and exploitation;
(e) Privacy while being treated and receiving care;
(f) Respect and dignity in receiving care, treatment, procedures, and services;
(g) The consequences of refusal of the treatment or procedure;
(h) Refusal of experimental treatment and drugs; and
(i) Confidentiality and privacy of records.
(6) Except in an emergency, documentation regarding informed consent shall be properly executed prior to the treatment or procedure.
Section 7. Medication.
(1) Medication orders.
(a) Medications, including oxygen, shall be administered to patients only upon the order of a physician or other licensed health care practitioner acting within his or her scope of practice.
(b) All orders, including verbal, shall be:
-
Received only by a licensed health care practitioner acting within his or her scope of practice; and
-
Authenticated and dated by a physician or other licensed health care practitioner acting within his or her scope of practice pursuant to the licensee's policies and procedures, but no later than seventy-two (72) hours after the order is given.
(c) Verbal orders received shall include:
-
The time of receipt of the order;
-
Description of the order; and
-
Identification of the physician or other licensed health care practitioner and the individual receiving the order.
(2) Administering medication.
(a) Each medication dose administered shall be properly recorded in the patient's record as the medication is administered.
(b) The medication administration record shall include the:
-
Name of the medication;
-
Dosage;
-
Mode of administration;
-
Date;
-
Time; and
-
Signature of the individual administering the medication.
(c) Initials may be utilized in lieu of a signature and identification of the individual's initials shall be located within the record.
(3) Medication storage.
(a) Medications shall be stored:
-
Under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety, and security; and
-
Safeguarded to prevent access by unauthorized persons.
(b) Expired or discontinued medications shall not be stored with current medications.
(c) Storage areas shall:
-
Be of sufficient size for clean and orderly storage;
-
Be locked if not under direct observation by a licensed health care practitioner; and
-
Not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf-life.
(d)
-
Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U.S. Pharmacopeia (36 - 46 degrees F.).
-
Food and drinks and laboratory specimens shall not be stored in the same refrigerator in which medications and biologicals are stored.
-
Blood and blood products may be stored in the same refrigerator with medications and biologicals if stored in a separate compartment from the medications and biologicals.
(e) Medications shall be stored:
-
Separately from poisonous substances, blood, or body fluids;
-
In a manner that provides for separation between oral and topical medications; and
-
Separately from food.
(4) Disposition of medications.
(a) Medications shall not be retained in stock after the expiration date on the label.
(b) Contaminated or deteriorated medications shall not be maintained.
Section 8. Emergency procedures and disaster preparedness.
(1) Emergency services.
(a) Appropriate equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer to a hospital, if necessary.
(b) The licensee shall make arrangements for obtaining blood and blood products to meet emergency situations.
(2) Disaster preparedness. The licensee shall establish plans, based on equipment and staff capabilities, to meet its responsibilities for providing emergency care.
(3) Emergency call numbers.
(a) In addition to access to "911," emergency call data shall:
-
Be immediately available; and
-
Include the telephone numbers of:
a. Fire and police departments;
b. Ambulance service; and
c. The Poison Control Center.
(b) Other emergency call information shall be available, including the names, addresses, and telephone numbers of staff members to be notified in case of emergency.
Section 9. Equipment Maintenance.
(1) Equipment utilized for providing treatment or procedures, including its component parts, shall be properly maintained to perform the functions for which it is designed.
(2) Equipment.
(a) Equipment used in the provision of care, treatment, procedures, and services shall:
-
Meet appropriate specifications and calibrations; and
-
Be monitored and operated in accordance with the manufacturer's guidelines.
(b) Records shall be maintained to indicate all testing and maintenance.
(c) If equipment for the administration of anesthesia is utilized, it shall be readily available, clean or sterile, and operating properly.
-
Anesthesia apparatus shall be equipped with a device to measure the oxygen component of the gas being inhaled by the patient.
-
The device shall emit audible and visual alarms if the proportion of oxygen falls below a safe level.
-
A record of the inspections made prior to each use of the anesthesia equipment and a record of all service and repair performed on all anesthesia machines, vaporizers, and ventilators shall be maintained and retained:
a. For a minimum of two (2) years from the date of the inspection, service, or repair or
b. Until the next Office of Inspector General survey.
Section 10. Physical Environment.
(1) Accessibility. A licensee shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to federal, state, and local laws.
(2) Fire safety. A fixed-site location shall be approved by the state Fire Marshal's office before licensure is granted by the cabinet.
(3) Environment. The building in which equipment is utilized shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each patient.
(4) Infection control. The licensee shall develop written infection control policies that are consistent with Centers for Disease Control guidelines, available at www.cdc.gov/ncidod/dhqp/guidelines.html, and shall include:
(a) Prevention of disease transmission to and from patients, visitors, and employees, including:
-
Universal blood and body fluid precautions;
-
Precautions against airborne transmittal of infections; and
-
Work restrictions for employees with infectious diseases; and
(b) Cleaning, disinfection, and sterilization methods used for equipment and the environment.
(5) Housekeeping and maintenance.
(a) The equipment location shall be neat, uncluttered, clean, and free of vermin and offensive odors.
(b) Hazardous cleaning solutions, compounds, and substances shall be:
-
Labeled;
-
Stored in closed metal containers;
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Kept separate from other cleaning materials; and
-
Kept in a locked storage area.
(c) Garbage and trash:
-
Shall be removed from the premises regularly; and
-
Containers shall be cleaned regularly as needed.
(d) A licensee shall establish and maintain a written policy for the handling and disposal of wastes, including any infectious, pathological, and contaminated wastes, which shall include the following:
-
Sharp wastes shall be segregated from other wastes and placed in puncture-resistant containers immediately after use;
-
A needle or other contaminated sharp shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii);
-
A sharp waste container shall be incinerated on or off-site or rendered nonhazardous; and
-
Any nondisposable sharps shall be placed in a hard walled container for transport to a processing area for decontamination.
(e) Disposable waste shall be:
-
Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
-
Handled, stored, and disposed of in such a way as to minimize direct exposure of personnel or patients to waste materials.
(f) An incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 or 401 KAR 61:010.
Section 11. Quality assurance program. A licensee shall have a written, implemented quality assurance program that:
(1) Includes effective mechanisms for reviewing and evaluating patient care; and
(2) Provides for appropriate responses to findings.
Section 12. Mobile Technology Units.
(1) All mobile technology units, e.g., self-contained vans or tractor trailers, that transport equipment from one (1) host site to another, shall meet the current standards of this administrative regulation and of the local, state, and federal Departments of Transportation for the permitting and safe operation of the vehicle.
(2) A mobile cardiac catheterization laboratory shall only provide services on the campus of a host hospital that has emergency medical and intensive coronary care services.
(3) A procedure shall not be performed on a patient in a mobile cardiac catheterization laboratory if any of the following are present:
(a) Recent myocardial infarction (within ten (10) days or less);
(b) Uncontrolled arrhythmias;
(c) Severe uncontrolled congestive heart failure;
(d) Current hospitalization with highly unstable angina; or
(e) The patient is under eighteen (18) years of age.
History
- RELATES TO: KRS 211.842 – 211.852, 216B.010-216B.170, 216B.990, 29 C.F.R. 1910.1030(d)(2)(vii), 45 C.F.R. 160, 164, 42 U.S.C. 263b(f)(1)(G), 1320d
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes the minimum licensure requirements for the operation of and services provided by a freestanding or mobile technology unit.
- History: 902 KAR 020:275. 23 Ky.R. 2645; 2999; eff. 1-15-1997; TAm eff. 3-11-2011; TAm eff. 12-10-2012; 42 Ky.R.2275, 2735; eff. 6-3-2016; 45 Ky.R. 485, 1031; eff. 11-2-2018; Crt eff. 9-3-2025.
902 KAR 20:280 Prescribed pediatric extended care centers {#sec-902-kar-20-280 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:280}
Section 1. Definitions.
(1) "Child life specialist" means an individual who has:
(a) A minimum bachelor's degree with an educational emphasis on:
-
Human growth and development;
-
Education, which may include early childhood education;
-
Psychology; or
-
A related field of study; and
(b) Current experience in planning and implementing developmental stimulation programs for children.
(2) "Developmentalist" means a master's prepared individual with current experience in:
(a) Transdisciplinary evaluation; and
(b) Treatment planning for children who are at risk for or experiencing developmental delay.
(3) "Medical director" means a board certified pediatrician who:
(a) Serves as the liaison between the PPEC center and the medical community;
(b) Reviews the quality and appropriateness of PPEC center services; and
(c) Is available for consultation to PPEC center staff.
(4) "Medically dependent or technologically dependent child" is defined by KRS 216.875(6).
(5) "Nursing director" means a registered nurse who:
(a) Is licensed pursuant to KRS 314.041;
(b) Is responsible for providing continuous supervision of PPEC center services; and
(c) Manages the daily operations of the facility.
(6) "Occupational therapist" is defined by KRS 319A.010(3).
(7) "Physical therapist" is defined by KRS 327.010(2).
(8) "Prescribed pediatric extended care center" or "PPEC center" is defined by KRS 216.875(1).
(9) "Prescribing physician" means a physician who:
(a) Is licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571; and
(b) Signs the order admitting a child to the PPEC center.
(10) "Primary care provider" means a health care practitioner who:
(a) Is licensed to practice in Kentucky;
(b) Maintains overall responsibility for a child's medical management; and
(c) Is available for consultation and collaboration with PPEC center staff.
(11) "Protocol of care" means a comprehensive plan for implementation of the following services:
(a) Medical;
(b) Nursing;
(c) Psychosocial;
(d) Developmental; and
(e) Educational therapies.
(12) "Social worker" means an individual who is:
(a) Licensed pursuant to KRS 335.090; and
(b) A graduate of a school of social work accredited by the Council on Social Worker Education.
(13) "Speech-language pathologist" is defined by KRS 334A.020(3).
Section 2. Scope of Operation and Services. A PPEC center shall be a nonresidential health care service that provides:
(1) A link in the continuum of care for medically dependent or technologically dependent children; and
(2) The following triad of services for children and their parents:
(a) Day health care;
(b) Developmental interventions; and
(c) Parent training programs.
Section 3. Applicability. Each PPEC center shall:
(1) Be equipped and staffed to accommodate no fewer than three (3) medically dependent or technologically dependent children;
(2) Be in compliance with this administrative regulation and federal, state, and local laws and regulations pertaining to the operation of PPEC centers;
(3) Have a minimum full-time equivalent staff of two (2) registered nurses and one (1) nursing assistant; and
(4) Meet the following ratios:
Section 4. Criteria for Admission. Each child admitted to a PPEC center shall meet at least the following criteria:
(1) An infant or child considered for admission to the PPEC center shall be medically dependent or technologically dependent with a complex condition requiring continual care, which may include:
(a) Supplemental oxygen;
(b) Ventilator dependence;
(c) Cystic fibrosis;
(d) Apnea;
(e) Spinal cord injury; or
(f) Malignancy;
(2) An infant or child shall not, prior to admission, present significant risk of infection to other children or personnel. The medical and nursing director may review, on a case-by-case basis, any child with a suspected infectious disease to determine appropriateness of admission;
(3) The child shall be medically stabilized, require skilled nursing care or other interventions, and be appropriate for outpatient care; and
(4) The primary care provider, in consultation with the parent or legal guardian, shall be responsible for recommending placement in a PPEC center upon consideration of medical, emotional, psychosocial, and environmental factors.
Section 5. Preadmission Conference.
(1) If a child meets the admission criteria established in Section 4 of this administrative regulation, the primary care provider or designee shall contact the medical or nursing director of the PPEC center to schedule a preadmission conference.
(2) If a child is hospitalized at the time of referral, preadmission planning shall include:
(a) The parent or legal guardian; and
(b) Relevant hospital medical, nursing, social services, and developmental staff to assure that the discharge plans shall be implemented upon admission to the PPEC center.
(3) If a child is not hospitalized at the time of referral, preadmission planning shall be conducted with the:
(a) Primary care provider;
(b) Parent or legal guardian;
(c) PPEC center representatives; and
(d) Representatives of other relevant agencies as determined by the primary care provider and nursing director.
(4) A preadmission planning conference shall:
(a) Be scheduled at least seventy-two (72) hours prior to placement; and
(b) Allow sufficient time to assure that the therapeutic plan can be implemented upon placement in the PPEC center.
(5) The protocol of care shall:
(a) Be developed under the direction of the PPEC center's nursing director during the preadmission planning conference;
(b) Specify the treatment plan needed to accommodate the medical, nursing, psychosocial, and educational needs of the child and family;
(c) Identify specific goals for care, including plans for achieving those goals;
(d) Include a schedule for evaluation of progress;
(e) Include procedures to follow in an emergency situation;
(f) Include criteria for discharge from the PPEC center; and
(g) Be signed by the:
-
Physician;
-
Authorized representative of the PPEC center; and
-
Parent or legal guardian.
(6) A consent form outlining the purpose of the PPEC center, family responsibilities, authorized treatment, appropriate liability release, and emergency disposition plans shall be:
(a) Signed by the parent or legal guardian; and
(b) Witnessed prior to admission to the PPEC center.
(7) A copy of the consent form shall be:
(a) Provided to the parent or legal guardian; and
(b) Maintained in the child's medical record.
Section 6. Admission Procedure.
(1) In consultation with the parent or legal guardian, a child may be referred to the PPEC center medical or nursing director for determination of placement.
(2)
(a) Each child admitted to a PPEC center shall be admitted in accordance with a physician's written order placed in the child's medical record.
(b) A copy of the order shall be provided to the child's parent or legal guardian.
Section 7. Provision of Services.
(1) Medical staff services.
(a) Each child admitted to a PPEC center shall be admitted upon prescription by the:
-
Child's prescribing physician; or
-
Medical director.
(b) The child's primary care provider shall maintain responsibility for the overall medical therapeutic plan.
(c) The medical director shall participate in review of the protocol of care. Prescribed therapies shall be adjusted in consultation with the primary care provider to accommodate the child's condition.
(d) The PPEC center shall coordinate the prescribed therapies for the child.
(2) Nursing staff services.
(a) A PPEC center nursing staff member shall participate in preadmission planning.
(b) Nursing personnel, under the direction of the nursing director, shall be responsible for implementing the nursing care.
(c) Nursing personnel shall be responsible for monitoring and documenting the effects of prescribed therapies.
(d) Nursing personnel shall inform the primary care provider and medical director of the results of therapeutic interventions.
(e) Nursing personnel shall participate in interdisciplinary staff meetings regarding the child's progress.
(f) Nursing personnel shall assure that the PPEC center provides an environment conducive to the:
-
Stabilization of the child's medical condition; and
-
Promotion of the child's development.
(g) Nursing personnel shall be responsible for maintaining the child's record in accordance with facility policies and procedures.
(h) Nursing personnel shall instruct the parent or legal guardian in how to provide the necessary therapies in the home.
(3) Developmental services.
(a)
-
Each child shall have a functional assessment and an individualized program plan to accommodate the child's developmental needs.
-
The following functional areas shall be included as appropriate:
a. Self-care;
b. Communication skills;
c. Social skills;
d. Motor skills;
e. Cognitive areas;
f. Play; and
g. Growth and development appropriate for age.
(b) The child's program plan shall:
-
Include specific programs and action steps to facilitate developmental progress;
-
Be reviewed at least quarterly;
-
Include measurable goals in need areas, or goals to enhance and normalize independent functioning in daily activities;
-
Describe the child's strengths and present performance level with respect to each goal;
-
Document skill areas in priority order; and
-
Include anticipatory planning for specific areas identified as at-risk for future problems.
(c) The child life specialist shall participate in interdisciplinary staff meetings.
(d) Each PPEC center shall:
-
Include the parent or legal guardian in care-related conferences; and
-
Train the parent or legal guardian on how to:
a. Perform necessary therapies; and
b. Meet the developmental and psychosocial needs of their child at home.
(e) PPEC center staff shall:
-
Make referrals to appropriate resources;
-
Refer to community, social, educational, and financial services; and
-
Refer or provide counseling to enhance coping skills, interpersonal relationships, and family functioning.
(4) Nutritional services.
(a) Therapeutic diets shall be maintained in the child's file.
(b) A registered dietician shall be available to provide assistance with:
-
Nutritional needs;
-
Special diets of individual children; and
-
The development of policies and procedures for the handling, serving, and storage of food.
(c) All food and formula, except for specialized formula, shall be provided by PPEC center staff under the supervision of the nursing director.
(d) Prepared foods shall be:
-
Kept under refrigeration with identifying dates; and
-
Labeled with the child's name.
Section 8. Quality Assurance.
(1) Each PPEC center shall have a quality assurance program to evaluate the provision of patient care.
(2) The quality assurance program shall:
(a) Be ongoing; and
(b) Have a written plan of implementation.
(3)
(a) All organized services related to patient care, including services furnished by a contractor, shall be evaluated at least every six (6) months.
(b) Nosocomial infections and medication therapy shall be evaluated.
(c) Evidence of involvement by the parent or legal guardian shall be evaluated at least every six (6) months.
Section 9. Administration.
(1) Each PPEC center shall develop, implement, and maintain written policies and procedures governing all child care and related medical or other services provided.
(2) Personnel policies and procedures shall specify qualifications and required ratios for staff employed by the PPEC center.
(3) Each PPEC center shall:
(a) Maintain a personnel record for each employee;
(b) Develop and maintain a current job description for each employee;
(c) Provide each employee with access to written personnel policies governing conditions of employment; and
(d) Provide an orientation and development program for all PPEC center employees.
(4) Policies and procedures pertaining to PPEC center services shall:
(a) Be available to the public; and
(b) Include a procedure manual with specifications for each therapeutic intervention. The manual shall be:
-
Available for use by all staff involved in the care of the children; and
-
Reviewed every six (6) months to assure that procedures conform to prevailing and acceptable treatment modalities.
(5) Each PPEC center shall maintain an admission and discharge register that:
(a) Lists children admitted by name with identifying information about each and the source from which the child was admitted;
(b) Identifies the reason for disposition; and
(c) Identifies the place to which the child is to be discharged.
(6) Each PPEC center shall maintain;
(a) A daily census record;
(b) An accident and incident record; and
(c) A complete medical and nursing history for each child.
(7) Each PPEC center shall:
(a) Conduct a review of each child's protocol of care quarterly and revise upon a change in the child's condition; and
(b) Include any recommendations or revisions to the protocol based on consultation with other professionals involved in the child's care.
(8) Any changes in the orders shall be documented and signed by the primary care provider.
(9) Prior to a discharge, a conference involving PPEC center staff, the primary care provider, the parent or legal guardian, and staff of other agencies involved in the patient's care shall be held to discuss postdischarge care and follow-up.
(10) A discharge order written by the primary care provider shall be documented and entered in the child's record.
(11) A discharge summary, including the reason for discharge, shall also be included in the child's record.
(12) Except in an emergency situation, other agencies involved in the care of the child shall be notified prior to the discharge date.
(13) Each PPEC center shall have linkage agreements through written agreements with providers of other levels of care that may be medically needed to supplement the services available at the center.
(14) Each PPEC center shall have written policies to ensure the reporting of cases of abuse, neglect, or exploitation of children to the Cabinet for Health and Family Services pursuant to KRS 620.030.
Section 10. Personnel.
(1) A board certified pediatrician shall serve as the medical director for the PPEC center. Responsibilities of the medical director shall include:
(a) Participation in preadmission planning to establish a protocol of care as described in Section 5(5) of this administrative regulation;
(b) Review of services to assure acceptable levels of quality of care;
(c) Maintenance of a liaison role with the medical community;
(d) Advisement on the development of new programs and modifications of existing programs; and
(e) Assurance that medical consultation shall be available if the medical director is absent.
(2) A nursing director shall be employed to provide continuous supervision of PPEC center services. The nursing director shall be responsible for:
(a) Daily operations of the PPEC center;
(b) All services rendered at the center;
(c) Personnel management;
(d) Organization and implementation of in-service education programs for staff;
(e) Assistance to the medical director in determining patient eligibility for admission to PPEC center;
(f) Assurance of adequate nursing representation at preadmission conference;
(g) Supervision of all patient records; and
(h) Documentation of the PPEC center's activities to assure compliance with rules and administrative regulations.
(3) Nursing services shall be provided within the nurse's scope of practice pursuant to KRS Chapter 314 and any administrative regulations promulgated thereunder.
(4) The nursing director shall have at least two (2) years nursing experience of which at least six (6) months shall have been spent in a pediatric intensive care, neonatal intensive care setting, PPEC center, or similar care setting in which the nurse provided care to medically fragile children.
(5) Staffing.
(a) The PPEC center shall employ nursing and ancillary staff that are necessary to:
-
Provide the services essential to the center's operation; and
-
Meet the level of care needs of the children enrolled.
(b) There shall be an individual personnel record for each person employed by the center, which includes the following:
-
Resume with employee's training and experience;
-
Evidence of current licensure or registration;
-
Reports of all accidents occurring on duty; and
-
Current certification in basic life support.
(c) The following categories of personnel shall be available to the PPEC center on an in-house or consultant basis:
-
Developmentalist;
-
Child life specialist;
-
Occupational therapist;
-
Physical therapist;
-
Speech-language pathologist; and
-
Social worker.
Section 11. In-service Training for Staff, Parents, and Legal Guardians.
(1) Monthly staff development programs appropriate to the category of personnel shall be conducted to maintain quality patient care.
(2) All staff development programs shall be documented.
(3) All personnel shall maintain current certification in basic life support.
(4) Each new employee shall participate in orientation to acquaint the employee with the philosophy, organization, program, practices, and goals of the PPEC center.
(5) A comprehensive orientation to acquaint the parent or legal guardian with the philosophy and services shall be provided at the time of the child's placement in the PPEC center.
(6) Staff development programs shall be provided to:
(a) Facilitate the ability of the staff to function as a member of an interdisciplinary team that includes health professionals and the parent or legal guardian;
(b) Improve communication skills to facilitate a collaborative relationship between the parent or legal guardian and professionals;
(c) Increase understanding of the effects that childhood illness has on the child's development and the parent or guardian;
(d) Increase understanding of and how to cope with the effects of childhood illnesses;
(e) Cover a variety of topics including:
-
Issues of death and dying;
-
Awareness of services available at the following:
a. Hospital;
b. School; and
c. Community, state, and professional organizations; and
- Fostering of advocacy skills; and
(f) Develop case management skills to assist the family in:
-
Setting priorities; and
-
Planning and implementing the child's care at home.
(7) Each PPEC center shall provide training in the implementation of new technology.
Section 12. Physical Environment.
(1) The building shall:
(a) Be suitable for the purpose intended; and
(b) Maintain a minimum of sixty (60) square feet of space per child, exclusive of the following:
-
Kitchen;
-
Bathroom;
-
Storage areas;
-
Stairways;
-
Unfinished basements; and
-
Attics.
(2) The PPEC center shall conform to or exceed the minimum standards for day care centers as specified in the most current version of the Kentucky Building Code, incorporated by reference in 815 KAR 7:120.
(3) Plumbing approval. Prior to licensure, all specifications shall be approved by the Kentucky Division of Plumbing, Department of Housing, Buildings and Construction.
(4) Transportation. Emergency transportation to a hospital shall be achieved within twenty (20) minutes normal driving time or less, with a PPEC center staff member accompanying the child unless the child's parent or legal guardian is immediately available to accompany the child to the hospital.
(5) Unless medically contraindicated, the PPEC center shall maintain a temperature range of seventy-two (72) degrees to eighty (80) degrees Fahrenheit.
(6) Accessibility. Each PPEC center shall meet requirements for making buildings and facilities accessible to and usable by persons with a disability pursuant to KRS 198B.260 and 815 KAR Chapter 7.
(7) Fire safety. Each PPEC center shall:
(a) Be approved by the State Fire Marshal's office prior to licensure; and
(b) Retain a copy of the current fire inspection report on file.
(8) Housekeeping and maintenance services.
(a) Housekeeping. Each PPEC center shall:
-
Maintain a clean and safe facility free of unpleasant odors; and
-
Ensure that odors are eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
(b) Maintenance. The premises shall be well kept and in good repair as follows:
-
The center shall insure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences are in good repair;
-
The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures shall be in good repair;
-
Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly;
-
A pest control program shall be in operation in each center. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock;
a. Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures shall be segregated from other wastes and aggregated in puncture resistant containers immediately after use.
b. Needles and syringes shall not be recapped, cut, dismantled, or destroyed after use, but shall be placed intact directly into a puncture resistant container.
c. The containers of sharp wastes shall either be incinerated, on site or off site, or disposed of in a sanitary landfill approved pursuant to 401 KAR 47:005 through 401 KAR 47:180; and
- The center shall establish a written policy for the handling and disposal of all infectious, pathological, and contaminated waste if the center generates them. Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 or 401 KAR 61:010.
a.
(i) Infectious waste shall be placed in double impervious plastic bags and each bag shall be two (2) mils in thickness.
(ii) A bag, when full, shall not exceed twenty-five (25) pounds.
(iii) All bags shall be securely closed and a tag, which reads "INFECTIOUS WASTE" and identifies the center from which the waste is being removed, shall be attached to the bag in a conspicuous manner.
b. The following wastes shall be disposed of by incineration, be autoclaved before disposal, or be carefully poured down a drain connected to a sanitary sewer:
(i) Blood;
(ii) Blood specimens;
(iii) Used blood tubes; or
(iv) Blood products.
Section 13. Emergency Procedures.
(1) There shall be a working telephone, which is neither locked nor a pay station, in the center.
(2) Emergency telephone numbers shall be posted on or in the immediate vicinity of all telephones.
History
- RELATES TO: KRS 198B.260, 216.875, 216.880, 216.885, 311.571, 314.041, 319A.010(3), 327.010(2), 334A.020(3), 335.090, 620.030
- STATUTORY AUTHORITY: KRS 216B.042(1), 216.890
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 216.890 requires the Cabinet for Health and Family Services to promulgate administrative regulations to implement the provisions of KRS 216.875 to 216.890, which include standards related to the operation of prescribed pediatric extended care (PPEC) centers. This administrative regulation establishes the requirements for prescribed pediatric extended care centers.
- History: 16 Ky.R. 302; Am. 554; 755; eff. 10-18-1989; 1479, 1762; eff. 5-5-2017; 46 Ky.R.1370; eff. 1-23-2020; Crt eff. 8-12-2026.
902 KAR 20:291 Alzheimer's nursing homes {#sec-902-kar-20-291 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:291}
Section 1. Definitions.
(1) "Activities of daily living" means activities of self-help (e.g., being able to feed, bathe and/or dress oneself), communication (e.g., being able to place phone calls, write letters and understanding instructions) and socialization (e.g., being able to shop, being considerate of others, working with others and participating in activities).
(2) "Administrator" means a person who is licensed as a nursing home administrator pursuant to KRS 216A.080.
(3) "Facility" means a nursing home facility constructed pursuant to KRS 216B.071.
(4) "License" means an authorization issued by the Cabinet for Human Resources for the purpose of operating a nursing home and offering nursing home services.
(5) "PRN medications" means medications administered as needed.
(6) "Qualified dietician" or "nutritionist" means a person certified pursuant to KRS 310.010 or 310.030.
(7) "Patient" means any resident admitted to an Alzheimer's facility.
(8) "Restraint" means any pharmaceutical agent or physical or mechanical device used to restrict the movement of a patient or the movement of a portion of a patient's body.
Section 2. Scope.
(1) Facilities constructed and operated pursuant to KRS 216B.071 and this administrative regulation shall provide care to residents with a primary diagnosis of Alzheimer's disease or related disorder.
(2) Facilities constructed pursuant to KRS 216B.071 shall be constructed in accordance with 902 KAR 20:046 and this administrative regulation.
(3) These facilities shall be subject to the provisions of KRS 216.535 to 216.593.
Section 3. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for the facility and for compliance with federal, state and local laws and regulations pertaining to the operation of the facility.
(2) Administrator.
(a) All facilities shall have an administrator who is responsible for the operation of the facility and who shall delegate such responsibility in his absence.
(b) The licensee shall contract for professional and supportive services not available in the facility as dictated by the needs of the patient. The contract shall be in writing.
(3) Administrative records.
(a) The facility shall maintain a permanent, chronological patient registry showing date of admission, name of patient, and date of discharge.
(b) The facility shall require and maintain written recommendations or comments from consultants regarding the program and its development on a per visit basis.
(c) Menu and food purchase records shall be maintained.
(d) A written report of any incident or accident involving a patient (including medication errors or drug reactions), visitor or staff shall be made and signed by the administrator or nursing services supervisor, and any staff member who witnessed the incident. The report shall be filed in an incident file.
(4) Policies. The facility shall establish written policies and procedures that govern all services provided by the facility. The written policies shall include:
(a) Patient care and services to include physician, nursing, pharmaceutical (including medication stop orders policy), and residential services.
(b) Adult and child protection. The facility shall have written policies which assure the reporting of allegations of abuse, neglect or exploitation of adults and children to the Cabinet for Human Resources pursuant to KRS Chapter 209 and KRS 620.
(c) Use of restraints. The facility shall have a written policy that addresses minimizing the use of restraints and a mechanism for monitoring and controlling their use.
(d) Missing patient procedures. The facility shall have a written procedure to specify in a step-by-step manner the actions which shall be taken by staff when a patient is determined to be lost, unaccounted for or on other unauthorized absence.
(5) Patient rights. Patient rights shall be provided for pursuant to KRS 216.510 to 216.525.
(6) Admission.
(a) Patients shall be admitted only upon the referral of a physician. Additionally, the facility shall admit only persons who have a primary diagnosis of Alzheimer's disease or related disorder. The facility shall not admit persons whose care needs exceed the capability of the facility.
(b) Upon admission the facility shall obtain the patient's medical diagnosis, physician's orders for the care of the patient and the transfer form. Within forty-eight (48) hours after admission the facility shall obtain a medical evaluation from the patient's physician including current medical findings, medical history and physical examination. The medical evaluation may be a copy of the discharge summary or history and physical report from a hospital or long-term care facility, if done within seven (7) days prior to admission.
(c) Upon admission the patient and a responsible member of his family or legal representative shall be informed in writing of the established policies of the facility including fees, reimbursement, visitation rights during serious illness, visiting hours, type of diets offered and services rendered.
(d) The facility shall provide and maintain a system for identifying each patient's personal property and facilities for safekeeping of his declared valuables. Each patient's clothing and other property shall be reserved for his own use.
(7) Discharge planning. The facility shall have a discharge planning program to assure the continuity of care for patients being transferred to another health care facility or being discharged to the home.
(8) Transfer procedures and agreements.
(a) The facility shall have written transfer procedures and agreements for the transfer of patients to other health care facilities which can provide a level of inpatient care not provided by the facility. Any facility which does not have a transfer agreement in effect but which documents a good faith attempt to enter into such an agreement shall be considered to be in compliance with the licensure requirement. The transfer procedures and agreements shall specify the responsibilities each institution assumes in the transfer of patients and establish responsibility for notifying the other institution promptly of the impending transfer of a patient and arrange for appropriate and safe transportation.
(b) When a patient's condition exceeds the scope of services of the facility, the patient, upon physician's orders (except in cases of life threatening emergency), shall be transferred promptly to an appropriate facility to meet the patient's needs, or services shall be contracted for from another community resource.
(c) If changes and progress occur which would enable the patient to function in a less structured and restrictive environment, and the less restrictive environment cannot be offered at the facility, the facility shall offer assistance in making arrangements for patients to be transferred to a setting which provides appropriate services.
(d) Except in an emergency, the patient, his next of kin, or guardian, if any, and the attending physician shall be consulted at least thirty (30) days in advance of the transfer or discharge of any patient.
(e) If the patient is transferred, a transfer form shall accompany the patient. The transfer form shall include at least: physician's orders (if available), current information relative to diagnosis with history of problems requiring special care, a summary of the course of prior treatment, special supplies or equipment needed for patient care, and pertinent social information on the patient and his family.
(9) Tuberculosis testing. All employees and patients shall be tested for tuberculosis in accordance with the provisions of 902 KAR 20:200, Tuberculosis testing in long-term care facilities.
(10) Personnel.
(a) Job descriptions. Written job descriptions shall be developed for each category of personnel, to include qualifications, lines of authority and specific duty assignments.
(b) Employee records. Current employee records shall be maintained and shall include an employment application and a record of each employee's training and experience, evidence of current licensure or registration where required by law, health records, records of in-service training and ongoing education, and the employee's name, address and Social Security number.
(c) Staffing requirements.
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The facility shall have adequate personnel to meet the needs of the patients on a twenty-four (24) hour basis. The number and classification of personnel required shall be based on the number of patients and the amount and kind of personal care, nursing care, supervision and program needed to meet the needs of the patients as determined by medical orders and by services required by this administrative regulation.
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When the staff/patient ratio does not meet the needs of the patients, the Division for Licensing and Regulation shall determine and inform the administrator in writing how many additional personnel are to be added and of what job classification and shall give the basis for this determination.
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Responsible staff member shall be on duty and awake at all times to assure prompt, appropriate action in cases of injury, illness, fire or other emergencies.
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Although emergency scheduling may require substitution of staff, every effort should be made to provide residents with familiar staff members in order to minimize resident confusion.
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Volunteers shall not be counted to make up minimum staffing requirements.
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The facility shall have a director of nursing service who is a registered nurse and who works full time during the day, and who devotes full time to the nursing service of the facility. If the director of nursing has administrative responsibility for the facility, there shall be an assistant director of nursing, who is a registered nurse, so that there shall be the equivalent of a full-time director of nursing service. The director of nursing shall be trained or experienced in areas of nursing service, administration, rehabilitation nursing, psychiatric or geriatric nursing. The director of the nursing service shall be responsible for:
a. Developing and maintaining nursing service objectives, standards of nursing practice, nursing procedure manuals, and written job description for each level of nursing personnel.
b. Recommending to the administrator the number and levels of nursing personnel to be employed, participating in their recruitment and selection and recommending termination of employment when necessary.
c. Assigning and supervising all levels of nursing personnel.
d. Participating in planning and budgeting for nursing care.
e. Participating in the development and implementation of patient care policies.
f. Coordinating nursing services with other patient care services.
g. Planning and conducting orientation programs for new nursing personnel and continuing in-service education for all nursing personnel.
h. Participating in the screening of prospective patients in terms of required nursing services and nursing skills available.
i. Assuring that a written monthly assessment of the patient's general condition is completed.
j. Assuring that a nursing care plan shall be established for each patient and that his plan shall be reviewed and modified as necessary.
k. Assuring that registered nurses, licensed practical nurses, nursing assistants, and certified medication aides are assigned duties consistent with their training and experience.
l. Assuring that a monthly review of each patient's medications is completed and notifying the physician when changes are appropriate.
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Supervising nurse. Nursing care shall be provided by or under the direction of a full-time registered nurse. The supervising nurse may be the director of nursing or the assistant director of nursing and shall be trained or experienced in the areas of nursing administration and supervision, rehabilitative nursing, psychiatric or geriatric nursing. The supervising nurse shall make daily rounds to all nursing units performing such functions as visiting each patient, and staff assignments, and whenever possible accompanying physicians when visiting patients.
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Charge nurse. There shall be at least one (1) registered nurse or licensed practical nurse on duty at all times who is responsible for the nursing care of patients during the nurse's tour of duty. When a licensed practical nurse is on duty, a registered nurse shall be on call.
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Pharmacist. The facility shall retain a licensed pharmacist on a full-time, part-time or consultant basis to direct pharmaceutical services.
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Therapists.
a. If rehabilitative services beyond rehabilitative nursing care are offered, whether directly or through cooperative arrangements with agencies that offer therapeutic services, these services shall be provided or supervised by qualified therapists to include licensed physical therapists, speech pathologists and occupational therapists.
b. When supervision is less than full time, it shall be provided on a planned basis and shall be frequent enough, in relation to the staff therapist's training and experience, to assure sufficient review of individual treatment plans and progress.
c. In a facility with an organized rehabilitation service using a multidisciplinary team approach to meet all the needs of the patient, and where all therapists' services are administered under the direct supervision of a physician qualified in physical medicine who will determine the goals and limits of the therapists' work, and prescribes modalities and frequency of therapy, persons with qualifications other than those described in clause a. of this subparagraph may be assigned duties appropriate to their training and experience.
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Dietary. Each facility shall have a full-time person designated by the administrator, responsible for the total food service operation of the facility and on duty a minimum of thirty-five (35) hours each week.
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The facility shall designate a person for the following areas who will be responsible for:
a. Medical records;
b. Arranging for social services;
c. Developing and implementing the activities program and therapeutic recreation; and
d. Developing and implementing staff training program.
- Community family support coordinator. A social worker licensed pursuant to KRS 335.090 or who has two (2) years of social work supervised experience in a health care setting working directly with individuals; or similar professional qualifications shall be utilized whose functions shall include:
a. Evaluation of resident's initial social history on admission;
b. Utilization of community resources;
c. Conducting quarterly family support group meetings; and
d. Identification and utilization of existing Alzheimer's network.
- Supportive personnel, consultants, assistants and volunteers shall be supervised and shall function within the policies and procedures of the facility.
(d) Health requirements. No employee contracting an infectious disease shall appear at work until the infection can no longer be transmitted.
(e) Orientation and in-service training. All staff members and consultants shall have documented training in the care and handling of Alzheimer's patients, including at least:
- Eight (8) hours of orientation to cover the following:
a. Facility Alzheimer's policies;
b. Etiology and treatment of dementias;
c. Stages of Alzheimer's disease;
d. Behavior management; and
e. Communication.
f. Resident's rights.
- Quarterly continuing education is required, six (6) hours of which shall be in Alzheimer's disease or related disorders.
(11) Medical records.
(a) The facility shall develop and maintain a system of records retention and filing to insure completeness and prompt location of each patient's record. The records shall be held confidential. The records shall be in ink or typed and shall be legible. Each entry shall be dated and signed. Each record shall include:
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Identification data including the patient's name, address and Social Security number (if available); name, address and telephone number of referral agency; name and telephone number of personal physician; name, address and telephone number of next of kin or other responsible person; and date of admission.
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Admitting medical evaluation by a physician including current medical findings, medical history, physical examination and diagnosis. (The medical evaluation may be a copy of the discharge summary or history and physical report from a hospital, or long-term care facility if done within seven (7) days prior to admission.)
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The physician's dated and signed orders for medication, diet, and therapeutic services.
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Physician's progress notes describing significant changes in the patient's condition, written at the time of each visit.
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Findings and recommendations of consultants.
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A medication sheet which contains the date, time given, name of each medication, dosage, administration method, name of prescribing physician and name of person who administered the medication.
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Nurse's notes indicating changes in patient's condition, actions, responses, attitudes, appetite, etc. Nursing personnel shall make notation of response to medications, response to treatments, mode and frequency of PRN medications administered, condition necessitating administration of PRN medication, reaction following PRN medication, visits by physician and phone calls to the physician, medically prescribed diets and preventive maintenance or rehabilitative nursing measures.
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Written assessment of the patient's monthly general condition.
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Reports of dental, laboratory and x-ray services (if applicable).
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Changes in patient's response to the activity and therapeutic recreation program.
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A discharge summary, signed and dated by the attending physician within one (1) month of discharge from the facility.
(b) Retention of records. After patient's death or discharge the completed medical record shall be placed in an inactive file and retained for five (5) years.
Section 4. Provision of Services.
(1) Physician services.
(a) The health care of every patient shall be under the supervision of a physician who, based on an evaluation of the patient's immediate and long-term needs, prescribes a planned regimen of medical care which covers indicated medications, treatments, rehabilitative services, diet, special procedures recommended for the health and safety of the patient, activities, plans for continuing care and discharge.
(b) Patients shall be evaluated by a physician at least once every thirty (30) days for the first sixty (60) days following admission. Subsequent to the 60th day following admission, the patients shall be evaluated by a physician every sixty (60) days unless justified and documented by the attending physician in the patient's medical record. There shall be evidence in the patient's medical record of the physician visits to the patient at medically appropriate intervals.
(c) There shall be evidence in the patient's medical record that the patient's attending physician has made arrangement for the medical care of the patient in the physician's absence.
(d) Availability of physicians for emergency care. The facility shall have arrangements with one (1) or more physicians who will be available to furnish necessary medical care in case of an emergency if the physician responsible for the care of the patient is not immediately available. A schedule listing the names and telephone numbers of these physicians and the specific days each shall be on call and shall be posted in each nursing station. There shall be established procedures to be followed in an emergency, which cover immediate care of the patient, persons to be notified, and reports to be prepared.
(2) Nursing services.
(a) Twenty-four (24) hour nursing service. There shall be twenty-four (24) hour nursing service with a sufficient number of nursing personnel on duty at all times to meet the total needs of patients. Nursing personnel shall include registered nurses or licensed practical nurses, aides, assistants, and certified medication aides. The amount of nursing time available for patient care shall be exclusive of nonnursing duties. Sufficient nursing time shall be available to assure that each patient:
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Shall receive treatments, medication, and diets as prescribed;
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Shall receive proper care to prevent decubiti and shall be kept comfortable, clean and well-groomed;
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Shall be protected from accident and injury by the adoption of indicated safety measures;
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Shall be treated with kindness and respect;
(b) Rehabilitative nursing care. There shall be an active program of rehabilitative nursing care directed toward assisting each patient to achieve and maintain his highest level of self-care and independence.
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Rehabilitative nursing care initiated in the hospital shall be continued immediately upon admission to the facility.
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Nursing personnel shall be taught rehabilitative nursing measures and shall practice them in their daily care of patients. These measures shall include:
a. Maintaining good body alignment and proper positioning of bedfast patients;
b. Encouraging and assisting bedfast patients to change positions at least every two (2) hours, day and night to stimulate circulation and prevent decubiti and deformities or more often if necessary;
c. Making every effort to keep patients active and out of bed for reasonable periods of time, except when contraindicated by physician's orders, and encouraging patients to achieve independence in activities of daily living by teaching self-care, transfer and ambulation activities;
d. Assisting patients to carry out prescribed physical therapy exercises between visits of the physical therapists.
(c) Dietary supervision. Nursing personnel shall assure that patients are served diets as prescribed. Patients needing help in eating shall be assisted promptly upon receipt of meals. Food and fluid intake of patients shall be observed and deviations from normal shall be reported to the charge nurse. Persistent unresolved problems shall be reported to the physician.
(d) Comprehensive assessment of resident needs. Nursing personnel shall make a comprehensive assessment of a resident's needs which describes the resident's capability to perform daily life functions and significant impairments in functional capacity:
- The comprehensive assessment must include at least the following information:
a. Medically defines conditions and prior medical history;
b. Medical status measurement;
c. Functional status;
d. Sensory and physical impairment;
e. Nutritional status and requirements;
f. Special treatments or procedures;
g. Psychosocial status;
h. Dental condition;
i. Activities potential;
j. Cognitive status; and
k. Drug therapy.
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Assessments must be conducted no later than fourteen (14) days after the date of admission and promptly after a significant change in the resident's physical or mental condition.
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Each assessment must be conducted or coordinated by a registered nurse who signs and certifies the completion of the assessment.
(3) Comprehensive assessments and care plans.
(a) Comprehensive assessments.
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The facility shall make a comprehensive assessment of a resident's needs, which describes the resident's capability to perform daily life functions and significant impairments in functional capacity.
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The comprehensive assessment shall include at least the following information:
a. Medically defined conditions and prior medical history;
b. Medical status measurement;
c. Functional status;
d. Sensory and physical impairments;
e. Nutritional status and requirements;
f. Special treatments or procedures;
g. Psychosocial status;
h. Discharge potential;
i. Dental condition;
j. Activities potential;
k. Rehabilitation potential;
l. Cognitive status; and
m. Drug therapy.
- Frequency. Assessments shall be conducted:
a. No later than fourteen (14) days after the date of admission;
b. Promptly after a significant change in the resident's physical or mental condition; and
c. In no case less often than once every twelve (12) months.
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Review of assessments. The nursing facility shall examine each resident no less than once every three (3) months, and as appropriate, revise the resident's assessment to assure the continued accuracy of the assessment.
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Use. The results of the assessment are used to develop, review, and revise the resident's comprehensive plan of care, under paragraph (4) of this section.
(b) Accuracy of assessments.
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Coordination. Each assessment shall be conducted or coordinated by a registered nurse who signs and certifies the completion of the assessment with the appropriate participation of health professionals.
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Certification. Each individual who completes a portion of the assessment shall sign and certify the accuracy of that portion of the assessment.
(c) Comprehensive care plans.
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The facility shall develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing and psychosocial needs that are identified in the comprehensive assessment.
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A comprehensive care plan shall be:
a. Developed within seven (7) days after completion of the comprehensive assessment;
b. Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and with the participation of the resident, the resident's family or legal representative, to the extent practicable; and
c. Periodically reviewed and revised by a team of qualified persons after each assessment.
- The services provided or arranged by the facility shall:
a. Meet professional standards of quality; and
b. Be provided by qualified persons in accordance with each resident's written plan of care.
(d) Discharge summary. When the facility anticipates discharge, a resident shall have a discharge summary that includes:
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A recapitulation of the resident's stay;
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A final summary of the resident's status to include items in subsection (2)(d) of this subsection, at the time of the discharge that shall be available for release to authorized persons and agencies, with the consent of the resident or legal representative; and
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A postdischarge plan of care that developed with the participation of the resident and his or her family, which will assist the resident to adjust to his or her new living environment.
(4) Specialized rehabilitative services.
(a) Rehabilitative services shall be provided upon written order of the physician which indicates anticipated goals and prescribes specific modalities to be used and frequency of physical, speech and occupational therapy services. These services may be contracted for from another community resource.
(b) If therapy services are provided they shall include:
- Physical therapy which includes:
a. Assisting the physician in his evaluation of patients by applying muscle, nerve, joint, and functional ability tests;
b. Treating patients to relieve pain, develop or restore functions, and maintain maximum performance, using physical means such as exercise, massage, heat, water, light, and electricity.
- Speech therapy which includes:
a. Service in speech pathology or audiology;
b. Cooperation in the evaluation of patients with speech, hearing, or language disorders;
c. Determination and recommendation of appropriate speech and hearing services;
- Occupational therapy services which includes:
a. Assisting the physician in his evaluation of the patient's level of function by applying diagnostic and prognostic tests.
b. Guiding the patient in his use of therapeutic creative and self care activities for improving function.
c. Therapists shall collaborate with the facility's medical and nursing staff in developing the patient's total plan of care.
d. Ambulation and therapeutic equipment. Commonly used ambulation and therapeutic equipment necessary for services offered shall be available for use in the facility such as parallel bars, handrails, wheelchairs, walkers, walkerettes, crutches and canes. The therapists shall advise the administrator concerning the purchase, rental, storage and maintenance of equipment and supplies.
(5) Personal care services. Personal care services shall include: assistance with bathing, shaving, cleaning and trimming of fingernails and toenails, cleaning of the mouth and teeth, and washing, grooming and cutting of hair.
(6) Pharmaceutical services.
(a) The facility shall provide appropriate methods and procedures for obtaining, dispensing, and administering drugs and biologicals, developed with the advice of a licensed pharmacist or a pharmaceutical advisory committee which includes one (1) or more licensed pharmacists.
(b) If the facility has a pharmacy department, a licensed pharmacist shall administer the department.
(c) If the facility does not have a pharmacy department, it shall have provision for promptly obtaining prescribed drugs and biologicals from a community or institutional pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy, pursuant to KRS 315.035.
(d) If the facility does not have a pharmacy department, but does maintain a supply of drugs:
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The consultant pharmacist shall be responsible for the control of all bulk drugs and maintain records of their receipt and disposition.
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The consultant pharmacist shall dispense drugs from the drug supply, properly label them and make them available to appropriate licensed nursing personnel.
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Provisions shall be made for emergency withdrawal of medications from the drug supply.
(e) An emergency medication kit approved by the facility's professional personnel shall be kept readily available. The facility shall maintain a record of what drugs are in the kit and document how the drugs are used.
(f) Medication services.
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Conformance with physician's orders. All medications administered to patients shall be ordered in writing by the patient's physician. Telephone orders shall be given only to a licensed nurse or pharmacist immediately reduced to writing, signed by the nurse and countersigned by the physician within fourteen (14) days. Medications not specifically limited as to time or number of doses, when ordered, shall be automatically stopped in accordance with the facility's written policy on stop orders. A registered nurse or pharmacist shall review each patient's medication profile at least monthly. The prescribing physician shall review the patient's medical profile at least every two (2) months. The patient's attending physician shall be notified of stop order policies and contacted promptly for renewal of such orders so that continuity of the patient's therapeutic regimen is not interrupted. Medications are to be released to patients on discharge only on the written authorization of the physician.
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Administration of medications. All medications shall be administered by licensed medical or nursing personnel in accordance with the Medical Practice Act (KRS 311.530 to 311.620) and Nurse Practice Act of (KRS Chapter 314) or by personnel who have completed a state approved training program, from a state-approved source. The administration of oral and topical medicines by certified medicine aides shall be under the supervision of licensed medical or nursing personnel. Intramuscular injections shall be administered by a licensed nurse or a physician. If intravenous injections are necessary they shall be administered by a licensed physician or registered nurse. Each dose administered shall be recorded in the medical record.
a. The nursing station shall have readily available items necessary for the proper administration of medications.
b. In administering medications, medication cards or other state approved systems shall be used and checked against the physician's orders.
c. Medications prescribed for one patient shall not be administered to any other patient.
d. Self-administration of medications by patients shall not be permitted except on special order of the patient's physician or in a predischarge program under the supervision of a licensed nurse.
e. Medication errors and drug reactions shall be immediately reported to the patient's physician and an entry thereof made in the patient's medical record as well as on an incident report.
f. Up-to-date medication reference texts and sources of information shall be provided for use by the nursing staff, (e.g., the American Hospital Formulary Service of the American Society of Hospital Pharmacists, Physicians Desk Reference or other suitable references).
- Labeling and storing medications.
a. All medications shall be plainly labeled with the patient's name, the name of the drug, strength, name of pharmacy, prescription number, date, physician name, caution statements and directions for use except where accepted modified unit dose systems conforming to federal and state laws are used. The medications of each patient shall be kept and stored in their original containers and transferring between containers shall be prohibited. All medicines kept by the facility shall be kept in a locked place and the persons in charge shall be responsible for giving the medicines and keeping them under lock and key. Medications requiring refrigeration shall be kept in a separate locked box of adequate size in the refrigerator in the medication area. Drugs for external use shall be stored separately from those administered by mouth and injection. Provisions shall also be made for the locked separate storage of medications of deceased and discharged patients until such medication is surrendered or destroyed in accordance with federal and state laws and regulations.
b. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the issuing pharmacist or pharmacy for relabeling or disposal. Containers having no labels shall be destroyed in accordance with state and federal laws.
c. Cabinets shall be well lighted and sufficient size to permit storage without crowding.
d. Medications no longer in use shall be disposed of or destroyed in accordance with federal and state laws and regulations.
e. Medications having an expiration date shall be removed from usage and properly disposed of after such date.
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Controlled substances. Controlled substances shall be kept under double lock (e.g., in a locked box in a locked cabinet). There shall be a controlled substances record, in which is recorded the name of the patient, the date, time, kind, dosage, balance remaining and method of administration of all controlled substances; the name of the physician who prescribed the medications; and the name of the nurse who administered it, or staff who supervised the self-administration. In addition, there shall be a recorded and signed Schedule II controlled substances count daily, and Schedule III, IV, and V controlled substances count once per week by those persons who have access to controlled substances. All controlled substances which are left over after the discharge or death of the patient shall be destroyed in accordance with KRS 218A.230, or 21 CFR 1307.21, or sent via registered mail to the Controlled Substances Enforcement Branch of the Kentucky Cabinet for Human Resources.
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Use of restraints. If a patient becomes disturbed or unmanageable, the patient's physician shall be notified in order to evaluate and direct the patient's care. No form of restraints or protective devices shall be used except under written orders of the attending physician. There shall be no PRN orders for restraints. Understanding that measures to prevent wandering may infringe on patient rights, care shall be exercised in the use of physical or mechanical devices or chemical restraints.
a. Restraints shall not be used as punishment, as discipline, as a convenience for the staff, or when not required to treat the resident's medical symptoms, or as a substitute for staff.
b. Physical or mechanical restraints that require lock and key shall not be used. Restraints shall be applied only by personnel trained in the proper application and observation of this equipment. Restraints shall be checked at least every one-half (1/2) hour and released at least ten (10) minutes every two (2) hours. During the patient's normal waking hours, the patient must be exercised during release periods. The checks and releases of restraints shall be recorded in the patient's medical record as they are completed. Such reports shall document the rationale or justification for the use of the procedure, a description of the specific procedures employed, and the physician's order. Restraints shall be comfortable and easily removed in case of an emergency.
c. The specific purpose and time-limited order for any restraint shall be written and reviewed according to facility policy. The frequency of such renewal shall not exceed sixty (60) days.
- Infection control and communicable diseases.
a. There shall be written infection control policies, which are consistent with the Center for Disease Control guidelines including:
(i) Policies which address the prevention of disease transmission to and from patients, visitors and employees, including: universal blood and body fluid precautions, precautions for infections which can be transmitted by the airborne route; and work restrictions for employees with infectious diseases.
(ii) Policies which address the cleaning, disinfection, and sterilization methods used for equipment and the environment.
b. The facility shall provide in-service education programs on the cause, effect, transmission, prevention and elimination of infections for all personnel responsible for direct patient care.
c. Sharp wastes.
(i) Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other wastes and placed in puncture resistant containers immediately after use.
(ii) Needles shall not be recapped by hand, purposely bent, broken, or otherwise manipulated by hand.
(iii) The containers for sharp wastes shall either be incinerated on- or off-site, or be rendered nonhazardous by a technology of equal or superior efficacy, which is approved by both the Cabinet for Human Resources and the Natural Resources and Environmental Protection Cabinet.
d. Disposable waste.
(i) All disposable waste shall be placed in suitable bags or closed containers so as to prevent leakage or spillage, and shall be handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
(ii) The facility shall establish specific written policies regarding handling and disposal of all wastes.
(iii) The following wastes shall be disposed of by incineration, autoclaved before disposal, or carefully poured down a drain connected to a sanitary sewer: blood, blood specimens, used blood tubes, or blood products.
(iv) Any wastes conveyed to a sanitary sewer shall comply with applicable federal, state, and local pretreatment regulations pursuant to 40 CFR 403 and 401 KAR 5:055, Section 9.
(v) Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 and 401 KAR 5:055.
e. Patients infected with the following diseases shall not be admitted to the facility: anthrax, campylobacteriosis, cholera, diphtheria, hepatitis A, measles, pertussis, plague, poliomyelitis, rabies (human), rebella, salmonellosis, shigellosis, typhoid fever, yersiniosis, brucellosis, giardiasis, leprosy, psittacosis, Q fever, tularemia, and typhus.
f. A facility may admit a (noninfectious) tuberculosis patient under continuing medical supervision for his tuberculosis disease.
g. Patients with active tuberculosis may be admitted to the facility whose isolation facilities and procedures have been specifically approved by the cabinet.
h. If, after admission, a patient is suspected of having a communicable disease that would endanger the health and welfare of other patients the administrator shall assure that a physician is contacted and that appropriate measures are taken on behalf of the patient with the communicable disease and the other patients.
(7) Diagnostic services. The facility shall have provisions for obtaining required clinical laboratory, x-ray and other diagnostic services. Laboratory services may be obtained from a laboratory which is part of a licensed hospital or a laboratory licensed pursuant to KRS 333.030 and any administrative regulations promulgated thereunder. Radiology services shall be obtained from a service licensed or registered pursuant to KRS 211.842 to 211.852 and any administrative regulations promulgated thereunder. If the facility provides its own diagnostic services, the service shall meet the applicable laws and administrative regulations. All diagnostic services shall be provided only on the request of a physician. The physician shall be notified promptly of the test results. Arrangements shall be made for the transportation of patients, if necessary, to and from the source of service. Simple tests, such as those customarily done by nursing personnel for diabetic patients may be done in the facility. All reports shall be included in the medical record.
(8) Dental services. The facility shall assist patients to obtain regular and emergency dental care. Provision for dental care: Patients shall be assisted to obtain regular and emergency dental care. An advisory dentist shall provide consultation, participate in in-service education, recommend policies concerning oral hygiene, and shall be available in case of emergency. The facility, when necessary, shall arrange for the patient to be transported to the dentist's office. Nursing personnel shall assist the patient to carry out the dentist's recommendations.
(9) Social services.
(a) Provision for medically related social needs. The medically related social needs of the patient shall be identified, and services provided to meet them, in admission of the patient, during his treatment and care in the facility.
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As a part of the process of evaluating a patient's need for services in a facility and whether the facility can offer appropriate care, emotional and social factors shall be considered in relation to medical and nursing requirements.
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As soon as possible after admission, there shall be an evaluation, based on medical, nursing and social factors, of the probable duration of the patient's need for care and a plan shall be formulated and recorded for providing such care.
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Subject to the requirements of KRS 216B.071, where there are indications that financial help will be needed, arrangements shall be made promptly for referral to an appropriate agency.
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Social and emotional factors related to the patient's illness, to his response to treatment and to his adjustment to care in the facility shall be recognized and appropriate action shall be taken when necessary to obtain casework services to assist in resolving problems in these areas.
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Knowledge of the patient's home situation, financial resources, community resources available to assist him, and pertinent information related to his medical and nursing requirements shall be used in making decisions regarding his discharge from the facility.
(b) Confidentiality of social data. Pertinent social data, and information about personal and family problems related to the patient's illness and care shall be made available only to the attending physician, appropriate members of the nursing staff, and other key personnel who are directly involved in the patient's care, or to recognized health or welfare agencies. There shall be appropriate policies and procedures for assuring the confidentiality of such information.
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The staff member responsible for social services shall participate in clinical staff conferences and confer with the attending physician at intervals during the patient's stay in the facility, and there shall be evidence in the record of such conferences.
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The staff member and nurses responsible for the patient's care shall confer frequently and there shall be evidence of effective working relationships between them.
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Records of pertinent social information and of action taken to meet social needs shall be maintained for each patient. Signed social service summaries shall be entered promptly in the patient's medical record for the benefit of all staff involved in the care of the patient.
(10) Patient activities. Activities suited to the needs and interests of patients shall be provided. Provision shall be made for activities which must be appropriate for the needs and interests of each resident, taking into consideration his or her specific impairment, state of disease. Activities programs shall be available to all residents and shall be planned and documented in the patient's interdisciplinary comprehensive assessment.
(a) The activity leader shall have specialized educational preparation concerning the care of an Alzheimer's patient, and use, to the fullest possible extent, community, social and recreational opportunities.
(b) Patients shall be encouraged but not forced to participate in such activities. Suitable activities are provided for patients unable to leave their rooms.
(c) Patients who are able and who wish to do so shall be assisted to attend religious services.
(d) Patient's request to see their clergymen shall be honored and space shall be provided for privacy during visits.
(e) Visiting hours shall be flexible and posted to permit and encourage visiting friends and relatives.
(f) The facility shall make available a variety of supplies and equipment adequate to satisfy the individual interests of patients. Examples of such supplies and equipment are: books and magazines, daily newspapers, games, stationery, radio and television and the like.
(11) Transportation.
(a) If transportation of patients is provided by the facility to community agencies or other activities, the following shall apply:
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Special provision shall be made for patients who use wheelchairs.
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An escort or assistant to the driver shall be provided in transporting patients to and from the facility if necessary for the patient's safety.
(b) The facility shall arrange for appropriate transportation in case of medical emergencies.
(12) Residential services.
(a) Dietary services. The facility shall provide or contract for food service to meet the dietary needs of the patients including modified diets or dietary restrictions as prescribed by the attending physician. When a facility contracts for food service, with an outside food management company, the company shall provide a qualified dietician on a full-time, part-time or consultant basis to the facility. The qualified dietician shall have continuing liaison with the medical and nursing staff of the facility for recommendations on dietetic policies affecting patient care. The company shall comply with all of the appropriate requirements for dietary services in this administrative regulation.
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Therapeutic diets. If the designated person responsible for food service is not a qualified dietician or nutritionist, consultation by a qualified dietician or qualified nutritionist shall be provided.
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Dietary staffing. There shall be sufficient food service personnel employed and their working hours, schedules of hours, on duty and days off shall be posted. If any food service personnel are assigned duties outside the dietary department, the duties shall not interfere with the sanitation, safety or time required for regular dietary assignments.
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Menu planning.
a. Menus shall be planned, written and rotated to avoid repetition. Nutrition needs shall be met in accordance with the current recommended dietary allowances of the Food and Nutrition Board of the National Research Council adjusted for age, sex and activity, and in accordance with physician's orders.
b. Meals shall correspond with the posted menu. Menus must be planned and posted one (1) week in advance. When changes in the menu are necessary, substitutions shall provide equal nutritive value and the changes shall be recorded on the menu and all menus shall be kept on file for thirty (30) days.
c. The daily menu shall include daily diet for all modified diets served within the facility based on an approved diet manual. The diet manual shall be a current manual with copies available in the dietary department, that has the approval of the professional staff of the facility. The diet manual shall indicate nutritional deficiencies of any diet. The dietician shall correlate and integrate the dietary aspects of the patient care with the patient and patient's chart through such methods as patient instruction, recording diet histories and participation in rounds and conferences.
- Food preparation and storage.
a. There shall be at least a three (3) day supply of food to prepare well balanced palatable meals. Records of food purchased for preparation shall be on file for thirty (30) days.
b. Food shall be prepared with consideration for any individual dietary requirement. Modified diets, nutrient concentrates and supplements shall be given only on the written orders of a physician.
c. At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the substantial evening meal and breakfast. Between meal snacks to include an evening snack before bedtime shall be offered to all patients. Adjustments shall be made when medically indicated.
d. Foods shall be prepared by methods that conserve nutritive value, flavor and appearance and shall be attractively served at the proper temperatures, and in a form to meet the individual needs. A file of tested recipes, adjusted to appropriate yield shall be maintained. Food shall be cut, chopped or ground to meet individual needs. If a patient refuses foods served, nutritional substitutions shall be offered.
e. All opened containers or leftover food items shall be covered and dated when refrigerated.
- Serving of food. When a patient cannot be served in the dining room, trays shall be provided for bedfast patients and shall rest on firm supports such as over-bed tables. Sturdy tray stands of proper height shall be provided for patients able to be out of bed.
a. Correct positioning of the patient to receive his tray shall be the responsibility of the direct patient care staff. Patients requiring help in eating shall be assisted within a reasonable length of time.
b. Adaptive self-help devices shall be provided to contribute to the patient's independence in eating.
- Sanitation. All facilities shall comply with all applicable provisions of KRS 219.011 to 219.081 and 902 KAR 45:005 (Kentucky's Food Service Establishment Act and Food Service Code).
(b) Housekeeping and maintenance services.
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The facility shall maintain a clean and safe facility free of unpleasant odors. Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans and other obvious sources.
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An adequate supply of clean linen shall be on hand at all times. Soiled clothing and linens shall receive immediate attention and shall not be allowed to accumulate. Clothing or bedding used by one patient shall not be used by another until it has been laundered or dry cleaned.
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Soiled linen shall be sorted and laundered in the soiled linen room in the laundry area. Handwashing facilities with hot and cold water, soap dispenser and paper towels shall be provided in the laundry area.
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Clean linen shall be sorted, dried, ironed, folded, transported, stored and distributed in a sanitary manner.
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Personal laundry of patients or staff shall be collected, transported, sorted, washed and dried in a sanitary manner, separate from bed linens.
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Patients' personal clothing shall be laundered as often as is necessary. Laundering of patients' personal clothing shall be the responsibility of the facility unless the patient or the patient's family accepts this responsibility. Patient's personal clothing laundered by or through the facility shall be marked to identify the patient-owner and returned to the correct patient.
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Maintenance. The premises shall be well kept and in good repair. Requirements shall include:
a. The facility shall insure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps and fences are in good repair.
b. The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing and electrical fixtures shall be in good repair. Windows and doors shall be screened.
c. Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly.
d. A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(c) Room accommodations.
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Each patient shall be provided a standard size bed or the equivalent at least thirty-six (36) inches wide, equipped with substantial springs, a clean comfortable mattress, a mattress cover, two (2) sheets and a pillow, and such bed covering as is required to keep the patients comfortable. Rubber or other impervious sheets shall be placed over the mattress cover whenever necessary. Beds occupied by patients shall be placed so that no patient may experience discomfort because of proximity to radiators, heat outlets, or by exposure to drafts.
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The facility shall provide window coverings, bedside tables with reading lamps (if appropriate), comfortable chairs, chest or dressers with mirrors, a night light, and storage space for clothing and other possessions.
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Patients shall not be housed in unapproved rooms or unapproved detached buildings.
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Basement rooms shall not be used for sleeping rooms for patients.
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Patients may have personal items and furniture when it is physically feasible.
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There shall be a sufficient number of tables provided that can be rolled over a patient's bed or be placed next to a bed to serve patients who cannot eat in the dining room.
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Each living room or lounge area and recreation area shall have an adequate number of reading lamps, and tables and chairs or settees of sound construction and satisfactory design.
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Dining room furnishings shall be adequate in number, well constructed and of satisfactory design for the patients.
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Each patient shall be permitted to have his own radio and television set in his room unless it interferes with or is disturbing to other patients.
Section 5. Alzheimer's Facility Requirements.
(1) The care of residents with Alzheimer's disease and other cognitive disorders require increased security and visual access. Measures to protect the residents from harm and to prevent them from leaving designated areas without supervision shall include frequent in-person observation of each resident and may also include the use of wide angle mirrors closed-circuit television monitors, and alarm systems.
(2) In addition to the required facility specifications in 902 KAR 20:046, the following shall be provided:
(a) Control doors, if used for security of the residents, shall be forty-four (44) inches in width each leaf, and swing in opposite directions. A latch or other fastening device on a door shall be provided with a knob, handle, panic bar, or other simple type of releasing device, the method of operation of which is obvious, even in darkness.
(b) Locking devices may be used on the control doors if the following criteria are met.
- The locking device, which shall not be a keylock device, shall be electronic and shall be released when the following occurs:
a. Upon activation of the fire alarm or sprinkler systems;
b. Power failure to the facility; and
c. By pressing a button located at the main staff station and at the monitoring station.
- Key pad or buttons may be located at the control doors for routine use by staff or service.
(3) Access to outdoor areas shall be provided and such areas shall be enclosed by walls or fencing that do not present a hazard.
(4) Any security measures taken to provide for the safety of wandering patients shall be as unobtrusive as possible.
History
- RELATES TO: KRS 216B.010-216B.131, 216B.990
- STATUTORY AUTHORITY: KRS 216B.042, 216B.071, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: The administrative regulation establishing standards for freestanding facilities limited to the care of patients with Alzheimer's or related disorders, 902 KAR 20:290, was found deficient by the Administrative Regulation Review Subcommittee at its August 6, 1991, meeting. The finding of deficiency resulted from the staff/patient ratio specified in Section 3(10)(c)2 ("Staffing requirements"). Legislation to establish the staff/patient ratio in KRS Chapter 216B was not enacted during the 1992 regular session of the General Assembly. Therefore, pursuant to KRS 13A.333(1), 902 KAR 20:290 expired. KRS 216B.042 requires the cabinet to establish standards for health facilities and health services, and authorizes it to promulgate administrative regulations. Without an administrative regulation establishing standards for freestanding facilities for patients suffering from Alzheimer's or related disorders, the cabinet would be in violation of the legislative mandate expressed in KRS 216B.042. KRS 13A.333(6) prohibits an administrative body from promulgating an administrative regulation that is identical to or substantially the same as an administrative regulation that has expired. This administrative regulation is not identical to or substantially the same as 902 KAR 20:290, because: (1) Only the section relating to the staff/patient ratio was found deficient; (2) this administrative regulation does not establish or require a staff/patient ratio; and (3) it is required, by legislative mandate, by KRS 216B.042.
- History: 19 Ky.R. 2199; 2466; eff. 6-7-1993; Crt eff. 05-07-2019; TAm eff. 3-20-2020; Crt eff. 2-9-2026.
902 KAR 20:300 Operation and services; nursing facilities {#sec-902-kar-20-300 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:300}
Section 1. Scope of Operations and Licensure.
(1) A nursing facility licensed under this administrative regulation shall comply with federal, state, and local laws and regulations pertaining to the operation of the facility, including compliance with the laws and regulations specified in this subsection.
(a) A nursing facility shall comply with the requirements of 42 C.F.R. 483.1-483.95.
(b) A nursing facility shall not be operated by or employ any person who is listed on the:
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Nurse aide abuse registry pursuant to KRS 216.532; or
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Caregiver misconduct registry established by KRS 209.032 and 922 KAR 5:120.
(c) A nursing facility shall comply with the preemployment criminal background check requirements of KRS 216.785 - 216.793.
(d) A nursing facility shall comply with the tuberculosis (TB) testing requirements established by:
-
902 KAR 20:200; and
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902 KAR 20:205;
(e) A nursing facility shall ensure that the rights of residents are protected in accordance with KRS 216.515 - 216.520.
(f) A nursing facility shall conspicuously display the posters required by KRS 216.525 that detail how an individual may make a written or oral complaint to the cabinet.
(g) A nursing facility shall provide the information required by KRS 216.535(3) upon admission of a nursing facility resident.
(h) A nursing facility shall comply with the requirements for access to the facility pursuant to KRS 216.540(2) - (5).
(i) A nursing facility shall comply with the posting requirements of KRS 216.543.
(j) Upon admission, a nursing facility shall provide a copy of the statement required by KRS 216.545(2) to the resident, resident's family member, or guardian.
(k) A nursing facility shall comply with the requirements for public inspection of the information and documents identified in KRS 216.547(1).
(l) A nursing facility shall comply with the license procedures and fee schedule established by 902 KAR 20:008.
(m) A nursing facility shall maintain written policies that assure the reporting of cases of abuse, neglect, or exploitation of adults pursuant to KRS 209.030(2) - (4).
(n) A nursing facility may allow an unlicensed staff person to administer medication in accordance with KRS 194A.705(2)(c) and 201 KAR 20:700 as follows:
-
Medication administration is delegated to the unlicensed staff person by an available nurse;
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If administration of oral or topical medication is delegated, the unlicensed staff person shall have a:
a. Certified medication aide I credential from a training and skills competency evaluation program approved by the Kentucky Board of Nursing (KBN); or
b. Kentucky medication aide credential from the Kentucky Community and Technical College System (KCTCS); and
- If administration of a preloaded insulin injection is delegated in addition to oral or topical medication, the unlicensed staff person shall have a certified medication aide II credential from a training and skills competency evaluation program approved by KBN.
(2) A nursing facility may participate in the Kentucky National Background Check Program established by 906 KAR 1:190 to satisfy the background check requirements of subsection (1)(b) and (c) of this section.
History
- RELATES TO: KRS 194A.705(2)(c), 209.030(2)-(4), 209.032, 216.510-216.525, 216.532, 216.535, 216.540, 216.543, 216.545, 216.547, 216.785-216.793, 42 C.F.R. 483.1-483.95
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of and services provided by nursing facilities.
- History: 17 Ky.R. 2319; 2730; 3121; eff. 5-3-1991; 45 Ky.R. 1117; eff. 12-12-2018; 50 Ky.R. 179; eff. 12-13-2023.
902 KAR 20:310 Facility specifications; nursing facility {#sec-902-kar-20-310 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:310}
Section 1. Definitions.
(1) "Board" means the Commission for Health Economics Control in Kentucky.
(2) "License" means an authorization issued by the cabinet for the purpose of operating a nursing facility.
(3) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Applicability.
(1) Nursing homes, skilled or intermediate care facilities that were found to be in compliance on their last annual licensure survey will be considered to be in compliance with this licensure administrative regulation, except for the requirements of Section 17(7)(d)3 of this administrative regulation, or any alterations.
(2) Applications for certificate of need submitted prior to December 1, 1990 may choose to build to either these specifications or to the specifications in the licensure category requested on their certificate of need application.
Section 3. Preparation and Approval of Plans and Specifications for New Construction or Facility Alterations.
(1) Before construction is begun for the erection of new buildings or alterations to existing buildings or any change in existing nursing facilities, the licensee or applicant shall submit plans to the licensure agency for approval.
(2) All architectural, mechanical and electrical drawings shall bear either the seal of an architect registered in the Commonwealth of Kentucky or the seal of a professional engineer registered in the Commonwealth of Kentucky, or both.
(3) Drawings shall not exceed thirty-six (36) by forty-six (46) inches when trimmed.
(4) All such plans and specifications must be approved by the licensure agency prior to commencement of construction of new buildings or alteration of existing buildings.
(5) Plans and specifications in specific detail as required by the Kentucky Building Code shall be submitted together with architectural and/or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. All such plans and specifications must be approved by the Department of Housing, Buildings and Construction and appropriate local building permits shall be obtained prior to commencement of any alteration.
Section 4. Submission of Plans and Specifications.
(1) First stage, schematic plans.
(a) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. Drawings shall include typical patient room layouts (scaled one-fourth (1/4) inch to one (1) foot) with dimensions noted. The proposed roads and walks, service and entrance courts, parking and orientation shall be shown in a plot plan.
(b) If the project is an addition or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangements of those buildings.
(2) Second stage, preliminary plans. Preliminary sketch plans shall include the following:
(a) Architectural: plans of basement and floors.
(b) Outline specifications.
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General description of the construction or alteration, including interior finishes, types and locations of acoustical material, and special floor covering;
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Description of the air-conditioning, heating, and ventilation systems and their controls, duct and piping systems; and dietary, laundry, sterilizing, and other special equipment;
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General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.
(3)
(a) Working drawings. Working drawings shall be complete and adequate for bid, contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work: architectural, structural, mechanical, and electrical. They shall include the following:
- Architectural drawings.
a. Approach plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new building structures, roadways, walks, and parking areas;
b. Plan of each basement, floor and roof;
c. Elevations of each facade;
d. Sections through building;
e. Required scale and full-size details;
f. Schedule of doors, windows, and room finishes;
g. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in contract shall be so indicated;
h. Conveying systems. Details of construction, machine and control space necessary, size and type of equipment, and utility requirements for the following: dumbwaiters-electric, hand, hydraulic; elevators-freight, passenger, patient; loading dock devices; pneumatic tube systems.
- Structural drawings.
a. Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members;
b. Dimensions of special openings;
c. Details of all special connections, assemblies, and expansion joints.
- Mechanical drawings.
a. Heating, steam piping, and air-condition systems. Radiators and steam heated equipment, such as sterilizers, warmers, and steam tables; heating and steam mains and branches with pipe sizes; sizes, types, and capacities of boilers, furnaces, hot water heater with stokers; oil burners, or gas burners; pumps, tanks, boiler breeching, and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping, and ducts; supply and exhaust ventilation systems with heating/cooling connections and piping; air quantities for all room supply and exhaust ventilating duct openings.
b. Plumbing, drainage, and standpipe systems. Size and elevation of: street sewer, house sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and water service with connections to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold and circulating branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections; gas, oxygen, and vacuum systems; standpipe and sprinkler systems where required; all fixtures and equipment that require water and drain connections.
- Electrical drawings.
a. Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building;
b. Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits with schedule of feeder breakers or switches;
c. Light outlets, receptacles, switches, power outlets, and circuits;
d. Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits;
e. Nurses' call systems with outlets for beds, duty stations, door signal light, annunciators, and wiring diagrams;
f. Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits;
g. All other electrically operated systems and equipment.
(b) Specifications. Specifications shall supplement the drawings to fully describe types, sizes, capacities, workmanship, finishes and other characteristics of all materials and equipment and shall include:
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Cover or title sheet;
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Index;
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Sections describing materials and workmanship in detail for each class of work;
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Access to the work. Representatives of the appropriate state agencies shall have access at all reasonable times to the work wherever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.
Section 5. Compliance with Building Codes, Ordinances and Regulations.
(1) This section may be administered independently from other sections of this administrative regulation.
(2) General. Nothing stated herein shall relieve the sponsor from compliance with building codes, ordinances, and regulations which are enforced by city, county, or state jurisdictions.
(3) The following requirements shall apply where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815 KAR 10:020, as amended;
(b) Requirements for plumbing pursuant to 815 KAR 20:010 through 20:190, as amended;
(c) Requirements for air contaminants for incinerators pursuant to 401 KRS 59:020 and 401 KAR 61:010;
(d) Requirements for elevators pursuant to 815 KAR 4:010; and
(e) Requirements for making buildings and facilities accessible to and usable by the physically handicapped, pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(4) Prior to occupancy, facility must have final approval from appropriate agencies.
(5) All facilities shall be currently approved by the Fire Marshal's Office in accordance with the Life Safety Code, before relicensure is granted by the licensure agency.
Section 6. Facility Requirements and Special Conditions.
(1) Independent facilities with a capacity of fifty (50) beds or less present special problems. The sizes of the various departments will depend upon the requirements of the facilities. Some functions allotted separate spaces or rooms in these general standards may be combined provided that the resulting plan will not compromise the standards of safety and of medical and nursing practices and the social needs of patients. In other respects, the general standards set forth herein, including the area requirements, shall apply.
(2) Facilities shall be available to the public, staff, and patients who may be physically handicapped with special attention given to ramps, drinking fountain height, mirrors, etc.
(3) The number of beds in a nursing unit shall not exceed sixty (60) unless additional services are provided, as deemed necessary by the licensure agency. At least two (2) rooms per nursing unit shall be designed for single person occupancy (one (1) bed) and shall have private toilet rooms with bath. At least sixty (60) percent of the beds shall be located in rooms designed for one (1) or two (2) beds.
Section 7. Nursing Unit.
(1) Patient rooms. Each patient room shall meet the following requirements:
(a) Maximum room capacity: four (4) patients;
(b) Patient rooms shall be designed to permit no more than two (2) beds side by side parallel to the window wall. Not less than a four (4) foot space shall be provided between beds, and at least a three (3) foot space between the side of a bed and the nearest wall, fixed cabinet, or heating/cooling element. A minimum of four (4) feet is required between foot of bed and opposite wall, or foot of opposite bed in multibed rooms;
(c) Window. All patient rooms must have windows opening to the outside. Sill shall not be higher than three (3) feet above the floor and shall be above grade. Window area to be at least eight (8) percent of patient room floor area;
(d) Lavatory. In single and two (2) bed rooms with private toilet room, the lavatory may be located in the toilet room. Where two (2) patient rooms share a common toilet, a lavatory shall be provided in each patient room;
(e) Wardrobe or closet for each patient. Minimum clean dimensions: one (1) foot deep by one (1) foot and eight (8) inches wide with full length hanging space clothes rod and shelf;
(f) Cubicle curtains, or equivalent built-in devices for complete privacy for each patient in each multibed room and in tub, shower and toilet rooms;
(g) No patient room shall be located more than 120 feet from the nurses' station, the clean workroom, and the soiled workroom. No room shall be used as a patient room where the access is through another patient's room;
(2) Patient toilet rooms.
(a) A toilet room shall be directly accessible from each patient room and from each central bathing area without going through the general corridor. One (1) toilet room may serve two (2) patient rooms but not more than four (4) beds. The minimum dimensions of any room containing only a toilet shall be three (3) feet by five (5) feet;
(b) Toilets must be easily usable by wheelchair patients. Grab bars shall be provided at all toilets;
(c) At least one (1) toilet for each sex shall be provided for training purposes and access by wheelchairs. It shall be accessible from the nursing corridor, may be part of the bathing area and shall have a minimum size, of five (5) feet by six (6) feet;
(d) Doors to toilet rooms shall have a minimum width of two (2) feet and ten (10) inches to admit a wheelchair.
(3) Service areas in each nursing unit. The size of each service area will depend on the number and types of beds within the unit include:
(a) Nurses' station for nurses' charting, doctors' charting, communications, and storage for supplies and nurses' personal effects;
(b) Staff lounge area. The area shall have personal storage space and a toilet room for staff;
(c) Visitors toilet room. The facility shall provide a toilet room for visitors. The staff toilet room may serve as the visitors toilet room if marked and accessible;
(d) Clean workroom for storage and assembly of supplies for nursing procedures containing work counter, sink;
(e) Soiled workroom containing clinical sink, work counter with two (2) compartment sink, waste receptacles, and soiled linen receptacles;
(f) Medicine room adjacent to nurses' station with sink, refrigerator, locked storage, and facilities for preparation and dispensing of medication (may be designated area within clean workroom if a self-contained cabinet is provided). The controlled substances locker must be under double lock;
(g) Clean linen storage with enclosed storage space (may be a designated area within the clean workroom);
(h) Nourishment station with storage space, sink, hot plate and refrigerator for serving between-meal nourishments (may serve one (1) nursing unit on same floor);
(i) Equipment storage room for storage of IV stands, inhalators, air mattresses, walkers, and similar bulky equipment (may serve more than one (1) nursing unit on same floor);
(j) Patient baths. One (1) shower stall or one (1) bathtub required for each fifteen (15) beds not individually served. There shall be at least one (1) freestanding bathtub in each bathroom. Grab bars or patient lift with a safety device shall be provided at all bathing fixtures. Each bathtub or shower enclosure in central bathing facilities shall provide space for a wheelchair and attendant. Showers in central bathing facilities shall not be less than four (4) feet square, without curbs, and designed to permit use from a wheelchair. Soap dishes in showers and bathrooms shall be recessed;
(k) Stretcher and wheelchair parking area or alcove;
(l) Janitor's closet for storage of housekeeping supplies and equipment. Floor receptor or service sink;
(m) Bedpan washing facilities. Separate bedpan washing closets in each nursing unit which are located so that bedpans need not be carried through lobbies, dining and recreation areas or day rooms are recommended. It will be acceptable, however, to have bedpan washing attachments for each patient room toilet.
(4) Patient's dining, TV viewing and recreation areas.
(a) The total areas set aside for these purposes shall be not less than thirty (30) square feet per bed for the first fifty (50) beds and twenty (20) square feet per bed for all beds in excess of fifty (50). Additional space shall be provided for outpatients if they participate in a day care program.
(b) Storage shall be provided for recreational equipment and supplies (e.g., wall cabinet and closets).
Section 8. Therapy Units.
(1) If the facility has a physical therapy unit the following shall be provided (depending on the program):
(a) Office (may also serve for occupational therapy office);
(b) Exercise and treatment areas with sink or lavatory and cubicle curtains around treatment areas;
(c) Hydrotherapy areas with cubicle curtains around treatment areas;
(d) Storage for supplies and equipment; and
(e) Toilet rooms located for convenient access by physical therapy patient (may also serve occupational therapy patients).
(2) If the facility has an occupational therapy unit it shall include:
(a) Office space (may be shared with physical therapy office);
(b) Therapy area with sink or lavatory;
(c) Storage for supplies and equipment;
(d) Toilet room (not required if other toilet facilities are convenient).
(3) Personal care room with space for shampoo sink and barber chair (not required in facility of less than twenty-five (25) beds).
(4) If the facility has more than 120 beds, it shall provide the following:
(a) Office space for a social worker;
(b) Toilet room (not required if other toilet facilities are convenient).
Section 9. Dietary Department. If a commercial service will be used or meals will be provided by an adjacent hospital, dietary areas and equipment shall be designed to accommodate the requirements for sanitary storage, processing, and handling, otherwise the following shall be provided:
(1) Food preparation center with a lavatory but no mirror;
(2) Food serving facilities to accommodate patients and staff;
(3) Dishwashing room with commercial-type and a lavatory;
(4) Potwashing facilities;
(5) Refrigerated storage to accommodate three (3) day supply;
(6) Dry storage to accommodate three (3) day supply;
(7) Cart-cleaning facilities;
(8) Cart storage area;
(9) Waste disposal facilities;
(10) Can washing facilities;
(11) Staff dining facilities;
(12) Patient dining facilities;
(13) Janitor's closet with storage for housekeeping supplies and equipment, floor receptor or service sink; and
(14) Toilet room which is conveniently accessible to dietary staff with a two (2) door separation from food preparation area or dining area.
Section 10. Administration Department. The facility shall have adequate administrative, public, and staff facilities (e.g., offices, lobby, toilet facilities) to accommodate the needs of the public, patients, and staff without interfering with the provision of medical care services.
Section 11. Laundry. The following shall be included:
(1) Soiled linen room;
(2) Clean linen and mending room;
(3) Linen cart storage;
(4) Lavatories accessible from soiled, clean, and processing rooms;
(5) Laundry processing room with commercial type equipment sufficient to take care of seven (7) days' needs within the workweek;
(6) Janitor's closet with storage for housekeeping supplies and equipment, floor receptor or service sink; and
(7) Storage for laundry supplies. (Subsections (5), (6) and (7) of this section need not be provided if laundry is processed outside the facility.)
Section 12. Storage and Service Areas.
(1) Central storage room(s) with at least ten (10) square bed for first fifty (50) beds; and five (5) square feet per bed for eleven (11) beds over fifty (50), to be concentrated in one (1) area.
(2) Adequate secure storage space must be provided for staff and volunteer's personal belongings.
(3) Engineering service and equipment areas. The following shall be provided:
(a) Boiler room;
(b) Mechanical and electrical equipment room(s) (can be combined with boiler room);
(c) Adequate storage for building maintenance and engineering supplies;
(d) Storage room for housekeeping equipment (need not be provided if space is available in janitor's closets or elsewhere);
(e) Incinerator space. If the facility has an incinerator, it shall be in a separate room, in a designated area within the boiler room, or outdoors;
(f) Yard equipment storage room for yard maintenance equipment and supplies.
Section 13. Details and Finishes. The facility shall be designed for maximum safety for the occupants to minimize the incidence of accidents. Hazards such as sharp corners shall be avoided. All details and finishes shall meet the following requirements:
(1) Details.
(a) Doors to patient toilet rooms and other rooms needing access for wheelchairs shall have a minimum width of two (2) feet and ten (10) inches.
(b) Such items as drinking fountains, telephone booths and vending machines shall be located so that they do not project into the required width of exit corridors.
(c) Handrails shall be provided on both sides of corridors used by patients in facilities with a clean distance of one-half (1/2) inch between handrail and wall.
(d) All doors to patient-room toilet rooms and patient-room bathrooms shall swing outward or shall be equipped with hardware which will permit access in any emergency.
(e) All doors opening onto corridors shall be swing-type except elevator doors. Alcoves and similar spaces which generally do not require doors are excluded from this requirement.
(f) Thresholds and expansion joint covers, if used, shall be flush with the floor.
(g) Grab bars and accessories in patient toilet, shower, and bathrooms shall have sufficient strength and anchorage to sustain a load of 250 pounds for five (5) minutes.
(h) Lavatories intended for use by patients shall be installed to permit wheelchairs to slide under.
(i) The location and arrangement of lavatories and sinks with blade handles intended for handwashing purposes shall provide sixteen (16) inches clearance each side of center line of fixture.
(j) Mirrors shall be arranged for convenient use by patients in wheelchairs as well as by patients in standing position.
(k) Towel dispensers shall be provided at all lavatories and sinks used for handwashing.
(l) If linen and refuse chutes are used, they shall be designed as follows:
-
Minimum diameter of gravity-type chutes shall be two (2) feet;
-
Chutes shall extend at least four (4) feet above the roof and shall be covered by a metal skylight glazed with thin plain glass or plastic.
(m) Ceiling heights.
-
The boiler room ceiling shall not be less than two (2) feet six (6) inches above the main boiler header and connecting piping with nine (9) feet headroom under piping for maintenance and access;
-
Corridors, storage rooms, patients' toilet room, and other minor rooms shall not be less than seven (7) feet and six (6) inches.
-
Ceilings in all other rooms shall not be less than eight (8) feet.
(n) Boiler room, food preparation centers, and laundries shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of eighty-five (85) degrees Fahrenheit.
(o) Noise reduction criteria. Provision shall be made to minimize sound transmission in:
-
Corridors in patient areas;
-
Nurses' stations;
-
Utility rooms;
-
Floor pantries; and
-
Lobbies and recreation areas.
(p) Special attention shall be given to sound transmission from boiler rooms, mechanical rooms, and kitchen, to patient bedroom areas.
(2) Finishes.
(a) Floors generally shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchen and related spaces shall be waterproof and grease-proof. In all areas where floors are subject to wetting, they shall have a nonslip finish. Carpeting is not permitted in the following areas: kitchen, dishwashing room, soiled utility room, janitor's closet, soiled linen rooms, storage room, bathrooms, public toilet rooms, patient toilet rooms, hydrotherapy rooms, treatment rooms, and any other room where the floor is subject to repeated wetting or soiling.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an unbroken surface.
(c) Walls generally shall be washable and in the immediate area of plumbing fixtures, the finish shall be moisture-proof. Wall bases in dietary areas shall be free of spaces that can harbor insects.
(d) Ceilings generally shall be washable or easily cleanable. This requirement does not apply to boiler rooms, mechanical and building equipment rooms, shops and similar spaces.
Section 14. Elevators. All facilities where either patient beds or inpatient facilities such as diagnostic, recreation, patient dining or therapy rooms are located on other than the first floor, shall have electric or electrohydraulic elevators as follows:
(1) Number of elevators. All facilities with patient beds or residential facilities located on any floor other than the first floor shall have at least one (1) hospital-type elevator and such additional elevators as determined by the licensure agency from a study of the facility plan and the estimated vertical transportation requirements.
(2) Cars and platforms. Elevator cars and platforms shall be constructed of noncombustible material, except that fire-retardant-treated material may be used if all exterior surfaces of the cars are covered with metal. Cars of hospital-type elevators shall have inside dimensions that will accommodate a patient's bed and attendants and shall be at least five (5) feet wide by seven (7) feet and six (6) inches deep. Car doors shall have a clear opening of not less than three (3) feet and eight (8) inches. Cars of all other required elevators shall have a clear opening of not less than three (3) feet.
(3) Leveling. Elevators shall have automatic leveling of the two (2) way automatic maintaining type with accuracy within plus or minus one-half (1/2) inch.
Section 15. Foundations. Foundations shall rest on natural solid ground if a satisfactory soil is available at reasonable depths. Proper soil bearing values shall be established in accordance with recognized standards. If solid ground is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement.
Section 16. Mechanical Requirements.
(1) General. Prior to completion of the contract and final acceptance of the facility, the architect and/or engineer shall obtain certification from the contractor that all mechanical systems have been tested and that the installation and performance of these systems conform to the requirements of the plans and specifications.
(2) Steam and hot water systems.
(a) Boilers. If boilers are used, a minimum of two (2) must be provided. The combined capacity of the boilers, based upon the published Steel Boiler Institute of Boiler and Radiator Manufacturer's net rating, must be able to supply 150 percent of the normal requirements of all systems and equipment.
(b) Covering. Boiler and smoke breeching, all steam supply piping and high pressure steam return piping, and hot water space heating supply and return piping shall be insulated.
(3) Temperatures and ventilating systems.
(a) Temperatures. A minimum temperature of seventy-one (71) degrees Fahrenheit, shall be provided for in all occupied areas in winter conditions. A maximum temperature of eighty-one (81) degrees Fahrenheit shall be provided for in occupied areas in summer conditions.
(b) Ventilation system details. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. The ventilation rates shown in Section 17, Table 1 of this administrative regulation, shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates if they are required to meet design conditions.
-
Outdoor ventilation air-intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five (25) feet from the exhausts from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight (8) feet above the ground level or, if installed through the roof, three (3) feet above roof level.
-
The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas shown in Section 17, Table 1 of this administrative regulation.
-
Room supply air inlets, recirculation, and exhaust air outlets installed in nonsensitive areas shall be located not less than three (3) inches above the floor.
-
Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate bathrooms, toilet rooms, or janitor's closets opening directly into corridors.
-
Filters.
a. Central systems that serve patient care areas shall be provided with filters rated at eighty (80) percent efficiency based upon the National Bureau of Standards Dust Spot Method with Atmospheric Dust.
b. Central systems that serve only areas other than patient care areas shall be provided with filters rated at twenty-five (25) percent efficiency based upon the National Bureau of Standards Dust Spot Method with Atmospheric Dust.
- Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and required temperatures in the facility.
(4) Plumbing and other piping systems.
(a) Lavatories and sinks required in patient care areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five (5) inches above the rim of the fixture. All fixtures used by medical and nursing staff, and all lavatories used by patients and food handlers shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall be at a distance from the center line of the sink to be operational.
(b) Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.
(5) Water supply system.
(a) Systems shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.
(b) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
(c) Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.
(d) Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitor's sinks and bedpan flushing attachments.
(e) Bedpan flushing devices shall be provided.
(f) Hot water distribution systems shall be arranged to provide hot water at each fixture at all times.
(g) Plumbing fixtures which require hot water and which are intended for patient use shall be supplied with water which is controlled to provide a maximum water temperature of 110 degrees Fahrenheit at the fixture.
(h) Piping over food preparation centers, food serving facilities, food storage areas, and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of, or condensation from, necessary overhead piping systems.
(6) Hot water heaters and tanks.
(a) The hot water heating equipment shall have sufficient capacity to supply the water at the temperature and amounts indicated below:
(b) A hot water system which supplies fixtures utilized by patients shall be equipped with an antiscald mixing valve.
(c) Storage tank(s) shall be provided and shall be fabricated of corrosion-resistant metal, or have noncorrosive lining.
(7) Plumbing approval. Prior to final approval of the plans and specifications by the licensure agency, the plumbing plans and specifications must be approved by the Division of Plumbing, Department of Housing, Buildings and Construction.
Section 17. Electrical Requirements.
(1) Electrical requirements of the Kentucky Building Code shall apply where applicable.
(2) The wiring in each facility shall be inspected by a certified electrical inspector and a certificate of approval shall be issued to the facility, prior to occupancy. However, the wiring in existing buildings shall be approved by a certified electrical inspector only when the building has not been previously so approved for health care occupancy or where the State Fire Marshal finds that a hazardous condition exists.
(3) Switchboard and power panels. All breakers and switches shall be indexed.
(4) Lighting.
(a) All spaces occupied by people, machinery, and equipment within buildings, and the approaches thereto, and parking lots shall have electric lighting.
(b) Patients' bedrooms shall have general lighting and night lighting. A reading light shall be provided for each patient. A fixed receptacle type night light mounted approximately sixteen (16) inches above the floor, shall be provided in each patient room. Patients' reading lights and other fixed lights not switched at the door shall have switch controls convenient for use at the luminaire. All switches for control of light in patient areas shall be of the quiet operating type.
(c) Lighting levels for the facility shall comply with the requirements of Section 17, Table 2 of this administrative regulation.
(5) Receptacles. Convenience outlets.
(a) Bedroom. Each patient bedroom shall have duplex receptacles on each side of the head of each bed (for parallel adjacent beds, only one (1) receptacle is required between the beds), receptacles for luminaries television and motorized beds, if used, and one (1) receptacle on another wall.
(b) Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of ends of corridors.
(6) Nurses' calling system. A nurses' calling station shall be installed at each patient bed and in each patient toilet, bath, and shower room. The nurses' call in toilet, bath, or shower rooms, shall be an emergency call. All calls shall register at the nurses' station and shall actuate a visible signal in the corridor at the patients' door, in the clean workroom, soiled workroom, and nourishment station of the nursing unit. Nurses' call systems which provide two (2) way voice communications shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operative.
(7) Emergency electric service.
(a) General. To provide electricity during an interruption of the normal electric supply that could affect the nursing care, treatment, or safety of the occupants, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
(b) Sources. The source of this emergency electric service shall be as follows:
-
An emergency generating set, when the normal service is supplied by one (1) or more central station transmission lines;
-
An emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
(c) Emergency generating set.
-
The required emergency generating set, including the prime mover and generator, shall be located on the premises and shall be reserved exclusively for supplying the emergency electric system. The emergency generator set shall be sufficient kilowatt capacity to supply all electrical connections itemized in paragraph (d) of this subsection.
-
In facilities constructed prior to the effective date of this administrative regulation which are supplied by at least two (2) dedicated and separate utility service feeders, an emergency generating set is not required.
(d) Emergency electrical connections. Emergency electric service shall be provided to circuits as follows:
- Lighting.
a. Exitways and all necessary ways of approach thereto, including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors;
b. Dining and recreation rooms;
c. Nursing station and medication preparation area;
d. Generator set location, switch-gear location, and boiler room;
e. Elevator; and
f. Night lights in patient rooms.
- Equipment. Essential to life safety and for protection of important or vital materials:
a. Nurses' calling system;
b. Alarm system including fire alarm actuated at manual stations, water-flow alarm devices of sprinkler system if electrically operated, fire-detecting and smoke-detecting systems, paging or speaker systems if intended for issuing instructions during emergency conditions, and alarms required for nonflammable medical gas systems, if installed;
c. Fire pump, if installed;
d. Sewerage or sump-lift pump, if installed;
e. At least one (1) duplex receptacle located on the headwall in each patient room;
f. One (1) elevator, where elevators are used for vertical transportation of patients. Provide manual switch-over to operate other elevators.
g. Equipment such as burners and pumps necessary for operation of one (1) or more boilers and their necessary auxiliaries and controls, required for heating and sterilization; and
h. Equipment necessary for maintaining telephone service.
- Emergency heating.
a. By September 1, 1992 an emergency heating system for the patient rooms, or the corridors of the facility designed at 150 percent efficiency, shall be required; or
b. Emergency heating of patient rooms or corridors shall not be required in areas where the facility is supplied by at least two (2) utility service feeders, each supplied by separate generating sources or a network distribution system fed by two (2) or more generators, with the facility feeders so routed, connected, and protected that a fault any place between the generators and the facility will not likely cause an interruption of more than one (1) of the facility service feeders; or
c. For a facility existing prior to the effective date of this administrative regulation, an acceptable transfer agreement with another facility which meets the requirements of clause a. or b. of this subparagraph or is supplied by a separate generating source or network distribution system which is so routed, connected, and protected that a fault any place between the generator and the transferring facility would not affect the receiving facility. This receiving facility shall be within a reasonable distance and provide adequate space to assure an orderly transfer. The transfer agreement shall specify how the resident will be cared for at the receiving facility.
(e) Details. The emergency system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting, all alarms, nurses' call, equipment necessary for maintaining telephone service, and receptacles in patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification. Storage battery-powered lights shall not be used as a substitute for the requirement of a generator. Where fuel is normally stored on the site, the storage capacity shall be sufficient for twenty-four (24) hour operation of required emergency electric services. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.
Section 18. Tables.
History
- RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulates health facilities and health services. This administrative regulation provides licensure requirements for structural specifications for the construction, alteration and maintenance of nursing facilities.
- History: 17 Ky.R. 2331; 2741; eff. 5-3-1991; Crt eff. 4-30-2019; TAm eff. 3-20-2020; Crt eff. 2-9-2026.
902 KAR 20:320 Level I and Level II psychiatric residential treatment facility operation and services {#sec-902-kar-20-320 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:320}
Section 1. Definitions.
(1) "BAMT" or "Blood Assay for Mycobacterium tuberculosis" means a diagnostic blood test that:
(a) Assesses for the presence of infection with M. tuberculosis; and
(b) Reports results as positive, negative, indeterminate, or borderline.
(2) "BAMT conversion" means a change in test result, on serial testing, from negative to positive.
(3) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy, or a medical officer of the government of the United States while engaged in the performance of official duties, who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A physician assistant licensed under KRS 311.840 to 311.862;
(h) A marriage and family therapist licensed and practicing in accordance with KRS 335.300;
(i) A professional clinical counselor licensed and practicing in accordance with KRS 335.500; or
(j) A licensed professional art therapist as defined by KRS 309.130(2).
(4) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapist associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4); or
(f) Licensed professional art therapist associate as defined by KRS 309.130(3).
(5) "Certified alcohol and drug counselor" is defined by KRS 309.080(2).
(6) "Chemical restraint" means the use of a drug that:
(a) Is administered to manage a resident's behavior in a way that reduces the safety risk to the resident or others;
(b) Has the temporary effect of restricting the resident's freedom of movement; and
(c) Is not a standard treatment for the resident's medical or psychiatric condition.
(7) "Child with a severe emotional disability" is defined by KRS 200.503(3).
(8) "Community support associate" means a paraprofessional who meets the application, training, and supervision requirements of 908 KAR 2:250.
(9) "Direct-care staff" means residential or child-care workers who directly supervise residents.
(10) "Directly observed therapy" or "DOT" means an adherence-enhancing strategy:
(a) In which a healthcare worker or other trained person watches a patient swallow each dose of medication; and
(b) Which is the standard care for all patients with TB disease and is a preferred option for patients treated for latent TB infection (LTBI).
(11) "DOPT" means Directly Observed Preventive Therapy, which is the DOT for treatment of LTBI.
(12) "Emergency safety intervention" is defined by 42 C.F.R. 483.352 and is the use of restraint or seclusion as an immediate response to an emergency safety situation.
(13) "Emergency safety situation" is defined by 42 C.F.R. 483.352 and is an unanticipated resident behavior that places the resident or others at serious threat of violence or injury if no intervention occurs and that calls for an emergency safety intervention.
(14) "Freestanding" is defined by KRS 216B.450(3).
(15) "Governing body" means the individual, agency, partnership, or corporation in which the ultimate responsibility and authority for the conduct of the facility is vested.
(16) "Home-like" is defined by KRS 216B.450(4).
(17) "Induration" means a firm area in the skin which develops as a reaction to injected tuberculin antigen if a person has tuberculosis infection and which is measured in accordance with Section 18(1) of this administrative regulation.
(18) "Latent TB infection" or "LTBI" means infection with M. tuberculosis without symptoms or signs of disease manifested.
(19) "Licensed assistant behavior analyst" is defined by KRS 319C.010(7).
(20) "Licensed behavior analyst" is defined by KRS 319C.010(6).
(21) "Licensed clinical alcohol and drug counselor" is defined by KRS 309.080(4).
(22) "Licensed clinical alcohol and drug counselor associate" is defined by KRS 309.080(5).
(23) "Licensure agency" means the Cabinet for Health and Family Services, Office of Inspector General.
(24) "Living unit" means:
(a) The area within a single building that is supplied by a Level I facility for daily living and therapeutic interaction of no more than nine (9) residents; or
(b) The area within a Level II facility that is designated for daily living and therapeutic interaction of no more than twelve (12) residents.
(25) "Mechanical restraint" means any device attached or adjacent to a resident's body that he or she cannot easily remove that restricts freedom of movement or normal access to his or her body.
(26) "Mental health associate" means:
(a)
-
An individual with a minimum of a bachelor's degree in a mental health related field;
-
A registered nurse; or
-
A licensed practical nurse with at least one (1) year's experience in a psychiatric inpatient or residential treatment setting for children; or
(b) An individual with:
-
A high school diploma or an equivalence certificate; and
-
At least two (2) years work experience in a psychiatric inpatient or residential treatment setting for children.
(27) "Mental health professional" is defined by KRS 645.020(7).
(28) "Peer support specialist" means a paraprofessional who meets the application, training, examination, and supervision requirements of 908 KAR 2:220, 908 KAR 2:230, or 908 KAR 2:240.
(29) "Personal restraint" means the application of physical force without the use of any device for the purpose of restraining the free movement of a resident's body and does not include briefly holding without undue force a resident in order to calm or comfort him or her or holding a resident's hand to safely escort him or her from one (1) area to another.
(30) "Psychiatric residential treatment facility" or "PRTF" is defined in KRS 216B.450(5) as a Level I facility or a Level II facility.
(31) "Qualified mental health personnel" is defined by KRS 215B.450(6).
(32) "Qualified mental health professional" is defined by KRS 216B.450(7).
(33) "Seclusion" means the involuntary confinement of a resident alone in a room or in an area from which the resident is physically prevented from leaving.
(34) "Serious injury" means any significant impairment of the physical condition of the resident as determined by qualified medical personnel and that may:
(a) Include:
-
Burns;
-
Lacerations;
-
Bone fractures;
-
Substantial hematoma; or
-
Injuries to internal organs; and
(b) Be self-inflicted or inflicted by someone else.
(35) "Serious occurrence" means a resident's death, a serious injury to the resident, or a resident's suicide attempt.
(36) "Time out" means the restriction of a resident for a period of time to a designated area from which the resident is not physically prevented from leaving, for the purpose of providing the resident an opportunity to regain self-control.
(37) "Tuberculin skin test" or "TST" means a diagnostic aid for finding M. tuberculosis infection that:
(a) Is performed by using the intradermal (Mantoux) technique using five (5) tuberculin units of purified protein derivative (PPD); and
(b) Has its results read forty-eight (48) to seventy-two (72) hours after injection and recorded in millimeters of induration.
(38) "Tuberculosis (TB) disease" means a condition caused by infection with a member of the M. tuberculosis complex that meets the descriptions established in Section 18(2) of this administrative regulation.
(39) "TST conversion" means a change in the result of a test for M. tuberculosis infection in which the condition is interpreted as having progressed from uninfected to infected in accordance with Section 18(3) of this administrative regulation.
(40) "Two-step TST" or "two-step testing" means a series of two (2) TSTs administered seven (7) to twenty-one (21) days apart and used for the baseline skin testing of persons who will receive serial TSTs, including healthcare workers and residents of psychiatric residential treatment facilities to reduce the likelihood of mistaking a boosted reaction for a new infection.
(41) "Unusual treatment" means any procedure not readily accepted as a standard method of treatment by the relevant profession.
Section 2. Licensure Application and Fee.
(1) An applicant for licensure as a Level I or Level II PRTF shall complete and submit to the Office of Inspector General an Application for License to Operate a Health Facility or Service, as required by 902 KAR 20:008, Section 2(1)(f).
(2) If an entity seeks to operate both a Level I and a Level II PRTF and is granted licensure to operate both levels, a separate license shall be issued for each level.
(3) The initial and annual fee for licensure as a Level I PRTF shall be $270.
(4)
(a) The initial and annual fee for licensure as a Level II PRTF that has nine (9) beds or less shall be $270.
(b)
-
The initial and annual fee for licensure as a Level II PRTF that has nine (9) beds to fifty (50) beds shall be $270; and
-
A fee of ten (10) dollars shall be added to the minimum fee of $270 for each bed beyond the ninth bed.
(5) If a Level I or Level II PRTF provides outpatient behavioral health services as described in Section 14(1) of this administrative regulation:
(a) The outpatient behavioral health services shall be provided:
-
On a separate floor, in a separate wing, or in a separate building from the PRTF; or
-
At an extension off the campus of the PRTF;
(b) The PRTF shall pay a fee in the amount of $250 per outpatient behavioral health services extension, submitted to the Office of Inspector General at the time of:
-
Initial licensure, if applicable;
-
The addition of a new outpatient behavioral health services extension to the PRTF's license; and
-
Renewal;
(c) Each off-campus extension or on-campus program of outpatient behavioral health services provided shall:
-
Be listed on the PRTF's license;
-
Have a program director who may serve as the same program director described in Section 6(2) of this administrative regulation; and
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Employ directly or by contract a sufficient number of personnel to provide outpatient behavioral health services; and
(d) An off-campus extension or a separate building on the campus of the PRTF where outpatient behavioral health services are provided shall comply with the physical environment requirements of Section 14(6) of this administrative regulation and be approved by the State Fire Marshal's office prior to:
-
Initial licensure;
-
The addition of the extension or on-campus program of outpatient behavioral health services in a separate building; or
-
A change of location.
Section 3. Location.
(1)
(a) A Level I psychiatric residential treatment facility shall be located in a freestanding structure.
(b) A Level II PRTF may be located:
-
In a separate part of a psychiatric hospital;
-
In a separate part of an acute care hospital;
-
In a completely detached building; or
-
On the campus of a Level I PRTF if the Level II beds are located on a separate floor, in a separate wing, or in a separate building from the Level I PRTF.
(c) A licensed Level II PRTF shall not be licensed for more than fifty (50) beds.
(2) In accordance with KRS 216B.455(5), multiple Level I PRTFs may be located on a common campus if each PRTF is freestanding.
(3)
(a)
-
If a Level I psychiatric residential treatment facility is located on grounds shared by another licensed facility other than a PRTF, the residents of the Level I or PRTF and the licensed facility with which it shares grounds shall not have any joint activities, except for organized education activities, organized recreational activities, or group therapy for children with similar treatment needs.
-
If a Level II PRTF is located on grounds shared by a Level I PRTF or a licensed private child-caring facility, the requirements in this subparagraph shall apply.
a. The residents of the Level II PRTF and the Level I PRTF or private child-caring facility with which it shares grounds shall not have any joint activities, except for organized education activities on campus, organized recreational activities, or group therapy for children with similar treatment needs in which dedicated Level II PRTF unit staff shall be present during the activity to ensure sufficient supervision.
b. Joint activities shall be documented in the resident's comprehensive treatment plan of care.
c. The maximum age range for joint activities shall be no more than five (5) years for residents age six (6) to twenty-one (21), and no more than three (3) years for residents in Level II facilities age four (4) to five (5).
(b) Direct-care staff of the licensed facility with which the Level I or Level II PRTF shares grounds may provide relief, replacement, or substitute staff coverage to the PRTF.
(c) For continuity of care, at least fifty (50) percent of direct care staff of the Level I or Level II PRTF shall be consistently and primarily assigned to the living unit.
Section 4. Licensure.
(1) A Level I or Level II psychiatric residential treatment facility shall comply with all the conditions for licensure established in 902 KAR 20:008.
(2) A Level I or Level II psychiatric residential treatment facility shall operate and provide services in compliance with all applicable federal, state, and local laws, regulations, and codes, and with accepted professional standards and principles that apply to professionals providing services in a facility.
(3) Pursuant to KRS 216B.455(3) and 216B.457(5) which require compliance with KRS 216B.105, a person shall not operate a PRTF without first obtaining a license issued by the Office of Inspector General.
(4) Pursuant to KRS 216B.455(4) and 216B.457(6), a PRTF shall be accredited by the Joint Commission, Council on Accreditation of Services for Families and Children, or any other accrediting body with comparable standards.
Section 5. Governing Body for a Level I or Level II PRTF. A PRTF shall have a governing body with overall authority and responsibility for the facility's operation.
(1)
(a) The governing body shall be a legally constituted entity in the Commonwealth of Kentucky by means of a charter, articles of incorporation, partnership agreement, franchise agreement, or legislative or executive act.
(b) A Level I and a Level II PRTF that are part of the same multifacility system, or a Level II PRTF operated by a psychiatric hospital, may share the same governing body.
(2) A facility that is part of a multifacility system or is operated by a government agency shall have a written description of the system's administrative structure and lines of authority.
(3) The authority and responsibility of any person designated to function as the governing body shall be specified in writing.
(4) If a business relationship exists between a governing body member and the organization, there shall be a conflict-of-interest policy that governs the member's participation in decisions influenced by the business interest.
(5) The responsibilities of the governing body shall be stated in writing and shall describe the process for the following:
(a) Adopting policies and procedures;
(b) Providing sufficient funds, staff, equipment, supplies, and facilities to assure that the facility is capable of providing appropriate and adequate services to residents;
(c) Overseeing the system of financial management and accountability;
(d) Adopting a program to monitor and evaluate the quality of all care provided and to appropriately address identified problems in care; and
(e) Electing, appointing, or employing the clinical and administrative leadership personnel of the facility, and defining the qualifications, authority, responsibility, and function of those positions.
(6) The governing body shall meet as a whole at least quarterly and keep records that demonstrate the ongoing discharge of its responsibilities.
(7) If a facility is a component of a larger organization, the facility staff, subject to the overall authority of the governing body, shall be given the necessary authority to plan, organize, and operate the program.
Section 6. Level I or Level II PRTF Program Director.
(1) A program director shall be responsible for the administrative management of the facility.
(2) A program director:
(a) Shall be qualified by training and experience to direct a treatment program for children and adolescents with emotional problems;
(b) Shall have at least minimum qualifications of a master's degree or bachelor's degree in the human services field including:
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Social work;
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Sociology;
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Psychology;
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Guidance and counseling;
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Education;
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Religion;
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Business administration;
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Criminal justice;
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Public administration;
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Child care administration;
-
Christian education;
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Divinity;
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Pastoral counseling;
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Nursing; or
-
Another human service field related to working with families and children;
(c)
-
With a master's degree shall have two (2) years of prior supervisory experience in a human services program; or
-
With a bachelor's degree shall have four (4) years of prior supervisory experience in a human services program; and
(d)
-
Shall have three (3) professional references, two (2) personal references, and a criminal record check performed every two (2) years through the Administrative Office of the Courts or the Kentucky State Police;
-
Shall not have a criminal conviction, or plea of guilty, pursuant to KRS 17.165 or a Class A felony; and
-
Shall be subject to the provisions of KRS 216B.457(12), which requires submission to a check of the central registry, and requires an employee to be removed from contact with a child under the conditions described in KRS 216B.457(12).
(3) A program director shall be responsible to the governing body in accordance with the bylaws, rules or policies for the following, unless the PRTF is part of a health care system under common ownership and governance in which the duties are assigned to, or are the responsibility of, the program director's supervisor or other staff:
(a) Overseeing the overall operation of the facility, including the control, utilization, and conservation of its physical and financial assets and the recruitment and direction of staff;
(b) Assuring that sufficient, qualified, and appropriately supervised staff are on duty to meet the needs of the residents at all times;
(c) Approving purchases and payroll;
(d) Assuring that treatment planning, medical supervision, and quality assurance occur as specified in this administrative regulation;
(e) Advising the governing body of all significant matters bearing on the facility's licensure and operations;
(f) Preparing reports or items necessary to assist the governing body in formulating policies and procedures to assure that the facility is capable of providing appropriate and adequate services to residents;
(g) Maintaining a written manual that defines policies and procedures and is revised and updated at the time changes in policies and procedures occur; and
(h) Assuring that all written facility policies, plans, and procedures are followed.
Section 7. Administration and Operation of a Level I or Level II PRTF.
(1) A Level I or Level II PRTF shall have written documentation of the following:
(a) An organizational chart that includes position titles and the name of the person occupying the position, and that shows the chain of command;
(b) A service philosophy with clearly defined assumptions and values;
(c) Estimates of the clinical needs of the children and adolescents served by the facility;
(d) The services provided by the facility in response to needs;
(e) The population served, including age groups and other relevant characteristics of the resident population;
(f) The intake or admission process, including how the initial contact is made with the resident and the family or significant others;
(g) The assessment and evaluation procedures provided by the facility;
(h) The methods used to deliver services to meet the identified clinical needs of the residents served;
(i) The methods used to deliver services to meet the basic needs of residents in a manner as consistent with normal daily living as possible;
(j) The methods used to create a home-like environment for all residents, including opportunities for family-style meals in which:
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Residents dine together;
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Residents may assist with preparation of certain dishes or help set the table; and
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Food may be placed in serving dishes on the table;
(k) The methods, means and linkages by which the facility involves residents in community activities, organizations, and events;
(l) The treatment planning process and the periodic review of therapy;
(m) The discharge and aftercare planning processes;
(n) The facility's therapeutic programs;
(o) How professional services are provided by qualified, experienced personnel;
(p) How mental health professionals in Level I facilities and qualified mental health professionals in Level II facilities and direct-care staff in Level I or Level II facilities who have been assigned specific treatment responsibilities are qualified by training or experience and have demonstrated competence and; or are supervised by a mental health professional or qualified mental health professional who is qualified by experience to supervise the treatment;
(q) How the facility is linked to regional interagency councils, psychiatric hospitals, community mental health centers, Department for Community Based Services offices and facilities, and school systems in the facility's service area;
(r) The means by which the facility provides, or makes arrangements for the provision of:
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Emergency services and crisis stabilization;
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Discharge and aftercare planning that promotes continuity of care; and
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Education and vocational services;
(s) Services the facility provides to improve stability of care and reduce re-hospitalization including:
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How psychiatric and nursing coverage is provided to assure the continuous ability to manage and administer medications in crisis situations except for those that may only be administered by a physician; and
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How direct-care staffing with supervision is provided to manage behavior problems in accordance with the residents' treatment plans, including an array of interventions that are alternatives to seclusion and restraint, and the staff training necessary to implement them; and
(t) If provided, a description of each outpatient behavioral health service provided pursuant to Section 14(1) of this administrative regulation.
(2) The documentation shall be:
(a) Made available to each mental health professional in a Level I PRTF or qualified mental health professional in a Level II PRTF and to the program director; and
(b) Reviewed and revised as necessary, in accordance with the changing needs of the residents and the community and with the overall objectives and goals of the facility. Revisions in the documentation shall incorporate, as appropriate, relevant findings from the facility's quality assurance and utilization review programs.
(3) Professional staff for a Level I or Level II PRTF.
(a) A Level I PRTF shall:
-
Employ a sufficient number of mental health professionals to meet the treatment needs of residents and the goals and objectives of the facility; and
-
Meet the requirements of this subparagraph with regard to professional staffing.
a.
(i) A board-eligible or board-certified child psychiatrist or board-certified adult psychiatrist shall be employed or contracted to meet the treatment needs of the residents and the functions which shall be performed by a psychiatrist specified within this administrative regulation.
(ii) If a facility has residents ages twelve (12) and under, the licensed psychiatrist shall be board-eligible or board-certified in child psychiatry.
(iii) The psychiatrist shall be present in the facility to provide professional services to the facility's residents at least weekly. The services provided shall include a review of each resident's progress and a meeting with the resident if clinically indicated.
b. A Level I PRTF shall employ at least one (1) full-time mental health professional.
c. A mental health professional in a Level I PRTF shall be available to assist on-site in emergencies on at least an on-call basis at all times.
d. A psychiatrist shall be available on at least an on-call basis at all times.
(b) A Level II PRTF shall:
-
Employ or contract with a sufficient number of qualified mental health professionals to meet the treatment needs of residents and the goals and objectives of the facility;
-
Ensure that at least one (1) qualified mental health professional shall be available to assist on-site in emergencies on at least an on-call basis at all times; and
-
Meet the requirements established in KRS 216B.457(9) with regard to professional staff.
a. In accordance with KRS 216B.457(9)(c), the professional services provided by the licensed psychiatrist shall include meeting with each resident at least one (1) time each week unless the resident is not at the facility due to a field trip, medical appointment, or other circumstance in which the resident is not at the facility.
b. A licensed psychiatrist shall be available on at least an on-call basis at all times.
(c) Clinical director.
- The administration of the facility shall designate one (1) full-time:
a. Mental health professional as the clinical director for a Level I PRTF; or
b. Qualified mental health professional as the clinical director for a Level II PRTF.
-
In addition to the requirements related to his or her profession, the clinical director shall have at least two (2) years of clinical experience in a mental health setting that serves children or adolescents with emotional problems.
-
The administration of the facility shall define the authority and duties of the clinical director.
-
An individual may serve as both the clinical director and the program director if the qualifications of both positions are met.
-
The clinical director shall be responsible for:
a. The maintenance of the facility's therapeutic milieu; and
b. Assuring that treatment plans developed in accordance with Section 12(3) of this administrative regulation are implemented.
a. A full-time mental health professional may be designated as clinical director for more than one (1) Level I PRTF if the Level I PRTFs are located on a common campus or in the same county.
b. A full-time qualified mental health professional designated as the clinical director of a Level II PRTF may service as the clinical director of more than one (1) PRTF if the PRTFs are located on a common campus or in the same county.
c. A full-time qualified mental health professional employed by a psychiatric hospital may serve as the clinical director of a Level II PRTF located on the same campus as the hospital or in the same county.
(4) Direct-care staff for a Level I PRTF.
(a) A Level I PRTF shall employ adequate direct-care staff to ensure the adequate provision of regular and emergency supervision of all residents twenty-four (24) hours a day.
(b) Level I Direct-care staff shall:
-
Have at least a high school diploma or equivalency; and
-
Complete a forty (40) hour training curriculum meeting the requirements of subsection (6)(c) of this section within one (1) month of employment.
(c) In order to assure that the residents are adequately supervised and are cared for in a safe and therapeutic manner, the direct-care staffing plan for a Level I PRTF shall meet the requirements established in this paragraph.
-
At least one (1) direct-care staff member who is a mental health associate shall be assigned direct-care responsibilities for a PRTF at all times during normal waking hours when residents are not in school.
-
At least one (1) direct-care staff member shall be assigned to direct-care responsibilities for each three (3) residents during normal waking hours when residents are not in school.
a. At least one (1) direct-care staff member shall be assigned direct-care responsibilities, be awake, and be continuously available on each living unit during all hours the residents are asleep.
b. A minimum of one (1) additional direct-care staff member who is a mental health associate shall be immediately available on the grounds of the PRTF to assist with emergencies or problems which might arise.
-
If a mental health professional is directly involved in an activity with a group of residents, he or she may meet the requirement for a direct-care staff member.
-
The direct-care staff member who is supervising residents shall know the whereabouts of each resident at all times.
(d) Written policies and procedures approved by the Level I PRTF's governing body shall:
-
Provide for the supervision of the direct-care staff; and
-
Describe the responsibilities of direct-care staff in relation to professional staff.
(5) Direct-care staff for a Level II PRTF.
(a) A Level II PRTF shall employ adequate direct-care staff to ensure the adequate provision of regular and emergency supervision of all residents twenty-four (24) hours a day.
(b) Level II direct-care staff shall:
-
Have at least a high school diploma or equivalence certificate; and
-
Complete a forty (40) hour training curriculum meeting the requirements of subsection (6)(c) of this section within one (1) month of employment.
(c) In order to assure that the residents are adequately supervised and are cared for in a safe and therapeutic manner, a Level II PRTF shall prepare a written staffing plan pursuant to KRS 216B.457(10)(a) that is tailored to meet the needs of the specific population of children and youth that will be admitted to the facility based on the facility's admission criteria.
(d) A Level II facility shall submit, follow, and revise a written staffing plan as required by KRS 216B.457(10)(a).
(6) Staff development.
(a) Level I or Level II PRTF staff development programs shall be provided and documented for administrative, professional, direct-care, and support staff.
(b) Level I or Level II PRTF professional and direct-care staff shall meet the continuing education requirements of their profession or, if there is not a continuing education requirement for that profession, be provided with forty (40) hours per year of in-service training
(c) Each Level I or Level II PRTF staff member working directly with residents shall receive annual training in the following areas:
-
Child and adolescent growth and development;
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Emergency and safety procedures;
-
Behavior management, including de-escalation training;
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Detection and reporting of child abuse or neglect;
-
Physical management procedures and techniques;
-
Infection control procedures; and
-
Training specific to the specialized nature of the facility.
(d) A Level I or Level II PRTF shall develop and implement a plan for staff to obtain training in first aid and cardiopulmonary resuscitation.
(7) Employment practices in a Level I or Level II PRTF.
(a) A Level I or Level II PRTF shall have employment and personnel policies and procedures designed, established, and maintained to promote the objectives of the facility, to ensure that an adequate number of qualified personnel under appropriate supervision is provided during all hours of operation, and to support quality of care and functions of the facility.
(b) The Level I or Level II PRTF's personnel policies and procedures shall be written, systematically reviewed, and approved on an annual basis by the governing body, and dated to indicate the time of last review.
(c) The Level I or Level II PRTF's personnel policies and procedures shall provide for the recruitment, selection, promotion, and termination of staff.
(d) The Level I or Level II PRTF shall maintain job descriptions that:
-
Specify the qualifications, duties, and supervisory relationship of the position;
-
Accurately reflect the actual job situation; and
-
Are revised if a change is made in the required qualifications, duties, supervision, or any other major job-related factor.
(e) The Level I or Level II PRTF shall provide a personnel orientation to all new employees.
(f)
-
The Level I or Level II PRTF's personnel policies and procedures shall be available and apply to all employees and shall be discussed with all new employees.
-
The Level I or Level II PRTF's facility administration shall establish a mechanism for notifying employees of changes in the personnel policies and procedures.
(g) The Level I or Level II PRTF's personnel policies and procedures shall describe methods and procedures for supervising all personnel, including volunteers.
(h)
- The Level I or Level II PRTF's personnel policies and procedures shall require:
a.
(i) A criminal records check through the Administrative Office of the Courts or the Kentucky State Police for all new staff and volunteers to assure that only persons whose presence does not jeopardize the health, safety, and welfare of residents are employed and used;
(ii) A subsequent criminal records check on each employee or volunteer, in accordance with KRS 216B.457(11);
(iii) Removal from contact with a child within the residential treatment center if the employee or volunteer has committed or been charged with a crime listed in KRS 216B.457(12)(a), or is the subject of a cabinet investigation, pursuant to KRS 216B.457(12)(b); and
(iv) A prohibition against working with a child until the conditions of KRS 216B.457(12)(c) are met; and
b.
(i) A check of the central registry, established under 922 KAR 1:470; and
(ii) A prohibition on employment or volunteer activities for any person listed on the registry, in accordance with KRS 216B.457(12)(d).
- If an employee or volunteer is removed from contact with a child, a PRTF may take other action, in accordance with KRS 216B.457(12)(e).
(i) The Level I or Level II PRTF's personnel policies and procedures shall provide for reporting and cooperating in the investigation of suspected cases of child abuse and neglect by facility personnel.
(j) A Level I or Level II PRTF's personnel record shall be kept on each staff member and shall contain the following items:
-
Name and address;
-
Verification of all training and experience and of licensure, certification, registration, or renewals;
-
Verification of submission to the background checks required by paragraph (h) of this subsection;
-
Performance appraisals;
-
Employee incident reports; and
-
Record of health exams related to employment, including compliance with the tuberculosis testing requirements of Section 25 of this administrative regulation.
(k) The Level I or Level II PRTF's personnel policies and procedures shall assure the confidentiality of personnel records and specify who has access to various types of personnel information.
(l) Performance appraisals shall relate job description and job performance and shall be written.
Section 8. Resident Rights.
(1) A Level I or Level II PRTF shall support and protect the basic human, civil, and constitutional rights of the individual resident.
(2) Written policy and procedure approved by the Level I or Level II PRTF's governing body shall provide a description of the resident's rights and the means by which these rights are protected and exercised.
(3) At the point of admission, a Level or Level II PRTF shall provide the resident and parent, guardian, or custodian with a clearly written and readable statement of rights and responsibilities. The statement shall be read to the resident or parent, guardian, or custodian if either cannot read and shall cover, at a minimum:
(a) Each resident's right to access treatment, regardless of race, religion, or ethnicity;
(b) Each resident's right to recognition and respect of his or her personal dignity in the provision of all treatment and care;
(c) Each resident's right to be provided treatment and care in the least restrictive environment possible;
(d) Each resident's right to an individualized treatment plan;
(e) Each resident's and family's right to participate in planning for treatment;
(f) The nature of care, procedures, and treatment that the resident shall receive;
(g) The right to informed consent related to the risks, side effects, and benefits of all medications and treatment procedures used;
(h) The right, to the extent permitted by law, to refuse the specific medications or treatment procedures and the responsibility of the facility if the resident refuses treatment, to seek appropriate legal alternatives or orders of involuntary treatment, or, in accordance with professional standards, to terminate the relationship with the resident upon reasonable notice; and
(i) The right to be free from restraint or seclusion, of any form, used as a means of coercion, discipline, convenience, or retaliation.
(4) The rights of residents in a Level I or Level II PRTF shall be written in language which is understandable to the resident, his or her parents, custodians, or guardians and shall be posted in appropriate areas of the facility.
(5) The policy and procedure concerning Level I or Level II PRTF resident rights shall assure and protect the resident's personal privacy within the constraints of his or her treatment plan. These rights to privacy shall at least include:
(a) Visitation by the resident's family or significant others in a suitable private area of the facility;
(b) Sending and receiving mail without hindrance or censorship; and
(c) Telephone communications with the resident's family or significant others at a reasonable frequency.
(6) If any rights to privacy are limited, the resident and his or her parent, guardian, or custodian shall receive a full explanation from the Level I or Level II PRTF. Limitations shall be documented in the resident's record and their therapeutic effectiveness shall be evaluated and documented by professional staff every seven (7) days.
(7) The right to initiate a complaint or grievance procedure and the means for requesting a hearing or review of a complaint shall be specified in a written policy approved by the Level I or Level II PRTF's governing body and made available to residents, parents, guardians, and custodians responsible for the resident. The procedure shall indicate:
(a) To whom the grievance is to be addressed; and
(b) Steps to be followed for filing a complaint, grievance, or appeal.
(8) The resident and his or her parent, guardian, or custodian shall be informed of the current and future use and disposition of products of special observation and audio-visual techniques such as one (1) way vision mirrors, tape recorders, videotapes, monitors, or photographs.
(9) The policy and procedure regarding resident's rights shall ensure the resident's right to confidentiality of all information recorded in his or her record maintained by the Level I or Level II facility. The facility shall ensure the initial and continuing training of all staff in the principles of confidentiality and privacy.
(10)
(a) A Level I or Level II resident shall be allowed to work for the facility only under the following conditions:
-
The work is part of the individual treatment plan;
-
The work is performed voluntarily;
-
The patient receives wages commensurate with the economic value of the work; and
-
The work project complies with applicable law and administrative regulation.
(b) The performance of tasks related to the responsibilities of family-like living, such as laundry and housekeeping, shall not be considered work for the facility and need not be compensated or voluntary.
(11) A Level I or Level II PRTF's written policy developed in consultation with professional and direct care staff and approved by the governing body shall provide for the measures utilized by the facility to discipline residents. These measures shall be fully explained to each resident and the resident's parent, guardian, or custodian.
(12) A Level I or Level II PRTF shall prohibit all cruel and unusual disciplinary measures including the following:
(a) Corporal punishment;
(b) Forced physical exercise;
(c) Forced fixed body positions;
(d) Group punishment for individual actions;
(e) Verbal abuse, ridicule, or humiliation;
(f) Denial of three (3) balanced nutritional meals per day;
(g) Denial of clothing, shelter, bedding, or personal hygiene needs;
(h) Denial of access to educational services;
(i) Denial of visitation, mail, or phone privileges for punishment;
(j) Exclusion of the resident from entry to his or her assigned living unit; and
(k) Restraint or seclusion as a punishment or employed for the convenience of staff.
(13) Written policy shall prohibit Level I or Level II PRTF residents from administering disciplinary measures upon one another and shall prohibit persons other than professional or direct-care staff from administering disciplinary measures to residents.
(14)
(a) Written rules of Level I or Level II PRTF resident conduct shall be developed in consultation with the professional and direct-care staff and be approved by the governing body.
(b) Residents shall participate in the development of the rules to a reasonable and appropriate extent.
(c) These rules shall be based on generally acceptable behavior for the resident population served.
(15) The application of disciplinary measures in a Level I or Level II PRTF shall relate to the violation of established rules.
Section 9. Resident Records.
(1) A Level I or Level II PRTF shall:
(a) Have written policies concerning resident and, if provided, outpatient client records approved by the governing body; and
(b) Maintain a written record on each resident or, if applicable, outpatient client to be directly accessible to staff members caring for the resident or outpatient client.
(2) The Level I or Level II PRTF resident record shall contain at a minimum:
(a) Basic identifying information;
(b) Appropriate court orders or consent of appropriate family members or guardians for admission, evaluation, and treatment;
(c) A provisional or admitting diagnosis which includes a physical diagnosis, if applicable, as well as a psychiatric diagnosis;
(d) The report by the parent, guardian, or custodian of the patient's immunization status;
(e) A psychosocial assessment of the resident and his or her family, including:
-
An evaluation of the effect of the family on the resident's condition and the effect of the resident's condition on the family; and
-
A summary of the resident's psychosocial needs;
(f) An evaluation of the resident's growth and development, including physical, emotional, cognitive, educational, and social development; and needs for play and daily activities;
(g) The resident's legal custody status, if applicable;
(h) The family's, guardian's, or custodian's expectations for, and involvement in, the assessment, treatment, and continuing care of the resident;
(i) Physical health assessment, including evaluations of the following:
-
Motor development and functioning;
-
Sensorimotor functioning;
-
Speech, hearing, and language functioning;
-
Visual functioning;
-
Immunization status; and
-
The results of the tuberculosis testing required by Sections 20 and 21 of this administrative regulation; and
(j) In a Level II PRTF that opts to provide bedrooms with sleeping accommodations for two (2) residents, documentation of placement in a single occupancy bedroom if recommended by the multidisciplinary team. The basis for the team's recommendation for a single occupancy bedroom shall be maintained in the record.
(3) The Level I or Level II PRTF resident record shall also include:
(a) Physician's notes which shall include an entry made at least weekly by the staff psychiatrist regarding the condition of the resident;
(b) Professional progress notes, which shall:
- Be completed following each professional service:
a. Daily; or
b. If the service is provided daily to groups of residents, through a weekly summary;
- Be signed and dated by the:
a. Mental health professional who provided the service in a Level I PRTF; or
b. Qualified mental health professional who provided the service in a Level II PRTF;
(c) Direct-care progress notes which shall:
-
Record implementation of all treatment and any unusual or significant events which occur for the resident;
-
Be completed at least by the end of each direct-care shift and summarized weekly; and
-
Be signed and dated by the direct-care staff making the entry;
(d) Special clinical justifications for the use of unusual treatment procedures, including emergency safety interventions, and reports;
(e) Discharge summary;
(f) If a patient dies, a summation statement in the form of a discharge summary, including events leading to the death, signed by the attending physician; and
(g) Documentation that any serious occurrence involving the resident was reported to the Department for Medicaid Services and to Kentucky Protection and Advocacy, and that any resident death was reported to the Centers for Medicare and Medicaid Services (CMS) regional office, as required by Sections 10(4) and 10(5) of this administrative regulation.
(4) An outpatient client record shall be maintained for each client receiving outpatient behavioral health services under Section 14(1) of this administrative regulation.
(a) Each entry shall be dated, signed, and indexed according to the outpatient service received.
(b) Each outpatient client record shall contain:
-
An identification sheet, including the client's name, address, age, gender, marital status, expected source of payment, and referral source;
-
Name, address, and telephone number of the client and client's parent or guardian;
-
Intake interview;
-
The signed and dated consent for treatment from the client's parent or guardian;
-
The report of the behavioral health assessment and other assessments as appropriate, which may include psychological testing;
-
The plan of care as described in Section 14(5) of this administrative regulation;
-
Examination, diagnosis, and progress notes by the physician, nurse, or other behavioral health professionals or treatment staff that relate to the implementation of plan of care objectives;
-
A record of all contacts with other providers, family members, community partners, or other contacts;
-
A record of medical treatment and administration of medication, if administered;
-
An original or original copy of all physician medication and treatment orders, if applicable; and
-
Documentation of orientation to the program and program rules.
(5) A Level I or Level II PRTF shall maintain confidentiality of resident and, if applicable, outpatient client records. Resident or outpatient client information shall be released only on written consent of the resident, outpatient client, or his or her parent, guardian, or custodian or as otherwise authorized by law. The written consent shall contain the following information:
(a) The name of the person, agency, or organization to which the information is to be disclosed;
(b) The specific information to be disclosed;
(c) The purpose of disclosure; and
(d) The date the consent was signed and the signature of the individual witnessing the consent.
Section 10. Quality Assurance.
(1) A Level I or Level II PRTF shall have an organized quality assurance program designed to enhance resident treatment and care, including outpatient services if provided, through the ongoing objective assessment of important aspects of care and the correction of identified problems.
(2) A Level I or Level II PRTF shall prepare a written quality assurance plan designed to ensure that there is an ongoing quality assurance program that includes effective mechanisms for reviewing and evaluating resident care, including outpatient services if provided, and that provides for appropriate response to findings.
(3) A Level I or Level II PRTF shall record all incidents or accidents that present a direct or immediate threat to the health, safety or security of any resident or staff member. Examples of incidents to be recorded include the following: physical violence, fighting, absence without leave, use or possession of drugs or alcohol, or inappropriate sexual behavior. The record shall be kept on file and retained at the facility and shall be made available for inspection by the licensure agency.
(4)
(a) A Level I or Level II PRTF shall report any serious occurrence involving a resident to the Department for Medicaid Services and to Kentucky Protection and Advocacy by no later than close of business the next business day after the serious occurrence.
(b) The report shall include:
-
The name of the resident involved in the serious occurrence;
-
A description of the occurrence; and
-
The name, street address, and telephone number of the facility.
(5) A Level I or Level II PRTF shall report the death of any resident to the Centers for Medicare and Medicaid Services (CMS) regional office by no later than close of business the next business day after the resident's death.
Section 11. Admission Criteria.
(1) A Level I or Level II PRTF shall have written admission criteria that are:
(a) Approved by the governing body; and
(b) Consistent with the facility's goals and objectives.
(2) Admission criteria shall be made available to referral sources and to parents, guardians, or custodians and shall include:
(a) Types of admission (crisis stabilization, long-term treatment);
(b) Age and sex of accepted residents;
(c) Criteria that preclude admission in a Level I or Level II PRTF;
(d) Clinical needs and problems typically addressed by the facility's programs and services;
(e) Criteria for discharge;
(f) Any preplacement requirements of the resident, his or her parents, guardians, custodians, or the placing agency; and
(g) Residency requirements. In a Level II PRTF that opts to provide bedrooms with sleeping accommodations for two (2) residents, the facility shall:
-
Place each newly admitted resident in a single occupancy bedroom until completion of the comprehensive treatment plan of care, which shall be completed within ten (10) calendar days of admission pursuant to Section 12(4)(c) of this administrative regulation;
-
Maintain a resident in a single occupancy bedroom if recommended in the comprehensive treatment plan of care; and
-
Provide notification and general information to each Level II resident's parent, guardian, or custodian about the installation of the electronic surveillance system required by 902 KAR 20:330, Section 6(3)(d), if the resident is placed in a bedroom shared with another resident.
(3) Pursuant to 42 C.F.R. 483.356, at admission, a facility shall:
(a) Inform both the incoming resident and the resident's parent or legal guardian of the facility's policy regarding the use of restraint or seclusion during an emergency safety situation that may occur while the resident is in the program;
(b) Communicate its restraint and seclusion policy in a language that the resident or his or her parent or legal guardian understands (including American Sign Language, if appropriate) and if necessary, the facility shall provide interpreters or translators;
(c) Obtain an acknowledgment, in writing, from the resident's parent or legal guardian that he or she has been informed of the facility's policy on the use of restraint or seclusion during an emergency safety situation. Staff shall file this acknowledgment in the resident's record; and
(d) Provide a copy of the facility policy to the resident's parent or legal guardian. The facility's policy shall provide contact information, including the phone number and mailing address for Kentucky Protection and Advocacy.
(4) Age limits.
(a) Residents admitted to a Level I PRTF shall have obtained age six (6), but not attained age eighteen (18).
(b) Residents in a Level I PRTF may remain in care until age twenty-one (21) if admitted by their 18th birthday.
(c) Pursuant to KRS 216B.450(5)(b), a Level II PRTF may provide inpatient psychiatric residential treatment and habilitation to persons who are age four (4) to twenty-one (21) years.
(d)
-
Admission criteria related to age at admission shall be determined by the age grouping of children currently in residence and shall reflect a range no greater than five (5) years in a living unit for residents six (6) years of age and older.
-
If a Level II PRTF admits residents who are four (4) or five (5) years of age, the age range shall not be more than three (3) years in the living unit.
(5) Children and adolescents who are a danger to self or others for whom the facility is unable to develop a risk-management plan shall not be admitted to a Level I PRTF.
(6)
(a) Except for paragraph (b) of this subsection, a Level II PRTF shall not refuse to admit a patient who meets the medical necessity criteria and facility criteria for Level II facility services pursuant to KRS 216B.457(2).
(b) A Level II PRTF shall refuse to admit a patient if the admission exceeds the facility's licensed bed capacity.
Section 12. Resident Management.
(1) Intake.
(a) A Level I or Level II PRTF shall have written policies and procedures approved by the facility administration for the intake process which addresses at a minimum the following:
-
Referral, records, and statistical data to be kept regarding applicants for residence;
-
Criteria for determining the eligibility of individuals for admission;
-
Methods used in the intake process which shall be based on the services provided by the facility and the needs of residents; and
-
Procurement of appropriate consent forms. This may include the release of educational and medical records.
(b) The intake process shall be designed to provide at least the following information:
-
Identification of agencies who have been involved in the treatment of the resident in the community and the anticipated extent of involvement of those agencies during and after the resident's stay in the facility;
-
Legal, custody and visitation orders; and
-
Proposed discharge plan and anticipated length of stay.
(c) The intake process shall include an orientation for the parent, guardian, or custodian as appropriate and the resident which includes the following:
-
The rights and responsibilities of residents, including the rules governing resident conduct and the types of infractions that can result in disciplinary action or discharge from the facility;
-
Rights, responsibilities, and expectations of the parent, guardian, or custodian; and
-
Preparation of the staff and residents of the facility for the new resident.
(d) Upon admission each resident of school age shall have been certified or be referred for assessment as a child with a disability pursuant to 20 U.S.C. 1400.
(2) Assessment.
(a) A complete evaluation and assessment shall be performed for each resident which includes at least physical, emotional, behavioral, social, recreational, educational, legal, vocational, and nutritional needs.
(b) An initial health screening for illness, injury, and communicable disease or other immediate needs shall be conducted within twenty-four (24) hours after admission by a nurse.
(c) A physician, nurse practitioner, or physician's assistant shall conduct a physical examination of each resident within fourteen (14) days after admission. Communication to schedule the physical examination of each resident shall be initiated within twenty-four (24) hours after admission. The physical examination shall include at least evaluations of the following:
-
Motor development and functioning;
-
Sensorimotor functioning;
-
Speech, hearing, and language functioning;
-
Visual functioning; and
-
Immunization status. If a resident's immunization is not complete as required by 902 KAR 2:060, the facility shall be responsible for its completion and shall begin to complete any immunizations which are outside of the set periodicity schedule within thirty (30) days of admission or the physical examination, whichever is later.
(d) If the resident has had a complete physical examination by a qualified physician, nurse practitioner, or physician's assistant within the previous three (3) months which includes the requirements of paragraph (c) of this subsection and if the facility obtains complete copies of the record, the physician, nurse practitioner, or physician's assistant may determine after reviewing the records and assessing the resident's physical health that a complete physical examination is not required. If that determination is made, the examination performed in the previous three (3) months shall be used to meet the requirement for a physical examination in paragraph (c) of this subsection.
(e) Facilities shall have all the necessary diagnostic tools and personnel available or have written agreements with another organization to provide physical health assessments, including electroencephalographic equipment, a qualified technician trained in dealing with children and adolescents, and a properly qualified physician to interpret electroencephalographic tracing of children and adolescents.
(f) An emotional and behavioral assessment of each resident that includes an examination by a psychiatrist shall be completed and entered in the resident's record. The emotional and behavioral assessment shall include the following:
-
A history of previous emotional, behavioral, and substance abuse problems and treatment;
-
The resident's current emotional and behavioral functioning, risk factors, protective factors and needs;
-
A direct psychiatric evaluation;
-
If indicated, psychological assessments, including intellectual, projective, and personality testing;
-
If indicated, other functional evaluations of language, self-care, and social-affective and visual-motor functioning; and
-
An evaluation of the developmental age factors of the resident.
(g) The facility shall have an assessment procedure for the early detection of mental health problems that are life threatening, are indicative of severe cognitive disorganization or deterioration, or may seriously affect the treatment or rehabilitation process.
(h) A social assessment of each resident shall be undertaken and include:
-
Environment and home;
-
Religion;
-
Childhood history;
-
Financial status;
-
The social, peer-group, and environmental setting from which the resident comes; and
-
The resident's family circumstances, including the constellation of the family group; the current living situation; and social, ethnic, cultural, emotional, and health factors, including drug and alcohol use.
(i) The social assessment shall include a determination of the need for participation of family members or significant others in the resident's treatment.
(j) An activities assessment of each resident shall include information relating to the individual's current skills, talents, aptitudes, and interest.
(k) An assessment shall be performed to evaluate the resident's potential for involvement in community activity, organizations, and events.
(l) For adolescents age fourteen (14) and older, a vocational assessment of the resident shall be done which includes the following:
-
Vocational history;
-
Education history, including academic and vocational training; and
-
A preliminary discussion, between the resident and the staff member doing the assessment, concerning the resident's past experiences with an attitude toward work, present motivations or areas of interest, and possibilities for future education, training, and employment.
(m) If appropriate, a legal assessment of the resident shall be undertaken and shall include the following:
-
A legal history; and
-
A preliminary discussion to determine the extent to which the legal situation will influence his or her progress in treatment and the urgency of the legal situation.
(3) Level I treatment plans.
(a)
-
Within seventy-two (72) hours following admission, a mental health professional shall develop an initial treatment plan that is based at least on an assessment of the resident's presenting problems, physical health, and emotional and behavioral status.
-
Appropriate therapeutic efforts shall begin before a master treatment plan is finalized.
(b)
- A comprehensive treatment plan of care shall be developed by a multidisciplinary team conference in conformity with 42 C.F.R. 441.156 within ten (10) days of admission for any resident remaining in treatment. It shall:
a. Be based on the comprehensive assessment of the resident's needs completed pursuant to subsection (2) of this section;
b. Include a substantiated diagnosis and the short-term and long-range treatment needs; and
c. Address the specific treatment modalities required to meet the resident's needs.
- The comprehensive treatment plan of care shall:
a. Contain specific and measurable goals for the resident to achieve;
b. Describe the services, activities, and programs to be provided to the resident, and shall specify staff members assigned to work with the resident and the time or frequency for each treatment procedure; and
c. Specify criteria to be met for termination of treatment; and
d. Include any referrals necessary for services not provided directly by the facility.
-
The resident shall participate to the maximum extent feasible in the development of his or her comprehensive treatment plan of care, and the participation shall be documented in the resident's record.
a. A specific plan for involving the resident's family or significant others shall be included in the comprehensive treatment plan of care.
b. The parent, guardian, or custodian shall be given the opportunity to participate in the multidisciplinary treatment plan conference if feasible and shall be given a copy of the resident's comprehensive treatment plan of care.
c. The comprehensive treatment plan of care shall identify the mental health professional who is responsible for coordinating and facilitating the family's involvement throughout treatment.
-
The comprehensive treatment plan of care shall be reviewed and updated through multidisciplinary team conferences as clinically indicated and at least thirty (30) days following the first ten (10) days of treatment. The comprehensive treatment plan of care shall be reviewed every thirty (30) days thereafter and updated every sixty (60) days or earlier if clinically indicated.
-
Following one (1) year of continuous treatment, the review and update may be conducted at three (3) month intervals.
(c) The comprehensive treatment plan of care and each review and update shall be signed by the participants in the multidisciplinary team conference that developed it.
(4) Level II PRTF treatment plans.
(a) A Level II PRTF shall develop and implement an initial treatment plan of care for each resident as required by KRS 216B.457(13).
(b) Appropriate therapeutic efforts shall begin before a comprehensive treatment plan of care is finalized.
(c)
-
A comprehensive treatment plan of care shall be developed by a multidisciplinary team conference in conformity with 42 C.F.R. 441.156 and KRS 216B.457(14).
-
In a Level II PRTF that opts to provide bedrooms with sleeping accommodations for two (2) residents, the comprehensive treatment plan of care shall document whether the facility's multidisciplinary team recommends placement of the resident in a private bedroom or in a double occupancy bedroom with another resident.
-
The comprehensive treatment plan of care shall:
a. Contain specific and measurable goals for the resident to achieve;
b. Describe the services, activities, and programs to be provided to the resident; and
c. Specify staff members assigned to work with the resident and the time or frequency for each treatment procedure.
-
The resident shall participate to the maximum extent feasible in the development of his or her comprehensive treatment plan of care, and the participation shall be documented in the resident's record.
a. A specific plan for involving the resident's family or significant others shall be included in the comprehensive treatment plan of care.
b. The parent, guardian, or custodian shall be given the opportunity to participate in the multidisciplinary treatment plan conference if feasible and shall be given a copy of the resident's comprehensive treatment plan of care.
c. The comprehensive treatment plan of care shall identify the mental health professional who is responsible for coordinating and facilitating the family's involvement throughout treatment.
(d) The comprehensive treatment plan of care shall be reviewed and documented as required by KRS 216B.457(15).
(5) Level I and Level II PRTF progress notes.
(a) Progress notes shall be entered in the resident's records, be used as a basis for reviewing the treatment plan, signed and dated by the individual making the entry and shall include the following:
-
Documentation of implementation of the treatment plan;
-
Chronological documentation of all treatment provided to the resident and documentation of the resident's clinical course; and
-
Descriptions of each change in each of the resident's conditions.
(b) All entries involving subjective interpretation of the resident's progress shall be supplemented with a description of the actual behavior observed.
(c) Efforts shall be made to secure written progress reports for residents receiving services from outside sources and, if available, to include them in the resident record.
(d) The resident's progress and current status in meeting the goals and objectives of his or her treatment plan shall be regularly recorded in the resident record.
(6) Discharge planning. A Level I or Level II PRTF shall have written policies and procedures for discharge of residents.
(a)
-
Discharge planning shall begin at admission and be documented in the resident's record.
-
At least ninety (90) days prior to the planned discharge of a resident from the facility, or within ten (10) days after admission if the anticipated length of stay is under ninety (90) days, the multidisciplinary team shall formulate a discharge and aftercare plan.
-
This plan shall be maintained in the resident's record and reviewed and updated with the comprehensive treatment plan of care.
(b) All discharge recommendations shall be determined through a conference, including the appropriate facility staff, the resident, the resident's parents, guardian, or custodian and, if indicated, the representative of the agency to whom the resident may be referred for any aftercare service, and the affected local school districts. All aftercare plans shall delineate those parties responsible for the provision of aftercare services.
(c) If the aftercare plan involves placement of the resident in another licensed program following discharge, facility staff shall share resident information with representatives of the aftercare program provider if authorized by written consent of the parent, guardian, or custodian.
(d) A Level I facility deciding to release a resident on an unplanned basis shall:
-
Have reached the decision to release at a multidisciplinary team conference chaired by the clinical director that determined, in writing, that services available through the facility cannot meet the needs of the resident;
-
Provide at least ninety-six (96) hours notice to the resident's parent, guardian, or custodian and the agency which will be providing aftercare services. If authorized by written consent of the parent, guardian, or custodian, the facility shall provide to the receiving agency copies of the resident's records and discharge summary; and
-
Consult with the receiving agency in situations involving placement for the purpose of ensuring that the placement reasonably meets the needs of the resident.
(e) Within fourteen (14) days of a resident's discharge from the facility, the facility shall compile and complete a written discharge summary for inclusion in the resident's record. The discharge summary shall include:
-
Name, address, phone number, and relationship of the person to whom the resident was released;
-
Description of circumstances leading to admission of the resident to the facility;
-
Significant problems of the resident;
-
Clinical course of the resident's treatment;
-
Assessment of remaining needs of the resident and alternative services recommended to meet those needs;
-
Special clinical management requirements including psychotropic drugs;
-
Brief descriptive overview of the aftercare plan designed for the resident; and
-
Circumstances leading to the unplanned or emergency discharge of the resident, if applicable.
Section 13. Services. A Level I or Level II PRTF shall provide the following services in a manner which takes into account and addresses the social life; emotional, cognitive, and physical growth and development; and the educational needs of the resident. Services shall include the opportunity for the resident to participate in community activities, organizations and events and shall provide a normalized environment for the resident.
(1) Level I or Level II mental health services.
(a) Mental health assessments and evaluations shall be provided as required in Section 12 of this administrative regulation.
(b) The mental health services available through the Level I or Level II PRTF shall include the services listed in this paragraph provided by staff of the Level I or Level II PRTF:
-
Case coordination services to assure the full integration of all services provided to each resident. Case coordination activities shall include monitoring the resident's daily functioning to assure the continuity of service in accordance with the resident's treatment plan and ensuring that all staff responsible for the care and delivery of services actively participate in the development and implementation of the resident's treatment plan;
-
Planned on-site therapies including individual, family, and group therapies as indicated by the comprehensive treatment plan of care.
a. These therapies shall include psychotherapy, interventions, or face-to-face contacts, which may be made verbally or using assistive communication, between staff and the resident to enhance the resident's psychological and social functioning as well as to facilitate the resident's integration into a family unit.
b. Contacts that are incidental to other activities shall be excluded from this service;
- Task and skill training to enhance a resident's age appropriate skills necessary to facilitate the resident's ability to care for himself or herself, and to function effectively in community settings. Task and skill training activities shall include homemaking, housekeeping, personal hygiene, budgeting, shopping, and the use of community resources.
(2) Level I or Level II physical health services.
(a) The physical health services available through the Level I or Level II PRTF facility shall include the following services provided either directly by the facility or written agreement:
-
Assessments and evaluations as required in Section 12 of this administrative regulation;
-
Diagnosis, treatment, and consultation for acute or chronic illnesses occurring during the resident's stay at the facility or for problems identified during an evaluation;
-
Preventive health care services to include periodic assessments in accordance with the periodicity schedule established by the American Academy of Pediatrics;
-
A dental examination within six (6) months of admission, periodic assessments in accordance with the periodicity schedule established by the American Dental Association, and treatment as needed;
-
Health and sex education; and
-
An ongoing immunization program.
(b) If physical health services are provided by written agreement with a provider of services other than the facility, the written agreement shall, at a minimum, address:
-
Referral of residents;
-
Qualifications of staff providing services;
-
Exchange of clinical information; and
-
Financial arrangements.
(c) A Level I or Level II PRTF shall not admit a resident who has a communicable disease or acute illness requiring treatment in an acute care inpatient setting.
(3) Level I or Level II dietary services.
(a) A Level I or Level II PRTF shall have written policies and procedures approved by the governing body for the provision of dietetic services for staff and residents which may be provided directly by the facility staff or through written contractual agreement.
(b) Adequate staff, space, equipment, and supplies shall be provided for safe sanitary operation of the dietetic service, the safe and sanitary handling and distribution of food, the care and cleaning of equipment and kitchen area, and the washing of dishes.
(c) The nutritional aspects of resident's care shall be planned, reviewed, and periodically evaluated by a licensed dietician pursuant to KRS 310.021 and employed by the facility as a staff member or consultant.
(d) The food shall be served to residents and staff in a common eating place and:
-
Shall account for the special food needs and tastes of residents;
-
Shall not be withheld as punishment; and
-
Shall provide for special dietary need of residents such as those relating to problems, such as diabetes and allergies.
(e) Residents shall participate in the preparation and serving of food as appropriate.
(f) At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the substantial evening meal and breakfast. The facility shall arrange for and make provision for between-meal and unscheduled snacks.
(g) Except for school lunches and meals at restaurants, all members of a living unit shall be provided their meals together as a therapeutic function of the living unit.
(4) Level I or Level II emergency services.
(a) A Level I or Level II PRTF shall provide for the prompt notification of the resident's parents, guardian, or custodian in case of serious illness, injury, surgery, emergency safety intervention, elopement, or death.
(b)
-
All staff shall be knowledgeable of a written plan and procedure for meeting potential disasters and emergencies such as fires or severe weather.
-
The plan shall be posted.
-
Staff shall be trained in properly reporting a fire, extinguishing a small fire, and in evacuation from the building.
-
Fire drills shall be practiced monthly, with a written record kept of all practiced fire drills, detailing the date, time, and residents who participated.
(c) The facility shall have written procedures to be followed by staff if a psychiatric, medical, or dental emergency of a resident occurs that specifies:
-
Notification of designated member of the facility's chain of command;
-
Designation of staff person who shall decide to refer resident to outside treatment resources;
-
Notification of resident's parent, guardian, or custodian;
-
Transportation to be used;
-
Staff member to accompany resident;
-
Necessary consent and referral forms to accompany resident; and
-
Name, location, and telephone of designated treatment resources.
(d) The facility shall have designated treatment resources who shall have agreed to accept a resident for emergency treatment. At a minimum the resources shall include:
-
Licensed physician and an alternate designee;
-
Licensed dentist and an alternate designee;
-
Licensed hospital; and
-
Licensed hospital with an accredited psychiatric unit.
(5) Level I or Level II pharmacy services. A Level I or Level II PRTF shall have written policies and procedures approved by the governing body for proper management of pharmaceuticals that are consistent with the requirements established in this subsection.
(a)
-
Medications shall be administered by a registered nurse, physician, or dentist, except if administered by a licensed practical nurse, certified medication aide, or direct care staff under the supervision of a registered nurse.
-
Direct care staff who administer medications shall have successfully completed a medicine administration course approved by the Kentucky Board of Nursing.
(b)
-
Medications shall not be given without a written order signed by a physician, dentist, advanced practice registered nurse as authorized in KRS 314.011(8) and 314.042(8), therapeutically-certified optometrist as authorized in KRS 320.240(14), or physician assistant as authorized by KRS 311.858.
-
Telephone orders for medications shall be given only to licensed nurses or a pharmacist and signed by a physician, dentist, advanced practice registered nurse, therapeutically-certified optometrist, or physician assistant within seventy-two (72) hours from the time the order is given.
(c) Medications shall be prescribed only if clinically indicated. The facility shall ensure that medication is not administered solely for the purpose of program management or control, and that medication is not prescribed for the purposes of experimentation or research.
(d) All medications shall require "stop orders".
(e) All prescriptions shall be reevaluated by the prescriber prior to its renewal.
(f) There shall be a systematic method for prescribing, ordering, receipting, storing, dispensing, administering, distributing and accounting for all medications.
(g) The facility shall provide maximum security storage of and accountability for all legend medications, syringes, and needles.
(h) Self-administration of medication shall be permitted only if specifically ordered by the responsible prescriber and supervised by a member of the professional staff or a mental health associate. Drugs to be self-administered shall be stored in a secured area and be made available to the resident at the time of administration.
(i) Residents permitted to self-administer drugs shall be counseled regarding the indications for which the drugs are to be used, the primary side effects, and the physical dosage forms which are to be administered.
(j) Drugs brought into the facility by residents shall not be administered unless they have been identified and unless written orders to administer these specific drugs are given by the responsible physician. Otherwise these drugs shall be packaged, sealed, and stored, and, if approved by the responsible physician, returned to the resident, parent, guardian, or custodian at the time of discharge.
(6) Level I or Level II education and vocational services.
(a) Educational and vocational services available through a PRTF shall include the minimum requirements of Kentucky Revised Statutes and federal laws and regulations regarding regular education, vocational education, and special education as appropriate to meet the needs of the residents.
- Educational services shall be provided by:
a. The facility;
b. The local school district in which the facility is located; or
c. A nonpublic school program which is specially accredited and approved by the Kentucky Department of Education to provide special education services to students with disabilities.
-
If the educational services are provided by the facility, the school program shall be specially accredited and approved by the Kentucky Department of Education to provide special education services to students with disabilities.
-
Educational services provided by a local school district shall be provided within the facility or within the local school district.
-
The facility's multidisciplinary team shall make a recommendation concerning the delivery site of educational services provided by a local school district that is based on least restrictive environment determinations for individual residents.
-
Education services approved by the Department of Education shall be available either on the same site or in close physical proximity to the PRTF.
(b) If the education services are not provided directly by the facility, there shall be a written plan for the provision of education services. The education provider shall be a state education department-approved program. The written plan shall, at a minimum, address:
-
Qualifications of staff providing educational services;
-
Participation of educational and vocational staff in the plan for the provision of educational services;
-
Access by staff of the facility to educational and vocational programs and records; and
-
Financial and service arrangements.
(c) The facility shall ensure that residents have opportunities to be educated in the least restrictive environment consistent with the treatment needs of the resident as determined by the multidisciplinary team and reflected in the resident's comprehensive treatment plan of care.
(d) The facility shall ensure that education services are developed and implemented with input from the child's education staff in conjunction with the comprehensive treatment plan of care and meet the requirements established in this paragraph.
-
Each resident's comprehensive treatment plan of care shall include formal academic goals for remediation and continuing education.
a. Each resident who is eligible for special education services shall have treatment activities developed by the multidisciplinary team, which shall be incorporated, as applicable, into the individualized education plan developed by the local school district.
b. The multidisciplinary team shall develop treatment activities which extend into the classroom as appropriate.
c. The program director or designee shall request an invitation to attend all individualized education plan or Admissions and Release Committee meetings.
d. If allowed, the program director or designee shall attend all individualized education plan or Admissions and Release Committee meetings.
- To avoid unnecessary duplication and make maximum use of resources, the services provided by the education and treatment components for children with disabilities pursuant to 20 U.S.C. 1400 shall be developed with the opportunity for input from both school personnel and the PRTF.
(e)
-
The facility shall provide or arrange for vocational services for residents, as is age appropriate and is in accordance with the comprehensive treatment plan of care.
-
The services shall be planned, implemented and supervised by a vocational counselor or appropriate therapist who shall be a full- or part-time employee of the facility or a consultant.
(f) Residents may be permitted to accumulate earnings in a bank account established with the resident by the facility.
(7) Level I or Level II PRTF activity services.
(a) A daily schedule of planned recreational activities shall be prepared for the approval of the clinical director prior to implementation of the schedule.
-
The schedule shall be for normal waking hours that residents are not in school, or in active treatment.
-
The schedule shall include a full range of activities which may include physical recreation, team sports, art, and music; attendance at recreational and cultural events in the community if appropriate; and individualized, directed activities like reading and crafts.
-
Nondirected leisure time shall be limited to two (2) one-half (1/2) hour periods on school days and three (3) one-half (1/2) hour periods on nonschool days.
-
The activity schedule shall identify the professional or direct-care staff who will lead and support each activity.
-
Changes made to the schedule as the schedule is implemented shall be indicated on a copy of each daily schedule maintained as a permanent record by the clinical director.
(b) Appropriate time, space, and equipment shall be provided by the facility for leisure activity and free play.
(c) The facility shall provide the means of observing holidays and personal milestones in keeping with the cultural and religious background of the residents.
(8) Speech, language, and hearing services. A Level I or Level II PRTF shall provide or arrange for speech, language, and hearing services to meet the identified needs of residents. These services shall be provided by the facility or through written agreement with a qualified speech-language and hearing clinician. The written agreement shall, at a minimum, address:
(a) Referral of residents;
(b) Qualifications of staff providing services;
(c) Exchange of clinical information; and
(d) Financial arrangements.
Section 14. Provision of Outpatient Behavioral Health Services, Requirements for Case Managers, Plan of Care, and Physical Environment Requirements.
(1) A Level I or Level II PRTF may provide one (1) or more of the following outpatient behavioral health services:
(a) Screening which shall be provided to a client age twenty-one (21) or younger by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice to determine the:
-
Likelihood that an individual has a mental health, substance use, or co-occurring disorder; and
-
Need for an assessment;
(b) Assessment which shall:
- Be provided to a client age twenty-one (21) or younger by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, a certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice who gathers information and engages in a process with the client, thereby enabling the professional to:
a. Establish the presence or absence of a mental health, substance use, or co-occurring disorder;
b. Determine the client's readiness for change;
c. Identify the client's strengths or problem areas which may affect the treatment and recovery processes; and
d. Engage the client in developing an appropriate treatment relationship;
-
Establish or rule out the existence of a clinical disorder or service need;
-
Include working with the client to develop a plan of care if a clinical disorder or service need is assessed; and
-
Not include psychological or psychiatric evaluations or assessments;
(c) Psychological testing which shall:
-
Be performed by a licensed psychologist, licensed psychological associate, or licensed psychological practitioner for a client age twenty-one (21) or younger; and
-
Include a psychodiagnostic assessment of personality, psychopathology, emotionality, or intellectual disabilities, and interpretation and written report of testing results;
(d) Crisis intervention which:
-
Shall be a therapeutic intervention for the purpose of immediately reducing or eliminating the risk of physical or emotional harm to the client or another individual;
-
Shall consist of clinical intervention and support services necessary to provide integrated crisis response, crisis stabilization interventions, or crisis prevention activities;
-
Shall be provided to a client age twenty-one (21) or younger:
a. On-site in the facility where the licensee provides outpatient behavioral health services;
b. As an immediate relief to the presenting problem or threat; and
c. In a face-to-face, one (1) on one (1) encounter;
-
May include verbal de-escalation, risk assessment, or cognitive therapy;
-
Shall be provided by one (1) or more of the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate;
-
Shall be followed by a referral to noncrisis services, if applicable; and
-
May include:
a. Further service prevention planning, including:
(i) Lethal means reduction for suicide risk; or
(ii) Substance use disorder relapse prevention; or
b. Verbal de-escalation, risk assessment, or cognitive therapy;
(e) Mobile crisis services which shall:
-
Be provided to a client age twenty-one (21) or younger;
-
Be available twenty-four (24) hours a day, seven (7) days a week, every day of the year;
-
Be provided for a duration of less than twenty-four (24) hours;
-
Not be an overnight service;
-
Be a multi-disciplinary team based intervention that ensures access to acute mental health and substance use services and supports to:
a. Reduce symptoms or harm; or
b. Safely transition an individual in an acute crisis to the appropriate, least restrictive level of care;
- Involve all services and supports necessary to provide:
a. Integrated crisis prevention;
b. Assessment and disposition;
c. Intervention;
d. Continuity of care recommendations; and
e. Follow-up services;
- Be provided face-to-face in a home or community setting by one (1) or more of the following practicing within his or her scope of practice:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Certified alcohol and drug counselor;
d. Licensed clinical alcohol and drug counselor; or
e. Licensed clinical alcohol and drug counselor associate; and
- Ensure access to a board certified or board-eligible psychiatrist for consultation twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(f) Day treatment which shall:
- Be a nonresidential, intensive treatment program designed for children who:
a. Have a substance use disorder, mental health disorder, or co-occurring disorder;
b. Are under twenty-one (21) years of age; and
c. Are at high risk of out-of-home placement due to a behavioral health issue;
-
Consist of an organized, behavioral health program of treatment and rehabilitative services for substance use disorder, mental health disorder, or a co-occurring disorder;
-
Have unified policies and procedures that address the facility's philosophy, admission and discharge criteria, admission and discharge process, staff training, and integrated case planning;
-
Include the following:
a. Individual outpatient therapy, family outpatient therapy, or group outpatient therapy;
b. Behavior management and social skill training;
c. Independent living skills that correlate to the age and developmental stage of the client; and
d. Services designed to explore and link with community resources before discharge and to assist the client and family with transition to community services after discharge;
- Be provided as follows:
a. In collaboration with the education services of the local education authority including those provided through 20 U.S.C. 1400 et seq. (Individuals with Disabilities Education Act) or 29 U.S.C. 701 et seq. (Section 504 of the Rehabilitation Act);
b. On school days and during scheduled breaks;
c. In coordination with the child's individual educational plan or Section 504 plan if the child has an individual educational plan or Section 504 plan;
d. By personnel that includes a behavioral health professional, a behavioral health professional under clinical supervision, a certified alcohol and drug counselor, a licensed clinical alcohol and drug counselor, a licensed clinical alcohol and drug counselor associate, or a peer support specialist practicing within his or her scope of practice; and
e. According to a linkage agreement with the local education authority that specifies the responsibilities of the local education authority and the day treatment provider; and
- Not include a therapeutic clinical service that is included in a child's individualized education plan;
(g) Peer support which:
-
Shall be provided by a peer support specialist;
-
Shall be structured and scheduled nonclinical therapeutic activity with a client or group of clients;
-
Shall promote socialization, recovery, self-advocacy, preservation, and enhancement of community living skills;
-
Shall be identified in the client's plan of care; and
-
If provided by a family peer support specialist who meets the requirements of 908 KAR 2:230, may be provided to an individual over the age of twenty-one (21) as follows:
a. The individual shall be a family member of a client age twenty-one (21) or younger who receives outpatient behavioral health services from the Level I or Level II PRTF; and
b. The family peer support services shall focus on the needs and treatment of the client as identified in the client's plan of care;
(h) Intensive outpatient program services which shall:
-
Offer a multi-modal, multi-disciplinary structured outpatient treatment program that is more intensive than individual outpatient therapy, group outpatient therapy, or family outpatient therapy;
-
Be provided to a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Be provided at least three (3) hours per day at least three (3) days per week;
-
Include the following:
a. Individual outpatient therapy;
b. Group outpatient therapy;
c. Family outpatient therapy unless contraindicated;
d. Crisis intervention; or
e. Psycho-education during which the client or client's family member shall be:
(i) Provided with knowledge regarding the client's diagnosis, the causes of the condition, and the reasons why a particular treatment might be effective for reducing symptoms; and
(ii) Taught how to cope with the client's diagnosis or condition in a successful manner;
- Include a treatment plan which shall:
a. Be individualized; and
b. Focus on stabilization and transition to a lesser level of care;
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
-
Include access to a board-certified or board-eligible psychiatrist for consultation;
-
Include access to a psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring; and
-
Be provided in a setting with a minimum client-to-staff ratio of ten (10) clients to one (1) staff person;
(i) Individual outpatient therapy which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
-
Be provided to a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Consist of:
a. A face-to-face encounter with the client; and
b. A behavioral health therapeutic intervention provided in accordance with the client's plan of care;
- Be aimed at:
a. Reducing adverse symptoms;
b. Reducing or eliminating the presenting problem of the client; and
c. Improving functioning;
-
Not exceed three (3) hours per day; and
-
Be provided by a behavioral health professional, a behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
(j) Group outpatient therapy which shall:
- Be provided to promote the:
a. Health and wellbeing of the client; or
b. Recovery from a substance related disorder;
-
Be provided to a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Consist of a face-to-face behavioral health therapeutic intervention provided in accordance with the client's plan of care;
-
Excluding multi-family group therapy, be provided in a group setting of nonrelated individuals, not to exceed twelve (12) individuals in size. For group outpatient therapy, a nonrelated individual means any individual who is not a spouse, significant other, parent or person with custodial control, child, sibling, stepparent, stepchild, step-brother, step-sister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild;
-
Focus on the psychological needs of the client as evidenced in the client's plan of care;
-
Center on goals including building and maintaining healthy relationships, personal goals setting, and the exercise of personal judgment;
-
Not include physical exercise, a recreational activity, an educational activity, or a social activity;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130;
-
Ensure that the group has a deliberate focus and defined course of treatment;
-
Ensure that the subject of group outpatient therapy shall be related to each client participating in the group; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice who shall maintain individual notes regarding each client within the group in the client's record;
(k) Family outpatient therapy which shall:
-
Consist of a face-to-face behavioral health therapeutic intervention provided through scheduled therapeutic visits between the therapist, at least one (1) member of the client's family, and the client unless the client's presence is not required in his or her plan of care;
-
Focus on the needs and treatment of a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Address issues interfering with the relational functioning of the family;
-
Seek to improve interpersonal relationships within the client's home environment;
-
Be provided to promote the health and wellbeing of the client or recovery from a substance use disorder;
-
Not exceed three (3) hours per day per client unless additional time is medically necessary in accordance with 907 KAR 3:130; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice;
(l) Collateral outpatient therapy which shall consist of a face-to-face behavioral health consultation:
-
With a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21), household member, legal representative, school personnel, or treating professional;
-
Provided by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice; and
-
Provided upon the written consent of a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21). Documentation of written consent shall be signed and maintained in the client's record;
(m) Service planning which shall be provided to a client age twenty-one (21) or younger by a behavioral health professional, behavioral health professional under clinical supervision, licensed behavior analyst, licensed assistant behavior analyst working under the supervision of a licensed behavior analyst to:
-
Assist a client in creating an individualized plan for services needed for maximum reduction of the effects of a mental health disorder;
-
Restore a client's functional level to the client's best possible functional level; and
-
Develop a service plan which:
a. Shall be directed by the client; and
b. May include:
(i) A mental health advance directive being filed with a local hospital;
(ii) A crisis plan; or
(iii) A relapse prevention strategy or plan;
(n) Screening, brief intervention, and referral to treatment for substance use disorders which shall:
-
Be an evidence-based early intervention approach for an individual with non-dependent substance use prior to the need for more extensive or specialized treatment;
-
Consist of:
a. Using a standardized screening tool to assess the individual for risky substance use behavior;
b. Engaging a client who demonstrates risky substance use behavior in a short conversation, providing feedback and advice;
c. Referring the client to therapy or other services that address substance use if the client is determined to need additional services; and
- Be provided by a behavioral health professional, behavioral health professional under clinical supervision, certified alcohol and drug counselor, licensed clinical alcohol and drug counselor, or licensed clinical alcohol and drug counselor associate practicing within his or her scope of practice to a client age twenty-one (21) or younger;
(o) Assertive community treatment for mental health disorders which shall:
-
Be provided to a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Include assessment, treatment planning, case management, psychiatric services, medication prescribing and monitoring, individual and group therapy, peer support, mobile crisis services, mental health consultation, family support, and basic living skills;
-
Be provided by a multidisciplinary team of at least four (4) professionals, including a psychiatrist, nurse, case manager, peer support specialist, and any other behavioral health professional or behavioral health professional under clinical supervision; and
-
Have adequate staffing to ensure that no caseload size exceeds ten (10) participants per team;
(p) Comprehensive community support services which shall:
-
Be provided to a client age twenty-one (21) or younger and may continue without disruption after the client reaches age twenty-two (22) if the service is continued for therapeutic benefit as identified in the client's plan of care;
-
Consist of activities needed to allow an individual with a mental health disorder to live with maximum independence in the community through the use of skills training as identified in the client's treatment plan;
-
Consist of using a variety of psychiatric rehabilitation techniques to:
a. Improve daily living skills;
b. Improve self-monitoring of symptoms and side effects;
c. Improve emotional regulation skills;
d. Improve crisis coping skills; and
e. Develop and enhance interpersonal skills; and
- Be provided by a;
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision;
c. Community support associate;
d. Licensed behavior analyst; or
e. Licensed assistant behavior analyst working under the supervision of a licensed behavior analyst;
(q) Therapeutic rehabilitation program for a child with a severe emotional disability which shall be provided to a client under twenty-one (21) years of age and shall:
-
Include services designed to maximize the reduction of the emotional disability and restoration of the client's functional level to the individual's best possible functioning;
-
Establish the client's own rehabilitative goals within the person-center plan of care;
-
Be delivered using a variety of psychiatric rehabilitation techniques focused on:
a. Improving daily living skills;
b. Self-monitoring of symptoms and side effects;
c. Emotional regulation skills;
d. Crisis coping skills; and
e. Interpersonal skills; and
- Be provided individually or in a group by a:
a. Behavioral health professional;
b. Behavioral health professional under clinical supervision; or
c. Peer support specialist; or
(r) Targeted case management services which shall:
- Include services to one (1) or more of the following target groups:
a. A client under age twenty-one (21) with substance use disorder;
b. A client under age twenty-one (21) with co-occurring mental health or substance use disorder and chronic or complex physical health issues; or
c. A child with a severe emotional disability as defined by KRS 200.503(3);
-
Be provided by a case manager as described in subsection (2), (3), or (4) of this section; and
-
Include the following assistance:
a. Comprehensive assessment and reassessment of client needs to determine the need for medical, educational, social, or other services. The reassessment shall be conducted annually or more often if needed based on changes in the client's condition;
b. Development of a specific care plan which shall be based on information collected during the assessment and revised if needed upon reassessment;
c. Referral and related activities, which may include:
(i) Scheduling appointments for the client to help the individual obtain needed services; or
(ii) Activities that help link the client with medical, social, educational providers, or other programs and services which address identified needs and achieve goals specified in the care plan;
d. Monitoring which shall be face-to-face and occur no less than once every three (3) months to determine that:
(i) Services are furnished according to the client's care plan;
(ii) Services in the care plan are adequate; and
(iii) Changes in the needs or status of the client are reflected in the care plan; and
e. Contacts with the client, family members, service providers, or others are conducted as frequently as needed to help the client:
(i) Access services;
(ii) Identify needs and supports to assist the client in obtaining services; and
(iii) Identify changes in the client's needs.
(2) A case manager who provides targeted case management services to clients with a substance use disorder shall:
(a) Be a certified alcohol and drug counselor, meet the grandfather requirements of 907 KAR 15:040, Section 4(1)(a)3, or have a bachelor's degree in a human services field, including:
-
Psychology;
-
Sociology;
-
Social work;
-
Family studies;
-
Human services;
-
Counseling;
-
Nursing;
-
Behavioral analysis;
-
Public health;
-
Special education;
-
Gerontology;
-
Recreational therapy;
-
Education;
-
Occupational therapy;
-
Physical therapy;
-
Speech-language pathology;
-
Rehabilitation counseling; or
-
Faith-based education;
(b)
-
Have a minimum of one (1) year of full-time employment working directly with adolescents in a human service setting after completion of a bachelor's degree as described in paragraph (a) of this subsection; or
-
Have a master's degree in a human services field as described in paragraph (a) of this subsection;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) Be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least two (2) times per month with at least one (1) of the contacts on an individual, in person basis.
(3) A case manager who provides targeted case management services to clients with a mental health or substance use disorder and chronic or complex physical health issues shall:
(a) Meet the requirements of subsection (2)(a) of this section;
(b)
-
After completion of a bachelor's degree, have a minimum of five (5) years of experience providing service coordination or referring clients with complex behavioral health needs and co-occurring disorders or multi-agency involvement to community based services; or
-
After completion of a master's degree in a human services field as described in subsection (2)(a) of this section, have a minimum of two (2) years of experience providing service coordination or referring clients with complex behavioral health needs and co-occurring disorders or multi-agency involvement to community based services;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) For a bachelor's level case manager, be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least three (3) times per month with at least two (2) of the contacts on an individual, in person basis.
(4) A case manager who provides targeted case management services to children with a severe emotional disability or clients with a severe mental illness shall:
(a) Meet the requirements of subsection (2)(a) of this section;
(b)
-
Have a minimum of one (1) year of full-time employment working directly with individuals with behavioral health needs after completion of a bachelor's degree in a behavioral science field as described in subsection (2)(a) of this section; or
-
Have a master's degree in a human services field as described in subsection (2)(a) of this section;
(c)
-
Have successfully completed case management training in accordance with 908 KAR 2:260; and
-
Successfully complete continuing education requirements in accordance with 908 KAR 2:260; and
(d) Be supervised by a behavioral health professional who:
-
Has completed case management training in accordance with 908 KAR 2:260; and
-
Has supervisory contact at least two (2) times per month with at least one (1) of the contacts on an individual in person basis.
(5) Plan of care.
(a) Each client receiving outpatient behavioral health services from a Level I or Level II PRTF shall have an individual plan of care signed by a behavioral health professional.
(b) A plan of care shall:
-
Describe the services to be provided to the client, including the frequency of services;
-
Contain measurable goals for the client to achieve, including the expected date of achievement for each goal;
-
Describe the client's functional abilities and limitations or diagnosis listed in the current edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders;
-
Specify each staff member assigned to work with the client;
-
Identify methods of involving the client's family or significant others if indicated;
-
Specify criteria to be met for termination of treatment;
-
Include any referrals necessary for services not provided directly by the chemical dependency treatment program; and
-
State the date scheduled for review of the plan.
(c) The client shall participate to the maximum extent feasible in the development of his or her plan of care, and the participation shall be documented in the client's record.
(d)
-
The initial plan of care shall be developed through multidisciplinary team conferences at least thirty (30) days following the first ten (10) days of treatment.
-
The plan of care for individuals receiving intensive outpatient program services shall be reviewed every thirty (30) days thereafter and updated every sixty (60) days or earlier if clinically indicated.
-
Except for intensive outpatient program services, the plan of care for individuals receiving any other outpatient behavioral health service described in subsection (1) of this section shall be reviewed and updated every six (6) months or earlier if clinically indicated.
-
The plan of care and each review and update shall be signed by the participants in the multidisciplinary team conference that developed it.
(6) Physical environment of an off-campus extension or separate building on the campus of the Level I or Level II PRTF where outpatient behavioral health services are provided.
(a) Accessibility. The off-campus extension or separate building on the campus of the PRTF shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and 815 KAR 7:120.
(b) Physical location and overall environment.
- The program shall:
a. Comply with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions;
b. Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;
c. Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day;
d. Have a reception and waiting area;
e. Provide a restroom; and
f. Have an administrative area.
- The condition of the physical location and the overall environment shall be maintained in such a manner that the safety and well-being of clients, personnel, and visitors are assured.
(c) Prior to occupancy, the facility shall have final approval from appropriate agencies.
Section 15. Use of Emergency Safety Interventions in a Level I or Level II PRTF.
(1) Pursuant to 42 C.F.R. 483.356(a)(3), restraint or seclusion shall not result in harm or injury to the resident and shall be used only:
(a) To ensure the safety of the resident or others during an emergency safety situation; and
(b) Until the emergency safety situation has ceased and the resident's safety and the safety of others can be ensured, even if the restraint or seclusion order has not expired.
(2)
(a) The use of mechanical restraint shall be prohibited in a Level I or Level II PRTF.
(b) Residents of a Level I or Level II PRTF shall not be held in a prone position during restraint. A Level I or Level II PRTF may use a supine hold:
-
As a last resort if other less restrictive interventions have proven to be ineffective; and
-
Only by staff who are trained to identify risks associated with positional, compression, or restraint asphyxiation, and who monitor to tenure that the resident's breathing is not impaired.
(3) Emergency safety interventions shall not be used as a means of coercion, punishment, convenience, or retaliation.
(4) Orders for restraint or seclusion shall be:
(a) By a physician or other licensed practitioner acting within his or her scope of practice who is trained in the use of emergency safety interventions;
(b) Carried out by trained staff;
(c) If the resident's treatment team physician is available, given only by that physician; and
(d) The least restrictive emergency safety intervention that is most likely to be effective in resolving the emergency safety situation based on consultation with staff.
(5) A Level I or Level II PRTF shall have a written plan approved by the governing body for the use of emergency safety interventions which at a minimum shall meet the following requirements:
(a) Any use of an emergency safety intervention shall require clinical justification;
(b) A rationale and the clinical indications for the use of an emergency safety intervention shall be clearly stated in the resident's record for each occurrence. The rationale shall address the inadequacy of less restrictive intervention techniques;
(c) The plan shall specify the length of time for which a specific approval remains effective;
(d) The plan shall specify the length of time the emergency safety intervention may be utilized; and
(e) The plan shall specify when continued or repeated emergency safety interventions shall trigger multidisciplinary team review.
(6) If an emergency safety situation requires restraint or seclusion and a practitioner authorized to order restraint or seclusion is not available in a Level I or Level II PRTF, a verbal order for restraint and seclusion may be obtained and carried out under the following conditions:
(a) The verbal order shall be given by a licensed practitioner, as authorized by the facility, who is acting within his or her scope of practice and is trained in the use of emergency safety interventions;
(b) The verbal order shall be received by a licensed practitioner, as authorized by the facility, who is acting within his or her scope of practice;
(c) The physician or ordering practitioner shall be immediately available, at least by telephone, for consultation during the time that restraint or seclusion is being carried out; and
(d) The verbal order shall be countersigned by the physician or ordering practitioner within seven (7) days of the date that the order was given, and included in the resident's record.
(7) An order for restraint or seclusion shall not exceed the shortest of:
(a) The duration of the emergency safety situation;
(b) Four (4) hours for a resident eighteen (18) to twenty-one (21) years of age;
(c) Two (2) hours for a resident nine (9) to seventeen (17) years of age;
(d) One (1) hour for a resident seven (7) to eight (8) years of age; or
(e) Thirty (30) minutes for a child four (4) to six (6) years of age.
(8) If an emergency safety situation exists beyond the time limit for the use of restraint or seclusion, a new order for restraint or seclusion shall be obtained.
(9) A resident that is placed in restraint or seclusion shall receive a face-to-face evaluation to determine physical and psychological well being. The evaluation shall:
(a) Be conducted by a licensed practitioner who is acting within his or her scope of practice and is trained in the use of emergency safety interventions;
(b) Include the resident's physical and psychological status, resident's behavior, appropriateness of the intervention measures, and any complications resulting from the intervention; and
(c) Be conducted within one (1) hour of restraint or seclusion being initiated.
(10) Each order for restraint or seclusion shall include:
(a) The name of the ordering physician or other licensed practitioner, acting within his or her scope of practice and trained in the use of emergency safety interventions;
(b) The date and time the order was obtained; and
(c) The emergency safety intervention ordered, including the length of time for which the physician or other licensed practitioner authorized its use.
(11)
(a) Staff shall document the emergency safety intervention in the resident's record.
(b) The documentation shall be completed by the end of the shift in which the intervention occurs.
(c) If the intervention does not end during the shift in which it began, documentation shall be completed during the shift in which it ends. Documentation shall include:
-
Each order for restraint or seclusion as described in subsection (10) of this section;
-
The time the emergency safety intervention actually began and ended;
-
The time and results of the evaluation required by subsection (9) of this section;
-
The emergency safety situation that required the resident to be restrained or put in seclusion; or
-
The name of staff involved in the emergency safety intervention.
(12) Staff who implement emergency safety interventions shall:
(a) Have documented training in the proper use of the procedure used;
(b) Be certified in physical management by a nationally-recognized training program in which certification is obtained through skills-based testing; and
(c) Receive annual training and recertification in crisis intervention and behavior management.
(13) Staff authorized by a Level I or Level II PRTF shall:
(a) Be constantly, physically present with a resident being restrained;
(b) Monitor the physical and psychological well being of a resident being restrained, and monitor the safe use of restraint throughout the duration of the emergency safety intervention; and
(c) Document observations of, and actions taken for, a resident being restrained.
(14) Within one (1) hour of initiation of restraint or seclusion, a physician or licensed practitioner acting within his or her scope of practice and trained in the use of emergency safety interventions shall conduct a face-to-face evaluation of the resident's physical and psychological well-being.
(15) Staff shall provide constant visual attention to a resident who is in seclusion, through physical presence or a window.
(16) Staff authorized by a Level I or Level II PRTF shall:
(a) Monitor the physical and psychological well being of the resident;
(b) Ensure that a resident in seclusion is provided:
-
Regular meals;
-
Hydration;
-
Bathing; and
-
Use of the toilet; and
(c) Document observations of, and actions taken for, a resident in restraint every fifteen (15) minutes.
(17) A procedure shall not be used at any time in a manner that causes harm or pain to a resident.
(18)
(a) A Level I or Level II PRTF shall notify the parent, guardian, or custodian of the resident who has been restrained or placed in seclusion as soon as possible after the initiation of each emergency safety intervention.
(b) The facility shall document in the resident's record that the parent, guardian, or custodian has been notified of the emergency safety intervention, including the date and time of notification and the name of the staff person providing the notification.
(19)
(a) Within twenty-four (24) hours after use of restraint or seclusion, staff involved in an emergency safety intervention and the resident shall have a face-to-face discussion.
(b) The discussion shall include all staff involved in the intervention except if the presence of a particular staff person may jeopardize the well-being of the resident. The discussion may include other staff and the resident's parent, guardian, or custodian.
(20) Within twenty-four (24) hours after the use of restraint or seclusion, all staff involved in the emergency safety intervention, and appropriate supervisory and administrative staff, shall conduct a debriefing session that includes a review and discussion of:
(a) The emergency safety situation that required the intervention, including a discussion of the precipitating factors that led up to the intervention;
(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 restraint or seclusion; and
(d) The outcome of the intervention, including any injuries that may have resulted from the use of restraint or seclusion.
(21) Application of time out.
(a) A resident in time out shall not be physically prevented from leaving the time out area.
(b) Time out may take place away from the area of activity or from other residents.
(c) Staff shall monitor the resident while he or she is in time out.
(22) A Level I or Level II PRTF shall not use extraordinary risk procedures, including experimental treatment modalities, psychosurgery, aversive conditioning, electroconvulsive therapies, behavior modification procedures that use painful stimuli, unusual medications, or investigational and experimental drugs.
(23) Unusual treatment shall require the informed consent of the resident and parent, guardian, or custodian prior to the provision of unusual treatment as follows:
(a) The proposed unusual treatment shall be reviewed and interpreted by the child's psychiatrist addressing:
-
The rationale for use;
-
Methods to be used;
-
Specified time to be used;
-
Who will provide the treatment; and
-
The methods that will be used to evaluate the efficacy of the treatment.
(b) The potential risks, side effects, and benefits of the proposed unusual treatment shall be explained, verbally and in writing, to the resident and the parent, guardian, or custodian prior to their granting approval for the unusual treatment. The approval shall be given in writing prior to implementation of the treatment.
(24) The clinical director or designee shall review all uses of unusual treatment procedures, including emergency safety interventions, on a daily basis. The daily review shall include an evaluation for the possibility of unusual or unwarranted patterns of use.
Section 16. Housekeeping Services.
(1) A Level I or Level II PRTF shall have policies and procedures for and services which maintain a clean, safe, and hygienic environment for residents and facility personnel. Policies and procedures shall include guidelines for at least the following:
(a) The use, cleaning, and care of equipment;
(b) Assessing the proper use of housekeeping and cleaning supplies;
(c) Evaluating the effectiveness of cleaning; and
(d) The role of the facility staff in maintaining a clean environment.
(2) A laundry service shall be provided by a Level I or Level II PRTF or through contractual agreement.
(3) Pest control shall be provided by a Level I or Level II PRTF or through contractual agreement.
Section 17. Infection Control.
(1) Because infections acquired in a Level I or Level II PRTF or brought into a Level I or Level II PRTF from the community are potential hazards for all persons having contact with the facility, there shall be an infection control program developed to prevent, identify, and control infections.
(2) Written policies and procedures pertaining to the operation of the infection control program shall be established, reviewed at least annually, and revised as necessary.
(3) A practical system shall be developed for reporting, evaluating, and maintaining records of infections among residents and personnel.
(4) The system shall include assignment of responsibility for the ongoing collection and analysis of data, as well as for the implementation of required follow-up actions.
(5) Corrective actions shall be taken on the basis of records and reports of infections and infection potentials among residents and personnel and shall be documented.
(6) All new employees shall be instructed in the importance of infection control and personal hygiene and in their responsibility in the infection control program.
(7) A Level I or Level II PRTF shall document that in-service education in infection prevention and control is provided for all services and program components.
Section 18. Tuberculosis Testing Requirements.
(1) Induration Measurements. The diameter of the firm area shall be measured transversely to the nearest millimeter to gauge the degree of reaction, and the result shall be recorded in millimeters.
(a) A reaction of ten (10) millimeters or more of induration shall be considered highly indicative of tuberculosis infection in a healthcare setting.
(b) A reaction of five (5) millimeters or more of induration may be significant in certain individuals, including HIV-infected persons, persons with immunosuppression, or recent contacts of persons with active TB disease.
(2) Tuberculosis (TB) disease.
(a) A person shall be diagnosed as having tuberculosis (TB) disease if the infection has progressed to causing clinical (manifesting signs or symptoms) or subclinical (early stage of disease in which signs or symptoms are not present, but other indications of disease activity are present, including radiographic abnormalities) illness.
-
Tuberculosis that is found in the lungs shall be called pulmonary TB and may be infectious.
-
Tuberculosis that occurs at a body site outside the lungs shall be called extra pulmonary disease and may be infectious in rare circumstances.
(b) If the only clinical finding is specific chest radiographic abnormalities, the condition shall be termed "inactive TB" and may be differentiated from active TB disease, which shall be accompanied by symptoms or other indications of disease activity, including the ability to culture reproducing TB organisms from respiratory secretions or specific chest radiographic finding.
(3)
(a) A TST conversion shall have occurred if there is a greater than ten (10) millimeters increase in the size of the TST induration during a two (2) year period in:
-
A health care worker with a documented negative (<10 mm) baseline two (2) step TST result; or
-
A person who is not a health care worker with a negative (<10 mm) TST result within two (2) years.
(b) A TST conversion shall be presumptive evidence of new M. tuberculosis infection and poses an increased risk for progression to TB disease.
Section 19. Admission of Residents under Treatment for Pulmonary Tuberculosis Disease.
(1) A Level I or Level II PRTF shall not admit a person under medical treatment for pulmonary tuberculosis disease unless the person is declared noninfectious by a licensed physician in conjunction with the local or state health department.
(2) Documentation of noninfectious status shall include:
(a) Documented TB disease treatment with multi-drug therapy for at least two (2) weeks;
(b) Documentation of clinical improvement on therapy;
(c) Three (3) consecutive sputum smears negative for acid-fast bacilli within the one (1) month period prior to admission; or
(d) Three (3) negative sputum cultures for TB.
Section 20. Tuberculin Skin Tests or BAMTs of Residents.
(1) For residents entering a facility, a TST or BAMT shall not be required if one (1) of the following is documented:
(a) A previously documented TST has shown ten (10) or more millimeters of induration;
(b) A previously documented TST has shown five (5) or more millimeters of induration for a resident who has medical reasons (HIV-infected persons, immunosuppression, or recent contact with a person with active TB disease) for his or her TST result to be interpreted as positive;
(c) A positive BAMT;
(d) The resident is currently receiving or has completed treatment of LTBI with nine (9) months of ionized or four (4) months of rifampin, or has completed a course of multiple-drug therapy for active TB disease; or
(e) The resident can document that he or she has had a TST or BAMT within three (3) months prior to admission and has previously been in a serial testing program at a medical facility.
(2)
(a) If a resident does not meet the criteria of subsection (1) of this section, a TST or a BAMT shall be required upon admission to the Level I or Level II facility.
(b)
-
A TST shall be required for residents less than five (5) years of age.
-
A TST result of five (5) or more millimeters of induration may be positive for those residents who have medical reasons (HIV-infected persons, immunosuppression, or recent contact with a person with active TB disease) for his or her TST result to be interpreted as positive.
-
For a resident without medical reasons as identified in subparagraph 2. of this paragraph whose initial TST shows less than ten (10) millimeters of induration, two-step TSTs shall be required for:
a. A resident age fourteen (14) years and older; or
b. A resident expected to stay longer than twelve (12) months unless the resident is able to document that he or she has had a TST within one (1) year prior to initial testing upon admission to the facility.
(3)
(a) The TST result of each resident shall be documented through recording of the date and millimeters of induration of the most recent skin test in the medical record.
(b) The medical record shall be labeled in a conspicuous manner (e.g. Problem Summary or Care Plan) with the notation "TST Positive" for each resident with a reaction of ten (10) or more millimeters of induration and for each resident with a reaction of five (5) or more millimeters of induration who has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for that TST result to be interpreted as positive.
(4)
(a) If performed and the result is positive or negative, only one (1) BAMT result shall be required on admission.
(b) A second BAMT shall be performed if the BAMT result is borderline or indeterminate.
(c) If a resident has a positive BAMT, the medical record shall be labeled in a conspicuous manner (e.g. Problem Summary or Care Plan) with the notation "BAMT Positive."
Section 21. Medical Evaluations and Chest X-rays of Residents.
(1) A resident shall receive a medical evaluation, which may include an HIV test, if the resident is found at the time of admission to have a:
(a) TST of ten (10) or more millimeters of induration;
(b) TST result of five (5) or more millimeters of induration if the resident has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for that TST result to be interpreted as positive; or
(c) Positive BAMT.
(d) A chest x-ray shall be performed unless a chest x-ray done within two (2) months prior to admission showed no evidence of tuberculosis disease.
(2)
(a) A resident who meets the criteria listed in subsection (1) of this section and who has no clinical evidence of active TB disease upon evaluation by a licensed physician and a negative chest x-ray shall be offered treatment for LTBI unless there is a medical contraindication.
(b) A resident who refuses treatment for LTBI or who has a medical contraindication shall be monitored according to the requirements established in Section 22 of this administrative regulation.
(3) A resident with an abnormal chest x-ray, consistent with TB disease, shall be:
(a) Evaluated for active tuberculosis disease; and
(b) If the resident is diagnosed with active tuberculosis disease, transferred to a facility with an airborne infection isolation (AII) room and started on multi-drug antituberculosis treatment that is administered by DOT.
Section 22. Monitoring of Residents with a Positive TST, a Positive BAMT, a TST Conversion, or a BAMT Conversion.
(1) A resident shall be monitored for development of pulmonary symptoms, including cough, sputum production, or chest pain, if the resident has a:
(a) TST result with ten (10) or more millimeters of induration;
(b) TST result of five (5) or more millimeters of induration if the resident has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for that TST result to be interpreted as positive;
(c) Positive BAMT;
(d) TST conversion; or
(e) BAMT conversion.
(2) If pulmonary symptoms, including cough, sputum production, or chest pain, develop and persist for three (3) weeks or longer:
(a) The resident shall have a medical evaluation;
(b) A chest x-ray shall be taken; and
(c) Three (3) sputum samples shall be submitted to the Division of Laboratory Services, Department for Public Health, Frankfort, Kentucky, for tuberculosis culture and smear.
(3) A resident with suspected or active TB disease shall be transferred to a facility with an AII room and started on multi-drug antituberculosis treatment that is administered by DOT.
Section 23. Monitoring of Residents with a Negative TST or a Negative BAMT who are Residents Longer than One
(1) Year. (1) Annual testing shall be required on or before the anniversary of the resident's last TST or BAMT.
(2) A TST shall be required for residents less than five (5) years of age.
(3) If pulmonary symptoms develop and persist for three (3) weeks or more:
(a) The resident shall have a medical evaluation;
(b) The tuberculin skin test shall be repeated;
(c) Three (3) sputum samples shall be submitted to the Division of Laboratory Services, Department for Health Services, Frankfort, Kentucky for tuberculosis culture and smear; and
(d) A chest x-ray shall be taken.
(4) A resident with suspected or active TB disease shall be transferred to a facility with an AII room and started on multi-drug antituberculosis treatment that is administered by DOT.
Section 24. Tuberculin Skin Tests or BAMTs for Staff.
(1) The TST or BAMT status of all PRTF facility staff members who have direct contact with residents shall be documented in the employee's health record.
(2) A TST or BAMT shall be initiated on each new staff member who has direct contact with residents before or during the first week of employment, and the results shall be documented in the employee's health record within the first month of employment.
(3) A TST or BAMT shall not be required at the time of initial employment if the employee documents one of the following:
(a) A prior TST of ten (10) or more millimeters of induration;
(b) A prior TST of five (5) or more millimeters of induration if the employee has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for his or her TST result to be interpreted as positive;
(c) A positive BAMT;
(d) A TST conversion;
(e) A BAMT conversion; or
(f) The employee is currently receiving or has completed treatment for LTBI.
(4)
(a) If performed and the result is positive or negative, one (1) BAMT test result shall be required on initial employment.
(b) A second BAMT shall be performed if the BAMT result is borderline or indeterminate.
(5) A TST result of five (5) or more millimeters of induration may be positive for a new employee who has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for his or her TST result to be interpreted as positive.
(6) A two-step TST shall be required for a new employee who does not have a medical reason as described in subsection (5) of this section and whose initial TST shows less than ten (10) millimeters of induration, unless the individual documents that he or she has had a TST within one (1) year prior to his or her current employment.
(7) A staff member who has never had a TST of ten (10) or more millimeters induration or a positive BAMT shall have a TST or BAMT annually on or before the anniversary of his or her last TST or BAMT.
Section 25. Medical Evaluations and Chest X-rays and Monitoring of Staff with a Positive TST, a Positive BAMT, a TST Conversion, or a BAMT Conversion.
(1) At the time of initial employment testing or annual testing, a staff member who has direct contact with residents shall have a medical evaluation, which may include an HIV test, if the staff member is found to have a:
(a) TST of ten (10) or more millimeters induration;
(b) TST result of five (5) or more millimeters of induration if the staff member has a medical reason (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for his or her TST result to be interpreted as positive;
(c) Positive BAMT;
(d) TST conversion; or
(e) BAMT conversion.
(2) A chest x-ray shall be performed unless a chest x-ray within the previous two (2) months showed no evidence of tuberculosis disease.
(3)
(a) A staff member with a negative chest x-ray shall be offered treatment for LTBI unless there is a medical contraindication.
(b) A staff member who refuses treatment for LTBI or who has a medical contraindication shall be monitored according to the requirements established in Section 28 of this administrative regulation.
(4)
(a) A staff member with an abnormal chest x-ray shall be evaluated for active tuberculosis disease, and three (3) sputum samples shall be submitted to the Division of Laboratory Services, Department for Public Health, Frankfort, Kentucky, for tuberculosis culture and smear.
(b) A staff member shall remain off work until cleared as being noninfectious for TB by a licensed physician.
(c) A staff member whose medical evaluation and laboratory tests are suspect for active tuberculosis disease shall be isolated (e.g. in an AII room or in home isolation) and started on four (4) drug antituberculosis treatment that is administered by DOT.
(5)
(a) A staff member under treatment for pulmonary tuberculosis disease may return to work in the facility after being declared noninfectious by a licensed physician in conjunction with the local or state health department.
(b) Documentation of noninfectious status shall include:
-
Documented TB disease treatment with multi-drug therapy for at least two (2) weeks;
-
Documentation of clinical improvement on therapy;
-
Three (3) consecutive sputum smears negative for acid-fast bacilli within the month prior to the employee's anticipated return to work; or
-
Three (3) negative sputum cultures for TB.
Section 26. Responsibility for Screening and Monitoring Requirements.
(1) The program director or clinical director of the facility shall be responsible for ensuring that all TSTs, BAMTs, chest x-rays and sputum samples submissions are done in accordance with Sections 18 through 28 of this administrative regulation.
(2) If a facility does not employ licensed professional staff with the technical training to carry out the screening and monitoring requirements, the program director or clinical director shall arrange for professional assistance from the local health department.
(3)
(a) Dates of all TSTs or BAMTs and results, all chest x-ray reports and all sputum sample culture and smear results for residents shall be recorded as a permanent part of the resident's medical record and be summarized on the individual's transfer form if an interfacility transfer occurs.
(b) The TST or BAMT status of all staff members and any TB related chest x-ray reports shall be documented in the employee's health record.
Section 27. Reporting to Local Health Departments. The following shall be reported to the local health department having jurisdiction by the program director or clinical director of the facility immediately upon becoming known:
(1) All residents and staff who have a TST of ten (10) millimeters or more induration;
(2) A TST result of five (5) or more millimeters of induration for all residents or staff who have medical reasons (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for their TST result to be interpreted as positive;
(3) A positive BAMT at the time of admission of a resident or employment of a staff member who has direct contact with residents;
(4) TST conversions or BAMT conversions on serial testing or identified in a contact investigation;
(5) Chest x-rays which are suspicious for TB disease;
(6) Sputum smears positive for acid-fast bacilli;
(7) Sputum cultures positive for Mycobacterium tuberculosis; or
(8) The initiation of multi-drug antituberculosis treatment.
Section 28. Treatment for LTBI.
(1) A resident or staff member with a TST conversion or a BAMT conversion shall be considered to be recently infected with Mycobacterium tuberculosis.
(2) Recently infected persons shall have a medical evaluation, which may include an HIV test, and shall include a chest x-ray.
(3)
(a) Individuals who meet the criteria listed in subsection (1) of this section and have no signs or symptoms of tuberculosis disease by medical evaluation or chest x-ray shall be offered treatment for LTBI with isoniazid for nine (9) months or rifampin for four (4) months, in collaboration with the local health department, unless medically contraindicated as determined by a licensed physician.
(b) Medications shall be administered to residents upon the written order of a physician and shall be given by DOPT.
(4)
(a) If a resident or staff member refuses treatment for LTBI or has a medical contraindication, the individual shall be advised of the clinical symptoms of active TB disease, and have an interval medical history for clinical symptoms of active TB disease every six (6) months during the two (2) years following conversion.
(b) A resident less than five (5) years of age who has a status change on admission to the facility or on annual testing shall be seen and monitored by a pediatrician.
(c) A resident or staff member who has a TST result of ten (10) millimeters or more induration or a positive BAMT at the time of admission of the resident or employment of the staff member shall be offered treatment for LTBI.
(d) A resident or staff member who has a TST result of five (5) or more millimeters of induration at the time of admission or employment and who has medical reasons (e.g. HIV-infected persons, immunosuppression, or recent contacts of persons with active TB disease) for his or her TST result to be interpreted as positive shall be offered treatment for LTBI.
(e) If a resident or staff member refuses treatment for LTBI detected on admission or employment or has a medical contraindication, the individual shall be educated about the clinical symptoms of active TB disease, and have an interval medical history for symptoms of active TB disease every six (6) months during the two (2) years following admission or employment. The education shall be documented in either the resident's medical record or the employee's health record.
(5) A resident who stays longer than one (1) year in the facility or staff member who documents completion of treatment for LTBI shall:
(a) Be exempt from further requirements for TSTs or BAMTs; and
(b) Receive education on the symptoms of active TB disease during his or her annual tuberculosis risk assessment and any other monitoring in accordance with Sections 21 or 26, or this section of this administrative regulation.
History
- RELATES TO: KRS 17.165, 17.500, 200.503, 216B.105, 216B.450-216B.457, 309.080, 309.130, 311.571, 311.840 – 311.862, 311.858, 314.011, 314.042, 319.050, 319.056, 319.064, 319C.010, 320.240, 335.100, 335.300, 335.080, 335.500, 439.3401, 645.020, 42 C.F.R. 441.156, 42 C.F.R. 483.350-483.376
- STATUTORY AUTHORITY: KRS 216B.042, 216B.455, 216B.457
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Kentucky Cabinet for Health and Family Services to promulgate administrative regulations to govern health facilities and services. KRS 216B.455 and 216B.457 require the cabinet to promulgate administrative regulations establishing requirements for psychiatric residential treatment facilities. This administrative regulation provides minimum licensure requirements regarding the operation of and services provided in Level I or Level II psychiatric residential treatment facilities, including those facilities which elect to provide outpatient behavioral health services.
- History: 17 Ky.R. 2110; Am. 2452; eff. 3-12-1991; 19 Ky.R. 1202; 1613; 1772; eff. 1-27-1993; 21 Ky.R. 1572; 1889; eff. 2-10-1995; 23 Ky.R. 2309; 3053; eff. 2-19-97; 24 Ky.R. 1966; eff. 5-18-1998; 32 Ky.R. 517; 667; eff. 10-19-2005; 37 Ky.R. 1574; 2223; 2402; eff. 5-6-2011; 41 Ky.R. 2393; 42 Ky.R. 698; eff. 11-18-2015; TAm eff. 3-20-2020; Cert Eff. 11-23-2021.
902 KAR 20:330 Psychiatric residential treatment facilities {#sec-902-kar-20-330 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:330}
Section 1. Definitions.
(1) "Certificate of need" is defined by KRS 216B.015(8).
(2) "Licensure agency" means the Cabinet for Health and Family Services, Office of the Inspector General.
(3) "Living unit" means:
(a) The area within a single building that is supplied by a Level I facility for daily living and therapeutic interaction of no more than nine (9) residents; or
(b) The area within a Level II facility that is designated for daily living and therapeutic interaction of no more than twelve (12) residents.
(4) "Psychiatric residential treatment facility" or "PRTF" is defined by KRS 216B.450(5) as a Level I facility or a Level II facility.
Section 2. Preparation and Approval of Plans and Specifications for a Level I or a Level II PRTF. After receipt of a certificate of need, if required under KRS Chapter 216B, and before initiation of new construction or renovation, or prior to making a change in function of a facility, the processes established in this section shall be followed.
(1) The licensee or applicant shall submit plans in sufficient detail to show compliance with this administrative regulation to the licensure agency for approval.
(2) Architectural, mechanical, and electrical drawings shall bear either the seal of a professional engineer registered in the Commonwealth of Kentucky or an architect registered in the Commonwealth of Kentucky.
(3) Drawings shall not exceed thirty-six (36) inches by forty-six (46) inches when trimmed.
(4) A copy of the narrative program for a project shall be provided to the licensure agency by the applicant or licensee and shall describe the functional space requirements, staffing patterns, departmental relationships, and organizational plans relating to the fulfillment of the mission and objectives of the facility.
(5) Plans and specifications shall be approved by the licensure agency prior to commencement of construction of a new building, renovation of an existing facility, or making a change in function of a facility.
(6) Plans and specifications in specific detail as required by the Kentucky Building Code, 815 KAR 7:120, shall be submitted together with architectural or engineering stamps as required by KRS Chapters 322 and 323, to the Department of Housing, Buildings and Construction for determining compliance with the Kentucky Building Code. Plans and specifications shall be approved by the Department of Housing, Buildings and Construction, and local building permits shall be obtained prior to commencement of construction.
(7) Representatives of the Cabinet for Health and Family Services shall have access at all reasonable times to the work wherever it is in preparation or progress.
Section 3. Level I and Level II PRTF: Compliance with Building Codes, Ordinances, and Administrative Regulations.
(1) A PRTF shall be in compliance with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions.
(2) The following requirements shall apply when a PRTF is constructed, modified, or renovated:
(a) Fire safety pursuant to 815 KAR 10:060;
(b) Plumbing pursuant to 815 KAR 20:010 through 20:195;
(c) Elevators pursuant to 815 KAR 4:010 through 4:025; and
(d) Building accessibility by persons with disabilities pursuant to 28 C.F.R. Part 36.
(3) New construction, modification, or renovation shall be approved by the Department of Housing, Buildings and Construction prior to occupancy.
Section 4. Level I and Level II PRTF: Facility Requirements and Special Conditions.
(1) A facility shall be accessible to and usable by persons with disabilities in compliance with the provisions of the Americans With Disabilities Act, 42 U.S.C. 12101 et seq.
(2) Access to a facility shall be by means of a paved or gravel roadway that is open, free from obstruction, and in good repair.
(3) The building structure and overall physical environment, including the number and type of diagnostic, clinical, and administrative rooms, educational facilities if applicable, and recreational space, shall:
(a) Be sufficient to meet the needs of the patient census and specialized program needs of the residents as described in the facility's narrative program document; and
(b) Ensure a secure environment for residents.
Section 5. Living Unit for a Level I PRTF. A living unit shall be located within a single building and shall comply with the requirements in this section.
(1) Bedrooms.
(a) A bedroom shall not be used for sleeping accommodations for more than two (2) residents.
(b) A bedroom shall be equipped with a bed for each resident that shall:
-
Be at least thirty-six (36) inches wide and sixty (60) inches long;
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Accommodate the resident's size;
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For proposals which entail renovation of an existing facility, be positioned to allow at least three (3) feet of free space between beds and four (4) feet of free space extending directly away from the foot of the bed; and
-
Be located sufficient distance from radiators, heat outlets, and drafts to avoid discomfort.
(c) For new construction, each:
-
Single occupancy bedroom shall have a minimum floor area of 100 square feet, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules; and
-
Semi-private bedroom used for sleeping accommodations for two (2) residents shall have a minimum floor area of eighty (80) square feet per bed, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules.
(d) A resident's bed shall be equipped with:
-
A support mechanism and a clean mattress;
-
A mattress cover with rubber or impervious sheets, if necessary; and
-
Two (2) sheets, a pillow, and bed covering of sufficient quality to maintain resident comfort.
(e) Separate sleeping quarters shall be maintained for male and female residents.
(f) A resident shall not be housed in a room, detached building, or other enclosure which has not been inspected and approved for occupancy by the licensure agency and the Department of Housing, Buildings and Construction.
(g) A bedroom shall not be located more than sixty (60) feet from a duty station, and the egress doorway shall be visible to the duty station at all times.
(h) A room shall not be used as a resident bedroom if the access is through another resident's bedroom.
(2) Bathrooms.
(a)
-
Proposals which entail renovation of an existing facility shall demonstrate that each living unit of a Level I facility shall have at least one (1) wash basin with hot and cold water, one (1) flush toilet, and one (1) bath or shower with hot and cold water for every five (5) residents or fraction thereof residing within the living unit.
-
For new construction, each living unit in a Level I facility shall have at least one (1) wash basin with hot and cold water, one (1) flush toilet, and one (1) bath or shower with hot and cold water for every four (4) residents or fraction thereof residing within the living unit.
(b) Separate toileting, bathing, and showering facilities shall be maintained and be available for each sex.
(c) Each bathroom shall have a wastebasket and an adequate supply of toilet paper, towels, and soap.
(d) If more than one (1) toilet is required or available in the same room, each shall be partitioned for privacy and shall include a door capable of remaining closed.
(e) Bathing and showering facilities shall have enclosures or screens for individual privacy. Shower heads shall be of institutional safety type.
(f) At least one (1) bathing facility shall have space that is accessible to a resident who uses a wheelchair. The wheelchair-accessible bathing facility may serve both sexes, and the facility shall provide staff to assist residents during bathing and showering.
(g) Each bathroom shall contain at least one (1) nondistorting mirror secured to the wall at a height which shall accommodate individuals with disabilities and other residents.
(h) A bathroom shall not be constructed in such a way as to require a resident to pass through another resident's bedroom for access. The bathroom shall have only one (1) door.
(3) A resident's wardrobe or closet shall have minimum dimensions of one (1) foot and ten (10) inches deep by one (1) foot and eight (8) inches wide with full-length hanging space including clothes rod and shelf. Additional areas shall be provided for storage of a resident's winter coats, raincoats, and other bulky articles of clothing and shall be locked and under staff control.
(4) Each resident shall have a chair and desk with minimum dimensions of one (1) foot and six (6) inches deep by three (3) feet wide by two (2) feet high.
(5) Windows accessible to the outside shall be secure and shall prevent unauthorized egress and ingress. Safety features shall be included on windows to ensure glass and glass fragments do not constitute a safety hazard.
(6) If a staff call system is available, provisions shall be made to permit removal of call buttons or use of blank plates if appropriately documented in a resident's treatment plan.
(7) Living, dining, and recreation.
(a) The total area provided for living and recreation shall not be less than forty (40) square feet per resident.
(b) The total area provided for dining shall not be less than fifteen (15) square feet per resident.
(c) The living area shall include comfortable seating for at least ten (10) persons.
(d) Indoor recreation equipment shall be available and appropriate for the ages served and shall be maintained in good condition.
(e) Enclosed storage shall be provided for recreational equipment and supplies.
(f) The facility shall provide space for outdoor recreation activities for residents. The outdoor area shall be free from litter, glass, and other objects which pose a safety hazard.
(g) Outdoor recreation equipment in good condition and appropriate for the ages of the residents shall be provided and maintained.
(8) Each service area shall include a duty station and medicine dispensing area.
(a) A duty station shall be constructed to include adequate space for charting and for conducting all other aspects of a patient's care.
(b) Provision shall be made for twenty-four (24) hour distribution of medicine to residents. This may be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.
-
Medication shall be kept in a locked storage area, a secure, self-contained dispensing unit, or other system capable of maintaining secure and controlled storage.
-
The medication dispensing area shall be under the treatment staff's visual control and shall contain a work counter, refrigerator, sink and locked storage for biologicals and drugs.
-
The medication dispensing unit may be located at the duty station, in a clean workroom, or in an alcove under direct control of the treatment or pharmacy staff.
-
All controlled substances shall be maintained by staff under double lock.
(c) A dedicated linen storage area shall be available and shall be used for storing clean linens.
(9) The living unit shall have at least one (1) operable food preparation area with sink, stove, and refrigerator, unless a kitchen is directly available within the same building as the living unit.
Section 6. Living Unit for a Level II PRTF.
(1) A living unit in a Level II PRTF shall:
(a) Accommodate a maximum of twelve (12) residents; and
(b) Serve one (1) gender.
(2) Environment.
(a) A Level II PRTF shall avoid hidden alcoves or blind areas.
(b) A Level II PRTF shall:
-
Be designed to prevent elopement;
-
Be designed to contain residents in the living unit until clinical staff are able to escort the resident or residents to an adjacent compartment or an exit stair;
-
Be designed to prevent contraband smuggling; and
-
Include provisions for monitoring and controlling visitor access and egress.
(c) Openings, including windows or doors, shall be controlled by locks, which shall be manual, electric, or magnetic.
(3) Bedrooms.
(a) A bedroom shall not be used for sleeping accommodations for more than two (2) residents.
(b) A bedroom shall be equipped with a bed that shall:
-
Be at least thirty-six (36) inches wide and sixty (60) inches long;
-
Accommodate the resident's size; and
-
Be located sufficient distance from radiators, heat outlets, and drafts to avoid discomfort.
(c) A resident's bed shall be equipped with:
-
A support mechanism and a clean mattress;
-
A mattress cover with rubber or impervious sheets, if necessary; and
-
Two (2) sheets, a pillow, and bed covering of sufficient quality to maintain resident comfort.
(d)
-
A single occupancy resident room shall have a minimum clear floor area of 100 square feet, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules.
-
A bedroom used for sleeping accommodations for two (2) residents shall:
a. For projects which entail the renovation of an existing licensed health facility, ensure that each bed is positioned to allow at least four (4) feet of free space between beds and four (4) feet of free space extending directly away from the foot of the bed;
b. In new construction, have a minimum floor area of eighty (80) square feet per bed, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves or vestibules; and
c. Be equipped with an electronic surveillance system that is used to monitor residents, thereby alerting Level II PRTF personnel at the exact time any situation occurs which may threaten the safety of either or both residents sharing the bedroom. The surveillance system shall:
(i) Be operational on a twenty-four (24) hour, seven (7) day a week basis;
(ii) Be under the operation and direction of the Level II PRTF's clinical director;
(iii) Have the capacity to alert PRTF personnel by means of an alarm system if one resident leaves his or her bed without requesting permission; and
(iv) Not be placed in a bathing or toilet room.
(e) A resident shall not be housed in a room, detached building, or other enclosure which has not been inspected and approved for occupancy by the licensure agency and the Department of Housing, Buildings and Construction.
(f) A bedroom shall not be located more than sixty (60) feet from a duty station, and the egress doorway shall be visible to the duty station at all times.
(g) A room shall not be used as a resident bedroom if the access is through another resident's bedroom.
(h) Each resident room shall have a chair and desk with minimum dimensions of one (1) foot and six (6) inches deep by three (3) feet wide by two (2) feet high.
(4) Resident storage.
(a) Each resident shall have within his or her room a separate wardrobe, locker, or closet for storing personal effects.
(b) Shelves for folded garments shall be used.
(c) Adequate storage shall be available for a daily change of clothes for seven (7) days.
(d) An area separate from the resident's wardrobe, locker, or closet shall be provided for storage of winter coats, raincoats, and other bulky articles of clothing, and shall be locked and under staff control.
(5) Shared bathing and toilet facilities.
(a)
-
For projects which entail the renovation of an existing licensed health facility, a bathtub or shower and a toilet shall be provided for each six (6) residents or fraction thereof.
-
For new construction, a bathtub or shower and a toilet shall be provided for every four (4) residents or fraction thereof.
(b) Each shower or bathing room shall have a toilet.
(c) Bathing facilities shall be designed and located for resident convenience and privacy.
(d) Separate bathing and showering facilities shall be maintained and be available for each sex.
(e) Each bathing facility shall have a wastebasket, an adequate supply of toilet paper, and meet the hand drying provisions established in subsection (10) of this section.
(f) If more than one (1) toilet is available in the same bathing room, each shall be partitioned for privacy and shall include a door capable of remaining closed.
(g) Bathing and showering facilities shall have enclosures or screens for individual privacy. Shower heads shall be of institutional safety type.
(h) At least one (1) bathing facility shall have space that is accessible to a resident who uses a wheelchair. The wheelchair-accessible bathing facility may serve both sexes, and the facility shall provide staff to assist residents during bathing and showering.
(i) Each bathing facility shall contain at least one (1) nondistorting mirror secured to the wall at a height which shall accommodate individuals with disabilities and other residents.
(j) A bathing facility shall not be constructed in such a way as to require a resident to pass through another resident's bedroom for access. The bathing facility shall have only one (1) door.
(k) If indicated in a resident safety risk assessment, toilet room doors shall be equipped with keyed locks that allow staff to control access to the toilet room.
(l) The door to the toilet room shall swing outward or be double–acting.
(m) Each entry door into a resident toilet room shall:
-
Be ADA (Americans with Disabilities Act) or ANSI (American National Standards Institute) compliant; and
-
Provide space for staff to transfer residents to the toilet using portable mechanical lifting equipment.
(n) Thresholds in toilet rooms that are ADA or ANSI-compliant shall be designed to facilitate use and prevent tipping of wheelchairs or other portable wheeled equipment by residents and staff.
(6) If a staff call system is available, provisions shall be made to permit removal of call buttons or use of blank plates if appropriately documented in a resident's treatment plan.
(7) Bathing facility hardware and accessories.
(a) Special design considerations for injury and suicide prevention shall be given to shower, bath, toilet, and sink hardware and accessories, including grab bars and toilet paper holders.
(b) ADA or ANSI-compliant grab bars shall be required in ten (10) percent of the toilet rooms. The space between the bar and the wall shall be filled to prevent a cord being tied around it.
(c) Grab bars in resident toilet rooms for fully ambulatory residents shall be removable.
(d) Bars, including those that are part of fixtures which may include soap dishes, shall be sufficiently anchored to sustain a concentrated load of 250 pounds.
(e) The following shall not be permitted:
-
Towel bars;
-
Shower curtain rods; and
-
Lever handles, unless a specifically designed anti-ligature lever handle is used.
(8) Sprinkler heads and other protrusions.
(a) In unsupervised resident areas, sprinkler heads shall be recessed or of a design to minimize resident access.
(b) In resident bedrooms and bathrooms, lighting fixtures, sprinkler heads, electrical outlets, and other appurtenances shall be of the tamper-resistant type.
(9) Hand-washing stations.
(a) General hand-washing stations used by staff, residents, and food handlers shall be trimmed with valves which may be operated without hands.
(b) Single-lever or wrist blade devices shall be permitted. Blade handles shall be at least four (4) inches.
(c)
-
Sensor-regulated water fixtures shall meet user need for temperature and length of time the water flows.
-
Electronic faucets shall be capable of functioning during loss of normal power.
-
Sensor-regulated faucets with manual temperature control shall be permitted.
(d) Hand-washing stations shall include liquid or foam soap dispensers.
(10) Provisions for hand drying. Hand-washing stations shall include a hand-drying device that does not require hands to contact the dispenser and shall include:
(a) Paper or cloth units enclosed to protect against dust or soil, and to ensure single-unit dispensing; or
(b) Hot air dryers if the installation eliminates possible contamination by recirculation of the air.
(11) Ceilings.
(a) Ceilings shall be monolithic.
(b) Ceiling systems of lay-in ceiling tile design shall not be permitted.
(c) In resident bathrooms:
-
The ceiling shall be secured from access; and
-
Plumbing, piping, duct-work, or other potentially hazardous elements shall be concealed above a ceiling.
(d) In resident bedrooms and bathrooms, ceiling access panels shall be secured.
(e) In resident bedrooms and bathrooms, ventilation grilles shall be:
-
Secured and shall have small perforations to eliminate their use as a tie-off point; or
-
Of sufficient height to prevent resident access.
(12) Doors and door hardware.
(a) Door openings for resident use shall have a minimum clear width of two (2) feet ten (10) inches.
(b) Doors for private resident bathrooms or shower areas shall swing out to allow for staff emergency access.
(c)
-
Door closers shall be avoided unless required.
-
Door closer devices, if required on the resident room door, shall be mounted on the public side of the door. The door closer shall be within view of a staff workstation.
(d) Door hinges shall be designed to minimize points for hanging and may include cut hinge type.
(e) Door lever handles. Except for specifically designed anti-ligature hardware, door lever handles shall point downward when in the latched or unlatched position.
(f) Door hardware shall have tamper-resistant fasteners.
(13) Windows.
(a) Each resident room shall have one (1) window.
(b) The minimum net glazing area shall be no less than eight (8) percent of the floor area of the resident's room.
(c) If an operable window is provided in a resident's room, operation of the window shall be restricted to inhibit possible escape or suicide.
(d) Windows shall be designed to limit the opportunities for residents to seriously harm themselves or others.
(e) Glazing (interior and exterior), borrowed lights, and glass mirrors shall be fabricated with laminated safety glass or protected by polycarbonate, laminate, or safety screens.
(f) Insect screens. Windows and outdoor doors that are frequently left open shall be equipped with insect screens.
(14) Furnishings.
(a) Furniture shall be constructed to withstand physical abuse.
(b) Drawer pulls shall be of the recessed type.
(15) Living, dining, and recreation.
(a) The total area provided for living and recreation shall not be less than forty (40) square feet per resident;
(b)
-
The total area provided for dining shall not be less than fifteen (15) square feet per resident.
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Each living unit shall have a dining area within the unit or adjacent to the unit. A dining area may be shared by two (2) living units if each unit:
a. Is adjacent to the dining area; and
b. Staggers meals so that the residents of both units do not dine together at the same time in the dining area.
(c) The living area shall:
-
Include comfortable seating for at least twelve (12) persons; and
-
Not be shared with another living unit within the same building.
(d) Indoor recreation equipment shall be available and appropriate for the ages served and shall be maintained in good condition.
(e) Enclosed storage shall be provided for recreational equipment and supplies.
(f) The facility shall provide space for outdoor recreation activities for residents. The outdoor area shall be free from litter, glass, and other objects which pose a safety hazard.
(g) Outdoor recreation equipment in good condition and appropriate for the ages of the residents shall be provided and maintained.
(h) A gymnasium or recreation area used by a Level II PRTF may be shared with a psychiatric hospital or Level I PRTF located within the same building or on the same campus.
(16) Each service area shall include a duty station and medicine dispensing area.
(a) A duty station shall be constructed to include adequate space for charting and for conducting all other aspects of a resident's care.
(b) Provision shall be made for twenty-four (24) hour distribution of medicine to residents and shall be from a medicine preparation room or unit, a self-contained medicine dispensing unit, or by another approved system.
-
Medication shall be kept in a locked storage area, a secure, self-contained dispensing unit, or other system capable of maintaining secure and controlled storage.
-
The medication dispensing area shall be under the treatment staff's visual control and shall contain a work counter, refrigerator, sink, and locked storage for biologicals and drugs.
-
The medication dispensing unit may be located at the duty station, in a clean workroom, or in an alcove under direct control of the treatment or pharmacy staff.
(c) A dedicated linen storage area shall be available and shall be used for storing clean linens.
(17) The living unit shall have at least one (1) operable food preparation area with sink, stove, and refrigerator, unless a kitchen is directly available within the same building as the living unit.
Section 7. Classroom Requirements for Level II PRTF Facilities.
(1) A Level II PRTF shall have classroom space to accommodate the residents' needs.
(2) A classroom capacity shall not exceed twelve (12) students.
Section 8. Kitchen Area for Level I and Level II PRTF Facilities.
(1) If a commercial service is used or if meals are provided by an adjacent facility, dietary areas and equipment shall ensure sanitary, efficient and safe storage, processing, and handling of food products.
(2) If meals are prepared on site, the facility shall have a food service area large enough to accommodate residents and staff, and which shall be capable of maintaining a three (3) day supply of refrigerated and dry foods.
(3) The kitchen area shall include a janitor's closet with sufficient space for storage of housekeeping supplies and equipment and shall include a locked area for hazardous materials.
Section 9. Administration Area for Level I and Level II PRTF Facilities. Space shall be available for administrative operations.
Section 10. Consultation and Visitation Rooms for Level I and Level II PRTF Facilities. Professional consultation rooms shall be available for interview, examination, treatment, and visitation. These rooms shall afford privacy for the resident.
Section 11. Pharmacy or Drug Area for Level I and Level II PRTF Facilities. Adequate facilities shall be available to accommodate the safe storage and handling of pharmaceuticals including double locking of controlled substances and refrigeration for biologicals and drugs which require refrigeration.
Section 12. Level I PRTF: Requirements for Rooms Designated for Seclusion.
(1) If a room designated for seclusion is provided by a Level I PRTF, it shall be:
(a) Completely padded and constructed to minimize the possibility of a resident's hiding, escape, injury, or suicide and shall not include fixtures, hardware, furniture, receptacles, switches, or other items that may present a risk to a secluded resident; and
(b) Used only for short-term occupancy by a resident who may have become violent or suicidal.
(2) The door to a seclusion room shall swing outward and shall have provisions for constant staff observation while maintaining privacy.
Section 13. Level II PRTF: Requirements for Rooms Designated for Seclusion.
(1) Each living unit shall have one (1) room designated for seclusion.
(2) The room designated for seclusion shall:
(a) Be constructed to minimize the possibility of a resident's hiding, escape, injury, or suicide and shall not include fixtures, hardware, furniture, receptacles, switches, or other items that may present a risk to a secluded resident;
(b) Have a minimum clear floor area of sixty (60) square feet with a minimum wall length of seven (7) feet and a maximum wall length of eleven (11) feet;
(c) Not contain outside corners or edges; and
(d)
-
For new construction, be accessed by an anteroom or vestibule that provides access to a toilet room. The door openings to the anteroom and the toilet room shall have a minimum clear width of three (3) feet eight (8) inches; or
-
If a proposal entails renovation of an existing licensed health facility:
a. An anteroom adjoining a seclusion room shall not be required; and
b. A toilet room used to accommodate a resident placed in the seclusion room:
(i) May be located within forty (40) feet of the seclusion room; and
(ii) Shall not be located in an area which would require the resident in seclusion to walk through a living, dining, or recreation area to access the toilet room.
(3) The walls, ceiling, and floor of the room designated for seclusion shall be designed to withstand direct and forceful impact.
(4) The entrance door to the room designated for seclusion shall swing out.
(5) Door openings shall be a minimum clear width of three (3) feet eight (8) inches and shall permit staff observation of the resident through a vision panel, while maintaining provisions for resident privacy.
(6) Minimum ceiling height shall be eight (8) feet.
(7) Electrical switches and receptacles shall be prohibited within the room designated for seclusion.
(8) Lighting fixtures within the seclusion room shall be tamper-resistant and designated to prevent injury to the resident.
Section 14. Storage and Service Areas for Level I and Level II PRTF Facilities.
(1) Storage space shall be provided.
(2) Engineering service and equipment areas shall be provided and shall include:
(a) Storage room for housekeeping equipment that cannot be accommodated by a janitor's closet or other storage area; and
(b) Refuse area located in an area convenient to the service entrance for holding trash prior to disposal.
Section 15. Details and Finishes for Level I and Level II PRTF Facilities. The facility shall be constructed and maintained to minimize risk to occupants, staff, and visitors, and shall comply with the following requirements:
(1) Details.
(a) All doors opening onto corridors shall be swing-type except elevator doors.
(b) All doors to a resident's bathroom toilet shall swing outward or shall be equipped with hardware that permits immediate access in case of emergency.
(c) Thresholds and expansion joint covers shall be flush with the floor.
(d) Ceiling height shall not be less than seven (7) feet and six (6) inches, and shall be no less than eight (8) feet in the room designated as the seclusion room in a Level II PRTF facility.
(2) Finishes.
(a) Floors shall be easily cleanable and shall have wear resistance appropriate for the location involved. Floors in the kitchen and related spaces shall be waterproof and grease-proof. Floors shall have a nonslip finish in all areas that are subject to moisture.
(b) Adjacent dissimilar floor materials shall be flush with each other to provide an even transition.
(c) Walls shall be washable and kept clean and shall be moisture-proof in areas that are adjacent to plumbing fixtures. Wall bases in dietary areas shall be free of spaces that can harbor insects.
(d) Ceilings shall be washable and kept clean and in good repair.
(e) Rooms containing heat-producing equipment such as laundries and food preparation areas shall be insulated and ventilated to prevent any floor surface from exceeding a temperature of ten (10) degrees Fahrenheit above the ambient room temperature.
Section 16. Construction for Level I and Level II PRTF Facilities.
(1) Foundations shall rest on natural solid ground if a satisfactory soil is available at reasonable depths.
(2) Proper soil bearing values shall be established in accordance with recognized standards.
(3) If solid ground is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement.
Section 17. Mechanical Requirements for Level I and Level II PRTF facilities.
(1) Steam and hot water systems. If boilers are provided in residential treatment facilities, the design and installation shall comply with 815 KAR 15:010 through 15:080.
(2) Temperature.
(a) A minimum temperature of sixty-eight (68) degrees Fahrenheit shall be provided in occupied areas during winter.
(b) A maximum temperature of eighty-five (85) degrees Fahrenheit shall be provided in occupied areas during summer.
(3) Plumbing and piping systems.
(a) All showers and bathtubs shall be equipped with a temperature-limiting device at the point of source or point of use which controls hot water at a maximum temperature of 120 degrees Fahrenheit.
(b) Fixtures used in the dietary area, the clean work room, and the medication preparation area shall be trimmed with valves which can be operated without the use of hands.
(c) If valves are equipped with blade handle controls, the controls shall be approximately four (4) inches in length.
(d) Fixtures shall be installed to provide adequate side clearance for proper use of the blade handles.
(4) Water supply systems.
(a) A water supply system shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.
(b) An operable valve shall be installed at each water service main, branch main, riser, and branch to a group of fixtures. Stop valves shall be installed at each fixture.
(c) Insulation shall be maintained on hot, cold and chilled water piping and waste piping on which condensation may occur. Insulation of cold and chilled water lines shall include an exterior barrier.
(d) Backflow preventers (vacuum breakers) shall be installed on hose bibs and on all fixtures onto which hoses or tubing can be attached.
(e) Hot water distribution systems shall be arranged to provide hot water at each fixture.
(f) Piping over food preparation centers, food serving facilities, food storage areas, and other areas where water leakage could impact the safety or health of residents shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of, or condensation from, overhead piping systems.
(5) Hot water heaters and tanks.
(a) Hot water heating equipment shall have sufficient capacity to supply the water at the temperature and amounts indicated below:
(b) A storage tank shall be provided and shall be fabricated of corrosion-resistant metal or have a noncorrosive lining.
(6) Prior to licensure, all plumbing specifications shall be approved by the Kentucky Division of Plumbing, Department of Housing, Buildings and Construction.
Section 18. Electrical Requirements for Level I and Level II PRTF Facilities.
(1) Electrical requirements of the Kentucky Building Code, 815 KAR 7:120, shall apply.
(2)
(a) Except as provided in paragraph (b) of this subsection, the wiring in each PRTF shall be inspected by a certified electrical inspector and a certificate of approval shall be issued to the facility prior to occupancy.
(b) The wiring in existing buildings shall be approved by a certified electrical inspector only if the building has not been previously so approved for health care occupancy or if the State Fire Marshal finds that a hazardous condition exists.
(3) All breakers and switches shall be indexed.
(4) Spaces occupied by people, machinery, and equipment within buildings, the corresponding approaches, and parking lots shall have electric lighting.
(5) Residents' bedrooms shall have general lighting, a night light, and, if appropriate, a reading light.
(6) A resident's bedroom shall have duplex receptacles as follows:
(a) One (1) side of the head of each bed; receptacles for luminaries, television and motorized beds, if used, and one (1) receptacle on another wall.
(b) Receptacles shall be of a safety type or protected with five (5) milliampere ground fault interrupters.
(7) Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of ends of corridors. Receptacles shall be of a safety type or protected with five (5) milliampere ground fault interrupters.
History
- RELATES TO: KRS 216B.105, 216B.450-216B.457
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105, 216B.455, 216B.457(21)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Health and Family Services regulate health facilities and services. KRS 216B.457 requires the cabinet to promulgate administrative regulations establishing requirements for psychiatric residential treatment facilities. This administrative regulation establishes physical plant requirements for Level I and Level II psychiatric residential treatment facilities (PRTF), and allows existing facilities or residential units, with modifications, to be licensed as a Level I PRTF facility.
- History: 17 Ky.R. 2123; eff. 3-12-1991; 19 Ky.R. 1214; 1624; eff. 2-17-1993; 24 Ky.R. 1978; eff. 5-18-1998; 32 Ky.R. 678; eff. 10-19-2005; 33 Ky.R. 2214; 2969; eff. 4-6-2007; 37 Ky.R. 1590; 2243; 2418; eff. 5-6-2011; Crt eff. 05-07-2019; Crt eff. 2-9-2026.
902 KAR 20:350 Boarding homes {#sec-902-kar-20-350 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:350}
Section 1. Definitions.
(1) "Home" means a boarding home.
(2) "Registrant" means the owner of the home.
(3) "Manager" means person responsible for the day-to-day operation of the home.
(4) "Resident" means any person, including a boarder as defined in KRS 216B.300(3), other than the registrant, manager or person related to the registrant or manager, who is living in the home. The resident may require some minimal degree of assistance or supervision, but not to the level of care provided by family care homes or personal care homes.
(5) "Potentially hazardous food" means any food or ingredient, natural or synthetic:
(a) In a form capable of supporting:
-
The rapid and progressive growth of infections or toxigenic microorganisms; or
-
The slower growth of Clostridium botulinum.
(b) Of animal origin, either raw or heat treated; and
(c) Of plant origin which:
-
Has been treated; or
-
Is raw seed sprouts.
(d) The following are excluded:
-
Air dried hard boiled eggs with shells intact;
-
Food with water activity (aw) value of 0.85 or less;
-
Food with a hydrogen ion concentration (ph) level of four and six-tenths (4.6) or below;
-
Food in unopened hermetically sealed containers that have been commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution; and
-
Food for which laboratory evidence demonstrates that rapid and progressive growth of infectious and toxigenic microorganisms or the slower growth of Clostridium botulinum cannot occur.
(6) "Human services center or facility" means a facility that provides full or part-time care to children or adults. This term shall include:
(a) Day care center;
(b) Family child care home;
(c) Adult day care center;
(d) Adult day health care facility;
(e) Family care home;
(f) Group home for the mentally retarded or developmentally disabled;
(g) Acute care, psychiatric, or comprehensive physical rehabilitation hospital;
(h) Intermediate care facility;
(i) Nursing facility;
(j) Nursing home;
(k) Personal care home;
(l) Skilled nursing facility;
(m) Psychiatric residential treatment facility;
(n) Child caring facility;
(o) Child placing agency;
(p) Rural primary care hospital;
(q) Alzheimer nursing home;
(r) Youth camp;
(s) Boarding home; or
(t) Alternate intermediate service for the mentally retarded or developmentally delayed.
Section 2. Scope of Operations and Services. Boarding homes are operated and maintained to provide residential and dining services for at least three (3) individuals in accordance with KRS 216B.300(4).
Section 3. Registration Procedure.
(1) An applicant seeking initial registration or a registrant seeking renewal shall:
(a) Submit an application on forms that the cabinet requires to the Department for Public Health, Health Services Building, 275 East Main St., Frankfort, KY, 40621; and
(b) Pay a registration fee of $100.
(2) Upon receipt of an application, the cabinet or its agents shall make an inspection of the home to determine compliance with the provisions of KRS Chapter 216B and this administrative regulation. When inspection reveals that the applicable requirements of KRS Chapter 216B and this administrative regulation have been met, registration shall be issued to the applicant by the cabinet.
(3) A receipt of registration shall be sent to the registrant.
(4) Unless renewed, initial registration shall expire on March 31 following the date of registration, as shown on the receipt of registration sent to the registrant, and every March 31 thereafter.
Section 4. Operation and Management of Boarding Homes Whose Residents Do Not Meet the KRS 216B.300(3) Definition of "Boarder".
(1) The registrant shall be legally responsible for the operation of the home and for compliance with all federal, state and local laws and administrative regulations pertaining to the operation of the home.
(2) The manager shall be a literate adult, at least eighteen (18) years of age, who has general knowledge of the residents' physical and mental condition.
(3) The manager shall be the person directly responsible for the twenty-four (24) hour daily operation of the home or for delegating that responsibility to another individual meeting criteria in subsection (2) of this section. The name of that individual to whom the responsibility may be designated shall be in writing and provided to the agents of the cabinet inspecting the home.
(4) The manager shall maintain records, located on the premises and available for inspection by the cabinet or its agents, which contain the following information (typed or in ink) about each resident who does not meet the KRS 216B.300(3) definition of a "boarder":
(a) Name and sex.
(b) Date of birth.
(c) Previous place of residence.
(d) Attending physician, mental health professional, and dentist, if any, address and phone number for each.
(e) Next of kin or responsible person (or agency), address and telephone number.
(f) Amount charged per week or month by the home.
(5) The manager shall have phone numbers of a hospital, an ambulance service, fire department, and a physician for emergencies posted by the telephone in large legible print.
(6) The manager shall have a written procedure for obtaining emergency services.
(7) All prescription medications taken by residents who do not meet the KRS 216B.300(3) definition of a "boarder" shall be noted in writing by the manager to include the date, time and dosage of the medication. The manager shall keep the original in a file and make it available to the cabinet or its agents upon request.
(8) The manager shall make a written report of any accident involving a resident, any incident involving a resident's health, welfare or safety, and any death of a resident. The manager shall keep the original in a file and make it available to the cabinet or its agents upon request.
(9) The manager shall provide for resident rights pursuant to KRS 216B.303.
(10) The registrant shall request and review all criminal conviction information for any applicant for employment or volunteer services from the Justice Cabinet prior to employing the applicant or utilizing the volunteer.
(11) Initial registrations may be denied and existing registrations may be revoked if the applicant for registration or the registrant has:
(a) Been convicted of a crime relating to abuse, neglect or exploitation of a child or an adult;
(b) Abused, neglected or exploited a child or an adult;
(c) Been listed on the Nurse's Aide Abuse Registry by the Office of the Inspector General; or
(d) Had a human services center or facility registration, certification, permit or license denied or revoked or voluntarily forfeits their certification, registration, license or permit after the cabinet initiates denial or revocation action.
(12) The manager shall report all suspected cases of abuse, neglect, or exploitation of adults or children to the cabinet pursuant to KRS Chapters 209 and 620.
(13) If a person who has job duties is known or is suspected to be infected with a communicable disease for which a reasonable probability for transmission exists due to the individual's job, the individual shall not perform these duties until such time as the infectious condition can no longer be reasonably expected to be transmitted. Disagreement regarding this requirement between the home and the individual involved shall be resolved by the individual's physician.
(14) The registration from the cabinet shall be posted in a conspicuous place in the home.
Section 5. Services to be Provided by Homes whose Residents Do Not Meet the KRS 216B.300(3) Definition of "Boarder".
(1) Basic services.
(a) All homes shall ensure that residents obtain basic room and board services.
(b) The home shall provide each resident with a lockable bureau or cupboard for storage of personal belongings.
(c) Mattress pads or covers shall be used on all mattresses. Beds, mattresses, springs, slats, mattress pads and cover shall be sanitary and in good repair. Each bed shall be provided with two (2) sheets; and one (1) pillow and one (1) pillowcase for each resident. Sheets and pillowcases shall be kept clean and changed at least once per week, or more often if necessary, or when there is a new resident. All beds shall be supplied with sufficient blankets or coverings to keep the resident warm.
(d) It shall be the responsibility of the manager, if a resident is unable due to an accident or acute illness, to obtain the services of a physician.
(e) Residents shall not require a degree of care exceeding the skill of the operator to provide.
(f) Prescription drugs for residents who do not meet the KRS 216B.300(3) definition of "boarder" shall be kept in a locked cabinet.
(2) Communicable diseases.
(a) The manager shall not allow individuals infected with the following diseases to reside in the home unless the individual's attending physician certifies in writing that the condition of the individual is not communicable to others in the home environment: anthrax, cammpylobacteriosis, cholera, diphtheria, hepatitis A, measles, pertussis, plague, poliomyelitis, rabies (human), rubella, salmonellosis, shigellosis, typhoid fever, yersiniosis, brucellosis, giardiasis, leprosy, psittacosis, Q fever, tuberculosis, tularemia, and typhus. If an attending physician is in doubt regarding the communicability of an individual's condition, the physician may contact the Department for Public Health.
(b) A home may admit a (noninfectious) tuberculosis patient under continuing medical supervision for the patient's tuberculosis disease.
(c) If a resident is suspected of having a communicable disease that would endanger the health and welfare of other residents, the manager shall assure that a physician is contacted and that appropriate measures are taken on behalf of that resident and the other residents in the home.
(3) Dietary services for residents who do not meet the KRS 216B.300(3) definition of a "boarder".
(a) Food supplies.
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Food shall be in sound condition and safe for human consumption. Food shall be obtained from sources that comply with the applicable laws relating to food safety. The use of food that was not prepared in an approved food processing establishment is prohibited.
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Fluid milk and fluid milk products used shall be pasteurized and shall comply with applicable law. Dry milk and milk products used shall be made from pasteurized milk and milk products. Raw milk shall not be provided or used in a home.
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Only clean shell eggs meeting applicable grade standards, or pasteurized liquid, frozen, or dry eggs, or pasteurized dry egg products shall be used.
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Only ice which has been manufactured with potable water and handled in a sanitary manner shall be used.
(b) Food protection.
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Prepared, or served, food shall be protected from cross-contamination between foods and from potential contamination by insects, insecticides, rodents, rodenticides, unclean equipment or utensils, unnecessary hand contact, draining, or overhead leakage or condensation, dust, coughs and sneezes or other agents of public health significance.
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The temperature of potentially hazardous foods shall be forty-five (45) degrees Fahrenheit or below, or 140 degrees Fahrenheit or above at all times, except during necessary times of preparation or service.
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Hermetically sealed (airtight) packages shall be handled so as to maintain product and container integrity.
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Pets may be present on the premises, but shall not be permitted in the kitchen.
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Laundry facilities.
a. In facilities that are initially licensed within one (1) year of the effective date of this administrative regulation, laundry facilities may be located in the kitchen, but shall not be used during food preparation and service.
b. In facilities that are initially licensed more than one (1) year after the effective date of this administrative regulation, laundry facilities shall not be located in the kitchen.
(c) Food preparation.
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Food shall be prepared with the least manual contact, using suitable utensils, and on surfaces that prior to use have been cleaned, rinsed and sanitized to prevent cross-contamination.
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Raw fruits and raw vegetables shall be washed thoroughly before being cooked or served.
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Potentially hazardous foods requiring cooking shall be cooked to heat all parts of the food to a temperature of at least 140 degrees Fahrenheit prior to being placed in steam tables or other hot storage facilities except that:
a. Poultry and poultry stuffings, and stuffed meats shall be cooked to heat all parts of the food to at least 165 degrees Fahrenheit with no interruption of the cooking process;
b. Raw pork and products containing raw pork shall be cooked to heat all parts of the food to at least 150 degrees Fahrenheit;
c. Rare roast beef shall be cooked to an internal temperature of at least 130 degrees Fahrenheit, and rare beef steak shall be cooked to a temperature of 130 degrees Fahrenheit;
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Reconstituted dry milk and dry milk products may be used in instant desserts and whipped products, or for cooking and baking purposes;
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Unpasteurized liquid, frozen, dry eggs and egg products shall be used only for cooking and baking purposes.
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Potentially hazardous foods that were cooked and then refrigerated shall be reheated rapidly to 165 degrees Fahrenheit or higher throughout before being served. Bainsmarie, warmers, and other hot food holding facilities are prohibited for the rapid reheating of potentially hazardous foods.
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Potentially hazardous foods shall be thawed:
a. In refrigerated units at a temperature not to exceed forty-five (45) degrees Fahrenheit; or
b. Under potable running water at a temperature of seventy (70) degrees Fahrenheit or below, with sufficient water velocity to agitate and float off loose food particles into the overflow and for a period that shall not exceed that reasonably required to thaw the food; or
c. In a microwave oven only when the food will be immediately transferred to conventional cooking units as part of a continuous cooking process, or when the entire, uninterrupted cooking process takes place in the microwave oven; or
d. As part of the conventional cooking process if the food is less than, or equal to, three (3) pounds.
(d) Food display and service.
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Food on display, other than whole, unprocessed raw fruits and unprocessed raw vegetables, shall be protected from contamination by the use of packaging, or by the use of easily cleanable display cases, serving line or salad bar protector devices, covered containers for self-service, or by other effective means. Potentially hazardous food other than milk, cream, cream cheese, or yogurt shall not be provided for resident self-service in the home.
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Condiments, seasonings and dressings for self-service use shall be provided in individual packages, or in dispensers or containers except that, for table service, catsup and other sauces may be served in the original container or pour-type dispenser. Sugar for resident use shall be provided in individual packages or in pour-type dispensers.
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Ice for resident use shall be dispensed with scoops, tongs, or other ice-dispensing utensils or through automatic self-service ice-dispensing equipment. Ice-dispensing utensils shall be stored on a clean surface or in the ice with the dispensing utensil's handle extended out of the ice. Between uses, ice transfer receptacles shall be stored in a way that protects them from contamination.
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Once served to a resident, portions of leftover food shall not be reused or re-served except that nonpotentially hazardous packaged food, that is still packaged and is still in sound condition may be re-served. However, single-service creamers and completely wrapped pats of butter or margarine may be re-served if still packaged and in sound condition.
(e) Employee health and practices.
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Employees engaged in food preparation, service and ware-washing operations shall thoroughly wash their hands and the exposed portions of their arms with soap or detergent and warm water before starting work, after smoking, eating, or using the toilet, and as often as is necessary during work to keep them clean. Employees shall keep their fingernails trimmed and clean.
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Employees shall wear clean outer clothing.
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Hairnets, hats, scarves, or similar hair coverings that effectively restrain head and facial hair shall be required for all employees working in food preparation areas.
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Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices during all working periods.
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Employees shall consume food or use tobacco only in designated areas. Such designated areas shall not be located in food preparation areas or in areas where the eating or tobacco use of an employee may result in contamination of food, equipment, or utensils.
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All employees shall wash their hands thoroughly with soap and warm water in an adequate hand-washing facility before starting work and as often as necessary to remove soil and contamination. The hands of all employees shall be kept clean, while engaged in handling of food and food contact surfaces.
(f) Equipment and utensils.
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Equipment and utensils shall be constructed and repaired with safe materials, including finishing materials; shall be corrosion resistant and nonabsorbent; and shall be smooth, easily cleanable, and durable under conditions of normal use. Single-service articles shall be made from clean, sanitary, safe materials. Equipment, utensils, and single-service articles shall not impart odors, color, taste, nor contribute to the contamination of food.
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Safe plastic or safe rubber or safe rubber-like materials shall be resistant under normal conditions of use to scratching, scoring, decomposition, crazing, chipping, and distortion, and shall be of sufficient weight and thickness to permit cleaning and sanitizing by normal ware-washing methods.
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Single-service articles shall not be reused.
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All equipment and utensils shall be maintained in good repair.
(g) Equipment and utensils/cleaning and sanitization.
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Food utensils and equipment shall be stored in a manner to avoid contamination.
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Food contact surfaces and sinks shall be smooth and easily cleanable.
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Food contact equipment, surfaces, tableware and utensils shall be cleaned and sanitized prior to food preparation for the public and after each use.
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Sinks, basins or other receptacles used for cleaning of equipment and utensils shall be cleaned and sanitized before use.
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Equipment and utensils shall be preflushed or prescrapped and, when necessary, presoaked to remove food particles and soil.
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Manual cleaning and sanitizing shall be conducted as follows:
a. For manual cleaning and sanitizing of cooking equipment, utensils and tableware, three (3) compartments shall be provided and used. The cabinet may allow the use of compartments other than sinks.
b. All five (5) steps of the ware-washing process shall be completed as follows:
(i) Prerinsing or scraping;
(ii) Application of cleaners for soil removal;
(iii) Rinsing to remove any abrasives and remove or dilute cleaning chemicals;
(iv) Sanitization; and
(v) Air drying and draining.
c. A sanitizing method approved by applicable provisions of the state retail food code shall be used.
d. Wash, rinse and sanitizing solution shall be maintained in a clean condition.
e. The washing solution shall be maintained at a temperature of 110 degrees Fahrenheit or above, or as specified on the manufacturer's label.
f. When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted by law, and a test kit or other device that measures the parts per million concentration of the solution shall be provided and used at least once each business day and each time the sanitizing solution is changed.
- Mechanical cleaning and sanitizing shall be conducted as follows:
a. Commercial dishwashers must comply with applicable provisions of the state retail food code.
b. A domestic or home-style dishwasher may be used provided the following performance criteria are met:
(i) The dishwasher shall effectively remove physical soil from all surfaces of dishes.
(ii) The dishwasher shall sanitize dishes by the application of sufficient accumulative heat.
(iii) The operator shall provide and use daily a maximum registering thermometer or a heat thermal label to determine that the dishwasher's internal temperature is a minimum of 150 degrees Fahrenheit after the final rinse and drying cycle.
(iv) The dishwasher shall be installed and operated according to manufacturer's instructions for the highest level of sanitization possible when sanitizing kitchen facilities' utensils and tableware; a copy of the instructions shall be available on the premises at all times.
- There shall be sufficient area or facilities such as portable dish tubs and drain boards for the proper handling of soiled utensils prior to washing and of cleaned utensils after sanitization so as not to interfere with safe food handling, hand washing and the proper use of dishwashing facilities. Equipment, utensils and tableware shall be air dried.
(h) Water supply and sewage disposal.
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Sufficient potable water for the needs of the establishment shall be provided from a source constructed, maintained, and operated pursuant to applicable requirements of the Cabinet for Natural Resources and Environmental Protection.
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Bottled and packaged potable water shall be obtained from a source that complies with applicable provisions of the Cabinet for Natural Resources and Environmental Protection, and the cabinet, and shall be handled and stored in a way that protects it from contamination. Bottled and packaged potable water for consumer self-service shall be dispensed from the original container.
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All sewage, including liquid waste, shall be disposed of by a public sewerage system or by a sewage disposal system constructed, maintained, and operated pursuant to the requirements of the Cabinet for Natural Resources and Environmental Protection, and the cabinet. Mop water shall not be disposed of in the dishwashing sink.
(i) Toilet facilities for employees.
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Toilet facilities shall be installed pursuant to requirements of the state plumbing code, shall be conveniently located, and shall be accessible to employees at all times.
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Bathrooms opening to the kitchen or dining area shall have adequate ventilation and a self-closing door. Ventilation may be provided by window(s) or by mechanical means. A soap dispenser and disposal towels shall be provided for hand washing in bathrooms used by food handlers.
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Toilet facilities, including toilet fixtures and any related vestibules, shall be kept clean and in good repair. A supply of toilet tissue shall be provided at each toilet at all times. Easily cleanable receptacles shall be provided for waste materials.
(j) Hand-washing facilities for employees.
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Hand-washing facilities shall be installed pursuant to the requirements of the State Plumbing Code and shall be conveniently located in the food preparation area.
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Each hand-washing facility shall be provided with hot and cold potable water tempered by means of a mixing valve or combination faucet.
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A supply of hand-cleansing soap or detergent shall be available from a dispensing unit at each hand-washing facility. A supply of sanitary towels or a hand-drying device providing heated air shall be conveniently located near each hand-washing facility. Common towels are prohibited. If disposable towels are used, easily cleanable waste receptacles shall be conveniently located near the hand-washing facilities.
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Employees shall thoroughly wash their hands and the exposed portions of their arms with soap or detergent and warm water before starting work, during work as often as is necessary to keep them clean, and after smoking, eating, drinking, or using the toilet. Employees shall keep their fingernails clean and trimmed.
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Hand washing shall take place at a hand-washing lavatory or designated service sink and not at food preparation sink or at a ware-washing sink.
(k) Insect and rodent control.
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Effective measures shall be utilized to minimize the entry, presence, and propagation of rodents or of flies, cockroaches, other insects. The premises shall be maintained in a condition that prevents the harborage or feeding of insects or rodents.
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Pesticides and rodenticides.
a. No person shall apply insecticides or rodenticides except as follows:
(i) In accordance with applicable requirements of the Kentucky Department of Agriculture's Pesticide Use and Application Act;
(ii) In accordance with the manufacturer's labeling; and
(iii) In such a way that food, food contact surfaces, and the supply of potable water are not contaminated.
b. No open pesticide or rodenticide bait boxes shall be used.
c. Pesticides, rodenticides and other toxic materials shall be stored apart from food, equipment, and utensils, and all containers of toxic material shall be clearly labeled for easy identification.
d. Pesticides and rodenticides shall be stored separated from other toxic and chemical compounds at all times.
(l) Therapeutic diets. Special diets or dietary restrictions shall be medically prescribed and provided accordingly.
(m) At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the evening meal and breakfast.
(n) All food showing evidence of spoilage or infestation shall be disposed of immediately upon detection.
(4) Housekeeping and sanitation. Each home shall:
(a) Have openings to the outside which shall be effectively protected against the entrance of insects by tight-fitting, self-closing doors, closed windows, screening, controlled air currents, or other means. Screen doors shall be self-closing, and screens for windows, doors, skylights, transoms, and other openings to the outside shall be tight fitting and free of breaks. Screening material shall not be less than sixteen (16) mesh to one (1) inch;
(b) Eliminate odors at their source by prompt and thorough cleaning of commodes and other obvious sources;
(c) Maintain the premises in such a manner as to prevent infestation by insects and rodents;
(d) Soiled clothing and linens shall be given immediate attention and shall be kept in a closed container. Once used, clothing or bedding shall be laundered before being used by another individual;
(e) All sewage and waste matter shall be disposed of into a public sewerage system, if available. In the event a public sewerage system is not available, disposal shall be made into a private system designed, constructed and operated in accordance with the requirements of the cabinet; provided, however, if a public sewerage system subsequently becomes available, connections shall be made thereto and any other sewerage system shall be discontinued.
(f) Collect and dispose of all garbage, refuse, trash, and litter in compliance with applicable state and local laws and regulations. Garbage containers shall be made of metal or other impervious material, and shall be watertight and rodent proof, and shall have tight-fitting covers.
Section 6. Accommodations. Each home shall:
(1) Be safe and of substantial construction and comply with applicable state and local laws relating to location, zoning, plumbing, and sanitation;
(2) Provide lighting with a minimum illumination level of fifty (50) foot-candles for each hall, stairway, entryway, resident area, and bathroom; a minimum illumination level of thirty (30) foot-candles shall be required for kitchens;
(3) Have a water supply which is potable, adequate and from an approved public supply of a municipality or water district, if available. In the event a public water supply of a municipality or a water district is not available, the supply shall be developed and approved in accordance with applicable requirements of the Natural Resources and Environmental Protection Cabinet; provided, however, if a public water supply of a municipality or water district subsequently becomes available, connections shall be made thereto and any other supply shall be discontinued;
(4) Have an ample supply of hot and cold running water available at all times for general use. The water temperature at any tap shall not exceed 110 degrees Fahrenheit and all plumbing shall be installed pursuant to the State Plumbing Code;
(5) Have adequate toilet and bathing facilities conveniently located as required by the State Plumbing Code. Toilet facilities shall be kept clean and in good repair;
(6) Have adequate ventilation in all areas used by residents. Toilet rooms shall be vented to the outside, if there is no window. There shall be an exterior window which can be opened in each resident room;
(7) Assure that beds occupied by residents shall be placed so no resident may experience discomfort due to proximity to radiators, heat outlets, or exposure to drafts;
(8) Not use stacked beds;
(9) Have beds and mattresses that are no less than thirty-three (33) inches wide and six (6) feet long;
(10) Not house residents in rooms or detached buildings or other enclosures which have not been previously inspected and approved for resident use, or in basements not approved by the cabinet for sleeping quarters. Approved basements must have an outside door;
(11) Not be located in a house trailer or motor home;
(12) Provide a heating system which can maintain an even temperature and is capable of maintaining a minimum temperature of seventy-two (72) degrees Fahrenheit in resident-occupied areas under winter conditions and a maximum temperature of eighty-five (85) degrees under summer conditions; and
(13) Be able to accept a resident who uses a wheelchair by assuring that the resident is able to enter and exit the home and utilize the bathroom facility without assistance (i.e., ramps, railings, etc.).
(14) Toilet rooms normally accessible and intended for public use shall comply with the provisions of Section 5(3)(i) of this administrative regulation.
Section 7. Safety. Each home shall take appropriate precautions to ensure the safety of the residents and visitors by:
(1) Having all exterior grounds including sidewalks, steps, porches, ramps, and fences in good repair;
(2) Having all of the home's interior including walls, ceilings, floors, floor coverings, steps, windows, window coverings, doors, plumbing, and electrical fixtures in good repair;
(3) Having a fire control and evacuation plan;
(4) Having an adequate number of 2A10 B:C rated fire extinguishers located throughout the home with a minimum of one (1) per floor or level of the residence;
(5) Having a 40 B:C rated fire extinguisher located within each food preparation area in the home;
(6) Having a person in charge thoroughly oriented in the evacuation of the residents in the event of a fire, with evacuation plans posted in individual rooms and common use areas; and
(7) Having smoke detectors located as follows:
(a) One (1) shall be located in each bedroom; and
(b) At least one (1) shall be located on each floor or level of the home;
(8) Having at least one (1) emergency lighting source available in the home that automatically illuminates with a loss of power to the home.
Section 8. Complaint Procedures.
(1) Complaints by registrants shall be directed to the appropriate agency.
(2) Every home shall conspicuously post a listing of agencies and their telephone numbers, including:
(a) The Protection and Advocacy Division of the Public Protection and Regulation Cabinet;
(b) The Adult Protective Services Division of the Department for Social Services;
(c) The health department of the county in which the home is situated; and
(d) The comprehensive care center for that area development district, and any other comprehensive care center that may serve residents in the home.
(e) The Division of Licensing and Regulation.
Section 9. Suspension of Registration.
(1) Whenever the cabinet has reason to believe that an imminent public health hazard exists, or whenever the registrant or manager has interfered with the authorized agents of the cabinet in the performance of their duties, the registration may be suspended immediately upon notice to the registrant without a hearing. In such event the registrant may request a hearing.
(2) In all other instances of violation of the provisions of this administrative regulation, the cabinet or its agents may serve upon the registrant a written notice specifying the violation(s) in question and afford a reasonable opportunity to correct same. Whenever there is a failure to comply with any written notice issued under the provisions of this administrative regulation, the registrant shall be notified in writing that the registration shall be suspended at the end of ten (10) days following service of such notice, unless a written request for a hearing is filed in accordance with 902 KAR 1:400.
Section 10. Reinstatement of Suspended Registration. Any registrant may, at any time, make application for a reinspection for the purpose of reinstatement of the registration. Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his opinion the conditions causing suspension have been corrected, the cabinet shall make a reinspection. If the applicant is found to be in compliance with the requirements of this administrative regulation, the registration shall be reinstated.
Section 11. Revocation of Registration. For serious or repeated violations of any of the requirements of this administrative regulation or for interference with the agents of the cabinet in the performance of their duties, the registration may be permanently revoked after an opportunity for a hearing has been provided by the cabinet. Prior to such action, the cabinet shall notify the registrant in writing, stating the reasons for which the registration is subject to revocation and advising that the registration shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for a hearing is filed in accordance with 902 KAR 1:400.
Section 12. Hearings. All administrative hearings shall be conducted in accordance with 902 KAR 1:400.
History
- RELATES TO: KRS 216B.300-216B.320, 216B.990
- STATUTORY AUTHORITY: KRS Chapter 13B, 216B.305, EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.305 mandates that the Cabinet for Health Services adopt standards through administrative regulation relating to boarding homes. This administrative regulation provides the standards for the operation of boarding homes. Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Department for Public Health and its programs under the Cabinet for Health Services.
- History: 902 KAR 020:350. 20 Ky.R. 719; 1016; eff. 12-6-1993; 22 Ky.R. 2422; eff. 8-1-1996; Crt eff. 4-25-2019; Crt eff. 10-13-2025.
902 KAR 20:360 Abortion facilities {#sec-902-kar-20-360 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:360}
Section 1. Definitions.
(1) "Abortion" is defined by KRS 311.720(1).
(2) "Abortion facility" is defined by KRS 216B.015(1).
(3) "Cabinet" is defined by KRS 216B.015(6).
(4) "Volunteer" means a person who is not an employee of the abortion facility, but has direct patient health care responsibilities performed within the abortion facility, and excludes any individual whose only duties include ushering patients into the facility.
Section 2. Licenses.
(1) A license to operate an abortion facility shall not be required for a health facility licensed in accordance with 902 KAR 20:016 or 902 KAR 20:106.
(2) A Kentucky-licensed acute-care hospital or ambulatory surgical center shall:
(a) Comply with the requirements of its respective licensure category and provide written notice of its intent to perform abortions to the Office of Inspector General, Division of Health Care, 275 East Main Street, Frankfort, Kentucky 40621;
(b) Comply with the reporting requirements of KRS 216B.0431; and
(c) Be exempt from any other licensure requirements of this administrative regulation.
(3) An abortion facility license required by KRS 216B.0431 shall be conspicuously posted in a public area of the facility.
(4) An applicant for licensure shall file with the Office of the Inspector General, Division of Health Care, 275 East Main Street, Frankfort, Kentucky 40621, an Application for License to Operate an Abortion Facility.
(5) An applicant for a license shall, as a condition precedent to licensure or relicensure, be in compliance with the applicable federal and state laws and administrative regulations relating to an abortion facility and the requirements established in this subsection.
(a) Compliance with licensure administrative regulations shall be ascertained through an onsite inspection of the facility. A licensure inspection may be unannounced.
(b) A representative of the Office of Inspector General shall have access to the facility during the hours that the facility operates.
(c) A regulatory violation identified during an inspection shall be transmitted in writing to the facility by the Office of Inspector General.
(d) The facility shall submit a written plan for the elimination or correction of the regulatory violation to the Office of Inspector General within ten (10) calendar days.
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The plan shall specify the date by which each violation shall be corrected.
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Following a review of the plan, the Office of Inspector General shall notify the facility in writing of the acceptability of the plan.
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If a portion or all of the plan is unacceptable:
a. The Office of Inspector General shall specify the reasons for the unacceptability; and
b. The facility shall modify or amend the plan and resubmit it to the Office of Inspector General within ten (10) calendar days.
(6) A licensee shall, as a condition of licensure or relicensure, be in compliance with the reporting requirements of KRS 213.101.
(7) An unannounced inspection shall be conducted:
(a) On a complaint allegation; and
(b) Utilizing the procedures established in subsection (5) of this section.
(8) A license shall remain in effect for one (1) year from the date of issuance unless otherwise expressly provided in the license certificate.
(9) A license shall be renewed upon payment of the prescribed fee and compliance with the licensure administrative regulations.
(10) Each license to operate shall be issued for the person or entity and premises named in the application.
(11) A new application shall be filed if there is change of ownership as established by 902 KAR 20:008, Section 2(16).
(a) Upon the filing of a new application for a license because of change of ownership, the new license shall be automatically issued for the remainder of the current licensure period.
(b) An additional fee shall not be charged for the remainder of the licensure period.
Section 3. Fee Schedule.
(1) Annual fees. The annual licensure fee (including a renewal) for abortion facilities shall be $155 for each licensed facility.
(2) Fees shall be paid by check made payable to Kentucky State Treasurer and sent to Cabinet for Health and Family Services, Division of Health Care, 275 East Main Street, 4EA, Frankfort, Kentucky 40621.
Section 4. Appeals.
(1) Notice of the denial, suspension, or revocation of a license, or application for a provisional license, or denial or rescission of a request for extension as set forth in Section 10(5) of this administrative regulation shall be made pursuant to the provisions of KRS Chapter 13B.
(2) A licensee may appeal the denial, suspension, or revocation of the facility's license or its application for a provisional license to the Secretary of the Cabinet for Health and Family Services, 275 East Main Street, Frankfort, Kentucky 40621.
(3) A hearing on the denial, suspension, or revocation of a license shall be conducted pursuant to the provisions of KRS Chapter 13B.
Section 5. Administration and Operation.
(1) Licensee.
(a) The licensee shall be legally responsible for the abortion facility and for compliance with federal, state, and local laws and regulations pertaining to the operation of the abortion facility.
(b) The licensee shall establish written policies for the administration and operation of the abortion facility.
(c) The licensee shall establish lines of authority and designate the staff person who shall be principally responsible for the daily operation of the abortion facility.
(2) Policies.
(a) Administrative policies. The abortion facility shall have written administrative policies covering all aspects of the operation, including:
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A description of organizational structure, staffing, and allocation of responsibility and accountability;
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A description of referral linkages with inpatient facilities and other providers;
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Policies and procedures for the guidance and control of personnel performances;
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A description of services included in the program;
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A description of the administrative and patient care records and reports;
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Procedures to be followed in the storage, handling, and administration of drugs and biologicals;
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A policy to specify the provision of emergency medical services; and
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Procedures to be followed in obtaining the voluntary and informed written consent of the pregnant woman as required by KRS 311.725 prior to performing an obstetric ultrasound in accordance with KRS 311.727.
(b) Patient rights policies. The abortion facility shall adopt written policies regarding the rights and responsibilities of patients. These patients' rights policies shall assure that each patient:
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Is informed of these rights and of a procedure for handling patient grievances;
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Is informed of services available at the abortion facility and of related charges, including any charges not covered under third-party payor arrangements;
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Is informed of her medical condition, unless medically contraindicated (as documented in her medical record), and is afforded the opportunity to participate in the planning of her medical treatment and to refuse to participate in experimental research;
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Is encouraged and assisted to understand and exercise her patient rights. To this end, she may voice grievances and recommend changes in policies and services. Upon the patient's request, the grievances and recommendations shall be conveyed within a reasonable time to an appropriate decision making level within the organization that has authority to take corrective action;
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Is assured confidential treatment of her records and is afforded the opportunity to approve or refuse the release of her records to any individual not involved in her care, except as required by Kentucky law or thirdparty payment contract; and
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Is treated with consideration, respect, and full recognition of her dignity and individuality, including privacy in treatment and in the care of her personal health needs.
(3) Personnel.
(a) A facility shall have a staff that is adequately trained and capable of providing appropriate service and supervision to the patients.
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The licensee shall obtain written applications for employment from all employees. The licensee shall obtain and verify information on the application as to education, training, experience, appropriate licensure, if applicable, and health and personal background of each employee.
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Prior to performing job duties, all employees and volunteers who have direct patient contact within the abortion facility shall have tuberculin testing conducted in accordance with 902 KAR 20:205.
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A person shall be designated in writing at each facility to coordinate TB screening of personnel and any other TB control activities.
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All professional and allied health professional staff members shall be currently certified with American Red Cross, American Heart Association, or an equivalent nationally recognized organization to perform cardiopulmonary resuscitation and capable of recognizing symptoms of distress.
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An employee or volunteer of the facility while afflicted with any infected wounds, boils, sores, or an acute respiratory infection or any other contagious disease or illness shall not work in any capacity in which there is a likelihood of that person transmitting disease to other individuals.
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Each facility shall have and execute a written orientation program to familiarize each new staff member with the facility and its policies and procedures, including:
a. Fire safety and other safety measures;
b. Medical emergencies;
c. Infection control; and
d. Confidentiality of patient information and records.
-
In-service training programs shall be planned and provided for all employees and volunteers to ensure and maintain their understanding of their duties and responsibilities.
-
Records shall be maintained to reflect in-service training program content and individual attendance.
-
The following training shall be provided at least annually:
a. Infection control, to include as a minimum:
(i) Universal precautions against blood-borne diseases;
(ii) General sanitation; and
(iii) Personal hygiene such as hand washing, use of masks and gloves, and instruction to staff if there is a likelihood of transmitting a disease to patients or other staff members;
b. Fire protection, including:
(i) Evacuating patients;
(ii) Proper use of fire extinguishers; and
(iii) Procedures for reporting fires;
c. Confidentiality of patient information and records, and protecting patient rights; and
d. Licensing regulations.
- Job descriptions.
a. Written job descriptions that adequately describe the duties of every position shall be maintained.
b. Each job description shall include:
(i) Position title;
(ii) Authority;
(iii) Specific responsibilities; and
(iv) Minimum qualifications.
c. Job descriptions shall be:
(i) Reviewed at least annually;
(ii) Kept current; and
(iii) Given to each employee and volunteer assigned to the position, including any revised job descriptions.
- A personnel file shall be maintained for each employee and for each volunteer as follows:
a. The records shall be:
(i) Completely and accurately documented; and
(ii) Readily available and systematically organized to facilitate the compilation and retrieval of information; and
b. The file shall contain:
(i) A current job description that reflects the individual's responsibilities and work assignments; and
(ii) Documentation of the individual's orientation, in-service education, appropriate licensure, if applicable, and TB testing.
(b) Clinical staff.
-
Physicians, nurses, and allied health professionals shall constitute the clinical staff.
-
The clinical staff shall meet at least quarterly to review and analyze their clinical experiences. Minutes shall be maintained of the meetings.
-
Physicians.
a. Abortions shall be performed only by a physician who is:
(i) Licensed to practice medicine in Kentucky; and
(ii) Properly qualified by training and experience to perform pregnancy termination procedures.
b. A physician shall remain on the premises until all patients are discharged.
(c) Nursing.
-
Nursing care shall be under the supervision of a registered nurse currently licensed in Kentucky.
-
A registered nurse shall be on duty to provide or supervise all nursing care of patients in preparation, during the termination procedure, the recovery period, and until all patients leave the facility.
-
Licensed practical nurses, working under appropriate supervision and direction of a registered nurse, may be employed as components of the nursing staff.
(d) Allied health professionals, working under appropriate direction and supervision, may be employed to work only within areas where their competency has been established.
Section 6. Patient Care.
(1) An abortion facility shall not serve patients whose needs exceed the resources or capabilities of the facility.
(2) The facility shall formulate and adhere to written patient care policies and procedures designed to ensure professional and safe care for patients, including the following:
(a) Admission criteria;
(b) Physician and nurse responsibilities for the services offered;
(c) Specific details regarding the preoperative procedures performed, to include history and physical examination, including:
-
Verification of pregnancy;
-
Estimation of gestational age;
-
Identification of any preexisting conditions or complications; and
-
An obstetric ultrasound as required by KRS 311.727;
(d) The actual abortion procedure, to include the use of:
-
IVs;
-
Fluids;
-
Analgesia oranesthesia. General anesthesia shall be administered only by personnel acting within the limits of their statutory scope of practice; and
-
Tissue examination and disposal;
(e) Postprocedure care and recovery room procedures to include emergency care;
(f) Provisions for the education of patient, family, and others, as appropriate in pre- and postprocedure care;
(g) Plans for follow-up patient care after discharge from the facility;
(h) Management and appropriate referral of high-risk conditions;
(i) Transfer of patients who, during the course of pregnancy termination, are determined to need care beyond that of the facility; and
(j) Infection control and sanitation procedures, including duties and responsibilities of the infection control committee. The infection control committee shall develop and implement specific patient care and administrative policies aimed at investigating, controlling, and preventing infections in the facility.
Section 7. Pharmaceutical Services. Pharmaceutical services shall be provided in accordance with accepted professional practice and federal, state, and local laws.
(1) Emergency drugs.
(a) Emergency kit or emergency drugs. Each facility shall maintain an emergency kit or stock supply of drugs and medicines for use in treating the emergency needs of patients in compliance with the requirements of this paragraph.
-
The emergency kit or stock supply of drugs and medicine shall be stored in such a manner as to prohibit its access by unauthorized personnel.
-
A listing of contents by drawer or shelf shall be placed on the cabinet or emergency cart to allow quick retrieval.
-
Contents shall correspond with the inventory list.
-
Drugs and equipment shall be available within the facility to treat, as a minimum, the following conditions:
a. Cardiac arrest;
b. Seizure;
c. Asthmatic attack;
d. Allergic reaction;
e. Narcotic toxicity;
f. Hypovolemic shock; or
g. Vasovagal shock.
(b) Drug Reference Sources. Each facility shall maintain reference sources for identifying and describing drugs and medicines.
(2) Administering drugs and medicines.
(a) Drugs and medicines shall not be administered to individual patients or to anyone within or outside the facility except by those authorized by law under orders of a physician or other ordering personnel acting within the limits of his or her statutory scope of practice.
(b) The orders shall be in writing and signed personally by the physician or other personnel who prescribes the drug or medicine.
(3) Medicine storage.
(a) Medicines and drugs maintained in the facility for daily administration shall not be expired and shall be properly stored and safeguarded in enclosures of sufficient size that are not accessible to unauthorized persons.
(b) Refrigerators used for storage of medications shall maintain an appropriate temperature as determined by the requirements established on the label of medications.
(c) A thermometer accurate to ± three (3) degrees Fahrenheit shall be maintained in these refrigerators.
(d) Only authorized personnel shall have access to storage enclosures.
(e) Controlled substances and ethyl alcohol, if stocked, shall be stored under double locks and in accordance with applicable state and federal laws.
(4) Medicine preparation area.
(a) Medicines and drugs shall be prepared for administration in an area that contains a counter and a sink.
(b) This area shall be located in such a manner as to prevent contamination of medicines being prepared for administration.
(5) Records. Records shall be kept of all stock supplies of controlled substances giving an accounting of all items received or administered.
(6) Poisonous substances. All poisonous substances shall be plainly labeled and kept in a cabinet or closet separate from medicines and drugs to be prepared for administration.
Section 8. Laboratory Services.
(1) Laboratory services shall be provided on site or through arrangement with a laboratory certified to provide the required procedures under 42 C.F.R. Part 493.
(a) Facilities for collecting specimens shall be available on site.
(b) If laboratory services are provided on site, the services shall be:
-
Directed by a person who qualifies as a director under KRS 333.090 and 42 C.F.R. Part 493; and
-
Performed in compliance with KRS Chapter 333 and 42 C.F.R. Part 493 standards.
(2) Prior to the procedure, laboratory tests shall include a recognized urine pregnancy test unless the physician identifies fetal heart beats or fetal movements on physical examination. If positive, the following additional tests shall be required:
(a) Urinalysis including albumin and glucose examination;
(b) Hematocrit or hemoglobin; and
(c) Determination of Rh factor with appropriate medical intervention.
(3)
(a) Aspirated tissues shall be examined to verify that villi or fetal parts are present.
(b) If villi or fetal parts cannot be identified with certainty, the tissue specimen shall be sent for further pathologic examination and the patient alerted to the possibility of an ectopic pregnancy.
(4) A written report of each laboratory test and examination shall be a part of the patient's record.
(5) If a patient is bleeding profusely and a transfusion of red blood cells is necessary, she shall be administered fluids and transported immediately to a Kentucky-licensed acute care hospital.
(6) All laboratory supplies shall be monitored for expiration dates, if applicable.
Section 9. Medical Waste Disposal.
(1) Sharp wastes.
(a) Sharp wastes, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other wastes and placed in puncture resistant containers immediately after use.
(b) A needle or other contaminated sharp shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Centers for Disease Control and Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
(c) A sharp waste container shall be incinerated on or off site, or be rendered nonhazardous.
(2) Disposable waste.
(a) All disposable waste shall be:
-
Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
-
Handled, stored, and disposed of in such a way as to minimize direct exposure of personnel to waste materials.
(b) The abortion facility shall establish specific written policies regarding handling and disposal of waste material.
(c) Pathological waste, such as tissues, organs, body parts, and bodily fluids, shall be incinerated.
(d) Blood, blood specimens, used blood tubes, or blood products shall be:
-
Disposed of by incineration;
-
Autoclaved before disposal; or
-
Carefully poured down a drain connected to sanitary sewer, subject to limitations in paragraph (e) of this subsection.
(e) Any wastes conveyed to a sanitary sewer shall comply with applicable federal, state, and local pretreatment law, including 40 C.F.R. 403 and relevant local ordinances.
(f) Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:023 or 401 KAR 61:013.
Section 10. Emergency Care.
(1) As required by KRS 216B.0435, an abortion facility shall enter into a written agreement with a Kentucky-licensed acute-care hospital and a local, Kentucky-licensed Class I ambulance service for the transport and treatment of a patient with unforeseen complications related to an abortion facility procedure.
(2) Each written agreement shall be filed with the cabinet pursuant to KRS 216B.0435(4) within ten (10) calendar days of finalization.
(3) A transfer agreement between the abortion facility and a Kentucky-licensed acute-care hospital shall:
(a) Be with a hospital located:
-
In the same county as the abortion facility; or
-
No further than twenty (20) minutes normal driving time from the abortion facility;
(b) Be a legally binding contractual document;
(c) Be signed by individuals authorized to execute the agreement on behalf of the abortion facility and hospital, who shall certify they have such authority;
(d) Require transfer of a patient if deemed medically necessary by the physician attending to the patient;
(e) Identify responsibilities of the abortion facility in which the abortion facility shall, at a minimum:
-
At the time of transfer, provide the hospital with complete and accurate information regarding the patient being transferred to the hospital;
-
Notify the hospital of the impending transfer of a patient and receive confirmation of the availability of appropriate facilities, services, and staff necessary for the care of the patient;
-
At the time of transfer, provide the hospital with copies of relevant portions of the patient's clinical record;
-
Transfer with the patient, the patient's medical records, demographic information, insurance information, and other information deemed necessary or otherwise required by law to facilitate the provision of medical care when the patient arrives at the hospital; and
-
Arrange for the immediate transfer of the patient's personal effects, including a document listing of the effects; and
(f) Identify responsibilities of the hospital in which the hospital shall, at a minimum:
-
Provide prompt and appropriate evaluation and treatment of a patient transferred to the hospital pursuant to the transfer agreement;
-
Accept responsibility for the patient's care when the patient is received by the hospital;
-
Direct charges performed by the hospital to the patient or patient's third-party payer; and
-
Acknowledge receipt of the patient's personal effects in writing signed by an authorized representative of the hospital and deliver the receipt to the abortion facility.
(4) A transport agreement between the abortion facility and a Kentucky-licensed Class I ambulance service capable of responding immediately to a call for emergency transport shall:
(a) Be with an ambulance service located:
-
In the same county as the abortion facility; or
-
No further than five (5) miles or ten (10) minutes normal driving time from the abortion facility;
(b) Be signed by individuals authorized to execute the agreement on behalf of the abortion facility and ambulance service, who shall certify they have such authority; and
(c) Identify responsibilities of the ambulance service in which the ambulance service shall agree, at a minimum to:
-
Provide services in accordance with all federal and state laws and administrative regulations applicable to emergency service entities;
-
Employ sufficient staff, including paramedics and emergency medical technicians, to provide patient care and operate vehicles and equipment in accordance with industry standards and applicable laws and administrative regulations;
-
Require all responding medical personnel to familiarize themselves with the floor plan of the abortion facility to minimize the time required to locate the patient in the facility and exit the facility with the patient as expeditiously as possible;
-
Acknowledge the existence of, and its familiarity with the terms of, the transfer agreement between the abortion facility and an acute care hospital; and
-
Transport the patient to the hospital that is party to the transfer agreement, unless otherwise directed by the patient.
(5) A licensed abortion facility applying for a renewal license or an applicant for a provisional license may submit a request in writing for extensions of time to comply with the transfer or transport agreement requirements to the cabinet's Office of Inspector General in accordance with the provisions of this subsection.
(a) Any request shall:
-
Be in writing;
-
Contain a certification under oath that the party seeking the extension of time has exhausted all reasonable efforts to obtain a transfer or transport agreement for a continuous ninety (90) calendar day period prior to the request; and
-
Contain a detailed description of the efforts taken to secure the agreements.
(b) In deciding to grant or deny the request for an extension of time, the inspector general shall consider all factors the inspector general deems relevant under the circumstances, but at least the following factors:
-
Whether the abortion facility or applicant made, and continues to make, a good faith effort to obtain a transfer or transport agreement;
-
Whether the abortion facility or applicant can provide the same level of patient care and safety via alternative health services during any extension period; and
-
Regulatory compliance history at the abortion facility and at any other health care facility owned, in whole or in part, by the applicant or any other individual or entity having an ownership interest with the facility.
(c) If the request is granted, the extension of time shall be effective for a time-period of ninety (90) calendar days from the date of issuance.
(d) If the request is granted for a transfer agreement, the transport agreement need not comply with subsection (4)(c)4. and 5. of this section for the duration of the extension of time.
(e) The inspector general may rescind a previously granted extension of time at any time upon determining that the applicant or abortion facility has not met, or is not meeting, the conditions of paragraph (b) of this subsection.
(f) If a request for an extension is denied, an applicant or licensee shall have ten (10) calendar days to submit a written request for reconsideration to the inspector general, whose decision shall be final. The licensee or applicant for provisional license may appeal a denial in accordance with Section 4 of this administrative regulation.
Section 11. Equipment and Supplies. There shall be appropriate equipment and supplies maintained for the patients to include:
(1) A bed or recliner suitable for recovery;
(2) Oxygen with flow meters and masks or equivalent;
(3) Mechanical suction;
(4) Resuscitation equipment to include resuscitation bags and oral airways;
(5) Emergency medications, intravenous fluids, and related supplies and equipment;
(6) A clock with a sweep second hand;
(7) Sterile suturing equipment and supplies;
(8) Adjustable examination light;
(9) Containers for soiled linen and waste materials with covers;
(10) Refrigerator; and
(11) Appropriate equipment for the administering of general anesthesia, if applicable.
Section 12. Consultation. Arrangements shall be made for consultation or referral services to be available as needed.
Section 13. Quality Improvement.
(1) The facility shall establish and implement a written plan for a quality improvement program for patient care that shall:
(a) Specify the individual responsible for coordinating the quality improvement program; and
(b) Provide for ongoing monitoring of staff and patient care services.
(2) There shall be an ongoing process for monitoring and evaluating the following:
(a) Patient care services;
(b) Staffing;
(c) Infection prevention and control;
(d) Housekeeping;
(e) Sanitation;
(f) Safety;
(g) Maintenance of physical plant and equipment;
(h) Patient care statistics; and
(i) Discharge planning services.
(3) Evaluation of patient care throughout the facility shall be criteria-based so that certain actions shall be taken or triggered if specific quantified, predetermined levels of outcomes or potential problems are identified.
(4) The quality improvement process shall incorporate quarterly review of a minimum of five (5) percent of medical records of patients undergoing procedures during a given quarter, but not less than five (5) records shall be reviewed.
(5)
(a) The quality improvement process shall include evaluation by patients of care and services provided by the facility.
(b) If the families of patients are involved in the care and services provided by the facility, the quality improvement process shall include a means for obtaining input from families of patients.
(6) The administrator shall review the findings of the quality improvement program to ensure that effective corrective actions have been taken, including as a minimum:
(a) Policy revisions;
(b) Procedural changes;
(c) Educational activities; and
(d) Follow-up on recommendations, which may include that additional actions are no longer indicated or needed.
(7) The quality improvement program shall identify and establish indicators of quality care specific to the facility that shall be monitored and evaluated.
(8) The results of the quality improvement program shall:
(a) Be submitted to the licensee for review at least annually; and
(b) Include at least the deficiencies found and recommendations for corrections or improvements.
(9) Deficiencies that jeopardize patient safety shall be reported immediately in writing to the licensee.
Section 14. Medical Records.
(1) Medical records shall be maintained for all patients examined or treated in the abortion facility.
(2) The medical records shall be:
(a) Completely and accurately documented;
(b) Readily available; and
(c) Systematically organized to facilitate the compilation and retrieval of information.
(3) All information shall be centralized in the patient's medical record.
(4) All entries shall be legibly written or typed, dated, and signed.
(5) The medical record shall include the following information:
(a) A face sheet with patient identification data, including:
-
Name;
-
Address;
-
Telephone number;
-
Social Security number;
-
Date of birth; and
-
Name, address and telephone number of the person to be notified if an emergency occurs;
(b) Signed consent for the procedure;
(c) Date of initial examination;
(d) Date of abortion;
(e) Referring and attending physicians' names and phone numbers, if applicable;
(f) Complete medical history to include medications currently being taken;
(g) Physical examination, to the extent necessary to determine the health status of the patient, within fifteen (15) days of the procedure, including detail of findings of pelvic examination and estimated gestational age, according to the first day of the last menstrual period;
(h) Results of diagnostic tests and examinations, including:
-
X-ray;
-
Electrocardiography;
-
Clinical laboratory;
-
Pathology;
-
Consultations; or
-
Ultrasound;
(i) Preoperative diagnosis;
(j) Counselor's notes, if applicable;
(k) Physician's orders;
(l) Complete record of abortion procedure to include:
-
Vital signs, including temperature, pulse, respiration, and blood pressure prior to and following the procedure;
-
Name of procedure performed;
-
Anesthetic agent utilized;
-
Name of attending physician performing the procedure;
-
Names of clinical assistants in attendance, including:
a. Other physicians;
b. Physician's assistants;
c. Anesthetists;
d. Nurses; or
e. Specially-trained technicians; and
- Signature of physician performing the procedure;
(m) Nurses' notes;
(n) Progress notes to include a postanesthesia note if general anesthesia is utilized;
(o) Attending physician's description of gross appearance of tissue removed;
(p) Final diagnosis;
(q) Condition on discharge;
(r) Post-op orders and follow-up care; and
(s) Documented verification that the woman has received information and was offered printed materials as required by KRS 311.725.
(6) The attending physician shall complete and sign the medical record within seventy-two (72) hours following discharge.
(7) Confidentiality of all patient records shall be maintained at all times.
(8) Transfer of records. The abortion facility shall:
(a) Establish systematic procedures to assist in continuity of care if the patient moves to another source of care; and
(b) Upon proper release, transfer medical records or an abstract thereof if requested.
(9) Retention of records. After patient's death or discharge, the complete medical record shall be placed in an inactive file and retained for six (6) years or, in case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.
Section 15. Infection Control.
(1) There shall be an infection control program developed to prevent, identify, and control infections.
(2) Written policies and procedures pertaining to the operation of the infection control program shall be:
(a) Established;
(b) Reviewed at least annually; and
(c) Revised as necessary.
(3) A practical system shall be developed for reporting, evaluating, and maintaining records of infections among patients and personnel.
(4) The system shall include assignment of responsibility for:
(a) The ongoing collection and analysis of data; and
(b) The implementation of required follow-up actions.
(5) Corrective actions shall be:
(a) Taken on the basis of records and reports of infections and infection potentials among patients and personnel; and
(b) Documented.
(6) All new employees shall be instructed on:
(a) The importance of infection control and personal hygiene; and
(b) Their responsibility in the infection control program.
(7) The facility shall document that in-service education in infection prevention and control is provided to all services and program components.
(8) Adequate space shall be provided for storage, maintenance, and distribution of sterile supplies and equipment.
(9) Sterile supplies and equipment shall:
(a) Not be mixed with unsterile supplies;
(b) Be stored in dust-proof and moisture-free units; and
(c) Be properly labeled.
(10) Sterilizing equipment of appropriate type shall be available and of adequate capacity to properly sterilize instruments and materials.
(11) The sterilizing equipment shall have approved control and safety features.
Section 16. Linen and Laundry.
(1) An adequate supply of clean linen or disposable materials shall be maintained to ensure a change of linen on procedure tables between patients.
(2) Provisions for proper laundering of linen and washable goods shall be made.
(3) Soiled and clean linen shall be handled and stored separately.
(4) Storage shall be in covered containers.
(5) A sufficient supply of cloth or disposable towels shall be available so that a fresh towel is used after each hand washing.
(6) Towels shall not be shared.
Section 17. Housekeeping.
(1) A facility shall be kept neat, clean, and free from odors.
(2) Accumulated waste material shall be removed daily or more often if necessary.
(3) There shall be frequent cleaning of floors, walls, ceilings, woodwork, and windows.
(4) The premises shall be kept free from rodent and insect infestation.
(5) Bath and toilet facilities shall be maintained in a clean and sanitary condition at all times.
(6) Cleaning materials and supplies shall be stored in a safe manner.
(7) All harmful agents shall be locked in a closet or cabinet used for this purpose only.
Section 18. Refuse and Waste Disposal.
(1) All garbage and waste shall be collected, stored, and disposed of in a manner designed to prevent the transmission of disease.
(2) Containers shall be washed and sanitized before being returned to work areas.
(3) Disposable type containers shall not be reused.
(4) Containers for garbage and refuse shall be:
(a) Covered and stored outside; and
(b) Placed on an approved platform to prevent:
-
Overturning by animals;
-
The entrance of flies; or
-
The creation of a nuisance.
(5) All solid waste shall be disposed of at sufficient frequencies in a manner so as not to create a rodent, insect, or other vermin problem.
(6) Immediately after emptying, containers for garbage shall be cleaned.
(7) All medical waste shall be managed in accordance with Section 9 of this administrative regulation.
Section 19. Outside Areas.
(1) All outside areas, grounds, and adjacent buildings shall be kept free of rubbish, grass, and weeds that may serve as a:
(a) Fire hazard; or
(b) Haven for insects, rodents, and other pests.
(2) Outside stairs, walkways, ramps, and porches shall be maintained free from accumulations of water, ice, snow, and other impediments.
Section 20. Disaster Preparedness.
(1) All staff shall be knowledgeable of a written plan and procedure for meeting potential disasters and emergencies such as fires or severe weather.
(2) The plan shall be posted.
(3) Staff shall be trained in:
(a) Properly reporting a fire;
(b) Extinguishing a small fire;
(c) Evacuation from the building; and
(d) Procedures for fire safety, including fire drills.
(4) All fire protection and alarm systems and other firefighting equipment shall be inspected and tested at least once each year, and more often if necessary to maintain them in serviceable condition.
Section 21. Facility Specifications.
(1) An abortion facility shall provide a functionally safe and sanitary environment for patients, personnel, and the public.
(2) An abortion facility shall include space for the following functions:
(a) Reception and waiting;
(b) Administrative activities such as patient admission, record storage, and business affairs;
(c) Patient dressing and storage of personal items;
(d) Preoperative evaluation, including:
-
Physical examination;
-
Laboratory testing; and
-
Preparation for anesthesia;
(e) Performance of surgical procedures;
(f) Preparation and sterilization of instruments;
(g) Storage of equipment, drugs, and fluids;
(h) Postanesthetic recovery; and
(i) Janitorial and utility support.
Section 22. Injunctive Relief. The Office of Inspector General shall refer instances where administrative penalties and legal sanctions have failed to prevent or cause a discontinuance of a violation of KRS Chapter 216B to the secretary of the cabinet for action in accordance with KRS 15.241.
Section 23. Incorporation by Reference.
(1) Form OIG 240, "Application for License to Operate an Abortion Facility", June 2017, is incorporated by reference.
(2) This material may be inspected, copied or obtained subject to applicable copyright law, at the Office of Inspector General, Division of Health Care, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 15.241, 213.101, 216B.010-216B.130, 216B.990, 311.710-311.830, 314.011(8), 314.042(8), Chapter 333, 29 C.F.R. 1910.1030, 40 C.F.R. Part 403, 42 C.F.R. Part 493
- STATUTORY AUTHORITY: KRS 216B.0431
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.0431 requires that the Cabinet for Health and Family Services regulate abortion facilities. This administrative regulation establishes the licensure requirements for abortion facilities.
- History: 25 Ky.R. 1293; Am. 2168; 2388; eff. 3-17-1999; 44 Ky.R. 371; eff. 10-11-2017; Cert eff. 7-18-2024.
902 KAR 20:365 Kentucky abortion-inducing drug certification program and registration of qualified physicians {#sec-902-kar-20-365 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:365}
Section 1. Definitions.
(1) "Abortion" is defined by KRS 311.720(1).
(2) "Abortion facility" is defined by KRS 216B.015(1).
(3) "Abortion-inducing drug" is defined by KRS 311.7731(2).
(4) "Cabinet" is defined by KRS 311.7731(5).
(5) "Distributor" is defined by KRS 311.7731(9).
(6) "Hospital" is defined by KRS 311.720(7).
(7) "Manufacturer" is defined by KRS 311.7731(9).
(8) "Physician" is defined by KRS 311.720(12).
(9) "Provide" is defined by KRS 311.7731(13).
(10) "Qualified physician" is defined by KRS 311.7731(14).
Section 2. Physician registration.
(1) In accordance with KRS 311.7733, only a qualified physician registered with the cabinet may provide abortion-inducing drugs to a pregnant person.
(2) To be eligible for registration, a qualified physician shall:
(a) Demonstrate compliance with KRS 216B.206(1)(a), (c), (m), and (n); and
(b) Certify compliance with KRS 216B.206(1)(b), (d) - (l), (o), and (p).
Section 3. Certification of manufacturers, distributors, pharmacies, and abortion facilities.
(1) In accordance with KRS 216B.202 and 216B.204, the following entities shall be certified by the cabinet:
(a) A manufacturer or distributor that transports, supplies, or sells abortion-inducing drugs;
(b) A pharmacy that dispenses abortion-inducing drugs; or
(c) A licensed abortion facility.
(2)
(a) To be eligible for certification, a manufacturer, distributor, or pharmacy shall:
-
Demonstrate compliance with KRS 216B.204(2)(a) and (d); and
-
Certify compliance with KRS 216B.204(2)(b), (c), (d), (e), and (f).
(b) In addition to complying with paragraph (a) of this subsection, a pharmacy shall also comply with KRS 216B.204(3) if the U.S. Food and Drug Administration (FDA) and drug manufacturers implement certification programs for pharmacies to dispense abortion-inducing drugs and compliance with KRS 216B.204(3) becomes possible. A pharmacy shall submit evidence of certification by the FDA within 180 days after creation and implementation of the FDA certification program and shall submit evidence of certification by the drug manufacturer within 180 days after creation and implementation of the manufacturer's certification program.
Section 4. Application and fees.
(1) A qualified physician applicant for registration to provide abortion-inducing drugs shall submit to the Office of Inspector General:
(a) A completed Application for Registration to Provide Abortion-Inducing Drugs;
(b) A completed Physician Dispensing Agreement Form; and
(c) An accompanying fee in the amount of $155, made payable to the Kentucky State Treasurer and sent to the Cabinet for Health and Family Services, Office of Inspector General, Division of Health Care, 275 East Main Street 5E-A, Frankfort, Kentucky 40621.
(2) A manufacturer, distributor, pharmacy, or abortion facility applicant for certification to transport, supply, sell, or dispense abortion-inducing drugs shall submit to the Office of Inspector General:
(a) A completed Application for Participation in the Abortion-Inducing Drug Certification Program; and
(b) An accompanying fee in the amount of $155, made payable to the Kentucky State Treasurer and sent to the Cabinet for Health and Family Services, Office of Inspector General, Division of Health Care, 275 East Main Street 5E-A, Frankfort, Kentucky 40621.
(3) As a condition of annual renewal, the application required by subsections (1) and (2) of this section and a renewal fee in the amount of $155 shall be submitted to the cabinet at least thirty (30) days prior to the date of expiration of the registration or certification. Renewal fees shall be paid as set out in paragraph (2)(b) of this section.
Section 5. Operations.
(1) A manufacturer, distributor, physician, qualified physician, pharmacy, abortion facility, and any other person shall comply with KRS 311.7733(2) prohibiting the use of courier, delivery, or mail services.
(2) In accordance with KRS 216B.204(1)(c), no person or entity shall intentionally, knowingly, or recklessly ship abortion-inducing drugs to a physician unless the physician is registered with the cabinet pursuant to this administrative regulation and as shown on the Office of Inspector General's Web site: https://chfs.ky.gov/agencies/os/oig/dhc/Pages/default.aspx.
(3) In accordance with KRS 216B.204(1)(g), a pharmacy shall not intentionally, knowingly, or recklessly dispense or distribute abortion-inducing drugs directly to a patient in Kentucky.
(4) In accordance with KRS 216B.204(1)(h), manufacturers and distributors shall intentionally and knowingly distribute only to certified pharmacies and in-person dispensing clinics, medical offices, abortion facilities, and hospitals that are in compliance with the United States Federal Drug Administration's outlined Mifepristone Risk Evaluation and Mitigation Strategy in effect on July 14, 2022.
(5) A qualified physician registered with the cabinet shall maintain hospital admitting privileges or enter into a written associated physician agreement as required by KRS 311.7734(1)(b) and comply with all other provisions of KRS 216B.206(2) and 311.7734.
Section 6. Complaints. In accordance with KRS 216B.210, a complaint regarding potential violations of the Abortion-Inducing Drug Certification Program may be submitted on the Office of Inspector General's Web site: https://chfs.ky.gov/agencies/os/oig/dhc/Pages/default.aspx.
Section 7. Denial, Suspension, Revocation, and Fines.
(1) The cabinet shall deny an application for registration or certification if:
(a) The applicant or existing agency knowingly misrepresents or submits false information on the application; or
(b) The applicant or existing agency fails to provide the information required by the application.
(2) The cabinet shall revoke or suspend certification and impose fines:
(a) In accordance with KRS 216B.208(1)(a) - (e); or
(b) If the cabinet determines that there has been substantial failure to comply with the provisions of this administrative regulation.
(3) If the cabinet determines that there has been substantial failure to comply with the provisions of this administrative regulation, the cabinet shall:
(a) Revoke or suspend registration of a physician and impose fines as set out in KRS 216B.208(1)(e)3.; and
(b) Immediately report the violation to the Kentucky Board of Medical Licensure and local law enforcement in accordance with KRS 216B.208(1).
Section 8. Notice of Adverse Action.
(1) Except as set out in KRS 216B.208(1)(e), OIG shall provide written notice of adverse action at least thirty (30) calendar days prior to the effective date of the denial or revocation.
(2) In accordance with KRS 216B.208(1)(e)1., the cabinet shall immediately notify a pharmacy, manufacturer, or distributor that its certification is suspended and will be permanently revoked if OIG determines that a certified entity has intentionally, knowingly, or recklessly violated KRS 216B.200 to 216B.210 and fails to demonstrate compliance within ninety (90) days.
(3) A notice of adverse action issued in accordance with subsection (1) or (2) of this section shall:
(a) Explain the reason for the denial or revocation, and monetary penalty if applicable;
(b) Advise the individual or entity that the right to request an appeal prior to the effective date of the denial or revocation, and monetary penalty if applicable; and
(c) Specify that the adverse action shall be stayed if an appeal is requested.
Section 9. Appeals. An individual or entity that submits a written request for appeal within thirty (30) calendar days of receiving a notice of adverse action, including revocation, shall be afforded a hearing in accordance with KRS 216B.105.
Section 10. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) Form OIG 20-365A, "Application for Registration to Provide Abortion-Inducing Drugs", November 2022 edition;
(b) Form OIG 20-365B, "Application for Participation in the Abortion-Inducing Drug Certification Program", November 2022 edition; and
(c) Form OIG 20-365C, "Physician Dispensing Agreement Form", November 2022 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dhc/Pages/ltcapplications.aspx.
History
- RELATES TO: KRS 216B.015, 216B.105, 216B.200 - 216B.210, 311.720(1), 311.7731, 311.7733, 311.7734
- STATUTORY AUTHORITY: KRS 216B.202(1), 216B.206
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.202(1) requires the cabinet to promulgate administrative regulations in accordance with KRS Chapter 13A to establish a certification program to oversee and regulate the distribution and dispensing of abortion-inducing drugs. KRS 216B.206 requires the cabinet to establish requirements for physicians who prescribe abortion-inducing drugs. KRS 311.7733 requires a physician to be registered with the cabinet before providing abortion-inducing drugs. This administrative regulation establishes requirements for physicians, manufacturers, distributors, and abortion facilities that prescribe, transport, supply, dispense, or sell abortion-inducing drugs.
- History: 49 Ky.R. 504, 1310, 1433; eff. 1-12-2023.
902 KAR 20:370 Operations and services; private duty nursing agencies {#sec-902-kar-20-370 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:370}
Section 1. Definitions.
(1) "Private duty nursing agency" means a public or private organization, including any partnership, corporation, or other legal entity, that provides or arranges for the provision of private duty nursing services.
(2) "Private duty nursing services" means the delivery of skilled nursing services as defined by subsection (3) of this section.
(3) "Skilled nursing services" means the delivery of nursing care to a patient of a private duty nursing agency that:
(a) Exceeds the level of routine health monitoring;
(b) Is clinically appropriate;
(c) Is provided on a continuous basis or as part-time or short-term nursing care;
(d) Is subject to:
-
A nursing reassessment no less than every ninety (90) days; and
-
Frequent changes in the plan of treatment;
(e) Is based on the expectation that the service will improve, restore, or maintain function, or slow the patient's decline of the disease or functional ability; and
(f) Includes skilled interventions provided directly by a licensed nurse. Examples of skilled interventions may include:
-
Bowel and bladder care;
-
Administering medications or oxygen;
-
Furnishing infusion therapy services;
-
Medication setups;
-
Treating decubitus ulcers, skin breakdown, or other types of wound care; or
-
Ventilation care.
Section 2. Scope.
(1) Private duty nursing services shall be:
(a) Ordered and directed by the treating, licensed practitioner or specialist after a face-to-face evaluation of the patient, which may be provided as a telehealth encounter;
(b) Provided by:
-
A registered nurse (RN) licensed in accordance with KRS 314.041; or
-
A licensed practical nurse (LPN) licensed in accordance with KRS 314.051; and
(c) Provided to a patient in his or her temporary or permanent place of residence or other community-based setting, including:
-
The patient's home; or
-
Outside of the patient's home, as necessitated by normal life activities.
(2) A private duty nursing agency shall not include:
(a) A registered nurse who provides nursing services as an independent practitioner; or
(b) An entity that seeks certification under Title XVIII of the Social Security Act.
Section 3. Administration.
(1) The licensee shall be legally responsible for:
(a) The operation of the private duty nursing agency; and
(b) Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the agency.
(2) The licensee shall:
(a) Establish lines of authority;
(b) Designate an administrator who shall be responsible for the daily operation of the agency;
(c) Establish and implement written administrative policies covering all aspects of operation, including:
-
A description of the agency's organizational structure, staffing, and allocation of responsibility and accountability;
-
Policies and procedures for the evaluation of personnel performance; and
-
A narrative describing in detail:
a. The services offered by the agency; and
b. Qualifications of personnel involved in the delivery of services;
(d) Establish procedures for the handling and administration of drugs and biologicals; and
(e) Maintain policies regarding the delivery and supervision of patient care that shall:
-
Be developed by a group of professional health providers, including at least one (1) physician or one (1) registered nurse; and
-
Include the following:
a. A description of the services provided;
b. A requirement for a written plan of treatment for each patient who receives private duty nursing services;
c. Guidelines to ensure coordination of treatment with other health facilities and practitioners that deliver services to patients of the agency;
d. Guidelines for the medical management of health problems, including conditions that require medical consultation or patient referral;
e. Procedures for the annual review and evaluation of the services provided;
f. Guidelines for patient and environment assessment; and
g. Guidelines to ensure that a patient is receiving adequate services for assistance with daily living activities.
Section 4. Personnel.
(1) Each private duty nursing agency shall have:
(a) A clinical director who is:
-
A Kentucky-licensed physician or advanced practice registered nurse with specialized training and experience in the range of services provided by the agency; and
-
Responsible for overseeing the clinical activities of the agency; and
(b) Adequate staffing to provide for effective patient care in accordance with the terms and conditions of the contract with the patient.
(2) Each private duty nursing agency's written personnel policies shall be:
(a) Available to each employee;
(b) Reviewed on an annual basis; and
(c) Revised as necessary.
(3) There shall be a written job description for each position that shall be reviewed and revised as necessary.
(4) There shall be an employee health and infection control program, including tuberculosis screening and testing in accordance with 902 KAR 20:205.
(5) The private duty nursing agency shall maintain a current personnel record for each employee, including:
(a) Evidence of each employee's current registration, certification, or licensure, if applicable;
(b) Documentation of the employee's training and experience;
(c) Evidence of an annual performance evaluation;
(d) Documentation of compliance with the agency's health and infection control program;
(e) A preemployment background check in which the agency shall not employ an individual in a position that involves providing direct services if the individual:
- Is listed on the:
a. Nurse aide or home health aide abuse registry pursuant to 906 KAR 1:100;
b. Caregiver misconduct registry pursuant to 922 KAR 5:120; or
c. Child abuse and neglect central registry pursuant to 922 KAR 1:470; or
- Has a conviction of, or a plea of guilty, an Alford plea, or a plea of nolo contendere to:
a. A felony offense that is related to:
(i) Theft;
(ii) Abuse, possession, or sale of illegal drugs;
(iii) Abuse, neglect, or exploitation of a child or an adult; or
(iv) A sexual crime; or
b. A misdemeanor offense related to abuse, neglect, or exploitation of an adult or child; and
(f) Evidence of orientation and, if needed, on-the-job training related to the employee's job responsibilities.
(6) An employee with direct patient care responsibilities shall have current cardiopulmonary resuscitation (CPR) certification from the American Heart Association, American Red Cross, or equivalent.
(7) Each licensed nurse of a private duty nursing agency shall provide services that:
(a) Are commensurate with the nurse's educational preparation and clinical competence;
(b) Address the nursing needs of the patient; and
(c) Are delivered in accordance with the patient's plan of treatment.
Section 5. Patient Records.
(1) Each private duty nursing agency shall maintain a clinical record for each patient that includes:
(a) Pertinent past and current medical, nursing, and social history, including information obtained from other providers;
(b) Name of the referring physician, or other ordering practitioner, if any, acting within the statutory scope of practice;
(c) Orders of the referring physician, or other ordering practitioner, if any, acting within the statutory scope of practice;
(d) Description of each contact, including the:
-
Condition or reason necessitating contact;
-
Assessment;
-
Service provided;
-
Medication and treatment prescribed; and
-
Disposition made; and
(e) Documentation of referrals made, including:
-
Reason for referral;
-
To whom the patient was referred; and
-
Information obtained from a referral source.
(2) Ownership.
(a) Medical records shall be the property of the private duty nursing agency.
(b) The original medical record shall not be removed except by court order.
(c) Copies of medical records or portions thereof may be used and disclosed in accordance with the requirements established in this administrative regulation.
(3) Confidentiality and Security: Use and Disclosure.
(a) The agency shall maintain the confidentiality and security of patient records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
(b) The private duty nursing agency may use and disclose patient records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
(c) A private duty nursing agency may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(d) Retention of records. After a patient's death or discharge, the completed medical record shall be placed in an inactive file and:
-
Retained for six (6) years; or
-
Three (3) years after the patient reaches the age of majority in accordance with KRS 2.015, whichever is longer.
(4) The agency shall:
(a) Designate a specific location for the maintenance and storage of the agency's medical records;
(b) Have provisions for storage of medical records in the event the agency ceases to operate; and
(c) Safeguard the record and its content against loss, defacement, or tampering.
Section 6. Private Duty Nursing Services.
(1) A private duty nursing agency shall develop a plan of treatment for each patient receiving private duty nursing services.
(2) The plan of treatment shall be developed in consultation with the:
(a) Prescribing practitioner;
(b) Agency personnel; and
(c) Patient, patient's family member, or patient's responsible party.
(3) The plan of treatment shall be reviewed:
(a) By the ordering practitioner in consultation with:
-
Agency personnel; and
-
The patient, patient's family member, or patient's responsible party; and
(b) At intervals as the severity of the patient's illness requires or at least once every two (2) months.
(4) Services shall be nonabusive and provided in a manner that ensures the greatest amount of safety and security for the patient.
(5) Private duty nursing agency personnel shall ensure that medical waste generated as a result of a service shall be removed from a patient's home and disposed of properly.
Section 7. Licensure. Within ninety (90) days from the most recent effective date of this administrative regulation, the cabinet shall:
(1) Convert any licensed home health agency that is not certified under Title XVIII of the Social Security Act to a licensed private duty nursing agency;
(2) Not require approval of a new certificate of need to convert an existing home health agency license to a private duty nursing license; and
(3) Require a home health agency that converts its license to a private duty nursing license to comply with the accreditation requirements of Section 8(1)(b) of this administrative regulation.
Section 8. Accreditation.
(1) A private duty nursing agency shall be accredited by the Joint Commission, Community Health Accreditation Program, Accreditation Commission for Health Care, or an accrediting body with equivalent standards within one (1) year from the date of:
(a) Initial, provisional licensure; or
(b) The most recent effective date of this administrative regulation.
(2)
(a) If a private duty nursing agency has not obtained accreditation in accordance with subsection (1) of this section, the agency may request an extension to complete the accreditation process.
(b) A request for extension shall:
- Be submitted in writing to the Office of Inspector General at least sixty (60) days prior to the:
a. Date of the licensee's first annual renewal; or
b. One (1) year anniversary from the most effective date of this administrative regulation;
- Include evidence that the agency:
a. Has initiated the process of becoming accredited within sixty (60) days of the:
(i) Date of provisional licensure; or
(ii) Most recent effective date of this administrative regulation; and
b. Is continuing its efforts to obtain accreditation; and
- Include an estimated timeframe by which approval of accreditation is anticipated, not to exceed two (2) years from the:
a. Date of provisional licensure; or
b. Most recent effective date of this administrative regulation.
(3) A licensee's provisional licensure status shall end on the date that the agency obtains accreditation.
(4) Proof of accreditation shall be provided to the Office of Inspector General:
(a) Upon receiving accreditation; and
(b) Yearly at the time of annual renewal.
(5) If a private duty nursing agency loses its accreditation or becomes accredited by a different accrediting organization, the licensee shall notify the Office of Inspector General no later than thirty (30) days from the date that:
(a) The licensee's accreditation was terminated; or
(b) Accreditation by a different organization that meets the requirements of subsection (1) of this section took effect.
(6) The cabinet shall revoke a license if a private duty nursing agency fails to meet one (1) of the following requirements:
(a) Become accredited in accordance with subsection (1) of this section;
(b) Request an extension in accordance with subsection (2) of this section;
(c) Achieve accreditation within two (2) years from the:
-
Date of provisional licensure, if a request for extension is submitted; or
-
Most recent effective date of this administrative regulation, if a request for extension is submitted; or
(d) Maintain accreditation.
History
- RELATES TO: KRS 2.015, 216B.020, 314.041, 314.051, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 - 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function and establish licensure standards to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of and services provided by private duty nursing agencies.
- History: 27 Ky.R. 3479; 28 Ky.R. 1150; eff. 10-17-2001; Crt eff. 4-30-2019; 46 Ky.R. 7105, 1523, 18573; eff. 12-9-2019.
902 KAR 20:380 Operation and services; residential hospice facilities {#sec-902-kar-20-380 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:380}
Section 1. Definitions.
(1) "Administrator" means a person who has:
(a) Served as an administrator for a hospice program in accordance with 902 KAR 20:140, or a residential hospice facility licensed in accordance with this administrative regulation; or
(b) A bachelor of arts or bachelor of science degree in a health care, human services, or administrative curriculum; or
(c) Equivalent administrative work experience in a health care facility.
(2) "Bereavement" means the period of time during which a person experiences, responds emotionally and adjusts to the loss by death of another person.
(3) "Facility" means a residential hospice facility.
(4) "Palliative care" means care directed at reducing or abating pain and other symptoms of the disease process in order to achieve relief of distress.
(5) "Qualified dietitian" means a person licensed pursuant to KRS 310.021.
(6) "Residential hospice facility" means a facility licensed pursuant to this administrative regulation and providing residential care for terminally-ill patients that includes skilled nursing care for the management of pain and acute and chronic symptoms.
(7) "Respite care patient" means a patient requiring assistance with daily living activities and medical management of pain and symptoms who is admitted to the facility in order to:
(a) Provide relief to a patient's normal caregiver; or
(b) Provide care when the patient does not have a caregiver to assist him in his home.
(8) "Sanitary sewer" is defined at KRS 220.010(1).
(9) "Terminally ill" means a fatal condition for which therapeutic strategies directed toward cure and control are no longer effective.
(10) "Volunteer" means a person who contributes time and talent to the facility without economic remuneration.
Section 2. Administration and Organization.
(1) The licensee shall be legally responsible for the operation of the residential hospice facility and for compliance with federal, state, and local law pertaining to the operation of the facility.
(2) The licensee shall have permanent facilities for the care of patients and storage of patient records.
(3) The licensee shall establish and enforce written policies for the administration and operation of the facility. The policies shall address the following:
(a) A description of the organizational structure of the facility, including:
-
Lines of authority;
-
Department organization; and
-
Job descriptions;
(b) Use of volunteers, volunteer selection criteria, training, and roles in the facility;
(c) Admission of patients;
(d) Quality assurance;
(e) A written disaster preparedness plan which includes:
-
Procedures to be followed in the event of an internal or external disaster; and
-
A requirement that the plan is periodically rehearsed with staff;
(f) Linkage agreements with providers of services and supplies;
(g) Patient restraint practices to include:
-
Procedure for obtaining an order from the patient's physician, physician assistant, or advanced registered nurse practitioner;
-
Procedure for the assessment and reassessment of the need for patient restraint, requiring the use of the least restrictive method;
-
Procedure detailing the methods for applying a patient restraint;
-
A policy requiring monitoring the use of a patient restraint; and
-
A policy requiring direct care staff to receive training on all aspects of the use of patient restraints; and
(h) Discharge, transfer, and termination of services.
(4) Medical records.
(a) A medical record shall be maintained for each individual admitted to the facility. The medical record shall include:
-
Written admission order from a physician;
-
Medical history;
-
Nursing assessment;
-
Social and psychological information on patient and family;
-
Orders from physicians and other practitioners acting within their statutory scope of practice;
-
The approved care plan;
-
Documentation of nursing services provided; and
-
Documentation of medical services provided.
(b) Retention of medical records.
-
After the death or discharge of an adult patient, the completed medical record shall be placed in an inactive file and retained for five (5) years.
-
After the death or discharge of a minor patient, the record shall be placed in an inactive file and retained for five (5) years from the date of the event, or three (3) years after the patient reaches the age of majority, whichever is longer.
(5) Personnel.
(a) The facility shall have:
- A medical director who is a licensed physician, available on at least a consultative basis, who shall:
a. Direct medical aspects of the facility's services; and
b. Participate in the development of medical policy and procedure;
- An administrator who shall:
a. Direct the daily operation of the facility; and
b. Implement policies and procedures for activities and services provided by facility personnel or by contract; and
- A patient-care coordinator who is a registered nurse who:
a. Shall have education or experience in skilled nursing services for the terminally ill; and
b. May serve as the facility administrator.
(b) The facility shall employ or have access to a sufficient number of qualified personnel as necessary to provide the services required by this administrative regulation, and as indicated by patient needs.
(c) Current employee records shall be maintained. Each record shall include the employee's:
-
Name, address, and Social Security number;
-
Record of training and experience;
-
Proof of current licensure, certification, or registration, if required by law;
-
Results of most recent skin test for tuberculosis; and
-
Performance evaluations.
(d) Supportive personnel, assistants and volunteers shall be supervised and shall function within the policies and procedures of the facility.
(e) An employee or volunteer shall have a test for tuberculosis prior to or within the first week of work and annually thereafter. An employee or volunteer with evidence of an infectious disease shall not be present in the facility until the infectious disease can no longer be transmitted.
(f) The facility shall conduct an orientation for new employees and volunteers.
(g) An employee of the facility who has direct patient care responsibilities shall have current cardiopulmonary resuscitation (CPR) certification from either the American Heart Association or the American Red Cross.
(6) Infection control.
(a) Each facility shall implement an infection control policy consistent with current Centers for Disease Control and Prevention (CDC) recommendations. The policy shall include:
-
Procedures for prevention, monitoring, and control of infection and communicable disease;
-
Measures for assessing and identifying a patient or health care worker at risk for infection and communicable disease;
-
Procedures for isolation of an infected or immunosuppressed patient, if applicable, which shall:
a. Implement the least restrictive method possible;
b. Protect others from pathogens; and
c. Maintain the patient's privacy and dignity.
(b) A facility choosing to offer services to a patient requiring isolation pursuant to CDC guidelines shall have at least one (1) private isolation room available. The room shall:
-
Have a separate toilet room with bathtub or shower and lavatory for the exclusive use of the patient, and allowing for direct entry from the patient bed area;
-
Have a ceiling that is readily washable, and without crevices that can retain dirt particles; and
-
Have an anteroom outside and immediately adjacent to the patient room with facilities for maintaining aseptic conditions, including a sink suitable for handwashing;
-
Have a ventilation system adequate for reduction of the risk of transmission of an airborne pathogen, with filter efficiency of at least ninety (90) percent, and meeting the following requirements:
-
Be approved for use by the Office of Inspector General prior to being occupied by a patient requiring isolation.
Section 3. Patient Care Requirements.
(1) A patient may be admitted to a facility only upon an order from a physician.
(2) The patient's attending physician or the medical director shall be responsible for the direct medical care of the patient's illness.
(3) The facility shall provide the following services directly:
(a) Coordination of the medical aspects of the facility;
(b) Assessment, by the interdisciplinary team, of the patient's physical, psychological, spiritual, social, and economic needs;
(c) Development and coordination of a care plan, based on the assessment required in paragraph (b) of this subsection, which includes the delineation of responsibilities of each interdisciplinary team member and provides for regularly scheduled interdisciplinary team meetings for planning, evaluation, and individual case management. This requirement may be satisfied by the continuation of the plan of care established for a patient by a hospice program, in accordance with 902 KAR 20:140, if the plan of care is reviewed and revised when the patient is admitted to the facility.
- Care plan development shall be the responsibility of an interdisciplinary team that shall include:
a. The patient;
b. The patient's family, if the patient wants them to participate;
c. The medical director;
d. A nurse;
e. A social worker;
f. The patient's attending physician; and
g. A representative of the clergy, if the patient so chooses.
- The care plan shall be reviewed by the patient's attending physician or the medical director, in consultation with facility personnel:
a. At such intervals as the change in the patient's condition requires; or
b. At least once every two (2) weeks.
-
The care plan shall be reviewed by the interdisciplinary team to ensure that a patient receives palliative care.
-
Verbal authorization to change the medical orders shall be reviewed and signed by the patient's attending physician or the medical director within seven (7) days after the order is issued.
-
Verbal authorization to change nonmedical orders of the care plan shall be reviewed and signed by the medical director within seven (7) days after the order was issued.
(d) Patient counseling and family bereavement counseling; and
(e) Education and training services for staff, volunteers, and family members.
Section 4. Services.
(1) Nursing services.
(a) The facility shall provide twenty-four (24) hour nursing services that shall:
-
Be sufficient to meet total nursing needs;
-
Be provided in accordance with the patient's plan of care;
-
Ensure a patient receives prescribed:
a. Treatments;
b. Medications; and
c. Diets; and
- Ensure a patient shall be:
a. Comfortable;
b. Clean;
c. Well groomed; and
d. Protected from accident, injury and infection.
(b) A registered nurse shall be on duty at all times.
(2) Pharmaceutical services.
(a) The facility shall provide appropriate methods and procedures for obtaining, directly or by contract, dispensing, and administering drugs and biologicals.
(b) If the facility has a pharmacy department it shall be operated pursuant to the requirements of KRS Chapter 315.
(c) If the facility does not have a pharmacy department it shall have an agreement for obtaining prescribed drugs and biologicals from a pharmacy holding a valid pharmacy permit issued by the Kentucky Board of Pharmacy operated pursuant to the requirements of KRS Chapter 315.
(d) Medication services.
- Except in a circumstance that requires or permits a verbal order, a medication shall not be given without a written order signed by a physician, or other ordering personnel acting within their statutory scope of practice.
a. A verbal order for a medication shall be given only to a licensed practical or registered nurse or a pharmacist and shall be signed by a member of the medical staff or other ordering practitioner as soon as possible after the order is given.
b. A verbal order for a medication, at the time received, shall be:
(i) Immediately transcribed by the person receiving the order;
(ii) Repeated back to the person requesting the order to ensure accuracy; and
(iii) Annotated on the patient's medical record, by the person receiving the order, as repeated and verified.
- Administration of medication. Medication shall be administered by licensed medical or nursing personnel in accordance with their statutory scope of practice, or by personnel who have completed a state-approved training program. An intramuscular injection shall be administered by a licensed nurse, physician's assistant, or physician. An intravenously-administered medication shall be administered by a licensed physician, physician's assistant, registered nurse, or a licensed practical nurse to whom the task has been properly delegated. Each dose administered shall be recorded in the medical record.
a. A medication prescribed for one (1) patient shall not be administered to any other patient.
b. Self-administration of a medication by a patient shall not be permitted except on special order of the patient's physician.
c. A medication error shall be immediately reported to the patient's physician and recorded in the patient's medical record and on an incident report.
d. A drug reaction shall be immediately reported to the patient's physician and the dispensing pharmacist recorded in the patient's medical record.
e. An up-to-date medication reference text and source of information shall be provided for use by the nursing staff, for example: the American Hospital Formulary Service of the American Society of Hospital Pharmacists, or the Physicians Desk Reference.
- Labeling and storing medications.
a. A medication shall be clearly labeled with the patient's name, the name of the drug, strength, name of pharmacy, prescription number, date, physician name, caution statements and directions for use, except where a modified unit dose system, conforming to federal and state law, is used. The medication of each patient shall be kept in the original container; transferring between containers shall be prohibited. A medicine stored by the facility shall be kept in a locked place. A medication requiring refrigeration shall be kept in the medication area's refrigerator, in a separate locked box. A drug for external use shall be stored separately from those administered by mouth, suppository, or injection. Provisions shall be made for the locked, separate storage of medication prescribed for a deceased or discharged patient until the medication is surrendered or destroyed in accordance with federal and state law.
b. A medication container having a soiled, damaged, incomplete, illegible, or makeshift label shall be returned to the issuing pharmacist or pharmacy for relabeling or disposal. A container having no label shall be destroyed in accordance with state and federal law.
c. A medication cabinet shall be well lighted and of sufficient size to permit storage without crowding.
d. Medication no longer in use shall be disposed of or destroyed in accordance with federal and state law.
e. A medication with an expired date shall be removed from usage and properly discarded.
f. Controlled substances.
(i) A controlled substance shall be kept under double lock, for example, in a locked box in a locked cabinet.
(ii) There shall be a controlled substances record maintained by the: staff pharmacist, consultant pharmacist, or nursing care coordinator.
(iii) The record shall contain the following information: the name of the patient, the date, time, kind, dosage, balance remaining and method of administration; the name of the physician who prescribed the medication; and the name of the nurse who administered it, or staff member who supervised the self-administration.
(iv) The staff pharmacist, consultant pharmacist, or nursing care coordinator shall complete a Schedule II controlled substances count at least daily, and Schedule III, IV and V controlled substances count at least once per week. Controlled substances remaining after the discharge or death of the patient shall be destroyed in accordance with federal and state law.
(3) Dietary services.
(a) The facility shall provide dietary services directly or through a written contractual agreement.
(b) If the dietary services are contracted, the facility shall ensure that the contractor complies with the requirements of this subsection.
(c) If dietary services are provided directly, the facility shall have a dietary department, organized, directed and staffed to provide quality food service and optimal nutritional care.
-
The dietary department shall be directed on a full-time basis by an individual who, by education or specialized training and experience, is knowledgeable in food service management.
-
The dietary service shall have at least one (1) qualified dietitian working full-time, part-time, or on a consultative basis, to supervise the nutritional aspects of patient care.
-
Sufficient additional personnel shall be employed to perform assigned duties to meet the dietary needs of all patients.
-
The dietary department shall have current written policies and procedures for food storage, handling, and preparation. Written dietary policy and procedure shall be available to dietary personnel.
-
An in-service training program, which shall include the proper handling of food, safety and personal grooming, shall be given at least quarterly for new dietary employees.
(d) Menus shall be planned, written and rotated to avoid repetition. Nutritional needs shall be met in accordance with recommended dietary allowances of the Food and Nutrition Board of the National Research Council of the National Academy of Sciences and in accordance with medical orders.
(e) Each meal shall correspond with the posted menu. When a change is necessary, substitution shall provide equal nutritive value and the change shall be recorded on the menu. Each menu shall be kept on file for thirty (30) days.
(f) Every diet, regular and therapeutic, shall be prescribed in writing, dated, and signed by the attending medical staff member or other ordering personnel acting within their statutory scope of practice. Information on the diet order shall be specific and complete and shall include the title of the diet, modifications in specific nutrients stating the amount to be allowed in the diet, and specific problems that may affect the diet or eating habits.
(g) Food shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at the proper temperatures and in a form to meet individual needs; for example, food shall be cut, chopped, or ground to meet individual patient needs.
(h) If a patient refuses foods served, nutritious substitutions shall be offered.
(i) Unless contraindicated in a patient's plan of care, at least three (3) meals or their equivalent shall be served daily.
(j) There shall not be more than a fifteen (15) hour span between a substantial evening meal and a breakfast unless otherwise directed by the attending medical staff member.
(k) Meals shall be served at regular times with between-meal or bedtime snacks of nourishing quality offered.
(l) If dietary services are provided directly, there shall be at least a three (3) day supply of food available in the facility at all times to prepare well-balanced palatable meals for all patients.
(m) If the dietary services are contracted, the facility shall develop a contingency plan to ensure the provision of dietary services in the case of an emergency.
(n) There shall be an identification system for each patient meal, and methods used to assure that each patient receives the appropriate diet as ordered.
(o) The facility shall comply with applicable provisions of KRS 219.011 to 219.081 and 902 KAR 45:005, the Retail Food Code.
Section 5. Facility Specifications.
(1) Fire protection and security. Each facility shall:
(a) Meet the provisions of the most current edition of the Life Safety Code of the National Fire Protection Association that are applicable to a residential hospice facility;
(b) Be inspected and approved by the local certified building department with jurisdiction of the area;
(c) Not house blind, nonambulatory, or physically-handicapped patients unless the building is properly equipped with a comprehensive sprinkler system;
(d) Have portable fire extinguishers readily available on all floors and in the kitchen and food preparation area;
(e) Have an emergency power source capable of providing electrical service for communication systems, alarm systems, egress lighting, and patient care areas;
(f) Install and maintain, in accordance with the manufacturer's specifications, a single station smoke detector in every living area, bedroom, corridor, stairwell, and storage area, and in the basement;
(g) Have an adequate water supply and an adequate system for sewage disposal;
(h) Maintain sturdy and securely fastened handrails, measuring thirty-six (36) inches or more above ground or floor level, on every interior and exterior stairway;
(i) Maintain floors in good repair;
(j) Maintain corridors, entrances, exits, and outside pathways in good repair and free of obstacles;
(k) Keep sidewalks, fire escape routes, and entrances free of snow, ice, and debris;
(l) Keep the grounds in an orderly, litter-free manner, clear of refuse and discarded objects, and mowed;
(m) Provide general outdoor lighting to adequately illuminate the walkways and drive; and
(n) Establish a procedure to ensure that exterior doors are locked between the hours of 9 p.m. and 7 a.m.
(2) Patient rooms.
(a) Each patient room shall:
- Contain a bathroom equipped with:
a. A toilet;
b. A sink suitable for handwashing; and
c. Either a shower or bathtub;
-
Be above grade level;
-
Contain, for each patient, a suitable bed and other appropriate furniture;
-
Have closet space that provides security and space for private belongings;
-
Contain no more than two (2) beds in a room occupied by a respite care patient and no more than one (1) bed in a room occupied by a nonrespite patient;
-
Measure at least 100 square feet for a single patient room and at least eighty (80) square feet per patient in a two (2) patient room; and
-
Be equipped with a suitable device for the patient to call direct care staff on duty.
(b) The facility shall allow a patient to place items for the personalization and comfort of his room.
(3) Visitation. The facility shall:
(a) Provide physical space for a patient to visit in private;
(b) Provide accommodation for family members to remain with a patient throughout the night;
(c) Provide accommodations for family privacy after the death of a patient; and
(d) Allow a patient to receive visitors, including small children, at any hour.
(4) Linens and housekeeping.
(a) The facility shall have available at all times a quantity of linen essential for proper care and comfort of patients.
(b) Linens shall be handled, stored, processed, and transported in such a manner as to prevent the spread of infection.
(c) Soiled linens and clothing shall be collected and encased in suitable bags or containers, in a well-ventilated area, separate from clean linens. Soiled linens and clothing shall not be permitted to accumulate in the facility.
(d) The facility shall establish and implement housekeeping and maintenance policies and procedures that assure the environment is:
-
Safe;
-
Clean; and
-
Sanitary.
(e) Cleaning procedures shall provide for the prompt, thorough cleaning of:
-
Commodes;
-
Urinals;
-
Bedpans;
-
Bathrooms; and
-
Other sources of contamination or odor.
(f) Cleaning shall be performed in a manner to minimize the spread of pathogens.
(5) Waste disposal.
(a) Sharp waste.
-
Sharp waste, including needles, scalpels, razors, or other sharp instruments used for patient care procedures, shall be segregated from other waste and placed in puncture resistant containers immediately after use.
-
A needle or other contaminated sharp instrument shall not be purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by Occupational Safety and Health Administration guidelines established in 29 C.F.R. 1910.1030(d)(2)(vii).
-
The containers of sharp waste shall be incinerated on or off site, or be otherwise rendered nonhazardous.
(b) Disposable waste.
-
Disposable waste shall be placed in suitable bags or closed containers to prevent leakage or spillage, and shall be handled, stored, and disposed of minimizing direct exposure of personnel to waste materials.
-
The facility shall establish specific written policies regarding handling and disposal of waste.
-
The following wastes shall be disposed of by incineration, or be autoclaved before disposal, or be carefully poured down a drain connected to a sanitary sewer: blood, blood specimens, used blood tubes, or blood products.
-
Wastes conveyed to a sanitary sewer shall comply with applicable federal, state, and local pretreatment law, including 40 C.F.R. 403, 401 KAR 5:557, and relevant local ordinances.
History
- RELATES TO: KRS 216B.010, 216B.015, 216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131, 216B.990, 311.560(4), 314.011(8), 314.041, 314.051, Chapter 315, 40 C.F.R. 403
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health Services to establish and enforce licensure standards and procedures for health facilities and health services. This administrative regulation establishes licensure requirements for residential hospice facility operation and services.
- History: 29 Ky.R. 614; 1628; eff. 12-18-2002; Crt eff. 4-30-2019; TAm eff. 3-20-2020; Crt eff. 2-9-2026.
902 KAR 20:390 Paid feeding assistants {#sec-902-kar-20-390 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:390}
Section 1. Definitions.
(1) "Complicated feeding problem" means a condition that requires supervision and assistance by a licensed nurse or certified nurse aide and includes:
(a) Difficulty with swallowing;
(b) Recurrent lung aspiration;
(c) Assistance through tube or parenteral/IV feedings; or
(d) Any other condition requiring the assistance of a licensed nurse or a certified nurse aide.
(2) "Licensed practical nurse" is defined by KRS 314.011(9).
(3) "Nursing facility" means a facility that is licensed under 902 KAR 20:300.
(4) "Paid feeding assistant" means a person who has completed the training and received a satisfactory score on the examination required by this administrative regulation and is employed or contracted by a nursing facility or skilled nursing facility to provide feeding assistance to a resident who does not have a complicated feeding problem.
(5) "Registered nurse" is defined by KRS 314.011(5).
(6) "Skilled nursing facility" means a facility that is licensed under 902 KAR 20:026.
Section 2. Use of a Paid Feeding Assistant.
(1) A licensed nursing facility or skilled nursing facility may employ a paid feeding assistant on a full- or part-time basis to assist with feeding a resident who shall:
(a) Not have a complicated feeding problem; and
(b) Be approved to receive the assistance based on the charge nurse's assessment and the most recent resident assessment and plan of care.
(2) A paid feeding assistant shall:
(a) Have successfully completed the training established in Section 3 of this administrative regulation;
(b) Have received orientation from the facility employing the paid feeding assistant that covers the following facility-specific areas:
-
Confidentiality of resident care and records;
-
Monitoring resident nutrition intake and output;
-
Emergency procedures;
-
Specific needs of the resident who will be assisted;
-
Use of the facility's emergency call system; and
-
Laws pertaining to resident abuse, neglect, and exploitation of a resident's property;
(c) Work under the supervision of a registered nurse or licensed practical nurse; and
(d) Not be employed if employment is prohibited by KRS 216.532, 216.936, or 216.789.
(3) In a medical emergency involving a resident who is being assisted by a paid feeding assistant, the paid feeding assistant shall immediately utilize the resident call system to summon the assistance of a supervisory nurse.
(4) Before a facility employs a paid feeding assistant who received training from another individual or entity, the facility shall:
(a) Contact the individual or entity that provided the training and document verification that the feeding assistant successfully completed the training required by Section 3 of this administrative regulation;
(b) Require the feeding assistant to retake and successfully pass the written and skills competency test; and
(c) Issue the feeding assistant a new certificate of training.
(5) The facility shall maintain a current list of residents who are approved to receive feeding assistance from a paid feeding assistant.
(6) A feeding assistant who is seeking employment and who has not been employed during the prior two (2) years as a paid feeding assistant shall be required to repeat and successfully complete the training and pass the examination before assisting a resident with feeding.
(7) A facility shall provide quarterly in-service training for paid feeding assistants concerning:
(a) Amendments to this administrative regulation; and
(b) Changes in pertinent facility policies and procedures.
Section 3. Training Program.
(1) A paid feeding assistant shall receive a minimum of eight (8) hours training in the current version of the curriculum published by the Cabinet for Health and Family Services, Office of Inspector General, entitled "Kentucky Paid Feeding Assistant Manual".
(2) Review of all curriculum material, a score of seventy-five (75) percent or greater on the written examination, and a score of 100 percent on the skills competency test established in the curriculum shall be required to successfully complete the paid feeding assistant training.
(3) The training shall include information on:
(a) Feeding techniques;
(b) Assistance with feeding and hydration;
(c) Communication and interpersonal skills;
(d) Appropriate responses to resident behavior;
(e) Safety and emergency procedures, including the Heimlich maneuver;
(f) Infection control;
(g) Resident rights; and
(h) Recognition of changes in the condition of a resident which are inconsistent with the resident's normal behavior and the importance of reporting changes to a supervisory nurse.
(4) The training shall be conducted by:
(a) A registered nurse; or
(b) A licensed practical nurse working under the supervision of a registered nurse.
(5) Before conducting paid feeding assistant training, the nurse shall:
(a) Read the "Kentucky Paid Feeding Assistant Manual";
(b) Complete the instructor assessment in Section 15 of the "Kentucky Paid Feeding Assistant Manual"; and
(c) Complete the instructor attestation form in Section 15 of the "Kentucky Paid Feeding Assistant Manual".
(6) A person who has successfully completed training and passed the examination shall be issued a certificate of training as established in Section 15 of the "Kentucky Paid Feeding Assistant Manual".
(7) A facility shall maintain a record of training and certification for all persons employed by the facility as paid feeding assistants.
(a) The documentation shall include:
-
Name and Social Security number of the person trained;
-
Name of the person who conducted the training;
-
Test scores of the written and skills competency tests;
-
Date of training;
-
Duration of training;
-
Location of training; and
-
Documentation of the successful completion of the training course for paid feeding assistants.
(b) A complete and accurate copy of the training and certification records pertaining to each paid feeding assistant employed by the facility shall be maintained on site and be available for inspection by representatives from the Office of Inspector General, and shall be maintained for at least three (3) years following the last day of the paid feeding assistant's employment.
Section 4. Incorporation by Reference.
(1) "Kentucky Paid Feeding Assistant Manual", April 2004 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, 5E-A, Frankfort, Kentucky 40621, Monday through Friday, 8:00 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.050, 216.532, 216.789, 216.936, 216B.040, 314.011(5), (9), 42 C.F.R. 483.75(q), 483.160, 488.301
- STATUTORY AUTHORITY: KRS 194A.050(1), 216B.042(1), 216B.075, 42 C.F.R. 483.35(h)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to establish licensure standards to ensure safe, adequate, and efficient health care facilities. KRS 216B.075 requires the cabinet to promulgate administrative regulations respecting application and review procedures to comply with any federal laws and regulations promulgated thereunder. 42 C.F.R. 483.35(h) authorizes the state agency to develop an approved training and practical skills program that establishes standards for paid feeding assistants and mandates supervision by a registered nurse or licensed practical nurse. This administrative regulation establishes certification requirements for the employment of paid feeding assistants in licensed nursing facilities and skilled nursing facilities to assist residents who only need encouragement or minimal assistance during mealtime.
- History: 33 Ky.R. 259; 820; 1089; eff. 10-18-2006; Crt eff. 4-30-2019; Crt eff. 2-9-2026.
902 KAR 20:410 Specialty intermediate care clinics {#sec-902-kar-20-410 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:410}
Section 1. Definitions.
(1) "Clinic" or "specialty intermediate care (IC) clinic" means a clinic located on the grounds of a state-owned facility licensed pursuant to 902 KAR 20:086 as an intermediate-care facility for the intellectually and developmentally disabled.
(2) "Developmental disability" is defined by 42 U.S.C. 15002(8)(A) as a severe, chronic disability of an individual that:
(a) Is attributable to a mental or physical impairment or combination of mental and physical impairments;
(b) Is manifested before the individual attains age twenty-two (22);
(c) Is likely to continue indefinitely;
(d) Results in substantial functional limitations in three (3) or more areas of major life activity, including:
-
Self-care;
-
Receptive and expressive language;
-
Learning;
-
Mobility;
-
Self direction;
-
Capacity for independent living; or
-
Economic self-sufficiency; and
(e) Reflects the individual's need for a combination and sequence of special, interdisciplinary, or generic services, individualized supports, or other forms of assistance that are of lifelong or extended duration and are individually planned and coordinated.
(3) "Intellectual disability" means an individual has:
(a) Significantly sub-average intellectual functioning;
(b) An intelligence quotient of seventy (70) or below;
(c) Concurrent deficits or impairments in present adaptive functioning in at least two (2) of the following areas:
-
Communication;
-
Self-care;
-
Home living;
-
Social or interpersonal skills;
-
Use of community resources;
-
Self-direction;
-
Functional academic skills;
-
Work;
-
Leisure; or
-
Health and safety; and
(d) Had an onset prior to eighteen (18) years of age.
(4) "Patient" means an individual who receives services provided by a specialty IC clinic and who:
(a) Is not a resident of, but qualifies for admission to an intermediate-care facility for the intellectually and developmentally disabled by meeting the patient status criteria established in 907 KAR 1:022, Section 4; or
(b) Is a resident of an intermediate-care facility for the intellectually and developmentally disabled which contracts with, or makes arrangements with the specialty IC clinic for outpatient services.
Section 2. Licensure Application and Fee.
(1) An applicant for licensure as a specialty IC clinic shall complete and submit to the Office of the Inspector General an Application for License to Operate a Health Facility or Service, pursuant to 902 KAR 20:008, Section 2(2)(f).
(2) The initial and annual fee for licensure as a specialty clinic shall be $500.
Section 3. Scope of Operations and Services.
(1) Services provided by a specialty IC clinic shall be individualized to meet the treatment needs of each of the specialty IC clinic's patients. Patients may receive one (1) or more of the following services from the clinic:
(a) Dental services;
(b) Psychiatric services;
(c) Psychological services;
(d) Psychotropic medication management;
(e) Neurology;
(f) Epileptology;
(g) Preventive health care;
(h) Medical assessment and treatment;
(i) Occupational therapy;
(j) Physical therapy;
(k) Speech therapy;
(l) Nutritional or dietary consultation;
(m) Mobility evaluation or treatment;
(n) Behavioral support services;
(o) Audiology;
(p) Ophthalmology;
(q) Pharmacy;
(r) Medication consultation;
(s) Medication management;
(t) Seizure management;
(u) Behavioral support services;
(v) Diagnostic services;
(w) Clinical laboratory services;
(x) Physician services; or
(y) Laboratory services.
(2) Off-site services.
(a) Specialty IC clinic personnel as identified in Section 5(4) of this administrative regulation may provide services off-site at a local health department or in a health facility licensed under 902 KAR Chapter 20 if the specialty IC clinic has an agreement to provide the off-site services at the health department or licensed health facility's location for the purpose of improving patient accessibility or accommodating the patient's individualized healthcare needs.
(b) A psychologist, psychiatrist, behavior specialist, or board certified behavior analyst directly employed by, or under contract with a specialty IC clinic, may provide behavioral assessments or consultation off-site:
-
In a patient's home; or
-
At a day service or other service site where the patient receives services.
Section 4. Administration and Policies.
(1) The licensee shall have legal responsibility for the specialty IC clinic, including responsibility for ensuring compliance with federal, state, and local laws and regulations pertaining to the operation of the clinic.
(2) The licensee shall establish lines of authority and designate an administrator who shall be principally responsible for the daily operation of the specialty IC clinic.
(3) A specialty IC clinic shall establish and follow written administrative policies covering all aspects of operation, including:
(a) A description of organizational structure, staffing, and allocation of responsibility and accountability;
(b) Policies and procedures for the guidance and control of personnel performances;
(c) A written program narrative describing in detail the:
-
Services offered;
-
Methods and protocols for service delivery;
-
Qualifications of personnel involved in the delivery of the services; and
-
Goals of the service;
(d) A description of how administrative and patient care records and reports are maintained; and
(e) Procedures to be followed if the clinic performs any functions related to the storage, handling, and administration of drugs and biologicals.
(4) Patient Care Policies. A specialty IC clinic shall develop patient care policies which address:
(a) A description of the services the clinic provides directly and those provided through agreement;
(b) Guidelines for the medical management of health problems which include the conditions requiring medical consultation or patient referral; and
(c) Procedures for the annual review and evaluation of the services provided by the clinic.
Section 5. Personnel.
(1)
(a) A specialty IC clinic shall have a medical director who is a licensed physician.
(b) The specialty IC clinic's medical director shall:
-
Be responsible for all medical aspects of the clinic and provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311;
-
Provide medical direction, supervision, and consultation to the staff;
-
In conjunction with the registered nurse described in subsection (2) of this section, participate in the development, execution, and periodic review of the clinic's written policies and services;
-
Periodically review the clinic's patient records, provide medical orders, and provide medical care services to patients of the clinic;
-
Be present for weekly consultation, or delegate responsibility for weekly consultation to another physician employed by, or under contract with the specialty IC clinic if a temporary absence is necessary; and
-
Be available within one (1) hour through direct telecommunication for consultation, assistance with medical emergencies, or patient referral. If a temporary absence is necessary, the medical director shall designate another physician who is employed by, or under contract with the specialty IC clinic to be available within one (1) hour through direct telecommunication for consultation, assistance with medical emergencies, or patient referral.
(2) A specialty IC clinic shall have at least one (1) registered nurse who shall:
(a) Have at least one (1) year experience in treating or working with individuals with an intellectual disability and a developmental disability;
(b) Participate in the development, execution, and periodic review of the written policies governing the services the clinic provides;
(c) Participate with the medical director in periodic review of patient health records;
(d) Provide services in accordance with clinic policies, established protocols, the Nurse Practice Act (KRS Chapter 314), and with administrative regulations promulgated thereunder;
(e) Arrange for or refer patients to needed services that cannot be provided at the clinic; and
(f) Assure that adequate patient health records are maintained and transferred when patients are referred.
(3) A specialty IC clinic shall maintain, through direct employment or contract, a sufficient number of qualified personnel to provide effective patient care and all other related services.
(4) Qualified personnel directly employed by, or under contract with a specialty IC clinic shall include:
(a) Physicians;
(b) Dentists;
(c) Dental hygienists;
(d) Physician assistants;
(e) Nurse practitioners;
(f) Registered nurses;
(g) Psychologists;
(h) Psychiatrists;
(i) Pharmacists;
(j) Audiologists;
(k) Optometrists;
(l) Dieticians;
(m) Behavior specialists;
(n) Board certified behavior analysts;
(o) Opthomalogists;
(p) Physical therapists;
(q) Speech therapists;
(r) Occupational therapists;
(s) Physical therapist assistants; and
(t) Occupational therapist assistants.
(5)
(a) Prior to providing any service described in Section 3(1) of this administrative regulation, all qualified personnel as identified in subsection (4) of this section shall submit to an in-state criminal background information check conducted by the Justice and Public Safety Cabinet or Administrative Office of the Courts.
(b) An out-of-state criminal background information check shall be obtained for any qualified personnel who have resided or been employed outside Kentucky.
(c) A clinic shall not knowingly employ any person who has been convicted of a felony offense under:
-
KRS Chapter 209;
-
KRS Chapter 218A;
-
KRS 507.020, 507.030, and 507.040;
-
KRS Chapter 509;
-
KRS Chapter 510;
-
KRS Chapter 511;
-
KRS Chapter 513;
-
KRS 514.030;
-
KRS Chapter 530;
-
KRS Chapter 531;
-
KRS 508.010, 508.020, 508.030, and 508.032;
-
A criminal statute of the United States or another state similar to subparagraphs 1 to 11 of this paragraph; or
-
A violation of the uniform code of military justice or military regulation similar to subparagraphs 1 to 11 of this paragraph which has caused the person to be discharged from the Armed Forces of the United States.
(d) A person who has received a pardon for an offense specified in paragraph (c) or has had the record of the offense expunged may be employed.
(6) A specialty IC clinic shall maintain written personnel policies which shall be available to all employees.
(7) A specialty IC clinic shall maintain a written job description for each position which shall be reviewed and revised as necessary.
(8) A specialty IC clinic shall maintain current personnel records for each employee. An employee's personnel record shall include the following:
(a) Employee's name and address;
(b) Evidence that the health care professional has a valid license or other valid credential required for the professional to be able to practice;
(c) Record of training and experience; and
(d) Record of performance evaluations.
(9)
(a) Specialty IC clinic personnel shall attend in-service training programs relating to their respective job duties. These training programs shall include:
-
Thorough job orientation for new personnel;
-
Regular in-service training programs;
-
Behavior management procedures and techniques;
-
Training in the detection and reporting of suspected abuse or neglect of a child or adult;
-
Training in the field of intellectual and developmental disabilities; and
-
Emergency and safety procedures.
(b) A written document describing the training programs completed by all clinic employees shall be maintained on the premises of the clinic.
Section 6. Medical Records.
(1) A specialty IC clinic shall maintain medical records which contain the following:
(a) Name of the patient;
(b) Description of each medical visit or contact, including:
-
Date of the visit;
-
Condition or reason for the visit;
-
Name of health care practitioner providing the service;
-
Description of the services provided; and
-
Any medications or treatments prescribed;
(c) Medical or social history relevant to the services provided, including data obtained from other providers;
(d) Names of referring physicians, if any, and physicians orders for special diagnostic services; and
(e) Documentation of all referrals made, including the reason for the referral and to whom the patient was referred.
(2) A specialty IC clinic shall maintain confidentiality of patient records at all times pursuant to and in accordance with federal, state and local laws and administrative regulations, including the privacy standard promulgated pursuant to Health Insurance Portability and Accountability Act (HIPAA), 45 C.F.R. 160 and 164.
(3) A specialty IC clinic shall:
(a) Establish systematic procedures to assist in continuity of care if the patient moves to another source of care;
(b) Transfer medical records or an abstract upon request, subject to required releases and authorizations; and
(c) Have a specific location designated for the storage and maintenance of the clinic's medical records, maintain scanned copies of the original medical records in an electronic format, or maintain electronic health records, available for copying to a disk or printing at the clinic.
(4)
(a) Medical records shall be maintained by the clinic for a period of six (6) years following the last treatment, assessment, or visit made by the patient, or three (3) years after the patient reaches age eighteen (18), whichever is longer.
(b) A provision shall be made for written designation of a specific location for the storage of medical records if the specialty IC clinic ceases to operate because of disaster, or for any other reason.
(5) A specialty IC clinic shall safeguard each clinic's medical records and content against loss, defacement, and tampering.
Section 7. Provision of Services.
(1) Equipment. Equipment used for direct patient care shall comply with the following:
(a) The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative, properly calibrated, and cleaned regularly;
(b) All personnel engaged in the operation of diagnostic equipment shall have adequate training and be currently licensed, registered or certified in accordance with applicable state statutes and administrative regulations; and
(c) A written plan shall be developed and maintained to provide for training of personnel in the safe and proper usage of the equipment.
(2) Diagnostic services. Diagnostic services shall be performed in accordance with the specialty IC clinic's protocol.
(a) Protocols for diagnostic examinations shall be developed by the medical director.
(b) Diagnostic services shall be provided under the supervision of a physician who is qualified by advanced training and experience in the use of the specific technique utilized for diagnostic purposes.
(c) Physical examination services shall be nonabusive and provided in a manner which ensures the greatest amount of safety and security for the patient.
-
Personnel performing physical examinations shall have adequate training and be currently licensed, registered, or certified in accordance with applicable Kentucky statutes and administrative regulations.
-
Personnel performing physical examinations shall be limited by the relevant scope of practice of state licensure.
(3) Referrals. A specialty IC clinic shall refer a patient for services that cannot be provided at the clinic.
(4) Restraints
(a) A specialty IC clinic shall promote a restraint free environment and ensure that restraints are used only for medical emergencies or if the resident poses an immediate risk to self or others.
(b) Use of any type of restraint as a health-related protection shall be prescribed by a physician if necessary during the conduct of specific medical procedure.
(c) The specialty IC clinic shall have a system to monitor and decrease the use of physical restraint and pre-sedation.
Section 8. Physical Environment.
(1) Accessibility. A specialty IC clinic shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(2) Fire safety. A specialty IC clinic shall be approved by the State Fire Marshal's office prior to initial licensure.
(3) Housekeeping and maintenance services.
(a) Housekeeping. A specialty IC clinic shall maintain a clean and safe facility free of unpleasant odors. Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans and other sources.
(b) Maintenance. The premises shall be well kept and in good repair as follows:
-
The clinic shall insure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences are in good repair;
-
The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing and electrical fixtures shall be in good repair. Windows and doors which can be opened for ventilation shall be screened;
-
Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly;
-
A pest control program shall be in operation in the clinic. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock;
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Sharp wastes, such as broken glass, scalpel blades, and hypodermic needles shall be segregated from other wastes and aggregated in rigid disposable containers immediately after use. Needles and syringes shall not be cut, dismantled, or destroyed after use but shall be placed intact directly into a rigid container. The rigid containers of sharp wastes shall either be incinerated, on site or off site, or disposed of in a sanitary landfill approved pursuant to 401 KAR 47:080; and
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The clinic shall establish a written policy for the handling and disposal of all infectious, pathological, and contaminated waste if the clinic generates them. Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 or 61:010.
a.
(i) Infectious waste shall be placed in double impervious plastic bags and each bag shall be two (2) mils in thickness.
(ii) A bag, if full, shall not exceed twenty five (25) pounds.
(iii) All bags shall be securely closed and a tag, which reads "INFECTIOUS WASTE" and identifies the clinic from which the waste is being removed and shall be attached to the bag in a conspicuous manner.
b. All unpreserved tissue specimens procedures shall be incinerated on or off site.
c. The following wastes shall be sterilized before disposal or be disposed of by incineration if they are combustible:
(i) Dressings and materials from open or contaminated wounds;
(ii) Waste materials and disposable linens from isolation rooms;
(iii) Culture plates;
(iv) Test tubes;
(v) Sputum cups; and
(vi) Contaminated sponges and swabs.
History
- RELATES TO: KRS 198B.260, 209, 216B.010-216B.131, 216B.990, 218A, 311, 314, 507.020, 507.030, 507.040, 508.010-508.032, 509-511, 513, 514.030, 530, 531, 45 C.F.R. 160, 164
- STATUTORY AUTHORITY: 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation provides minimum licensure requirements for the operation of specialty intermediate care clinics.
- History: 37 Ky.R. 1142; 1731; 2019; eff. 3-4-2011; TAm eff. 12-10-2012; Crt eff. 1-11-2019.
902 KAR 20:420 Pain management facilities {#sec-902-kar-20-420 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:420}
Section 1. Definitions.
(1) "Adverse action" means action taken by the Cabinet for Health and Family Services, Office of Inspector General, to deny, suspend, or revoke a pain management facility's license to operate.
(2) "License" means an authorization issued by the cabinet for the purpose of operating a pain management facility.
(3) "Licensee" means the owner, individual, agency, partnership, or corporation, in which the ultimate responsibility and authority for the conduct of the pain management facility, or a satellite facility, is vested.
(4) "National and State Background Check Program" means an initiative implemented by the cabinet pursuant to 906 KAR 1:190 for the performance of:
(a) Registry checks; and
(b) Fingerprint-supported criminal background checks performed by the Department of Kentucky State Police and the Federal Bureau of Investigation.
(5) "Pain management facility" or "facility" is defined by KRS 218A.175(1)
(6) "Satellite facility" means a pain management facility permitted by KRS 218A.175(2)(b) to open and operate under the license of a parent pain management facility that:
(a) Is licensed under this administrative regulation pursuant to the physician-ownership exemption of KRS 218A.175(2)(a); and
(b) Does not have a pending adverse action.
(7) "Unencumbered license" means a license that has not been restricted by the state professional licensing board due to an administrative sanction or criminal conviction relating to a controlled substance.
Section 2. Satellite Facilities. A satellite facility shall comply with the requirements established by this administrative regulation for parent pain management facilities, including background checks, administration, staffing, equipment, and physical environment.
Section 3. Ownership.
(1) A facility licensed pursuant to this administrative regulation shall be immediately disqualified from the physician-ownership exemption of KRS 218A.175, and the cabinet shall revoke the facility's license pursuant to Section 11(3) of this administrative regulation if:
(a) An administrative sanction or criminal conviction relating to a controlled substance is imposed on the parent or satellite facility or any person contracted or employed by the parent or satellite facility for an act or omission done within the scope of the facility's licensure or the person's employment; or
(b) A change of ownership occurs, except for a transfer of whole or partial ownership as permitted by KRS 218A.175(2)(b).
(2)
(a) A change of ownership shall be deemed to occur if any ownership interest, or capital stock or voting rights of a corporation is purchased, leased, or otherwise acquired by one (1) person from another for an existing facility licensed pursuant to this administrative regulation.
(b) The pain management facility's license shall not be transferred to a new owner, except for a transfer of whole or partial ownership interest in the facility as permitted by KRS 218A.175(2)(b).
Section 4. Background Checks and Prohibition Against Employment.
(1)
(a) All owners, operators, and employees, including contract employees of a pain management facility, shall submit to a fingerprint-supported national and state criminal background check.
(b) A facility may use Kentucky's National and State Background Check Program established by 906 KAR 1:190 to satisfy the criminal background check requirement of paragraph (a) of this subsection.
(2) A facility shall not be licensed if owned in part by, contracts with, or employs a physician or prescribing practitioner:
(a) Whose Drug Enforcement Administration number has ever been revoked;
(b) Whose application for a license to prescribe, dispense, or administer a controlled substance has been denied by any jurisdiction;
(c) Who has had any disciplinary limitation placed on his or her license by:
-
The Kentucky Board of Medical Licensure;
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The Kentucky Board of Nursing;
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The Kentucky Board of Dentistry;
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The Kentucky Board of Optometric Examiners;
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The State Board of Podiatry;
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Any other board that licenses or regulates a person who is entitled to prescribe or dispense controlled substances to humans; or
-
A licensing board of another state if the disciplinary action resulted from illegal or improper prescribing or dispensing of controlled substances; or
(d) Who has been convicted of or pleaded guilty or nolo contendere to, regardless of adjudication, an offense that constitutes a felony for receipt of illicit and diverted drugs, including a controlled substance listed as Schedule I, Schedule II, Schedule III, Schedule IV, or Schedule V in this state or the United States.
(3) In addition to physicians and prescribing practitioners, a facility shall not employ any individual directly, or by contract, who has been convicted of or pleaded guilty or nolo contendere to, regardless of adjudication, a drug-related offense as described in subsection (2)(d) of this section.
Section 5. Licensure Application, Fee, and Renewal.
(1) A licensee which elects to open and operate no more than two (2) additional satellite facilities shall:
(a) As a condition precedent to adding a satellite facility to the parent pain management facility's license, ensure that the satellite facility is in compliance with this administrative regulation and KRS 218A.175, which may be determined through an on-site inspection of the satellite facility; and
(b) Submit a completed Application for License to Operate a Pain Management Facility prior to opening the satellite facility accompanied by a fee of $2,000 per each satellite facility.
(2) A license shall:
(a) Expire one (1) year from the date of issuance; and
(b) Be renewed if the licensee:
-
Submits a completed Application for License to Operate a Pain Management Facility accompanied by an annual re-licensure fee of $2,000, plus a fee of $2,000 per satellite facility; and
-
Has no pending adverse action.
(3) A pain management facility that does not have a pending adverse action but has failed to renew its license on or before the expiration date shall cease operating the facility unless:
(a) The items required under subsection (2)(b) of this section have been submitted; and
(b) The Office of Inspector General has provided the facility with a notice granting temporary authority to operate pending completion of the renewal process.
Section 6. Facility Patients. To determine if the majority of patients of the practitioners at the facility are provided treatment for pain that includes the use of controlled substances, the Office of Inspector General:
(1) Shall have access to the facility pursuant to KRS 216B.042, including the facility's patient records;
(2) Shall calculate the majority of patients based upon the number of unduplicated patients treated in a one (1) month time period; and
(3) May use data from the Kentucky All Schedule Prescription Electronic Reporting (KASPER) Program to determine if the majority of the patients of the facility's practitioners are prescribed controlled substances.
Section 7. Administration Requirements for Parent and Satellite Pain Management Facilities.
(1) A facility shall be located in a fixed site.
(2) Each facility shall post the license conspicuously in a public area of the facility.
(3) Licensee.
(a) The licensee shall be legally responsible for:
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All activities within the facility, including the actions of the physicians and prescribing practitioners; and
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Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the facility, including the Drug Abuse Prevention and Control Act (21 U.S.C. 801 to 971 et. seq.) and KRS Chapter 218A, 902 KAR Chapter 20, and 902 KAR Chapter 55.
(b) The licensee shall establish lines of authority and designate an administrator who:
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May serve in a dual role as the facility's medical director; and
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Shall be principally responsible for the daily operation of the facility.
(4) Policies. The facility shall establish and follow written administrative policies covering all aspects of operation, including:
(a) A description of organizational structure, staffing, and allocation of responsibility and accountability;
(b) A description of linkages with inpatient facilities and other providers;
(c) Policies and procedures for the guidance and control of personnel performances;
(d) A written program narrative describing in detail each service offered, methods and protocols for service delivery, qualifications of personnel involved in the delivery of the services, and goals of each service;
(e) A description of the administrative and patient care records and reports;
(f) Procedures to be followed if the facility performs any functions related to the storage, handling, and administration of drugs and biologicals; and
(g) Procedures for compliance with KRS 218A.175(4).
(5) Referral. If an individual seeks or is in need of care and treatment beyond the scope of services offered by the facility, the facility:
(a) Shall immediately advise the individual that he or she should seek services elsewhere; and
(b) May make a referral on behalf of the individual.
(6) Personnel.
(a) Prescribers. Each prescriber employed or contracted by a facility shall be board certified and have a full, active, and unencumbered license to practice in the commonwealth issued under KRS Chapter 311 or 314.
(b) Medical director. The facility's medical director shall:
-
Be responsible for complying with all requirements related to the licensure and operation of the facility;
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Be physically present practicing medicine in the facility for at least fifty (50) percent of the time that patients are present in the facility;
-
Be board certified and have a full, active, and unencumbered license to practice medicine in the commonwealth issued under KRS Chapter 311; and
-
Not be permitted to serve in a dual role as the medical director of both the parent facility and a satellite facility.
(c) Medical director's qualifications. The facility's medical director shall meet one (1) of the requirements established in KRS 218A.175(3)(a) through (e).
(d) Within ten (10) calendar days after termination of the medical director, the facility shall notify the cabinet of the identity of the individual designated as medical director, including the identity of any interim medical director, until a permanent director is secured for the facility.
(e) The facility's medical director shall sign and submit the Pain Management Facility Data Reporting Form to the cabinet within thirty (30) calendar days of the quarter ending March 31, June 30, September 30, and December 31 of each year. The medical director shall document the following on the Pain Management Facility Data Reporting Form:
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The number of new and repeat patients seen and treated at the facility who are prescribed controlled substance medications for the treatment of chronic, nonmalignant pain;
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The number of patients discharged due to drug abuse;
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The number of patients discharged due to drug diversion; and
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The number of patients treated at the facility whose domicile is located somewhere other than in Kentucky. A patient's domicile shall be the patient's fixed or permanent home to which he or she intends to return even though he or she may temporarily reside elsewhere.
(f) The medical director shall, within ten (10) days after the facility hires a prescriber of controlled substances or ten (10) days after termination of a prescriber of controlled substances, notify the cabinet in writing and report the name of the prescriber.
(7) Staffing. At least one (1) physician and one (1) practical nurse, licensed practical nurse, or registered nurse shall be on duty in the facility during all hours the facility is operational.
(8) Job descriptions. There shall be a written job description for each position which shall be reviewed and revised as necessary.
(9) Personnel records. Current personnel records shall be maintained for each employee and include the following:
(a) Name, address, and social security number;
(b) Evidence of current certification or licensure of personnel;
(c) Records of training and experience;
(d) Records of each performance evaluation; and
(e) Annual verification of certification or licensure.
(10) In-service training.
(a) All personnel shall participate in orientation and annual in-service training programs relating to their respective job activities.
(b) All licensed prescribers in a facility shall comply with the professional standards established by their respective licensing boards for the completion of continuing professional education. Each licensed physician who prescribes or dispenses a controlled substance to a patient in the facility as part of his or her employment agreement with the facility shall successfully complete a minimum of ten (10) hours of Category I continuing medical education in pain management during each registration period throughout his or her employment agreement with the facility.
(11) Quality assurance program.
(a) Each facility shall have an ongoing quality assurance program that:
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Monitors and evaluates the quality and appropriateness of patient care;
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Evaluates methods to improve patient care;
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Identifies and corrects deficiencies within the facility;
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Alerts the designated physician or prescribing practitioner to identify and resolve recurring problems; and
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Provides for opportunities to improve the facility's performance and to enhance and improve the quality of care provided to the public.
(b) The medical director shall establish a quality assurance program that includes the following components:
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The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients;
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The identification of trends or patterns of incidents;
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The development and implementation of measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients; and
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The documentation of these functions and periodic review no less than quarterly of this information by the designated physician or prescribing practitioner.
(12) Medical records. Each facility shall maintain accurate, readily accessible, and complete medical records that conform to the professional standards established by the respective licensing board for prescribers of controlled substances in the facility.
(13) Professional standards for prescribing and dispensing controlled substances.
(a) Each licensed prescriber in a facility shall comply with the professional standards relating to the prescribing and dispensing of controlled substances established by the respective professional licensing board.
(b) A representative from the Office of Inspector General shall review facility records, including the facility's patient records, to verify facility compliance with administrative regulations promulgated by professional licensing boards pursuant to KRS 218A.205 which establish standards for licensees authorized to prescribe or dispense controlled substances.
(14) Kentucky Health Information Exchange (KHIE). Each facility shall participate in KHIE pursuant to the requirements of 900 KAR 9:010.
Section 8. Equipment. Equipment used for direct patient care by a facility shall comply with the requirements established in this section.
(1) The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative and properly calibrated.
(2) All personnel engaged in the operation of diagnostic equipment shall have adequate training and be currently licensed, registered, or certified in accordance with applicable state statutes and administrative regulations.
(3) A written plan shall be developed and maintained to provide for training of personnel in the safe and proper usage of the equipment.
Section 9. Physical Environment.
(1) Accessibility. The facility shall meet requirements for making buildings and facilities accessible to and usable by the physically handicapped pursuant to KRS 198B.260 and administrative regulations promulgated thereunder.
(2) Fire safety. A new license to operate a satellite facility or a new license to operate a facility upon approval of a change of location shall not be issued before the facility obtains approval from the State Fire Marshal's office for the satellite facility or new location.
(3) Physical location and overall environment.
(a) The facility shall:
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Comply with building codes, ordinances, and administrative regulations which are enforced by city, county, or state jurisdictions;
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Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;
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Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day;
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Have a reception and waiting area;
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Provide a restroom;
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Have an administrative area, including room for storage of medical records, supplies, and equipment;
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Have private patient examination rooms;
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Have treatment rooms, if treatment is being provided to the patients; and
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Display a printed sign located in a conspicuous place in the waiting room viewable by the public with the name and contact information of the facility's medical director and the names of all physicians and prescribers practicing in the facility.
(b) The condition of the physical location and the overall environment shall be maintained so that the safety and well-being of patients, personnel, and visitors are assured.
(4) Housekeeping and maintenance services.
(a) The facility shall maintain a clean and safe facility free of unpleasant odors.
(b) Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans, and other sources.
(c)
- The facility shall provide a hand washing facility in each exam room with:
a. Hot and cold water and blade type operating handles;
b. Knee or foot controls; or
c. Motion activated technology.
- A soap dispenser, disposable towels or electronic hand dryers, and a waste receptacle shall be provided at each hand washing sink.
(d) The premises shall be well kept and in good repair. Requirements shall include:
-
The facility shall ensure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences are in good repair;
-
The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing, and electrical fixtures shall be in good repair. Windows and doors which can be opened for ventilation shall be screened;
-
Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly; and
-
A pest control program shall be in operation in the facility. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock.
(5) The facility shall develop written infection control policies that are consistent with Centers for Disease Control guidelines and include:
(a) Prevention of disease transmission to and from patients, visitors, and employees, including:
-
Universal blood and body fluid precautions;
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Precautions against airborne transmittal of infections;
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Work restrictions for employees with infectious diseases; and
-
Cleaning, disinfection, and sterilization methods used for equipment and the environment; and
(b) Annual in-service education programs on the cause, effect, transmission, prevention, and elimination of infections.
(6) Hazardous cleaning solutions, compounds, and substances shall be:
(a) Labeled;
(b) Stored in closed metal containers;
(c) Kept separate from other cleaning materials; and
(d) Kept in a locked storage area apart from the exam room.
(7) The facility shall be kept free from insects and rodents, and their nesting places.
(8) Garbage and trash:
(a) Shall be removed from the premises regularly; and
(b) Containers shall be cleaned daily.
(9) A facility shall establish and maintain a written policy for the handling and disposal of wastes, including any infectious, pathological, or contaminated wastes, which shall include the requirements established in this subsection.
(a) Sharp wastes shall be segregated from other wastes and placed in puncture-resistant containers immediately after use.
(b) A needle or other contaminated sharp shall not be recapped, purposely bent, broken, or otherwise manipulated by hand as a means of disposal, except as permitted by the Centers for Disease Control and the Occupational Safety and Health Administration guidelines at 29 C.F.R. 1910.1030(d)(2)(vii).
(c) A sharp waste container shall be incinerated on or off-site or rendered nonhazardous.
(d) Any nondisposable sharps shall be placed in a hard walled container for transport to a processing area for decontamination.
(10)
(a) Disposable waste shall be:
-
Placed in a suitable bag or closed container so as to prevent leakage or spillage; and
-
Handled, stored, and disposed of in such a way as to minimize direct exposure of personnel or patients to waste materials.
(b) The facility shall establish specific written policies regarding handling and disposal of waste material.
Section 10. Inspections.
(1) The cabinet shall conduct unannounced inspections of the pain management facility no less than annually, including a review of the patient records, to ensure that the facility complies with the provisions of this administrative regulation and KRS 218A.175.
(2) A representative from the Office of Inspector General shall have access to the facility and the facility's records pursuant to KRS 216B.042.
(3) Violations.
(a) The Office of Inspector General shall notify the pain management facility in writing of a regulatory violation identified during an inspection.
(b) The facility shall submit to the Office of Inspector General, within ten (10) days of the notice, a written plan for the correction of the regulatory violation.
- The plan shall be signed by the facility's administrator, the licensee, or the medical director and shall specify:
a. The date by which the violation shall be corrected;
b. The specific measures utilized to correct the violation; and
c. The specific measures utilized to ensure the violation will not recur.
- The Office of Inspector General shall review the plan and notify the facility of the decision to:
a. Accept the plan;
b. Not accept the plan; or
c. Deny, suspend, or revoke the license for a substantial regulatory violation in accordance with KRS 216B.105(2).
- The notice specified in subparagraph 2.b. of this paragraph shall:
a. State the specific reasons the plan is unacceptable; and
b. Require an amended plan of correction within ten (10) days of receipt of the notice.
- The Office of Inspector General shall review the amended plan of correction and notify the facility in writing of the decision to:
a. Accept the plan;
b. Deny, suspend, or revoke the license for a substantial regulatory violation in accordance with KRS 216B.105(2); or
c. Require the facility to submit an acceptable plan of correction.
- A facility that fails to submit an acceptable amended plan of correction shall be notified that the license shall be denied, suspended, or revoked in accordance with KRS 216B.105(2).
(4) Complaints. An unannounced inspection shall be conducted:
(a) In response to a credible, relevant complaint or allegation; and
(b) According to procedures established in this section.
Section 11. Denial and Revocation.
(1) The cabinet shall deny an Application for License to Operate a Pain Management Facility at the time of annual renewal or the addition of a satellite facility if:
(a) The facility fails to comply with Section 4(2) and (3), or 7(6) of this administrative regulation;
(b) Any person with ownership interest in the facility has had previous ownership interest in a health care facility which had its license revoked or voluntarily relinquished its license as the result of an investigation or pending disciplinary action;
(c) An administrative sanction or criminal conviction relating to controlled substances has been imposed on the facility or any person employed by the facility for an act or omission done within the scope of the facility's license or the person's employment; or
(d) The facility fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by Section 10(3) of this administrative regulation.
(2) If during inspection of the pain management facility the cabinet has probable cause to believe that a physician or other prescriber practicing at the facility may be engaged in the improper, inappropriate, or illegal prescribing or dispensing of a controlled substance, the cabinet shall:
(a) Refer the physician or other prescriber practicing at the pain management facility to the appropriate professional licensing board and appropriate law enforcement agency; and
(b) Suspend a facility's license pending resolution of any investigation into the matter by a licensing board or law enforcement agency, and resolution of the appeals process if applicable.
(3) The cabinet shall revoke a license if it finds that:
(a) In accordance with KRS 216B.105(2), there has been a substantial failure by the facility, or its satellite facility, to comply with the provisions of this administrative regulation;
(b) An administrative sanction or criminal conviction relating to controlled substances is imposed on the facility or any person employed by the facility for an act or omission done within the scope of the facility's license or the person's employment;
(c) A change of ownership has occurred, except for a transfer of whole or partial ownership as permitted by KRS 218A.175(2)(b);
(d) The facility fails to accept private health insurance as one (1) of the facility's allowable forms of payment for goods or services provided, or the facility fails to accept payment for services rendered or goods provided only from the patient or the patient's insurer, guarantor, spouse, parent, guardian, or legal custodian;
(e) The facility fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by Section 10(3) of this administrative regulation; or
(f) The facility fails to comply with Section 4(2) and (3), 7(6)(a), (b), or (c), or 7(7) of this administrative regulation.
(4) The denial or revocation of a facility's license shall be mailed to the applicant or licensee, by certified mail, return receipt requested, or by personal service. Notice of the denial or revocation shall set forth the particular reasons for the action.
(5) The denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee, within the thirty (30) day period, files a request in writing for a hearing with the cabinet.
(6) Emergency action to suspend a license.
(a) The cabinet shall take emergency action to suspend a pain management facility's license if the cabinet has probable cause to believe that:
-
The continued operation of the facility would constitute a danger to the health, welfare, or safety of the facility's patients or of the general public; or
-
A physician or other prescriber practicing at the facility may be engaged in the improper, inappropriate, or illegal prescribing or dispensing of a controlled substance.
(b)
-
The pain management facility shall cease operating immediately on the date the facility is served with the notice of emergency suspension.
-
Notice of the emergency suspension shall set forth the particular reasons for the action.
(c) If the cabinet issues an emergency suspension of the facility's license pursuant to paragraph (a)2 of this subsection, the cabinet shall refer the physician or other prescriber practicing at the pain management facility to the appropriate professional licensing board and appropriate law enforcement agency.
(7) Notice of an emergency suspension shall be served on the facility by certified mail, return receipt requested, or by personal service.
(8)
(a) Any facility required to comply with an emergency suspension issued under subsection (6) of this section may submit a written request for an emergency hearing within five (5) calendar days of receipt of the notice to determine the propriety of the suspension.
(b) The cabinet shall conduct an emergency hearing within ten (10) working days of the request for hearing.
(c) Within five (5) working days of completion of the hearing, the cabinet's hearing officer shall render a written decision affirming, modifying, or revoking the emergency suspension.
(d) The emergency suspension shall be affirmed if there is substantial evidence of an immediate danger to the public health, safety, or welfare.
(9) The decision rendered under subsection (8) of this section shall be a final order of the agency on the matter, and any party aggrieved by the decision may appeal to circuit court.
(10) If the cabinet issues an emergency suspension, the cabinet shall take action to revoke the facility's license pursuant to subsection (3) of this section if:
(a) The facility fails to submit a written request for an emergency hearing within five (5) calendar days of receipt of notice of the emergency suspension;
(b) The decision rendered under subsection (8) of this section affirms that there is substantial evidence of an immediate danger to the public health, safety, or welfare; or
(c) Referral to a professional licensing board and law enforcement agency in accordance with subsection (6)(c) of this section results in an administrative sanction or criminal conviction relating to controlled substances against a physician or prescribing practitioner employed by, or under contract with, the facility.
(11) Pursuant to KRS 216B.050, the cabinet may compel obedience to its lawful orders.
Section 12. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) OIG 20:240, "Application for License to Operate a Pain Management Facility", June 2015 edition; and
(b) OIG 20:240-1, "Pain Management Facility Data Reporting Form", June 2012 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 198B.260, 216B.010-216B.131, 216B.990, 218A.175, 311, 314, 29 C.F.R. 1910.1030(d)(2)(vii), 21 U.S.C. 801 - 971
- STATUTORY AUTHORITY: KRS 216B.042, 216B.105, 218A.175
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. KRS 216B.105 authorizes the cabinet to promulgate administrative regulations to deny, revoke, modify, or suspend a license issued by the cabinet, if it finds that there has been a substantial failure to comply with the provisions of KRS Chapter 216B or this administrative regulation. KRS 218A.175 imposes a physician-ownership or investment requirement on all pain management facilities except for those health facilities operating as a pain management facility on April 24, 2012, unless there is an administrative sanction or criminal conviction relating to controlled substances imposed on the facility or any person employed by the facility for an act or omission done within the scope of the facility's license or the person's employment. This administrative regulation establishes the minimum licensure requirements for the operation of a pain management facility that is exempt from the physician-ownership requirement of KRS 218A.175.
- History: 39 Ky.R. 684; 1212; 1409; 2027; eff. 3-4-2013; TAm. 5-28-2013; 42 Ky.R. 553; 1202; eff. 11-6-2015; Cert Eff. 11-23-2021.
902 KAR 20:430 Facilities specifications, operation and services; behavioral health services organizations for mental health treatment {#sec-902-kar-20-430 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:430}
Section 1. Definitions.
(1) "Adult peer support specialist" means an individual who meets the requirements for an adult peer support specialist established by 908 KAR 2:220.
(2) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy, or a medical officer of the government of the United States while engaged in the performance of official duties, who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc. or the American Osteopathic Board of Neurology and Psychiatry;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A physician assistant licensed under KRS 311.840 to 311.862;
(h) A licensed marriage and family therapist as defined by KRS 335.300;
(i) A licensed professional clinical counselor as defined by KRS 335.500;
(j) A licensed professional art therapist as defined by KRS 309.130(2); or
(k) A licensed behavior analyst as defined by KRS 319C.010(6).
(3) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapist associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4);
(f) Licensed professional art therapist associate as defined by KRS 309.130(3); or
(g) Registered behavior technician under the supervision of a licensed behavior analyst.
(4) "Behavioral health services organization" means an entity licensed under this administrative regulation to provide behavioral health services as described in Section 5 of this administrative regulation.
(5) "Cabinet" means the Cabinet for Health and Family Services.
(6) "Child with a serious emotional disability" is defined by KRS 200.503(3).
(7) "Community support associate" means a paraprofessional who meets the application, training, and supervision requirements of 908 KAR 2:250.
(8) "Family peer support specialist" means an individual who meets the requirements for a family peer support specialist established by 908 KAR 2:230.
(9) "Severe mental illness" means the conditions defined by KRS 210.005(2) and (3).
(10) "Targeted case manager" means an individual who meets the requirements for a targeted case manager established by 908 KAR 2:260.
(11) "Telehealth" is defined by KRS 205.510(15).
(12) "Youth peer support specialist" means an individual who meets the requirements for a youth peer support specialist established by 908 KAR 2:240.
Section 2. Licensure Application and Fees.
(1) An applicant for initial licensure as a behavioral health services organization shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate a Behavioral Health Services Organization; and
(b) An accompanying initial licensure fee in the amount of $750, made payable to the Kentucky State Treasurer.
(2) At least sixty (60) calendar days prior to the date of annual renewal, a behavioral health services organization shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate a Behavioral Health Services Organization; and
(b) An annual renewal fee of $500, made payable to the Kentucky State Treasurer.
(3) A behavioral health services organization:
(a) May provide behavioral health services as described in Section 5 of this administrative regulation at extension locations separate from its permanent facility; and
(b) Shall pay a fee in the amount of $250 per extension, submitted to the Office of Inspector General at the time of initial licensure, renewal, or the addition of a new extension to the organization's license.
(4)
(a) Name change. A behavioral health services organization shall:
-
Notify the Office of Inspector General in writing within ten (10) calendar days of the effective date of a change in the organization's name; and
-
Submit a processing fee of twenty-five (25) dollars.
(b) Change of location. A behavioral health services organization shall not change the location where a program is operated until an Application for License to Operate a Behavioral Health Services Organization accompanied by a fee of $100 is filed with the Office of Inspector General.
(c) Change of ownership.
-
The new owner of a behavioral health services organization shall submit to the Office of Inspector General an Application for License to Operate a Behavioral Health Services Organization accompanied by a fee of $750 within ten (10) calendar days of the effective date of the ownership change.
-
A change of ownership for a license shall be deemed to occur if more than twenty-five (25) percent of an existing behavioral health services organization or capital stock or voting rights of a corporation is purchased, leased, or otherwise acquired by one (1) person from another.
(5) To obtain approval of initial licensure or renew a license to operate a behavioral health services organization, the licensee shall be in compliance with this administrative regulation and federal, state, and local laws and regulations pertaining to the operation of the organization.
Section 3. Scope of Operation and Services.
(1) A behavioral health services organization shall:
(a) Provide behavioral health services, as described in Section 5 of this administrative regulation, to meet client needs for treatment of a:
-
Mental health disorder; or
-
Co-occurring mental health and substance use disorder (SUD) in which:
a. The mental health disorder is the primary diagnosis and SUD is the secondary diagnosis; and
b. Services are provided by a licensed practitioner qualified to treat co-occurring mental health and SUD:
(i) Under the scope of the practitioner's licensure; and
(ii) In accordance with 907 KAR 15:020, Section 3(2)(b); and
(b) Unless an extension is granted pursuant to subsection (2) of this section, become accredited within one (1) year of initial licensure by one (1) of the following:
-
Joint Commission;
-
Commission on Accreditation of Rehabilitation Facilities;
-
Council on Accreditation; or
-
A nationally recognized accreditation organization.
(2)
(a) If a behavioral health services organization has not obtained accreditation in accordance with subsection (1)(b) of this section within one (1) year of initial licensure, the organization may request a one (1) time only extension to complete the accreditation process.
(b) A request for extension shall:
-
Be submitted in writing to the Office of Inspector General at least sixty (60) days prior to the date of annual renewal;
-
Include evidence that the organization initiated the process of becoming accredited within sixty (60) days of initial licensure and is continuing its efforts to obtain accreditation; and
-
Include an estimated timeframe by which approval of accreditation is anticipated.
(3) The cabinet shall revoke a license if a behavioral health services organization fails to meet one (1) of the following requirements:
(a) Become accredited in accordance with subsection (1)(b) of this section;
(b) Request an extension in accordance with subsection (2) of this section if accreditation has not been obtained within one (1) year of initial licensure; or
(c) Maintain accreditation.
(4) Proof of accreditation shall be provided to the Office of Inspector General upon receiving accreditation and at the time of annual renewal described in Section 2(2) of this administrative regulation.
Section 4. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for:
(a) The behavioral health services organization;
(b) The establishment of administrative policy; and
(c) Ensuring compliance with federal, state, and local laws and regulations pertaining to the operation of the organization.
(2) Executive director. The licensee shall establish lines of authority and designate an executive director who:
(a) May serve in a dual role as the organization's program director described in subsection (5)(a) of this section;
(b) Shall be responsible for the administrative management of the organization, including:
-
The total program of the organization in accordance with the organization's written policies; and
-
Evaluation of the program as it relates to the needs of each client; and
(c) Shall have a master's degree in business administration or a human services field, or a bachelor's degree in a human services field, including:
-
Social work;
-
Sociology;
-
Psychology;
-
Guidance and counseling;
-
Education;
-
Religion;
-
Business administration;
-
Criminal justice;
-
Public administration;
-
Child care administration;
-
Christian education;
-
Divinity;
-
Pastoral counseling;
-
Nursing;
-
Public health; or
-
Another human service field related to working with children with serious emotional disabilities or clients with severe mental illness.
(3) An executive director with a master's degree shall have a minimum of two (2) years of prior supervisory experience in a human services program.
(4) An executive director with a bachelor's degree shall have a minimum of two (2) years of prior experience in a human services program plus two (2) years of prior supervisory experience in a human services program.
(5) Personnel. A behavioral health services organization shall employ the following personnel directly or by contract:
(a) A program director who shall be a:
-
Psychiatrist;
-
Physician;
-
Certified or licensed psychologist;
-
Licensed psychological practitioner;
-
Advanced practice registered nurse;
-
Licensed professional clinical counselor;
-
Licensed marriage and family therapist;
-
Licensed professional art therapist;
-
Licensed behavior analyst; or
-
Licensed clinical social worker; and
(b) A sufficient number of personnel to provide behavioral health services, which may include:
-
Behavioral health professionals;
-
Behavioral health professionals under clinical supervision;
-
Targeted case managers;
-
Peer support specialists; or
-
Community support associates.
(6) Background checks.
(a) The executive director and all personnel of a behavioral health services organization shall:
-
Have a criminal record check performed upon initial hire through the Administrative Office of the Courts or the Kentucky State Police;
-
Not have a criminal conviction, or plea of guilty, to a:
a. Sex crime as specified in KRS 17.500;
b. Violent crime as specified in KRS 439.3401;
c. Criminal offense against a minor as specified in KRS 17.500; or
d. Class A felony; and
- Not be listed on the following:
a. Central registry established by 922 KAR 1:470, if the BHSO provides services to clients under age eighteen (18);
b. Nurse aide or home health aide abuse registry established by 906 KAR 1:100; or
c. Caregiver misconduct registry established by 922 KAR 5:120.
(b) A behavioral health services organization shall perform annual criminal record and registry checks as described in paragraph (a) of this subsection on a random sample of at least twenty-five (25) percent of all personnel.
(7) Policies. The behavioral health services organization shall establish written policies for the administration and operation of the organization, which shall be available to all personnel and include:
(a) A description of the organizational structure specifying the responsibility, function, and interrelations of each organizational unit, and the lines of administrative and clinical authority;
(b) The organization's method and procedure for storage, dispensing, and administering a drug or biological agent;
(c) A client grievance procedure as described in subsection (11) of this section;
(d) The organization's procedure for maintaining the confidentiality of client records in accordance with federal, state, and local statutes and regulations; and
(e) Personnel policy, including:
-
A job description and qualifications for each personnel category;
-
A plan for orientation of personnel to the policies and objectives of the organization and on-the-job training, if necessary; and
-
An annual training program for staff, which shall include:
a. Detection and reporting of abuse, neglect, or exploitation;
b. Behavioral management, including de-escalation training;
c. Physical management procedures and techniques; and
d. Emergency and safety procedures.
(8) Personnel record. A personnel record shall be kept on each staff member and shall contain the following items:
(a) Name and address;
(b) Verification of all training and experience, including licensure, certification, registration, or renewals;
(c) Verification of submission to the background check requirements of subsection (6) of this section;
(d) Annual performance appraisals; and
(e) Employee incident reports.
(9) After hours services.
(a) The behavioral health services organization shall provide, directly or through written agreement with another behavioral health services provider, access to emergency services face-to-face or via telehealth twenty-four (24) hours per day, seven (7) days per week.
(b) Emergency services shall include interventions necessary to screen, assess, refer, and treat an individual from the point of the identified emergency or behavioral health crisis to the point of resolution of the emergency or crisis.
(10) Quality assurance and utilization review.
(a) The behavioral health services organization shall have a quality assurance and utilization review program designed to:
-
Enhance treatment and care through the ongoing objective assessment of services provided, including the correction of identified problems; and
-
Provide an effective mechanism for review and evaluation of the service needs of each client.
(b) The need for continuing services shall be evaluated immediately upon a change in a client's service needs or a change in the client's condition to ensure that proper arrangements have been made for:
-
Discharge;
-
Transfer; or
-
Referral to another service provider, if appropriate.
(11) Client grievance policy. The behavioral health services organization shall have written policies and procedures governing client grievances, which shall include the following:
(a) Identification of a behavioral health services organization ombudsman;
(b) A process for filing a written client grievance;
(c) An appeals process with time frames for filing and responding to a grievance in writing;
(d) Protection for a client from interference, coercion, discrimination, or reprisal; and
(e) Conspicuous posting of the grievance procedures in a public area to inform a client of:
-
His or her right to file a grievance;
-
The process for filing a grievance; and
-
The address and telephone number of the behavioral health services organization's and cabinet's ombudsman.
Section 5. Services. A behavioral health services organization shall provide treatment to meet client needs, including one (1) or more of the following:
(1) Screening, which shall be provided face-to-face or via telehealth by a behavioral health professional or behavioral health professional under clinical supervision to determine the:
(a) Likelihood that an individual has a mental health, substance use, or co-occurring disorder; and
(b) Need for an in-depth assessment;
(2) Assessment, which shall:
(a) Be provided face-to-face or via telehealth by a behavioral health professional or behavioral health professional under clinical supervision who gathers information and engages in a process with the client to:
-
Establish the presence or absence of a mental health disorder, substance use disorder, or co-occurring disorder;
-
Determine the client's readiness for change;
-
Identify the client's strengths or problem areas that may affect the treatment and recovery processes; and
-
Engage the client in developing an appropriate treatment relationship;
(b) Establish or rule out the existence of a clinical disorder or service need;
(c) Include working with the client to develop a plan of care if a clinical disorder or service need is assessed; and
(d) Not include psychological or psychiatric evaluations or assessments;
(3) Psychological testing, which shall:
(a) Be performed by a licensed psychologist, certified psychologist with autonomous functioning, certified psychologist, licensed psychological associate, or licensed psychological practitioner; and
(b) Include a psychodiagnostic assessment of personality, psychopathology, emotionality, or intellectual disabilities, and interpretation and written report of testing results;
(4) Crisis intervention, which:
(a) Shall be a therapeutic intervention for the purpose of immediately reducing or eliminating the risk of physical or emotional harm to the client or another individual;
(b) Shall consist of clinical intervention and support services necessary to provide integrated crisis response, crisis stabilization interventions, or crisis prevention activities;
(c) Shall be provided:
-
As an immediate relief to the presenting problem or threat; and
-
In a one (1) on one (1) encounter or as a comparable service provided via telehealth;
(d) Shall be provided by a:
-
Behavioral health professional; or
-
Behavioral health professional under clinical supervision;
(e) Shall be followed by a referral to noncrisis services, if applicable; and
(f) May include:
-
Further service prevention planning, including lethal means reduction for suicide risk; or
-
Verbal de-escalation, risk assessment, or cognitive therapy;
(5) Mobile crisis services, which shall:
(a) Be available twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(b) Be provided for a duration of less than twenty-four (24) hours;
(c) Not be an overnight service;
(d) Be a multi-disciplinary team based intervention that ensures access to acute mental health services and supports to:
-
Reduce symptoms or harm; or
-
Safely transition an individual in an acute crisis to the appropriate, least restrictive level of care;
(e) Involve all services and supports necessary to provide:
-
Integrated crisis prevention;
-
Assessment and disposition;
-
Intervention;
-
Continuity of care recommendations; and
-
Follow-up services;
(f) Be provided face-to-face in a home or community setting by:
-
A behavioral health professional;
-
A behavioral health professional under clinical supervision; or
-
An adult, family, or youth peer support specialist, as appropriate, working under the supervision of a behavioral health professional; and
(g) Ensure access to a board certified or board-eligible psychiatrist twenty-four (24) hours a day, seven (7) days a week, every day of the year;
(6) Day treatment, which shall:
(a) Be a nonresidential, intensive treatment program designed for children who:
-
Have a mental health disorder;
-
Are under twenty-one (21) years of age; and
-
Are at high risk of out-of-home placement due to a behavioral health issue;
(b) Consist of an organized, behavioral health program of treatment and rehabilitative services for mental health disorder;
(c) Have unified policies and procedures that address the organization's philosophy, admission and discharge criteria, admission and discharge process, staff training, and integrated case planning;
(d) Include the following:
-
Individual outpatient therapy, family outpatient therapy, or group outpatient therapy;
-
Behavior management and social skill training;
-
Independent living skills that correlate to the age and development stage of the client; or
-
Services designed to explore and link with community resources before discharge and to assist the client and family with transition to community services after discharge;
(e) Be provided as follows:
-
In collaboration with the education services of the local education authority including those provided through 20 U.S.C. 1400 et seq. (Individuals with Disabilities Education Act) or 29 U.S.C. 701 et seq. (Section 504 of the Rehabilitation Act);
-
On school days and during scheduled school breaks;
-
In coordination with the child's individual educational plan or Section 504 plan if the child has an individual educational plan or Section 504 plan;
-
By personnel that includes a behavioral health professional, a behavioral health professional under clinical supervision, or a family or youth peer support specialist, as appropriate, and working under the supervision of a behavioral health professional; and
-
According to a linkage agreement with the local education authority that specifies the responsibilities of the local education authority and the day treatment provider; and
(f) Not include a therapeutic clinical service that is included in a child's individualized education plan;
(7) Peer support, which shall:
(a) Be provided face-to-face by an adult, family, or youth peer support specialist, as appropriate, working under the supervision of a behavioral health professional;
(b) Be a structured and scheduled nonclinical therapeutic activity with a client or group of clients;
(c) Promote socialization, recovery, self-advocacy, preservation, and enhancement of community living skills;
(d) Be identified in the client's plan of care developed through a person-centered planning process; and
(e) If provided to clients in a group setting, not exceed eight (8) individuals within any group at a time;
(8) Intensive outpatient program services, which shall:
(a) Offer a multi-modal, multi-disciplinary structured outpatient treatment program that is more intensive than individual outpatient therapy, group outpatient therapy, or family outpatient therapy;
(b) Be provided at least:
-
Three (3) hours per day at least three (3) days per week for adults; or
-
Six (6) hours per week for adolescents;
(c) Include:
-
Individual outpatient therapy, group outpatient therapy, or family outpatient therapy unless contraindicated;
-
Crisis intervention; or
-
Psycho-education that is related to identified goals in the client's treatment plan. If psycho-education is provided, the client or client's family member shall be:
a. Provided with knowledge regarding the client's diagnosis, the causes of the condition, and the reasons why a particular treatment might be effective for reducing symptoms; and
b. Taught how to cope with the client's diagnosis or condition in a successful manner;
(d) Include a treatment plan, which shall:
-
Be individualized; and
-
Focus on stabilization and transition to a lower level of care;
(e) Be provided by a behavioral health professional or behavioral health professional under clinical supervision;
(f) Include access to a board-certified or board-eligible psychiatrist for consultation;
(g) Include access to a psychiatrist, other physician, or advanced practice registered nurse for medication prescribing and monitoring; and
(h) Be provided in a setting with a minimum client-to-staff ratio of ten (10) clients to one (1) staff person;
(9) Individual outpatient therapy, which shall:
(a) Be provided to promote the:
-
Health and wellbeing of the client; and
-
Restoration of a client to his or her best possible functional level;
(b) Consist of a:
a. Face-to-face, one (1) on one (1) encounter between program staff and the client; or
b. Telehealth consultation; and
- Behavioral health therapeutic intervention provided in accordance with the client's plan of care;
(c) Be aimed at:
-
Reducing adverse symptoms;
-
Reducing or eliminating the presenting problem of the client; and
-
Improving functioning;
(d) Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time with the client is medically necessary in accordance with 907 KAR 3:130; and
(e) Be provided by a behavioral health professional or behavioral health professional under clinical supervision;
(10) Group outpatient therapy, which shall:
(a) Be provided to promote the:
-
Health and wellbeing of the client; and
-
Restoration of a client to his or her best possible functional level;
(b) Consist of a face-to-face behavioral health therapeutic intervention provided in accordance with the client's plan of care;
(c) Excluding multi-family group therapy, be provided in a group setting of nonrelated individuals, not to exceed twelve (12) individuals in size. For group outpatient therapy, a nonrelated individual means any individual who is not a spouse, significant other, parent or person with custodial control, child, sibling, stepparent, stepchild, step-brother, step-sister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild;
(d) Focus on the psychological needs of the client as evidenced in the client's plan of care;
(e) Center on goals including building and maintaining healthy relationships, personal goals setting, and the exercise of personal judgment;
(f) Not include physical exercise, a recreational activity, an educational activity, or a social activity;
(g) Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time with the client is medically necessary in accordance with 907 KAR 3:130;
(h) Ensure that the group has a deliberate focus and defined course of treatment;
(i) Ensure that the subject of group outpatient therapy is related to each client participating in the group; and
(j) Be provided by a behavioral health professional or behavioral health professional under clinical supervision who shall maintain individual notes regarding each client within the group in the client's record;
(11) Family outpatient therapy, which shall:
(a) Consist of a behavioral health therapeutic intervention provided face-to-face or via telehealth through scheduled therapeutic visits between the therapist, the client, and at least one (1) member of the client's family;
(b) Address issues interfering with the relational functioning of the family;
(c) Seek to improve interpersonal relationships within the client's home environment;
(d) Be provided to promote the health and wellbeing of the client, including restoration of a client to his or her best possible functional level;
(e) Not exceed three (3) hours per day alone or in combination with any other outpatient therapy unless additional time with the client is medically necessary in accordance with 907 KAR 3:130; and
(f) Be provided by a behavioral health professional or behavioral health professional under clinical supervision;
(12) Collateral outpatient therapy, which shall consist of a face-to-face or telehealth consultation:
(a) With a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21), household member, legal representative, school personnel, or treating professional;
(b) Provided by a behavioral health professional or behavioral health professional under clinical supervision; and
(c) Provided upon the written consent of a parent, caregiver, or person who has custodial control of a client under the age of twenty-one (21). Documentation of written consent shall be signed and maintained in the client's record;
(13) Service planning, which shall be provided face-to-face by a behavioral health professional or behavioral health professional under clinical supervision, either of which shall be of the client's choosing to:
(a) Assist the client in creating an individualized plan for services and developing measurable goals and objectives needed for maximum reduction of the effects of mental health disorder;
(b) Restore the client's functional level to the client's best possible functional level; and
(c) Develop a service plan, which:
-
Shall be directed and signed by the client; and
-
May include:
a. A mental health advance directive being filed with a local hospital;
b. A crisis plan; or
c. A relapse prevention strategy or plan;
(14) Screening, brief intervention and referral to treatment for substance use disorders, which shall:
(a) Be an evidence-based early intervention approach for an individual with non-dependent substance use to provide an effective strategy for intervention prior to the need for more extensive or specialized treatment; and
(b) Consist of:
-
Using a standardized screening tool to assess the individual for risky substance use behavior;
-
Engaging a client who demonstrates risky substance use behavior in a short conversation, providing feedback and advice;
-
Referring the client to therapy or other services that address substance use if the client is determined to need additional services; and
-
Be provided by a behavioral health professional, behavioral health professional under clinical supervision, or a certified alcohol and drug counselor;
(15) Assertive community treatment for mental health disorders, which shall:
(a) Include assessment, treatment planning, case management, psychiatric services, individual, family, or group therapy, peer support, mobile crisis services, crisis intervention, mental health consultation with other treating professionals who may have information for the purpose of treatment planning and service delivery, family support to improve family relations to reduce conflict and increase the client's autonomy and independent functioning, or basic living skills focused on teaching activities of daily living necessary to maintain independent functioning and community living;
(b) Be provided face-to-face by a multidisciplinary team of at least four (4) professionals, including a nurse, case manager, peer support specialist, and any other behavioral health professional or behavioral health professional under clinical supervision; and
(c) Have adequate staffing to ensure that no caseload size exceeds ten (10) participants per team member;
(16) Comprehensive community support services, which shall:
(a) Consist of activities needed to allow an individual with a mental health disorder to live with maximum independence in the community through the use of skills training as identified in the client's treatment plan;
(b) Consist of using a variety of psychiatric rehabilitation techniques to:
-
Improve daily living skills;
-
Improve self-monitoring of symptoms and side effects;
-
Improve emotional regulation skills;
-
Improve crisis coping skills; and
-
Develop and enhance interpersonal skills; and
(c) Be provided face-to-face by a:
-
Behavioral health professional;
-
Behavioral health professional under clinical supervision;
-
Community support associate under the supervision of a behavioral health professional; or
-
Registered behavior technician;
(17) Therapeutic rehabilitation program for an adult with a severe mental illness or child with a serious emotional disability, which shall:
(a) Include face-to-face services designed to maximize the reduction of mental illness or emotional disability and restoration of the client's functional level to the individual's best possible functioning;
(b) Require the client to be responsible for establishing his or her own rehabilitative goals within the person-centered plan of care;
(c) Be delivered using a variety of psychiatric rehabilitation techniques focused on:
-
Improving daily living skills;
-
Self-monitoring of symptoms and side effects;
-
Emotional regulation skills;
-
Crisis coping skills; and
-
Interpersonal skills; and
(d) Be provided individually or in a group by a:
-
Behavioral health professional, except for a licensed behavioral analyst;
-
Behavioral health professional under clinical supervision, except for a registered behavior technician; or
-
Peer support specialist under the supervision of a behavioral health professional;
(18) Targeted case management services, which shall:
(a) Include services to:
- A child with a serious emotional disability or co-occurring disorder that includes a:
a. Chronic or complex physical health issue; or
b. Secondary SUD diagnosis; or
- An adult with severe mental illness or co-occurring disorder that includes a:
a. Chronic or complex physical health issue; or
b. Secondary SUD diagnosis;
(b) Be provided by a targeted case manager; and
(c) Include the following assistance:
-
Comprehensive assessment and reassessment of client needs to determine the need for medical, educational, social, or other services. The reassessment shall be conducted annually or more often if needed based on changes in the client's condition;
-
Development of a specific care plan, which shall be based on information collected during the assessment and revised if needed upon reassessment;
-
Referral and related activities, which may include:
a. Scheduling appointments for the client to help the individual obtain needed services; or
b. Activities that help link the client with medical, social, educational providers, or other programs and services that address identified needs and achieve goals specified in the care plan; and
- Monitoring, which shall be face-to-face and occur no less than once every three (3) months to determine that:
a. Services are furnished according to the client's care plan;
b. Services in the care plan are adequate; and
c. Changes in the needs or status of the client are reflected in the care plan; and
- Contacts with the client, family members, service providers, or others are conducted as frequently as needed to help the client:
a. Access services;
b. Identify needs and supports to assist the client in obtaining services; and
c. Identify changes in the client's needs; or
(19) Partial hospitalization, which:
(a) Shall be short-term, with an average of four (4) to six (6) weeks;
(b) Shall be an intensive treatment program for an individual who is experiencing significant impairment to daily functioning due to a mental health disorder;
(c) May be provided to an adult or a minor;
(d) Shall be based on an inability of community-based therapies or intensive outpatient services to adequately treat the client;
(e) Shall consist of:
-
Individual outpatient therapy;
-
Group outpatient therapy;
-
Family outpatient therapy; or
-
Medication management;
(f) If provided to minors, shall include an agreement with the local educational authority including those provided through 20 U.S.C. 1400 et seq. or 29 U.S.C. 701 et seq.;
(g) Shall be provided for at least five (5) hours per day, four (4) days per week, and focused on one (1) primary presenting problem;
(h) Shall include the following personnel for the purpose of providing medical care, if necessary:
-
An on-site advanced practice registered nurse, physician assistant, or physician; and
-
A board-certified or board-eligible psychiatrist available for consultation; and
(i) Shall provide services utilizing a recognized intervention protocol based on nationally accepted treatment principles.
Section 6. Plan of Care.
(1) Each client receiving direct treatment from a behavioral health services organization shall have an individual plan of care signed by a behavioral health professional.
(2) A plan of care shall:
(a) Describe the services to be provided to the client, including the frequency of services;
(b) Contain measurable goals for the client to achieve, including the expected date of achievement for each goal;
(c) Describe the client's functional abilities and limitations, or diagnosis listed in the current edition of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders;
(d) Specify each staff member assigned to work with the client;
(e) Identify methods of involving the client's family or significant others if indicated;
(f) Specify criteria to be met for termination of treatment;
(g) Include any referrals necessary for services not provided directly by the behavioral health services organization; and
(h) State the date scheduled for review of the plan.
(3) The client shall participate to the maximum extent feasible in the development of his or her plan of care, and the participation shall be documented in the client's record.
(4)
(a) The initial plan of care shall be developed through multidisciplinary team conferences as clinically indicated and at least thirty (30) days following the first ten (10) days of treatment.
(b)
-
The plan of care for an individual receiving intensive outpatient program services or partial hospitalization shall be reviewed every thirty (30) days thereafter and updated every sixty (60) days or earlier if clinically indicated.
-
The plan of care for an individual receiving any other outpatient service as described by Section 5 of this administrative regulation shall be reviewed and updated every six (6) months thereafter or earlier if clinically indicated.
(c) The plan of care and each review and update shall be signed by the participants in the multidisciplinary team conference that developed it.
(5) A medical service, including a change of medication, a diet restriction, or a restriction on physical activity shall be ordered by a physician or other ordering practitioner acting within the limits of his or her statutory scope of practice.
Section 7. Client Records.
(1) A client record shall be maintained for each individual receiving services.
(2) Each entry shall be current, dated, signed, and indexed according to the service received.
(3) Each client record shall contain:
(a) An identification sheet, including the client's name, address, age, gender, marital status, expected source of payment, and referral source;
(b) Information on the purpose for seeking a service;
(c) If applicable, consent of appropriate family members or guardians for admission, evaluation, and treatment;
(d) Screening information pertaining to the mental health disorder;
(e) If applicable, a psychosocial history;
(f) If applicable, staff notes on services provided;
(g) If applicable, the client's plan of care;
(h) If applicable, disposition;
(i) If applicable, assigned status;
(j) If applicable, assigned therapists; and
(k) If applicable, a termination study recapitulating findings and events during treatment, clinical impressions, and condition on termination.
(4) Ownership.
(a) Client records shall be the property of the organization.
(b) The original client record shall not be removed from the organization except by court order or subpoena.
(c) Copies of a client record or portions of the record may be used and disclosed. Use and disclosure shall be as established by subsection (6) of this section.
(5) Retention of records. After a client's death or discharge, the completed client record shall be placed in an inactive file and:
(a) Retained for six (6) years; or
(b) If a minor, three (3) years after the client reaches the age of majority under state law, whichever is the longest.
(6) Confidentiality and Security: Use and Disclosure.
(a) The organization shall maintain the confidentiality and security of client records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164.
(b) The organization may use and disclose client records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(c) A behavioral health services organization may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
Section 8. Client Rights.
(1) A behavioral health services organization shall have written policies and procedures to ensure that the rights of a client are protected while receiving one (1) or more services as described in Section 5 of this administrative regulation.
(2) A behavioral health services organization shall have written policies and procedures governing client grievances pursuant to Section 4(11) of this administrative regulation.
(3) A client shall not be unlawfully discriminated against in determining eligibility for a service.
(4) During a behavioral health services organization's intake procedures, a client shall sign a statement that specifies that the client has the right to:
(a) Give informed consent to receive a service.
-
An adult shall sign an informed consent to receive a service.
-
A parent, caregiver, or person who has custodial control of a child shall sign an informed consent for the child to receive a service;
(b) Have input into his or her plan of care and be informed of the plan's content;
(c) Receive individualized treatment;
(d) File a grievance, recommendation, or opinion regarding the services the client receives;
(e) Give informed written consent regarding participation in a research study with the exception of a child whose parent or guardian shall give informed written consent;
(f) Confidentiality according to Section 7(6) of this administrative regulation;
(g) Request a written statement of the charge for a service and be informed of the policy for the assessment and payment of fees;
(h) Be informed of the rules of client conduct and responsibilities;
(i) Be treated with consideration, respect, and personal dignity;
(j) Review his or her client record in accordance with the organization's policy; and
(k) Receive one (1) free copy of his or her client record.
(5) The statement of client rights as described in subsection (4) of this section shall be:
(a) Provided to the client;
(b) If the client is a minor or incapacitated, provided to the client's parent, guardian, or other legal representative in addition to the client; and
(c) Read to the client or client's parent, guardian, or other legal representative if requested or if either cannot read.
(6) If a client is restricted from exercising a client right because it is contraindicated by the client's physical or mental condition, there shall be documentation in the client record of the reason for the restriction and of the explanation given to the client.
Section 9. Physical Environment.
(1) Accessibility. A behavioral health services organization shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and 815 KAR 7:120.
(2) Fire safety. A behavioral health services organization shall be approved by the State Fire Marshal's office prior to initial licensure or if an organization changes location.
(3) Physical location and overall environment.
(a) A behavioral health services organization shall:
-
Comply with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdictions;
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Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;
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Have a publicly listed telephone number and a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day;
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Have a reception and waiting area;
-
Provide a restroom; and
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Have an administrative area.
(b) The condition of the physical location and the overall environment shall be maintained in such a manner that the safety and well-being of clients, personnel, and visitors are assured.
(4) Prior to occupancy, the facility shall have final approval from appropriate agencies.
Section 10. License Procedures. The behavioral health services organization shall be subject to the provisions of 902 KAR 20:008, Sections 1, 2, 5, 6, and 7.
Section 11. Denial and Revocation.
(1) The cabinet shall deny an Application for License to Operate a Behavioral Health Services Organization if:
(a) Any person with ownership interest in the organization has had previous ownership interest in a health care facility that had its license revoked or voluntarily relinquished its license as the result of an investigation or pending disciplinary action;
(b) Any person with ownership interest in the organization has been discontinued from participation in the Medicaid Program due to fraud or abuse of the program; or
(c) The applicant fails after the initial inspection to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13).
(2) The cabinet shall revoke a license if it finds that:
(a) In accordance with KRS 216B.105(2), there has been a substantial failure by the behavioral health services organization to comply with the provisions of this administrative regulation;
(b) The behavioral health services organization fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13); or
(c) The behavioral health services organization is terminated from participation in the Medicaid Program pursuant to 907 KAR 1:671.
(3) The denial or revocation of a behavioral health services organization's license shall be mailed to the applicant or licensee, by certified mail, return receipt requested, or by personal service. Notice of the denial or revocation shall set forth the particular reasons for the action.
(4) The denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee, within the thirty (30) day period, files a request in writing for a hearing with the cabinet.
(5) Urgent action to suspend a license.
(a) The cabinet shall take urgent action to suspend a behavioral health services organization's license if the cabinet has probable cause to believe that the continued operation of the organization would constitute an immediate danger to the health, welfare, or safety of its patients.
(b)
-
The behavioral health services organization shall be served with notice of the hearing on the urgent suspension to be held no sooner than twenty (20) days from the delivery of the notice.
-
Notice of the urgent suspension shall set forth the particular reasons for the action.
(6) Notice of a hearing on an urgent suspension shall be served on the behavioral health services organization by certified mail, return receipt requested, or by personal service.
(7)
(a) Within five (5) working days of completion of the hearing, the cabinet's hearing officer shall render a written decision affirming, modifying, or revoking the urgent suspension.
(b) The urgent suspension shall be affirmed if there is substantial evidence of an immediate danger to the public health, safety, or welfare.
(8) The decision rendered under subsection (7) of this section shall be a final order of the agency on the matter, and any party aggrieved by the decision may appeal to circuit court.
(9) If the cabinet issues an urgent suspension, the cabinet shall take action to revoke the behavioral health services organization's license pursuant to subsection (3) of this section if:
(a) The organization fails to attend the expedited hearing; or
(b) The decision rendered under subsection (7) of this section affirms that there is substantial evidence of an immediate danger to the public health, safety, or welfare.
(10) Pursuant to KRS 216B.050, the cabinet may compel obedience to its lawful orders.
Section 12. Incorporation by Reference.
(1) The OIG 20:430, "Application for License to Operate a Behavioral Health Services Organization", October 2019 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 17.500, 198B.260, 200.503(2), 205.510, 210.005(2), (3), 216B.050, 216B.105, 309.130, 311.860, 314.042, 319.050, 319.056, 319.064, 319C.010, 335.080, 335.100, 335.300, 335.500, 439.3401, 45 C.F.R. Parts 160, 164, 20 U.S.C. 1400 et seq., 29 U.S.C. 701 et seq., 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of behavioral health services organizations (BHSO) that provide behavioral health services necessary to treat, support, and encourage individuals with a mental health disorder or co-occurring mental health and secondary substance use disorder (SUD) to achieve and maintain the highest possible level of health and self-sufficiency.
- History: 41 Ky.R. 343; Am. 1104; eff. 1346; eff. 12-17-2014; 46 Ky.R. 709, 1528; eff. 12-9-2019; TAm eff. 3-20-2020.
902 KAR 20:440 Facilities specifications, operation and services; residential crisis stabilization units {#sec-902-kar-20-440 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:440}
Section 1. Definitions.
(1) "Behavioral health professional" means:
(a) A psychiatrist licensed under the laws of Kentucky to practice medicine or osteopathy, or a medical officer of the government of the United States while engaged in the performance of official duties, who is certified or eligible to apply for certification by the American Board of Psychiatry and Neurology, Inc. or the American Osteopathic Board of Neurology and Psychiatry;
(b) A physician licensed in Kentucky to practice medicine or osteopathy in accordance with KRS 311.571;
(c) A psychologist licensed and practicing in accordance with KRS 319.050;
(d) A certified psychologist with autonomous functioning or licensed psychological practitioner practicing in accordance with KRS 319.056;
(e) A clinical social worker licensed and practicing in accordance with KRS 335.100;
(f) An advanced practice registered nurse licensed and practicing in accordance with KRS 314.042;
(g) A physician assistant as defined by KRS 311.840(3);
(h) A licensed marriage and family therapist as defined by KRS 335.300(2);
(i) A licensed professional clinical counselor as defined by KRS 335.500(3); or
(j) A licensed professional art therapist as defined by KRS 309.130(2).
(2) "Behavioral health professional under clinical supervision" means a:
(a) Psychologist certified and practicing in accordance with KRS 319.056;
(b) Licensed psychological associate licensed and practicing in accordance with KRS 319.064;
(c) Marriage and family therapy associate as defined by KRS 335.300(3);
(d) Social worker certified and practicing in accordance with KRS 335.080;
(e) Licensed professional counselor associate as defined by KRS 335.500(4); or
(f) Licensed professional art therapist associate as defined by KRS 309.130(3).
(3) "Cabinet" means the Cabinet for Health and Family Services.
(4) "Certified alcohol and drug counselor" is defined by KRS 309.080(2).
(5) "Chemical restraint" means the use of a drug that:
(a) Is administered to manage a resident's behavior in a way that reduces the risk to the resident or others;
(b) Has the temporary effect of restricting the resident's freedom of movement; and
(c) Is not a standard treatment for the resident's medical or psychiatric condition.
(6) "Child with a severe emotional disability" is defined by KRS 200.503(3).
(7) "Crisis stabilization unit" means a community-based facility that is not part of an inpatient unit and that provides crisis services to no more than sixteen (16) clients who require overnight stays.
(8) "Licensed clinical alcohol and drug counselor" is defined by KRS 309.080(4)
(9) "Mechanical restraint" means any device attached or adjacent to a resident's body that he or she cannot easily remove that restricts freedom of movement or normal access to his or her body.
(10) "Peer support specialist" means a paraprofessional who:
(a) Is a registered alcohol and drug peer support specialist in accordance with KRS 309.0831; or
(b)
-
Meets the application, training, examination, and supervision requirements of 908 KAR 2:220, 908 KAR 2:230, or 908 KAR 2:240; and
-
Works under the supervision of one (1) of the following:
a. Physician;
b. Psychiatrist;
c. Licensed psychologist;
d. Licensed psychological practitioner;
e. Licensed psychological associate;
f. Licensed clinical social worker;
g. Licensed marriage and family therapist;
h. Licensed professional clinical counselor;
i. Certified social worker;
j. Licensed marriage and family therapy associate;
k. Licensed professional counselor associate;
l. Licensed professional art therapist;
m. Licensed professional art therapist associate;
n. Advanced practice registered nurse;
o. Physician assistant;
p. Certified alcohol and drug counselor; or
q. Licensed clinical alcohol and drug counselor.
(11) "Personal restraint" means the application of physical force without the use of any device for the purpose of restraining the free movement of a resident's body and does not include briefly holding without undue force a resident in order to calm or comfort him or her or holding a resident's hand to safely escort him or her from one (1) area to another.
(12) "Seclusion" means the involuntary confinement of a resident alone in a room or in an area from which the resident is physically prevented from leaving.
(13) (12) "Serious mental illness", "severe mental illness", or "SMI" means a diagnosis of a major mental disorder as included in the current edition of the Diagnostic and Statistical Manual of Mental Disorders under:
(a) Schizophrenia spectrum and other psychotic disorders;
(b) Bipolar and related disorders;
(c) Depressive disorders; or
(d) Post-traumatic stress disorders (under trauma and stressor related disorders).
(14) "Substance use disorder" is defined by KRS 222.005(12).
(15) "Time out" means the restriction of a resident for a period of time to a designated area from which the resident is not physically prevented from leaving, for the purpose of providing the resident an opportunity to regain self-control.
Section 2. Licensure Application and Fees.
(1) An applicant for initial licensure as a residential crisis stabilization unit shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate a Residential Crisis Stabilization Unit; and
(b) An accompanying initial licensure fee in the amount of $750, made payable to the Kentucky State Treasurer.
(2) At least sixty (60) calendar days prior to the date of annual renewal, a residential crisis stabilization unit shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate a Residential Crisis Stabilization Unit; and
(b) An annual renewal fee of $500, made payable to the Kentucky State Treasurer.
(3)
(a) Name change. A residential crisis stabilization unit shall:
-
Notify the Office of Inspector General in writing within ten (10) calendar days of the effective date of a change in the unit's name; and
-
Submit a processing fee of twenty-five (25) dollars.
(b) Change of location. A residential crisis stabilization unit shall not change the location where the unit is operating until an Application for License to Operate a Residential Crisis Stabilization Unit accompanied by a fee of $100 is filed with the Office of Inspector General.
(c) Change of ownership.
-
The new owner of a residential crisis stabilization unit shall submit to the Office of Inspector General an Application for License to Operate a Residential Crisis Stabilization Unit accompanied by a fee of $750 within ten (10) calendar days of the effective date of the ownership change.
-
A change of ownership for a license shall be deemed to occur in accordance with the criteria of 902 KAR 20:008, Section 2(16).
(4) To obtain approval of initial licensure or renew a license to operate a residential crisis stabilization unit, the applicant or licensee shall be in compliance with this administrative regulation and federal, state, and local laws and administrative regulations pertaining to the operation of the unit.
Section 3. Accreditation.
(1) Unless an extension is granted pursuant to subsection (2) of this section, an entity licensed under this administrative regulation to operate a residential crisis stabilization unit shall become accredited within one (1) year of initial licensure by:
(a) The Joint Commission;
(b) The Commission on Accreditation of Rehabilitation Facilities;
(c) The Council on Accreditation; or
(d) A nationally recognized accreditation organization.
(2)
(a) If a residential crisis stabilization unit has not obtained accreditation in accordance with subsection (1) of this section within one (1) year of initial licensure, the facility may request a one (1) time only extension to complete the accreditation process.
(b) A request for extension shall:
-
Be submitted in writing to the Office of Inspector General at least sixty (60) days prior to the date of annual renewal;
-
Include evidence that the facility initiated the process of becoming accredited within sixty (60) days of initial licensure and is continuing its efforts to obtain accreditation; and
-
Include an estimated timeframe by which approval of accreditation is anticipated.
(3) The cabinet shall revoke the license if the residential crisis stabilization unit fails to:
(a)
-
Become accredited in accordance with subsection (1) of this section; or
a. Request an extension in accordance with subsection (2) of this section if accreditation will not be obtained within one (1) year of initial licensure; and
b. Become accredited during the extension granted in accordance with subsection (2) of this section; or
(b) Maintain accreditation.
(4) Proof of accreditation shall be provided to the Office of Inspector General upon receiving accreditation within one (1) year of initial licensure and at the time of annual renewal established in Section 2(2) of this administrative regulation.
Section 4. Administration and Operation.
(1) The licensee shall be legally responsible for:
(a) The residential crisis stabilization unit;
(b) The establishment of administrative policy; and
(c) Ensuring compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the residential crisis stabilization unit.
(2) Executive director. The licensee shall establish lines of authority and designate an executive director who:
(a) May serve in a dual role as the residential crisis stabilization unit's program director established in subsection (5) of this section;
(b) May serve in a dual role as the executive director of a behavioral health services organization (BHSO) or alcohol and other drug treatment entity (AODE) if:
-
The residential crisis stabilization unit and the BHSO or AODE are owned by the same entity; and
-
The residential crisis stabilization unit has a linkage with the BHSO or AODE to assist with continuity of care if needed after discharge from the residential crisis stabilization unit;
(c) Shall be responsible for the administrative management of the residential crisis stabilization unit, including:
-
The total program of the unit in accordance with the unit's written policies; and
-
Evaluation of the unit as it relates to the needs of each resident; and
(d) Shall have a master's degree in business administration or a human services field, or a bachelor's degree in a human services field, including:
-
Social work;
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Sociology;
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Psychology;
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Guidance and counseling;
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Education;
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Religion;
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Business administration;
-
Criminal justice;
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Public administration;
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Child care administration;
-
Christian education;
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Divinity;
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Pastoral counseling;
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Nursing;
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Public health; or
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Another human service field related to working with children with severe emotional disabilities or clients with severe mental illness.
(3) An executive director with a master's degree shall have a minimum of two (2) years of prior supervisory experience in a human services program.
(4) An executive director with a bachelor's degree shall have a minimum of two (2) years of prior experience in a human services program plus two (2) years of prior supervisory experience in a human services program.
(5) A residential crisis stabilization unit shall have a program director who:
(a) May serve in a dual role as the program director of a BHSO or AODE if:
-
The residential crisis stabilization unit and the BHSO or AODE are owned by the same entity; and
-
The residential crisis stabilization unit has a linkage with the BHSO or AODE to assist with continuity of care if needed after discharge from the residential crisis stabilization unit; and
(b) Shall be a:
-
Psychiatrist;
-
Physician;
-
Licensed psychologist or certified psychologist with autonomous functioning;
-
Licensed psychological practitioner;
-
Advanced practice registered nurse;
-
Licensed professional clinical counselor;
-
Licensed marriage and family therapist;
-
Licensed professional art therapist;
-
Licensed behavior analyst; or
-
Licensed clinical social worker.
Section 5. License Procedures. An entity licensed under this administrative regulation to operate a residential crisis stabilization unit shall be subject to the provisions of 902 KAR 20:008, Sections 1, 2, 5, 6, and 7.
Section 6. Background Checks and Personnel Records.
(1) All personnel of a residential crisis stabilization unit shall:
(a) Have a criminal record check performed upon initial hire and every two (2) years through the Administrative Office of the Courts or the Kentucky State Police;
(b) Not have a criminal conviction, or plea of guilty, to a:
-
Sex crime as defined by KRS 17.500(8);
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Violent crime as established in KRS 439.3401;
-
Criminal offense against a minor as established in KRS 17.500; or
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Class A felony; and
(c) Not be listed on the:
-
Central registry established by 922 KAR 1:470;
-
Nurse aide or home health aide abuse registry established by 906 KAR 1:100; or
-
Caregiver misconduct registry established by 922 KAR 5:120.
(2) Prior to initial hire, an out-of-state criminal background information check shall be obtained for any applicant recommended for employment in a residential crisis stabilization unit who has resided or resides outside of the Commonwealth.
(3) A residential crisis stabilization unit shall perform annual criminal record and registry checks as established in subsection (1) of this section on a random sample of at least twenty-five (25) percent of all personnel.
(4) A personnel record shall be kept on each staff member and shall contain:
(a) Name and address;
(b) Verification of all training and experience, including licensure, certification, registration, or renewals;
(c) Verification of submission to the background check requirements of subsections (1), (2), and (3) of this section;
(d) Performance appraisals conducted no less than annually; and
(e) Employee incident reports.
Section 7. Quality Assurance and Utilization Review.
(1) The residential crisis stabilization unit shall have a quality assurance and utilization review program designed to:
(a) Enhance treatment and care through the ongoing objective assessment of services provided, including the correction of identified problems; and
(b) Provide an effective mechanism for review and evaluation of the service needs of each client.
(2) The need for continuing services shall be evaluated immediately upon a change in a client's service needs or a change in the client's condition to ensure that proper arrangements have been made for:
(a) Discharge;
(b) Transfer; or
(c) Referral to another service provider, if appropriate.
Section 8. Client Grievance Policy. The residential crisis stabilization unit shall have written policies and procedures governing client grievances, which shall include:
(1) A process for filing a written client grievance;
(2) An appeals process with time frames for filing and responding to a grievance in writing;
(3) Protection for a client from interference, coercion, discrimination, or reprisal; and
(4) Conspicuous posting of the grievance procedures in a public area to inform a client of:
(a) His or her right to file a grievance;
(b) The process for filing a grievance; and
(c) The address and telephone number of the cabinet's ombudsman.
Section 9. Services and Staffing.
(1) An entity licensed under this administrative regulation to operate a residential crisis stabilization unit shall provide:
(a) Screening as established by 907 KAR 15:070, Section 3(2)(a);
(b) Assessment as established by 907 KAR 15:070, Section 3(2)(b);
(c) Service planning as established by 907 KAR 15:070, Section 3(2)(e);
(d) Individual therapy as established by 907 KAR 15:070, Section 3(2)(c);
(e) Group therapy as established by 907 KAR 15:070, Section 3(2)(d); and
(f) Psychiatric services.
(2) An entity licensed under this administrative regulation to operate a residential crisis stabilization unit may provide:
(a) Family therapy as established by 907 KAR 15:070, Section 3(2)(f);
(b) Peer support by a peer support specialist as established by 907 KAR 15:070, Section 3(2)(g); or
(c) Medication assisted treatment, excluding methadone-based treatment, as established by 907 KAR 15:070, Section 3(2)(i).
(3)
(a) Except as provided by paragraph (b) of this subsection, the services identified in subsection (1) and (2)(a) of this section shall be delivered by a behavioral health professional or a behavioral health professional under clinical supervision.
(b) In addition to the professionals identified in paragraph (a) of this subsection, the services identified in subsection (1)(a), (b), (d), and (e) and subsection (2)(a) of this section may be provided by a certified alcohol and drug counselor or licensed clinical alcohol and drug counselor.
(c)
-
A residential crisis stabilization unit shall have access to a board-certified or board-eligible psychiatrist twenty-four (24) hours per day, seven (7) days per week.
-
The psychiatrist may serve more than one (1) residential crisis stabilization unit and be available through telehealth consultation.
(d) The psychiatrist shall be available to evaluate, provide treatment, and participate in treatment planning.
(4) If a crisis stabilization program serves adults with a severe mental illness or substance use disorder and children with severe emotional disabilities:
(a) The programs shall not be located on the same campus; and
(b) The children's program shall serve clients:
-
Under the age of eighteen (18); or
-
Up to the age of twenty-one (21) if developmentally appropriate for the client.
(5) A residential crisis stabilization unit shall:
(a) Provide treatment for acute withdrawal as established by 907 KAR 15:070, Section 3(2)(h), if appropriate;
(b) Complete a mental status evaluation and physical health questionnaire of the client upon admission;
(c) Have written policies and procedures for:
-
Crisis intervention; and
-
Discharge planning, which shall begin at the time of admission and aftercare planning processes;
(d) Make referrals for physical health services to include diagnosis, treatment, and consultation for acute or chronic illnesses occurring during the client's stay in the residential crisis stabilization unit or identified during the admission assessment;
(e) Have a description of linkages with behavioral health services organizations licensed under 902 KAR 20:430 or other programs, including entities licensed as an AODE, that:
-
Address identified needs and achieve goals specified in the treatment plan; and
-
Help promote continuity of care after discharge;
(f) Have at least one (1) direct-care staff member assigned direct-care responsibility for:
-
Every four (4) clients during normal waking hours; and
-
Every six (6) clients during normal sleeping hours;
(g) Ensure that administrative management of the unit is provided by the unit's executive director;
(h) Provide a training program for direct-care staff pertaining to:
-
The care of clients in a residential crisis stabilization unit;
-
Detection and reporting of abuse, neglect, or exploitation;
-
Emergency and safety procedures;
-
Behavior management, including de-escalation training;
-
Physical management procedures and techniques;
-
Suicide prevention and care; and
-
Trauma informed care; and
(i) Assure that each client shall be:
-
In need of short-term behavior management and at risk of placement in a higher level of care;
-
Able to take care of his or her own personal needs, if an adult;
-
Medically able to participate in services; and
-
Served in the least restrictive environment available in the community.
(6) If providing treatment for acute withdrawal in accordance with subsection (5) of this section, a residential crisis stabilization unit shall:
(a) Meet the requirements established by 907 KAR 15:070, Section 2(1)(r); and
(b) Possess an appropriate level of care certification as established by 907 KAR 15:070, Section 3(6).
Section 10. Client Records.
(1) A client record shall be maintained for each individual receiving services.
(2) Each entry shall be current, dated, signed, and indexed according to the service received.
(3) Each client record shall contain:
(a) An identification sheet, including the client's name, address, date of birth, gender, marital status, expected source of payment, and referral source;
(b) Information on the purpose for seeking a service;
(c) If applicable, consent via signature of an appropriate family member or guardian for admission, evaluation, and treatment;
(d) Mental status evaluation and physical health questionnaire of the client taken upon admission;
(e) Staff notes for all services provided;
(f) Documentation of treatment planning, including diagnosis and all services to be provided; and
(g) Documentation of medication prescribing and monitoring used in treatment.
(4) Ownership.
(a) Client records shall be the property of the residential crisis stabilization unit.
(b) The original client record shall not be removed from the unit except by court order or subpoena.
(c) Copies of a client record or portions of the record may be used and disclosed. Use and disclosure shall be as established by subsection (6) of this section.
(5) Retention of records. After a client's death or discharge, the completed client record shall be placed in an inactive file and be retained for at least the longer of:
(a) Six (6) years; or
(b) If a minor, three (3) years after the client reaches the age of majority pursuant to KRS 2.015.
(6) Confidentiality and Security: Use and Disclosure.
(a) The residential crisis stabilization unit shall maintain the confidentiality and security of client records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, including the security requirements mandated by 45 C.F.R. Part 164, Subparts A and C, or as provided by applicable federal or state law, including 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(b) The residential crisis stabilization unit may use and disclose client records. Use and disclosure shall be as established or required by:
-
HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164; or
-
42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
(c) A residential crisis stabilization unit may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, or 42 U.S.C. 290ee-3, and the Confidentiality of Alcohol and Drug Abuse Patient Records, 42 C.F.R. Part 2.
Section 11. Client Rights.
(1) A residential crisis stabilization unit shall have written policies and procedures to ensure that the rights of a client are protected, including a statement of rights and responsibilities, which shall be:
(a) Provided at the time of admission:
-
To the client; or
-
If the client is a minor or incapacitated, to the client, client's parent, guardian, or other legal representative;
(b) Read to the client or client's parent, guardian, or other legal representative if requested or if either cannot read;
(c) Written in language that is understandable to the client;
(d) Conspicuously posted in a public area of the facility; and
(e) Cover the:
-
Right to treatment, regardless of race, religion, or ethnicity;
-
Right to recognition and respect of personal dignity in the provision of all treatment and care;
-
Right to be provided treatment and care in the least restrictive environment possible;
-
Right to an individualized plan of care;
-
Right of the client, including the client's parent, guardian, or other legal representative if the client is a minor or incapacitated, to participate in treatment planning;
-
Nature of care, procedures, and treatment provided;
-
Right to an explanation of risks, side effects, and benefits of all medications and treatment procedures used;
-
Right to be free from verbal, sexual, physical, or mental abuse; and
-
Right, to the extent permitted by law, to refuse the specific medications or treatment procedures and the responsibility of the facility if the client refuses treatment, to seek appropriate legal alternatives or orders of involuntary treatment, or in accordance with professional standards, to terminate the relationship with the client upon reasonable notice.
(2) A residential crisis stabilization unit's written policies and procedures concerning client rights shall assure and protect the client's personal privacy within the constraints of his or her plan of care, including:
(a) Visitation by family or significant others in a suitable area of the facility; and
(b) Telephone communications with family or significant others at a reasonable frequency.
(3)
(a) If a privacy right is limited, a full explanation shall be given to the client or the client's parent, guardian, or other legal representative if the client is a minor or incapacitated.
(b) Documentation shall be included in the client's record of any privacy limitation.
(4) Information shall be provided to the client, or the client's parent, guardian, or other legal representative if the client is a minor or incapacitated, regarding the use and disposition of special observation and audio visual techniques, which may include:
(a) One (1) way vision mirror;
(b) Audio recording;
(c) Video tape recording;
(d) Television;
(e) Movie; or
(f) Photographs.
(5)
(a) If the residential crisis stabilization unit serves children as established in Section 9(4)(b) of this administrative regulation, written policy and procedures shall be developed in consultation with professional and direct-care staff to provide for behavior management of residents, including the use of a time-out room.
(b)
- Behavior management techniques:
a. Shall be explained fully to each client and, if the client is a minor or incapacitated, the client's parent, guardian, or other legal representative; and
b. May include time out or personal restraint.
- Prone holds, chemical restraint, and mechanical restraint shall be prohibited in a residential crisis stabilization unit.
(c) The unit shall prohibit cruel and unusual disciplinary measures including:
-
Corporal punishment;
-
Forced physical exercise;
-
Forced fixed body positions;
-
Group punishment for individual actions;
-
Verbal abuse, ridicule, or humiliation;
-
Denial of three (3) balanced nutritional meals per day;
-
Denial of clothing, shelter, bedding, or personal hygiene needs;
-
Denial of access to educational services;
-
Denial of visitation, mail, or phone privileges for punishment;
-
Exclusion of the resident from entry to his or her assigned living unit; and
-
Personal restraint or seclusion as a punishment or employed for the convenience of staff.
(d) Written policy shall prohibit residents from administering disciplinary measures upon one another and shall prohibit persons other than professional or direct-care staff from administering disciplinary measures to residents.
(6) If personal restraint is used as a safe behavioral management technique, the residential crisis stabilization unit shall have a policy that shall:
(a) Establish criteria for appropriate use of personal restraint;
(b) Establish documentation requirements; and
(c) Ensure that staff who implement the use of personal restraint shall:
-
Have documented training in the proper use of the procedure used;
-
Be certified in physical management by a nationally-recognized training program in which certification is obtained through skilled-out testing; and
-
Receive annual training and recertification in crisis intervention and behavior management.
Section 12. Reports of Abuse, Neglect, or Exploitation.
(1) A residential crisis stabilization unit shall have written policies that assure:
(a) The reporting of cases of abuse, neglect, or exploitation of adults and children to the cabinet pursuant to KRS Chapters 209 and 620; and
(b) That a resident may file a complaint with the cabinet concerning resident abuse, neglect, or exploitation.
(2) The unit shall have evidence that all allegations of abuse, neglect, or exploitation are thoroughly investigated internally and shall prevent further potential abuse while the investigation is in progress.
Section 13. Medication Prescribing and Monitoring in a Residential Crisis Stabilization Unit.
(1) Medication prescribing and monitoring shall be under the direction of a licensed psychiatrist, a licensed physician supervised by a psychiatrist, or an APRN certified in psychiatric-mental health nursing practice who meets the requirements established in 201 KAR 20:057.
(2) Prescriptions concerning medication shall not exceed an order for more than five (5) refills.
(3) Medication prescribing and monitoring used in treatment shall be recorded in the staff notes and on a special medications chart in the client record.
(4) A copy of the prescription shall be kept in the client record.
(5) A blood or other laboratory test or examination shall be performed in accordance with accepted medical practice on each client receiving medication prescribed or administered by the residential crisis stabilization unit staff.
(6) Drug supplies shall be stored under proper sanitary, temperature, light, and moisture conditions.
(7) Medication kept by the unit shall be properly labeled.
(8) A medication shall be stored in the originally received container unless transferred to another container by a pharmacist or another person licensed to transfer the medication.
(9) Medication kept in the unit shall be kept in a locked cabinet.
(10) A controlled substance shall be kept under double lock (for example, in a locked box in a locked cabinet).
(11) There shall be a controlled substances record, in which is recorded:
(a) The name of the client;
(b) The date, time, dosage, balance remaining, and method of administration of each controlled substance;
(c) The name of the prescribing physician or other ordering practitioner acting within the scope of his or her license to practice; and
(d) The name of the nurse who administered it or staff who supervised the self-administration.
(12) Access to the locked cabinet shall be restricted to a designated medication nurse or other authorized personnel.
(13) Medication to be self-administered shall be made available to the client at the time of administration.
Section 14. Facility Requirements.
(1) Living Unit. A living unit shall be located within a single building in which there is at least 120 square feet of space for each resident in the facility.
(2) Bedrooms.
(a) More than four (4) clients shall not sleep in the same bedroom.
(b) A bedroom shall be equipped with a bed for each client.
(c) A bed shall:
-
Be at least thirty-six (36) inches wide and at least five (5) feet in length;
-
Be long and wide enough to accommodate the client's size;
-
Have a mattress cover, two (2) sheets, a pillow, and bed covering to keep the client comfortable;
-
Be equipped with a support mechanism and a clean mattress; and
-
Be placed so that a client shall not experience discomfort because of proximity to a radiator or heat outlet, or exposure to a draft.
(d) There shall be separate sleeping quarters for males and females.
(e) A client shall not be housed in a room, a detached building, or other enclosure that has not previously been inspected and approved for residential use by the Office of Inspector General and the Department of Housing, Buildings and Construction.
(3) Bathrooms.
(a) For every eight (8) residents, each residential crisis stabilization unit shall have at least one (1):
-
Wash basin with hot and cold water;
-
Bath or shower with hot and cold water; and
-
Flush toilet.
(b) If separate toilet and bathing facilities are not provided, males and females shall not be permitted to use those facilities at the same time.
(4) Living area.
(a) The living area shall provide comfortable seating for all clients housed within the residential crisis stabilization unit.
(b) Each living unit shall be equipped with a:
-
Working sink; and
-
Stove and refrigerator, unless a kitchen is directly available within the same building as the living unit.
(5) There shall be adequate lighting, heating, heated water, and ventilation.
(6) There shall be space for a client to store personal belongings, including a receptacle where personal property may be stored and locked.
(7) The residential crisis stabilization unit shall be kept in good repair, neat, clean, free from accumulations of dirt and rubbish, and free from foul, stale, and musty odors.
(8) The residential crisis stabilization unit shall be kept free from insects and rodents with their harborages eliminated.
(9) The residential crisis stabilization unit shall establish an infection control system that includes training personnel on proper hygiene related to infections prevalent among alcohol and other drug abusers.
(10) Services shall be provided in an area where clients are ensured privacy and confidentiality.
Section 15. Facility Specifications.
(1) A residential crisis stabilization unit shall:
(a) Be of safe and substantial construction;
(b) Be in compliance with applicable state and local laws relating to zoning, construction, plumbing, safety, and sanitation;
(c) Be approved by the State Fire Marshal's office prior to initial licensure or if the unit changes location; and
(d) Meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities pursuant to KRS 198B.260 and 815 KAR 7:120.
(2) A residential crisis stabilization unit shall:
(a) Have a written emergency plan and procedures for meeting potential disasters such as fires or severe weather;
(b) Post the emergency plan conspicuously in a public area of the unit and provide a copy to all personnel;
(c) Provide training for all personnel on how to report a fire, extinguish a small fire, and evacuate a building; and
(d) Practice fire drills monthly, with a written record kept of all practiced fire drills, detailing the date, time, and residents who participated.
Section 16. Denial and Revocation.
(1) The cabinet shall deny an Application for License to Operate a Residential Crisis Stabilization Unit if:
(a) Any person with ownership interest in the residential crisis stabilization unit has had previous ownership interest in a health care facility that had its license revoked or voluntarily relinquished its license as the result of an investigation or pending disciplinary action;
(b) Any person with ownership interest in the residential crisis stabilization unit has been discontinued from participation in the Medicaid Program due to fraud or abuse of the program; or
(c) The applicant fails after the initial inspection to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13).
(2) The cabinet shall revoke a license if it finds that:
(a) In accordance with KRS 216B.105(2), there has been a substantial failure by the residential crisis stabilization unit to comply with the provisions of this administrative regulation;
(b) The residential crisis stabilization unit fails to submit an acceptable plan of correction or fails to submit an acceptable amended plan of correction within the timeframes required by 902 KAR 20:008, Section 2(13); or
(c) The residential crisis stabilization unit is terminated from participation in the Medicaid Program pursuant to 907 KAR 1:671.
(3) The denial or revocation of a residential crisis stabilization unit's license shall be mailed to the applicant or licensee, by certified mail, return receipt requested, or by personal service. Notice of the denial or revocation shall state the particular reasons for the action.
(4) The denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee, within the thirty (30) day period, files a request in writing for a hearing with the cabinet.
(5) Urgent action to suspend a license.
(a) The cabinet shall take urgent action to suspend a residential crisis stabilization unit's license if the cabinet has probable cause to believe that the continued operation of the unit would constitute an immediate danger to the health, welfare, or safety of its residents.
(b)
-
The residential crisis stabilization unit shall be served with notice of the hearing on the urgent suspension to be held no sooner than twenty (20) days from the delivery of the notice.
-
Notice of the urgent suspension shall state the particular reasons for the action.
(6) Notice of a hearing on an urgent suspension shall be served on the residential crisis stabilization unit by certified mail, return receipt requested, or by personal service.
(7)
(a) Within five (5) working days of completion of the hearing, the cabinet's hearing officer shall render a written decision affirming, modifying, or revoking the urgent suspension.
(b) The urgent suspension shall be affirmed if there is substantial evidence of an immediate danger to the health, safety, or welfare of the residents.
(8) The decision rendered under subsection (7) of this section shall be a final order of the agency on the matter, and any party aggrieved by the decision may appeal to circuit court.
(9) If the cabinet issues an urgent suspension, the cabinet shall take action to revoke the residential crisis stabilization unit's license pursuant to subsection (3) of this section if:
(a) The facility fails to attend the expedited hearing; or
(b) The decision rendered under subsection (7) of this section affirms that there is substantial evidence of an immediate danger to the health, safety, or welfare of the residents.
(10) Pursuant to KRS 216B.050, the cabinet may compel obedience to its lawful orders.
Section 17. Incorporation by Reference.
(1) The OIG 20:440, "Application for License to Operate a Residential Crisis Stabilization Unit", October 2014 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 17.500, 200.503(2), 210.005, 216B.050, 216B.105(2), 309.080(4), 309.0831, 309.130(2), 311.571, 311.840 – 311.862, 314.042, 319.050, 319.056, 319.064, 319C.010, 335.080, 335.100, 335.300, 335.500, 439.3401, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 – 1320d-8, 42 U.S.C. 209ee-3, 42 C.F.R. Part 2
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of residential crisis stabilization units that serve at-risk children or children with severe emotional disabilities, at-risk adults or adults with severe mental illness, or individuals with substance use disorder or co-occurring disorders.
- History: 41 Ky.R. 351; Am. 1114; eff. 1355; eff. 12-17-2014; 47 Ky.R. 1114, 1760, 1989; eff. 6-16-2021.
902 KAR 20:450 Ambulatory infusion agencies {#sec-902-kar-20-450 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:450}
Section 1. Definitions.
(1) "Ambulatory infusion center" means an outpatient treatment center that provides infusion therapy services, excluding an off-campus, Kentucky-hospital owned center or service that meets the licensing exemption criteria of 900 KAR 6:130, Section 3(3).
(2) "Home" means a place of residence used as the home of an individual, including an institution that is used as a home. An institution used as a home shall not include a:
(a) Hospital, including critical access hospital; or
(b) Long-term care facility defined by KRS 216.510(1).
(3) "Infusion drug" means a parenteral drug or biological administered intravenously, or subcutaneously for an administration period of fifteen (15) minutes or more, in the patient's home or in an ambulatory infusion center through:
(a) An injection; or
(b) A pump that is an item of durable medical equipment, excluding:
-
An insulin pump system; or
-
A self-administered drug or biological on a self-administered drug exclusion list.
(4) "Infusion therapy services" means the preparation, administration, or furnishing of parenteral medications, parenteral nutritional services, or administration of drugs intrathecally to an individual in:
(a) The individual's home; or
(b) An ambulatory infusion center.
Section 2. Licensure Application and Fees.
(1) An applicant for an initial, provisional license or annual renewal as an ambulatory infusion agency shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate an Ambulatory Infusion Agency; and
(b) An accompanying fee in the amount of $500, made payable to the Kentucky State Treasurer.
(2)
(a) Name change. An ambulatory infusion agency shall:
-
Notify the Office of Inspector General in writing within ten (10) calendar days of the effective date of a change in the agency's name; and
-
Submit a processing fee of twenty-five (25) dollars.
(b) Change of location. An ambulatory infusion agency shall not change the location where a facility is operated until an Application for License to Operate an Ambulatory Infusion Agency accompanied by a fee of $100 is filed with the Office of Inspector General.
(c) Change of ownership.
-
The new owner of an agency shall submit to the Office of Inspector General an Application for License to Operate an Ambulatory Infusion Agency accompanied by a fee of $500 within ten (10) calendar days of the effective date of the ownership change.
-
A change of ownership for a license shall be deemed to occur if more than twenty-five (25) percent of an existing ambulatory infusion agency or capital stock or voting rights of a corporation is purchased, leased, or otherwise acquired by one (1) person from another.
(3) An extension site location shall not be allowed for any entity licensed under this administrative regulation.
(4) An ambulatory infusion agency shall have an office location in Kentucky.
Section 3. Scope of Operation and Services.
(1) A licensee:
(a) Shall furnish infusion therapy services to an individual with an acute or chronic condition that requires administration of infusion drugs in the home or an ambulatory infusion center;
(b) Shall ensure the safe and effective provision and administration of infusion therapy services on a seven (7) day-a-week, twenty-four (24) hour-a-day basis, if provided in the patient's home;
(c) Shall be accredited by a national accrediting organization that meets the requirements of 42 C.F.R. 488.1000 to 488.1050 within one (1) year of initial, provisional licensure;
(d) Shall ensure that each patient's plan of care is established by a physician, or other prescribing practitioner as authorized under the practitioner's scope of practice, who shall be responsible for:
-
Prescribing the type, amount, and duration of the infusion therapy services that are to be furnished; and
-
Review of each patient's plan of care:
a. At least every thirty (30) days; or
b. As often as deemed necessary in accordance with the physician or prescribing practitioner's order on file in the patient's medical record;
(e) Shall provide the skilled nursing services component of infusion therapy services in accordance with the patient's plan of care, including:
-
Clinical notes that shall be signed, recorded, and incorporated in the patient's medical record within three (3) working days of providing the service;
-
Notifying the pharmacist, prescribing practitioner, and applicable agency staff regarding any significant change in the patient's condition; and
-
Patient education and monitoring; and
(f) May provide other professional services in addition to the skilled nursing services component, such as pharmacy services or durable medical equipment required for the delivery of infusion therapy services.
(2)
(a) If an ambulatory infusion agency has not obtained accreditation in accordance with subsection (1)(c) of this section within one (1) year of initial licensure, the agency may request an extension to complete the accreditation process.
(b) A request for extension shall:
-
Be submitted in writing to the Office of Inspector General at least sixty (60) days prior to the date of annual renewal;
-
Include evidence that the agency has initiated the process of becoming accredited within sixty (60) days of initial, provisional licensure and is continuing its efforts to obtain accreditation; and
-
Include an estimated timeframe by which approval of accreditation is anticipated, not to exceed two (2) years from the date of initial, provisional licensure.
(3) A licensee's provisional licensure status shall end on the date that the agency obtains accreditation.
(4) Proof of accreditation shall be provided to the Office of Inspector General:
(a) Upon receiving accreditation; and
(b) At the time of annual renewal.
(5) If an ambulatory infusion agency loses its accreditation or becomes accredited by a different accrediting organization, the licensee shall notify the Office of Inspector General no later than thirty (30) days from the date that:
(a) The licensee's accreditation was terminated; or
(b) Accreditation by a different organization that meets the requirements of 42 C.F.R. 488.1000 to 488.1050 took effect.
(6) The cabinet shall revoke a license if an ambulatory infusion agency fails to meet one (1) of the following requirements:
(a) Become accredited in accordance with subsection (1)(c) of this section;
(b) Request an extension in accordance with subsection (2) of this section;
(c) Achieve accreditation within two (2) years from the date of initial, provisional licensure if a request for extension is submitted; or
(d) Maintain accreditation.
Section 4. Inspections.
(1) If an ambulatory infusion agency demonstrates evidence of full accreditation, the annual renewal process shall not require an on-site survey by the cabinet.
(2) Nothing in this administrative regulation shall prevent the cabinet from:
(a) Conducting an investigation related to a complaint; or
(b) Making an on-site survey of a fully accredited ambulatory infusion agency if the cabinet deems necessary.
Section 5. Administration and Operation.
(1) Licensee. The licensee shall be legally responsible for:
(a) The operation of the ambulatory infusion agency;
(b) Ensuring compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the agency;
(c) Designating an administrator who shall be responsible for the daily operation of the agency;
(d) Establishing and implementing written administrative policies covering all aspects of operation, including:
-
A description of the agency's organizational structure, staffing, and allocation of responsibility and accountability;
-
Procedures for the evaluation of personnel performance; and
-
A narrative describing in detail:
a. The services offered by the agency; and
b. Qualifications of personnel involved in the delivery of services, including verification that each nurse employed directly or by contract has a license in good standing from the Kentucky Board of Nursing;
(e) Establishing procedures for the handling and administration of drugs and biologicals;
(f) Developing written infection control policies that are consistent with Centers for Disease Control guidelines, available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf, including:
-
Prevention of disease transmission; and
-
Cleaning, disinfection, and sterilization methods used for equipment and the environment; and
(g) Establishing guidelines to ensure the coordination of treatment with other health facilities and practitioners that deliver services to patients of the agency.
(2) Background checks. All owners and agency personnel in a position that involves providing direct services shall:
(a) Have a criminal record check performed upon initial hire through the Administrative Office of the Courts or the Kentucky State Police;
(b) Not have a criminal conviction, or plea of guilty, to a:
-
Sex crime as specified in KRS 17.500(8);
-
Violent crime as specified in KRS 439.3401;
-
Felony offense related to:
a. Theft;
b. Abuse, possession, or sale of illegal drugs; or
c. Abuse, neglect, or exploitation of a child or an adult; or
- Misdemeanor offense related to abuse, neglect, or exploitation of a child or an adult; and
(c) Not be listed on the following:
-
Central registry established by 922 KAR 1:470;
-
Nurse aide or home health aide abuse registry established by 906 KAR 1:100; or
-
Caregiver misconduct registry established by 922 KAR 5:120.
(3) Personnel record. A personnel record shall be kept on each staff member and shall contain the following items:
(a) Name and address;
(b) Verification of all training and experience, including documentation of the employee's professional licensure status, if applicable;
(c) Verification of submission to the background check requirements of subsection (2) of this section;
(d) Annual performance appraisals; and
(e) Employee incident reports.
Section 6. Patient records.
(1) Ownership.
(a) Medical records shall be the property of the ambulatory infusion agency.
(b) The original medical record shall not be removed except by court order.
(c) Copies of medical records or portions thereof may be used and disclosed in accordance with the requirements established in this administrative regulation.
(2) Confidentiality and Security: Use and Disclosure.
(a) The agency shall maintain the confidentiality and security of patient records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
(b) The agency may use and disclose patient records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
(c) An ambulatory infusion agency may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(d) Retention of records. After a patient's death or discharge, the completed medical record shall be placed in an inactive file and retained for at least:
-
Six (6) years; or
-
Three (3) years after the patient reaches the age of majority in accordance with KRS 2.015, whichever is longer.
(3) The agency shall:
(a) Designate a specific location for the maintenance and storage of the agency's medical records;
(b) Have provisions for storage of medical records in the event the agency ceases to operate; and
(c) Safeguard the record and its content against loss, defacement, or tampering.
Section 7. Incorporation by Reference.
(1) The form, OIG 008, "Application for License to Operate an Ambulatory Infusion Agency", September 2019 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 17.500(8), 216B.042, 439.3401, 42 C.F.R. 486.500–486.525, 42 C.F.R. 488.1000–488.1050, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2–1320d-8
- STATUTORY AUTHORITY: KRS 216B.042
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of ambulatory infusion agencies that provide infusion therapy services in a patient's home or in an ambulatory infusion center.
- History: 46 Ky.R. 2281; eff. 2-27-2020; TAm eff. 3-202-2020.
902 KAR 20:470 Kentucky heart attack response and treatment recognition process {#sec-902-kar-20-470 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:470}
Section 1. Definition. "Department" is defined by KRS 211.340.
Section 2. Hospital Level of Heart Attack Response and Treatment Recognition.
(1) A hospital seeking recognition in the statewide system for heart attack response and treatment shall complete and submit to the department the Step-by-Step Guide for Recognition in the Kentucky Statewide System for Heart Attack Response and Treatment.
(2) The application shall include a copy of the hospital's approval documentation from a nationally recognized guidelines-based organization that provides certification or accreditation for heart attack response and treatment, and that includes the:
(a) Name of the certifying or accrediting organization;
(b) Type of certification or accreditation received;
(c) Date of certification or accreditation; and
(d) Expiration date of certification or accreditation.
(3) A hospital's application for recognition in the statewide system for heart attack response and treatment by the department is voluntary.
(4) Upon receipt of the information required by subsection (2) of this section, the department shall list the hospital according to the designated level of cardiac care.
(5) A recognized hospital shall annually verify continuation ofcertification or accreditation by a nationally recognized guidelines-based organization.
(6) A hospital that has obtained a state certificate of need for percutaneous coronary intervention or open-heart surgery may submit an application for recognition in the statewide system for heart attack response and treatment. The application shall include:
(a) A copy of the hospital's accreditation by a nationally recognized organization; and
(b) Evidence of the approved certificate of need.
Section 3. Revocation of Recognition.
(1) A recognized hospital that is unable to maintain current designation as a Level I Comprehensive Cardiac Center, Level II Primary Heart Attack Center, or Level III Acute Heart Attack Ready in accordance with KRS 211.341 shall notify the department within twenty (20) business days of knowledge they will not be maintaining their current designation.
(2) If the department becomes aware of a significant change in the status of the hospital that may potentially affect recognition status, the department may request confirmation of current certification or accreditation from the hospital.
(3) If the hospital is unable to provide the documentation requested, the department may revoke the hospital's recognition.
(4) If the recognition is revoked, the hospital may reapply for recognition by providing the information required by Section 2 of this administrative regulation.
(5) Following the re-application required by subsection (4) of this section, the department shall reinstate the recognition.
Section 4. Incorporation by Reference.
(1) The "Step-by-Step Guide for Recognition in the Kentucky Statewide System for Heart Attack Response and Treatment," 1/2023, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissioner's Office, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. and is available at https://chfs.ky.gov/agencies/dph/dpqi/cdpb/Pages/heartdiseasestroke.aspx.
History
- RELATES TO: KRS 211.340, 211.341, 211.342, 211.343
- STATUTORY AUTHORITY: KRS 194A.050, 211.343
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.343 requires the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide system for heart attack response and treatment by recognizing licensed hospitals according to an assigned level of cardiac care, and to establish and implement a plan for achieving continuous quality improvement in the quality of care provided under a statewide system for heart attack response and treatment. This administrative regulation establishes the hospital recognition process for Kentucky's cardiac care system.
- History: 49 Ky.R.219, 1807; eff. 6-21-2023.
902 KAR 20:480 Assisted living communities {#sec-902-kar-20-480 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:480}
Section 1. Definitions.
(1) "Activities of daily living" is defined by KRS 194A.700(1).
(2) "Ambulatory" is defined by KRS 194A.700(2).
(3) "Assistance with activities of daily living and instrumental activities of daily living" is defined by KRS 194A.700(3).
(4) "Assistance with self-administration of medication" is defined by KRS 194A.700(4).
(5) "Assisted living community" is defined by KRS 194A.700(5).
(6) "Assisted living community with dementia care" is defined by KRS 194A.700(6).
(7) "Assisted living services" is defined by KRS 194A.700(7).
(8) "Basic health and health-related services" is defined by KRS 194A.700(8).
(9) "Dementia" is defined by KRS 194A.700(10).
(10) "Dementia care services" is defined by KRS 194A.700(11).
(11) "Dementia-trained staff" is defined by KRS 194A.700(12).
(12) "Direct care service" is defined by KRS 216.718(4).
(13) "Hands-on assistance" is defined by KRS 194A.700(13).
(14) "Health facility" is defined by KRS 216B.015(13) to include assisted living communities.
(15) " Immediate family member" means a:
(a) Spouse;
(b) Child;
(c) Stepchild;
(d) Son-in-law;
(e) Daughter-in-law; or
(f) Grandchild.
(16) "Instrumental activities of daily living" is defined by KRS 194A.700(15).
(17) "Legal representative" means a person legally responsible for representing or standing in the place of the resident to conduct the resident's affairs.
(18) "Licensed health professional" means a person who:
(a) Possesses a current Kentucky license or multistate licensure privilege to practice in Kentucky; and
(b) Provides services to ALC-BH or ALC-DC residents, including the delegation of tasks pursuant to KRS 194A.700(7)(h) as authorized under the professional's scope of practice.
(19) "Living unit" is defined by KRS 194A.700(16).
(20) "Managing agent" means an individual or legal entity designated by the licensee through a management agreement to act on behalf of the licensee in the on-site management of the assisted living community.
(21) "Medication administration" is defined by KRS 194A.700(17).
(22) "Medication management" is defined by KRS 194A.700(18).
(23) "Medication reconciliation" means the process of identifying the most accurate list of all medications the resident is taking, including the name, dosage, frequency, and route, by comparing the resident record to an external list of medications obtained from the resident, hospital, prescriber, or other provider.
(24) "Medication setup" is defined by KRS 194A.700(19).
(25) "Nurse" is defined by KRS 314.011(3).
(26) "Nursing task" is defined by 201 KAR 20:400, Section 1(11).
(27) "Person-centered care" is defined by KRS 194A.700(21).
(28) "PRN" means as needed.
(29) "Quality management activity" means evaluating the quality of care by:
(a) Reviewing resident services, complaints made, and other issues that have occurred; and
(b) Determining if changes in services, staffing, or other procedures need to be made to ensure safe and competent services to residents.
(30) "Resident" is defined by KRS 194A.700(22).
(31) "Secured dementia care unit" is defined by KRS 194A.700(23).
(32) "Service plan" is defined by KRS 194A.700(24).
(33) "Significant financial interest" means the lawful ownership of an out-of-state or a Kentucky-licensed health facility or health service, or other entity regulated by the cabinet, whether by share, contribution, or otherwise, in an amount equal to or greater than twenty-five (25) percent of total ownership of the out-of-state or Kentucky-licensed health facility or health service, or other cabinet-regulated entity.
(34) "Temporary condition" is defined by KRS 194A.700(26).
(35) "Unlicensed personnel" is defined by KRS 194A.700(27).
(36) "Volunteer":
(a) Means a person who has duties that are equivalent to the duties of an employee providing direct care services and the duties involve, or might involve, one-on-one contact with a resident; and
(b) Does not mean a member of a community-based or faith-based organization or group that provides volunteer services that do not involve unsupervised interaction with a resident.
Section 2. Licensure Categories.
(1) The licensure categories established by this administrative regulation shall include:
(a) A social model assisted living community (ALC) license for any facility that provides assisted living services, excluding basic health and health-related services;
(b) An assisted living community with basic health care (ALC-BH) license for any facility that:
-
Provides assisted living services, including basic health and health-related services directly to its residents; and
-
Does not have a secured dementia care unit; and
(c) An ALC with dementia care (ALC-DC) license for any facility that provides assisted living services and dementia care services in a secured dementia unit.
(2) In accordance with KRS 194A.710(3), a license issued under this administrative regulation shall not be assignable or transferable.
(3) In accordance with KRS 194A.704, a personal care home that is in substantial compliance with KRS 194A.703 shall convert its license to an ALC-BH or ALC-DC license, if applicable, by submitting the application, accompanying documentation, and fee required by Section 3(2) of this administrative regulation at least sixty (60) days prior to the date of annual renewal of the facility's personal care home license.
Section 3. Licensure Application and Fees.
(1) In accordance with KRS 216B.020(1), an ALC, ALC-BH, or ALC-DC shall be exempt from certificate of need.
(2) An applicant for a provisional, initial license or annual renewal as an ALC, ALC-BH, or ALC-DC shall submit to the Office of Inspector General:
(a) A completed Application for License to Operate an Assisted Living Community at least sixty (60) days prior to the:
-
Planned opening; or
-
Annual renewal date;
(b) Proof of approval by the State Fire Marshal's office;
(c) A copy of a blank lease agreement that includes the elements required by KRS 194A.713 and any documentation incorporated in the agreement;
(d) An organizational chart that identifies all entities and individuals with a significant financial interest in the prospective or existing licensee, including the relationship with the licensee and with each other;
(e) A description of any special programming that may be provided in accordance with KRS 194A.713(11);
(f) If applying for a provisional, initial license, or if changes have been made since the date of the previous renewal, a copy of the facility's floor plan that shall identify the:
-
Living units, including features that meet the requirements of KRS 194A.703(1);
-
Central dining area;
-
Laundry facility; and
-
Central living room;
(g) If in the preceding seven (7) years any individual with a significant financial interest in the entity seeking initial licensure or renewal as an ALC, ALC-BH, or ALC-DC had a significant financial interest in an out-of-state or a Kentucky-licensed health facility or health service, or other entity regulated by the cabinet, that had its license or certificate to operate denied, suspended, revoked, or voluntarily relinquished as the result of an investigation or adverse action that placed patients, residents, or clients at risk of death or serious harm;
(h)
- A copy of the applicant's compliance history for any other care facility the applicant operates if applying for a provisional, initial license as an:
a. ALC or ALC-BH; or
b. ALC-DC that did not have a dementia unit in operation prior to July 14, 2022.
- Documentation of the applicant's compliance history, including a copy of all enforcement action issued by the regulatory agency against the care facility including violations, fines, or negative action against the facility's license during the seven (7) year period prior to application for a provisional, initial license; and
(i) A nonrefundable fee made payable to the Kentucky State Treasurer in accordance with the fee schedule established in this paragraph.
(3)
(a) Name change. An ALC, ALC-BH, or ALC-DC shall:
-
Notify the Office of Inspector General in writing within ten (10) calendar days of the effective date of a change in the facility's name; and
-
Submit a processing fee of twenty-five (25) dollars.
(b) Change of location. An ALC, ALC-BH, or ALC-DC shall not change the location of the facility until an Application for License to Operate an Assisted Living Community accompanied by the documentation and fees required by subsection (2)(i) of this section have been submitted to the Office of Inspector General.
(c) Change in number of living units.
- An ALC, ALC-BH, or ALC-DC shall submit an Application for Licensure to Operate an Assisted Living Community to the Office of Inspector General:
a. At least sixty (60) days prior to an increase in the number of living units; and
b. Accompanied by a fee of sixty (60) dollars per each additional unit.
- If there is a decrease in the number of living units, an ALC, ALC-BH, or ALC-DC shall notify the Office of Inspector General within sixty (60) days of the decrease.
(d) Change of ownership.
-
The new owner of an ALC, ALC-BH, or ALC-DC shall submit an Application for Licensure to Operate an Assisted Living Community accompanied by a fee of $500 within ten (10) calendar days of the effective date of the ownership change.
-
A change of ownership for a license shall be deemed to occur if more than twenty-five (25) percent of an existing facility or capital stock or voting rights of a corporation is purchased, leased, or otherwise acquired by one (1) person from another.
(e) Change of managing agent. An ALC, ALC-BH, or ALC-DC shall submit an updated Application for Licensure to Operate an Assisted Living Community accompanied by a fee of twenty-five (25) dollars within ten (10) calendar days of the effective date of a change of managing agents.
(f) Information shared with lending institutions relative to financing for ALC projects. The cabinet's fee for providing information in accordance with KRS 194A.729 shall be $250.
(g) Voluntary termination of operations.
- An ALC or ALC-BH shall notify:
a. The Office of Inspector General at least sixty (60) days prior to voluntarily relinquishing its license; and
b. Residents at least sixty (60) days prior to closure unless there is a sudden termination due to:
(i) Fire;
(ii) Natural disaster; or
(iii) Closure by a governmental agency.
- An ALC-DC that elects to voluntarily terminate operations shall:
a. Relinquish its license; and
b. Comply with notification requirements and other the steps for voluntary relinquishment established by KRS 194A.7063.
(4) Upon receipt of an application accompanied by the documentation and fees required by subsection (2) or subsection (3)(b), (c), or (d) of this section, the Office of Inspector General shall:
(a) Review the application for completeness; and
(b) Return the application and accompanying licensure fee if:
-
An individual having a significant financial interest in the facility, within the seven (7) year period prior to the application date, had a significant financial interest in an out-of-state or a Kentucky-licensed health facility or health service, or other entity regulated by the cabinet, that had its license or certificate to operate denied, suspended, revoked, or voluntarily relinquished as the result of an investigation or adverse action that placed patients, residents, or clients at risk of death or serious harm; or
-
The cabinet finds that the applicant misrepresented or submitted false information on the application.
Section 4. Regulatory Functions and Authority to Enter Upon the Premises.
(1) In accordance with KRS 216.530, inspection of an ALC, ALC-BH, or ALC-DC shall be unannounced.
(2) Licensure review inspections shall be conducted in accordance with the survey intervals established by KRS 194A.707(2).
(3) Nothing in this administrative regulation shall prevent the cabinet from:
(a) Conducting an investigation related to a complaint; or
(b) Making an on-site survey of an ALC, ALC-BH, or ALC-DC more often if necessary.
(4) An ALC, ALC-BH, or ALC-DC shall comply with the:
(a) Inspection requirements of 902 KAR 20:008, Section 2(12)(b) and (c);
(b) Procedures for correcting violations established by 902 KAR 20:008, Section 2(13); and
(c) Civil monetary penalties as established under KRS 194A.722(5) for any violation that poses imminent danger to a resident in which substantial risk of death or serious mental or physical harm is present.
Section 5. License Requirements.
(1) In accordance with KRS 194A.707(3) and 194A.710(1), an entity shall not operate as ALC, ALC-BH, or ALC-DC unless it is licensed.
(2) The licensee shall be legally responsible for:
(a) The management, control, and operation of the facility in accordance with KRS 194A.710(1), regardless of the existence of a management agreement or subcontract; and
(b) Compliance with federal, state, and local laws and administrative regulations pertaining to the operation of the ALC, ALC-BH, or ALC-DC.
(3) An ALC, ALC-BH, or ALC-DC shall not represent that the facility provides any service other than a service it is licensed to provide.
(4)
(a) Upon approving an application, the cabinet shall issue a single license for each building that is operated by the licensee as an ALC, ALC-BH, or ALC-DC, except as established under paragraph (b)1. through 3. of this subsection.
(b)
- Upon approving an application for an ALC, ALC-BH, or ALC-DC, the cabinet shall issue a single license for two (2) or more buildings on a campus if:
a. The buildings are operated by the same licensee; and
b. The residents in each building are served under the same licensure category.
- A license for two (2) or more buildings on a campus shall identify the:
a. Address;
b. Licensed resident capacity of each building; and
c. Licensure category.
- If an assisted living community operates a secured dementia unit in addition to another assisted living licensure level on the same campus, the cabinet shall issue a separate license for the:
a. ALC-DC; and
b. ALC or ALC-BH depending on the level of services provided.
- An assisted living community that provides services on the same campus to residents in need of social model services only and residents in need of basic health and health-related services outside of a secured dementia unit shall apply for licensure as an ALC-BH.[If]
Section 6. Physical Plant Requirements.
(1) An ALC, ALC-BH, and ALC-DC shall comply with the requirements for living units as established by KRS 194A.703, including compliance with applicable building and safety codes as determined by the enforcement authority with jurisdiction.
(2) Pursuant to KRS 216.595(3), an ALC-DC may request a waiver from the cabinet regarding building requirements to address the specialized needs of individuals with Alzheimer's disease or other brain disorders.
(3) The request for a waiver shall follow the same process as a facility's request for a variance pursuant to 902 KAR 20:008, Sections 5 and 6.
Section 7. Operations and Services.
(1) Resident criteria.
(a) In accordance with KRS 194A.711, a resident of an ALC, ALC-BH, or ALC-DC shall be ambulatory unless due to a temporary condition.
(b) An ALC, ALC-BH, or ALC-DC shall require a medical examination in accordance with KRS 216.765(1) prior to admission of a resident.
(c)
- An ALC, ALC-BH, or ALC-DC shall complete a functional needs assessment for each resident in accordance with KRS 194A.705(6) and provide a copy to the resident:
a. Upon move-in; and
b. As needed with updated information if there is a change in the resident's condition, but no later than once every twelve (12) months.
- The functional needs assessment shall be administered by a staff person with at least:
a. A bachelor's degree in health or human services or a related field;
b. An associate's degree in health or human services or a related field and at least one (1) year of experience working with the elderly or conducting assessments; or
c. A high school diploma or its equivalency and two (2) years of experience working with the elderly or conducting assessments.
- The functional needs assessment shall be used to ensure that the prospective or current resident:
a. Meets the eligibility criteria pursuant to KRS 194A.711;
b. Has at least minimal ability to verbally direct or physically participate in activities of daily living (ADL) or instrumental activities of daily living (IADL) during the time in which assistance is provided;
c. Is free from signs and symptoms of any communicable disease that is likely to be transmitted to other residents or staff;
d. Does not have any special dietary needs that the facility is unable to meet; and
e. Does not require twenty-four (24) hour nursing supervision.
a. If a nurse or staff person who completes the functional needs assessment determines that a resident is able to safely self-administer medications without assistance and the resident keeps the medication locked in his or her living unit, the nurse or staff person shall counsel the resident at least one (1) time each month to ascertain if the:
(i) Resident continues to be capable of self-administering medication; and
(ii) Security of the medication continues to be maintained.
b. The facility shall keep a written record of the monthly counseling.
c. For a resident who keeps his or her medication locked in a central medication storage area:
(i) The resident may be permitted entrance or access to the area for the purpose of self-administration; and
(ii) A facility staff member must remain in or at the storage area the entire time the resident is present.
(2) Minimum requirements. Each ALC, ALC-BH, and ALC-DC shall:
(a) Provide each resident with a copy of the resident's rights established by KRS 216.515;
(b) Provide each resident with access to the services required by KRS 194A.705(1) according to the lease agreement;
(c) Except for a social model ALC, provide each resident with access to basic health and health-related services;
(d) Permit a resident to arrange for additional services under direct contract or arrangement with an outside party pursuant to KRS 194A.705(3) if permitted by the policies of the ALC, ALC-BH, or ALC-DC;
(e) Utilize a person-centered care planning and service delivery process;
(f) Provide an emergency response system or personal medical alert device for residents to request assistance twenty-four (24) hours per day, seven (7) days per week;
(g) Allow residents the ability to furnish and decorate the resident's unit within the terms of the lease agreement;
(h) Allow the resident the right to choose a roommate if sharing a unit;
(i) Except for a resident of a secured dementia unit in an ALC-DC, notify the resident that the living unit shall have a lockable entry door in accordance with KRS 194A.703(1)(b). The licensee shall:
-
Provide the locks on the unit;
-
Ensure that only a staff member with a specific need to enter the unit shall have access to the unit and provide advance notice to the resident before entrance, if possible; and
-
Not lock a resident in the resident's unit;
(j) Develop and implement a staffing plan for determining staffing levels that:
-
Includes an evaluation conducted at least twice a year of the appropriateness of staffing levels in the facility;
-
Ensures sufficient staffing at all times to meet the scheduled and reasonably foreseeable unscheduled needs of each resident as required by the residents' functional needs assessments and service plans on a twenty-four (24) hour per day basis; and
-
Ensures that the facility can respond promptly and effectively to:
a. Individual resident emergencies; and
b. Emergency, safety, and disaster situations affecting staff or residents in the facility;
(k) Ensure that one (1) or more staff shall be:
-
Available twenty-four (24) hours per day, seven (7) days per week; and
-
Responsible for responding to the requests of residents for assistance with health or safety needs;
(l) Upon the request of the resident, provide directly or assist with arranging for transportation to:
-
Medical and social services appointments;
-
Shopping; and
-
Recreation;
(m) Upon the request of the resident, provide assistance with accessing available community resources and social services;
(n) Provide culturally appropriate programs that help:
-
Residents remain connected to their traditional lifeways; and
-
Promote culturally sensitive interactions between staff and residents; and
(o) Allow residents to voluntarily engage in one (1) or more IADLs without assistance or with minimal assistance as documented in the resident's service plan, but shall not force a resident to perform IADLs such as housekeeping, shopping, or laundry.
(3) Lease agreements.
(a) Upon entering into a lease agreement, each ALC, ALC-BH, and ALC-DC shall inform the resident in writing according to KRS 194A.705(4) about policies relating to the provision of services and contracting or arranging for additional services.
(b) A lease agreement entered into between a resident and an ALC, ALC-BH, or ALC-DC shall meet the minimum content requirements of KRS 194A.713.
(4) Policies and procedures. Each ALC, ALC-BH, and ALC-DC shall maintain written policies and procedures that are up-to-date and include:
(a) Reporting and recordkeeping of alleged or actual cases of abuse, neglect, or exploitation of an adult in accordance with KRS 194A.709 and KRS 209.030(2) through (4) to the:
-
Office of Inspector General, Division of Health Care; and
-
Department for Community Based Services;
(b) A description of dementia or other brain disorder-specific staff training as required by KRS 216.595(2)(i) if the facility provides special care for persons with a medical diagnosis of Alzheimer's disease or other brain disorders;
(c) How priority will be given to assist a resident during an emergency if evacuation of the facility is necessary and the resident requires hands-on assistance from another person to walk, transfer, or move from place to place with or without an assistive device pursuant to KRS 194A.717(5);
(d) Grievance policies required by KRS 194A.713(14);
(e) Except for a social model ALC, a method that incorporates at least four (4) components in an ongoing resident assessment done by a registered nurse or manager's (director) designee in accordance with KRS 216B.160(7);
(f) Conducting a functional needs assessment pursuant to KRS 194A.705(6);
(g) Infection control practices that address:
-
The prevention of disease transmission; and
-
Cleaning, disinfection, and sterilization methods used for equipment and the environment;
(h) Reminders for medications, treatments, or exercises, if applicable;
(i) Except for a social model ALC, ensuring that all nurses and health professionals have current and valid licenses to practice;
(j) Medication and treatment management, if the facility provides these services;
(k) Except for a social model ALC, delegation of:
-
Nursing tasks in accordance with 201 KAR 20:400; or
-
Therapeutic or other tasks assigned by other licensed health professionals;
(l) Except for a social model ALC, supervision of nurses and licensed health professionals;
(m) Except for a social model ALC, supervision of unlicensed personnel performing delegated tasks, which shall include how the facility ensures compliance with the supervision requirements of 201 KAR 20:400, Section 4, if nursing tasks are delegated;
(n) Cardiopulmonary resuscitation unless the policies of the facility state that this procedure is not initiated by its staff, and each resident or prospective resident is informed of the facility's policy pursuant to KRS 194A.719(1)(d); and
(o) Compliance with the requirements of KRS 216B.165, including assurance that retaliatory action shall not be taken against a staff member who in good faith reports a resident care or safety problem.
(5) Resident grievances.Each ALC, ALC-BH, and ALC-DC shall post in a conspicuous place:
(a) Information about the facility's grievance procedures;
(b) The name, telephone number, and e-mail contact information for the individuals who are responsible for handling resident grievances;
(c) Contact information for the state long-term care ombudsman; and
(d) Information for reporting suspected abuse, neglect, or exploitation of an adult.
Section 8. Business Operations.
(1) Display of license. The original current license shall be displayed at the main entrance of each ALC, ALC-BH, and ALC-DC.
(2) Quality management activity.
(a) Each ALC, ALC-BH, or ALC-DC shall engage in quality management activity appropriate to the size of the facility and relevant to the type of services provided.
(b) Documentation about the facility's quality management activity shall be:
-
Maintained for at least two (2) years; and
-
Available to the Office of Inspector General at the time of the survey, investigation, or renewal.
(3) Restrictions.
(a) An ALC, ALC-BH, ALC-DC, or staff person shall not:
-
Accept a power-of-attorney from a resident for any purpose or accept appointment as a guardian or conservator; or
-
Borrow a resident's funds or personal or real property or convert a resident's property to the possession of the facility or staff person.
(b) An ALC, ALC-BH, ALC-DC, or staff person shall not serve as a resident's designated contact person or legal representative unless the staff person is an immediate family member of the resident.
(4) Resident finances and property.
(a) An ALC, ALC-BH, or ALC-DC may assist a resident with household budgeting, including paying bills and purchasing household goods, but shall not otherwise manage a resident's property except as established in paragraphs (b) and (c) of this subsection.
(b) If an ALC, ALC-BH, or ALC-DC accepts responsibility for managing a resident's personal funds as evidenced by the facility's written acknowledgment, the facility shall comply with KRS 216.515(8).
(c) Within thirty (30) days of the effective date of a facility-initiated or resident-initiated termination of housing or services or the death of the resident, the ALC, ALC-BH, or ALC-DC shall:
-
Provide to the resident, resident's legal representative, or resident's designated contact person a final statement of account;
-
Provide any refunds due; and
-
Return any money, property, or valuables held in trust or custody by the facility.
Section 9. Dietary Services.
(1)
(a) Dining area. Access to central dining shall be provided for residents of an ALC, ALC-BH, or ALC-DC in accordance with KRS 194A.703(2), including three (3) meals and snacks made available each day in accordance with KRS 194A.705(1)(b) with flexibility for residents in a secure dementia care unit.
(b) In addition to subsection (1) of this section, subsections (2) through (5) of this section of this administrative regulation shall apply to facilities licensed to operate as an ALC-BH or ALC-DC.
(2) Therapeutic diets. If the facility provides therapeutic diets and the staff member responsible for food services is not a licensed dietician or certified nutritionist, the responsible staff person shall consult with a licensed dietician or certified nutritionist.
(3) Menu planning.
(a) Menus shall be planned in writing and rotated to avoid repetition.
(b) An ALC-BH or ALC-DC shall meet the nutritional needs of residents.
(c) Meals shall correspond with the posted menu.
(d) Menus shall be planned and posted at least one (1) week in advance.
(e) If changes in the menu are necessary:
-
Substitutions shall provide equal nutritive value;
-
The changes shall be recorded on the menu; and
-
Menus shall be kept on file for at least thirty (30) days.
(4) Food preparation and storage.
(a) There shall be at least a three (3) day supply of food to prepare well-balanced, palatable meals.
(b) Food shall be prepared with consideration for any individual dietary requirement.
(c) Modified diets, nutrient concentrates, and supplements shall be given only on the written order of a licensed health professional.
(d) At least three (3) meals per day shall be served with not more than a fifteen (15) hour span between the evening meal and breakfast.
(e) At least two (2) hot meals daily shall be offered.
(f) Between-meal snacks, including an evening snack before bedtime shall be offered to all residents.
(g) Adjustments shall be made if medically contraindicated.
(h) Food shall be:
-
Prepared by methods that conserve nutritive value, flavor, and appearance; and
-
Served at the proper temperature and in a form to meet individual needs.
(i) A file of tested recipes, adjusted to appropriate yield, shall be maintained.
(j) Food shall be cut, chopped, or ground to meet individual needs.
(k) If a resident refuses food served, substitutes of equal nutritional value and complementary to the remainder of the meal shall be offered and recorded.
(l) All opened containers or leftover food items shall be covered and dated when refrigerated.
(m) Drinking water shall be readily available to the residents at all times.
(n) Food services shall be provided in accordance with 902 KAR 45:005.
(5)
(a) Nothing in this administrative regulation shall be construed as taking precedence over the resident's right to make decisions regarding his or her eating and dining.
(b) Information about the resident's eating and dining preferences shall be included in the resident's service plan based on the resident's preferences.
(c) If the resident's eating and dining preferences have a potential health risk, staff shall inform the resident and the resident's designated contact person or legal representative.
Section 10. Employee Records and Requirements.
(1) Each ALC, ALC-BH, or ALC-DC shall maintain a current record of each:
(a) Staff person employed by the facility directly or by contract; and
(b) Regularly scheduled volunteer providing direct care services.
(2) The record for each staff person shall include:
(a) Evidence of current professional licensure, registration, or certification, if applicable;
(b) Documentation of orientation completed within thirty (30) days from the date of hire and annual training;
(c) Documentation of annual performance evaluations;
(d) Current job description, including qualifications, responsibilities, and identification of each staff person who provides supervision;
(e) Documentation of background checks in accordance with Section 14(1) of this administrative regulation; and
(f) Record of any health exams related to employment, including compliance with the tuberculosis testing requirements of 902 KAR 20:205.
(3) The record for each regularly scheduled volunteer shall include documentation of background checks in accordance with Section 14(1) of this administrative regulation.
(4) Each record shall be retained for at least three (3) years after an employee or volunteer ceases to be employed by or provides services at the facility.
(5) If a facility ceases operation, records shall be maintained for at least three (3) years after facility operations cease.
Section 11. Prevention and Control of Tuberculosis and Other Communicable Diseases.
(1) Each ALC, ALC-BH, and ALC-DC shall maintain written evidence of compliance with the screening and testing requirements of:
(a) 902 KAR 20:200, Tuberculosis (TB) testing for residents in long-term care settings: and
(b) 902 KAR 20:205, Tuberculosis (TB) testing for health care workers.
(2) An ALC, ALC-BH, and ALC-DC shall follow current requirements related to communicable diseases pursuant to KRS 194A.717(4).
(3) In accordance with KRS 194A.707(6), each ALC, ALC-BH, and ALC-DC may provide residents or their designated representatives with educational information or educational opportunities on influenza disease by September 1 of each year.
Section 12. Disaster planning and emergency preparedness plan.
(1) Each ALC, ALC-BH, and ALC-DC shall:
(a) Have a written emergency disaster plan that:
-
Contains a plan for evacuation, including the written policy required by Section 7(4)(c) of this administrative regulation and KRS 194A.717(5);
-
Addresses elements of sheltering in place or provides instructions for finding a safe location indoors and staying there until given an all clear or told to evacuate;
-
Identifies temporary relocation sites; and
-
Details staff assignments in the event of a disaster or an emergency;
(b) Post an emergency disaster plan prominently;
(c) Provide building emergency exit diagrams to all residents;
(d) Post emergency exit diagrams on each floor; and
(e) Have a written policy and procedure regarding missing tenant residents.
(2)
(a) Each ALC, ALC-BH, and ALC-DC shall:
-
Provide emergency and disaster training to all staff during the initial staff orientation and annually; and
-
Make emergency and disaster training available to residents annually.
(b) Staff who have not received emergency and disaster training shall work only if staff trained for emergencies and disaster are also working on site.
Section 13. Resident Records.
(1) Each ALC, ALC-BH, and ALC-DC shall maintain a record for each resident.
(2) Entries in the resident record shall be current, legible, permanently recorded, dated, and authenticated with the name and title of the staff person making the entry.
(3) Resident records, whether written or electronic, shall be protected against loss, tampering, or unauthorized disclosure.
(4) Each resident record shall include the:
(a) Resident's name, date of birth, address, and telephone number;
(b) Name, address, and telephone number of the resident's legal representative or designated contact person;
(c) Names, addresses, and telephone numbers of the resident's health and medical service providers, if known;
(d) Health information, including medical history, allergies, tuberculosis test results, vaccination information, and if the provider is managing medications, treatments, or therapies, documentation of the administration of all medications or delivery of treatments or therapy services;
(e) The resident's advance directives, if any;
(f) Copies of any health care directives, guardianships, powers of attorney, or conservatorships;
(g) The resident's current and previous functional needs assessments and service plans;
(h) All records of communications pertinent to the resident's services;
(i) Documentation of significant changes in the resident's status and actions taken in response to the needs of the resident, including reporting to the appropriate supervisor or licensed health professional;
(j) Documentation of any incident or accident involving the resident and actions taken in response to the needs of the resident, including reporting to the appropriate supervisor or licensed health professional;
(k) Documentation that services have been provided as identified in the service plan and according to any required orders received from the resident's health care practitioner;
(l) Documentation of administration of medications and delivery of therapeutic services;
(m) Documentation of all verbal prescription orders received by phone and signed by the authorized health professional within thirty (30) days;
(n) Documentation that the resident has received and reviewed the resident's rights;
(o) Documentation of complaints received and any resolution;
(p) Documentation of move-out or transfer to another setting, if applicable; and
(q) Other documentation relevant to the resident's services or status.
(5) With the resident's knowledge and consent, if a resident is relocated to another facility or if care is transferred to another service provider, the ALC, ALC-BH, or ALC-DC shall convey to the new facility or provider the:
(a) Resident's full name, date of birth, and insurance information;
(b) Name, telephone number, and address of the resident's designated contacts or legal representatives, if any;
(c) Resident's current documented diagnoses that are relevant to the services being provided;
(d) Resident's known allergies that are relevant to the services being provided;
(e) Name and telephone number of the resident's physician, if known, and the current physician orders that are relevant to the services being provided;
(f) All medication administration records and treatment sheets that are relevant to the services being provided;
(g) Most recent functional needs assessment; and
(h) If applicable, copies of health care directives, "do not resuscitate" orders, and guardianship orders or powers of attorney.
(6)
(a) Following a resident's move-out or termination of services, an ALC, ALC-BH, or ALC-DC shall retain a resident's record for at least six (6) years.
(b) Arrangements shall be made for secure storage and retrieval of resident records if the facility ceases to operate.
(7) Ownership.
(a) Any medical records shall be the property of the ALC, ALC-BH, or ALC-DC.
(b) The original medical record shall not be removed except by court order.
(c) Copies of medical records or portions thereof may be used and disclosed in accordance with the requirements established in this administrative regulation.
(8) Confidentiality and Security: Use and Disclosure.
(a) The ALC, ALC-BH, or ALC-DC shall maintain the confidentiality and security of resident records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, and as provided by applicable federal or state law.
(b) The ALC, ALC-BH, or ALC-DC may use and disclose resident records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 through 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.
(c) An ALC, ALC-BH, or ALC-DC may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
Section 14. Staff Requirements.
(1) Background checks.
(a) All owners, staff, and regularly scheduled volunteers in a position that involves providing direct care services to residents, which may include access to the belongings, funds, or personal information of residents, shall:
-
Have a criminal record check performed pursuant to KRS 216.789(3);
-
In accordance with KRS 216.789(1), not have a criminal conviction or plea of guilty to a felony offense related to:
a. Theft;
b. Abuse or sale of illegal drugs;
c. Abuse, neglect, or exploitation of an adult; or
d. A sexual crime;
-
In accordance with KRS 216.789(2), not have a criminal conviction or plea of guilty to a misdemeanor offense related to abuse, neglect, or exploitation of an adult;
-
Not have a criminal conviction or plea of guilty to a felony or misdemeanor offense related to abuse, neglect, or exploitation of a child;
-
In accordance with KRS 209.032, not be listed on the caregiver misconduct registry established by 922 KAR 5:120; and
-
In accordance with KRS 216.532, not be listed on the nurse aide abuse registry established by 906 KAR 1:100.
(b) Staff in a position that involves providing direct care services to residents shall submit to a:
-
Criminal background check upon initial hire and no less than every two (2) years thereafter; and
-
Check of the following registries upon initial hire and annually thereafter:
a. Caregiver misconduct registry;
b. Nurse aide abuse registry; and
c. Central registry established by 922 KAR 1:470.
(c) An ALC, ALC-BH, or ALC-DC may use Kentucky's national background check program established by 906 KAR 1:190 to satisfy the background check requirements of paragraphs (a) and (b) of this subsection.
(d) In accordance with KRS 216.789(4), an ALC, ALC-BH, or ALC-DC may temporarily employ an applicant pending receipt of the results of a criminal record check performed upon initial hire.
(2) Licensed health professionals and nurses. A licensed health professional or nurse who provides services to residents of an ALC-BH or ALC-DC shall possess a current Kentucky license or multistate licensure privilege to practice in Kentucky.
(3) Staffing.
(a) In accordance with KRS 194A.717(1), staffing in an ALC, ALC-BH, or ALC-DC shall be sufficient in number and qualifications to meet the twenty-four (24) hour scheduled needs of each resident pursuant to the lease agreement, functional needs assessment, and service plan.
(b) In accordance with KRS 194A.717(2), at least one (1) staff person shall be awake and on-site at all times at each:
-
Licensed entity; or
-
Building on the same campus for two (2) or more buildings operated by the same licensee.
(c) The designated manager (director) of the facility shall meet the requirements of KRS 194A.717(3).
(4) Availability of nurse.An ALC-BH and ALC-DC shall have a nurse readily available in person, by telephone, or by other means of live, two-way communication to unlicensed staff at times the staff is providing delegated nursing tasks.
(5) Delegation of assisted living services.
(a)
-
A nurse in an ALC-BH or ALC-DC may delegate tasks in accordance with 201 KAR 20:400.
-
A licensed health professional in an ALC-BH or ALC-DC may delegate tasks in accordance with the professional's scope of practice standards only to those staff who possess the knowledge and skills consistent with the complexity of the tasks delegated.
(b) The ALC-BH or ALC-DC shall establish and implement a system to communicate up-to-date information to the nurse or appropriate licensed health professional regarding current available staff so the nurse or licensed health professional has sufficient information to determine the appropriateness of delegating tasks to meet individual resident needs and preferences.
(c) If the nurse or licensed health professional delegates tasks to unlicensed personnel, the nurse or health professional shall ensure that prior to the delegation the unlicensed staff person shall:
-
Be trained in the proper methods to perform the tasks; and
-
Demonstrate competence in performing the tasks.
(d) If an unlicensed staff person has not regularly performed the delegated assisted living task during the previous twenty-four (24) month period, the unlicensed staff person shall demonstrate competency in the task to the nurse or appropriate licensed health professional.
(e) The nurse or licensed health professional shall document delegated nursing or other assigned tasks in the resident's record.
(6) Supervision of staff providing non-health related services.
(a) Staff who provide only those assisted living services established in KRS 194A.700(7)(a) through(f), (i), or (n) shall be supervised periodically to:
-
Verify that the work is being performed competently; and
-
Identify problems and solutions to address issues relating to the staff's ability to provide the services.
(b) The supervision of unlicensed personnel shall be done by staff who:
-
Have the authority, skills, and ability to provide the supervision of unlicensed personnel;
-
Can implement changes as needed; and
-
Can train staff.
(c) Supervision may include:
-
Direct observation of an unlicensed staff person while the unlicensed staff person is providing the services; and
-
Indirect methods of gaining input, such as gathering feedback from the resident.
(d) Supervisory review of unlicensed staff shall be provided at a frequency based on the unlicensed staff person's knowledge, skills, and performance.
(7) Supervision of staff providing delegated nursing or therapy tasks.
(a) An unlicensed staff person who performs:
-
Delegated nursing tasks shall be supervised by a nurse pursuant to the requirements of 201 KAR 20:400, Section 4; or
-
Therapy tasks shall be supervised by an appropriate licensed health professional according to the facility's policy to:
a. Verify that the work is being performed competently; and
b. Identify problems and solutions related to the staff person's ability to perform the tasks.
(b) Supervision of an unlicensed staff person performing medication or treatment administration:
-
Shall be provided by a nurse or appropriately licensed health professional; and
-
May include observation of the staff person administering the medication or treatment and the interaction with the resident.
(c) The direct supervision of an unlicensed staff person performing a delegated task shall be provided the first time the staff person performs the delegated task and on an as needed basis thereafter based on performance.
(8) Orientation and annual training.
(a) Prior to working independently with residents and within thirty (30) days from the date of hire, all staff and management shall receive orientation education that addresses the topics required by KRS 194A.719(1)(a) through (k) with emphasis on those most applicable to the employee's assigned duties.
(b) All staff and management shall receive annual training in accordance with KRS 194A.719(2), which shall include in-service education regarding Alzheimer's disease and other types of dementia.
Section 15. Medication Management.
(1) Medication management services.
(a) This section of this administrative regulation shall apply to facilities licensed to operate as an ALC-BH or ALC-DC.
(b) Medications or therapeutic services shall not be administered or provided to any resident except on the order of a licensed health care practitioner as authorized under the practitioner's scope of practice.
(c) Each facility under this section shall develop, implement, and maintain written medication management policies and procedures developed under the supervision and direction of a nurse, appropriate licensed health professional, or pharmacist consistent with scope of practice standards.
(d) The policies and procedures shall address:
-
Requesting and receiving prescriptions for medications;
-
Preparing and giving medications;
-
Verifying that prescription drugs are administered as prescribed;
-
Documenting medication management activities;
-
Storage of medications, which shall include compliance with the requirements established in clauses a. through c. of this subparagraph.
a. All medications shall be kept in a locked place.
b. All medications requiring refrigeration shall be kept in a separate locked box in the refrigerator in the medication area.
c. Drugs for external use shall be stored separately from those administered by mouth or injection;
-
Monitoring and evaluating medication use;
-
Resolving medication errors;
-
Communicating with the prescriber, pharmacist, resident, and if applicable, designated contact person or legal representative;
-
Disposing of unused medications; and
-
Educating residents and designated contacts or legal representatives about medications.
(e) If controlled substances are being managed, the policies and procedures shall identify how the facility shall ensure security and accountability for the overall management, control, and disposition of those substances in accordance with subsection (21) of this section.
(f) All resident medications shall be plainly labeled with the:
-
Resident's name;
-
Name of the drug;
-
Strength;
-
Name of the pharmacy;
-
Prescription number;
-
Date;
-
Prescriber's name; and
-
Caution statements and directions for use, unless a modified unit dose drug distribution system is used.
(2) Provision of medication management services. Prior to providing medication management services to a resident pursuant to orders from the resident's health care practitioner in accordance with KRS 194A.708(1)(d), the facility shall have a nurse or other licensed health professional conduct an assessment that shall:
(a) Be face-to-face with the resident;
(b) Determine what medication management services will be provided and how the services will be provided;
(c) Include an identification and review of all medications the resident is known to be taking. The review and identification shall include:
-
Indications for medications;
-
Side effects;
-
Contraindications; and
-
Possible allergic or adverse reactions, and actions to address these issues;
(d) Identify interventions needed in the management of medications to prevent diversion of medication by the resident or others who may have access to the medications; and
(e) Provide instructions to the resident and designated contacts or legal representatives on interventions to prevent diversion of medications, such as misuse, theft, or illegal or improper disposition of medications.
(3) Individualized medication monitoring and reassessment. The ALC-BH or ALC-DC shall reassess the resident's medication management services in accordance with subsection (2) of this section:
(a) If the resident presents with symptoms or other issues that may be medication-related; and
(b) No later than every twelve (12) months.
(4) Resident refusal. The ALC-BH or ALC-DC shall:
(a) Document in the resident's record any refusal for an assessment for medication management;
(b) Discuss the possible consequences of the resident's refusal with the:
-
Resident;
-
Resident's designated contact person or legal representative; or
-
Both individuals established by subparagraphs 1. and 2. of this paragraph; and
(c) Document the discussion in the resident's record.
(5) Individualized medication management plan.
(a) For each resident receiving medication management services, the ALC-BH or ALC-DC shall develop and maintain a current individualized medication management record for each resident based on the resident's assessment.
(b) The medication management record shall be updated if there is a change and contain:
-
A statement describing the medication management services that will be provided to the resident;
-
A description of storage of medications that:
a. Is based on the resident's needs and preferences;
b. Reduces risk of diversion; and
c. Is consistent with the manufacturer's directions;
-
Documentation of specific instructions relating to the administration of medications to the resident;
-
Identification of persons responsible for monitoring medication supplies and ensuring that medication refills are ordered on a timely basis;
-
Identification of medication management tasks that may be delegated to unlicensed personnel;
-
Procedures for staff to notify a nurse or appropriate licensed health professional if a problem arises with medication management services; and
-
Any resident-specific requirements related to:
a. Documenting medication administration;
b. Verification that all medications are administered as prescribed; and
c. Monitoring of medication use to prevent possible complications or adverse reactions.
(c) Medication reconciliation shall be completed by a nurse, licensed health professional acting within the professional's scope of practice, or authorized prescriber for each resident receiving medication management services.
(6) Administration of medication. A licensed health professional may:
(a) Administer medications. as authorized under the professional's scope of practice; or
(b) Delegate medication administration tasks in accordance with subsection (7) and subsection (21)(c) and (d) of this section.
(7) Delegation of medication administration.
(a) In accordance with the credentialing requirements of KRS 194A.705(2)(c), a nurse or other appropriate licensed health professional may delegate medication administration to an unlicensed staff person in an ALC-BH or ALC-DC as follows:
- If administration of oral or topical medication is delegated, the unlicensed staff person shall have a:
a. Certified medication aide I credential from a training and skills competency evaluation program approved by the Kentucky Board of Nursing (KBN); or
b. Kentucky medication aide credential from the Kentucky Community and Technical College System (KCTCS); and
- If administration of a preloaded insulin injection is delegated in addition to oral or topical medication, the unlicensed staff person shall have a certified medication aide II credential from a training and skills competency evaluation program approved by the Kentucky Board of Nursing (KBN).
(b) An ALC-BH or ALC-DC shall ensure that each nurse or licensed health professional who delegates the administration of oral or topical medication, or preloaded injectable insulin has:
-
Specified, in writing, specific instructions for each resident and documented those instructions in the resident's records; and
-
Communicated with the unlicensed personnel about the individual needs of the resident.
(c) In accordance with KRS 194A.705(2)(d), unlicensed personnel who administer medications to residents of an apartment-style personal care home required by KRS 194A.704 to convert to a licensed assisted living community shall comply with the medication aide credentialing requirements established in paragraph (a) of this subsection no later than December 29, 2023.
(d) The ALC-BH or ALC-DC shall ensure that a nurse or licensed health professional is readily available during times the unlicensed staff administers medications in accordance with Section 14(4) of this administrative regulation.
(8) Documentation of administration of medications.
(a) Each medication administered shall be documented in the resident's record.
(b) The documentation shall include the:
- Signature and title of the staff person who:
a. Administered the medication; or
b. Delegated a PRN medication in accordance with subsection (21)(d) of this section.
-
Medication name, dosage, date, and time administered; and
-
Method and route of administration.
(c) The staff person shall document the:
-
Reason why medication administration was not completed as prescribed, if applicable;
-
Any follow-up procedures that were provided to meet the resident's needs if medication was not administered as prescribed and in compliance with the resident's medication management plan; and
-
If a PRN medication is delegated, name of the certified medication aide who administered a PRN medication.
(9) Documentation of medication setup. At the time of medication setup, the authorized health professional shall document the following in the resident's record:
(a) Date of medication setup;
(b) Name of medication;
(c) Quantity of dose;
(d) Times to be administered;
(e) Route of administration; and
(f) Name of the staff person completing the medication setup.
(10) Medication management for residents who will be away from the facility.
(a) An ALC-BH or ALC-DC shall develop and implement policies and procedures for giving accurate and current medications to the resident for planned or unplanned times away from the facility according to the resident's individualized medication management plan.
(b) The policies and procedures shall state that:
- a For planned time away non-controlled substance, medications shall be obtained from the pharmacy or set up by the nurse or authorized health professional; and
b. For unplanned time away, if the pharmacy is not able to provide the medications, a nurse or authorized health professional shall provide non-controlled substance medications in the amounts and dosages needed for the length of the anticipated absence, not to exceed seven (7) calendar days.
- For planned or unplanned time away, controlled substance medications shall be obtained from the pharmacy or other authorized dispensing practitioner and kept in the original container bearing the original prescription label.
(c) The ALC-BH or ALC-DC shall:
-
Provide the resident with written information on medications, including any special instructions for administering or handling the medications;
-
Place the medications in a medication container or containers appropriate to the provider's medication system; and
-
Label the container or containers with the:
a. Resident's name; and
b. The dates and times that the medications are scheduled.
(11) Over-the-counter drugs and dietary supplements not prescribed.
(a) An ALC-BH or ALC-DC providing medication management services for over-the-counter drugs or dietary supplements shall retain those items in the original labeled container with directions for use prior to setting up for immediate or later administration.
(b) The ALC-BH or ALC-DC shall verify that the medications are up to date and stored as appropriate.
(12) Prescriptions. There shall be a current written or electronically recorded prescription for all prescribed medications that the ALC-BH or ALC-DC is managing for the resident.
(13) Renewal of prescriptions. Prescriptions shall be renewed at least every twelve (12) months or more frequently as indicated by the assessment in subsection (2) of this section.
(14) Verbal prescription orders. If an order is received by telephone, the order shall be:
(a) Recorded in the resident's medication management record; and
(b) Signed by the physician or health care practitioner as authorized under the practitioner's scope of practice within thirty (30) days.
(15) Written or electronic prescription. At the time a written or electronic prescription is received, it shall be:
(a) Communicated to the nurse in charge; and
(b) Recorded or placed in the resident's record.
(16) Medications provided by resident or family members. If a staff person becomes aware of any medications or dietary supplements that are being used by the resident that are not included in the assessment for medication management services, the staff person shall advise the nurse and document that in the resident record.
(17) Storage of medications. Except for the storage of controlled substances that shall be kept under a double lock in accordance with subsection (21)(b) of this section, an ALC-BH or ALC-DC shall store all prescription medications in securely locked and substantially constructed compartments according to the manufacturer's directions and permit only authorized personnel to have access.
(18) Prescription drugs.
(a) A non-controlled prescription drug, prior to being set up for immediate or later administration, shall be kept in the original container in which it was dispensed by the pharmacy bearing the original prescription label with legible information, including the expiration or beyond-use date of a time-dated drug.
(b) A controlled substance shall:
-
Not be set up for later administration; and
-
Be kept in the original container in which it was dispensed by the pharmacy or other authorized dispensing practitioner bearing the original prescription label.
(19) Prohibitions. A prescription drug supply for one (1) resident shall not be used or saved for use by anyone other than the resident.
(20) Disposition of medications.
(a) Any current medications being managed by the ALC-BH or ALC-DC shall be provided to the resident if:
-
The resident's service plan ends; or
-
Medication management services are no longer part of the service plan.
(b) The ALC-BH or ALC-DC shall dispose of any medications remaining with the facility:
-
That are discontinued or expired; or
-
Upon termination of the service plan or the resident's death.
(c) Upon disposition, the facility shall document in the resident's record the disposition of the medication, including:
-
The medication's name, strength, prescription number as applicable, and quantity;
-
How the medication was disposed of or to whom the medications were given;
-
Date of disposition; and
-
Names of staff and other individuals involved in the disposition.
(21) Controlled substances.
(a) An ALC-BH or ALC-DC shall not keep any controlled substances or other habit forming drugs, hypodermic needles, or syringes except under the specific direction of a prescribing practitioner.
(b) Controlled substances shall be kept under double lock, for example, stored in a locked box in a locked cabinet, and keys or access codes to the locked box and locked cabinet shall be accessible to designated staff only.
(c) A nurse may delegate administration of a regularly scheduled controlled substance to a certified medication aide (CMA) if the medication has been prescribed and labeled in a container for a specific resident.
(d) For a controlled substance ordered on a PRN basis, a nurse may delegate administration to a CMA if:
-
The medication has been prescribed and labeled in a container for a specific resident;
-
The nurse assesses the resident, in person or virtually, prior to administration of the PRN controlled substance;
-
The nurse assesses the resident, in person or virtually, following the administration of the PRN controlled substance; and
-
The nurse documents administration of the PRN controlled substance by a CMA in the resident's record.
(e) There shall be a controlled substances bound record book with numbered pages that includes:
-
Name of the resident;
-
Date, time, kind, dosage, and method of administration of each controlled substance;
-
Name of the practitioner who prescribed the medications; and
-
Name of the nurse or CMA who:
a. Administered the controlled substance; or
b. provided assistance with self-administration of medication by a resident whose medical record includes a written determination from an appropriately authorized health professional that the resident is able to safely self-administer a controlled substance under supervision.
(f) An appropriately authorized licensed health professional with access to controlled substances shall be responsible for maintaining a recorded and signed:
-
Schedule II controlled substances count daily; and
-
Schedule III, IV, and V controlled substances count at least one (1) time per week.
(g) All expired or unused controlled substances shall be disposed of, or destroyed in accordance with 21 C.F.R. Part 1317 no later than thirty (30) days:
-
After expiration of the medication; or
-
From the date the medication was discontinued.
(h) If controlled substances are destroyed on-site:
-
The method of destruction shall render the drug unavailable and unusable;
-
The administrator or staff person designated by the administrator shall be responsible for destroying the controlled substances with at least one (1) witness present; and
-
A readily retrievable record of the destroyed controlled substances shall be maintained for a minimum of eighteen (18) months from the date of destruction and contain the:
a. Date of destruction;
b. Resident name;
c. Drug name;
d. Drug strength;
e. Quantity;
f. Method of destruction;
g. Name and signature of the person responsible for the destruction; and
h. Name of the witness.
(i) For purposes of this paragraph, an ALC-BH or ALC-DC shall be treated the same as a licensed personal care home that stores and administers controlled substances in an emergency medication kit (EMK) in which case the facility shall comply with the same:
-
Requirement for licensed personnel established by 201 KAR 2:370, Section 2(4)(i);
-
Requirements for storage and administration established by 902 KAR 55:070, Section 2(2), (5), and (7) through (9); and
-
Limitation on the number and quantity of medications established by 902 KAR 55:070, Section 2(6).
(22) Emergency drugs for non-controlled substances in an EMK.
(a) For purposes of this paragraph, an ALC-BH or ALC-DC shall be treated the same as a licensed personal care home that stores and administers non-controlled substances in an EMK in which case the facility shall comply with the same:
-
Requirement for licensed personnel established by 201 KAR 2:370, Section 2(4)(i); and
-
Limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(4)(b).
(b) An ALC-BH or ALC-DC that stores and administers non-controlled substances from a long-term care facility (LTCF) drug stock shall comply with the limitation on the number and quantity of medications established by 201 KAR 2:370, Section 2(5)(b).
(23) Loss or spillage.
(a) An ALC-BH or ALC-DC shall develop and implement procedures to address loss or spillage of all controlled substances.
(b) The procedures shall require that if spillage of a controlled substance occurs, a notation shall be made in the resident's record explaining the spillage and the actions taken.
(c) The notation shall be signed by the person responsible for the spillage and include verification that any contaminated substance was disposed of.
(d) The procedures shall require that the ALC-BH or ALC-DC:
-
Investigate any known loss or unaccounted for prescription drugs;
-
Document the investigation in required records; and
-
Provide a copy of the detailed list of controlled substances lost, destroyed, or stolen to the Office of Inspector General:
a. Division of Audits and Investigations as soon as practical pursuant to KRS 218A.200(6); and
b. Division of Health Care.
Section 16. Assisted Living Communities with Dementia Care.
(1) Except as established in KRS 194A.7061(4), a provisional or initial license holder as an ALC-DC shall provide services in a manner that is consistent with the requirements of KRS 194.7061(1) through (3).
(2) An ALC-DC shall comply with KRS 194A.7065 and KRS 216.595.
(3) The manager (director) of an ALC-DC shall complete at least ten (10) hours of annual dementia-specific training in the topics established by KRS 194A.7201(2).
(4) An ALC-DC shall:
(a) Develop policies and procedures in accordance with KRS 194A.708(1); and
(b) Provide a copy of the policies and procedures to the resident and the resident's designated contact person or legal representative at the time of move-in.
(5) An ALC-DC shall ensure that the facility complies with the staffing standards established by KRS 194A.7203, including the requirement for only dementia-trained staff to care for residents on its secured dementia unit unless a temporary emergency situation exists.
(6) An ALC-DC shall:
(a) Provide all of the services listed in KRS 194A.7052(1);
(b) Evaluate each resident on its secured dementia unit for engagement in activities and develop an individualized activity plan pursuant to KRS 194A.7052(2) and (3);
(c) Provide a selection of daily structured and non-structured activities for residents on its secured dementia unit in accordance with KRS 194A.7052(4);
(d) Evaluate behavioral symptoms that negatively impact residents on its secured dementia unit and others in the facility and comply with the requirements of KRS 194A.7052(5);
(e) Offer support services to the families of residents on its secured dementia unit and others with significant relationships at least every six (6) months in accordance with KRS 194A.7052(6); and
(f) For dementia care units constructed after July 14, 2022, offer access to secured outdoor space in accordance with KRS 194A.7052(7).
(7) In addition to the training requirements of Section 14(8) of this administrative regulation, an ALC-DC shall meet the training requirements of KRS 194A.7205 for direct care staff who work in the facility's secured dementia care unit.
Section 17. Violation of Standards. An ALC, ALC-BH, or ALC-DC shall comply with any applicable enforcement actions authorized by KRS 194A.722 and 902 KAR 20:008, Sections 7 and 8 for violations of the standards established by this administrative regulation, KRS 194A.700 through 194A.729, 216.532, or 216.789.
Section 18. Denial and Revocation.
(1) In addition to the reasons for denial or revocation of a license in accordance with 902 KAR 20:008, Section 8, the cabinet shall deny or revoke an ALC, ALC-BH, or ALC-DC license if:
(a) There has been a substantial failure by the facility to comply with the provisions of:
-
KRS 194A.700 through 194A.729, 216.532, or 216.789; or
-
This administrative regulation;
(b) The facility allows, aids, or abets the commission of any illegal act in the provision of assisted living services;
(c) The facility performs any act detrimental to the health, safety, or welfare of a resident;
(d) The facility obtains licensure by fraud or misrepresentation, including a false statement of a material in fact in:
-
The Application for License to Operate an Assisted Living Community; or
-
Any records required by this administrative regulation;
(e) The facility denies a representative of the cabinet access to any part of the facility's books, records, files, employees, or residents;
(f) The facility interferes with or impedes the performance of the duties and responsibilities of the long-term care ombudsman;
(g) The facility interferes with or impedes a representative of the cabinet in the enforcement of this administrative regulation or fails to fully cooperate with a survey or investigation by the cabinet;
(h) The facility destroys or makes unavailable any records or other evidence relating to the facility's compliance with this administrative regulation;
(i) The facility refuses to initiate a background check or otherwise fails to comply with the requirements of KRS 216.789;
(j) The facility fails to timely pay any fines assessed by the cabinet;
(k) The facility violates any applicable building or safety codes as determined by the building code or safety code enforcement authority with jurisdiction;
(l) There have been repeated incidents in the facility of personnel performing services beyond their competency level;
(m) The facility continues to operate beyond the scope of the facility's license after the timeframe established for correction of the violation; or
(n) An individual with a significant financial interest in the facility:
-
Is convicted of a felony or gross misdemeanor that relates to the operation of the facility or directly affects resident safety or care; or
-
Had the application returned in accordance with Section 3(4)(b) of this administrative regulation.
(2) The cabinet shall follow the notification requirements of 902 KAR 20:008, Section 8(2) and (3) for denial or revocation.
(3) In accordance with KRS 216B.105(2), the denial or revocation shall become final and conclusive thirty (30) days after notice is given, unless the applicant or licensee files a request in writing for a hearing with the cabinet within thirty (30) days after the date of the notice.
Section 19. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) Form OIG – 20:480, "Application for Licensure to Operate an Assisted Living Community", November 2022 edition; and
(b) Form OIG – 20:480-A, "Functional Needs Assessment", July 2023 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dhc/Pages/ltcapplications.aspx.
History
- RELATES TO: KRS 194A.700 — 194A.729, 209.030(2) – (4), 209.032, 216.515, 216.530, 216.532, 216.595, 216.718, 216.765, 216.789, 216B.015(13), 216B.020(1), 216B.105, 216B.160, 216B.165, 218A.200(6), 314.011(3), 21 C.F.R. Part 1317, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 194A.707(1), (9), 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.707(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations under KRS Chapter 13A for an initial and re-licensure review process for assisted living communities, including licensure procedure for application, approval or denial, revocation, and appeals. KRS 194A.707(9) authorizes the cabinet to promulgate administrative regulations to establish an assisted living community and assisted living community with dementia care licensure fee that shall not exceed costs of the program to the cabinet. KRS 216B.042(1) requires the cabinet to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes the minimum licensure requirements for the operation of social model assisted living communities (ALC), assisted living communities that provide basic health and health-related services (ALC-BH), and assisted living communities with a secured dementia care unit (ALC-DC).
- History: 49 Ky.R. 1380; 1946; 2295; 50 Ky.R. 683; eff. 7-25-2023.
902 KAR 20:490 Rural emergency hospitals {#sec-902-kar-20-490 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:490}
Section 1. Definition. "Rural emergency hospital (REH)" is defined by 42 C.F.R. 485.50.
Section 2. Licensure.
(1) A facility shall be eligible to apply for a license as an REH if the facility was, as of December 27, 2020:
(a) Licensed as a critical access hospital pursuant to 906 KAR 1:110; or
(b)
-
Licensed as a general acute care hospital pursuant to 902 KAR 20:016;
-
Had fifty (50) or fewer beds; and
-
Was considered rural or treated as being located in a rural area in accordance with 42 C.F.R. 485.506(b) or (c).
(2) Except for beds the REH maintains in a distinct part unit licensed as a skilled nursing facility, the facility's inpatient beds shall be delicensed.
Section 3. Application and Fees.
(1) A facility that applies for initial licensure or annual renewal as an REH shall submit to the Office of Inspector General:
(a) A completed Application for Licensure to Operate a Rural Emergency Hospital; and
(b) An accompanying fee in the amount of $1,000, made payable to the Kentucky State Treasurer.
(2) As a condition of annual renewal, the application required by subsection (1) of this section shall be submitted to the cabinet at least sixty (60) days prior to the date of expiration of the REH's licensure.
Section 4. Change of Status.
(1) An REH shall report a change of:
(a) Name or location in accordance with the requirements of 902 KAR 20:008, Section 3(3); or
(b) Ownership in accordance with the requirements of 902 KAR 20:008, Section 2(16).
(2) Failure to renew a license by the annual renewal date shall result in a late penalty pursuant to 902 KAR 20:008, Section 3(4).
Section 5. Services and Basic Requirements.
(1) An REH shall comply with applicable federal, state, and local laws and regulations pertaining to the operation of the facility, including compliance with 42 C.F.R. 485.506 – 485.546.
(2) An REH shall:
(a) Provide emergency department services and observation care, including compliance with the requirements of:
-
42 C.F.R. 485.516; and
-
42 C.F.R. 485.618 with respect to:
a. Twenty-four (24) hour availability of emergency services;
b. Equipment, supplies, and medication;
c. Blood and blood products;
d. Personnel; and
e. Coordination with emergency response systems;
(b) Provide basic laboratory services in accordance with 42 C.F.R. 485.518;
(c) Maintain, or have available, diagnostic radiologic services in accordance with 42 C.F.R. 485.520;
(d) Have pharmaceutical services that meet the needs of its patients in accordance with 42 C.F.R. 485.522; and
(e) In accordance with 42 C.F.R. 485.538, have in effect a transfer agreement with at least one (1) hospital that is a level I or level II trauma center for the referral and transfer of patients requiring emergency medical care beyond the capabilities of the REH.
(3) In accordance with 42 C.F.R. 485.524(a), an REH may provide outpatient and medical health diagnostic and therapeutic items and services that are commonly provided in a physician's office or at another entry point into the health care delivery system, including:
(a) Therapeutic radiologic services;
(b) Laboratory services;
(c) Outpatient rehabilitation;
(d) Surgical services;
(e) Maternal health services; or
(f) Behavioral health services.
(4) An REH may provide skilled nursing facility services in a distinct part unit in accordance with 42 C.F.R. 485.546.
Section 6. Personnel. An REH shall assure that licensed personnel meet the applicable standards required by the appropriate professional licensing board and provide services within the applicable scope of practice.
Section 7. Patient Records.
(1) Ownership.
(a) Medical records shall be the property of the REH.
(b) The original medical record shall not be removed except by court order.
(c) Copies of medical records or portions thereof may be used and disclosed in accordance with the requirements established in this administrative regulation.
(2) Confidentiality and Security: Use and disclosure.
(a) The REH shall maintain the confidentiality and security of patient records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.
(b) The REH may use and disclose patient records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8; 45 C.F.R. Parts 160 and 164; and as established in this administrative regulation.
(c) An REH may establish higher levels of confidentiality and security than those required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.
(d) Retention of records. After a patient's death or discharge, the completed medical record shall be placed in an inactive file and retained for at least:
-
Six (6) years; or
-
Three (3) years after the patient reaches the age of majority in accordance with KRS 2.015, whichever is longer.
(3) The REH shall:
(a) Designate a specific location for the maintenance and storage of the agency's medical records;
(b) Have provisions for storage of medical records in the event the agency ceases to operate; and
(c) Safeguard the record and its content against loss, defacement, or tampering.
Section 8. Incorporation by Reference.
(1) "Application for Licensure to Operate a Rural Emergency Hospital", form OIG-20:490, December 2022 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dhc/Pages/ltcapplications.aspx.
History
- RELATES TO: KRS 2.015, 42 C.F.R. 485.500 — 485.546, 42 C.F.R. 485.618, 45 C.F.R. Part 160, Part 164, 42 U.S.C. 1320d-2 – 1320d-8
- STATUTORY AUTHORITY: KRS 216B.042(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary for the proper administration of the licensure function, which includes establishing licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes the minimum requirements for licensure as a rural emergency hospital.
- History: 49 Ky.R.219, 1807; eff. 6-21-2023.
902 KAR 20:500 Medical reserve corps {#sec-902-kar-20-500 omnilex-key=us-ky-regs-official--title-902--902 KAR 20:500}
Section 1. Definitions.
(1) "Declared emergency" is defined by KRS 39A.020(7).
(2) "Department" means the Department for Public Health.
(3) "Emergency" is defined by KRS 39A.020(12).
(4) "Health services" is defined by KRS 39A.350(7).
(5) "Medical reserve corps" means the formally established network of volunteers, including volunteer health practitioners who are licensed to practice in Kentucky, registered with the department to provide emergency response services as directed by the department.
(6) "Voluntary health practitioner" is defined by KRS 39A.350(11).
Section 2. Applicability. The provisions of this administrative regulation shall only be applicable to volunteers who are active in the Health Emergency Listing of Professionals for Surge (K HELPS) system and who provide state-sanctioned emergency response, health, or veterinary services as directed by the department.
Section 3. Medical Reserve Corps Volunteer Registration.
(1) All medical reserve corps volunteers shall:
(a) Register with the department through K HELPS at https://www.chfs.ky.gov/agencies/dph/dphps/phpb/Pages/khelps.aspx; and
(b) Have a criminal background check completed.
(2) Individuals seeking to register as a voluntary health practitioner shall:
(a) Submit proof of current licensure; and
(b) Be in good standing with the applicable licensure board.
(3) A voluntary health practitioner shall adhere to the scope of practice from the applicable licensure board.
(4) A non-medical volunteer shall not perform tasks outside their existing skill level or experience.
(5) A volunteer active within the K HELPS system who, in good faith and in the performance of his or her duties, acts in compliance with KRS 39A.350 to 39A.366 shall not be liable in damages to any person or government entity in tort or other civil action, including an action upon a medical, dental, chiropractic, optometric, or other health-related claim or veterinary claim, for injury, death, or loss to person or property that may arise from an act or omission of that volunteer unless such act or omission was the result of gross negligence or willful misconduct.
Section 4. Workers' Compensation Coverage for Medical Reserve Corps Volunteers.
(1) In accordance with KRS 342.640(3), a volunteer who is active in the K HELPS system, an active member of the medical reserve corps, and in good standing with the department shall be considered an employee of the state for purposes of any medical workers' compensation benefits concerning any injury incurred while traveling to and from or providing emergency response or health services as directed by the department.
(2) A volunteer who is active in the K HELPS system, an active member of the medical reserve corps, and in good standing with the department shall be eligible for coverage under the department's worker's compensation coverage while providing emergency response services or health services in response to an emergency, declared emergency, or in disaster-related exercises, testing, or other training activities as directed by the department.
(3) Workers' compensation benefits for volunteers shall be limited to those medical benefits provided to state employees.
History
- RELATES TO: KRS 39A.020, 39A.350, 39A.356, 39A.358, 342.640
- STATUTORY AUTHORITY: KRS 39A.362, 194A.050(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 39A.362 authorizes the Cabinet for Health and Family Services to promulgate an administrative regulation to implement KRS 39A.350 to 39A.366. KRS 194A.050(1) requires the secretary of the cabinet to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. This administrative regulation establishes a volunteer health practitioner's eligibility for worker's compensation coverage during an emergency or declared emergency response.
- History: 50 Ky.R. 280; eff. 10-25-2023.
Chapter 21 Programs for the Underserved
902 KAR 21:020 Kentucky Colon Cancer Screening Program {#sec-902-kar-21-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 21:020}
Section 1. Definitions.
(1) "Applicant" means an individual desiring services paid in part by the screening program.
(2) "Contractor" means a person or facility that agrees to the terms of participation of the screening program in contract and ensures services are delivered pursuant to the screening program terms.
(3) "Department" is defined by KRS 214.540(1)(a).
(4) "Program" is defined by KRS 214.540(1)(b).
Section 2. Eligibility Criteria.
(1) In order to receive a service established in Section 3 of this administrative regulation, an applicant shall:
(a) Meet the eligibility for screening pursuant to American Cancer Society Colorectal Cancer Screening Guidelines;
(b) Be a legal resident of Kentucky;
(c) Have an individual income at or below 300 percent of the federal poverty level, established annually by the United States Department of Health and Human Services pursuant to 42 U.S.C. 9902(2); and
(d) If covered by health insurance, have an out-of-pocket maximum that is five (5) percent or more of the individual's annual income.
(2) A service received without prior authorization from the screening program shall be covered.
Section 3. Services. If funding is available, the services to be paid in part by the program shall include colon cancer screening tests and may include:
(1) Referral, examination, and rescreening for individuals for whom further examination or treatment is indicated by the colon cancer screening;
(2) Surveillance; and
(3) Treatment.
Section 4. Contractor Responsibility. A contractor shall:
(1) Complete a KCCSP 101, Kentucky Colon Cancer Screening Program Eligibility and Enrollment, with the applicant;
(2) Review the completed KCCSP 102, Kentucky Colon Cancer Screening Program Affidavit;
(3) Determine applicant eligibility pursuant to Section 2 of this administrative regulation;
(4) If the applicant is eligible, provide service or referral for service; and
(5) Report program data into the data collection system pursuant to Section 5 of this administrative regulation.
Section 5. Fees.
(1) A nominal fee up to five (5) dollars may be charged for colon cancer screening services as specified by the Department for Public Health.
(2) A contractor shall have approval of the department before charging an applicant fee.
Section 6. Data Collection System. The contractor shall submit to the department:
(1) The total number of colon cancer screening services specified in Section 3 conducted; and
(2) The applicant demographic information as documented on the KCCSP 101 form.
Section 7. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) FormKCCSP 101, "Kentucky Colon Cancer Screening Program Eligibility and Enrollment", 11/2018; and
(b) FormKCCSP 102, "Kentucky Colon Cancer Screening Program Affidavit", 11/2018.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, First Floor, Health Services Building, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 205.520, 214.540, 214.542, 214.543, 304.17A-257, 42 U.S.C. 9902(2)
- STATUTORY AUTHORITY: KRS 194A.050(1), 214.542(6)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 214.542(6) requires the Department for Public Health to promulgate administrative regulations to implement the Kentucky Colon Cancer Screening Program. This administrative regulation establishes the eligibility criteria, services, and requirements for participation in the colon cancer screening program.
- History: 902 KAR 021:020. New 43 Ky.R. 1348, 1592, 1767; eff. 5-5-2017; TAm eff. 5-1-2018; 46 Ky.R. 719; eff. 11-1-2019; Crt eff. 5-14-2026.
902 KAR 21:030 Pediatric Cancer Research and Treatment Grant Program {#sec-902-kar-21-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 21:030}
Section 1. Definitions.
(1) "Applicant" means a not-for-profit entity, academic medical center, or government agency in Kentucky offering research funding and treatment to Kentucky children impacted by pediatric cancer and applying for a grant pursuant to this administrative regulation.
(2) "Board" means the Pediatric Cancer Research Trust Fund Board created by KRS 211.596.
(3) "Funding" means a financial grant from the Pediatric Cancer Research Trust Fund created by KRS 211.595.
Section 2. Application Process.
(1) An applicant may apply or reapply each year for grant funding.
(2) To apply for grant funding, an applicant shall mail to the board:
(a) A completed PCRTF 101, Pediatric Cancer Research Trust Fund, Application for Research and Treatment Grant Program:
-
Postmarked on or before the date specified in the applicable grant notice; and
-
Addressed to the Department for Public Health, Division of Prevention and Quality Improvement, Chronic Disease Prevention Branch, 275 East Main Street, Frankfort, Kentucky 40621;
(b) A project description that includes the following information:
-
The need for the funding;
-
The goals and objectives, including how many people will be affected and in what geographic area;
-
The outcomes directly related to the impact of the research;
-
An implementation plan describing how the objectives will be met;
-
A timeline for implementation of the proposed research;
-
Plans designed to measure the success of the research; and
-
Intent to provide a semi-annual progress report and a year-end progress report documenting progress toward meeting the grant objectives; and
(c) The following financial information:
-
A detailed budget of requested funds; and
-
A description of any other sources of funds for the research including in-kind participation.
(3) A faxed or incomplete application shall not be considered for funding.
Section 3. Duties of the Board.
(1) The board shall:
(a) Hold meetings and conduct board business pursuant to KRS 211.596;
(b) Advertise a grant funding opportunity on the Cabinet for Health and Family Services Web site including:
-
A postmark date for submission of an application;
-
The mailing address for the application as specified in Section 2(2)(a)2. of this administrative regulation; and
-
An anticipated grant award date;
(c) Review and score applications based on the following criteria:
-
Relevancy to the mission of the Pediatric Cancer Research Trust Fund;
-
Offer of research funding and treatment specifically for pediatric cancer to Kentucky children impacted by the disease;
-
Proposal to address the prioritized list of programs and research projects the board has identified; and
-
Enhancement, but not duplication, of a program or research project currently provided in the same geographic area; and
(d) To the extent funds are available:
-
Award a Pediatric Cancer Research and Treatment Grant to a selected applicant; and
-
Notify the applicant of the award decision:
a. Within ninety (90) days after application deadline;
b. In writing; and
c. By certified mail.
(2) The board's decision for award selection shall be final.
(3) A selected applicant shall sign and return a grant agreement:
(a) To the board; and
(b) Postmarked within two (2) weeks of receipt.
(4) If a research grant is awarded, the grant shall be contingent upon a grant recipient's appropriate Institutional Review Board approval if applicable.
Section 4. Grant Objectives Reporting.
(1) A grant recipient shall provide semi-annual and year-end progress reports to the board as specified in Section 2(2)(b)7 of this administrative regulation.
(2) A grant recipient that is not making progress toward meeting grant objectives, as determined by the board, shall be notified in writing that objectives are not being met. The grant recipient shall:
(a) Submit to the board within thirty (30) days of receiving the notice a corrective action plan addressing the objectives that are not being met; and
(b) Reimburse the board for grant funds received to date if the corrective action plan is not implemented.
Section 5. Incorporation by Reference.
(1) Form "PCRTF 101, Pediatric Cancer Research Trust Fund, Application for Research and Treatment Grant Program", 3/2017, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Health Services Building, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 141.445, 194A.095, 211.595-597
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.597(2) and (3)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.597(3) requires the Pediatric Cancer Research Trust Fund Board to promulgate administrative regulations necessary to carry out the provisions of KRS 211.596. KRS 211.597(2) requires the Pediatric Cancer Research Trust Fund Board to promulgate administrative regulations to establish a competitive, open grant program to provide funding to specific entities offering research funding and treatment for pediatric cancer for Kentucky children impacted by the disease. This administrative regulation establishes the Pediatric Cancer Research and Treatment Grant Program.
- History: 43 Ky.R. 1910, 2148; eff. 6-21-2017; Cert. eff. 8-10-2023.
902 KAR 21:040 Community health worker certification {#sec-902-kar-21-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 21:040}
Section 1. Definitions.
(1) "Applicant" means an individual applying to be certified or recertified as a community health worker.
(2) "Certification" means the voluntary process by which the department grants recognition and use of a credential to individuals who are eligible to practice as certified community health workers.
(3) "Certified community health worker" or "CCHW" is defined by Ky Acts ch. 86.
(4) "Code of ethics" means the commonly understood principles and practices that all health and social service professionals are subject to. The Community Health Worker (CHW) code of ethics is maintained by the Kentucky Office of Community Health Workers and is available at https://chfs.ky.gov/agencies/dph/dpqi/cdpb/Pages/chwp.aspx.
(5) "Core competencies" means the knowledge and skills gained through education and experience, and includes:
(a) Communication;
(b) Use of public health concepts and approaches;
(c) Organizational and community outreach;
(d) Advocacy and community capacity building;
(e) Care coordination and system navigation;
(f) Health coaching;
(g) Documentation, reporting, and outcome management; and
(h) Legal, ethical, and professional conduct.
(6) "Department" means the Kentucky Department for Public Health.
(7) "Program" means the Kentucky Office of Community Health Workers (KOCHW) in the Department for Public Health.
(8) "Verifiable employment" means employment that can be confirmed by the department and that demonstrates achievement of a minimum standard of proficiency in the core competencies.
Section 2. Application for Initial Certification.
(1) An applicant for initial certification as a certified community health worker shall meet the qualifications listed in Ky Acts ch. 86.
(2) Applications shall be submitted to the program for review and approval.
(3) All applications shall include a color photograph of the applicant.
(4) A nonrefundable application fee of fifty (50) dollars by check or money order made payable to the Kentucky State Treasurer shall be submitted to the program.
(5) The application shall not be considered complete and shall not be processed until all information and any subsequent documentation requested by the program is provided.
(6) If an application is denied, the applicant shall be notified in writing of the decision and given the opportunity to reapply or appeal the denial decision.
(7) Once an application is approved, a certificate with a certificate number shall be issued.
Section 3. Certified Community Health Worker Eligibility.
(1) An applicant for certification as a community health worker may be eligible based on training or verifiable employment.
(2) To be eligible based on training, the applicant shall submit:
(a) Documentation of successful completion of a competency-based training program by a KOCHW approved organization. Training shall be completed within three (3) years prior to application; and
(b) Documentation of successful completion of a minimum of forty (40) hours of verifiable mentorship completed within three (3) years prior to application.
(3) To be eligible based on experience the applicant shall have a minimum of 2,500 hours of verifiable employment as a community health worker within three (3) years prior to application.
Section 4. Renewal of a Current Certificate.
(1) All certificates for CCHWs shall be renewed annually by October 31.
(2) A CCHW who holds a current certificate and has completed the continuing education requirements for renewal in Section 6 of this administrative regulation may apply to renew their certificate by:
(a) Submitting a complete application; and
(b) Payment of the twenty-five (25) dollar renewal application fee by check or money order made payable to the Kentucky State Treasurer.
Section 5. Extension for Renewal.
(1) A CCHW may submit a written request for an extension to submit the renewal paperwork. This written request shall:
(a) Be received by the program on or before October 31; and
(b) Provide justification for the request.
(2) The program may grant an extension beyond the October 31 deadline based on extenuating circumstances beyond the control of the CCHW.
(3) The CCHW shall be notified in writing of the program's decision to grant or deny the extension.
(4) Failure to submit the renewal or request an extension by the October 31 deadline shall result in expiration of the certificate.
Section 6. Continuing Education Requirements.
(1) Continuing education requirements for renewal shall be fulfilled during each annual renewal period.
(2) A CCHW shall complete a minimum of ten (10) contact hours of continuing education related to the core competencies each annual renewal period.
(3) Credit for semester hours taken at a college or university shall be:
(a) Consistent with the community health worker core competencies; and
(b) Approved at three (3) credits for each semester hour.
(4) Continuing education courses may be:
(a) Completed in person before a live presenter;
(b) Through home or self-study; or
(c) Delivered through electronic media or technology including distance learning, online, or teleconference.
(5) Effective October 31, 2023, all CCHWs shall complete a KOCHW approved training in oral healthcare, infant and maternal healthcare, and geriatric healthcare.
(a) CHWs who hold a current certification shall complete the training by October 2023 for renewal.
(b) CHWs who become newly certified shall complete the training within twelve (12) months of certification.
(c) These are one-time requirements and shall not need to be repeated.
(6) The program shall maintain a record of all approved community health worker training providers on the program's website.
(7) Providers of approved curricula shall notify the program within twenty (20) business days of a trainee's successful completion of a community health worker training.
Section 7. Certified Community Health Worker Scope of Practice. A certified community health worker may:
(1) Provide cultural mediation among individuals, communities, and health and social service systems;
(2) Provide culturally appropriate health education and information;
(3) Provide care coordination, case management, and system navigation services;
(4) Provide coaching and social support;
(5) Advocate for individuals and communities;
(6) Build individual and community capacity;
(7) Provide direct services;
(8) Implement individual and community assessments;
(9) Conduct outreach; or
(10) Participate in evaluation and research.
Section 8. Complaint Procedures.
(1) Any organization or individual may file a signed written complaint.
(2) The complaint shall be sent to the Kentucky Office of Community Health Workers, 275 East Main Street, HS2W-E, Frankfort, Kentucky 40621 or by email at chw.certification@ky.gov, subject line "Community Health Worker Complaint".
(3) The complaint shall include:
(a) A statement that the CCHW has violated the requirements of this administrative regulation or the CHW code of ethics;
(b) The facts on which the complaint is based; and
(c) The signature and contact information for the complainant.
(4) The program shall provide notice to the CCHW named in the complaint that a complaint has been filed and provide the CCHW an opportunity to respond to the complaint, including a proposal to resolve the complaint.
(5) The alleged violation shall have occurred not more than one (1) year before the date that the complaint is received by the program.
(6) Within sixty (60) calendar days after a complaint is filed, the program shall:
(a) Carry out an independent investigation, if the program determines that an investigation is necessary;
(b) Give the complainant the opportunity to submit additional information, either orally or in writing, about the allegations in the complaint;
(c) Review all relevant information and make a determination as to whether the CCHW has violated the requirements of this administrative regulation or the code of ethics; and
(d) Issue a written decision to the complainant that addresses each allegation in the complaint and contains the reasons for the program's final decision.
Section 9. Denial, Suspension, and Revocation of a Certificate.
(1) The program reserves the right to:
(a) Deny an application for certification or renewal; and
(b) Conduct an audit of a CCHW.
(2) Written notice of the denial of an application for certification or renewal shall be provided to the applicant and include:
(a) The applicant's opportunity to reapply; or
(b) Right to appeal.
(3) A request to appeal the denial of a certificate shall be submitted to the department within ten (10) days from the date listed on the written notice issued pursuant to subsection (2) of this section and provide evidence that the denial was in error.
(4) The department shall re-evaluate the evidence and issue a final notice to the applicant within ten (10) days.
(5) An applicant whose application is denied following the appeal shall be ineligible to apply for a period of one (1) year following the final notice of denial.
(6) A certificate may be suspended if:
(a) Audit findings show the CCHW has violated the requirements of the program; or
(b) The CCHW is found in violation of the CHW code of ethics.
(7) Written notice of the suspension shall be provided to the CCHW and include the right to appeal.
(8) A request to appeal the suspension shall be submitted to the program within ten (10) days of the notice and include evidence that the suspension is in error or the reason for the suspension has been corrected.
(9) Failure to submit a request to appeal the suspension within ten (10) days shall result in permanent suspension of the certificate.
(10) A certificate that has been suspended for one (1) year shall be considered revoked.
(11) During the period of suspension, the CCHW shall return the certification and identification card to the program and shall not engage in the practice of community health work until the suspension is lifted or further disciplinary action is taken.
(12) A certificate shall be revoked for repeated violations of the requirements of this administrative regulation or the CHW code of ethics.
(13) Written notice of the revocation shall be provided to the CCHW and include the right to request a hearing in accordance with KRS Chapter 13B.
History
- RELATES TO: KRS13B.080-160, 211.090, 211.180
- STATUTORY AUTHORITY: KRS 194A.050, 2022 Ky Acts ch. 86
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. Ky Acts ch. 86 authorizes the Department for Public Health to promulgate administrative regulations for the certification of community health workers. This administrative regulation establishes the certification requirements for a community health worker.
- History: 49 Ky.R. 506, 1096; eff. 11-15-2022.
Chapter 22 Kentucky Board of Family Health Care Providers
902 KAR 22:040 Charitable health care providers {#sec-902-kar-22-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 22:040}
Section 1. Definitions.
(1) "Charitable health care provider" is defined by KRS 216.940(1).
(2) "Sponsoring organization" is defined by KRS 216.940(3).
Section 2. Registration Requirements.
(1) Pursuant to KRS 216.941(3), a charitable health care provider shall file with the cabinet a completed Form CHP-1, Registration of Charitable Health Care Providers.
(2) Pursuant to KRS 216.941(3), a sponsoring organization shall file with the cabinet a completed Form SO/CHP-1, Registration of Sponsoring Organization of Charitable Health Care Providers.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) CHP-1, Registration of Charitable Health Care Providers, September 2004; and
(b) SO/CHP-1, Registration of Sponsoring Organizations of Charitable Health Care Providers, October 2005.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Division of Adult and Child Health Improvement, Community Health Branch, 275 East Main Street, Frankfort, Kentucky, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 216.940, 216.941, 304.40-075
- STATUTORY AUTHORITY: KRS 216.941(3)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 216.941(3) requires a charitable health care provider or sponsoring organization to register with the cabinet by filing a registration form required by the cabinet prior to providing charitable health care services in Kentucky. This administrative regulation establishes the registration forms required for a charitable health care provider or sponsoring organization.
- History: 25 Ky.R. 2074; 26 Ky.R. 397; eff. 8-16-99; 27 Ky.R. 1933; eff. 3-6-2001; 32 Ky.R. 565; 891; eff. 11-16-05; Crt eff. 11-26-2019; Crt eff. 9-2-2026.
Chapter 23 Women's Health
902 KAR 23:010 Breast Cancer Research and Education Grant Program {#sec-902-kar-23-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 23:010}
Section 1. Definitions.
(1) "Applicant" means a not-for-profit entity, educational institution, or government agency in Kentucky offering programs or services as described in KRS 211.590(2) and applying for a grant pursuant to this administrative regulation.
(2) "Board" means the Breast Cancer Research and Education Trust Fund Board created by KRS 211.585.
(3) "Funding" means a financial grant from the Breast Cancer Research and Education Trust Fund created by KRS 211.580.
Section 2. Application Process.
(1) An applicant may apply or reapply each year for grant funding to support the applicant's program or service in the areas established by KRS 211.590(2).
(2) To apply for grant funding, an applicant shall mail to the board:
(a) A completed "Breast Cancer Research and Education Trust Fund, Application for Research and Education Grant Program" grant application form:
-
Postmarked on or before the date specified in the applicable grant notice; and
-
Addressed to the Cabinet for Health and Family Services, Department for Human Support Services, Division of Women's Physical and Mental Health, 275 East Main Street, Frankfort, Kentucky 40621; and
(b) A project description that includes the following information:
-
The need of the program or service;
-
The goals and objectives including how many people will be affected and in what geographic area;
-
The outcomes directly related to the changes or impact of the program or service;
-
An implementation plan describing how the objectives will be met;
-
A timeline for implementation of the proposed program or service;
-
Plans designed to measure the success of the program or service; and
-
Intent to provide semi-annual and year-end progress reports documenting satisfactory progress toward meeting the grant objectives; and
(c) The following financial information:
-
A detailed budget of requested funds; and
-
A description of any other sources of funds for the program or service including in-kind participation.
(3) A faxed or incomplete application shall not be considered for funding.
Section 3. Duties of the Board.
(1) The board shall:
(a) Hold meetings and conduct board business pursuant to KRS 211.585(9);
(b) Advertise a grant on the Cabinet for Health and Family Services Web site including:
-
A postmark date for submission of an application;
-
The mailing address for the application as specified in Section 2(2)(a)2 of this administrative regulation; and
-
An anticipated grant award date;
(c) Review and score applications based on the following criteria:
-
Relevancy to the mission of the Breast Cancer Research and Education Trust Fund;
-
Offer of a program or service in the areas of:
a. Research;
b. Education;
c. Awareness;
d. Treatment; or
e. Screening;
-
Proposal to serve the medically underserved population;
-
Proposal to address the prioritized list of programs and research projects the board has identified; and
-
Enhancement but not duplication of a program or service currently provided in the same geographic area;
(d) Give first preference to programs and priorities for grant awards according to the following priorities established by the board in accordance with KRS 211.590(2)(a) and (b):
-
Disparate populations;
-
Never and rarely screened; and
-
Translational research in clinical demonstration projects; and
(e) To the extent funds are available, award a Breast Cancer Research and Education Grant:
-
To a selected applicant; and
-
Notify the applicant of the award decision:
a. Within ninety (90) days after application deadline;
b. In writing; and
c. By certified mail.
(2) The board's decision for award selection shall be final.
(3) The successful applicant shall sign and return a grant agreement:
(a) To the board; and
(b) Postmarked within two (2) weeks of receipt.
(4) If a research grant is awarded, the grant shall be contingent upon a grant recipient's appropriate Institutional Review Board approval if applicable.
Section 4. Grant Objectives Reporting.
(1) A grant recipient shall provide semi-annual and year-end progress reports to the board as specified in Section 2(2)(b)7.
(2) A grant recipient that is not making satisfactory progress toward meeting grant objectives, as determined by the board, shall be notified in writing that objectives are not being met. The grant recipient shall:
(a) Submit to the board within thirty (30) days of receiving the notice a corrective action plan addressing the objectives that are not being met; and
(b) Reimburse the board for grant funds received to date if the corrective action plan is not implemented.
Section 5. Incorporation by Reference.
(1) "The Breast Cancer Research and Education Trust Fund, Application for Research and Education Grant Program", edition 12/06, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 141.446, 194A.095, 211.580, 211.585, 211.590(1), (4)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.590(2), (3)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.590(3) authorizes the Breast Cancer Research and Education Trust Fund Board to promulgate administrative regulations necessary to carry out the provisions of KRS 211.580 to 211.590. KRS 211.590(2) requires the Breast Cancer Research and Education Trust Fund Board to promulgate administrative regulations to establish a competitive grant program to provide funding to organizations offering programs or services in the areas of breast cancer research, education, awareness, treatment, and screening. This administrative regulation establishes the Breast Cancer Research and Education Grant Program.
- History: 33 Ky.R. 1479; 1822; eff. 2-2-2007; Recodified from 920 KAR 3:010; 4-12-2017; Crt eff. 11-5-2019; Crt eff. 8-12-2026.
Chapter 28 Trauma System
902 KAR 28:010 Definitions for 902 KAR Chapter 28 {#sec-902-kar-28-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:010}
Section 1. Definitions.
(1) "ABEM" means the American Board of Emergency Medicine.
(2) "ACS COT" means the American College of Surgeons Committee on Trauma.
(3) "Adult" means an individual who has attained eighteen (18) years of age.
(4) "AOBEM" means the American Osteopathic Board of Emergency Medicine.
(5) "ATCN" means the Advanced Trauma Care for Nurses course for registered nurses of the American College of Surgeons Society of Trauma Nurses.
(6) "ATLS" means the Advanced Trauma Life Support course of the American College of Surgeons.
(7) "Board certified" means the physician has been certified by the appropriate specialty board recognized by the American Board of Medical Specialties.
(8) "Commissioner" means the commissioner of the Kentucky Department for Public Health.
(9) "Consultation" means the peer review process that:
(a) A hospital may request prior to verification to assess the hospital's system of trauma care, institutional capabilities, and preparedness for verification; and
(b) Is conducted in accordance with 902 KAR 28:030, Section 2(1)(a).
(10) "Department" means the Department for Public Health, Cabinet for Health and Family Services.
(11) "Designation" means the process established in 902 KAR 28:020 by which a hospital is identified by the department as an appropriate facility to receive traumatically injured patients.
(12) "Emergency medical services" or "EMS" is defined by KRS 311A.010(9).
(13) "Health Insurance Portability and Accountability Act of 1996" or "HIPAA" means the federal law codified at 45 C.F.R. Parts 160, 162, and 164 that covers the use of a patient's protected health information.
(14) "ITLS" or "International Trauma Life Support" means an international standard training course for pre-hospital trauma care designed by the American College of Surgeons.
(15) "Kentucky Trauma Advisory Committee" or "KyTAC" means the advisory committee established by KRS 211.494(3).
(16) "Kentucky Trauma Data Bank" or "KTDB" means a database of information submitted by designated trauma centers on the operation, quality, and services provided to patients, consistent with the standards of the National Trauma Data Bank (NTDB) as established by the American College of Surgeons Committee on Trauma (ASC COT).
(17) "Kentucky Trauma Hospital Reference Manual" means the detailed reference document that:
(a) Provides guidance, information, references, and resources to assist hospital facilities:
-
Seeking designation as a trauma center pursuant to 902 KAR 28:020 or 28:030; or
-
Designated as a trauma center pursuant to 902 KAR 28:020 or 28:030;
(b) Is published by the Kentucky Trauma Advisory Committee and available on the Kentucky Hospital Association Web site at https://www.kyha.com/kentucky-trauma-system; and
(c) Is incorporated by reference in 902 KAR 28:030, Section 3.
(18) "Level I trauma center" means a regional trauma center that:
(a) Provides total care of every aspect of injury from prevention through rehabilitation; and
(b) Meets the requirements for a Level I trauma center established in 902 KAR 28:020.
(19) "Level II trauma center" means a regional trauma center that:
(a) Provides screening and initial trauma care of the injured patient regardless of the severity of injury; and
(b) Meets the requirements for a Level II trauma center established in 902 KAR 28:020.
(20) "Level III trauma center" means a regional trauma center that:
(a) Provides prompt assessment, resuscitation, emergency operations, and stabilization;
(b) Arranges for transfer, if warranted, to a facility that can provide trauma care at a higher level;
(c) Serves communities that do not have immediate access to a Level I or Level II trauma center; and
(d) Meets the requirements for a Level III trauma center established in 902 KAR 28:020.
(21) "Level IV trauma center" means a regional trauma center that:
(a) Provides advanced trauma life support before a patient is transferred to a higher level of care;
(b) Is located in a hospital emergency department; and
(c) Meets the requirements for a Level IV trauma center established in 902 KAR 28:030.
(22) "Multidisciplinary trauma review committee" means a committee composed of the facility's trauma services medical director and other members of the facility trauma team that reviews trauma related morbidity and mortality in a hospital.
(23) "NTDB" or "National Trauma Data Bank" means the national repository of trauma registry data established by the ACS COT and found at https://www.facs.org/quality-programs/trauma/quality/national-trauma-data-bank/.
(24) "Prehospital care provider" means an individual or organization certified or licensed by the Kentucky Board of Emergency Medical Services to provide out-of-hospital emergency medical services.
(25) "Process improvement program" means a quality assurance program established by a trauma center in accordance with the requirements of the ACS COT or the KyTAC that:
(a) Continually evaluates the performance and quality of care provided by a trauma center; and
(b) Recommends quality improvements to the trauma care program of the center.
(26) "Protected health information" means a patient's information as defined in the Health Insurance Portability and Accountability Act of 1996, or HIPAA, 45 C.F.R. Parts 160, 162, and 164.
(27) "Response time" means the interval between notification and arrival of the general surgeon, surgical specialist, or other medical professional in the emergency department or operating room.
(28) "RTTDC" or "Rural Trauma Team Development Course" means a course developed by ACS COT for rural hospitals to help a rural hospital develop its trauma team.
(29) "TNCC" or "Trauma Nursing Care Course" means a training course that focuses on trauma care for nurses developed by the Emergency Nurses Association.
(30) "Transfer agreement" means the formal, written agreement between hospitals for the transfer and acceptance of patients that meets the requirements established in 902 KAR 28:030.
(31) "Trauma" is defined by KRS 211.492(1) and 311A.010(23).
(32) "Trauma center" is defined by KRS 211.492(2).
(33) "Trauma center verification" is defined by KRS 211.492(3).
(34) "Trauma coordinator" or "trauma services manager" means an individual:
(a) Designated by the hospital with responsibility for the coordination of all trauma care activities and who works in collaboration with the trauma services medical director; and
(b) Responsible for the requirements established in 902 KAR 28:030.
(35) "Trauma registry" means a database comprised of trauma center data that is submitted by a hospital designated as a trauma center consistent with the standards of the National Trauma Data Bank (NTDB) as established by the American College of Surgeons Committee on Trauma (ASC COT).
(36) "Trauma services medical director" means the physician designated by the hospital to coordinate trauma care.
(37) "Trauma system" means the integrated network of hospitals and medical services including transportation that strives to provide the timely and appropriate services relative to the degree of the patient's injury.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496, 311A.010, 45 C.F.R. Parts 160, 162, 164
- STATUTORY AUTHORITY: KRS 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the definitions for 902 KAR Chapter 28 pertaining to the statewide trauma care system.
- History: 38 Ky.R. 1673; 1859; eff. 6-1-2012; Crt eff. 9-11-2019; 51 Ky.R. 809; eff. 2-13-2025.
902 KAR 28:020 Kentucky trauma system designation process {#sec-902-kar-28-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:020}
Section 1. Hospital Trauma Center Designation. A hospital shall receive designation as a trauma center by the Department for Public Health following successful completion of the verification and review process established in this administrative regulation and 902 KAR 28:030.
(1) Each hospital seeking designation in the Kentucky trauma care system shall adhere to:
(a) The criteria established by the American College of Surgeons Verification Review Committee that is available at https://www.facs.org/quality-programs/trauma/quality/verification-review-and-consultation-program/, if the facility is seeking designation as a Level I, II, or III trauma center; or
(b) The standards for Level IV designation established in 902 KAR 28:030.
(2) Each hospital in Kentucky that volunteers to become part of the trauma care system shall make application to the Commissioner of Public Health using the:
(a) KYTAC-Application-1, Hospital Application for Level IV Verification and Kentucky Designation as a Trauma Center, if the facility is seeking designation as a Level IV trauma center; or
(b) KYTAC-Application-2, Hospital Application for Kentucky Trauma Center Designation, if the facility is seeking designation as a Level I, II, or III trauma center.
(3)
(a)
-
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following trauma center verification.
-
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit by either ACS COT or a Kentucky verification team.
(b) Each hospital shall be reverified to maintain trauma designation.
(4) Only those hospitals that are designated trauma centers under the provisions of 902 KAR 28:010 through 28:060 shall be recognized by the commonwealth as belonging to the Kentucky Trauma Care System and may hold themselves out to the public as a trauma center.
Section 2. Level I, II, or III Designation.
(1) Upon being notified that the ACS COT has been requested to conduct a Level I, II, or III trauma center verification visit, and with the agreement of both the applying hospital and the ACS COT, the commissioner shall direct a representative of the department or the KyTAC to participate as an observer during the site visit.
(2) The commissioner shall issue a certificate of designation in the Kentucky trauma care system concurrent with the recommendations and time period specified in the ACS COT documents upon receipt of the KYTAC-Application-2, the appropriate fees, and a copy of the ACS COT documents indicating satisfactory verification to their latest standards.
(3) The state-issued designation certificate shall be posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.
Section 3. Level IV Trauma Center Designation.
(1) Designation process.
(a) Once the facility has completed the Level IV verification and review process pursuant to Section 1 of this administrative regulation, the original completed KYTAC-Application-1 shall be forwarded to KyTAC. KyTAC shall conduct a review of the facility's compliance with this administrative regulation and 902 KAR 28:030 and make recommendations to the commissioner within sixty (60) days of receipt of the application.
(b)
- If the facility meets all the requirements of this administrative regulation and 902 KAR 28:030, a certificate of trauma center designation shall be:
a. Issued by the commissioner for a three (3) year period following completion of the trauma center verification process except as provided by subparagraph 2. of this paragraph; and
b. Posted in a public area of the hospital adjacent to the Kentucky facility licensure certificate.
-
If the facility has a deficiency that is not deemed critical to the effective functioning of the trauma center, the commissioner may issue a provisional designation certificate for a period of time less than three (3) years to provide time to address or correct the deficiency. The commissioner shall send a written notice informing the facility of that determination, and the facility may be subject to a subsequent audit or re-verification of the finding to confirm that it was satisfactorily addressed. The facility may appeal the decision in accordance with 902 KAR 28:060.
-
If the facility does not meet the requirements of this administrative regulation and 902 KAR 28:030, the commissioner shall send a written notice to the facility informing the facility of that determination. The facility may appeal the decision in accordance with 902 KAR 28:060.
(c)
-
Except as provided by subparagraph 2. of this paragraph, designation shall be for a three (3) year period following satisfactory completion of the trauma center verification process.
-
Designation shall be for less than a three (3) year period following trauma center verification if the facility received a shorter provisional designation to address a non-critical deficiency identified during the verification site visit in accordance with paragraph (b)2. of this subsection.
(2) Redesignation. At least four (4) months preceding the expiration of a designation certificate, the hospital shall initiate the process established in 902 KAR 28:030 for reverification and redesignation.
Section 4. Designation Suspension or Revocation.
(1) A designated trauma center hospital that is unable to meet the applicable minimum required criteria of a Level I, Level II, or Level III trauma center as established by ACS COT, or a Level IV trauma center as established in 902 KAR 28:030, shall notify the commissioner within five (5) business days of the event that caused the facility to fall below minimum criteria.
(2) If the commissioner becomes aware of a significant change in the status of the trauma care program at a designated hospital that may potentially affect its designation status, the commissioner may:
(a) Request confirmation of continued designation status from the hospital; or
(b) Assign a representative of KyTAC or a designee to conduct a site visit to review the status of the trauma program and report the findings to the commissioner within thirty (30) days of assignment.
(3) The commissioner may consult with KyTAC and the ACS COT on information received from the hospital and site visit, and may:
(a) Suspend the hospital's designation;
(b) Place the facility into a probationary status pending resolution within thirty (30) days of the disciplinary action; or
(c) Revoke the hospital's designation.
(4) If the designation is revoked, and if the facility seeks redesignation, the facility shall correct the identified problems, and request, at its expense, a focused review to demonstrate that each problem has been corrected.
(5) Following the review required by subsection (4) of this section, the commissioner shall:
(a) Reinstate the designation;
(b) Request that the facility reapply for verification at a lower level;
(c) Deny redesignation; or
(d) Refer the matter to KyTAC for determination of other appropriate action.
(6) A hospital not able to meet trauma center criteria at the initial designation level shall not hold designation as a trauma center until reverified at an appropriate level and redesignated.
Section 5. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) KYTAC-Application-1, "Hospital Application for Level IV Verification and Kentucky Designation as a Trauma Center", January 2024; and
(b) KYTAC-Application-2, "Hospital Application for Kentucky Trauma Center Designation", January 2024.
(2) This material:
(a) May be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissioner's Office, 275 East Main Street, Frankfort, Kentucky 406012, Monday through Friday, 8 a.m. to 4:30 p.m.; and
(b) Is available online at https://www.kyha.com/kentucky-trauma-system/.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
- STATUTORY AUTHORITY: KRS 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the voluntary hospital designation process for Kentucky's trauma system.
- History: 26 Ky.R. 668; 1008; eff. 11-15-1999; 38 Ky.R. 1676; 1860; eff. 6-1-2012; Crt eff. 9-11-2019; 51 Ky.R. 812, 1480; eff. 2-13-2025.
902 KAR 28:030 Kentucky's trauma system level IV criteria {#sec-902-kar-28-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:030}
Section 1. Level IV Trauma Centers.
(1) A hospital that seeks designation as a Level IV trauma center shall meet the criteria established in this subsection.
(a) Trauma program.
-
A trauma program shall be created with agreement from the hospital's board of directors, administration, and medical staff.
-
The board of directors, administration, medical, nursing, and ancillary staff shall commit to provide trauma care at the level for which the facility is seeking trauma center verification.
-
A board resolution advising of that commitment shall be submitted with the KYTAC-Application-1, incorporated by reference in 902 KAR 28:020, Section 5.
-
The trauma program shall adopt and meet the "Pediatric Readiness in the Emergency Department" policy guidance for care of children, as endorsed by the American Academy of Pediatrics (AAP), the American College of Emergency Physicians (ACEP), the American College of Surgeons, and the Emergency Nurses Association (ENA), and published at https://www.annemergmed.com/article/S0196-0644(18)31167-3/pdf.
(b) Trauma services medical director.
-
The trauma services medical director shall be a physician on staff at the facility.
-
The job description shall include roles and responsibilities for trauma care, including trauma team formation, supervision and leadership, and continuing education.
-
The medical director shall act as the medical staff liaison to administration and nursing staff, and as the primary contact for that facility with other trauma centers in the region.
-
The medical director shall maintain certification as an Advanced Trauma Life Support (ATLS) provider if not Board Certified/Board Eligible by the American Board of Emergency Medicine (ABEM) or the American Osteopathic Board of Emergency Medicine (AOBEM). The trauma services medical director shall participate in a Rural Trauma Team Development Course (RTTDC).
(c) Trauma coordinator.
-
The facility shall have a trauma coordinator who may be referred to as the trauma services manager or trauma program manager.
-
The trauma coordinator shall work with the medical director to coordinate and implement the facility's trauma care response.
-
The job description of this position shall include time dedicated to the trauma program, separate from other duties the trauma coordinator may have at the facility.
(d) Emergency department coverage.
-
The facility shall have twenty-four (24) hour physician coverage of the emergency department and a designated physician medical director for the emergency department.
-
A mid-level provider, such as a nurse practitioner or physician assistant, may serve as the trauma team leader. A designated emergency department physician shall be present for immediate consultation during trauma team activations.
(e) Emergency department physicians. Physicians assigned to the emergency department of a Level IV Trauma Center shall:
-
Be licensed in the Commonwealth of Kentucky; and
a. Maintain current Advanced Trauma Life Support© (ATLS) provider certification; or
b. Be certified by ABEM or AOBEM.
(f) Surgical staff.
-
Orthopedic surgery, plastic surgery, and radiology medical staff availability shall be documented by published call schedules.
-
If surgical services are provided, anesthesia coverage shall be provided.
-
Surgical staff shall document completion of fifteen (15) hours of annual trauma-related continuing medical education for surgeons completed every three (3) years as part of the CME required by the Kentucky Board of Medical Licensure.
-
Surgical specialties participating in the trauma team shall have at least one (1) representative of its specialty attend more than half of the hospital's multi-disciplinary trauma review committee meetings.
(g) Prior to being assigned to the facility's trauma team, nurses responsible for trauma care at the facility shall have completed one of the following professional education courses specific to trauma care:
-
Trauma Nursing Core Course (TNCC); or
-
Advanced Trauma Care for Nurses (ATCN).
(h) Transfer Protocols.
-
The facility shall have a written transfer protocol describing the method to transfer the trauma patient requiring a higher level of care.
-
The transfer protocol shall address:
a. Available ground or air transport services;
b. Alternative transport services;
c. Receiving trauma centers and trauma surgeon contact information;
d. What supplies, records, and resources shall be available for use to affect the transfer; and
e. Specific anatomic and physiologic criteria that will immediately initiate transfer to definitive care.
- The transfer protocol shall be developed with involvement of each local ground EMS provider and regional air medical provider to assure seamless patient care during transfer and be consistent with the protocol examples found in the Kentucky Trauma Hospital Reference Manual.
(i) Transfer agreements. A Level IV Trauma Center shall have:
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A written agreement with a verified Level I, II, or III trauma center or a hospital whose capabilities exceed that of a Level IV facility regarding the transfer and care of adult and pediatric trauma patients;
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A written agreement with back-up transfer agreements specifically for burn patients if the primary regional receiving facility does not have the required capacity; and
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Transfer plans that shall be defined and consistent with the examples found in the Kentucky Trauma Hospital Reference Manual.
(j) Radiology.
-
The facility shall have a radiologic technologist available on-site twenty-four (24) hours a day to provide basic plain films used in the evaluation of trauma patients.
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A twenty (20) minute response time for trauma team activation shall be required. Response times shall be documented and monitored by the trauma coordinator and the facility's process improvement program.
-
The facility shall have computed tomography and sonography capabilities.
(k) Clinical laboratory.
-
The facility shall have a lab technician available on duty or on-call twenty-four (24) hours a day to perform basic studies used in the initial evaluation of trauma patients, including Complete Blood Count, typing, coagulation profile, and Arterial Blood Gas.
-
A twenty (20) minute response time from trauma team activation shall be required for a lab technician. Response times shall be documented and monitored by the trauma coordinator and the facility's process improvement program.
-
The lab or facility blood bank shall have at least two (2) units of O-negative blood available for trauma patients, to be infused at the facility or while en route to definitive care.
-
Access to blood and blood products during an emergency situation if the lab is not staffed shall be documented.
-
The facility shall have the capability to conduct micro-sampling.
(l) Respiratory therapy.
-
The facility shall have a respiratory care practitioner on duty or on-call twenty-four (24) hours a day to respond to the emergency department if the trauma team is activated.
-
A twenty (20) minute response time from trauma team activation shall be required if a respiratory care practitioner is not on-site. Response times shall be documented and monitored by the trauma coordinator and the facility's process improvement program.
-
Other trained health care personnel may fulfill the respiratory care practitioner's role until the designated respiratory care practitioner arrives.
(2) Trauma Team Activation Protocol. A facility designated as a Level IV Trauma Center shall have a written trauma team activation protocol in place that:
(a) Documents the members of the trauma team and their response requirements if activated;
(b) Establishes the criteria based on severity, anatomy, or physiology of the injury for trauma team activation and provides the names of each person authorized to activate the trauma team; and
(c) Is consistent with the examples of trauma team activation protocols found in the Kentucky Trauma Hospital Reference Manual.
(3) Performance improvement.
(a) A facility designated as a Level IV Trauma Center shall develop a performance improvement program that includes:
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An in-house trauma registry or a secure on-line trauma registry system; and
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A written policy outlining the quality and performance improvement (PI) portion of the trauma program, which shall include:
a. The names of each person responsible for performing PI reviews;
b. The names of the multidisciplinary trauma review committee;
c. The composition by name and position of the morbidity and mortality review committee;
d. The minimum number of cases to be reviewed annually including:
(i) Patients requiring transfer;
(ii) Record of each trauma death;
(iii) Noncompliance of trauma team members to response time requirements;
(iv) Bypasses;
(v) Transfers; and
(vi) Trauma care provided by physicians not meeting minimal education requirements;
e. Frequency of performance improvement meetings;
f. Minimum requirements for member attendance by position; and
g. Feedback obtained from patients transferred to a Level I, II, or III trauma center.
(b) Each performance improvement program shall be consistent with the examples in the Kentucky Trauma Hospital Reference Manual.
(4) Level IV Trauma Center emergency department.
(a) Basic and essential equipment and supplies for the care and treatment of both adult and pediatric patients shall be present in a Level IV Trauma Center emergency room.
(b) A Level IV Trauma Center emergency room shall contain items described as the minimum equipment and supply lists found in the Kentucky Trauma Hospital Reference Manual.
(5) Level IV Trauma Center designated treatment rooms.
(a) Any operating room available and used for the surgical care of victims of trauma shall have the following:
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Operating room staff available within thirty (30) minutes of notification;
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Anesthesia staff available within thirty (30) minutes of notification; and
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Age-specific equipment including thermal control equipment for patients, fluids, and blood products.
(b) Post-anesthetic recovery shall contain equipment for monitoring and resuscitation, pulse oximetry, and thermal control.
(c) Required resuscitation equipment shall include:
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Airway and ventilation;
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Pulse oximetry;
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Suction;
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Electro Cardiogram;
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Defibrillator;
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IV administration sets;
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Large bore vascular catheters;
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Cricothyroidotomy;
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Thoracostomy;
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Emergency drugs;
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Broselow or Handtevy pediatric resuscitation system equipment and supplies;
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Fluid and body warmer,
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Qualitative CO2 detector; and
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EMS communication equipment.
(6) Trauma diversion.
(a) The Level IV trauma center shall have a policy in place that outlines the circumstances that shall trigger a trauma diversion and the procedures to be followed, including procedures if one (1) or more hospital resources are functioning at maximum capacity or are otherwise unavailable.
(b) This process shall be coordinated with the EMS providers in the service area and potential receiving facilities.
(c) Examples of trauma diversion protocols shall be found in the Kentucky Trauma Hospital Reference Manual.
(7) Other Level IV requirements. A facility designated as a Level IV trauma center may:
(a) Host or participate in a joint RTTDC program. Participation by physicians, members of administration, nursing, ancillary support staff, and local prehospital care providers shall be strongly encouraged;
(b) Conduct or participate in local or regional outreach education, specifically ATLS, APLS, ENPC, TNCC, and ITLS/PHTLS courses, and conduct or participate in local or regional presentations of trauma-related CME for physicians, nurses, prehospital staff, and other personnel; and
(c) Participate in injury prevention programs organized by the facility or in cooperation with the Kentucky Injury Prevention Research Center (KIPRC), law enforcement, fire, EMS and other safety organizations. Documentation of injury prevention program activities shall be available for review during the trauma center verification or reverification process.
Section 2. Level IV Site Visits.
(1) A hospital may request a site visit from a peer review team for a consultation visit, a verification visit, or a reverification visit.
(a) A consultation visit shall be conducted to assess the facility's system of trauma care delivery or to prepare for a verification visit.
-
A consultation visit shall follow the same format as a verification visit.
-
Site visit reviewers shall provide recommendations to aid a facility in attaining verification readiness.
(b) A verification visit shall be conducted to confirm the facility is performing as a trauma center according to the criteria listed in Section 1 of this administrative regulation.
-
Site visit reviewers shall provide a report of findings to the KyTAC.
-
The KyTAC, upon receipt and review of the report, shall recommend to the Commissioner of Public Health that:
a. A Certificate of Designation be issued, and that the Commissioner designate the facility as a Level IV Trauma Center; or
b. The facility be notified of deficiencies in writing and a focus review visit scheduled within eight (8) months of the date of the original verification visit to review those deficiencies and verify that they have been isolated and corrected.
(c) A reverification visit shall be requested by a facility previously issued a certificate of designation if the facility does not want its certificate of designation to expire.
-
The facility shall schedule a reverification visit at least four (4) months prior to the expiration date of its current certificate of designation as a Level IV Trauma Center.
-
A facility whose current certificate of designation has lapsed due to the facility's failure to initiate reverification shall submit a new KYTAC-Application-1 as required by 902 KAR 28:020 and this administrative regulation.
-
A reverification visit shall follow the same procedures established in subsection (2) of this section.
(2) Site visit teams.
(a) A site visit team shall be composed of a minimum number of persons as follows:
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Consultation visit: Two (2) members;
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Verification visit: Two (2) members;
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Reverification visit: Two (2) members; or
-
Focus review visit: Two (2) members, one (1) of whom shall have been on the original verification team.
(b) At least one (1) site visit team member shall be a physician or registered nurse trauma center program manager.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Kentucky Trauma Hospital Reference Manual", May 2024; and
(b) "Pediatric Readiness in the Emergency Department", Annals of Emergency Medicine, December 2018.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissioner's Office, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
(3) "Kentucky Trauma Hospital Reference Manual" is available online at https://www.kyha.com/kentucky-trauma-system/.
(4) "Pediatric Readiness in the Emergency Department", Annals of Emergency Medicine, is available online at https://www.annemergmed.com/article/S0196-0644(18)31167-3/pdf.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
- STATUTORY AUTHORITY: KRS 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the criteria for a Level IV trauma center in the Kentucky Trauma Care System.
- History: 26 Ky.R. 668; 1008; eff. 11-15-1999; 38 Ky.R. 1676; 1860; eff. 6-1-2012; Crt eff. 9-11-2019; 51 Ky.R. 812, 1480; eff. 2-13-2025.
902 KAR 28:040 Kentucky's Trauma Registry and Data Bank System {#sec-902-kar-28-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:040}
Section 1. Trauma Center Registries.
(1) All trauma centers designated by the Commissioner for Public Health in the Kentucky Trauma Care System shall:
(a) Establish and maintain a trauma registry that is compatible with the current NTDB standards established in the National Trauma Data Standard Data Dictionary available from the American College of Surgeons at https://www.facs.org/quality-programs/trauma/quality/national-trauma-data-bank/national-trauma-data-standard/; and
(b) Have a secure, on-line system that is NTDB and HIPAA compliant.
(2) An individual trauma center registry shall have its new or updated trauma data uploaded electronically at least quarterly to the KTDB.
(3) Trauma Registry. The inclusion criteria for the KTDB shall be specified in the Kentucky Trauma Hospital Reference Manual incorporated by reference in 902 KAR 28:030, Section 3.
Section 2. Kentucky Trauma Data Bank.
(1) The department shall maintain a single statewide Kentucky Trauma Data Bank (KTDB) to be the statewide repository for trauma registry data submitted by each designated trauma center.
(2) A request for data from the KTDB shall be directed to the Kentucky Commissioner for Public Health.
(3) A request for a report on a specific trauma center shall be addressed to the trauma coordinator or trauma program manager of the trauma center in question.
(4) Pursuant to KRS 211.494(6), data obtained through a trauma registry shall be considered protected health information.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
- STATUTORY AUTHORITY: 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the criteria for use of a trauma registry and the Kentucky Trauma Data Bank by a trauma center in the Kentucky trauma care system.
- History: 26 Ky.R. 668; 1008; eff. 11-15-1999; 38 Ky.R. 1679; 1862; eff. 6-1-2012; Crt eff. 9-11-2019; 51 Ky.R. 816; eff. 2-13-2025.
902 KAR 28:050 Kentucky's Trauma System Appeals Process {#sec-902-kar-28-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:050}
Section 1. Appeals Process.
(1) An applicant may appeal a decision of the Department for Public Health within thirty (30) days of the date of notification that:
(a) The applicant was denied verification or designation as a trauma center;
(b) A designated trauma center was denied reverification; or
(c) A designated trauma center designation was revoked or suspended.
(2) To initiate an appeal, the applicant shall submit a written request for a hearing pursuant to KRS Chapter 13B to the Commissioner of Public Health.
(3) Each appeal shall be conducted in accordance with KRS Chapter 13B.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
- STATUTORY AUTHORITY: 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the appeal process for a facility that has been denied verification or designation as a trauma center.
- History: 38 Ky.R. 1683; 1864; eff. 6-1-2012; Crt eff. 9-11-2019; Crt eff. 8-12-2026.
902 KAR 28:060 Kentucky Trauma System Fees {#sec-902-kar-28-060 omnilex-key=us-ky-regs-official--title-902--902 KAR 28:060}
Section 1. State Trauma Center Application.
(1) A facility applying for Level I, Level II, Level III, or Level IV trauma center designation in the state trauma care system shall:
(a) Complete the application process as established in 902 KAR 28:020; and
(b) Submit an application fee of:
-
$500 if applying for a Level I, Level ll, or Level lll designation; or
-
$1000 if applying for a Level lV designation.
(2) The application fee shall be:
(a) Paid by check made payable to the Kentucky State Treasurer; and
(b) Sent to the Department for Public Health with the application.
Section 2. Level I, Level II, and Level III Verification and Designation Fees.
(1) A site visit for a Level I, Level II, or Level III trauma system verification shall be conducted by ACS COT.
(2) Any cost or additional fees associated with these site visits shall be determined by ACS COT and paid by the applicant in accordance with ACS COT policies.
Section 3. Fees for Level IV Trauma System Verification and Designation.
(1) Prior to submission of an application, an applicant seeking Level IV designation shall have a verification site visit in accordance with 902 KAR 28:030, Section 2.
(2) Fees for any site visit shall be the responsibility of the applicant.
(3) Site visit expenses shall be $1,000 per team member per day honorarium in addition to the travel expenses specified by the Finance and Administration Cabinet in 200 KAR 2:006, Section 7.
(4) The hospital may request the Commissioner for Public Health to appoint additional team members. The requesting hospital shall be responsible for any additional cost associated with the request as outlined in subsection (2) of this section.
(5) The applicant shall be notified by the department of the estimated costs associated with any site visit prior to the visit.
(6) Payment for these charges shall be made by check payable to the Kentucky State Treasurer and forwarded to the Department for Public Health upon confirmation of the scheduled site visit.
History
- RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
- STATUTORY AUTHORITY: 211.494(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the fee structure for the Kentucky Trauma Care System.
- History: 38 Ky.R. 1689; 1865; eff. 6-1-2012; Crt eff. 9-11-2019; Crt eff. 7-1-2026.
Chapter 30 Kentucky Early Intervention System
902 KAR 30:001 Definitions for 902 KAR Chapter 30 {#sec-902-kar-30-001 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:001}
Section 1. Definitions.
(1) "Ability to pay" means a family has an income at 200 percent of the poverty level or above.
(2) "Assessment" means the ongoing procedures used by appropriate qualified service providers throughout the child's period of eligibility in First Steps to identify:
(a) The child's unique strengths and needs and the services appropriate to meet those needs;
(b) The resources, priorities, and concerns of the family; and
(c) The supports and services necessary to enhance the family's capacity to meet the developmental needs of the family's infant or toddler with a disability.
(3) "Assistive technology device" means any item, piece of equipment, or product system:
(a) Whether acquired commercially off the shelf, modified, or customized;
(b) That is used to:
-
Increase, maintain, or improve the functional capabilities of a child with a disability; and
-
Implement the individualized family service plan; and
(c) Except for a medical device that is surgically implanted, including a cochlear implant, or the optimization (e.g. mapping), maintenance, or replacement of that device.
(4) "Assistive Technology Service" means a service that directly assists the child with a disability in the selection, acquisition, or use of an assistive technology device in accordance with 20 U.S.C. 1401(2).
(5) "Cabinet-approved criterion referenced instrument" means any of the three (3) assessments, incorporated by reference in 902 KAR 30:120, used to assess children from birth to three (3) years of age.
(6) "Cabinet-approved screening protocol" means a screening protocol that is:
(a) Designed to evaluate the developmental status of children; and
(b) Used by the cabinet.
(7) "Child find" is defined by KRS 200.654(3).
(8) "Consent" is defined by 34 C.F.R. 303.7.
(9) "Destruction" means the physical destruction of the record or ensuring that personal identifiers are removed so that the record is no longer personally identifiable under 34 C.F.R. 303.29.
(10) "Direct supervision" means the continuous, on-site observation and guidance as activities are implemented with children and families.
(11) "District Early Intervention Committee" or "DEIC" is defined by KRS 200.654(6).
(12) "Early intervention record" means all records, electronic and hard copy, regarding a child that are required to be collected, maintained, or used under part C of the Individuals with Disabilities Education Act, 20 U.S.C. 1400-1482, and 902 KAR Chapter 30.
(13) "Early intervention service provider" is defined by 34 C.F.R. 303.12.
(14) "Early intervention services" is defined by 34 C.F.R. 303.13(a)-(d) and 34 C.F.R. 303.16.
(15) "Established risk" means a diagnosed physical or mental condition that has a high probability of resulting in a developmental delay.
(16) "Evaluation" means the use of procedures to determine eligibility for First Steps services in accordance with 902 KAR 30:120.
(17) "Extraordinary family expenses" means those out of pocket expenses, including purchases, medical care cost, and home or automobile modifications to accommodate the needs related to the eligible child's disability and to other family members with a disability, except for medical services for other family members without a disability.
(18) "Family-centered" means practices that:
(a) Are driven by the family's priorities and concerns;
(b) Support the family's role as the constant in a child's life;
(c) Complement a family's natural activity settings and daily routines; and
(d) Support, respect, encourage, and enhance the strengths, competence, and confidence of the family.
(19) "First Steps" means Kentucky's early intervention system, which is defined by KRS 200.654(8).
(20) "First Steps data management system" means the online data system that consists of each child's early intervention record and financial management data.
(21) "Homeless child" means a child who meets the federal definition of homeless children and youths established in 42 U.S.C. 11434a(2).
(22) "Inability to pay" means a family's income is below 200 percent of the poverty level.
(23) "Indirect supervision" means the regular, periodic, on-site observation and guidance as activities are implemented with children and families.
(24) "Individualized family service plan" or "IFSP" means an individual family service plan as defined by 34 C.F.R. 303.340.
(25) "Initial assessment" means the assessment of the child and family assessment conducted prior to the child's first IFSP meeting.
(26) "Kentucky Early Childhood Data System" or "KEDS" means the internet based data collection system to provide data for analysis to determine the degree to which Kentucky's children are meeting the major child outcomes and learning standards required by the Office of Special Education Programs (OSEP) in the United States Department of Education and the state early childhood standards.
(27) "Multidisciplinary team" is defined by 34 C.F.R. 303.24
(28) "Natural environments" is defined by 34 C.F.R. 303.26.
(29) "Parent" means:
(a) A natural, adoptive, or foster parent of a child;
(b) A guardian, except for the state if the child is a ward of the state;
(c) An individual acting in the place of a natural or adoptive parent including a grandparent, stepparent, or other relative with whom the child lives, or an individual who is legally responsible for the child's welfare; or
(d) An individual assigned as a surrogate parent pursuant to 20 U.S.C. 1439(a)(5).
(30) "Part C Coordinator" means the individual designated by the cabinet to be Kentucky's liaison with the federal Department of Education, Office of Special Education Programs (OSEP), to oversee the state's implementation of the early intervention system.
(31) "Participating provider or agency" is defined by 34 C.F.R. 303.403(c).
(32) "Period of eligibility" means the time from referral to First Steps to termination of services due to:
(a) Failure to meet initial program eligibility requirements;
(b) Attainment of age three (3);
(c) Documented refusal of service by the child's parent or legal guardian, inclusive of disappearance; or
(d) Change of residence to another state.
(33) "Personally identifiable" means information that contains:
(a) The name of the child, the child's parent, or other family member;
(b) The address of the child;
(c) A personal identifier, such as the child's social security number or TOTS number; or
(d) A list of personal characteristics or other information that would make it possible to identify the child with reasonable certainty.
(34) "Point of entry" or "POE" is defined by KRS 200.654(12).
(35) "Prematurity" means a gestational age, at birth, of less than thirty-seven (37) weeks.
(36) "Primary referral source" is defined by 34 C.F.R. 303.302(c) and 34 C.F.R. 303.303(c).
(37) "Primary service provider" means a professional who is a member of the IFSP team and is selected by the parent as the team lead to provide regular support to the family.
(38) "Qualified service provider" means a provider who meets the qualifications listed in 902 KAR 30:150.
(39) "Record review team" means a group of early intervention experts representing each discipline of early intervention providers as listed in 902 KAR 30:150, Section 2(1)(a)-(r), who are utilized by the state lead agency to review complex cases for eligibility and service provision, and make recommendations to IFSP teams.
(40) "Referral" means a child identified between birth and three (3) years of age who is:
(a) A Kentucky resident or a homeless child within the boundaries of the Commonwealth; and
(b) Suspected of having an established risk diagnosis or a developmental delay.
(41) "State Lead Agency" means the designated staff in the Department for Public Health who are responsible for implementing the First Steps Program in accordance with 34 C.F.R. 303.22, 20 U.S.C. Chapter 33, and KRS 200.650 to 200.676.
(42) "Ward of the state" means a child declared by a circuit court judge to be a ward of the state pursuant to KRS 625.043(2) or 625.100(2).
History
- RELATES TO: KRS 200.650-200.676, 20 U.S.C. Chapter 33, 34 C.F.R. Part 303
- STATUTORY AUTHORITY: KRS 194A.050, 200.660(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions, to enter into contracts with service providers, and to promulgate administrative regulations necessary to implement KRS 200.650 to 200.676. This administrative regulation establishes the definitions for 902 KAR Chapter 30 pertaining to First Steps, Kentucky's Early Intervention Program.
- History: 39 Ky.R. 2403; Am. 40 Ky.R. 602; eff. 10-16-2013; 2869; 41 Ky.R. 784; eff. 10-15-2014; Cert. eff. 6-15-2021.
902 KAR 30:110 Point of Entry and service coordination {#sec-902-kar-30-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:110}
Section 1. Point of Entry.
(1)
(a) The point of entry (POE) staff shall serve as the local lead agency and shall coordinate child find efforts with:
-
Programs authorized under part B of the Individuals with Disabilities Education Act (IDEA), 20 U.S.C 1400; and
-
Other state and federal programs serving this population.
(b) The primary referral sources described in paragraph (a) of this subsection may include:
-
Maternal and child health programs, including the Maternal, Infant and Early Childhood Home Visiting Program, under Title V of the Social Security Act (42 U.S.C 701(a));
-
Early Periodic Screening, Diagnosis, and Treatment (EPSDT) under Title XIX of the Social Security Act (42 U.S.C 1396(a)(43) and 1396(a)(4)(B));
-
Head Start, including Early Head Start programs under section 645A of the Head Start Act (42 U.S.C. 9801);
-
Supplemental Security Income (SSI) programs under Title XVI of the Social Security Act (42 U.S.C 1381);
-
Child protection and child welfare programs, including programs administered by and services provided through the foster care agency and the state agency responsible for administering the Child Abuse Prevention and Treatment Act (CAPTA) (42 U.S.C. 5106(a)) and 922 KAR 1:330, Section 3(10)-(11);
-
Programs authorized through 42 U.S.C 15001 to 15009, the Developmental Disabilities Assistance and Bill of Rights Act;
-
Child care programs and early learning programs;
-
Programs that provide services under the Family Violence Prevention and Services Act (42 U.S.C. 10401);
-
Early Hearing Detection and Intervention (EDHI) systems (42 U.S.C. 280g-1) administered by the Centers for Disease Control (CDC);
-
The Children's Health Insurance Program (CHIP) authorized under Title XXI of the Social Security Act (42 U.S.C. 1397aa);
-
Hospitals, including prenatal and postnatal care facilities, and physicians;
-
Parents, including parents of infants and toddlers; and
-
Homeless shelters.
(c) Primary referral sources are required to refer a child as soon as possible, but in no case more than seven (7) days after the child has been identified as potentially eligible.
(2) Each POE shall have procedures in place that provide for accepting the referrals of a child under the age of three (3) who:
(a) Is the subject of a substantiated case of child abuse or neglect;
(b) Who has a suspected developmental delay; or
(c) Is identified as directly affected by illegal substance abuse or withdrawal symptoms resulting from prenatal drug exposure.
(3) Each POE staff shall maintain accessibility and provide public awareness activities in each of their districts.
(4) The POE staff shall maintain communication with the District Early Intervention Committee (DEIC) and the state lead agency on matters of child find, service options, and other issues relevant to the First Steps Program.
(5) The POE staff shall accept all referrals for First Steps services to determine eligibility for programs.
(a) Upon receiving a telephone or written referral, POE staff shall determine if:
-
The family is aware that a referral is being made; and
-
The referral is appropriate based on:
a. The child's age, which shall be between birth and three (3) years old;
b. The family's residence within the assigned district or the family being homeless; and
c. An established risk diagnosis or a developmental concern.
(b) A child who is referred due to a developmental concern, and not screened by the primary referral source, shall have a cabinet approved screening protocol completed prior to the initial evaluation.
(c) If the point of entry finds the child does not meet the criteria established in paragraph (a)2. of this subsection, the POE shall provide to the referral source appropriate resources for the child and family for services that meet that child's needs. These resources may include:
-
Public schools;
-
The Department for Community Based Services;
-
Medical services;
-
Other appropriate community services; or
-
Another POE if residency alone is the reason for an inappropriate referral.
(d) If it is determined that the child meets the criteria established in paragraph (a)2. of this subsection, POE staff shall contact the family by telephone or letter within five (5) working days of receipt of the referral to provide information about the program and obtain consent for intake.
(e) For a child referred due to an established risk condition, if the family is interested in early intervention services, the POE staff shall assign a service coordinator and continue with the intake process.
(f) For a child referred due to a developmental concern that has been confirmed by administration of the cabinet approved screening protocol, if the family is interested in early intervention services, the POE staff shall assign a service coordinator and continue with the intake process.
(g) The parent or guardian of a child referred due to a developmental concern shall:
-
Be provided with prior written notice of the POE's intent to administer the cabinet approved screening protocol. The notice shall include the option to request an evaluation at any time during the screening procedure; and
-
Give written consent prior to the administration of the cabinet approved screening protocol by signing the Notice of Action and Consent for Screening, Evaluation and Assessment (FS-8).
(h) If the family is not interested in participating, the family shall be provided contact information for the POE and other community resources. The POE staff shall document in the child's record the refusal of services.
(i) If the POE staff is unable to contact the family within five (5) working days from the date of the referral, a follow-up letter shall be sent to the family and the case closed.
(j) If the POE is able to contact the family initially, but the family fails to return the screening protocol or consent, the POE shall send a First Steps Notice of Action (FS-9) and close the case five (5) working days from the date of notice.
(6) All children who are two (2) years and ten and one-half (10 1/2) months old to age three (3) years when first referred to First Steps shall not be eligible for First Steps. The POE shall notify the parent or guardian in writing that due to the child's age at the time of referral, the First Steps Program shall not provide an evaluation to determine eligibility for First Steps, but with written consent shall refer the child to the state and local education agency or other community resource.
(7) The POE staff shall maintain a complete record on all children referred through the POE and provide data to the state lead agency as requested. A complete record shall include:
(a) A hard copy of all documents that include a parent signature;
(b) Any correspondence generated by the POE; and
(c) The data entered into the child's electronic early intervention record in the First Steps data management system.
(8) The POE staff shall provide data as requested by the DEIC.
Section 2. Service Coordination.
(1) The service coordinator shall serve as the main point of contact in helping families obtain the services and assistance they need.
(2) During the intake process, the service coordinator shall:
(a) Identify the purpose of the visit;
(b) Discuss the role of the service coordinator;
(c) Explain the First Steps service delivery system, including:
-
The consultative model and primary service provider; and
-
The First Steps system of payment, which includes:
a. The family share participation fee; and
b. The billing of public and private insurance for early intervention services;
(d) Interview the family and document findings related to:
-
The parent or guardian's developmental concern for the child; and
-
The pregnancy, birth, and health information;
(e) Explain the family rights by reviewing the Family Rights Handbook;
(f) Discuss the forty-five (45) day timeline and determine the next action needed to determine eligibility for the child;
(g) Discuss evaluation and service options;
(h) Obtain parent or guardian signature on the First Steps Consent to Release/Obtain Information (FS-10) form for medical and developmental information;
(i) Collect insurance information and data necessary for billing and obtain parent or guardian signature on the Notice and Consent for Use of Private Insurance (FS-12A) form;
(j) Assess the family's ability to pay using the Financial Assessment Verification (FS-13) form; and
(k) Inform the family of the transition process by:
-
Providing the Notice of Transition (FS-11); and
-
Obtaining parental consent to the transition process.
(l) Inform the family of the right to decline, within thirty (30) days of consent, or to revoke consent at any time, for participation in the transition activities, which includes:
-
The disclosure of personally identifiable information to the Kentucky Department of Education (KDE) and the local education authority (LEA); and
-
Having a transition conference.
(3) The service coordinator shall:
(a) Assist the parents of infants and toddlers with disabilities with obtaining access to needed early intervention services and other services identified in the IFSP, including making referrals to providers for needed services and scheduling appointments for infants and toddlers with disabilities and their families;
(b) Coordinate the provision of early intervention services and other services, including educational, social, or medical services that are not provided for diagnostic or evaluative purposes, that the child needs or is being provided;
(c) Coordinate evaluations and assessments;
(d) Facilitate and participate in the development, review, and evaluation of IFSPs;
(e) Conduct referral and other activities to assist families in identifying available early intervention service providers;
(f) Coordinate, facilitate, and monitor the delivery of early intervention services to ensure that the services are provided in a timely manner;
(g) Conduct follow-up activities to determine that appropriate early intervention services are being provided;
(h) Coordinate the funding sources for service;
(i) Facilitate the development of a transition plan to preschool, school, or, if appropriate, to other services;
(j) Provide written confirmation in accordance with 34 C.F.R. 303.342(d)(2) to the parent or guardian and all IFSP team members of the date, time, and location of the meetings for the initial and annual Individual Family Service Plan (IFSP), the six (6) month review, and any other IFSP team meeting or the transition conference at least seven (7) calendar days prior to the IFSP, review, or transition conference date;
(k) If there is a cancellation of an IFSP meeting, notify the IFSP members in writing of the rescheduling of the IFSP meeting within five (5) working days of the cancelled meeting date;
(l) Reassess the family's ability to pay at the six (6) month review and annual IFSP meeting, and at other times if requested by the family; and
(m) Following the IFSP meeting:
-
Enter all IFSP data into the First Steps data management system;
-
Finalize the plan within five (5) working days of the date of the meeting;
-
Provide a written copy to the parent or guardian within five (5) working days of the meeting and provide copies to persons identified and consented to by the family; and
-
Refer the family to appropriate agencies for service identified on the IFSP in accordance with 902 KAR 30:130, Section 2(5)(i).
(4) The service coordinator shall inform the family of the family's rights and procedural safeguards by:
(a) Summarizing the Family Rights Handbook at the initial IFSP, at each subsequent IFSP, and at any time the family requests;
(b) Familiarizing the family with the procedural safeguards at every IFSP meeting;
(c) Ensuring that all materials are given to the family in a format the family can understand in the family's native language; and
(d) Assisting the family, at the family's request, with resolving conflicts among service providers.
(5) The service coordinator shall assist the family in identifying available service providers by:
(a) Keeping current on all available services in the district; and
(b) Having available to the families a list of all eligible First Steps services providers in each district. If the family chooses a service provider outside the First Steps approved provider list, the service coordinator shall inform the family that the provider is not approved through First Steps and may result in a cost to the family.
(6) The service coordinator shall ensure that service coordination is available to families, at their request, during normal business hours.
(7) The service coordinator shall contact the child's family at a minimum of one (1) time per plan to discuss service coordination needs, unless otherwise stipulated in the IFSP.
(8) If a family desires a change in the family's service coordinator, the family shall contact the POE, and the POE shall seek to resolve the situation.
(9) The service coordinator shall inform the family of the transition process by:
(a) Reviewing the Notice of Transition (FS-11) and obtaining parental consent for the transition procedures. With parental consent, the service coordinator shall:
-
Ensure that all potential agencies and programs that could provide service to a particular child after the age of three (3) are included when introducing the parents to future program possibilities;
-
Hold a transition conference at least ninety (90) calendar days and, at the discretion of all parties, not more than nine (9) months prior to the child's third birthday. The transition conference shall involve the family, IFSP team, the special education local school district representative, and staff from potential next placement options; and
-
Include at least one (1) transition outcome as a part of every IFSP that is consistent with 34 C.F.R. 303.344(h); and
(b) Confirming child find information was transmitted to the LEA and, with parental consent, releasing additional information needed by the LEA to ensure the continuity of services from the part C program to the part B program. This additional information may include:
-
The most recent evaluation and assessment of the child;
-
The most recent assessment of the family; and
-
The most recent IFSP.
(10) The service coordinator shall ensure that all contacts with the family or other service providers are documented in the child's record in the First Steps data management system. This documentation shall occur within ten (10) calendar days of the date of service and shall include:
(a) The date of contact;
(b) Amount of time spent;
(c) Reason for contact;
(d) Type of contact whether by telephone or face-to-face;
(e) Result of contact; and
(f) Plan for further action.
(11) The service coordinator shall document in the First Steps data management system all contacts attempted but not made.
(12) The service coordinator shall encourage the family to access all services identified on the individualized family service plan.
(13) If the family wants to voluntarily terminate a service or all services, the service coordinator shall:
(a) Document in the child's record which services are ending and the date of termination; and
(b) Send a follow-up letter that meets the requirements for prior written notice as specified in 34 C.F.R. 303.421 to the family which includes what services are terminating, and the date services will terminate, within five (5) working days after notice from the family of the family's choice to end services.
(14) If the family is absent from a scheduled service with no prior notice for two (2) consecutive visits, the service provider shall notify the service coordinator after the last absence. If the service coordinator receives notice of no show from a provider, the service coordinator shall:
(a) Document the service provider's contact and try to make contact with the family to discuss the circumstances. The service coordinator shall:
-
If contact is made, notify each provider of the result of the discussion; or
-
If unable to contact the family within five (5) working days, send the family a notice of action without consent to indicate service will be terminated within five (5) working days of the date of the notice; and
(b) Notify the service provider, in writing, if services are terminated and the date of termination.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Family Rights Handbook", April 2014;
(b) "First Steps Notice of Action (FS-9)", September 2012;
(c) "First Steps Consent to Release/Obtain Information (FS-10)", April 2014;
(d) "Financial Assessment Verification (FS-13)", May 2012;
(e) "Notice and Consent for Use of Private Insurance (FS-12A)", May 2012;
(f) "Notice of Action and Consent for Screening, Evaluation and Assessment (FS-8)", March 2014; and
(g) "Notice of Transition (FS-11)", March 2013.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 200.662, 200.664, 200.668, 200.670, 34 C.F.R. 303.34, 303.164, 303.165, 303.167, 303.303, 303.342, 303.344, 303.403, 303.421, 20 U.S.C. 1400, 1435, 42 U.S.C. 280g-1, 701, 1381, 1396, 1397, 5106, 9801, 10401, 15001-15009
- STATUTORY AUTHORITY: KRS 194A.050, 200.660(8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions, to enter into contracts with service providers, and to promulgate administrative regulations necessary to implement KRS 200.650 to 200.676. This administrative regulation establishes the point of entry and service coordination provisions pertaining to First Steps, Kentucky's Early Intervention Program.
- History: 23 Ky.R. 3129; Am. 3847; 4168; eff. 6-16-1997; recodified from 908 KAR 2:110, 10-25-2001; 31 Ky.R. 482; 1267; eff. 1-19-2005; Recodified from 911 KAR 2:110, 5-17-2010; 37 Ky.R. 512; 1253; 1661; eff. 2-4-2011; 39 Ky.R. 2410; 40 Ky.R. 602; eff. 10-16-2013; 2872; 41 Ky.R. 786; eff. 10-15-2014; Cert. eff. 6-15-2021.
902 KAR 30:120 Evaluation and eligibility {#sec-902-kar-30-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:120}
Section 1. Initial Eligibility.
(1) Initial eligibility shall be determined by the review of:
(a) The results of at least one (1) multi-domain evaluation instrument designed to confirm the presence of a significant developmental delay;
(b) Information about the infant or toddler's developmental history through parent interview;
(c) Identification of the infant or toddler's level of functioning in each developmental area;
(d) Information from other sources, such as childcare workers; and
(e) All available relevant medical and educational records.
(2) An infant or toddler shall be eligible for services if the infant or toddler:
(a) Is between birth and three (3) years of age;
(b) Is a resident of Kentucky or homeless within the boundaries of the state at the time of referral and resides in Kentucky while receiving early intervention services; and
(c)
-
Has a documented established risk condition that has a high probability of resulting in developmental delay; or
-
Is determined to have a significant developmental delay based on the evaluation and assessment process.
(3) Eligibility by established risk conditions:
(a) In accordance with KRS 200.654(10)(b), an infant or toddler meeting the criteria established in subsection (1)(a) and (b) of this section with a suspected established risk condition shall be eligible once the diagnosis is confirmed by a physician. The established risk condition shall be documented in the infant or toddler's record through the KEIS online data management system.
(b) The Kentucky Early Intervention System Established Risk Conditions list shall be maintained by KEIS .
-
An infant or toddler with an established risk shall have a five (5) area assessment, assessing the five (5) areas listed in subsection (4)(a) of this section, completed by a primary level evaluator using a cabinet-approved, criterion-referenced assessment instrument in lieu of a norm-referenced evaluation, in accordance with 902 KAR 30:130.
-
If the established risk condition relates to hearing loss, the five (5) area assessment shall be performed by a speech therapist or a teacher of the deaf and hard of hearing.
(4) Eligibility by developmental delay:
(a) An infant or toddler meeting the criteria established in subsection (2)(a) and (b) of this section shall be eligible for services if the infant or toddler is determined to have a developmental delay, based on the evaluation and assessment process, in one (1) or more of the following domains of development:
-
Total cognitive development;
-
Total communication area through speech and language development, that shall include expressive and receptive language;
-
Total physical development including motor development, vision, hearing, and general health status;
-
Total social and emotional development; or
-
Total adaptive skills development.
(b) Evidence of a developmental delay shall be determined on a norm-referenced test by the infant or toddler's score that is:
-
Two (2) standard deviations below the mean in one (1) skill area; or
-
At least one and one-half (1 1/2) standard deviations below the mean in two (2) skill areas.
(c)
- If a norm-referenced test reveals a delay in one (1) of the five (5) skill areas, but does not meet the eligibility criteria required by paragraph (b) of this subsection, a more in-depth standardized test in that area of development may be administered if the following is evident:
a. The parent has a concern or suspects the infant or toddler's delay is greater than the testing revealed; and
b. A different norm-referenced test tool reveals a standardized score that would meet eligibility criteria.
- The results of the alternate testing required by subparagraph 1. of this paragraph shall be considered as part of the infant or toddler's eligibility if the standardized scores indicate a delay of at least two (2) standard deviations below the mean.
(5) Eligibility by professional judgment. An infant or toddler may be determined eligible by informed clinical opinion by the following multidisciplinary evaluation teams of professionals:
(a) An approved neonatal follow-up program team, as described in 902 KAR 30:150 Section 2(3)(f);
(b) An approved intensive level evaluation team, as described in 902 KAR 30:150 Section 2(3)(e); or
(c) The designated record review team, if reviewing for eligibility.
Section 2. Initial Evaluation.
(1) Prior to the administration of an evaluation instrument, the infant or toddler's vision and hearing status shall be determined through screening or evaluation.
(2) An infant or toddler referred to KEIS who meets the criteria established in Section 1(2)(a) and (b) of this administrative regulation shall receive an initial evaluation if:
(a) There is a suspected developmental delay confirmed by the cabinet-approved screening protocol;
(b) The infant or toddler does not have an established risk diagnosis; and
(c) The parent requests and consents to an evaluation that includes norm-referenced and criterion-referenced instruments.
(3) For an infant or toddler without an established risk diagnosis, an initial evaluation shall be used to:
(a) Determine developmental status; and
(b) Establish the baselines for progress monitoring.
(4) For an infant or toddler with an established risk diagnosis, a cabinet-approved criterion-referenced assessment shall be completed to:
(a) Determine developmental status for program planning; and
(b) Establish the baseline for progress monitoring.
(5)
(a) Initial evaluations shall include the five (5) developmental areas identified in Section 1(4)(a) of this administrative regulation using norm-referenced standardized instruments that provide a standard deviation score in the total domain for the five (5) areas and shall include a cabinet-approved criterion-referenced assessment instrument, in accordance with 902 KAR 30:130.
(b) The initial evaluation shall include:
- A medical component completed by a qualified medical professional that includes:
a. A complete history;
b. Physical examination; and
c. Other medical information; and
- A developmental component completed by a cabinet-approved initial evaluator, in accordance with 902 KAR 30:150, that includes:
a. A statement of the infant or toddler's health status during the evaluation, including notation of health issues that affect the results of the evaluation; and
b. Completion of each appropriate instrument needed to determine the infant or toddler's unique strengths and needs.
(c) An evaluation report shall be entered into the KEIS data management system:
-
Within five (5) business days of the completion of the evaluation; and
-
In clear, concise language that is easily understood by the family.
(6) Infant or toddler records of evaluations transferred from a developmental evaluator outside the program shall be reviewed by the POE staff and shall be used for eligibility determination if:
(a) The records meet evaluation timelines established in subsection (7) of this section; and
(b) The records contain the developmental evaluation information required by subsection (5)(b) of this section.
(7) If there is a developmental evaluation available, as required by subsection (5)(b) of this section, it shall be considered as part of the infant or toddler's eligibility if the evaluation was performed within:
(a) Three (3) months prior to referral to KEIS for an infant under twelve (12) months of age; or
(b) Six (6) months prior to referral to KEIS for a toddler who is at least twelve (12) months up to three (3) years of age.
(8)
(a) An infant or toddler referred to KEIS who was born premature shall be evaluated and assessed using an adjusted gestational age to account for prematurity, unless the toddler is twenty-four (24) months of age or older at the time of the referral.
(b) For an infant who is less than six (6) months corrected age, the initial evaluation shall be done by an approved intensive level evaluation team, an approved neonatal follow-up program team, or an approved district child evaluation specialist in accordance with Section 1(5) of this administrative regulation.
(9) If the infant or toddler does not have an established risk diagnosis and is determined not eligible, the POE staff shall:
(a) Provide a Notice of Action (FS-9) in accordance with 34 C.F.R. 303.421; and
(b) Discuss available community resources.
(10) Eligibility for cases that are complex or have contradictory information from the initial evaluation shall be determined by record review. Upon receiving a referral, the record review team shall conduct a review of all available evidence and issue an eligibility determination within ten (10) calendar days.
Section 3. Annual Redetermination of Eligibility.
(1) A redetermination of eligibility shall occur at least annually.
(2) An infant or toddler shall have continuing program eligibility for services if:
(a) The infant or toddler is eligible by age and residency; and
(b) The result of the most recent progress review, including the annual five (5) area assessment, demonstrates:
-
A significant delay in at least one (1) or more developmental areas; and
-
Continued services are required in order to support continuing developmental progress.
(3) Based on the results of the redetermination of eligibility, the IFSP team shall:
(a) Continue with the same or modified outcomes and services; or
(b) Transition the infant or toddler from services.
(4) Redetermination of eligibility shall not be used to address concerns that are medical in nature.
(a) The annual redetermination shall be part of the infant or toddler's ongoing assessment and shall include an assessment in all five (5) areas using a cabinet-approved criterion-referenced instrument, in accordance with 902 KAR 30:130, and shall be completed between thirty (30) and sixty (60) calendar days prior to the annual IFSP date.
(b) If a person directly involved in conducting the evaluation and assessments is unable to attend an IFSP meeting, arrangements shall be made for that person's involvement by other means including participating in an audio-only or audio-visual conference call, designating a representative to attend the meeting, or making records and reports available at the meeting.
Section 4. Determination of Hearing Status.
(1) If the referral is for an infant or toddler who has a diagnosis of a hearing loss, in accordance with KRS 200.654(10)(b), the infant or toddler shall be considered to have an established risk diagnosis and be eligible for services and the referral process shall continue.
(2) If the referral is for an infant or toddler who is suspected of having a hearing loss, with no verification of degree of loss or diagnosis, and who is suspected of having developmental delays, the POE staff shall initiate the evaluation that shall include an audiological evaluation at a cabinet-approved Infant Audiological Assessment and Diagnostic Center as specified by KRS 211.647 and 216.2970.
Section 5. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Notice of Action (FS-9)", October 2021 edition; and
(b) "Kentucky Early Intervention System Established Risk Conditions", January 2022.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
(3) This material is available on the agency's Web site at https://chfs.ky.gov/agencies/dph/dmch/ecdb/Pages/keis.aspx.
History
- RELATES TO: KRS 200.654, 200.668, 211.647, 216.2970, 34 C.F.R. 303.322, 303.421
- STATUTORY AUTHORITY: KRS 194A.050, 200.660(7), 34 C.F.R. 303.300, 303.321, 20 U.S.C. 1434
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer funds to implement the provisions of KRS 200.650 to 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes the evaluation, eligibility, and redetermination of eligibility requirements for the Kentucky Early Intervention System (KEIS).
- History: 23 Ky.R. 3133; Am. 3851; 4171; eff. 6-16-1997; 25 Ky.R. 661; 1407; eff. 1-19-1999; Recodified from 908 KAR 2:120, 10-25-2001; 30 Ky.R. 318; 619; 1287; eff. 9-16-2003; 31 Ky.R. 485; 1270; eff. 1-19-2005; Recodified from 911 KAR 2:120, 5-17-2010; 37 Ky.R. 518; 1259; 1665; eff. 2-4-2011; 39 Ky.R. 2410; 40 Ky.R. 839; eff. 10-16-2013; TAm eff. 5-16-2014; 2876; 41 Ky.R. 788; eff. 10-15-2014; Cert. eff. 6-15-2021; 48 Ky.R. 263; 49 Ky.R. 577; eff. 9-28-2022.
902 KAR 30:130 Assessment, service planning, and assistive technology {#sec-902-kar-30-130 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:130}
Section 1. Child Assessment.
(1) Assessment shall be an on-going procedure used by personnel meeting the qualifications established in 902 KAR 30:150, Section (2)(a)-(p), throughout the child's period of eligibility for First Steps. An assessment shall reflect:
(a) The child's unique strengths and needs; and
(b) The services appropriate to meet those needs.
(2) All evaluations and assessments of the child and family shall be conducted in a nondiscriminatory manner and selected and administered so as not to be racially or culturally discriminatory.
(3) Unless clearly not feasible to do so, all assessments of a child shall be conducted in the native language of the child.
(4) Assessments shall reflect appropriate multisource and multimeasures. One (1) source or one (1) measure shall not be used as the sole criterion for determining an intervention program.
(a) Assessment methods shall include direct assessment and at least one (1) of the following:
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Observations;
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Interview and parent reports; or
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Behavioral checklist and inventories.
(b) Direct assessment shall include one (1) or more instruments that are:
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Appropriate for an infant or toddler and allow for adaptations for a disability as needed; and
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Criterion-referenced, which compares the child's level of development with skills listed in a chronological sequence of typical development.
(5) If, after the initial evaluation and assessments are completed, the IFSP team determines that a subsequent assessment is warranted, the following shall be documented on the IFSP:
(a) The IFSP team's reasons for an additional assessment;
(b) Whether a current provider on the IFSP team can assess the area or areas of concern; and
(c) Circumstances relating to the child's ability or the family's capacity to address the child's developmental needs that warrant the subsequent assessment.
(6) POE staff shall obtain a physician's or advanced practice registered nurse's (APRN's) written approval in order to complete an assessment on a child deemed medically fragile. The approval shall be specific as to the modifications needed to accommodate the child's medical status.
(7) A formal, direct assessment shall include a written report if performed for initial assessment, the annual assessment, or exit assessment, or if authorized by the IFSP. This report shall include:
(a) A description of the assessment instruments used in accordance with subsection (4)(b) of this section;
(b) A description of the assessment activities in accordance with subsection (4)(a) of this section;
(c) Identifying information, including:
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The child's First Steps identification number;
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The name of the child;
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The child's age at the date of the assessment;
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The name of the service provider and discipline;
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The date of the assessment;
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The setting of the assessment;
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The state of health of the child during the assessment including a statement of the child's vision and hearing status;
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The parent's assessment of the child's performance in comparison to abilities demonstrated by the child in more familiar circumstances;
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The medical diagnosis if the child has an established risk condition;
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Who was present for the assessment; and
(d) A profile of the child's level of performance, in a narrative form which shall indicate the:
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Child's unique strengths and needs;
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Skills achieved since the last report, if applicable; and
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Current and emerging skills, including skills performed independently and with assistance.
(8) Item level data from the cabinet-approved criterion referenced assessment protocol, in accordance with this administrative regulation, shall be submitted electronically to the Kentucky Early Childhood Data System within five (5) working days of the completion of the assessment.
(9)
(a) The initial or other formal assessments, with written reports, shall be completed and recorded in the child's record using the First Steps data management system within five (5) working days of the provider completing the assessment.
(b) The provider who performed the assessment shall:
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Write the report in family-appropriate language that the child's family can easily understand;
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Provide the written report to the family within the time frame established in paragraph (a) of this subsection; and
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Document in the child's record the date the report was mailed to the family.
(c) If the time frame established in paragraph (a) of this subsection is not met due to illness of the child or a request by the parent, the assessor shall document the reason for the delay in the child's record.
(10)
(a) An assessment provided as a general practice of a discipline, not due to the child or family's needs, shall be authorized as an early intervention service, not as an assessment.
(b) Ongoing assessment shall ensure that the IFSP and services are flexible and accessible.
(11) Five (5) working days prior to either the annual or six (6) month review of the IFSP or the expiration date of the IFSP, a service provider shall complete progress reports in the online data management system and provide a copy to the family.
(12)
(a) Within thirty (30) days prior to exiting the First Steps program at age three (3), each child shall receive an assessment in all five (5) developmental domains using a cabinet-approved criterion referenced instrument, in accordance with this administrative regulation.
(b) The assessment used for annual redetermination of eligibility may be used to meet the assessment required by paragraph (a) of this subsection if it is completed within ninety (90) days prior to the child's exit from the First Steps Program.
Section 2. Family Assessment.
(1) The family assessment shall be conducted with the family of a child eligible for early intervention services to identify the family's resources, priorities, and concerns for their child.
(2) The identification of the family's resources, priorities, and concerns shall be:
(a) Voluntary on the part of the family;
(b) Family directed;
(c) Based on information provided by the family through an assessment tool and personal interview with those members who elect to participate in the assessment; and
(d) Used to determine the supports and services necessary to enhance the family's capacity to meet the developmental needs of the eligible child.
(3) Unless clearly not feasible to do so, the family assessment shall be conducted in the native language of the family members being assessed.
(4) POE staff shall provide a written report of the family assessment to the family within five (5) working days of the parent interview.
(5) The family assessment report shall contain recommendations that address the family's priorities as well as the child's holistic needs based on the review of pertinent medical, social, and developmental information.
(6) The family assessment shall be updated prior to the six (6) month IFSP meeting and shall be re-administered prior to the annual IFSP meeting.
Section 3. Individualized Family Service Plan (IFSP).
(1) For a child who has been evaluated for the first time and determined eligible in accordance with 902 KAR 30:120, a meeting to develop the initial IFSP shall be conducted within forty-five (45) days after the point of entry receives the referral.
(2) The IFSP shall be reviewed by convening a meeting at least every six (6) months. An IFSP team meeting shall be convened more frequently if:
(a) A periodic IFSP review meeting is requested by:
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The family; or
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The family and a team member; or
(b) An early intervention service is added or increased.
(3) The purpose of the periodic review shall be to determine:
(a) The degree to which progress toward achieving the results or outcome identified in the IFSP is being made; and
(b) Whether modification or revision of the results, outcomes, or early intervention services identified in the IFSP is necessary.
(4) The review may be carried out by a meeting or by another means that is acceptable to the parents and other participants.
(5) A face to face meeting shall be conducted on at least an annual basis to evaluate and revise, as appropriate, the IFSP for a child and the child's family.
(6) IFSP meetings shall be conducted:
(a) In settings and at times that are convenient for the family; and
(b) In the native language of the family or other mode of communication used by the family, unless it is clearly not feasible to do so.
(7) The contents of the IFSP shall be fully explained to the parent and informed written consent obtained prior to the provision of early intervention services described in the IFSP. The signed IFSP shall be a contract between the family and service providers. A service included on the IFSP shall be provided as authorized, unless the family chooses not to receive the service and this choice is documented in the child's record.
(8) Each initial meeting and each annual IFSP team meeting to evaluate the IFSP shall include the following participants:
(a) The parent or parents of the child;
(b) Other family members, as requested by the parent, if feasible to do so;
(c) An advocate or person outside the family, if the parent requests that the person participate;
(d) The service coordinator who is responsible for implementing the IFSP;
(e) The person directly involved in conducting the evaluation and assessment of the child; and
(f) As appropriate, the provider who will be providing early intervention service to the child and family.
(9) If the person identified in subsection (8)(e) of this section is unable to attend a meeting, arrangements shall be made for that person's participation through other means, including one (1) of the following:
(a) Participating in a telephone conference call;
(b) Having a knowledgeable representative attend the meeting; or
(c) Making pertinent records available at the meeting.
(10) The IFSP shall include:
(a) Information about the child's present level of developmental functioning. Information shall cover the following domains:
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Physical development that includes fine and gross motor skills, vision, hearing, and general health status;
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Cognitive development that includes skills related to the child's mental development and includes basic sensorimotor skills, as well as preacademic skills;
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Communication development that includes skills related to exchanging information or feelings, including receptive and expressive communication and communication with peers and adults;
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Social and emotional development that includes skills related to the ability of the child to successfully and appropriately select and carry out their interpersonal goals; and
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Adaptive development that includes self-help skills and the ability of the child's sensory systems to integrate successfully for independent functions;
(b) Performance levels to determine strengths which can be used to enhance functional skills in daily routines when planning instructional strategies to teach skills;
(c) A description of:
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Underlying factors that may affect the child's development including the established risk condition; and
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What motivates the child, as determined on the basis of observation in natural settings, during child interaction, and through parent report;
(d) With concurrence of the family, a statement of the family's resources, priorities, and concerns related to enhancing the development of the child;
(e)
- A statement of the measurable results or measurable outcomes expected to be achieved for the child, including pre-literacy and language skills as developmentally appropriate for the child, which shall:
a. Be functionally stated;
b. Be representative of the family's own priorities;
c. Fit naturally into the family's routines or schedules;
d. Reflect the use of the family's own resources and social support network; and
e. Be flexible to meet the child and family's needs in current and possible future environments;
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The criteria, procedures, and time lines used to determine the degree to which progress toward achieving the outcomes is being made; and
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A statement indicating whether modifications or revision of the outcomes or services are necessary;
(f) At least one (1) measurable transition outcome that addresses any upcoming changes relevant to the child and family or, if the child is two (2) years or older, the steps and services to be taken to support a smooth transition of the child to preschool or other appropriate services. This shall include:
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Discussions with, and training of, parents, as appropriate, regarding future placements and other matters related to the child's transition;
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Activities to be used to help prepare the child for changes in the service delivery;
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Specific steps that will help the child adjust to and function in the new setting or activity; and
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Identification of transition service and other activities the IFSP team determines are necessary to support the transition of the child;
(g) The statement of the specific early intervention services, based on peer-reviewed research to the extent practicable, that are necessary to meet the unique needs of the child and family to achieve the results or outcomes and which:
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Are stated in length, frequency, intensity, duration, location and method of delivering services; and
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Include payment arrangements;
(h)
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A description of the natural environment, which includes natural settings and service delivery systems, in which the early intervention service is to be provided;
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How the skills shall be transferred to a caregiver so that the caregiver can incorporate the strategies and activities into the child's natural environment;
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How the child's services may be integrated into a setting in which other children without disabilities participate; and
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If the service cannot be provided in a natural environment, the reason, including:
a. Why the early intervention service cannot be achieved satisfactorily in a natural environment;
b. How the service is supported by the peer reviewed research;
c. How the service provided in this location or using this approach will support the child's ability to function in his or her natural environment; and
d. A timeline as to when the service might be expected to be delivered in a natural environment approach;
(i) The dates for initiation of the services and the anticipated duration of those services;
(j)
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Other services that the child needs that are not early intervention services, such as medical services or housing for the family; and
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Identification of the funding sources and providers to be used for those services or the steps that will be taken to secure those services through public or private resources;
(k) The name of:
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The service coordinator representing the child's or family's needs who shall be responsible for the implementation of the IFSP and coordination with other agencies and person in accordance with 902 KAR 30:110, Section 2; and
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The primary service provider;
(l) A review of the Family Rights Handbook; and
(m) A statement signed by the parent that complies with KRS 200.664(6).
(11) The IFSP shall be finalized within five (5) working days of the meeting.
(12)
(a) An authorized IFSP shall be valid for a period not to exceed six (6) months. An amendment that is made to the IFSP shall be valid for the remaining period of the plan.
(b) A parent or guardian's signature on the IFSP shall constitute written consent for early intervention services.
(13) In the development and implementation of the IFSP, IFSP team members shall:
(a) Provide a family-centered approach to early intervention;
(b) Honor the racial, ethnic, cultural, and socioeconomic diversity of families;
(c) Show respect for and acceptance of the diversity of family-centered early intervention;
(d) Allow families to choose the level and nature of their involvement in early intervention services;
(e) Facilitate and promote family and professional collaboration and partnerships, which are the keys to family-centered early intervention and to successful implementation of the IFSP process;
(f) Plan and implement the IFSP using a team approach;
(g) Reexamine their traditional roles and practices and develop new practices as appropriate that promote mutual respect and partnerships which may include a transdisciplinary approach;
(h) Determine the settings for service delivery based on the child's results or outcomes that are identified by the team; and
(i) Ensure that families have access and knowledge of services that shall:
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Be provided in as normal a fashion and environment as possible;
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Promote the integration of the child and family within the community;
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Be embedded in the family's normal routines and activities; and
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Be conducted in the family's natural environment, if possible, and in a way that services promote integration into a community setting which includes children without disabilities.
(14) If an agency or professional not participating on the IFSP team but active in the child's life makes a recommendation for an early intervention service, it shall not be provided as a First Steps service unless:
(a) The IFSP team:
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Considers the recommendation;
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Determines that it relates to a chosen outcome or result, and family priority; and
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Agrees that it is a necessary service; and
(b) The service is not covered by another payor source.
Section 4. Assistive Technology.
(1) To access assistive technology services and devices, the child shall:
(a) Be eligible for First Steps; and
(b) Have the need for and use of assistive technology devices and services documented in the IFSP.
(2) Prior to submitting a request for purchase of an assistive technology device, the service coordinator shall attempt to obtain funding from at least two (2) sources outside the First Steps and Medicaid systems.
(3) The First Steps assistive technology review team shall review:
(a) Each equipment request for which the purchase price exceeds $100; or
(b) A request submitted by the service coordinator, other POE staff, or state lead agency staff.
(4) A request shall be processed within ten (10) working days of the receipt of required information. The required information shall include:
(a) A current IFSP;
(b) Assessments with recommendations;
(c) Justification statement for each device based on needs, including documentation of attempts to find alternative funding sources;
(d) Information regarding the equipment or device request, including information regarding the training of the family on the use of equipment; and
(e) Documentation of safety and approved uses in the birth to three (3) age population.
(5) The decision made through the review process may be appealed to the Part C Coordinator who shall:
(a) Consult with the monitoring assistive technology review team; and
(b) Issue the final decision.
(6) If the IFSP team is not in agreement with the decision of the Part C Coordinator:
(a) The child's IFSP team shall reconvene for an IFSP meeting with a representative from the assistive technology review team and a representative of the state lead agency; and
(b) If the IFSP team concludes at that IFSP meeting that the assistive technology device is still needed, payment for the device shall be authorized for the duration of the current IFSP.
(7) A request for purchase shall be made no later than ninety (90) days prior to the child's third birthday.
(8) Assistive technology devices purchased solely through First Steps funding shall be the property of the program. When the child exits the program, the family shall:
(a) Return the item to the POE office for the district where the child resides; or
(b) Purchase the item from the program at a depreciated cost.
(9) Assistive technology devices may be rented through a contracted assistive technology provider to:
(a) Determine the appropriateness of the requested item prior to purchase;
(b) Assist the child in achieving the IFSP outcomes or results; or
(c) Address short term needs of the child while awaiting receipt of a purchased device.
(10) The payment for assistive technology devices shall be made in accordance with 902 KAR 30:200 Section 2(5)(a) and (b).
(11) Items that cannot be returned for sanitary reasons, such as adapted utensils, shall not be rented.
Section 5. Incorporation by Reference.
(1) "Individualized Family Service Plan", September 2012, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 200.660(6), 200.664, 34 C.F.R. 303.321, 303.340-303.346, 20 U.S.C. 1435, 1436, 1437
- STATUTORY AUTHORITY: KRS 194A.050(1), 200.660(8), 20 U.S.C. 1436
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer funds appropriated to implement the provisions of KRS 200.650 to 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes the requirements for assessment, the Individualized Family Service Plans used in First Steps, and assistive technology.
- History: 23 Ky.R. 3139; Am. 3857; eff. 6-16-1997; 25 Ky.R. 667; 1414; eff. 1-19-1999; Recodified from 908 KAR 2:140, 10-25-2001; 31 Ky.R. 496; 1425; eff. 2-22-2005; Recodified from 911 KAR 2:140, 5-17-2010; 37 Ky.R. 526; 1267; 1673; eff. 2-4-2011; 39 Ky.R. 2413; 40 Ky.R. 605; eff. 10-16-2013; 2879; 41 Ky.R. 790; eff. 10-15-2014; Cert. eff. 6-15-2021.
902 KAR 30:150 Personnel qualifications {#sec-902-kar-30-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:150}
Section 1. Enrollment Process for Provider Participation.
(1) The program shall enroll providers to carry out the early intervention services according to the provisions of KRS 200.650 to 200.676.
(2) The program shall contract only with an individual or agency who meets the qualifications established in Section 2 of this administrative regulation.
(3) The program shall reserve the right to contract or not contract with any potential provider or agency.
(4) Any provider or agency that wishes to participate as a provider in the First Steps program shall submit an application packet to the cabinet.
(a) The application packet for the individual provider shall include:
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A copy of the provider's professional license, registration, or certificate; and
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The Individual Provider Application (RF 6A(I)).
(b) The application packet for the agency shall include:
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A copy of each provider's professional license, registration, or certificate; and
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The Agency Application (RF 6A(A)).
(c) All potential providers shall:
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Have a background check performed by the Administrative Office of the Courts, the Division of Protection and Permanency, and the Sex Offender Registry, with those agencies submitting the results of each background check directly to the cabinet;
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Agree to provide service within the individual's or agency's scope of practice and in accordance with state and federal regulations and laws relating to First Steps; and
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Be enrolled as a participating provider prior to being eligible to receive reimbursement in accordance with federal and state laws.
(5) The application shall not be considered complete and shall not be processed until all information and any subsequent documentation requested by the program is provided.
(6) Upon receipt of an approved application packet, the applicant shall be notified of their eligibility to complete orientation training.
(7) After successful completion of orientation training, the Service Provider Agreement shall be executed and the provider shall be issued a contract number that shall be used by the provider solely for identification purposes.
(8) A provider's participation shall begin and end on the dates specified in the executed Service Provider Agreement.
(9) If an agency is the enrolled provider, the agency shall be responsible for ensuring that all staff from that agency providing First Steps services meet the First Steps personnel qualifications.
(10) Provider enrollment shall be renewed every even-numbered year.
(a) An individual wishing to renew the Service Provider Agreement shall submit:
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The Individual Provider Application (Renewal) (RF 6B);
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A copy of their current licensure for their discipline;
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A signed Service Provider Agreement;
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A notarized Required Affidavit for Bidders, Offerors, and Contractors;
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A signed First Steps Provider Code of Ethical Conduct;
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A completed First Steps Record of Provider Signature (RF-23);
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A Service Catchment Area;
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A copy of current professional liability insurance;
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Authorization for Electronic Deposit of Vendor Payment (Form SAS63);
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Request for Taxpayer Identification Number and Certification (W-9); and
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Documentation of completion of required trainings as outlined in the expiring Service Provider Agreement.
(b) An agency wishing to renew the Service Provider Agreement shall submit:
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The Agency Application (Renewal) (RF 6B(A));
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A copy of the current licensure for all service providers listed on the agency application;
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A Service Provider Agreement signed by the agency administrator;
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A notarized Multi-provider affidavit;
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A signed First Steps Provider Code of Ethical Conduct for all service providers listed on the agency application;
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A completed First Steps Record of Provider Signature (RF-23) for all service providers listed on the agency application;
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A Service Catchment Area for all service providers listed on the agency application;
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A copy of current professional liability insurance for the agency;
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Authorization for Electronic Deposit of Vendor Payment (Form SAS63);
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Request for Taxpayer Identification Number and Certification (W-9); and
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Documentation of completion of required trainings as outlined in the expiring Service Provider Agreement for all agency staff listed on the service provider agreement.
(11) If a provider agency is enrolling to provide group services, the agency shall submit:
(a) A copy of a valid child care licensure that meets the requirements stated in 922 KAR 2:090; or
(b) Approval as a contractor for group instruction through the Kentucky Department of Education.
Section 2. Personnel Qualifications.
(1) Minimum qualifications for professionals or disciplines providing services in First Steps shall be as established in this subsection.
(a) An audiologist shall have:
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A master's degree; and
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A license from the Kentucky Board of Speech-Language Pathology and Audiology.
(b) A licensed marriage and family therapist shall have:
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A master's degree; and
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A license from the Kentucky Board of Licensure of Marriage and Family Therapists.
(c) A developmental interventionist shall have:
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A bachelor's degree; and
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An interdisciplinary early childhood education (IECE) certificate, a probationary or emergency IECE certificate, or a valid statement of eligibility for IECE certification issued by the Kentucky Educational Professional Standards Board, Division of Certification.
(d) A nurse shall have:
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An associate degree or diploma from a registered program; and
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A license from the Kentucky Board of Nursing.
(e) A dietitian shall have:
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A bachelor's degree; and
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A license from the Kentucky Board of Licensure and Certification for Dietitians and Nutritionists.
(f) An occupational therapist shall have:
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A bachelor's degree; and
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A license from the Kentucky Board of Licensure for Occupational Therapy.
(g) An orientation and mobility (O and M) specialist shall have a bachelor's degree in Special Education with emphasis on visual impairment and O and M, in accordance with the Division of Exceptional Children Services, Kentucky Department of Education.
(h) A physician shall have:
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A doctor of medicine degree or doctor of osteopathy degree; and
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A license from the Kentucky Board of Medical Licensure.
(i) A physical therapist shall have:
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A bachelor's degree; and
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A license from the Kentucky Board of Physical Therapy.
(j) A licensed psychologist shall have:
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A doctoral degree; and
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A license from the Kentucky Board of Examiners of Psychology.
(k)
- A certified psychologist with autonomous functioning, a licensed psychological practitioner, a certified psychologist or licensed psychological associate shall have:
a. A master's degree; and
b. A license or a certificate from the Kentucky Board of Examiners of Psychology.
- A licensed psychological associate shall be under the supervision of an actively enrolled First Steps psychologist.
(l) A social worker shall have:
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A bachelor's degree; and
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A license from the Kentucky Board of Social Work.
(m) A speech-language pathologist shall have:
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A master's degree; and
a. A license from the Kentucky Board of Speech-Language Pathology and Audiology; or
b. An interim license from the Kentucky Board of Speech-Language Pathology and Audiology and be under the supervision of a currently enrolled First Steps speech-language pathologist.
(n) A teacher of children who are deaf and hard of hearing shall have:
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A bachelor's degree; and
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A certificate for teaching the hearing impaired, or a certificate for teaching the hearing impaired with sign language proficiency, grades P-12, issued by the Kentucky Education Professional Standards Board, Division of Certification.
(o) A teacher of the visually impaired shall have:
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A bachelor's degree; and
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A certificate for teaching the visually impaired, grades P-12, issued by the Kentucky Education Professional Standards Board, Division of Certification.
(p) A licensed professional clinical counselor shall have:
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A master's degree; and
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A license from the Kentucky Board of Licensed Professional Counselors.
(q) An optometrist shall have:
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A degree from an accredited school or college of optometry; and
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A license from the Kentucky Board of Optometric Examiners.
(r) An ophthalmologist shall have:
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A doctor of medicine degree or doctor of osteopathy degree;
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A license from the Kentucky Board of Medical Licensure; and
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Certification from the American Board of Ophthalmology.
(2) The minimum qualification for paraprofessionals providing services in First Steps shall be as established in this subsection.
(a) An occupational therapy assistant shall have:
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An associate's degree in occupational therapy; and
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A license from the Kentucky Board of Licensure for Occupational Therapy.
(b) A physical therapist's assistant shall have:
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An associate degree in physical therapy assistance; and
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A license from the Kentucky Board of Physical Therapy.
(c) Paraprofessionals shall be under the supervision of a currently enrolled First Steps provider of that discipline as required by the professional's licensing board practice act.
(3) The minimum qualifications for recognized service positions providing services in First Steps shall be as established in this subsection.
(a) A Point of Entry manager shall:
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Be employed by the Point of Entry;
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Meet the minimum highest entry-level requirement for one (1) of the professions identified in subsection (1)(b), (c), (d), (f), (i), (j), (l), (m), or (p) of this section;
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Have four (4) years of professional experience in an early childhood education capacity or community health agency that serves families with children birth through five (5) years of age in a position in which the following skills and competencies have been demonstrated:
a. Strong interpersonal communication skills, both written and verbal;
b. Ability to create and maintain accurate reports;
c. Ability to handle multiple tasks concurrently, meet deadlines, work independently, and exercise good judgment; and
d. Establish collaboration and leadership while working with families and service providers; and
- Demonstrate progressive responsibility in a supervisory or management capacity in a community or public health organization for two (2) years of the experience.
(b) A service coordinator shall:
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Be employed by the Point of Entry;
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Meet the minimum highest entry-level requirement for one (1) of the professions identified in subsection (1)(a)-(r) of this section; or
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Have a bachelor's degree and the equivalency of two (2) years' experience in working with young children ages birth through five (5) years, or have a bachelor's degree and two (2) years' experience working with families with young children ages birth through five (5) years, in a position in which the following skills and competencies have been demonstrated:
a. Communication skills in interviewing, negotiating and mediating, and providing informal support;
b. Problem-solving by finding and utilizing services and resources, resolving conflicts, integrating services using formal and informal channels, and enabling families to use problem-solving;
c. Organization by maintaining accurate data collection and resource information, exhibiting flexibility in scheduling, and developing plans; and
d. Collaboration and leadership through developing relationships with families, enabling families to develop their decision-making skills, and establishing collaborative relationships with service providers.
(c) A District Child Evaluation Specialist shall:
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Be employed by the Point of Entry to conduct screening, evaluations and assessments, and provide consultation to service coordinators and initial evaluators;
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Meet the minimum highest entry-level requirements for one (1) of the professions identified in subsection (1)(a)-(r) of this section;
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Have two (2) years' experience working directly with young children birth through two (2) years of age, including children with disabilities or atypical development;
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Have one (1) year of experience in using standardized instruments and procedures to evaluate infants and toddlers birth through two (2) years of age, completed as part of formal training or in supervised practice; and
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Be approved by the cabinet in accordance with KRS 200.666(1).
(d) An initial evaluator shall:
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Meet the minimum highest entry-level requirements for one (1) of the professions delineated in this administrative regulation;
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Have two (2) years' experience working directly with young children birth through two (2) years of age, including children with disabilities or atypical development;
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Have one (1) year of experience in using standardized instruments and procedures to evaluate infants and toddlers birth through two (2) years of age, completed as part of formal training or in supervised practice; and
-
Be approved by the cabinet in accordance with KRS 200.666(1).
(e) An intensive level evaluation team shall be approved by the Part C Coordinator and shall include:
a. A board certified medical professional with expertise in early childhood development;
b. A board certified developmental pediatrician;
c. A pediatrician who has training and experience in the area of early childhood development;
d. A board certified pediatric psychiatrist; or
e. A board certified pediatric neurologist; and
- One (1) or more developmental professionals identified in subsection (1)(a)-(r) of this section.
(f) An approved neonatal follow-up program team shall be a university-based program that has:
-
Submitted to the cabinet the credentials and documentation of experience in conducting assessments for the birth to three (3) age population for each proposed team member; and
-
Contracted with the cabinet to conduct neuro-developmental follow-up of high risk infants.
(g) An assistive technology specialist shall:
a.
(i) Meet the minimum highest entry-level requirements for one (1) of the professions delineated in this administrative regulation; and
(ii) Have extensive knowledge, training, and experience in the field of assistive technologies for infants and toddlers with disabilities; or
b.
(i) Meet the qualifications established in clause a.(ii) of this paragraph; and
(ii) Be employed by an agency that currently provides assistive technology service in First Steps; and
- Be approved by the cabinet in accordance with KRS 200.666(1).
(h) To be an approved assistive technology review team, an assistive technology center shall:
-
Submit to the cabinet the credentials and documentation of experience in providing services to the birth to three (3) age population for each proposed team member; and
-
Contract with the cabinet to conduct reviews of requests for assistive technology devices in accordance with 902 KAR 30:130, Section 4.
(i) A respite provider shall:
-
Meet all license, administrative regulations, and other requirements applicable to the setting in which respite is provided; and
-
Be approved by the individualized family service planning team.
(j) A sign language and cued language specialist shall:
-
Meet the qualifications established in 201 KAR 39:030, Section 1(3)(c); and
-
Be approved by the cabinet in accordance with KRS 200.666(1).
Section 3. Field Experiences - Intervention services implemented by a student.
(1) With family consent, a student may provide early intervention services under the direct one-to-one supervision of a provider qualified in accordance with Sections 1 and 2 of this administrative regulation.
(2) A student who provides early intervention services shall complete and sign staff notes for each session in which the student facilitates or provides intervention.
(3) The approved First Steps provider shall also include a staff note for each session involving a student.
Section 4. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Form 6A(I), Individual Provider Application (New)", 2014-2016 edition;
(b) "Form 6A(A) Agency Application (New)", 2014-2016 edition;
(c) "Form 6B(I) Individual Provider Application (Renewal)", 2014-2016 edition;
(d) "Form 6B(A) Agency Application (Renewal)", November 2013 edition;
(e) "First Steps Provider Code of Ethical Conduct", October 2013 edition;
(f) "Form 5A, Service Provider Agreement", FY 2014-2016;
(g) "Required Affidavit for Bidders, Offerors, and Contractors", November 2009;
(h) "First Steps Record of Provider Signature (RF-23)", August 2008 edition;
(i) "Service Catchment Area", (RF 6 Attachment), 2014-2016;
(j) "Authorization for Electronic Deposit of Vendor Payment", (Form SAS63), July 2006 edition; and
(k) "Request for Taxpayer Identification Number and Certification", (W-9), January 2002 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 200.650-200.676, 34 C.F.R. 303.31, 303.119, 303.121, 20 U.S.C. 1435(8), (9)
- STATUTORY AUTHORITY: KRS 194A.050, 200.660
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions of KRS 200.650 to 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes the provider qualifications for participation in First Steps, Kentucky's Early Intervention Program.
- History: 23 Ky.R. 3142; Am. 3860; eff. 6-16-1997; Recodified from 908 KAR 2:150, 10-25-2001; 31 Ky.R. 499; 1280; eff. 1-19-2005; Recodified from 911 KAR 2:150, 5-17-2010; 37 Ky.R. 532; 1272; 1677; eff. 2-4-2011; 39 Ky.R. 2419; eff. 10-16-2013; 40 Ky.R. 2883; 41 Ky.R. 509; 793; eff. 10-15-2014; Cert. eff. 6-15-2021.
902 KAR 30:160 Covered services {#sec-902-kar-30-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:160}
Section 1. Covered Services.
(1) Services shall be covered if the services are included and authorized through parent signature on the Individualized Family Service Plan (IFSP) developed by an IFSP team which shall include, at a minimum, the family and two (2):
(a) Professionals as identified in 902 KAR 30:150, Section 2(1);
(b) Paraprofessionals as identified in 902 KAR 30:150, Section 2(2); or
(c) Service positions as identified in 902 KAR 30:150, Section 2(3).
(2) Services covered shall include:
(a) Service coordination as provided in accordance with 902 KAR 30:110, Section 3, and this paragraph:
-
A child shall have only one (1) designated service coordinator at a given time;
-
Service coordination shall be provided by qualified professionals in accordance with 902 KAR 30:150, Section 2(3)(b); and
-
Service coordination shall be provided under the limitations of 902 KAR 30:200, Sections 2(3)(b)-(d);
(b) Initial evaluation as provided in accordance with 902 KAR 30:120 and this paragraph. Initial evaluation shall be:
-
Considered the first level of a two (2) tier system of evaluation; and
-
Provided by qualified professionals in accordance with 902 KAR 30:150, Section 2(3)(c) and (d);
(c) Intensive team evaluation as provided in accordance with 902 KAR 30:120, Section 1(4) and (5)(b), and this paragraph. Intensive team evaluation shall be:
-
Considered the second level of a two (2) tier system of evaluation; and
-
Provided by qualified professionals in accordance with 902 KAR 30:150, Section 2(3)(e);
(d) Assessment of the child as provided in accordance with 902 KAR 30:130, Section 1, and 902 KAR 30:200, Section 3(1);
(e) Early intervention.
-
Early intervention shall be provided in accordance with 34 C.F.R. 303.13(a) through (b).
-
Except as provided in subparagraph 3. of this paragraph, early intervention, which is face-to-face intervention with the child and caregivers within the context of the environment, shall include four (4) types of service:
a. Individual home or community service which shall include intervention provided by a First Steps qualified professional to an eligible child at the child's home or other natural setting in which children under three (3) years of age are typically found (including non-First Steps provider day care centers or family day care homes) under the limitations of 902 KAR 30:200, Section 3(2);
b. Individual office or center-based service which shall include intervention provided by First Steps qualified professionals to an eligible child at the professional's office or center site under the limitations of 902 KAR 30:200, Section 3(2);
c. Group intervention which shall include the provision of early intervention services by First Steps qualified personnel in a group, with two (2) or more eligible children, at an early intervention professional's site, office, center, or other community-based setting where children under three (3) years of age are typically found.
(i) The group may also include children without disabilities as long as a three (3) to one (1) ratio of children to staff is maintained.
(ii) Group intervention shall be provided under the limitations of 902 KAR 30:200, Section 3(2)(b); or
d. Co-treatment which shall occur if more than one (1) provider is present and providing early intervention services at the same time. Each provider's service log shall document:
(i) Why this approach is being used;
(ii) The outcomes and activities;
(iii) Who is performing the activities; and
(iv) That the service providers involved are providing or learning about the early intervention at the same time.
-
If early intervention services are provided by a psychologist, counselor, marriage and family therapist, or social worker, the child shall not be required to attend the intervention. The reason the child's presence is clinically contraindicated shall be documented in the service note.
-
Disciplines providing early intervention shall be qualified professionals in accordance with 902 KAR 30:150, Section 2(1), or qualified paraprofessionals in accordance with 902 KAR 30:150, Section 2(2), and shall include the following:
a. An audiologist;
b. A marriage and family therapist;
c. A developmental interventionist;
d. A nurse;
e. A dietician;
f. An occupational therapist;
g. An occupational therapy assistant;
h. An orientation and mobility specialist;
i. A physical therapist;
j. A physical therapist's assistant;
k. A licensed psychologist, a certified psychologist with autonomous functioning, a licensed psychological practitioner, certified psychologist, or licensed psychological associate;
l. A speech-language pathologist;
m. A licensed social worker;
n. A licensed professional clinical counselor (LPCC);
o. A teacher of the visually impaired;
p. A teacher of the deaf and hard of hearing;
q. A physician;
r. An optometrist;
s. An ophthalmologist; or
t. A sign language and cued language specialist;
(f) Collateral service as provided in accordance with 902 KAR 30:200, Section 3(4);
(g) Assistive technology in accordance with 902 KAR 30:001, Section 1(3), and 30:130, Section 4;
(h) Respite which shall be a service provided to the family of an eligible child for the purpose of providing relief from the care of the child in order to strengthen the family's ability to attend to the child's developmental needs under the limitations of 902 KAR 30:200, Section 3(3);
(i) Transportation and related cost which shall be the costs of travel that are necessary to enable an eligible child to receive early intervention services; and
(j) Language access services for all families consistent with the provisions of the Individuals with Disabilities Education Improvement Act (IDEA), 34 C.F.R. 303.421(c), that, at a minimum, assists the family in understanding the purpose of First Steps and the family's procedural safeguards during referral, eligibility determination activities, and IFSP meetings.
History
- RELATES TO: KRS 200.656, 34 C.F.R. 303.13, 303.421(c), 20 U.S.C. 1435,
- STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 200.660
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions of KRS 200.650 to 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes the provisions of covered services under First Steps, Kentucky's Early Intervention Program.
- History: 908 KAR 2:160: 23 Ky.R. 3145; 3863; eff. 6-16-1997; 25 Ky.R. 670; 1417; eff. 1-19-1999; Recodified as 911 KAR 2:160, 10-25-2001; Recodified as 902 KAR 30:160, 5-17-2010; 37 Ky.R. 536; 1282; 1680; eff. 2-4-2011; 39 Ky.R. 2422; eff. 10-16-2013; 40 Ky.R. 2887; eff. 10-15-2014; Cert. eff. 6-15-2021.
902 KAR 30:180 Procedural safeguards {#sec-902-kar-30-180 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:180}
Section 1. Records.
(1) In accordance with 34 C.F.R. 303.400 through 303.417, the parents of a child eligible for the Kentucky Early Intervention Program shall be afforded the opportunity to inspect, review, and receive records relating to evaluations and assessments, eligibility determinations, the development and implementation of IFSPs, individual complaints dealing with the child, and any other records maintained by First Steps staff about the child and the child's family.
(2) The first requested copy of the early intervention record released to the parent or guardian shall be at no cost.
(3) A fee of ten (10) dollars shall be charged for each additional copy and shall not prevent the parent or guardian from exercising the right to inspect and review those records.
(4) An early intervention provider or agency shall inform parents when personally identifiable information collected, maintained, or used during the provision of early intervention services is no longer needed to provide services to the child.
Section 2. Parental notice and consent.
(1) Prior written notice.
(a) Prior written notice shall be given to the parents of an eligible child at least five (5) working days before the Point of Entry (POE) staff or service provider proposes or refuses to initiate or change the identification, evaluation, or placement of the child, or the provision of appropriate early intervention services to the child and the child's family.
(b) The notice shall be in sufficient detail to inform the parents about:
-
The action that is being proposed or refused;
-
The reasons for taking the action;
-
All procedural safeguards that are available to the parent; and
-
The procedures under 34 C.F.R. 303.430-303.434.
(c) The written prior notice shall be:
-
Written in language understandable to the general public; and
-
Provided in the native language or other mode of communication of the parents, unless it is clearly not feasible to do so.
(d) If the native language or other mode of communication of the parent is not a written language, the POE staff, or designated service provider, shall take steps to ensure that:
-
The notice is translated orally or by other means to the parent in the parent's native language or other mode of communication;
-
The parent understands the notice; and
-
There is written evidence that the requirements of this paragraph have been met.
(2) Parent consent.
(a) Written parental consent shall be obtained before:
-
Administering any screening procedures;
-
Conducting all evaluations and assessments of a child;
-
Initiating the provision of early intervention services;
-
Billing private insurance; and
-
Disclosing personally identifiable information.
(b) If consent is not given for screening, evaluation, assessment, or early intervention services, the POE shall make reasonable efforts to ensure that the parent understands:
-
The nature of the evaluation and assessment or the services available; and
-
That the child will not receive the evaluation and assessment or services unless consent is given.
(3) The parents of an eligible child may determine if they, their child, or other family members will accept or decline any early intervention service, and may decline a service after first accepting it, without jeopardizing other early intervention services.
Section 3. Representation of Children and Surrogate Parents.
(1) Each POE shall ensure that the rights of an eligible child are protected if:
(a) A parent, as defined in 902 KAR 30:001, Section 1(29), cannot be identified;
(b) The POE, after reasonable efforts, cannot discover the whereabouts of a parent; or
(c) The child is a ward of the state.
(2) If the child is a foster child and does not reside with the child's parents, the POE shall make reasonable efforts to obtain the informed consent of the parent for an initial evaluation. The POE shall not be required to obtain parental consent if:
(a) Despite reasonable efforts, the POE cannot discover the whereabouts of the parent;
(b) The rights of the parents have been terminated; or
(c) The rights of the parents to make educational decisions have been subrogated by a court and the consent for initial evaluation has been given by someone appointed by the judge to represent the child.
(3)
(a) If more than one (1) party meets the definition of parent under 902 KAR 30:001, Section 1(29), the biological or adoptive parent shall be presumed to be the parent unless the biological or adoptive parent does not have the legal authority to make educational decisions for the child.
(b) If there is a judicial order that identifies a specific person to act as the parent of a child or to make educational decisions on behalf of a child, the order shall prevail.
(4)
(a) A POE shall determine if a child needs a surrogate parent and, if so, shall assign a surrogate parent to the child.
(b) The surrogate parent of the child shall have all the rights afforded parents under 34 C.F.R. Part 303 to make decisions about early intervention issues for a child.
(c) A POE shall ensure the rights of a child are protected by appointing a surrogate parent to make educational decisions for the child if:
-
An individual cannot be identified as a parent;
-
The POE, after reasonable efforts, cannot discover the whereabouts of the parents;
-
The child is a ward of the state; or
-
The child is an unaccompanied homeless child.
(5) The POE shall keep a record of the reasonable efforts made to discover the whereabouts of the parents, including:
(a) Detailed records of the telephone calls made or attempted and the results of those calls;
(b) Copies of correspondence sent to the parents and any responses received; and
(c) Detailed records of visits made to the parent's home or place of employment and the results of those visits.
(6) The POE shall have a procedure for selecting surrogates that is approved by the Department of Public Health. The department shall approve a procedure that is established to ensure that a surrogate:
(a) Is not an employee of the Kentucky Department for Public Health, the POE, or any other state agency that is involved in early intervention services or care of the child;
(b) Does not have any personal or professional interest that conflicts with the interests of the child; and
(c) Has knowledge and skills that ensure adequate representation of the child.
(7) A person who is otherwise qualified to be a surrogate parent shall not be considered an employee of the POE solely because he or she is paid by the POE to serve as a surrogate parent.
(8) If a child is an unaccompanied homeless child, appropriate staff of emergency shelters, transitional shelters, or street outreach programs may be appointed as temporary surrogate parents without regard to the criteria listed in subsection (6) of this section until a surrogate parent can be appointed that meets all the requirements of this section.
(9) The POE shall make reasonable efforts to ensure the assignment of a surrogate not more than thirty (30) calendar days after there is a determination by the Point of Entry that the child needs a surrogate.
(10) Responsibilities. A surrogate parent shall represent a child in all matters related to:
(a) The evaluation and assessment of the child;
(b) Development and implementation of the child's IFSPs, including annual evaluations and periodic reviews;
(c) The ongoing provision of early intervention services to the child; and
(d) Any other rights established under this administrative regulation.
Section 4. Mediation.
(1) Each POE shall ensure that procedures are established and implemented to allow parties to disputes involving any matter concerning the identification, evaluation, placement of the child or the provision of appropriate early intervention services to resolve the disputes through a mediation process which, at a minimum, shall be available if a hearing is requested under 34 C.F.R. 303.431.
(2) The POE agency shall use the mediation system established by the Department for Public Health.
(a) Mediation shall be adopted as an option to resolve complaints.
(b) Mediation shall be voluntary and freely agreed to by both parties, and shall not deny or delay a parent's right to a due process hearing to be conducted at any time.
(c) Unless the parent of a child and the cabinet otherwise agree, the child shall continue to receive the early intervention services currently being provided during the interim of any proceeding involving a complaint. If the complaint involves the application for initial services, the child shall receive those services that are not in dispute.
(d) Mediators shall be trained in applicable state and federal law relating to the First Steps program.
(3) Time table for mediation.
(a) Within five (5) working days after a request for mediation is made to the department using a Mediation/Due Process Request Form, the appointment of a mediator shall be made.
(b) Either party may waive the mediation and, if waived, the parents shall be informed by the department within two (2) working days of this decision.
(c) Mediation shall be completed within thirty (30) working days of the receipt by the department of the request for mediation.
(d) At any time during the mediation process, a request for a due process hearing may be initiated.
(e) If the parties resolve a dispute through the mediation process, the parties shall execute a legally binding agreement that is signed by both the parent and a representative of the lead agency who has the authority to enter into an agreement.
(f) A copy of the legally binding agreement shall be mailed by the mediator to each party within five (5) working days following the mediation conference. A copy shall also be filed by the mediator with the department. The agreement shall specify in writing the agreement reached by the parties.
(4) A written mediation agreement shall not conflict with state and federal laws and shall be to the satisfaction of both parties. Satisfaction shall be indicated by the signature of both parties on the legally binding agreement.
(5) Discussions that occur during the mediation process shall be confidential and shall not be used as evidence in any subsequent due process hearing or civil proceeding. The parties to the mediation process shall be required to sign a confidentiality pledge prior to the commencement of the process.
Section 5. Due Process Procedures for Parents and Children.
(1) An administrative hearing shall be conducted within fifteen (15) days of receipt of a request for hearing by an impartial hearing officer appointed by the secretary of the cabinet.
(2) The hearing shall be conducted in accordance with the requirements of KRS Chapter 13B.080.
(3) A recommended decision conforming in content to the requirements of KRS 13B.110 shall be forwarded to the family and the cabinet within ten (10) days of the administrative hearing.
(4) All parties to the appeal shall have five (5) days to file written exceptions to the recommended decision.
(5) A final decision on the recommendation shall be made no later than thirty (30) days following receipt of the appeal.
(6) Any parent involved in an administrative hearing may:
(a) Be accompanied and advised by counsel and by individuals with special knowledge or training with respect to early intervention services for children eligible for the First Steps Program;
(b) Present evidence and confront, cross-examine, and compel the attendance of witnesses;
(c) Prohibit the introduction of any evidence at the proceeding that has not been disclosed to the parent at least five (5) days before the proceeding;
(d) Obtain a written or electronic verbatim transcription of the proceeding; and
(e) Obtain written findings of fact and decisions.
(7) Any proceeding for implementing the complaint resolution process established in Section 4 of this administrative regulation shall be held at a time and place that is reasonably convenient to the parent.
(8) Any party aggrieved by the findings and decision regarding an administrative hearing may bring a civil action in state or federal court under 20 U.S.C. 1439(a)(1).
(9) During the pendency of any proceeding involving a hearing under this section, unless the POE and parents of a child otherwise agree, the child shall continue to receive the appropriate early intervention services currently being provided. If the complaint involves an application for initial early intervention services, the child shall receive those services that are not in dispute.
Section 6. State Complaint Procedures. The procedures established in this section shall apply to the Cabinet for Health and Family Services, Department for Public Health as to written complaints submitted pursuant to 34 C.F.R. 303.432-303.434.
(1) Any organization or individual may file a signed written complaint. The complaint shall be submitted on a First Steps Complaint Form and shall include:
(a) A statement that the state lead agency, point of entry, or early intervention provider has violated a requirement of state or federal law;
(b) The facts on which the complaint is based; and
(c) The signature and contact information for the complainant.
(2) If the alleged violation is with respect to a specific child, the complaint shall include:
(a) The child's name and residential address;
(b) The name of the early intervention provider serving the child;
(c) A description of the nature of the problem of the child, including facts related to the problem; and
(d) A proposed resolution of the problem to the extent known and available to the party at the time the complaint is filed.
(3) The alleged violation shall have occurred not more than one (1) year before the date that the complaint is received by the Department for Public Health.
(4) The party filing the complaint shall forward a copy of the complaint to the point of entry or early intervention provider serving the child at the same time the party files the complaint with the state lead agency.
(5) Within sixty (60) calendar days after a complaint is filed, the Department for Public Health shall:
(a) Carry out an independent on-site investigation, if the agency determines that an investigation is necessary;
(b) Give the complainant the opportunity to submit additional information, either orally or in writing, about the allegations in the complaint;
(c) Provide the point of entry or early intervention provider an opportunity to respond to the complaint, including:
-
A proposal to resolve the complaint; and
-
An opportunity for a parent who has filed a complaint and the point of entry or early intervention provider to voluntarily engage in mediation, in accordance with Section 4 of this administrative regulation;
(d) Review all relevant information and make an independent determination as to whether the point of entry or early intervention provider is violating a requirement of the Kentucky Early Intervention System;
(e) Issue a written decision to the complainant that addresses each allegation in the complaint and contains:
-
Findings of fact and conclusions; and
-
The reasons for the agency's final decision;
(f) Permit an extension of the sixty (60) day time limit only if exceptional circumstances exist with respect to a particular complaint; and
(g) Include procedures for effective implementation of the state lead agency's final decision, if needed, including:
-
Technical assistance activities;
-
Negotiations; and
-
Corrective actions to achieve compliance.
(6) If a written complaint is received that is also the subject of a due process hearing or contains multiple issues, of which one or more are part of a due process hearing, the Department for Public Health shall set aside any part of the complaint that is being addressed in the due process hearing until the conclusion of the hearing. Any issue in the complaint that is not a part of the due process action shall be resolved within the sixty (60) calendar-day timeline using the complaint procedures established in this section.
(7) If an issue is raised in a complaint filed under this section that has previously been decided in a due process hearing involving the same parties, the:
(a) Hearing decision shall be binding; and
(b) Agency shall inform the complainant of that effect.
(8) A complaint alleging the state lead agency, point of entry, or early intervention provider's failure to implement a due process decision shall be resolved by the Department for Public Health.
Section 7. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "First Steps Complaint Form", August 2012 edition; and
(b) "Mediation/Due Process Request Form", March 2014 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 13B.080, 13B.110, 200.672, 34 C.F.R. 303.400-303.438, 20 U.S.C. 1439
- STATUTORY AUTHORITY: KRS 194A.050, 200.660
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions of KRS 200.650 to 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes procedural safeguards for families participating in First Steps, Kentucky's Early Intervention System.
- History: 23 Ky.R. 3149; eff. 6-16-97; Recodified from 908 KAR 2:180, 10-25-2001; Recodified from 911 KAR 2:180, 5-17-2010; 37 Ky.R. 538; 1272; 1682; eff. 2-4-2011; 39 Ky.R. 2425; 40 Ky.R. 841; eff. 10-16-2013; 2889; 41 Ky.R. 513; eff. 10-15-2014; TAm eff. 7-18-2018; Cert. eff. 6-15-2021.
902 KAR 30:200 Coverage and payment for services {#sec-902-kar-30-200 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:200}
Section 1. Participation Requirements. An Kentucky Early Intervention System (KEIS) early intervention service provider or agency, approved in accordance with 902 KAR 30:150, shall:
(1) Submit to an ongoing review by the Department for Public Health, or its agent, for compliance with 902 KAR Chapter 30;
(2)
(a) Meet the qualifications for a professional or paraprofessional established in 902 KAR 30:150; or
(b) Employ or contract with a professional or paraprofessional who meets the qualifications established in 902 KAR 30:150;
(3) Ensure that a professional or paraprofessional employed by the provider who provides a service in the KEIS program shall complete training on KEIS philosophy, practices, and procedures provided by Department for Public Health representatives before providing services;
(4) Agree to provide KEIS services as authorized by an Individualized Family Service Plan (IFSP) as required by 902 KAR 30:130;
(5) Agree to maintain and submit, as requested by the Department for Public Health, required information, records, and reports to ensure compliance with 902 KAR Chapter 30;
(6) Establish a contractual arrangement directly with the Cabinet for Health and Family Services for the provision of KEIS services; and
(7) Agree to provide upon request information necessary for reimbursement for services by the Cabinet for Health and Family Services in accordance with this administrative regulation.
Section 2. Reimbursement.
(1) The Department for Public Health shall reimburse a participating KEIS provider or agency:
(a) The lower of the actual billed charge for the service; or
(b) The fixed upper limit established in this section for the service being provided.
(2) A charge submitted to the Department for Public Health shall be the provider's usual and customary charge for the same service.
(3) The fixed upper limit for services shall be as established in this subsection.
(a) Initial evaluation. The developmental component of the initial evaluation for an infant or toddler without an established risk condition shall be provided by face-to-face contact with the infant or toddler and parent. Payment shall be $311 for a completed evaluation as a single unit of service.
(b) Five (5) Area Assessment. The developmental component of the initial evaluation for an infant or toddler with an established risk condition shall be provided by face-to-face contact with the infant or toddler and parent. Payment shall be $201 for a completed assessment as a single unit of service.
(c) Annual or exit assessment. The annual or exit assessment shall be provided by face-to-face contact with the infant or toddler and parent. Payment shall be $201 for a completed assessment as a single unit of service.
(d) Discipline-specific assessment. The discipline-specific assessment conducted by an early intervention service provider shall be provided by face-to-face contact with the infant or toddler and parent. Payment shall be $201 for a completed assessment as a single unit of service.
(e) Record review. A record review shall be provided by a Department for Public Health approved team and paid at the contracted amount.
(f) Intensive clinic evaluation. The intensive level evaluation shall be provided by a Department for Public Health approved team and shall include face-to-face contact with the infant or toddler and parent. A board-certified physician shall be included on the team. Payment shall be $1,100 for a completed evaluation as a single unit of service. An individual provider shall not be reimbursed for participation on the intensive evaluation team.
(g) Early intervention or collateral services in accordance with Section 4(1), (2), (4) and (5) of this administrative regulation shall be the fixed upper limits established in this paragraph.
- The fee for collateral service or an early intervention service, including cotreatment, shall be:
a. Seventy-two (72) dollars per hour of service in an office, clinic, or center-based site;
b. $102 per hour of service in a home or community-based site, including childcare settings; or
c. Eighty-nine (89) dollars per hour for a tele-intervention service, if the service is provided by:
(i) An audiologist;
(ii) A certified social worker;
(iii) Cued language transliterator;
(iv) A developmental interventionist;
(v) A dietitian;
(vi) A licensed clinical social worker;
(vii) A licensed marriage and family therapist;
(viii) A licensed psychologist, licensed psychological practitioner, licensed professional clinical counselor, or a certified psychologist with autonomous functioning;
(ix) An occupational therapist;
(x) An orientation and mobility specialist;
(xi) A physical therapist;
(xii) A registered nurse;
(xiii) A sign language specialist;
(xiv) A speech therapist;
(xv) A teacher of the deaf and hard of hearing; or
(xvi) A teacher of the visually impaired.
a. Early intervention service providers established in subparagraph 1. of this paragraph shall be eligible for a one-time payment of $500 once the provider obtains initial fidelity in the KEIS coaching program; and
b. An additional payment of $102 shall be made to eligible early intervention service providers for the submission of a required video for fidelity authentication that successfully demonstrates fidelity.
- The fee for collateral service or an early intervention service, including cotreatment, shall be:
a. Seventy (70) dollars per hour of service in an office, clinic, or center-based site;
b. Ninety-three (93) dollars per hour of service in a home or community-based site, including childcare settings; or
c. Eighty-one (81) dollars per hour for a tele-intervention service, if the service is provided by:
(i) An assistive technology specialist;
(ii) A cued language transliterator paraprofessional;
(iii) A licensed psychological associate or a certified psychologist; or
(iv) A sign language and cued language paraprofessional.
- The fee for collateral service or an early intervention service, including cotreatment, shall be:
a. Fifty-three (53) dollars per hour of service in an office, clinic, or center-based site;
b. Eighty-one (81) dollars per hour of service in a home or community-based site, including childcare settings; or
c. Seventy (70) dollars per hour of service for tele-intervention service, if the service is provided by:
(i) An occupational therapy assistant; or
(ii) A physical therapy assistant.
- The fee for collateral service shall be eighty-seven (87) dollars per hour of service in an office, clinic, or center-based site, if the service is provided by:
a. A nurse practitioner;
b. An ophthalmologist;
c. An optometrist; or
d. A physician.
(h) Respite shall be nine (9) dollars per hour.
(4)
(a) For early intervention or collateral services, hours shall be determined using the beginning and ending time for a service.
- The hours shall be computed as established in clauses a. through d. of this subparagraph.
a. Fifteen (15) to twenty-nine (29) minutes shall equal 0.25 hours.
b. Thirty (30) to forty-four (44) minutes shall equal 0.50 hours.
c. Forty-five (45) to fifty-nine (59) minutes shall equal 0.75 hours.
d. Sixty (60) to seventy-four (74) minutes shall equal one (1) hour.
- Services shall be documented in the KEIS data management system and shall include:
a. A service note describing the intervention provided during the session;
b. A list of participants present during the early intervention session;
c. The caregiver's report of progress since the last session, including any modifications to the suggested intervention or barriers to implementing the intervention;
d. The parent's and child's response to intervention that describes the skill level of the parent and child and if the skill has increased, decreased, or stayed the same and the method used to measure progress; and
e. The plan for the next visit, based on the family's and child's response to intervention and the IFSP outcome.
(b) Service documentation shall be entered within ten (10) calendar days of the service delivery date. Documentation entered after ten (10) calendar days from the date of service shall be immediately disapproved for payment.
(c) Once the provider has entered a corrected service log, a payment adjustment shall be made. Payment shall be prorated on the following scale:
-
Correction entered within one (1) to five (5) calendar days, claim paid at a ten (10) dollar reduction;
-
Correction entered within six (6) to ten (10) calendar days, claim paid at a fifteen (15) dollar reduction;
-
Correction entered within eleven (11) to fifteen (15) calendar days, claim paid at a twenty-five (25) dollar reduction;
-
Correction entered within sixteen (16) to thirty (30) calendar days, claim paid at one half the maximum KEIS payment; and
-
Correction entered after thirty (30) calendar days or beyond shall be disapproved and not adjusted for payment.
(d) For service coordination services, hours shall be determined using the beginning and ending time for a service documented in staff notes in accordance with 902 KAR 30:110, Section 2(10).
- The hours shall be computed as established in clauses a. through d. of this subparagraph.
a. One (1) to twenty-two (22) minutes shall equal 0.25 hours.
b. Twenty-three (23) to thirty-seven (37) minutes shall equal 0.50 hours.
c. Thirty-eight (38) to fifty-two (52) minutes shall equal 0.75 hours.
d. Fifty-three (53) to sixty-seven (67) minutes shall equal one (1) hour.
- Service coordination minutes spent over the course of a day for an individual infant, toddler, or family shall be accumulated at the end of the day in order to determine the total number of hours spent.
(5) Payment for assistive technology devices shall be made in accordance with 902 KAR 30:130, Section 4.
(a) The total rental cost of an assistive technology device shall not exceed the purchase price of that device. The length of rental shall be based on the purchase price of the device and shall not exceed ten (10) months in length.
(b) The total purchase cost of an assistive technology device shall include the actual cost of the item being purchased, all related shipping charges, and an administrative fee not to exceed ten (10) percent.
(6) Transportation costs shall be reimbursed if the service is necessary to enable an eligible infant or toddler to receive early intervention services. Reimbursement and related cost of travel shall be the lesser of the billed charge or:
(a) For a commercial transportation carrier, an amount derived by multiplying one (1) dollar by the actual number of loaded miles using the most direct route;
(b) For a private automobile carrier, an amount equal to twenty-five (25) cents per loaded mile transported; or
(c) For a noncommercial group carrier, an amount equal to fifty (50) cents per eligible infant or toddler per mile transported.
(7) Payment for a group intervention service shall be thirty-two (32) dollars per infant or toddler per hour of direct contact service for each infant or toddler in the group with a limit of three (3) eligible children per professional or paraprofessional who can practice without direct supervision.
Section 3. Tele-intervention Services.
(1) Tele-intervention services shall be:
(a) Documented and authorized on the IFSP; and
(b) Provided with the same processes and standards as face-to-face services.
(2) The written informed consent for tele-intervention services signed by the parent may include electronic signatures and transmission.
(3) Tele-intervention shall be based on:
(a) A shortage of a provider discipline needed to address the needs of the infant or toddler; or
(b) The unique needs of the infant or toddler and the infant or toddler's family.
Section 4. Limitations.
(1) Service Assessments.
(a) Payment for a discipline specific assessment shall be limited to three (3) assessments per discipline per infant or toddler, unless:
-
Additional hours are necessary based on the reasons established in paragraph (b) of this subsection and documented in accordance with 902 KAR 30:130, Section 1(7); and
-
Preauthorized by the Department for Public Health in accordance with Section 5 of this administrative regulation.
(b)
-
A service assessment payment shall not be made for the provision of routine early intervention services by a discipline in the general practice of that discipline.
-
Payment for a service assessment shall be restricted to the need for additional testing due to new concerns or significant change in the infant's or toddler's status that impacts the early intervention services authorized on the IFSP.
-
Routine activity of assessing progress and outcomes shall be billed as early intervention.
(2) Unless prior authorized by the Department for Public Health in accordance with Section 5 of this administrative regulation, limitations for payment of early intervention services shall be as established in this subsection.
(a) For office, center, or home and community-based sites:
- Payment shall be limited to no more than one (1) hour per day per infant or toddler per discipline by a:
a. Professional meeting the qualifications established in 902 KAR 30:150; or
b. Paraprofessional meeting the qualifications established in 902 KAR 30:150.
- Payment shall be limited to no more than twenty-four (24) hours for a single discipline and thirty-six (36) hours for more than one (1) discipline during a six (6) month period and for group shall be limited to an additional forty-eight (48) hours during a six (6) month period.
(b) Group intervention shall include the provision of early intervention services by KEIS qualified personnel, with two (2) or more eligible infants or toddlers, at an early intervention professional's office, center, or other community-based setting where infants and toddlers typically spend their time.
-
The group may also include infants and toddlers without disabilities if a three (3) to one (1) ratio of children to staff is maintained.
-
Infants and toddlers shall not be eligible for both group and individual early intervention services by the same discipline concurrently on the IFSP
(c) Payment for siblings seen at the same time shall be calculated by dividing the total time spent by the number of siblings to get the amount of time to bill per infant or toddler.
(d) Payment for a service shall be limited to a service that is authorized by the IFSP team in accordance with 902 KAR 30:130, Section 3(3).
(e)
-
Except as provided in subparagraph 2. of this paragraph, payment shall be limited to a service provided as a face-to-face contact or tele-intervention with the infant or toddler and either the parent or caregiver.
-
Early intervention family services authorized by KRS 200.654(7) may be provided without the infant or toddler present if the reason the infant's or toddler's presence is clinically contraindicated is documented in the session note.
(3) Respite shall be a service provided to the family of an eligible infant or toddler for the purpose of providing relief from the care of the infant or toddler in order to strengthen the family's ability to attend to the child's developmental needs. Payment shall:
(a) Be limited to no more than eight (8) hours of respite per month, per eligible infant or toddler;
(b) Not be allowed to accumulate beyond each month; and
(c) Be limited to families in crisis, or strong potential for crisis without the provision of respite.
(4) Payment for collateral services shall be a billable service for the enrolled KEIS providers who are providing early intervention services for the eligible infant or toddler through an IFSP and paid by KEIS.
(a) Payment for attending the IFSP meeting shall be limited to no more than one (1) hour.
(b) Payment for attendance at one (1) Admissions and Release Committee (ARC) meeting held prior to a toddler's third birthday shall be limited to the service coordinator and primary coach provider selected by the IFSP team.
(c) Participation at an initial IFSP meeting by an initial evaluator shall be limited to an evaluator who conducted the initial evaluation in accordance with 902 KAR 30:120, Section 2(5)(a). Payment shall be at the collateral services rate for the discipline that the evaluator represents.
(5)
(a) Cotreatment shall occur if more than one (1) provider is present and providing early intervention services at the same time. Each provider's service log shall document:
-
Why the cotreatment approach was used; and
-
A description of the intervention strategies and coaching suggestions.
(b) Payment shall be limited to three (3) disciplines providing services concurrently.
(6) Unless prior authorized by the Department for Public Health due to a shortage of direct service providers, an initial evaluator shall not be eligible to provide early intervention to an infant or toddler whom the evaluator evaluated and that resulted in the infant or toddler becoming eligible.
Section 5. Prior Authorization Process.
(1) Authorization for payment for early intervention services beyond the limits established in Section 4 of this administrative regulation shall be submitted to the cabinet or its designee, as determined by the Department for Public Health, approved prior to the service being delivered, and shall include:
(a) A service exception request completed in the KEIS data management system; and
(b) Supporting documentation.
(2) The record review team shall issue a written recommendation for the IFSP team to consider within ten (10) calendar days of receipt of the request.
(3) If the IFSP team is not in agreement with the recommendation of the record review team:
(a) A request for further review shall be submitted to the Department for Public Health; and
(b) A three (3) person team from the Department for Public Health, Division of Maternal and Child Health, including the division director, shall render a recommendation.
(4) If the IFSP team is not in agreement with the three (3) person team recommendation established in subsection (3)(b) of this section:
(a) The infant's or toddler's IFSP team shall be asked to reconvene for an IFSP meeting with a representative from the record review team and a representative from the three (3) member team; and
(b) If the IFSP team concludes at that IFSP meeting that the services are still needed, payment for the service shall be authorized for the duration of the current IFSP.
Section 6. System of Payment and Fees.
(1) All families enrolling in KEIS shall be assessed for the family's ability to pay a participation fee for early intervention services in accordance with KRS 200.654 (7)(f) to (m). Families with private or public insurance shall not be charged disproportionately more than families without insurance.
(2) A charge to the family shall not be made for:
(a) Child find activities;
(b) Evaluation and assessment of the infant, toddler, and family;
(c) Service coordination;
(d) Administrative activities supporting the development, review, and evaluation of individualized family service plans; and
(e) The implementation of procedural safeguards.
(3) Families shall be notified of the KEIS System of Payments during the intake meeting, at the initial IFSP meeting, and at each subsequent IFSP meeting.
(4) Payment of fees shall be for the purpose ofmaximizing available sources of funding for early intervention services.
(5) The family share payment shall:
(a) Be based on a sliding fee scale;
(b) Be explained to the family by the point of entry staff; and
(c) Begin with the provision of an early intervention service and continue for the duration of participation in early intervention services.
(6) The ability to pay shall be determined based on:
(a) The level of the family gross income identified on the last Federal Internal Revenue Service statement or check stubs from the four (4) most recent consecutive pay periods, as reported by the family; and
(b) The level of income matched with the level of poverty, utilizing the federal poverty guidelines as published annually by the Federal Department of Health and Human Services as established in subparagraphs 1. through 9. of this paragraph.
-
Below 249 percent of poverty, there shall be no payment.
-
From 250 percent of poverty to 299 percent, the payment shall be five (5) dollars per month of participation.
-
From 300 percent of poverty to 349 percent, the payment shall be ten (10) dollars per month of participation.
-
From 350 percent of poverty to 399 percent, the payment shall be twenty-five (25) dollars per month of participation.
-
From 400 percent of poverty to 449 percent, the payment shall be seventy-five (75) dollars per month of participation.
-
From 450 percent of poverty to 499 percent, the payment shall be $150 per month of participation.
-
From 500 percent of poverty to 549 percent, the payment shall be $200 per month of participation.
-
From 550 percent of poverty to 599 percent, the payment shall be $300 per month of participation.
-
At 600 percent of poverty and above, the payment shall be $400 per month of participation.
(7) The family share participation fee shall not:
(a) Exceed the cost of the actual monthly Part C service;
(b) Apply to a family whose infant or toddler is covered by public insurance benefits (Medicaid); or
(c) Prevent or delay an infant or toddler from receiving services.
(8) The family may request a reduction or waiver of the family share fee if the family is unable to pay as established in paragraphs (a) and (b) of this subsection.
(a) The service coordinator shall submit the request on the Family Share Extraordinary Family Expenses Worksheet through TOTS to the Department for Public Health, KEIS Family Share Administrator, on behalf of the family to have the amount of the family share payment reduced or eliminated for a period not to exceed three (3) calendar months. A request shall not be submitted for a retroactive period unless extenuating circumstances, such as an unexpected hospitalization, occurs.
(b) The family shall undergo a financial review by the Department for Public Health that may:
-
Adjust the gross household income by subtracting extraordinary expenses; and
a. Result in a calculation of a new family share payment amount based on the family's adjusted income compared to the percentage of the poverty level established in subsection (6)(b) of this section. If a recalculation is completed, the Department for Public Health shall conduct a review at least quarterly; or
b. Suspend or reduce the family share payment, based on a verified financial crisis that would be exacerbated by their obligated family share payment. The Department for Public Health shall conduct a review at least quarterly.
(9) In accordance with 902 KAR 30:180, the family may contest the imposition of a fee or the determination of their ability to pay by filing:
(a) A Mediation/Due Process Request Form, incorporated by reference in 902 KAR 30:180 to request mediation or a due process hearing;
(b) A written complaint; or
(c) An appeal to the Part C Coordinator for final resolution.
(10) Income shall be verified during the intake process and at six (6) month intervals and more often if changes in household income will result in a change in the amount of the obligated family share payment.
(11) A family that refuses to have its income verified shall be assessed a family share payment of $400 per month of participation.
(12) If multiple children in a family receive early intervention services, the family share payment shall be the same as if there were one (1) child receiving services.
Section 7. Use of Insurance.
(1) Public Insurance.
(a) The state lead agency shall be the enrolled Medicaid provider for early intervention services. A contracted provider or agency shall not bill Medicaid directly for early intervention services provided in accordance with the IFSP.
(b) Written notification in accordance with 34 C.F.R. 303.520 (a)(3)(i) through(iv) shall be provided to the infant's or toddler's parent or guardian before the use of public benefits or insurance to pay for early intervention services.
(c) A parent or guardian shall not be required to sign up for or enroll in public benefits or insurance programs as a condition of receiving early intervention services.
(2) Private Insurance.
(a) Parent or guardian written consent shall be obtained:
-
For the use of private insurance to pay for the initial provision of an early intervention service on the IFSP; and
-
Each time written consent for services is required due to an increase in the frequency, length, duration, or intensity in the provision of service in the child's IFSP.
(b) A family who chooses to use private insurance for payment of KEIS service shall not be responsible for payment of insurance deductibles or copayments related to this service.
(c) The fee paid to the early intervention provider by KEIS shall be the full reimbursement from KEIS and the provider shall not charge the family any co-pay or deductible associated with the services.
(d) Families shall be responsible for payment of their insurance premiums.
(e) Federal Part C funds may be used to pay the cost of insurance premiums if obtaining insurance for the infant or toddler is the most cost-effective method for KEIS to pay for early intervention services.
(f) A family who has the ability to pay and gives consent for the use of private insurance may waive the family share fee. If the consent to bill private insurance is revoked by the family, the family shall be assessed the corresponding family share fee.
(g) A family who has the ability to pay and does not give consent for the use of private insurance shall be assessed a family share fee as described in Section 6(6)(b) of this administrative regulation.
(h) If a family is assessed as having an inability to pay and does not give consent for the use of private insurance, this lack of consent shall not prevent or delay an infant or toddler from receiving services.
(i) If a family receives payment from insurance, these funds shall be surrendered to the early intervention provider for services rendered. Failure to surrender the payment shall result in the amount of the insurance payment being added to the family share balance due.
(j) A provider shall bill a third-party insurance for an early intervention service prior to billing KEIS. Documentation regarding the billing, the third-party insurance representative's response, and payment, if any, shall be maintained in the early intervention record and submitted through the KEIS data management system.
Section 8. Use of Funds.
(1) Consistent with 34 C.F.R. 303.120 through 303.122 and 303.220 through 303.226, the state lead agency may use the federal Part C funds for activities or expenses that are reasonable and necessary for implementing the KEIS program for infants and toddlers with disabilities including:
(a) For direct early intervention services for infants and toddlers with disabilities and their families that are not otherwise funded through other public or private sources;
(b) To expand and improve services for infants and toddlers with disabilities and their families; and
(c) To strengthen the statewide system by initiating, expanding, or improving collaborative efforts related to at-risk infants and toddlers, including establishing linkages with appropriate public and private community-based organizations, service, and personnel for the purposes of:
-
Identifying and evaluating at-risk infants and toddlers;
-
Making referrals for the infants and toddlers identified and evaluated under subparagraph 1. of this subsection; and
-
Conducting periodic follow-up on each referral, to determine if the status of the infant or toddler involved has changed with respect to eligibility for services.
(2) In accordance with 34 C.F.R. 303.500, Part C funds shall be the payor of last resort.
Section 9. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Family Share Extraordinary Family Expenses Worksheet", FS-24, June 2021; and
(b) "Notice of System of Payments", FS-48, March 2024.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
(3) This material may also be obtained at the cabinet's Web site at https://www.chfs.ky.gov/agencies/dph/dmch/ecdb/Pages/keis.aspx.
History
- RELATES TO: KRS 200.654, 200.672, 34 C.F.R. 303.120 - 122, 303.220 - 226, 303.500, 303.520, 303.521
- STATUTORY AUTHORITY: KRS 194A.050, 200.660(3), (7), (8)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) authorizes the Secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to implement programs mandated by federal law, or to qualify for the receipt of federal funds. KRS 200.660 requires the Cabinet for Health and Family Services to administer funds appropriated to implement the provisions of KRS 200.650 through 200.676, to enter into contracts with early intervention service providers, and to promulgate administrative regulations necessary to implement KRS 200.650 through 200.676. This administrative regulation establishes the provisions relating to early intervention services for which payment shall be made on behalf of eligible recipients.
- History: 24 Ky.R. 811; Am. 1109; eff. 11-14-1997; 25 Ky.R. 672; 1420; 1663; eff. 1-19-1999; Recodified from 908 KAR 2:200, 10-25-2001; 29 Ky.R. 2795; 30 Ky.R. 330; 630; 893; eff. 8-20-2003; 31 Ky.R. 502; 1427; eff. 2-22-2005; 35 Ky.R. 2825; 36 Ky.R. 311; eff. 8-12-2009; Recodified from 911 KAR 2:200, 5-17-2010; 37 Ky.R. 542; 1282; 1685; eff. 2-4-2011; 39 Ky.R. 2428; eff. 10-16-2013; 40 Ky.R. 2893; eff. 10-15-2014; Cert. eff. 6-15-2021; 51 Ky.R. 398, 1289; eff. 2-5-2025.
902 KAR 30:210 Enhanced early intervention services in response to declared national or state public health emergency {#sec-902-kar-30-210 omnilex-key=us-ky-regs-official--title-902--902 KAR 30:210}
Section 1. Definitions.
(1) "Declared national or state public health emergency" means a formal declaration by the President of the United States or the Governor of Kentucky of an extraordinary event that is determined to constitute a public health risk through the spread of disease.
(2) "Tele-intervention service" means early intervention services provided through the internet with both video and audio features and with the early intervention provider and family both present in real time.
Section 2. Enhanced Early Intervention Services in Response to a Declared National or State Public Health Emergency.
(1) Early intervention services and requirements may be enhanced to allow for tele-intervention services if a national or state public health emergency has been declared.
(2) Early intervention services that are otherwise designated as face-to-face in accordance with 902 KAR 30:160 may be provided through tele-intervention with informed parental consent if:
(a) Informed parental consent is obtained verbally for the purposes of tele-intervention services;
(b) Written consent is received by the point of entry within ten (10) days of the verbal consent; and
(c) The date verbal consent is obtained is documented in the child's electronic record.
(3) Each provider utilizing tele-intervention services shall take all necessary steps to maintain confidentiality with 34 C.F.R. Part 99, 34 C.F.R. 303.402, and 45 C.F.R. Part 160.
(4) Tele-intervention services shall be reimbursed at the usual and customary rate as established in 902 KAR 30:200, Section 2.
(5) Tele-intervention services shall revert to face-to-face service delivery methods following the end of the declared national or state public health emergency.
History
- RELATES TO: KRS 200.650 - 200.676, 34 C.F.R. Part 99, 34 C.F.R. Part 303, 45 C.F.R. Part 160, 20 U.S.C. 1431-1444
- STATUTORY AUTHORITY: KRS 194A.050, 200.660
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 200.660 requires the Cabinet for Health and Family Services to administer all funds appropriated to implement provisions of KRS 200.650 through 200.676, to enter into contracts with service providers, and to promulgate administrative regulations. This administrative regulation establishes the provisions for providing tele-intervention services if a national or state public health emergency has been declared.
- History: 47 Ky.R. 2220; 48 Ky.R. 60; eff. 7-21-2021.
Chapter 45 Food and Cosmetics
902 KAR 45:001 Definitions for hemp-derived cannabinoid products {#sec-902-kar-45-001 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:001}
Section 1. Definitions.
(1) "Adult-use cannabinoid" means a product with intoxicating properties that changes the function of the nervous system and results in alterations of perception, cognition, or behavior.
(2) "Approved source" means:
(a) A Kentucky hemp grower or handler licensed by the Kentucky Department of Agriculture, or an out-of-state hemp grower or handler who is duly authorized to produce hemp under the laws of the applicable jurisdiction;
(b) A hemp product manufacturer or processor permitted by the Kentucky Department for Public Health; or
(c) A manufacturer or processor permitted by another state regulatory authority for hemp-derived cannabinoid products if that state has been approved by the department as having equivalent state standards for processing, laboratory testing, and labeling requirements.
(3) "Cabinet" is defined by KRS 217.015(3).
(4) "Cannabidiol" or "CBD" is defined by KRS 217.039(1)(a).
(5) "Cannabinoid" means a compound found in the hemp plant Cannabis sativa L from a United States Department of Agriculture sanctioned domestic hemp production program and does not include cannabinoids derived from any other substance.
(6) "Cannabinoid product class" means a group of cannabinoid products that:
(a) Have all ingredients in common; and
(b) Are produced by or for the same company.
(7) "Cartoon" means any drawing or other depiction of an object, person, animal, creature, or any similar caricature that satisfies any of the following criteria:
(a) The use of comically exaggerated features;
(b) The attribution of human characteristics to animals, plants or other objects, or the similar use of anthropomorphic technique; or
(c) The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury, X-ray vision, tunneling at very high speeds, or transformation.
(8) ''Child-resistant'' means packaging that is:
(a) Designed or constructed to be significantly difficult for children under five (5) years of age to open and not difficult for adults to use properly; and
(b) Resealable to maintain this effectiveness for children through multiple openings for any product intended for more than a single use or containing multiple servings.
(9) "Cosmetic" is defined by KRS 217.015(7).
(10) "Direct supervision" means the continuous, on-site observation of an employee with the supervisor physically present.
(11) "Food service establishment" is defined by KRS 217.015(21).
(12) "Hemp" is defined by KRS 260.850(5).
(13) "Hemp-derived cannabinoid" means an ingestible, inhalable, or cosmetic product that is processed or derived from hemp.
(14) "Home-based processor" is defined by KRS 217.015(56).
(15) "Hydrogenation" means the chemical reaction between molecular hydrogen (H2) and another compound or element.
(16) "Imminent health hazard" is defined by KRS 217.015(24).
(17) "Infused" means adding a cannabinoid ingredient to an ingestible cannabinoid product.
(18) "Non-intoxicating cannabinoid" means a product with non-psychoactive properties that does not change the function of the nervous system and does not result in alteration of perception, cognition, or behavior.
(19) "Person" is defined by KRS 217.015(32).
(20) "Proof of age" is defined by KRS 438.305(4).
(21) "Revocation" means the permit to operate is cancelled by the department.
(22) "Serious adverse event" means a medical occurrence associated with the use of a cannabinoid product that results in:
(a) Death;
(b) A life-threatening event;
(c) Inpatient hospitalization, or prolongation of an existing hospitalization;
(d) A persistent or significant incapacity, or substantial disruption in the ability to conduct normal life functions; or
(e) A congenital anomaly or birth defect.
(23) "Tentatively identified compounds" or "TIC" means compounds detected in a sample that are not among the target analytes.
History
- RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035, 217.037, 217.039, 260.850, 438.305(4), 2023 Ky Acts ch. 78
- STATUTORY AUTHORITY: KRS 217.125, 217.135
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215. KRS 217.135 authorizes the secretary to establish food standards by administrative regulation including a reasonable definition, standard of identity, and designation of optional ingredients that shall be named on the label. This administrative regulation establishes the definitions applicable to hemp-derived cannabinoid products.
- History: 50 Ky.R. 2535; 51 Ky.R. 68, 909, 1118; eff. 11-18-2024.
902 KAR 45:005 Kentucky food code {#sec-902-kar-45-005 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:005}
Section 1. Definitions.
(1) "2013 FDA Food Code" means the 2013 edition of the Food Code published by the U.S. Public Health Service and the U.S. Food and Drug Administration.
(2) "Cabinet" is defined by KRS 217.015(3).
(3) "Complex food preparation" means the process of preparing a food item that includes two (2) or more complete trips through the temperature danger zone between forty-one (41) degrees Fahrenheit and 135 degrees Fahrenheit.
(4) "Kentucky State Plumbing Code" is defined by KRS 318.130.
(5) "Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.
(6) "Restricted concessions" means a food service establishment, whether mobile or stationary, limited to preparing and serving only menu items and ingredients considered to be low-risk in relation to foodborne illness.
(7) "Statewide mobile food unit" means a fully enclosed, self-contained food service establishment that operates from a vehicle or is otherwise mobile.
Section 2. Revisions to the 2013 FDA Food Code. The 2013 edition of the FDA Food Code shall apply to Kentucky food establishments with the addition of the provisions established in this section.
(1) FDA Food Code Subparagraph 2-102.11(B) shall be replaced with the following sentence: Being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program or a local health department class that addresses the food safety issues described in 2-102.11(C) of the 2013 FDA food code.
(2) FDA Food Code Subparagraph 6-501.115 shall be supplemented with the Kentucky-specific exceptions established in this subsection.
(a) A dog may be allowed in an outdoor dining area if:
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The outdoor dining area is not fully enclosed; and
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There is an entrance to the outdoor dining area that is separate from the main entrance and the sole means of entry for a patron with a dog.
(b) Employees shall not permit a dog to come into physical contact with:
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Food;
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Serving dishes;
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Utensils;
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Tableware;
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Linens;
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Unwrapped single-service and single-use articles; or
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Other food service items that could result in contamination of food or a food-contact surface.
(c) An employee engaged in the preparation or handling of food shall avoid physical contact with a patron dog. If an employee has physical contact with a patron dog, the employee shall wash his or her hands prior to returning to work.
(d) All accidents involving dog vomit, feces, or urination shall be cleaned immediately and the area sanitized with an approved product. A kit with the appropriate materials for this purpose shall be made available for use in the designated outdoor dining area.
(e) Signage shall be posted at each entrance to the outdoor dining area stating that dogs:
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May be allowed in the area;
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Shall not be served food or water in wares used for human consumption;
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Shall not be allowed on chairs, seats, or tables; and
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Shall be kept on a leash and under the control of an adult at all times.
(f) The food establishment may refuse to serve the patron with a dog if:
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The patron fails to exercise reasonable control over the dog; or
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The dog is behaving in a manner that compromises or threatens to compromise the health or safety of any person present.
Section 3. Statewide Mobile Food Units.
(1) All food products served in a statewide mobile food unit shall be cooked or prepared in:
(a) A statewide mobile food unit permitted by the cabinet; or
(b) A food service establishment permitted by the cabinet.
(2) Complex food preparation shall not be performed in a statewide mobile food unit.
(3) The statewide mobile food unit shall not serve as a catering operation unless it meets additional permitting requirements as a catering kitchen.
(4) The statewide mobile food unit shall be serviced and cleaned every day of operation.
(5) The statewide mobile food unit shall meet the sanitation and plumbing requirements contained in the 2013 FDA Food Code and the Kentucky State Plumbing Code.
(6) Sewage and other liquid wastes shall be removed according to the 2013 FDA Food Code and the Kentucky State Plumbing Code.
Section 4. Restricted Concessions.
(1) Restricted concessions may include:
(a) Flavored ice;
(b) Shaved ice;
(c) Snow cones with commercially mixed and packaged flavorings;
(d) Pork rinds;
(e) Roasted peanuts, almonds, pecans, or walnuts, without the shell;
(f) Nacho cheese and chips;
(g) Cotton candy;
(h) Pre-cooked, commercially processed hotdogs, frankfurters, or similar meats (such as bratwurst or Italian sausage) that are grilled, steamed, or boiled on-site;
(i) Pre-packaged sandwiches;
(j) Pre-packaged ice cream or popsicles;
(k) Prepackaged, commercially processed snack foods (such as pretzels or chips) from a state or federal permitted food manufacturer;
(l) Shelf-stable, pre-packaged baked goods; or
(m) Commercially produced bottled or canned soft drinks, water, ice tea, or lemonade.
(2) Sanitation requirements.
(a) If public water is available, a restricted concession facility shall follow the requirements of the Kentucky State Plumbing Code.
(b) If public water is not available, a restricted concession facility may operate under temporary sanitation if:
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There is an adequate amount of stored potable water available;
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Tubs, buckets, or similar containers for washing, rinsing, and sanitizing equipment large enough to completely immerse the largest item used in operation are available;
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There are adequate hand washing facilities; and
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Permanent or portable toilet facilities are conveniently located and have hand washing facilities available.
(c) The restricted concession facility shall provide adequate cold and hot storage for food products and safe storage areas for the storage of dry food and single service articles.
(d) A restricted concession facility shall be constructed or located in such a way that food and utensils shall be protected from potential contamination, including from insects, dust, and debris.
Section 5. Bed and Breakfast.
(1) A bed and breakfast establishment shall not be subject to this administrative regulation if:
(a) The bed and breakfast establishment is:
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In a one (1) family, privately owned residential dwelling unit that has guest rooms or suites used, rented, or hired out for occupancy; and
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Occupied for sleeping purposes by persons not affiliated by the single-family unit;
(b) The owner or caretaker of the bed and breakfast establishment resides on the premises or property adjacent to the premises during the periods of occupancy;
(c) The number of available guest rooms does not exceed nine (9);
(d) The number of overnight guests does not exceed eighteen (18); and
(e) Breakfast and other meals are served.
(2) Guests shall be informed by placards posted at the registration area that the food is prepared in a kitchen that is not regulated and inspected by the regulatory authority.
(3) A bed and breakfast establishment that does not meet all of the requirements established in subsection (1)(a) to (e) of this section shall meet the requirements of this administrative regulation.
Section 6. Inspections and Violations.
(1) If an inspection is made of an establishment, the findings shall:
(a) Be recorded on Form DFS-208, Food Establishment Inspection Report, using the:
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1/09 edition for an inspection conducted before July 1, 2019; or
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10/17 edition for an inspection conducted on or after July 1, 2019; and
(b) Constitute a written notice to the permit holder.
(2) A copy of the inspection report shall be provided to the permit holder or person in charge.
(3) The inspection report form shall summarize the requirements of this administrative regulation and shall set forth a point value for each requirement.
(4) The rating score of the establishment shall be the total of the point value for all violations subtracted from 100.
(5) The inspection report form shall specify a period of time for the correction of the violations found pursuant to this subsection.
(a) If the rating score of the establishment is eighty-five (85) or more, all violations of one (1) point items shall be corrected prior to the next routine inspection.
(b) If the rating score of the establishment is at least seventy (70) but not more than eighty-four (84), all violations of one (1) point items shall be corrected within a period not to exceed thirty (30) days.
(c) Regardless of the rating score of the establishment, all violations of priority items shall be corrected within a time period not to exceed ten (10) days.
(6) The inspection report shall state that:
(a) Failure to comply with a time limit for correction may result in the suspension of a permit; and
(b) An opportunity for appeal shall be provided if a written request for a hearing is filed in accordance with 902 KAR 1:400.
Section 7. Permit Suspension.
(1) If the rating score of the establishment is less than seventy (70), the establishment shall be issued a Form DFS-214, Notice of Enforcement of intent to suspend the permit in accordance with 902 KAR 1:400.
(2) A permit shall be suspended immediately upon notice to the permit holder without a hearing if:
(a) The cabinet has reason to believe that an imminent public health hazard exists;
(b) The permit holder or an authorized agent has interfered with the cabinet in the performance of its duties after its agents have duly and officially identified themselves; or
(c) An inspection of an establishment reveals a rating score of less than sixty (60).
(3) A permit holder subject to suspension of a permit may submit a Form DFS-215, Application for Reinstatement, in accordance with 902 KAR 1:400.
(4) The permit holder whose permit has been suspended may request a hearing in accordance with 902 KAR 1:400.
(5) If a food service establishment is required under the provisions of this administrative regulation to cease operations, it shall not resume operations until a reinspection determines that conditions responsible for the requirement to cease operations no longer exist.
Section 8. Methods of Conducting Evaluations of Retail Food Programs. The evaluation and standardization procedures for retail food programs shall be governed by the FDA Procedures for Standardization of Retail Food Safety Inspection Officers, Procedures Manual.
Section 9. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Food Code", U.S. Public Health Service, FDA, 2013;
(b) "FDA Procedures for Standardization of Retail Food Safety Inspection Officers, Procedures Manual", U.S. Public Health Service, 2015;
(c) "DFS-208, Food Establishment Inspection Report", edition 10/17;
(d) "DFS-214, Notice of Enforcement ", edition 3/2018; and
(e) "DFS-215, Application for Reinstatement, edition 03/2018.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Cabinet for Health and Family Services, Department for Public Health, Division of Public Health Protection and Safety, Food Safety Branch, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.005-217.205, 217.280-217.390, 217.990-217.992, 219.011
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1)(c), 217.125
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1), 217.125, 211.090(3), and 211.180(1)(c) authorize the Cabinet for Health and Family Services to regulate food service establishments and retail food stores. This administrative regulation establishes a uniform code for the regulation of all food service establishments and retail food stores for the purpose of protecting the public health.
- History: 902 KAR 045:005. KDC-22; 1 Ky.R. 645; eff. 4-9-1975; Am. 6 Ky.R. 361; 564; eff. 5-7-1980; 9 Ky.R. 1335; eff. 7-6-1983; 11 Ky.R. 482; eff. 10-9-1984; 17 Ky.R. 512; 1395; eff. 9-19-1990; 18 Ky.R. 3045; 3404; eff. 5-18-1992; 20 Ky.R. 140; 1831; eff. 1-10-1994; 22 Ky.R. 2432; eff. 8-1-1996; 35 Ky.R. 1624; 2255; eff. 5-1-2009; 45 Ky.R. 1127, 2132; eff. 2-21-2019; Crt eff. 10-13-2025.
902 KAR 45:012 Hemp-derived cannabinoid product retail and food service establishment requirements {#sec-902-kar-45-012 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:012}
Section 1. Retail Establishment and Food Service Establishment Registration.
(1)
(a) Only approved cannabinoid products or class of products in accordance with 902 KAR 45:021 may be sold in retail and food service establishments. All other cannabinoid products or class of products shall be prohibited.
(b) All cannabinoid products or class of products shall be registered in accordance with 902 KAR 45:021, Section 1(4).
(c) A retailer or distributorshall ensure that all cannabinoid products sold are properly registered with the department.
(2) Retail establishments and food service establishments offering adult-use cannabinoid products shall be permitted by the cabinet in accordance with this administrative regulation.
(3) The permit shall be:
(a) Nontransferable in regard to person or address;
(b) Renewed annually; and
(c) Include a $2,000 annual permit fee.
(4) All retail establishments registered with the department prior to December 31, 2024, shall have the fee required by subsection (3)(d) of this section waived until the date of the next annual renewal.
(5) A retailer shall ensure all locations are permitted by the cabinet.
(6) Retail establishments and food service establishments, not permitted by the cabinet, offering adult-use cannabinoid products at a temporary event or festival shall:
(a) Register with the cabinet at https://redcap.chfs.ky.gov/surveys/?s=C8AHC9AYMP74REEM; and
(b) Include a $250 temporary event registration fee.
(7) Retail establishments offering adult-use cannabinoid products shall not be located within 1,000 feet of an elementary, middle, or high school. Retail establishments registered with the department prior to December 31, 2024, shall be exempted from the location requirements.
(8) An in-state business that distributes, sells, or serves adult-use hemp-derived cannabinoid products shall not employ any person who is under twenty-one (21) years of age, unless the person employed is at least eighteen (18) years of age and under the direct supervision of a person twenty-one (21) years of age or older.
Section 2. Retail Sale of Cannabinoid Products.
(1) All cannabinoid products sold in a retail establishment shall:
(a) Be from an approved source;
(b) Be packaged and labeled in accordance with 902 KAR 45:021, Section 3; and
(c) Have a valid certificate of analysis available upon request.
(2) Cannabinoid retailers shall maintain records of wholesale cannabinoid product purchase, including the name and address of the cannabinoid processor or manufacturer, and the wholesaler or distributor.
(3) The following hemp-derived products shall not be marketed, sold, or distributed direct to the consumer in a retail setting:
(a) Whole hemp buds;
(b) Ground hemp floral material;
(c) Ground hemp leaf material; and
(d) Any hemp product with a total delta-9 THC concentration in excess of zero and three-tenths (0.3) percent.
(4) All adult-use cannabinoid products shall:
(a) Be secured in the retail setting to prevent theft or other access to persons under the age of twenty-one (21); and
(b) Not be sold, gifted, or otherwise transferred to any person under the age of twenty-one (21).
(5)
(a) Any person who sells adult-use cannabinoid products at retail shall require proof of age of the buyer to verify the buyer is age twenty-one (21) years or older; and
(b) May deliver or ship adult-use cannabinoid products to consumers over twenty-one (21) years of age in packages clearly marked "Adult-use only".
(6) All persons located in another state or country who deliver, ship, or cause to be delivered or shipped cannabinoid products directly to any Kentucky consumer shall be registered in accordance with 902 KAR 45:021.
Section 3. Ingestible Cannabinoid Products at Food Service Establishments.
(1) Only registered, pre-packaged adult-use ingestible cannabinoid products may be offered as ready-to-consume or for direct consumption at food service establishments.
(2) Adult-use cannabinoids shall not be added to an ingestible food product at a food service establishment.
(3) Non-intoxicating cannabinoids may be added to an ingestible product prior to retail sale at a food service establishment.
(4) The non-intoxicating cannabinoid shall be obtained from an approved source.
(5) The food service establishment shall obtain a valid certificate of analysis from the approved source and provide a copy upon inspection.
(6) A food service establishment offering non-intoxicating cannabinoid products in a finished food product shall provide to consumers upon request:
(a) The common name of the product; and
(b) The manufacturer or distributor of the product.
(7) A food service establishment shall notify the cabinet within twenty-four (24) hours of becoming aware or within twenty-four (24 hours) of when the food service establishment should have been aware of any serious adverse event to a hemp-derived cannabinoid product sold by the establishment.
Section 4. Inspection and Enforcement.
(1)
(a) Retail establishments offering adult-use cannabinoid products shall be inspected by the cabinet or its duly authorized agent; and
(b) Retail establishments offering only non-intoxicating cannabinoid products may be inspected by the cabinet or its duly authorized agent upon complaint, receipt of a report of a serious adverse event, or at the discretion of the cabinet.
(2) The location of the permitted establishment, all general business records, including employee records, and vehicles utilized to transport products are subject to reasonable inspection.
(3) All cannabinoid establishments, whether permitted or not, shall cooperate with the cabinet or its duly authorized agent during any inspections, complaint investigation, requests for information or data, in order to verify compliance with this administrative regulation.
(4)
(a) Products not in compliance with this administrative regulation shall be seized by the cabinet or its duly authorized agent.
(b) The permit holder shall be given notice that they have ten (10) days to file an appeal pursuant to subsection (12) of this section.
(c) If no request for an appeal is filed, seized products shall be destroyed.
(5) The permit holder shall take immediate steps to correct conditions that have caused an imminent health hazard.
(6)
(a) The permit holder shall notify the cabinet within twenty-four (24) hours of the knowledge of an imminent health hazard that cannot be controlled by immediate corrective action or if product, product packaging, cosmetic, or cosmetic packaging has become contaminated because of an imminent health hazard.
(b) Notification to the cabinet shall be made by:
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Email to food.safety@ky.gov; or
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Phone to (502) 564-7181.
(7) If the cabinet has evidence that a permit holder has failed to act to correct an imminent health hazard:
(a) The permit shall be suspended immediately; and
(b) The permit holder may request an administrative hearing in accordance with KRS Chapter 13B.
(8) A permit holder shall notify the cabinet within twenty-four (24) hours of becoming aware of any serious adverse event to a cannabinoid product sold or transferred by the permit holder.
(9) In all other instances of violation of this administrative regulation, the cabinet shall serve the permit holder with a written notice specifying the violation and afford the holder an opportunity to correct.
(10) If a permit holder has failed to comply with the written notice within the timeframe granted, the cabinet shall issue a notice of intent to suspend the permit.
(11)
(a) The notice in subsection (9) of this section shall include notification that the permit shall be suspended at the end of ten (10) days following service of the notice, unless a written request for an administrative hearing is filed with the cabinet by the permit holder within the ten (10) day period; and
(b) The administrative hearing shall be conducted in accordance with KRS 13B.080.
(12) For a permitted establishment that has had a suspended permit two (2) or more times within a five (5) year period, the cabinet shall initiate permit revocation proceedings. Prior to this action, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit revocation is being sought and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative hearing is filed with the cabinet pursuant to KRS Chapter 13B by the permit holder within the ten (10) day period.
(13) Any person who knowingly violates any provision of this administrative regulation may be fined, found guilty of a criminal offense, or both pursuant to KRS 217.992.
(14) State and local law enforcement officers shall have concurrent jurisdiction to enforce violations of this section.
History
- RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035, 217.037, 217.039, 217.992, 2023 Ky Acts ch. 78
- STATUTORY AUTHORITY: KRS 217.125, 217.127, 217.135, 217.155
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215. KRS 217.125(2) requires the secretary to provide by administrative regulation a schedule of fees for permits to operate and for inspection activities carried out by the cabinet pursuant to KRS 217.025 through 217.390. KRS 217.135 authorizes the secretary to establish food standards by administrative regulation including a reasonable definition, standard of identity, and designation of optional ingredients that shall be named on the label. KRS 217.155 allows the cabinet or its duly authorized agent free access at reasonable times for the purpose of inspection any factory, warehouse, or establishment where foods, drugs, devices, or cosmetics are manufactured or held for sale. This administrative regulation establishes the requirements for retail sale of hemp-derived cannabinoid products, including the permit fee, and methods for use of hemp-derived cannabinoid as an additive to food products. Retail establishments registered with the department prior to December 31, 2024 shall be exempted from the permit fee requirement until the annual renewal date. In accordance with 2023 Ky. Act ch 78, in order to limit the ability of minor children accessing adult-use hemp-derived cannabinoid use products, this administrative regulation prohibits the sale of adult-use products within 1,000 feet of an elementary, middle, or high school. Retail establishments registered with the department prior to December 31, 2024 online at https://redcap.chfs.ky.gov/surveys/?s=C8AHC9AYMP74REEM shall be exempted from this location requirement.
- History: 50 Ky.R. 2537; 51 Ky.R. 578; eff. 2-5-2025.
902 KAR 45:020 Kentucky shellfish dealer standards and requirements {#sec-902-kar-45-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:020}
Section 1. Definitions.
(1) "Air gap" means the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture, or other device and the flood level rim of that receptacle.
(2) "AOAC" means the Association of Official Analytical Chemists.
(3) "APHA" means the American Public Health Association.
(4) "Approved" means acceptable to the cabinet or responsible regulatory authority based on a determination of conformity with principles, practices, and generally-recognized standards that protect public health.
(5) "Approved classification" means a classification used to identify a growing area where harvest for direct marketing is allowed.
(6) "Aquaculture" means the cultivation of seed in natural or artificial growing areas, or the cultivation of shellfish other than seed in growing areas.
(7) "Assure" means to make the best efforts within reasonable limits of manpower and resources to fulfill the objective of this administrative regulation.
(8) "Backflow" means the flow of water or other liquids, mixtures. or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.
(9) "Back siphonage" means the flowing back of used, contaminated, or polluted water from a plumbing fixture, vessel, or other source into potable water supply pipes because of negative pressure in the water supply pipes.
(10) "Blower" means a receptacle for washing shucked shellfish which uses forced air as a means of agitation.
(11) "Broker" means any person who is not a dealer but who arranges the packaging, shipping, sale, or distribution of molluscan shellfish without taking ownership or physical custody of the shellfish.
(12) "Cabinet" is defined by KRS 217.015(3).
(13) "Certified shellfish dealer" means a person to whom certification is issued for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor.
(14) "Certified shellfish dealer processing facility" means a structure or vehicle utilized by the certified shellfish dealer for postharvest shellfish processing, including shucking, packaging, repackaging, shipping, reshipping, or depuration processing.
(15) "Certification number" means the unique identification number established in Section 2(10) of this administrative regulation and issued by the cabinet to a certified shellfish dealer for each location.
(16) "Commingle" means the act of combining different lots of shellstock or shucked shellfish.
(17) "Coliform group" means of the aerobic and facultative anaerobic, gram negative, nonsporeforming, rod-shaped bacilli which ferment lactose broth with gas formation within forty-eight (48) hours at ninety-five (95) degrees Fahrenheit.
(18) "Compliance schedule" means a written schedule, approved by the cabinet, that provides a correction time period for the certified shellfish dealer to eliminate deficiencies.
(19) "Conditionally approved" means a classification used to identify a growing area which meets criteria for the approved classification except under certain conditions described in a management plan.
(20) "Container" means any bag, sack, tote, conveyance, or other receptacle used for containing shellfish for holding or transporting.
(21) "Corrosion-resistant materials" means materials that maintain their original surface characteristics under normal exposure to the foods being contacted, normal use of cleaning compounds and bactericidal solutions, and other conditions of use.
(22) "Critical control point" means a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can, as a result be prevented, eliminated or reduced to acceptable levels.
(23) "Critical deficiency" means a condition or practice noted as a deficiency on the NSSP Standardized Shellfish Plan Inspection Form which:
(a) Results in the production of a product that is unwholesome; or
(b) Presents a threat to the health or safety of the consumer.
(24) "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
(25) "Cross connection" means an unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not, or cannot be, approved as safe and potable.
(26) "Cull" means to remove dead or unsafe shellstock from a lot of shellstock.
(27) "Depuration" means the process of reducing the pathogenic organisms that may be present in shellstock by using a controlled aquatic environment as the treatment process.
(28) "Depuration processor" or "DP" means a person who harvests or receives shellstock from growing areas in the approved or conditionally-approved, restricted, or conditionally-restricted classification and submits the shellstock to an approved depuration process.
(29) "Direct marketing" means the sale for human consumption of shellfish which:
(a) Does not require depuration or relaying prior to sale; or
(b) Has been subjected to depuration or relaying activities.
(30) "Dry storage" means the storage of shellstock out of water.
(31) "Easily cleanable" means a surface which is:
(a) Readily accessible; and
(b) Is made of materials, has a finish, and is so fabricated that residues may be effectively removed by normal cleaning methods.
(32) "EPA" means the United States Environmental Protection Agency.
(33) "FDA" means the US Food and Drug Administration.
(34) "Fecal coliform" means the portion of the coliform group which will produce gas from lactose in an EC or A-1 multiple tube procedure liquid medium within twenty-four (24) (plus two (2)) hours in a water bath maintained at 112 degrees Fahrenheit.
(35) "Food contact surface" means an equipment surface or utensil which normally comes into direct or indirect contact with shucked shellfish.
(36) "Food safety hazard" means any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
(37) "Growing area" means any site which supports, or could support, the propagation of shellstock by natural or artificial means.
(38) "HACCP" or "Hazard Analysis and Critical Control Point" means a systematic, science-based approach used in food production as a means to assure food safety.
(39) "HACCP plan" means a written document that delineates the formal procedures that a certified shellfish dealer follows to implement the HACCP requirements set forth in Section 6 of this administrative regulation.
(40) "Handwashing" means the process established in Section 11(32) of this administrative regulation.
(41) "Harvest" means the act of removing shellstock from growing areas and its placement on or in a manmade conveyance or other means of transport.
(42) "Harvest area" means an area that contains commercial quantities of shellstock and may include aquaculture sites and facilities.
(43) "Harvester" means a person who takes shellstock by any means from a growing area.
(44) "Heat shock" means the process of subjecting shellstock to any form of heat treatment prior to shucking, including steam, hot water, or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the shellfish.
(45) "ICSSL" or "Interstate Certified Shellfish Shippers List" FDA publication of shellfish dealers, domestic and foreign, who have been certified by a state or foreign authority. The ICSSL is available on-line at the following Web address: http://vm.cfsan.fda.gov/%7Eear/shellfis.html.
(46) "Importer" means any certified shellfish dealer who introduces molluscan shellfish into domestic commerce and has ownership of the shellfish without needing physical custody of the shellfish.
(47) "Includes" or "including" means includes or including by way of illustration and not by way of limitation.
(48) "Key deficiency" means a condition or practice noted as a deficiency on the NSSP Standardized Shellfish Processing Plant Inspection Form which may result in adulterated, decomposed, misbranded, or unwholesome product.
(49) "Label" means a label as defined by KRS 217.015(26) affixed to, or appearing upon, any package containing shellfish.
(50) "Lot of shellstock" means a single type of bulk shellstock, or containers of shellstock, of no more than one (1) day's harvest from a single defined growing area gathered by one (1) or more harvesters.
(51) "Lot of shucked shellfish" means a collection of containers of no more than one (1) day's shucked shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking.
(52) "Lot of shucked shellfish for depuration" means shellstock harvested from a particular area during a single day's harvest and delivered to one (1) depuration plant.
(53) "Marine biotoxin" means any poisonous compound produced by marine microorganisms and accumulated by shellstock.
(54) "MPN" or "Most probable number" means a statistical estimate of the number of bacteria per unit volume and is determined from the number of positive results in a series of fermentation tubes.
(55) "National Shellfish Sanitation Program" or "NSSP" means the cooperative state-FDA-Industry Program for the sanitary control of shellfish.
(56) "Other deficiency" means a condition or practice noted as a deficiency on the NSSP Standardized Shellfish Processing Plant Inspection Form that is not defined as critical, or key, and is not in accordance with the requirements of this administrative regulation.
(57) "Person" means any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, and any partnership, association, corporation, or other entity.
(58) "Point source" means any discernible, confined, and discrete conveyance including any pipe, ditch, channel, tunnel, or conduit that carries pollution.
(59) "Poisonous or deleterious substance" means a toxic substance occurring naturally, or added to, the environment for which a regulatory tolerance limit or action level has been established in shellfish to protect public health.
(60) "Postharvest processing" means processing of shellfish for the purpose of added safety or quality that involves hazards not addressed by controls in Sections 11 through 14 of this administrative regulation.
(61) "Potable water" means water defined as potable under the provisions of 401 KAR Chapter 8.
(62) "Principal display panel" means that part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of retail sale.
(63) "Private water system" means a water system as defined in 401 KAR Chapter 8 that is constructed, maintained, and operated pursuant to applicable requirements of the Kentucky Environmental and Public Protection Cabinet.
(64) "Process batch" means a quantity of shellstock used to fill each separate tank or a series of tanks supplied by a single-process water system for a specified depuration cycle in a depuration activity.
(65) "Process water" means the water used in the scheduled depuration process.
(66) "Prohibited Classification" means a classification used to identify a growing area where the harvest of shellstock, for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.
(67) "Public water system" means a water system as defined in 401 KAR Chapter 8 that is designed, constructed, maintained, and operated pursuant to applicable requirements of the Kentucky Environmental and Public Protection Cabinet.
(68) "Raw" means shellfish that have not been thermally processed:
(a) To an internal temperature of 145 degrees Fahrenheit or greater for fifteen (15) seconds (or equivalent); or
(b) Altering the organoleptic characteristics.
(69) "Repacker" or "RP" means any person, other than the original certified shucker-packer, that repackages shucked shellfish into other containers.
(70) "Repacking shellstock" means the practice of removing shellstock from containers and placing it into other containers.
(71) "Reshipper" or "RS" means a person that purchases shucked shellfish or shellstock from certified shellfish dealers and sells the product without repacking or relabeling to other certified shellfish dealers, wholesalers, or retailers.
(72) "Safe materials" means articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of, or otherwise adversely affect, the characteristics of any food.
(73) "Sanitation control record" means records that document the monitoring of sanitation practices and conditions during processing.
(74) "Sanitize" means to adequately treat food contact surfaces by a process that is effective in:
(a) Destroying vegetative cells of microorganisms of public health significance;
(b) Substantially reducing the numbers of other undesirable microorganisms; and
(c) Not adversely affecting the product or its safety for the consumer.
(75) "Semipublic water supply" means a water supply as defined in 401 KAR Chapter 8 that is constructed, maintained, and operated pursuant to applicable requirements of the Kentucky Environmental and Public Protection Cabinet.
(76) "Shellfish" means all aspects of:
(a) Oysters, clams, or mussels, whether:
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Shucked or in the shell;
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Raw, including postharvest processed;
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Frozen or unfrozen;
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Whole or in-part; and
(b) Scallops in any form, except if the final product form is the adductor muscle only.
(77) "Shellstock" means live molluscan shellfish in the shell.
(78) "Shellstock packing" means the process of placing shellstock into containers for introduction into commerce.
(79) "Shellstock shipper" or "SS" means a certified shellfish dealer who grows, harvests, buys, or repacks and sells shellstock or ships shucked shellfish and does not shuck shellfish or repack shucked shellfish.
(80) "Shucker-packer" or "SP" means a certified shellfish dealer that shucks and packs shellfish, acts as a shellstock shipper or reshipper, or repacks shellfish originating from other certified shellfish dealers.
(81) "Swing deficiency" means a deficiency noted on the NSSP Standardized Shellfish Processing Plant Inspection Form which, depending upon the severity and circumstance, is either a "critical" or "key" deficiency.
(82) "Transaction record" means the form or forms used to document each purchase or sale of shellfish at the wholesale level, and includes shellfish harvest and sales records, ledgers, purchase records, invoices, and bills of lading.
(83) "Wet storage" means the temporary storage, by a certified shellfish dealer, of shellstock from growing areas in the approved classification or in the open status of the conditionally-approved classification in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater.
(84) "Wholesale" means any sale to any other person than the ultimate consumer or his or her family.
Section 2. Shellfish Dealer Certification Requirements.
(1) A person shall not act as a shellfish dealer prior to obtaining certification from the cabinet. A person shall not engage in the wholesale handling of shellfish, operate, or conduct an establishment for the shucking, repacking, reshipping, or otherwise processing of shellfish without a certificate issued by the cabinet.
(2) Certification shall be issued only to persons who meet the established requirements for certification as established in this administrative regulation.
(3) A person making application for a shellfish dealer certification shall:
(a) Make application to the cabinet on form DFS 200 and complete the application for certification to handle oysters, clams, mussels, or scallops (DFS 255) and provide all identifying information required on each application form;
(b) Have and implement a HACCP plan, and have a program of sanitation monitoring and record keeping in compliance with Sections 6 and 7 of this administrative regulation, except for the requirement for harvester identification on a certified shellfish dealer's tag; and
(c) Have a business address at which inspections of facilities, activities, equipment, records, and vehicles can be conducted.
(4) Upon receipt of the initial application for shellfish dealer certification, accompanied by a $100 certification fee, and upon approval of the certified shellfish dealer processing facility, an initial certification shall be issued by the cabinet if the applicant meets the hazard analysis critical control point (HACCP) requirements of this administrative regulation and complies with the following inspectional requirements relative to the NSSP standardized shellfish processing plant inspection form ISSC Form 93-01(A):
(a) Hazard Analysis Critical Control Point (HACCP) requirements:
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No critical deficiencies as identified on the ISSC Form 93-01(A);
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Not more than two (2) key deficiencies as identified on the ISSC Form 93-01(A); and
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Not more than two (2) other deficiencies as identified on the ISSC Form 93-01(A).
(b) Sanitation items and additional model ordinance requirements:
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No critical deficiencies as identified on the ISSC Form 93-01(A);
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Not more than two (2) key deficiencies as identified on the ISSC Form 93-01(A); and
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Not more than three (3) other deficiencies as identified on the ISSC Form 93-01(A).
(c) The initial shellfish dealer certification shall include a compliance schedule to correct any deficiencies not corrected by the shellfish dealer during the inspection.
(5) Shellfish dealer certifications shall expire on December 31 following the date of certification and each December 31 thereafter.
(6) Shellfish dealer certifications are renewable annually upon submittal of application accompanied by an annual fee of $100, if the dealer is in compliance with this administrative regulation.
(7) The cabinet shall not renew the certification for any shellfish dealer until the dealer:
(a) Meets the requirements of subsection (4)a and b of this section. The number of deficiencies allowed under subsection (4)a and b of this section shall include carry-over deficiencies from an existing compliance schedule approved by the cabinet and new deficiencies identified during the certification renewal inspection; and
(b) Agrees to a compliance schedule to address any new deficiencies not corrected by the shellfish dealer during the inspection.
(8) The cabinet shall not issue certification to a shellfish dealer whose certification has been suspended or revoked until the shellfish dealer meets the requirements for initial certification as provided under this administrative regulation.
(9) A shellfish processing facility shall not operate without a valid shellfish dealer certification issued by the cabinet. The shellfish dealer certification shall not be transferable with respect to persons or locations.
(10) The cabinet shall issue only one (1) certification number to a dealer for a location. A person or dealer may obtain more than one (1) certification if each business is:
(a) Maintained as a separate entity; and
(b) Is not found at the same location.
(11) A certification number shall consist of a one (1) to five (5) digit Arabic number preceded by the two (2) letter state abbreviation and followed by a two (2) letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with this administrative regulation using the following terms:
(a) Shellstock shipper (SS);
(b) Shucker-packer (SP);
(c) Repacker (RP);
(d) Reshipper (RS); and
(e) Depuration processor (DP).
(12) A person shall not sell, offer for sale, or have in his or her possession with intent to sell, shellfish which have been taken from a place classified as "prohibited" or otherwise closed to harvesting by the pertinent regulatory authorities or from a place condemned by authorities having supervision at the point of origin of the shellfish.
(13) A person shall not receive or accept shipment of shellfish for shucking, repacking, shipping, storage, or sale unless the Kentucky shellfish dealer holds a current certificate issued pursuant to this administrative regulation. Shellfish originating from out-of-state sources shall be received from states or countries that have received the endorsement of the U.S. Food and Drug Administration and the shellfish dealer shall be listed in the current USFDA Interstate Certified Shellfish Shippers List.
(14) Food processing establishments handling shellstock for interstate distribution shall meet the requirements of this administrative regulation to assure the sale or distribution of shellfish from safe sources and to assure shellfish has not been adulterated during cultivating, harvesting, processing, shipping, or handling.
(15) A person who ships and receives shellstock or shucked shellfish in interstate or intrastate commerce shall be certified as a certified shellfish dealer. The type of shellfish dealer certification issued shall be as follows:
(a) A person who shucks shellfish shall be certified as a shucker-packer.
(b) A person who repacks shucked shellfish shall be certified as a shucker-packer or repacker.
(c) A person who repacks shellstock shall be certified as a shellstock shipper.
(d) A person who purchases shellstock or shucked shellfish from shellfish dealers and sells the product without repacking or relabeling to other shellfish dealers, wholesalers, or retailers shall be certified as a reshipper.
(16) After a person is certified, the cabinet shall make unannounced inspections of the shellfish dealer's facilities:
(a) During periods of activity; and
(b) At the following minimum frequencies:
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Within thirty (30) days of beginning activities if the dealer was certified on the basis of a preoperational inspection;
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At least quarterly for shellfish dealer activities certified as shucker-packer or repacker; and
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At least semiannually for other shellfish dealer certifications.
(17) Inspection results shall be recorded on the NSSP Standardized Shellfish Processing Plant Inspection Form (ISSC Form 93-01A). The cabinet shall provide a copy of the completed inspection forms to the person in charge at the shellfish facility at the inspection.
Section 3. Transportation.
(1) The harvester, or dealer who transports shellstock from the harvester to the original dealer, shall assure that a truck used to transport shellstock is properly constructed, operated, and maintained to prevent contamination, deterioration, and decomposition.
(2) Storage bins on trucks or other vehicles used in the transport of shellstock for direct marketing shall be kept clean with potable water and provided with effective drainage.
(3) Shellstock shall be transported in refrigerated trucks if the shellstock have been previously refrigerated or if ambient air temperature and time of travel are such that unacceptable bacterial growth or deterioration may occur.
(4) Prechilled trucks or other vehicles shall be used if ambient air temperatures are such that unacceptable bacterial growth or deterioration may occur.
(5) If mechanical refrigeration units are used, the units shall be:
(a) Equipped with automatic controls; and
(b) Capable of maintaining the ambient air temperature in the storage area at temperatures of forty-five (45) degrees Fahrenheit or less.
(6) Ice used to cool shellstock during transport shall meet the requirements of Section 11(10) of this administrative regulation.
(7) There shall not be cats, dogs, and other animals in any part of the truck or other vehicle where shellstock is stored.
Section 4. Receiving Shellfish.
(1) The certified shellfish dealer shall reject or discard shellfish shipments which:
(a) Do not originate from a licensed harvester or dealer; or
(b) Are unwholesome or adulterated, inadequately protected, or whose source cannot be identified.
(2) Transportation agents or common carriers used by a certified shellfish dealer are not required to be certified.
(3) The dealer shall:
(a) Inspect incoming shellfish shipments to assure that the shipments are received under the conditions required in this administrative regulation;
(b) Ensure that shellstock are not permitted to remain without ice, mechanical refrigeration, or other approved means of lowering the internal body temperature of the shellstock to, or maintaining it at, fifty (50) degrees Fahrenheit or less for more than two (2) hours at points of transfer such as loading docks;
(c) Ensure that shucked shellfish are not permitted to remain without ice, mechanical refrigeration, or other approved means of maintaining shellfish temperature at forty-five (45) degrees Fahrenheit or less; and
(d) Ensure that frozen shellfish remain frozen.
(4) All containers used to transport shellstock shall be:
(a) Constructed to allow for easy cleaning; and
(b) Operated and maintained to prevent product contamination.
(5) All containers shall be cleaned with:
(a) Potable water; and
(b) Detergents, sanitizers, and other supplies acceptable for food contact surfaces.
(6) Containers used for storing shellfish shall be clean and fabricated from safe materials.
(7) If the entire cargo consists of shellfish products only, except for bulk shipments, shellstock shipments shall be shipped on pallets. If the conveyance does not have a channeled floor, pallets shall be used for all shellfish.
(8) If the conveyance has mixed cargos, the shellfish may be shipped as part of a mixed cargo of seafood or other food product only if:
(a) Shellfish products are protected from contamination by the other cargo;
(b) All cargo is placed on pallets; and
(c) No other cargo is placed on or above the shellfish unless all cargo is packed in sealed, crush resistant, waterproof containers.
(9) Ice used to cool shellfish shall meet the requirements of Section 11(10) of this administrative regulation.
Section 5. Shipping Times.
(1) If the shipping time is four (4) hours or less, the certified shellfish dealer may provide thermal recorders during shipment, but shall comply with the following shellfish shipping requirements:
(a) Shellfish shall be shipped well iced or by using other acceptable means of refrigeration;
(b) If mechanical refrigeration units are used, the units shall be equipped with automatic controls and shall be capable of maintaining the ambient air in the storage area at temperatures of forty-five (45) degrees Fahrenheit or less; and
(c) Lack of ice or other acceptable types of refrigeration shall be considered an unsatisfactory shipping condition.
(2) If the shipping time is greater than four (4) hours, the certified shellfish dealer shall comply with the following shellfish shipping requirements:
(a) Shellfish shall be shipped in mechanically-refrigerated conveyances which are equipped with automatic controls and capable of maintaining the ambient air in the storage area at temperatures of forty-five (45) degrees Fahrenheit or less; or
(b) Shipped in containers with an internal ambient air temperature maintained at or below temperatures of forty-five (45) degrees Fahrenheit or less; and
(c) Unless the certified shellfish dealer has an approved HACCP plan with an alternate means of monitoring time-temperature, the initial dealer shall assure that a suitable time-temperature recording device accompanies each shipment of shellfish.
(3) The initial certified shellfish dealer shall note the date and time on the temperature-indicating device, if appropriate.
(4) Each receiving certified shellfish dealer shall write the date and time on the temperature-indicating device, if appropriate, when the shipment is received and the doors of the conveyance or the containers are opened.
(5) The final receiving certified shellfish dealer shall keep the time-temperature recording chart or other record of time and temperature in a file and shall make it available to the cabinet upon request.
(6) An inoperative temperature-indicating device shall be considered as no recording device.
Section 6. HACCP Requirements for Certified Shellfish Dealers.
(1) A certified shellfish dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of shellfish product processed or handled by that dealer and to identify the preventive measures that the certified shellfish dealer can apply to control those hazards. The dealer shall determine food safety hazards that can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest.
(2) A certified shellfish dealer shall have and implement a written HACCP plan.
(a) A HACCP plan shall be specific to each location where shellfish products are processed by that dealer and, except as specified in paragraph (b) of this subsection, each kind of shellfish product processed by the certified shellfish dealer; and
(b) The HACCP plan may group kinds of shellfish products together, or group kinds of production methods together, if the food safety hazard, critical control points, critical limits, and procedures required to be identified and performed in subsection (3) of this section are identical for all shellfish products so grouped or for all production methods so grouped.
(3) The HACCP plan shall, at a minimum:
(a) List the food safety hazards that are reasonably likely to occur, as identified in accordance with Section 6(1) of this administrative regulation for the following:
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Natural toxins;
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Microbiological contamination;
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Chemical contamination;
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Pesticides;
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Drug residues;
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Unapproved use of direct or indirect food or color additives; and
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Physical hazards;
(b) List the critical control points for each of the identified food safety hazards, including as appropriate:
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Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest. At a minimum, the critical control points shall include those identified in Sections 11(1) through (5), 12(1) through (3), 13(1) and (2), and 14(1) through (3) of this administrative regulation;
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Critical control points designed to control food safety hazards that could be introduced in the processing plant environment. At a minimum, the critical control points shall include those identified in Sections 11(1) through (5), 12(1) through (3), 13(1) and (2), and 14(1) through (3) of this administrative regulation;
(c) List the critical limits that must be met at each of the critical control points. At a minimum, the critical limits shall include those listed in Sections 11 through 14 of this administrative regulation, as applicable. The critical limits identified in Sections 11 through 14 of this administrative regulation, shall be met as components of good manufacturing practices;
(d) List the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;
(e) Include any corrective action plans that have been developed to be followed in response to deviations from critical limits at critical control points;
(f) Provide for a record-keeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring; and
(g) List the verification procedures, and frequency thereof, that the certified shellfish dealer will use in accordance with subsection (9) of this section.
(4) The HACCP plan shall be signed and dated, either by the most responsible individual on site at the processing facility or by a higher-level official of the certified shellfish dealer. This signature shall signify that the HACCP plan has been accepted for implementation by the certified shellfish dealer.
(5) The HACCP plan shall be signed and dated:
(a) Upon initial acceptance;
(b) Upon any modification; and
(c) Upon verification of the plan in accordance with subsection (9) of this section.
(6) If a deviation from a critical limit occurs, a certified shellfish dealer shall take corrective action either by:
(a) Following a corrective action plan that is appropriate for the particular deviation; or
(b) Following the procedures in subsection (7) of this section.
(7) If a deviation from a critical limit occurs, and the certified shellfish dealer does not have a corrective action plan that is appropriate for that deviation, the certified shellfish dealer shall:
(a) Segregate and hold the affected product, at least until the requirements of paragraphs (b) and (c) of this subsection are met;
(b) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have been trained in accordance with subsections (19) through (21) of this section, or experience, to perform the review;
(c) Take corrective action, if necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;
(d) Take corrective action, if necessary, to correct the cause of the deviation; and
(e) Perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with subsections (19) through (21) of this section, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.
(8) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (9) of this section and the record-keeping requirements of subsections (12) through (18) of this section.
(9) A certified shellfish dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include:
(a) A reassessment of the adequacy of the HACCP plan if any changes occur that could affect the hazard analysis or alter the HACCP plan in any way or at least annually. The reassessment shall be performed by an individual who has been trained in accordance with subsections (19) through (21) of this section. The HACCP plan shall be modified immediately if a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (3) of this section;
(b) Ongoing verification activities including:
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A review of consumer complaints that have been received by the certified shellfish dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;
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The calibration of process-monitoring instruments; and
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At the option of the dealer, the performing of periodic end product or in-process testing;
(c) A review, including signing and dating, by an individual who has been trained in accordance with subsections (19) through (21) of this section, of the records that document:
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The monitoring of critical control points. This review shall ensure that the records are complete and verify that the documents reflect values that are within the critical limits. This review shall occur within one (1) week of the day that the records are made;
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The taking of corrective actions. This review shall ensure that the records are complete and verify that appropriate corrective actions were taken in accordance with subsections (6) through (8) of this section. This review shall occur within one (1) week of the day that the records are made; and
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The calibrating of any process-monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the certified shellfish dealer's verification activities. This review shall ensure that the records are complete, and that these activities occurred in accordance with the certified shellfish dealer's written procedures. These reviews shall occur within a reasonable time after the records are made.
(10) Certified shellfish dealers shall immediately follow the procedures in subsections (6) through (8) of this section, if any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.
(11) The calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing, in accordance with subsection (9)(b)2 and 3 of this section, shall be documented in records that are subject to the record-keeping requirements of subsections (12) through (18) of this section.
(12) Records required by this administrative regulation shall include:
(a) The name and location of the certified shellfish dealer;
(b) The date and time of the activity that the record reflects;
(c) The signature or initials of the person performing the operation; and
(d) If appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records when observed.
(13) Except as provided by subsection (14) of this section, records required by this administrative regulation shall be retained at the certified shellfish dealer processing facility for at least one (1) year after the date they were prepared if refrigerated products, and for at least two (2) years after the date they were prepared if frozen products.
(14) Records that relate to the general adequacy of equipment or processes being used by a certified shellfish dealer, including the results of scientific studies and evaluations, shall be retained at the certified shellfish dealer processing facility for at least two (2) years after their applicability to the product being produced at the facility.
(15) If the certified shellfish dealer processing facility is closed for a prolonged period between seasonal operations, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably-accessible location at the end of the seasonal operations, but shall be immediately returned for official review upon request.
(16) Records required by this administrative regulation, including HACCP plans, shall be available for official review and copying at reasonable times.
(17) Tags on containers of shellstock are not subject to the requirements of this administrative regulation unless they are used to fulfill the requirements of Section 8 of this administrative regulation.
(18) The maintenance of records on computers is acceptable, if appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.
(19) At a minimum, the following functions shall be performed by an individual who has successfully completed an approved training curriculum in the application of HACCP principles to perform these functions:
(a) Develop a HACCP plan;
(b) Reassess and modify the HACCP plan in accordance with the corrective action procedures specified in subsection (7)(e) of this section, and verify the HACCP plan in accordance with the verification activities specified in subsection (9)(a) and (b) of this section; and
(c) Perform the record review required by subsection (9)(c) of this section.
(20) An individual described in subsection (19) of this section shall provide the cabinet, upon request, a copy of their certificate of completion of training for the application of HACCP principles for shellfish processing.
(21) Relevant job experience may qualify an individual to perform the functions specified in subsection (19) of this section. The trained individual need not be an employee of the certified shellfish dealer.
Section 7. General Sanitation Requirements.
(1) A certified shellfish dealer shall monitor eight (8) key areas of sanitation conditions and practices with of sufficient frequency to ensure, at a minimum, conformance with the applicable requirements contained within Kentucky's Food, Drug and Cosmetic Act, KRS Chapter 217, and Sections 11(6) through (54), 12(4) through (42), 13(3) through (44), and 14(4) through (33) of this administrative regulation. The eight (8) key sanitation areas to be monitored are:
(a) Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
(b) Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
(c) Prevention of cross contamination from unsanitary objects to food, food packaging materials, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product;
(d) Maintenance of hand washing, hand sanitizing, and toilet facilities;
(e) Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants;
(f) Proper labeling, storage, and use of toxic compounds;
(g) Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
(h) Exclusion of pests from the food plant.
(2) A certified shellfish dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by subsection (1) of this section. These records shall comply with the requirements of Section 6(12) through (18) of this administrative regulation.
(3) A dealer shall comply with the pertinent food establishment requirements of the Kentucky Food, Drug and Cosmetic Act, KRS Chapter 217, and the physical facility requirements contained in Sections 11 through 14 of this administrative regulation that are applicable to the plant and the food being processed.
(4) Certified shellfish dealers shall adopt and follow written procedures for conducting recalls of adulterated or misbranded shellfish products including: Timely notification of the cabinet of a situation requiring a recall, timely notification of consignee who received the affected product, and effective removal or correction of the affected product.
Section 8. Shellstock Identification.
(1) The certified shellfish dealer shall buy shellfish only from sources certified by the cabinet or listed in the ICSSL.
(2) The certified shellfish dealer's tags shall be:
(a) Durable, waterproof, and approved by the cabinet prior to use; and
(b) At least two and five-eighths (2 5/8) inches by five and one-fourth (5 1/4) inches in size.
(3) The certified shellfish dealer's tag shall contain the following indelible, legible information in the order specified below:
(a) The certified shellfish dealer's name and address;
(b) The certified shellfish dealer's certification number as assigned by the cabinet and the original shellstock shipper's certification number;
(c) The date of harvest (if depurated, the date of depuration processing);
(d) The most precise identification of the harvest location as is practicable including the initials of the state of harvest, and the designation of the growing area by indexing, administrative or geographic designation. If growing areas have not been indexed, an appropriate geographical or administrative designation shall be used, and if depurated, the depuration cycle or lot number shall be included;
(e) If the shellstock has been placed in wet storage in a certified shellfish dealer's operation, the statement: "This product is a product of (name of state) and was wet stored at (facility certification number) from (date) to (date)";
(f) The type and quantity of shellstock;
(g) The following statement in bold, capitalized type: "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS"
(h) Shellstock intended for raw consumption shall include a consumer advisory. The following statement, or an equivalent statement, shall be included on all shellstock: "RETAILERS INFORM YOUR CUSTOMERS" "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of food-borne illness, especially if you have certain medical conditions"; and
(i) The statement "Keep Refrigerated" or an equivalent statement.
(4) If both the certified shellfish dealer and harvester tags appear on the container, the certified shellfish dealer's tag shall not be required to duplicate the information on the harvester's tag.
(5) If the shellstock is removed from the original container, the tag on the new container shall meet all applicable labeling and shellstock identification requirements of this administrative regulation.
(6) If shellstock are sold in bulk, the certified shellfish dealer shall provide a transaction record prior to shipment. This transaction record shall contain the information required in Section 10(5) through (10) of this administrative regulation with the addition of the name of the consignee.
Section 9. Shucked Shellfish Labeling.
(1) If the shucker-packer uses returnable containers to transport shucked shellfish between dealers for the purpose of further processing or packing, the returnable containers shall be exempt from the labeling requirements in this administrative regulation. If returnable containers are used, the shipment shall be accompanied by a transaction record containing:
(a) The original shucker-packer's name and certification number;
(b) The shucking date; and
(c) The quantity of shellfish per container and the total number of containers.
(2) If the certified shellfish dealer uses master shipping cartons, the master cartons shall be exempt from these labeling requirements if the individual containers within the carton are properly labeled.
(3) At a minimum, the certified shellfish dealer shall label each individual package containing fresh or frozen shucked shellfish meat in a legible and indelible form in accordance with the following:
(a) 21 C.F.R. Part 101 Nutrition Labeling of Food;
(b) Federal Fair Packaging and Labeling Act, 15 U.S.C. Chapter 39;
(c) 21 C.F.R. 161.30;
(d) 21 C.F.R. 161.130; and
(e) 21 C.F.R. 161.136.
(4) The certified shellfish dealer shall assure that each package containing less than sixty-four (64) fluid ounces of fresh or frozen shellfish shall have:
(a) The shucker-packer's or repacker's certification number on the label; and
(b) A "sell by date" which provides a reasonable subsequent shelf-life or the words "Best if used by" followed by a date if the product would be expected to reach the end of its shelf-life. The date shall consist of the abbreviation for the month and number of the day of the month. For frozen shellfish, the year shall be added to the date.
(5) The certified shellfish dealer shall assure that each package containing sixty-four (64) or more fluid ounces of fresh or frozen shellfish shall have:
(a) The shucker-packer's or repacker's certification number on the label; and
(b) A "Date shucked" which shall:
-
For fresh shellfish, consist of the number of the day of the year or the month and the number of the day of the month;
-
For frozen shellfish, include the year; and
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Appear on the lid and sidewall or bottom of disposable containers.
(6) If the certified shellfish dealer thaws and repacks frozen shellfish, the dealer shall label the shellfish container as previously frozen.
(7) The certified shellfish dealer shall provide label information in a legible and indelible form.
(8) If the certified shellfish dealer elects to repack shellfish, the dealer shall pack and label shellfish in accordance with this section except that the original date of shucking shall be used in establishing the sell by date.
Section 10. Shipping Documents and Records.
(1) A shellfish shipment shall be accompanied by a shipping document.
(2) The shipping document shall contain:
(a) The name, address, and certification number of the shipping dealer;
(b) The name and address of the major consignee; and
(c) The kind and quantity of the shellfish product.
(3) The receiving certified shellfish dealer shall:
(a) Maintain in a file a copy of the completed shipping document; and
(b) Make the shipping document available to the cabinet upon request.
(4) If the shipment is subdivided to different certified shellfish dealers, a receiving certified shellfish dealer shall maintain records sufficient to trace the portion received back to the original shipment.
(5) A certified shellfish dealer shall have a business address at which transaction records are maintained.
(6) A certified shellfish dealer shall maintain complete, accurate, and legible records of the cabinet's required information.
(7) Transaction records shall be sufficient to:
(a) Document that the shellfish are from a source authorized under this administrative regulation;
(b) Permit a container of shellfish to be traced back to the specific incoming lot of shucked shellfish from which it was taken; and
(c) Permit a lot of shucked shellfish or a lot of shellstock to be traced back to the growing area, date of harvest, and, if possible, the harvester or group of harvesters.
(8) Purchase and sales shall be recorded:
(a) In a permanently-bound ledger book; or
(b) In retrievable electronic computer files or discs.
(9) The transaction records shall be retained as follows:
(a) If fresh shellfish, for a minimum of one (1) year; and
(b) If In the case of frozen shellfish, for at least two (2) years or the shelf-life of the product, whichever is longer.
Section 11. Requirements for Certified Shellfish Dealers Engaged in Shucking and Packing.
(1) The certified shellfish dealer shall shuck and pack only shellstock which is from sources certified by the cabinet or listed in the ICSSL; and identified with a tag on each container or a transaction record on each bulk shipment.
(2) The certified shellfish dealer shall ensure upon receipt that shellfish has been transported iced or in a conveyance maintained at or below an ambient air temperature of forty-five (45) degrees Fahrenheit.
(3) The certified shellfish dealer shall ensure that the storage of shellstock, once placed under temperature control and until sale to the processor or final consumer, shall be:
(a) Stored in ice; or
(b) Placed and stored in a storage area or conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice, mechanical refrigeration, or other approved methods of refrigeration for more than two (2) hours at points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(4) The certified shellfish dealer that processes shall ensure that:
(a) For shellstock refrigerated prior to shucking, shucked meats are chilled to an internal temperature of forty-five (45) degrees Fahrenheit or less within four (4) hours of removal from refrigeration; and
(b) If heat shock is used, once heat-shocked shellstock is shucked, the shucked shellfish meats shall be cooled to forty-five (45) degrees Fahrenheit or less within two (2) hours after the heat shock process.
(5) The certified shellfish dealer shall store shucked and packed shellfish in covered containers at an ambient air temperature in the storage area of forty-five (45) degrees Fahrenheit or less, or covered in ice to maintain the internal product temperature of forty-five (45) degrees Fahrenheit.
(6) The certified shellfish dealer shall provide a water supply that is potable, adequate, and from an approved public supply of a municipality or water district, if available.
(7) If a public water supply of a municipality or a water district is not available, the supply for the certified shellfish dealer processing facility shall be developed and approved pursuant to applicable requirements of 401 KAR Chapter 8, Public Water Supply.
(8) The certified shellfish dealer shall have the water supply sampled in accordance with the provisions of 401 KAR Chapter 8, as applicable, and shall maintain sample results on file at the plant.
(9) The certified shellfish dealer shall assure that steam used in food processing or that comes in contact with food contact surfaces is free from any additives or deleterious substances.
(10) Ice used in the processing, storage, or transport of shellstock or shucked shellfish shall:
(a) Be made on-site from potable water in a commercial ice machine; or
(b) Come from a facility which holds a valid permit to operate as an ice manufacturer.
(11) Water from a potable water supply shall be used to wash shellstock.
(12) If the certified shellfish dealer uses a system to wash shellstock which recirculates water, the dealer shall:
(a) Obtain approval from the cabinet for the construction or remodeling of the system by submitting construction plans for approval prior to construction or renovation;
(b) Provide a water treatment and disinfection system to treat an adequate quantity of water to a quality acceptable for shellstock washing which, after disinfection, meets the coliform standards for drinking water, and does not leave unacceptable residues in the shellstock; and
(c) Test bacteriological water quality daily.
(13) The certified shellfish dealer shall design, install, modify, repair, and maintain all plumbing and plumbing fixtures to:
(a) Prevent contamination of water supplies; and
(b) Prevent cross-connection between the pressurized potable water supply and water from an unacceptable source in accordance with 815 KAR Chapter 20, State Plumbing Code. The certified shellfish dealer shall install and maintain in good working order devices to protect against backflow and back siphonage.
(14) Shellstock washing storage tanks and related plumbing shall be fabricated from safe materials and tank construction that:
(a) Is easily accessible for cleaning and inspection;
(b) Is self-draining; and
(c) Meets the requirements for food contact surfaces in accordance with subsection (16) of this section.
(15) Except for equipment in continuous use and placed in service prior to January 1, 1989, the certified shellfish dealer shall use only equipment which conforms to the Shellfish Industry Equipment Construction Guide.
(16) Food contact surfaces of equipment and utensils used by the certified shellfish dealer, including plastic ware and finished product containers, shall be:
(a) Constructed in a manner and with materials that can be cleaned, sanitized, maintained, or replaced in a manner to prevent contamination of shellfish products;
(b) Free from exposed screws, bolts, or rivet heads on food contact surfaces; and
(c) Fabricated from food grade materials.
(17) The certified shellfish dealer shall assure that all joints on food contact surfaces have smooth, easily cleanable surfaces and are welded.
(18) Shucking blocks shall be provided which are:
(a) Easily cleanable;
(b) Fabricated from safe material;
(c) Solid, one (1) piece construction; and
(d) Easily removed from the shucking bench, unless the block is an integral part of the bench.
(19) The certified shellfish dealer shall provide a temperature measuring device accurate to plus or minus two (2) degrees Fahrenheit for use in monitoring product temperatures.
(20) Equipment used in heat shock processing shall meet the requirements of subsection (15) through (17) of this section.
(21) Equipment used to handle ice shall be kept clean and stored in a sanitary manner, and shall meet the construction requirements in subsections (15) through (17) of this section.
(22) Food contact surfaces of equipment, utensils and containers shall be cleaned and sanitized to prevent contamination of shellfish and other food contact surfaces. The certified shellfish dealer shall:
(a) Provide adequate cleaning supplies and equipment, including three (3) compartment sinks, brushes, detergents, and sanitizers. Hot water and pressure hoses shall be available within the plant;
(b) Sanitize equipment and utensils prior to the start-up of each day's activities and following interruption during which food contact surfaces may have been contaminated;
(c) Wash and rinse equipment and utensils at the end of each day; and
(d) Provide a test kit or other device that accurately measures the parts per million concentration of the chemical sanitizing agent in use.
(23) Conveyances and equipment which come into contact with stored shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent shellstock contamination.
(24) Shellfish shall be protected from contamination by washing and rinsing shucking containers and sanitizing before each filling.
(25) Containers which may have become contaminated during storage shall be washed, rinsed, and sanitized prior to use or shall be discarded.
(26) Shucked shellfish shall be packed in clean, covered containers and stored in a manner which assures their protection from contamination.
(27) If used, the finger cots or gloves shall be:
(a) Made of impermeable materials except if the use of this material is inappropriate or incompatible with the work being done;
(b) Sanitized at least twice daily;
(c) Cleaned more often, if necessary;
(d) Properly stored until used; and
(e) Maintained in a clean, intact, and sanitary condition.
(28) Shellstock shall be stored in a manner to protect shellstock from contamination in dry storage and at points of transfer.
(29) Shucked shellfish shall be protected from contamination.
(30) Shellstock shall not be placed in containers with standing water for the purposes of washing shellstock or loosening sediment.
(31) Equipment and utensils shall be stored in a manner to prevent splash, dust, and contamination.
(32) Handwashing shall include the following:
(a) Wetting hands and forearms with running water at a temperature of 110-120 °F;
(b) Applying antibacterial or antimicrobial soap and thoroughly distributing over hands and forearms;
(c) Rubbing hands vigorously for at least twenty (20) seconds, covering all surfaces of the hands, forearms, and fingers, paying special attention to the thumbs, backs of fingers, and spaces between the fingers;
(d) Rinsing hands and forearms thoroughly to remove residual soap;
(e) Drying hands and forearms with paper towels dispensed from a sanitary dispenser or by utilizing a hand drying device that provides heated air; and
(f) Application of an approved hand sanitizer.
(33) If the same employee works in both the shucking and packing areas, the employee shall wash their hands immediately and thoroughly after entering each work area.
(34) The certified shellfish dealer shall require all employees to wash their hands in an approved hand washing facility:
(a) Before starting work;
(b) After each absence from the work station;
(c) After each work interruption; and
(d) If their hands may have become soiled or contaminated.
(35) Hand washing facilities with warm water at a minimum temperature of 110 degrees Fahrenheit, dispensed from a hot and cold mixing or combination faucet, under pressure, shall be provided.
(36) Sewage and liquid disposable wastes shall be properly removed from the facility.
(37) Toilets shall be provided and conveniently located in accordance with 815 KAR Chapter 20, State Plumbing Code.
(38) The certified shellfish dealer shall provide toilet facilities with an adequate supply of toilet paper in a suitable holder.
(39) Shellfish shall be protected from contamination while being transferred from one point to another during handling and processing.
(40) The certified shellfish dealer shall provide lighting throughout the facility that is sufficient to promote good manufacturing practices.
(41) Lighting fixtures, light bulbs, skylights, or other glass suspended over food storage or processing activities in areas where shellfish are exposed shall be of the safety type or shielded to prevent food contamination in case of breakage.
(42) Food contact surfaces shall be protected from contamination and adulteration by using cleaning compounds and sanitizing agents in accordance with manufacturer label directions.
(43) Ice that is not made on site in the shellfish processing facility shall be inspected upon receipt and rejected if the ice may have been subject to contamination.
(44) Ice shall be stored in a safe and sanitary manner to prevent contamination of the ice.
(45) Ventilation shall be provided to minimize condensation in areas where food is stored, processed, or packed.
(46) The certified shellfish dealer shall assure that only toxic substances necessary for plant activities are present in the certified shellfish dealer processing facility.
(47) The following categories of toxic substances shall be stored separately:
(a) Insecticides and rodenticides;
(b) Detergents, sanitizers, and related cleaning agents; and
(c) Caustic acids, polishes, and other chemicals.
(48) The certified shellfish dealer shall not store toxic substances above shellfish or food contact surfaces.
(49) If pesticides are used, the certified shellfish dealer shall apply pesticides in full compliance with the manufacturer's labeling and in a manner to prevent the contamination of any shellfish or packaging materials with residues.
(50) Cleaning compounds and sanitizing agents shall be properly labeled and used in accordance with the manufacturer's label directions.
(51) Toxic substances shall be labeled and used in accordance with the manufacturer's label directions.
(52) The certified shellfish dealer shall take all reasonable precautions to assure that an employee with a communicable disease that can be transmitted through food, shall be excluded from working in any capacity in which the employee may come in contact with shellfish or with food contact surfaces.
(53) An employee with an open, exposed, or infected wound shall keep it covered with a proper bandage, an impermeable barrier, and a single-use glove for a hand lesion.
(54) The certified shellfish dealer shall operate the certified shellfish dealer processing facility to assure that pests are excluded.
(55) The physical certified shellfish dealer processing facility shall be maintained in good repair.
(56) The certified shellfish dealer shall operate the certified shellfish dealer processing facility to provide protection from contamination and adulteration by assuring that dirt and other filth are excluded from the facility or activities.
(57) Animals or unauthorized persons shall not be allowed in portions of the certified shellfish dealer processing facility where shellfish are stored, handled, processed or packaged, or where food handling equipment, utensils, and packaging materials are cleaned or stored.
(58) Air pump intakes shall be located in a protected place. Air filters shall be installed on all blower air pump intakes. Oil bath type filters shall not be used.
(59) The shucking and packing operation shall be separated by use of:
(a) Separate rooms;
(b) Partitions; or
(c) Spacing which is sufficient to protect product from adulteration or cross-contamination.
(60) Manufacturing activities which could result in the contamination of shellfish shall be separated by adequate barriers.
(61) The certified shellfish dealer shall provide toilet room doors which are tight fitting, self closing, and do not open directly into a processing area.
(62) Sanitary conditions shall be maintained throughout the shellfish processing facility.
(63) Dry area floors shall be hard, smooth, easily cleanable, and in good repair.
(64) Wet area floors used in areas to store shellstock, process food, and clean equipment and utensils shall be constructed of easily cleanable, impervious, and corrosion resistant materials which:
(a) Are graded to provide adequate drainage;
(b) Have even surfaces and are free from cracks that create sanitary problems and interfere with drainage; and
(c) Have sealed junctions between floors and walls to render them impervious to water.
(65) Walls, ceilings, and interior surfaces of rooms where shellfish are stored, handled, processed, or packaged shall be constructed of easily cleanable, corrosion resistant, impervious materials.
(66) Grounds around the facility shall be maintained to be free from rodent attraction and harborage, and inadequate drainage conditions.
(67) Hand washing facilities shall be provided which are:
(a) Convenient to work areas;
(b) Separate from the three (3) compartment sinks used for cleaning equipment and utensils; and
(c) Plumbed to an approved sewage disposal system in accordance with 815 KAR Chapter 20, State Plumbing Code.
(68) The certified shellfish dealer shall provide at least one (1) conveniently located hand sink in the packing room.
(69) The certified shellfish dealer shall provide at each hand washing facility:
(a) A supply of hand cleansing soap or detergent;
(b) A conveniently-located supply of single-service towels in a suitable dispenser or a hand-drying device that provides heated air;
(c) An easily cleanable, covered waste receptacle;
(d) Approved hand sanitizer; and
(e) Hand washing signs in a language understood by the employees;
(70) Plumbing and plumbing fixtures shall be designed, installed, modified, repaired, and maintained in accordance with 815 KAR Chapter 20, State Plumbing Code, to provide a water system that is adequate in quantity and under pressure, and includes:
(a) Cold and warm water at all sinks; and
(b) Hand washing facilities adequate in number and size for the number of employees and that are located where supervisors can observe employee use.
(71) Adequate floor drainage, including backflow preventers, such as air gaps, shall be provided if floors are:
(a) Used in shellstock storage;
(b) Used for food holding units;
(c) Cleaned by hosing, flooding, or similar methods; and
(d) Subject to the discharge of water or other liquid waste on the floor during normal activities.
(72) A safe, effective means of sewage disposal for the certified shellfish dealer processing facility shall be provided. Sewage shall be disposed of into a public sewerage system, if available. If a public sewerage system is not available, disposal shall be made into a private system designed, constructed, and operated pursuant to 902 KAR 10:060 through 110, Kentucky On-site Sewage Disposal Systems, or 401 KAR Chapter 5, Water Quality.
(73) Drainage or waste pipes shall not be installed over food processing or food storage areas, or over areas in which containers and utensils are washed or stored.
(74) Ventilation, heating, or cooling systems shall not create conditions that may cause shellfish products to become contaminated.
(75) To insure that insects and vermin are not present in the facility, the dealer shall employ necessary internal and external insect and vermin control measures including tight-fitting, self-closing doors; screening of not less than fifteen (15) mesh per inch; and controlled air currents.
(76) Disposal of waste materials, shell, and other nonedible materials shall be promptly and effectively removed from the shucking bench or table. Areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin.
(77) Nonfood contact surfaces of equipment and utensils utilized by the certified shellfish dealer, including plastic ware, shall be designed and fabricated for durability under conditions of normal use and shall be resistant to denting, buckling, pitting, chipping, and crazing and be made from materials that can be cleaned, sanitized, maintained, or replaced.
(78) The certified shellfish dealer shall use easily cleanable, corrosion resistant, impervious materials, free from cracks to construct:
(a) Shucking benches and contiguous walls;
(b) Stands or stalls and stools for shuckers; and
(c) Nonfood contact surfaces in shellfish storage or handling areas.
(79) Shucking benches shall drain completely and rapidly, and shall drain away from any shellfish on the benches.
(80) Cleaning activities for equipment and utensils shall be conducted in a manner and at a frequency appropriate to prevent contamination of shellfish and food contact surfaces.
(81) Conveyances and equipment which come into contact with stored shellstock shall be cleaned and maintained in a manner and frequency as necessary to prevent shellstock contamination.
(82) The certified shellfish dealer shall:
(a) Assure that shellstock is:
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Reasonably free of sediment; and
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Culled;
(b) Completely empty shucking buckets at the packing room so that no overage is returned to the shucker;
(c) Inspect incoming shipments and shall reject dead or inadequately protected shellstock;
(d) Not allow the use of dip buckets for hand or knife rinsing;
(e) Not have on the premises usable containers or container covers bearing a certification number different from the one issued for those premises unless documentation exists to verify the legitimate source of the containers and the containers contain shellfish from that source;
(f) Wash, blow, and rinse shellfish meats in accordance with 21 C.F.R. 161.130;
(g) Thoroughly drain, clean as necessary, and pack shucked shellfish meats promptly after delivery to the packing room;
(h) Conduct packing activities to conform to applicable food additive requirements contained in KRS Chapter 217, and 21 C.F.R. Part 170 through 189;
(i) Store packaged shellfish, if they are to be frozen, at an ambient temperature of zero degrees Fahrenheit or less, and frozen solid within twelve (12) hours following the initiation of freezing; and
(j) Not commingle shellstock during shucking.
(83) A certified shellfish dealer that uses heat shock to prepare shellstock for shucking shall:
(a) Post the schedule for the heat shock process in a conspicuous location; and
(b) Make sure responsible persons are familiar with the requirements;
(c) Cool hot-dipped shellstock immediately after the heat shock process. This cooling shall be accomplished by:
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Dipping in an ice bath; or
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Use of flowing potable water; and
(d) If a heat shock water tank is used, the certified shellfish dealer shall completely drain and flush the tank at three (3) hour intervals or less so that mud and debris which have accumulated in the dip tank are eliminated.
(84) An employee handling shucked shellfish shall:
(a) Wear effective hair restraints;
(b) Remove hand jewelry that cannot be sanitized or secured;
(c) Wear finger cots or gloves if jewelry cannot be removed; and
(d) Wear clean outer garments, which are rinsed or changed as necessary to be kept clean.
(85) In an area where shellfish are shucked or packed and in an area which is used for cleaning or storage of utensils, the certified shellfish dealer shall not allow employees to:
(a) Store clothing or other personal belongings;
(b) Eat or drink;
(c) Spit; or
(d) Use tobacco in any form.
(86) A reliable, competent individual shall be designated to supervise general plant management and activities and monitor compliance with this administrative regulation.
(87) Cleaning procedures shall be developed and supervised to assure that cleaning activities do not result in contamination of shellfish or food contact surfaces.
(88) Supervisors shall be:
(a) Trained in proper food handling techniques and food protection principles; and
(b) Knowledgeable of personal hygiene and sanitary practice requirements contained within 21 C.F.R. Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food.
(89) The certified shellfish dealer shall require that supervisors:
(a) Monitor employee hygiene practices, including hand washing, eating, and smoking at work stations, and the storage of personal items or clothing;
(b) Assure that proper sanitary practices are implemented, including:
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Plant and equipment clean-up;
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Rapid product handling; and
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Shellfish protection from contamination; and
(c) Require employees to:
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Be trained in proper food handling; and personal hygiene practices; and
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Report any symptoms of illness.
Section 12. Requirements for Certified Shellfish Dealers Engaged in Repacking of Shucked Shellfish.
(1) The certified shellfish dealer receiving shellfish shall repack only shellfish which:
(a) Originated from a certified shellfish dealer;
(b) Are identified with a label as specified in Section 8 of this administrative regulation; and
(c) Has been transported iced or in a conveyance maintained at or below an ambient air temperature of forty-five (45) degrees Fahrenheit.
(2) The certified shellfish dealer processing shellfish shall ensure that repacked shellfish:
(a) Do not exceed an internal temperature of forty-five (45) degrees Fahrenheit for more than two (2) hours during processing; and
(b) Are maintained at a temperature less than forty-five (45) degrees Fahrenheit in any portion of frozen shellfish thawed for repacking.
(3) The certified shellfish dealer shall store repacked, shucked shellfish in covered containers at an ambient air temperature of forty-five (45) degrees Fahrenheit or less, or covered in ice to maintain an internal product temperature of forty-five (45) degrees Fahrenheit or less.
(4) The certified shellfish dealer shall comply with Section 11(6) through (10), (13), (15) through (17), (19), (21), (22), (25), (27), (29), (31), (32), (34) through (58), (61) through (75), (77), (80), (81), and (84) through (89) of this administrative regulation.
(5) Shucked shellfish shall be repacked in clean containers:
(a) Fabricated from food grade materials; and
(b) Stored in a manner which assures their protection from contamination.
(6) The certified shellfish dealer shall assure that employees working in direct contact with shellfish processing activities or food contact surfaces maintain a high level of personal hygiene and cleanliness.
(7) Disposal of waste materials shall not create a public health hazard or nuisance.
(8) Areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin.
(9) The certified shellfish dealer shall use easily cleanable, corrosion resistant, impervious materials, free from cracks to construct nonfood contact surfaces in shellfish storage or handling areas.
(10) The certified shellfish dealer shall:
(a) Not commingle shellfish from different lots;
(b) Repack shucked shellfish meats only into containers labeled with the authorized certification number;
(c) Not have on the premises usable containers or container covers bearing a certification number different from the one issued for those premises unless documentation exists to verify the legitimate source of the containers and the containers contain shellfish from that source;
(d) Wash, blow, and rinse shellfish meats in accordance with 21 C.F.R. 161.130;
(e) Thoroughly drain, clean as necessary, and repack shucked shellfish meats promptly;
(f) Conduct repacking activities to conform to applicable food additive requirement contained in KRS Chapter 217, and 21 C.F.R. Parts 170 through 189; and
(g) Store packaged shellfish, if they are to be frozen, at an ambient temperature of zero degrees Fahrenheit or less and frozen solid within twelve (12) hours following the initiation of freezing.
Section 13. Requirements for Certified Shellfish Dealers Engaged in Shellstock Shipping.
(1) The certified shellfish dealer receiving shellstock shall ship or repack only shellstock which is obtained from:
(a) Sources certified by the cabinet or listed in the ICSSL;
(b) A certified shellfish dealer who has transported the shellfish iced or in a conveyance maintained at an ambient air temperature at or below forty-five (45) degrees Fahrenheit;
(c) A licensed harvester who has:
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Harvested the shellstock from an approved or conditionally-approved area in the open status as identified by the tag; and
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Identified the shellstock with a tag on each container or transaction record on each bulk shipment; or
(d) A certified shellfish dealer who has identified the shellstock with a tag on each container.
(2) The certified shellfish dealer storing shellstock shall ensure that once placed under temperature control and until sold to the processor or final consumer, shellstock shall be:
(a) Iced; or
(b) Placed in a storage area or conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice, mechanical refrigeration, or other approved methods of refrigeration, as required in paragraphs (a) and (b) of this subsection for more than two (2) hours at points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(3) The certified shellfish dealer shall comply with Section 11(6) through (17), (19), (21), (22), (25), (27) through (32), (34) through (57), (61) through (67), (69), (70) through (75), (77), (80), (81), and (85) through (89) of this administrative regulation.
(4) Shellstock shall be packed in clean containers.
(5) The certified shellfish dealer shall operate the certified shellfish dealer processing facility to provide adequate protection from contamination and adulteration by assuring that dirt and other filth are excluded from the certified shellfish dealer processing facility.
(6) Disposal of waste materials shall not create a public health hazard or nuisance.
(7) Areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin.
(8) The certified shellfish dealer shall use easily cleanable, corrosion resistant, impervious materials, free from cracks to construct any nonfood contact surfaces in shellstock storage or handling areas.
(9) The certified shellfish dealer shall:
(a) Assure that shellshock is:
-
Alive;
-
Reasonably free of sediment; and
-
Culled; and
(b) Not commingle shellstock during repacking.
(10) The certified shellfish dealer shall inspect incoming shipments and shall reject dead or inadequately-protected shellstock.
(11) A certified shellfish dealer whose activity consists of trucks or docking facilities only shall:
(a) Have a permanent business address at which records are maintained and inspections can be performed; and
(b) Not repack shellstock.
(12) A certified shellfish dealer who stores or repacks shellstock shall have:
(a) A facility for proper storage or repacking of shellstock; or
(b) Arrangements with a facility approved by the cabinet for the storage or repacking of shellstock.
Section 14. Requirements for Certified Shellfish Dealers Engaged in Reshipping.
(1) The certified shellfish dealer shall reship only shellfish received which at receiving:
(a) Are from sources certified by the cabinet or listed in the ICSSL;
(b) Are identified with a tag as specified in Section 8 of this administrative regulation or a label as specified in Section 9 of this administrative regulation; and
(c) Originated from a certified shellfish dealer who has transported the shellstock iced or in a conveyance maintained at or below an ambient air temperature of forty-five (45) degrees Fahrenheit.
(2) The certified shellfish dealer shall ensure that, once placed under temperature control and until sold to the processor or final consumer, shellstock shall be:
(a) Iced; or
(b) Placed in a storage area or conveyance maintained at forty-five (45) degrees Fahrenheit or less;
(c) Not permitted to remain without ice, mechanical refrigeration, or other approved means of refrigeration, as required in paragraphs (a) and (b) of this subsection, for more than two (2) hours at points of transfer such as loading docks; and
(d) Not permitted to be placed in wet storage.
(3) The certified shellfish dealer shall store shucked shellfish at a temperature of forty-five (45) degrees Fahrenheit or less.
(4) The certified shellfish dealer shall comply with Section 11(6), (7), (8), (10), (13), (28), (29), (31), (32), (34) through (43), (45) through (57), (61) through (67), (69) through (75), (77), (78), (80), (81), and (85) through (89) of this administrative regulation.
(5) Equipment used to handle ice shall be kept clean and stored in a sanitary manner and shall meet the construction requirements in Section 11(15) through (17) of this administrative regulation.
(6) Disposal of waste materials shall not create a public health hazard or nuisance.
(7) Areas and receptacles used for the storage or conveyance of waste shall be operated and maintained to prevent attraction, harborage, or breeding places for insects and vermin.
(8) The certified shellfish dealer shall:
(a) Buy shellfish only from sources holding a valid certification issued by the cabinet or listed in the most current ICSSL; and
(b) Add the dealer's name and certification number to the package.
(9) The certified shellfish dealer shall not:
(a) Commingle, sort, or repack shellstock or shucked shellfish; or
(b) Remove or alter any existing tag or label.
(10) A certified shellfish dealer whose activity consists of trucks only shall have:
(a) A facility for the storage of shellfish; or
(b) Arrangements with a facility that meets the minimum sanitation requirements for a refrigerated or frozen food storage warehouse in accordance with KRS Chapter 217; and
(c) A permanent business address at which records are maintained and inspections can be performed.
Section 15. Plan Review of Future Construction. If a certified shellfish dealer processing facility is constructed or extensively remodeled, or plumbing relocated, or additional plumbing added, or if an existing structure is converted for use as a certified shellfish dealer processing facility; properly prepared plans and specifications for the construction, renovation, or alteration; showing layout, arrangements, size, location and type of facilities and a plumbing riser diagram shall be submitted to the cabinet for approval before work is begun.
Section 16. Denial, Suspension, Revocation or Nonrenewal of Shellfish Dealer Certification.
(1) The cabinet, after notice to the applicant, shall deny initial shellfish dealer certification for failure to comply with the requirements of this administrative regulation.
(2) The cabinet, after notice to a certificate holder, and after an opportunity for a conference, may suspend, permanently revoke, or deny certificate renewal for failure to comply with the requirements of this administrative regulation. Following conference proceedings, a certificate holder may request a formal hearing pursuant to KRS Chapter 13B.
(3) If the cabinet has substantial reason to believe that an imminent public health hazard exists, or if the certificate holder has interfered with the cabinet in the performance of its duties, after the cabinet agents have duly and officially identified themselves, the certification shall be suspended immediately upon notice to the certificate holder without a conference. In this event, the certificate holder may request a conference on form DFS-212. If requested, the conference shall be granted as soon as practical, or in any event, not to exceed seven (7) days.
(4) In all other cases, a shellfish dealer's certification shall not be renewed or reinstated until the shellfish dealer complies with the requirements for initial certification found in Section 2 of this administrative regulation and is able to demonstrate substantial compliance with other pertinent requirements of this administrative regulation specific to the particular type of certification being sought.
(5) If an inspection reveals the presence of a critical deficiency as identified on the ISSC Form 93-01(A):
(a) The deficiency shall be corrected during that inspection; or
(b) The certified shellfish dealer shall cease production in areas of the facility affected by deficiency.
(6) If the certified shellfish dealer fails to comply with subsection (5) of this section, the cabinet shall immediately begin actions to suspend or revoke the certified shellfish dealer's certification.
(7) If the cabinet has reason to believe that a critical deficiency may have resulted in product contamination, the cabinet shall take appropriate action to prevent contaminated or adulterated product from reaching consumers. If necessary the cabinet shall:
(a) Quarantine undistributed lots of shellfish that may have been adulterated;
(b) Coordinate with the certified shellfish dealer a recall of distributed shellfish; and
(c) Immediately notify the appropriate federal and state health authorities where the product was distributed and the ISSC.
(8) If an inspection detects any key or other deficiencies as identified on the ISSC Form 93-01(A) that are not already covered in a compliance schedule, the cabinet, working with the certified shellfish dealer, shall develop a compliance schedule to correct the new key or other deficiencies.
(9) If a certified shellfish dealer has failed to meet a compliance schedule for the correction of objectionable conditions noted during a previous inspection, the cabinet shall:
(a) If unique circumstances prevail, consider revising the compliance schedule;
(b) Seek suspension or revocation of the shellfish dealer's certification; or
(c) Seek other administrative remedies as provided by KRS Chapter 217.
(10) If an inspection detects four (4) or more new key deficiencies as identified on the ISSC Form 93-01(A), the cabinet shall initiate the following enforcement action towards the certified shellfish dealer:
(a) Revise the existing compliance schedule;
(b) Suspend or revoke the shellfish dealer's certification; or
(c) Seek other administrative remedies as provided by KRS Chapter 217.
(11) Any shellfish dealer whose shellfish dealer certification has been suspended may make a request in writing for reinstatement of the certification.
Section 17. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Appendix B.1., Mulluscan Shellfish Model Ordinance-Shellfish Industry Equipment Construction Guide", 2003;
(b) "DFS-200, Facility Profile", 7-01;
(c) "DFS-255, Application for Certification to Handle Oysters, Clams, Mussels or Scallops", 2005;
(d) "Shellfish Dealer Certification", 2005;
(e) "DFS-220, Food Plant Inspection Form", 04-04;
(f) "ISSC Form 93-01 (A), NSSP Standardized Shellfish Processing Plant Inspection Form", 2000;
(g) "DFS-214, Enforcement Notice", 8-96;
(h) "DFS-212, Request for Conference";
(i) "DFS-213, Notice of Conference"; and
(j) "DFS-215, Application for Reinstatement of Shellfish Dealer Certification", (2-95).
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Cabinet for Health and Family Services, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.005-217.205, 217.992, 318.130
- STATUTORY AUTHORITY: KRS 194A.050, 217.125
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) authorizes the Cabinet for Health and Family Services to protect the public against the adulteration and misbranding of foods. This administrative regulation establishes minimum sanitary standards for shellfish dealer certification, for dealers in both interstate and intrastate commerce, based upon the National Shellfish Sanitation Program Model Ordinance.
- History: FDC-6; 1 Ky.R. 534; eff. 3-12-1975; 20 Ky.R. 1413; 1843; eff. 1-10-1994; 22 Ky.R. 2450; eff. 8-1-1996; 32 Ky.R. 1155; 1405; eff. 3-2-2006; Crt eff. 11-5-2019; TAm eff. 3-20-2020; Crt eff. 9-2-2026.
902 KAR 45:021 Hemp-derived cannabinoid products registration, processing, manufacturing, storage and distribution requirements {#sec-902-kar-45-021 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:021}
Section 1. Permit and Product Registration.
(1) In-state permit.
(a) A person located in Kentucky seeking to process, manufacture, store, or distribute hemp-derived cannabinoid products shall be permitted by the cabinet.
(b) The permit shall:
-
Be nontransferable in regard to person or address;
-
Be posted in a conspicuous place in the facility;
-
Be renewed annually;
-
Include the fee paid in accordance with the following:
a. For a hemp processing permit, the fee is $3,000;
b. For a hemp manufacturing permit, the fee is $1,000;
c. For a hemp cannabinoid wholesale warehouse and distributor permit, the fee is $1,000; and
d. For a hemp cosmetic permit, the fee is $200; and
- Include the product registration fee required by subsection (5) of this section.
(2) The permit fee established pursuant to subsection (1)(b)4. of this section shall be waived for all facilities permitted as of December 31, 2024, and thosefacilities shall pay the permit fee at next annual renewal date.
(3)
(a) All out-of-state processors and manufacturers of hemp-derived cannabinoid products available for distribution in Kentucky shall complete the business registration as required by the department.
(b) The registration for an out-of-state processor or manufacturer shall:
-
Be renewed annually by December 31 each year; and
-
Include:
a. A copy of the current, valid permit to process or manufacture hemp-derived cannabinoids issued from the state regulatory authority;
b. A copy of the state regulation pertaining to the production of hemp-derived cannabinoid products;
c. The fee required by subparagraph (1)(b)4.c. of this section; and
d. The product registration fee required by subsection (5) of this section.
(4) Cannabinoids requiring registration:
(a) Adult-use cannabinoids shall include:
(b) Non-intoxicating cannabinoids shall include:
(c) All other cannabinoids are prohibited for sale in Kentucky unless pre-approved by the cabinet.
(5) Product registration fee.
(a) An initial product registration fee of $200 shall be paid for each cannabinoid product or cannabinoid product class sold in Kentucky.
(b) The fee shall be paid to the cabinet by check or money order made payable to the Kentucky State Treasurer.
(6) A new product registration and fee shall be required for changes:
(a) In the chemical composition or formula of the cannabinoid product;
(b) To the serving size or directions for use; or
(c) To the product label.
(7) All in-state processors and manufacturers permitted by the cabinet, and all out-of-state processors and manufacturers registering with the cabinet shall submit:
(a) The name and address of the applicant;
(b) The name and address of the brand or company whose name shall appear on the label, if other than the applicant's;
(c) The name of the product;
(d) The name and address of the origin of the adult-use cannabinoid product with which the final product was manufactured;
(e) A complete copy of the front and back of the label that will appear on the product; and
(f) A certificate of analysis from an accredited third-party laboratory for the lot for each product.
(8) A new product registration shall be required for any changes to the requirements of subsection (7) of this section.
Section 2. Processing, Manufacture, Storage, or Distribution of Hemp-derived Cannabinoid Products.
(1) All processors and manufacturers shall meet:
(a) The applicable requirements of 902 KAR 45:160 Section 2(1)(u); and
(b) The requirements of 902 KAR 45:160, Sections 4 through 11, and 14.
(2) Cannabinoid products shall not be manufactured, marketed, sold, or distributed by a home-based processor.
(3) The following hemp-derived products shall not be manufactured with the intent for retail sale:
(a) Hemp cigarettes;
(b) Hemp cigars;
(c) Chew, dip, or other smokeless material consisting of hemp leaf material or hemp floral material;
(d) Hemp leaf material or floral material teas; and
(e) Hemp bud or floral material.
(4) A business that processes, manufactures, warehouses, distributes, sells, or serves adult-use hemp-derived cannabinoid products shall not employ any person who is under twenty-one (21) years of age, unless the person employed is at least eighteen (18) years of age and under the direct supervision of a person twenty-one (21) years of age or older.
(5) Non-intoxicating cannabinoid products shall:
(a) Have at least a fifteen (15) non-intoxicating cannabinoid to one (1) adult-use cannabinoid ratio; and
(b) Contain two and five-tenths (2.5) milligrams or less of adult-use cannabinoid per serving.
(6) Products not meeting the requirements of subsection (5) of this section shall be considered adult-use products.
(7) The serving size of an ingestible cannabinoid product shall be:
(a) As a whole unit where one (1) unit equals one (1) serving;
(b) Equal to the maximum amount recommended, as appropriate, on the label for consumption per occasion in whole units; and
(c) Based on the amount typically consumed.
(8) A hemp-derived cannabinoid processing or manufacturing facility shall not treat or otherwise adulterate a cannabinoid product with:
(a) Any non-cannabinoid additive that increases toxicity or addictive potential, excluding caffeine;
(b) Alcohol;
(c) Nicotine; or
(d) Other chemicals that may increase carcinogenicity or cardiac effects.
(9) All products shall be homogenized to ensure uniform distribution of cannabinoids throughout the product.
(10) Only permitted hemp-derived cannabinoid processing facilities shall perform cannabinoid extraction, conversion, catalyzation, distillation, hydrogenation, or other refinement processes.
(11) A hemp-derived cannabinoid processor or manufacturer shall only use the following solvents: water, glycerin, vegetable oils, animal fats, butane, propane, carbon dioxide, ethanol, isopropanol, acetone, heptane, ethyl acetate, and pentane. The use of any other solvent is expressly prohibited unless pre-approved by the cabinet.
(12) A hemp-derived cannabinoid processor using hydrocarbon-based solvents shall use only those solvents of ninety-nine (99) percent or better purity. Nonhydrocarbon-based solvents shall be food grade.
(13)
(a) A current copy of safety data sheets and a receipt of purchase for all solvents used or to be used in an extraction process shall be kept on file;
(b) The processor shall retain in its facility a certificate of analysis (COA) from the original manufacturer with purity and impurity limits and results for all solvents used; and
(c) Certificates shall be retained for two (2) years.
(14)
(a) Solvents shall be collected and stored in food-grade containers to maintain purity; and
(b) Solvent containers shall be replaced or safely purged, cleaned, and sanitized periodically.
(15) Extraction processes shall take place in an environment properly ventilated to control all sources of ignition where a flammable atmosphere is, or could be, present.
(16) Cannabinoid processing facilities shall not use pressurized canned flammable fuel, such as butane intended for use in outdoor activities, handheld torch devices, and refillable cigarette lighters.
(17) Cannabinoid processing facilities using carbon dioxide shall have equipment and facilities approved by local fire code officials, if applicable.
(18) Processes using flammable gas or flammable liquid shall have leak or gas detection measures, or both.
(19) A permittee shall not use dimethylsulfoxide (DMSO) in the manufacture of hemp-derived cannabinoid products, and possession upon the permitted premises is prohibited.
(20)
(a) A hemp-derived cannabinoid manufacturer may use terpenes or other hemp essential oil but shall not use non-cannabinoid derived inactive ingredients not listed in the federal Food and Drug Administration inactive ingredient database at https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm in the manufacture of inhalable hemp-derived cannabinoid product and distillate intended for use through a vaporizer delivery device or pressurized metered dose inhaler; and
(b) Any non-cannabinoid derived inactive ingredients used shall be less than or equal to the concentration listed in the database.
(21) The following substances shall be prohibited in hemp-derived cannabinoid extraction intended for inhalation:
(a) Acetates;
(b) Medium-chain triglycerides (MCT);
(c) Polyethylene glycol (PEG);
(d) Propylene glycol (PG or PPG);
(e) Diketones:
-
2,3-butanedione (Diacetyl);
-
2,3-pentanedione (acetylpropionyl); and
-
3-hydroxybutanone (acetoin);
(f) Myclobutanil;
(g) Artificial food coloring; and
(h) Benzoic acid.
(22) Hazard analysis and risk-based preventive controls.
(a) Processing facilities shall conduct a hazard analysis in accordance with 902 KAR 45:160 Section 2(1)(u) to identify and evaluate, based on experience, illness data, scientific report, and other information known, or reasonably foreseeable hazards associated with each type of cannabinoid product produced by extraction, conversion, catalyzation, or distillation, hydrogenation, or other refinement processes, and shall include:
-
Processing reagents or catalysis;
-
Processing by-products or compounds; and
-
Tentatively identified compounds.
(b) The hazard analysis shall include an evaluation of the hazards identified to assess the severity of illness or injury from the hazard and the probability that the hazard will occur in the absence of preventive controls.
(c) A processing facility shall identify and implement preventive controls to provide assurances that any hazards requiring a preventive control shall be significantly minimized or prevented, and the hemp-derived cannabinoid product not adulterated.
(d) The cabinet may initiate an investigation of a processing facility as a result of a by-product or compound with no toxicity study or a TICs report from a testing facility and may require a processing or manufacturing facility to submit samples for additional testing, including testing for analytes that are not required by this administrative regulation, at the processing or manufacturing facility's expense.
Section 3. Record Keeping.
(1) A master formulation record shall be prepared and maintained for each unique hemp-derived cannabinoid product.
(2) The master formulation record shall include at least the following information:
(a) Name of the cannabinoid product;
(b) Ingredient identities and amounts;
(c) Specifications on the delivery device (if applicable);
(d) Complete instructions for preparing the cannabinoid product, including equipment, supplies, and description of the manufacturing steps;
(e) Process controls and procedures; and
(f) Any other information needed to describe the production and ensure its repeatability.
(3) A batch or process lot manufacturing record shall be created for each production batch of cannabinoid product.
(4) The batch manufacturing record shall include at the least the following information:
(a) Name of the cannabinoid product;
(b) Master formulation record reference for the cannabinoid product;
(c) Date and time of preparation of the cannabinoid product;
(d) Production batch number;
(e) Signature or initials of individuals involved in each manufacturing step;
(f) Name, vendor, or manufacturer, production batch number, and expiration date of each ingredient;
(g) Weight or measurement of each ingredient;
(h) Documentation of process controls;
(i) Any deviations from the master formulation record, and any problems or errors experienced during the manufacture, and corrective actions; and
(j) Total quantity of the cannabinoid product manufactured.
Section 4. Product Packaging and Labeling.
(1) Each cannabinoid product manufactured, marketed, sold, or distributed in the commonwealth shall be packaged and labeled in accordance with KRS 217.037, HB 544, 2023 Ky. Acts ch. 78, and this administrative regulation.
(2) Each container of adult-use cannabinoid product, excluding cosmetics, shall:
(a) Have a tamper-evident seal; and
(b) Be in child-resistant packaging.
(3) Each container of non-intoxicating cannabinoid product or cosmetic shall have a tamper-evident seal.
(4) Cannabinoid product packaging shall not include:
(a) Any cartoon images;
(b) Likeness to images, characters, or phrases that are popularly used to advertise to children;
(c) Likeness to or imitation of any commercially available candy, snack, baked good, or beverage packaging or labeling;
(d) The terms "candy" or "candies", or any variation in the spelling of these words; or
(e) The logo of the department or cabinet, or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any person to believe the product has been endorsed, manufactured, or used by any state, county, or municipality or any agency thereof, excluding the use of seals associated with state or federal programs used in accordance with state or federal law and regulations.
(5) The total amount of hemp-derived cannabinoid per serving and the total amount per container shall accurately reflect testing results and shall not contain less than eighty (80) percent or more than 120% of the concentration of total cannabinoid content as listed on the product label:
(a) For hemp-derived cannabinoid ingestible and inhalable products, potency shall be labeled as milligrams per serving for total tetrahydrocannabinol and the primary cannabinoid marketed, as applicable; and milligrams per package for total tetrahydrocannabinol and the primary cannabinoids marketed; and
(b) Other hemp-derived cannabinoids labeled milligrams per gram (mg/g) per serving, excluding cosmetics, and milligrams per package, if listed on the label.
(6) Adult-use hemp-derived cannabinoid products shall include the following warning label statements:
(a) "Warning: Contains THC";
(b) "This product is intended for use by adults 21 years and older. Keep out of reach of children";
(c) "There may be health risks associated with the consumption of this product";
(d) "There may be additional health risks associated with the consumption of this product for those who are pregnant, nursing, or plan to become pregnant";
(e) "The intoxicating effects of this product may be delayed by two or more hours";
(f) "May cause drowsiness or impairment. Do not drive a motor vehicle or operate machinery while using this product"; and
(g) "Use of this product may result in a positive drug screen".
(7) A quick response or QR code may be used as a link to the warning statements required by subsection (6) of this section. The QR code shall be labeled as "Warning Statements" directly above or below the code and shall be large enough to be smart-phone readable.
Section 5. Inspection and Enforcement.
(1) The cabinet or its duly authorized agent shall conduct an onsite inspection of all permitted cannabinoid processing and manufacturing establishments, storage warehouses, and distribution centers.
(2) The location of the permitted establishment, all general business records, including employee records, and vehicles utilized to transport products are subject to reasonable inspection.
(3) All cannabinoid establishments, whether permitted or not, shall cooperate with the cabinet or its duly authorized agent during any inspections, complaint investigation, and requests for information or data, in order to verify compliance with this administrative regulation.
(4)
(a) All products not in compliance with this administrative regulation may be seized by the cabinet or its duly authorized agent.
(b) The permit holder shall be given notice that it hasten (10) days to file an appeal pursuant to subsection (12) of this section.
(c) If a request for an appeal is not filed, seized products shall be destroyed.
(5) The permit holder shall take immediate steps to correct conditions that have caused an imminent health hazard.
(6)
(a) The permit holder shall notify the cabinet within twenty-four (24) hours of the knowledge of an imminent health hazard that cannot be controlled by immediate corrective action or if product, product packaging, cosmetic, or cosmetic packaging has become contaminated because of an imminent health hazard.
(b) Notification to the cabinet shall be made by:
-
Email to food.safety@ky.gov; or
-
Phone to (502)564-7181.
(7) If the cabinet has evidence that a permit holder has failed to act to correct an imminent health hazard, the following enforcement provisions shall be initiated:
(a) Suspend the permit without an administrative hearing; or
(b) Suspend that portion of the operation affected by the imminent health hazard without an administrative hearing.
(8) If a permit suspension is due to an imminent health hazard, the permit holder may submit a request for an administrative hearing to the cabinet in accordance with KRS Chapter 13B.
(9) A permit holder shall notify the cabinet within twenty-four (24) hours of becoming aware of any serious adverse event to a hemp-derived cannabinoid product sold or transferred by the permit holder.
(10) In all other instances of violation of this administrative regulation, the cabinet shall serve the permit holder with a written notice specifying the violation and afford the holder an opportunity to correct.
(11) If a permit holder has failed to comply with the written notice within the timeframe granted, the cabinet shall issue a notice of intent to suspend the permit.
(12)
(a) The notice in subsection (11) of this section shall include notification that the permit shall be suspended at the end of ten (10) days following service of the notice, unless a written request for an administrative hearing is filed with the cabinet by the permit holder within the ten (10) day period; and
(b) The administrative hearing shall be conducted in accordance with KRS 13B.080.
(13) For a permitted facility that has had a suspended permit two (2) or more times within a five (5) year period, the cabinet shall initiate permit revocation proceedings. Prior to this action, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit revocation is being sought and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative hearing is filed with the cabinet pursuant to KRS Chapter 13B by the permit holder within the ten (10) day period.
(14) Any person who violates any provision of this administrative regulation may be fined, found guilty ofa criminal offense, or both pursuant to KRS 217.992.
(15) State and local law enforcement officers shall have concurrent jurisdiction to enforce violations of this administrative regulation.
History
- RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035, 217.037, 217.039, 217.992, 2023 Ky Acts ch. 78
- STATUTORY AUTHORITY: KRS 217.125, 217.127, 217.135, 217.155
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215. KRS 217.125(2), (4) requires the secretary to provide by administrative regulation a schedule of fees for permits to operate and for inspection activities carried out by the cabinet pursuant to KRS 217.025 through 217.390. KRS 217.135 authorizes the secretary to establish food standards by administrative regulation including a reasonable definition, standard of identity, and designation of optional ingredients that shall be named on the label. KRS 217.155 authorizes the cabinet or its duly authorized agent free access at reasonable times for the purpose of inspecting any factory, warehouse, or establishment where foods, drugs, devices, or cosmetics are manufactured or held for sale. This administrative regulation establishes the product registration, the processing and manufacturing procedures for hemp-derived cannabinoid products, including the permit fee, and the labeling and packaging requirements for products containing hemp-derived cannabinoids. Establishments permitted with the department prior to December 31, 2024, shall be exempted from the permit fee requirement until the annual renewal date.
- History: 50 Ky.R. 2537; 51 Ky.R. 682, 1119; eff. 11-18-2024.
902 KAR 45:031 Hemp-derived cannabinoid product sampling and testing requirements {#sec-902-kar-45-031 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:031}
Section 1. Product Sampling and Testing Requirements.
(1) Sampling and testing for all cannabinoid products shall be:
(a) Done for each batch or process lot; and
(b) Conducted with representative samples to ensure:
-
All batches or process lots are adequately assessed for contaminants; and
-
The cannabinoid profile is consistent throughout.
(2) Testing shall only be performed on the final product equivalent to what will be consumed.
(3) Samples shall be collected using appropriate aseptic techniques.
(4) A cannabinoid processing or manufacturing facility shall assign each batch or process lot a unique batch or lot number that shall be:
(a) Documented and maintained in the processing and manufacturing facility for at least two (2) years and available to the department upon request;
(b) Provided to the individual responsible for taking samples; and
(c) Included on the product package or label.
(5) Sample size, handling, storage, and disposal.
(a) Cannabinoid products samples shall consist of enough material from the batch or process lot to ensure that the required attributes in the products are homogenous and consistent with the testing facility's accredited sampling policies and procedures.
(b) A cannabinoid processing or manufacturing permittee shall prepare sampling policies and procedures that contain the information necessary for collecting and transporting samples from cannabinoid products in a manner that does not endanger the integrity of the sample for any analysis required by this administrative regulation.
(6) Reserve samples.
(a) Processors and manufacturers shall collect and hold reserve samples of each batch or process lot of packaged and labeled product.
(b) The reserve samples shall:
-
Be held using the same container-closure system that the packaged and labeled product is distributed, or if distributing to be packaged and labeled, using a container-closure system that provides the same characteristics to protect against contamination or deterioration;
-
Be identified with the batch or process number;
-
Be retained for the shelf-life date, as applicable, or for two (2) years from the date of distribution of the last batch or process lot of the product associated with the reserve sample; and
-
Consist of at least twice the quantity necessary for all tests or examinations to determine if the product meets specifications.
(7) Laboratory requirements.
(a) Testing facilities used by the cannabinoid processing or manufacturing facility shall be an independent third-party, fully accredited to the standard established by International Organization for Standardization (ISO) 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body.
(b) The testing facility shall:
-
Maintain ISO 17025 accreditation; and
-
Comply with all required analytes standards for the relevant test methods of:
a. Cannabinoids;
b. Microbial impurities;
c. Mycotoxins;
d. Residual pesticides;
e. Heavy metals; and
f. Residual solvents, if applicable.
(c) Cannabinoid processing or manufacturing facilities shall maintain on file proof of a valid certificate of accreditation for the laboratory completing product testing that:
-
Is issued by an accreditation organization; and
-
Attests to the laboratory's competence to perform testing, including all the required analytes for the relevant test methods required.
(8) Testing requirements.
(a) A processing or manufacturing facility shall test every batch or process lot of cannabinoid product for sale or distribution prior to sell or transfer.
(b) Testing shall be performed using a cannabinoid quantification technique with a high enough specificity and sensitivity to differentiate between cannabinoids and isomers of cannabinoids.
(c) Cannabinoid products shall be tested for:
-
Cannabinoids, which shall include all cannabinoids specified in 902 KAR 45:021, Section 1(4)(a);
-
Microbial impurities;
-
Mycotoxins;
-
Residual pesticides;
-
Heavy metals; and
-
Residual solvents, if applicable.
(d) Infused cannabinoid products may not require additional testing for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents, as applicable, if the cannabinoid distillate used to make an infused product was:
-
Tested for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents in compliance with this administrative regulation; and
-
Test results indicate the batch or process lot was within established limits.
(e) An infused cannabinoid product shall be tested if the addition of ingredients or processing practice create a reasonable or foreseeable microbial impurity, mycotoxin, residual pesticide, heavy metals, or residual solvents hazard.
(f) All vaporizer delivery device or pressurized metered dose inhaler cartridge batches or process lots shall be tested for acetates.
(g) In accordance with KRS 217.039, all applicable certificates of analysis shall accompany the final product.
Section 2. Standards for Cannabinoid Testing.
(1) A testing facility shall establish a limit of quantitation of one (1) milligram per gram (mg/g) or lower for all adult-use cannabinoids analyzed and reported.
(2) A testing facility shall report the result of the cannabinoid testing on the certificate of analysis, that includes at minimum:
(a) Total tetrahydrocannabinol concentration, calculated in accordance with subsection (3) of this section and reported in percentages;
(b) Tetrahydrocannabinol-A concentration;
(c) Milligrams per serving for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable;
(d) Milligrams per package for total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics, as applicable; and
(e) The results of all other hemp-derived cannabinoids analyzed on the COA both as a percentage and milligrams per gram (mg/g).
(3) The following calculation shall be used for calculating total tetrahydrocannabinol concentration expressed in weight: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g) on a dry weight basis.
(4) For cannabinoid infused products, excluding cosmetics, potency shall be reported as milligrams of total tetrahydrocannabinol and the primary cannabinoid marketed, excluding cosmetics per gram.
(5) Cannabinoid products shall not contain a delta-9 tetrahydrocannabinol concentration of more than three-tenths of one percent (0.3) on a dry weight basis.
(6) The serving size from a vaporizer delivery device or pressurized metered dose inhaler shall not exceed one (1) inhalation lasting two (2) seconds per serving.
Section 3. Standards for Microbial Impurities.
(1) Cannabinoid products shall be tested by a testing facility for the presence of microbial impurities.
(2) The sample of inhalable cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:
(a) Total Escherichia coli is not detected above 100 colony forming units/gram;
(b) Shiga toxin–producing Escherichia coli is not detected in one (1) gram;
(c) Salmonella spp. is not detected in one (1) gram;
(d) Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in one (1) gram; and
(e) A total combined yeast and mold do not exceed 100,000 colony forming units per gram.
(3) The sample of ingestible or cosmetic cannabinoid products shall be deemed to have passed the microbial impurities testing if the following conditions are met:
(a) Total Escherichia coli is not detected above 100 colony forming units/gram;
(b) Shiga toxin–producing Escherichia coli is not detected in one (1) gram;
(c) Salmonella spp. is not detected in one (1) gram; and
(d) A total combined yeast and mold do not exceed 100,000 colony forming units per gram.
(4) If the sample fails microbial impurities testing, the batch or process lot from which the sample was collected shall not be released for retail sale.
(5) If a sample from a batch or process lot of a cannabinoid product fails microbiological contaminant testing, the batch may be further processed if the processing method effectively sterilizes the batch.
(6) A batch or process lot that is sterilized in accordance with subsection (5) of this section shall be sampled and tested in accordance with this administrative regulation, if not otherwise required for that product, for microbiological contaminants, and residual solvents.
(7) A batch or process lot that fails microbiological contaminant testing after undergoing a sterilization process in accordance with subsection (5) of this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
Section 4. Standards for Mycotoxin Testing.
(1) Cannabinoid products shall be tested by a testing facility for the following mycotoxins: aflatoxin B1, B2, G1, and G2 ochratoxin A.
(2) A batch or process lot shall be deemed to have passed mycotoxin testing if the following conditions are met:
(a) Total of aflatoxin B1, B2, G1, and G2 does not exceed twenty (20) microgram per kilogram (µg/kg) of substance; and
(b) Ochratoxin A does not exceed twenty (20) µg/kg of substance.
(3) A batch or process lot that fails mycotoxin testing in accordance with this subsection shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
Section 5. Standards for Testing Residual Pesticides.
(1) Cannabinoid products shall be tested by a testing facility for the following residual pesticides and shall not exceed the maximum allowable concentration for each:
(2) A batch or process lot that fails residual pesticide testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
Section 6. Standards for Testing for Heavy Metals.
(1) Cannabinoid products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:
(a) Arsenic, maximum allowable concentration: one and five-tenths (1.5) ppm;
(b) Cadmium, maximum allowable concentration: zero and four-tenths (0.4) ppm;
(c) Lead, maximum allowable concentration: one (1) ppm; and
(d) Mercury, maximum allowable concentration: one and two-tenths (1.2) ppm.
(2) Cannabinoid distillate intended for inhalable products shall be tested by a testing facility for the following metals and shall not exceed the maximum allowable concentration for each:
(a) Arsenic, maximum allowable concentration: zero and two-tenths (0.2) ppm;
(b) Cadmium, maximum allowable concentration: zero and two-tenths (0.2) ppm;
(c) Lead, maximum allowable concentration: zero and five-tenths (0.5) ppm; and
(d) Mercury, maximum allowable concentration: zero and one-tenths (0.1) ppm.
(3) A batch or process lot that fails heavy metals testing in accordance with this section shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
Section 7. Standards for Testing Residual Solvents.
(1) Cannabinoid products shall be tested by a testing facility for residual solvents, as appropriate, and shall not exceed the maximum allowable concentration for each solvent used according to the table below:
(2) A processing or manufacturing facility shall be exempt from testing for solvents if the facility:
(a) Did not use any solvent listed in subsection (1) of this section;
(b) Used a mechanical extraction process to separate cannabinoids; or
(c) Used only water, animal fat, or vegetable oil as a solvent to separate the cannabinoids.
(3) If a sample from a batch or process lot fails solvent testing, the batch or process lot may be remediated using procedures that would reduce the concentration of solvents to less than the action level.
(4) A batch or process lot that is remediated in accordance with subsection (3) of this section shall be:
(a) Sampled and tested in accordance with this administrative regulation; and
(b) Tested for solvents if not otherwise required for that product under this administrative regulation.
(5) A batch or process lot that fails solvent testing that is not remediated or that if remediated fails testing shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
Section 8. Standards for Water Activity.
(1) Plant material, such as flower, shake, and plant trim, used to process and manufacture hemp-derived cannabinoid products shall have a water activity (Aw) rate of less than 0.65.
(2) If the plant material sample fails testing for water activity, the batch from which the sample was taken may:
(a) Be used to make a cannabinoid distillate; or
(b) Continue to dry or cure.
(3) Plant material that undergoes additional drying or curing as described in subsection (2)(b) of this section shall be re-sampled and tested in accordance with this section.
Section 9. Failed Testing and Remediation.
(1) A sample that fails any initial testing may be reanalyzed by the testing facility.
(2) If the reanalyzed sample passes, the processing or manufacturing facility shall resample the batch or process lot using another accredited testing facility to confirm the result in order for the batch or process lot to pass testing.
(3) A batch or process lot shall fail testing if the testing facility detects the presence of a contaminant in a sample above any limit of detection (LOD) established in this administrative regulation:
(a) During an initial test where no reanalysis is requested; or
(b) Upon reanalysis as described in this subsection.
(4) If a sample fails a test or a reanalysis, the batch or process lot:
(a) May be remediated or sterilized in accordance with this administrative regulation; or
(b) If it cannot be remediated or sterilized in accordance with this administrative regulation, it shall be destroyed in a manner that renders the batch or process lot denatured and unusable.
(5) A hemp-derived cannabinoid product batch or process lot shall only be remediated twice. If the batch or process lot fails after a second remediation attempt and the second retesting, the entire batch or process lot shall be destroyed in a manner approved by the cabinet.
(6) A hemp-derived cannabinoid product from a batch or process lot that failed testing shall not be combined with another batch or process lot. Mixed products shall be considered adulterated, regardless of the LOD or defect level of the final product.
Section 10. Certificate of Analysis.
(1) The testing facility shall:
(a) Generate a certificate of analysis (COA) for each representative sample that the testing facility analyzes; and
(b) Ensure the COA contains the results of all required analyses performed for the representative sample.
(2) The COA shall contain, at minimum:
(a) The testing facility's name, premises address, and license number, processor's or manufacturer's name, and premises address;
(b) Batch or lot number of the batch or process lot from which the sample was obtained. For products that are already packaged at the time of sampling, the labeled batch or lot number on the packaged hemp-derived cannabinoid products shall match the batch or lot number on the COA;
(c) Sample identifying information, including matrix type and unique sample identifiers;
(d) Sample history, including the date collected, the date received by the testing facility, and the date of all sample analyses and corresponding testing results;
(e) The analytical methods, analytical instrumentation used, and corresponding LOD and limits of quantitation (LOQ);
(f) Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any; and
(g) A chromatograph of the cannabinoid test results.
(3) The testing facility shall report test results for each representative sample on the COA as an overall "pass" or "fail" for the entire batch:
(a) When reporting qualitative results for each analyte, the testing facility shall indicate "pass" or "fail";
(b) When reporting quantitative results for each analyte, the testing facility shall use the appropriate units of measurement as required in accordance with this administrative regulation;
(c) When reporting results for each test method, the testing facility shall indicate "pass" or "fail";
(d) When reporting results for any analytes that were detected below the analytical method LOQ, indicate "<LOQ", notwithstanding cannabinoid results;
(e) When reporting results for any analytes that were not detected or detected below the LOD, indicate "ND"; and
(f) Indicate "NT" for any test that the testing facility did not perform.
(4)
(a) In accordance with 2023 Ky. Acts ch. 78, a cannabinoid manufacturer or processor that ships adult-use products out-of-state for use or sale outside the Commonwealth of Kentucky:
-
Shall abide by the testing and labeling requirements of this administrative regulation if the receiving state or jurisdiction does not have testing and labeling requirements; or
-
May defer to the receiving state's testing requirements if that state has equivalent testing requirements.
-
Products intended for out-of-state sale shall be stored separately from in-state products and shall have signage indicating the products are for out-of-state sale.
(b) Batch number of the batch from which the sample was obtained shall be on the COA for all products shipped out of state.
History
- RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035, 217.037, 217.039, 260.850, 438.305(4), 2023 Ky Acts ch. 78
- STATUTORY AUTHORITY: KRS 217.125, 217.155
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 through 217.215. KRS 217.155 authorizes the cabinet or its duly authorized agent free access at reasonable times for the purpose of inspection any factory, warehouse, or establishment where foods, drugs, devices, or cosmetics are manufactured or held for sale. This administrative regulation establishes the hemp-derived cannabinoid product sampling and testing requirements.
- History: 50 Ky.R. 2545; 51 Ky.R. 690, 912; eff. 11-18-2024.
902 KAR 45:065 Tattooing {#sec-902-kar-45-065 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:065}
Section 1. Definitions.
(1) "Antiseptic" means a substance applied to the skin that reduces the number of microorganisms.
(2) "Autoclave" means a device intended to sterilize products by means of pressurized steam.
(3) "Blood" is defined by 29 C.F.R. 1910.1030.
(4) "Bloodborne pathogen training" means training that meets the requirements established in 29 C.F.R. 1910.1030.
(5) "Contaminated" is defined by 29 C.F.R. 1910.1030.
(6) "Contaminated sharps" is defined by 29 C.F.R. 1910.1030.
(7) "Disinfectant" means a product that is tuberculocidal and registered with the federal Environmental Protection Agency as indicated on the label for use in disinfection.
(8) "Hand washing" means the act of cleaning the hands for the purpose of removing dirt, soil, or microorganisms through the use of soap, warm water, and friction.
(9) "Instrument" means any tattooing implement that comes into contact with blood or skin to be tattooed such as needles, needle bars, needle tubes, or other implements used to insert pigment.
(10) "Minor" is defined by KRS 387.010(1).
(11) "Mobile studio" means a tattooing studio that is designed to be readily movable.
(12) "Purchased presterilized" means procedure set-ups that are sold individually packaged, processed, and marked with a sterilization lot number and expiration date to render them free of all microorganisms.
(13) "Registration" means the issuance of a document by the local health department to a tattoo artist authorizing the tattoo artist to engage in the business of tattooing.
(14) "Regulated waste" is defined by 29 C.F.R. 1910.1030.
(15) "Service animal" is defined by 28 C.F.R. 36.104.
(16) "Sterilization" means a validated process used to render a product free from viable microorganisms.
(17) "Studio" means a facility as defined by KRS 211.760(1)(b).
(18) "Studio certificate" means the document issued by the local health department to a studio owner certifying that the studio, after inspection, was in compliance with the applicable provisions of this administrative regulation.
(19) "Studio owner" means:
(a) An owner of a facility where tattooing is conducted;
(b) A sole proprietor who performs tattooing; or
(c) A person who employs tattoo artists.
(20) "Tattoo artist" means a person registered by the local health department to engage in tattooing.
(21) "Tattooing" is defined by KRS 211.760(1)(c).
(22) "Temporary permit" means a permit to operate at a fixed location for no more than seven (7) calendar days, and that:
(a) Is nontransferable; and
(b) Cannot be renewed for ninety (90) days after the expiration.
(23) "Ultrasonic cleaner" means a device that transmits high-energy, high-frequency sound waves into a fluid-filled container, used to remove deposits from instruments and appliances.
Section 2. Registration of Tattoo Artist.
(1) A person shall not advertise or solicit business with the intent to perform tattooing, or use or assume the title of tattooist, unless registered with the local health department in the district or county where the person is to tattoo.
(2) All tattooing shall be under the authority of a Kentucky certified studio.
(3) A tattoo artist shall not engage in the act of tattooing unless that person has proof of completion of bloodborne pathogen training.
(4) The artist shall maintain documentation of completion of bloodborne pathogen training at the studio.
(5) An applicant for registration as a tattoo artist shall be at least eighteen (18) years of age at the time of application.
(6) An applicant for registration shall submit to the local health department in the district or county where the applicant intends to perform tattooing:
(a) A completed DFS-303, Application for Certification or Registration available at https://www.chfs.ky.gov/agencies/dph/dafm/Pages/lhddocuments.aspx;
(b) Payment of $100 registration fee; and
(c) Proof of completion of approved bloodborne pathogen training as required by subsection (3) of this section.
(7) The tattoo artist registration shall be:
(a) Mailed to the owner of the Kentucky certified studio listed on the application for registration;
(b) Prominently displayed to the public in the workstation; and
(c) Nontransferable from:
-
One (1) person to another; or
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One (1) district or county to another.
(8) Each registration shall be valid for one (1) calendar year and expire on December 31st of each year.
(9) A late renewal fee of fifty (50) dollars shall be assessed on each tattoo artist registration renewal application not received by January 31st each year.
Section 3. Studio Certification.
(1) A person shall not engage in the business of tattooing unless the owner of the facility holds a studio certificate issued by the local health department in the district or county where the person is to tattoo.
(2) A holder of a studio certificate issued under this administrative regulation shall not allow a person to tattoo unless the individual is registered in accordance with Section 2 of this administrative regulation.
(3) An application for a studio certificate shall be:
(a) On DFS-200, Application for Permit or License available at https://www.chfs.ky.gov/agencies/dph/dafm/gendocs/DFS200.pdf;
(b) Submitted to the local health department in the district or county where the studio is located; and
(c) Accompanied by an annual inspection fee of:
-
$400 for the studio with one (1) to four (4) work stations; and
-
An additional fifty (50) dollars for each additional work station over four (4).
(4) A studio certificate shall not be issued or renewed unless the studio has been inspected and found to be in compliance with the provisions of this administrative regulation.
(5) The studio certificate shall be:
(a) Prominently displayed to the public in the studio; and
(b) Nontransferable from:
-
One (1) person to another; or
-
One (1) location to another.
(6) The studio certificate shall expire December 31st each year.
(7) A late renewal fee of $100 shall be assessed on each studio certificate renewal application not received by January 31st each year.
Section 4. Studio Requirements.
(1) A studio shall:
(a) Be kept clean and in good repair;
(b) Be free of insect and rodent infestation;
(c) Store only items necessary to its operation and maintenance;
(d) Provide artificial light of at least twenty (20) foot-candles;
(e) Be well ventilated;
(f) Not permit the presence of a pet or other animal in the studio, except for a service animal;
(g) Not use a room otherwise used as living or sleeping quarters;
(h) Use a solid, self-closing door to separate living or sleeping quarters from the business operation;
(i) Have convenient, clean, and sanitary toilet and hand-washing facilities for the use of clientele with liquid soap, single-use paper towels from a sanitary dispenser or air dryer, covered waste receptacle, and self-closing door;
(j) Be organized to keep clean areas separate from contaminated areas;
(k) Have a utility sink that shall only be used to wash contaminated instruments;
(l) Use, clean, and maintain equipment according to manufacturers' recommendations;
(m) Use an approved disinfectant;
(n) Have plumbing sized, installed, and maintained in accordance with 815 KAR Chapter 20;
(o) Have sufficient potable water supply for the needs of the studio provided from a source constructed, maintained, and operated pursuant to the applicable requirements established in 401 KAR Chapter 8; and
(p) Dispose of sewage, including liquid waste, by connection to:
-
A public sewer system, if available; or
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A private sewer system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5 and 902 KAR Chapter 10.
(2) A workstation shall:
(a) Have nonporous, smooth, easy-to-clean floors and walls;
(b) Have surfaces, including counters, cabinets, chairs, and dispensers, composed of smooth, nonporous material able to withstand repeated cleaning and disinfecting;
(c) Be kept clean, organized, and in good repair;
(d)
-
Have all product containers clearly labeled with common product name in English; and
-
If filling a product container from a larger bulk container, retain the original container on the studio premises;
(e) Have at least sixty (60) square feet of floor space with permanent walls a minimum of four (4) feet high between workstations;
(f) Have 100 foot-candles of light at the procedure level;
(g) Have unimpeded access to a hand sink;
(h) Have a sink for each artist with hot and cold water, delivered by a faucet, operated by wrist, knee, or foot action, or other hands-free method;
- Each sink shall be supplied with:
a. Liquid soap; and
b. Single-use paper towels dispensed from a sanitary dispenser; and
- A hand sink shall not be used for any other purpose;
(i) Be designated as a tattoo workstation, and shall not be used for any other purpose;
(j) Have plastic or metal waste receptacles:
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With or without a lid; and
-
If the waste receptacle has a lid, the lid shall be foot operated; and
(k) Have a container for disposable sharps that:
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Is rigid, puncture proof, and leak proof on sides and bottom;
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Is closeable and sealable; and
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If sealed, is leak resistant and incapable of being opened without great difficulty.
Section 5. Cleaning and Sterilization.
(1) A studio using any reusable instruments, materials, or supplies may have a one (1) room or two (2) room cleaning and sterilization arrangement.
(a) A two (2) room arrangement shall have:
- One (1) room for contaminated items, equipped with:
a. A utility sink with minimum dimensions of 18 in. x 18 in. x 12 in.;
b. A hand sink;
c. A presoak container;
d. An ultrasonic cleaner; and
e. Autoclaving packaging materials; and
- A second room for autoclave sterilization of instruments and equipment.
(b) A one (1) room cleaning and sterilization process shall be arranged to provide two (2) distinct areas.
-
Nonporous barriers may be utilized to delineate the two (2) distinct areas.
-
The cleaning area shall be equipped in accordance with paragraph (a)1. of this subsection.
-
The ultrasonic cleaner shall be as far away as possible from the autoclave to prevent contamination of sterile instruments, equipment, or other items.
(2) A studio that uses only presterilized disposable instruments, materials, and supplies shall not be required to have a separate room or area for autoclave, ultrasonic cleaner, and sterilization.
(3) All instruments shall be disposable or be made of surgical implant stainless steel and shall have only rubber gripping that can be removed and sanitized on the handles.
(4) Instruments shall be processed as follows:
(a) Soak contaminated reusable instruments in a covered container of cool water with detergent until ready to be cleaned and sterilized;
(b) Wash hands and forearms;
(c) Use disposable, single-use gloves, such as examination or surgical gloves;
(d) Prepare the ultrasonic cleaner according to manufacturer's instructions;
(e) Take instruments apart and rinse in warm water;
(f) Load the ultrasonic cleaner and process according to manufacturer's recommendations, disposing of the ultrasonic cleaner liquid after each use;
(g) Wash hands and forearms;
(h) Wearing examination gloves, remove instruments from the ultrasonic cleaner, rinse with clean water, allow to air dry; and
(i) Store cleaned instruments in a labeled, covered, nonporous container until packaged for sterilization.
(5) Autoclave equipment. Equipment used to sterilize instruments shall:
(a) Be sold as sterilizing equipment for medical instruments;
(b) Be used, cleaned, and maintained to manufacturer's instructions; and
(c) Meet the minimum requirements for sterilization as verified by a negative spore test.
(6)
(a) Reusable instruments placed in contact with skin that is tattooed shall be cleaned and sterilized;
(b) Disinfection shall not be used in place of cleaning and sterilization; and
(c) Liquid sterilants shall not be used for sterilization of reusable instruments.
(7) Instrument sterilization. Instruments that touch skin to be tattooed shall be sterilized as follows:
(a) Wash hands and forearms;
(b) Use clean disposable, single-use gloves, such as surgical or examination gloves;
(c) Package cleaned instruments individually in:
-
Paper-and-plastic peel-pack with color change indicator; or
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Package as set-ups with color change indicator;
(d) Label with content, date, lot number, and preparer's initials;
(e) Load the sterilizer and process according to the manufacturer's directions;
(f) Remove the items from autoclave only when completely dry and cool;
(g) Store the items in a nonporous, clean, dry, labeled container, cabinet, or other place that is protected from dust and contamination; and
(h)
-
Sterilized instruments shall be resterilized at intervals of no more than six (6) months from the date of the last sterilization; and
-
New packaging shall be used when instruments are resterilized.
(8) Sterilization equipment monitoring.
(a) Sterilization equipment shall be tested:
-
During the initial installation;
-
After any major repair; and
-
At least monthly by using a commercial biological monitoring system;
(b) Biological indicator test results for each sterilization unit used in the studio shall be kept on site, and made available for inspection at time of inspection; and
(c) Sterilization monitoring shall be noted on sterilizer log.
(9) Sterilizer recordkeeping. A sterilizer log system shall be maintained for each sterilizer in the studio. For each sterilization cycle the following information shall be documented:
(a) Date of load;
(b) Lot number;
(c) Preparer's name;
(d) The general contents of the load;
(e) The exposure time and temperature or the sterilizer recording chart or tape; and
(f) The results of the chemical indicator.
Section 6. Studio Owner Responsibilities. The owner of a certified studio shall:
(1) Exclude any tattoo artist who is:
(a) Infected with a disease in a communicable form that can be transmitted by blood;
(b) A carrier of organisms that cause disease;
(c) Infected with a boil or an infected wound; or
(d) Diagnosed with an acute respiratory infection;
(2) Report any accident involving exposure to body fluids to the local or district health department;
(3) Receive, review, and distribute tattoo artist registrations for artists registered with the certified studio. If the artist is no longer registered with the certified studio, the registration shall be returned to the district or local health department where the certified studio is located;
(4) Maintain a record of all persons performing any activity within the studio that is regulated by the cabinet. The record shall include at a minimum the following information:
(a) Full name;
(b) Date of birth;
(c) Home address;
(d) Phone number;
(e) Email address if available;
(f) Photograph of tattoo artist; and
(g) Complete description of all tattooing procedures performed by the tattoo artist;
(5) Maintain a current copy of this administrative regulation at the studio for use by tattoo artists;
(6) Maintain an adequate supply of sterilized needles and tubes for each artist;
(7) Not resterilize or reuse single-use, disposable components; and
(8) If presterilized, disposable instruments are utilized, maintain and make available the following records at all times to the local health department:
(a) An accurate inventory of all purchased presterilized instruments by name with the date purchased and the quantity on hand; and
(b) Invoices for the purchase of all purchased presterilized instruments.
Section 7. Tattooing of Minors.
(1) A person shall not perform any tattoo procedure on a minor without custodial parent or legal guardian consent.
(2) A minor shall be at least sixteen (16) years old with custodial parent or legal guardian consent prior to tattooing.
(3) Consent shall be provided by a written notarized statement that contains an official seal or assigned identification of the notary.
(4) The notarized statement shall contain:
(a) The printed name of the custodial parent or legal guardian;
(b) The government issued photo identification number of the custodial parent or legal guardian;
(c) The address and phone number of the custodial parent or legal guardian;
(d) The printed name of the minor child;
(e) The date of birth of the minor child;
(f) The government issued photo identification number of the minor child, if applicable;
(g) A statement that the custodial parent or legal guardian is fully aware of the tattoo procedure and gives his or her consent for the procedure to be performed;
(h) The signature of the custodial parent or legal guardian; and
(i) The date of the signature of the custodial parent or legal guardian.
(5) The custodial parent or legal guardian, and minor client shall complete the attestation requirements of Section 8(3)(g) of this administrative regulation.
Section 8. Client Information and Records.
(1) Before receiving a tattoo, the client shall be provided written information that:
(a) Tattooing poses a risk of infection;
(b) Tattooing is permanent; and
(c) Removal of a tattoo may leave scars.
(2) Before the application of a tattoo, the client shall be provided written, verbal, or electronic aftercare instructions that includes:
(a) Information on the care of the site of the tattoo;
(b) Instructions on possible side effects;
(c) Information on any restrictions;
(d) Information on signs and symptoms of infection; and
(e) Instructions to consult a physician if signs and symptoms of infection, such as fever, excessive swelling, excessive redness, or drainage occur.
(3) A record of all clients who have received any tattoos shall be kept by the studio owner. The record shall include:
(a) Studio name and certificate number;
(b) The date the procedure was performed;
(c) Client's name, date of birth, address, and phone number;
(d)
-
Copy of client's government issued photo ID, if applicable; or
-
Copy of custodial parent or legal guardian's government issued photo ID;
(e) Name of the tattoo artist who performed the procedure;
(f) The type, location, and description of the procedure; and
(g) Client's attestation to the fact that the client:
-
Is not intoxicated or under the influence of drugs or alcohol;
-
Is not pregnant; and
-
Has not ingested an anticoagulant that thins the blood or interferes with blood clotting within the past twenty-four (24) hours.
(4) Records of each client shall be maintained for two (2) years.
(5) Client records and consent and other required records shall be made readily available to inspectors.
Section 9. Disposal of Regulated Wastes. All wastes produced during the process of tattooing shall be separated for disposal into two (2) classifications as established in this section.
(1) Contaminated sharps shall be disposed of by using a licensed medical waste disposal company.
(2) Regulated waste shall be bagged, securely tied, and disposed of daily in a trash container that prevents unauthorized access. This material shall be disposed of in a site approved by a general trash hauler.
Section 10. Standard Operating Procedures for Tattooing.
(1) Tattooing shall not be applied on skin that has a rash, pimples, evidence of infection, open lesions, sunburn, or manifests any evidence of an unhealthy condition without written clearance by a licensed medical provider.
(2) The tattoo artist shall follow the procedures listed in this section in preparation for tattooing.
(a) The tattoo artist and the client shall not eat, drink, or use tobacco products, an electronic cigarette, or other vapor producing product in the workstation.
(b) The tattoo artist shall wash hands and forearms prior to and after every procedure.
(c) The tattoo artist shall wear new clean disposable examination gloves for every client. If a glove is pierced, torn, or contaminated in any way, or if there is an interruption in the application of the tattoo:
-
Both gloves shall be removed immediately and discarded;
-
The hands and forearms shall be washed; and
-
New, clean examination gloves shall be used.
(d) The tattoo artist shall use a new disposable lap cloth, drape, or apron for each client. All lap cloths, drapes, and aprons shall be stored in a closed cabinet or container until used.
(e) The tattoo artist shall wear clean clothing.
(3) All instruments, equipment, and items to be used in the procedure shall be placed on plastic film or a disposable, plastic backed towel.
(4) All inks, dyes, and pigments used in a procedure shall be:
(a) Nontoxic;
(b) Dispensed from containers in a manner to prevent contamination of the unused portion in the supply bottle; and
(c) Discarded:
-
After the procedure; or
-
When the original container label becomes unreadable.
(5) Inks, dyes, and pigments transferred from bulk containers shall be labeled with:
(a) Manufacturer name;
(b) Lot number; and
(c) A statement of nontoxicity.
(6) All devices used to apply inks, dyes, or pigments shall be designed to prevent backflow of inks or pigments into the machine.
(7) If a workstation rinse cup is used, a fresh cup shall be used for each client and discarded immediately upon completion of the procedure.
(8) All single-use ointment tubes, applicators, and supplies placed on the plastic backed towel shall be discarded immediately after use.
(9) Tattoo needles shall be used once and discarded.
(10) If the tattoo artist uses any reusable components, autoclave equipment shall be required.
(11) The sharps container and waste receptacle shall be positioned to be within easy reach and in a manner to prevent contamination.
Section 11. Application of the Tattoo. The tattoo artist shall use the procedure in this section when applying a tattoo.
(1) Disinfect the chair or table and tray.
(2) Position the client.
(3) Arrange all instruments and supplies to be used in the procedure on plastic film or on a clean, disposable plastic backed towel within easy reach.
(4) Wash hands and forearms, and use new, clean examination gloves.
(5) Gently clean the client's skin with soap and water and apply an antiseptic that is appropriate for the area where the tattoo is to be applied. If shaving is necessary, use a new, single-use disposable razor.
(6) Acetate or other reusable stencils shall not be used. Place the design on the skin by one (1) of the following methods:
(a) Free-hand drawing using a new disposable marker; or
(b) Apply a single-use hectographic or tissue stencil using an approved product dispensed from a container in a manner that does not contaminate the unused portion.
(7) Remove gloves, wash hands, and use new clean examination gloves.
(8) Open sterile needles in front of the client and place them into the tattoo machine without touching the end of the needles.
(9) Apply the tattoo.
(10) Apply a thin layer of suitable cream and if appropriate, cover the area with a suitable nonstick dressing. Plastic film intended for household use shall not be used.
(11) When the tattooing is complete, the tattoo artist shall answer any questions and provide the client with instructions regarding the tattoo and aftercare.
(12) Immediately after the client leaves the workstation, the tattoo artist shall break down the workstation, properly dispose of any sharps, soak any reusable instruments for later cleaning, and clean and disinfect any surface that may have become contaminated.
Section 12. Standard Operating Procedures for a Mobile Studio.
(1) An application for mobile studio certificate shall be:
(a) On DFS-200, Application for Permit or License;
(b) Submitted to the local health department in the district or county where the mobile studio owner resides; and
(c) Accompanied by a fee of:
-
$400 for the studio with one (1) to four (4) workstations; and
-
An additional fifty (50) dollars for each additional workstation over four (4).
(2) The mobile studio certificate shall be:
(a) Valid for statewide operation;
(b) Prominently displayed to the public in the mobile studio; and
(c) Nontransferable from one (1) person to another.
(3) The mobile studio certificate shall expire December 31 each year.
(4) A late renewal fee of $100 shall be assessed on each mobile studio registration renewal application not received by January 31 each year.
(5) If not currently registered in accordance with Section 2(6) of this administrative regulation, the tattoo artist shall be registered with the local health department in each district or county where the mobile studio is operated, and pay the appropriate fees.
(6) The mobile studio shall be used exclusively for performing tattooing. Habitation, cooking, and animals, except service animals, shall not be allowed in the mobile studio.
(7) The mobile studio shall:
(a) Meet the sterilization, operating, and clientele requirements, and tattoo performance procedures as a stationary studio; and
(b) Be inspected by the local health department prior to operation.
(8) Any on-board restroom shall be supplied with:
(a) Hot running water and cold running water;
(b) Toilet paper;
(c) Liquid soap;
(d) Single-use paper towels from a sanitary dispenser;
(e) A covered waste receptacle; and
(f) A self-closing door.
(9) If the vehicle lacks an on-board restroom, the owner shall not operate the studio unless it is within 200 feet of a public restroom with hand-washing facilities.
(10) All plumbing shall comply with the requirements of 815 KAR Chapter 20.
(11)
(a) Each mobile studio shall have a potable water system under pressure.
(b) The system shall be of sufficient capability to furnish enough hot and cold water for hand washing, instrument cleaning, and sanitization pursuant to the requirements of this administrative regulation.
(c) The water inlet shall be:
-
Located in a position that it will not be contaminated by waste discharge, road dust, oil, or grease; and
-
Provided with a transition connection of a size or type that will prevent its use for any other service.
(d) All water distribution pipes or tubing shall be constructed and installed in accordance with 815 KAR Chapter 20.
(e) Hoses, if used, shall bear the National Sanitation Foundation potable water (NSF-pw) mark and be fitted with a backflow prevention device.
(12)
(a) Each mobile studio shall have a permanently installed retention tank that is at least fifty (50) percent larger than the potable water supply tank.
(b) Wastewater shall be discharged into a public sewage system.
(c) Liquid wastewater shall not be discharged from the retention tank if the mobile studio is in motion.
(d) All connections on the vehicle for servicing the mobile studio waste disposal shall be of a different size or type than those used for supplying potable water to the mobile studio.
(e) The wastewater connection shall be located below the water connection to preclude contamination of the potable water system.
Section 13. Standard Operating Procedures for a Temporary Permit.
(1) The event organizer or studio owner for the event shall submit to the local health department in the district or county where the temporary studio is to be located:
(a) A DFS-200, Application for Permit or License, accompanied by a $100 permit fee for each workstation;
(b) A layout of the event floor showing where the tattoo artists will be tattooing;
(c) A list of all tattoo artists participating in the event that includes:
-
Name of tattoo artist;
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Artist date of birth;
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Home address;
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Phone number;
-
Email address;
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Proof of artist completion of bloodborne pathogen training;
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Studio name;
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Studio address;
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Studio owner name; and
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Description of procedures to be performed at the event; and
(d) A copy of the client consent form to be used during the event.
(2) The event organizer or studio owner for the event shall:
(a) Be responsible for ensuring that the event is run in a manner that is safe for the tattoo artists and the general public;
(b) Provide a separate cleaning and sterilization room as a backup, unless only presterilized disposables are used for the event;
(c) Provide an approved autoclave that has certification of a negative spore test within thirty (30) days prior to the event;
(d) Arrange for pick-up and disposal of regulated waste in accordance with Section 9 of this administrative regulation; and
(e) Ensure the cleaning and sterilization room, if used, is disinfected at the close of the event.
(3) Prior to the event, the tattoo artist participating in the event shall:
(a) Be registered in accordance with Section 2 of this administrative regulation with the local health department in the district or county where the temporary studio is operated;
(b) Submit the $100 registration fee required by Section 2(6)(b) of this administrative regulation; and
(c)
-
Ensure an adequate supply of presterilized instruments and supplies are available to last the length of the event; or
-
Provide certification of an autoclave negative spore test completed within thirty (30) days prior to the event if tattooing with reusable instruments.
(4) The temporary workstation shall meet the following minimum conditions:
(a) Be at least 5 ft. x 10 ft., and be constructed in a manner to separate the tattoo artist from the public in such a way as to protect the procedure area from contamination, and to prevent accidental exposure of the public to potentially-infectious materials created during tattooing;
(b) Have a floor and sides that are:
-
Smooth, nonporous, and easy to clean; or
-
Covered in plastic if the floor and sides are not smooth, nonporous, and easy to clean;
(c) Have at least 100 foot-candles of light available at the procedure level; and
(d) Be equipped with a hand-wash facility that shall be:
a. A portable hand-washing station; or
b. A minimum of a one (1) gallon container with a lever-type spigot, filled with warm potable water that:
(i) Is placed at least thirty (30) inches off the floor to allow for easy use;
(ii) Is supplied with a bucket to catch the wastewater; and
(iii) Has a minimum reserve of five (5) gallons warm potable water available; and
- Supplied with:
a. Liquid soap; and
b. Single-use paper towels from a sanitary dispenser.
(5) Wastewater shall be disposed of into a public sewerage system, if available. If a public sewerage system is not available, disposal shall be made into a private system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5 and 902 KAR Chapter 10.
Section 14. Inspection of Studios.
(1) At least twice per year, the cabinet or the local or district health department shall inspect each studio and shall make as many additional inspections and re-inspections as are necessary for the enforcement of this administrative regulation.
(2)
(a) The cabinet or the local or district health department inspector shall record the inspection findings on an inspection report form DFS-342.
(b) The inspection report form shall:
-
Summarize the requirements of this administrative regulation; and
-
Set forth a weighted point value for each requirement.
(3) The rating score of the studio shall be the total of the weighted point value for all violations, subtracted from 100.
(4) The inspector shall provide the original inspection report to the certificate holder or the holder's designee. The findings shall:
(a) Set forth the specific violations, if found; and
(b) Establish a period of time for the correction of the violations specified, pursuant to the provisions established in this paragraph.
-
If the rating score of the studio is eighty-five (85) or more, all violations of one (1) and two (2) point weighted items shall be corrected before the next routine inspection.
-
If the rating score of the studio is at least seventy (70) but not more than eighty-four (84), all violations of one (1) and two (2) point weighted items shall be corrected within a period not to exceed thirty (30) days.
-
Regardless of the rating score of the studio, all violations of three (3) or four (4) point weighted items shall be corrected within ten (10) days.
-
If the rating score of the studio is less than seventy (70), the studio shall be issued a notice of intent to suspend the studio certification. The certification shall be suspended within ten (10) days after receipt of the notice unless a written request to an administrative conference is filed with the local or district health department within the ten (10) day period.
(5) Notices provided for under this administrative regulation shall be properly served if:
(a) The original of the inspection report form or other notice has been delivered personally to the certificate holder or person in charge; or
(b) The notice has been sent by registered or certified mail, return receipt requested, to the last known address of the certificate holder.
(6) Failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in suspension or revocation of the certificate or the individual's registration.
(7) Temporary and mobile studios shall correct any violative conditions within twenty-four (24) hours.
Section 15. Suspension of Studio Certificates or Individual's Registration.
(1) The studio certificate or the individual's registration shall be suspended immediately upon notice to the certificate holder or registered individual if:
(a) The cabinet or the local or district health department has reason to believe that an imminent public health hazard exists;
(b) The studio certificate holder or registered individual has interfered with the cabinet or the local or district health department in the performance of its duties; or
(c) An inspection of a studio reveals a rating score of less than sixty (60).
(2) The studio certificate holder or individual registration holder whose certificate or registration has been suspended may request an administrative conference in accordance with 902 KAR 1:400.
(3) The cabinet or the local or district health department shall notify, in writing, the studio certificate holder or registered individual who fails to comply with a written notice issued under the provisions of this section, that the studio certificate or individual's registration shall be suspended at the end of ten (10) days following service of this notice unless a request for an administrative conference is requested.
Section 16. Revocation of a Studio Certificate or an Individual's Registration.
(1) For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with agents of the cabinet or the local or district health department in the performance of its duties, a studio certificate or an individual's registration may be permanently revoked.
(2) Prior to this action, the cabinet or the local or district health department shall notify the studio certificate holder or registered artist, in writing:
(a) Stating the reasons the studio certificate or individual registration is subject to revocation; and
(b) Advising that the studio certificate or individual registration shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative conference is filed with the cabinet by the certificate or registration holder within the ten (10) day period.
(3) A studio certificate or individual registration may be suspended for cause pending its revocation or an administrative conference relative to the revocation.
Section 17. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) DFS-200, "Application for Permit or License", 07/19;
(b) DFS-303, "Application for Certification or Registration", Rev. 9/23; and
(c) DFS-342, "Tattoo and Body Piercing Studio Inspection Report", Rev. 2/19.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Division of Public Health Protection and Safety, Public Safety Branch, 275 East Main Street, Frankfort, Kentucky, Monday through Friday, 8 a.m. to 4:30 p.m. and available online at https://chfs.ky.gov/agencies/dph/dafm/Pages/lhddocuments.aspx.
History
- RELATES TO: KRS 387.010, 28 C.F.R. 36.104, 29 C.F.R. 1910.1030
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.760
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.760(2) requires nonmedical persons who engage in or carry on any business of tattooing to register with a local health department. KRS 211.760(3) requires the cabinet to promulgate administrative regulations relating to places of business that provide tattooing, tattooing equipment, the control of disease, parental consent and age restrictions for tattooing, and other matters necessary to protect public health. This administrative regulation establishes the standards for tattooing.
- History: 30 Ky.R. 1712; 1931; eff. 2-16-2004; 45 Ky.R. 3294; 46 Ky.R. 492; 921; 1138; eff. 9-9-2019; TAm eff. 11-23-2022; 50 Ky.R. 955, 1533; eff.1-18-2024.
902 KAR 45:070 Body piercing and ear piercing {#sec-902-kar-45-070 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:070}
Section 1. Definitions.
(1) "Antiseptic" means a substance applied to the skin that reduces the number of microorganisms.
(2) "Autoclave" means a device intended to sterilize products by means of pressurized steam.
(3) "Blood" is defined by 29 C.F.R. 1910.1030.
(4) "Bloodborne pathogen training" means training that meets the requirements established in 29 C.F.R. 1910.1030.
(5) "Body piercer" means a person registered by the local health department to engage in body piercing or ear piercing.
(6) "Body piercing" is defined by KRS 211.760(1)(a).
(7) "Contaminated" is defined by 29 C.F.R. 1910.1030.
(8) "Contaminated sharps" is defined by 29 C.F.R. 1910.1030.
(9) "Disinfectant" means a product that is tuberculocidal and registered with the federal Environmental Protection Agency as indicated on the label for use in disinfection.
(10) "Ear piercing instrument" or "piercing instrument" means a hand-pressured instrument, which does not make contact with the client, utilizing encapsulated presterilized earrings used exclusively for piercing the lobe of the ear.
(11) "Handwashing" means the act of cleaning the hands for the purpose of removing dirt, soil, or microorganisms through the use of soap, warm water, and friction.
(12) "Instrument" means any body-piercing implement that comes into contact with blood or skin to be pierced, such as needles, needle tubes, forceps, hemostats, tweezers, or other implements used to puncture or pierce the human body.
(13) "Jewelry" means any personal ornament or decoration inserted into a newly-pierced area.
(14) "Limited ear piercing" means piercing only the lobe of the ear with an ear piercing instrument.
(15) "Minor" is defined by KRS 387.010(1).
(16) "Mobile studio" means a body-piercing studio that is designed to be readily movable.
(17) "Purchased presterilized" means jewelry or instruments that are sold individually packaged, processed, and marked with a sterilization lot number, and expiration date to render them free of all microorganisms.
(18) "Registration" means the issuance of a document by the local health department to a body piercer or ear piercer authorizing the person named in the document to engage in the business of body piercing or ear piercing.
(19) "Regulated waste" is defined by 29 C.F.R. 1910.1030.
(20) "Service animal" is defined by 28 C.F.R. 36.104.
(21) "Sterilization" means a validated process used to render a product free from viable microorganisms.
(22) "Studio" means a facility as defined by KRS 211.760(1)(b).
(23) "Studio certificate" means the issuance of a document by the local health department to a studio owner certifying that the studio, after inspection, was in compliance with the applicable provisions of this administrative regulation.
(24) "Studio owner" means:
(a) An owner of a facility where body piercing or ear piercing is conducted;
(b) A sole proprietor who performs body piercing or ear piercing; or
(c) A person who employs body piercers or ear piercers.
(25) "Temporary permit" means a permit to operate at a fixed location for no more than seven (7) calendar days that:
(a) Is nontransferable; and
(b) Cannot be renewed for ninety (90) days after the expiration.
(26) "Ultrasonic cleaner" means a device that transmits high-energy, high-frequency sound waves into a fluid-filled container, used to remove deposits from instruments and appliances.
Section 2. Registration.
(1) A person shall not act as or engage in the business of body piercing or ear piercing unless registered with the local health department in the district or county where the person is to body pierce or perform ear piercing.
(2) All body piercing or ear piercing shall be under the authority of a Kentucky certified studio.
(3) A body piercer or ear piercer shall not engage in the act of piercing unless that person has proof of completion of bloodborne pathogen training.
(4) The body piercer or ear piercer shall maintain documentation of completion of bloodborne pathogen training at the studio.
(5) An applicant for registration shall be at least eighteen (18) years of age at the time of application.
(6) An applicant for registration shall submit to the local health department in the district or county where the applicant intends to perform body piercing or ear piercing:
(a) A completed DFS-303, Application for Certification or Registration, incorporated by reference in 902 KAR 45:065;
(b) Payment of $100 registration fee; and
(c) Proof of completion of approved bloodborne pathogen training as required by subsection (3) of this section.
(7) The body piercer or ear piercer registration shall be:
(a) Mailed to the owner of the Kentucky certified studio listed on the application for registration;
(b) Prominently displayed to the public in the workstation; and
(c) Nontransferable from:
-
One (1) person to another; or
-
One (1) district or county to another.
(8) A registration shall be valid for one (1) calendar year and expire on December 31st of each year.
(9) A late renewal fee of fifty (50) dollars shall be assessed on each body piercer or ear piercer certification renewal application not received by January 31st each year.
Section 3. Studio Certification.
(1) A person shall not engage in the business of body piercing or ear piercing unless the owner of the facility holds a studio certificate issued by the local health department in the district or county where the person is to body pierce or perform ear piercing.
(2) A holder of a studio certificate issued under this administrative regulation shall not allow a person to engage in body piercing or ear piercing unless the individual is registered in accordance with Section 2 of this administrative regulation.
(3) An application for a studio certificate shall be:
(a) On DFS-200, Application for Permit or License, incorporated by reference in 902 KAR 45:065, and available at https://www.chfs.ky.gov/agencies/dph/dafm/gendocs/DFS200.pdf;
(b) Submitted to the local health department in the district or county where the studio is located; and
(c) Accompanied by an annual inspection fee of:
-
$400 for a body piercing studio with one (1) to four (4) work stations;
-
$200 for an ear piercing studio with one (1) to four (4) work stations; and
-
An additional fifty dollars ($50) for each additional work station over four (4).
(4) A studio certificate shall not be issued or renewed unless the studio has been inspected and found to be in compliance with the provisions of this administrative regulation.
(5) A studio certificate shall be:
(a) Prominently displayed to the public in the studio; and
(b) Nontransferable from:
-
One (1) person to another; or
-
One (1) location to another.
(6) The studio certificate shall be valid for one (1) calendar year and expire December 31st each year.
(7) A late renewal fee of one-half (1/2) the annual inspection fee shall be assessed on each studio registration renewal application not received by January 31st each year.
Section 4. Studio Requirements.
(1) A studio shall:
(a) Be kept clean and in good repair;
(b) Be free of insect and rodent infestation;
(c) Store only items necessary to its operation and maintenance;
(d) Provide artificial light of at least twenty (20) foot-candles;
(e) Be well ventilated;
(f) Not permit the presence of an animal in the studio, except for a service animal;
(g) Not use a room otherwise used as living or sleeping quarters;
(h) Use a solid, self-closing door to separate living or sleeping quarters from the business operation;
(i) Have convenient, clean, and sanitary toilet and handwashing facilities for the use of clientele with liquid soap, single-use paper towels from a sanitary dispenser or air dryer, a covered waste receptacle, and a self-closing door;
(j) Be organized to keep clean areas separate from contaminated areas;
(k) Have a utility sink that shall only be used to wash contaminated instruments;
(l) Use, clean, and maintain equipment according to manufacturers' recommendations;
(m) Use an approved disinfectant;
(n) Have plumbing sized, installed, and maintained in accordance with 815 KAR Chapter 20;
(o) Have sufficient potable water supply for the needs of the studio provided from a source constructed, maintained, and operated pursuant to the applicable requirements established in 401 KAR Chapter 8; and
(p) Dispose of sewage by connection to:
-
A public sewer system, if available; or
-
A private sewer system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5 and 902 KAR Chapter 10.
(2) A workstation shall:
(a) Have nonporous, smooth, easy-to-clean floors and walls;
(b) Have surfaces, including counters, cabinets, chairs, and dispensers, composed of smooth, nonporous material able to withstand repeated cleaning and disinfecting;
(c) Be kept clean, organized, and in good repair;
(d)
-
Have all product containers clearly labeled with common product name in English; and
-
If filling a product container from a larger bulk container, retain the original container on the premises;
(e) Have at least sixty (60) square feet of floor space with permanent walls a minimum of four (4) feet high between workstations;
(f) Have 100 foot-candles of light at the procedure level;
(g) Have unimpeded access to a hand sink;
(h) Have a sink for each body piercer with hot and cold water, delivered by a faucet, operated by wrist, knee, or foot action, or other hands-free method;
- Each sink shall be supplied with:
a. Liquid soap; and
b. Single use paper towels dispensed from a sanitary dispenser; and
- A hand sink shall not be used for any other purpose;
(i) Be designated as a body piercing workstation, and shall not be used for any other purpose;
(j) Have plastic or metal waste receptacles:
-
With or without a lid; and
-
If the waste receptacle has a lid, the lid shall be foot operated; and
(k) Have a container for disposable sharps that:
-
Is rigid, puncture proof, and leak proof on sides and bottom;
-
Is closeable and sealable; and
-
If sealed, is leak resistant and incapable of being opened without great difficulty.
Section 5. Cleaning and Sterilization.
(1) A studio using any reusable instruments, materials, or supplies may have a one (1) room or two (2) room cleaning and sterilization arrangement.
(a) A two (2) room arrangement shall have:
- One (1) room for contaminated items, equipped with:
a. A utility sink with minimum dimensions of 18 in. x 18 in. x 12 in.;
b. A hand sink;
c. A presoak container;
d. An ultrasonic cleaner; and
e. Autoclaving packaging materials; and
- A second room that contains an autoclave for sterilization of instruments, equipment, and body jewelry or decorations.
(b) A one (1) room cleaning and sterilization process shall be arranged to provide two (2) distinct areas.
-
The ultrasonic cleaner shall be as far away as possible from the autoclave to prevent contamination of sterile instruments, equipment, jewelry, or other items.
-
The cleaning area shall be equipped in accordance with paragraph (a)1. of this subsection.
-
Nonporous barriers may be utilized to delineate the two (2) distinct areas.
(2) A body piercer that shares a certified studio with a tattoo artist shall have a dedicated ultrasonic cleaner for cleaning body piercing instruments or equipment.
(3) A studio that uses only presterilized disposable instruments, materials, and supplies shall not be required to have a separate room or area for autoclave, ultrasonic cleaner, and sterilization.
(4) All instruments shall be disposable or be made of surgical implant stainless steel and shall have only rubber gripping that can be removed and sanitized on the handles.
(5) Instruments shall be processed as follows:
(a) Soak contaminated reusable instruments in a covered container of cool water with detergent until ready to be cleaned and sterilized;
(b) Wash hands and forearms;
(c) Use disposable, single-use gloves, such as examination or surgical gloves;
(d) Prepare the ultrasonic cleaner according to manufacturer's instructions;
(e) Take instruments apart and rinse in warm water;
(f) Load the ultrasonic cleaner and process according to manufacturer's recommendations, disposing of the ultrasonic cleaner liquid after each use;
(g) Wash hands and forearms;
(h) Wearing examination gloves, remove instruments from the ultrasonic cleaner, rinse with clean water, and allow to air dry; and
(i) Store cleaned instruments in a labeled, covered, nonporous container until packaged for sterilization.
(6) Sterilization equipment. Equipment used to sterilize instruments shall:
(a) Be sold as sterilizing equipment for medical instruments;
(b) Be used, cleaned, and maintained to manufacturer's instructions; and
(c) Meet the minimum requirements for sterilization.
(7) Reusable instruments.
(a) Reusable instruments that come in contact with skin that is body pierced shall be cleaned and sterilized;
(b) Disinfection shall not be used in place of cleaning and sterilization; and
(c) Liquid sterilants shall not be used for sterilization of reusable instruments.
(8) Instrument sterilization. Instruments that come in contact with the skin shall be sterilized as follows:
(a) Wash hands and forearms;
(b) Use clean disposable, single-use surgical or examination gloves;
(c) Package cleaned instruments individually in:
-
Paper and plastic peel-packs with color change indicator; or
-
Package as setups with color change indicator;
(d) Label with content, date, lot number, and preparer's initials;
(e) Load the autoclave and process according to manufacturer's directions;
(f) Remove the items from autoclave only when completely dry and cool;
(g) Store the items in a nonporous, clean, dry, labeled container, cabinet, or other place that is protected from dust and contamination; and
(h)
-
Sterilized instruments shall be resterilized at intervals of no more than six (6) months from the date of the last sterilization; and
-
New packaging shall be used when instruments are resterilized.
(9) Sterilization equipment monitoring.
(a) Sterilization equipment shall be tested:
-
During the initial installation;
-
After any major repair; and
-
At least monthly by using a commercial biological monitoring system;
(b) Biological indicator test results for each sterilization unit used in the studio shall be kept on site, and made available for inspection at time of inspection; and
(c) Sterilization monitoring shall be noted on the sterilizer log.
(10) Autoclave recordkeeping. An autoclave log system shall be maintained for each sterilizer in the studio. For each sterilization cycle the following information shall be documented:
(a) Date of load;
(b) Lot number;
(c) Preparer's name;
(d) The general contents of the load;
(e) The exposure time and temperature or the sterilizer recording chart or tape; and
(f) The results of the chemical indicator.
Section 6. Studio Owner Responsibilities. The owner of a certified studio shall:
(1) Exclude a body piercer or ear piercer who is:
(a) Infected with a disease in a communicable form that can be transmitted by blood;
(b) A carrier of organisms that cause disease;
(c) Infected with a boil or an infected wound; or
(d) Diagnosed with an acute respiratory infection;
(2) Report any accident involving exposure to body fluids to the local or district health department;
(3) Receive, review, and distribute body piercer or ear piercer registrations for the piercer registered with the certified studio. If the body piercer or ear piercer is no longer registered with the certified studio, the registration shall be returned to the district or local health department where the certified studio is located;
(4) Maintain a record of all persons performing any activity within the studio that is regulated by the cabinet. The record shall include at a minimum the following information:
(a) Full name;
(b) Date of birth;
(c) Home address;
(d) Phone number;
(e) Email address;
(f) Photograph of body piercer or ear piercer; and
(g) Complete description of all body piercing or ear piercing procedures performed by the body piercer or ear piercer;
(5) Maintain a current copy of this administrative regulation at the studio for use by body piercers or ear piercers;
(6) Maintain an adequate supply of sterilized needles, instruments, jewelry, and other decorations for each piercer;
(7) Not resterilize or reuse single-use, disposable components;
(8) Maintain records in accordance with Section 8(3) of this administrative regulation;
(9) Maintain an accurate inventory of all purchased presterilized instruments and jewelry by name with the date purchased and the quantity on hand; and
(10) Maintain invoices for the purchase of all purchased presterilized instruments and jewelry.
Section 7. Piercing of Minors.
(1) A person shall not:
(a) Perform any body piercing or ear piercing procedure on a minor without custodial parent or legal guardian consent; and
(b) In accordance with KRS 508.125, perform any genital piercing on a female who is under eighteen (18) years of age.
(2) A minor shall be at least sixteen (16) years old with custodial parent or legal guardian consent prior to body piercing, with the exception of piercing the lobe of the ear.
(3) Consent shall be provided by a written notarized statement that contains an official seal or assigned identification of notary.
(4) The notarized statement shall contain:
(a) The printed name of the custodial parent or legal guardian;
(b) The government issued photo identification number of the custodial parent or legal guardian;
(c) The address and phone number of the custodial parent or legal guardian;
(d) The printed name of the minor child;
(e) The date of birth of the minor child;
(f) The government issued photo identification number of the minor child, if applicable;
(g) A statement that the custodial parent or legal guardian is fully aware of the body piercing procedure and gives their consent for the procedure to be performed;
(h) The signature of the custodial parent or legal guardian; and
(i) The date of the signature of the custodial parent or legal guardian.
(5) The custodial parent or legal guardian shall complete the attestation requirements of Section 8(3)(g) of this administrative regulation.
Section 8. Client Information and Records.
(1) Before receiving a body piercing or ear piercing, the client shall be provided written information that the piercing poses a risk of infection.
(2) Before the body piercing or ear piercing, the client shall be provided written, verbal, or electronic aftercare instructions that include the following information:
(a) Information on the care of the site of the piercing;
(b) Instructions on possible side effects;
(c) Information on any restrictions;
(d) Information on signs and symptoms of infection; and
(e) Instructions to consult a physician if signs and symptoms of infection such as fever, excessive swelling, excessive redness, or drainage occur.
(3) A record of all clients who have received any body piercings or ear piercings shall be kept by the studio owner. The record shall include the following information:
(a) Studio name and registration number;
(b) The date the procedure was performed;
(c) Client's name, date of birth, address, and phone number;
(d)
-
Copy of client's government issued photo ID, if applicable; or
-
Copy of custodial parent or legal guardian's government issued photo identification;
(e) Name of the body piercer or ear piercer who performed each procedure;
(f) The type, location, and description of the procedure; and
(g) An attestation to the fact that the client:
-
Is not intoxicated or under the influence of drugs or alcohol; and
-
Has not ingested an anticoagulant that thins the blood or interferes with blood clotting within the past twenty-four (24) hours.
(4) Records of each client shall be maintained for two (2) years.(5) Client records, consent and other required records shall be made readily available to inspectors.
Section 9. Disposal of Regulated Wastes. All wastes produced during the process of body piercing or ear piercing shall be separated for disposal into two (2) classifications as follows:
(1) Contaminated sharps shall be disposed of by using a licensed medical waste disposal company; and
(2) Regulated waste shall be bagged, securely tied, and disposed of daily in a trash container that prevents unauthorized access. This material shall be disposed of in a site approved by a general trash hauler.
Section 10. Standard Operating Procedures for Body Piercing.
(1) Sterile jewelry shall be:
(a) Made of implant stainless steel, solid 14K or 18K white or yellow gold, niobium, titanium, or platinum;
(b) Free of scratches, nicks, or irregular surfaces; and
(c) Internally threaded or threadless.
(2) Body piercing shall not be performed on skin that has a rash, pimples, evidence of infection, open lesions, or sunburn, or manifests any evidence of an unhealthy condition without written clearance by a licensed medical provider.
(3) The body piercer shall follow the procedures listed in this section in preparation for body piercing:
(a) The body piercer and the client shall not eat, drink, or use tobacco products, an electronic cigarette, or other vapor producing product in the workstation;
(b) The body piercer shall wash hands and forearms prior to and after every procedure;
(c) The body piercer shall wear new clean disposable examination gloves for every client. If a glove is pierced, torn, or contaminated in any way, or if there is an interruption in the body piercing, both gloves shall be removed immediately, discarded, hands and forearms washed, and new, clean examination gloves used;
(d) The body piercer shall wear clean clothing;
(e) All instruments, needles, jewelry, and items to be used in the procedure shall be placed on plastic film or on a plastic-backed towel;
(f) Only hollow needles shall be used for body piercing;
(g) Only presterilized jewelry shall be installed in a fresh piercing;
(h) All single-use disposable items shall be placed on plastic film or on a plastic backed towel and shall be discarded after each client including:
-
Corks;
-
Rubber bands;
-
Skin prepping materials;
-
Marking devices;
-
Dental bibs;
-
Tray covers;
-
Gauze; and
-
Applicators; and
(i) The sharps container and waste receptacle shall be positioned within easy reach and in a manner to prevent contamination.
Section 11. Performance of Body Piercing. The body piercer shall use the procedure in this section when performing a body piercing:
(1) Disinfect the chair or table, and tray;
(2) Wash hands and forearms;
(3) Use new disposable gloves and arrange all instruments and supplies to be used in the procedure on plastic film or on a clean, disposable plastic-backed towel within easy reach;
(4) Position the client;
(5) Clean the skin, mark the location of the piercing with a new, disposable marking device, and apply an antiseptic to the area to be pierced;
(6) Remove and discard all materials used to prep the client, including gloves;
(7) Wash hands and forearms and use new, clean gloves;
(8) Hold or stabilize the tissue with sterile instruments only. Pierce the skin using a sterile, single-use piercing needle;
(9) Immediately after use, place all needles, snip wires, or any other sharps into a sharps container;
(10) When the body piercing is complete, answer any questions regarding the piercing and provide aftercare instructions to the client; and
(11) Immediately after the client leaves the workstation, place contaminated instruments into a covered container that is labeled "contaminated instruments" and disinfect all surfaces that have come into contact with the client or the client's tissues, including the piercing tray, chair, or table.
Section 12. Standard Operating Procedures for Limited Ear Piercing.
(1) A limited ear piercing studio shall be exempt from Sections 5, 9(1), 10, and 11 of this administrative regulation.
(2) Ear piercing studs and clasps shall not be used under any circumstances anywhere on the body other than the lobe of the ear.
(3) An ear piercer shall:
(a) Be registered in accordance with Section 2 of this administrative regulation;
(b) Not allow any eating, drinking, or use of tobacco products, an electronic cigarette, or other vapor producing product in the area where ear piercing is conducted;
(c) Obtain consent for the procedure in accordance with Section 7 of this administrative regulation;
(d) Obtain client information in accordance with Section 8 of this administrative regulation;
(e) Wash their hands and forearms before and after each piercing is performed;
(f) Wear new, clean disposable gloves for every client. If a glove is pierced, torn, or contaminated in any way, or if there is an interruption in the ear piercing, both gloves shall be removed immediately, discarded, hands and forearms washed, and new, clean examination gloves used;
(g) Wear clean clothing;
(h) Load presterilized, encapsulated cartridges for earrings into the ear piercing instrument without touching the cartridge, stud, or clasp;
(i) Answer any questions prior to performing an ear piercing;
(j) Clean the ear with an antiseptic towelette before the procedure and mark the location of the piercing with a single use disposable marking pen or a surgical marking pen sanitized by design such as an iodine-based or alcohol;
(k) Provide the client with instructions regarding aftercare; and
(l) Immediately after the client leaves the ear piercing area, thoroughly disinfect the piercing instrument with an approved disinfectant.
(4) When not in use, the piercing instrument shall be stored in a cabinet or other place that is protected from dust and contamination.
Section 13. Standard Operating Procedures for a Mobile Studio.
(1) An application for mobile studio certificate shall be:
(a) On DFS-200, Application for Permit or License;
(b) Submitted to the local health department in the district or county where the mobile studio owner resides; and
(c) Accompanied by a fee of:
-
$400 for the studio with one (1) to four (4) workstations; and
-
An additional fifty dollars ($50) for each additional workstation over four (4).
(2) The mobile studio certificate shall be:
(a) Valid for statewide operation;
(b) Prominently displayed to the public in the mobile studio; and
(c) Nontransferable from one (1) person to another.
(3) The mobile studio certificate shall expire December 31 each year.
(4) A late renewal fee of $100 shall be assessed on each mobile studio registration renewal application not received by January 31 each year.
(5) If not currently registered in accordance with Section 2(6) of this administrative regulation, each body piercer and ear piercer shall be registered with the local health department in each district or county in which the studio is operated, and pay the appropriate fees.
(6) The mobile studio shall be used exclusively for performing body or ear piercing. Habitation, cooking, and animals, except service animals, shall not be allowed in the mobile studio.
(7) The mobile studio shall be inspected by the local health department prior to operation.
(8) Any onboard restroom shall be supplied with hot and cold running water and shall be supplied with toilet paper, liquid soap, single-use paper towels from a sanitary dispenser, a covered waste receptacle, and a self-closing door.
(9) If the vehicle lacks an onboard restroom, the owner shall not operate the studio unless it is within 200 feet of a public restroom with handwashing facilities.
(10) All plumbing shall comply with the requirements of 815 KAR Chapter 20.
(11)
(a) Each mobile studio shall have a potable water system under pressure.
(b) The system shall be of sufficient capability to furnish enough hot and cold water for handwashing, instrument cleaning, and sanitization pursuant to the requirements of this administrative regulation.
(c) The water inlet shall be:
-
Located in a position that it will not be contaminated by waste discharge, road dust, oil, or grease; and
-
Provided with a transition connection of a size or type that will prevent its use for any other service.
(d) All water distribution pipes or tubing shall be constructed and installed in accordance with 815 KAR Chapter 20.
(e) Hoses, if used, shall bear the National Sanitation Foundation potable water (NSF-pw) mark and be fitted with a backflow prevention device.
(12)
(a) Each mobile studio shall have a permanently installed retention tank that is at least fifty (50) percent larger than the potable water supply tank.
(b) Wastewater shall be discharged into a public sewage system.
(c) Liquid wastewater shall not be discharged from the retention tank if the mobile studio is in motion.
(d) All connections on the vehicle for servicing the mobile studio waste disposal shall be of a different size or type than those used for supplying potable water to the mobile studio.
(e) The wastewater connection shall be located below the water connection to preclude contamination of the potable water system.
Section 14. Standard Operating Procedures for a Temporary Permit.
(1) At least thirty (30) days prior to the event date, the event organizer or studio owner for the event shall submit to the local health department in the district or county where the temporary studio is to be located:
(a) A DFS-200, Application for Permit or License, incorporated by reference in 902 KAR 45:065, accompanied by a $100 registration fee for each workstation;
(b) A layout of the event floor showing where body piercing and ear piercing will be performed;
(c) A list of all body piercers and ear piercers participating in the event that includes:
-
Name of body piercer or ear piercer;
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Piercer's date of birth;
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Home address;
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Phone number;
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Email address;
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Proof of piercer completion of bloodborne pathogen training;
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Studio name;
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Studio address;
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Studio owner name; and
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Description of body piercing and ear piercing procedures to be performed at the event; and
(d) A copy of the client consent form to be used during the event.
(2) The event organizer or studio owner for the event shall be responsible for ensuring that the event is run in a manner that is safe for the body piercers, ear piercers, and the general public.
(3) Each participant who performs body or ear piercing shall bring enough presterilized instruments and supplies to last for the whole event.
(4) The event coordinator or studio owner shall:
(a) Provide a separate cleaning and sterilization room as a backup, unless only presterilized disposables are used for the event;
(b) Provide an approved autoclave that has certification of a negative spore test within thirty (30) days prior to the event;
(c) Arrange for pickup and disposal of regulated waste in accordance with Section 9 of this administrative regulation; and
(d) Ensure the cleaning and sterilization room, if used, is disinfected at the close of the event.
(5) The temporary workstation shall meet the following minimum conditions:
(a) Be at least 5 ft. x 10 ft., and be constructed in a manner to separate the body and ear piercer from the public in such a way as to protect the procedure area from contamination, and to prevent accidental exposure of the public to potentially-infectious materials created during piercing.
(b) Have a floor and sides that are smooth, nonporous, and easy to clean;
(c) Have at least 100 foot-candles of light available at the level where the piercing is conducted;
(d) Be supplied with an adequate supply of paper or plastic barrier film to protect equipment and any other item that needs to be protected to prevent cross-contamination; and
(e) Be equipped with a hand-wash facility that shall be:
a. A portable handwashing station; or
b. A minimum of a one (1) gallon container with a lever-type spigot, filled with warm potable water that:
(i) Is placed at least thirty (30) inches off the floor to allow for easy use;
(ii) Is supplied with a bucket to catch the wastewater; and
(iii) Has a minimum reserve of five (5) gallons of warm potable water available; and
- Is supplied with:
a. Liquid soap; and
b. Single use paper towels from a sanitary dispenser.
(6) Waste water shall be disposed of into a public sewerage system, if available. If a public sewerage system is not available, disposal shall be made into a private system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5 and 902 KAR Chapter 10.
Section 15. Inspection of Studios.
(1) The cabinet or the local or district health department shall inspect each body piercing studio at least twice per year and each ear piercing studio once per year and shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2)
(a) The cabinet or the local or district health department inspector shall record the inspection findings for body piercing studios on an inspection report form DFS-342, incorporated by reference in 902 KAR 45:065.
(b) The inspection report form shall:
-
Summarize the requirements of this administrative regulation; and
-
Set forth a weighted point value for each requirement.
(3) The rating score of the studio shall be the total of the weighted point value for all violations, subtracted from 100.
(4) The inspector shall provide the original inspection report to the certificate holder or designee. The findings shall:
(a) Set forth the specific violations if found; and
(b) Establish a period of time for the correction of the violations specified, pursuant to the provisions established in this paragraph.
-
If the rating score of the studio is eighty-five (85) or more, all violations of one (1) and two (2) point weighted items shall be corrected before the next routine inspection.
-
If the rating score of the studio is at least seventy (70) and not more than eighty-four (84), all violations of one (1) and two (2) point weighted items shall be corrected within a period not to exceed thirty (30) days.
-
Regardless of the rating score of the studio, all violations of three (3) or four (4) point weighted items shall be corrected within ten (10) days.
-
If the rating score of the studio is less than seventy (70), the studio shall be issued a notice of intent to suspend the studio certification. The certification shall be suspended within ten (10) days after receipt of the notice unless a written request to an administrative conference is filed with the local or district health department within the ten (10) day period.
(5)
(a) The cabinet or local health department inspector shall record the findings for limited ear piercing studios on inspection report form DFS-253.
(b) The inspection report form shall summarize the requirements of this administrative regulation.
(c) The inspector shall provide the original of the inspection report to the certificate holder or designee.
(d) The findings shall set forth the specific violations if found.
(e) All violations shall be corrected within twenty-four (24) hours.
(6) Notices provided for under this administrative regulation shall be properly served if:
(a) The original inspection report form or other notice has been delivered personally to the certificate holder or person in charge; or
(b) The notice has been sent by registered or certified mail, return receipt requested, to the last known address of the certificate holder.
(7) Failure to comply with any notice issued pursuant to the provisions of this administrative regulation may result in suspension or revocation of the studio certificate or the individual's registration.
(8) A temporary or mobile studio shall correct any violative conditions within twenty-four (24) hours.
Section 16. Suspension of Studio Certificates or Individual's Registration.
(1) The studio certificate or the individual's registration shall be suspended immediately upon notice to the holder if:
(a) The cabinet or the local or district health department has reason to believe that an imminent public health hazard exists;
(b) The studio certificate holder or registered individual has interfered with the cabinet or the local or district health department in the performance of its duties; or
(c) An inspection of a studio reveals a rating score of less than sixty (60).
(2) The studio certificate holder or individual registration holder whose certificate or registration has been suspended may request an administrative conference in accordance with 902 KAR 1:400.
(3) The cabinet or the local or district health department shall notify, in writing, the studio certificate holder or registered individual who fails to comply with a written notice issued under the provisions of this section, that the studio certificate or individual's registration shall be suspended at the end of ten (10) days following service of this notice unless a request for an administrative conference is requested.
Section 17. Revocation of a Studio Certificate or an Individual's Registration.
(1) For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with agents of the cabinet or the local or district health department in the performance of its duties, a studio certificate or an individual's registration may be permanently revoked.
(2) Prior to this action, the cabinet or the local or district health department shall notify the studio certificate holder or registered individual, in writing, stating the reasons for which the studio certificate or registration is subject to revocation and advising that the studio certificate or registration shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative conference is filed with the cabinet by the certificate or registration holder within the ten (10) day period.
(3) A studio certificate or individual registration may be suspended for cause pending its revocation or an administrative hearing relative to the revocation.
Section 18. Incorporation by Reference.
(1) DFS-253, "Limited Ear Piercing Studio Inspection Report", Rev. 01/23, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Division of Public Health Protection and Safety, Public Safety Branch, 275 East Main Street, Frankfort, Kentucky, Monday through Friday, 8 a.m. to 4:30 p.m. or at https://www.chfs.ky.gov/agencies/dph/dafm/Pages/lhddocuments.aspx?View=All&Title=Forms%20and%20Documents&Page=1.
History
- RELATES TO: KRS 387.010, 508.125, 28 C.F.R. 36.104, 29 C.F.R. 1910.1030
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.760
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.760(2) requires nonmedical persons who engage in or carry on any business of body piercing to register with a local health department. KRS 211.760(3) requires the cabinet to promulgate administrative regulations relating to places of business that provide body piercing or ear piercing, the equipment used in body piercing and ear piercing, the control of disease, parental consent for body piercing or ear piercing, the age restrictions for body piercing, and other matters necessary to protect public health . This administrative regulation establishes the standards for body piercing and ear piercing.
- History: 30 Ky.R. 529; 1248; eff. 11-19-2003; 31 Ky.R. 447; 1157; eff. 1-4-2005; 45 Ky.R. 3304, 46 Ky.R. 502, 929; 1146; eff. 9-9-2019; 50 Ky.R. 962, 1538; eff. 1-18-2024.
902 KAR 45:075 Tanning facilities {#sec-902-kar-45-075 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:075}
Section 1. Definitions.
(1) "Consent" means to give assent or approval.
(2) "Guardian" is defined by KRS 387.010(3).
(3) "Minor" is defined by KRS 387.010(1).
(4) "Parent" is defined by KRS 387.010(7)
(5) "Protective eyewear" is defined by 21 C.F.R. 1040.20(6).
(6) "Registration" means the issuance of a document by the local health department to a tanning facility authorizing the person named in the document to engage in the business of operating a tanning facility.
(7) "Tanning device" is defined by KRS 217.920(2).
(8) "Tanning facility" is defined by KRS 217.920(3).
Section 2. Tanning Facilities Registration.
(1) A tanning facility shall register with the local health department in accordance with KRS 217.924(3) by submitting a completed application form DFS-303, Application for Certification/Registration, incorporated by reference in 902 KAR 45:065, and a fee of seventy-five (75) dollars to the district or county health department at the time of registration.
(2) Registration shall be valid for one (1) calendar year and shall expire on December 31st of each year.
Section 3. Use by Minors. Minors shall not use a tanning device except in accordance with KRS 217.922.
Section 4. Facility Responsibilities.
(1) A tanning facility shall give each customer a written statement in accordance with KRS 217.924(1) and 21 C.F.R. 1040.20.
(2) Each tanning facility shall maintain written or electronic consent forms and records in accordance with KRS 217.924(2); and
(3) Each tanning facility shall ensure patrons use protective eyewear by:
(a) Providing single use disposable eyewear; or
(b) Requiring patrons to provide their own eyewear.
Section 5. Monitoring.
(1) The cabinet or local health department shall conduct on-site monitoring of a tanning facility upon:
(a) Initial facility registration; or
(b) Receipt of a complaint through the local health department.
(2) Each monitoring visit shall be recorded using the DFS-400, Tanning Facility Registration/Monitoring (Rev. 2/19) form.
Section 6. Suspension of Registration.
(1) If a violation is discovered, the local health department shall serve a registered facility with a written notice by providing the DFS-400, Tanning Facility Registration/Monitoring (Rev. 2/19) form, specifying the nature of the violation and shall allow the facility thirty (30) days for corrective action.
(2) Reinspection shall be conducted no later than thirty (30) days following the issuance of the DFS-400. If the violation is unresolved, the facility shall receive an additional thirty (30) days to correct the violation.
(3) At the end of sixty (60) days, if the violation has not been corrected, the registration of the tanning facility shall be suspended. The notice of suspension shall be provided in accordance with 902 KAR 1:400 Section 1.
(4) A facility whose registration has been suspended may apply to the local health department for a re-inspection.
Section 7. Incorporation by Reference.
(1) "DFS-400, Tanning Facility Registration/Monitor" (Rev. 2/19) is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Division of Public Health Protection and Safety, Food Safety Branch, 275 East Main Street, Frankfort, Kentucky, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.920-928, 387.010, 21 C.F.R. 1040.20
- STATUTORY AUTHORITY: KRS 217.924, 217.926
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.924 requires all indoor tanning facilities to register with the local health department and pay a fee not to exceed administrative costs of the program. KRS 217.926 requires the Cabinet for Health and Family Services to promulgate administrative regulations relating to the registration and monitoring of tanning facilities. This administrative regulation establishes the responsibilities of tanning facilities, the procedures for their registration and monitoring, and the required registration fee structure.
- History: 902 KAR 045:075. 34 Ky.R. 511; Am. 761; eff. 10-17-2007; 45 Ky.R. 3314; eff. 9-9-2019; Crt eff. 5-14-2026.
902 KAR 45:080 Salvage {#sec-902-kar-45-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:080}
Section 1. Citation of Regulation. This administrative regulation may be cited as the "State Food and Cosmetic Salvage Regulation."
Section 2. Definitions. The following definitions shall apply in the interpretation and the enforcement of this administrative regulation:
(1) "Employee" means any person employed by a salvage processing plant or salvage distributor who does, or may in any manner handle or come in contact with the handling, storing, transporting, or selling of distressed, salvageable or salvaged food, cosmetics, or other items listed under subsection (9) of this section.
(2) "Distressed merchandise" means any food, cosmetic, or other item listed under subsection (9) of this section which has had the label lost or which has been subjected to possible damage due to accident, mishandling, fire, flood, adverse weather, or to any other similar cause; or which is suspected of having been rendered unsafe or unsuitable for human or animal consumption or use, or which is misbranded, short filled, over or inadequately processed, or below grade.
(3) "Nonsalvageable merchandise" means "distressed merchandise," as defined in subsection (3) of this section, which cannot be safely or practically reconditioned.
(4) "Perishable food" means that there exists a significant risk of spoilage or deterioration when a food has not been properly stored, or handled.
(5) "Potentially hazardous food" means any food or ingredient, natural or synthetic:
(a) In a form capable of supporting the:
-
Rapid and progressive growth of infectious or toxigenic microorganisms; or
-
Slower growth of Clostridium botulinum.
(b) Of animal origin, either raw or heat treated; and
(c) Of plant origin which:
-
Has been treated; or
-
Is raw seed sprouts.
(d) The following are excluded:
-
Air dried hard boiled eggs with shells intact;
-
Food with water activity (aw) value of 0.85 or less;
-
Food with a hydrogen ion concentration (pH) level of four and six-tenths (4.6) or below;
-
Foods in unopened hermetically sealed containers that have been commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution; and
-
Food for which laboratory evidence demonstrates that rapid and progressive growth of infectious and toxigenic microorganisms or the slower growth of Clostridium botulinum cannot occur.
(6) "Reconditioning" means any appropriate process or procedure by which distressed merchandise can be brought into compliance with all cabinet requirements making it suitable for consumption or use as human or animal feed.
(7) "Salvageable merchandise" means any distressed food, cosmetic, or other item listed under subsection (9) of this section which can be reconditioned, labeled, relabeled, repackaged, recoopered, sorted, cleaned, culled or by any other means be salvaged to the satisfaction of the cabinet.
(8) "Salvaged merchandise" means previously distressed merchandise which has been reconditioned or salvaged pursuant to the provisions of this administrative regulation and is acceptable for such human or animal consumption or use as may be designated by the cabinet.
(9) "Sanitize" means adequate treatment of food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing numbers of other microorganisms. Such treatments shall not adversely affect the product and shall be safe to the consumer.
(10) "Vehicle" means any truck, car, bus, railcar, aircraft, boat, ship, or other means by which distressed, salvageable or salvaged merchandise is transported from one (1) location to another.
(11) "Salvage dealer" means any person who is engaged in selling or distributing salvaged merchandise.
(12) "Salvage processor" means any person who engages in the business of reconditioning salvageable or salvaged merchandise for sale or further distribution.
(13) "Supplier" means any person who transfers distressed merchandise to a salvage processor.
Section 3. Permit Requirements.
(1) No person shall operate a salvage processing plant or act as a salvage dealer or distributor within the Commonwealth of Kentucky, who does not possess a permit issued by the cabinet. Only a person who complies with the requirements of this administrative regulation shall be entitled to receive and retain such a permit which will be of two (2) types:
(a) Salvage processing permit; and
(b) Salvage distributing permit. Permits shall not be transferable from one (1) person to another person or place. A permit shall be posted in every processing plant, and each distributor shall have a copy of a valid permit in each vehicle which he operates. The name and address of the salvage processing plant or distributor and the permit number must be conspicuously displayed on the outside of all vehicles being used for salvage operations. Each permit shall expire on December 31 next following its date of issuance.
(2) Issuance of permits. Any person desiring to operate a salvage processing plant or act as a salvage distributor shall make written application for a permit on Form DFS-200. This form is incorporated by reference and may be viewed or obtained at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday between the hours of 8 a.m. and 4:30 p.m. Upon receipt of such an application, the cabinet shall make an inspection of the salvage processing plant or distributor's operations to determine compliance with the provisions of this administrative regulation. When inspection reveals that the applicable requirements of this administrative regulation have been met, a permit shall be issued to the applicant by the cabinet.
Section 4. Notice to Cabinet of Distressed Merchandise. It shall be the duty of any person owning or having possession of any merchandise listed in Section 2(9) of this administrative regulation which becomes distressed merchandise to notify the cabinet if possible prior to such merchandise being removed from the premises at which it was located at the time it became distressed merchandise. If emergency removal of distressed merchandise is required, notice to the cabinet shall be made as soon thereafter as possible. It shall also be the duty of the owner or manager of the salvage processing plant to notify the cabinet within forty-eight (48) hours or, as soon as possible thereafter, whenever distressed merchandise subject to the provisions of this administrative regulation is obtained.
Section 5. Movement of Distressed Merchandise. Distressed merchandise shall be moved from the site of a fire, flood, sewer back-up, wreck or other cause as expeditiously as possible after compliance with Section 4 of this administrative regulation so as not to become putrid, unwholesome, rodent or insect harborages, or otherwise, a menace to public health. All distressed and salvageable merchandise of a perishable nature shall, prior to reconditioning, be transported only in vehicles provided with adequate refrigeration or freezing capabilities necessary for product maintenance. No interstate movement of known distressed or salvageable merchandise shall be made without the prior approval of the cabinet, the appropriate control agency in the state receiving the merchandise, and the Federal Food and Drug Administration.
Section 6. Handling of Distressed Merchandise.
(1) If distressed articles unrelated to foods, cosmetics, etc. are also salvaged, they shall be handled in rooms separate from those in which foods are reconditioned.
(2) Sufficient precautions shall be taken to prevent cross-contamination (e.g., animal feed to human food) among the various types of merchandise which are salvageable or salvaged.
Section 7. Reconditioning and Labeling of Distressed Merchandise.
(1) All salvageable distressed merchandise shall be reconditioned prior to sale or distribution except for such sale or distribution to a person holding a valid salvage processing permit issued by the cabinet.
(2) All metal cans of food offered for sale or distribution shall be free of any evidence of rust pitting, and essentially free of dents (especially at rim, end double seams and/or side seams). Any metal container for which buffing is required to remove pitted rust and leakers, springers, flippers, and swells shall be deemed unfit for sale or distribution. Containers, including metal and glass containers with press caps, screw caps, pull rings or other types of openings which have been in contact with water, liquid foam, or other deleterious substances, as a result of firefighting efforts, flood, sewer back-up, or similar mishaps, shall be deemed unfit for sale or distribution, i.e., nonsalvageable merchandise as defined in Section 2(4) of this administrative regulation, except that consideration may be given to reconditioning spirits by distillation where feasible.
(3) All metal containers of food, other than those mentioned in subsection (2) of this section, whose integrity has not been compromised and whose integrity would not be compromised by the reconditioning, and which have been partially or totally submerged in water, liquid foam, or other deleterious substance as the result of flood, sewer back-up, or other reasons shall, after thorough cleaning, be subjected to a sanitizing rinse of a concentration of 100 ppm available chlorine for a minimum period of one (1) minute, or shall be sanitized by another method approved by the cabinet, and subsequently be treated to inhibit rust formation. All other types of packages (including cans or tins which are opened by pull tabs) so damaged shall be deemed unsafe for use or sale.
(4) Label removal. Any cans showing surface rust shall, after having their labels removed, be inspected and destroyed if they contain pin holes. If salvageable, they shall then be cleaned by a method approved by the cabinet before relabeling. Any container of food with the label or mandatory information missing, that cannot be identified and relabeled correctly, shall not be sold. When original labels are missing or illegible, relabeling or overlabeling shall be required.
(5) Relabeling. All salvaged merchandise shall be labeled to indicate that the merchandise has been salvaged. All salvaged merchandise in containers is to be provided with labeling meeting the appropriate requirements of KRS 217.035 and 217.037. Where original labels are removed from containers which are to be resold or redistributed, the replacement labels must show as the distributor, the name and address of the salvage processing plant.
Section 8. Records of Distressed Merchandise. A written record or receipt of distressed, salvageable and salvaged merchandise shall be kept by the salvage processing plant and shall be kept open for inspection by the cabinet during business hours. The records shall include the name of the product, the name and address of the manufacturer or distributor, the production code, container sizes, source of the distressed merchandise, the date received, the type of damage, and the salvage process conducted. These records shall be kept on the premises of the salvage processing plant for a period of one (1) year following the completion of transactions involving a lot of merchandise.
Section 9. Protection from Contamination.
(1) All salvageable and salvaged merchandise, while being stored or reconditioned at a salvage processing plant, or during transportation, shall be protected from contamination. All perishable foods as well as those susceptible to microbial contamination shall be stored at such temperatures as will protect against spoilage. All potentially hazardous foods shall be maintained at safe temperatures (forty-five (45) degrees Fahrenheit or below or 140 degrees Fahrenheit or above). Frozen foods shall be maintained at zero degrees Fahrenheit or below. Poisonous and toxic materials shall not be transported with distressed, salvageable or salvaged merchandise or stored in a salvage processing plant; unless effective separation is provided. However, such poisonous and toxic materials as are required to maintain sanitary conditions and for sanitation purposes may be used or stored in salvage processing plants. Such poisonous and toxic materials shall be identified, and shall be used only in such manner and under such conditions as will not contaminate distressed, salvageable or salvaged merchandise, shall not constitute a hazard to employees and, when not in use, shall be stored in cabinets which are used for no other purpose.
(2) Segregation of merchandise. All salvageable merchandise shall be promptly sorted and segregated from nonsalvageable merchandise to prevent further contamination of the merchandise to be reconditioned for sale or distribution.
Section 10. Personnel Health and Disease Control.
(1) No employee while affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, or an acute respiratory infection, shall work in an area of a salvage processing plant or for a salvage distributor in any capacity in which there is a likelihood of such person contaminating salvageable or salvaged merchandise with pathogenic organisms, or transmitting disease to other individuals; and no person known or suspected of being affected with any such disease or condition shall be employed in such an area or capacity. If the manager or person in charge of the establishment has reason to suspect that any employee has contracted any disease in a communicable form or has become a carrier of such disease, he or she shall notify the cabinet immediately.
(2) All employees shall wear clean outer garments, maintain a high degree of personal cleanliness, and conform to good hygienic practices while on duty. Employees shall wash their hands thoroughly in an approved hand-washing facility before starting work, and as often as may be necessary to remove soil and contamination. No employee shall resume work after visiting the toilet room without first washing his or her hands. The consumption of food or beverages and the use of tobacco in any form shall be allowed only in designated areas and not in areas where food is exposed or in areas used for washing equipment and utensils.
Section 11. Salvage Processing Plant Equipment and Utensils.
(1) All equipment and utensils used in a salvage processing plant shall be so designed and of such material and workmanship as to be smooth, easily cleanable and durable, and shall be in good repair; and the surfaces of such equipment and utensils coming in contact with food and other food contact surfaces shall, in addition, be easily accessible for cleaning, nontoxic, corrosion-resistant and nonabsorbent; provided, that, when approved by the cabinet, exceptions may be made to the above materials requirements.
(2) All equipment shall be so installed and maintained as to facilitate the cleaning thereof, and of all adjacent areas. Equipment which was installed prior to March 12, 1975 which does not meet fully the above requirements, may be continued in use if it is in good repair, capable of being maintained in a sanitary condition and surfaces coming in contact with salvageable or salvaged merchandise are nontoxic.
Section 12. Equipment and Utensil Cleaning and Sanitization.
(1) Effective means of cleaning and sanitizing equipment, utensils, and soiled food containers, shall be provided. In new or extensively altered salvaged processing plants a three (3) compartment sink and/or a suitable automatic pressurized spray-type ware washing machine capable of washing and sanitizing with hot water or chemical sanitizers shall be provided and conveniently located within the processing area.
(2) Cleaning frequency. All utensils and food-contact surfaces in a salvage processing plant shall be thoroughly cleaned and sanitized prior to use. All other surfaces of equipment shall be cleaned at such intervals as necessary. After cleaning and until use, all equipment and utensils shall be stored and handled as to be protected from contamination.
Section 13. Salvage Processing Plant Sanitary Facilities and Controls.
(1) Water supply. The water supply shall be adequate, of a safe, sanitary quality and from a source approved by the Natural Resources and Environmental Protection Cabinet. Hot and cold running water under pressure shall be provided in all areas where foods, or cosmetics are processed, or equipment, utensils, or containers are washed.
(2) Sewage. All sewage and other liquid waste shall be disposed of in a public sewerage system or, in the absence thereof, in a manner approved by the Natural Resources and Environmental Protection Cabinet or the cabinet.
(3) Plumbing. All plumbing shall comply with the State Plumbing Code.
(4) Toilet facilities. Each salvage processing plant shall be provided with adequate, conveniently located toilet facilities for its employees. In new establishments or establishments that are extensively altered, toilet facilities shall be provided in accordance with the requirements of the State Plumbing Code. Toilet fixtures shall be of sanitary design and readily cleanable. Toilet facilities, including rooms and fixtures, shall be kept in a clean condition and in good repair. The doors of all toilet rooms shall be self-closing. Toilet tissue shall be provided. Easily cleanable receptacles shall be provided for waste materials and such receptacles in toilet rooms shall be covered.
(5) Lavatories. Each salvage processing plant shall be provided with adequate, conveniently located hand-washing facilities for its employees, including a lavatory or lavatories equipped with hot and cold or tempered running water, hand-cleansing soap or detergent, and approved sanitary towels or other approved hand-drying devices. Such facilities shall be kept clean and in good repair.
(6) Garbage and refuse. All refuse containing foods or cosmetics shall be kept in leak-proof, nonabsorbent containers be kept in leak-proof, nonabsorbent containers which shall be kept covered with tight-fitting lids when filled or stored, or not in continuous use; provided, that such containers need not be covered when stored in a special vermin-proofed room or enclosure, or in a waste refrigerator. All other refuse shall be stored in containers, rooms, or areas in an approved manner. Adequate cleaning facilities shall be provided, and each container, room or area shall be thoroughly cleaned after the emptying or removal of refuse. All refuse shall be disposed of with sufficient frequency and in such a manner as to prevent contamination of salvaged product and surrounding processing areas.
(7) Insect and rodent control. Effective measures shall be taken to protect against the entrance, breeding, and presence of rodents, insects, and other vermin in the salvage processing plant.
Section 14. Salvage Plant Construction and Maintenance.
(1) Floors. The floor surfaces in all rooms and areas in which salvageable or salvaged merchandise is stored or processed and in which utensils are washed, and in walk-in refrigerators, dressing or locker rooms, and toilet rooms, should be constructed as to be easily cleanable. All floors shall be kept clean and in good repair. Floor drains shall be provided in all rooms where floors are subjected to flooding-type cleaning or where normal operations release or discharge water or other liquid waste onto the floor.
(2) Walls and ceilings. The walls and ceilings of all rooms shall be clean and in good repair.
(3) Lighting.
(a) At least thirty (30) foot-candles of light at a distance of thirty (30) inches from the floor shall be provided in all areas in which salvageable or salvaged merchandise is processed or stored, where utensils are washed, and in hand-washing areas. Dressing or locker rooms, toilet rooms, and refuse storage areas should be adequately lighted. During all cleanup activities, adequate light shall be provided in all other areas to facilitate cleaning and good sanitation.
(b) Protective shielding.
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Shielding to protect against broken glass falling onto unpackaged food shall be provided for all artificial lighting fixtures located over or within food-storage, food-preparation, and food-display areas.
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Infrared or other heat lamps shall be protected against breakage by a shield surrounding and extending beyond the bulb, leaving only the face of the bulb exposed.
(4) Ventilation. All rooms and processing areas in the salvage processing plant should be well ventilated. Ventilation hoods and devices when used shall be designed to prevent condensate from dripping into foods or cosmetics, or onto preparation surfaces. Filters, when used, shall be readily removable for cleaning or replacement. Ventilation systems shall comply with applicable state and local fire-prevention requirements and shall, when vented to the outside air, discharge in such manner as not to create a nuisance.
(5) Locker area. Adequate facilities should be provided for the orderly storage of employee's clothing and personal belongings.
(6) Housekeeping. All parts of the salvage processing plant and its premises shall be kept clean and free of litter and refuse. Cleaning operations shall be conducted in such a manner as to prevent contamination of salvageable and salvaged merchandise. None of the operations connected with a salvage processing plant shall be conducted in any room used as an employee lounge or living or sleeping quarters. Soiled coats and aprons should be kept in suitable containers until removed for laundering. No live birds or animals shall be allowed in any area used for the conduct of a salvage processing plant's operations or for the storage of salvageable and salvaged merchandise except that patrol dogs accompanying security or police officers are permitted. Guide dogs accompanying blind persons shall be permitted in sales areas.
(7) Vehicles. Vehicles used to transport distressed, salvageable, or salvaged merchandise should be maintained in a clean condition to protect the product from contamination.
Section 15. Plan Review of Future Construction. When a salvage processing plant is hereafter constructed or extensively remodeled, or when an existing structure is converted for use as a salvage processing plant, properly prepared plans and specifications for such construction, remodeling, or alteration, showing layout, arrangements, and construction materials of work areas and the location, size and type of fixed equipment facilities, and a plumbing riser diagram shall be submitted to the cabinet for approval before such work is begun.
Section 16. Inspections; Notices.
(1) Inspection. At least once every twelve (12) months, the cabinet shall inspect each salvage processing plant and distributor and shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) Inspection records. Whenever the cabinet makes an inspection of a salvage processing plant or distributor, its representative shall record the findings on an inspection report form provided for this purpose, and shall furnish a copy of such inspection report form to the permit holder or his representative in charge.
(3) Issuance of notices. Whenever the cabinet makes an inspection of a salvage processing plant or distributor and determines that any of the requirements of this administrative regulation have been violated, the cabinet shall notify the permit holder or person in charge of such violations by means of an inspection report form or other written notice. In such notification, the cabinet shall:
(a) Set forth the specific violations found.
(b) Establish a specific and reasonable period of time for the correction of the violations found.
(c) State that failure to comply with any notice issued in accordance with the provisions of this administrative regulation may result in suspension of the permit.
(d) State that an opportunity for appeal from any notice of inspection findings will be provided if a written request for a hearing is filed with the cabinet within the period of time established in the notice for correction.
(4) Service of notices. Notices provided for under this section shall be deemed to have been properly served when a copy of the inspection report form or other notice has been delivered personally to the permit holder or person in charge, or such notice has been sent by registered or certified mail, return receipt requested, to the last known address of the permit holder. A copy of such notice shall be filed with the records of the cabinet.
Section 17. Salvage Processing Plants and Distributors Outside Jurisdiction of the Cabinet. Salvaged merchandise from salvage processing plants and distributors located outside the jurisdiction of the Commonwealth of Kentucky may be sold within the state, if such plants and distributors conform to the provisions of this administrative regulation or to substantially equivalent provisions and have a valid permit from the cabinet. To determine the extent of compliance with such provisions, the cabinet may accept reports from responsible authorities in other jurisdictions where such plants and distributors are located.
Section 18. Suspension and Revocation of Permits.
(1) Whenever the cabinet has reason to believe that an imminent public health hazard exists, or whenever the permit holder has interfered with the cabinet in the performance of its duties, the permit may be suspended immediately upon notice to the permit holder without a hearing. In such event, the permit holder may request a hearing.
(2) In all other instances of violation of the provisions of this administrative regulation, the cabinet shall serve upon the holder of the permit a written notice specifying the violations in question and afford the holder a reasonable opportunity to correct same. Whenever a permit holder or operator has failed to comply with any written notice issued under the provisions of this administrative regulation, the permit holder or operator shall be notified in writing that the permit shall be suspended at the end of ten (10) days following service of such notice, unless a written request for a hearing is filed in accordance with 902 KAR 1:400.
(3) Reinstatement of suspended permits. Any person whose permit has been suspended may at any time make application for a reinspection for the purpose of reinstatement of the permit. Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his opinion the conditions causing the suspension of the permit have been corrected, the cabinet shall make a reinspection. If the applicant is complying with the requirements of this administrative regulation, the permit shall be reinstated.
(4) Revocation of permits. For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with the cabinet in the performance of its duties, the permit may be permanently revoked after an opportunity for a hearing has been provided by the cabinet. Prior to such action, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit is subject to revocation and advising that the permit shall be permanently revoked at the end of ten (10) days following service of such notice, unless a request for a hearing is filed in accordance with 902 KAR 1:400. A permit may be suspended for cause pending its revocation or a hearing relative thereto.
(5) Hearings. All administrative hearings shall be conducted in accordance with 902 KAR 1:400.
History
- RELATES TO: KRS 217.005-217.215, 217.992
- STATUTORY AUTHORITY: KRS Chapter 13B, 194.050, 211.090, EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: The Kentucky Food, Drug and Cosmetic Act, KRS 217.005 to 217.215 and 217.992 authorizes the Cabinet for Health Services to regulate the misbranding and adulteration of foods and cosmetics. This administrative regulation establishes uniform requirements relating to the disposition of salvaged foods, cosmetics and related merchandise. Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Department for Public Health and its programs under the Cabinet for Health Services.
- History: 1 Ky.R. 55; eff. 3-12-1975; 13 Ky.R. 2134; eff. 7-2-1987; 18 Ky.R. 869; eff. 10-16-1991; 22 Ky.R. 2459; eff. 8-1-1996; Crt eff. 11-5-2019; Crt eff. 8-12-2026.
902 KAR 45:090 Home-based processors and farmers market home-based microprocessors {#sec-902-kar-45-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:090}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 217.015(3).
(2) "Certified roadside stand" means a physical location listed with the Kentucky Farm Bureau for the direct-to-consumer marketing of limited Kentucky grown and produced food products.
(3) "Easily cleanable" means that surfaces are readily accessible and made of a material and finish and so fabricated that residue can be effectively removed by normal cleaning methods.
(4) "Equipment" means articles used in the preparation and processing of food.
(5) "Farmer" is defined by KRS 217.015(59).
(6) "Farmers market" or "farmers market temporary food service establishment" is defined by KRS 217.015(60).
(7) "Food contact surfaces" means those surfaces with which food can come in contact, and those surfaces that drain onto surfaces that can come in contact with food.
(8) "Permitted kitchen" means a food service establishment or food processing firm that holds a valid permit to process food, pursuant to the Kentucky Food, Drug and Cosmetic Act, KRS 217.005 to 217.215, and issued by the Cabinet for Health and Family Services.
(9) "Potentially hazardous food" means a food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting the rapid and progressive growth of infectious or toxigenic microorganisms, the growth and toxin production of Clostridium botulinum, or in raw shell eggs, the growth of Salmonella Enteritidis. "Potentially hazardous food" includes:
(a) An animal food (a food of animal origin) that is raw or heat-treated;
(b) A food of plant origin that is heat-treated or consists of raw seed sprouts;
(c) Cut melons; and
(d) Garlic-in-oil mixtures that are not modified in a way that makes the product nonpotentially hazardous.
(10) "Primary ingredients" means an agricultural or horticultural product that:
(a) Has been grown, harvested, and processed by the farmer as a predominant ingredient of a food product with the exception of "flour", as defined by KRS 217.015(17), for use in:
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"Bread" as defined by KRS 217.015(2); or
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Other items listed in KRS 217.015(56); and
(b) Does not include oil, vinegar, sugar, and other seasonings or spices used in the production of home processed or microprocessed foods.
(11) "Processing authority" means:
(a) The Food Science Professionals of the University of Kentucky, Department of Agriculture, who review and approve established scheduled processes, for adequate process times and pressures for the size of jar, style of pack, and kind of food being canned, by home-based microprocessors; or
(b) A qualified entity in accordance with 21 C.F.R. 113.83 and 114.83.
(12) "Single-service article" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one (1) time or one (1) person use after which they are intended for discard.
(13) "Single-use article" means utensils and bulk food containers designed and constructed to be used once and discarded such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number ten (10) cans that do not meet the materials, durability, strength, and clean ability specifications for multiuse utensils.
(14) "Utensil" means any food-contact implement used in the storage, preparation, transportation, dispensing, or sale of food.
(15) "Ware-washing" means the cleaning and sanitizing of food-contact surfaces of equipment and utensils such as kitchenware.
Section 2. Limitations on Certain Home-based Processed and Home-based Microprocessed Food Products.
(1) A home-based processor may produce:
(a) Foods listed in KRS 217.015(56);
(b) Dried or freeze dried whole fruits or vegetables;
(c) Candy that shall be:
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Produced without added alcohol; and
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Made with no bare-hand contact;
(d) Maple syrup;
(e) Pecan pies;
(f) Granola that may be made with dried grains;
(g) Trail or snack mix that may be made with dried fruit, nuts, or seeds; and
(h) Popcorn that may be plain or have added seasonings.
(2) A home-based microprocessor shall produce foods as authorized by KRS 217.015(57).
(3) The following foods shall not be processed or offered for sale by a home-based processor or home-based microprocessor:
(a) Crème filled pies;
(b) Custard;
(c) Custard pies;
(d) Pies with meringue topping;
(e) Cheesecake;
(f) Cream, custard, or meringue pastries;
(g) Raw seed sprouts;
(h) Garlic-in-oil products; and
(i) Pureed baby foods.
(4) Vacuum packaging of food in a container other than a mason-type jar shall be prohibited.
(5) A jam or jelly processed in less than ten (10) minutes shall be filled into a sterile empty jar. Sterilization shall be accomplished by submerging the jar in boiling water for:
(a) At least ten (10) minutes at an altitude of less than 1,000 feet above sea level; and
(b) One (1) additional minute for each additional 1,000 feet elevation above sea level.
(6) If a boiling-water canner is utilized in the production of food by a home-based processor, the canner shall be deep enough so that at least one (1) inch of briskly boiling water will be over the tops of jars during processing.
(7) If an electric range is used for heating, the boiling-water canner shall have a flat bottom and shall be no more than four (4) inches wider than the element on which it is heated.
Section 3. Standards for Home-based Processing.
(1) A home-based processor shall maintain basic hygiene, cleanliness, and sanitation while producing home-based processor products and shall comply with the standards established in paragraphs (a) through (f) of this subsection during production, packaging, and handling of products for sale. The home-based processor shall:
(a) Regularly wash hands with soap and water;
(b) Keep kitchen equipment and utensils used for home-based processing clean and maintained in a good state of repair;
(c) Wash, rinse, and sanitize all food contact surfaces, equipment, and utensils used for food preparation before each use;
(d) Keep children under age twelve (12) and pets or other animals out of the kitchen during home-based processing related activities;
(e) Cease performing any domestic activities in the kitchen, such as family meal preparation, dishwashing, or washing and drying laundry; and
(f) Not produce, package, or handle any home-processed products while infected with a contagious disease or illness.
(2) A home-based processor doing business in the state shall be a resident of Kentucky.
(3) A home-based processor may advertise and accept orders and payments in person, electronically, or via the internet or phone.
(4) A home-based processor shall provide all home-based processed foods direct to the consumer through pick-up or delivery, and at flea markets, farmers markets, festivals, county fairs, craft fairs, and non-profit charity events, or a roadside stand.
(5) Home-based processed food products shall:
(a) Be labeled as required by KRS 217.136(3); and
(b) Contain allergen information as specified by 21 U.S.C. 343(w).
(6) A home-based processor shall not be required to have grown a primary ingredient for each of their products produced.
(7) Beginning January 1, 2020, a home-based processor shall register with the Department for Public Health, Food Safety Branch. A home-based processor shall submit:
(a) A DFS-250 Application for Home-based Processor, available from the Kentucky Food Safety Branch or at University of Kentucky Extension Service Office; and
(b) A fifty (50) dollar registration fee.
(8) The home-based processor registration shall be valid for one (1) year. A home-based processor registration shall expire March 31 of each year and is renewable upon submission of a DFS-250 and accompanied by an annual fee of fifty (50) dollars.
(9) Inspection of a home-based processor facility shall be made upon complaint, utilizing the DFS-252, Home-based Processor/Microprocessor Inspection Report.
Section 4. Home-based Microprocessor Certification.
(1) A Kentucky farmer desiring to grow, harvest, process, and market Kentucky grown microprocessed food products and participate in the training program shall submit a DFS-251, Application for Home-based Microprocessor, which is available from the Department for Public Health, Food Safety Branch or at University of Kentucky Extension Service Office.
(2) The application for certification shall be submitted to the cabinet and include the following information and attachments:
(a) Name and address, including:
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The physical address and acreage of the farmland on which the primary food product ingredients are to be grown; and
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The name and address of the property owner if not owned by the farmer;
(b) The name and address of the primary residence occupied by the farmer;
(c) Type of water source. Sufficient potable water for the needs of the facility shall be provided from a source constructed, maintained, and operated pursuant to applicable requirements established in 401 KAR Chapter 8;
(d) Type of sewage disposal. Sewage, including liquid waste, shall be disposed of by a public sewage system, or if a public sewer system is not available, sewage disposal shall be made into a private sewage disposal system designed, constructed, and operated in accordance with the requirements of 902 KAR Chapter 10 and 401 KAR Chapter 5;
(e) A listing of the food products to be processed and marketed by the farmer;
(f) Verification of attendance and successful completion of the Food Processing School including:
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Verification of attendance and successful completion of the Food Processing School provided by the University of Kentucky Extension Office in compliance with KRS 217.015(58)(a) by the farmer for the manufacture of the microprocessed food products; or
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Verification of attendance and successful completion of a food processing school approved pursuant to 21 C.F.R. 114.10; and
(g) Documentation from the processing authority for an established scheduled process for each food item that is to be processed by the home-based microprocessor.
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Any change in the recipe shall constitute a recipe deviation, and a new review and approval shall be required from the processing authority prior to processing.
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Each additional product shall have a separate written established scheduled process and shall be submitted to the processing authority for review prior to processing.
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All established scheduled processes shall be maintained and made available upon request by the cabinet.
(3)
(a) Prior to marketing home-based products, the application for home-based microprocessor, along with the required water source approval, shall be submitted to the cabinet.
(b) The cabinet shall notify the applicant if the application is approved or denied.
(c) If the application is approved, the home-based microprocessor may begin marketing home-based products.
(d) If the application is denied:
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The cabinet shall notify the applicant in writing of the reasons for the denial; and
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The home-based microprocessor may appeal in accordance with Section 9(5) of this administrative regulation.
(4) Product labels for home-based microprocessed foods shall be labeled in accordance with KRS 217.005 to 217.215 and 21 U.S.C. 343(w). Draft copies of all home-based microprocessed food product labels shall be submitted for review by the cabinet prior to labeling and marketing.
(5) The certification requirements established in this subsection shall apply to a home-based microprocessor.
(a) Each home-based microprocessor certification shall be issued only for the premises and person named in the application and shall be nontransferable.
(b) The certification shall be posted in a conspicuous place in the processing establishment and a copy shall be posted at the point of sale.
(c) Home-based microprocessed food products shall only be marketed by the certificate holder that processed the food product.
(6) Each home-based microprocessor certification shall be valid for one (1) year, unless previously suspended or revoked. A home-based microprocessor certification shall expire March 31 of each year and shall be renewable annually upon submittal of an application accompanied by an annual fee of fifty (50) dollars.
(7) Attendance at a food processing school as required by subsection (2)(f) of this section shall be required every three (3) years or upon any change or addition of food products to be processed.
Section 5. Production Standards for Home-based Microprocessors.
(1) At all times, including while being stored, prepared, offered, dispensed, or transported, food ingredients and processed products shall be protected from:
(a) Cross-contamination; and
(b) Potential contamination by:
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Insects;
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Insecticides;
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Rodents;
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Rodenticides;
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Unclean equipment or utensils;
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Unnecessary hand contact;
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Draining;
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Overhead leakage or condensation;
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Dust;
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Coughs;
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Sneezes; or
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Other agents of public health significance.
(2) Pets and other animals shall not be allowed in the kitchen and shall be kept out of food preparation areas during microprocessing related activities.
(3) Children under age twelve (12) shall not be allowed in the kitchen area during microprocessing related activities.
(4) Smoking or use of any form of tobacco shall not be allowed in the kitchen area during microprocessing related activities.
(5) Laundry facilities may be present in the residential kitchen, but shall not be used during microprocessing related activities.
(6) Home-based microprocessors shall restrict the use of the food preparation area during any processing activity. Cooking facilities, in the residential kitchen, shall not be available for personal use during home-based microprocessing activities.
(7) Vehicles used in transporting home-based microprocessed food products shall be maintained in a safe and sanitary manner in accordance with KRS 217.290. Vehicle compartments used to transport animals shall not be used for transporting home-based microprocessed foods.
(8) Products made by a home-based microprocessor shall not be used or offered for consumption in a retail food establishment or through interstate commerce.
(9) Food Supplies.
(a) The primary ingredients used in home-based microprocessed products shall have been grown by the microprocessor.
(b) All other ingredients in the products shall be in sound condition, safe for human consumption, obtained from a state or federal permitted food manufacturer, and stored and protected separate and apart from personal use food ingredients.
(c) Prior to processing, the temperature of potentially hazardous foods shall be forty-one (41) degrees Fahrenheit or below, or 135 degrees Fahrenheit or above, except during necessary times of preparation.
(d) Jar seals for microprocessed foods shall be inspected within twelve (12) to twenty-four (24) hours after cooling. A container inspected and found to not be properly sealed shall be discarded. Reprocessing of an unsealed jar shall be prohibited.
(e) For each microprocessed food item, the headspace above the food in a jar and below its lid shall be in compliance with the established scheduled process for that food.
(f) Hermetically-sealed packages shall be handled so as to maintain product and container integrity.
(g) A product processed by a home-based microprocessor shall be packaged in food grade material.
(10)
(a) Food shall be prepared:
-
With a minimum of bare hand contact;
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On a food-contact surface; and
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With clean utensils that have been sanitized.
(b) Raw fruits and raw vegetables that will be cooked, cut, or combined with other ingredients or that will be otherwise processed into food products by the home-based microprocessor shall first be thoroughly cleaned with potable water.
(11) Equipment and utensils.
(a) Equipment.
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Equipment shall be deemed adequate by the processing authority for the food being processed. Use of boiling water canners shall be prohibited for processing of low-acid canned foods.
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Open-kettle canning and the processing of freshly-filled jars in a conventional oven, microwave oven, or dishwasher shall be prohibited.
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All low-acid food shall be sterilized at temperatures of 240 to 250 degrees Fahrenheit, in pressure canners operated at ten (10) to fifteen (15) PSIG as measured by a dial gauge, or weighted gauge if deemed appropriate by the processing authority. The processing authority shall ensure that each weighted-gauge pressure canner utilized by a microprocessor is operated at the correct pressure for the corresponding altitude.
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A pressure canner shall not have been manufactured prior to year 2000, and the manufacturer shall currently be in business with the ability to provide canner parts and calibration of temperature dial gauges.
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A pressure canner utilized in the microprocessing of foods shall, at minimum;
a. Be of a sixteen (16) quart capacity; and
b. Contain at least seven (7) quart jars during processing.
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Use of pressure saucepans with less than sixteen (16) quart capacities shall be prohibited.
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Each temperature dial gauge shall be annually verified for accuracy by the manufacturer of the canner or other qualified laboratory. Verification records shall be maintained by the home-based microprocessor and shall be made available to the cabinet upon request.
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A timing device shall be available and used to verify appropriate processing time as designated in the established scheduled process.
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Only regular and wide-mouth mason-type, threaded, home-canning jars with self-sealing, two (2) piece canning lids with screw bands shall be used for microprocessed foods. Mayonnaise-type jars, jars with wire bails and glass caps, and one (1) piece zinc porcelain-lined caps shall be prohibited.
(b) Equipment and utensils shall be:
-
Constructed and repaired with safe materials, including finishing materials;
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Corrosion resistant and nonabsorbent;
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Maintained in good repair; and
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Smooth, easily cleanable, and durable under conditions of normal use.
(c) Single-service articles shall be made from clean, sanitary, and safe materials.
(d) Equipment, utensils, and single-service articles shall not impart odors, color, taste, or contaminants to food.
(e) Single-service and single-use articles shall not be reused.
(f) Safe plastic or rubber-like materials that are resistant, under normal conditions of use, to scratching, scoring, decomposition, crazing, chipping, or distortion, and are of sufficient weight and thickness to permit cleaning and sanitizing by normal ware-washing methods shall be permitted for repeated use.
Section 6. Sanitation Requirements for Home-based Microprocessors.
(1) A farmer or processing assistant shall not process food in a home-based microprocessing facility while there is a likelihood of contaminating food or a food-contact surface, or transmitting a disease to another person, if the individual is:
(a) Infected with a communicable disease that can be passed by food;
(b) A carrier of an organism that causes a communicable disease;
(c) Affected with a boil, infected wound, or acute respiratory infection; or
(d) Has a symptom caused by illness, infection, or other source that is associated with an acute gastrointestinal illness such as diarrhea, fever, vomiting, jaundice, or sore throat with fever.
(2)
(a) Each person engaged in a food preparation and ware-washing operation of a home-based microprocessing facility shall wash his or her hands and exposed portions of arms thoroughly, with soap or detergent and warm water:
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Before starting work;
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After smoking;
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After eating;
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After handling nonwashed fruits and vegetables;
-
After using the toilet; and
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As often as is necessary during work to keep hands and forearms clean.
(b) A hand-washing facility with hot and cold potable water shall comply with the requirements of 815 KAR 7:125, and shall be conveniently located.
(c) A supply of hand-cleaning soap or detergent shall be available at each hand-washing facility.
(d) A supply of sanitary towels or a hand-drying device providing heated air shall be conveniently located near each hand-washing facility.
(e) An easily-cleanable waste receptacle shall be conveniently located near the hand-washing facility.
(f) A soap dispenser and disposable towels for use in hand-washing shall be provided at the kitchen sink. This sink shall not be used for hand-washing after toilet use.
(g) Hand-washing facilities, soap, detergent dispensers, hand-drying devices, and all related facilities shall be kept clean and in good repair.
(3) Each worker of a home-based microprocessing facility shall keep his or her fingernails trimmed and clean.
(4) Each worker of a home-based microprocessing facility shall wear clean outer clothing.
(5) Each worker in the food preparation area of a home-based microprocessing facility shall wear a hairnet, hat, scarf, or similar hair covering that effectively restrains head and facial hair.
(6) Each worker of a home-based microprocessing facility shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices during working periods.
(7) Each worker of a home-based microprocessing facility shall consume food or use tobacco only in designated areas. A designated area shall not be located in a food preparation area or in an area where the worker's activity could result in contamination of food, water, equipment, or utensils.
(8) Cleaning and sanitizing of equipment and utensils.
(a) Food utensils and equipment shall be stored in a manner to avoid contamination.
(b) Food-contact surfaces and sinks shall be smooth and easily cleanable.
(c) Food-contact equipment, surfaces, and utensils shall be cleaned and sanitized prior to microprocessing related activities and after each use.
(d) Sinks, basins, or other receptacles used for cleaning of equipment and utensils shall be cleaned and sanitized before use.
(e) Equipment and utensils shall be prerinsed or prescraped and, if necessary, presoaked to remove food particles and soil.
(f) Manual cleaning and sanitizing shall be conducted as established in subparagraphs 1. through 5. of this paragraph.
-
For manual cleaning and sanitizing of cooking equipment, and utensils, three (3) compartments shall be provided and used. A two (2) compartment sink, with an additional portable tub may be used.
-
Each of the following five (5) steps of the ware-washing process shall be completed:
a. Prerinsing or scraping;
b. Washing with hot detergent solution;
c. Rinsing to remove abrasives and cleaning chemicals;
d. Sanitizing, using a method approved by the applicable provisions of 902 KAR 45:005, Section 2, the Kentucky Food Code; and
e. Air-drying and draining.
-
Washing, rinsing, and sanitizing solutions shall be maintained in a clean condition.
-
The washing solution shall be maintained at a minimum temperature of at least ninety-five (95) degrees Fahrenheit.
-
Chemical sanitizer shall not have a concentration higher than the maximum permitted by law. A test kit or other device shall be provided to measure the parts per million concentration of the solution.
(g) Mechanical cleaning and sanitizing shall be conducted as established in this subsection. A domestic or home-style dishwasher may be used if the performance criteria established in this subsection are met.
-
The dishwasher shall effectively remove physical solids from all surfaces of dishes.
-
The dishwasher shall sanitize dishes by the application of sufficient accumulative heat.
-
The operator shall provide and use daily a maximum registering thermometer or a heat thermal label to determine that the dishwasher's internal temperature is at least 150 degrees Fahrenheit after the final rinse and drying cycle.
-
The dishwasher shall be installed and operated according to manufacturer's instructions for the highest level possible while sanitizing the kitchen facility's utensils and tableware. A copy of the manufacturer's instructions shall be available on the premises.
(h) There shall be sufficient area or facilities, such as portable dish tubs and drain boards, for the proper handling of:
-
Soiled utensils prior to washing; and
-
Cleaned utensils after sanitizing.
(i) Manually-cleaned equipment, utensils, and tableware shall be air-dried.
(9) Toilet facilities.
(a) Toilet facilities shall be:
-
Installed pursuant to requirements of 815 KAR 7:125;
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Conveniently located; and
-
Accessible to workers at all times.
(b) A toilet facility, including toilet fixtures and a related vestibule, shall be kept clean and in good repair. A supply of toilet tissue shall be provided at each toilet at all times. Easily cleanable receptacles shall be provided for waste materials.
(10) The floors, walls, ceilings, and attached equipment in food preparation and storage areas and in workers bathrooms of a home-based microprocessor facility shall be fabricated from easily cleanable material, maintained in good repair, and kept clean.
(11) Artificial lighting shall be provided sufficient to facilitate sanitary food handling and cleaning of facilities.
(12) The use and storage of pesticides and rodenticides.
(a) A person shall not apply insecticides or rodenticides except:
-
In accordance with requirements of KRS 217B.500 to 217B.990 and 302 KAR Chapter 29;
-
In accordance with the manufacturer's labeling; and
-
In such a way that food, food-contact surfaces, and the supply of potable water shall not be contaminated.
(b) Open pesticide or rodenticide bait boxes shall not be used.
(c) Pesticides, rodenticides, and other toxic materials shall be stored apart from food, equipment, and utensils. Every container of toxic material shall be clearly labeled for easy identification.
(d) Pesticides and rodenticides shall be stored separated from other toxic and chemical compounds at all times.
(13) Garbage and refuse shall be disposed of often enough and in a manner to prevent the development of objectionable odors and the attraction of pests. If garbage or refuse is burned on the premises, it shall be done by controlled incineration that prevents the escape of particulate matter pursuant to 401 KAR Chapter 63.
Section 7. Microprocessors Utilizing Permitted Kitchens.
(1) A microprocessor may elect to process food products utilizing a kitchen that currently holds a valid permit to operate issued by the cabinet.
(2) A microprocessor utilizing a permitted kitchen shall comply with Sections 2, 4, 5, and 6 of this administrative regulation.
(a) A microprocessor utilizing a permitted kitchen shall provide a copy of a signed, written agreement between the facility owner and the farmer that authorizes the use of the permitted kitchen for microprocessing and the name, address, and permit number of the facility.
(b) Microprocessed food products shall not be made during periods of time while the permitted facility is in operation.
(c) Microprocessed food products shall be stored at the farmer's primary residence and shall be maintained separate and apart from the personal use food supplies.
(d) Microprocessed food products made in a permitted kitchen shall only be sold at farmers markets, certified roadside stands, or from the microprocessor's farm.
Section 8. Inspections, Notices, Records.
(1) Inspections. At least once every four (4) years, the cabinet shall inspect each home-based microprocessor and shall make as many additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) Inspection records. The cabinet representative inspecting a home-based microprocessor shall record the findings on the DFS 252, Home-based Processor/Microprocessor Inspection Report, and shall provide a copy of the inspection report to the certificate holder or his representative in charge.
(3) Issuances of notices. If an inspection reveals a violation of this administrative regulation, the cabinet shall notify the certificate holder or the certificate holder's representative in charge. In the notification, the cabinet shall establish:
(a) The specific violations found; and
(b) A specific and reasonable period of time for the correction of the violations found pursuant to this paragraph. The report of inspection shall state:
-
Failure to comply with a notice from the cabinet or local health department, or with a time limit for correction of a violation, shall result in regulatory action up to and including suspension of the certificate, as provided in KRS 217.126;
-
An opportunity for appeal from an adverse notice or inspection finding shall be provided if a written request is filed with the cabinet within ten (10) days following service of notice, in accordance with 902 KAR 1:400; and
-
Failure to comply with a notice issued in accordance with the provisions of this administrative regulation may result in suspension of the certificate.
(4) Service of notice. A notice provided for under this section shall be properly served if a copy of the DFS-252 inspection report form or other notice has been delivered personally to the certificate holder or person in charge, or the notice has been sent by registered or certified mail, return receipt requested, to the last known address of the certificate holder. A copy of the notice shall be filed with the cabinet.
(5) The cabinet shall maintain a record of all certified home-based microprocessors and shall provide this information to the University of Kentucky Cooperative Extension Service Office and local health departments.
Section 9. Certificate Suspension, Revocation, or Denial.
(1) A home-based microprocessor certificate shall be suspended immediately, upon notice to the certificate holder, if:
(a) The cabinet has reason to believe that an imminent public health hazard exists; or
(b) The certificate holder has interfered with the cabinet in the performance of its duties.
(2) Except as provided in subsection (1) of this section, the cabinet shall allow a certificate holder a reasonable opportunity to correct a violation. The cabinet shall notify, in writing, a certificate holder or operator who fails to comply with a written notice issued under the provisions of this administrative regulation that the certificate shall be suspended at the end of ten (10) days following service of the notice, unless a written request is filed in accordance with 902 KAR 1:400.
(3) Reinstatement of suspended certificate. A person whose certificate has been suspended may make application for a reinspection in accordance with 902 KAR 1:400.
(4) Revocation of certificate. For serious or repeated violations of the requirements of this administrative regulation, or for interference with the cabinet in the performance of its duties, a certificate may be permanently revoked. Before a permanent revocation action is taken, the cabinet shall notify the certificate holder in writing, stating the reasons the certificate is subject to revocation and advising that the certificate shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an appeal is filed in accordance with 902 KAR 1:400. A certificate may be suspended for cause pending revocation.
(5) Denial. Any applicant denied the issuance of a certificate by the cabinet within ten (10) days of service of the notice may appeal the certificate denial in accordance with 902 KAR 1:400.
Section 10. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "DFS-250, Application for Home-based Processor", 03/19;
(b) "DFS-251, Application for Home-based Microprocessor", 05/18; and
(c) "DFS-252, Home-based Processor/Microprocessor Inspection Report", 05/18.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Cabinet for Health and Family Services, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.005-217.215, 217.290, 217.992, 217B.555, 217B.990, 21 C.F.R. 113.83, 114.10, 114.83, 21 U.S.C 343(w)
- STATUTORY AUTHORITY: KRS 194A.050, 217.125(1), 217.137, 217.138
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125, 217.137, and 217.138 authorize the Secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of home-based processors and home-based microprocessors. This administrative regulation establishes a uniform code for the manufacture and marketing of limited-based Kentucky grown home microprocessed food products at farmers markets, certified roadside stands, or from the microprocessor's farm and for the manufacture and marketing of limited home-based processor food products from the home, at a market, roadside stand, community event, or online.
- History: 902 KAR 045:090. 30 Ky.R. 535; Am. 1239; eff. 11-19-2003; 45 Ky.R. 1130, 2136; eff. 2-21-2019; 46 Ky.R. 264; eff. 9-9-2019; Crt eff. 5-14-2026.
902 KAR 45:100 Vending machines; food and beverages {#sec-902-kar-45-100 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:100}
Section 1. Citation of Regulation. This administrative regulation may be cited as the "State Food and Beverage Vending Machine Code."
Section 2. Sale of Adulterated or Misbranded Food Prohibited.
(1) No person shall sell, offer or expose for sale, through vending machines, or have in his possession with intent to sell therefrom, any food which is adulterated or misbranded as set forth in KRS 217.025 and 217.035 of the Kentucky Food, Drug and Cosmetic Act.
(2) Samples of food may be taken and examined by the cabinet as often as may be necessary to determine freedom from adulteration or misbranding.
Section 3. Sanitation Requirements for Vending Machine Operations.
(1) Food supplies. At all times, including while being prepared, stored, loaded, displayed, or transported, food intended for sale through vending machines and condiments or other foods available at vending machine locations shall be wholesome, correctly labeled and processed under sanitary conditions acceptable to the cabinet and shall be protected from contamination by all agents, including dust, insects, rodents, unclean equipment and utensils, unnecessary handling, coughs, sneezes, flooding, draining, and overhead leakage or condensation. All meat and meat products and poultry and poultry products shall have been inspected and passed for wholesomeness by an official governmental agency. All hermetically sealed foods offered for sale shall have been processed in approved food processing establishments. Home prepared food shall not be used or offered for sale through vending machines. Special requirements.
(a) Milk and fluid milk products offered for sale through vending machines shall be pasteurized, shall meet the Grade A quality standards as established by law, and shall be dispensed only in individual original containers.
(b) Milk and fluid milk products and fluid nondairy products (creaming agents) shall not be dispensed in vending machines as additional ingredients in hot liquid beverages or other foods.
(c) Fresh fruits which may be eaten without peeling shall be thoroughly washed in potable water at the packing plant by the processor, or at the commissary before being placed in the vending machines for dispensing. The washed fruit shall be protected from contamination after the washing process.
(d) All food, other than fresh fruit, shall be stored or packaged in clean protective containers, and all food shall be handled and vended in a sanitary manner.
(e) Potentially hazardous food offered for sale through vending machines shall be dispensed to the consumer in the individual, original container or package into which it was placed at the commissary or at the manufacturer's or processor's plant. Potentially hazardous food shall not be dispensed from bulk food machines.
(f) Potentially hazardous food shall be maintained at safe temperatures except as follows:
-
During necessary periods of preparation and packaging; and
-
During the actual time required to load or otherwise service the machine and for a maximum machine ambient temperature recovery period of thirty (30) minutes following completion of loading or servicing operation.
(2) Consumer containers. All food-contact surfaces of containers shall be protected from contamination. If condiments or other foods are provided for service in conjunction with food dispensed by a vending machine, they shall be packaged in individual portions in single-service containers or shall be dispensed from approved sanitary dispensers which are washed, sanitized and filled at the commissary, or be commercially prepared in nonreusable containers. Relish bowls and similar condiment containers shall not be used at unattended locations. Drinking straws, stirrers, toothpicks, spoons, knives, forks, and similar articles which are provided in conjunction with food dispensed by a vending machine shall be individually wrapped or dispensed from bulk containers in a sanitary manner.
(3) Equipment maintenance and operations.
(a) Vending machines dispensing potentially hazardous food shall be provided with adequate refrigerating or heating units, or both, and thermostatic controls which insure the maintenance of applicable temperatures at all times. Such vending machines shall also have controls which prevent the machine from vending potentially hazardous food until serviced by the company, in the event of power failure or other conditions, resulting in noncompliance with temperature requirements in the food storage compartment. Hot food vending machines designed to heat foods through the potentially hazardous range of forty-five (45) degrees Fahrenheit to 140 degrees Fahrenheit, shall also be equipped with automatic controls which prevent the machine from vending such food if heating through this temperature range is not accomplished in 120 minutes or less. Provided, however, equipment which was installed prior to March 12, 1975 that does not meet fully the above requirements, may be continued in use if it is in good repair, capable of being maintained in a sanitary condition, and the food contact surfaces are nontoxic.
(b) Potentially hazardous food that has failed to conform to the time-temperature requirements of this administrative regulation, shall be removed from the vending machine, and be denatured or otherwise rendered unusable for human consumption.
(c) Vending machines dispensing potentially hazardous food shall be provided with one (1) or more thermometers which, to an accuracy of plus or minus three (3) degrees Fahrenheit, indicate the air temperature of the warmest part of the refrigerated food storage compartment, or the coldest part of the heated food storage compartment, whichever is applicable.
(4) Inspection of vending machine commissaries. All commissaries providing food for vending machines covered by this administrative regulation shall comply with the applicable provisions of the current "State Food Service Code."
(5) Machine location.
(a) Vending machines, ovens and other equipment shall be located in a room, area or space which can be maintained in a clean condition and which is protected from overhead leakage or condensation from water, waste, or sewer piping. The immediate area in which the equipment is located shall be well lighted and ventilated. Each vending machine shall be located so that the space around and under the machine can be easily cleaned and maintained, and so that insect and rodent harborage is not created.
(b) The floor area where vending machines are located shall be reasonably smooth, of cleanable construction, and be capable of withstanding repeated washing and scrubbing. This space and the immediate surroundings of each vending machine shall be maintained in a clean condition.
(c) Adequate hand-washing facilities, including hot and cold or tempered running water, soap and individual towels, shall be convenient to the machine location and shall be available for use by employees servicing or loading bulk food machines.
(6) Single-service articles. Single-service articles shall be purchased in sanitary packages which protect the articles from contamination, shall be stored in a clean, dry place until used, and shall be handled in a sanitary manner. Such articles shall be furnished to the customer in the original individual wrapper or from a sanitary single-service dispenser. All single-service articles shall be protected from manual contact, dust, insects, rodents, and other contamination.
(7) Other equipment.
(a) All other equipment at the vending location must be kept clean. Food-contact surfaces, if any, must be cleaned, rinsed and sanitized at a frequency established by the cabinet based upon the type of product being dispensed.
(b) The cavities and door edges of microwave ovens shall be kept free of encrusted grease deposits and other accumulated soils and shall be cleaned daily, or as often as is necessary to achieve the safe, sanitary operation thereof. All doors, seals, hinges, and latch fasteners (screws and related hardware) shall be kept tight and adjusted in accordance with manufacturer's procedures. Microwave ovens shall be in compliance with applicable safety standards of the United States Food and Drug Administration's Center for Devices and Radiological Health.
(c) Food-contact surfaces of all equipment and utensils must be protected from contamination at all times including while being transported from the commissary to the vending location.
(8) Exterior construction and maintenance.
(a) The vending machine shall be of sturdy construction and the exterior shall be designed, fabricated, finished, and maintained to facilitate its being kept clean and to minimize the entrance of insects and rodents. The exterior of the machine shall be kept clean.
(b) Door and panel access openings to the food and container storage spaces of the machine shall be tight fitting, and if necessary, gasketed to prevent the entrance of dust, moisture, insects, and rodents.
(c) All ventilation louvers or openings into vending machines shall be effectively screened. Screening material for openings into food and container storage spaces of the machine shall be not less than sixteen (16) mesh to the inch or equivalent. Screening material for openings into condenser units which are separated from food and container storage spaces shall be not less than eight (8) mesh to the inch or equivalent.
(d) In all vending machines in which the condenser unit is an integral part of the machine, such unit when located below the food and container storage space, shall be separated from such space by a dust proof barrier, and when located above, shall be sealed from such space.
(e) In order to prevent seepage underneath the machine and to promote cleaning, free standing vending machines shall have one (1) or more of these elevation or movability features:
-
Be light enough to be manually moved with ease by one (1) person; or
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Be elevated on legs or extended side walls to afford, with or without kick plates, and unobstructed vertical space of at least six (6) inches under the machine; or
-
Mounted on rollers or casters which permit easy movement; or
-
Be sealed to the floor. Where used, kick plates shall be easily removable or be capable of being rotated. These kick plates shall be designed and installed to make the area under the machine easily accessible for routine cleaning without unlocking the cabinet door.
(f) Counter type machines shall be:
-
Sealed to the counter; or
-
Mounted on four (4) inch legs or the equivalent; or
-
Easily moved for cleaning with service connections in place.
(g) All service connections through an exterior wall of the machine including water, gas, electrical, and refrigeration connections, shall be grommeted, or closed with no opening over 1/32 inch to prevent the entrance of insects and rodents. All service connections to machines vending potentially hazardous food shall be such as to discourage unauthorized or unintentional disconnection.
(9) Interior construction and maintenance.
(a) The nonfood-contact surfaces of the interior of vending machines shall be designed and constructed to permit easy cleaning and to facilitate maintenance operations and shall be kept clean and in good repair. Inaccessible surfaces and areas shall be minimized.
(b) All food-contact surfaces of vending machines shall be smooth, in good repair, and free of breaks, corrosion, open seams, cracks, and chipped places. The design of such surfaces shall preclude routine contact between food and "V" type threaded surfaces except that in equipment where such contact is unavoidable, such as ice makers, such threads shall be minimized. All joints and welds in food-contact surfaces shall be smooth, and all internal angles and corners of such surfaces shall be rounded to facilitate cleaning.
(c) If solder or other sealer is used on food-contact surfaces, it shall be composed of safe materials and be corrosion resistant.
(d) All food-contact surfaces of vending machines, including containers, pipes, valves, and fittings, shall be constructed and repaired with safe materials, including finishing materials; shall be corrosion-resistant, nonabsorbent, easily cleanable and durable under conditions of normal use and shall be cleaned, rinsed, and sanitized at a frequency established by the cabinet based upon the type of product being dispensed.
(e) All food-contact surfaces, unless designed for in-place cleaning, shall be accessible for manual cleaning, rinsing, sanitizing, and inspection:
-
Without being disassembled; or
-
By disassembly without the use of tools; or
-
By easy disassembling with the use of only simple tools such as a screwdriver or an open-end wrench.
(f) All food-contact parts or surfaces not designed for in-place cleaning (paragraph (g) of this subsection) shall be cleaned, rinsed and sanitized in clean portable containers or in utensil washing sinks at the location or at the commissary. Cleaning shall consist of washing in warm water containing a suitable detergent and brushing or wiping, as appropriate. Rinsing shall consist of immersion or wiping with clean clear rinse water. Sanitizing shall be accomplished by:
-
Immersion or rinsing in water of at least 170 degrees Fahrenheit for thirty (30) seconds; or
-
Immersion for one (1) minute in a chemical sanitizing solution containing at least fifty (50) parts per million (p.p.m.) of available chlorine, or twelve and five-tenths (12.5) p.p.m. of available iodine, or 200 p.p.m. of quaternary ammonium sanitizer.
-
When chemicals are used for sanitization, a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used.
(g) In machines designed so that food-contact surfaces are not readily removable, all such surfaces intended for in-place cleaning shall be designed and fabricated that:
-
Cleaning and sanitizing solutions can be circulated throughout a fixed system using an effective cleaning and sanitizing regimen; and
-
Cleaning and sanitizing solutions will contact all food-contact surfaces; and
-
The system is self-draining or capable of being completely evacuated; and
-
The procedures utilized result in thorough cleaning of the equipment.
(h) The openings into all nonpressurized containers used for the storage of vendible food, including water, shall be provided with covers which prevent contamination from reaching the interior of the containers. Such covers shall be designed to provide a flange which overlaps the opening, and shall be sloped to provide drainage from the cover wherever the collection of condensation, moisture, or splash is possible. Concave covers are prohibited. Any port opening through the cover shall be flanged upward at least three-sixteenths (3/16) of an inch, and shall be provided with an overlapping cover flanged downward. Condensation, drip, or dust deflecting aprons shall be provided on all piping, thermometers, equipment, rotary shafts, and other functional parts extending into the food container unless a watertight joint is provided. Such aprons shall be considered as satisfactory covers for those openings which are in continuous use. Gaskets, if used, shall be of safe materials, relatively stable, and relatively nonabsorbent, and shall have a smooth surface. All gasket retaining grooves shall be easily cleanable.
(i) The delivery tube or chute and orifice of all bulk food vending machines shall be protected from normal manual contact, dust, insects, rodents, and other contamination. The design shall divert condensation or moisture from the normal filling position of the container receiving the food. The vending stage of such machines shall be provided with a tight-fitting, self-closing door or cover which is kept closed except when food is being removed. The cup filling area or platform of controlled location vending machines shall not require a door or cover if there is no opening in the cabinet interior at the point other than for dispensing tube(s) or trapped waste tubing.
(j) The food storage compartment and other compartments in refrigerated vending machines which are subject to condensation or cooling water retention shall be self-draining or equipped with a drain outlet which permits complete draining. In vending machines designed to store cartoned beverages, diversion devices, and retention pans or drains for leakage shall be provided. All such drains, devices, and retention pans shall be easily cleanable.
(k) Can and bottle openers which come into contact with the food or the food-contact surfaces of the containers shall be constructed of corrosion-resistant, nonabsorbent, and safe materials and shall be kept clean. Cutting or piercing parts of multiuse openers which come into contact with the food or food-contact surface of containers shall be reasonably protected from manual contact, dust, insects, rodents, and other contamination; and such parts shall be readily removable for cleaning.
(l) Lighting fixtures located in vending machines shall be shielded, coated or otherwise shatter resistant, except that this requirement shall not apply to vending machines which dispense only prepackaged foods.
(10) Water supply.
(a) All water used in vending machines shall be of a safe and sanitary quality and from a source constructed and operated in accordance with applicable standards of the Natural Resources and Environmental Protection Cabinet. Water used as a food ingredient shall be piped to the vending machine under pressure.
(b) All plumbing connections and fittings shall be installed and maintained in accordance with the State Plumbing Code.
(c) If used, water filters or other water conditioning devices shall be of a type which may be disassembled for periodic cleaning or replacement of the active element. Replacement elements shall be handled in a sanitary manner.
(d) To prevent leaching of toxic materials caused by possible interaction of carbonated water, piping and contact surfaces, postmix soft drink vending machines manufactured after January 1, 1975, which are designed with an incoming water supply air gap shall have no copper tubing or other potentially toxic water system tubing between the air gap and the downstream, carbonated water dispensing nozzle.
(e) To prevent leaching of toxic materials caused by possible interaction of carbonated water, piping and contact surfaces, postmix soft drink vending machines which are directly connected to the external water supply system shall be equipped with a double (or two (2) single) spring-loaded check valves or other devices which will provide positive protection against the entrance of carbon dioxide or carbonated water into the water supply system. Backflow preventive devices shall be located to facilitate servicing and maintenance. No copper tubing or other potentially toxic tubing or contact surfaces shall be permitted in or downstream from the check valves or backflow devices. These check valves or devices should be inspected and cleaned or replaced annually.
(f) Where spring-loaded check valves are used to prevent the backflow of carbon dioxide into accessible upstream copper or other potentially toxic piping or tubing, a screen of not less than 100 mesh to the inch shall be installed in the water line immediately upstream from the check valves in a location which permits servicing or replacement.
(g) In all vending machines in which carbon dioxide is used as a propellant, all food-contact surfaces from the check valves or other protective devices, including the valves or devices, shall be of such material as to preclude the production of toxic substances which might result from interaction with carbon dioxide or carbonated water.
(11) Waste disposal.
(a) All trash and other solid or liquid waste shall be removed from the machine location as frequently as may be necessary to prevent nuisance and unsightliness, and shall be disposed of in accordance with applicable administrative regulations of the Natural Resources and Environmental Protection Cabinet.
(b) Self-closing, leak-proof, easily cleanable, insect-proof, and rodent-proof waste receptacles shall be provided in the vicinity of each machine or machines to receive used cups, cartons, wrappers, straws, closures, and other items.
(c) Plastic bags and wet-strength paper bags may be used to line the receptacles. Soiled waste receptacles shall be cleaned at a frequency to prevent insect and rodent attraction.
(d) Waste receptacles shall not be located within the vending machines with the exception of those machines dispensing only packaged food with crown closures; in which case, the closure receptacles may be located within the machine. Waste receptacles shall not be located under counters or otherwise enclosed in a manner that will create a nuisance or prevent space around and under the counter or enclosure from being easily cleaned and maintained. Suitable racks and cases shall be provided for multiuse containers or bottles.
(e) Containers shall be provided within all machines dispensing liquid food in bulk for the collection of drip, spillage, overflow, or other internal wastes. Such machines shall be equipped with an automatic shutoff device at the waste pail or other devices or valves which will place the machine out of operation before the waste pail overflows. Such devices shall prevent water or liquid product from continuously running in the event of the failure of any single control, high level control, or other flow control device in the liquid product or water system.
(f) Containers or surfaces on which such wastes may accumulate shall be readily removable for cleaning, shall be easily cleanable, and shall be corrosion-resistant. If liquid wastes from drip, spillage, or overflow, which originate within the machine are discharged into a sewerage system, the connection to the sewer shall be through an air gap.
(12) Delivery of food, equipment, and supplies to machine locations. Food, food-contact surfaces of containers, equipment and supplies, shall be protected from contamination while in transit to machine location. Potentially hazardous food, while in transit and in storage on location, shall be maintained at safe temperatures.
(13) Personnel - cleanliness.
(a) Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices while engaged in direct handling of foods, or food-contact surfaces of utensils or equipment.
(b) Employees shall thoroughly wash their hands with soap and warm water immediately prior to engaging in any vending machine servicing operation which may bring them into contact with food, or with food-contact surfaces of utensils, containers, or equipment. While engaged in such service operations, employees shall wear clean outer garments, shall not use tobacco in any form and shall keep their fingernails clean and trimmed.
Section 4. Health and Disease Controls. No person while affected with any disease in a communicable form, or while a carrier of such disease, or while afflicted with boils, infected wounds, sores, a cold, diarrhea, gastrointestinal upsets, or a respiratory infection, shall work in any area of a commissary or vending operation in any capacity in which there is a likelihood of such person contaminating food or food-contact surfaces with pathogenic organisms or transmitting disease to other individuals; and no person known or suspected of being affected with any such disease or condition shall be employed in such an area or capacity. If the manager or person in charge of the vending machine or commissary operation has reason to suspect that any employee has contracted any disease in a communicable form or has become a carrier of such disease, he shall notify the cabinet immediately.
Section 5. Procedure when Infection is Suspected. When the cabinet has reasonable cause to suspect the possibility of disease transmission from any employee, the cabinet shall secure a morbidity history of the suspected employee or make such other investigation as may be indicated, and take appropriate action. The cabinet may require any or all of the following:
(1) The immediate exclusion of the employee from all commissaries and vending machine operations.
(2) The immediate closure of the commissaries and operations concerned until, in the opinion of the cabinet, no further danger of disease outbreak exists.
(3) Restriction of the employee's services to some area of work where there would be no danger of transmitting disease.
(4) Adequate medical examination of the employee and of his associates, with such laboratory examinations as may be indicated.
Section 6. Issuance of Permits.
(1) No person shall operate a vending machine company within the Commonwealth of Kentucky who does not possess a valid permit issued to him by the cabinet as provided by KRS 217.809. Only a person who complies with the requirements of this administrative regulation shall be entitled to receive and retain such a permit. Permits shall not be transferable from one company to another company or place. A valid permit shall be conspicuously posted in the headquarters office of every food vending company.
(2) Any person desiring to operate one (1) or more vending machines in the Commonwealth of Kentucky shall make application in writing on Form DFS-208. This form is incorporated by reference and may be viewed or obtained at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday between the hours of 8 a.m. and 4:30 p.m. Such applicant shall provide the following information:
(a) The applicant's full name, post office address, and whether such applicant is an individual, firm or corporation. If any partnership exists, the names of the partners, together with their addresses, shall be included.
(b) The location of the commissary or commissaries and of other establishments where vending machines are repaired or renovated.
(c) The identity and form of the products to be dispensed through vending machines and the number of each such type vending machine in the applicant's possession.
(d) The company shall maintain and make available to the cabinet upon request, a list of the number of all vending machines operated by the company and their specific locations within each county served and of all commissaries or other establishments from which the machines are serviced.
(e) Accompany each application for a permit to operate a vending machine company with the correct fee as provided by KRS 217.811.
(f) The application shall contain the signature of the applicant or applicants.
(3) Upon receipt of such application, the cabinet shall make an inspection of the vending machine company to determine compliance with the provisions of this administrative regulation. A numbered operator's permit shall be issued to the applicant by the cabinet after compliance by the operator with the applicable provisions of this administrative regulation.
(4) The company shall provide on each machine or on a wall placard placed at the location of the machine(s) the company's name, address and telephone number. This identification shall also contain the words "Cabinet for Human Resources Permit ______" or "CHR Permit _______." Such information shall be readily visible after placement on the machine or at the machine location.
(5) Whenever a machine is no longer in service, is sold or transferred to another vending machine company, the company holding the permit for that machine shall remove the identification for such machine.
Section 7. Suspension of Permits.
(1) Whenever the cabinet has reason to believe that an imminent public health hazard exists, or whenever the permit holder has interfered with the cabinet's personnel in the performance of their duties, the permit may be suspended immediately upon notice to the permit holder without a hearing. In such event, the permit holder may request a hearing.
(2) In all other instances of violation of the provisions of this administrative regulation, the cabinet shall serve upon the holder of the permit a written notice specifying the violation(s) in question and afford the holder a reasonable opportunity to correct same. Whenever a permit holder has failed to comply with any written notice issued under the provisions of this administrative regulation, the permit holder or operator shall be notified in writing that the permit shall be suspended at the end of ten (10) days following service of such notice, unless a written request for a hearing is filed in accordance with 902 KAR 1:400.
Section 8. Reinstatement of Suspended Permits. Any company whose permit has been suspended may, at any time, make application for a reinspection for the purpose of reinstatement of the permit. Within ten (10) days following receipt of a written request, including a statement signed by the applicant that in his opinion the conditions causing suspension of the permit have been corrected, the cabinet shall make a reinspection. If the applicant is complying with the requirements of this administrative regulation, the permit shall be reinstated.
Section 9. Revocation of Permits. For serious or repeated violations of any of the requirements of this administrative regulation, or for interference with the cabinet's personnel in the performance of their duties, the permit may be permanently revoked after an opportunity for a hearing has been provided by the cabinet. Prior to such action, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit is subject to revocation and advising the permit shall be permanently revoked at the end of ten (10) days following service of such notice, unless a written request for a hearing is filed in accordance with 902 KAR 1:400. A permit may be suspended for cause pending its revocation or a hearing relative thereto.
Section 10. Hearings. All administrative hearings shall be conducted in accordance with 902 KAR 1:400.
Section 11. Inspection Frequency. The cabinet shall inspect each new vending machine company prior to its operation and as often as deemed necessary thereafter by the cabinet. The cabinet shall inspect commissaries preparing food for vending purposes at least once every six (6) months and shall make as many additional inspections or reinspections as are necessary to obtain compliance with established requirements.
Section 12. Access for Inspection. Representatives of the cabinet, after proper identification shall be permitted to enter at any reasonable time, upon any private or public property within the Commonwealth of Kentucky where vending machines or commissaries are operated, or from which such machines are otherwise serviced, for the purpose of determining compliance with the vending machine law. The company shall make provisions for the cabinet's representatives to have access, either in company with an employee, or otherwise to the interior of all vending machines operated by the company.
Section 13. Inspection Records. Whenever the cabinet makes an inspection of a commissary or a vending machine location, they shall record their findings on inspection report forms provided for this purpose, and shall furnish a copy of such inspection report forms to the permit holder or his representative.
Section 14. Issuance of Notices. Whenever the cabinet makes an inspection of a commissary or a vending machine location and discovers that any requirements of this administrative regulation have been violated, it shall notify the company of such violations by means of an inspection report form or other written notices. In such notification, the cabinet shall:
(1) Set forth the specific violations found;
(2) Establish a specific and reasonable period of time for the correction of the violations found;
(3) State that failure to comply with any notice issued in accordance with the provisions of this administrative regulation may result in suspension of permit;
(4) State that an opportunity for appeal from any notice or inspectional findings will be provided if a written request for a hearing is filed in accordance with 902 KAR 1:400.
Section 15. Service of Notices. Notices provided for under this administrative regulation shall be deemed to have been properly served when a copy of the inspection report form or other notice has been delivered personally to the permit holder or person in charge, or such notice has been sent by registered or certified mail, return receipt requested, to the last known address of the permit holder. A copy of such notice shall be filed with the records of the cabinet.
Section 16. Commissaries Located Outside of the Commonwealth of Kentucky. Food from commissaries located outside the jurisdiction of the Commonwealth of Kentucky may be sold within this state if such commissaries conform to the provisions of the state food service code or to substantially equivalent provisions of such state. To determine the extent of compliance for the issuance of a permit to a company located outside the state, the initial application for a permit and the application yearly thereafter shall be accomplished by a copy of the most recent sanitation inspection report from the responsible health authority having jurisdiction where such a commissary or commissaries are located. Out-of-state companies shall, upon request of the cabinet, submit copies of the most recent sanitation inspection report at other times during the permit year.
Section 17. Plan Review of Future Construction. Whenever a vending machine commissary is hereafter constructed or extensively remodeled, or whenever an existing structure is converted for use as a commissary, properly prepared plans and specifications for such construction, remodeling or alteration, showing layout, arrangements and construction materials of work areas, and the location, size and type of fixed equipment and facilities, and a plumbing riser diagram shall be submitted to and approved by the cabinet before work is begun.
History
- RELATES TO: KRS 217.808-217.812, 217.990(8)
- STATUTORY AUTHORITY: KRS Chapter 13B, 194.050, 211.090, EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health Services is empowered by KRS 217.808 et. seq. to regulate food vending machines. This administrative regulation relates to the sanitation and inspection of food vending machines, food vending commissaries and the issuance and suspension of permits. The purpose of this administrative regulation is to establish uniform requirements for the regulation of food vending machines and food vending commissaries in Kentucky. Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Department for Public Health and its programs under the Cabinet for Health Services.
- History: FV-1; 1 Ky.R. 552; eff. 3-12-1975; 13 Ky.R. 2139; eff. 7-2-1987; 18 Ky.R. 875; eff. 10-16-1991; 22 Ky.R. 2463; eff. 8-1-1996; Crt eff. 11-5-2019; Crt eff. 8-12-2026.
902 KAR 45:110 Permits and fees for retail food establishments, vending machine companies, and restricted food concessions {#sec-902-kar-45-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:110}
Section 1. Fees.
(1) A fee shall be assessed for inspection of a retail food store or food service establishment conducted by the cabinet or local health department to determine compliance with the provisions of KRS 217.025, 217.035, and 217.037 pertaining to:
(a) Adulteration;
(b) Misbranding;
(c) Packaging; or
(d) Labeling of food products.
(2) A fee shall be assessed for inspection of a food service establishment conducted by the cabinet or local health department to determine compliance with the provisions of 902 KAR 45:005.
(3) The fee for the inspection of a retail food store or a food service establishment shall be assessed according to the total square footage of the establishment:
(a) Zero - 1,000 square feet – ninety (90) dollars;
(b) 1,001 - 10,000 square feet - $155;
(c) 10,001 - 20,000 square feet - $215;
(d) 20,001 - 30,000 square feet - $250; or
(e) 30,001 or more square feet - $375.
(4) An application for a permit to operate a mobile retail food store shall be accompanied by an annual fee of sixty (60) dollars.
(5) An application for a permit to operate a vending machine company shall be accompanied by the annual permit fee of $125 plus a fee for the total number of vending machines operated by the applicant:
(a) One (1) – twenty-five (25) machines – sixty (60) dollars;
(b) Twenty-six (26) – fifty (50) machines – ninety (90) dollars;
(c) Fifty-one (51) – 100 machines - $125;
(d) 101 – 150 machines - $155; and
(e) 151 and over machines - $250.
(6) An application for a permit to operate a permanent food service establishment shall be accompanied by an annual fee of $125, plus the following fee if applicable:
(a) Fee for the number of seats:
-
One (1) to twenty-five (25) seats – seventy-five (75) dollars;
-
Twenty-six (26) to fifty (50) seats - $125;
-
Fifty-one (51) to 100 seats - $155;
-
101 to 200 seats - $185; or
-
201 or more seats - $215;
(b) Drive-through window - $155; and
(c) Catering operation - $135.
(7) An application for a permit to operate a statewide mobile food unit shall be accompanied by an annual fee of $200.
(8) An application for a permit to operate a temporary food service establishment shall be accompanied by a fee according to the length of the event:
(a) One (1) to three (3) day event – sixty (60) dollars;
(b) Four (4) to seven (7) day event – ninety (90) dollars; or
(c) Eight (8) to fourteen (14) day event - $125.
(9) An application for a permit to operate a farmer's market temporary food service establishment shall be accompanied by a fee of $100.
(10) An application for a permit to operate a restricted food concession or mobile restricted food concession shall be accompanied by an annual fee of $125.
Section 2. Payment of Fees. Fees shall be made payable to the local health department having jurisdiction by a:
(1) Retail food store;
(2) Mobile retail food store;
(3) Vending machine company;
(4) Statewide mobile food unit;
(5) Temporary food establishment;
(6) Restricted food concession; or
(7) Food service establishment.
History
- RELATES TO: KRS 217.015, 217.025, 217.035, 217.037, 217.085, 217.095, 217.125, 217.155, 217.811
- STATUTORY AUTHORITY: KRS 217.125(1), (4), 217.811
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act. KRS 217.125(4) requires the secretary to provide by administrative regulation a schedule of reasonable fees to be paid by retail food establishments and restricted food concessions for permits to operate and for inspection activities carried out by the cabinet. KRS 217.811 requires the cabinet to provide by administrative regulation a schedule of fees for operating a vending machine company. This administrative regulation establishes the schedule of fees.
- History: 9 Ky.R. 300; Am. 593; eff. 12-1-82; 14 Ky.R. 2082; eff. 8-3-88; 16 Ky.R. 2786; eff. 7-18-90; 17 Ky.R. 526; eff. 9-19-90; 19 Ky.R. 301; 732; eff. 8-28-92; 21 Ky.R. 1794; eff. 2-15-95; 27 Ky.R. 1938; 2480; eff. 3-6-2001; 41 Ky.R. 2414; 42 Ky.R. 320; eff. 9-4-2015.; 47 Ky.R. 212, 1048, 1230; eff. 12-15-2020
902 KAR 45:120 Inspection and permit fees for recreational vehicle communities, youth camps, and private water supplies {#sec-902-kar-45-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:120}
Section 1. Youth camps. An annual fee shall be assessed for an inspection conducted by the cabinet or its representative of a youth camp according to the following schedule:
(1) Day youth camp - seventy-five (75) dollars;
(2) Primitive youth camp - fifty (50) dollars; or
(3) Residential youth camp with:
(a) Twenty (20) beds or fewer – seventy-five (75) dollars;
(b) Twenty-one (21) to fifty (50) beds - $100; or
(c) Fifty-one (51) or more beds - $125.
Section 2. Permit and Inspection Fees for Recreational Vehicle Communities.
(1) An application for an annual permit to operate a recreational vehicle community shall be accompanied by a fee of $150.
(2) The fee for an annual inspection of a recreational vehicle community shall depend on the number of spaces in the community as set forth in the following schedule:
(a) Two (2) to ten (10) spaces - $150;
(b) Eleven (11) to fifty (50) spaces - $225;
(c) Fifty-one (51) to 100 spaces - $300;
(d) 101 to 200 spaces - $375; or
(e) 201 or more spaces - $450.
(3) An application for a permit to construct or alter a recreational vehicle community shall be accompanied by a fee of seventy (70) dollars.
Section 3. Private Water Supply Sampling. The fee for the sampling of a private water supply shall be fifty (50) dollars.
Section 4. Payment of Fees. Fees shall be paid to the local health department having jurisdiction. Fees received by local health departments shall be deposited in the Kentucky State Treasury. Inspection fees shall be submitted with the application for a permit to operate.
Section 5. Exemptions.
(1) A facility operated by the Cabinet for Health and Family Services or the Justice and Public Safety Cabinet shall be exempt from the payment of inspection fees.
(2) If a local health department samples a private water supply as part of an investigation of illness, the sample shall be taken without charging a fee.
History
- RELATES TO: KRS 194A.050, 211.180, 211.345, 219.340, 219.350, 219.991(2)
- STATUTORY AUTHORITY: KRS 194A.050(3), 211.180(2), 211.345, 219.340(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(3) and 211.180(2) authorize the Secretary for the Cabinet for Health and Family Services to establish by administrative regulation a schedule of reasonable fees to be paid by recreational vehicle communities and youth camps to cover the cost of permitting and inspection activities carried out by the cabinet. KRS 211.345 authorizes the cabinet to establish a program for the sampling of private water supplies. This administrative regulation establishes the permit and inspection fees to be charged to recreational vehicle communities, youth camps, and for the sampling of private water supplies.
- History: 9 Ky.R. 300; eff. 12-1-1982; Am. 14 Ky.R. 2083; eff. 8-3-1988; 16 Ky.R. 2787; eff. 7-8-90; 17 Ky.R. 528; eff. 9-19-1990; 19 Ky.R. 302; eff. 8-28-1992; 27 Ky.R. 1940; 2481; eff. 3-6-2001; 34 Ky.R. 424; 762; eff. 10-17-2007; 41 Ky.R. 2672; 42 Ky.R. 780; 1207; eff. 11-6-2015; 45 Ky.R. 3571; eff. 8-19-2019; Crt eff. 4-21-2026.
902 KAR 45:150 School sanitation {#sec-902-kar-45-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:150}
Section 1. Definitions.
(1) "Approved sewage disposal system" means a sewage disposal system approved by the Department for Public Health consistent with 902 KAR 10:085, Section 1(2).
(2) "Approved water supply" means that the source of water:
(a) Is a spring, well, public water system, or other source of water;
(b) Has been sampled and analyzed by the Energy and Environment Cabinet, Department for Environmental Protection, Division of Water;
(c) Has been found to be of a safe and sanitary quality and quantity in accordance with 401 KAR Chapter 8; and
(d) Has been approved by the Energy and Environment Cabinet, Department for Environmental Protection, Division of Water.
(3) "Cabinet" means the Cabinet for Health and Family Services and its designated agents.
(4) "Designated agents" means local health department environmentalists that are duly registered sanitarians environmental health specialists.
(5) "Local Board of Education" means a duly elected or appointed Board, any private agency, or organization that operates, controls, or supervises a school or system of schools.
(6) "Person" means an individual, firm, partnership, company, corporation, trustee, association, or any public or private entity owning or operating a school.
(7) "School" means any area, parcel, or tract of land on which facilities are established, maintained, or operated for educational purposes, including public, parochial, and private facilities enrolling students in any of the grades kindergarten through the 12th grade including vocational education facilities, but excluding day care facilities, and individuals teaching their own children.
(8) "Semipermanent school structure" means any school structure that is constructed off-site and transported to the school site and is intended to serve as temporary classroom or other facility and not made a fixed portion of any existing school structure.
(9) "State Plumbing Code" means 815 KAR Chapter 20.
(10) "Tempered water" means a water temperature of at least ninety (90) degrees Fahrenheit to a maximum temperature of 110○ F.
Section 2. Water Supply.
(1)
(a) The water supply shall be potable and from an approved public water supply, if available.
(b) If an approved public water supply is not available, the supply for the school shall be developed and approved pursuant to applicable requirements of the Energy and Environment Cabinet. If an approved public water supply subsequently becomes available, connections shall be made to it and the school supply shall be discontinued.
(2) The water supply shall be of adequate quantity and under sufficient pressure to permit unrestricted use.
(3)
(a) All drinking fountain installations shall meet the requirements of the State Plumbing Code and shall be maintained in proper working order with adequate pressure and in a clean sanitary condition. Provision shall be made so that small children can drink with ease.
(b) In lieu of water fountains, portable drinking water containers may be used. If portable drinking water containers are used, they shall be of easily cleanable construction, kept securely closed and designed so that water may be withdrawn from the container only by water tap or faucet, and shall be maintained in a sanitary condition.
(c) If paper drinking cups are used, they shall be stored and dispensed in a sanitary manner and discarded after use. Common drinking cups shall not be used.
Section 3. Sewage and Solid Waste Disposal.
(1)
(a) All sewage and liquid waste matter shall be disposed of into a public sewer system, if available.
(b) If a public sewer is not available, disposal shall be made into a private sewage disposal system designed, constructed, and operated pursuant to the requirements of the cabinet or the Energy and Environment Cabinet. If a public sewer system subsequently becomes available, connections shall be made to it and the school's private sewage disposal system shall be discontinued.
(2) All plumbing shall comply with the State Plumbing Code.
(3) All private sewage disposal systems shall be operated in a manner that does not create a nuisance or possible hazard to public health. Nonwater carriage toilets may be utilized if consistent with 902 KAR 10:085, Section 1(2).
(4) All waste paper and solid waste shall be disposed of so as not to create a health or safety hazard and in a manner approved by the Energy Environment Cabinet.
(5)
(a) Containers shall be provided in all classrooms and hallways for storage of solid waste.
(b) All bulk solid waste shall be stored in containers, adequate in number to contain the waste, with tight-fitting lids.
(c) All bulk solid waste storage areas shall be constructed and maintained to prevent the entry and harborage of insects, rodents, and other vermin.
(d) All solid waste containers shall be of easily cleanable construction, kept clean and in good repair.
Section 4. Restroom Facilities.
(1) All schools shall provide restroom facilities pursuant to the requirements of the State Plumbing Code.
(2) All restrooms, locker rooms, and toilet, shower and hand-washing fixtures shall be maintained in a clean, sanitary condition.
(3) All restroom and locker room floors, walls, toilet partitions, ceilings, windows, and fixtures shall be maintained in good repair.
(4) A minimum of twenty (20) foot-candles of light shall be provided in all restrooms and locker rooms as measured at a height of thirty (30) inches above the floor.
(5)
(a) An ample supply of toilet tissue and soap shall be provided.
(b) Disposable paper towels, cloth roll-type dispenser towels, or electric hand-drying devices shall be provided.
(c) Easily cleanable waste receptacles shall be provided in each restroom and locker room and shall be kept clean and in good repair.
(d) Waste receptacles shall be of covered-type design in all restrooms and locker rooms for female teachers and female students in grades seven (7) and above.
(6)
(a) All hand-washing and shower facilities shall be supplied with hot and cold or tempered water under pressure.
(b) Temperature and pressure control devices shall be installed on all shower facilities pursuant to the requirements of the State Plumbing Code.
(7) For a parochial school of thirty-five (35) or less students if the school privies do not have running potable water under pressure:
(a) The pupils shall be provided with potable water from an approved public water supply, if available, or a private water supply approved by the Energy and Environment Cabinet Drinking Water Branch for hand washing purposes that meets the following requirements:
- The water shall be placed in an insulated container that:
a. Is rated to keep the temperature of the water from dropping below ninety (90) to 110○ F for a period of two (2) hours;
b. Holds a minimum of ten (10) gallons of water; and
c. Has a spigot that is capable of allowing water to run continuously without being held or depressed by hand in order to allow both hands to be washed together;
-
The temperature of the water shall be a minimum of ninety (90) degrees Fahrenheit and shall not exceed 110○ F when placed in the container;
-
If the water in the container falls below ninety (90) degrees Fahrenheit, it shall be reheated to ninety (90) degrees Fahrenheit or replaced with water that meets the requirements of subparagraph 2 of this paragraph; and
-
The amount of water in the container shall be inspected at least twice during the school day and replenished as necessary to keep a supply of water constantly available during the entire school day;
(b) A record shall be kept showing that the water has been inspected and replenished as required by paragraph (a)4 of this subsection; and
(c) The wastewater generated from hand washing shall be disposed of in an approved sewage disposal system.
(8)
(a) All windows used for room ventilation in restrooms and locker rooms shall be screened to prevent the entry of insects and other vermin.
(b) Except as provided in paragraph (c), (d), or (e) of this subsection, all restrooms and locker rooms in schools without central heating and air-conditioning or other closed-environment type heating, ventilation, and air-conditioning systems shall have self-closing doors.
(c) Schools with less than ten (10) students shall not be required to have self-closing doors.
(d) In those schools at which closed-environment type HVAC systems are provided, self-closing doors shall not be required if effective odor and insect entry control is demonstrated.
(e) In school restroom and locker room facilities used by small children, any self-closing devices on all doors shall be adjusted to provide closure without presenting a safety hazard to students.
Section 5. Lighting.
(1)
(a) All school classrooms, study rooms, industrial arts shops, gymnasiums, enclosed swimming pools, auditoriums, stairways, and hallways shall be adequately lighted.
(b) All lighting shall be installed so that glare will be eliminated.
(c) Illumination levels as listed below shall be provided as measured at a height of thirty (30) inches above the floor:
(d) In certain areas such as industrial arts work benches, power tool locations, welding, and foundry locations, art work benches, home economics kitchens, and laboratories, additional spot illumination shall be provided if necessary to maintain adequate lighting especially if safety hazards are present.
(2) Windows, shades, and light fixtures shall be kept clean and in good repair at all times the school is in session.
Section 6. Building, Heating and Ventilation.
(1) All walls, ceilings, floors, furniture, drapes, curtains, and blinds shall be kept in good repair.
(2)
(a) All floors shall be kept clean and free of litter.
(b) All walls, ceilings, furniture, drapes, curtains, and blinds shall be kept clean.
(c) All floors shall be cleaned using dustless methods.
(d) Special attention shall be given to maintain floor areas around drinking fountains and toilet and hand-washing facilities free of water spillage.
(3) School buildings shall be maintained free of insect or rodent harborage and infestation. Extermination methods and other measures to control insects and rodents shall be pursuant to applicable state laws and administrative regulations.
(4) School buildings shall maintain a minimum indoor temperature for occupied spaces of sixty-eight (68) degrees Fahrenheit at a point measured thirty (30) inches above the floor. The installation of portable space heaters shall not be used to achieve compliance.
(5) Schools with ten (10) or more students shall provide sufficient storage space for outer clothing, play equipment, school supplies, and student's sack lunches. This space shall be easily accessible, well lighted, easily cleanable, ventilated and be designed, constructed, and maintained to reduce fire hazards.
(6)
(a) Adequate storage space shall be provided for the storage of janitorial supplies and combustible or poisonous materials and shall be kept locked at all times when not under direct supervision by maintenance staff or faculty.
(b) All janitorial or other supplies of a poisonous, caustic, or combustible nature shall be stored in the original container or, if dispensed from bulk containers, only in properly identified containers designed for that use.
(c) All poisonous, caustic, and combustible materials shall be stored in an area from food products.
(d) Soft drink or other food or drink containers shall not be used for storage of toxic materials.
Section 7. Safety.
(1)
(a) All school buildings shall have approved-type fire extinguishers provided of sufficient number and fire rating type as determined by the State Fire Marshal or local fire departments.
(b) All exits shall comply with the requirements of the State Fire Marshal.
(2) Each school building shall have adequate first aid material available and easily accessible and shall be equipped with the following items:
(a) Compresses and bandages to include:
-
A one (1) inch compress-on adhesive;
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Assorted sterile bandage compresses in individual packages;
-
Triangular bandages (2 in. x 2 in.) and (4 in. x 4 in.); and
-
Sterile gauze in individual packages of about one (1) square yard one (1) inch and two (2) inch rolled;
(b) Wire or thin board splints;
(c) Adhesive tape;
(d) Scissors;
(e) Forceps (two (2) inch splinter);
(f) Toothpicks;
(g) Paper cups;
(h) Disposable facial tissues;
(i) Aromatic spirits of ammonia;
(j) Thermometer;
(k) Soap;
(l) Petroleum jelly;
(m) Biohazard waste bags;
(n) Nonlatex gloves;
(o) Cotton balls;
(p) One-way resuscitation mask;
(q) Water source or normal saline;
(r) Ice packs (chemical ice bags);
(s) Resealable plastic bags;
(t) Telephone number of the nearest Poison Control Center;
(u) Safety pins; and
(v) Flashlight with spare batteries.
(3) A current edition of the Red Cross First Aid Manual shall be available in each school building.
(4) The principal, head teacher, or a designated faculty member shall possess current, valid certification in the Red Cross Multimedia or Standard First Aid courses to render trained aid in case of injury.
(5)
(a) All play areas shall be designed, landscaped, and protected to provide a safe place for children to play.
(b) There shall be no obstructions in the area, and the ground shall be well drained and relatively level.
(c) Wells, cisterns, sewage treatment plants, and other open pits shall be fenced, have securely sealed tops, or otherwise be suitably protected to prevent safety hazards to students.
(6)
(a) All playground equipment shall be designed and constructed for heavy usage and shall be maintained in good repair and in safe condition.
(b) Any playground equipment found to be in defective condition which presents a safety hazard shall be immediately dismantled or otherwise rendered inaccessible to students until it is repaired or replaced.
(c) The electrical system, wiring, fixtures, and equipment shall be designed, constructed, installed, and maintained pursuant to 815 KAR 7120 and 10:060.
(d) Spliced electrical extension cords or other nonapproved electrical wiring, fixtures, or equipment shall not be used.
(e) Buildings and equipment shall be maintained to eliminate potential danger from holes, glass, splinters, sharp projections, and other hazardous conditions.
(7) All school buses shall be maintained clean, free of litter and dust, and free of sharp projections or other safety hazards in the entrance and interior seating area.
Section 8. Inspection of Schools.
(1) At least once each six (6) months, the cabinet shall inspect each school and shall make additional inspections and reinspections as are necessary for the enforcement of this administrative regulation.
(2) If a representative of the cabinet makes an inspection of a school, he shall record his findings on Form DFS-301, "School Inspection Report", and provide the principal or head teacher with a copy. The inspection report shall:
(a) Set forth each specific violation if found;
(b) Establish a specific and reasonable period of time for the correction of each violation found;
(c) State that failure to comply with any notice issued shall result in further action being taken; and
(d) Advise the party inspected of its right to request a hearing on Form DFS-212, "Request for Conference", which is incorporated by reference in 902 KAR 1:400, before the cabinet. The request shall be filed within ten (10) days of the completed inspection.
(3) All administrative hearings shall be conducted in accordance with 902 KAR 1:400.
(4) Following inspections of school buildings and premises, the cabinet shall report suspected noncompliance with applicable requirements of other state agencies to those agencies.
Section 9. Plan review of future construction.
(1) A person shall not begin to construct or extensively alter a school, or convert an existing structure for use as a school, until construction plans and specifications meeting the requirements of subsection (2) of this section have been:
(a) Submitted to the cabinet for its review; and
(b) After approval by the cabinet, submitted to the Energy and Environment Cabinet for final approval.
(2) The plans and specifications shall:
(a) Show the layout, arrangements, and construction materials;
(b) Show the location, size, and type of fixed equipment and facilities; and
(c) Include a plumbing riser diagram.
Section 10. Existing Facilities and Equipment. Facilities and equipment being used by existing schools on October 9, 1984, which do not fully meet the design and construction requirements of this administrative regulation, may be continued in use, if the facility or equipment:
(1) Is in good repair;
(2) Is capable being maintained in a sanitary condition; and
(3) Creates no health or safety hazards.
Section 11. Incorporation by Reference.
(1) Form DFS-301, "School Inspection Report", rev. 2/97, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Ky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.180, 212.210, 212.990
- STATUTORY AUTHORITY: KRS 194.050, 211.090,
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.180 and 212.210 requires the Cabinet for Health and Family Services to regulate certain public health matters including the detection, prevention, and control of communicable disease and health hazards relating to sanitation and safety in schools. This administrative regulation establishes uniform standards for schools and includes sanitary standards for operation, inspections, and enforcement procedures necessary to insure a safe and sanitary environment.
- History: 902 KAR 020:150. 11 Ky.R. 526; 700; eff. 10-9-1984; 17 Ky.R. 529; 1409; eff. 10-14-1990; 22 Ky.R. 2469; eff. 8-1-1996; 33 Ky.R. 1728; eff. 3-1-2007; 35 Ky.R. 433; 838; eff. 10-15-2008; Crt eff. 4-5-2019; TAm eff. 3-20-2020; Crt eff. 10-13-2025.
902 KAR 45:160 Kentucky food and cosmetic processing, packaging, storage, and distribution operations {#sec-902-kar-45-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:160}
Section 1. Definitions.
(1) "Adulterated" is defined by KRS 217.025.
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Food processing establishment" is defined by KRS 217.015(20).
(4) "Food storage warehouse" is defined by KRS 217.015(22).
(5) "Imminent health hazard" is defined by KRS 217.015(24).
(6) "Misbranded" is defined by KRS 217.035.
(7) "No Action Indicated" or "NAI" means a plant inspection classification that indicates the firm has no violating condition or that only a minor violation was noted at the time of inspection.
(8) "Official Action Indicated" or "OAI" means a plant inspection classification that indicates a condition noted during the inspection was significant enough to pose an imminent health hazard or was an uncorrected VAI condition on a previous inspection.
(9) "Plant" means a food processing establishment, cosmetic processing establishment, or a food storage warehouse.
(10) "Ready-to-eat" means food that is in a form that is edible without washing, cooking, or additional preparation by the food plant or the consumer to achieve food safety, and is expected to be consumed in that form.
(11) "Specialized processes" means foods processed under 21 C.F.R. Parts 113, 114, 120, and 123.
(12) "State Plumbing Code" means the code established by KRS Chapter 318 and 815 KAR Chapter 20.
(13) "Voluntary Action Indicated" or "VAI" means a plant inspection classification that indicates a condition was noted during the inspection that is in violation of this administrative regulation but was not significant enough to pose an imminent health hazard.
Section 2. Applicability.
(1) Except as provided in subsection (2) of this section, a plant shall comply with the following federal requirements:
(a) 21 U.S.C. 373, Records;
(b) 21 C.F.R. 1.20 - 1.24, General labeling requirements;
(c) 21 C.F.R. 7.1 - 7.13, General provisions;
(d) 21 C.F.R. 7.40 - 7.59, Food recalls provisions;
(e) 21 C.F.R. 70.20 - 70.25, Packaging and labeling requirements;
(f) 21 C.F.R. 73.1 - 73.615, Listing of food color additives exempt from certification;
(g) 21 C.F.R. 74.101 - 74.706, Listing of food color additives subject to certification;
(h) 21 C.F.R. Part 81, General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics;
(i) 21 C.F.R. 82.3 - 82.706, Listing of certified provisionally listed food colors and specifications;
(j) 21 C.F.R. 100.155, Salt and iodized salt;
(k) 21 C.F.R. Part 101, Food labeling;
(l) 21 C.F.R. Part 102, Common or usual name for nonstandardized foods;
(m) 21 C.F.R. Part 104, Nutritional quality guidelines for foods;
(n) 21 C.F.R. Part 105, Foods for special dietary use;
(o) 21 C.F.R. Part 106, Infant formula quality control procedures;
(p) 21 C.F.R. Part 107, Infant formula;
(q) 21 C.F.R. 108 Subpart B, Specific requirements and conditions for exemption from or compliance with an emergency permit;
(r) 21 C.F.R. Part 109, Unavoidable contaminants in food for human consumption and food packaging materials;
(s) 21 C.F.R. Part 113, Low acid foods;
(t) 21 C.F.R. Part 114, Acidified foods;
(u) 21 C.F.R. Part 117, Hazard analysis and critical control point (HACCP) systems;
(v) 21 C.F.R. Part 120, Hazard analysis and critical control point (HACCP) systems;
(w) 21 C.F.R. Part 123, Fish and fishery products;
(x) 21 C.F.R. Part 129, Processing and bottling of bottled drinking water;
(y) 21 C.F.R. Part 130, Food standards general;
(z) 21 C.F.R. 133.10, 133.124, 133.125, 133.167 – 133.169, 133.171, 133.173 – 133.176, 133.179 – 133.180, Cheeses and related cheese products;
(aa) 21 C.F.R. Part 135, Frozen desserts;
(bb) 21 C.F.R. Part 136, Bakery products;
(cc) 21 C.F.R. Part 137, Cereal flours and related products;
(dd) 21 C.F.R. Part 139, Macaroni and noodle products;
(ee) 21 C.F.R. Part 145, Canned fruits;
(ff) 21 C.F.R. Part 146, Canned fruit juices;
(gg) 21 C.F.R. Part 150, Fruit butters, jellies, preserves, and related products;
(hh) 21 C.F.R. Part 152, Fruit pies;
(ii) 21 C.F.R. Part 155, Canned vegetables;
(jj) 21 C.F.R. Part 156, Vegetable juices;
(kk) 21 C.F.R. Part 158, Frozen vegetables;
(ll) 21 C.F.R. Part 160, Eggs and egg product;
(mm) 21 C.F.R. Part 161, Fish and shellfish;
(nn) 21 C.F.R. Part 163, Cacao products;
(oo) 21 C.F.R. Part 164, Tree nut and peanut products;
(pp) 21 C.F.R. Part 165, Beverages;
(qq) 21 C.F.R. Part 166, Margarine;
(rr) 21 C.F.R. Part 168, Sweeteners and table syrups;
(ss) 21 C.F.R. Part 169, Food dressings and flavorings;
(tt) 21 C.F.R. Part 170, Food additives;
(uu) 21 C.F.R. Part 172, Food additives permitted for direct addition to food for human consumption;
(vv) 21 C.F.R. Part 173, Secondary direct food additives permitted in food for human consumption;
(ww) 21 C.F.R. Part 174, Indirect food additives: general;
(xx) 21 C.F.R. Part 175, Indirect food additives: adhesives and components of coatings;
(yy) 21 C.F.R. Part 176, Indirect food additives: paper and paperboard components;
(zz) 21 C.F.R. Part 177, Indirect food additives: polymers;
(aaa) 21 C.F.R. Part 178, Indirect food additives: adjuvants, production aids, and sanitizers;
(bbb) 21 C.F.R. Part 180, Food additives permitted in food or in contact with food on an interim basis pending additional study;
(ccc) 21 C.F.R. Part 181, Prior sanctioned food ingredients;
(ddd) 21 C.F.R. Part 182, Substances generally recognized as safe;
(eee) 21 C.F.R. Part 184, Direct food substances affirmed as generally recognized as safe;
(fff) 21 C.F.R. Part 186, Indirect food substances affirmed as generally recognized as safe;
(ggg) 21 C.F.R. Part 189, Substances prohibited from use in human food; and
(hhh) 21 U.S.C. 321, 343 to 345, 374, 374a, Nutritional and food allergen labeling requirements.
(2) The following federal regulations shall not apply:
(a) 21 C.F.R. 101.69;
(b) 21 C.F.R. 101.108;
(c) 21 C.F.R. 102.19;
(d) 21 C.F.R. 106.120;
(e) 21 C.F.R. 107.200 - 107.280;
(f) 21 C.F.R. 120.14;
(g) 21 C.F.R. 123.12;
(h) 21 C.F.R. 130.5 - 130.6;
(i) 21 C.F.R. 130.17;
(j) 21 C.F.R. 170.6;
(k) 21 C.F.R. 170.15; and
(l) 21 C.F.R. 170.17.
Section 3. Permits.
(1) Before operating, a food or cosmetic manufacturing or processing plant, packaging plant, storage warehouse, or distribution warehouse shall obtain a permit from the cabinet in accordance with KRS 217.125.
(2) Application for a permit shall be made on a DFS-260, Application for Permit to Operate a Food Plant or Cosmetic Manufacturing Plant, and shall be submitted to the cabinet with the annual fee established by 902 KAR 45:180.
(3) A permit for food or cosmetic manufacturing or processing plant, packaging, storage, or distribution shall only be issued:
(a) In the name of the applicant;
(b) For the location identified in the application; and
(c) For a firm that is in compliance with this administrative regulation and KRS 217.005 - 217.215.
(4) A permit shall:
(a) Be posted in a conspicuous place in the firm;
(b) Expire on December 31 of each year; and
(c) Be renewed in accordance with KRS 217.125(12) by submitting the form and fee required by subsection (2) of this section.
(5) Failure to apply for or renew a permit to operate a food or cosmetic manufacturing or processing plant, packaging plant, storage warehouse, or distribution warehouse shall result in the cabinet issuing a Food or Cosmetic Manufacturing Plant Enforcement Notice (DFS-263) to cease operation.
(6) Food processing plants shall be classified by the highest risk level of the food processed.
(a) A high risk food plant:
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Is engaged in international, interstate, statewide, or regional distribution; and
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Uses one (1) or all of the following manufacturing processes:
a. Time and temperature controlled foods that are ready-to-eat;
b. High risk foods that are considered ready-to-eat; or
c. Foods that require specialized processes to decrease risk potential.
(b) A medium risk food plant processes foods that are either ready-to-eat foods or potentially hazardous foods, but not both.
(c) A low risk food plant processes foods that are not time and temperature controlled.
Section 4. Plan Review.
(1) Approval shall be obtained from the cabinet or its local health department agent prior to beginning work, if:
(a) A plant is constructed, remodeled, or altered;
(b) A plant's plumbing is relocated;
(c) Additional plumbing is added to a plant; or
(d) An existing structure is converted for use as a plant.
(2) To obtain approval, an applicant shall submit plans and specifications for the construction, remodeling, or alteration to the local health department in the county in which the construction, remodeling, or alteration will take place.
(3) Plans shall be prepared to show:
(a) Equipment layout;
(b) Size;
(c) Location and type of facilities; and
(d) Plumbing riser diagram.
Section 5. Construction and Maintenance.
(1) The floor of the preparation, storage, and utensil washing area, walk-in refrigerator, dressing room, locker room, toilet room, and vestibule shall be:
(a) Smooth;
(b) Durable;
(c) Non-absorbent; and
(d) Easily cleaned.
(2) Floors shall be cleaned and maintained.
(3) A juncture of a wall with a floor shall be covered and sealed.
(4) The juncture between the wall and floor shall be tight-fitting.
(5)
(a) A floor drain shall be provided in a floor that is water flushed for cleaning or that receives discharge of water or other fluid waste from equipment.
(b) Floors shall be graded to drain all parts of the floor.
(6) Drip or condensate from fixtures, ducts, and pipes shall not contaminate food, food-contact surfaces, or food-packaging materials.
(7) Mats shall be:
(a) Non-absorbent;
(b) Slip resistant; and
(c) Easily cleaned.
(8) Mats shall not be used as storage racks.
(9) Exposed utility service lines and pipes shall be installed to prevent tripping hazards and cleaning obstructions.
(10) Walls and ceilings, including doors, windows, skylights, and similar closures, shall be maintained in good repair.
(11) Walls and ceilings of all preparation and warewashing areas shall be:
(a) Smooth;
(b) Non-absorbent; and
(c) Easily cleaned.
(12) Studs, joists, and rafters shall not be exposed in:
(a) Walk-in-refrigerators;
(b) Preparation areas; and
(c) Warewashing areas.
(13) Doors shall be:
(a) Solid;
(b) Tight-fitting; and
(c) Closed, except during cleaning or maintenance.
(14) Light fixtures, vent covers, wall-mounted fans, and similar equipment attached to walls or ceilings shall be kept clean and maintained in good repair.
(15) Aisles and working spaces shall be:
(a) Unobstructed; and
(b) Of a width to permit employees to perform their duties and protect against contaminating food, cosmetics, or surfaces with clothing or by personal contact.
(16) Lighting shall be provided in:
(a) Hand washing areas;
(b) Dressing and locker rooms;
(c) Toilet rooms;
(d) Areas where food or cosmetics are examined, processed, or stored; and
(e) Areas where equipment or utensils are cleaned.
(17) Lighting, glass fixtures, and skylights suspended over exposed packaging materials shall be made of safety glass or otherwise shielded to protect against contamination in case of breakage.
(18) Ventilation or exhaust control equipment shall be provided to minimize odors or vapors in areas where odors or vapors may contaminate food.
(19) Fans and other air-blowing equipment shall be located and operated in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.
(20) Protection against pests shall be provided.
Section 6. Water Supply.
(1) The water supply shall be:
(a) Potable;
(b) Of sufficient quantity to meet plant needs; and
(c) From an approved public water system, if available.
(2) If a public water system is not available, the supply for the plant shall be approved pursuant to 401 KAR Chapters 8 and 11.
(3) If a community public water system later becomes available and has the capacity to serve the facility, connections may be made to it. The non-community water supply shall then be discontinued and inactivated.
(4) Hot and cold running water under pressure shall be provided in all areas where it is needed for:
(a) Processing food or cosmetics;
(b) Cleaning equipment, utensils, and packaging materials; and
(c) Employee sanitary facilities.
(5) Bottled water plants shall have their water supply system designed, approved, and operated in accordance with 401 KAR 8:700.
Section 7. Plumbing.
(1) All plumbing shall comply with the minimum fixture requirements, and be sized, installed, and maintained in accordance with the State Plumbing Code.
(2) All utensils used in food or cosmetic processing that are not a part of a clean-in-place operation shall be washed, rinsed, and sanitized in:
(a) A permanently plumbed three (3) compartment sink; or
(b) A commercial dishwasher installed and operated in compliance with the State Plumbing Code and the manufacturer's instructions.
(3) If a three (3) compartment sink is utilized, the sink compartments shall be large enough to permit the accommodation of the equipment and utensils and each compartment of the sink shall be supplied with hot and cold potable running water under pressure.
(4) Clean-in-place equipment shall be cleaned or sanitized according to manufacturer instructions and industry best practices for the commodity being processed.
(5) Written sanitation procedures shall be maintained for each type of clean-in-place equipment.
(6) A service sink or curbed cleaning facility with a drain that allows for disposal of mop and cleaning solution water shall be provided.
(7) A person, firm, or corporation shall not construct, install, or alter any plumbing without having procured a plumbing construction permit from the Department of Housing, Buildings and Construction, under KRS Chapter 318.
Section 8. Sewage Disposal.
(1) All sewage shall be disposed of into a public sewerage system, if available.
(2) If a public sewerage system is not available, disposal shall be made into a private system designed, constructed, and operated pursuant to the requirements of 401 KAR Chapter 5 or 902 KAR 10:085.
(3) If a public sewerage system becomes available, connection shall be made and the private sewerage system shall be discontinued.
Section 9. Toilet Facilities. Toilet facilities shall meet the fixture and construction requirements of KRS Chapter 318 and the State Plumbing Code.
Section 10. Hand Washing Facilities.
(1) Hand washing facilities shall be installed in accordance with KRS Chapter 318 and the State Plumbing Code where:
(a) Food or cosmetic are prepared;
(b) Utensils are washed; and
(c) Sanitary practices require employees to wash and sanitize their hands.
(2) All hand washing facilities shall be provided with:
(a) Soap;
(b) Disposable hand drying towels or mechanical hand drying devices; and
(c) Non-absorbent waste receptacles.
(3) Hand sanitizer shall not be used instead of hand washing.
(4) Lavatories used for hand washing shall not be used for food or cosmetic preparation or for washing equipment or utensils.
(5) Lavatories, soap dispensers, and hand drying devices shall be kept clean and maintained.
Section 11. Food Transportation.
(1) Vehicles used for the transportation of food shall be maintained and loaded in a manner to prevent cross-contamination of food.
(2) Vehicles that transport refrigerated food shall be capable of maintaining:
(a) Frozen food in a frozen state; and
(b) Refrigerated foods at forty-five (45) degrees Fahrenheit or below.
Section 12. Inspection Frequencies.
(1) The cabinet shall assign an inspection frequency to each food processing plant based upon the degree of risk associated with the commodity processed, packaged, stored, or distributed by the plant.
(2) The cabinet shall assign the inspection frequencies as follows:
(a) High risk food plants shall be inspected no less than once every 1,080 days;
(b) Medium risk food plants shall be inspected no less than once every 1,260 days; and
(c) Low risk food plants shall be inspected no less than once every 1,440 days.
(3) Cosmetic manufacturing plants shall be inspected no less than once every 1,440 days.
(4) The cabinet shall conduct additional inspections as necessary for enforcement pursuant to this administrative regulation.
Section 13. Violations.
(1) If a plant has committed a violation of this administrative regulation, an opportunity to correct the violation shall be provided in accordance with the following classifications:
(a) NAI - No changes in the inspection frequency are warranted under this classification;
(b) VAI - A follow-up inspection is warranted within a period of time not to exceed ninety (90) days to determine if the violation causing this classification has been corrected; or
(c) OAI - A follow-up inspection shall be conducted within a period of time not to exceed forty-five (45) days to determine if the violation causing the classification has been corrected. A plant may also be classified as OAI if it continually fails to correct a violation previously classified under a VAI designation or if an imminent health hazard is noted during an inspection.
(2) Upon completion of the inspection, a recommended classification of NAI, VAI, or OAI and the timeframe for correction of the violation shall be specified on a DFS-220, Food or Cosmetic Plant Inspection Report.
(3) If, during a follow-up inspection, the violation noted on the previous inspection has not been corrected within the timeframe specified by the cabinet, the cabinet shall:
(a) Extend the timeframe for corrective action if the cabinet determines that progress towards compliance has been made; or
(b) Initiate enforcement provisions pursuant to Section 17 of this administrative regulation.
Section 14. Food or Cosmetic Plant Environmental Sampling. The cabinet shall collect an environmental sample in an area of the plant as necessary for the enforcement of this administrative regulation.
Section 15. Examination and Detention of Foods and Cosmetics.
(1) The cabinet shall examine and collect samples of food or cosmetic as often as necessary for the enforcement of this administrative regulation.
(2) If a food or cosmetic is considered to be adulterated or misbranded, DFS-265, Food or Cosmetic Plant Quarantine-Final Disposition Report, shall be issued to the permit holder or person in charge pursuant to KRS 217.115.
Section 16. Imminent Health Hazard and Notification Requirements.
(1) The permit holder shall take immediate steps to correct conditions that have caused an imminent health hazard.
(2)
(a) The permit holder shall notify the cabinet within twenty-four (24) hours of the knowledge of an imminent health hazard that cannot be controlled by immediate corrective action or if food, food contact equipment, food packaging, cosmetic, or cosmetic packaging has become contaminated because of an imminent health hazard.
(b) Written notification to the cabinet shall be made by:
-
Email to CHFSDPHENV@KY.gov; or
-
Fax to 502-696-1882.
(3) If the cabinet has evidence that a plant has failed to act to correct an imminent health hazard, enforcement provisions shall be initiated pursuant to Section 17 of this administrative regulation.
Section 17. Enforcement Provisions.
(1) If the cabinet has substantial reason to believe that a permit holder has failed to act to correct an imminent health hazard or if the permit holder or an authorized agent has interfered with the cabinet in the performance of its duties after its agents have duly and officially identified themselves, the cabinet shall immediately notify the permit holder using the DFS-263, Food or Cosmetic Plant Enforcement Notice and:
(a) Suspend the permit without a conference; or
(b) Suspend that portion of the plant operation affected by the imminent health hazard without a conference.
(2) If a permit suspension is due to an imminent health hazard, the permit holder may request a conference on a DFS-267, Request for Conference. A conference shall be granted as soon as practical, not to exceed seven (7) days from the receipt of the Request for Conference.
(3) In all other instances of violation of this administrative regulation, the cabinet shall serve the permit holder with a written notice specifying the violation and afford the holder an opportunity to correct.
(4) If a permit holder or operator has failed to comply with an OAI inspection notice within the timeframe granted, the cabinet shall issue a Notice of Intent to Suspend Permit on a DFS-263, Food or Cosmetic Plant Enforcement Notice.
(5) When a Notice of Intent to Suspend Permit is issued, the permit holder or operator shall be notified in writing that the permit shall be suspended at the end of ten (10) days following service of the notice, unless a written request for a conference is filed with the cabinet by the permit holder within the ten (10) day period.
(6) Any person whose permit has been suspended may make application on a DFS-269, Application for Reinstatement, for a re-inspection for the purpose of reinstatement of the permit. Within seven (7) days following receipt of a written request, including a statement signed by the applicant that in his opinion the condition causing suspension of the permit has been corrected, the cabinet shall make an inspection, and if the inspection reveals that the condition causing suspension of the permit has been corrected, the permit shall be reinstated.
(7) For a plant that has had a suspended permit two (2) or more times within a five (5) year period, the cabinet shall initiate permit revocation proceedings. Prior to this action, the cabinet shall notify the permit holder in writing on a DFS-263, Food or Cosmetic Plant Enforcement Notice, stating the reasons for which the permit revocation is being sought and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative hearing is filed with the cabinet pursuant to KRS Chapter 13B by the permit holder within the ten (10) day period.
(8) Notice provided for under this administrative regulation shall be deemed to have been properly served if:
(a) A copy of the inspection report or other notice has been delivered personally to the permit holder; or
(b) The notice has been sent by registered or certified mail, return receipt.
Section 18. Administrative Conferences. An administrative conference shall be conducted pursuant to 902 KAR 1:400.
Section 19. Administrative Hearings. An administrative hearing shall be conducted pursuant to KRS Chapter 13B.
Section 20. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "DFS-220, Food or Cosmetic Plant Inspection Report", 8/20;
(b) "DFS-260, Application for Permit to Operate a Food Plant or Cosmetic Manufacturing Plant", 8/20;
(c) "DFS-263, Food or Cosmetic Plant Enforcement Notice", 8/20;
(d) "DFS-265, Food or Cosmetic Plant Quarantine-Final Disposition Report", 8/20;
(e) "DFS-267, Request for Conference", 8/20; and
(f) "DFS-269, Application for Reinstatement", 8/20.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Cabinet for Health and Family Services, Department for Public Health, Division of Public Health Protection and Safety, Food Safety Branch, 275 East Main Street, Frankfort, Kentucky 40602, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 13B, 194A.005, 217.005 - 217.205, 271.215, 217.290 - 217.390, 217.990 - 217.992, 318.130, 21 C.F.R. Part 1, 7, 70, 73, 74, 81, 82, 100 - 102, 104 - 107, 108 Subpart B, 109, 113, 114, 117, 120, 123, 129, 130, 133, 135 - 137, 139, 145, 146, 150, 152, 155, 156, 158, 160, 161, 163 - 166, 168, 169, 170, 172 - 178, 180 - 189, 21 U.S.C. 321, 343-345, 373, 374, 374a
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1), 217.125(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) and 217.125(1) authorize the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of KRS 217.005 to 217.215. The secretary is authorized to promulgate administrative regulations consistent with those promulgated under the federal act and the Fair Packaging and Labeling Act. This administrative regulation establishes procedures and requirements for food and cosmetic processing, packaging, storage, and distribution operations for the purpose of protecting public health.
- History: 41 Ky.R. 2470; 42 Ky.R. 321; eff. 9-4-2015; 45 Ky.R. 495, 1040; eff. 11-2-2018; 47 Ky.R. 1488; eff. 6-16-2021.
902 KAR 45:180 Permits and fees for food processing plants, food storage warehouses, salvage processors and distributors, cosmetic manufacturers, and certificate of free sale {#sec-902-kar-45-180 omnilex-key=us-ky-regs-official--title-902--902 KAR 45:180}
Section 1. Definitions.
(1) "Ready-to-eat" means food that is in a form that is edible without washing, cooking, or additional preparation by the food plant or the consumer to achieve food safety, and is expected to be consumed in that form.
(2) "Specialized processes" means foods processed under 21 C.F.R. Parts 113, 114, 120, or 123.
Section 2. Classification. Food processing and storage facilities shall be classified by the highest risk level of the food processed or stored.
(1) A facility shall be classified as a high risk food plant or risk level 1 if the facility:
(a) Is engaged in international, interstate, statewide, or regional distribution; and
(b) Uses one (1) or all of the following manufacturing processes:
-
Time and temperature controlled foods that are ready-to-eat;
-
High risk foods that are considered ready-to-eat; or
-
Foods that require specialized processes to decrease risk potential.
(2) A facility shall be classified as a medium risk food plant or risk level 2 if the facility processes foods that are either ready-to-eat foods or potentially hazardous foods, but not both.
(3) A facility shall be classified as a low risk food plant or risk level 3 if the facility processes foods that are not time and temperature controlled.
Section 3. Fees.
(1) A permit fee shall be required for inspections conducted by the cabinet or the local health department to determine compliance with:
(a) 902 KAR 45:080 for a salvage distributor or a salvage processing plant;
(b) KRS 217.025, 217.035, and 217.037 for a food processing plant or food storage warehouse; or
(c) KRS 217.085 and 217.095 for a cosmetic manufacturer.
(2) The fee for the inspection of a food processing plant, storage warehouse, or salvage processing facility shall be:
(a) Assessed according to the:
-
Total square footage of the facility; and
-
Highest risk level of commodity manufactured by or stored at the facility: and
(b) Calculated as established in this paragraph.
- If the facility is between zero to 1,000 square feet, the fee:
a. For risk level 1 shall be $135;
b. For risk level 2 shall be $130; or
c. For risk level 3 shall be $125.
- If the facility is between 1,001 to 5,000 square feet, the fee:
a. For risk level 1 shall be $190;
b. For risk level 2 shall be $180; or
c. For risk level 3 shall be $170.
- If the facility is between 5,001 to 20,000 square feet, the fee:
a. For risk level 1 shall be $350;
b. For risk level 2 shall be $300; or
c. For risk level 3 shall be $250.
- If the facility is between 20,001 to 40,000 square feet, the fee:
a. For risk level 1 shall be $500;
b. For risk level 2 shall be $450; or
c. For risk level 3 shall be $400.
- If the facility is between 40,001 to 80,000 square feet, the fee:
a. For risk level 1 shall be $600;
b. For risk level 2 shall be $550; or
c. For risk level 3 shall be $500.
- If the facility is between 80,001 to 150,000 square feet, the fee:
a. For risk level 1 shall be $750;
b. For risk level 2 shall be $700; or
c. For risk level 3 shall be $650.
- If the facility is greater than 150,000 square feet, the fee:
a. For risk level 1 shall be $1,000;
b. For risk level 2 shall be $900; or
c. For risk level 3 shall be $800..
(3) A fee for the inspection of a cosmetic manufacturer shall be $125.
(4) A request for a certificate of free sale or export authorizing a Kentucky food processing plant holding a valid permit to operate to export a product outside of the United States shall be accompanied by a service fee of fifty (50) dollars for each certificate requested.
(5) Fees shall be made payable to the Kentucky State Treasurer and forwarded to the Kentucky Department for Public Health, Food Safety Branch, 275 East Main Street, Frankfort, Kentucky 40621.
History
- RELATES TO: KRS 217.015, 217.025, 217.035, 217.037, 217.085, 217.095, 217.155, 21 C.F.R. Parts 113, 114, 120, 123
- STATUTORY AUTHORITY: KRS 217.125(1), (2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations for the efficient administration and enforcement of the Kentucky Food, Drug and Cosmetic Act. KRS 217.125(2) requires the secretary to provide by administrative regulation a schedule of reasonable fees to be paid by food processing plants, food storage warehouses, salvage distributors, salvage processing plants, and cosmetic manufacturers for permits to operate and for inspection activities carried out by the cabinet. This administrative regulation establishes the schedule of fees.
- History: 47 Ky.R. 231; 1050; 1590; eff. 2-11-2021.
Chapter 47 Hazardous Substances
902 KAR 47:010 Definitions {#sec-902-kar-47-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 47:010}
Section 1. Definitions. In addition to the definitions set forth in KRS 217.660, the following terms are defined as follows:
(1) "Combustible" means a substance which has a flash point of 100 to 150 degrees Fahrenheit.
(2) "Extremely flammable" means a substance which has a flash point of twenty (20) degrees Fahrenheit or less.
(3) "Extremely flammable contents of self-pressurized container" means contents of a self-pressurized container that a flashback (a flame extending back to the dispenser) is obtained at any degree of valve opening and the flash point is less than twenty (20) degrees Fahrenheit.
(4) "Extremely flammable solid" means a solid substance that ignites and burns at an ambient temperature of eighty (80) degrees Fahrenheit or less if subjected to friction, percussion, or electrical spark.
(5) "Federal Act" means PL 86-613 74 Stat. 372; 15 USC, Sec. 1261, et seq., including the amendments thereto.
(6) "Flammable contents of self-pressurized container" means contents of a self-pressurized container that a flame projection exceeding eighteen (18) inches is obtained at full valve opening or a flashback (a flame extending back to the dispenser) is obtained at a degree of valve opening.
(7) "Flammable solid" means a solid substance that ignites and burns with a self-sustained flame at a rate greater than one-tenth (1/10) inch per second along its major axis.
(8) "Flammable" applies to substances having a flashpoint above twenty (20) degrees Fahrenheit and below 100 degrees Fahrenheit.
(9) "Principal display panel" means the portion of the immediate container, and an outer container or wrapping, which bears the labeling designed to be most prominently displayed, shown, presented, or examined under conditions of retail sale.
(10) "General home and household use" means a hazardous substance, whether or not packaged, that under a customary or reasonably foreseeable condition of purchase, storage, or use, may be brought into or around a house, apartment, or other place where people dwell, or in or around a related building or shed including a garage, carport, barn, or storage shed. The term includes articles, such as polishes or cleaners, designed primarily for professional use but which are available in retail stores, such as hobby shops, for nonprofessional use. Also included are items such as antifreeze and radiator cleaners that, although principally for car use, may be stored in or around dwelling places. The term does not include industrial supplies that might be taken into the home by a serviceman. An article labeled as, and marketed solely for, industrial use does not become subject to these administrative regulations because of the possibility that an industrial worker may take a supply for his own use. Size of unit or container is not the only index of whether the article is suitable for use in or around the household. The test is whether, under a reasonably foreseeable condition of purchase, storage, or use, the article may be found in or around a dwelling.
(11) "Highly toxic" means a substance which falls within any the following categories:
(a) Produces death within fourteen (14) days in half or more than half of a group of ten (10) or more laboratory white rats each weighing between 200 and 300 grams, at a single dose of fifty (50) milligrams or less per kilogram of body weight, if orally administered;
(b) Produces death within fourteen (14) days in half or more than half of a group of ten (10) or more laboratory white rats each weighing between 200 and 300 grams, if inhaled continuously for a period of one (1) hour or less at an atmospheric concentration of 200 parts per million per liter by volume or less of gas or vapor or two (2) milligrams per liter by volume or less of mist or dust, provided the concentration is likely to be encountered by man if the substance is used in a reasonably foreseeable manner; or
(c) Produces death within fourteen (14) days in half or more than half of a group of ten (10) or more rabbits tested in a dosage of 200 milligrams or less per kilogram of body weight, if administered by continuous contact with bare skin for twenty-four (24) hours or less.
Section 2. Strong Sensitizer. KRS 217.660(4)(d) directs the Secretary for Human Resources to designate as hazardous substances any substance or mixture of substances which is a "strong sensitizer." On the basis of frequency of occurrence and severity of reaction information, the cabinet finds that the following substances have a significant potential for causing hypersensitivity and, therefore, meet the definition for "strong sensitizer" in KRS 217.660(4)(d):
(1) Paraphenylenediamine and products containing it;
(2) Powdered orris root and products containing it;
(3) Epoxy resins systems containing in any concentration ethylenediamine, diethylenetriamine, and diglycidyl ethers of molecular weight of less than 200;
(4) Formaldehyde and products containing one (1) percent or more formaldehyde; and
(5) Oil of bergamot and products containing two (2) percent or more of oil of bergamot.
History
- RELATES TO: KRS 217.650-217.710
- STATUTORY AUTHORITY: KRS 194.050, 211.180, 211.090, 217.690
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.690 authorizes the Cabinet for Human Resources to adopt administrative regulations to regulate the control of hazardous substances in Kentucky. The purpose of this administrative regulation is to provide definitions that are applicable to all other Cabinet for Human Resources administrative regulations relating to hazardous substances, and to designate as hazardous substances any substance or mixture of substances which is a "strong sensitizer."
- History: 902 KAR 0477:010. 3 Ky.R. 736; eff. 6-1-1977; 15 Ky.R. 2453; eff. 8-5-1989; 20 Ky.R. 2213; eff. 3-14-1994; Crt eff. 3-22-2019; Crt eff. 10-13-2025.
902 KAR 47:020 Labeling and identification standards {#sec-902-kar-47-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 47:020}
Section 1. Conspicuousness of Labeling Requirements.
(1) The signal word, the statement of the principal hazard or hazards, and instructions to read carefully any cautionary information that may be placed elsewhere on the label shall appear together on the main panel of the label. The information shall be placed together and distinctively apart from other wording or designs. The necessary prominence shall be achieved by placement within the borders of a square or rectangle with or without a borderline, and by use of suitable contrasts with the background achieved by distinctive typography or color, and by both color and typography if needed.
(2) If the product is "highly toxic" the labeling shall also include in conjunction with the word "poison" the skull and crossbones symbol. The word "poison" is not considered a signal word as that term is used in subsection (1) of this section.
(3) The signal word and statement of hazard shall be in capital letters. The signal word (and the word "poison" if required) and statements of hazard shall meet the type size requirements set forth in subsection (9) of this section.
(4) All the items of label information required by KRS 217.670 or by administrative regulations prescribing additional information may appear on the main panel; but if they do not, all the items not required by subsection (1) of this section to appear on the main panel shall be placed together in a distinctive place elsewhere on the label with adequate contrast achieved by typography, color, or layout. The name and place of business of the manufacturer, packer, or distributor may appear separately on the same or on a different panel. The type size used shall be no smaller than the type size required in subsection (9) of this section, Table 1.
(5) Collapsible metal tubes containing hazardous substances shall be labeled so that all items of label information required by KRS 217.670 or by administrative regulations shall appear as close to the dispensing end of the container as possible. The size, placement, and conspicuousness of these statements shall conform with subsections (1), (3), (4), and (9) of this section.
(6) Unpackaged hazardous substances shall be labeled so that all items of information required by the law or by administrative regulations shall appear upon the article. If the labeling is impracticable because of the size or nature of the article, the required cautionary labeling shall be displayed by a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout conditions of merchandising and distribution to the ultimate consumer. The size, placement, and conspicuousness of these statements shall conform with subsections (1), (3), (4), and (9) of this section.
(7) If accompanying literature includes or bears directions for use (by printed word, picture, design, or combination thereof), the literature including a placard, pamphlet, booklet, book, sign, or other graphic visual device shall bear all the information required by KRS 217.670.
(8) For the purposes of determining the proper type size for cautionary labeling, the area of the principal display panel shall be computed as follows:
(a) In the case of a rectangular package, where one (1) entire side is the principal display panel, the result of the height times the width of that side shall be the area of the principal display panel.
(b) In the case of a cylindrical or nearly cylindrical container or tube on which the principal display panel appears on the side, the area of the principal display panel shall be forty (40) percent of the result of the height of the container times its circumference.
(c) In the case of another shape of container, the area of the principal display panel shall be forty (40) percent of the total surface of the container, excluding areas such as flanges at tops and bottoms. If a container presents an obvious principal display panel (such as an oval or hour-glass shaped area on the side of a container for dishwashing detergent), the area to be measured shall be the entire area of obvious principal display panel.
(9) The type size of cautionary labeling shall be reasonably related to the type size of another printing appearing on the same panel, but shall meet the minimum size requirements computed for the area of the principal display indicated in Table 1 below:
Section 2. Special Labeling Requirements. In addition to the requirements of KRS 217.670 the following hazardous substances are deemed to be misbranded unless the label includes the requirements stated below:
(1) Charcoal briquettes and other forms of charcoal for cooking or heating. Because inhalation of the carbon monoxide produced by burning charcoal indoors or in confined areas may cause serious injury or death, containers of the products shall bear the following borderlined statements: "WARNING; Do Not Use for Indoor Heating or Cooking Unless Ventilation is Provided for Exhausting Fumes to Outside. Toxic Fumes May Accumulate and Cause Death". For bags of charcoal, the above statement shall appear within a heavy borderline in a color sharply contrasting to that of the background, on both front and back panels in the upper twenty-five (25) percent of the panels of the bag at least two (2) inches below the seam, and at least one (1) inch above reading material or design elements in type size as follows: The signal word "WARNING" shall appear in capital letters at least three-eighths (3/8) inch in height; the remaining text of the warning statement shall be printed in letters at least three-sixteenths (3/16) inch in height.
(2) Diethylene glycol. Because diethylene glycol and mixtures containing ten (10) percent or more by weight of diethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, the products shall be labeled with the signal word "Warning" and the statement "Harmful if swallowed."
(3) Ethylene glycol. Because ethylene glycol and mixtures containing ten (10) percent or more by weight of ethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, the products shall be labeled with the signal word "Warning" and the statement "Harmful or fatal if swallowed."
(4) Methyl alcohol (methanol). Because death and blindness can result from the ingestion of methyl alcohol, the label for this substance and mixtures containing four (4) percent or more by weight of this substance shall include the signal word "Danger," the additional word "Poison," and the skull and crossbones symbol. The statement of hazard shall include "Vapor harmful" and "May be fatal or cause blindness if swallowed." The label shall also bear the statement "Cannot be made nonpoisonous."
(5) Turpentine. Because turpentine (including gum turpentine, gum spirits of turpentine, steam-distilled wood turpentine, sulfate wood turpentine, and destructively distilled wood turpentine) and products containing ten (10) percent or more by weight of the turpentine, in addition to oral toxicity resulting in systemic poisoning, may be aspirated into the lungs resulting in chemical pneumonitis, pneumonia, and pulmonary edema, the products shall be labeled with the signal word "Danger" and the statement of hazard "Harmful or fatal if swallowed."
(6) Benzene, toluene, xylene, petroleum distillates:
(a) Because inhalation of the vapors of products containing five (5) percent or more by weight of benzene may cause blood dyscrasias, the products shall be labeled with the signal word "Danger," the statement of hazard "Vapor harmful," the word "poison," and the skull and crossbones symbol. If the product contains ten (10) percent or more by weight of benzene, it shall bear the additional statement of hazard "Harmful or fatal if swallowed" and the additional statements "If swallowed, do not induce vomiting. Call physician immediately."
(b) Because products containing ten (10) percent or more by weight of toluene, xylene, or other substances or combination thereof listed in this section may be aspirated into the lungs, with resulting chemical pneumonitis, pneumonia, and pulmonary edema, the products shall be labeled with the signal word "Danger," the statement of hazard "Harmful or fatal if swallowed," and the statements "If swallowed, do no induce vomiting. Call physician immediately."
(c) Because inhalation of the vapor of products containing ten (10) percent or more by weight of toluene or xylene or combination may cause systemic injury, the products shall bear the statement of hazard "Vapor harmful" in addition to the statements otherwise prescribed in this section.
(7) Use of the word "Poison." For the following substances, and at the following concentrations, the word "Poison" is necessary instead of a signal word:
(a) Hydrochloric acid and any preparation containing free or chemically unneutralized hydrochloric acid (HCl) in a concentration of ten (10) percent or more.
(b) Sulfuric acid and any preparation containing free or chemically unneutralized sulfuric acid (H2SO4) in a concentration of ten (10) percent or more;
(c) Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO3) in a concentration of five (5) percent or more;
(d) Carbolic acid (C6H5OH), also known as phenol, and any preparation containing carbolic acid in a concentration of five (5) percent or more;
(e) Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (H2C2O4) in a concentration of ten (10) percent or more;
(f) Any salt of oxalic acid and any preparation containing the salt in a concentration of ten (10) percent or more;
(g) Acetic acid or any preparation containing free or chemically unneutralized acetic acid (HC2H2O2) in a concentration of twenty (20) percent or more;
(h) Hypochlorous acid, free or combined, and any preparation containing the same in a concentration that will yield ten (10) percent or more by weight of available chlorine;
(i) Potassium hydroxide and any preparation containing free or chemically unneutralized potassium hydroxide (KOH) including caustic potash and vienna paste (vienna caustic), in a concentration of ten (10) percent or more;
(j) Sodium hydroxide and any preparation containing free or chemically unneutralized sodium hydroxide (NaOH), including caustic soda and lye in a concentration of ten (10) percent or more;
(k) Silver nitrate, sometimes known as lunar caustic, and any preparation containing silver nitrate (AgNO3) in a concentration of five (5) percent or more; and
(l) Ammonia water and any preparation containing free or chemically uncombined ammonia (NH3), including ammonium hydroxide and "hartshorn," in a concentration of five (5) percent or more.
(8) Fire extinguishers. If a substance or mixture of substances labeled for use in or as a fire extinguisher produces substances that are toxic if used according to label directions to extinguish a fire, the containers for the substances shall bear the following labeling:
(a) If substances are produced that meet the definition of highly toxic, the signal word "Danger" and the statement of hazard "Poisonous gases formed when used to extinguish flame or on contact with heat" shall be used.
(b) If substances are produced that meet the definition of toxic, the signal word "Caution" or "Warning" and the statement of hazard "Dangerous gas formed when used to extinguish flame or on contact with heat" shall be used.
(c) Regardless of whether paragraphs (a) or (b) of this subsection applies, a substance or mixture of substances labeled for use as a fire extinguisher that, if applied to an electrical fire, would subject the user to the likelihood of electrical shock shall be conspicuously labeled "Caution: Do not use on electrical wires."
(d) All substances or mixtures of substances specified in this subsection shall also bear the additional statements "Used in an enclosed place; may be fatal" and "Do not enter area until well ventilated and all odor of chemical has disappeared."
Section 3. Deceptive Use of Disclaimers. A hazardous substance shall not be deemed to have met the requirements of KRS 217.670 or the cabinet's administrative regulations if there appears in or on the label (or in accompanying literature) words, statements, designs, or other graphic material that negates or disclaims the label statements required by law or administrative regulation.
History
- RELATES TO: KRS 217.650-217.710
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.180, 217.690
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.690 authorizes the Cabinet for Human Resources to adopt administrative regulations to regulate the control of hazardous substances in Kentucky. The purpose of this administrative regulation is to provide uniform standards relating to the "conspicuousness" of labeling requirements; to specify requirements to identify hazardous substances that present special hazards and require specialized labeling to protect the public health; and to prevent the deceptive use of disclaimers on labels of hazardous substances.
- History: 902 KAR 047:020. 3 Ky.R. 737; eff. 6-1-1977; 4 Ky.R. 86; eff. 10-5-1977; 20 Ky.R. 2215; eff. 3-14-1994; Crt eff. 3-22-2019; Crt eff. 10-13-2025.
902 KAR 47:030 Exemptions {#sec-902-kar-47-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 47:030}
Section 1. Exemptions. Exemptions for small packages, minor hazards and special circumstances, set forth in regulations promulgated under 15 USC Sec. 1261-1276, shall be exempted in Kentucky.
Section 2. Banned Hazardous Substances Dangerous to Public Health. If a hazardous substance is banned pursuant to federal law by the U.S. Consumer Product Safety Commission, the Cabinet may, if it deems the article to be dangerous to public health, quarantine the article pursuant to KRS 217.700.
Section 3. Variance between State and Federal Regulations. If a variance exists between the regulations adopted under KRS 217.650 to 217.710 and those adopted under 15 USC Sec. 1261-1276, compliance with the federal regulations shall be deemed compliance with the provisions of the administrative regulations adopted under KRS 217.650 to 217.710.
Section 4. Test Procedures for Hazardous Substances. The test procedures prescribed under 15 USC Sec. 1261-1276 and federal regulations shall be applicable to all administrative regulations adopted by the cabinet relating to hazardous substances.
History
- RELATES TO: KRS 217.650-217.710, 16 C.F.R. Part 1500.83
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.180, 217.690
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.650 to 217.710 authorizes the Cabinet for Human Resources to regulate the control of hazardous substances in Kentucky. KRS 217.670(2) authorizes the Secretary for Human Resources to provide minimum information which shall appear on the labels for small packages. The purpose of this administrative regulation is to provide label exemption requirements for specified small packages, minor hazards, and special circumstances; to coordinate federal-state action if an article is banned and deemed to be dangerous to the public health; to assure uniformity for variance between the regulations adopted under the state and federal acts; and to assure uniformity of test procedures.
- History: 902 KAR 047:030. 3 Ky.R. 739; eff. 6-1-1977; 20 Ky.R. 2218; eff. 3-14-1994; Crt eff. 3-22-2019; Crt eff. 10-13-2025.
902 KAR 47:200 Public health methamphetamine contamination {#sec-902-kar-47-200 omnilex-key=us-ky-regs-official--title-902--902 KAR 47:200}
Section 1. Definitions.
(1) "Cabinet" means the Kentucky Cabinet for Health and Family Services.
(2) "Commissioner" means the commissioner of the Kentucky Department for Public Health.
(3) "Clandestine Drug Lab Preliminary Assessment Tier Selection Criteria Form (TASS), DEP 1016 means the evaluation tool incorporated by reference in 401 KAR 101:030 and used by law enforcement to determine the tiered level of methamphetamine contamination within the inhabitable property.
(4) "Decontaminated" means the removal of methamphetamine contamination from an inhabitable property in a manner in accordance with 401 KAR 101:040.
(5) "Disclosure" means the notification made by the owner of a methamphetamine contaminated property to a potential buyer, lessee, or renter of that property advising them that the property is contaminated.
(6) "Methamphetamine Disclosure Statement" means the documentation provided by the property owner to the potential buyer, lessee, or renter that conforms to the requirements established in Section 4(2) of this administrative regulation.
(7) "Notice of Methamphetamine Contamination" means the form DFS 407 used to denote methamphetamine contamination within an inhabitable property.
(8) "Posted" or "posting" means the physical affixing of the Notice of Methamphetamine Contamination to the entrances of an inhabitable property with one (1) or more rooms with living, sanitary, and sleeping facilities arranged for the use of one (1) family or individual.
(9) "Released" means the authorization by the cabinet for the removal of the posted Notice of Methamphetamine Contamination and an authorization to the property owner that all disclosure requirements established in this administrative regulation are no longer applicable.
Section 2. Posting of Property.
(1) Upon written notification received from law enforcement that an inhabitable property has been found to contain evidence of methamphetamine contamination and has had posted a Notice of Methamphetamine Contamination on all exterior entrances to the inhabitable property, the local health department shall request from the responding law enforcement agency a copy of the Clandestine Drug Lab Preliminary Assessment Tier Selection Criteria Form (TASS), DEP 1016, incorporated by reference in 401 KAR 101:030.
(2) Upon receipt of the issuance of a Notice of Methamphetamine Contamination by law enforcement, the local health department shall within ten (10) business days:
(a) Notify by certified mail the property owner listed on the deed of the inhabitable property that the property has been posted with a Notice of Methamphetamine Contamination;
(b) Notify the cabinet in writing that a Notice of Methamphetamine Contamination has been posted upon the property;
(c) Provide the cabinet with a copy of the Clandestine Drug Lab Preliminary Assessment Tier Selection Criteria Form (TASS), DEP 1016;
(d) Notify the Kentucky State Police Methamphetamine Coordinator; and
(e) Notify the Energy and Environment Cabinet Superfund Branch.
(3) The Notice of Methamphetamine Contamination shall remain posted at the property entrances until the property owner receives notification from the local health department as established in Section 5(2) of this administrative regulation that the posting may be removed.
Section 3. Appeals Process.
(1) A homeowner listed on the deed of the property who has received a Notice of Methamphetamine Contamination and who believes that the notice has been issued improperly may make a written request of appeal to the Commissioner of Public Health, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, within thirty (30) days of the date the notice was posted on the property.
(2) Upon receipt of an appeal, the commissioner shall forward the request to the Administrative Hearings Branch, which shall set the date, time, and place for the hearing requested within sixty (60) days of the date postmarked on the appeal envelope.
(3) The notice of appeal hearing shall conform to KRS 13B.050;
(4) The appeal hearing shall be conducted by a hearing officer appointed by the commissioner and in accordance with KRS 13B.080, 13B.090, and 13B.110.
(5) The hearing officer shall make a recommended order in accordance with KRS 13B.110.
(6) The secretary shall:
(a) Issue a final order in accordance with KRS 13B.120 after receipt of the hearing officer's recommended order; and
(b) Forward a copy of the final order to the Department of Public Health.
(7) An official record of the appeal hearing complying with KRS 13B.130 shall be retained by the Cabinet for Health and Family Services' Administrative Hearings Branch.
Section 4. Disclosure Requirements.
(1) A property owner who chooses not to decontaminate a posted property contaminated by the production of methamphetamine shall disclose, in writing, the presence of contamination including the following information to all prospective buyers, tenants, and lessees of the property:
(a) The physical address of the property;
(b) The location within the posted property that was used in the production of methamphetamine; and
(c) A copy of the Notice of Methamphetamine Contamination.
(2) The property owner shall sign and date the Methamphetamine Disclosure Statement and maintain a copy of the Methamphetamine Disclosure Statement and documents attached thereto for the duration of their ownership.
(3) If a posted inhabitable property is sold or ownership is otherwise transferred, the new owner shall assume all responsibility for disclosure as established in this section.
(4) Upon request by the prospective buyer, tenant, or lessee, the property owner shall provide a copy of any documentation related to the methamphetamine contamination provided to the owner by law enforcement, the Energy and Environment Cabinet, the Department for Public Health, or the local health department.
(5) In cases if the posted inhabitable property is a mobile home, the owner shall assume all responsibilities for disclosure if the property is relocated to a new physical address.
(6) Failure by the property owner to disclose methamphetamine contamination as outlined in this section shall constitute a Class D Felony as required under KRS 224.99-010.
Section 5. Removal of the Posting.
(1) The local health department shall authorize the removal of the Notice of Methamphetamine Contamination if:
(a) The property has been decontaminated and written approval for release by the Energy and Environment Cabinet has been received; or
(b) A properly submitted appeal as established in Section 3 of this administrative regulation has resulted in the secretary determining the property was issued a Notice of Methamphetamine Contamination improperly and a copy of such determination has been received by the local health department.
(2) The local health department shall notify, in writing within ten (10) business days of notification established in subsection (1) of this section the property owner listed on the deed of the property that:
(a) The Notice of Methamphetamine Contamination has been authorized to be removed from the entrances of the inhabitable property; and
(b) Disclosure requirements no longer apply.
(3) The local health department shall notify within ten (10) business days the cabinet, the Division of Waste Management, and the Kentucky State Police Methamphetamine Coordinator that the inhabitable property has been released.
(4) The local health department shall retain copies of notifications of release from Energy and Environmental Cabinet for at least seven (7) years.
Section 6. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "DFS 407, Notice of Methamphetamine Contamination", July 2009; and
(b) "DFS 407, Notice of Methamphetamine Contamination", 2009.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.180, 212.210, 218A.1431, 224.01-410, 224.99-010(14), (15)
- STATUTORY AUTHORITY: KRS 211.180, 212.210, 224.01-410(9), (10)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 224.01-410(9) requires the Department for Public Health to promulgate administrative regulations to establish requirements for notices, notice posting, and notice removal for an inhabitable property contaminated with methamphetamine. KRS 224.01-410(10) requires the Department for Public Health to promulgate administrative regulations to establish disclosure requirements for a methamphetamine property if the property is to be leased, rented, or sold. This administrative regulation establishes standards for the posting and removal of warning signs for a methamphetamine-contaminated property and establishes disclosure and appeal procedures for the owner of a methamphetamine-contaminated property if the property is to be leased, rented, or sold.
- History: 902 KAR 047:200. 35 Ky.R. 2843; 36 Ky.R. 328; eff. 8-12-2009; Crt eff. 3-22-2019; Crt eff. 10-13-2025.
Chapter 48 Lead Abatement
902 KAR 48:010 Definitions for 902 KAR Chapter 48 {#sec-902-kar-48-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 48:010}
Section 1. Definitions.
(1) "Abatement permit" means a permit issued by the department to a person who plans to conduct lead-hazard abatement in target housing or child-occupied facilities.
(2) "Abatement permit holder" means a person who:
(a) Is certified by the department to conduct lead abatement activities; and
(b) Has been issued a permit by the department to conduct specific lead abatement activities.
(3) "Abatement plan" means a detailed, written description of proposed planned abatement activities for lead-hazard abatement, environmental lead-hazard control, cleanup, and clearance.
(4) "Accredited training program" means a program for training individuals engaged in lead-hazard detection and abatement activities, conducted by a training provider accredited by the department.
(5) "Adequate quality control" is defined by 40 C.F.R. 745.223.
(6) "Approved course" means a training course:
(a) Approved under the initial accreditation requirement of a training program; and
(b) Conducted by a provider who has met the notification and reporting requirements of 902 KAR 48:030, Section 12.
(7) "Certificate of accreditation" means the document issued by the department to a training provider certifying that the provider has been approved to provide training courses for individuals who perform lead-hazard detection and abatement activities.
(8) "Chewable surface" is defined by 40 C.F.R. 745.63.
(9) "Child" means a person six (6) years of age or younger.
(10) "Child-occupied facility" is defined by KRS 211.9061(1).
(11) "Clearance level" is defined by 40 C.F.R. 745.223.
(12) "Common area" is defined by 40 C.F.R. 745.223.
(13) "Composite dust sample" means a sample of dust:
(a) Consisting of two (2) or more subsamples;
(b) Representing each component being tested; and
(c) Containing a subsample from only one (1) type of component.
(14) "Containment" is defined by 40 C.F.R. 745.223.
(15) "Course test blue print" is defined by 40 C.F.R. 745.223.
(16) "Department" is defined at KRS 211.9061(2).
(17) "Deteriorated paint" is defined by 40 C.F.R. 745.63.
(18) "Discipline" means a category of work performed by one (1) of the following persons:
(a) Lead-hazard inspector;
(b) Lead-hazard risk assessor;
(c) Lead-hazard dust sampling technician;
(d) Lead-hazard abatement worker;
(e) Lead-hazard abatement supervisor;
(f) Lead-hazard project designer; or
(g) Lead-hazard abatement company.
(19) "Distinct painting history" is defined by 40 C.F.R. 745.223.
(20) "Documented methodologies" is defined by 40 C.F.R. 745.223.
(21) "Dripline" is defined by 40 C.F.R. 745.63.
(22) "Dust-lead hazard" is defined by 40 C.F.R. 745.65(b).
(23) "Encapsulant" is defined by 40 C.F.R. 745.223.
(24) "Encapsulation" is defined by 40 C.F.R. 745.223.
(25) "Enclosure" is defined by 40 C.F.R. 745.223.
(26) "Equivalent method" means a method demonstrated to the department by a certified person that:
(a) Is equally protective as documented methodologies;
(b) Ensures adequate quality control; and
(c) Protects the environment.
(27) "EPA" means the U.S. Environmental Protection Agency.
(28) "Friction surface" is defined by 40 C.F.R. 745.63.
(29) "Guest instructor" is defined by 40 C.F.R. 745.223.
(30) "Hands-on skills assessment" is defined by 40 C.F.R. 745.223.
(31) "Impact surface" is defined by 40 C.F.R. 745.63.
(32) "Interim control" is defined by 40 C.F.R. 745.223.
(33) "Interior window sill" is defined by 40 C.F.R. 745.63.
(34) "Large-scale" means an abatement project with ten (10) or more residential dwellings.
(35) "Lead-hazard" means a hazard due to excessive amounts of lead in:
(a) Paint;
(b) Dust; or
(c) Soil.
(36) "Lead-hazard abatement" is defined by KRS 211.9061(4).
(37) "Lead-hazard abatement worker" means a person certified by the department to perform physical lead-hazard abatement activities.
(38) "Lead-hazard company" means a firm certified by the department to perform lead-hazard assessment and abatement activities in target housing and child-occupied facilities.
(39) "Lead-hazard detection" is defined by KRS 211.9061(3).
(40) "Lead-hazard dust sampling technician" means person who performs clearance evaluation and sampling for nonabatement activities that may create a lead dust hazard.
(41) "Lead-hazard inspection" means an examination of painted surfaces within the interior or exterior of a residential structure or child-occupied facility, to determine if hazardous levels of lead are present.
(42) "Lead-hazard inspector" means a person certified by the department to conduct:
(a) Lead-hazard inspections;
(b) Sample collection; and
(c) Lead-hazard dust clearance.
(43) "Lead-hazard project designer" means a person certified by the department to prepare the following items for a lead-hazard abatement project, in accordance with 902 KAR 48:040, Section 7:
(a) Abatement project plans;
(b) Abatement reports; and
(c) Occupant protection plans.
(44) "Lead-hazard risk assessment" means an on-site investigation to determine the existence, nature, severity, location of lead hazards.
(45) "Lead-hazard risk assessor" means a person certified by the department to conduct:
(a) Lead-hazard inspections;
(b) Risk assessments;
(c) Lead-hazard screens;
(d) Sample collection; and
(e) Lead-hazard dust clearance.
(46) "Lead-hazard screen" means a risk-assessment activity requiring reduced sampling.
(47) "Lead-hazard supervisor" means a person certified by the department to:
(a) Supervise lead-hazard abatement activities; and
(b) Prepare, in accordance with 902 KAR 48:040, Section 7:
-
Abatement plans;
-
Abatement reports; and
-
Occupant protection plans.
(48) "Living area" is defined by 40 C.F.R. 745.223.
(49) "Permanently covered soil" is defined by 40 C.F.R. 745.223.
(50) "Person" is defined at KRS 217.660(3).
(51) "Play area" is defined by 40 C.F.R. 745.63.
(52) "Post-abatement report" means a report prepared at the conclusion of an abatement project, after clearance has been achieved, in accordance with 902 KAR 48:040, Section 16.
(53) "Quality assurance inspection" means an inspection conducted by the department to determine whether a lead abatement activity complies with:
(a) Certification requirements;
(b) Work practices; and
(c) Performance standards.
(54) "Quality control plan" means a written plan prepared by the training manager describing in-house controls to assure that the program meets the requirements in 902 KAR 48:030, Section 5.
(55) "Recognized laboratory" is defined by 40 C.F.R. 745.223.
(56) "Reduction" is defined by 40 C.F.R. 745.223.
(57) "Related work experience" means experience in a profession associated with lead, asbestos, or environmental remediation work; building renovation and remodeling; or building construction.
(58) "Residential dwelling" is defined by 40 C.F.R. 745.223.
(59) "Room" is defined by 40 C.F.R. 745.63.
(60) "Small-scale" means an abatement project with less than ten (10) residential dwellings.
(61) "Soil-lead hazard" is defined by 40 C.F.R. 745.65(c).
(62) "Soil sample" means a sample collected in a representative location using:
(a) ASTM E 1727 "Standards Practice for Field Collection of Soil Samples for Lead Determination by Atomic Spectroscopy Techniques";
(b) A documented methodology; or
(c) An equivalent method.
(63) "Target housing" is defined by KRS 211.9061(5).
(64) "Third-party examination" means a written test approved and administered by the department or its designated agent.
(65) "Training day" means eight (8) training hours.
(66) "Training hour" is defined by 40 C.F.R. 745.223.
(67) "Training manager" is defined by 40 C.F.R. 745.223.
(68) "Window trough" is defined by 40 C.F.R. 745.63.
(69) "Wipe sample" is defined by 40 C.F.R. 745.63.
(70) "XRF" means an x-ray fluorescence device that indicates the lead levels of paint on a painted surface.
History
- RELATES TO: KRS 211.180, 211.900-211.905, 211.9061-211.9079, 211.994, 217.660, 217.801, 40 C.F.R. Part 745
- STATUTORY AUTHORITY: KRS 211.090(3), 211.9065(4), 211.9067, 211.9071
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.9065(4) and 211.9067 authorize the Department for Public Health to promulgate administrative regulations relating to the training, certification of persons, and standards and procedures for activities related to conducting lead-hazard assessment and abatement activities in target housing or child-occupied facilities. KRS 211.9071 requires the department to comply with the applicable rules and regulations of all federal agencies having jurisdiction over issues concerning lead-hazards. This administrative regulation establishes definitions for 902 KAR Chapter 48.
- History: 28 Ky.R. 1278; 1866; eff. 2-7-2002; Crt eff. 11-5-2019; 48 Ky.R. 661; eff. 11-23-2021; Crt. eff 8-12-2026.
902 KAR 48:020 Training and certification requirements for persons who perform lead-hazard detection or abatement {#sec-902-kar-48-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 48:020}
Section 1. Application Procedures. An applicant for certification shall submit to the department:
(1) An application fee:
(a) In the amount established in Section 8 of this administrative regulation;
(b) By check or money order; and
(c) Made payable to the Kentucky State Treasurer;
(2) An "Application for Individual Certification"; and
(3) The following documents:
(a) A current color photograph of the applicant at least two (2) by two (2) inches in size;
(b) A copy of a course completion certificate received from a course approved by the department; and
(c) Documentation demonstrating that the applicant has met the initial requirements established for the indicated discipline, as described in Section 4 of this administrative regulation.
Section 2. Departmental Review and Certification.
(1) The department shall:
(a) Review and approve or disapprove the application for initial certification or recertification; and
(b) Notify the applicant, within ten (10) working days of receipt of the application, of the results of the review.
(2) An applicant whose application for a discipline requiring a third-party examination is approved shall:
(a) Pay to the department the examination fee in an amount established in Section 8 of this administrative regulation;
(b) Schedule with the department a date and time to take the examination;
(c) Be permitted to take the examination three (3) times within a twelve (12) month period of time;
(d) If the applicant fails the third examination, complete another approved course before reapplying for certification;
(e) If the applicant passes or is not required to take an examination, shall pay a discipline fee in an amount established in Section 8 of this administrative regulation.
(3) If an application is found to be deficient:
(a) The department shall notify the applicant that:
-
Specified supplemental documentation is required;
-
Additional education or training is required; or
-
Other specified information is necessary to determine the applicant's qualifications.
(b) The applicant shall:
-
Submit the requested information before qualifying to take the required examination or otherwise complete the application process; and
-
Within twelve (12) months, become certified by the department; or
-
Reapply for certification and pay additional specified fees.
(4) The department shall:
(a) Grant individual certification upon:
-
Satisfaction of the requirements for application approval and education or training; and
-
Payment of the discipline fee;
(b) Issue a certification certificate and identification card valid for a period of two (2) years from the date of completion of the required course of training.
Section 3. Certification Through Reciprocity. An applicant shall be considered for certification by the department under an equivalent certification agreement established at KRS 211.9069.
Section 4. Initial Requirements for Each Discipline.
(1) Lead-hazard abatement worker shall successfully complete a departmental-approved lead abatement worker course.
(2) Lead-hazard inspector shall:
(a) Successfully complete an approved training course for inspectors;
(b) Have a high school diploma or equivalent; or
(c) Have a least one (1) year's related work experience.
(3) Lead-hazard risk assessor shall:
(a) Successfully complete an approved inspector course prior to the completion of an approved risk assessor course; and
(b) Have at least one (1) of the following:
-
Certification as an industrial hygienist, professional engineer, registered architect, or registered sanitarian;
-
A bachelor's degree, and one (1) year related work experience;
-
An associate degree, and two (2) years related work experience; or
-
A high school diploma or equivalent, and at least (3) years related work experience.
(4) Lead-hazard supervisor shall have:
(a) Successfully completed an accredited training course for supervisors;
(b) A high school diploma or equivalent; and
(c) At least two (2) years related work experience.
(5) Lead-hazard project designer shall have:
(a) Successfully completed an approved training course for supervisor prior to successfully completing an approved project designer course; and
(b) One (1) of the following:
-
A bachelor's degree in engineering, architecture, or a related profession, and one (1) year related work experience; or
-
Four (4) years related work experience.
(6) Lead dust sampling technician shall have:
(a) Successfully completed an approved training course; and
(b) Successfully completed department proficiency requirements.
Section 5. Certification of Lead-hazard Company.
(1) A company shall be certified by the department prior to conducting lead-hazard assessment and abatement activities and shall qualify as follows.
(2) The company applying for certification shall:
(a) Pay an application fee as identified in Section 8 of this administrative regulation; and
(b) Submit an "Application for Company Certification" with the following information:
-
A list of department certified employees; and
-
Notarized affidavit stating that the company is knowledgeable of and will follow the work practice standards established by 902 KAR 48:040.
Section 6. Individual Recertification.
(1) An applicant for recertification shall, at least thirty (30) days before the expiration date indicated on the certificate, submit to the department:
(a) A completed application;
(b) A fee established at Section 8 of this administrative regulation; and
(c) Documentation of successful completion of an approved refresher course, for the appropriate discipline, taken within the last twelve (12) months of the certification period.
(2) An applicant who applies for recertification after the time specified in subsection (1) of this section, but within six (6) months after the certification has lapsed, shall:
(a) Pass a department-approved refresher course; and
(b) Retake and pass the applicable third-party examination under the process identified in Section 2 of this administrative regulation.
(3) An applicant who fails to reapply for certification after six (6) months from the date that the certification has lapsed shall:
(a) Pass an initial course; and
(b) Reapply through the certification process as identified in Section 2 of this administrative regulation.
Section 7. Company Recertification. A lead-hazard company shall apply for recertification by submitting:
(1) The fee established by Section 8 of this administrative regulation;
(2) A current listing, as of the date of recertification, of certification numbers identifying the employees engaged in lead-hazard activities; and
(3) A notarized affidavit certifying that the company:
(a) Has continued to use the work practice standards established by 902 KAR 48:040; and
(b) Uses only departmental-certified employees to conduct lead-hazard activities in target housing and child-occupied facilities in the Commonwealth.
Section 8. Fee Schedule.
Section 9. Suspension, Revocation, Denial and Modification of Certificates. If the department suspends, revokes, denies, or modifies certification, it shall notify the certificate holder, in writing, of the following:
(1) The legal and factual basis for the suspension, revocation, denial, or modification;
(2) The commencement date and duration of the suspension, revocation, or modification;
(3) Action, if any, which the certified person may take to avoid suspension, revocation, or modification, or to receive certification in the future;
(4) The opportunity and method for requesting a hearing prior to final department action; and
(5) Other information the department deems appropriate.
Section 10. Administrative Hearings. An administrative hearing shall be conducted in accordance with 902 KAR 1:400.
Section 11. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Application for Individual Certification", 5/2021 edition; and
(b) "Application for Company Certification", 4/2021 edition.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Environmental Lead Program, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. or online at https://chfs.ky.gov/agencies/dph/dphps/psb/Pages/lead.aspx.
History
- RELATES TO: KRS 211.180, 211.900-211.905, 211.990, 211.994, 217.801
- STATUTORY AUTHORITY: KRS 211.090(3), 211.9063, 211.9067, 211.9069
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.9063(3) requires the Department for Public Health to promulgate administrative regulations to establish the training and testing requirements and procedures for certification of persons who perform or offer to perform lead-hazard detection or abatement in target housing or child-occupied facilities. KRS 211.9063(4) requires the department to promulgate administrative regulations to provide for the enforcement of the certification program. KRS 211.9067 requires the department to promulgate administrative regulations to establish a schedule of fees for permits and certification and accreditation programs. KRS 211.9069 authorizes the department to establish terms and conditions for granting equivalent certificates. This administrative regulation establishes requirements, procedures, and fees for lead-hazard related permits, certification, and accreditation, establishes terms and conditions for equivalent certification, and establishes procedures for the enforcement of the certification program.
- History: 28 Ky.R. 1281; 1869; eff. 2-7-2002; TAm eff. 9-13-2018; Crt eff. 1-11-2019; 48 Ky.R. 665; eff. 11-23-2021.
902 KAR 48:030 Accreditation of training programs and providers of educational programs for individuals who perform lead-hazard detection and abatement {#sec-902-kar-48-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 48:030}
Section 1. Initial Application Requirements for Training Programs. A training provider shall submit:
(1) An application review fee of $200 in the form of a check or money order payable to the Kentucky State Treasurer, unless exempted by federal or state law or regulation;
(2) An "Application for Lead-Hazard Training Accreditation";
(3) The name of training manager;
(4) A list of training courses proposed for accreditation;
(5) Documentation of the training manager qualifications as identified in Section 5 of this administrative regulation;
(6) Documentation of principal instructor's qualifications as identified in Section 5 of this administrative regulation;
(7) Copies of student and instructor manuals for each course;
(8) Course outlines;
(9) Copies of course agendas;
(10) The description of the activities and procedures that will be used for conducting the hands-on skills assessment for each course;
(11) Copies of hands-on skills assessment forms;
(12) Copies of course test blueprints;
(13) Copies of course tests;
(14) A copy of the quality control plan; and
(15) The location and description of the facilities and equipment used for providing lecture and hands-on training.
Section 2. Review of Accreditation Documentation.
(1) The department shall, within thirty (30) calendar days after the receipt of an application for accreditation:
(a) Approve or disapprove the application for accreditation; and
(b) Notify the applicant of its action.
(2) During the thirty (30) day period established by subsection (1) of this section, the department may request clarification or additional information from the applicant.
(3) If the department approves an application for a training program, it shall:
(a) Notify the applicant of its approval in writing; and
(b) Indicate the appropriate course fees that are to be paid to the department.
(4) On receipt of the required fee of $200 for each initial and refresher course, the department shall issue a certificate of accreditation to the training provider.
(5) If the department denies an application it shall:
(a) Notify the applicant of its denial in writing; and
(b) List the necessary additions or corrections to the application.
(6) The training provider shall have six (6) months to:
(a) Make the corrections specified in the notice of denial; and
(b) Reapply for accreditation.
(7) The provider shall be required to pay another application review fee of $200 to the department before the accreditation review process will be undertaken, if the training provider does not:
(a) Correct the deficiencies; and
(b) Resubmit the application within the six (6) months of the initial application date.
Section 3. Amending Training Program Accreditation.
(1) The accreditation of a training program shall be for two (2) years.
(2) After the training provider has applied for and received program accreditation, the provider may add a course discipline by:
(a) Amending the original accredited training program application in writing; and
(b) Paying the application and course fee.
(3) A course added to the training program during the two (2) year accreditation period shall be included with, and applied for under, the application for reaccreditation of the training program.
Section 4. Training Provider Facilities and General Course Requirements.
(1) A training provider shall provide:
(a) Adequate facilities for the delivery of the:
-
Lecture;
-
Course test;
-
Hands-on training; and
-
Assessment activities;
(b) One (1) instructor per ten (10) students when conducting hands-on skills activities and assessments;
(c) Hands-on skills training equipment consistent with current technology;
(d) Audiovisual equipment to provide effective instruction and lecture to students; and
(e) Lighting and space for effective student learning.
(2) A training provider shall:
(a) Give a course test at the completion of each course;
(b) Confirm the identity of each student by examining a photographic identification; and
(c) If applicable, conduct a hands-on skill assessment.
(3) A training provider shall not issue a course completion certificate unless the student has:
(a) Successfully completed the hands-on skills assessment;
(b) Received a score of seventy (70) percent on the course test; and
(c) Attended a least ninety (90) percent of each training day for the length of the course.
(4) If necessary, the training provider may allow the student up to two (2) weeks following the course to:
(a) Retake and pass the course examination; and
(b) Complete the hands-on skills assessment requirements.
(5) A course completion certificate shall include:
(a) The name of the student;
(b) The name of the course;
(c) The inclusive dates of the training;
(d) The name and address of the training program;
(e) The signature of the principal instructor;
(f) The signature of the training manager;
(g) The language in which the course was taught, if other than English; and
(h) A unique identification number for each student.
Section 5. Training Manager and Principal Instructor Qualifications.
(1) The training manager shall have:
(a) Two (2) or more years of experience, education, or training in teaching adults; and
(b) A bachelor or graduate degree in:
-
Building construction technology;
-
Engineering;
-
Industrial hygiene;
-
Safety;
-
Public health;
-
Education;
-
Business administration; or
-
Program management; or
(c) Two (2) or more years of experience managing an occupational health and safety training program specializing in environmental hazards; and
(d) Experience in the construction industry, in one (1) of the following areas:
-
Lead or asbestos abatement;
-
Painting;
-
Carpentry;
-
Renovation;
-
Remodeling;
-
Occupational safety and health;
-
Industrial hygiene; or
-
A related field.
(2) The principal instructor shall have:
(a) Two (2) years of experience in adult education and training;
(b) Completed an EPA-model or department approved initial course that the principal instructor will teach, except the worker course; and
(c) Experience, education, or training in:
-
Lead or asbestos abatement;
-
Painting;
-
Carpentry;
-
Renovating;
-
Remodeling;
-
Occupational safety and health; or
-
Industrial hygiene.
Section 6. Training Manager's Duties. The training manager shall:
(1) Designate a qualified principal instructor to:
(a) Organize the course; and
(b) Oversee the teaching of course materials;
(2) Designate guest instructors as needed to provide:
(a) Instruction specific to the lecture;
(b) Hands-on activities; and
(c) Work practice procedures and standards of a course;
(3) Maintain the validity and integrity of the hands-on skills assessment to ensure that the activities:
(a) Accurately evaluate the trainees' performance of the work practices and procedures associated with the course topics; and
(b) Reflect current technologies, standards and needs of the students;
(4) Maintain the validity and integrity of the course test to ensure that it accurately evaluates the trainees' knowledge and retention of the course topics;
(5) Ensure that the course test was developed in accordance with the course test blueprint submitted with the training accreditation application;
(6) Develop the quality assurance control plan, that:
(a) Is to be used to maintain and improve the quality of the training program over time; and
(b) Contains the procedures for the:
-
Periodic revision of training materials and the course test to reflect innovations in the field; and
-
Training manager's annual review of principal instructor competency; and
(7) Ensure that the training program complies with the requirements of this administrative regulation.
Section 7. Knowledge of Work Practice Standards.
(1) The training provider shall offer courses that teach:
(a) The work practice standards established in 902 KAR 48:040 for conducting lead-hazard activities; and
(b) Other related standards developed by:
-
The EPA; and
-
Other federal and state agencies.
(2) Work practice standards shall be taught in the appropriate courses to provide trainees with knowledge needed to perform safe, effective lead-hazard assessment or abatement activities in target housing and child-occupied facilities.
Section 8. Requirements for Initial Courses.
(1) The lead-hazard inspector course shall:
(a) Consist of at least twenty-four (24) training hours;
(b) Include at least eight (8) hours of hands-on training activities; and
(c) Include the following minimum curriculum requirements for inspector course topics:
-
Role and responsibilities of an inspector;
-
Background information on lead and its adverse health effects;
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Background information on federal, state and local regulations that pertain to lead hazards and lead-hazard assessment and abatement activities;
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Lead-hazard inspection methods, including selection of rooms and components for sampling or testing, with hands-on activities;
-
Paint, dust, water and soil sampling methodologies, with hands-on activities;
-
Clearance standards and testing, including random sampling, with hands-on activities;
-
Preparation of an inspection report, with hands-on activities; and
-
Recordkeeping.
(2) The lead-hazard risk assessor course shall:
(a) Consist of at least sixteen (16) training hours;
(b) Include at least four (4) hours of hands-on training activities; and
(c) Include the following minimum curriculum requirements for the risk assessor course topics:
-
Role and responsibilities of the risk assessor;
-
Collection of background information to perform a risk assessment;
-
Sources of environmental lead contamination found in paint, surface dust, soil, water and air, packaging and food;
-
Visual inspection for the purpose of identifying potential sources of lead hazards, with hands-on activities;
-
Lead-hazard screening protocol;
-
Sampling for other sources of lead exposure, with hands-on activities;
-
Interpretation of lead-sampling results, including applicable federal or state regulations pertaining to lead hazards, with hand-on activities;
-
Development of hazard control options, the role of interim controls, and operation and maintenance activities to reduce lead hazards; and
-
Preparation of a risk-assessment report.
(3) The lead-hazard supervisor course shall:
(a) Consist of at least thirty-two (32) training hours;
(b) Include at least eight (8) hours of hands-on activities; and
(c) Include the following minimum curriculum requirements for the supervisor course topics:
-
Role and responsibilities of a supervisor;
-
Background information on lead and its adverse health effects;
-
Background information on federal, state, and local regulations that pertain to lead hazards and lead-hazard assessment and abatement activities;
-
Liability and insurance issues relating to lead-hazard abatement;
-
Risk assessment and inspection report interpretation, with hands-on activities;
-
Development and implementation of an abatement and occupant protection plan;
-
Lead-hazard recognition and control, with hands-on activities;
-
Lead-hazard abatement and reduction methods, including restricted practices, with hands-on activities;
-
Interior dust abatement, cleanup, or lead-hazard control and reduction methods, with hand-on activities;
-
Soil and exterior lead dust abatement or lead-hazard control and reduction methods, with hands-on activities;
-
Clearance standards and testing;
-
Cleanup and waste disposal; and
-
Recordkeeping.
(4) The lead-hazard project designer course shall:
(a) Consist of at least eight (8) training hours; and
(b) Include the following minimum requirements for the project designer course:
-
Role and responsibilities of a project designer;
-
Development and implementation of an occupant protection plan for large-scale abatement projects;
-
Lead-hazard abatement and lead-hazard reduction methods, including restricted practices for large-scale abatement projects;
-
Interior dust abatement, cleanup, or lead-hazard control and reduction methods for abatement projects;
-
Clearance standards and testing for large-scale abatement projects; and
-
Integration of lead-hazard abatement methods with modernization and rehabilitation projects for large-scale abatement projects.
(5) The lead-hazard abatement worker course shall:
(a) Consist of at least sixteen (16) training hours;
(b) Include at least eight (8) hours of hands-on training activities; and
(c) Include the following minimum requirements for the worker course:
-
Role and responsibilities of an abatement worker;
-
Background information on lead and its adverse health effects;
-
Background information on federal, state, and local regulations and guidance to lead-hazard abatement;
-
Lead-hazard recognition and control, with hands-on activities;
-
Lead-hazard abatement and lead-hazard reduction methods, including restricted practices, with hands-on activities;
-
Interior dust abatement methods, cleanup, or lead-hazard reduction, with hands-on activities; and
-
Soil and exterior dust abatement methods of lead-hazard reduction, with hands-on activities.
(6) Lead-hazard dust sampling technician course shall:
(a) Consist of eight (8) training hours;
(b) Include at least two (2) hours hands-on training; and
(c) Include the following minimum curriculum for lead technician course:
-
Role and responsibilities of a lead technician;
-
Background information on lead and its adverse health effects;
-
Background information on federal, state and local law pertaining to lead-hazard evaluation and sampling activities;
-
Lead-hazard dust sampling methodologies, with hands-on activities;
-
Lead-hazard clearance techniques;
-
Preparation of a clearance report with hand-on activities; and
-
Recordkeeping.
Section 9. Requirements for Refresher Courses.
(1) To obtain accreditation to offer a refresher-training course, the provider shall meet the following minimum requirements:
(a) The training provider shall have been accredited by the department to teach the related initial course; and
(b) The refresher course shall teach the same topics as the initial course and shall include:
-
An overview of current safety practices relating to lead-hazard activities, including specific information pertaining to the appropriate discipline;
-
Current law relating to lead-hazard abatement, inspection, assessment activities, including specific information pertaining to the applicable discipline; and
-
Current technologies relating to lead-hazard activities, including specific information pertaining to the applicable discipline.
(2) The training hour requirements for a refresher course shall be:
(a) Eight (8) hours if the initial course was more than eight (8) hours; or
(b) Four (4) hours if the initial course was eight (8) hours or less.
(3) For each training course offered, the training provider shall:
(a) Provide relevant hands-on skills assessments; and
(b) Give a test at the completion of the course.
Section 10. Renewal of Accreditation of Training Program.
(1) Accreditation for a training program shall be for a two (2) year period following issuance.
(2) At least thirty (30) days prior to the expiration date of accreditation a training provider shall:
(a) Apply for renewal of accreditation; and
(b) Submit the following fees:
-
Reapplication review fee of $100; and
-
Course fee of $150 per course.
(3) A training provider shall also submit:
(a) An updated "Application for Lead-Hazard Training Accreditation";
(b) A list of courses for which the training provider is applying for renewal of accreditation; and
(c) Updated material and other information identified in Section 2 of this administrative regulation.
(4) The application shall be reviewed and approved or denied pursuant to provisions identified in Section 3 of this administrative regulation.
(5) If a training provider fails to apply for renewal of accreditation in accordance with this section, the training provider shall apply for initial accreditation, as established in Section 2 of this administrative regulation.
Section 11. Recordkeeping Requirements.
(1) An accredited training provider shall maintain, update, and make available to the department upon request the following records:
(a) Current curriculum, course materials, and documents reflecting changes made to these materials;
(b) Information regarding how the hands-on assessment is conducted, including:
-
Who conducts the assessment;
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How the skills are graded;
-
What facilities are used; and
-
The pass or fail rate;
(c) The quality control plan; and
(d) Results of:
-
Student hands-on skills assessments and course tests; and
-
A copy of each student's course completion certificate.
(2) The training provider shall retain the documentation for a minimum of three (3) years and six (6) months.
Section 12. Notification Requirements.
(1) The training provider shall notify the department in writing within fourteen (14) calendar days of a change in the following information:
(a) Management;
(b) Organization; or
(c) Address; and
(d) The transfer of records to the new training provider's address.
(2) The training provider shall provide written notification to the department at least fourteen (14) calendar days prior to the course start date, indicating the following information:
(a) Training provider name;
(b) Telephone number;
(c) Course name;
(d) Course location;
(e) Course start and end dates;
(f) Name of the principal instructor;
(g) Qualifications for principal instructor if not currently approved under the program accreditation by the department;
(h) Updated course materials including changes in the course agenda; and
(i) Indication if guest instructors are to be used.
(3) The training provider shall provide written notification of course correction or cancellation at a minimum of two (2) days prior to the course start date.
(4) Within fourteen (14) calendar days after the completion of a course, the provider shall provide to the department a student attendance listing containing:
(a) The name of the initial, or refresher course;
(b) Student information as follows:
-
Name;
-
Address;
-
Company affiliation if any; and
-
Test scores.
(5) A course shall not be approved if the provider fails to provide notice required by this section.
(6) The department may revoke a training program's accreditation, as authorized by KRS 211.9065(4), if a deficiency in compliance with this section is of such severity as to warrant revocation.
(7) The department may allow the training provider a variance in the notification period as identified in subsection (2) of this section if the provider:
(a) Submits a variance request in writing; and
(b) Indicates the reasons for a reduced notification time.
Section 13. Course and Training Provider Audits.
(1) The training provider shall permit access to representatives of the department in order to conduct on-site:
(a) Audits at the provider location; and
(b) Monitoring of the training courses.
(2) The department shall, if needed, use other methods to verify the documentation and continued requirements for accreditation.
Section 14. Notice to Suspend, Revoke, Deny Accreditation.
(1) The department shall suspend or revoke the accreditation of a training program if the department determines that the training provider has failed to comply with the requirements established by this administrative regulation.
(2) If the department suspends, revokes, or denies the accreditation of the training program, it shall notify the affected entity in writing of the following:
(a) The legal and factual basis for the suspension, revocation, or denial;
(b) The commencement date and duration of the suspension, or revocation; and
(c) The opportunity and method for requesting a hearing prior to final department action.
Section 15. Administrative Hearings. Administrative hearings shall be conducted in accordance with 902 KAR 1:400.
Section 16. Incorporation by Reference.
(1) "Application for Lead-Hazard Training Accreditation", 4/2021, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Environmental Lead Program, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. or online at https://chfs.ky.gov/agencies/dph/dphps/psb/Pages/lead.aspx.
History
- RELATES TO: KRS 211.180, 211.9063, 211.9069, 211.9071, 211.9075, 211.990, 217.801
- STATUTORY AUTHORITY: KRS 211.9065, 211.9067
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.9065(3) requires the Department for Public Health to promulgate administrative regulations relating to the accreditation of training programs and providers of educational programs for individuals who perform lead-hazard detection or abatement activities in target housing or child-occupied facilities. KRS 211.9067 requires the department to promulgate administrative regulations to establish a schedule of fees for certification and accreditation programs. KRS 211.9065(4) requires the department to promulgate administrative regulations to provide for enforcement of the programs. This administrative regulation establishes requirements for accreditation, curriculum content, training experience, competency and proficiency qualifications, and establishes fees for functions performed by the department.
- History: 28 Ky.R. 1284; 1871; eff. 2-7-2002; TAm eff. 9-13-2018; Crt eff. 1-11-2019; TAm eff. 1-25-2019; 48 Ky.R. 668; eff. 11-23-2021.
902 KAR 48:040 Lead-hazard abatement permit fees, permit requirements and procedures, and standards for performing lead-hazard detection and abatement {#sec-902-kar-48-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 48:040}
Section 1. Work Practice Requirements and Methodologies. Lead-hazard detection and abatement activities shall comply with:
(1) The work practice standards and procedures established by this administrative regulation;
(2) Documented methodologies recognized in federal EPA rules identified in 40 C.F.R. 745.227;
(3) Equivalent methodologies; or
(4) Local ordinances.
Section 2. Lead-Hazard Inspections.
(1) A lead-hazard inspection shall be conducted by a certified lead-hazard inspector or risk assessor.
(2) The sites and components specified in subsection (3) of this section shall be:
(a) Selected according to technical methodologies specified in Section 1 of this administrative regulation;
(b) Tested for the presence of lead in paint; and
(c) Excluded from testing if the inspector or risk assessor determines that the components were:
-
Replaced or built after 1978; or
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Not coated with lead-based paint or similar coating.
(3) The sampling scheme shall be:
(a) For a single residential dwelling or child-occupied facility, interior and exterior components with a distinct painting history; and
(b) For a multifamily dwelling or child-occupied facility, additional components with a distinct painting history in common areas.
(4) Paint shall:
(a) Be sampled under the technical methodologies specified in Section 1 of this administrative regulation; and
(b) Tested in the following manner:
-
The analysis of paint to determine the presence of lead shall be conducted using documented methodologies that incorporate adequate quality control procedures; and
-
Paint chip samples that have been collected shall be analyzed by an EPA-recognized laboratory to determine if they contain hazardous levels of lead.
(5) A certified lead-hazard inspector or risk assessor shall prepare a lead-hazard inspection report that shall include:
(a) Date of each lead-hazard inspection;
(b) Address of building;
(c) Date of construction;
(d) Apartment numbers, if applicable;
(e) Name, address, and telephone number of the owner of each residential dwelling or child-occupied facility;
(f) Name, signature, and certification number of the certified lead-hazard inspector or risk assessor who conducted the inspection;
(g) Name, address, and telephone number of the firm or individual employing each lead-hazard inspector or risk assessor, if applicable;
(h) Name, address, and telephone number of the laboratory that conducted an analysis of collected samples, if applicable;
(i) The testing method, testing device, or sampling procedure employed for paint analysis, including:
-
Quality control data; and
-
If used, the serial number and radioactive materials license number of the XRF device;
(j) Specific locations of each painted component tested; and
(k) The results of the lead-hazard inspection expressed in terms appropriate to the sampling method used.
(6) A copy of the lead-hazard inspection report shall be submitted to the department within thirty (30) days after the completion of the inspection.
Section 3. Lead-Hazard Screens.
(1) A lead-hazard screen shall be conducted by a certified lead-hazard risk assessor.
(2) For a residential dwelling or child-occupied facility, the lead-hazard risk assessor shall:
(a) Collect background information regarding the physical characteristics and occupant use patterns of the residential dwelling or child-occupied facility that may cause lead exposure to a child;
(b) Conduct a visual inspection to determine if deteriorated paint is present;
(c) Test for the presence of lead on each surface with deteriorated paint determined to have a distinct painting history;
(d) Collect paint chip and dust wipe samples using the technical methodologies specified in Section 1 of this administrative regulation;
(e) Collect at least two (2) composite dust wipe samples from each room where children are most likely to come in contact with dust, as follows:
-
One (1) from the floors; and
-
One (1) from the window troughs or sills;
(f) For a multifamily dwelling, collect one (1) additional sample from each common area where children are most likely to come in contact with lead dust;
(g) Submit paint chip or dust samples to an EPA-approved laboratory for analysis;
(h) Prepare a lead-hazard screening report that shall include:
-
The applicable component information required for a complete lead-hazard risk assessment identified in Section 4 of this administrative regulation; and
-
If warranted, recommendations for a follow-up lead-hazard risk assessment and other appropriate action; and
(i) Submit to the department, within thirty (30) days from the completion of the assessment, a copy of the lead-hazard screening report.
Section 4. Lead-Hazard Risk Assessments.
(1) A risk assessment shall be conducted by a certified lead-hazard risk assessor.
(2) A lead-hazard risk assessor shall:
(a) Collect samples using a methodology specified in Section 1 of this administrative regulation;
(b) Conduct a visual inspection of a residential dwelling or child-occupied facility to:
-
Locate deteriorated paint;
-
Assess the extent and causes of the deterioration of paint;
-
Inspect for other potential sources of lead hazard; and
-
Observe any chewable, friction, or impact surfaces;
(c) Collect information regarding the physical characteristics and occupant use patterns of the residential dwelling or child-occupied facility that may cause lead exposure to children;
(d) Test every surface coated with visibly-deteriorated paint for the presence of lead;
(e) For a residential dwelling, collect dust wipe samples, either composite or single surface, from the interior window sills and floor, where children are most likely to come into contact with dust in the living area;
(f) For a multifamily dwelling, collect additional dust wipe samples in the following locations:
-
Each common area adjacent to the residential dwelling or child-occupied facility from which samples have been taken; and
-
Each common area in the building;
(g) For a child-occupied facility, collect dust wipe samples in the following locations:
-
Each room, hallway, or stairwell; and
-
Other common areas;
(h) Collect soil samples at the following locations:
-
Exterior play areas where bare soil is present;
-
Dripline or foundation areas where bare soil is present; and
-
The rest of the yard where bare soil is present;
(i) Submit collected paint chip, dust wipe, or soil samples to an EPA-recognized laboratory; and
(j) Prepare a lead-hazard risk assessment report.
(3) The information provided in a report shall include:
(a) Date of assessment;
(b) Address of each building;
(c) Date of construction of buildings;
(d) Apartment numbers, if applicable;
(e) Name, address, and telephone number of each owner of each building;
(f) Name, signature, and certification number of the lead-hazard risk assessor conducting the assessment;
(g) Name, address, and telephone number of the firm or individual employing each lead-hazard risk assessor, if applicable:
(h) Name, address, and telephone number of each recognized laboratory conducting an analysis of collected samples;
(i) Results of the visual inspection;
(j) Testing method and sampling procedure for paint analysis employed;
(k) Specific locations of each painted component tested for the presence of lead;
(l) Diagram or floor plan showing testing locations;
(m) Data collected from on-site testing, including:
-
Quality control data; and
-
If used, the serial number of the XRF device;
(n) Results of laboratory analysis on:
-
Collected paint;
-
Soil; and
-
Dust wipe samples;
(o) Other sampling results;
(p) Background information collected described at subsection (2)(c) of this section;
(q) The history of any previous lead-hazard inspection or analysis for the presence of lead, lead-hazard assessments, or other lead hazards found in the residence, that have been given consideration, as a part of the present lead-hazard determination;
(r) A description of:
-
The location, type, and severity of identified lead hazards associated with paint; and
-
Other potential lead hazards;
(s) A description of interim controls or lead-hazard abatement for each identified lead hazard, including:
-
Description of interim controls or lead-hazard abatement options; and
-
Recommendations for addressing the lead hazard; and
(t) If the use of an encapsulant or enclosure is recommended, a suggested maintenance and monitoring schedule is required.
(4) A copy of the lead-hazard risk assessment report shall be submitted to the department within thirty (30) days after the completion of the assessment.
Section 5. Lead-Hazard Abatement Permit Application.
(1) The certified person who prepared the abatement plan shall submit:
(a) An "Application for Lead-Hazard Abatement Activities";
(b) An abatement plan with components as identified in Section 7(3) of this administrative regulation;
(c) An occupant protection plan with components identified in Section 7(4) of this administrative regulation; and
(d) The fee established by Section 6 of this administrative regulation.
(2) The department shall consider and render a decision regarding an application in accordance with KRS 211.9063(6).
(3) If an application is not approved, the applicant shall:
(a) Be notified in writing of the deficiencies;
(b) Correct the deficiencies indicated in the department's notice of disapproval; and
(c) Submit to the department:
-
The corrected application; and
-
An additional application review fee.
(4) A lead-hazard abatement permit shall be valid for the dates of issuance, unless extended by the department for the following conditions:
(a) Written request seven (7) days prior to expiration date by the lead-hazard abatement permit holder; and
(b) Provision of the following information:
-
Amended dates of abatement;
-
An amended abatement plan, if applicable; and
-
An amended occupant protection plan, if applicable.
(5) If the lead-hazard abatement activity has not been completed within the dates of issuance or permit dates extended, the lead-hazard abatement permit holder shall:
(a) Apply for an amended permit; and
(b) Pay the amended permit fee established in Section 6 of this administrative regulation.
Section 6. Application and Lead-Hazard Abatement Permit Fee Schedule.
(1) The fee for a lead-hazard abatement permit shall be:
(a) For each single family dwelling or child-occupied facility, $225;
(b) For a multifamily dwelling, $100 per residence;
(c) Exterior abatement, $125 per building; and
(d) Soil abatement, fifty (50) dollars per project.
(2) Other fees required are:
(a) Application review fee, fifty (50) dollars;
(b) Amended permit, twenty-five (25) dollars; and
(c) Reinspection fee, $100.
Section 7. Lead-Hazard Abatement and Occupant Protection Plans.
(1) Lead-hazard abatement and occupant protection plans for small-scale projects shall be prepared by a lead-hazard supervisor.
(2) Lead-hazard abatement and occupant protection plans shall be prepared by a lead- hazard project designer if:
(a) The project is a large-scale project; and
(b) The planned abatement activity creates additional lead waste material not considered low waste, such as:
-
Filtered personal or commercial water;
-
Disposable personal protective clothing; and
-
Plastic sheeting.
(3) An abatement plan shall include:
(a) Name and certification number of the lead-hazard supervisor or project designer who prepared the plan;
(b) Name and certification numbers of all lead-hazard personnel working at the site;
(c) Anticipated start and finish dates;
(d) Daily work hours at the project;
(e) Copy of job specifications relating to the project;
(f) Location of the site;
(g) Type of structure;
(h) Sequence of work activity;
(i) Lead-hazard abatement methods to be used;
(j) Diagram or floor plan showing;
-
Containment locations, including fencing;
-
Lead-hazard warning signs;
-
Wash stations and waste locations; and
-
Entrance and egress;
(k) Enclosure and containment methods and locations;
(l) Locations of rooms and components where lead-hazard abatement will occur;
(m) Reason for the selection of particular lead-hazard abatement methods for each component;
(n) If encapsulants are to be used, product usage information;
(o) Cleanup measures; and
(p) Name and address of the lead-hazard inspector or risk assessor conducting lead-hazard clearance testing.
(4) An occupant protection plan shall be:
(a) Unique to the residential dwelling or child-occupied facility;
(b) Developed prior to the lead-hazard abatement; and
(c) A detailed, written description of the measures and management procedures that will be taken during the lead-hazard abatement to protect the occupants of the building from exposure to lead hazards.
Section 8. Lead-Hazard Abatement On-site Project Requirements.
(1) In compliance with KRS 211.9063(5), a lead-hazard abatement activity shall not be conducted until the department issues a permit.
(2) The abatement permit shall be kept at the lead-hazard abatement site until:
(a) Project is complete;
(b) Lead-hazard clearance is achieved; and
(c) The department has conducted the quality assurance inspection required by KRS 211.9063(6).
(3) Only lead-hazard personnel shall be allowed on the lead-hazard abatement site during the time that lead-hazard abatement activities are being conducted.
(4) All lead-hazard personnel shall keep the department-issued identification card in possession while on site.
(5) The lead-hazard supervisor or project designer who prepared the lead-hazard abatement plan shall be:
(a) Available, within two (2) hours, to the lead-hazard abatement workers while lead-hazard abatement activities are conducted; and
(b) On site during:
-
Work site preparation;
-
The post lead-hazard abatement cleanup of work areas; and
-
At the time of the departmental quality assurance inspection.
(6) The lead-hazard abatement permit holder shall ensure that all lead-hazard abatement and post lead-hazard abatement activities comply with Section 1 of this administrative regulation.
Section 9. Specific Lead-Hazard Abatement Practices.
(1) Soil abatement shall be conducted as follows:
(a) If soil containing a hazardous level of lead is removed, the lead-hazard abatement permit holder shall provide analytical information to the department that the replacement soil does not contain amounts over the established in Section 14 of this administrative regulation; or
(b) If soil containing a hazardous lead level is not removed, the lead hazard in the soil shall be considered abated when permanently covered soil is obtained by a method identified in Section 1 of this administrative regulation.
(2) The following work practices used for lead-based paint removal shall be prohibited:
(a) Open-flame burning or torching; or
(b) Machine sanding or grinding, or abrasive blasting or sandblasting unless conducted using a high efficiency particulate air exhaust control that removes particles of three-tenths (0.3) microns or larger from the air at 99.97 percent or greater efficiency.
(c) Dry scraping unless:
-
In conjunction with heat guns;
-
Around electrical outlets; or
-
In the treatment of defective paint spots that total no more than:
a. Two (2) square feet on surfaces within a room; or
b. Twenty (20) square feet on exterior surfaces.
(d) Use of a heat gun at temperatures that exceed 1,100 degrees Fahrenheit.
Section 10. Post Abatement Lead-Hazard Clearance Procedures.
(1) Post abatement lead-hazard clearance procedures shall be performed according to a method identified in Section 1 of this administrative regulation.
(2) Post abatement lead-hazard clearance shall be performed by a lead-hazard inspector or risk assessor.
(3) Lead-hazard clearance after a nonabatement activity, such as renovation or remodeling, shall be performed by a lead-hazard inspector, risk assessor, or sampling technician.
(4) A visual inspection shall be conducted before sampling to examine for deteriorated paint, dust, or debris.
(5) Clearance sampling shall not take place if deteriorated painted surfaces or visible amounts of dust or debris are found during the visual inspection.
(6) Sampling shall be conducted using single or composite dust wipe sampling as identified in Section 1 of this administrative regulation.
(7)
(a) The certified person who conducted the clearance shall compare the residual lead levels, as determined by the laboratory analysis from each dust wipe sample, with clearance dust levels established by Section 13 of this administrative regulation.
(b) If the residual lead levels in a dust wipe sample exceed accepted clearance levels, each component represented by the failed sample shall be recleaned and retested until clearance dust levels have been met.
(8) In a multifamily dwelling with similarly constructed and maintained residential units, random sampling for clearance shall be conducted in accordance with documented methodologies.
(9) The person who conducted the lead-hazard abatement and post abatement cleanup in the residential dwelling shall not be provided knowledge of the units selected for the random sample.
Section 11. Lead-Hazard Clearance Report.
(1) After a lead-hazard clearance, the certified person shall prepare a report containing:
(a) Name of the lead-hazard inspector, risk assessor, or sampling technician conducting the clearance;
(b) Departmental certification number;
(c) Address of the property;
(d) Specified units and areas effected;
(e) Dates of clearance examination;
(f) Results of visual assessment;
(g) Results of dust wipe sample analysis;
(h) Name and address of laboratory used;
(i) Project activity information; and
(j) Lead-hazard reduction or abatement methods used.
(2) A copy of the lead-hazard clearance report shall be submitted to the department within thirty (30) days after the completion of the lead-hazard clearance.
Section 12. Levels of Lead in Paint. The determination of lead-based paint shall be in accordance with 40 C.F.R. 745.227(h).
Section 13. Dust-Lead Hazards and Clearance Dust Levels. The maximum acceptable levels used for lead-hazard clearance or other evaluation after the disturbance of lead-based paint, or for determination of potential dust-lead hazards in a residential structure or child-occupied facility shall be:
(1) In accordance with 40 C.F.R. 745.227 for interior components; and
(2) Below 800 µg/ft² for exterior components.
Section 14. Soil Lead Hazards. The determination of a soil lead hazard shall be in accordance with 40 C.F.R. 745.227(h).
Section 15. Quality Assurance Inspection.
(1) A lead-hazard abatement permit holder shall notify the department of the completion of the abatement services and clearance testing.
(2) The department shall proceed in accordance with quality assurance inspection provisions of KRS 211.9063(6).
(3) A lead-hazard abatement permit holder shall provide the department with access to the project unit to conduct a quality assurance inspection.
(4) If a department inspector discovers visual dust or paint chips, or violative work practices and standards, the inspector shall:
(a) Not conduct sampling; and
(b) Notify the lead-hazard abatement permit holder that another inspection shall be conducted after:
-
Cleanup has been completed; and
-
Another clearance is conducted.
(5) If a dust wipe sample exceeds clearance levels:
(a) The components making up the failed sample shall be:
-
Recleaned; or
-
Otherwise lead-hazard abated; and
(b) Another lead-hazard clearance shall be conducted.
(6) For each failed inspection, the lead-hazard abatement permit holder shall pay a reinspection fee as established by Section 6 of this administrative regulation.
Section 16. Post-Abatement Report.
(1)
(a) A post-abatement report shall be prepared by either the lead-hazard supervisor or project designer who prepared the abatement plan.
(b) The post-abatement report shall include the:
-
Start and completion dates of lead-hazard abatement;
-
Name and addresses of the lead-hazard supervisor or project designer preparing the report;
-
Changes made to the occupant protection plan and the lead-hazard abatement plan;
-
Name, address, and signature of each lead-hazard risk assessor or inspector conducting lead-hazard clearance sampling and the date of testing;
-
The name of each recognized laboratory that conducted the analysis;
-
Results of:
a. Lead-hazard clearance testing; and
b. Soil analysis, if applicable; and
- Suggested monitoring of encapsulation or enclosure plan according to a methodology identified in Section 1 of this administrative regulation.
(2) The post-abatement report shall be submitted to the department within thirty (30) days after the completion of the lead-hazard abatement project.
Section 17. Recordkeeping. A report required by this administrative regulation shall be retained by the lead-hazard abatement permit holder, or other certified individual who prepared the report, for three (3) years.
Section 18. Administrative Hearings. An administrative hearing relating to the subject matter of this administrative regulation shall be conducted in accordance with 902 KAR 1:400.
Section 19. Incorporation by Reference.
(1) "Application for Lead-Hazard Abatement Activities", 4/2021, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Environmental Lead Program, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. or online at https://chfs.ky.gov/agencies/dph/dphps/psb/Pages/lead.aspx.
History
- RELATES TO: KRS 211.180, 211.9063, 211.9071, 217.801, 40 C.F.R. 745.227
- STATUTORY AUTHORITY: KRS 211.090(3), 211.9075
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.9075 requires the Department for Public Health to promulgate administrative regulations relating to lead-hazard detection and abatement. This administrative regulation establishes the lead-hazard abatement permit application process, including application and permit fees, permit requirements and procedures, and the standards for performing lead-hazard detection and abatement activities in target housing or child-occupied facilities.
- History: 28 Ky.R. 1288; 1875; eff. 2-7-2002; Crt eff. 1-11-2019; TAm eff. 3-20-2020; 48 Ky.R. 673; eff. 11-23-2021.
Chapter 50 Milk and Milk Products
902 KAR 50:005 Milk Advisory Committee {#sec-902-kar-50-005 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:005}
Section 1. Procedure for the Selection of Nominees. The secretary shall appoint:
(1) Three (3) processors or representatives thereof, from nominations received from:
(a) An organization representing processors in Kentucky, which may nominate two (2) candidates for each of the three (3) positions; or
(b) An individual processor, who may submit his or her own name for consideration for appointment;
(2) Three (3) producers or representatives thereof, from nominations received from:
(a) An organization representing milk producers in Kentucky, which may nominate two (2) candidates for each position; or
(b) An individual milk producer, who may submit his or her own name for consideration for appointment; and
(3) Two (2) citizens at large to represent consumers, from nominations received from an organization that represents consumers in Kentucky, which:
(a) May submit two (2) names for each position for consideration for appointment; and
(b) Shall not nominate an individual who is directly connected with the producing, processing, or distribution of dairy products.
Section 2. Purpose and Operating Procedure.
(1) The milk advisory committee shall:
(a) Advise the department on matters pertaining to the Grade A Milk Industry or the milk-for-manufacturing industry, respectively;
(b) Provide the department with technical review and comment on proposed new department administrative regulations or amendments to existing administrative regulations; and
(c) Provide the department with other advice and direction as necessary.
(2)
(a) Members shall elect the chairperson and vice chairperson of the committee.
(b) The terms of the chairperson and vice chairperson shall be two (2) years unless:
-
Their terms on the committee expire and they are not reappointed;
-
A resignation of the chairperson or vice chairperson occurs; or
-
An additional election is called for by a majority vote of the committee members, in which the chairperson and vice chairperson may be eligible for reelection.
(3) The committee shall meet at least semiannually and on other occasions:
(a) As necessary;
(b) On call of the chairperson; or
(c) Upon request of the secretary.
(4) The meeting place and time shall be announced a minimum of five (5) days prior to a meeting.
(5) A total of five (5) of the eight (8) committee members shall constitute a quorum.
(6) A member may call a special meeting with the written endorsement of at least four (4) other committee members.
(7) The chairperson shall preside at all committee meetings and appoint subcommittees.
(8) The vice chairperson shall preside over committee meetings in the absence of the chairperson and serve as chairperson if the position is vacated until a new chairperson is elected by the members.
(9) If the chairperson and vice chairperson are absent from a regular or special meeting of the committee, the committee shall choose a committee member to function as chairperson of that meeting.
History
- RELATES TO: KRS 217C.010
- STATUTORY AUTHORITY: KRS 194.050(1), 217C.070(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 217C.070 requires the secretary to appoint a Milk Advisory Committee and requires the procedures for selection of advisory nominees to be in accordance with the administrative regulations of the secretary. This administrative regulation establishes procedures for the selection of nominees for appointment to the Milk Advisory Committee.
- History: 902 KAR 050:005. 2 Ky.R. 491; eff. 4-14-1976; 20 Ky.R. 658; eff. 10-21-1993; 46 Ky.R. 721; eff. 11-1-2019; Crt eff. 5-14-2026.
902 KAR 50:010 Definitions for milk and milk products {#sec-902-kar-50-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:010}
Section 1. Definitions.
(1) "Adulterated " means any milk or milk product adulterated as provided by KRS 217.025.
(2) "Cabinet" is defined by KRS 217C.030(2).
(3) "Certified sample collector" or "Certified sampler" means an employee of the department, fieldman or milk hauler who has been approved to collect milk samples for regulatory purposes.
(4) "Cleaned-in-place" means the procedure by which sanitary pipeline or pieces of dairy equipment are mechanically cleaned-in-place by circulation.
(5) "Dairy farm" means a place where one (1) or more milking cows or goats are kept for milking purposes, and from which a part or all of the milk produced is delivered, sold, or offered for sale to a dairy, plant, receiving station or transfer station.
(6) "Department" means the Department for Public Health.
(7) "Distributor" means a permitted person, place, or location that sells or contributes permitted products to the consumer.
(8) "Goat milk" is defined by 7 C.F.R. 58.101(k)(2).
(9) "Grade A milk and milk products" means those products produced, processed, transported and distributed in accordance with 902 KAR 50:110.
(10) "Handler" is defined by KRS 247.453(7).
(11) "Inspector" means an employee of the department who is qualified, trained, and authorized to:
(a) Perform dairy farm or plant inspections, or both;
(b) Grade raw milk;
(c) Evaluate quality control programs of milk plants; and
(d) Carry out the enforcement procedures of the department's administrative regulations relating to milk and milk products.
(12) "Manufactured milk and milk products" means those products produced, processed, transported and distributed in accordance with the department's manufacturing milk administrative regulations.
(13) "Milk" is defined by 21 C.F.R. 131.110(a).
(14) "Milk grader" means a person who is qualified for the grading of raw milk in accordance with quality standards and procedures.
(15) "Milk hauler" or "hauler" means any person who transports milk or raw milk products to or from a milk plant, receiving station or transfer station.
(16) "Milk plant" or "plant" means any place, premises, or establishment where milk or milk products are processed, stored, pasteurized, aseptically processed and packaged, or prepared for distribution.
(17) "Misbranded " means any milk or milk product misbranded as provided by KRS 217.035.
(18) "Official laboratory" means the biological, chemical, or physical laboratory which is under the direct supervision of the department.
(19) "Officially designated laboratory" means a designated milk industry or commercial laboratory authorized by the department for the examination of producer samples, commingled milk tank truck samples, milk containers, or finished products.
(20) "Pasteurized" is defined by:
(a) 7 C.F.R. 58.101(n) for products having dairy ingredients with a fat content of ten (10) percent or more, or contain added sweeteners, and condensed milk;
(b) 21 C.F.R. 131.3(b) for milk and cream;
(c) 21 C.F.R. 133.3(d) for cheese and related cheese products; and
(d) 21 C.F.R. 135.3 for frozen desserts.
(21) "Person" is defined by KRS 217.015(32).
(22) "Producer" is defined by KRS 247.4453(3).
(23) "Receiving station" is defined by 7 C.F.R. 58.101(y).
(24) "Sanitizing solution" is defined by 21 C.F.R. 178.1010.
(25) "Transfer station" is defined by 7 C.F.R. 58.101(z).
(26) "Use by" means the date on a consumer package or container of Grade A pasteurized milk or milk products subsequent to the date of manufacturing, processing or packaging that represents the period of time the product will remain unspoiled and acceptable for consumption when transported, handled and stored under approved conditions. The terms "Sale by" or "Best if used by" shall have the same meaning as "use by".
History
- RELATES TO: KRS 217.015, 217.025, 217.035, 217C.030, 247.4453, 247.453, 7 C.F.R. 58.101, 21 C.F.R. 131.3(b), 133.3(d), 135.3, 178.1010
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 authorizes the cabinet to regulate the production, transportation, processing, handling, sampling, examination, grading, labeling, standards of identity, sale and other matters relating to milk and milk products as may be necessary to protect the public health. This administrative regulation defines terms applicable to 902 KAR Chapter 50.
- History: 1 Ky.R. 279; eff. 1-8-1975; 79; eff. 8-7-1984; 13 Ky.R. 543; eff. 10-2-1986; 18 Ky.R. 1453; eff. 1-10-1992; 47 Ky.R. 435; eff. 11-19-2020.
902 KAR 50:031 Standards for producer eligibility for manufactured grade milk {#sec-902-kar-50-031 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:031}
Section 1. Manufactured Milk Producer Permits and Inspections.
(1) Any person seeking to offer raw milk for manufacturing shall submit an Application for Permit to Sell Raw Milk for Pasteurization to the department.
(2) Prior to the issuance of a permit to a manufacturing milk producer, the cabinet shall conduct an inspection of the producer's facilities.
(3) If the producer is not in compliance with 902 KAR 50:032:
(a) A permit shall not be issued;
(b) The violation shall be given in writing; and
(c) The violation shall be posted in a visible place at the dairy farm.
(4) A permit shall be issued if the inspection reveals compliance with 902 KAR 50:032.
(5) All producers shall possess a valid permit prior to beginning shipment of milk.
(6) Permits shall:
(a) Be non-transferable with respect to persons or locations; and
(b) Remain valid unless suspended or revoked by the cabinet.
Section 2. Producer Eligibility Requirements.
(1) New producers.
(a) A test for bacterial quality and sediment shall be made in accordance with 7 C.F.R. 58.138 on the first shipment of milk or after a period of non-shipment for more than ten (10) days.
(b) Subsequent tests of milk shall meet the requirements for frequency of testing and producer compliance outlined in Section 3(7)(a) of this administrative regulation.
(2) Transfer producers.
(a) Prior to collection and acceptance of milk from a transfer producer, the receiving station shall review the official status of the producer with the cabinet.
(b) The existing status of a transfer producer with regard to farm sanitation and milk quality record shall be in effect with the receiving station.
(c) A producer whose permit has been suspended by the cabinet is not eligible to transfer until the permit has been reinstated, unless approved by the cabinet.
(d) The receiving station shall sample each transfer producer's milk within ten (10) days after receipt of the producer's first shipment of milk.
(e) Subsequent sample results shall be in accordance with the provisions of Section 3 of this administrative regulation.
(3) Grade A Producer.
(a) A Grade A producer whose permit has been suspended shall be allowed to sell milk as a degraded producer to a manufacturing milk company if the Grade A violative sample is within manufacturing standards set forth in this administrative regulation.
(b) A degraded producer shall not sell milk to a manufacturing milk company for a period in excess of ten (10) days without applying for and obtaining a milk for manufacturing producer permit.
(c) Grade A surplus milk shall be tested or screened by the manufacturing milk company upon arrival to ensure the milk is in compliance with this administrative regulation.
(d) Milking by hand shall be prohibited.
Section 3. Quality Requirements for Raw Milk.
(1) Classification of raw milk for manufacturing purposes shall be in accordance with 7 C.F.R. 58.132.
(2) Sight and odor testing shall be in accordance with 7 C.F.R. 58.133(a).
(3) Bacterial classification shall be in accordance with 7 C.F.R. 58.135.
(4) Sediment content classification shall be in accordance with 7 C.F.R. 58.134.
(5) Somatic cell count shall be in accordance with 7 C.F.R. 58.133(b).
(6) Drug residue classification shall be in accordance with 7 C.F.R. 58.133(c).
(7) Examinations and tests to detect excessive water, chemical contaminants, or other adulterants shall be conducted by the cabinet as required by the Food and Drug Administration and the United States Department of Agriculture.
(a) Frequency of tests.
-
Bacterial estimate: monthly.
-
Sediment content: monthly.
-
Abnormal milk: four (4) times each six (6) months.
-
Drug residues: all marketed manufacturing grade milk shall be sampled and tested for drug residues prior to processing.
(b) Quality tests in this section shall be performed in an official laboratory or an officially designated laboratory.
Section 4. Personnel Health and Cleanliness.
(1) All personnel involved in production of manufactured milk shall comply with:
(a) 7 C.F.R. 58.129, Cleanliness; and
(b) 7 C.F.R. 58.130, Health.
(2) If reasonable cause exists to suspect the possibility of transmission of infection from any person involved with the handling of milk for manufacturing purposes, the cabinet shall require the following measures:
(a) Immediate exclusion of that person from milk handling;
(b) Immediate exclusion of the milk supply concerned; and
(c) Medical and bacteriological examination of the person and body discharges.
Section 5. Prohibited Acts Relating to Manufactured Milk Producers. The following acts are prohibited:
(1) No person shall produce, sell, or offer for sale any manufactured milk or milk products without a permit as provided in 902 KAR 50:032, 902 KAR 50:033, and this administrative regulation.
(2) No person shall produce, provide, sell, offer, or expose for sale, or have in possession with intent to sell, any manufactured milk or milk product which is adulterated, misbranded, or in violation of 902 KAR 50:032, 902 KAR 50:033, or this administrative regulation.
(3) No person shall prohibit the inspection, taking of a sample, or access to records or evidence to a duly authorized agent of the cabinet.
(4) No person shall remove, destroy, alter, forge, or falsely represent any tag, stamp, mark, or label used by the cabinet.
(5) No person shall remove or dispose of a detained or quarantined article without proper authority from the cabinet.
(6) Milking by hand shall be prohibited.
Section 6. Survey Procedures.
(1) The department may conduct a survey at least one (1) time every two (2) years on all producers assigned to milk companies, producer associations, or producer groups.
(2) A producer, company, association, or group found to have an unsatisfactory rating shall be notified and given a reasonable period of time, not to exceed six (6) months, to attain a satisfactory rating.
(3) A producer who fails to receive an acceptable rating upon resurvey shall be inspected by the cabinet to determine individual compliance.
(4) A producer who fails a survey may have a permit suspended in accordance with 902 KAR 50:032, 902 KAR 50:033, and this administrative regulation.
(5) No producer shall be allowed to transfer to another company during the resurvey period unless authorized by the cabinet.
Section 7.
(1) The "Application for Permit to Sell Raw Milk for Pasteurization", 2/2020, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.015, 217C.010, 217C.020, 217C.030, 217C.060, 217C.100, 217C.990, 7 C.F.R. Part 58 Subpart B
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 authorizes the cabinet to promulgate administrative regulations for the issuance and revocation of permits for milk producers, haulers, transfer stations, processing plants, pasteurization plants, and distributors. This administrative regulation sets uniform standards for the production, handling, examination, grading, and sale of manufactured milk and milk products.
- History: 20 Ky.R. 2276; eff. 3-14-1994; 47 Ky.R. 439; eff. 11-19-2020.
902 KAR 50:032 Standards for farm requirements for manufactured grade milk {#sec-902-kar-50-032 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:032}
Section 1. Farm Requirements for Milk for Manufacturing.
(1) Health of herd.
(a) General health. All animals in the herd shall be maintained in a healthy condition.
(b) Tuberculin test. The herd shall be located in an area within the state that meets the requirements of a modified accredited area in which not more than one-half (1/2) of one (1) percent of the cattle have been found to be infected with tuberculosis in accordance with the provisions of the Bovine Tuberculosis Eradication, Uniform Methods and Rules, 2005.
-
If the herd is not located in a modified accredited area, it shall be tested annually under the jurisdiction of the program.
-
Additions to the herd shall be from a modified accredited area or from herds meeting the requirements of this administrative regulation.
(c) Brucellosis test. The herd shall be located in an area within the state in which the percentage of cattle affected with brucellosis does not exceed one (1) percent, and the percentage of herds in which brucellosis is present does not exceed five (5) percent, in accordance with provisions of the Brucellosis Eradication, Uniform Methods and Rules, 2003, for establishing and maintaining certified brucellosis-free areas.
-
If the herd is located in an area that does not meet these requirements, the herd shall be blood-tested annually or milk-ring-tested semiannually.
-
Additions to the herd shall be from herds meeting the requirements of this administrative regulation.
(2) Milking procedures. Milking shall be done in an approved milking barn, stable, or parlor under relatively dust free conditions.
(a) The udders, flanks, and teats of all milking cows shall be free of dirt and dust at time of milking as far as is practicable.
(b) Cows which secrete abnormal milk shall be milked last or with separate equipment. This milk shall be excluded from the supply, and shall be prohibited from sale under this administrative regulation.
(c) Milking directly into cans shall be prohibited.
(3) Milking barn or milking area. An approved milking area shall be provided to allow sanitary milking operations.
(a) Work areas shall have a minimum of ten (10) foot candles of light properly distributed for both day and night milking.
(b) The milking area shall be well ventilated to minimize odors and prevent excessive condensation.
(c) Floors and gutters shall be kept clean, in good repair, graded to drain, and constructed of concrete or other impervious materials.
(d) No swine or fowl shall be permitted in the milking area.
(e) Bedding shall be permitted in the milking area if kept clean and manure is removed daily. Bedding shall be relatively dust free.
(f) The milk area ceiling shall be dust tight to prevent the entry of dust from feed stored overhead.
(g) Walls and ceilings shall be kept clean and in good repair.
(h) Feed shall be stored in a manner not to increase the dust content of the air or attract flies in the milking area.
(i) The milking area floor shall be kept clean and the manure removed daily.
(j) All manure removed from the milking area shall be discarded to prevent cows from accessing the accumulation, and minimize fly breeding.
(k) Outside surfaces of pipeline systems located in the milking area shall be kept clean.
(l) Milk stools, surcingles, and antikickers shall be kept clean and stored above the floor.
(4) Cow yard and cattle housing area. The cow yard and cattle housing area shall be constructed to be well drained and relatively free of organic waste.
(a) The cow yard shall be graded to drain as well as local conditions will permit.
(b) Cow yards which are muddy due to recent rains shall not be considered in violation of this section.
(c) The cattle housing area shall be free of excessive manure, soiled bedding, and waste material to prevent the soiling of cows' udders.
(5) Milkhouse or milkroom. There shall be a conveniently located milkhouse or milkroom for the cooling, handling, and storing of milk; and the washing, sanitizing, and storing of equipment and utensils.
(a) The floor shall be constructed of concrete and well drained.
(b) The walls and ceilings shall be constructed of relatively smooth, easily cleanable material.
(c) A drain through the floor or wall shall be provided. The drain shall not be located under the bulk tank. The drain may discharge to the surface of the ground if waste from the drain does not pool or cause an insect breeding problem.
(d) The milkhouse space shall be large enough to meet the following requirements:
-
Walkways and working areas shall be a minimum of thirty (30) inches wide;
-
The bulk tank shall be kept a minimum of eighteen (18) inches from the walls on all sides, except tanks that extend through the wall; and
-
There shall be a minimum of six (6) inches between the lowest point of the bulk tank and the floor.
(e) Artificial light shall be provided with a minimum 100 watts capacity. The light fixture shall not be located over the bulk tank.
(f) Ventilation shall be sufficient to prevent odors and condensation.
(g) The milkhouse shall be kept clean and free from unnecessary articles and used only for purposes permitted by the cabinet.
(h) Only insecticides and rodenticides approved for use in the milkhouse shall be stored in the milkhouse. Insecticides and rodenticides shall be stored to prevent contamination of milk, milking equipment, sinks, or cleaning supplies.
(i) All outer openings shall be screened or protected against the entrance of insects and rodents. Outer doors shall open outward and be self-closing, except doors between the milkroom and milking area may open either way or both ways and shall be self-closing. If during the winter months a screen door is taken down, the milkhouse door may open inward if it is self-closing.
(j) Bulk tank installations shall have an approved hose port properly constructed through the outer wall for milk pickup operations.
(k) Running water under pressure shall be provided. Water heating facilities conveniently available to supply hot water to the milkhouse shall be provided for all bulk tank installations.
(l) A two (2) compartment wash and rinse vat shall be provided; if milking equipment is cleaned-in-place, a double compartment wash vat will be acceptable.
(m) A concrete slab at least four (4) feet by four (4) feet shall be located outside the milkhouse under the hose port.
(n) The milkhouse shall be supplied with approved brushes, cleaners, and sanitizers to properly clean and sanitize equipment and utensils.
(6) Utensils and equipment.
(a) All reusable utensils, containers, and equipment used in milking procedures, handling, storage, and transportation of milk and milk products shall be:
-
Free from rust, open seams, milkstone, or any unsanitary condition;
-
Washed, rinsed, drained after each milking, stored in suitable facilities, and sanitized immediately before each use;
-
Constructed of smooth, heavy-gauge material, with a non-corrodible surface that is non-absorbent and non-toxic, and can be easily cleaned; and
-
Readily accessible for inspection.
(b) All farm bulk tanks shall comply with 7 C.F.R. 58.131(2) for construction and shall be installed in accordance with this administrative regulation.
(c) Single service articles shall be properly stored and shall not be reused.
(d) Strainers, if used, shall use single-service strainer pads only. Woven-wire cloth strainers shall not be used.
(e) New or replacement milk cans shall have an umbrella-type cover.
(f) All cleaned-in-place milk pipelines shall be rigid and self-draining. All connections shall provide a smooth, flush interior surface.
(g) Prior to use, all multiuse containers, equipment, and other utensils used in handling, storage, or transportation of milk or milk products shall be subjected to a cleaning and sanitation process.
(h) Steam, hot-water, or hot-air treatment may be accepted if the equipment or containers are completely immersed or exposed for the required time, or longer, and at the required temperature, or higher, throughout the period of exposure.
(i) Pouring hot or boiling water from vessel to vessel shall not be acceptable.
(j) All milk containers, utensils, and other equipment, with the exception of milking machine pulsators and air hoses, shall be immersed for at least one (1) minute in, or exposure for at least one (1) minute to a flow of, an approved chemical bactericide containing at least fifty (50) parts per million (ppm) chlorine or other approved sanitizer of proper strength.
(k) All milk contact surfaces shall be wetted by the bactericidal solutions.
(l) Bactericidal sprays may be used for large equipment.
(m) Chemical solutions, once used, shall not be reused for bactericidal treatment on any subsequent day, but may be reused for other purposes.
(n) All containers and other utensils used in the handling, storage, or transportation of milk or milk products, unless stored in bactericidal solutions, shall be stored to drain dry, and to prevent contamination before being used.
(o) Milk utensils and equipment shall be left in the bactericidal solution or stored in the milkhouse on racks to protect them from contamination, inverting articles that can be inverted.
(p) Pipeline milkers that are cleaned-in-place may be stored in place.
(q) Storage racks shall be constructed of metal protected against rusting, with the lowest shelf not less than twenty-four (24) inches above the floor.
(r) Strainer pads, parchment papers, and gaskets shall be stored in the original package or in a suitable container or cabinet to protect them from contamination.
(s) All equipment and utensils shall be accessible for inspection.
(t) After bactericidal treatment, containers and other milk and milk product utensils shall be handled to prevent contamination of any surface that milk or milk products come into contact.
(u) Sanitized product-contact surfaces, including farm bulk tank openings and outlets, shall be protected against contact with non-sanitized equipment, utensils, hands, clothing, splash, condensation, and other sources of contamination.
(v) Any sanitized product-contact surface exposed to contamination, shall be cleaned and sanitized before being used.
Section 2. Cooling.
(1)
(a) All milk shall be cooled within two (2) hours after milking to fifty (50) degrees Fahrenheit or lower and maintained at a maximum of fifty (50) degrees Fahrenheit until transferred to the transport truck, unless delivered to the plant within two (2) hours after milking.
(b) Milk in bulk tanks shall be cooled to a maximum of forty (40) degrees Fahrenheit within two (2) hours after milking and maintained at a maximum of fifty (50) degrees Fahrenheit until transferred to the transport truck.
(c) If the first milking does not reach the bulk tank agitators, cooling shall be considered in violation.
(2) Cooling facilities shall be available to cool and store a full supply of milk between pickup at a maximum of fifty (50) degrees Fahrenheit.
(3) Bulk tanks shall be designed and sized for everyday or every other day pickup. No bulk tank milk shall be picked up after three (3) days except in case of emergency. Paper towels shall be available for wiping the bulk tank measuring stick during milk pickup.
(4) Milk shall not be transferred from one (1) producer to another or received by one (1) producer from another.
Section 3. Water supply.
(1) Each producer shall have a properly located and protected water supply.
(2) The supply shall:
(a) Be of a sufficient size to meet the needs of the producer to properly clean equipment, milkhouse, and milking area;
(b) Be protected against surface water and, in the case of cisterns, have a filter or roof wash barrel approved by the cabinet; and
(c) Not be within 100 feet of any cesspool, privy, or lateral field unless approved by the cabinet.
(3) All new producers shall have a negative bacteriological water sample analysis prior to the issuance of a permit.
(4) If the cabinet is in doubt to the physical protection of the supply, a water sample shall be collected and analyzed by the cabinet.
(5) Samples that do not meet the requirements of this administrative regulation shall be retested within thirty (30) days after notification is given to the producer in writing by the cabinet.
(6) If two (2) consecutive samples are found to be in excess of the coliform standard, a notice of intent to suspend permit shall be issued by the cabinet and a follow-up sample collected within thirty (30) days. If the follow-up sample is in excess of the standard, the producer may be suspended until a negative sample is obtained.
(7) A water sample shall be:
(a) Taken after any repair or alteration of the water supply has been made;
(b) Taken at least every thirty-six (36) months; and
(c) Meet the requirement of this subsection.
Section 4. Waste Disposal.
(1) Manure, discarded milk, and toilet waste shall be properly disposed in a manner approved by the cabinet.
(2) Waste discharging to the ground surface shall not pool or promote fly breeding.
(3) Waste from flush type toilets shall be properly disposed underground.
(4) Pit privies shall be properly constructed to prevent fly breeding.
Section 5. Material Incorporated by Reference.
(1) The following material is incorporated by reference:
(a) "Bovine Tuberculosis Eradication, Uniform Methods and Rules", 2005; and
(b) "Brucellosis Eradication, Uniform Methods and Rules", 2003.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 217.005-217.215, 217C.010-217C.990, 7 C.F.R. 58.131(2)
- STATUTORY AUTHORITY: KRS 194A.050(1), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate programs and fulfill the responsibilities vested in the cabinet. KRS 217C.040 authorizes the secretary to adopt rules and regulations for the inspection of dairy herds, dairy farms, and such other matters relating to milk and milk products as may be necessary to protect the public health. This administrative regulation sets uniform standards for dairy herd health, milking procedures, safe handling of milk, sanitization of all milking equipment and utensils, farm construction, and inspection of dairy farms.
- History: 20 Ky.R. 2278; eff. 3-14-1994; 47 Ky.R. 442; eff. 11-19-2020.
902 KAR 50:033 Standards for enforcement procedures for manufactured grade milk {#sec-902-kar-50-033 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:033}
Section 1. Enforcement Procedures for Raw Milk.
(1) Sight and odor.
(a) Bulk tank loads or individual producer milk received at a processing facility shall be examined on an organoleptic basis by the hauler or by the milk grader.
(b) Milk shall not be received if any off odors or abnormal conditions are found which will adversely affect the finished product.
(c) Producer milk rejected for sight and odor by a hauler or milk grader shall be tagged with a reject tag.
(2) Bacterial estimates.
(a) At least one (1) time each month at irregular intervals, an official sample of each producer's milk shall be tested.
(b) Producers shall be notified of the results of all tests performed.
-
A producer shall be given a notice of intent to suspend permit by the cabinet if two (2) of the last four (4) counts exceed bacterial standards specified in 902 KAR 50:031 Section 3(3).
-
An additional sample shall be taken within twenty-one (21) days of sending the notice, but not before the lapse of three (3) days.
-
A producer shall remain under notice of intent to suspend permit if two (2) of the last four (4) samples exceed the standards.
-
A producer's permit shall be suspended by the cabinet if three (3) of the last five (5) samples exceed the standard.
(c) A producer may be issued a temporary permit by the cabinet upon receipt from the producer of a satisfactory farm inspection and form DFS-7A, Application for Reinstatement of Permit.
-
If the sample from the first milk offered for sale is in compliance, the permit shall be reinstated.
-
If the sample is not in compliance, the temporary permit shall be withdrawn.
(d) Upon issuance of the temporary permit, the producer shall have no milk in the bulk tank produced during the period the permit was suspended unless specified by the cabinet. Three (3) samples shall then be taken at the rate of not more than two (2) per week on separate days within a three (3) week period.
(e) The cabinet may reinstate the producer's permit upon receipt of a bacteria sample in compliance with standards set in 902 KAR 50:031 Section 3(3).
(3) Sediment.
(a) If the sediment disc is classified as #1, #2, or #3 the producer's milk may be accepted.
(b) If the sediment disc is classified #3, the producer shall be notified by the cabinet in writing and a second milk sample shall be collected by a certified sampler and retested on the next milk pickup.
-
If the second sample is classified #3, the producer shall be issued a notice of intent to suspend permit and an additional sample shall be collected and tested.
-
If the additional sample fails to obtain a #1 or #2 sediment sample result, the producer's permit shall be suspended.
-
If the second sample is classified #4, the producer's permit shall be suspended.
(c) If the sediment disc is classified as #4, the producer shall be notified by the cabinet in writing and the producer's milk sample shall be collected by a certified sampler and retested on the next milk pickup. If the retest of this sample fails to obtain a #1 or #2 sediment sample result, the producer's permit shall be suspended.
(d) The permit suspension shall be in effect until a #1 or #2 sediment test is obtained and upon receipt by the cabinet of an Application for Reinstatement of Permit.
(4) Abnormal milk.
(a) At least four (4) times each six (6) months an official sample of each producer's milk shall be tested for somatic cell count.
(b) The producer shall be notified in writing of tests showing a somatic cell count in excess of the standard specified in 902 KAR 50:031 Section 3(5).
(c) If two (2) of the last four (4) somatic cell counts exceed this standard, the producer shall be given a notice of intent to suspend their permit by the cabinet.
-
The producer shall remain under notice if two (2) of the last four (4) samples exceed the limit; and
-
An additional sample shall be collected within twenty-one (21) days after issuance of the notice of intent to suspend permit, but not before the lapse of three (3) days.
(d) A producer's permit shall be suspended by the cabinet if three (3) of the last five (5) somatic cell counts exceed the limit.
(e) Upon receipt of an Application for Reinstatement of Permit, a sample shall be analyzed. If the sample is in compliance, the permit shall be reinstated.
(f) Three (3) samples shall be taken at the rate of not more than two (2) per week on separate days within a three (3) week period.
(5) Drug residues.
(a) All marketed milk shall be sampled prior to processing using approved screening procedures defined in 902 KAR 50:031 Section 3(6).
-
If the presence of drug residue is detected, a confirmatory test approved by the cabinet shall be performed.
-
If the confirmatory test result is positive for drug residue, the milk shall be disposed of either in a manner that removes it from the human and animal food chain or acceptably reconditioned for animal food as determined by the cabinet.
-
If a commingled sample is positive, each producer's milk represented in the sample shall be tested immediately.
(b) All positive drug residue sample results shall be reported to the Milk Safety Branch, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621.
(c) Milk for manufacturing permit shall be suspended upon confirmed positive drug residue sample.
-
First suspension within a twelve (12) month period shall require a two (2) day minimum loss of milk or equivalent as determined by the cabinet.
-
Second suspension within a twelve (12) month period shall require a four (4) day minimum loss of milk or equivalent as determined by the cabinet.
-
Third suspension within a twelve (12) month period shall require a four (4) day minimum loss of milk or equivalent as determined by the cabinet.
(d) The milk for manufacturing permit shall be temporarily reinstated for fourteen (14) days if a negative drug residue sample of raw milk is reported to the cabinet, and the cabinet is in receipt of an Application for Reinstatement of Permit.
-
The milk for manufacturing permit shall be reinstated after the cabinet receives a copy of the 2019 Milk and Dairy Beef Residue Prevention Producer's Certificate of Participation signed by the producer and his veterinarian.
-
Failure to return the completion certificate within fourteen (14) days of the temporary reinstatement shall result in a minimum one (1) day temporary permit suspension.
Section 2. Manufacturing Milk Producer Permit Suspension and Reinstatement. In addition to the penalties established in KRS 217C.990, the cabinet may suspend or revoke an individual producer's permit, in accordance with KRS 217C.040.
(1) The cabinet shall, upon notice to the producer, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists;
(b) The producer or an employee has interfered with the cabinet in the performance of the cabinet's duties; or
(c) The producer or an employee has falsified any records or documents.
(2)
(a) In accordance with KRS 13B.070(3), a producer whose permit has been suspended three (3) times within a twelve (12) month period for a violation of any type in accordance with 902 KAR 50:031, 902 KAR 50:032, or this administrative regulation, shall be issued a notice that upon the fourth suspension within a twelve (12) month period the producer shall appear at the cabinet for a conference to show cause why the permit should be reinstated.
(b) Upon the fourth suspension within a twelve (12) month period, the producer shall appear before the cabinet to show cause why the permit should be reinstated.
(c) At this conference the cabinet may set conditions under which the permit may be reinstated.
(d) This permit suspension shall remain in effect until the conditions of the conference have been met.
(3) In all other instances of violation of 902 KAR 50:031, 902 KAR 50:032, or this administrative regulation, the cabinet shall:
(a) Serve on the producer a written notice stating the violation; and
(b) Afford the producer a reasonable opportunity to correct the violation.
(4) A producer whose permit has been suspended may, at any time, submit an Application for Reinstatement of Permit.
(5) Suspension of a permit shall remain in effect until the violation has been corrected to the satisfaction of the cabinet.
(6) For serious or repeated violations of any of the requirements of 902 KAR 50:031, 902 KAR 50:032, or this administrative regulation the producer's permit may be permanently revoked.
(7) Prior to revocation, the cabinet shall notify the producer in writing, stating the reasons for which the permit is subject to revocation and advising the permit shall be permanently revoked at the end of ten (10) days following the service of the notice, unless the Request for Hearing is filed with the Milk Safety Branch.
(8) The hearing shall be conducted in accordance with KRS 217C.100.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "2019 Milk and Dairy Beef Residue Prevention Producer's Certificate of Participation";
(b) "Application for Reinstatement of Permit", DFS-7A, 4/2020; and
(c) "Request for a Hearing", DFS 8, 4/2020.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 217.025, 217.045, 217C.010-217C.990
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040, 217C.100
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Service to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 authorizes the cabinet to promulgate administrative regulations for the issuing and revocation of permits to milk producers, haulers, transfer stations, processing plants, pasteurization plants, and distributors, and to adopt separate regulations regulating Grade A milk products and milk for manufacturing purposes. This administrative regulation sets uniform standards for the enforcement of 902 KAR 50:031 and 902 KAR 50:032 pertaining to the production, transportation, handling, sampling, examination, grading, and sale of manufactured milk and milk products; inspection of dairy farms; and the revocation and reinstatement of producer permits.
- History: 20 Ky.R. 2281; eff. 3-14-1994; 47 Ky.R. 446; eff. 11-19-2020.
902 KAR 50:040 Hauler requirements {#sec-902-kar-50-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:040}
Section 1. Milk Hauler Permit Requirements.
(1) A person shall not haul raw milk in this state without a permit from the cabinet.
(2) Individual producer delivery or transport delivery between plants or receiving and transfer stations shall not be required to have a permit.
(3) An owner of a bulk tank route truck shall immediately notify the cabinet of each new hauler.
(a) Each new hauler shall submit an Application for Permit to Haul Milk and Collect Samples of Raw Milk to the department to obtain a permit before hauling milk.
(b) A new hauler that has been inspected and certified by the cabinet shall be issued a temporary permit that is valid until the next hauler training session.
(c) Upon successful completion of the training course, the hauler shall be issued a permit.
(4) A permit shall not be transferable with respect to the person or location.
(5) A permit shall continue in force unless suspended or revoked for cause.
(6) Each hauler collecting raw milk samples for regulatory purposes shall be permitted by the cabinet as an "Official Sample Collector," according to this administrative regulation.
(7) Each hauler shall be inspected and recertified each twelve (12) months.
Section 2. Bulk Milk Hauler Standards.
(1) Each bulk milk hauler shall only use an accurate thermometer approved by the cabinet when collecting milk from dairy farms.
(2) Hands and outer clothing shall be clean during all pickup operations.
(3) A milk hauler shall smell milk for off-odors.
(4) A visual examination shall be made of the raw milk in the bulk tank.
(5) Milk visibly unfit for human consumption pursuant to KRS Chapter 217 shall be rejected and not collected.
(6) The bulk tank lid shall be closed immediately after making the visual examination if possible.
(7) The milk transfer hose used to withdraw raw milk from the farm bulk tank shall enter the milkhouse only through the hoseport provided for that purpose.
(8) If milk has leaked past the core of the outlet valve of the farm bulk tank, the outlet port of the valve shall be washed and sanitized prior to withdrawing the milk.
(9) The cap from the end of the transfer hose shall be handled in a sanitary manner and stored to prevent contamination while milk is being pumped from the farm bulk tank into the bulk milk tank truck.
(10) After the milk has been removed from the farm bulk tank, the bottom of the tank shall be observed for sediment and other foreign material.
(11) Sediment and other foreign material conditions observed shall be noted on the plant and producer's copy of the ticket.
(12) The following information concerning the collection of milk shall be recorded on the weight ticket and the producer's chart at the milkhouse:
(a) Date;
(b) Time;
(c) Temperature;
(d) Hauler identification; and
(e) Weight of the milk.
(13) After the milk has been removed from the farm bulk tank, the transfer hose shall be removed and recapped before the farm bulk tank is rinsed with water. After recapping, the transfer hose shall be rinsed free of exterior soil.
(14) A bulk milk hauler shall not collect milk from a dairy farm for delivery to a milk plant, receiving station, or transfer station unless the farm holds a valid permit or authorization for sale from the cabinet.
(15) At the time of collection of milk from each dairy farm, the bulk milk hauler shall collect the entire volume of acceptable milk being stored in the bulk tanks. Only milk in properly constructed and operated equipment shall be collected.
(16) All precautions shall be taken to prevent the entrance of flies into the milkhouse.
(17)
(a) At least one (1) time each three (3) months, the bulk milk hauler shall check the accuracy of the thermometer of each milk producer's bulk milk tanks against the hauler's thermometer.
(b) The hauler's thermometer shall be compared to a certified thermometer and corrections shall be made each six (6) months.
(c) The temperatures obtained from both thermometers shall be entered on the weigh ticket.
(d) If there is a difference between the readings on the two (2) thermometers, the reading of the bulk milk hauler's thermometer shall be reported as the official temperature on that day and each succeeding day until the thermometer on the bulk milk tank is adjusted or repaired to be accurate.
(18) If milk in a bulk tank is rejected, the reason for rejection shall be noted by the hauler and the tank shall be tagged with appropriate tags approved by the cabinet.
Section 3. Sampling Appurtenances for Bulk Milk Trucks. Every bulk milk tank truck used to collect raw milk on a bulk milk route shall be equipped with:
(1) A sample dipper or other sampling device of sanitary construction approved by the cabinet;
(2) A container suitable for the storage of the sample dipper in a sanitizing solution en route between the farms. If other sampling devices are used, they shall be protected from contamination;
(3) A sample carrying case constructed of approved material and capable of maintaining producer raw milk samples at temperatures of thirty-two (32) to forty (40) degrees Fahrenheit from the time the samples are collected until they are delivered to the milk plant, receiving station, or transfer station; and
(4) Sample racks, approved by the cabinet, of sufficient size to hold all samples of raw milk in an upright position.
Section 4. Sample Collection from Bulk Tanks.
(1) A sample shall be taken from the:
(a) Bulk milk tank of each milk producer represented on the load of raw milk being transported to a milk plant, receiving station, or transfer station; and
(b) Bulk tank truck after the last producer pickup.
(2) A sample of milk from each farm bulk tank shall be collected after the milk has been thoroughly agitated a minimum of five (5) minutes for bulk tanks less than 1,000 gallons, or ten (10) minutes for bulk tanks 1,000 gallons or more, before opening the outlet valve.
(3) A sample shall be collected in the manner established in this subsection.
(a) If a sample dipper is used, it shall be cleaned and transported between farms on the bulk milk route in an approved sanitizing solution equivalent to 100 parts per million (ppm) chlorine. Other sampling devices shall be kept free of contamination.
(b) After removal from the sanitizing solution, all of the sanitizing solution shall be drained from the sample dipper.
(c) The sample dipper shall be rinsed two (2) times in the milk in the farm bulk tank and completely drained before collecting the sample.
(d) A sample shall be collected from the bulk tank and placed in a sterile container.
(e) The sample container shall be closed and immediately placed in melting ice water in the sample carrying case.
(f) The top of the sample container shall not be submerged in the refrigerant.
(g) Producer raw milk samples shall be maintained at temperatures of thirty-two (32) to forty (40) degrees Fahrenheit until delivered to the milk plant, receiving station, or transfer station.
(h) Samples shall not be frozen.
(4) Each sample shall be identified with date and time collected, the temperature of the milk in the farm bulk tank, the route and name or identity number of the milk producer, and the name of the person collecting the sample.
(5) Prior to or at the time of collecting raw milk from the first milk producer on the bulk milk route, the bulk milk hauler shall collect a sample of milk for temperature determination. The temperature sample shall have date, time, and temperature recorded on the sample container. The sample shall be refrigerated until it arrives at the laboratory.
(6) Sampling equipment shall be rinsed in clean water immediately after each usage.
Section 5. Frequency of Raw Milk Pickup.
(1) All raw milk for manufacturing purposes shall be collected as required by 902 KAR 50:031.
(2) Raw milk collection frequencies may be waived by the cabinet in the case of an emergency.
(3) All Grade A bulk tank raw milk shall be collected at least every seventy-two (72) hours.
(4) Collection of raw milk, from the first producer on the bulk milk pickup route to the final producer, shall be without undue delay.
(5) Collection of a partial load of milk, holding the milk overnight, and finishing the collection the following day shall not be permitted unless pump and pickup hose have been washed and sanitized at a location approved by the cabinet.
Section 6. Bulk Milk Tank Truck Owner Standards.
(1) Every bulk tank truck used to collect raw milk on a bulk milk route shall be of sanitary design and construction.
(2) The owner of the bulk tank connected to the truck chassis shall:
(a) Be responsible for maintaining the bulk tank and milk contact appurtenances in good repair and in a clean, sanitary condition; and
(b) Obtain an identification number from the cabinet that shall be placed on the rear of the tank in letters at least three (3) inches high.
(3) Each bulk milk tank truck and milk contact appurtenances shall be cleaned after the completion of each day's usage and sanitized prior to beginning the next day's operation in a manner and at a location approved by the cabinet.
(4) Each plant, receiving or transfer station, or other location that washes bulk tank trucks shall provide truck wash tags.
(5) The company or person responsible for washing the bulk tank truck shall affix a wash tag in the interior pump compartment of the truck signifying the date and location where the truck and appurtenances were cleaned and sanitized, and the signature of the person responsible. Over the road tankers without rear pump compartments shall have the wash tag affixed to the top manhole cover or the outlet valve.
(6) A receiving location shall not receive milk from a truck not properly tagged signifying date and location cleaned, unless approved by the cabinet.
(7) Cleaning tags shall be removed when a truck is unloaded and the tags shall be maintained at the receiving location for a minimum of ninety (90) days.
(8) A truck that picks up and delivers two (2) loads of milk in the same day shall have a new cleaning tag affixed after the first load is delivered explaining why the truck is running unwashed on the second trip.
(9) Wash tag requirements shall apply to all farm bulk milk pickup trucks and milk transport tankers.
(10) If a transport truck is not washed by the plant that loads the truck, the truck shall have a wash tag prior to loading.
(11) A bulk milk truck shall have a properly identified wash tag before the milk is received and unloaded unless approved by the cabinet.
(12) The bulk milk tank and its milk contact appurtenances shall be protected from contamination after being cleaned and sanitized.
(13) Milk in bulk milk tank trucks shall be maintained at a temperature of forty-five (45) degrees Fahrenheit or less for Grade A milk and fifty (50) degrees Fahrenheit or less for manufacturing milk from the time of collection until delivered to a milk plant, receiving station, or transfer station. Grade A milk may be collected within two (2) hours after milking if the blend temperature in the farm bulk cooler does not exceed fifty (50) degrees Fahrenheit.
(14) Milk in farm bulk tanks in excess of forty-five (45) degrees Fahrenheit for Grade A milk and fifty (50) degrees Fahrenheit for manufacturing milk shall not be commingled with other producers' milk on a bulk tank truck, except as provided for in subsection (13) of this section.
(15) The name of the milk plant or company or the name and address of the owner of the bulk milk pickup tank shall be legibly marked on both sides or on the rear of the vehicle in letters not less than one and one-half (1 1/2) inches in height.
(16) Each bulk milk route owner shall provide a bulk milk hauler who holds a valid permit for all bulk milk collection. The permit shall be carried on the person or in the vehicle. A milk processing plant shall not receive raw milk from a Kentucky producer if the milk has not been collected by a permitted hauler.
Section 7. Milk Plant, Receiving Station, and Transfer Station Standards.
(1) The milk plant, receiving station, or transfer station shall have competent personnel to receive producer raw milk samples from each bulk milk tank truck.
(2) The temperature of the temperature sample shall be recorded and the samples shall be properly identified and stored prior to delivery to the laboratory.
(3) The milk plant, receiving station, or transfer station shall be responsible for providing facilities for the storage of producer raw milk samples at a temperature of thirty-two (32) to forty (40) degrees Fahrenheit.
(4) Raw milk samples shall be maintained at the temperature specified in subsection (3) of this section until they are received by the laboratory for analysis.
(5) A producer raw milk sample shall not be transferred to another sample container after the sample has been collected by the bulk milk hauler.
(6) Required laboratory analysis shall begin no later than thirty-six (36) hours after the first sample on the route was collected.
(7) A milk producer or bulk milk hauler shall not receive notice of which samples are to be used for bacteriological analysis.
Section 8. Milk Hauler Permit Suspension, Revocation, and Reinstatement. In addition to the penalties established in KRS 217C.990, the cabinet may suspend or revoke a milk hauler's permit, in accordance with KRS 217C.040.
(1) The cabinet shall, upon notice to the hauler and owner, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists;
(b) The hauler or owner has interfered with the cabinet in the performance of the cabinet's duties; or
(c) The hauler or owner has falsified any records or documents.
(2) In all other instances of violation of this administrative regulation, the cabinet shall:
(a) Serve on the hauler a written notice stating the violation; and
(b) Afford the hauler the opportunity to correct the violation.
(3) A hauler whose permit has been suspended may, at any time, submit an Application for Reinstatement of Permit, incorporated by reference in 902 KAR 50:033.
(4) Suspension of a permit shall remain in effect until the violation has been corrected to the satisfaction of the cabinet.
(5) For serious or repeated violations of this administrative regulation, the hauler's permit may be permanently revoked.
(6) Prior to revocation, the cabinet shall notify the hauler in writing, stating the reasons for which the permit is subject to revocation and advising the permit shall be permanently revoked at the end of ten (10) days following the service of the notice, unless the Request for a Hearing, incorporated by reference in 902 KAR 50:033, is filed with the Milk Safety Branch.
(7) The hearing shall be conducted in accordance with KRS 217C.100.
Section 9. Incorporation by Reference.
(1) "Application for Permit to Haul Milk and Collect Samples of Raw Milk", 1/2020, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, Chapter 217, 217C.010-217C.990
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090, 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health of citizens of the Commonwealth, and necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 217C.040 authorizes the cabinet to promulgate administrative regulations for the production, transportation, processing, handling, sampling, examination, grading, and sale of milk and milk products; and the issuing and revocation of permits to milk producers, haulers, transfer stations, and processing plants. This administrative regulation provides uniform standards for the transportation, handling, sampling, examination, and grading of raw milk and the issuance and revocation of milk hauler permits.
- History: MMP-1; 1 Ky.R. 287; eff. 1-8-1975; 8 Ky.R. 172; 343; eff. 11-5-1981; 20 Ky.R. 2219; eff. 3-14-1994; 47 Ky.R. 449, 1401; eff. 2-4-2021.
902 KAR 50:050 Manufacturing plant requirements {#sec-902-kar-50-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:050}
Section 1. Permits and Inspections.
(1) All persons desiring to operate a manufactured milk plant, receiving station, transfer station, or be a handler of manufactured milk, shall submit to the cabinet a "Plant Application for Permit".
(2) A qualified representative of the cabinet shall inspect each plant, receiving station, and transfer station:
(a) Prior to issuance of a permit; and
(b) At least annually thereafter.
(3) Only a person in compliance with the requirements of this administrative regulation shall be entitled to a permit.
(4) A permit shall not be transferable with respect to persons or locations.
(5) Manufactured milk and milk products from points beyond the limits of routine inspection of the Commonwealth of Kentucky, or its police jurisdiction, may be sold in the Commonwealth of Kentucky, or its police jurisdiction, if the milk or milk products are:
(a) Produced and processed under administrative regulations substantially equivalent to this administrative regulation; and
(b) The out-of-jurisdiction governmental unit concerned accepts Kentucky's manufactured milk and milk products on a reciprocal basis.
(6) Properly prepared plans for transfer stations, receiving stations, and milk plants regulated under this administrative regulation that are constructed, reconstructed or extensively altered, shall be submitted to the cabinet for approval before work is begun.
Section 2. Standards for Manufactured Milk Plants, Receiving Stations, Transfer Stations, and Handlers.
(1) All premises, buildings, facilities, equipment and utensils shall comply with 7 C.F.R. 58.125 through 128.
(2) All personnel shall comply with:
(a) 7 C.F.R. 58.129 for cleanliness; and
(b) 7 C.F.R. 58.130 for health.
(3) The transport of raw milk shall be in compliance with 7 C.F.R. 58.131 except that milk shall not be transported in milk cans.
(4) Receiving stations shall comply with 7 C.F.R. 58.131(b)(1).
(5) Transfer stations shall comply with 7 C.F.R. 58.131(b)(2).
Section 3. Prohibited Acts Relating to Manufactured Milk Plants, Receiving Stations, Transfer Stations, and Handlers. A person shall not:
(1) Process, handle, provide, sell, offer or expose for sale, or have in possession with intent to sell a milk or milk product for manufacturing purposes which is adulterated, misbranded or otherwise in violation of this administrative regulation;
(2) Prohibit, to a duly-authorized agent of the cabinet:
(a) Entry or inspection;
(b) The taking of a sample; or
(c) Access to records or evidence;
(3) Remove, destroy, alter, forge or falsely represent a tag, stamp, mark, or label used by the cabinet; or
(4) Remove or dispose of a detained or quarantined article without proper authorization from the cabinet.
Section 4. Manufactured Milk Plant, Receiving Station, Transfer Station and Handler Permit Suspension and Reinstatement.
(1) In addition to the penalties established in KRS 217C.990, the cabinet may suspend or revoke a permit issued under this administrative regulation.
(2) The cabinet shall, upon notice to the permit holder, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists;
(b) The permit holder or an employee has interfered with the cabinet in the performance of the cabinet's duties; or
(c) The permit holder or an employee has falsified any records or documents.
(3) In all other instances of violation of this administrative regulation, the cabinet shall:
(a) Serve on the permit holder a written notice stating the violation; and
(b) Afford the permit holder a reasonable opportunity to correct the violation.
(4) A permit holder whose permit has been suspended may, at any time, submit an "Application for Reinstatement of Permit", incorporated by reference in 902 KAR 50:033.
(5) Suspension of a permit shall remain in effect until the violation has been corrected to the satisfaction of the cabinet.
(6) For serious or repeated violations of this administrative regulation the permit may be permanently revoked.
(7) Prior to revocation, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit is subject to revocation and advising the permit shall be permanently revoked at the end of ten (10) days following the service of the notice, unless the "Request for a Hearing", incorporated by reference in 902 KAR 50:033, is filed with the Milk Safety Branch.
Section 5. Trade Secrets. A person who, in an official capacity, obtains under the provisions of this administrative regulation, information which is entitled to protection as a trade secret, including information as to quantity, quality, source of disposition of milk or milk products, or results of an inspection or test, shall not use the information to his own advantage or reveal it to an unauthorized person.
Section 6. Incorporation by Reference.
(1) "Plant Application for Permit", 1/2020, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.090, 217C.010, 217C.070, 217C.990, 260.813, 7 C.F.R. 58 Subpart B
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040, 217C.060
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 requires the secretary to regulate, in the interest of the public health, all aspects relating to the production and sale of milk. KRS 217C.060 authorizes the cabinet to enter into reciprocal agreements with milk control officials of federal and state agencies having standards substantially equivalent to the regulations of the secretary. This administrative regulation establishes uniform sanitary and operational standards for manufactured milk plants, receiving stations, transfer stations, and handlers, and the process for issuance and revocation of permits.
- History: FDC 14-1; 1 Ky.R. 288; eff. 1-8-1975; 5 Ky.R. 263; eff. 11-1-1978; 12 Ky.R. 1913; eff. 7-2-1986; 18 Ky.R. 1463; eff. 1-10-1992; 29 Ky.R. 2771; 30 Ky.R. 286; eff. 8-13-2003; 47 Ky.R. 576; eff. 12-15-2020.
902 KAR 50:080 Standards of identity and labeling requirements {#sec-902-kar-50-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:080}
Section 1. Labeling and Identification Requirements.
(1) All Grade A pasteurized milk and milk products offered for sale or sold in this state shall be labeled in accordance with 21 C.F.R Part 101.
(2) Milk, cream, and yogurt shall be identified in accordance with 21 C.F.R. Part 131.
(3) Cheese and related cheese products shall be identified in accordance with 21 C.F.R. Part 133.
(4) Frozen desserts shall be identified in accordance with 21 C.F.R. Part 135.
(5) Margarine shall be identified in accordance with 21 C.F.R. Part 166.
Section 2. Use By Date Required.
(1) No person shall sell or offer for sale any Grade A pasteurized milk or milk product in this state in a consumer package that does not bear the use by date as required by this administrative regulation.
(2) The use by date shall:
(a) Be in a form that is conspicuous, legible, and understandable;
(b) Be boldface print in contrast to the background, by typography, color, embossing, debossing, molding, or other manner on the package;
(c) Be placed on the part of the container most likely to be displayed for retail sale; and
(d) Not interfere with legibility of other mandatory labeling requirements of the product.
(3) The use by date shall be expressed:
(a) By the first three (3) letters of the month followed by or preceded by the numeral or numerals constituting the appropriate calendar date; or
(b) Numerically by the number of the month preceding the number of the day.
Section 3. Certification of Use By Date Required.
(1) Each distributor or processor manufacturing, processing, or packaging Grade A pasteurized milk and milk products for sale within this state shall:
(a) Comply with the provisions of this administrative regulation;
(b) Certify to the cabinet the use by date for each product; and
(c) Provide the cabinet with the research data used to support the product use by date certification request.
(2) Samples of products for use by date evaluation may be obtained at processing plants, delivery trucks, distributors, or from retail outlets. The temperature and use by date shall be officially recorded at the time of sample collection.
Section 4. Enforcement.
(1) No milk or milk products shall be offered for sale as a Grade A product after the expiration of the use by date shown on the container.
(2) All milk and milk products offered for sale after the expiration of the use by date shall be deemed to be misbranded.
(3) If a product is not sold within the period specified by the use by date, the product shall be returned to the milk plant of origin for destruction.
History
- RELATES TO: KRS 217.035, 217.037, 217C.030, 217C.060, 217C.990, 21 C.F.R. Parts 101, 131, 133, 135, 166
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 requires the cabinet adopt rules and regulations regulating the labeling, standards of identity, sale and other matters relating to milk and milk products as may be necessary to protect the public health. This administrative regulation establishes uniform standards for identifying and labeling Grade A pasteurized milk and milk products sold in Kentucky.
- History: MMP-6; 1 Ky.R. 293; eff. 1-8-1975; 20 Ky.R. 2222; eff. 3-14-1994; l 47 Ky.R. 579; eff. 12-15-2020.
902 KAR 50:090 Milk adulteration {#sec-902-kar-50-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:090}
Section 1. Antibiotics and other Inhibitory Substances Enforcement Procedure.
(1) Sampling procedure.
(a) Antibiotic tests shall be performed a minimum of four (4) times during any consecutive six (6) months on each producer's milk or on raw commingled loads and all Grade A processed milk (except cultured products). When commingled milk is tested, milk from each individual producer shall be represented in the sample.
(b) Commingled loads that show any level of antibiotics shall require each individual producer's milk on the load to be tested.
(c)
-
An individual producer's milk sample found to be positive shall be reported to the Milk Safety Branch and confirmed by laboratory report; and
-
No additional milk shall be collected from the individual producer until the producer is compliant with enforcement procedures listed in subsection (4) of this section.
(2) All loads of raw milk shall be screened for antibiotics and other inhibitory substances prior to receipt by the plant.
(3) Utilization of milk on a load showing levels of antibiotics shall be as follows:
(a) A load of raw milk with an antibiotic level below the M-a-85 (Revision #16) standards, may be accepted by the plant.
(b) A load of raw milk with a positive antibiotic level above the M-a-85 (Revision #16) standards shall not be utilized by the plant and shall be reported to the Milk Safety Branch.
(c) If a load of raw milk is commingled into a plant storage tank with other loads and later found to be positive, the storage tank shall be tested and found to be negative prior to processing.
(d) Intentional blending of loads found to be positive for antibiotics shall be prohibited.
(e) Raw milk inadvertently processed and later found to be positive for antibiotics or other inhibitory substances shall be reported to the Milk Safety Branch prior to shipment for sale. Each case will be handled individually and may require testing to determine if antibiotics are present which would prohibit sale.
(4) Enforcement procedures.
(a) Producers with first antibiotic or other inhibitory substances violation during the past twelve (12) months shall require a negative sample to be obtained from the producer's milk supply by a certified sample collector prior to the milk being collected by the hauler. Test results shall be reported to the Milk Safety Branch as soon as possible.
(b) Producers with the second antibiotic or other inhibitory substances violation during the past twelve (12) months shall:
-
Be notified by the Milk Safety Branch of the suspension by telephone and confirmed by letter. The letter confirming the suspension shall include an Application for Reinstatement of Permit, DFS-7A, incorporated by reference in 902 KAR 50:033.
-
Prior to an official sample being collected for reinstatement purposes, the producer shall request permit reinstatement in writing and indicate the problem has been corrected.
-
A representative of the Milk Safety Branch shall visit the dairy producer after the request for reinstatement is received and prior to the first official sample being taken.
-
During this farm visit the producer shall demonstrate a method of marking cows treated with antibiotics to assure milk from treated cows is not offered for sale.
-
Upon acceptance of the exclusion procedure for treated cows, an official sample shall be collected and found to be negative for antibiotics prior to shipment.
-
The first shipment of milk following the negative sample shall not exceed four (4) milkings for Grade A purposes or six (6) milkings for manufacturing purposes.
(c) Producers with more than two (2) antibiotic or other inhibitory substances violations during the past twelve (12) months shall:
-
Have their permits suspended; and
-
May request an administrative hearing by submitting a Request for a Hearing, incorporated by reference in 902 KAR 50:033, to the Milk Safety Branch within ten (10) days, to show cause why their permit should not be revoked.
-
The hearing shall be conducted in accordance with KRS 217C.100.
(5) Company or producer association policy. Companies or producer associations having policies requiring producer penalties for offering milk for sale containing antibiotics or other inhibitory substances may have precedence over the enforcement policy outlined in this administrative regulation provided that:
(a) The policy is filed in writing with the Milk Safety Branch;
(b) The policy is approved by the Milk Safety Branch as being as or more stringent than the enforcement procedures listed in this administrative regulation; and
(c) Evidence is forwarded in writing that company policy was carried out on each positive producer's milk sample found.
Section 2. Adulterated Milk (Excessive Water).
(1)
(a) Producers whose milk supplies are found to contain over ten (10) percent excessive water shall be issued a notice requiring the supply to be withheld from sale immediately.
(b) Milk from this supply shall not be sold until a sample is collected by a certified sample collector, analyzed in a certified laboratory, and is negative for excessive water.
(2)
(a) Producers whose milk supplies are found to contain more than two (2) percent but less than ten (10) percent excessive water shall be issued a notice of adulteration and the milk supply resampled after the lapse of three (3) days.
(b) Should the resample continue to show more than two (2) percent excessive water, the producer shall be issued a notice requiring the supply to be withheld from sale immediately.
(c) Milk shall not be sold from this supply until a sample is collected by a certified sample collector, analyzed in a certified laboratory, and is negative for excessive water.
(3)
(a) Producers whose milk supplies are found to contain between five-tenths (.5) percent to two (2) percent excessive water shall be notified and the milk supply resampled after a lapse of three (3) days.
(b) Should the resample continue to have between five-tenths (.5) percent to two (2) percent excessive water, a supervised sample shall be collected by an inspector or other authorized person. The supervised sample shall be used as a future reference point for the accurate freezing point for the supply.
(4) Producers who repeatedly have milk samples test positive for excessive water shall be issued a notice of permit suspension.
(5) A producer whose permit has been suspended may, at any time, submit an "Application for Reinstatement of Permit", DFS-7A, incorporated by reference in 902 KAR 50:033, to the Milk Safety Branch.
(6) Suspension of a permit shall remain in effect until a negative excessive water sample is obtained.
Section 3. Procedures for Testing Milk Samples for Chemical Contaminants.
(1) Raw milk samples shall be collected and analyzed for chemical contaminants a minimum of annually from all bulk tank truck loads representing Kentucky dairy producers and imported supplies from other states.
(2) Semiannual samples shall be collected from loads having a previous history of chemical contaminants.
(3) Finished milk and milk products manufactured and sold within Kentucky shall also be collected and analyzed.
(4)
(a) Whenever a Kentucky inspected bulk tank load of raw milk tests positive for any level of a chemical contaminant, the individual milk producers represented on the load will be immediately notified by telephone and confirmed by letter.
(b) Milk from each individual producer shall be sampled on a screening basis after notification.
(c) If out-of-state bulk tank loads are found to be contaminated, the shipping state regulatory agency will be immediately notified by telephone and confirmed in writing.
(5)
(a) Whenever laboratory results of an individual producer's milk sample shows a violation of an established tolerance level for a particular chemical contaminant, the supply shall be withheld from the market channels.
(b) The producer shall be notified by telephone and confirmed in writing.
(c) An additional follow-up confirming sample shall be collected within ten (10) working days after notification of exclusion.
(d) Continued sampling of an excluded milk producer's supply shall be maintained until an acceptable level of the contaminant is attained.
(e) The frequency of additional sampling may be at seven (7), fifteen (15), thirty (30), or sixty (60) day intervals. Higher levels will be sampled on a more frequent basis.
(f) Whenever levels based on an official sample fall below acceptable tolerance levels, the producer will be notified by telephone and confirmed in writing that the supply is again acceptable for sale.
(6)
(a) A producer may assist with testing individual cows, feeds, and water supplies at their own expense.
(b) Results from producer obtained testing shall be submitted to the Milk Safety Branch.
(7) The following procedure will be followed whenever any level of polychlorinated biphenyls (PCBs) are found in a producer's milk supply:
(a) The milk producer shall be notified of the level of PCBs in the milk supply by telephone, confirmed by letter, and the milk supply excluded.
(b) A farm inspection shall be made to determine the type of silo being used.
(c) Concrete silos coated with cumar or other sealers containing PCBs shall be condemned for use with the dairy herd.
(d) A producer with a condemned silo may:
-
Abandon the silo (do not store feed); or
-
Recoat the silo. If a silo is recoated, the producer shall notify the Milk Safety Branch for approval prior to the silo being filled.
(e) The producer's milk supply shall be placed on a continuous surveillance program until a negative sample is obtained.
Section 4. Incorporation by Reference.
(1) "M-a-85 (Revision #16)", December 2018, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Milk Safety Branch, Division of Public Health Protection and Safety, Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS Chapter 13B, 211.090, 217.025, 217C.060, 217C.100
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.180(1)(c), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Cabinet for Health and Family Service to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.180(1)(c) authorizes the cabinet to promulgate administrative regulations for the safe handling of food and food products. KRS 217C.040 authorizes the cabinet to promulgate regulations for the the production, transportation, processing, handling, sampling, examination, grading, sale, and other matters relating to Grade A and manufactured milk and milk products as may be necessary to protect the public health. This administrative regulation establishes enforcement procedures to prevent the sale of Grade A and manufactured milk and milk products adulterated with antibiotics and other inhibitory substances, chemicals, and excessive water.
- History: 11 Ky.R. 26; eff. 5-21-1984; 112; eff. 8-7-1984; 18 Ky.R. 1466; eff. 1-10-1992; 47 Ky.R. 581; eff. 12-15-2020.
902 KAR 50:110 Grade A milk and milk products standards and Grade A milk sanitation requirements {#sec-902-kar-50-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:110}
Section 1. Grade A Milk and Milk Products. The permit, sanitary, and quality requirements for the production, processing, handling, and distribution of Grade A milk and milk products shall be in accordance with the:
(1) Evaluation of Milk Laboratories, 2017 edition;
(2) Grade "A" Pasteurized Milk Ordinance, 2017 edition; and
(3) Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments, 2017 edition.
Section 2. Methods of Making Sanitation Ratings of Milk Supplies. The sanitation rating methods of Grade A milk producers, processors, and handlers shall be in accordance with the Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers, 2017 edition.
Section 3. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Evaluation of Milk Laboratories", 2017;
(b) "Grade 'A' Pasteurized Milk Ordinance", 2017;
(c) "Methods of Making Sanitation Ratings of Milk Shippers and the Certifications/Listings of Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers", 2017; and
(d) "Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments", 2017.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Cabinet for Health and Family Services, Department for Public Health, Division of Public Health Protection and Safety, Milk Safety Branch, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.050, 217C.010-217C.990
- STATUTORY AUTHORITY: KRS 194A.050(1), 217C.040
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) authorizes the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 217C.040 authorizes the secretary to adopt rules and regulations regulating the production, transportation, processing, handling, sampling, examination, grading, standards of identity, and sale of milk and milk products, and such other matters relating to Grade A milk and milk products as may be necessary to protect the public health. This administrative regulation incorporates materials related to permit requirements and sanitary standards for Grade A milk producers, processors, handlers and distributors, Grade A dry and condensed milk, Grade A dry and condensed whey, and the fabrication of single-service containers and closures for milk and milk products.
- History: 11 Ky.R. 115; eff. 8-7-84; Am. 12 Ky.R. 1918; eff. 7-2-86; 18 Ky.R. 1469; eff. 1-10-92; 29 Ky.R. 2773; 30 Ky.R. 288; eff. 8-13-2003; 31 Ky.R. 632; 946; eff. 11-17-2003; 31 Ky.R. 632; 946; eff. 11-17-2004; 37 Ky.R. 1798; 2182; eff. 4-1-2011; 45 Ky.R. 3316; eff. 7-19-2019; Crt eff. 4-21-2026.
902 KAR 50:120 Unpasteurized goat milk {#sec-902-kar-50-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 50:120}
Section 1. Applicability.
(1) This administrative regulation is applicable only to dairy goat farms offering unpasteurized goat milk direct to the consumer.
(2) All other dairy goat farms shall follow the applicable administrative regulation under 902 KAR Chapter 50.
(3) Milk produced in compliance with the requirements of this administrative regulation shall not guarantee the absence of pathogenic organisms.
Section 2. Sale Restrictions.
(1) The sale of unpasteurized goat milk pursuant to this administrative regulation shall be from on the farm sales only.
(2) Unpasteurized goat milk for direct consumer consumption shall only be sold from a permitted goat producer to persons with a written recommendation from a physician.
(3) A written recommendation statement from a physician shall be:
(a) For a specific individual;
(b) Kept on file at the producer location for one (1) year; and
(c) Subject to inspection by the cabinet.
(4) The producer shall keep on file records stating the volume of unpasteurized goat milk sold and the date of sales to each person having submitted a written recommendation statement.
Section 3. Permits.
(1) A person shall not sell or offer for sale unpasteurized goat milk, without first obtaining a permit from the cabinet.
(2) Prior to the issuance of a permit to dairy goat producer offering unpasteurized goat milk for sale, the cabinet shall conduct an inspection of the producer's facilities.
(3) If the producer is not in compliance with this administrative regulation:
(a) The permit shall not be issued;
(b) The violations shall be given to the producer in writing; and
(c) The findings posted in a conspicuous place at the farm.
(4) A permit shall be issued if the inspection reveals compliance with this administrative regulation.
(5) Permits shall not be transferable with respect to persons or locations and shall remain valid unless suspended or revoked by the cabinet.
Section 4. Inspection of Goat Farm.
(1) Each dairy goat farm offering unpasteurized milk for sale shall be inspected at least one (1) time each two (2) months after the issuance of a permit.
(2) If the violation of any requirement of this administrative regulation is found to exist on an inspection, a second inspection shall be required after the time necessary to remedy the violation, but not before three (3) days.
(3) This second inspection shall be used to determine compliance with the requirements of this administrative regulation.
(4) If a violation of the same requirement of this administrative regulation is found on the second inspection, the permit shall be suspended in accordance with Section 12 of this administrative regulation.
(5) A copy of the inspection report shall be:
(a) Provided to the producer or other responsible person;
(b) Posted in a conspicuous place on an inside wall of the milk house; and
(c) Filed with the department.
(6) Every producer offering unpasteurized goat milk for sell shall, upon request of the cabinet, permit access of officially designated persons to all parts of the milk house or facilities to determine compliance with the provisions of this administrative regulation.
Section 5. Animal Health.
(1) All milk shall be from herds that are free from tuberculosis and brucellosis.
(a) Tuberculin test. The herd shall be located in an area within the state which meets the requirements of a modified accredited area in which not more than one-half (1/2) of one (1) percent of the goat herd have been found to be infected with tuberculosis. This requirement is in accordance with the "Bovine Tuberculosis Eradication, Uniform Methods and Rules", incorporated by reference in 902 KAR 50:032.
(b) Brucellosis test. The herd shall be located in an area within the state in which the percentage of the goat herd affected with brucellosis does not exceed one (1) percent and the percentage of herds in which brucellosis is present does not exceed five (5) percent, in accordance with the "Brucellosis Eradication, Uniform Methods and Rules", incorporated by reference in 902 KAR 50:032.
(2) A certificate identifying test results of each animal, signed by a veterinarian, shall be submitted to the cabinet for each test required by this section.
(3) Failure to comply with the requirements of this section shall result in immediate permit suspension.
Section 6. Sampling Frequency and Required Test.
(1) A representative sample of the unpasteurized goat milk shall be collected at the farm by the cabinet each month.
(2) All samples shall be analyzed for bacteria count, somatic cell count, antibiotics, adulteration with water, and temperature in an official laboratory or an officially designated laboratory.
(3) Additional samples shall be collected at the farm by the cabinet at least every two (2) months and analyzed for pathogenic organisms in an official laboratory.
(4) Samples of unpasteurized goat milk may be collected for pesticide analysis as directed by the cabinet.
(5)
(a) If two (2) of the last four (4) consecutive bacterial counts, somatic cell counts, or cooling temperatures, taken on separate days, exceed the limit established in Section 7 of this administrative regulation, the cabinet shall send a written notice to the producer;
(b) The notice shall be in effect so long as two (2) of the last four (4) consecutive samples exceed the limit of the standard; and
(c) An additional sample shall be taken within twenty-one (21) days of the sending of the notice, but not before the lapse of three (3) days.
(6) Immediate suspension of permit in accordance with Section 12 of this administrative regulation shall be instituted if the limit established in Section 7 of this administrative regulation is violated by three (3) of the last five (5) bacterial counts, cooling temperatures, or somatic cell counts.
(7)
(a) If an antibiotic or pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected.
(b) An additional sample shall be taken and tested for antibiotic or pesticide residues.
(c) Milk shall not be offered for sale until it is shown, by a subsequent sample, to be free of antibiotic or pesticide residues or below the actionable levels established for residues.
(8) If pathogenic organisms are found in the milk, immediate permit suspension shall occur and milk shall not be sold from the farm until at least four (4) consecutive tests taken on separate days contain no pathogenic organisms upon laboratory analysis.
Section 7. Bacterial, Chemical, and Temperature Standards.
(1) Unpasteurized goat milk shall be produced, handled, stored, and packaged to conform to the following standards:
(a) Temperature - cooled to between thirty-six (36) and forty (40) degrees Fahrenheit or less within two (2) hours after milking. Subsequent milkings shall not exceed forty-five (45) degrees Fahrenheit if blended with previous milkings.
(b) Bacterial limits - not to exceed 20,000 per milliliter.
(c) Somatic cells - not to exceed 1,000,000 per milliliter.
(d) Antibiotics - negative.
(e) Coliform - not to exceed ten (10) per milliliter.
(f) Pathogens - negative.
(g) Pesticides and chemical adulterants - negative.
(2) No process, manipulation, or additives shall be applied to the milk, other than appropriate refrigeration, for the purpose of removing or deactivating microorganisms.
Section 8. Sanitation Requirements.
(1) The milking area, milk house operations, and equipment shall be located and conducted to prevent contamination of milk, equipment, containers, and utensils.
(2) Abnormal milk.
(a) Goats that show evidence of secreting abnormal milk based upon bacteriological, chemical, or physical examination, shall be milked last or with separate equipment and the milk shall be discarded.
(b) Goats treated with, or who have consumed chemical, medicinal, or radioactive agents capable of being secreted in the milk and damaging to human health, shall be milked last or with separate equipment and the milk discarded.
(3) Milking barn or parlor construction.
(a) A milking barn or parlor shall be provided on all farms and located to be readily accessible to both the milk room and animal housing area.
(b) The milking barn or parlor shall:
-
Have floors constructed of concrete or equally impervious material;
-
Have walls and ceilings that are water resistant, cleanable, smooth, in good repair, and the ceiling dust tight;
-
Be provided with natural or artificial light, well distributed for day or night milking;
-
Have ventilation and fresh air inlets for air circulation to prevent condensation and excessive odors;
-
Not be overcrowded; and
-
Have dust tight covered boxes or bins, or separate storage facilities for feed.
(c) The interior of the milking barn or parlor shall be kept clean.
(d) Swine and fowl shall be kept out of the milking area.
(4) Goat yard.
(a) The goat yard shall be graded and drained, and shall have no standing pools of water or accumulations of organic wastes.
(b) In loafing or goat housing areas, goat droppings and soiled bedding shall be removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the goat's udder and flanks.
(c) Waste feed shall not be allowed to accumulate.
(d) Manure packs shall be properly drained and shall provide a firm footing.
(e) Swine shall be kept out of the goat yard.
(5) Milk house or room construction and facilities.
(a) A milk house or room shall:
- Be a sufficient size for the:
a. Cooling, handling, storing, and packaging of milk; and
b. Washing, sanitizing, and storing of milk containers and utensils, except as provided in subsections (8)(c) and (d) of this section;
-
Have a smooth floor constructed of concrete or equally impervious material graded to drain, and maintained in good repair;
-
Have walls and ceilings constructed of smooth material, in good repair, and well painted or finished in an equally suitable manner;
-
Have adequate natural or artificial light and be well ventilated;
-
Be used for only milk house operations; and
-
Be free of trash, animals, and fowl.
(b) There shall not be a direct opening from the milk house or room into a barn, stable, or room used for domestic purposes.
(c) A direct opening between the milk house and milking barn, or parlor, is permitted if a tight-fitting, self-closing solid door hinged to be single or double acting is provided.
(d) Potable water under pressure shall be piped into the milk house.
(e) The milk house shall be equipped with a two (2) compartment wash vat and adequate hot water heating facilities.
(f) Separate handwashing facilities shall be provided in the milk house with running potable water, soap or detergent, and individual sanitary towels.
(g) Bottling or packaging may be carried out in the milk house or room if it is done in a sanitary manner and by a method that prevents contamination.
(6) Toilet. Every farm shall be provided with one (1) or more toilets, conveniently located and properly constructed, operated, and maintained in a sanitary manner. The waste shall be inaccessible to flies and shall not pollute the soil surface or contaminate the water supply.
(7) Water supply. Water for milk house or room, and milking operations shall be:
(a) From a supply properly located, protected, and operated; and
(b) Easily accessible, adequate, and of a safe, sanitary quality.
(c) No cross-connection shall exist between a safe water supply and an unsafe or questionable water supply, or any other source of pollution.
(d) A well or other source of water shall be located and constructed to prevent underground or surface contamination from a sewerage system, privy, or other source of pollution from reaching the water supply.
(e) Individual water supplies and water supply systems that have been repaired or become contaminated shall be thoroughly disinfected before being placed in use. The supply shall be made free of the disinfectant by pumping to waste before a sample for bacteriological testing shall be collected.
(f) All containers and tanks used in the transportation of water shall be sealed and protected from possible contamination. These containers and tanks shall be subjected to a thorough cleaning and a bacteriological treatment prior to filling with potable water to be used at the farm.
(g) Samples for bacteriological examination shall be taken upon the initial approval of the physical structure, if a repair or alteration of the water supply system has been made, and at least every year.
(8) Utensils and equipment.
(a) All multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be:
-
Made of smooth, nonabsorbent, corrosion-resistant, nontoxic materials;
-
Constructed for easy cleaning; and
-
In good repair.
(b) Multiple-use woven material shall not be used for straining milk.
(c) All single-service articles shall be manufactured, packaged, transported, and handled in a sanitary manner. Articles intended for single-service use shall not be reused.
(d) Containers for purchasing milk may be provided by the person purchasing the milk, and these containers shall not be washed, sanitized, or stored at the farm.
(e) The product-contact surfaces of all multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be:
-
Cleaned after each usage; and
-
Sanitized before each use.
(f) After sanitization, all containers, utensils, and equipment shall be handled in a manner to prevent contamination of a product-contact surface.
(g) All containers, utensils, and equipment used in the handling, storage, or transportation of milk, unless stored in sanitizing solutions, shall be stored to assure complete drainage, and protected from contamination prior to use.
(h) Pipeline milking equipment such as milker claws, inflations, weigh jars, meters, milk hoses, milk receivers, tubular coolers, and milk pumps that are designed for mechanical cleaning may be stored in the milking barn or parlor if this equipment is designed, installed, and operated to protect the product and solution-contact surfaces from contamination at all times.
(9) Insect and rodent control.
(a) Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects, rodents, and chemicals used to control vermin;
(b) Milk houses or rooms shall be free of insects and rodents; and
(c) Surroundings shall be kept neat, clean, and free of conditions that harbor or are conducive to the breeding of insects and rodents.
Section 9. Milking Procedures.
(1) All milking shall be done in the milking barn or parlor.
(2) Milking by hand shall be prohibited.
(3) The flanks, udders, and bellies of all milking goats shall be free from visible dirt.
(4) All brushing shall be completed prior to milking.
(5) The udders and teats of all milking goats shall be cleaned and treated with a sanitizing solution prior to milking, and shall be dry before milking.
(6) Hands shall be washed clean and dried with an individual sanitary towel immediately before milking or performing any milk house function, and immediately after the interruption of any of these activities.
(7) All personnel shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.
Section 10. Personnel Health.
(1) A person shall not work at the farm in any capacity while having a disease in a communicable form, or being a carrier of a communicable disease.
(2) The owner of a dairy goat farm on which a communicable disease occurs, or who suspects that an employee has contracted a disease in a communicable form, or has become a carrier of a disease, shall notify the cabinet immediately.
(3) If reasonable cause exists to suspect the possibility of transmission of infection from a person involved with the handling of milk, the cabinet shall require the following measures:
(a) The immediate exclusion of that person from milk handling;
(b) The immediate exclusion of the milk supply concerned from distribution and sale; and
(c) Adequate medical and bacteriological examination of the person involved in milk production or handling activities.
Section 11. Trade Secrets. No person shall, in an official capacity, obtain information under the provisions of this administrative regulation including information as to the quantity, quality, source, or disposition of milk or milk products, or results of inspections or tests to use the information to his or her own advantage or to reveal it to an unauthorized person.
Section 12. Permit Suspension, Revocation and Hearing Procedure. In addition to the penalties established in KRS 217C.990, the cabinet may suspend or revoke an individual producer's permit, in accordance with KRS 217C.040.
(1) The cabinet shall, upon notice to the producer, immediately suspend the permit if:
(a) There is reason to believe that an imminent public health hazard exists;
(b) The producer or an employee has interfered with the cabinet in the performance of the cabinet's duties; or
(c) The producer or an employee has falsified records.
(2)
(a) A producer whose permit has been suspended three (3) times within a twelve (12) month period for a violation of any type in accordance with this administrative regulation, shall be issued a notice that upon the fourth suspension within a twelve (12) month period the producer shall appear at the cabinet for a conference to show cause why the permit should be reinstated.
(b) Upon the fourth suspension within a twelve (12) month period, the producer shall appear before the cabinet to show cause why the permit should be reinstated.
(c) At this conference the cabinet may set conditions under which the permit may be reinstated.
(d) This permit suspension shall remain in effect until the conditions of the conference have been met.
(3) In all other instances of violation of this administrative regulation, the cabinet shall:
(a) Serve on the producer a written notice stating the violation; and
(b) Afford the producer a reasonable opportunity to correct the violation.
(4) A producer whose permit has been suspended may, at any time, submit an "Application for Reinstatement of Permit" incorporated by reference in 902 KAR 50:033.
(5) Suspension of a permit shall remain in effect until the violation has been corrected.
(6) For serious or repeated violations of any of the requirements of this administrative regulation the producer's permit may be permanently revoked.
(7) Prior to revocation, the cabinet shall notify the producer in writing, stating the reasons for which the permit is subject to revocation and advising the permit shall be permanently revoked at the end of ten (10) days following the service of the notice, unless the "Request for a Hearing", incorporated by reference in 902 KAR 50:033, is filed in accordance with KRS 217C.100.
History
- RELATES TO: KRS Chapter 217C
- STATUTORY AUTHORITY: KRS 217C.090
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217C.090 authorizes the secretary of the Cabinet for Health and Family Services to issue administrative regulations allowing, upon written recommendation of a physician, the sale of goat milk which has not been pasteurized. This administrative regulation establishes uniform standards for the production, handling, sampling, examination, and sale, at the farm, of goat's milk which has not been pasteurized; the inspection of the goat farm facilities; and the issuance, revocation, and reinstatement of farm permits.
- History: 15 Ky.R. 763; 987; eff. 9-21-1988; 20 Ky.R. 2222; eff. 3-14-1994; 47 Ky.R. 584; eff. 12-15-2020.
Chapter 55 Controlled Substances
902 KAR 55:015 Schedules of controlled substances {#sec-902-kar-55-015 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:015}
Section 1. Schedule I Controlled Substances.
(1) Each substance that is scheduled or designated as a Schedule I controlled substance under 21 C.F.R. 1308.11, including a substance temporarily scheduled or designated under 21 C.F.R. 1308.11(h) or 1308.49, shall be scheduled or designated at the state level as a Schedule I controlled substance.
(2) The Cabinet for Health and Family Services designates the following as Schedule I controlled substances:
(a) tianeptine;
(b) bromazolam; and
(c) 7-hydroxymitragynine (7-OH) concentrated at a level above 400 parts per million on a dry weight basis. This designation does not apply to mitragynine.
(3) The following shall be exempt from control as a Schedule I substance:
(a) Cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols pursuant to the exemption established in 21 C.F.R. 1308.35; and
(b) Any substance or product exempt from the definition of marijuana pursuant to KRS 218A.010(27)(a) – (f).
Section 2. Schedule II Controlled Substances. Each substance that is scheduled or designated as a Schedule II controlled substance under 21 C.F.R. 1308.12 shall be scheduled or designated at the state level as a Schedule II controlled substance.
Section 3. Schedule III Controlled Substances.
(1) Except as provided by subsection (2) of this section, each substance that is scheduled or designated as a Schedule III controlled substance under 21 C.F.R. 1308.13 shall be scheduled or designated at the state level as a Schedule III controlled substance.
(2) The Cabinet for Health and Family Services designates the following as Schedule III controlled substances:
(a) Pentazocine;
(b) Barbital;
(c) Methylphenobarbital; and
(d) Phenobarbital.
(3) This section shall not apply to any material, compound, mixture, or preparation containing any quantity of an anabolic steroid substance, or any isomer, ester, salt, or derivative thereof that is:
(a) Expressly intended for administration through implant to livestock or other nonhuman species; and
(b) Approved by the United States Food and Drug Administration for use as described in this subsection.
Section 4. Schedule IV Controlled Substances.
(1) Except as provided by subsection (2) of this section and Section 3(2) of this administrative regulation, each substance that is scheduled or designated as a Schedule IV controlled substance under 21 C.F.R. 1308.14 shall be scheduled or designated at the state level as a Schedule IV controlled substance.
(2) The Cabinet for Health and Family Services designates the following as a Schedule IV controlled substance: nalbuphine.
Section 5. Schedule V Controlled Substances.
(1) Except as provided by subsection (2) of this section, each substance that is scheduled or designated as a Schedule V controlled substance under 21 C.F.R. 1308.15 shall be scheduled or designated at the state level as a Schedule V controlled substance.
(2) The Cabinet for Health and Family Services designates the following as a Schedule V controlled substance: gabapentin.
Section 6. Dispensing Without Prescription. A controlled substance listed in Schedule V, which is not a prescription drug under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 to 399f, may be dispensed by a pharmacist without a prescription to a purchaser at retail, if:
(1) The medicinal preparation contains, in addition to the controlled substances, some drug or drugs conferring upon it medicinal qualities other than those possessed by the controlled substances alone;
(2) Not more than 240cc (eight (8) ounces) or more than forty-eight (48) dosage units of any controlled substance containing opium is dispensed at retail to the same purchaser in any given forty-eight (48) hour period;
(3) The labeling and packaging is in accordance with the current requirements of KRS 217.005 to 217.215, 21 U.S.C. 301 to 399f, and the United States Pharmacopeia;
(4) The preparation is dispensed or sold in good faith as a medicine and not for the purpose of evading the provisions of KRS Chapter 218A;
(5) The preparation is not displayed in areas open to the public;
(6) The dispensing is made only by a pharmacist and not by a nonpharmacist employee even if under the supervision of a pharmacist. After the pharmacist has fulfilled his or her professional and legal responsibilities as set forth in this section, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist;
(7) The purchaser is at least eighteen (18) years of age;
(8) The pharmacist requires every purchaser of a controlled substance under this section not known to the pharmacist to furnish suitable identification, including proof of age if appropriate; and
(9) The dispensing of exempt controlled substances under this administrative regulation is recorded in a bound book that shall be maintained in accordance with the recordkeeping requirements of KRS 218A.200 and contain the:
(a) Name and address of the purchaser;
(b) Name and quantity of controlled substance purchased;
(c) Date of each purchase; and
(d) Name or initials of the pharmacist who dispensed the substance to the purchaser.
History
- RELATES TO: KRS 217.005-217.215, 218A.010, 218A.020, 218A.040, 218A.060, 218A.080, 218A.100, 218A.120, 218A.200, 21 C.F.R. 1308.11, 1308.12, 1308.13, 1308.14, 1308.15, 1308.35, 1308.49, 21 U.S.C. 301 – 399f,
- STATUTORY AUTHORITY: KRS 218A.020(1), (3)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(1) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations in order to add, delete, or reschedule substances enumerated in KRS Chapter 218A. KRS 218A.020(3) authorizes the Cabinet for Health and Family Services to promulgate administrative regulations to control substances at the state level in the same numerical schedule corresponding to the federal schedule or control a substance in a more restrictive schedule than the federal schedule. This administrative regulation designates Schedule I, II, III, IV, and V drugs. This administrative regulation differs from the federal regulation, 21 C.F.R. 1308.11, because it designates tianeptine and bromazolam as Schedule I controlled substances. The Cabinet for Health and Family Services recognizes that tianeptine and bromazolam have no accepted medical use in treatment and inclusion on Kentucky's Schedule I list will help reduce the risk to public health. This administrative regulation differs from the federal regulation, 21 C.F.R. 1308.14, because it designates pentazocine, barbital, methylphenobarbital, and phenobarbital as a Schedule III controlled substance. The federal regulation designates these substances as a Schedule IV controlled substance. The Cabinet for Health and Family Services recognizes that pentazocine and derivatives of barbituric acid or its salts have significant abuse potential, and inclusion on Kentucky's Schedule III list will help reduce the risk to public health. This administrative regulation further differs from the federal regulation, 21 C.F.R. 1308.14-1308.15, because it designates nalbuphine as a Schedule IV controlled substance and gabapentin as a Schedule V controlled substance. The Cabinet for Health and Family Services recognizes that nalbuphine and gabapentin have significant abuse potential, and inclusion on Kentucky's controlled substances schedules will help reduce the risk to public health.
- History: 902 KAR 055:015. 7 Ky.R. 794; eff. 5-6-1981; Recodified from 901 KAR 1:015, 4-14-1982; 11 Ky.R. 1674; eff. 6-4-1985; 12 Ky.R. 266; eff. 9-10-1985; 1175; eff. 2-4-1986; 13 Ky.R. 1944; eff. 6-9-1987; 15 Ky.R. 863; eff. 11-4-1988; 20 Ky.R. 659; eff. 10-21-1993; 39 Ky.R. 1789; 2032; eff. 5-3-2013; 42 Ky.R. 1972; eff. 3-4-2016; 43 Ky.R. 1068, 1381; eff. 3-3-2017; 44 Ky.R. 143, 531; eff. 9-20-2017; 49 Ky.R. 2171; eff. 10-25-2023; 52 Ky.R. 626, 1368; eff. 3-12-2026.
902 KAR 55:040 Excluded nonnarcotic substances {#sec-902-kar-55-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:040}
Section 1. Excluded Substances. The Cabinet for Health and Family Services shall exclude from all state schedules established in accordance with KRS 218A.020(1), (3) and 902 KAR 55:015 any nonnarcotic substance that may be lawfully sold over-the-counter without a prescription if the substance has been excluded from all federal schedules pursuant to 21 U.S.C. 811(g)(1) and as listed in 21 C.F.R. 1308.22.
History
- RELATES TO: KRS 218A.020-218A.120, 21 C.F.R. 1308.22, 21 U.S.C. 301-399f, 801-971
- STATUTORY AUTHORITY: KRS 218A.020(4), 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(4) requires the Cabinet for Health and Family Services to exclude any nonnarcotic substance from a schedule if the substance may be lawfully sold over the counter without prescription under the provisions of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399f), the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801-971), or KRS Chapter 218A. KRS 218A.250 requires the Cabinet for Health and Family Services to promulgate administrative regulations to carry out the provisions of KRS Chapter 218A. This administrative regulation excludes certain nonnarcotic substances from scheduling pursuant to KRS 218A.020(4).
- History: 1 Ky.R. 635; eff. 4-9-1975; Recodified from 901 KAR 1:040, 4-14-1982; 11 Ky.R. 1679; eff. 6-4-1985; 18 Ky.R. 1471; eff. 2-7-1992; 19 Ky.R. 1665; 2251; eff. 3-17-1993; 20 Ky.R. 863; eff. 12-6-1993; 21 Ky.R. 1393; eff. 1-9-1995; 23 Ky.R. 3985; 24 Ky.R. 126; eff. 7-16-1997; 44 Ky.R. 147, 534; eff. 9-20-2017; Cert eff. 7-18-2024.
902 KAR 55:045 Exempt prescription products {#sec-902-kar-55-045 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:045}
Section 1. Exempt Prescription Products.
(1) Except as provided by subsection (2) of this section, the Cabinet for Health and Family Services exempts prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS 218A.150 – 218A.172, 218A.180, 218A.200, and 218A.202 if the products have received approval as exempt prescription products pursuant to 21 C.F.R. 1308.32.
(2) All products containing butalbital shall:
(a) Be reported to the Kentucky All-Schedule Prescription Electronic Reporting System in accordance with the requirements established in 902 KAR 55:110; and
(b) Not be exempt from the licensing, distribution, and recordkeeping provisions of KRS 218A.150 – 218A.172, 218A.180, and 218A.200.
History
- RELATES TO: KRS 218A.020-218A.250, 21 C.F.R. 1308.31-1308.32
- STATUTORY AUTHORITY: KRS 218A.020
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020(3) provides that if a controlled substance is designated, rescheduled, or deleted as a controlled substance under federal law and notice is given to the Cabinet for Health and Family Services, the Cabinet for Health and Family Services may similarly control the substance under KRS Chapter 218A by administrative regulation. This administrative regulation exempts prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A if the products have received approval as an exempt prescription product pursuant to 21 C.F.R. 1308.32.
- History: 6 Ky.R. 377; eff. 2-6-1980; Recodified from 901 KAR 1:041, 4-14-1982; Am. 11 Ky.R. 1680; eff. 6-4-1985; 18 Ky.R. 1472; eff. 2-7-1992; 19 Ky.R. 1666; 2251; eff. 3-17-1993; 20 Ky.R. 864; eff. 12-6-1993; 21 Ky.R. 1394; eff. 1-9-1995; 23 Ky.R. 4228; eff. 7-16-1997; 25 Ky.R. 629; 1631; eff. 1-19-1999; 26 Ky.R. 903; 1171; eff. 12-15-1999; 40 Ky.R. 2635; 41 Ky.R. 290; eff. 9-17-2014; Cert. eff. 7-6-2021.
902 KAR 55:060 Requirements for distribution of small amounts of controlled substances without manufacturer's or wholesaler's licenses {#sec-902-kar-55-060 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:060}
Section 1. Distribution of Controlled Substances by Pharmacy to Practitioner or other Pharmacy.
(1) A pharmacy may distribute a quantity of a controlled substance to a practitioner or another pharmacy, without being licensed as a manufacturer or wholesaler in Kentucky if it:
(a) Is licensed in Kentucky;
(b) Is registered with the U.S. Drug Enforcement Administration; and
(c) Makes the distribution to a practitioner or pharmacy that is registered with the U.S. Drug Enforcement Administration.
(2) The distribution shall be recorded by the distributing pharmacy and by the receiving practitioner or pharmacy in accordance with KRS 218A.200;
(3) A readily retrievable record of the distribution shall be maintained showing:
(a) Date of distribution;
(b) Name, form and quantity of the substance distributed; and
(c) Name, address and registration number of the purchaser.
(4) The total number of dosage units of all controlled substances distributed by a pharmacy pursuant to this administrative regulation during a twelve (12) month period shall not exceed five (5) percent of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the twelve (12) month period. If the five (5) percent limitation is expected to be exceeded, the pharmacy shall obtain a license to distribute controlled substances in accordance with KRS 218A.160 and 218A.170; and
(5) A prescription shall not be issued by a practitioner to obtain any controlled substance for the purpose of general dispensing, administering or office use.
History
- RELATES TO: KRS 218A.010-218A.020, 218A.150-218A.200, 21 C.F.R. 1304.03, 1305.03, 1307.11
- STATUTORY AUTHORITY: KRS 194.050, 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.250 directs the Cabinet for Human Resources to adopt rules and administrative regulations for carrying out the provisions of KRS Chapter 218A relating to controlled substances. KRS 218A.170(2) provides that all sales and distributions of controlled substances shall be in accordance with the federal controlled substances laws, including the requirements governing the use of order forms. The purpose of this administrative regulation is to provide for the distribution of small amounts of controlled substances by pharmacies to practitioners or other pharmacies, without the necessity of obtaining a state license as a manufacturer or a wholesaler, in accordance with applicable federal laws and regulations.
- History: 902 KAR 055:060. 901 KAR 1:070 - 7 Ky.R. 888; eff. 6-3-1981; Recodified as 902 KAR 55:060, eff. 4-14-1982; 11 Ky.R. 1681; eff. 6-4-1985; 18 Ky.R. 1244; 1890; eff. 11-25-1991; 20 Ky.R. 1425; eff. 1-10-1994; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 55:065 Return of prescription drugs prohibited, exceptions {#sec-902-kar-55-065 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:065}
Section 1. Return of Prescription Drugs Prohibited; Exceptions.
(1) No pharmacist, practitioner, or agent thereof shall accept the return of a prescription drug for reuse or resale unless:
(a) The drug is in a sealed container by which it can be readily determined by a pharmacist employed by the dispensing pharmacy or by the dispensing practitioner that entry or attempted entry by any means has not been made;
(b) The drug container meets the standards of the United States Pharmacopoeia for storage conditions including temperature, light sensitivity, moisture, chemical, and physical stability;
(c) The drug labeling and packaging has not been altered or defaced and the identity of the drug, its potency, lot number, and expiration date are legible;
(d) The drug does not require refrigeration; and
(e) The drug is returned to a pharmacist employed by the dispensing pharmacy or to the dispensing practitioner within fourteen (14) days.
(2) Subsection (1)(d) and (e) of this section shall be waived if all other conditions are met and if:
(a) The drug was dispensed for a patient in a health care facility licensed by the Cabinet for Human Resources;
(b) The drug has not come into the physical possession of the person for whom it was prescribed;
(c) The drug has been under the continuous control of personnel in the health care facility who are trained and knowledgeable in the storage and administration of drugs;
(d) The drug has been properly stored in an area which is regularly inspected by a pharmacist; and
(e) The drug is not expired.
(3) Drugs distributed within an acute care facility shall be exempt from the provisions of subsection (1)(a), (d) and (e) of this section.
(4) Nothing in this administrative regulation shall be construed to require a pharmacist or practitioner to accept the return of a prescription drug.
History
- RELATES TO: KRS 217.005-217.215, 217.992
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 217.125
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 217.125 authorizes the Cabinet for Human Resources to administer the provisions of KRS 217.005 to 217.215 and 217.992. The purpose of this administrative regulation is to prevent the dispensing of prescription drugs that may be adulterated or misbranded.
- History: 902 KAR 055:065. 15 Ky.R. 1618; 1853; eff. 3-15-1989; 20 Ky.R. 2226; eff. 3-14-1994; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 55:070 Emergency medication kits in long-term care facilities {#sec-902-kar-55-070 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:070}
Section 1. Definitions.
(1) "Emergency medication kit" or "EMK" is defined by 201 KAR 2:370, Section 1(3).
(2) "Practitioner" is defined by KRS 218A.010(39).
Section 2. Storage of Controlled Substances in an EMK.
(1) A pharmacy provider may place one (1) EMK that contains controlled substances in:
(a) A residential hospice facility licensed in accordance with 902 KAR 20:380;
(b) A nursing home licensed in accordance with 902 KAR 20:048;
(c) A nursing facility licensed in accordance with 902 KAR 20:300;
(d) An intermediate care facility licensed in accordance with 902 KAR 20:051;
(e) A personal care home pursuant to 201 KAR 2:370, Section 2(4)(i); or
(f) An intermediate care facility for individuals with intellectual disabilities licensed in accordance with 902 KAR 20:086.
(2) A long-term care facility with an EMK shall:
(a) Implement and maintain on-site a copy of written policies and procedures developed in consultation with the pharmacy provider, including responsibilities specific to the facility and the pharmacy as it relates to procuring, using, storing, securing, and replacing controlled substances in the kit;
(b) Maintain a complete and accurate record of all controlled substances to be kept in the EMK, including the disposition of the controlled substances; and
(c) Ensure that the EMK is stored in a limited access area such as a securely locked:
-
Substantially constructed cabinet; or
-
Room with restricted access.
(3) Controlled substances in the EMK shall be the property of the pharmacy provider.
(4) The pharmacy provider shall:
(a) Implement and maintain a copy of the written policies and procedures required by subsection (2)(a) of this section;
(b) Maintain a complete and accurate record of all controlled substances to be kept in the EMK, including the disposition of the controlled substances;
(c) Be responsible for the labeling, storage, security, and accountability of all controlled substances in the EMK;
(d) Document completion of a physical inventory of the controlled substances no less than one (1) time per month; and
(e) Report theft or loss of controlled substances from the EMK pursuant to:
-
KRS 218A.200(6);
-
KRS 315.335; and
-
201 KAR 2:205, Section 2(3)(g).
(5) Controlled substances stored in the EMK shall be selected by the facility's:
(a) Medical director or other physician;
(b) Consultant pharmacist; and
(c) Director of nursing.
(6) Controlled substances in the EMK shall not exceed six (6) individual doses each of ten (10) different controlled substances, plus two (2) multi-dose packages in the smallest unit that is commercially available.
(7) A controlled substance from the EMK shall be administered only upon the prescription order of an authorized practitioner who determines that the resident has an immediate medical need.
(8) Access to a controlled substance in the EMK shall be limited to a:
(a) Practitioner;
(b) Registered nurse; or
(c) Other person authorized by law in this state to access and administer the prescribed medication.
(9) If an EMK is opened for any reason, the facility shall notify the pharmacy provider within twenty-four (24) hours after the kit has been opened for the pharmacy to restock and reseal the kit promptly, if necessary.
Section 3. Adverse Action.
(1) The Cabinet for Health and Family Services shall deny, suspend, or revoke the privilege of supplying or possessing an EMK if the cabinet finds substantial noncompliance with Section 2 of this administrative regulation.
(2) The pharmacy provider or facility may file an appeal with the cabinet within (10) calendar days of the cabinet's notice of denial, suspension, or revocation.
(3) If the pharmacy provider or facility requests an administrative hearing, the cabinet shall:
(a) Appoint a hearing officer; and
(b) Proceed pursuant to KRS 13B.050.
(4) The administrative hearing shall be conducted by a hearing officer appointed by the secretary and held in accordance with KRS 13B.080, 13B.090, and 13B.110.
(5) The secretary shall issue a final order in accordance with KRS 13B.120.
History
- RELATES TO: KRS 13B.050, 13B.080, 13B.090, 13B.110, 13B.120, 218A.010(39), 218A.200(6), 315.335
- STATUTORY AUTHORITY: KRS 194A.050(1), 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the Secretary of the Cabinet for Health and Family Service to promulgate administrative regulations necessary to implement programs mandated by federal law, or to qualify for the receipt of federal funds and cooperate with other state and federal agencies for the proper administration of the cabinet and its programs. KRS 218A.250 requires the Cabinet for Health and Family Services to promulgate administrative regulations for carrying out the provisions of KRS Chapter 218A. This administrative regulation establishes requirements related to the placement of emergency medication kits with controlled substances in long-term care facilities.
- History: 15 Ky.R. 1352; eff. 12-13-1988; 20 Ky.R. 2227; eff. 3-14-1994; 22 Ky.R. 2481; eff. 8-1-1996; 33 Ky.R. 2218; 2973; eff. 4-6-2007; Crt eff. 05-07-2019; 46 Ky.R. 270; eff. 11-18-2019; Crt eff 2-9-2026.
902 KAR 55:080 Written prescriptions to be signed by practitioner {#sec-902-kar-55-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:080}
Section 1. A written prescription for a controlled substance shall be signed only by a practitioner who is authorized to prescribe controlled substances under the laws of the jurisdiction in which he is licensed to practice his profession.
Section 2. A written prescription for a controlled substance shall be written with ink, indelible pencil or typewriter and may be prepared by an agent for the practitioner's signature. The prescription shall be manually signed by the practitioner which may be in the same manner as he would sign a check or legal document.
History
- RELATES TO: KRS Chapter 218A
- STATUTORY AUTHORITY: KRS 194.050, 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.250 directs the Cabinet for Human Resources to adopt rules and administrative regulations for carrying out the provisions of KRS Chapter 218A relating to controlled substances. The purpose of this administrative regulation is to clarify who is authorized to sign a prescription for controlled substances and the form of the signature, which must be in accordance with federal regulation.
- History: 902 KAR 055:080. 17 Ky.R. 3607; eff. 7-17-1991; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 55:090 Exempt anabolic steroid products {#sec-902-kar-55-090 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:090}
Section 1. Exempt Anabolic Steroid Products. The Cabinet for Health and Family Services exempts anabolic steroid products from the licensing, distribution, recordkeeping, and reporting provisions of KRS 218A.150 – 218A.172, 218A.180, 218A.200, and 218A.202 if the products have received approval as exempt anabolic steroid products pursuant to 21 C.F.R. 1308.34.
History
- RELATES TO: KRS 218A.010-218A.250, 21 C.F.R. 1308.13, 1308.33-1308.34, 21 U.S.C. 801, 812
- STATUTORY AUTHORITY: KRS 218A.020
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.020 authorizes the Cabinet for Health and Family Services to add, delete, or reschedule substances enumerated in KRS Chapter 218A. This administrative regulation exempts certain anabolic steroid products from the licensing, distribution, recordkeeping, and reporting provisions of KRS Chapter 218A if the products have received approval as an exempt anabolic steroid product pursuant to 21 C.F.R. 1308.34.
- History: 19 Ky.R. 2207; eff. 4-21-1993; 21 Ky.R. 1395; eff. 1-9-1995; 23 Ky.R. 3986; eff. 7-16-1997; 26 Ky.R. 907; 1174; eff. 12-15-1999; 29 Ky.R. 820; 1278; eff. 10-16-2002; 40 Ky.R. 2639; eff. 9-17-2014; Cert. eff. 7-6-2021.
902 KAR 55:095 Prescription for Schedule II controlled substance – authorization of oral prescriptions for immediate administration, facsimile transmission, or partial filling {#sec-902-kar-55-095 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:095}
Section 1. Definitions.
(1) "Hospice" means a hospice program licensed pursuant to KRS 216B.042.
(2) "Immediate administration" means an emergency situation in which the prescribing practitioner authorizes an oral prescription for a Schedule II controlled substance, pursuant to KRS 218A.180(1):
(a) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;
(b) An appropriate alternative treatment is not available, including administration of a drug that is not a Schedule II controlled substance; and
(c) 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.
(3) "Long-term care facility" or "LTCF" is defined by KRS 216.535(1)(a) and, pursuant to KRS 218A.180(1), excludes a family care home or personal care home.
Section 2. Oral Prescription Only for Immediate Administration.
(1) A pharmacist may dispense a Schedule II controlled substance upon receiving oral authorization from a prescribing practitioner under the following conditions:
(a) Pursuant to KRS 218A.180(1), the prescription shall be needed for immediate administration to a patient enrolled in a hospice program or a resident of a long-term care facility;
(b) The quantity prescribed and dispensed shall be limited to the amount adequate to treat the patient or resident during the period in which immediate administration is necessary; and
(c) The prescribing practitioner personally communicates the oral prescription.
(2) Except for the signature of the prescribing practitioner, the prescription shall:
(a) Be immediately reduced to writing by the pharmacist in accordance with KRS 218A.180(6); and
(b) Contain all information required by KRS 218A.180(5) and 21 C.F.R. 1306.05.
(3) 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) A callback to the prescribing practitioner using the practitioner's phone number as listed in the telephone directory; or
(b) Other good faith efforts to ensure the practitioner's identity.
(4) Within seven (7) days after authorizing an oral prescription for immediate administration, the prescribing practitioner shall cause a written or electronic prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist and demonstrate compliance with the requirements established in this subsection.
(a) In addition to conforming to the requirements of KRS 218A.180(5),21 C.F.R. 1306.05, 902 KAR 55:105 and 902 KAR 55:130, the prescription shall:
-
Have written on its face "Authorization for Emergency Dispensing" and the date of the oral order; and
-
Be delivered to the pharmacist:
a. In person;
b. By mail; or
c. Electronically pursuant to paragraph (d) of this subsection.
(b) If delivered by mail, the prescription shall be postmarked within seven (7) days of the date of the oral prescription for immediate administration.
(c) Upon receipt, the dispensing pharmacist shall attach the paper prescription to the oral prescription for immediate administration that was earlier reduced to writing.
(d) For electronic prescriptions, the pharmacist shall annotate the record of the prescription with the:
-
Original authorization; and
-
Date of the oral order.
(e) If the prescribing practitioner fails to deliver a written prescription to the pharmacist in accordance with this subsection, the pharmacist shall notify the nearest Drug Enforcement Administration (DEA) office.
(f) Failure of the pharmacist to comply with paragraph (e) of this subsection shall void the authority conferred by this subsection to dispense without a written prescription of a prescribing practitioner.
(5) A central fill pharmacy shall not be authorized under subsection (4) of this section to prepare prescriptions for a Schedule II controlled substance upon receiving an oral authorization from a retail pharmacist or a prescribing practitioner.
(6) Dispensing a Schedule II controlled substance beyond the period necessary for immediate administration shall be pursuant to a written or electronic prescription signed by the prescribing practitioner.
Section 3. Transmission by Facsimile of a Prescription for a Schedule II Controlled Substance.
(1) A prescription prepared in accordance with KRS 218A.180, 21 C.F.R. 1306.05, 902 KAR 55:080, and 902 KAR 55:105, Section 2, for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by a practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
(2) A prescription prepared in accordance with KRS 218A.180, 21 C.F.R. 1306.05, 902 KAR 55:080, and 902 KAR 55:105, Section 2, for a Schedule II controlled substance for a resident of a long-term care facility may be transmitted by a practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
(3)
(a) A prescription prepared in accordance with KRS 218A.180, 21 C.F.R. 1306.05, 902 KAR 55:080, and 902 KAR 55:105, Section 2, for a Schedule II controlled substance for a hospice patient may be transmitted by a practitioner or the practitioner's agent to the dispensing pharmacy by facsimile.
(b) The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient.
(4) The facsimile prescription shall:
(a) Serve as the original written prescription for the purposes of subsections (1) to (3) of this section and as allowed by KRS 218A.180(1) for the dispensing of a Schedule II controlled substance; and
(b) Be maintained in the same manner as an original prescription.
Section 4. Partial Filling of a Prescription for a Schedule II Controlled Substance.
(1) Except as provided in subsections (2) and (3) of this section, a pharmacist may partially fill a prescription for a controlled substance listed in Schedule II if the pharmacist:
(a) Is unable to dispense the full quantity called for in a written prescription or oral prescription for immediate administration as authorized by Section 2 of this administrative regulation;
(b) Makes a notation of the quantity dispensed:
-
On the face of the written prescription;
-
In the written record of the oral prescription for immediate administration; or
-
In the electronic prescription record; and
(c) Dispenses the remaining portion of the prescription within seventy-two (72) hours of the first partial filling. If the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist shall notify the prescribing practitioner. No further quantity shall be dispensed without a new written prescription.
(2) A prescription for a Schedule II controlled substance written for a patient in a long-term care facility or for a patient with a documented terminal illness may be dispensed in partial quantities, including individual dosage units, if:
(a) The pharmacist records on the prescription whether the patient is "terminally ill" or an "LTCF patient";
(b) The pharmacist records on the back of the written prescription or on another appropriate record, uniformly maintained and readily retrievable, the following data:
-
The date of the partial dispensing;
-
The quantity dispensed;
-
The remaining quantity authorized to be dispensed; and
-
The identification of the dispensing pharmacist;
(c) The pharmacist contacts the practitioner prior to dispensing the partial quantity if there is any question whether the patient is terminally ill because both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient;
(d) The total quantity dispensed in all partial dispensings does not exceed the quantity prescribed;
(e) The partial dispensing occurs at the pharmacy where the original prescription is on file; and
(f) No dispensing occurs beyond sixty (60) days from date of issuance of the prescription.
(3) For a patient who is not terminally ill or a resident of a long-term care facility, a written prescription for a Schedule II controlled substance may be dispensed in partial quantities in accordance with the requirements established in this subsection.
(a) The partial dispensing shall be requested by the patient or the prescribing practitioner who issued the prescription.
(b) Dispensing shall not occur beyond thirty (30) days from the date of issuance of the prescription.
(c) The pharmacist shall comply with requirements established in subsection (2)(b), (d), and (e) of this section.
(4) The information required by this section pertaining to current Schedule II prescriptions may be maintained in a computerized system if the system has the capability to permit:
(a) Output (display or printout) of the:
-
Original prescription number;
-
Date of issue;
-
Identification of the prescribing practitioner;
-
Identification of the patient;
-
Address of the long-term care facility, hospital, or residence of the patient, if applicable;
-
Identification of medication authorized, including:
a. Dosage;
b. Form;
c. Strength; and
d. Quantity;
-
Listing of the partial fillings that have been dispensed under each prescription; and
-
Information required in 21 C.F.R. 1306.13(b);
(b) Immediate or real time updating of the prescription record each time a partial filling of the prescription is conducted; and
(c) Retrieval of partially filled Schedule II prescription information that is the same as required by KRS 218A.180(7) for Schedule III and IV prescription refill information.
(5) A prescription that is partially filled and does not comply with the requirements of this section shall be deemed to have been filled in violation of KRS 218A.200(3), (4) and 21 C.F.R. 1306.13.
History
- RELATES TO: KRS 216.510(1), 216B.042, 218A.060, 218A.180, 218A.200, 21 C.F.R. 290.10, 1306.05, 1306.11-1306.14
- STATUTORY AUTHORITY: KRS 194A.050, 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050 requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary under applicable state laws to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of the individual citizens of the Commonwealth; operate the programs and fulfill the responsibilities vested in the cabinet; implement programs mandated by federal law; qualify for the receipt of federal funds; and cooperate with other state and federal agencies for the proper administration of the cabinet and its programs. KRS 218A.250 requires the Cabinet for Health and Family Services to promulgate administrative regulations for carrying out the provisions of KRS Chapter 218A relating to controlled substances. This administrative regulation permits the transmission of prescriptions for Schedule II controlled substances between the prescriber and dispenser via oral authorization for immediate administration or by facsimile to facilitate the delivery of medications to certain patients whose need for medication shall be initiated or changed quickly. This administrative regulation also permits the partial filling of prescriptions for Schedule II controlled substances if requested by the patient or prescribing practitioner to patients whose medication needs may be long term but who wish to store limited quantities or in situations where the pharmacy is unable to supply the full quantity prescribed.
- History: 902 KAR 055:095. 21 Ky.R. 2589; 22 Ky.R. 291; eff. 7-26-1995; 24 Ky.R. 1165; eff. 1-12-1998; 44 Ky.R. 149, 534; eff. 9-20-2017; 52 Ky.R. 1447, 1831; eff. 8-4-2026.
902 KAR 55:105 Controlled substance prescription blanks {#sec-902-kar-55-105 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:105}
Section 1. Definitions.
(1) "Logo" means a symbol utilized by an individual, a pharmacy, professional practice, professional association, or hospital.
(2) "Security prescription blank" means a prescription blank that complies with the requirements of Section 3 of this administrative regulation.
Section 2. Security Prescription Blanks Required.
(1) Beginning January 1, 1999, a written prescription for a controlled substance shall be on a security prescription blank unless, pursuant to Section 7 of this administrative regulation, the cabinet has granted a waiver to the practitioner who wrote the prescription or to the pharmacy that dispenses it.
(2) A practitioner who is licensed in Kentucky and in another state shall utilize a security prescription blank for writing a prescription for a controlled substance while practicing his profession within the Commonwealth unless, pursuant to Section 7 of this administrative regulation, the cabinet has granted a waiver to the practitioner or to the pharmacy that dispenses the controlled substance.
Section 3. Requirements of a Security Prescription Blank.
(1) A prescription for a controlled substance shall contain the following security features:
(a) A latent, repetitive "void" pattern screened at five (5) percent in pantone green shall be printed across the entire front of the prescription blank. If a prescription is photocopied, the word "void" shall appear in a pattern across the entire front of the prescription;
(b) A watermark shall be printed on the backside of the prescription blank so that it shall only be seen at a forty-five (45) degree angle. The watermark shall consist of the words "Kentucky Security Prescription", and appear horizontally in a step-and-repeated format in five (5) lines on the back of the prescription using twelve (12) point Helvetica bold type style;
(c) An opaque Rx symbol shall appear in the upper right-hand corner, one-eighth (1/8) of an inch from the top of the prescription blank and five-sixteenths (5/16) of an inch from the right side of the prescription blank. The symbol shall be three-fourths (3/4) of an inch in size and disappear if the prescription copy is lightened;
(d) Six (6) quantity check off boxes shall be printed on the form and the following quantities shall appear:
-
☐ 1–24;
-
☐ 25–49;
-
☐ 50-74;
-
☐ 75-100;
-
☐ 101-150;
-
☐ 151 and over;
(e) A logo may appear on the prescription blank. The upper left one (1) inch square of the prescription blank shall be reserved for a logo;
(f) The following statement shall be printed on the bottom of the prescription blank: "Prescription is void if more than one (1) prescription is written per blank";
(g) Refill options shall appear below any logo on the left side of the prescription blank in the following order: Refill NR 1 2 3 4 5; and
(h) A prescription blank shall be four and one-quarter (4 1/4) inches high and five and one-half (5 1/2) inches wide.
(2) A prescription shall bear the preprinted, stamped, typed, or manually printed name, address and telephone number of the prescribing practitioner.
(3) A prescription blank for a controlled substance shall not contain:
(a) An advertisement on the front or the back of the prescription blank;
(b) The preprinted name of a controlled substance; or
(c) The written, typed, or rubber-stamped name of a controlled substance until the prescription blank is signed, dated and issued to a patient.
(4) A prescription blank for a controlled substance shall provide space for the patient's name and address, the practitioner's signature and the practitioner's DEA registration number.
Section 4. Other Requirements.
(1) Only one (1) prescription shall be written per prescription blank.
(2) A quantity check-off box that corresponds to the quantity prescribed shall be marked.
(3) If a prescribed drug is a schedule III, IV or V controlled substance, a refill option shall be marked.
(4) If a prescription for a schedule III, IV, or V controlled substance will be transmitted to a pharmacy by facsimile, the practitioner or the practitioner's agent shall, prior to transmission, write or stamp "FAXED" on the face of the original prescription along with the date and the person's initials.
(5) If a pharmacist uses due diligence in ascertaining the validity of a prescription, a prescription for a schedule III, IV, or V controlled substance that is transmitted to a pharmacy by facsimile shall be exempt from the requirement of green ink in Section 3(1)(a) of this administrative regulation and the requirement of a watermark in Section 3(1)(b) of this administrative regulation.
(6) If a prescription for a schedule III, IV or V controlled substance has been transmitted to a pharmacy by facsimile, the transmitting practitioner shall file the original prescription in the patient's record.
Section 5. Exceptions. A pharmacist shall not be required to use a security prescription blank to record an oral prescription or a transferred prescription for a Schedule III, IV, or V controlled substance.
Section 6. Printers, Reproducers or Distributors of Security Prescription Blanks.
(1) A printer, reproducer or distributor of security prescription blanks shall require a written purchase order or request for security prescription blanks. A written purchase order or request shall remain on file for two (2) years.
(2) A purchase order or request shall be signed by:
(a) A practitioner whose name shall be printed on the security prescription blanks; or
(b) The chief medical official of a health care facility or pharmacist-in-charge of a pharmacy, if the security prescription blanks are requested on behalf of a practitioner who stamps, types or manually prints his name, address, telephone number and DEA number on the security prescription blank.
(3) The provisions of this section shall not apply to distributions between printers, reproducers, or distributors.
Section 7. Waiver of Security Prescription Blanks.
(1) A practitioner or a pharmacy may apply in writing to the cabinet for a waiver from the requirement for security prescription blanks. A request for a waiver shall include:
(a) A detailed statement of the security features provided by the system proposed by the applicant for the prevention of forgery or alteration of an original prescription; or
(b) The format of the alternative prescription blank.
(2) The system or prescription blank proposed by the applicant shall provide a level of security equivalent to a security prescription blank.
(3) The cabinet shall grant or deny the application in writing within sixty (60) days after the request is received.
(4) When a waiver has been granted, the cabinet may suspend or revoke the waiver if the alternative system or alternative prescription blank does not provide security equivalent to a security prescription blank.
(5) Upon notification of denial, suspension, or revocation of the waiver of the requirement for a security prescription blank, the practitioner or pharmacy may request a hearing. The administrative hearing shall be conducted in accordance with 902 KAR 1:400.
History
- RELATES TO: KRS 218A.030-218A.140, 218A.204, 218A.170-218A.240, 218A.281, 218A.282, 218A.284, 218A.286, 218A.288
- STATUTORY AUTHORITY: KRS 194A.030, 194A.050, 211.090, 218A.204, 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.204 requires the cabinet to promulgate administrative regulations that establish security requirements for a prescription blank used by a practitioner to write a prescription for a controlled substance. The purpose of this administrative regulation is to establish minimum requirements that will decrease the potential for forgery or alteration of a prescription or a prescription blank for a controlled substance.
- History: 902 KAR 055:105. 25 Ky.R. 721; 1074; 1366; eff. 12-16-1998; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 55:110 Monitoring system for prescription controlled substances {#sec-902-kar-55-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:110}
Section 1. Definitions.
(1) "Branch" means the Drug Enforcement and Professional Practices Branch in the Division of Audits and Investigations, Office of Inspector General, Cabinet for Health and Family Services.
(2) "Cabinet personnel" means an individual who:
(a)
-
Is directly employed by the Cabinet for Health and Family Services; or
-
Is employed by an agent or contractor of the cabinet;
(b) Has undergone KASPER training; and
(c) Has been approved to use the KASPER system.
(3) "Central registry" is an entity defined by 908 KAR 1:374, Section 1(3) that may report information to KASPER on behalf of a narcotic treatment program.
(4) "Dispenser" is defined by KRS 218A.010(12), and:
(a) Includes a dispenser who has a DEA (Drug Enforcement Administration) number or is a pharmacist who owns or is employed by a facility that operates a pharmacy that has a DEA number;
(b) Includes a narcotic treatment program licensed pursuant to 908 KAR 1:374; and
(c) Does not include an individual licensed to practice veterinary medicine under KRS Chapter 321.
(5) "Health facility" is defined by KRS 216B.015(13).
(6) "KASPER" means Kentucky All-Schedule Prescription Electronic Reporting System.
(7) "Patient identifier" means a patient's:
(a) Full name;
(b) Address, including zip code;
(c) Date of birth; and
(d) Social Security number or an alternative identification number established pursuant to Section 5 of this administrative regulation.
(8) "Practitioner" is defined by KRS 218A.010(40).
(9) "Report" means a compilation of data concerning a patient, dispenser, practitioner, or controlled substance.
(10) "Suspected drug overdose" means an acute condition that:
(a) Includes conditions such as physical illness, coma, mania, or hysteria that is the result of consumption or use of a controlled substance, or another substance with which a controlled substance was combined; and
(b) Relates to injury or poisoning by any substance corresponding to the following International Classification of Disease (ICD) version 10 (ICD-10) codes available at https://www.cms.gov/Medicare/Coding/ICD10:
-
T40;
-
T42; or
-
T43.
Section 2. Data Reporting.
(1) A dispenser or a health facility that has a DEA number shall report all dispensed Schedule II, III, IV, or V controlled substances, except:
(a) During the circumstances specified in KRS 218A.202(3)(a) through (c); or
(b) If the controlled substance is dispensed by a narcotic treatment program for use to treat substance use disorder and the patient has not provided written consent that meets the requirements of 42 C.F.R. 2.31.
(2) A dispenser of a Schedule II, III, IV, or V controlled substance shall transmit or provide the following data to the cabinet or the cabinet's agent:
(a) Patient identifier;
(b) National drug code of the drug dispensed;
(c) Metric quantity of the drug dispensed;
(d) Date of dispensing;
(e) Estimated days the supply of dispensed medication will last;
(f) Drug Enforcement Administration registration number of the prescriber;
(g) Prescription number or dispensing identification number assigned by the dispenser or health facility; and
(h) The Drug Enforcement Administration registration number of the dispenser.
(3) The data identified in subsection (2) of this section shall be transmitted no later than close of business on the business day immediately following the dispensing unless the cabinet grants an extension as provided in subsection (4) or (5) of this section.
(4)
(a) An extension may be granted if the dispenser, health facility, or central registry:
-
Suffers a mechanical or electronic failure; or
-
Cannot meet the deadline established by subsection (3) of this section because of reasons beyond his or her control.
(b) To request an extension, a written request shall:
- Be submitted to the branch:
a. Within twenty-four (24) hours of discovery of the circumstances necessitating the request; or
b. If state offices are closed, on the next day that state offices are open for business following discovery of the circumstances necessitating the request; and
- Provide a justification for the extension, including the length of time the extension is necessary.
(5) An extension shall be granted if the cabinet or its agent is unable to receive electronic reports transmitted by the dispenser.
(6) Except as provided in subsection (8) of this section, the data shall be transmitted by:
(a) An electronic device compatible with the receiving device of the cabinet or the cabinet's agent;
(b) Secure File Transfer Protocol;
(c) https protocol; or
(d) Secure Virtual Private Network connection.
(7) The data shall be transmitted in the telecommunications format for controlled substances established by the most recent version of the Implementation Guide, ASAP Standard for Prescription Monitoring Programs, developed by the American Society for Automation in Pharmacy available at asapnet.org, or a comparable format approved by the branch.
(8) A dispenser who does not have an automated recordkeeping system capable of producing an electronic report in the telecommunications format for controlled substances established by the Implementation Guide, ASAP Standard for Prescription Monitoring Programs shall report the data identified in subsection (2) of this section using an Internet accessible web portal designated by the cabinet.
(9) To meet the reporting requirement of KRS 218A.202(4), a hospital shall report to the cabinet all positive toxicology screens ordered by the hospital's emergency department to evaluate a patient's suspected drug overdose via the Kentucky Health Information Exchange.
Section 3. Compliance. A dispenser may presume that the patient identification information provided by the patient or the patient's agent in accordance with Section 5 of this administrative regulation is correct.
Section 4. Request for Report.
(1) A written or electronic request shall be filed with the cabinet prior to the release of a report, except for a subpoena issued by a grand jury or an appropriate court order issued by a court of competent jurisdiction.
(2) A request for a KASPER patient report shall be made electronically at www.chfs.ky.gov/KASPER.
(3)
(a) A request for a KASPER provider report made by a law enforcement or prosecutorial official authorized to receive data under KRS 218A.202, or a designated representative of a board responsible for the licensure, regulation, or discipline of prescribing practitioners shall be made by written application on the KASPER Report Request for Law Enforcement and Licensure Boards, Form DCB-20L.
(b) If the request made by a law enforcement or prosecutorial official authorized to receive data under KRS 218A.202 is for KASPER data on dispensing of controlled substances by a narcotic treatment program to treat substance use disorder, a report shall not be disclosed to the official unless there is a valid court order and subpoena requiring the release of the information and all other applicable provisions of 42 C.F.R. Part 2, Subpart E are met.
(4) A medical examiner engaged in a death investigation pursuant to KRS 72.026 may query KASPER for a report on the decedent.
Section 5. Patient Identification Number.
(1) A patient or the person obtaining the controlled substance on behalf of the patient shall disclose to the dispenser the patient's Social Security number for purposes of the dispenser's mandatory reporting to KASPER.
(2) If a patient is an adult who does not have a Social Security number, the patient's driver's license number shall be disclosed.
(3) If a patient is an adult who has not been assigned a Social Security number or a driver's license number, the number 000-00-0000 shall be used in the Social Security field.
(4) If a patient is a child who does not have a Social Security number or a driver's license number, the number "000-00-0000" shall be used in the Social Security field.
(5) If a patient is an animal, the number "000-00-0000" shall be used in the Social Security number field.
Section 6. KASPER Data and Trend Reports. Cabinet personnel shall have authorized access to the data obtained from the KASPER system and trend reports in accordance with KRS 218A.240(7)(a).
Section 7. Data Retention. Data shall be maintained in KASPER according to the Office of Inspector General's retention schedule on file with the State Libraries, Archives and Records Commission.
Section 8. Error Resolution.
(1) A patient, patient's representative, practitioner, pharmacist, health facility, or private practitioner's office or clinic to whom a report has been disclosed under KRS 218A.202(9) or this administrative regulation may request that information contained in KASPER be corrected if the patient, patient's representative, practitioner, pharmacist, health facility, or private practitioner's office or clinic believes that any information is inaccurate. The patient, patient's representative, practitioner, pharmacist, health facility, or private practitioner's office or clinic shall:
(a) Contact the dispenser who reported the information required by Section 2(2) of this administrative regulation; and
(b) Request that the dispenser correct the information.
(2) If, upon receipt of a request from a patient, patient's representative, practitioner, pharmacist, health facility, or private practitioner's office or clinic pursuant to subsection (1) of this section, the dispenser confirms that the information was reported in error, the dispenser shall:
(a) Transmit corrected information to update the KASPER database within seven (7) calendar days of the request for the correction; and
(b) Notify the patient, patient's representative, practitioner, pharmacist, health facility, or private practitioner's office or clinic that the corrected information has been transmitted.
(3) If a dispenser identifies a KASPER system generated error, the dispenser shall notify the branch. Upon verification of the error, the branch shall:
(a) Correct the information in the KASPER database; and
(b) Notify the patient, patient's representative, practitioner, pharmacist, health facility, private practitioner's office or clinic within five (5) working days of the correction.
Section 9. Referrals to Licensing Boards. If the cabinet becomes aware that a prescriber or dispenser has failed to comply with the reporting requirements of KRS 218A.202 and this administrative regulation, the cabinet shall notify the licensing board or agency responsible for licensing the prescriber or dispenser.
Section 10. Disclosure of Data or Report.
(1) The cabinet shall only disclose data to:
(a) The persons and entities authorized to receive that data under KRS 218A.202(7); and
(b) The persons and entities authorized to receive data pursuant to 42 C.F.R. Part 2, Subparts C, D, and E if the data to be disclosed includes information on controlled substances dispensed by a narcotic treatment program for use to treat substance use disorder.
(2) As a condition precedent to the disclosure of data or a report pursuant to KRS 218A.202(7)(f), a hospital or long-term care facility shall maintain, and provide upon request by the cabinet, a copy of the hospital or long-term care facility's policy for the management of KASPER data and reports, which:
(a) Describes the hospital or long-term care facility's internal procedures for educating the designated employee or employees on the:
-
Proper use of the KASPER system;
-
Prohibition on the improper use or intentional disclosure of KASPER data to unauthorized individuals; and
-
Sanctions imposed for the improper use or intentional disclosure of KASPER data to unauthorized individuals, including criminal misdemeanor offenses; and
(b) Describes the hospital or long-term care facility's internal procedures for auditing the account, including:
-
The manner in which an employee is added to or removed from access to the account if the employee ends employment or is no longer designated to query KASPER; and
-
The actions taken if a designated employee with access to the employer's KASPER account intentionally misuses his or her privileges to KASPER data or a report, which shall include a report of the incident to the branch.
(3)
(a) An individual authorized to receive data under KRS 218A.202(7) shall not provide the data to any other entity except:
-
As provided in KRS 218A.202(9); and
-
For substance use disorder treatment data, as provided in 42 C.F.R. 2.32; or
(b) As provided in paragraph (c) of this subsection.
(c) In addition to the purposes authorized under KRS 218A.202(9)(e), and pursuant to KRS 218A.205(2)(a) and (6), a practitioner or pharmacist who obtains KASPER data or a report under KRS 218A.202(7)(e)1. or who in good faith believes that any person, including a patient, has violated the law in attempting to obtain a prescription for a controlled substance, may report suspected improper or illegal use of a controlled substance to law enforcement or the appropriate licensing board.
(4) A hospital or long-term care facility shall maintain and adhere to the entity's internal policy regarding the management of KASPER data and reports.
Section 11. Incorporation by Reference.
(1) "KASPER Report Request for Law Enforcement and Licensure Boards", Form DCB-20L, October 2022, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Drug Enforcement and Professional Practices Branch, Office of the Inspector General, Cabinet for Health and Family Services, 275 E. Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may also be viewed on the Office of Inspector General's Web site at: https://chfs.ky.gov/agencies/os/oig/dai/deppb/Pages/kasper.aspx.
History
- RELATES TO: KRS 72.026, 216B.015(13), 218A.010(12), (40), 218A.202, 218A.205(2)(a), (6), 218A.240(7)(a), 42 C.F.R. Part 2
- STATUTORY AUTHORITY: KRS 194A.050, 218A.202(1), (18), 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.202(1) directs the Cabinet for Health and Family Services to establish and maintain an electronic system for monitoring Schedule II, III, IV, and V controlled substances. KRS 218A.250 requires the cabinet to promulgate administrative regulations pursuant to KRS Chapter 13A for carrying out the provisions of KRS Chapter 218A. This administrative regulation establishes criteria for reporting prescription data, establishes procedures to correct errors, and allows for disclosure of data to authorized persons.
- History: 25 Ky.R. 966; 1367; eff. 12-16-1998; 32 Ky.R. 1927; 33 Ky.R. 120; eff. 7-24-2006; 34 Ky.R. 2609; 35 Ky.R. 283; eff. 9-5-2008; 2615; eff. 7-31-2009; 39 Ky.R. 629; 1218; 1413; 2033; eff. 3-4-2013; 44 Ky.R. 378, 1026, 1346; eff. 1-5-2018; TAm eff. 3-20-2020; 49 Ky.R. 1357, 2111; eff. 6-21-2023.
902 KAR 55:115 Drug possession by hospice or home health agency {#sec-902-kar-55-115 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:115}
Section 1. Authorized Employees. A pharmacy may place a legend drug listed in KRS 315.300 with an authorized employee of a hospice or a home health agency if the pharmacy maintains a record of the license that authorizes the employee to administer legend drugs.
Section 2. Written Agreement. Each party to a written agreement between a pharmacy and a home health agency or a pharmacy and a hospice shall maintain a copy of the written agreement.
Section 3. Protocol.
(1) A protocol required by KRS 315.300 may be included in the written agreement or may be a separate document.
(2) If the protocol is a separate document, a copy shall be maintained by the pharmacy and by the hospice or home health agency.
(3) The protocol shall be reviewed not less than annually and modified if necessary.
Section 4. Records.
(1) The pharmacy record of a drug placed with authorized employees of a hospice or home health agency shall be retained for five (5) years.
(2) The record of a drug administered by authorized employees of a hospice or home health agency shall be retained by the pharmacy for five (5) years.
History
- RELATES TO: KRS 217.005-217.215, 217.992
- STATUTORY AUTHORITY: KRS 194A.050, 211.090, 217.125, 315.300
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.300 authorizes the Cabinet for Health Services to promulgate administrative regulations that implement the possession of certain drugs by a hospice or home health agency. The purpose of this administrative regulation is to establish criteria that a pharmacy, hospice or home health agency must meet in order to insure that drugs belonging to a pharmacy, that are stored in a hospice or home health agency, are safe and effective for administration to patients.
- History: 902 KAR 055:115. 25 Ky.R. 723; 1369; eff. 12-16-1998; Crt eff. 1-11-2019; Crt eff. 11-24-2025.
902 KAR 55:120 Disposal of prescription controlled substances {#sec-902-kar-55-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:120}
Section 1. Methods of Disposal. A long-term care facility or other cabinet-licensed facility with custodial control of patient-owned controlled substance medications shall:
(1) Dispose of all expired, abandoned, or otherwise unwanted controlled substances in accordance with 21 C.F.R. Part 1317; and
(2) Develop and implement written policies and procedures for the disposal of controlled substances. Disposal methods shall include:
(a) On-site destruction that renders the controlled substance unrecoverable and beyond reclamation so that the medication cannot be diverted; or
(b) Transfer of the controlled substance to an authorized collection receptacle maintained by a:
-
Law enforcement agency; or
-
Pharmacy.
Section 2. Procedures for Disposal.
(1) If a patient's controlled substance medication has expired, been abandoned, or is otherwise unwanted, either the facility's responsible person or the director of nursing and a witness who is employed by the facility shall perform and document:
(a) Removal of the patient's controlled substances from the medication cart or storage area;
(b) Transfer of the medications to a separate secure storage area; and
(c) Use of a disposal method established by Section 1(2) of this administrative regulation no later than thirty (30) days from the date the patient's controlled substances are removed from the medication cart or storage area.
(2) The facility shall maintain a readily retrievable record of controlled substances removed from the medication cart or other area of storage. The record shall:
(a) Be maintained for a minimum of eighteen (18) months from the date of disposal;
(b) Be made available upon request by the cabinet for purposes of inspection; and
(c) Contain the following information:
-
Amount of controlled substances destroyed on-site or transferred to a collection receptacle;
-
Disposal method;
-
Date of disposal;
-
Patient name;
-
Drug name;
-
Drug strength; and
-
Name of the responsible person or director of nursing and witness responsible for the transfer and disposal of the medications.
(3) Controlled substances shall not be destroyed by flushing into a sewage treatment system unless disposal by flushing is permitted by:
(a) Instructions on the label;
(b) The patient information leaflet with the medication; or
(c) The U.S. Food and Drug Administration's (FDA) flush list posted on the FDA webpage: https://www.fda.gov/media/85219/download.
(4) The cabinet shall take adverse action against a facility's license in accordance with 902 KAR 20:008, Section 8, or 908 KAR 1:370, Section 20, if the cabinet finds that there has been a substantial failure by the facility to comply with the provisions of this administrative regulation.
History
- RELATES TO: 21 C.F.R. Part 1317
- STATUTORY AUTHORITY: KRS 218A.250
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.250 requires the Cabinet for Health and Family Services to promulgate administrative regulations for carrying out the provisions of KRS Chapter 218A. This administrative regulation establishes safe, secure, and responsible methods for the disposal of unused or unwanted prescription controlled substances by long-term care facilities and other cabinet-licensed facilities with custodial control of patient-owned controlled substance medications.
- History: 902 KAR 055:120. 46 Ky.R. 824; eff. 11-1-2019; Crt eff. 5-14-2026.
902 KAR 55:130 Electronic prescribing of controlled substances {#sec-902-kar-55-130 omnilex-key=us-ky-regs-official--title-902--902 KAR 55:130}
Section 1. Prescription Requirements.
(1) Beginning January 1, 2021, a prescription for a controlled substance shall:
(a) Be transmitted electronically to a pharmacy, except as provided by KRS 218A.182(1)(a)-(l); and
(b) Contain the:
-
Full legal name, gender, address, and date of birth of the person for whom the controlled substance is intended;
-
Name, address, Drug Enforcement Administration (DEA) registration number, telephone number, and electronic signature of the prescribing practitioner;
-
Drug name, strength, dosage form, quantity prescribed, specific directions for use, and number of refills (if authorized); and
-
Date upon which the prescription was issued and signed electronically by the prescribing practitioner.
(2) In accordance with KRS 218A.182(2), a pharmacist who receives a written, oral, or faxed prescription for a controlled substance:
(a) Shall not be required to verify that the prescription is subject to an exception provided in KRS 218A.182(1)(a)-(l); and
(b) May dispense a controlled substance pursuant to an otherwise valid written, oral, or fax prescription.
Section 2. Waiver from the EPCS Mandate.
(1) A practitioner who is unable to comply with the EPCS mandate may petition the cabinet for a temporary waiver based upon:
(a) Economic hardship;
(b) Technological limitations that are not reasonably within the control of the practitioner; or
(c) Other exceptional circumstances.
(2) A practitioner seeking an initial waiver from the EPCS mandate shall submit a completed Temporary Exemption Form, no later than November 1, 2020.
(3) A request for renewal of an approved waiver shall be submitted on the Temporary Exemption Form at least sixty (60) days in advance of the expiration of the waiver.
(4) A completed Temporary Exemption Form shall include:
(a) The name, practice address, phone number of the practice point of contact, professional license number, and Drug Enforcement Administration (DEA) registration number of the practitioner seeking the waiver;
(b) The practitioner's current electronic prescribing capabilities;
(c) The reason the practitioner is seeking the waiver;
(d) Supporting documentation to justify the reason for the waiver, including the following mandatory documentation:
- For an economic hardship exemption:
a. Attestation of the practitioner's current gross annual income; and
b. At least two (2) quotes documenting the cost to the practitioner of implementing EPCS;
- For a technological limitation exemption:
a. Documentation showing the:
(i) Available internet service providers;
(ii) Speed and bandwidth available from each provider; and
(iii) Any data caps imposed by the internet service provider; and
b. Documentation showing the minimum technological requirements from at least two (2) electronic prescribing platform vendors;
(e) The anticipated date of compliance with the EPCS mandate; and
(f) If the practitioner is requesting renewal of an approved waiver:
-
Information relating to the practitioner's actions during the previous waiver period to work toward compliance with the EPCS mandate; or
-
An explanation as to why no progress has been made.
(5) Upon consideration of all information provided by the practitioner on a Temporary Exemption Form, the cabinet shall approve or deny the request for an initial or renewal waiver based on the criteria established by this subsection.
(a) If the reason for the waiver is economic hardship and the cost, to the practitioner, of compliance with the EPCS mandate would exceed five (5) percent of the practitioner's gross annual income as self-reported, the cabinet shall approve the request.
(b) If the reason for the waiver is technological limitations and the internet service providers available do not have the technological capabilities required by the electronic prescribing platform, the cabinet shall approve the request.
(c) If the reason for the waiver is other exceptional circumstances, the cabinet shall evaluate the description of the exceptional circumstances on a case-by-case basis.
(d) If the practitioner seeks renewal of a previous waiver, the cabinet shall consider:
-
Updated information as it relates to the practitioner working toward compliance with the EPCS mandate; or
-
The explanation as to why no progress has been made.
(6)
(a) The cabinet may approve a waiver, or the renewal of a current waiver, for a specified period of time not to exceed one (1) year from the date of approval.
(b) The cabinet shall not approve more than two (2) renewal waivers.
Section 3. Enforcement. It shall be the duty of the cabinet to enforce the provisions of this administrative regulation.
Section 4. Penalties.
(1) The cabinet shall make a referral to the appropriate professional licensing board and impose a fine of $1,000 against a practitioner for each violation, not to exceed $2,000 during a twelve (12) month period, in which the cabinet substantiates that the practitioner has:
(a) Falsified information on the Temporary Exemption Form or the form's supporting documentation;
(b) Failed to request a timely waiver in accordance with KRS 218A.182(1)(i) and Section 2(1) to (4) of this administrative regulation and the practitioner is noncompliant with the EPCS mandate; or
(c) Failed to transmit a prescription for a controlled substance electronically to a pharmacy after expiration of the practitioner's waiver, except for prescriptions that meet the exemption criteria of KRS 218A.182(a)-(h) and (j)-(l).
(2) A practitioner may file an appeal with the cabinet within twenty (20) calendar days of the cabinet's written notice of the violation and fine.
(3) If the practitioner requests an administrative hearing, the cabinet shall:
(a) Appoint a hearing officer; and
(b) Proceed pursuant to KRS 13B.050.
(4) The administrative hearing shall be conducted by a hearing officer appointed by the secretary and held in accordance with KRS 13B.080, 13B.090, and 13B.110.
(5) The secretary shall issue a final order in accordance with KRS 13B.120.
Section 5. Incorporation by Reference.
(1) The OIG 55:130, "Temporary Exemption Form", October 2019 edition, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of Inspector General, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 13B.050, 13B.080, 13B.090, 13B.110, 13B.120, 218A.182
- STATUTORY AUTHORITY: KRS 218A.182
- NECESSITY, FUNCTION, AND CONFORMITY: In accordance with KRS 218A.182, which takes effect on January 1, 2021, electronic prescribing for all schedule II-V controlled substances is required by each practitioner who issues the prescription to a pharmacy. KRS 218A.182(1) identifies certain prescriptions that are exempt from the electronic prescribing mandate, including a temporary waiver for entities that demonstrate economic hardship, technological limitations, or other exceptional circumstances. KRS 218A.182(3) requires the cabinet to promulgate administrative regulations to implement the electronic prescribing mandate, including enforcement mechanisms, waivers of requirements, and the appropriate penalties for violations. This administrative regulation establishes requirements related to the electronic prescribing of controlled substances (EPCS).
- History: 17 Ky.R. 719; eff. 10-14-1990; 20 Ky.R. 1694; eff. 2-2-1994; 22 Ky.R. 358; 725; eff. 10-5-1995; 26 Ky.R. 2320; 27 Ky.R. 962; eff. 10-16-2000; 35 Ky.R. 1894; 2223; eff. 5-1-2009; Crt eff. 7-1-2019; 46 Ky.R. 1760, 2640; eff. 6-30-2020.
Chapter 100 Radiology
902 KAR 100:005 General applicability {#sec-902-kar-100-005 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:005}
Section 1. General Applicability of State Radiation Administrative Regulations. The Cabinet for Human Resources' radiation administrative regulations shall apply to the possession and use of sources of ionizing and electronic product radiation in Kentucky and to the handling and disposal of radioactive waste in Kentucky except if exclusive jurisdiction has been retained by the United States Nuclear Regulatory Commission as authorized by applicable federal laws and regulations. The cabinet's radiation administrative regulations shall not be interpreted as limiting the exposure of patients to radiation by licensed state practitioners of the healing arts who are authorized by virtue of their license to use sources of radiation, or by qualified individuals acting under their direction. The classification and certification of operators of sources of radiation as provided by KRS 211.870, 211.890, and 211.993 are not included within the scope of these administrative regulations.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. This administrative regulation specifies the general applicability of the Cabinet for Human Resources' radiation administrative regulations.
- History: 1 Ky.R. 380; eff. 2-5-75; 2 Ky.R. 477; eff. 4-14-76; 12 Ky.R. 978; eff. 1-3-86; 18 Ky.R. 1473; eff. 1-10-92; Crt eff. 11-26-2019; Crt eff. 9-2-2026.
902 KAR 100:010 Definitions for 902 KAR Chapter 100 {#sec-902-kar-100-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:010}
Section 1. Definitions.
(1) "A1" and "A2":
(a) "A1" means the maximum activity of special form radioactive material permitted in a Type A package;
(b) "A2" means the maximum activity of radioactive material, other than special form radioactive material, LSA, and SCO material, permitted in a Type A package;
(c) These values are listed in 10 C.F.R. 71, Appendix A, or may be derived under the procedure prescribed in 10 C.F.R. 71 Appendix A.
(2) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the rad and the gray (Gy).
(3) "Accelerator" means a machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of one (1) MeV, such as the cyclotron, synchrotron, synchrocyclotron, betatron, linear accelerator, and Van de Graaff electrostatic generator.
(4) "Accessible surface" means the external surface of the enclosure or housing provided by the manufacturer.
(5) "Act" means the "Kentucky Radiation Control Act of 1978", as established in KRS 211.840.
(6) "Activity" means the rate of disintegration (transformation) or decay of radioactive material. The units of activity are the curie (Ci) and the becquerel (Bq).
(7) "Address of use" means the building or buildings that are identified on the license and where radioactive material may be received, used or stored.
(8) "Adult" means an individual eighteen (18) or more years of age.
(9) "Agreement state" means a state with which the United States Nuclear Regulatory Commission or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, 42 U.S.C. 200 et seq., as amended (73 Stat. 689).
(10) "Airborne radioactive material" means radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
(11) "Airborne radioactivity area" means a room, enclosure, or area in which airborne radioactive material, composed wholly or partly of radioactive material, exists in concentrations:
(a) In excess of the derived air concentrations specified in 10 C.F.R. 20 Appendix B; or
(b) That an individual present in the area without respiratory protective equipment may exceed an intake of six-tenths (0.6) percent of the annual limit on intake or twelve (12) DAC hours.
(12) "Air kerma (K)" means the kinetic energy released in air by ionizing radiation. Kerma is determined as the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy).
(13) "Air-purifying respirator" means a respirator with an air-purifying filer, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.
(14) "Alert" means the notice given when an event may occur, is in progress, or has occurred that may lead to a release of radioactive material, but the release is not expected to require a response by an off-site response organization in order to protect persons offsite.
(15) "Aluminum equivalent" means the thickness of type 1100 aluminum, which is composed of at least ninety-nine (99.0) percent aluminum, 0.12 percent copper, affording the same attenuation, under specified conditions, as the material for which it is substituted.
(16) "Analytical x-ray system" means a system which utilizes x-rays for the examination of the structure of materials, such as x-ray diffraction and spectrographic equipment.
(17) "Annual limit on intake" or "ALI" means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of annual intake of a given radionuclide by the reference man that would result in:
(a) A committed effective dose equivalent of five (5) rems, or 0.05 Sv; or
(b) A committed dose equivalent of fifty (50) rems, or five-tenths (0.5) Sv, to an individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are established in 10 C.F.R. 20 Appendix B.
(18) "Area of use" means a portion of a physical structure that has been set aside for the purpose of receiving, using or storing radioactive material.
(19) "As low as reasonably achievable" or "ALARA" means making every reasonable effort to maintain exposures to radiation as far below the dose limits established in 902 KAR 100:019 as practical, consistent with the purpose for which the licensed activity is undertaken. ALARA shall take into account the state of technology, the economics of improvement in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, in relation to the utilization of nuclear energy and radioactive materials in the public interest.
(20) "Assigned protection factor" or "APF" means the expected workplace level of respirator protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration may be estimated by dividing the ambient airborne concentration by the APF.
(21) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.
(22) "Attenuation" means the reduction of exposure rate upon passage of radiation through matter.
(23) "Attenuation block" means a block or stack, having dimensions twenty (20) centimeters by twenty (20) centimeters by three and eight-tenths (3.8) centimeters, of type 1100 aluminum alloy or other materials having equivalent attenuation.
(24) "Authorized medical physicist" means an individual who:
(a) Meets the requirements in 902 KAR 100:072, Sections (63) and 65(1); or
(b) Is identified as an authorized medical physicist or teletherapy physicist on:
-
A specific medical use licensee issued by the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state;
-
A medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee;
-
A permit issued by the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state broad scope medical use licensee; or
-
A permit issued by the U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee.
(25) "Authorized nuclear pharmacist" means a pharmacist who:
(a) Meets the requirements in 902 KAR 100:072, Sections 63 and 66(1);
(b) Is identified as an authorized nuclear pharmacist on a:
-
Specific license issued by the cabinet, state, or U.S. Nuclear Regulatory Commission that authorizes the medical use or the practice of nuclear pharmacy;
-
Permit issued by a U.S. Nuclear Regulatory Commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;
-
Permit issued by the cabinet, U.S. Nuclear Regulatory Commission, or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or
-
Permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy;
(c) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or
(d) Is designated as an authorized nuclear pharmacist under 902 KAR 100:058, Section 9(2)(c).
(26) "Authorized user" means a physician, dentist, or podiatrist who:
(a) Meets the requirements in 902 KAR 100:072, Sections 63 and 68(1), 69(1), 70(1), 71(1), 72(1), 74(1), 76(1), or 77(1); or
(b) Is identified as an authorized user on:
-
The cabinet's, U.S. Nuclear Regulatory Commission's, or an agreement state's license that authorizes the medical use of radioactive material;
-
A permit issued by a U.S. Nuclear Regulatory Commission master material licensee that is authorized to permit the medical use of radioactive material;
-
A permit issued by the cabinet, U.S. Nuclear Regulatory Commission, or agreement state licensee of broad scope that is authorized to permit the medical use of radioactive material; or
-
A permit issued by a U.S. Nuclear Regulatory Commission master material license broad scope permittee that is authorized to permit the medical use of radioactive material.
(27) "Automatic exposure control" means a device that automatically controls one (1) or more technique factors in order to obtain, at a preselected location, a required quantity of radiation.
(28) "Background radiation" means radiation not under the control of the licensee, including:
(a) From cosmic sources;
(b) Naturally occurring radioactive materials;
(c) Radon that is not a decay product of source or special nuclear material; and
(d) Global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents. Background radiation shall not include radiation from radioactive materials regulated by the Cabinet for Health and Family Services.
(29) "Beam axis" means the axis of rotation of the beam limiting device.
(30) "Beam limiting device" or "collimator" means a device that provides a means to restrict the dimensions of the x-ray field.
(31) "Beam monitoring system" means a system designed to detect and measure the radiation present in the useful beam.
(32) "Beam scattering foil" means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.
(33) "Becquerel" means a unit, in the International System of Units (SI), of measurement of radioactivity equal to one (1) transformation per second.
(34) "Bioassay" or "radiobioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, by direct measurement (in vivo counting) or by analysis and evaluation of materials excreted or removed from the human body.
(35) "Brachytherapy" means a method of radiation therapy in which an encapsulated source or group of sources is utilized to deliver radiation at a distance to a few centimeters, by surface, intracavitary, or interstitial application.
(36) "Broker" or "waste broker" means a person who takes possession of low-level waste solely for the purposes of consolidation and shipment.
(37) "By-product material" means:
(a) 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; or
(b) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations shall not constitute by-product material within this definition.
(38) "Cabinet" means Cabinet for Health Services, or its duly authorized representatives.
(39) "Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet shielded so that radiation levels at every location on the exterior meet the limitations specified in 902 KAR 100:019, Section 11.
(40) "Cabinet x-ray system" means an x-ray system with the x-ray tube installed or used in a permanent enclosure in which the enclosure is intended to contain at least that portion of the material being irradiated, not to include x-ray systems used by licensed practitioners of the healing arts. The enclosure:
(a) May be the architectural structure or may be independent of the architectural structure;
(b) Shall provide attenuation of the radiation to meet the requirements of 902 KAR 100:105; and
(c) Shall exclude personnel from its interior during the generation of x-radiation.
(41) "Calendar quarter" means between twelve (12) and fourteen (14) consecutive weeks.
(a) The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be arranged so that no day is included in more than one (1) calendar quarter and no day in a one (1) year period is omitted from inclusion within a calendar quarter.
(b) A licensee or registrant shall not change the method observed of determining calendar quarters, except at the beginning of a calendar year.
(42) "Calibration" means the determination of:
(a) The response or reading of an instrument relative to a series of known radiation values over the range of the instrument; or
(b) The strength of a source of radiation relative to a standard.
(43) "Carrier" is defined by KRS 174.405(1).
(44) "Cephalometric device" means a device intended for the radiographic visualization and measurement of the dimensions of the human head.
(45) "Certificate holder" means a person who has been issued a certificate of compliance or other package approval by the U.S. Nuclear Regulatory Commission.
(46) "Certificate of Compliance" or "CoC" means the certificate issued by the U.S. Nuclear Regulatory Commission under 10 C.F.R. Part 71, which approves the design of a package for the transportation of radioactive material.
(47) "Certified cabinet x-ray system" means an x-ray system that has been certified pursuant to 21 C.F.R. 1010.2 as being manufactured and assembled according to the provisions of 21 C.F.R. 1020.40.
(48) "Certified component" means a component of an x-ray system subject to 21 C.F.R. Subchapter J.
(49) "Certified system" means an x-ray system that has one (1) or more certified component.
(50) "C.F.R." means Code of Federal Regulations.
(51) "Changeable filters" means a filter, exclusive of inherent filtration, which can be removed from the useful beam through an electronic, mechanical, or physical process.
(52) "Chemical description" means a description of the principal chemical characteristics of a low-level radioactive waste.
(53) "Class" or "lung class" or "inhalation class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials shall be classified as D, W, or Y, which applies to a range of clearance half-times:
(a) For Class D (Days) of less than ten (10) days;
(b) For Class W (Weeks) from ten (10) to 100 days; and
(c) For Class Y (Years) of greater than 100 days.
(54) "Close reflection by water" means immediate contact by water of sufficient thickness for maximum reflection of neutrons.
(55) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.
(56) "Collimator" means a device used to limit the size, shape, and direction of the primary radiation beam.
(57) "Commission" means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
(58) "Committed dose equivalent (HT,50)" means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the fifty (50) year period following the intake.
(59) "Committed effective dose equivalent (HE,50)" means the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues (HE,50 = ∑WTHT,50).
(60) "Computer-readable medium" means the cabinet's computer can transfer the information from the medium into its memory.
(61) "Computed tomography" or "CT" means the production of a tomogram by the acquisition and computer processing of x-ray transmission data.
(62) "Consignee" means the designated receiver of the shipment of low-level radioactive waste.
(63) "Consignment" means each shipment of a package or groups of packages or load of radioactive material officered by a shipper for transport.
(64) "Constraint" or "dose constraint" means a value above which specified licensee actions are required.
(65) "Contact therapy system" means an x-ray system used for therapy with the x-ray tube port placed in contact with or within five (5) centimeters of the surface being treated.
(66) "Containment system" means the assembly of components of the package intended to retain the radioactive material during transport.
(67) "Controlled area" means an area, outside of a restricted area but inside the site boundary, to which access can be limited by the licensee or registrant for a stated reason.
(68) "Cooling curve" means the graphical relationship between heat units stored and cooling time.
(69) "Conveyance" means:
(a) For transport by public highway or rail, a transport vehicle or large freight container;
(b) For transport by water, a vessel or a hold, compartment, or defined deck area of a vessel including a transport vehicle on board the vessel; or
(c) Transportation by an aircraft.
(70) "Critical group" means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.
(71) "Criticality Safety Index" or "CSI", means the dimensionless number, rounded up to the next tenth, assigned to and placed on the label of a fissile material package, to designate the degree of control of accumulation of packages containing fissile material during transportation. Determination of the criticality safety index is described in 10 C.F.R. 71.22, 71.23, and 71.59.
(72) "Curie" means a quantity of radioactivity.
(a) One (1) curie (Ci) is that quantity of radioactive material that decays at the rate of 3.7 x 1010 disintegrations per second (dps).
(b) Commonly used submultiples of the curie are the millicurie and the microcurie.
-
One (1) millicurie (mCi) = 0.001 curie = 3.7 x 107 dps.
-
One (1) microcurie (uCi) = 0.000001 curie = 3.7 x 104 dps.
(73) "Dead man switch" means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
(74) "Declared pregnant woman" means a woman who has voluntarily informed the licensee, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.
(75) "Decommission" means the:
(a) Safe removal from service of a facility or site;
(b) Termination of license; and
(c) Reduction of residual radioactivity to a level permitting release of the property:
-
For unrestricted use; or
-
Under restricted conditions.
(76) "Decontamination facility" means a facility operating under the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state license whose principal purpose is decontamination of equipment or materials to accomplish recycle, reuse, or other waste management objectives, and is not considered to be a consignee for LLW shipments.
(77) "Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. The source may also be used for other purposes.
(78) "Deep-dose equivalent (Hd)" which applies to external whole-body exposure, means the dose equivalent at a tissue depth of one (1) centimeter (cm) (1000 mg/cm2).
(79) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.
(80) "Derived air concentration" or "DAC" means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of 2,000 hours under conditions of light work, results in an intake of one (1) ALI.
(a) "Light work" produces an inhalation rate of one and two-tenths (1.2) cubic meters (1.2m3) of air per hour.
(b) DAC values are given in 10 C.F.R., 20 Appendix B.
(81) "Derived air concentration-hour" or "DAC-hour" means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAC-hours to represent one (1) ALI, equivalent to a committed effective dose equivalent of five (5) rems (0.05 Sv).
(82) "Deuterium" means deuterium and any deuterium compounds, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000.
(83) "Diagnostic clinical procedure manual" means the collection of written procedures, methods, instructions, and precautions by which the licensee performs diagnostic clinical procedures, where each diagnostic clinical procedure:
(a) Has been approved by the authorized user; and
(b) Includes the radiopharmaceutical name, dosage, and route of administration.
(84) "Diagnostic source assembly" means the tube housing assembly with a beam-limiting device attached.
(85) "Diagnostic-type protective tube housing" means an x-ray tube housing so constructed that the leakage radiation measured at a distance of one (1) meter from the source cannot exceed 100 milliroentgens in one (1) hour if the tube is operated at its maximum continuous rated current for the maximum tube potential.
(86) "Diagnostic x-ray system" means an x-ray system designed for irradiation of a part of the human body for the purpose of diagnosis or visualization.
(87) "Direct scatter radiation" means that scattered radiation that has been deviated in direction only by materials irradiated by the useful beam. (See also "scattered radiation").
(88) "Disposable container" means a container principally used to confine low-level radioactive waste during disposal operations at a land disposal facility. (See also "high integrity container".) For some shipments, the disposal container may be transport package.
(89) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Disposal respirator may include, but not limit to a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).
(90) "Disposal" means the disposition of waste as authorized by 902 KAR 100:021.
(91) "Distinguishable from background" means that the detectable concentration of a radionuclide is statistically different from the background concentrations of that radionuclide in the vicinity of the site or, in the case of structures, in similar materials using adequate measurements technology, survey, and statistical techniques.
(92) "Dose" or "radiation dose" means:
(a) Absorbed dose;
(b) Dose equivalent;
(c) Effective dose equivalent;
(d) Committed dose equivalent;
(e) Committed effective dose equivalent; or
(f) Total effective dose equivalent.
(93) "Dose commitment" means the total radiation dose to a part of the body that results from retention in the body of radioactive material. Estimation assumes the period of exposure to retained material to be less than fifty (50) years.
(94) "Dose equivalent (HT)" means the product of the absorbed dose in tissue, the quality factor, and other necessary modifying factors at the location of interest. The units of dose equivalent are the rem and sievert (Sv).
(95) Dose monitor unit (DMU)" means a unit response from the beam monitoring system from which the absorbed dose can be calculated.
(96) "Dosimetry processor" means an individual or an organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the equipment.
(97) "DOT" means the U.S. Department of Transportation.
(98) "Effective dose equivalent (HE)" means the sum of the products of the dose equivalent to the organ or tissue (HT) and the weighting factors (WT) applicable to each of the body organs or tissues that are irradiated (HE = WTHT).
(99) "Embryo or fetus" means the developing human organism from conception until the time of birth.
(100) "Energy compensation source or "ECS" means a small sealed source, with an activity not exceeding 100 microcuries (3.7 MBq), used within a logging tool, or other tool components, to provide a reference standard to maintain the tool's calibration when in use.
(101) "Entrance or access point" means a location through which an individual may gain access to a radiation area or radioactive material, including an entry or exit portal of sufficient size to permit human entry, irrespective of its intended use.
(102) "Entrance exposure rate" means the roentgens per unit time at the point the center of the useful beam enters the patient.
(103) "Environmental Protection Agency "EPA" Identification number" means the number received by a transporter following application to the EPA as required by 40 C.F.R. Part 263.
(104) "Exclusive use" means the sole use of a conveyance by a single consignor in which initial, intermediate, and final loading and unloading are carried out under the direction of the consignor or consignee.
(a) Consignor and carrier shall each ensure that loading and unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment.
(b) Consignor shall include with the shipping paper information provided to the carrier, specific written instructions for maintenance of exclusive use shipment controls.
(105) "Exposure" means being exposed to ionizing radiation or to radioactive material.
(106) "Exposure rate" means the exposure per unit of time.
(107) "External beam radiation therapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.
(108) "External dose" means that portion of the dose equivalent received from radiation sources outside the body.
(109) "Extremity" means hand, elbow, arm below the elbow, foot, knee, or leg below the knee.
(110) "Eye dose equivalent". See "lens dose equivalent".
(111) "Facility" means a location at which one (1) or more devices or sources are installed or located within one (1) building, vehicle, or under one (1) roof, under the same administrative control.
(112) "Field emission equipment" means equipment which uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.
(113) "Field-flattening filter" means a filter used to homogenize the absorbed dose rate over the radiation field.
(114) "Field station" means a facility where radioactive sources may be stored or used and from which equipment is dispatched to temporary job sites.
(115) "Filter" means the material in the useful beam which usually absorbs preferentially the less penetrating radiations.
(a) "Inherent filtration" means the filter permanently in the useful beam. It includes the window of the x-ray tube and the permanent tube enclosure.
(b) "Added filter" means the filter added to the inherent filtration.
(c) "Total filter" means the sum of the inherent and added filters.
(116) "Filtering facepiece (dust mask)" means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.
(117)
(a) "Fissile material" means the:
-
Radionuclides uranium-233, uranium-235, plutonium-239, and plutonium-241, or any combination of these radionuclides; and
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Fissile nuclides themselves, not material containing fissile nuclides.
(b) Fissile material does not include unirradiated natural and depleted uranium; and natural or depleted uranium that has been irradiated in thermal reactors only;
(c) Fissile material also excludes certain controls as provided in 10 C.F.R. 71.15.
(118) "Fissile material package" means a fissile material packaging together with its fissile material contents.
(119) "Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator while worn.
(120) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.
(121) "Fluoroscopic imaging assembly" means a component that comprises a reception system in which x-ray photons produce a fluoroscopic image. It includes equipment housings, electrical interlocks if present, the primary protective barrier, and structural material providing linkage between the image receptor and the diagnostic source assembly.
(122) "Focal spot" means the area projected on the anode of the x-ray tube by the electrons accelerated from the cathode and from which the useful beam originates.
(123) "Former U.S. Atomic Energy Commission (AEC) or U.S. Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.
(124) "Gantry" means that part of a radiation producing machine supporting and allowing movements of the radiation head about a center of rotation.
(125) "General purpose radiographic x-ray system" means a radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions.
(126) "Generally applicable environmental radiation standards" means standards issued by the Environmental Protection Agency (EPA) under the authority of 42 U.S.C. sec. 2011 et seq., that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.
(127) "Generator" or means a licensee operating under the cabinet, U.S. Nuclear Regulatory Commission or an agreement state who:
(a) Is a waste generator as defined in this administrative regulation; or
(b) Is the licensee to whom waste can be attributed within the context of the Low Level Radioactive Waste Policy Amendments Act of 1985, such as, waste generated as a result of decontamination or recycle activities.
(128) "Gonad shield" means a protective barrier for the testes or ovaries.
(129) "Graphite" means graphite with a boron equivalent content less than five (5) parts per million and density greater than one and five-tenths (1.5) grams per cubic centimeter.
(130) "Gray" or "Gy" means the SI unit of absorbed dose. One (1) gray equals an absorbed dose of one (1) Joule/kilogram (100 rads).
(131) "Half-value layer" or "HVL" means the thickness of specified material which attenuates the beam of radiation to one-half (1/2) of its original air kerma rate, exposure rate or absorbed dose rate. This excludes the contribution of scattered radiation, other than that which might be present initially in the beam concerned.
(132) "Healing arts screening" means the testing of human beings using x-ray machines for the detection or evaluation of health indications if these tests are not specifically and individually ordered by a licensed practitioner of the healing arts legally authorized to prescribe these x-ray tests for the purpose of diagnosis or treatment.
(133) "Heat unit" means a unit of energy equal to the product of the peak kilovoltage, milliamperes, and seconds.
(134) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.
(135) "High integrity container or "HIC" means a container commonly designated to meet the structural stability requirements of 10 C.F.R. 61.56, and to meet the U.S. Department of Transportation requirements for a Type A package.
(136) "High radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body may result in an individual receiving a dose equivalent in excess of one-tenth (0.1) rem (1m Sv) in one (1) hour at thirty (30) centimeters from the radiation source or thirty (30) centimeters from a surface that the radiation penetrates.
(137) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.
(138) "Human use" means the internal or external administration of radiation or radioactive materials to human beings.
(139) "Image intensifier" means a device that converts instantaneously, by means of photoemissive surfaces and electronic circuitry, an x-ray pattern into a light pattern of greater intensity than would have been produced by the original x-ray pattern.
(140) "Image receptor" means a device that transforms incident radiation into a visual image or into another form which can be made into a visual image by further transformations.
(141) "Image receptor support" means, for mammographic systems, that part of the system designed to support the image receptor in a horizontal plane during a mammographic examination.
(142) "Individual" means a human being.
(143) "Individual monitoring" means the assessment of:
(a) Dose equivalent by the use of an individual monitoring device;
(b) Committed effective dose equivalent by:
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Bioassay; or
-
Determination of the time-weighted air concentrations to which an individual has been exposed; or
(c) Dose equivalent by the use of survey data.
(144) "Individual monitoring device" or "individual monitoring equipment" means a device designed to be worn by a single individual for the assessment of dose equivalent, such as film badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, or personal ("lapel") air sampling devices.
(145) "Industrial radiography" means the examination of the macroscopic structure of materials by nondestructive methods utilizing sources of radiation.
(146) "Injection tool" means a device used for controlled subsurface injection of radioactive tracer material.
(147) "Interlock" means a device preventing the start or continued operation of equipment unless certain predetermined conditions prevail.
(148) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.
(149) "Irradiation" means the exposure of matter to ionizing radiation.
(150) "Kilovolt (kV) {kilo electron volt}" means the energy equal to that acquired by a particle with one (1) electron charge in passing through a potential difference of 1,000 volts in a vacuum. (Note: current convention is to use kV for photons and keV for electrons.)
(151) "Kilovolt peak" or "kVp" means the crest value in kilovolts of the potential difference of a pulsating potential generator. If only one-half (1/2) of the wave is used, the value refers to the useful half of the wave.
(152) "Lead equivalent" means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.
(153) "Leakage radiation" means radiation emanating from the diagnostic or therapeutic source assembly, except for the useful beam.
(154) "Leakage technique factor" means, with respect to different tube housing assemblies:
(a) For capacitor energy storage equipment: the maximum rated number of exposures in an hour for operation at the maximum rated peak tube potential, with a charge per exposure of ten (10) milliampere seconds (mAs) or the minimum obtainable from the unit, whichever is larger.
(b) For field emission equipment rated for pulsed operation: the maximum rated number of x-ray pulses in an hour for operation at the maximum rated peak tube potential.
(c) For all other equipment: the maximum rated continuous tube current for the maximum rated peak tube potential.
(155) "Lens dose equivalent" or "LDE" means the external exposure of the lens of the eye, and is taken as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).
(156) "License" means a license issued by the cabinet under 902 KAR Chapter 100.
(157) "Licensed material" means radioactive material, source material, or special nuclear material received, possessed, used, or transferred, under a general or specific license issued by the cabinet, U.S. Nuclear Regulatory Commission or an agreement state.
(158) "Light field" means the area illuminated by light, simulating the radiation field.
(159) "Limits" or "dose limits"" means the permissible upper bounds of radiation doses.
(160) "Lixiscope" means a portable light-intensified imaging device using a sealed source.
(161) "Logging assistant" means an individual who, under the personal supervision of a logging supervisor:
(a) Handles sealed sources or tracers that are not in logging tools or shipping containers; or
(b) Uses survey instruments in well-logging activities.
(162) "Logging supervisor" means the individual who provides personal supervision of the utilization of sources of radiation at the well site.
(163) "Logging tool" means a device used subsurface to perform well-logging.
(164) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.
(165) "Lost or missing licensed material" means licensed material whose location is unknown. It includes material that has been shipped but has not reached its destination and whose location cannot be readily traced in the transportation system.
(166) "Low-level radioactive waste" means radioactive waste not classified as:
(a) High-level radioactive waste;
(b) Transuranic waste;
(c) Spent nuclear fuel; or
(d) By-product material as defined in Section 11e(2) of the Atomic Energy Act of 1954, 42 U.S.C. 2014.
(167) "Low specific activity" or "LSA" means radioactive material with limited specific activity, which is nonfissile or is excepted pursuant to 10 C.F.R. 71.15 and that satisfies the descriptions and limits established in paragraphs (a), (b), and (c) of this subsection. Shielding materials surrounding the LSA material shall not be considered in determining the estimated average specific activity of the package contents. LSA material shall be in one (1) of three (3) groups:
(a) LSA-I:
-
Uranium and thorium ores, uranium or thorium concentrates of these ores, and other ores containing naturally occurring radioactive nuclides that are not intended to be processed for the use of these radionuclides;
-
Solid unirradiated natural or depleted uranium or natural thorium or their solid or liquid compounds or mixtures;
-
Radioactive material for which the A2 value is unlimited; or
-
Other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed thirty (30) times the value for exempt material activity concentration determined in 10 C.F.R. 71 Appendix A.
(b) LSA-II:
-
Water with tritium concentration up to 20.0 curies/liter (0.8 TBq/liter); or
-
Material in which the radioactive material is distributed throughout, and the average specific activity does not exceed 10-4 A2/gram for solids and gases, and 10-5 A2/gram for liquids.
(c) LSA-III: Solids (e.g., consolidated wastes, activated materials), excluding powders, that satisfy the requirements of 10 C.F.R. 71.77 in which:
-
The radioactive material is distributed throughout a solid or a collection of solid objects;
-
Is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.);
-
The radioactive material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of radioactive material per package by leaching, when placed in water for seven (7) days, would not exceed 0.1 A2; and the average specific activity of the solid does not exceed 2 x 10-3 A2/gram; and
-
The average specific activity of the solid does not exceed 2 x 10-3 A2/gram.
(168) "Low toxicity alpha emitter" means natural uranium, depleted uranium, natural thorium, uranium-235, uranium-238, thorium-232, thorium-228 or thorium-230 when contained in ores or physical or chemical concentrates or tailings; or alpha emitters with a half-life of less than ten (10) days.
(169) "mA" means milliampere.
(170) "Management" means the chief executive officer or that individual's designee.
(171) "mAs" means milliampere second.
(172) "Maximum normal operating pressure" means the maximum gauge pressure that would develop in the containment system in a period of one (1) year under the heat condition specified in 10 C.F.R. Part 71.71(c)(1), in the absence of venting, external cooling by an ancillary system, or operational controls during transport.
(173) "Medical institution" means an organization in which several medical disciplines are practiced.
(174) "Medical use" means the intentional internal or external administration of radioactive material, or the radiation therefrom, to patients or human research subjects under the supervision of an authorized user.
(175) "Member of the public" means an individual except when the individual is receiving an occupational dose.
(176) "Microscopic analytical x-ray equipment" means a device which utilizes x-rays for examining the microscopic structure of materials. This includes x-ray diffraction and spectrographic equipment.
(177) "Mineral logging" means logging performed for the purpose of mineral exploration other than oil or gas.
(178) "Minor" means an individual less than eighteen (18) years of age.
(179) "Misadministration" means the administration of:
(a) A radiopharmaceutical dosage greater than thirty (30) microcuries of sodium iodide I-125 or I-131:
-
Involving the wrong patient or human research subject or the wrong radiopharmaceutical; or
-
If both the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage and the difference between the administered dosage and prescribe dosage exceeds thirty (30) microcuries.
(b) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:
-
Involving the wrong patient, human research subject, radiopharmaceutical, or route of administration; or
-
If the administered dosage differs from the prescribed dosage by more than twenty (20) percent of the prescribed dosage.
(c) A gamma stereotactic radiosurgery radiation dose:
-
Involving the wrong patient, human research subject, or treatment site; or
-
If the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent.
(d) A teletherapy radiation dose:
-
Involving the wrong patient, human research subject, mode of treatment, or treatment site;
-
If the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten (10) percent;
-
If the calculated weekly administered dose is thirty (30) percent greater than the weekly prescribed dose; or
-
If the calculated total administered dose differs from the total prescribed dose by more than twenty (20) percent.
(e) A brachytherapy radiation dose:
-
Involving the wrong patient, human research subject, radioisotope, or treatment site except for permanent implant seeds that were implanted in the correct site but migrated outside the treatment site;
-
Involving a sealed source that is leaking;
-
If, for a temporary implant, one (1) or more sealed sources are not removed upon completion of the procedure; or
-
If the calculated administered dose differs from the prescribed dose by more than twenty (20) percent.
(f) A diagnostic radiopharmaceutical dosage, other than quantities greater than thirty (30) microcuries of sodium iodide I-125 or I-131:
-
Involving the wrong patient, human research subject, radiopharmaceutical, or route of administration, or if the administered dosage differs from the prescribed dosage; and
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If the dose to the patient or human research subject exceeds five (5) rems effective dose equivalent or fifty (50) rems dose equivalent to an individual organ.
(180) "Mobile nuclear medicine service" means the transportation and medical use of radioactive material.
(181) "Monitor unit (MU)" (See "Dose monitor unit").
(182) "Monitoring" or "radiation monitoring" or "radiation protection monitoring" means the measurement of radiation levels, concentrations, surface area concentrations or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses.
(183) "Moving beam radiation therapy" means radiation therapy with any planned displacement of radiation field or patient relative to each other, or with any planned change of absorbed dose distribution. It includes arc, skip, conformal, intensity modulation and rotational therapy.
(184) "Natural thorium" means thorium with the naturally occurring distribution of thorium isotopes; that is, 100 weight percent thorium-232.
(185) "Negative pressure respirator (tight fitting)" means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.
(186) "Nominal treatment distance" means:
(a) For electron irradiation, the distance from the scattering foil, virtual source, or exit window of the electron beam to the entrance surface of the irradiated object along the central axis of the useful beam.
(b) For x-ray irradiation, the virtual source or target to isocenter distance along the central axis of the useful beam. For non-isocentric equipment, this distance shall be that specified by the manufacturer.
(187) "Nonstochastic effect" or "deterministic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist.
(188) "Normal form radioactive material" means radioactive material that has not been demonstrated to qualify as "special form radioactive material."
(189) "NRC" means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.
(190)
(a) "NRC Forms 540, 540A, 541, 541A, 542, and 542A" means official NRC forms as referenced in 902 KAR 100:021.
(b) Licensees need not use originals of these forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information.
(c) Upon agreement between the shipper and consignee, NRC Forms 541, 541A, 542, and 542A may be completed, transmitted, and stored in electronic media.
(d) The electronic media shall have the capability for producing legible, accurate, and complete records in the format of the uniform manifest.
(191) "Occupational dose" means dose received by an individual in the course of employment in which the individual's assigned duties for the licensee or registrant involve exposure to sources of radiation, whether in the possession of the licensee, registrant, or other person. Occupational dose shall not include dose received:
(a) From background radiation;
(b) As a medical patient;
(c) From voluntary participation in a medical research program;
(d) As a member of the public; or
(e) From exposure to individuals administered radioactive material and released in accordance with 902 KAR 100:072, Section 27.
(192) "Operating procedures" means detailed written instructions, such as:
(a) Normal operation of equipment and movable shielding;
(b) Closing of interlock circuits;
(c) Manipulation of controls;
(d) Radiation monitoring procedures for personnel and areas;
(e) Testing of interlocks; and
(f) Recordkeeping requirements.
(193) "Output" means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
(194) "Package" means the packaging together with its radioactive contents as presented for transport:
(a) Fissile material package or Type AF package, Type BF package, Type B(U)F package, or Type B(M)F package are all fissile material packaging types together with its fissile material complete.
(b) Type A package means a Type A packaging together with its radioactive contents. A Type A package is defined and shall comply with the DOT regulations in 49 C.F.R. Part 173.
(c) Type B package means a Type B packaging together with its radioactive contents.
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On approval, a Type B package design is designated by the U.S. Nuclear Regulatory Commission as B(U) unless the package has a maximum normal operating pressure of more than 100 pounds/in2 (700 kPa) gauge or a pressure relief device that would allow the release of radioactive material to the environment under the tests specified in 10 C.F.R. Part 71.73 (hypothetical accident conditions), in which case it will receive a designation B(M).
-
B(U) refers to the need for unilateral approval of international shipments.
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B(M) refers to the need for multilaterial approval of international shipments.
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There is no distinction made in how packages with these designations might be used in domestic transportation.
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To determine their distinction for international transportation, refer to U.S. Department of Transportation Regulations in 49 C.F.R. Part 173.
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A Type B package approved before September 6, 1983, was designated only as Type B. Limitations on its use are specified in 902 KAR 100:070, Section 7.
(195) "Packaging" means the assembly of components necessary to ensure compliance with the requirements of 902 KAR 100:070.
(a) It may consist of one (1) or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, and devices for cooling or absorbing mechanical shocks.
(b) The vehicle, tie-down system, and auxiliary equipment may be designated as part of the packaging.
(196) "Patient" means an individual subjected to healing arts examination, diagnosis, or treatment.
(197) "Peak tube potential" means the maximum value of the potential difference across the x-ray tube during an exposure.
(198) "Periodic quality assurance check" means a procedure which is performed to ensure that a previous calibration continues to be valid.
(199) "Permanent radiographic installation" means an installation or structure designed or intended for radiography and in which radiography is regularly performed.
(200) "Person" is defined by KRS 216B.015(16).
(201) "Personal supervision" means guidance and instruction by the supervisor who is physically present at the job site and watching the performance of the operation in proximity so that contact can be maintained and immediate assistance given as required.
(202) "Personnel monitoring equipment" means a device designed to be worn or carried by an individual for the purpose of estimating the dose received by the individual.
(203) "Phantom" means a volume of material behaving in a manner similar to tissue with respect to the attenuation and scattering of radiation.
(204) "Phototimer" means a method for controlling radiation exposures to image receptors by the amount of radiation which reaches a radiation monitoring device. The radiation monitoring device is part of an electronic circuit which controls the duration of time the tube is activated. See "automatic exposure control".
(205) "Physical description" means the items called for on NRC Form 541 to describe low-level radioactive waste.
(206) "Physician" is defined by KRS 311.720(9).
(207) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual dose limits.
(208) "Position indicating device" means a device on dental x-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.
(209) "Positive pressure respirator" means a respirator in which the pressure inside the respirator inlet covering exceeds the ambient air pressure outside the respirator.
(210) "Powered air-purifying respirator" or "PAPR" means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.
(211) "Preceptor" means an individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a Radiation Safety Officer.
(212) "Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.
(213) "Preregistrant" means a person who is preregistered with the cabinet for the intent of obtaining a radiation producing machine registerable under 902 KAR 100:110.
(214) "Preregistration" means preregistration with the cabinet as specified in 902 KAR 100:110.
(215) "Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:
(a) In a written directive;
(b) In the diagnostic clinical procedures manual; or
(c) In an appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
(216) "Prescribed dose" means:
(a) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;
(b) For teletherapy, the total dose and dose per fraction as documented in the written directive;
(c) For manual brachytherapy, the total source strength and exposure time or the total dose, as documented in the written directive; or
(d) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.
(217) "Primary dose monitoring system" means a system that:
(a) Monitors the useful beam during irradiation; and
(b) Terminates irradiation if a preselected number of dose monitor units have been acquired.
(218) "Principal activities" means activities authorized by the license that are essential to achieving the purpose for which the license was issued or amended. "Principal activities" do not include:
(a) Storage during which licensed material is not accessed for use or disposal; and
(b) Activities incidental to decontamination or decommissioning.
(219) "Protective apron" means an apron made of radiation absorbing materials of at least 0.25 mm lead equivalency; that is, if the HVL of the apron is not less than 0.25 mm lead at normal operating voltages.
(220) "Protective barrier" means a barrier of radiation absorbing material used to reduce radiation exposure.
(a) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the required degree.
(b) "Secondary protective barrier" means a barrier sufficient to attenuate the stray radiation to the required degree.
(221) "Protective glove" means a glove made of radiation absorbing materials of at least 0.25 mm lead equivalency; that is, if the HVL of the glove is not less than 0.25 mm lead at normal operating voltages.
(222) "Public dose" means the dose received by a member of the public from sources of radiation from licensed or registered operations. It shall not include radiation received:
(a) As an occupational dose;
(b) From background radiation;
(c) As a medical patient;
(d) From voluntary participation in a medical research program; or
(e) From exposure to an individual administered radioactive material and released in accordance with 902 KAR 100:072, Section 27.
(223) "Qualified expert" means an individual who has been recognized by the cabinet to possess the knowledge and training to:
(a) Measure ionizing radiation;
(b) Evaluate safety techniques; and
(c) Advise regarding radiation protection needs.
(224) "Qualitative fit test or "QFT" means a pass or fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.
(225) "Quality factor" or "Q" means the modifying factor used to derive dose equivalent from absorbed dose.
(a) Quality factors and absorbed dose equivalencies:
(b) If it is more convenient to measure the neutron fluence rate than to determine the neutron dose equivalent rate in rems per hour or sieverts per hour, as provided in paragraph (a) of this subsection, one (1) rem (0.01 sievert) of neutron radiation of unknown energies may, for purposes of the regulations in this part, be assumed to result from a total fluence of twenty-five (25) million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee may use the fluence rate per unit dose equivalent or the appropriate Q value from paragraph (c) of this subsection to convert a measured tissue dose in rads to dose equivalent in rems.
(c) Mean quality factors, Q, and fluency per unit dose equivalent for monoenergetic neutrons:
(226) "Quantitative fit test "QNFT" means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.
(227) "Quarter" is defined by KRS 341.080(1)(b).
(228) "Rad" means the special unit of absorbed dose. One (1) rad equals an absorbed dose of 0.01 joule per kilogram (0.01 gray) or 100 ergs per gram.
(229) "Radiation" means ionizing radiation.
(a) It includes the following:
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Gamma rays;
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X-rays;
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Alpha particles;
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Beta particles;
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High speed electrons;
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Neutrons;
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High-speed protons; and
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Other atomic particles capable of producing ions.
(b) It excludes nonionizing radiations, such as:
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Sound;
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Microwaves;
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Radiowaves; or
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Visible, infrared, or ultraviolet light.
(c) The following are specific forms of radiation:
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"Leakage radiation" means radiation coming from within the tube or source housing except the useful beam.
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"Scattered radiation" means radiation that, during passage through matter, has been deviated in direction, and may have been modified by a decrease in energy.
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"Useful radiation" or "primary beam" means radiation that passes through the window, aperture, cone, or other beam limiting device of the tube or source housing.
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"Stray radiation" means the sum of leakage and scattered radiation.
(230) "Radiation area" means an area, accessible to individuals, in which there exists radiation at levels that an individual may receive in excess of five (5) millirems (0.05 mSv) in one (1) hour at thirty (30) centimeters from the radiation source or from a surface that the radiation penetrates.
(231) "Radiation detector" means a device which, in the presence of radiation, by either direct or indirect means, provides a signal or other indication suitable for use in measuring one (1) or more quantities of incident radiation.
(232) "Radiation head" means the structure from which the useful beam emerges.
(233) "Radiation machine" means a device capable of producing radiation, except a device that produces radiation only from radioactive material.
(234) "Radiation safety officer" means an individual who:
(a) Meets the requirements in 902 KAR 100:072, Sections 63 and 64(1) or (3)(a); or
(b) Is identified as a radiation safety officer on:
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A specific medical use licensee issued by the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state; or
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A medical use permit issued by a U.S. Nuclear Regulatory Commission master material licensee.
(235) "Radiation therapy simulation system" means a fluoroscopic or radiographic x-ray system intended for:
(a) Localizing the volume to be exposed during radiation therapy; and
(b) Confirming the position and size of the therapeutic irradiation field.
(236) "Radioactive marker" means radioactive material placed subsurface or on a structure intended for subsurface use for the purpose of depth determination or direction orientation.
(237) "Radioactive material" means a solid, liquid, or gas, which emits radiation spontaneously.
(238) "Radioactivity" means the disintegration of unstable atomic nuclei by the emission of radiation.
(239) "Radiograph" means an image receptor on which the image is created directly or indirectly by an x-ray pattern and results in a permanent record.
(240) "Radiographer" means an individual who performs or who, in attendance at the site where sources of radiation are being used, personally supervises industrial radiographic operations and who is responsible to the licensee or registrant for assuring compliance with the requirements of administrative regulations and license conditions.
(241) "Radiographer's assistant" means an individual who, under the personal supervision of a radiographer, uses sources of radiation, related handling tools, or survey instruments in industrial radiography.
(242) "Radiographer instructor" means a radiographer who has been authorized by the cabinet to provide on-the-job training to radiographer trainees under 902 KAR 100:100, Section 14.
(243) "Radiographer trainee" means an individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handling tools, or radiation survey instruments during the course of instruction.
(244) "Radiographic exposure device" means an instrument containing a sealed source fastened or contained within, in which the sealed source or its shielding may be moved, or otherwise changed, from a shielded to an unshielded position for purposes of making a radiographic exposure.
(245) "Radiographic imaging system" means a system designed to record a permanent or semipermanent image on an image receptor by the action of ionizing radiation.
(246) "Radiographic personnel" means a:
(a) Radiographer;
(b) Radiographer instructor; or
(c) Radiographer trainee.
(247) "Rating" means the operating limits specified by the component manufacturer.
(248) "Recordable event" means the administration of:
(a) A radiopharmaceutical or radiation without a written directive, if a written directive is required;
(b) A radiopharmaceutical or radiation if a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record;
(c) A radiopharmaceutical dosage greater than thirty (30) microcuries of sodium iodide I-125 or I-131 if:
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The administered dosage differs from the prescribed dosage by more than twenty (20) percent; and
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The difference between the administered dosage and prescribed dosage exceeds fifteen (15) microcuries;
(d) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, if the administered dosage differs from the prescribed dosage by more than twenty (20) percent;
(e) A teletherapy radiation dose, if the calculated weekly administered dose is fifteen (15) percent greater than the weekly prescribed dose; or
(f) A brachytherapy radiation dose, if the calculated administered dose differs from the prescribed dose by more than twenty (20) percent.
(249) "Recording" means producing a permanent form of an image resulting from x-ray photons.
(250) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics arrived at by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.
(251) "Registrant" means a person who is registered with the cabinet and is legally obligated to register with the cabinet under 902 KAR 100:110.
(252) "Registration" means registration with the cabinet under 902 KAR 100:110.
(253) "Regulations of the U.S. Department of Transportation" means the regulations in 49 C.F.R. Parts 100-189.
(254) "Rem" means a special unit of quantities expressed as dose equivalent. The dose equivalent in rems is equal to the absorbed dose in rads multiplied by the quality factor (one (1) rem = 0.01 sievert).
(255) "Research and development" means:
(a) Theoretical analysis, exploration, or experimentation; or
(b) 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.
(256) "Residential location" means an area where structures for human habitation are located.
(257) "Residual radioactivity" means low-level radioactive waste resulting from processing or decontamination activities that cannot be easily separated into distinct batches attributable to specific waste generators. This waste is attributable to the processor or decontamination facility, as applicable.
(258) "Respiratory protective device" means an apparatus used to reduce an individual's intake of airborne radioactive materials.
(259) "Restricted area" means an area access to which is limited by the licensee or registrant for purposes of protection of individuals against undue risks from exposure to radiation and radioactive materials. A restricted area shall not include areas used as residential quarters, although a separate room or rooms in a residential building may be set apart as a restricted area.
(260) "Roentgen" or "R" means the special unit of exposure. One (1) roentgen (R) equals 2.58 x 10-4 coulombs per kilogram of air. See "Exposure".
(261) "Sanitary sewerage" means a system of public sewers for carrying off waste, water, and refuse, but excludes sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee.
(262) "Sealed source" means radioactive material that is encased in a capsule designed to prevent leakage or escape of the radioactive material.
(263) "Secondary dose monitoring system" means a system which terminates irradiation upon failure of the primary system.
(264) "Self-contained breathing apparatus" or "SCBA" means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.
(265) "Shallow-dose equivalent (HS)", with respect to external exposure of the skin of the whole body or the skin of an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (seven (7) mg/cm2).
(266) "Shielded position" means the location within the radiographic exposure device or storage container which, by manufacturer's design, is the proper location for storage of the sealed source.
(267) "Shielded-room radiography" means industrial radiography conducted in a room shielded so that radiation levels at every location on the exterior meet the limitations specified in 902 KAR 100:019, Section 10.
(268) "Shipper" means the licensed entity, the generator that offers low-level radioactive waste for transportation, and may consign the waste to a licensed waste collector, waste processor, or land disposal facility operator.
(269) "Shipping paper" means NRC Form 540, and if required, 540A, or their equivalent, and includes the information required by the U.S. Department of Transportation in 49 C.F.R. Part 172.
(270) "Shutter" means a device attached to the tube housing assembly which can totally intercept the useful beam and which has a lead equivalency not less than that of the tube housing assembly.
(271) "Sievert" means:
(a) The International System (SI) unit of quantities expressed as dose equivalent. The dose equivalent in sieverts is equal to the absorbed dose in grays multiplied by the quality factor (1 Sv=100 rems).
(b) See the table in the definition of "quality factors" for the quality factors to convert absorbed dose to dose equivalent.
(272) "Site area emergency" means the existence of situation where an event may occur, is in progress, or has occurred that may:
(a) Lead to a significant release of radioactive material; and
(b) Require a response by an off-site response organization to protect persons off site.
(273) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.
(274) "Source" means the focal spot of the x-ray tube.
(275) "Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources.
(276) "Source holder" means a housing or assembly into which a radioactive source is placed for the purpose of facilitating the handling and use of the source.
(277) "Source image receptor distance" or "SID" means the distance from the source to the center of the input surface of the image receptor.
(278) "Source material" means:
(a) Uranium or thorium, or a combination thereof, in a physical or chemical form; or
(b) Ores that contain by weight 0.05 percent or more of:
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Uranium;
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Thorium; or
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A combination of uranium and thorium.
(c) Source material does not include special nuclear material.
(279) "Source of radiation" means a radioactive material or device, or equipment emitting or capable of producing radiation.
(280) "Special form radioactive material" means radioactive material that satisfies the following conditions:
(a) It is a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;
(b) The piece or capsule has at least one (1) dimension not less than five (5) millimeters (0.197 inch); and
(c)
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It satisfies the test requirements specified by the NRC in 10 C.F.R. Part 71.75.
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A special form encapsulation designed under the NRC requirements in 10 C.F.R. 71.4 in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used.
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A special form encapsulation designed in accordance with the NRC requirements in 10 C.F.R. 71.4 in effect on March 31, 1996, and constructed before April 1, 1998 may continue to be used.
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Any other special form encapsulation shall meet the specifications of this definition.
(281) "Special nuclear material" means:
(a) Plutonium, uranium 233, uranium enriched in the isotope U-233 or in the isotope U-235, and other material which the Governor declares by order to be special nuclear material after the United States Nuclear Regulatory Commission, or successor thereto, has determined the material to be special nuclear material, but does not include source material; or
(b) Material artificially enriched by one (1) of the foregoing, but does not include source material.
(282) "Special nuclear material in quantities not sufficient to form a critical mass" means:
(a) Uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235;
(b) U-233 in quantities not exceeding 200 grams;
(c) Plutonium in quantities not exceeding 200 grams; or
(d) A combination of them as specified by the following formula:
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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.
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The sum of these ratios for the different kinds of special nuclear material in combination shall not exceed one (1).
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For example, the following quantities in combination would not exceed the limitation and are within the formula:
(283) "Special purpose x-ray system" means a radiographic x-ray system which, by design, is limited to radiographic examination of a specific anatomical region.
(284) "Specific activity" means the radioactivity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the radioactivity per unit mass of the material.
(285) "Spot check" means a procedure performed to assure that a previous calibration continues to be valid.
(286) "Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during that fluoroscopic procedure.
(287) "Spot-film device" means 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 an image intensifier for the purpose of making a radiograph.
(288) "SSD" means the distance between the source and the skin of the patient.
(289) "Stationary beam radiation therapy" means radiation therapy without displacement of one (1) or more mechanical axes relative to the patient during irradiation.
(290) "Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose plus threshold factors.
(291) "Storage" or "waste storage" means the holding of waste for treatment or disposal for a period of twenty-four (24) hours or more.
(292) "Storage area" means:
(a) A location, facility, or vehicle used to store, transport, or secure a radiographic exposure device, storage container, or sealed source if the source is not in use; and
(b) Which is locked or has a physical barrier to prevent accidental exposure, tampering with, or unauthorized removal of the device, container, or source.
(293) "Storage container" means a device in which a sealed source is transported or stored.
(294) "Stray radiation" means the sum of leakage and scattered radiation.
(295) "Subsurface tracer study" means the release of a substance tagged with radioactive material for the purpose of tracing the movement or position of the tagged substance in the well-bore or adjacent formation.
(296) "Supplied-air respirator "SAR" "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designated to be carried by the user.
(297) "Surface contaminated object" or "SCO" means a solid object that is not classed as radioactive material, but which has radioactive material distributed on a surface. SCO must be in one (1) of two (2) groups with surface activity not exceeding the following limits:
(a) SCO-I: A solid object on which:
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The nonfixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 10-4 microcurie/cm2 (4 Bq/cm2) for beta and gamma and low toxicity alpha emitters, or 10-5 microcurie/cm2 (0.4 Bq/cm2) for all other alpha emitters;
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The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 1.0 microcurie/cm2 (4x104 Bq/cm2) for beta and gamma and low toxicity alpha emitters, or 0.1 microcurie/cm2 (4x103 Bq/cm2) for all other alpha emitters; and
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The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 1 microcurie/cm2 (4x104 Bq/cm2) for beta and gamma and low toxicity alpha emitters, for 0.1 microcurie/cm2 (4x103 Bq/cm2) for all other alpha emitters.
(b) SCO-II: A solid object on which the limits for SCO-I are exceeded and on which:
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The nonfixed contamination on the accessible surface averaged over 300cm2 (or the area of the surface if less than 300 cm2) does not exceed 10-2 microcurie/cm2 (400 Bq/cm2) for beta and gamma and low toxicity alpha emitters or 10-3 microcurie/cm2 (40 Bq/cm2) for all other alpha emitters;
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The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 20 microcuries/cm2 (8x105 Bq/cm2) for beta and gamma and low toxicity alpha emitters, or 2 microcuries/cm2 (8x104 Bq/cm2) for all other alpha emitters; and
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The nonfixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 20 microcuries/cm2 (8x105 Bq/cm2) for beta and gamma and low toxicity alpha emitters, or 2 microcuries/cm2 (8x104 Bq/cm2) for all other alpha emitters.
(298) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of sources of radiation. If appropriate, the evaluation shall include at least:
(a) A physical survey of the location of sources of radiation; and
(b) Measurements or calculations of levels of radiation or concentrations or quantities of radioactive material present.
(299) "Target" means that part of an x-ray tube or accelerator onto which a beam of accelerated particles is directed to produce ionizing radiation or other particles.
(300) "Technique factors" means the conditions of operation. They are specified as follows:
(a) For capacitor energy storage equipment, peak tube potential in kV and quantity of charge in mAs;
(b) For field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses;
(c) For CT x-ray systems designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mA, x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of tube current, x-ray pulse width, and the number of x-ray pulses in mAs;
(d) For CT x-ray systems 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 if the scan time and exposure time are equivalent; and
(e) For other equipment, peak tube potential in kV and tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs.
(301) "Technically Enhanced Naturally Occurring Radioactive Material "TENORM" means N.O.R.M., which has been separated to various degrees from the original ore or other material, refining or implementing it.
(302) "Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.
(303) "Teletherapy physicist" means the individual identified as the teletherapy physicist on a cabinet license.
(304) "Temporary job site" means a location to which radioactive material has been dispatched to perform a job, operation, or study other than the location listed in a specific license or certificate of registration.
(305) "Tenth-value layer (TVL)" means the thickness of a specified material that attenuates X-radiation or gamma radiation to an extent that the air kerma rate, exposure rate, or absorbed dose rate is reduced to one-tenth of the value measured without the material at the same point.
(306) "Termination of irradiation" means the stopping of irradiation in a fashion that does not permit continuance of irradiation without the resetting of operating conditions at the control panel.
(307) "Tests" means the process of verifying compliance with an applicable regulation.
(308) "Therapeutic radiation machines" means x-ray or electron-producing equipment designed and used for external beam radiation therapy.
(309) "Therapeutic-type protective tube housing" means:
(a) For x-ray therapy equipment not capable of operating at 500 kVp or above: an x-ray tube housing so constructed that the leakage radiation at a distance of one (1) meter from the target does not exceed one (1) roentgen in one (1) hour if the tube is operated at its maximum rated tube potential. Small areas of reduced protection are acceptable providing the average reading over a 100-square centimeter area at one (1) meter distance from the target does not exceed the value established in this paragraph; or
(b) For x-ray therapy equipment capable of operating at 500 kVp or above: an x-ray tube housing so constructed that the leakage radiation at a distance of one (1) meter from the target does not exceed one-tenth (0.1) percent of the useful beam exposure rate at one (1) meter from the target, for its operating conditions. Small areas of reduced protection are acceptable providing the average reading over a 100-square centimeter area at one (1) meter distance from the target does not exceed the value established in this paragraph.
(310) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.
(311) "Tomogram" means the depiction of the x-ray attenuation properties of a section through the body.
(312) "Total effective dose equivalent" or "TEDE" means the sum of the deep-dose equivalent (for external exposures) and the committed effective dose equivalent (for internal exposures).
(313) "Traceable to a national standard" means that a quantity or a measurement has been compared to a national standard directly or indirectly through one (1) or more intermediate steps and that comparisons have been documented.
(314) "Transport container" means a package that is designed to provide radiation safety and security if sealed sources are transported and which meets the requirements of the 49 C.F.R. 173, Subpart I.
(315) "Transport index" means:
(a) The dimensionless number that designates the degree of control to be exercised by the carrier during transportation, rounded up to the next tenth required to be placed on the label of a package.
(b) The transport index is determined by multiplying the maximum radiation level in millisievert (mSv) per hour at one (1) meter (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one (1) meter (3.3 feet).
(316) "Treatment" or "waste treatment" means a method, technique, or process, including storage for radioactive decay, designed to change the physical, chemical, or biological characteristics or composition of a waste in order to render the waste for transport, storage or disposal, amendable to recovery, convertible to another usable material, or reduced in volume.
(317) "Treatment site" means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.
(318) "Tritium neutron generator target source" means a tritium source used within a neutron generator tube to produce neutrons.
(319) "Tube" means an x-ray tube, unless otherwise specified.
(320) "Tube housing assembly" means the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements if they are contained within the tube housing.
(321) "Tube rating chart" means the set of curves which specify the rated limits of operation of the tube in terms of the technique factors.
(322) "Type A quantity" means a quantity of radioactive material, the aggregate radioactivity of which does not exceed A1 for special form radioactive material or A2 for normal form radioactive material, where A1 and A2 are given in 10 C.F.R. 71 Appendix A, or may be determined by procedures described in 10 C.F.R. 71 Appendix A.
(323) "Type B packaging" means a packaging designed to retain the integrity of containment and shielding required by U.S. Nuclear Regulatory Commission regulations if subjected to the normal conditions of transport and hypothetical accident test conditions established in 10 C.F.R. Part 71.
(324) "Type B quantity" means a quantity of radioactive material greater than a Type A quantity.
(325) "Uniform low-level radioactive waste manifest" or "uniform manifest" means the combination of NRC Forms 540, 541, and if necessary, 542, or their equivalents, and their respective continuation sheets as needed, or equivalent.
(326) "Unirradiated uranium" means uranium containing not more than 2x103 Bq of plutonium per gram of uranium-235, not more than 9 x 106 Bq of fission products per gram of uranium-235, and not more than 5 x 10-3 gram of uranium-236 per gram of uranium-235.
(327) "U.S. Department of Energy" means the Department of Energy established by 42 U.S.C. 7101 et seq., to the extent that the department exercises functions formerly vested in the U.S. Atomic Energy Commission, its chairman, members, officers and components and transferred to the U.S. Energy Research and Development Administration and to the Administrator thereof and retransferred to the Secretary of Energy in 42 U.S.C. 7151, effective October 1, 1977.
(328) "Unrefined and unprocessed ore" means ore in its natural form prior to processing, such as grinding, roasting, beneficiating, or refining.
(329) "Unrestricted area" means an area access to which is not controlled or limited by the licensee or registrant for purposes of protection of individuals from exposure to radiation and radioactive material.
(330) "Uranium - natural, depleted, enriched" means:
(a) "Natural uranium" means uranium with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight percent uranium-235, and the remainder by weight essentially uranium-238);
(b) "Depleted uranium" means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes;
(c) "Enriched uranium" means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes.
(331) "Uranium fuel cycle" means the operations of milling of uranium ore, chemical conversion of uranium, isotopic enrichment of uranium, fabrication of uranium fuel, generation of electricity by a light-water-cooled nuclear power plant using uranium fuel, and reprocessing of spent uranium fuel to the extent that these activities directly support the production of electrical power for public use. Uranium fuel cycle shall not include mining operations, operations at waste disposal sites, transportation of radioactive material in support of these operations, and the reuse of recovered nonuranium special nuclear and byproduct materials from the cycle.
(332) "Useful beam" means the radiation that passes through the tube housing port and the aperture of the beam limiting device if the exposure switch or timer is activated.
(333) "User" means an individual who personally utilizes or manipulates a source of radiation.
(334) "User seal check" or "fit check" means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamylacetate check.
(335) "Variable-aperture beam limiting device" means a beam limiting device that has capacity for stepless adjustment of the x-ray field size at a given SID.
(336) "Vendor" means a person who sells radiation producing machines or accelerators registerable with the cabinet as specified by 902 KAR 100:110.
(337) "Vendor registrant" means a vendor who is registered with the cabinet.
(338) "Vendor registration" means registration of a vendor with the cabinet described by 902 KAR 100:110.
(339) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body may result in an individual receiving an absorbed dose in excess of 500 rads (five (5) grays) in one (1) hour at one (1) meter from a radiation source or one (1) meter from a surface that the radiation penetrates.
(340) "Virtual source" means a point from which radiation appears to originate.
(341) "Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.
(342) "Visiting authorized nuclear pharmacist" means a nuclear pharmacist who is not identified on the license of the licensee being visited.
(343) "Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.
(344) "Waste". See "low-level radioactive waste".
(345) "Waste collector" means an entity, operating under the cabinet, U.S. Nuclear Regulatory Commission or agreement state license whose principal purpose is to collect and consolidate low level waste generated by others and to transfer this waste, without processing or repackaging the collected waste, to another licensed waste collector, licensed waste processor, or licensed land disposal facility.
(346) "Waste description" means the physical, chemical, and radiological description of a low-level radioactive waste as called for on NRC Form 541.
(347) "Waste generator" means an entity, operating under the cabinet, U.S. Nuclear Regulatory Commission, or agreement state license, who:
(a) Possesses any material or component that contains radioactivity or is radioactively contaminated for which the licensee foresees no further use; and
(b) Transfers this material or component to a licensed land disposal facility or to a licensed waste collector or processor for handling or treatment prior to disposal. A licensee performing processing or decontamination services may be waste generator if the transfer of low-level radioactive waste from its facility is defined as "residual waste".
(348) "Waste processor" means an entity, operating under a cabinet, U.S. Regulatory Commission or agreement state license, whose principal purpose is to process, repackage, or treat low-level radioactive material or waste generated by others prior to eventual transfer of waste to a licensed low-level radioactive waste land disposal facility.
(349) "Waste type" means a waste within a disposal container having a unique physical description, such as a specific waste descriptor code or description, or a waste sorbed on or solidified in a specifically defined media.
(350) "Wedge filter" means an added filter effecting continuous progressive attenuation on the useful beam or a part thereof.
(351) "Week" means seven (7) consecutive days starting on Sunday.
(352) "Weighting factor (WT)", for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects if the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of (WT) are:
(353) "Well-bore" means a drilled hole in which wire line service operations and subsurface tracer studies are performed.
(354) "Well-logging" means the lowering and raising of measuring devices or tools which may contain sources of radiation in well-bores or cavities for the purpose of obtaining information about the well or adjacent formations.
(355) "Whole body" means, for purposes of external exposure, head, trunk (including male gonads), arms above the elbow, or legs above the knee.
(356) "Wire line" means a cable containing one (1) or more electrical conductors which is used to lower and raise logging tools in the well-bore.
(357) "Wire line service operation" means an evaluation or mechanical service which is performed in the well-bore using devices on a wire line.
(358) "Worker" means an individual engaged in activities licensed or registered by the cabinet and controlled by a licensee or registrant, but does not include the licensee or registrant.
(359) "Working level" or "WL" means a combination of short-lived radon daughters (for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212) in one (1) liter of air that results in the ultimate emission of 1.3x105MeV of potential alpha particle energy.
(360) "Working level month" or "WLM" means an exposure to one (1) working level for 170 hours (2,000 working hours per year/twelve (12) months per year = approximately 170 hours per month).
(361) "Written directive" means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified in paragraph (f) of this subsection, and containing the following information:
(a) For an administration of quantities greater than thirty (30) microcuries of sodium iodide I-125 or I-131: the dosage;
(b) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or I-131: the radiopharmaceutical, dosage, and route of administration;
(c) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose;
(d) For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period;
(e) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or
(f) For all other brachytherapy:
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Prior to implementation: the radioisotope, number of sources, and source strengths; and
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After implantation, but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
(362) "X-ray control" means a device which controls input power to the x-ray high-voltage generator or the x-ray tube. It includes timers, phototimers, automatic brightness stabilizers, and similar devices which control the technique factors of an x-ray exposure.
(363) "X-ray equipment" means an x-ray system, subsystem, or component thereof. X-ray equipment is further classified as:
(a) "Mobile" means x-ray equipment mounted on a permanent base with wheels or casters for moving while completely assembled.
(b) "Portable" means x-ray equipment designed to be hand-carried.
(c) "Stationary" means x-ray equipment which is installed in a fixed location.
(d) "Transportable" means x-ray equipment installed in a vehicle or trailer.
(364) "X-ray field" means that area of the intersection of the useful beam 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 exposure rate is one-fourth (1/4) of the maximum in the intersection.
(365) "X-ray high-voltage generator" means a device that 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, high-voltage switches, electrical protective devices, and other appropriate elements.
(366) "X-ray subsystem" means a combination of two (2) or more components of an x-ray system.
(367) "X-ray system" means an assemblage of components for the controlled production of x-rays. It includes an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and necessary supporting structures. Additional components that function with the system are considered integral parts of the system.
(368) "X-ray tube" means an electron tube designed to be used primarily for the production of x-rays.
(369) "Year" means the period of time, beginning in January, used to determine compliance with the provisions of 902 KAR Chapter 100. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant if:
(a) The change is made at the beginning of the year; and
(b) A day is not omitted or duplicated in consecutive years.
History
- RELATES TO: KRS 211.840, 211.842-211.852, 211.990(4), 10 C.F.R. 20.1003-20.1005, NCRP Report 141, 42 U.S.C. 2011 et seq.
- STATUTORY AUTHORITY: KRS 194A.050, 211.090(3), 211.844, 10 C.F.R. 20.1003-20.1005
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 authorizes the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The Nuclear Regulatory Commission (NRC) approves or denies Kentucky's program for regulating radioactive materials after the effective date of administrative regulations within 902 KAR Chapter 100. The federal guidance manual, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements - SA - 200, issued June 5, 2009, provides parameters states shall follow in order for approval. The parameters include the provision that definitions shall be identical to NRC definitions. This administrative regulation establishes definitions for 902 KAR Chapter 100.
- History: 1 Ky.R. 381; eff. 2-5-1975; Am. 12 Ky.R. 979; eff. 1-3-1986; 16 Ky.R. 2515; 17 Ky.R. 39; eff. 6-27-1990; 18 Ky.R. 1474; eff. 1-10-1992; 21 Ky.R. 610; 1057; eff. 9-21-1994; 24 Ky.R. 2770; 25 Ky.R. 336; eff. 8-17-1998; 26 Ky.R. 2371; 27 Ky.R. 782; eff. 9-11-2000; 37 Ky.R. 1799; 2594; eff. 6-3-2011; 41 Ky.R. 867; 1568; eff. 2-5-2015; TAm eff. 9-27-2019; Cert. eff. 11-12-2021.
902 KAR 100:012 Fee schedule {#sec-902-kar-100-012 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:012}
Section 1. Radiation Producing Machine Schedule of Annual Fees and Charges. The following schedule, established in subsections (1) through (4) of this section, of annual fees shall apply to radiation producing machine registrants. A "Registration Application for Radiation Producing Machines", RPS 402 shall be accompanied by the appropriate fee established in subsections (1) through (4) of this section.
(1) A diagnostic x-ray machine shall be $131.25.
(2) A therapeutic x-ray machine including particle accelerators shall be $525.
(3) Industrial, dental, and other x-ray machines not specified in subsections (1) and (2) of this section shall be $89.25.
(4) Shielding evaluation, per room:
(a) Diagnostic facilities shall be $600; and
(b) Linear accelerator shall be $1,500.
Section 2. Radioactive Material License Schedule of Annual Fees and Charges. The following schedule, established in subsections (1) through (5) of this section, shall apply to radioactive material licenses. An initial and renewal application, incorporated by reference in 902 KAR 100:040, shall be accompanied by the fee established in this section.
(1) A specific radioactive material license initial and annual fee.
(a) Human use.
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Nuclear medicine, imaging shall be $2,205.
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Nuclear medicine, radiopharmaceutical therapy shall be $2,205.
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Nuclear medicine, permanent implant shall be $2,835.
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Nuclear medicine, temporary implant shall be $1,575.
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Nuclear medicine, mobile imaging shall be $2,625.
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Teletherapy or Gamma Stereotactic Radiosurgery shall be $4,200.
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Broad scope, medical shall be $7,875.
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Other shall be $1,312.50.
(b) Industrial radiography shall be $4,200.
(c) Wireline service shall be $2,625.
(d) Broad scope, academic shall be $3,675.
(e) Nuclear laundry shall be $7,875.
(f) Irradiator.
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Self-contained shall be $1,837.50.
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Unshielded during irradiation shall be $4,410.
(g) Manufacturing, processing, or distribution.
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Industrial gauging devices shall be $4,725.
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In vitro-In vivo kits shall be $3,780.
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Radiopharmaceuticals shall be $5,460.
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Other shall be $3,780.
(h) Industrial gauging devices.
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Fixed shall be $1,155.
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Portable shall be $1,365.
(i) In vitro, academic, environmental, or clinical laboratory shall be $1,312.50.
(j) Veterinary use shall be $2,205.
(k) Services, such as leak testing shall be $1,312.50.
(l) An application for review of a new sealed source or device or custom device shall be $4,600 plus the applicable fee in paragraphs (a) through (k) of this subsection.
(m) An amendment for review of a sealed source or device shall be $1,575.
(n) A byproduct, source, or special nuclear material license or other license authorizing decommissioning, decontamination, reclamation, or site restoration shall be $7,875.
(o) The fee shall be $10,500 for a license specifically authorizing:
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The receipt of prepackaged byproduct, source material, or special nuclear material from other persons; and
-
the disposal of the material by transfer to a person authorized to receive or dispose of the material.
(p) A license specifically authorizing the receipt of waste byproduct material, source material, or special nuclear material from a person for the purpose of storage, treatment, and packaging for transfer to a person authorized to receive or dispose of radioactive material shall be $26,250.
(2) A general radioactive material license initial and annual fee.
(a) In vitro or medical use specified in 902 KAR 100:050, Sections 4 and 5 shall be $1,312.50.
(b) Measuring, gauging, or a controlling device except emergency exit signs shall be $300 per device not to exceed $1,260 per use location.
(3) An application to amend an existing specific license shall be $210.
(4) An application for initial reciprocal recognition of an out-of-state license as established by 902 KAR 100:065. The fee shall be equal to the applicable fee for an in-state licensee.
(5) A licensee required to pay an annual fee pursuant to this administrative regulation may qualify as a small entity pursuant to form RPS-526, Small Entity Certification. If a licensee qualifies as a small entity, based on Kentucky Department of Revenue review and approval, and completes and submits form RPS-526 with its annual fee payment each year, the licensee shall pay the reduced annual fee.
Section 3. Inspection Fee.
(1) The cost of a routine interval inspection shall be covered in the annual licensing renewal fee.
(2) One (1) or more additional inspections shall be conducted to ensure ongoing public health and safety if any of the conditions established in paragraphs (a) through (d) exist:
(a) Willful neglect or careless disregard that has, or could lead to, a threat to public health and safety;
(b) Failure to take appropriate and timely action to correct documented violations of statutes, regulations, or conditions of the license or permit;
(c) A substantiated violation that indicates a lack of management oversight or that the radiation safety officer is not adequately performing duties; or
(d) Repeated violations from the previous inspection.
(3) The fee for each additional inspection shall be $525.
Section 4. Shipment of Radioactive Material and Waste. The shipper or carrier shall provide full cost reimbursement within thirty (30) days of receipt of the invoice, for all escorts of shipments of radioactive material, spent nuclear fuel, transuranic waste, radioactive waste, and other radioactive material or waste through Kentucky.
Section 5. Site Investigations, Remediation Projects, and Scoping Surveys. The licensee, remediation contractor, or other responsible party shall provide full cost reimbursement for review and oversight of site investigations, remediation projects, and scoping surveys to include project evaluation and planning, sample collection, analysis, and independent validation as applicable.
Section 6. Qualified Experts, Vendors and Service Providers. The schedule established in subsections (1) and (2) of this section shall apply to any entity or individual seeking or maintaining a designation as a qualified expert, vendor, or service provider as defined in 902 KAR 100:010.
(1) Qualified experts.
(a) Initial application shall be $105.
(b) Annual fee shall be $52.50.
(2) Vendors and service providers shall be $315.
Section 7. General Requirements.
(1) A general radioactive material license shall expire on July 31 following the date of issuance.
(2) A radiation producing machine registration certificate shall expire on the last day of the month, one (1) year after the date of issuance.
(3) A general radioactive material license fee shall be paid on or before July 31.
(4) A specific radioactive material license shall be renewed annually based on the expiration date stated in the license.
(5) A renewal fee shall be paid within forty-five (45) days of the bill date. A payment postmarked more than forty-five (45) days of the bill date shall be subject to a $100 late payment penalty per license, device, or x-ray machine in addition to the renewal fee.
(6) Payment of a fee or other charge shall be submitted to the Radiation Health Branch, Cabinet for Health and Family Services, 275 East Main Street, Mailstop HS1C A, Frankfort, Kentucky 40621-0001, in the form of a check or money order payable to the Kentucky State Treasurer or paid online at https://prd.webapps.chfs.ky.gov/rad_epay/.
(7) If a check issued for payment of the fee established in this administrative regulation is returned to the state treasurer due to insufficient funds, the payor shall resubmit payment by money order or cashier's check.
(8) A registration and licensing application fee shall be nonrefundable.
(9) Failure to submit an applicable fee established in this administrative regulation shall be deemed a violation and subject to the provisions of 902 KAR 100:170.
Section 8. Incorporation by Reference. The following material is incorporated by reference:
(1) "RPS-526, Small Entity Certification" edition 6/2020, is incorporated by reference; and.
(2) "Registration Application for Radiation Producing Machines" RPS 402, 4/2016.
(3) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, Department for Public Health, Division of Public Health Protection and Safety, Radiation Health Branch, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8:00 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.840-211.852, 211.990(4), 523.100
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844, 211.848(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.848(1) requires the cabinet to establish a reasonable schedule of fees and charges by administrative regulation. This administrative regulation establishes a schedule of fees and charges for radioactive material licensees; radiation producing machine registrants; others who may receive, possess, use, transfer, or dispose of sources of radiation; and vendors, service providers, and qualified experts providing services in Kentucky.
- History: 6 Ky.R. 378; eff. 2-6-80; Am. 11 Ky.R. 1330; eff. 4-9-85; 12 Ky.R. 1388; eff. 3-4-86; 14 Ky.R. 2085; eff. 6-22-88; 16 Ky.R. 2522; eff. 6-27-90; 18 Ky.R. 1484; eff. 1-10-92; 19 Ky.R. 303; eff. 8-28-92; 29 Ky.R. 822; 1633; eff. 12-18-2002; 31 Ky.R. 633; 947; eff. 11-17-2004; 41 Ky.R. 882; 1683; eff. 2-26-2015; TAm eff. 3-20-2020; 47 Ky.R. 453; eff. 11-19-2020.
902 KAR 100:015 General requirements {#sec-902-kar-100-015 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:015}
Section 1. Applicability. This administrative regulation shall apply to persons who receive, possess, use, transfer, own, or acquire radioactive sources or ionizing or electronic product radiation in Kentucky.
Section 2. Exposure to be Maintained as Low as is Reasonably Achievable. All persons shall make every reasonable effort to maintain radiation exposures and releases of radioactive materials in effluents to unrestricted areas as low as is reasonably achievable. The term "as low as reasonably achievable" means as low as is reasonably achievable taking into account the state of technology, the economics of improvements in relation to benefits to the public health and safety, other societal and socioeconomic considerations, and in relation to the utilization of sources of radiation in the public interest.
Section 3. Prohibited Uses. The following uses of radiation are prohibited in Kentucky:
(1) Hand-held fluoroscopic screens shall not be used.
(2) Shoe-fitting fluoroscopic devices shall not be used.
(3) Sources of radiation detrimental to public health, safety, or property shall not be used.
(4) No person shall use sources of radiation in a manner to intentionally expose an individual except as specifically allowed by these administrative regulations or by license authorization.
Section 4. Records. Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in these administrative regulations.
Section 5. Inspections.
(1) Each licensee and registrant shall afford to the cabinet, at all reasonable times, opportunity to inspect sources of radiation and the premises and facilities where such sources of radiation are used or stored.
(2) Each licensee and registrant shall make available for inspection, to the cabinet, records maintained as required by these administrative regulations.
Section 6. Tests. Each licensee and registrant shall perform or permit the cabinet to perform such tests as the cabinet deems appropriate or necessary including, but not limited to, tests of:
(1) Sources of radiation;
(2) Facilities where sources of radiation are used or stored;
(3) Radiation detection and monitoring instruments; and
(4) Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.
Section 7. Exemptions.
(1) General provision. The cabinet may, upon application or its own initiative, grant such exemptions or exceptions from the requirements of these administrative regulations as it determines are authorized by law or administrative regulation and that will not result in undue hazard to public health, safety, or property.
(2) United States Department of Energy and U.S. Nuclear Regulatory Commission contractors. A U.S. Department of Energy or U.S. Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within Kentucky is exempt from these administrative regulations to the extent that the contractor or subcontractor under his contract receives, possesses, uses, transfers, or acquires sources of radiation:
(a) Prime contractors performing work for the U.S. Department of at United States government-owned or controlled sites, including the transportation of sources of radiation to or from the sites and the performance of contract services during temporary interruptions of transportation;
(b) Prime contractors of the U.S. Department of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components atomic weapons;
(c) Prime contractors of the U.S. Department of Energy using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and
(d) A prime contractor or subcontractor of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission if the state and the U.S. Nuclear Regulatory Commission jointly determine:
-
That under the terms of the contract or subcontract, there is adequate assurance that the authorized work can be accomplished without undue risk to the public health and safety; and
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That the exemption of the prime contractor or subcontractor is authorized by law.
Section 8. Additional Requirements. The cabinet may, by rule, administrative regulation, or order, impose upon a licensee or registrant, requirements in addition to those established in these administrative regulations as it deems appropriate or necessary to minimize danger to public health, safety, or property.
Section 9. Impounding. Sources of radiation may be subject to impoundment by the cabinet as necessary to minimize danger to public health, safety, or property. The impoundment by the cabinet shall not relieve the owner of the responsibility for the sources.
Section 10. Communications. Communications, reports and applications filed concerning these administrative regulations, shall be addressed to: Manager, Radiation Control, Kentucky Cabinet for Human Resources, 275 East Main Street, Frankfort, Kentucky 40621.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation provides for general requirements, prohibitions, and exemptions that shall be applicable to persons who possess or use sources of ionizing or electronic product radiation in Kentucky.
- History: 1 Ky.R. 384; eff. 2-5-1975; 2 Ky.R. 477; eff. 4-14-1976; 3 Ky.R. 164; eff. 9-1-1976; 12 Ky.R. 987; eff. 1-3-1986; 18 Ky.R. 1485; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff.4-21-2026.
902 KAR 100:019 Standards for protection against radiation {#sec-902-kar-100-019 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:019}
Section 1. Radiation Protection Implementation.
(1) This administrative regulation shall not limit actions required in order to protect against an immediate danger to public health and safety.
(2) This administrative regulation shall apply to a person registered by the cabinet to receive, possess, use, transfer, or dispose of sources of radiation.
(3) The limits in this administrative regulation shall not apply to doses due to background radiation, exposure of patients to radiation for the purpose of medical diagnosis or therapy, or voluntary participation in medical research programs.
Section 2. Radiation Protection Programs. A person or registrant shall:
(1) Develop, document, and implement a radiation protection program commensurate with the scope and extent of the person's activities and sufficient to ensure compliance with the provisions of this administrative regulation.
(2) Use procedures and engineering controls based upon sound radiation protection principles, to the extent practical, to achieve occupational doses and doses to members of the public that shall be as low as reasonably achievable (ALARA) pursuant to 902 KAR 100:015, Section 2.
(3) Annually review the radiation protection program content and implementation.
Section 3. Occupational Dose Limits for Adults.
(1) A person or registrant shall control the occupational dose to individual adults, except for planned special exposures as established in Section 5 of this administrative regulation, to:
(a) An annual limit, which shall be the more limiting of the:
-
Total effective dose equivalent being equal to five (5) rems (0.05 SV); and
-
Sum of the deep-dose equivalent and the committed dose equivalent to an individual organ or tissue, other than the lens of the eye, being equal to fifty (50) rems ((0.50) Sv); and
(b) The annual limits to the lens of the eye, the skin, and the extremities, which shall be:
-
A lens dose equivalent of fifteen (15) rems (0.15 Sv); and
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A shallow-dose equivalent of fifty (50) rems (five-tenths (0.50) Sv) to the skin of the whole body or to the skin of an extremity.
(2) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime as established in Section 5(3)(a) and (b) of this administrative regulation.
(3) The assigned deep-dose equivalent and shallow-dose equivalent shall be for the part of the body receiving the highest exposure. The assigned shallow dose equivalent shall be the dose averaged over the contiguous ten (10) square centimeters of skin receiving the highest exposure. If the individual monitoring device was not in the region of highest potential exposure, the deep-dose equivalent, lens dose equivalent, and shallow-dose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits.
(4) A person or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by a person as described in Section 20 of this administrative regulation.
Section 4. Compliance with Summation of Doses from Radiation Producing Machines and Radioactive Materials. A registrant who is required to monitor for dose received by exposure to both radiation producing machines and radioactive materials shall demonstrate compliance with the dose limits by following the requirements of 902 KAR Chapter 100.
Section 5. Planned Special Exposures.
(1) A registrant may authorize an adult worker to receive doses in addition to, and accounted for separately from the doses received under, the limits specified in Section 3 of this administrative regulation provided each of the following conditions are satisfied:
(a) The registrant authorizes a planned special exposure only in an exceptional situation if alternatives that may avoid the dose estimated to result from the planned special exposure are unavailable or impractical;
(b) The registrant, and employer if the employer is not the registrant, specifically authorize the planned special exposure, in writing, before the exposure occurs; and
(c) Before a planned special exposure, the registrant ensures that the individuals involved are:
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Informed of the purpose of the planned operation;
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Informed of the estimated doses, associated potential risks, specific radiation levels, or other conditions that may be involved in performing the task; and
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Instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present.
(2) Prior to permitting an individual to participate in a planned special exposure, a registrant shall ascertain prior doses as required by Section 20(2) of this administrative regulation during the lifetime of the individual for each individual involved.
(3) Subject to Section 3(2) of this administrative regulation, a registrant shall not authorize a planned special exposure that shall cause an individual to receive a dose from planned special exposures and doses in excess of the limits to exceed:
(a) The numerical values of the dose limits in Section 3(1) of this administrative regulation in a year; and
(b) Five (5) times the annual dose limits in Section 3(1) of this administrative regulation during the individual's lifetime.
(4) A registrant shall:
(a) Maintain records of the conduct of a planned special exposure pursuant to Section 21 of this administrative regulation; and
(b) Submit a written report pursuant to Section 28 of this administrative regulation.
(5) A registrant shall record the best estimate of the dose resulting from the planned special exposure in the individual's record and inform the individual, in writing, of the dose within thirty (30) days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual by Section 3(1) of this administrative regulation but shall be included in evaluations required by subsections (2) and (3) of this section.
Section 6. Occupational Dose Limits for Minors. The annual occupational dose limits for minors shall be ten (10) percent of the annual dose limits specified for adult workers in Section 3 of this administrative regulation.
Section 7. Dose Equivalent to an Embryo or Fetus.
(1) A registrant shall ensure that the dose equivalent to an embryo or fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five-tenths (0.5) rem (5 mSv). Recordkeeping requirements are established in Section 22 of this administrative regulation.
(2) A registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman to satisfy the limit in subsection (1) of this section.
(3) The dose equivalent to an embryo or fetus shall be taken as the sum of:
(a) The deep-dose equivalent to the declared pregnant woman; and
(b) The dose equivalent to the embryo or fetus resulting from radionuclides in the embryo or fetus and radionuclides in the declared pregnant woman.
(4) If the dose equivalent to the embryo or fetus is found to have exceeded five-tenths (0.5) rem (five (5) mSv), or is within 0.05 rem (five-tenths (0.5) mSv) of this dose, by the time the woman declares the pregnancy to a registrant, the registrant shall be in compliance with subsection (1) of this section if the additional dose equivalent to the embryo or fetus does not exceed 0.05 rem (five-tenths (0.5) mSv) during the remainder of the pregnancy.
Section 8. Radiation Dose Limits for Individual Members of the Public.
(1) A registrant shall conduct operations to ensure that the:
(a) Total effective dose equivalent to individual members of the public from registered and other operations shall not exceed 0.1 rem (one (1) mSv) in a year, exclusive of the dose contributions from:
-
Background radiation;
-
A medical administration the individual received; and
-
Voluntary participation in medical research programs; and
(b) Dose in an unrestricted area from external sources shall not exceed 0.002 rem (0.02 mSv) in one (1) hour.
(2) If a registrant permits members of the public to have access to controlled areas, the limits for members of the public specified in this section shall apply to those individuals.
(3) A registrant or applicant for registration may apply for prior authorization to operate up to an annual dose limit for an individual member of the public of five-tenths (0.5) rem (five (5) mSv). The application shall include:
(a) Demonstration of the need for, and the expected duration of, operations in excess of the limit in subsection (1) of this section;
(b) A registrant's program to assess and control dose within the five-tenths (0.5) rem (five (5) mSv) annual limit; and
(c) The procedures to be followed to maintain the dose ALARA.
(4) The cabinet may impose additional restrictions on the total allowable radiation levels in unrestricted areas.
Section 9. Compliance with Dose Limits for Individual Members of the Public.
(1) To demonstrate compliance with the dose limits for individual members of the public in Section 8 of this administrative regulation, a registrant shall make or cause to be made surveys ofradiation levels in unrestricted and controlled areas.
(2) A registrant shall show compliance with the annual dose limit in Section 8 of this administrative regulation by:
(a) Demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the registered operation shall not exceed the annual dose limit; or
(b) Demonstrating thatif an individual were continually present in an unrestricted area, the dose from external sources shall not exceed 0.002 rem (0.02 mSv) in an hour and 0.05 rem (five-tenths (0.5) mSv) in a year.
Section 10. Surveys and Monitoring.
(1) A registrant shall make or cause to be made, surveys that are:
(a) Necessary for the registrant to comply with the provisions in this administrative regulation; and
(b) Reasonable under the circumstances to evaluate:
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The magnitude and extent of radiation levels; and
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The potential radiological hazards.
(2) A registrant shall ensure that instruments and equipment used for quantitative radiation measurements (for example, dose rate) are calibrated periodically for the radiation measured.
(3) Personnel dosimeters, except direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to the extremities, that require processing to determine the radiation doses used by registrants to comply with Section 3 of this administrative regulation, other applicable provisions of 902 KAR Chapter 100, or conditions specified, shall be processed and evaluated by a dosimetry processor:
(a) Holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and
(b) Approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.
Section 11. Conditions Requiring Individual Monitoring of External Occupational Dose.
(1) A registrant shall monitor exposures to radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this administrative regulation.
(2) At a minimum, the registrant shall monitor occupational exposure to radiation, from registered and unregistered radiation sources under the registrant's control, and shall supply and require the use of individual monitoring devices by:
(a) Adults likely to receive, in one (1) year from radiation sources external to the body, a dose in excess of ten (10) percent of the limits in Section 3(1) of this administrative regulation;
(b) Minors likely to receive, in one (1) year from sources external to the body, a deep dose equivalent in excess of 0.1 rem (1 mSv), a lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose equivalent to the skin or to the extremities in excess of five-tenths (0.5) rem (5 mSv);
(c) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of 0.1 rem (1mSv). All of the occupational doses in Section 3 continue to be applicable to the declared pregnant worker as long as the embryo or fetus dose limit is not exceeded; and
(d) Individuals entering a high or very high radiation area.
Section 12. Control of Access to High Radiation Areas.
(1) A registrant shall ensure that each entrance or access point to a high radiation area shall have at least one (1) of the following features:
(a) A control device that, upon entry into the area, shall cause the level of radiation to be reduced below the level an individual may receive a deep-dose equivalent of 0.1 rem (one (1) mSv) in one (1) hour at thirty (30) centimeters from the radiation source or from a surface that the radiation penetrates;
(b) A control device that shall energize a conspicuous visible or audible alarm signal so the individual entering the high radiation area and the supervisor of the activity shall be made aware of the entry; or
(c) Entryways that shall be locked, except during periods that access to the areas is required, with positive control over each individual entry.
(2) In place of the controls required by subsection (1) of this section for a high radiation area, a registrant may substitute continuous direct or electronic surveillance that shall be capable of preventing unauthorized entry.
(3) A registrant may make a written request to the cabinet for approval of an alternative method for controlling access to high radiation areas. The cabinet may grant approval for a reasonable request if the alternative method is appropriately protective of health and safety. The cabinet may require additional information related to the request.
(4) A registrant shall establish the controls required by subsections (1) and (3) of this section that shall not prevent individuals from leaving a high radiation area.
Section 13. Control of Access to Very High Radiation Areas.
(1) In addition to the provisions in Section 12 of this administrative regulation, a registrant shall institute additional measures to ensure that an individual shall not be able to gain unauthorized or inadvertent access to areas in which radiation levels may be encountered at 500 rads (five (5) grays) or more in one (1) hour at one (1) meter from a radiation source or a surface through which the radiation penetrates.
(2) A registrant shall not be required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as established in subsection (1) of this section if the registrant has met the specific requirements for access and control specified in 902 KAR 100:115, 100:136, 100:137, and 100:155.
Section 14. Caution Signs and Standard Radiation Symbol.
(1) Unless otherwise authorized by the cabinet, the symbol established in this section shall use the colors magenta, purple, or black on yellow background. The symbol established in this section shall be the three (3) bladed design:
(a) Cross-hatched area shall be magenta, purple, or black; and
(b) The background shall be yellow.
(2) Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this section, a registrant may provide on or near the required signs and labels additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.
Section 15. Posting Requirements.
(1) Posting of radiation areas. A registrant shall post a radiation area with a conspicuous sign or signs bearing the radiation symbol and the words: "CAUTION, RADIATION AREA".
(2) Posting of high radiation areas. A registrant shall post a high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words: "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA".
(3) Posting of very high radiation areas. A registrant shall post a very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words: "GRAVE DANGER, VERY HIGH RADIATION AREA".
Section 16. Exceptions to Posting Requirements.A registrant shall not be required to post caution signs in areas or rooms containing sources of radiation for periods of less than eight (8) hours if the following conditions are met:
(1) The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to radiation in excess of the limits established in this administrative regulation; and
(2) The area or room is subject to the registrant's control.
Section 17. General Provisions for Records.
(1)
(a) A registrant shall use the units roentgen, rad, and rem, including multiples and subdivisions, and shall clearly indicate the units of quantities on records required by this administrative regulation.
(b) All quantities shall be recorded as stated in paragraph (a) of this section, except that the registrant may record quantities in the International System of Units (SI) in parentheses following each of the units specified in paragraph (a) of this section.
(2) A registrant shall make a clear distinction among the quantities entered on the records required by this administrative regulation, such as:
(a) Total effective dose equivalent;
(b) Shallow-dose equivalent;
(c) Eye dose equivalent;
(d) Deep-dose equivalent; and
(e) Committed effective dose equivalent.
Section 18. Records of Radiation Protection Programs.
(1) A registrant shall maintain records of the radiation protection program, including:
(a) The provisions of the program; and
(b) Audits and other reviews of program content and implementation.
(2) A registrant shall retain records required by subsection (1)(a) of this section until the cabinet terminates each pertinent registration requiring the record.
(3) A registrant shall retain records required by subsection (1)(b) of this section for at least three (3) years after the record is made.
Section 19. Records of Surveys.
(1) A registrant shall:
(a) Maintain records showing the results of surveys and calibrations required by Section 10 of this administrative regulation; and
(b) Retain records for at least three (3) years after the record is made.
(2) A registrant shall retain results of surveys to determine the dose from external sources of radiation and used, in the absence of or in combination with individual monitoring data, in the assessment of individual dose equivalents until the cabinet terminates the pertinent registration requiring the record.
Section 20. Determination of Prior Occupational Dose.
(1) For an individual likely to receive, in a year, an occupational dose requiring monitoring under Section 11 of this administrative regulation, the registrant shall:
(a) Determine the occupational radiation dose received during the current year; and
(b) Attempt to obtain the records of lifetime cumulative occupational radiation dose.
(2) Prior to permitting an individual to participate in a planned special exposure, a registrant shall determine:
(a) The external doses from previous planned special exposures; and
(b) Doses in excess of the limits, including doses received during accidents and emergencies, received during the lifetime of the individual.
(3) In complying with the requirements of subsection (1) of this section, a registrant may:
(a) Accept, as a record of the occupational dose the individual received during the current year, a written signed statement from the individual or from the individual's most recent employer for work involving radiation exposure, that discloses the nature and amount of an occupational dose the individual may have received during the current year;
(b) Accept, as the record of lifetime cumulative radiation dose, an up-to-date Nuclear Regulatory Commission (NRC) Form 4, Cumulative Occupational Dose History, available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html, or equivalent, signed by the individual and counter-signed by an:
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Appropriate official of the most recent employer for work involving radiation exposure; or
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The individual's current employer if the individual is not employed by the registrant; or
(c) Obtain reports of the individual's dose equivalent from the most recent employer for work involving radiation exposure, or the individual's current employer if the individual is not employed by the registrant, by telephone, electronic media, or letter. If the authenticity of the transmitted report cannot be established, a registrant shall request a written verification of the dose data.
(4) A registrant shall record the exposure history, as required by subsection (1) of this section, on NRC Form 4, Cumulative Occupational Dose History, or other clear and legible record, of the information required on that form.
(a) The form or record shall:
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Show each period the individual received occupational exposure to radiation; and
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Be signed by the individual who received the exposure.
(b) For each period a registrant obtains reports, the registrant shall use the dose shown in the report in preparing NRC Form 4, Cumulative Occupational Dose History.
(c) For a period in which a registrant does not obtain a report, the registrant shall place a notation on NRC Form 4, Cumulative Occupational Dose History, indicating the periods of time for which data are not available.
(5) If a registrant is unable to obtain a complete record of an individual's current and previously accumulated occupational dose, the registrant shall assume:
(a) In establishing administrative controls under Section 3(4) of this administrative regulation for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (twelve and five-tenths (12.5) mSv) for each quarter for which records were unavailable and the individual was engaged in activities that may have resulted in occupational radiation exposure; and
(b) That the individual is not available for planned special exposures.
(6) A registrant shall:
(a) Retain the records on NRC Form 4, Cumulative Occupational Dose History, or equivalent, at least until the cabinet terminates the pertinent registration requiring this record; and
(b) Retain records used in preparing NRC Form 4, Cumulative Occupational Dose History, for at least three (3) years after the record is made.
Section 21. Records of Planned Special Exposures.
(1) For each use of the provisions of Section 5 of this administrative regulation for planned special exposures, a registrant shall maintain records that include:
(a) The name of the management official who authorized the planned special exposure;
(b) A copy of the signed authorization; and
(c) Description of:
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The exceptional circumstances requiring the use of a planned special exposure;
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What actions were necessary;
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Why the actions were necessary;
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How doses were maintained ALARA;
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What individual and collective doses were expected to result; and
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The doses actually received in the planned special exposure.
(2) A registrant shall retain the records at least until the cabinet terminates the registration requiring these records.
Section 22. Records of Individual Monitoring Results.
(1) A registrant shall maintain records of doses received:
(a) By individuals for whom monitoring was required by Section 11 of this administrative regulation; and
(b) During planned special exposures, accidents, and emergency conditions.
(2) The recordkeeping requirements shall include, if applicable:
(a) Deep-dose equivalent to the whole body;
(b) Lens dose equivalent;
(c) Shallow-dose equivalent to the skin and extremities; and
(d) Total effective dose equivalent, if required by Section 4 of this administrative regulation.
(3) A registrant shall make entries of the records specified in subsection (1) of this section at least annually.
(4) A registrant shall maintain the records specified in subsection (1) of this section on NRC Form 5, Occupational Dose Record for a Monitoring Period, available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html, in accordance with the instructions for NRC Form 5, or in clear and legible records containing the information required by NRC Form 5.
(5) The records required under this section shall be protected from public disclosure because of their personal privacy nature.
(6) A registrant shall maintain the:
(a) Records of dose to an embryo or fetus with the records of dose to the declared pregnant woman; and
(b) Declaration of pregnancy on file, which may be maintained separately from the dose records.
(7) A registrant shall retain each required form or record at least until the cabinet terminates the pertinent license or registration requiring the record.
(8) Assessments of dose equivalent and records made using units in effect before a registrant's adoption of this administrative regulation need not to be changed.
Section 23. Records of Dose to Individual Members of the Public.
(1) A registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public.
(2) A registrant shall retain the records required by subsection (1) of this section at least until the cabinet terminates the pertinent registration requiring the record.
Section 24. Form of Records.
(1) Records required by 902 KAR Chapter 100 shall be legible throughout the specified retention period.
(2) The record shall be:
(a) The original; or
(b) A reproduced copy.
(3) The record may be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period.
(4) Records such as letters, drawings, and specifications shall include pertinent information such as stamps, initials, and signatures.
(5) A registrant shall maintain adequate safeguards against tampering with and loss of records.
Section 25. Reports of Theft or Loss of Registered Sources of Radiation.
(1) A registrant shall report to the cabinet a lost, stolen, or missing registered radiation producing machine within thirty (30) days after the occurrence.
(2) The report shall include:
(a) A description of the registered machine involved, including:
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Type of machine;
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Make and model of machine; and
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Maximum outputs;
(b) The date the loss or theft became known to the registrant; and
(c) A description of the circumstances under which the loss or theft occurred registered becomes known to the registrant,.
Section 26. Notification of Incidents.
(1) Immediate notification. A registrant shall immediately report an event involving radiation producing machines possessed by the registrant that may have caused, or threatens to cause, an individual to receive:
(a) A total effective dose equivalent of twenty-five (25) rems (0.25 Sv) or more;
(b) A lens dose equivalent of seventy-five (75) rems (0.75 Sv) or more; or
(c) A shallow-dose equivalent to the skin or extremities of 250 rads (two and five-tenths (2.5) Gy) or more.
(2) Twenty-four (24) hour notification. A registrant shall, within twenty-four (24) hours of discovery of the event, report an event that may have caused, or shall threaten to cause,an individual to receive, in a period of twenty-four (24) hours:
(a) A total effective dose equivalent exceeding five (5) rems (0.05 Sv);
(b) A lens dose equivalent exceeding fifteen (15) rems (0.15 Sv); or
(c) A shallow-dose equivalent to the skin or extremities exceeding fifty (50) rems (five-tenths (0.5) Sv).
(3) A registrant shall prepare and file a report with the cabinet as required by this section so that names of individuals who have received exposure to radiation are stated in a separate and detachable part of the report.
(4) A registrant shall make reports required by subsections (1) and (2) of this section to the cabinet by telephone.
(5) The provisions of this section shall not include doses that result from planned special exposures that are within the limits for planned special exposures, and are reported under Section 28 of this administrative regulation.
Section 27. Reports of Exposures and Radiation Levels Exceeding the Limits.
(1) Reportable events. In addition to the notification required by Section 26 of this administrative regulation, a registrant shall submit a written report within thirty (30) days after learning of one (1) or more of the following occurrences:
(a) An incident for which notification shall be required by Section 26 of this administrative regulation; or
(b) Doses in excess of one (1) of the following:
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Occupational dose limits for adults in Section 3 of this administrative regulation;
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Occupational dose limits for a minor in Section 6 of this administrative regulation;
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Limits for an embryo or fetus of a declared pregnant woman in Section 7 of this administrative regulation;
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Limits for an individual member of the public in Section 8 of this administrative regulation; or
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Applicable limit in the registration; or
(c) Levels of radiation in:
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A restricted area in excess of an applicable limit in the registration; or
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An unrestricted area in excess of ten (10) times an applicable limit set forth in this administrative regulation or the registration, regardless of whether exposure of an individual in excess of the limits in Section 8 of this administrative regulation occurs.
(2) Contents of reports.
(a) A report required by subsection (1) of this section shall describe the extent of exposure of individuals to radiation including, as appropriate:
-
Estimates of each individual's dose;
-
The levels of radiation involved;
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The cause of the elevated exposures or dose rates; and
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Corrective steps taken or planned to ensure against a recurrence, including the schedule for achieving conformance with applicable limits.
(b) A report filed under subsection (1) of this section shall include for each individual exposed:
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Name of the individual;
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Social Security number; and
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Date of birth.
(c) The report shall be prepared so that information is stated in a separate and detachable part.
(d) With respect to the limit for the embryo or fetus, the identifiers shall be of the declared pregnant woman.
(3) A registrant who makes a report under subsection (1) of this section shall submit the report, in writing, to the Manager of the Radiation Health Branch, Department for Health Services, 275 East Main Street, Frankfort, Kentucky 40621.
Section 28. Reports of Planned Special Exposures.
(1) A registrant shall submit a written report to the Manager of the Radiation Health Branch, Department for Health Services, 275 East Main Street, Frankfort, Kentucky 40621, within thirty (30) days following a planned special exposure conducted in accordance with Section 5 of this administrative regulation.
(2) A registrant shall:
(a) Inform the Manager of the Radiation Health Branch that a planned special exposure was conducted;
(b) Indicate the date the planned special exposure occurred; and
(c) Provide the information required by Section 21 of this administrative regulation.
Section 29. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) "Cumulative Occupational Dose History", NRC Form 4, November 2020; and
(b) "Occupational Dose Record for Monitoring Period", NRC Form 5, January 2021.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of the Commissioner of Public Health, 275 East Main Street, Frankfort, Kentucky 40621, 8 a.m. until 4:30 p.m., Monday through Friday.
(3) This material is also available at https://www.nrc.gov/reading-rm/doc-collections/forms/index.html.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844 requires the cabinet to provide by administrative regulation for the registration of the possession or use of sources of ionizing or electronic product radiation. This administrative regulation establishes standards for the protection of the user and general public against radiation exposure; for protection against ionizing radiation resulting from activities conducted by persons issued registrations by the cabinet; and to control the receipt, possession, use, transfer, and disposal of sources of radiation by a person or registrant.
- History: 20 Ky.R. 2460; Am. 2791; eff. 4-11-1994; 24 Ky.R. 1982; eff. 5-18-1998; 38 Ky.R. 348; 927; eff. 11-16-2011; 41 Ky.R. 885; 1581; eff. 2-5-2015; Cert. eff. 11-12-2021; 50 Ky.R.182, 1129; eff. 12-13-2023.
902 KAR 100:021 Disposal of radioactive material {#sec-902-kar-100-021 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:021}
Section 1. General Requirements.
(1) A person or licensee shall dispose of radioactive material or waste only:
(a) By transfer to an authorized recipient as provided in 902 KAR 100:040, Section 12, or 902 KAR 100:022;
(b) By decay in storage;
(c) By release in an effluent within the limits in 902 KAR 100:019, Section 10; or
(d) As authorized by Sections 2, 3, 4, or 5 of this administrative regulation.
(2) A person shall be specifically licensed to receive waste containing radioactive material or waste from other persons for:
(a) Treatment prior to disposal;
(b) Treatment or disposal by incineration;
(c) Decay in storage; or
(d) Disposal at a land disposal facility licensed under 902 KAR 100:022.
Section 2. Method for Obtaining Approval of Proposed Disposal Procedures. A person, licensee, or applicant for a license may apply to the cabinet for approval of a proposed procedure, not authorized in 902 KAR 100:019, 100:021, 100:022, 100:050, or 100:072, to dispose of radioactive material or waste generated by their activity. An application shall include:
(1) A description of the waste containing radioactive material to be disposed of, including the:
(a) Physical and chemical properties important to risk evaluation; and
(b) Proposed manner and conditions of waste disposal;
(2) An analysis and evaluation of pertinent information on the nature of the environment;
(3) The nature and location of other potentially affected licensed and unlicensed facilities; and
(4) An analysis and a procedure to ensure doses shall be maintained ALARA and within the dose limits in 902 KAR 100:019, Sections 3, 8, 9, and 10.
Section 3. Disposal by Release into Sanitary Sewerage.
(1) A person or licensee may discharge licensed material into sanitary sewerage under the following conditions:
(a) The material shall be readily soluble or shall be readily dispersible biological material, in water;
(b) The quantity of licensed or other radioactive material that the licensee released into the sewer in one (1) month, divided by the average monthly volume of water released into the sewer by the licensee, shall not exceed the concentration in 10 C.F.R. 20, Appendix B;
(c) For the release of more than one (1) radionuclide, the following conditions shall be satisfied:
-
The licensee shall determine the fraction of the limit in 10 C.F.R. 20, Appendix B, represented by discharges into the sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide in 10 C.F.R. 20, Appendix B; and
-
The sum of the fractions for each radionuclide required by subsection (1)(c)1 of this section shall not exceed unity; and
(d) The total quantity of licensed and other radioactive material that the licensee releases into the sewerage system in a year shall not exceed five (5) curies (185 GBq) of hydrogen-3, one (1) curie (37 GBq) of carbon-14, and one (1) curie of other radioactive materials combined.
(2) Excreta from an individual undergoing medical diagnosis or therapy with radioactive material shall not be subject to the limitations contained in subsection (1) of this section.
Section 4. Treatment or Disposal by Incineration. A licensee may treat or dispose of licensed material by incineration only:
(1) In the amounts and forms specified in Section 5 of this administrative regulation; or
(2) As specifically approved by the cabinet in accordance with Section 2 of this administrative regulation.
Section 5. Disposal of Specific Wastes.
(1) A person or licensee may dispose of the following radioactive material without regard to its radioactivity:
(a) 0.05 microcurie or less of hydrogen-3, or tritium, carbon-14, or iodine-125 per gram of medium used for liquid scintillation counting or in vitro clinical or in vivo laboratory testing; and
(b) 0.05 microcurie (1.85 kBq) or less of hydrogen-3, carbon-14, or iodine-125 per gram of animal tissue averaged over the weight of the entire animal.
(2) A licensee shall not dispose of tissue pursuant to subsection (1)(b) of this section in a manner that may permit its use as food for a human or as animal feed.
(3) A licensee shall maintain records required by Section 11 of this administrative regulation.
(4) A licensee shall comply with other applicable federal, state, and local regulations governing other toxic or hazardous properties of these materials.
Section 6. Classification of Radioactive Waste for Near-Surface Disposal.
(1) Considerations. Determination of the classification of waste shall be given the following considerations:
(a)
-
The concentration of long-lived radionuclides, and their shorter-lived precursors, whose potential hazard shall persist long after a precaution such as an institutional control, improved waste form, and deeper disposal have ceased to be effective.
-
The precaution delays the time long-lived radionuclides may cause an exposure.
-
The magnitude of the potential dose is limited by the concentration and availability of the radionuclide at the time of exposure; and
(b) The concentration of a shorter-lived radionuclide for which a requirement on an institutional control, waste form, and disposal methods are effective.
(2) Classes of waste.
(a)
-
Class A waste shall be segregated from other waste classes at the disposal site, except for waste described at subparagraph 2 of this paragraph.
-
The physical form and characteristics of Class A waste shall meet the minimum requirements in Section 7 of this administrative regulation.
-
If Class A waste also meets the stability requirements in Section 7(2) of this administrative regulation, it shall not be necessary to segregate Class A waste for disposal.
(b)
-
Class B waste shall meet more rigorous requirements on waste form to ensure stability after disposal.
-
The physical form and characteristics of Class B waste shall meet both the minimum and stability requirements in Section 7 of this administrative regulation.
(c)
-
Class C waste shall meet more rigorous requirements on waste form to ensure stability and shall require additional measures at the disposal facility to protect against inadvertent intrusion.
-
The physical form and characteristics of Class C waste shall meet both the minimum and stability requirements in Section 7 of this administrative regulation.
(3) Classification determined by long-lived radionuclides. If the waste contains only a radionuclide in Table 1 of this subsection, classification shall be determined as follows:
(a) If the concentration does not exceed one-tenth (0.1) times the value in Table 1, the waste shall be Class A.
(b) If the concentration exceeds one-tenth (0.1) times the value, but does not exceed the value in Table 1, the waste shall be Class C.
(c) If the concentration exceeds the value in Table 1, as established in 10 C.F.R. 61.55, the waste shall not generally be acceptable for near-surface disposal.
(d) For waste containing a mixture of radionuclides in Table 1, the total concentration shall be determined by the sum of fractions rule described in subsection (7) of this section.
(4) Classification determined by short-lived radionuclides.
(a) If the waste contains none of the radionuclides in Table 1 of subsection (3) of this section, classification shall be determined based on the concentrations shown in Table 2 of this subsection.
(b) If a radionuclide is not in Table 2, it shall not be considered in determining the waste class.
-
If the concentration does not exceed the value in Column 1, the waste shall be Class A.
-
If the concentration exceeds the value in Column 1, but does not exceed the value in Column 2, the waste shall be Class B.
-
If the concentration exceeds the value in Column 2, but does not exceed the value in Column 3, the waste shall be Class C.
-
If the concentration exceeds the value in Column 3, as established in 10 C.F.R. 61.55, the waste shall not generally be acceptable for near-surface disposal.
-
For waste containing a mixture of the radionuclides in Table 2, the total concentration shall be determined by the sum of fractions rule described in subsection (7) of this section.
(5) Classification determined by both long-lived and short-lived radionuclides.
(a) If the waste contains a mixture of radionuclides, some in Table 1 of this section, and some in Table 2 of this section, classification shall be determined as follows:
(b) If the concentration of a radionuclide in Table 1 does not exceed one-tenth (0.1) times the value in Table 1, the class shall be determined by the concentration of a radionuclide in Table 2.
(c) If the concentration of a radionuclide in Table 1 exceeds one-tenth (0.1) times the value, but does not exceed the value in Table 1, the waste shall be Class C, if the concentration of a radionuclide in Table 2 does not exceed the value shown in Column 3 of Table 2.
(6) Classification of waste with a radionuclide other than those in Tables 1 and 2. If the waste contains none of the radionuclides in Table 1 or 2 of this section, the waste shall be Class A.
(7) The sum of fractions rule for mixtures of radionuclides. The following shall be considered in determining classification for waste that contains a mixture of radionuclides:
(a) The sum of fractions shall be determined by dividing each radionuclide concentration by the appropriate limit and adding the resulting values.
(b) The appropriate limit shall be taken from the same column of the same table.
(c) The sum of the fractions for the column shall be less than one (1.0) if the waste class is determined by that column.
(d) Example: A waste contains Sr-90 in a concentration of fifty (50) curies/cubic meter and Cs-137 in a concentration of twenty-two (22) curies/cubic meter. Because the concentrations both exceed the values in Column 1, Table 2, they shall be compared to Column 2 values. For Sr-90 fraction, 50/150 = 0.33; for Cs-137 fraction, 22/44 = 0.5; the sum of the fractions = 0.83. Because the sum is less than one (1.0), the waste shall be Class B.
(8) Determination of concentrations in waste.
(a) If there is reasonable assurance that an indirect method may be correlated with an actual measurement, the concentration of a radionuclide may be determined by an indirect method, such as use of a scaling factor, which relates the inferred concentration of one (1) radionuclide to another that is measured or radionuclide material accountability.
(b) If the units are expressed as nanocuries per gram, the concentration of a radionuclide may be averaged over the volume or weight of the waste.
Section 7. Radioactive Waste Characteristics.
(1) The following minimum requirements for each class of waste facilitate handling and provide protection of health and safety of personnel at the disposal site:
(a) Waste shall be packaged in conformance with the conditions of the license issued to the site operator to which the waste shall be shipped. If the conditions of the site license are more restrictive than the provisions of this administrative regulation, the site license conditions shall govern.
(b) Waste shall not be packaged for disposal in a cardboard or fiberboard box.
(c) Liquid waste shall be solidified or packaged in sufficient absorbent material to absorb twice the volume of the liquid.
(d) Solid waste containing liquid shall contain as little freestanding and noncorrosive liquid as is reasonably achievable. The liquid shall not exceed one (1) percent of the volume.
(e) Waste shall not be readily capable of:
-
Detonation;
-
Explosive decomposition or reaction at normal pressures and temperatures; or
-
Explosive reaction with water.
(f) Waste shall not contain, or be capable of generating, quantities of toxic gases, vapors, or fumes harmful to a person transporting, handling, or disposing of the waste. This shall not apply to radioactive gaseous waste packaged in accordance with paragraph (h) of this subsection.
(g) Waste shall not be pyrophoric. Pyrophoric material contained in waste shall be treated, prepared, and packaged to be nonflammable.
(h) Waste in a gaseous form shall be packaged at a pressure that shall not exceed one and five-tenths (1.5) atmospheres at twenty (20) degrees Centigrade. Total activity shall not exceed 100 curies per container.
(i) Waste containing hazardous, biological, pathogenic, or infectious material shall be treated to reduce to the maximum extent practicable the potential hazard from the nonradiological material.
(2) Stability shall ensure that the waste shall not structurally degrade and affect overall stability of the site through slumping, collapse, or other failure of the disposal unit and lead to water infiltration. Stability shall also be a factor in limiting exposure to an inadvertent intruder, since it provides a recognizable and nondispersible waste. The following requirements shall provide stability of the waste:
(a) Waste shall have structural stability.
- A structurally-stable waste form shall maintain its physical dimension and its form under expected disposal conditions, such as:
a. Weight of overburden and compaction equipment;
b. Presence of moisture and microbial activity; and
c. Internal factors such as radiation effects and chemical changes.
- Structural stability may be provided by:
a. The waste form itself;
b. Processing the waste to a stable form; or
c. Placing the waste in a disposal container or structure that provides stability after disposal.
(b) Unless otherwise exempted in subsection (1)(c) and (d) of this section, liquid waste or waste containing liquid shall be converted into a form that contains as little free standing and noncorrosive liquid as is reasonably achievable. The liquid shall not exceed one (1) percent of the volume of the waste if the waste is in a disposal container designed to ensure stability, or five-tenths (0.5) percent of the volume of the waste for waste processed to a stable form.
(c) Void spaces within and between the waste and its package shall be eliminated.
Section 8. Labeling. Each package of waste shall be clearly labeled to identify if it is Class A, Class B, or Class C waste, in accordance with Section 6 of this administrative regulation.
Section 9. Transfer for Disposal and Manifests.
(1) The requirements of this section and Section 10 of this administrative regulation shall:
(a) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in 902 KAR 100:010, who ships low-level waste either directly or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility as established in 902 KAR 100:022;
(b) Establish a manifest tracking system; and
(c) Supplement existing requirements concerning transfers and recordkeeping for the wastes being transferred.
(2) Any licensee shipping radioactive material intended for ultimate disposal at a licensed land disposal facility shall document the information required on U.S. Nuclear Regulatory Commission's Uniform Low-Level Radioactive Waste Manifest, or its equivalent, and transfer this recorded manifest information to the intended consignee in accordance with Section 10 of this administrative regulation.
(3) The shipment manifest shall include a certification by the waste generator as specified in Section 10(12) of this administrative regulation.
(4) A person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Section 10(13) of this administrative regulation.
Section 10. Requirements for Low-level Waste Transfers Intended for Disposal at Land Disposal Facilities and Manifests.
(1) A waste generator, collector, or processor who transports, or offers for transportation, low-level radioactive waste intended for ultimate disposal at a licensed low-level radioactive waste land disposal facility shall prepare a manifest reflecting information requested on the following applicable forms, or their equivalent:
(a) NRC Form 540, Uniform Low-Level Radioactive Waste Manifest, Shipping Paper;
(b) NRC Form 541, Uniform Low-Level Radioactive Waste Manifest, Container and Waste Description; and
(c) If necessary, NRC Form 542, Uniform Low-Level Radioactive Waste Manifest, Manifest Index and Regional Compact Tabulation.
(2) NRC Forms 540 and 540A shall be completed and shall physically accompany the pertinent low-level waste shipment.
(3) Upon agreement between shipper and consignee, NRC Forms 541, 541A, 542 and 542A may be completed, transmitted, and stored in electronic media with the capability for producing legible, accurate, and complete records on the respective forms.
(4) A licensee shall not be required by the cabinet to comply with the manifesting requirements of this section, if they ship:
(a) LLW for processing and expect its return for storage as prescribed by their license, prior to disposal at a licensed land disposal facility;
(b) LLW that is being returned to the licensee who is the waste generator or generator, as defined in 902 KAR 100:010; or
(c) Radioactive contaminated material to a waste processor that becomes the processor's residual waste.
(5) For guidance in completing a form, refer to instructions that accompany the form.
(6) A copy of a manifest required by this section may be legible carbon copies, photocopies, or computer printouts that reproduce the data in the format of the uniform manifest.
(7) Information on hazardous, medical, or other waste, required to meet U.S. Environmental Protection Agency regulations, for example, 40 C.F.R. Parts 259 and 261, is not addressed in this section, and shall be provided on the required EPA form. The required EPA form shall accompany the Uniform Low-Level Radioactive Waste Manifest required by this section.
(8) The shipper of the radioactive waste, shall provide the following information on the uniform manifest:
(a) The name, facility address, and telephone number of the licensee shipping the waste;
(b) An explicit declaration indicating whether the shipper shall be acting as a waste generator, collector, processor, or a combination of these identifiers for purposes of the manifested shipment; and
(c) The name, address, and telephone number, or the name and U.S. Environmental Protection Agency hazardous identification number, for the carrier transporting the waste.
(d) The shipper of the radioactive waste shall provide, on the uniform manifest, the following information:
-
The date of the waste shipment;
-
The total number of packages or disposal containers;
-
The total disposal volume and disposal weight in the shipment;
-
The total radionuclide activity in the shipment;
-
The activity of each of the radionuclides, hydrogen-3, carbon-14, technetium-99, and iodine-129 contained in the shipment;
-
The total masses of uranium-233, uranium-235, and plutonium in special nuclear material; and
-
The total mass of uranium and thorium in source material.
(9) The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding the waste and disposal container of waste in the shipment:
(a) An alphabetic or numeric identification that uniquely identifies each disposal container in the shipment;
(b) A physical description of the disposal container, including the manufacturer and model of a high integrity container;
(c) The volume displaced by the disposal container;
(d) The gross weight of the disposal container, including the waste;
(e) For waste consigned to a disposal facility, the maximum radiation level at the surface of each disposal container;
(f) A physical and chemical description of the waste;
(g) The total weight percentage of a chelating agent for waste containing more than one-tenth (0.1) percent of a chelating agent by weight, and the identity of the principal chelating agent;
(h) The approximate volume of waste within a container;
(i) The sorbing or solidification media, if present, and the identity of the solidification media vendor and brand name;
(j)
-
The identity and activity of a radionuclide contained in each container;
-
The masses of uranium-233, uranium-235, and plutonium in special nuclear material;
-
The masses of uranium and thorium in source material; and
-
The identity and activity of each radionuclide associated with, or contained in, discrete waste types within a disposal container, such as:
a. Activated materials;
b. Contaminated equipment;
c. Mechanical filters;
d. Sealed sources or devices; and
e. Wastes in solidification or stabilization media;
(k) The total radioactivity within each container;
(l) The classification of the waste in accordance with Section 6 of this administrative regulation, for wastes cosigned to a disposal facility; and
(m) Identification of waste not meeting the structural stability requirements of Section 7(2) of this administrative regulation.
(10) The shipper of the radioactive waste shall provide the following information on the uniform manifest regarding a waste shipment delivered without a disposal container:
(a) The approximate volume and weight of the waste;
(b) A physical and chemical description of the waste;
(c) The total weight percentage of a chelating agent if the chelating agent exceeds one-tenth (0.1) percent by weight, and the identity of the principal chelating agent;
(d) The classification of the waste in accordance with Section 6 of this administrative regulation for waste cosigned to a disposal facility;
(e) Identification of waste not meeting the structural stability requirements of Section 7(2) of this administrative regulation;
(f)
-
The identity and activity of a radionuclide contained in the waste;
-
The masses of uranium-233, uranium-235, and plutonium in special nuclear material;
-
The masses of uranium and thorium in source material; and
(g) For a waste cosigned to a disposal facility, the maximum radiation level at the surface of the waste.
(11)
(a) The origin of the LLW resulting from activities of a processor may be attributable to one (1) or more generators, including a waste generator. The requirements in this subsection apply to:
-
A disposal container enclosing a mixture of waste originating from different generators; and
-
A mixture of waste shipped in a form without a disposal container, for which portions of the mixture within the shipment originate from different generators.
(b) For a homogeneous mixture of a waste, such as incinerator ash, provide the:
-
Waste description applicable to the mixture; and
-
Volume of the waste attributed to each generator;
(c) For a heterogeneous mixture of a waste such as:
-
The combined products from a large compactor, identify each generator contributing waste to the disposal container; and
-
A discrete waste type, for example, activated materials, contaminated equipment, mechanical filters, sealed sources or devices, and wastes in solidification or stabilization media, the identity and activity of individual radionuclides contained on the waste type within the disposal container;
(d) For a generator, the following information shall be provided:
-
The volume of waste within the disposal container;
-
A physical and chemical description of the waste, including, if present, the solidification agent;
-
The total weight percentage of a chelating agent for a disposal container containing more than one-tenth (0.1) percent of a chelating agent by weight, plus the identity of the principal chelating agent;
-
The sorbing or solidification media, if present, and the identity of the solidification media vendor and brand name if the media is claimed to meet stability requirements in Section 7(2) of this administrative regulation; and
a. Radionuclide identity and activity contained in the waste;
b. The mass of uranium-233, uranium-235, and plutonium in special nuclear material; and
c. The mass of uranium and thorium in source material if contained in the waste.
(12)
(a) An authorized representative of the waste generator, processor, or collector shall certify, by signing and dating the shipment manifest, that the transported materials are:
-
Properly classified;
-
Described;
-
Packaged;
-
Marked;
-
Labeled; and
-
In proper condition for transportation according to 10 C.F.R. 20, Appendix G to Part 20, and the NRC; and
(b) A collector in signing the certification shall certify that nothing has been done to the collected waste which would invalidate the waste generator's certification.
(13) A licensee who transfers waste to a licensed waste processor for waste treatment or repackaging shall comply with the requirements of paragraphs (d) through (l) of this subsection. A licensee who transfers waste to a land disposal facility or a licensed waste collector shall:
(a) Prepare waste to meet a classification in Section 6 of this administrative regulation and the waste characteristics requirements in Section 7 of this administrative regulation;
(b) Label each disposal container, or transport container if potential radiation hazards preclude labeling of the individual disposal container, of waste to identify if the waste is Class A, Class B, Class C, or greater than Class C waste, in accordance with Section 6 of this administrative regulation;
(c) Conduct a quality assurance program including, management evaluation of audits to assure compliance with Sections 6 and 7 of this administrative regulation.
(d) Prepare the NRC Uniform Low-Level Radioactive Waste Manifest as required by this subsection;
(e) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that:
-
Receipt of the manifest precedes the LLW shipment;
-
The manifest and the waste are delivered to the consignee at the same time; or
-
Both methods of manifest delivery described in subparagraphs 1 and 2 of this paragraph are used.
(f) Include NRC Form 540 and Form 540A, if required, with the shipment, regardless of the option chosen in paragraph (e) of this subsection;
(g) Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540;
(h) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 902 KAR 100:040; and
(i) For a shipment, or parts of a shipment, for which acknowledgment of receipt has not been received within the times established in this section, conduct an investigation in accordance with subsection (17) of this section.
(14) A waste collector licensee who handles only prepackaged waste shall:
(a) Acknowledge receipt of the waste from the generator within one (1) week of receipt by returning a signed copy of NRC Form 540;
(b) Prepare a new manifest to reflect consolidated shipments that meet the requirements of this section, including identification of the generator of each container of waste in the shipment;
(c) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that either:
-
Receipt of the manifest precedes the LLW shipment; or
-
The manifest and the waste are delivered to the consignee at the same time; or
-
Both methods of manifest delivery described in subparagraphs 1 and 2 of this paragraph are used;
(d) Include NRC Form 540 and Form 540A, if required, with the shipment regardless of the option chosen in paragraph (c) of this subsection;
(e) Receive acknowledgement of the receipt of the shipment in the form of a signed copy of NRC Form 540;
(f) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material as required by 902 KAR 100:040;
(g) For a shipment, or parts of a shipment, for which acknowledgment of receipt is not received within the time established in this section, conduct an investigation in accordance with subsection (17) of this section;
(h) Notify the shipper and the cabinet if a shipment, or part of a shipment, has not arrived within sixty (60) days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.
(15) A licensed waste processor who treats or repackages waste shall:
(a) Acknowledge receipt of the waste from the shipper within one (1) week of receipt by returning a signed copy of the manifest or equivalent documentation;
(b) Prepare a new manifest that meets the requirements of this subsection:
-
Preparation of the new manifest shall reflect that the processor shall be responsible for meeting these requirements; and
-
For each container of waste in the shipment, the manifest shall identify the waste generators, the preprocessed waste volume, and other information required by subsection (11) of this section;
(c) Prepare waste to meet a classification in Section 6 of this administrative regulation and the waste characteristics requirement in Section 7 of this administrative regulation;
(d) Label each package of waste to identify the waste as Class A, Class B, or Class C, in accordance with Sections 6 and 8 of this administrative regulation;
(e) Conduct a quality control program to assure compliance with Sections 6 and 7 of this administrative regulation, including management evaluation of audits;
(f) Forward a copy or electronically transfer the Uniform Low-Level Radioactive Waste Manifest to the intended consignee so that:
-
Receipt of the manifest precedes the LLW shipment;
-
The manifest and the waste are delivered to the consignee at the same time; or
-
Both methods of manifest delivery described in subparagraphs 1 and 2 of this paragraph are used;
(g) Include NRC Form 540 and 540A, if required with the shipment regardless of the option chosen in subsection (15)(f) of this section;
(h) Retain a copy of or electronically store the Uniform Low-Level Radioactive Waste Manifest and documentation of acknowledgment of receipt as the record of transfer of licensed material required by 902 KAR 100:040;
(i) Receive acknowledgment of the receipt of the shipment in the form of a signed copy of NRC Form 540;
(j) For a shipment or part of a shipment for which acknowledgment of receipt is not received within the time established in this section, conduct an investigation in accordance with subsection (17) of this section; and
(k) Notify the shipper and the cabinet when a shipment, or part of a shipment, has not arrived within sixty (60) days after receipt of an advance manifest, unless notified by the shipper that the shipment has been cancelled.
(16) The land disposal facility operator shall:
(a) Acknowledge receipt of the waste within one (1) week of receipt by returning a signed copy of the manifest or equivalent documentation to the licensee that last possessed the waste and transferred the waste to the operator. If the returned copy of the manifest or equivalent documentation indicates discrepancies between materials on the manifest and materials received, copies or electronic transfer of the affected forms shall be returned indicating the discrepancy;
(b) Maintain copies of completed manifests, or equivalent documentation, and electronically store the information required by 10 C.F.R. 61.80(l) until the cabinet terminates the license; and
(c) Notify the shipper, generator, collector, or processor and the cabinet if a shipment, or part of a shipment, has not arrived within sixty (60) days after the advance manifest was received, unless notified by the shipper that the shipment has been cancelled.
(17)
(a) The shipper shall investigate a shipment or part of a shipment for which acknowledgment is not received within the time established in this section, if the shipper has not received notification of receipt within twenty (20) days after transfer.
(b) The investigation shall include tracing the shipment and filing a report with the cabinet.
(c) A licensee who conducts a trace investigation shall file a written report with the cabinet within two (2) weeks of completion of the investigation.
Section 11. Records.
(1) A licensee shall maintain a record in the same units used in this administrative regulation.
(2) A record of disposal of licensed material required by this administrative regulation shall be maintained until the cabinet authorizes disposition, or in accordance with 902 KAR 100:072, Section 29.
(3) A licensee shall maintain a record of the disposal of licensed materials required by 902 KAR 100:022 and Sections 2, 3, 4, and 5 of this administrative regulation, and disposal by burial in soil, including burials authorized before January 28, 1981.
(4) A licensee shall retain the records required in subsection (3) of this section until the cabinet terminates each pertinent license requiring the record.
Section 12. Annual Report of Waste Generated.
(1) A licensee issued a specific license, pursuant to 902 KAR 100:040, shall file an annual report with the cabinet containing information regarding low-level radioactive waste associated with activities authorized by the license. The report shall be filed if the licensee was, or was not, a waste generator during the reporting period.
(2) The report shall contain information regarding the waste for a period of one (1) calendar year and shall be filed no later than January 15 of the following year.
(3) The report shall be filed on a Low-Level Radioactive Waste (LLW) Report Form provided by the cabinet and shall contain types and amounts of generated waste and estimates of future wastes to be generated.
Section 13. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) NRC Form 540, "Uniform Low-Level Radioactive Waste Manifest, Shipping Paper", 7/2007;
(b) NRC Form 540A, "Uniform Low-Level Radioactive Waste Manifest", 7/2007;
(c) NRC Form 541, "Uniform Low-Level Radioactive Waste Manifest, Container and Waste Description", 7/2007;
(d) NRC Form 541A, "Uniform Low-Level Radioactive Waste Manifest", 7/2007;
(e) NRC Form 542, "Uniform Low-Level Radioactive Waste Manifest, Manifest Index and Regional Compact Tabulation", 8/2010;
(f) NRC Form 542A, "Uniform Low-Level Radioactive Waste Manifest, Manifest Index and Regional Compact Tabulation", 8/2010; and
(g) "Low-Level Radioactive Waste (LLW) Report", 3/2011.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, Office of the Commissioner, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 20.2001-.2007, Appendix G-20.2001-.2401, 61
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050(1), 211.090(3), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of a source of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation provides waste disposal limitations for radioactive material and shall apply to a person disposing of radioactive material or waste.
- History: 12 Ky.R. 1123; eff. 1-3-1986; 16 Ky.R. 2538; eff. 6-27-1990; 20 Ky.R. 2380; 2867; eff. 5-18-1994; 28 Ky.R. 1940; 2210; eff. 3-28-2002; 37 Ky.R. 1814; 2607; eff. 6-3-2011; Crt eff. 8-16-2019; TAm eff. 3-20-2020; Crt eff. 4-21-2026.
902 KAR 100:022 Licensing requirements for land disposal of radioactive waste {#sec-902-kar-100-022 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:022}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. Except as established in subsections (1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 61.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 61.4;
(b) 10 C.F.R. 61.5;
(c) 10 C.F.R. 61.8;
(d) 10 C.F.R. 61.16;
(e) 10 C.F.R. 61.20;
(f) 10 C.F.R. 61.23 (i) and (j);
(g) 10 C.F.R. 61.70;
(h) 10 C.F.R. 61.71;
(i) 10 C.F.R. 61.72;
(j) 10 C.F.R. 61.73;
(k) 10 C.F.R. 61.83; or
(l) 10 C.F.R. 61.84.
(2) Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) Reference to the NRC, the Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch, the NRC or an agreement state.
(4) The report required by 10 C.F.R. 61.80(h) and (i) shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 255-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 61, 40 C.F.R. 261, 42 U.S.C. 2011 - 2297g-4
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1),
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes procedures, criteria, terms, and conditions upon which the cabinet issues licenses for the land disposal of radioactive wastes received from other persons.
- History: 12 Ky.R. 1128; eff. 1-3-1986; 18 Ky.R. 1487; eff. 1-10-1992; 38 Ky.R. 364; 942; eff. 11-16-2011; 45 Ky.R. 499, 1240, 1622; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:030 Quantities of radioactive material requiring labeling {#sec-902-kar-100-030 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:030}
Section 1. Quantities. 10 C.F.R. Part 20 Appendix C provides the quantities of radioactive material requiring labeling as set forth in 902 KAR 100:019.
Section 2. Combination of Radionuclides.
(1) If there is involved a combination of radionuclides in known amounts, the limit for the combination shall be derived by determining for each radionuclide in the combination, the ratio between the quantity present in the combination and the limit otherwise established for the specific radionuclide when not in combination; and
(2) The sum of the ratios for all radionuclides in the combination shall not exceed one (1), or unity.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. Part 20
- STATUTORY AUTHORITY: KRS 194.050(1), 211.090, 211.180(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. This administrative regulation establishes quantity requirements for the labeling of radioactive material licensed under 902 KAR Chapter 100.
- History: 1 Ky.R. 1159; Am. 2 Ky.R. 218; rejected 12-10-1975; 3 Ky.R. 637; eff. 3-2-1977; 5 Ky.R. 630; 1068; eff. 6-6-1979; 12 Ky.R. 1427; eff. 3-4-1986; 18 Ky.R. 1506; eff. 1-10-1992; 21 Ky.R. 621; 1068; eff. 9-21-1994; 42 Ky.R. 2985; 43 Ky.R.212; eff. 8-17-2016; Cert. eff. 5-9-2023.
902 KAR 100:037 Physical protection of category 1 and category 2 quantities of radioactive material {#sec-902-kar-100-037 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:037}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 194A.005(1).
(2) "Licensee" means a person subject to 10 C.F.R. Part 37, Physical protection of category 1 and category 2 quantities of radioactive material.
Section 2. Applicability. This administrative regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 37 except as established in subsections
(1) and (2) of this section. (1) The licensee shall not be subject to:
(a) 10 C.F.R. 37.7;
(b) 10 C.F.R. 37.13;
(c) 10 C.F.R. 37.107; or
(d) 10 C.F.R. 37.109.
(2) Reference to the commission or NRC shall be deemed to be a reference to the cabinet, Department for Public Health, Radiation Health Branch, except in:
(a) 10 C.F.R. 37.5, Definitions: Agreement State, Byproduct material, Commission, Fingerprint orders, and Person;
(b) 10 C.F.R. 37.25;
(c) 10 C.F.R. 37.27;
(d) 10 C.F.R. 37.29; or
(e) 10 C.F.R. 37.71.
Section 3. Reporting of events or notifications. The required reporting of events or notifications to the Radiation Health Branch shall be directed to:
(1) 275 East Main Street, Mailstop HS1C-A, Frankfort, Kentucky 40621;
(2) (502) 564-3700, Monday through Friday from 8 a.m. to 4:30 p.m.; or
(3) (800) 255-2587, at other hours.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842 - 211.852, 211.990(4), 10 C.F.R. Part 37
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes requirements for the physical security of Category 1 and Category 2 quantities of radioactive material.
- History: 42 Ky.R. 1669; eff. 2-5-2016.
902 KAR 100:040 General provisions for specific licenses {#sec-902-kar-100-040 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:040}
Section 1. License Requirement. Except for persons exempted by 902 KAR 100:015 and 100:045, a person shall not manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material except as authorized in a specific or general license issued in accordance with 902 KAR Chapter 100. Authority to transfer possession or control by the manufacturer; processor; or producer of equipment, devices, commodity, or other products containing radioactive material whose subsequent possession, use, transfer, or disposal by other persons are exempted from regulatory requirements, may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D. C., 20555.
Section 2. Types of Licenses.
(1) Licenses for radioactive material shall be of two (2) types:
(a) General; or
(b) Specific.
(2) Except as specified in 902 KAR 100:050, general licenses shall be:
(a) Effective without the filing of an application with the cabinet or the issuance of licensing documents to the licensee; and
(b) Subject to other applicable requirements of 902 KAR Chapter 100 and limitations of 902 KAR 100:050.
(3) Specific licenses shall require:
(a) The submission of an application to the cabinet; and
(b) The issuance of a licensing document by the cabinet.
(4) Each license shall be subject to applicable requirements of 902 KAR Chapter 100 and to limitations specified in the licensing document.
Section 3. Filing of Application for a Specific License.
(1) An application for specific license shall be filed with the Cabinet for Health and Family Services on Form RPS-7, incorporated by reference.
(2)
(a) After the filing of the original application, or before the expiration of the license if the applicant has already been granted, the Cabinet may require additional information in order to determine if:
-
The application is to be granted or denied; or
-
A license is to be modified or revoked.
(b) Prelicensing visits may be made to the applicant's facility for the purpose of obtaining information in addition to that furnished in the original application.
(c) If the applicant or licensee fails to respond within thirty (30) days of receipt to a written request, for additional information, the cabinet shall suspend, modify, or revoke the license in accordance with 902 KAR 100:170, or shall deny the application.
(3) The application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.
(4) An application for a license may include a request for a license authorizing one (1) or more activities if the application specifies the additional activities and complies with the provisions of 902 KAR Chapter 100 relating to specific licenses.
(5)
(a) The applicant may incorporate in the application, by reference, information contained in previous applications, statements, or reports filed with the cabinet, if references are clear and specific.
(b) Information provided to the cabinet by an applicant or licensee, or information required to be maintained by statute, by 902 KAR Chapter 100, cabinet orders, or license conditions, shall be complete and accurate in all aspects.
(6) An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source shall:
(a) Identify the source or device by manufacture and model number as registered with:
-
The cabinet;
-
The U.S. Nuclear Regulatory Commission; or
-
An agreement state; and
(b) Contain the information identified in 902 KAR 100:058, Section 1.
(7) An application for a specific license shall contain, if required by the administrative regulation referenced:
(a)
-
A proposed decommissioning funding plan; or
-
A certification of financial assurance for decommissioning in accordance with 902 KAR 100:042; and
(b) An emergency plan for responding to a release in accordance with 902 KAR 100:041.
Section 4. General Requirements for the Issuance of a Specific License.
(1) A license application shall be approved if the cabinet determines:
(a) The applicant is qualified by reason of training and experience to use the radioactive material in question for the purpose requested, in accordance with 902 KAR Chapter 100, and in a manner that minimizes danger to public health and safety or property;
(b) The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;
(c) The issuance of the license will not be adverse to the health and safety of the public; and
(d) The applicant satisfies applicable special requirements in 902 KAR Chapter 100.
(2) For an application for a license to receive and possess radioactive material that the cabinet determines will significantly affect the quality of the environment, the following shall apply:
(a) The secretary of the cabinet or his designee shall, before commencement of construction of the plant or facility in which the activity is to be conducted, weigh the environmental, economic, technical, and other benefits against environmental costs and shall consider available alternatives.
(b) The secretary shall, if appropriate, approve a license modified by conditions designed to protect environmental values.
(c) Commencement of construction prior to cabinet determination shall be grounds for denial of a license to receive and possess radioactive material in the plant or facility. As used in this subsection, "commencement of construction" shall include clearing of land, excavation, or other substantial action that would adversely affect the environment of a site, but shall not include site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.
(3)
(a) The licensee shall notify the cabinet in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy under Title 11 of the United States Code by or against:
-
The licensee;
-
An entity, as defined in 11 U.S.C. 101(14) or (15), controlling the licensee or listing the license or licensee as property of the estate; or
-
An affiliate, as defined in 11 U.S.C. 101(2), of the licensee.
(b) The notification shall indicate:
-
The bankruptcy court in which the petition for bankruptcy was filed; and
-
The date and case number of the filing of the petition.
Section 5. Issuance of Specific Licenses.
(1) Upon a determination that an application meets the requirements of KRS 211.842 to 211.852 and 902 KAR Chapter 100, the cabinet shall issue a specific license authorizing the proposed activity in a form containing necessary and appropriate conditions and limitations.
(2) The cabinet may incorporate in a license when issued, or thereafter by appropriate rule, 902 KAR Chapter 100, or order, or as specified in Section 13 of this administrative regulation, additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to 902 KAR Chapter 100 as it deems appropriate or necessary in order to:
(a) Minimize danger to public health and safety or property;
(b) Require reports are maintained and the keeping of records, and provide for inspections of activities under the license as may be appropriate or necessary; and
(c) Prevent loss or theft of licensed material.
Section 6. Specific Terms and Conditions of Licenses.
(1) A license issued pursuant to this administrative regulation shall be subject to the provisions of KRS 211.842 to 211.852, 902 KAR Chapter 100, and orders of the cabinet.
(2) Neither the license nor a right under the license shall be assigned or otherwise transferred in violation of the provisions of KRS 211.842 to 211.852.
(3) A licensee under 902 KAR Chapter 100 shall confine use and possession of the licensed radioactive material to the locations and purposes authorized in the license.
(4) A portable gauge licensee shall use a minimum of two (2) independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, if portable gauges are not under the control and constant surveillance of the licensee.
Section 7. Expiration and Termination of Licenses.
(1) Except as specified in subsection (4) of this section and in Section 8 of this administrative regulation, a specific license shall expire at midnight on the day, month, and year stated in the license.
(2) A licensee shall promptly notify the cabinet, in writing, and request termination of the license, if the licensee decides to terminate activities involving licensed materials. This notification and request for termination of the license shall include:
(a) The reports and information specified in subsection (3)(d) and (e) of this section; and
(b) A plan for completion of decommissioning, if required by 902 KAR 100:042 or by license condition.
(3) If a licensee does not submit an application for license renewal under Section 8 of this administrative regulation, the licensee, on or before the expiration date specified in the license, shall:
(a) Terminate use of radioactive material;
(b) Remove radioactive contamination to the extent practicable except for those procedures covered by subsection (4) of this section;
(c) Properly dispose of radioactive material;
(d) File the Disposition of Radioactive Material, "Form RPS-10", with the Cabinet for Health and Family Services; and
(e) If licensed to possess radioactive material with a half-life greater than 120 days in an unsealed form, forward to the cabinet:
-
Records of disposal of radioactive material made pursuant to 902 KAR 100:021, Sections 3-6, including burials authorized before January 28, 1981; and
-
Records required by 902 KAR 100:019, Section 31(2)(d).
(f) If licensed activities are transferred or assigned in accordance with 902 KAR 100:040, Section 6, a licensee authorized to possess radioactive material with a half-life greater than 120 days, in an unsealed form, shall transfer the following records to the new licensee. The new licensee shall be responsible for maintaining these records until the license is terminated:
-
Records of disposal of licensed material made pursuant to 902 KAR 100:021, Sections 3 through 6 of this administrative regulation, including burials authorized before January 28, 1981; and
-
Records required by 902 KAR 100:019, Section 31(2)(d).
(g) Prior to license termination, a licensee shall forward the records required by 902 KAR 100:042, Section 15(3), to the cabinet.
(4) A specific license continues in effect, beyond the expiration date if necessary, with respect to possession of radioactive material until the cabinet notifies the licensee in writing that the license shall be terminated. During this time, the licensee shall:
(a) Limit actions involving radioactive material to those related to decommissioning; and
(b) Continue to control entry to restricted areas until they are suitable for release for unrestricted use and the cabinet notifies the licensee in writing that the license shall be terminated.
Section 8. Renewal of License. If a licensee has filed, an application in proper form for renewal or for a new license authorizing the same activities more than thirty (30) days prior to expiration of an existing license, the existing license shall not expire until the application has been finally determined by the cabinet.
Section 9. Amendment of Licenses.
(1) An application for amendment of a license at the request of the licensee shall specify the respects in which the licensee desires the license to be amended and the grounds for the amendment.
(2) Every five (5) years or at the request of the cabinet, the licensee shall be required to amend the license in its entirety by submitting a complete application.
Section 10. Cabinet Action on Applications to Renew or Amend. In considering an application by a licensee to renew or amend his license, the cabinet shall apply the requirements of 902 KAR Chapter 100.
Section 11. Inalienability of Licenses. A license issued or granted under 902 KAR Chapter 100 or right to possess or utilize radioactive material granted by a license issued under 902 KAR Chapter 100 shall not be transferred, assigned, or otherwise disposed of, through transfer of control of a license to a person unless the cabinet, after securing full information, finds that the transfer is in accordance with the requirements of 902 KAR Chapter 100 and gives its consent in writing.
Section 12. Transfer of Material.
(1) A licensee shall not transfer radioactive material except as authorized by this administrative regulation.
(2) Except as stated in the license and subject to the provisions of subsections (3) and (4) of this section, a licensee may transfer radioactive material subject to the acceptance of the transferee to a person:
(a) Exempt from the requirements for a license as specified in this administrative regulation to the extent permitted under the exemption;
(b) Authorized to receive radioactive material under terms of a general license as specified in 902 KAR 100:050, or its equivalent, or a specific license or equivalent licensing document, issued by the cabinet, the U.S. Nuclear Regulatory Commission, or an agreement state;
(c) Otherwise authorized to receive radioactive material by the federal government or an agency thereof, the cabinet, or an agreement state; or
(d) As otherwise authorized by the cabinet in writing.
(3) Before transferring radioactive material to a specific licensee of the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state or to a general licensee who is required to register with the cabinet, U.S. Nuclear Regulatory Commission, or an agreement state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.
(4) The following methods for the verification required by this administrative regulation shall be acceptable:
(a) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;
(b) The transferor may have in his possession a written certificate by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date;
(c) For emergency shipments, the transferor may accept oral certification by the transferee that the transferee is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date, if the oral certification is confirmed in writing within ten (10) days of the shipment.
(d) The transferor may obtain other sources of information compiled by a reporting service from official records of the cabinet, the U.S. Nuclear Regulatory Commission, or the licensing agency of an agreement state as to the identity of licensees and the scope and expiration dates of licenses and registration; or
(e) If none of the methods of verification described in paragraphs (a) through (d) of this subsection are readily available or if a transferor desires to verify that information received by one (1) of the methods is correct or up-to-date, the transferor may obtain and record confirmation from the cabinet, U.S. Nuclear Regulatory Commission, or the licensing agency of an agreement state that the transferee is licensed to receive the radioactive material.
(5) Shipment and transport of radioactive material shall meet the requirements of 902 KAR Chapter 100.
Section 13. Modification, Revocation, and Suspension of Licenses.
(1) The terms and conditions of a license shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to or violation of KRS 211.842 to 211.852, 902 KAR Chapter 100, or orders issued by the cabinet.
(2) A license may be revoked, suspended, or modified, in whole or in part, for:
(a) A material false statement in the application or in a statement of fact required under provisions of KRS 211.842 to 211.852;
(b) A condition revealed by application or statement of fact;
(c) A report, record, or inspection, or other means that would warrant the cabinet to refuse to grant a license on an original application; or
(d) A violation of, or failure to observe the terms and conditions of KRS 211.842 to 211.852, the license, 902 KAR Chapter 100, or orders of the cabinet.
(3) Except in a case of willful violation or in which the public health, interest, or safety requires otherwise, a license shall not be modified, suspended, or revoked unless, prior to the institution of proceedings.
(a) The cabinet shall notify the licensee in writing, according to 902 KAR 1:400, Section 1, of the fact or conduct that may warrant cabinet action on the license.
(b) The cabinet shall provide the licensee with the opportunity for a conference and conference report according to 902 KAR 1:400, Sections 1 through 3.
(c) If no conference is requested within the timeframe, the Cabinet shall notify the licensee in writing according to 902 KAR 1:400 Section 2(a)-(c) and Section 3(2) of its final action and the licensee's right to appeal.
(4) A licensee whose license is suspended or revoked, shall have a right to a hearing under 902 KAR 1:400, Section 4 by, by making a written request as described in that Section.
Section 14. Retention of Records.
(1) A person who receives radioactive material in accordance with a license issued under 902 KAR Chapter 100 shall keep records showing the receipt, transfer, and disposal of radioactive material.
(2)
(a) Records of receipt of radioactive material that are required by subsection (1) of this section shall be maintained as long as the licensee retains possession of the radioactive material and for two (2) years following transfer or disposal of the radioactive material.
(b) Records of transfer of radioactive material shall be maintained by the licensee who transferred the material for five (5) years after the transfer.
(c) Records of disposal of radioactive material shall be maintained in accordance with 902 KAR 100:021.
(3) Other records required by 902 KAR Chapter 100 or by a license condition shall be maintained for the period specified in 902 KAR Chapter 100. If the retention period is not specified by 902 KAR Chapter 100 or a license condition, the records shall be permanently maintained unless the cabinet authorizes disposition upon proper application for destruction.
(4) Records required to be maintained by 902 KAR Chapter 100 shall be:
(a) The original, a reproduced copy, or a microform if duly authenticated by authorized personnel and capable of producing a clear and legible copy after storage for the period specified by 902 KAR Chapter 100; or
(b) In electronic media with the capability for producing legible, accurate, and complete records during the required retention period.
(5) Records, including letters, drawings, and specifications, shall include pertinent authentication stamps, initials, or signatures. The licensee shall maintain adequate safeguards against tampering with, and loss of, records.
Section 15. Reporting Requirements.
(1) Immediate report. A licensee shall notify the Cabinet for Health and Family Services, Radiation Health Branch, no later than four (4) hours, after the discovery of an event that prevents or overcomes immediate protective actions necessary to avoid exposure to radiation or radioactive materials or a release of radioactive materials that may exceed regulatory limits. An event includes a fire, explosion, or toxic gas release.
(2) Twenty-four (24) hour report. A licensee shall notify the Cabinet for Health and Family Services, Radiation Health Branch within twenty-four (24) hours after the discovery of an event involving radioactive material, as follows:
(a) An unplanned contamination event that:
-
Requires access to the contaminated area, by workers or the public, to be restricted for more than twenty-four (24) hours by imposing additional radiological controls or by prohibiting entry into the area;
-
Involves a quantity of material greater than five (5) times the lowest annual limit on intake specified in 10 C.F.R. 20, Appendix B, for the material; and
-
Requires access to the area restricted for a reason other than to allow isotopes with a half-life of less than twenty-four (24) hours to decay prior to decontamination;
(b) An event in which equipment is disabled or fails to function as designed, if:
-
The equipment is required by administrative regulation or license condition to prevent a release exceeding regulatory limits, to prevent an exposure to radiation or radioactive material exceeding regulatory limits, or to mitigate the consequences of an accident;
-
The equipment is required to be available and operable if it is disabled or fails to function; and
-
Redundant equipment is not available and operable to perform the required safety function;
(c) An event that requires unplanned medical treatment, at a medical facility, of an individual with spreadable radioactive contamination on the individual's clothing or body; or
(d) An unplanned fire or explosion damaging radioactive material or a device, container, or equipment containing radioactive material, if:
-
The quantity of material involved is greater than five (5) times the lowest annual limit on intake specified in 10 C.F.R. 20, Appendix B, for the radioactive material; and
-
The damage affects the integrity of the radioactive material or its container.
(3) A report by a licensee in response to the requirements of this section shall be made as follows:
(a) A licensee shall make a report as required by subsections (1) and (2) of this section by telephone to the Cabinet for Health and Family Services, Radiation Health Branch at (502) 564-3700 from 8 a.m.-4:30 p.m. Eastern Time Monday through Friday, or at (800) 255-2587 at other hours. To the extent that the information is available at the time of notification, the information provided in these reports shall include:
-
The caller's name and call back telephone number;
-
A description of the event, including date and time;
-
The exact location of the event;
-
The isotopes, quantities, and chemical and physical form of the radioactive material involved; and
-
Available personnel radiation exposure data.
(b) A licensee who makes a telephone report shall submit a written follow-up report within thirty (30) days of the initial report. A written report prepared pursuant to another administrative regulation of 902 KAR Chapter 100 may be submitted to fulfill this requirement, if the report contains the necessary information and the appropriate distribution is made. The report shall be sent to the Manager, Radiation Health Branch, 275 East Main Street, Frankfort, Kentucky 40621. The report shall include the following:
-
A description of the event, including the probable cause and the manufacturer and model number, if applicable, of equipment that failed or malfunctioned;
-
The exact location of the event;
-
The isotopes, quantities, and chemical and physical form of the radioactive material involved;
-
Date and time of the event;
-
Corrective actions taken or planned and results of evaluations or assessments; and
-
The extent of every exposure of every individual to radiation or to a radioactive material, without identification of any individual by name.
Section 16. Material Incorporated by Reference.
(1) The following material is incorporated by reference:
(a) Cabinet for Health and Family Services Form RPS-7 "Application for Radioactive Material License", 6/2011;
(b) Cabinet for Health and Family Services Form RPS-10 "Disposition of Radioactive Material" 3/2011; and
(c) "Annual Low Level Radioactive Waste (LLRW) Report", 3/2011.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Office of the Commissioner of Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 30.31-30.34, 30.36-30.39, 30.41, 30.50, 30.51, 30.61, 11 U.S.C. 101(2), (14)
- STATUTORY AUTHORITY: KRS 194A.050, 211.090(3), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health and Family Services to promulgate administrative regulations for regulating and licensing the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes general provisions for the issuance of specific licenses to possess, use, or transfer radioactive material within Kentucky.
- History: 1 Ky.R. 394; eff. 2-5-1975; 3 Ky.R. 413; eff. 12-1-1976; 12 Ky.R. 1017; eff. 1-3-1986; 16 Ky.R. 2542; eff. 6-27-1990; 19 Ky.R. 1916; 2437; eff. 4-21-1993; 21 Ky.R. 2298; eff. 4-19-1995; 22 Ky.R. 2483; eff. 8-1-1996; 23 Ky.R. 3988; eff. 8-20-1997; 26 Ky.R. 2382; 27 Ky.R. 793; eff. 9-11-2000; 38 Ky.R. 372; 949; eff. 11-16-2011; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:041 Quantities of radioactive materials requiring consideration of the need for an emergency plan {#sec-902-kar-100-041 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:041}
Section 1. General Requirements. A license application to possess, or a license authorizing the possession of, radioactive materials in unsealed form, on foils or plated sources, or sealed in glass, in excess of the quantities established in Section 4(1) of this administrative regulation shall contain:
(1) An evaluation showing the maximum dose to a person off site due to a release of radioactive materials would not exceed one (1) rem effective dose equivalent or five (5) rems to the thyroid; or
(2) An emergency plan for responding to a release of radioactive material.
Section 2. Factors Supporting an Evaluation. One (1) or more of the following factors may be used to support an evaluation submitted pursuant to Section 1(1) of this administrative regulation:
(1) The radioactive material is physically separated so that only a portion may be involved in an accident.
(2) The radioactive material, or part of the radioactive material, would not be subject to release during an accident because of, the material's storage or packaging.
(3) The release fraction in the respirable size range may be lower than the release fraction shown in Section 4(1) of this administrative regulation, due to the chemical or physical form of the material.
(4) The solubility of the radioactive material may reduce the dose received.
(5) Facility design or engineered safety features in the facility may cause the release fraction to be lower than the limits established in Section 4(1) of this administrative regulation.
(6) Operating restrictions or procedures may prevent a release fraction as large as that shown in Section 4(1) of this administrative regulation.
(7) Other relevant factors, as determined by the cabinet, may affect the evaluation appropriate for the specific facility.
Section 3. Emergency Plan Information.
(1) An emergency plan for responding to a release of radioactive material submitted pursuant to Section 1(2) of this administrative regulation shall include:
(a) Facility description. A brief description of the licensee's facility and area near the site.
(b) Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.
(c) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.
(d) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.
(e) Mitigation of consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers on site, and the program for maintaining the equipment.
(f) Assessment of a release. A brief description of the methods and equipment to assess releases of radioactive materials.
(g) Responsibilities. A brief description of the responsibilities of licensee personnel if an accident occurs, including identification of personnel responsible for promptly notifying off site response organizations and the Radiation Health and Toxic Agents Branch, and responsibilities for developing, maintaining, and updating the plan.
(h) Notification and coordination. A brief description of the means to promptly notify off site response organizations and request off site assistance, including medical assistance for the treatment of contaminated or injured on site workers, if appropriate.
-
A control point shall be established.
-
Unavailability of personnel, parts of a facility, and equipment shall not exempt the licensee from notification and coordination requirements.
-
The licensee shall notify:
a. Appropriate off site response organizations immediately after the licensee declares an emergency; and
b. The Radiation Health and Toxic Agents Branch within one (1) hour.
(i) Information to be communicated. A brief description of the information to be given to off site response organizations and the Radiation Health and Toxic Agents Branch, including:
-
Facility status;
-
Radioactive releases; and
-
Recommended protective action, if necessary.
(j) Training. A brief description of the frequency, performance objectives, and licensee's plan for training workers to respond to an emergency, including special instructions and orientation tours offered by licensee to fire, police, medical, and other emergency personnel. Training shall:
-
Familiarize personnel with site-specific emergency procedures; and
-
Thoroughly prepare site personnel for responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for the scenarios.
(k) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.
(l) Exercises.
- Provisions for conducting quarterly communication checks with off site response organizations, and biennial on site exercises to test response to simulated emergencies.
a. Quarterly communication checks with off site response organizations shall include the check and update of necessary telephone numbers.
b. The licensee shall invite off site response organizations to participate in the biennial exercises. Participation of off site response organizations in biennial exercises, although recommended, is not required.
-
Exercises shall use accident scenarios postulated as most probable for the specific site, and the scenarios shall not be known to most exercise participants.
-
The licensee shall critique each exercise using individuals without direct implementation responsibility for the plan. Critiques of exercises shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response.
-
Deficiencies found by the critiques shall be corrected.
(m) Hazardous chemicals. A certification stating the applicant has met responsibilities pursuant to 42 USC 11001, Emergency Planning and Community Right-to-Know Act of 1986, if applicable to the applicant's activities at the proposed place of use of the radioactive material.
(2) The licensee shall allow off site accident response organizations sixty (60) days to comment on the licensee's emergency plan before submitting the plan to Radiation Health and Toxic Agents Branch. The licensee shall provide comments received within the sixty (60) days to the Radiation Health and Toxic Agents Branch with the emergency plan.
Section 4. Quantities of Radioactive Materials.
(1) The following table establishes the quantities of radioactive materials requiring consideration of the need of an emergency plan for responding to a release:
(2) For a combination of radioactive materials, consideration of the need for an emergency plan shall be required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in subsection (1) of this section exceeds one (1).
(3) Waste packaged in Type B containers shall not require an emergency plan.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 30.32, 30.72, 42 U.S.C. 11001
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050, 211.090(3), 211.844, 42 U.S.C. 11001
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 authorizes the Cabinet for Health Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation, and the handling and disposal of radioactive waste. This administrative regulation establishes requirements for emergency plans for responding to a release of radioactive material or waste, and shall apply to a person, applicant, or licensee required to submit an emergency plan.
- History: 20 Ky.R. 2511; eff. 4-11-1994; 26 Ky.R. 2389; 27 Ky.R. 800; eff. 9-11-2000; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:042 Decommissioning and financial surety {#sec-902-kar-100-042 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:042}
Section 1. General Provisions and Scope.
(1) This administrative regulation shall apply to the decommissioning and financial assurance requirements of a facility licensed under 902 KAR 100:040 or 100:022, as well as other facilities subject to the cabinet's jurisdiction under KRS 211.842 to 211.852. For a low-level waste disposal facility licensed pursuant to 902 KAR 100:022, the criteria for decommissioning shall apply to only an ancillary surface facility that supports radioactive waste disposal activities.
(2) This administrative regulation shall not apply to a site that has:
(a) Been decommissioned prior to the effective date of this administrative regulation;
(b) Previously submitted and received cabinet approval on a license termination or decommissioning plan prior to the effective date of this administrative regulation; or
(c) Submitted a license termination or decommissioning plan with an application, as required by 902 KAR 100:040, Section 7.
(3) After a site has been decommissioned and the license terminated in accordance with this administrative regulation, the cabinet shall require additional cleanup if, based on new information, it determines that necessary criteria were not met and residual radioactivity at the site may result in significant threat to public health and safety.
(4) To calculate Total Effective Dose Equivalent (TEDE) to the average member of the critical group, the licensee shall determine the peak annual TEDE dose expected within the first 1,000 years after decommissioning.
Section 2. Radiological Criteria for Unrestricted Use.
(1) A site shall be considered acceptable for unrestricted use if:
(a) The residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed twenty-five (25) millirem (0.25 mSv) per year, including radioactivity from groundwater sources of drinking water; and
(b) The residual radioactivity has been reduced to As Low as Reasonably Achievable (ALARA) levels.
(2) Determination of ALARA levels shall take into account every foreseeable potential detriment that may result from decontamination and waste disposal.
Section 3. Criteria for License Termination Under Restricted Conditions. The cabinet shall terminate a license under restricted conditions if one (1) or more of the following circumstances exist at the site:
(1) The licensee demonstrates that further reductions in residual radioactivity necessary to comply with Section 2 of this administrative regulation:
(a) May result in net public or environmental harm; or
(b) The residual levels associated with restricted conditions are ALARA. Determination of ALARA levels shall take into account every foreseeable potential detriment that may result from decontamination and waste disposal;
(2) The licensee has made provisions for legally enforceable institutional controls that provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed twenty-five (25) mrem (0.25 mSv) per year;
(3) The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for necessary control and maintenance of the site. Acceptable financial assurance mechanisms shall include:
(a) Funds placed into an account segregated from the licensee's assets and outside the licensee's administrative control, as established in Section 15(2)(a) of this administrative regulation;
(b) Surety method, insurance, or other guarantee method as described in Section 15(2)(b) of this administrative regulation;
(c) For a federal, state, or local government licensee, a statement of intent as described in Section 15(2)(d) of this administrative regulation; or
(d) For a governmental entity assuming custody and ownership of a site, an arrangement deemed acceptable by the governmental entity.
(4) The licensee has submitted a decommissioning or license termination plan to the cabinet indicating the licensee's intent to decommission in accordance with Section 14(1) of this administrative regulation and specifying that the licensee intends to decommission by restricting use of the site. The licensee shall document in the plan how the advice of potentially affected individuals and institutions in the community has been sought, analyzed, and incorporated, as appropriate.
(a) A licensee proposing to decommission by restricting use of the site shall seek advice from potentially-affected parties if:
- Institutional controls proposed by the licensee:
a. Provide reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group will not exceed twenty-five (25) mrem (0.25 mSv) TEDE per year;
b. Are enforceable; and
c. Will not impose undue burdens on the local community or other affected parties; and
- The licensee has provided sufficient financial assurance to enable an independent third party, including a governmental custodian of a site, to assume and carry out responsibilities for necessary control and maintenance of the site;
(b) In seeking advice on the issues identified in paragraph (a) of this subsection, the licensee shall provide for:
-
Participation by representatives of a broad cross section of potentially-affected community interests;
-
An opportunity for a comprehensive, collective discussion on the issues by the participants; and
-
A publicly available summary of the results of the discussions, including a description of the participants' viewpoints and the extent of agreement and disagreement among the participants; and
(5) Residual radioactivity at the site has been reduced so that if the institutional controls were no longer in effect, there is reasonable assurance that the TEDE from residual radioactivity distinguishable from background to the average member of the critical group is ALARA and shall not exceed:
(a) 100 mrem (1 mSv) per year; or
(b) 500 mrem (5 mSv) per year, if the licensee:
-
Demonstrates that further reductions in residual radioactivity necessary to comply with the value in subsection (5)(a) of this section are not technically achievable, are prohibitively expensive, or may result in net public or environmental harm;
-
Makes provisions for durable institutional controls;
-
Provides sufficient financial assurance to enable a responsible government entity or independent third party, including a governmental custodian of a site, to:
a. Carry out periodic rechecks of the site at least every five (5) years to assure that the institutional controls remain in place as necessary to meet the criteria established in subsection (2) of this section; and
b. Assume and carry out responsibilities for necessary control and maintenance of the institutional controls. Acceptable financial assurance mechanisms shall be as established in subsection (3) of this section.
Section 4. Alternate Criteria for License Termination.
(1) The cabinet may terminate a license using alternate criteria greater than the dose criterion established in Sections 2 and 3(2) or (4)(a)1a of this administrative regulation, if the licensee:
(a) Submits an analysis of possible sources of exposure in support of assurance that:
-
Public health and safety continues to be protected; and
-
It is unlikely that the dose from manmade sources combined, other than medical, are more than the 100 mrem/year (1 mSv/y) limit of 902 KAR 100:019, Section 10(1)(a);
(b) Has employed restrictions on site use, to the extent practical, according to the provisions of Section 3 of this administrative regulation;
(c) Reduces doses to ALARA levels, taking into consideration potential detriments expected to result from decontamination and waste disposal; and
(d) Has submitted a decommissioning or license termination plan to the cabinet indicating the licensee's intent to decommission in accordance with Section 14(1) of this administrative regulation, and specifying that the licensee proposes to decommission by use of alternate criteria.
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The licensee shall document in the plan how the advice of potentially-affected individuals and institutions in the community has been sought, analyzed, and addressed, as appropriate.
-
In seeking advice, the licensee shall provide for:
a. Participation by representatives of a broad cross section of potentially-affected community interests;
b. An opportunity for a comprehensive, collective discussion on the issues by the participants; and
c. A publicly available summary of the results of discussions, including a description of the participant's viewpoints and the extent of agreement and disagreement among the participants.
(2) The use of alternate criteria to terminate a license requires the approval of the cabinet, after consideration of recommendations that address comments provided by state and federal agencies and public comments submitted pursuant to Section 5 of this administrative regulation.
Section 5. Public Notification and Public Participation. Upon receipt of a license termination or decommissioning plan from the licensee, or a proposal by the licensee for release of a site pursuant to Section 3 or 4 of this administrative regulation, or if the cabinets determines a notice to be in the public interest, the cabinet shall:
(1) Notify and solicit comments from:
(a) Local and state governments in the vicinity of the site; and
(b) Other state and federal agencies, if the licensee proposes to release a site pursuant to Section 4 of this administrative regulation.
(2) Publish a notice to solicit comments from potentially affected parties. Publication shall be in a medium readily accessible to individuals in the vicinity of the site, and may be:
(a) Local newspaper;
(b) Letters to state and local organizations; or
(c) Other appropriate media.
Section 6. Minimization of Contamination. An applicant for a license or for an amendment in its entirety shall:
(1) Describe in the application how facility design and procedures for operation shall minimize contamination of the facility and the environment to the extent practicable;
(2) Facilitate eventual decommissioning; and
(3) Minimize the generation of radioactive waste, to the extent practicable.
Section 7. Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning.
(1) An applicant or licensee shall provide reasonable assurance of the availability of funds for decommissioning based upon:
(a) Obtaining a parent company to guarantee the availability of funds for decommissioning costs; and
(b) A demonstration that the parent company meets financial requirements.
(2) Financial test.
(a) To pass the financial test, the parent company shall meet one (1) of the following criteria:
- The parent company shall have:
a. Two (2) of the following three (3) ratios:
(i) A ratio of total liabilities to net worth less than two (2);
(ii) A ratio of the sum of net income plus depreciation, depletion, and amortization to total liabilities greater than one-tenth (0.1); or
(iii) A ratio of current assets to current liabilities greater than one and five-tenths (1.5);
b. Net working capital and tangible net worth each at least six (6) times the current decommissioning cost estimates for the total of facilities or parts of the facilities, or prescribed amount if a certification is used;
c. Tangible net worth of at least $10,000,000; and
d. Assets located in the United States amounting to at least ninety (90) percent of the total assets or at least six (6) times the current decommissioning cost estimates for the total of facilities or parts of the facilities, or prescribed amount if a certification is used; or
- The parent company shall have:
a. A current rating for its most recent bond issuance of AAA, AA, A, or BBB as issued by Standard and Poor's, or AAA, AA, A, or BAA as issued by Moody's;
b. Tangible net worth each at least six (6) times the current decommissioning cost estimates for the total of facilities or parts of the facilities, or prescribed amount if a certification is used;
c. Tangible net worth of at least $10,000,000; and
d. Assets located in the United States amounting to at least ninety (90) percent of the total assets or at least six (6) times the current decommissioning cost estimates for the total of facilities or parts of the facilities, or prescribed amount if a certification is used; or
(b) The parent company's independent certified public accountant shall compare the data used by the parent company in the financial test, which shall be derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in the financial statement. The licensee shall inform the cabinet, within ninety (90) days, of matters coming to the auditor's attention that cause the auditor to believe that:
-
The data specified in the financial test requires adjustment; and
-
The company no longer passes the test.
(c)
-
After the initial financial test, the parent company shall repeat the passage of the test within ninety (90) days after the close of each succeeding fiscal year.
a. If the parent company no longer meets the requirements of subsection (2)(a) of this section, the licensee shall notify the cabinet of its intent to establish alternate financial assurance.
b. The notice shall be sent by certified mail within ninety (90) days after the end of the fiscal year for which the year-end financial data show that the parent company no longer meets the financial test requirements.
c. The licensee shall provide alternate financial assurance within 120 days after the end of a fiscal year.
(3) Parent company guarantee. The terms of a parent company guarantee that an applicant or licensee obtains shall provide that:
(a) The parent company guarantee shall remain in force unless the guarantor notifies the licensee and the cabinet, by certified mail, return receipt requested, of cancellation. Cancellation shall not occur during the 120 days beginning on the date of receipt of the notice of cancellation as evidenced by the return receipts.
(b) If the licensee fails to provide sufficient alternate financial assurance within ninety (90) days after receipt by the licensee and cabinet of a notice of cancellation of the parent company guarantee from the guarantor, the guarantor shall provide an alternative financial assurance in the name of the licensee.
(c) The parent company guarantee and financial test provisions shall remain in effect until the cabinet has terminated the license.
(d) If a trust is established for decommissioning costs, the trustee and trust shall be acceptable to the cabinet. An acceptable trustee shall include an appropriate state or federal government agency or an entity that has the authority to act as a trustee and whose trust operations are regulated and examined by a federal or state agency.
Section 8. Criteria Relating to Use of Financial Tests and Self-guarantees for Providing Reasonable Assurance of Funds for Decommissioning.
(1) An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based upon:
(a) Furnishing its own guarantee of funds available for decommissioning costs pursuant to subsection (3) of this section; and
(b) A demonstration that the company passes the financial test established in subsection (2) of this section.
(2) Financial test.
(a) To pass the financial test, a company shall meet the following criteria:
-
Tangible net worth shall be at least ten (10) times the total current decommissioning cost estimate for the total of facilities or parts of the facilities or the current amount required if certification is used.
-
Assets located in the United States shall amount to at least ninety (90) percent of total assets or at least ten (10) times the total current decommissioning cost estimate for the total of facilities or parts of the facilities or the current amount required if certification is used.
-
A current rating for its most recent bond issuance of AAA, AA, or A as issued by Standard and Poor's, or Aaa, Aa, or A as issued by Moody's.
(b) To pass the financial test, a company shall meet the following additional requirements:
-
The company shall have at least one (1) class of equity securities registered pursuant to 15 U.S.C. 2B.
-
The company's independent certified public accountant shall compare the data used by the company in the financial test, which shall be derived from the independently audited, year-end financial statements for the latest fiscal year, with the amounts in the financial statement. The licensee shall inform the cabinet, within ninety (90) days, of matters coming to the attention of the auditor that cause the auditor to believe that:
a. The data specified in the financial test requires adjustment; and
b. The company no longer passes the test.
- After the initial financial test, the company shall repeat passage of the test within ninety (90) days after the close of each succeeding fiscal year.
(c) If the licensee no longer meets the requirements of paragraph (a) of this subsection, the licensee shall notify the cabinet immediately of the licensee's intent to establish alternate financial assurance within 120 days of the notice.
(3) Company self-guarantee. The terms of a self-guarantee that an applicant or licensee furnishes shall provide that:
(a) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the cabinet. Cancellation shall not occur during the 120 days beginning on the date of receipt of the notice of cancellation by the cabinet, as evidenced by the return receipt.
(b) The licensee shall provide alternative financial assurance as specified in 902 KAR Chapter 100 within ninety (90) days following receipt by the cabinet of a notice of cancellation of the guarantee.
(c) The guarantee and financial test provisions shall remain in effect until the cabinet has terminated the license or until another financial assurance method acceptable to the cabinet has been put into effect by the licensee.
(d) The licensee shall promptly forward to the cabinet and the licensee's independent auditor the reports covering the latest fiscal year filed by the licensee with the Securities and Exchange Commission pursuant to the requirements of 15 U.S.C. 78m.
(e) If the licensee's most recent bond issuance ceases to be rated "A" or above by either Standard and Poor's or Moody's, the licensee shall notify to the cabinet, in writing, within twenty (20) days after publication of the change by the rating service. If the licensee's most recent bond issuance ceases to be rated "A" or above by both Standard and Poor's and Moody's, the licensee shall no longer meet the requirements of subsection (2)(a) of this section.
(f) An applicant or licensee shall provide to the cabinet a written commitment by a corporate officer stating that the licensee shall fund and carry out the required decommissioning activities or, upon issuance of an order by the cabinet, the licensee shall set up and fund a trust in the amount of the current cost estimates for decommissioning.
Section 9. Criteria Relating To Use of Financial Tests and Self-guarantee for Providing Reasonable Assurance of Funds for Decommissioning by Commercial Companies that Have No Outstanding Rated Bonds.
(1) An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based upon:
(a) Furnishing its own guarantee of the availability of funds for decommissioning costs pursuant to subsection (3) of this section; and
(b) A demonstration that the company passes the financial test established in subsection (2) of this section.
(2) Financial test.
(a) To pass the financial test a company shall meet the following criteria:
-
Tangible net worth greater than $10,000,000, or at least ten (10) times the total current decommissioning cost estimate, or the current amount required if certification is used, whichever is greater, for decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.
-
Assets located in the United States amounting to at least ninety (90) percent of total assets or at least ten (10) times the total current decommissioning cost estimate, or the current amount required if certification is used for decommissioning activities for which the company is responsible as self-guaranteeing licensee and as parent-guarantor.
-
A ratio of cash flow divided by total liabilities greater than 0.15 and a ratio of total liabilities divided by net worth less than one and five-tenths (1.5).
(b) A company shall also meet the following financial requirements:
- The company's independent certified public accountant shall compare the data used by the company in the financial test, which shall be derived from the independently audited year-end financial statement based on United States generally accepted accounting practices, for the latest fiscal year with the amounts in the financial statement. The licensee shall inform the cabinet within ninety (90) days of matters that cause the auditor to believe that:
a. The data specified in the financial test requires adjustment; and
b. The company no longer passes the test.
-
After the initial financial test, the company shall repeat passage of the test within ninety (90) days after the close of each succeeding fiscal year.
a. If the licensee no longer meets the requirements of paragraph (a) of this subsection, the licensee shall notify the cabinet of intent to establish alternative financial assurance.
b. The notice shall be sent by certified mail, return receipt requested, within ninety (90) days after the end of the fiscal year for which the year-end financial data show that the licensee no longer meets the financial test requirements.
c. The licensee shall provide alternative financial assurance within 120 days after the end of the fiscal year.
(3) Company self-guarantee. The terms of a self-guarantee which an applicant or licensee furnishes shall provide that:
(a) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the cabinet. Cancellation shall not occur until an alternative financial assurance mechanism is in place;
(b) The licensee shall provide alternative financial assurance, as specified in this administrative regulation, within ninety (90) days following receipt by the cabinet of a notice of cancellation of the guarantee;
(c) The guarantee and financial test provisions shall remain in effect until the cabinet has terminated the license or until another financial assurance method acceptable to the cabinet has been put into effect by the licensee; and
(d) An applicant or licensee shall provide to the cabinet a written commitment by a corporate officer stating that the licensee shall fund and carry out the required decommissioning activities or, upon issuance of an order by the cabinet, the licensee shall set up and fund a trust in the amount of the current cost estimates for decommissioning.
Section 10. Criteria Relating to Use of Financial Tests and Self-guarantee for Providing Reasonable Assurance of Funds for Decommissioning by Nonprofit Colleges, Universities, and Hospitals.
(1) An applicant or licensee may provide reasonable assurance of the availability of funds for decommissioning based upon:
(a) Furnishing its own guarantee of the availability of funds for decommissioning costs; and
(b) A demonstration that the applicant or licensee passes the financial test established in subsection (2) of this section.
(2) Financial test.
(a) A college or university shall meet either of the following criteria:
-
For an applicant or licensee that issues bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poor's, or Aaa, Aa, or A as issued by Moody's; or
-
For an applicant or licensee that does not issue bonds, unrestricted endowment consisting of assets located in the United States of at least $50,000,000, or at least thirty (30) times the total current decommissioning cost estimate, or the current amount required if certification is used, whichever is greater, for decommissioning activities for which the college or university is responsible as a self-guaranteeing licensee.
(b) A hospital shall meet the following criteria:
-
For an applicant or licensee that issues bonds, a current rating for its most recent uninsured, uncollateralized, and unencumbered bond issuance of AAA, AA, or A as issued by Standard and Poor's, or Aaa, Aa, or A as issued by Moody's; or
-
For an applicant or licensee that does not issue bonds:
a. The result of total revenues minus total expenditures divided by total revenues shall be equal to or greater than 0.04;
b. Long term debt divided by net fixed assets shall be less than or equal to 0.67;
c. The sum of current assets plus depreciation funds, divided by current liabilities, shall be greater than or equal to 2.55; and
d. Operating revenues shall be at least 100 times the total current decommissioning cost estimate, or the current amount required if certification is used, for decommissioning activities for which the hospital is responsible as a self-guaranteeing license.
(c) A licensee shall meet the requirements established in subparagraphs 1. through 3. of this paragraph.
- A licensee's independent certified public accountant shall compare the data used by the licensee in the financial test, which shall be derived from the independently audited year-end financial statements, based on United States generally accepted accounting practices, for the latest fiscal year, with the amounts in the financial statement. The licensee shall inform the cabinet, within ninety (90) days, of matters coming to the attention of the auditor that cause the auditor to believe that:
a. The data specified in the financial test requires adjustment; and
b. The licensee no longer passes the test.
-
After the initial financial test, a licensee shall repeat passage of the test within ninety (90) days after the close of each succeeding fiscal year.
-
If a licensee no longer meets the requirements of subsection (1) of this section, the licensee shall notify the cabinet of its intent to establish alternative financial assurance. The notice shall be sent by certified mail, return receipt requested, within ninety (90) days after the end of the fiscal year for which the year-end financial data show that the licensee no longer meets the financial test requirements. The licensee shall provide alternate financial assurance within 120 days after the end of the fiscal year.
(3) Self-guarantee. The terms of a self-guarantee that an applicant or licensee furnishes shall provide that:
(a) The guarantee shall remain in force unless the licensee sends notice of cancellation by certified mail, return receipt requested, to the cabinet. Cancellation shall not occur unless an alternative financial assurance mechanism is in place.
(b) The licensee shall provide alternative financial assurance, as specified in this administrative regulation, within ninety (90) days following receipt by the cabinet of a notice of cancellation of the guarantee.
(c) The guarantee and financial test provisions shall remain in effect until the cabinet has terminated the license or until another financial assurance method acceptable to the cabinet has been put into effect by the licensee.
(d) An applicant or licensee shall provide to the cabinet a written commitment by a corporate officer or officer of the institution stating that the licensee shall:
-
Fund and carry out the required decommissioning activities; or
-
Upon issuance of an order by the cabinet, set up and fund a trust in the amount of current cost estimates for decommissioning.
(e) If the licensee's most recent bond issuance ceases to be rated "A" or above by either Standard and Poor's or Moody's, the licensee shall notify the cabinet, in writing, within twenty (20) days after publication of the change by the rating service.
Section 11. Financial Assurance and Recordkeeping for Decommissioning for Radioactive Material.
(1)
(a) An applicant for a specific license authorizing the possession and use of unsealed radioactive material of half-life greater than 120 days and in quantities exceeding 105 times the applicable quantities in Section 16 of this administrative regulation shall submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation.
(b) A decommissioning funding plan shall also be submitted if a combination of isotopes is involved, and if R divided by 105 is greater than one (1) (known as the "unity rule"), where R is defined as the sum of the ratios of the quantity of an isotope to the applicable value in Section 16 of this administrative regulation.
(c) A holder of, or applicant for, a specific license authorizing the possession and use of sealed sources or plated foils of half-life greater than 120 days and in quantities exceeding 1012 times the applicable quantities in Section 16, or if a combination of isotopes is involved if R, divided by 1012 is greater than one (1) (known as the "unity rule"), where R is defined as the sum or the ratios of the quantity of an isotope to the applicable value in Section 16 of this administrative regulation, shall submit a decommissioning funding plan as described in Section 15(1) of this administrative regulation.
(2) An applicant for a specific license authorizing possession and use of radioactive material of half-life greater than 120 days and in quantities specified in subsection (4) of this section shall:
(a) Submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation; or
(b) Submit a certification that financial assurance for decommissioning has been provided in the amount established by subsection (4) of this section, using one (1) of the methods established in Section 15 of this administrative regulation. For an applicant, the certification may state that the appropriate assurance shall be obtained after the application has been approved and the license issued, but before the receipt of licensed material. If an applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation shall be submitted to the cabinet before receipt of licensed material. If an applicant does not defer execution of the financial instrument, the applicant shall submit to the cabinet, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation.
(3)
(a) A holder of a specific license of a type described in subsection (1) or (2) of this section, shall provide financial assurance for decommissioning in accordance with the criteria established in this section.
(b) A holder of a specific license of a type described in subsection (1) of this section shall submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000 in accordance with the criteria established in this section. If a licensee submits a certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in an application for license renewal.
(c) A holder of a specific license of a type described in subsection (2) of this section shall submit a decommissioning funding plan as described in Section 15 of this administrative regulation, or a certification of financial assurance for decommissioning in accordance with the criteria established in this section.
(d) A waste collector or waste processor, as defined in 902 KAR 100:010, shall provide financial assurance in an amount based on a decommissioning funding plan as established in Section 15 of this administrative regulation. The decommissioning funding plan shall include the cost of disposal of the maximum amount (curies) of radioactive material permitted by the license, and the cost of disposal of the maximum quantity, by volume, of radioactive material that could be present at the licensee's facility at any time, in addition to the cost to remediate the licensee's site to meet the license termination criteria of 902 KAR 100:019. The decommissioning funding plan shall be submitted by December 3, 2006.
(4) The following is a list of required amounts of financial assurance for decommissioning, listed by quantity of radioactive material:
(a) Greater than 104 but less than or equal to 105 times the applicable quantities established in Section 16 of this administrative regulation, in unsealed form. For a combination of isotopes, if R, as defined in subsection (1) of this section, divided by 104 is greater than one (1) but R divided by 105 is less than or equal to one (1), the amount shall be $1,125,000.
(b) Greater than 103 but less than or equal to 104 times the applicable quantities established in Section 16 of this administrative regulation, in unsealed form. For a combination of isotopes, if R, as defined in subsection (1) of this section, divided by 103 is greater than one (1) but R divided by 104 is less than or equal to one (1), the amount shall be $225,000.
(c) Greater than 1010 but less than or equal to 1012 times the applicable quantities established in Section 16 of this administrative regulation, in sealed sources or plated foils. For a combination of isotopes, if R, as defined in subsection (1) of this section, divided by 1010 is greater than one (1), the amount shall be $113,000.
(d)
-
A licensee required to submit the $1,125,000 amount shall do so by June 30, 2010.
-
A licensee required to submit the $113,000 or $225,000 amount shall do so by June 30, 2010.
-
A licensee having possession limits exceeding the upper bounds of this list shall base financial assurance on a decommissioning funding plan.
Section 12. Financial Assurance and Recordkeeping for Decommissioning for Source Material. Criteria for providing financial assurance for decommissioning, except for licenses authorizing the receipt, possession, and use of source material for uranium or thorium milling, or radioactive material at sites formerly associated with such milling, shall be as established in subsections (1) and (2) of this section.
(1) An applicant for a specific license authorizing the possession and use of more than 100 millicuries (mCi) of source material in a readily dispersible form shall submit a decommissioning funding plan as described in Section 15(1) of this administrative regulation.
(2) An applicant for a specific license authorizing possession and use of quantities of source material greater than ten (10) millicuries (mCi) but less than or equal to 100 millicuries (mCi) in a readily dispersible form shall submit:
(a) A decommissioning funding plan as established in Section 15(1) of this administrative regulation; or
(b) A certification that financial assurance for decommissioning has been provided in the amount of $225,000 using one (1) of the methods described in Section 15 of this administrative regulation.
-
The certification may state that the appropriate assurance shall be obtained after the application has been approved and the license issued, but before the receipt of licensed material.
-
If an applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation shall be submitted to the cabinet prior to receipt of licensed material.
-
If an applicant does not defer execution of the financial instrument, the applicant shall submit to the cabinet, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation.
(c)
-
A holder of a specific license covered by subsection (1) of this section or by this subsection, shall provide financial assurance for decommissioning in accordance with the criteria established in this section.
-
A holder of a specific license of a type described in subsection (1) of this section shall submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation, or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000, in accordance with the criteria in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in an application for license renewal.
-
A holder of a specific license of a type established in this subsection shall submit a decommissioning funding plan, as described in Section 15(1) of this administrative regulation, or a certification of financial assurance for decommissioning in accordance with the criteria established in this section.
Section 13. Financial Assurance and Recordkeeping for Decommissioning for Special Nuclear Material.
(1)
(a) An applicant for a specific license of the type authorizing the possession and use of unsealed nuclear material in quantities exceeding 105 times the applicable quantity established in Section 16 of this administrative regulation shall submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation.
(b) A decommissioning funding plan shall be submitted if a combination of isotopes is involved, and if R divided by 105 is greater than one (1) (known as the "unity rule"), where R is the sum of the ratios of the quantity of each isotope to the applicable value in Section 16 of this administrative regulation.
(2) An applicant for a specific license authorizing possession and use of unsealed special nuclear material in quantities specified in subsection (4) of this section, shall submit:
(a) A decommissioning funding plan as described in Section 15(1) of this administrative regulation; or
(b) A certification that financial assurance for decommissioning has been provided in an amount established in subsection (4) of this section, using one (1) of the methods established in Section 15 of this administrative regulation.
-
The certification may state that the appropriate assurance shall be obtained after the application has been approved and the license issued, but before the receipt of licensed material.
-
If an applicant defers execution of the financial instrument until after the license has been issued, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation shall be submitted to the cabinet before receipt of licensed material.
-
If an applicant does not defer execution of the financial instrument, the applicant shall submit to the cabinet, as part of the certification, a signed original of the financial instrument obtained to satisfy the requirements of Section 15 of this administrative regulation.
(3)
(a) A holder of a specific license that is of a type established in subsection (1) of this section, shall provide financial assurance for decommissioning in accordance with the criteria established in this section.
(b) A holder of a specific license of a type established in subsection (1) of this section shall submit a decommissioning funding plan as established in Section 15(1) of this administrative regulation, or a certification of financial assurance for decommissioning in an amount at least equal to $1,125,000, in accordance with the criteria established in this section. If the licensee submits the certification of financial assurance rather than a decommissioning funding plan, the licensee shall include a decommissioning funding plan in an application for license renewal.
(c) Each holder of a specific license of a type established in subsection (1) of this section shall submit:
-
A decommissioning funding plan, established in Section 15(1) of this administrative regulation; or
-
A certification of financial assurance for decommissioning, in accordance with the criteria established in this section.
(4) Required amounts of financial assurance for decommissioning, listed by quantity of material:
(a) Greater than 104 but less than or equal to 105 times the applicable quantities established in Section 16 of this administrative regulation. For a combination of isotopes, if R, as defined in subsection (1) of this section, divided by 104 is greater than one (1) but R divided by 105 is less than or equal to one (1), the amount shall be $1,125,000.
(b) Greater than 103 but less than or equal to 104 times the applicable quantities established in Section 16 of this administrative regulation. For a combination of isotopes, if R, as defined in subsection (1) of this section, divided by 103 is greater than one (1) but R divided by 104 is less than or equal to one (1), the amount shall be $225,000.
(c) A licensee having possession limits exceeding the upper bounds of this section shall base financial assurance on a decommissioning funding plan.
Section 14. Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas.
(1) Within sixty (60) days of the occurrence one (1) of the following events, a licensee shall notify the cabinet in writing and shall either begin decommissioning the licensee's site, separate building, or outdoor area containing residual radioactivity, so that the building or outdoor area is suitable for release in accordance with cabinet requirements established in this administrative regulation, or shall submit within twelve (12) months of notification a decommissioning plan, if required by subsection (4)(a) of this section, and shall begin decommissioning upon approval of that plan if:
(a) The license has expired pursuant to 902 KAR 100:040, Section 7;
(b) The licensee has decided to permanently cease principal activities, as established in this section, at the entire site, in a separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is unsuitable for release in accordance with cabinet requirements established in this administrative regulation;
(c) Principal activities under the license have not been conducted for a period of twenty-four (24) months; or
(d) Principal activities have not been conducted for a period of twenty-four (24) months in a separate building or outdoor area that contains residual radioactivity, so that the building or outdoor area is unsuitable for release in accordance with cabinet requirements.
(2) Coincident with the notification required by subsection (1) of this section, the licensee shall maintain in effect all decommissioning financial assurances established by the licensee pursuant to Sections 11, 12, and 13 of this administrative regulation in conjunction with a license issuance or renewal or as required by this section. The amount of the financial assurance shall be increased or decreased, as appropriate, to cover the detailed cost estimate for decommissioning established pursuant to subsection (4)(d)5 of this section.
(a) A licensee who has not provided financial assurance to cover the detailed cost estimate submitted with the decommissioning plan shall do so within one year (1) after the effective date of this administrative regulation.
(b) Following approval of the decommissioning plan, and with cabinet approval, a licensee may reduce the amount of the financial assurance as decommissioning proceeds and radiological contamination is reduced at the site.
(3)
(a) The cabinet may grant a request to extend the time periods established in this section if the cabinet determines that an extension is not detrimental to public health or safety and is in the public interest.
(b) The request shall be submitted at least thirty (30) days before the notification required by subsection (1) of this section.
(c) The schedule for decommissioning established in subsection (1) of this section shall not commence until the cabinet has made a determination on the request.
(4)
(a) A decommissioning plan shall be submitted if required by a license condition or if the procedures and activities necessary to carry out decommissioning of the site, a separate building, or outdoor area have not been approved by the cabinet previously, and the decommissioning procedures may increase potential risk to the health or safety of workers or to the public, as in:
-
Procedures involving techniques not applied routinely during cleanup or maintenance operations;
-
Workers entering areas not normally occupied where surface contamination and radiation levels are significantly higher than routinely encountered during operation;
-
Procedures potentially resulting in significantly greater airborne concentrations of radioactive materials than are present during operation; or
-
Procedures potentially resulting in significantly greater releases of radioactive material to the environment than those associated with operation.
(b) The cabinet may approve an alternate schedule for submittal of a decommissioning plan required pursuant to subsection (1) of this section if the cabinet determines that the alternative schedule is necessary to the effective conduct of decommissioning operations and presents no undue risk from radiation to public health or safety, and is in the public interest.
(c) A procedure with a potential health or safety impact, including a procedure listed in paragraph (a) of this subsection, shall not be carried out prior to approval of the decommissioning plan.
(d) A proposed decommissioning plan for a site, separate building, or outdoor area shall include:
-
A description of the conditions of the site, separate building, or outdoor area sufficient to evaluate the acceptability of the plan;
-
A description of planned decommissioning activities;
-
A description of methods used to ensure protection of workers and the environment against radiation hazards during decommissioning;
-
A description of the planned final radiation survey;
-
An updated detailed cost estimate for decommissioning, comparison of that estimate with present funds set aside for decommissioning, and a plan for assuring the availability of adequate funds for completion of decommissioning; and
-
For decommissioning plans calling for completion of decommissioning later than twenty-four (24) months after plan approval, a justification for the delay based on the criteria in subsection (6) of this section.
(e) The proposed decommissioning plan shall be approved by the cabinet if the information demonstrates completion as soon as practicable and adequate protection for the health and safety of workers and the public.
(5)
(a) A licensee shall complete decommissioning of the site, separate building, or outdoor area as soon as practicable, but within twenty-four (24) months following the initiation of decommissioning, except as provided in subsection (6) of this section.
(b) If decommissioning involves the entire site, the licensee shall request license termination as soon as practicable, but within twenty-four (24) months following the initiation of decommissioning, except as provided in subsection (6) of this section.
(6) The cabinet shall approve a request for an alternative schedule for completion of decommissioning of the site, separate building, or outdoor area, and license termination if appropriate, if the cabinet determines that the alternative is warranted by consideration of:
(a) If it is technically feasible to complete decommissioning within the allotted twenty-four (24) month period;
(b) If sufficient waste disposal capacity is available to allow completion of decommissioning within the allotted twenty-four (24) month period;
(c) If a significant volume reduction in wastes requiring disposal can be achieved by allowing short-lived radionuclides to decay;
(d) If a significant reduction in radiation exposure to workers can be achieved by allowing short-lived radionuclides to decay; and
(e) Other site-specific factors, such as the regulatory requirements of other government agencies, lawsuits, groundwater treatment activities, monitored natural groundwater restoration, actions that may result in more environmental harm than deferred cleanup, and other factors beyond the control of the licensee.
(7) As the final step in decommissioning, the licensee shall:
(a) Certify the disposition of all licensed material, including accumulated wastes, by submitting a completed cabinet Form RPS-10, incorporated by reference in 902 KAR 100:040, or equivalent information; and
(b) Conduct a radiation survey of the premises where the licensed activities were carried out and submit a report of the results of this survey, unless the licensee demonstrates in some other manner that the premises are suitable for release in accordance with the criteria for decommissioning established in Sections 1 through 6 of this administrative regulation. The licensee shall, as appropriate:
- Report levels:
a. Of gamma radiation in units of microroentgen (µR) (millisieverts, mSv) per hour at one (1) meter from surfaces;
b. Of radioactivity, including alpha and beta, in units of disintegrations per minute, microcuries (megabecquerels) per 100 square centimeters removable and fixed radiation for surfaces;
c. Microcuries (megabecquerels) per milliliter for water; and
d. Picocuries (Becquerels) per gram for solids such as soils or concrete; and
- Specify the survey instruments used and certify that each instrument is properly calibrated and tested.
(8) Specific licenses, including expired licenses, shall be terminated by written notice to the licensee if the cabinet determines that:
(a)
-
Radioactive material has been properly disposed of;
-
Reasonable effort has been made to eliminate residual radioactive contamination, if present; and
a. A radiation survey has been performed that demonstrates that the premises are suitable for release in accordance with the criteria for decommissioning established in Sections 1 through 6 of this administrative regulation; or
b. Other information submitted by the licensee is sufficient to demonstrate that the premises are suitable for release in accordance with the criteria for decommissioning established in Sections 1 through 6 of this administrative regulation; or
(b) Records required by 902 KAR 100:040, Section 7(3)(e), and Section 15(3) of this administrative regulation have been received.
Section 15. Financial Assurance Methods.
(1) A decommissioning funding plan shall contain a cost estimate for decommissioning and a description of the method of assuring funds for decommissioning from subsection (2) of this section, including means for adjusting cost estimates and associated funding levels periodically over the life of the facility. Cost estimates shall be adjusted at intervals not to exceed three (3) years. The decommissioning funding plan shall also contain:
(a) A certification by the licensee that financial assurance for decommissioning has been provided in the amount of the cost estimate for decommissioning; and
(b) A signed original of the financial instrument obtained to satisfy the requirements of subsection (2) of this section.
(2) Financial assurance for decommissioning shall be provided by one (1) or more of the following methods:
(a) A prepayment deposited prior to the start of operation into an account segregated from licensee assets and outside the licensee's administrative control of cash or liquid assets so that the amount of funds may be sufficient to pay decommissioning costs. Prepayment shall be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.
(b) A surety method, insurance, or other guarantee method.
-
These methods guarantee that decommissioning costs shall be paid.
-
A surety method shall be in the form of a surety bond, letter of credit, or line of credit.
-
A parent company guarantee of funds for decommissioning costs based on a financial test may be used if the guarantee and test are as contained in Section 7 of this administrative regulation.
-
A parent company guarantee shall not be used in combination with another financial method to satisfy the requirements of this section.
-
For commercial corporations that issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs based on a financial test may be used. If used, the guarantee and test shall be in accordance with Section 8 of this administrative regulation.
-
For commercial companies that do not issue bonds, a guarantee of funds by the applicant or licensee for decommissioning costs may be used if the guarantee and test are in accordance with Section 9 of this administrative regulation.
-
For nonprofit entities, such as colleges, universities, and nonprofit hospitals, a guarantee of funds by the applicant or licensee may be used if the guarantee and test are in accordance with Section 10 of this administrative regulation.
-
A guarantee by the applicant or licensee shall not be used in combination with another financial method used to satisfy the requirements of this section, or in a situation in which the applicant or licensee has a parent company holding majority control of the voting stock of the company.
-
A surety method, or insurance used to provide financial assurance for decommissioning, shall contain the following conditions:
a. The surety method or insurance shall be open-ended or, if written for a specified term, shall be renewed automatically unless the issuer notifies the cabinet, the beneficiary, and the licensee at least ninety (90) days prior to the renewal date of its intention not to renew. The surety method or insurance shall provide that the full face amount be paid to the beneficiary automatically, prior to expiration, without proof of forfeiture, if the licensee fails to provide a replacement acceptable to the cabinet within thirty (30) days after receipt of notification of cancellation.
b. The surety method or insurance shall be payable to a trust established for decommissioning costs. The trustee and trust shall be acceptable to the cabinet. An acceptable trustee shall include an appropriate state or federal government agency or an entity that has the authority to act as a trustee, and whose trust operations are regulated and examined by a federal or state agency.
c. The surety method or insurance shall remain in effect until the cabinet has terminated the license.
(c) An external sinking fund in which deposits are made at least annually, coupled with a surety method or insurance, the value of which may decrease by the amount being accumulated in the sinking fund.
-
An external sinking fund shall be a fund established and maintained by setting aside funds periodically in an account segregated from licensee assets and outside the licensee's administrative control, in which the total amount of funds may be sufficient to pay decommissioning costs at the time termination of operation is expected.
-
An external sinking fund shall be in the form of a trust, escrow account, government fund, certificate of deposit, or deposit of government securities.
-
The surety or insurance provisions shall be as stated in subsection (2)(b) of this section.
(d) For a federal, state, or local government licensee, a statement of intent containing a cost estimate for decommissioning or an amount based on the tables in Sections 11, 12, and 13 of this administrative regulation and indicating that funds for decommissioning shall be obtained as necessary.
(e) If a governmental entity is assuming custody and ownership of a site, an arrangement that is deemed acceptable by the governmental entity.
(3)
(a) Each person licensed pursuant to 902 KAR 100:040 shall keep records of information pertinent to the decommissioning of a facility in an identified location until the site is released for unrestricted use.
(b) Before licensed activities shall be transferred or assigned in accordance with 902 KAR 100:040, Section 6, a licensee shall transfer the records established in this subsection to the new licensee.
(c) The new licensee shall be responsible for maintaining these records until the license is terminated.
(d) If records pertinent to the decommissioning of a facility are kept for other purposes, reference to the records and their locations shall be used.
(e) Information the cabinet considers pertinent to decommissioning shall consist of:
- Records of spills or other unusual occurrences involving the spread of contamination in and around the facility, equipment, or site.
a. The records may be limited to instances in which contamination remains after a cleanup procedure or if there is reasonable likelihood that contaminants may have spread to inaccessible areas as in the case of possible seepage into porous materials such as concrete.
b. The records shall include all known information on identification of involved nuclides, quantities, forms, and concentrations.
- As-built drawings and modifications of structures and equipment in restricted areas where radioactive materials are used, or stored, and of locations of possible inaccessible contamination, such as buried pipes, which may be subject to contamination.
a. If required drawings are referenced, each relevant document need not be indexed individually.
b. If drawings are not available, the licensee shall substitute appropriate records of available information concerning these areas and locations.
- A list contained in a single document and updated every two (2) years, except for areas containing only sealed sources, if the sources have not leaked or no contamination remains after a leak, or radioactive materials having half-lives of less than sixty-five (65) days, or depleted uranium used only for shielding or as penetrators in unused munitions:
a. Areas designated and formerly designated restricted areas as defined in 902 KAR 100:010, Section 1. For requirements prior to January 26, 1994, see 902 KAR 100:010, Section 1 contained in the 1990 edition of 902 KAR Chapter 100;
b. Areas outside of restricted areas that require documentation under subsection (3) of this section;
c. Areas outside of restricted areas where current and previous wastes have been buried as documented under 902 KAR 100:021, Section 11; and
d. Areas outside of restricted areas that contain material so that, if the license expired, the licensee shall be required to either decontaminate the area to meet the criteria for decommissioning in this administrative regulation or to apply for approval for disposal under 902 KAR 100:021, Section 2.
- Records of the cost estimate performed for the decommissioning funding plan or of the amount certified for decommissioning, and records of the funding method used for assuring funds if either a funding plan or certification is used.
Section 16. Quantities1 of Licensed Material.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 20.1401-20.1406, 30, Appendices A-E, 30.35, 30.36, 40.36, 70.25, 15 U.S.C. 2B, 78m
- STATUTORY AUTHORITY: KRS 194A.050, 211.090(3), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health and Family Services to regulate the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes requirements for decommissioning and financial assurance of radioactive material licensees.
- History: 20 Ky.R. 2511; eff. 4-11-1994; Am. 26 Ky.R. 2444; 27 Ky.R. 801; eff. 9-11-2000; 38 Ky.R. 376; 952; eff. 11-16-2011; 41 Ky.R. 897; 1592; eff. 2-5-2015; Cert. eff. 11-12-2021.
902 KAR 100:045 Exemptions {#sec-902-kar-100-045 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:045}
Section 1. Exemption of Source Material. The exemptions in this section do not authorize manufacture of the products described. A person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, or transfers:
(1) Source material in a chemical mixture, compound, solution, or alloy in which the source material is by weight less than one-twentieth of one (1) percent (0.05 percent) of the mixture, compound, solution, or alloy;
(2) Unrefined and unprocessed ore containing source material; except that, as authorized in a specific license, the person shall not refine or possess the ore.
(3)
(a) Any quantity of thorium contained in:
-
An incandescent gas mantle;
-
A vacuum tube;
-
A welding rod;
-
An electric lamp for illuminating purposes, if each lamp contains less than fifty (50) milligrams of thorium;
-
A germicidal lamp, sun lamp, or lamp for outdoor or industrial lighting, if each lamp contains less than two (2) grams of thorium;
-
A rare earth metal, compound, mixture, or product containing not more than 0.25 percent by weight thorium, uranium, or a combination of these; or
-
Personal neutron dosimeters, if each dosimeter contains less than fifty (50) milligrams of thorium.
(b) Source material contained in the following products:
-
Glazed ceramic tableware, if the glaze contains less than twenty (20) percent by weight source material;
-
Glassware containing not more than ten (10) percent 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;
-
Glass enamel or glass enamel frit containing not more than ten (10) percent by weight source material imported or ordered for importation into the United States, or initially distributed by manufacturers in the United States, before July 25, 1983;
-
Piezoelectric ceramic containing not more than two (2) percent by weight source material.
(c) Photographic film, negatives, and prints containing uranium or thorium.
(d) A finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, if the thorium content of the alloy does not exceed four (4) percent by weight. The exemption contained in this paragraph shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of the product or part.
(e) Uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of the counterweights, if:
-
The counterweights are manufactured in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission authorizing distribution by the licensee pursuant to 10 CFR Part 40;
-
Each counterweight has been impressed with following legend clearly legible through plating or other covering: "DEPLETED URANIUM;"
-
Each counterweight is labeled or marked, durably and legibly, with the manufacturer's identification, and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED;" and
-
The exemption contained in this subsection shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of the counterweights other than repair or restoration of a plating or other covering.
(f) Natural or depleted uranium metal used as shielding constituting part of a shipping container, if:
-
The shipping container is impressed, conspicuously and legibly, with the legend "CAUTION - RADIOACTIVE SHIELDING - URANIUM"; and
-
The uranium metal is encased in mild steel or equally fire resistant metal of minimum wall thickness of one-eighth inch (3.2mm).
(g) Thorium contained in finished optical lenses, if each lens contains less than thirty (30) percent by weight of thorium. The exemption contained in this subsection shall not be deemed to authorize:
-
The shaping, grinding, or polishing of lens or manufacturing processes other than the assembly of lens into optical systems and devices without any alteration of the lens; or
-
The receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.
(h) Uranium contained in detector heads for use in fire detection units, if each detector head contains not more than 0.005 microcurie of uranium.
(i) Thorium contained in a finished aircraft engine part containing nickel-thoria alloy, if:
-
The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and
-
The thorium content in the nickel-thoria alloy does not exceed four (4) percent by weight.
Section 2. Exemption of Radioactive Material Other than Source Material.
(1) Exempt concentrations. A person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of the amounts established in 902 KAR 100:085 except:
(a) This exemption shall not apply to the transfer of radioactive material contained in a food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to a human being; and
(b) A person shall not introduce radioactive material into a product or material knowing or having reason to believe that the product will be transferred to persons exempt under this subsection or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state, except in accordance with a license issued as authorized by 902 KAR Chapter 100.
(2) Certain items containing radioactive material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, a person is exempt from the requirements established in 902 KAR Chapter 100 if he receives, possesses, uses, transfers, owns, or acquires the following products:
(a) Timepieces or hand or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:
-
Twenty-five (25) millicuries of tritium per timepiece;
-
Five (5) millicuries of tritium per hand;
-
Fifteen (15) millicuries of tritium per dial including the bezel;
-
100 microcuries of promethium-147 per watch or 200 microcuries of promethium-147 per other timepiece;
-
Twenty (20) microcuries of promethium-147 per watch hand or forty (40) microcuries of promethium-147 per other timepiece hand; or
-
Sixty (60) microcuries of promethium-147 per watch dial or 120 microcuries of promethium-147 per other timepiece dial including the bezel;
-
The radiation dose rate from hands and dials containing promethium-147 shall not exceed, when measured through fifty (50) milligrams per square centimeter of absorber:
a. For wrist watches, one-tenth (0.1) millirad per hour at ten (10) centimeters from a surface;
b. For pocket watches, one-tenth (0.1) millirad per hour at one (1) centimeter from a surface;
c. For other timepiece, two-tenths (0.2) millirad per hour at ten (10) centimeters from a surface.
- One (1) microcurie of radium-226 per timepiece in timepieces acquired prior to January 3, 1986.
(b) A lock illuminator containing not more than fifteen (15) millicuries of tritium or not more than two (2) millicuries of promethium-147 installed in an automobile lock. The radiation dose rate from each lock illuminator containing promethium-147 shall not exceed one (1) millirad per hour at one (1) centimeter from a surface when measured through fifty (50) milligrams per square centimeter of absorber.
(c) A precision balance containing not more than one (1) millicurie of tritium per balance or not more than five-tenths (0.5) millicurie of tritium per balance part.
(d) An automobile shift quadrant containing not more than twenty-five (25) millicuries of tritium.
(e) A marine compass containing not more than 750 millicuries of tritium gas and other marine navigational instrument containing not more than 250 millicuries of tritium gas.
(f) A thermostat dial or pointer containing not more than twenty-five (25) millicuries of tritium per thermostat.
(g) An electron tube if it does not contain more than one (1) of the following specified quantities of radioactive material:
-
150 millicuries of tritium per microwave receiver protector tube or ten (10) millicuries of tritium per other electron tube;
-
One (1) microcurie of cobalt-60;
-
Five (5) microcuries of nickel-63;
-
Thirty (30) microcuries of krypton-85;
-
Five (5) microcuries of cesium-137;
-
Thirty (30) microcuries of promethium-147; and, that the radiation dose rate due to radioactive material contained in each electron tube does not exceed one (1) millirad per hour at one (1) centimeter from a surface when measured through seven (7) milligrams per square centimeter of absorber. For purposes of this subparagraph, "electron tubes" include spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, radiation detection tubes, and other completely sealed tubes that are designed to conduct or control electrical currents.
(h) An ionizing radiation measuring instrument containing, for purposes of internal calibration or standardization, one (1) or more sources of radioactive material, if:
-
Each source contains no more than one (1) exempt quantity established in 902 KAR 100:080;
-
Each instrument contains no more than ten (10) exempt quantities. For purposes of this requirement, an instrument's source(s) may contain either one (1) or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one (1) or more of the exempt quantities in 902 KAR 100:080, except that the sum of the fractions shall not exceed unity; and
-
For purposes of this paragraph, 0.05 microcuries of americium-241 is considered an exempt quantity under 902 KAR 100:080.
(i) A spark cap irradiator containing not more than one (1) microcurie of cobalt-60 per irradiator, for use in an electrically-ignited fuel oil burner having a firing rate of at least three (3) gallons per hour.
Section 3. Resins Containing Scandium-46 and Designed for Sand Consolidation in Oil Wells.
(1) A person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires synthetic plastic resins containing scandium-46, which are designed for sand consolidation in oil wells.
(2) A qualifying resin shall have been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the cabinet or an agreement state to the manufacturer of the resin, as authorized by licensing requirements equivalent to those in Section 32.16 and 32.17 of 10 CFR Part 32.
(3) The exemption established in subsection (1) of this section does not authorize the manufacture of resins containing scandium-46.
Section 4. Gas and Aerosol Detectors Containing Radioactive Material.
(1) A person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards if:
(a) Detectors containing by-product material have been manufactured, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission as authorized by Section 32.26 of 10 CFR, Part 32, authorizing the transfer of the detectors to persons who are exempt from regulatory requirements; or
(b) Detectors containing other than by-product, source, or special nuclear material have been manufactured or transferred in accordance with a specific license issued by the cabinet or an agreement state under requirements equivalent to those established in 902 KAR 100:058, authorizing the transfer of the detectors to persons who are exempt from regulatory requirements.
(2) The exemption established in subsection (1) of this section does not apply to persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material.
Section 5. Self-luminous Products Containing Tritium, Krypton-85, or Promethium-147.
(1) Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, a person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires tritium, krypton-85, or promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission as authorized by Section 32.22 of 10 CFR, Part 32, authorizing the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this subsection does not apply to tritium, krypton-85, or promethium-147, used in products for frivolous purposes or in toys or adornments.
(2) Radium-226. A person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, or owns articles containing less than one-tenth (0.1) microcurie of radium-226 which were acquired prior to January 3, 1986.
Section 6. Exempt Quantities.
(1) Except as provided in subsections (3) and (4) of this section, a person is exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity established in 902 KAR 100:080.
(2) A person who possesses radioactive material received or acquired under the general license formerly provided in RH-8, Section 3(a)(2) of the Kentucky State Board of Health "RH" Regulations, effective October, 1968, is exempt from the requirements for a license established in 902 KAR Chapter 100 if the person possesses, uses, transfers or owns the radioactive material. The exemption does not apply for radium-226.
(3) Subsections (1) and (2) of this section do not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into a product intended for commercial distribution.
(4) A person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities established in 902 KAR 100:080 knowing or having reason to believe that the quantities of radioactive material will be transferred to persons exempt under this subsection or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission as authorized by Section 32.18 of 10 CFR, Part 32, or by the cabinet, which states that the radioactive material may be transferred by the licensee to persons exempt under this paragraph or the equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 7. Radioactive Drug: Capsules Containing Carbon-14 Urea for "in vivo" Diagnostic Use for Humans.
(1) Except as provided in subsection (2) of this section, a person shall be exempt from the requirements for a license established in 902 KAR 100:040 and 902 KAR 100:073 if that person receives, possesses, uses, transfers, owns, or acquires capsules containing one (1) microcurie (37 kBq) carbon-14 urea each, allowing for nominal variation that may occur during the manufacturing process, for "in vivo" diagnostic use for humans.
(2) A person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license in accordance to 902 KAR 100:040.
(3) A person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license issued by the U.S. Nuclear Regulatory Commission in accordance to 10 CFR Part 32, Section 32.21.
(4) Nothing in this section shall relieve a person from complying with applicable federal and state requirements governing receipt, administration, and use of pharmaceutical substances or dangerous materials.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 30.15, 30.16, 30.19-30.21, 40.11, 40.13
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050, 211.090(3), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes exemptions from the requirements of 902 KAR Chapter 100 for certain uses of radioactive material and for specific devices containing radioactive material.
- History: 1 Ky.R. 396; eff. 2-5-1975; 12 Ky.R. 1020; eff. 1-3-1986; 13 Ky.R. 1766; eff. 5-14-1987; 18 Ky.R. 1510; eff. 1-10-1992; 26 Ky.R. 2392; 27 Ky.R. 967; eff. 10-16-2000; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:050 General licenses {#sec-902-kar-100-050 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:050}
Section 1. Definitions.
(1) "Agreement state" means a state that the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to this administrative regulation or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation establishes the requirements for licensees who manufacture or use radioactive material under a general license. Except as established in subsections (1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 31.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 31.4;
(b) 10 C.F.R. 31.22; or
(c) 10 C.F.R. 31. 23.
(2) Application for specific license. Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3)
(a) Reference to the NRC, Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch.
(b) In 10 C.F.R. 31.5(b)(1)(ii), 31.5(c)(3)(ii), 31.5(c)(8)(i), 31.6, 31.7(a), 31.10(a), 31.10(b)(1), and 31.12(c)(4), reference to "an agreement state", shall be deemed to be a reference to "the NRC, or an agreement state".
(c) In 10 C.F.R. 31.6, reference to "any non-agreement state" or "offshore waters" shall be deemed a reference to the "Commonwealth of Kentucky".
(4) Notifications and reports required by 10 C.F.R. Part 31 shall be directed to the manager, Radiation Health Branch at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 225-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 194A.005, 211.842-211.852, 211.990(4), 10 C.F.R. Part 31, 42 U.S.C. 2021
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary to promulgate, administrative regulations necessary to implement programs mandated by federal law, to qualify for the receipt of federal funds, and to cooperate with other state and federal agencies. KRS 211.844 authorizes the cabinet to provide by regulation for the registration and licensing of the possession or use of any source of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes the general licensing requirements for certain uses of radioactive material and specific devices containing radioactive material.
- History: 1 Ky.R. 397; eff. 2-5-1975; 12 Ky.R. 1023; eff. 1-3-1986; 16 Ky.R. 2546; eff. 6-27-1990; Crt eff. 8-16-2019; 50 Ky.R. 199, 1141; eff, 12-13-2023.
902 KAR 100:052 Specific domestic licenses of broad scope for byproduct material {#sec-902-kar-100-052 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:052}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) " Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement state.
Section 2. Applicability. This administrative regulation establishes requirements for specific licensees to possess, use, or transfer byproduct material for licenses of broad scope. Except as established in subsections
(1) through (3) of this section, the licensee shall comply with 10 C.F.R. Part 33. (1) The licensee shall not be subject to:
(a) 10 C.F.R. 33.8;
(b) 10 C.F.R. 33.21; or
(c) 10 C.F.R. 33.23.
(2) Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) The "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch" shall be used instead of federal references to the "Commission" and the "NRC.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. Part 33, 42 U.S.C. 2021
- STATUTORY AUTHORITY: KRS 194.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Health and Family Services is authorized by KRS 211.844(1) to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation prescribes requirements for the issuance of specific licenses of broad scope for byproduct material.
- History: 6 Ky.R. 219; eff. 12-5-1979; 12 Ky.R. 1033; eff. 1-3-1986; 18 Ky.R. 1513; eff. 1-10-1992; 45 Ky.R. 508, 1630; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:058 Specific licenses to manufacture, assemble, repair, or distribute products {#sec-902-kar-100-058 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:058}
Section 1. Definitions.
(1) "Agreement state" means a state that the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:185 and this administrative regulation;
(b) A specific licensed issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation establishes the requirements for licensees who manufacture or use radioactive material under a general license. Except as established in subsections (1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 32.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 32.1(c)(1);
(b) 10 C.F.R. 32.8;
(c) 10 C.F.R. 32.11;
(d) 10 C.F.R. 32.12;
(e) 10 C.F.R. 32.14;
(f) 10 C.F.R. 32.15;
(g) 10 C.F.R. 32.16;
(h) 10 C.F.R. 32.18;
(i) 10 C.F.R. 32.19;
(j) 10 C.F.R. 32.20;
(k) 10 C.F.R. 32.21;
(l) 10 C.F.R. 32.21a;
(m) 10 C.F.R. 32.22;
(n) 10 C.F.R. 32.23;
(o) 10 C.F.R. 32.25;
(p) 10 C.F.R. 32.26;
(q) 10 C.F.R. 32.27;
(r) 10 C.F.R. 32.28;
(s) 10 C.F.R. 32.29;
(t) 10 C.F.R. 32.30;
(u) 10 C.F.R. 32.31;
(v) 10 C.F.R. 32.32;
(w) 10 C.F.R. 32.301; or
(x) 10 C.F.R. 32.303.
(2)
(a) Reference to the NRC, Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch.
(b) Reference to "Commission" or "agreement state" shall be deemed to be a reference to "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", "Commission", or "agreement state".
(3) Reference to "NRC Form 313, Application for Material License" shall be deemed to be a reference to Form RPS-7, incorporated by reference in 902 KAR 100:040.
(4) Notifications and reports required by 10 C.F.R. Part 32 shall be directed to the manager, Radiation Health Branch at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 225-2587: Telephone, for hours except those established in paragraph (c) of this subsection..
History
- RELATES TO: KRS 194A.005, 211.842-211.852, 211.990(4), 10 C.F.R. Part 32, 42 U.S.C. 2021(b)
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050(1), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to implement programs mandated by federal law, to qualify for the receipt of federal funds, and to cooperate with other state and federal agencies. KRS 211.844 requires the cabinet to promulgate administrative regulations concerning the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes requirements for issuing specific licenses to persons who manufacture, assemble, repair, or distribute commodities, products, or devices, that contain radioactive material.
- History: 1 Ky.R. 396; eff. 2-5-1975; Am. 12 Ky.R. 1020; eff. 1-3-1986; 13 Ky.R. 1766; eff. 5-14-1987; 18 Ky.R. 1510; eff. 1-10-1992; 26 Ky.R. 2395; 27 Ky.R. 970; eff. 10-16-2000; 37 Ky.R. 1820; 2612; eff. 6-3-2011; 41 Ky.R. 907; 1601; eff. 2-5-2015; Cert. eff. 11-12-2021; 50 Ky.R. 205, 1147; eff. 12-13-2023.
902 KAR 100:065 Reciprocal recognition {#sec-902-kar-100-065 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:065}
Section 1. Definitions.
(1) "Agreement state" means a state that the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040, 902 KAR 100:185, and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 150 except as established in subsection (1) through (3) of this section.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 150.3 Definitions:
-
Agreement state; and
-
Foreign Obligations;
(b) 10 C.F.R. 150.4;
(c) 10 C.F.R. 150.5;
(d) 10 C.F.R. 150.7;
(e) 10 C.F.R. 150.10;
(f) 10 C.F.R. 150.14;
(g) 10 C.F.R. 150.15;
(h) 10 C.F.R. 150.15a;
(i) 10 C.F.R. 150.16;
(j) 10 C.F.R. 150.17;
(k) 10 C.F.R. 150.17a;
(l) 10 C.F.R. 150.19;
(m) 10 C.F.R. 150.21;
(n) 10 C.F.R. 150.30;
(o) 10 C.F.R. 150.31;
(p) 10 C.F.R. 150.32; and
(q) 10 C.F.R. 150.33.
(2)
(a) Reference to the NRC, Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch.
(b) As referenced in 10 C.F.R. 150.2, reference to the "Commission" or "Atomic Energy Commission" shall remain and shall not be deemed to reference the "cabinet".
(c) As referenced in 10 C.F.R. 150.20(a)(1)(i), (ii), (iii), (b), (b)(3), and (b)(4), reference to "non-agreement states", "areas of exclusive federal jurisdiction within agreement states", or "offshore waters" shall be deemed as reference to the Commonwealth of Kentucky.
(d) As referenced in 10 C.F.R. 150.20 reference to an "agreement state license", a "license issued by an agreement state", or a "license from an agreement state" shall be deemed to reference a "Nuclear Regulatory Commission license", a "license issued by the Nuclear Regulatory Commission", or a "license from the Nuclear Regulatory Commission".
(3) Notifications and reports required by 10 C.F.R. Part 150 shall be directed to the manager, Radiation Health Branch at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 225-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
Section 3. The out-of-state licensee requesting reciprocity shall pay an annual fee in accordance with 902 KAR 100:012.
History
- RELATES TO: KRS 194A.005, 211.842-211.852, 211.990(4), 10 C.F.R. Part 150, 42 U.S.C. 2021(b)
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050(1), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary to promulgate administrative regulations necessary to implement programs mandated by federal law, to qualify for the receipt of federal funds, and to cooperate with other state and federal agencies. KRS 211.844 requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation provides for the reciprocal recognition of radioactive material licenses issued by the United States Nuclear Regulatory Commission or another agreement state.
- History: 1 Ky.R. 403; eff. 2-5-1975; 3 Ky.R. 165; eff. 9-1-1976; 12 Ky.R. 1043; eff. 1-3-1986; 18 Ky.R. 1523; eff. 1-10-1992; 27 Ky.R. 1613; 2164; eff. 2-1-2001; Crt eff. 8-16-2019; 50 Ky.R. 212,1154; eff. 12-13-2023.
902 KAR 100:070 Packaging and transportation of radioactive material {#sec-902-kar-100-070 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:070}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Armed escort" is defined by 10 C.F.R. 73.2.
(3) "Cabinet" is defined by KRS 194A.005(1).
(4) "Highway route controlled quantity" is defined by 49 C.F.R. 173.403.
(5) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement state.
Section 2. Applicability. This administration regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 71 except as established in subsections (1) through (3) of this section.
(1) The licensee shall not be subject to the following:
(a) 10 C.F.R. 71.2;
(b) 10 C.F.R. 71.6;
(c) 10 C.F.R. 71.11;
(d) 10 C.F.R. 71.14(b);
(e) 10 C.F.R. 71.19;
(f) 10 C.F.R. 71.31;
(g) 10 C.F.R. 71.33;
(h) 10 C.F.R. 71.35;
(i) 10 C.F.R. 71.37;
(j) 10 C.F.R. 71.38;
(k) 10 C.F.R. 71.39;
(l) 10 C.F.R. 71.41;
(m) 10 C.F.R. 71.43;
(n) 10 C.F.R. 71.45;
(o) 10 C.F.R. 71.51;
(p) 10 C.F.R. 71.55;
(q) 10 C.F.R. 71.59;
(r) 10 C.F.R. 71.61;
(s) 10 C.F.R. 71.63;
(t) 10 C.F.R. 71.64;
(u) 10 C.F.R. 71.65;
(v) 10 C.F.R. 71.70;
(w) 10 C.F.R. 71.71;
(x) 10 C.F.R. 71.73;
(y) 10 C.F.R. 71.74;
(z) 10 C.F.R. 71.75;
(aa) 10 C.F.R. 71.77;
(bb) 10 C.F.R. 71.85 (a)-(c);
(cc) 10 C.F.R. 71.91(b);
(dd) 10 C.F.R. 71.101(c)(2), (d) and (e); or
(ee) 10 C.F.R. 71.107-125.
(2) Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) Reference to the "Commission", "NRC", or an agreement state shall be deemed to be a reference to the "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", the NRC, or an agreement state except as established in the following:
(a) 10 C.F.R. 71.17; and
(b) 10 C.F.R. 71.88.
(4) Reference to the Commission, NRC, Nuclear Regulatory Commission, United States Nuclear Regulatory Commission, or Administrator of the appropriate Regional Office in 10 C.F.R. Part 71 shall be deemed to be reference to the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch, except when used in the following:
(a) 10 C.F.R 71.5(b);
(b) 10 C.F.R. 71.10;
(c) 10 C.F.R. 71.17(c)(3) and (e);
(d) 10 C.F.R. 71.85(c);
(e) 10 C.F.R. 71.88(a)(4);
(f) 10 C.F.R. 71.93(c);
(g) 10 C.F.R. 71.95; and
(h) 10 C.F.R. 71.97(c)(3)(iii) and (f).
Section 3. Transport of Highway Route Controlled Quantities.
(1) Advanced notification shall be provided in accordance with 10 C.F.R. 71.97 prior to the transport, or delivery to a carrier for transport, of highway route controlled quantities.
(2) All licensees of the cabinet, NRC, or another Agreement state shall arrange for armed escort when transporting materials through the Commonwealth.
(3) Armed escort may be provided by either the Kentucky State Police (KSP) or private security firm meeting the requirements of 10 C.F.R. 73.37.
(4) The cabinet may require advanced notice of and armed escort for other quantities of radioactive materials for the protection of public health and safety.
(5) Payment for escort provided by KSP shall be made in accordance with 902 KAR 100.012, Section 4.
Section 4. Notice to Employees. The KR-441 "Notice to Employees" shall be posted instead of the NRC Form 3 as specified in 10 C.F.R. Part 71.
Section 5. Incorporation by Reference.
(1) KR-441 "Notice to Employees" 9/18, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Division of Public Health Protection and Safety, Radiation Health Branch, 275 East Main Street, Frankfort, Kentucky, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 71, 73.2, 73.37, 49 C.F.R. 173.403, 42 U.S.C. 2011
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes requirements for packaging and transportation of radioactive material.
- History: 1 Ky.R. 403; eff. 2-5-1975; 2 Ky.R. 479; eff. 4-14-1976; 12 Ky.R. 1044; eff. 1-3-1986; 13 Ky.R. 1769; eff. 5-14-1987; 18 Ky.R. 1525; eff. 1-10-1992; 26 Ky.R. 2402; 27 Ky.R. 976; eff. 10-16-2000; 37 Ky.R. 1827; 2618; eff. 6-3-2011; 41 Ky.R. 914; 1606; eff. 2-5-2015; 45 Ky.R. 510, 1248, 1631; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:072 Medical use of byproduct material {#sec-902-kar-100-072 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:072}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement state.
Section 2. Applicability. This administrative regulation establishes requirements for the medical use of byproduct material and for issuance of specific licensees authorizing the use of this material. Except as established in subsections
(1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 35. (1) The licensee shall not be subject to:
(a) 10 C.F.R. 35.8;
(b) 10 C.F.R. 35.11(c)(1);
(c) 10 C.F.R. 35.13(a)(1);
(d) 10 C.F.R. 35.4001; or
(e) 10 C.F.R. 35.4002.
(2) Application for specific license. Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) Reference to the NRC, the Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch, the NRC, or an agreement state.
(4) Notifications and reports required by 10 C.F.R. 35.14, 35.3045, 35.3047, and 35.3067 shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 255-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. Part 35, 45 C.F.R. Part 46, 42 U.S.C. 2021
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes requirements and provisions for the use of byproduct material in the healing arts, for issuance of licenses authorizing the medical use of byproduct material and for specific licensees to possess, use, and transfer byproduct material for medical uses.
- History: 31 Ky.R. 656; 1163; eff. 1-4-2005; 37 Ky.R. 1837; 2627; eff. 6-3-2011; 41 Ky.R. 921; 1612; eff. 2-5-2015; 45 Ky.R. 517, 1255, 1637; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:080 Exempt quantities {#sec-902-kar-100-080 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:080}
Section 1. Applicability. This administrative regulation exempts certain quantities of radionuclides from the requirements of 902 KAR Chapter 100.
Section 2. Quantities. Except as provided in other applicable provisions of 902 KAR Chapter 100, a person shall be exempt from the requirements established in 902 KAR Chapter 100 to the extent that the person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in individual quantities not in excess of those listed in 10 C.F.R. 30.71 Schedule B.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 30.71
- STATUTORY AUTHORITY: KRS 194.050(1), 211.090, 211.180(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. This administrative regulation establishes a list of quantities of specific radionuclides that are exempted from the requirements of 902 KAR Chapter 100.
- History: 1 Ky.R. 404; eff. 2-5-1975; Am. 12 Ky.R. 1058; eff. 1-3-1986; Am. Ky.R. 1536; eff. 1-10-1992; 42 Ky.R. 2990; 43 Ky.R. 216; eff. 8-17-2016; Cert. eff. 6-12-2023.
902 KAR 100:085 Exempt concentrations {#sec-902-kar-100-085 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:085}
Section 1. Applicability. This administrative regulation exempts certain concentrations of radionuclides from the requirements of the cabinet's radiation administrative regulations.
Section 2. Concentrations. Except as provided in other applicable provisions of 902 KAR Chapter 100, a person shall be exempt from the requirements established in 902 KAR Chapter 100 if the person receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in 10 C.F.R. 30.70 Schedule A
Section 3. The Combination of Radionuclides. The following applies to the combination of nuclides:
(1) In expressing the concentrations in Section 2 of this administrative regulation, the activity stated is that of the parent nuclide and takes into account the daughters; and
(2) For purposes of 902 KAR 100:045, Section 3, if a combination of nuclides is involved, the limit for the combination shall be derived by determining, for each nuclide in the product, the ratio between the radioactivity concentration present in the product and the exempt radioactivity concentration established in Section 2 of this administrative regulation for the specific nuclide if not in combination. The sum of the ratios shall not exceed one (1), or unity.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 10 C.F.R. 30.70
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. This administrative regulation establishes a list of concentrations for specific radionuclides that are exempted from the requirements of 902 KAR Chapter 100.
- History: 1 Ky.R. 405; eff. 2-5-1975; Am. 12 Ky.R. 1059; eff. 1-3-1986; Am. Ky.R. 1537; eff. 1-10-1992; 26 Ky.R. 2416; 27 Ky.R. 989; eff. 10-16-2000; 42 Ky.R. 2993; 43 Ky.R. 217; eff. 8-17-2016; Cert. eff. 6-12-2023.
902 KAR 100:100 Licenses for industrial radiography and radiation safety requirements for industrial radiographic operations {#sec-902-kar-100-100 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:100}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1). (3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 34 except as established in subsections
(1) through (4) of this section. (1) The licensee shall not be subject to the following:
(a) 10 C.F.R. 34.5;
(b) 10 C.F.R. 34.8;
(c) 10 C.F.R. 34.11;
(d) 10 C.F.R. 34.121; or
(e) 10 C.F.R. 34.123.
(2) Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) Reference to the "Commission", "NRC", or an agreement state shall be deemed to be a reference to the "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", the NRC, or an agreement state.
(4) Notifications required by 10 C.F.R. 34.101 shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 546-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday from 8 a.m. to 4:30 p.m.; or
(d) (800) 255-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 34, 42 U.S.C. 2011
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844(1) requires the Cabinet for Health and Family Services to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes radiation safety requirements for industrial radiographic operations and shall apply to licensees who use sources of radiation for industrial radiography.
- History: 1 Ky.R. 408; eff. 1-5-1975; 3 Ky.R. 167; eff. 9-1-1976; 12 Ky.R. 1065; eff. 1-3-1986; 16 Ky.R. 2552; eff. 6-27-1990; 20 Ky.R. 2398; eff. 4-11-1994; 21 Ky.R. 2305; eff. 4-19-1995; 27 Ky.R. 1615; 2165; eff. 2-1-2001; 38 Ky.R. 387; 961; eff. 11-16-2011; 41 Ky.R. 945; 1635; eff. 2-5-2015; 45 Ky.R. 542; 1280; 1661; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:105 X-rays; general {#sec-902-kar-100-105 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:105}
Section 1. Applicability. This administrative regulation shall apply to x-ray systems and persons, equipment, and materials used in connection with the possession, use, or operation of these systems. X-ray systems shall comply with the requirements of this administrative regulation and with other administrative regulations pertinent to the particular system employed.
Section 2. Administrative Control.
(1) No person shall make, sell, lease, transfer, lend, or install x-ray systems or the accessories used in connection with the systems unless the accessories and systems, if properly placed in operation and properly used, meet the requirements of these administrative regulations. These provisions include, but are not limited to, the delivery of cones or collimators, filters, adequate timers, and fluoroscopic shutters, if applicable.
(2) The registrant shall be responsible for directing the operation of the x-ray systems he has registered with the cabinet. In the operation of the x-ray system, the registrant or his agent shall ensure that the following requirements are met:
(a) An x-ray system which does not meet the provisions of these administrative regulations shall not be operated unless a specific exemption in writing has been granted by the cabinet. If the registrant advises an agent of the cabinet that he no longer uses an x-ray system, the cabinet may inactivate the system. Inactivated x-ray systems may be reactivated only by the cabinet or with its written permission. Inactivation of an x-ray system may be accomplished by one (1) of the following means:
-
An inactivation seal(s), numbers and instructions approved by the cabinet, may be placed on an x-ray system so as to prevent energizing the system. X-ray systems so sealed as inactive shall not be utilized and the seal or attached instructions shall not be removed without the express authorization of the cabinet.
-
The cabinet may approve the removal of portions of the x-ray system so as to render the system inoperative or so as to allow only those portions of the system to remain operative which are in compliance with these administrative regulations. X-ray systems or portions of x-ray systems having been so inactivated shall not be operated or be made operative by reinstallation of the removed portions of the system without the express authorization of the cabinet. X-ray systems so inactivated shall be clearly labeled showing the limitations of the x-ray system. The labels shall not be removed without the express authorization of the cabinet.
(b) Individuals operating x-ray systems shall be adequately instructed in safe operating procedures and shall be competent in the safe use of the system.
(c) Written safety procedures and rules for the particular x-ray system shall be posted in a conspicuous place beside each x-ray system's control panel and a copy of these administrative regulations shall be made available in each general work area.
(d) The following exposures are prohibited:
-
Exposure of an individual to the useful beam for training or demonstration purposes; and
-
Exposure of individuals for the purpose of mass screenings, except if authorized by a licensed practitioner of the healing arts within the scope of his professional license.
(e) If a patient or film is provided with auxiliary support during a radiation exposure, the registrant shall:
-
Provide mechanical holding devices to be used if the technique permits;
-
Provide written safety procedures, as required by this administrative regulation, which shall indicate the requirements for selecting a person to hold a patient or film and the procedure which the holder shall follow;
-
Provide the human holder with protection from radiation exposure as required by these administrative regulations; and
-
Ensure that no person is used routinely to hold film or patients.
(f) If protective clothing is worn on portions of the body and a monitoring device(s) are required, at least one (1) monitoring device shall be utilized as follows:
-
If an apron is worn, the monitoring device shall be worn at the neck area outside of the apron; and
-
If more than one (1) device is used and a record is made of the data, each dose shall be identified with the area where the device was worn on the body.
(g) A personnel monitoring device shall not be exposed to deceptively indicate a dose delivered to an individual.
(h) The registrant shall maintain the following information for each x-ray system for inspection by the cabinet:
-
Maximum rating of technique factors;
-
Tube rating charts and cooling curves; and
-
Records of surveys, calibrations, maintenance and modifications performed on the x-ray system along with the names of persons who performed the service; and
-
For equipment registered after the effective date of these administrative regulations, aluminum equivalent filtration of the useful beam, including routine variations.
(i) Each installation shall be provided with primary barriers and secondary barriers as are necessary to ensure compliance with these administrative regulations. This requirement shall be deemed to be met, if the thickness of barriers are equivalent to those as computed in accordance with the National Council of Radiation Protection Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X-rays and Gamma Rays of Energies up to 10 MeV"; and
-
Doors that are an integral part of primary and secondary barriers shall be closed during x-ray procedures; and
-
Doors in Section subparagraph 1 of this paragraph "CLOSE DOOR DURING X-RAY PROCEDURES".
(j) If a darkroom is used in connection with an x-ray system the following requirements shall apply:
-
The darkroom shall be constructed so that film being processed, handled, or stored is exposed only to light which has passed through a safe light filter; and
-
Adequate safety lighting shall be provided in each darkroom so that the radiance and spectral emissions of the safelight, bulb and filter combination shall not fog (the film) above the base fog level if exposed for one (1) minute at a distance of 120 centimeters from the lamp(s). Film manufacturer's recommendations for a safelight and its placement shall be adjudged to meet this criterion.
(k) Automatic processors and other closed processing systems shall meet the following requirements:
-
Preventive maintenance shall be performed on the unit, except for extended periods of nonuse, on a frequency basis which is not less than that schedule recommended by the manufacturer. If no schedule is available from the manufacturer, a maintenance schedule shall be established which preserves good film quality; and
-
After a full cleansing of the processor, a film shall be exposed to a density of approximately one (1), with one-half (1/2) of the film protected from the exposure. The film shall be developed, kept near the unit and at least one (1) test film daily (exposed under techniques identical with those used for the original test film) shall be compared with the original test film to evaluate the adequacy of the unit's developing capability and base fog level.
(l) Manual processing systems shall meet the following requirements:
-
A device shall be available which indicates the actual temperature of the developer in degrees Fahrenheit or Celsius;
-
The amount of time that the film remains in the developer solution shall be controlled. At the end of a preset time interval, the timing mechanism used for controlling the development time shall provide a visible or audible signal;
-
A time-temperature technique consistent with the film or developer manufacturer's requirements shall be used; and
-
A temperature control system shall be available to maintain the temperature of the developing solution within the range specified by the manufacturer. A means shall be provided to control the temperature of the fixer and the rinse water to within five (5) degrees Fahrenheit of the temperature of the developer solution. Exceptions to the requirements of this subparagraph may be authorized by the cabinet on the basis of a written request providing details of the developing procedure to be used, methods of controlling developing conditions, and an adequate justification for the exception.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of a source of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide general requirements for the possession, use, and operation of x-ray systems.
- History: 1 Ky.R. 410; eff. 2-5-1975; 3 Ky.R. 550; eff. 3-2-1977; 12 Ky.R. 1389; eff. 3-4-1986; 18 Ky.R. 1542; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:110 Registration of x-ray {#sec-902-kar-100-110 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:110}
Section 1. Applicability. This administrative regulation shall apply to radiation producing machines received, possessed, used, or transferred in the Commonwealth of Kentucky. The provisions of this administrative regulation are in addition to other applicable radiation administrative regulations.
Section 2. Preregistration. The person proposing to operate a radiation producing machine or accelerator except those specifically exempted in Section 5 of this administrative regulation shall preregister with the cabinet prior to acquisition of the machine. Preregistration under this section shall contain the following information and other information as may be required:
(1) Name and address of the person having administrative control and responsibility for the proposed facility.
(2) Address where the machine is to be located and used except that a central headquarters address may be given for a mobile x-ray to be used at various temporary field locations.
(3) A designation of the general category of proposed use (dental, medical, industrial, veterinary, or other.)
(4) Plans and specifications for the proposed facility and an evaluation by a qualified expert as required by 902 KAR 100:160.
Section 3. Registration.
(1) The preregistrant shall notify the cabinet within ten (10) days of the acquisition of a radiation producing machine or accelerator. Registration under this section requires the following information and other information as may be required:
(a) A change which renders the information required in Section 2 of this administrative regulation no longer accurate.
(b) A description of the type, model, serial number of the radiation machine and its rated capacity in peak kilovolts and milliamperes.
(c) Date of initial operation of the radiation producing machine or accelerator.
(d) Vendor registration number, name, address and telephone number.
(2) The registrant shall notify the cabinet within ten (10) days of a change which increases the rating of the machine or of a change which renders the information required in subsection (1) of this section no longer accurate. A change of ownership or possession of the machine shall terminate the registration.
(3) Each registrant, or his estate, if deceased, who permanently discontinues the use of or transfers radiation machines at an installation shall notify the cabinet in writing within thirty (30) days of this action. If a transfer occurs, the notification shall include the name and address of the transferee.
(4) No person in an advertisement shall refer to the fact that a radiation machine is registered with the cabinet, and no person shall state or imply that an activity under the registration has been approved by the cabinet.
(5) The registrant shall be subject to applicable requirements of these administrative regulations.
(6) If a radiation machine is to be brought into this state, the person proposing to bring the machine into the state shall give written notice to the cabinet at least two (2) days before the machine enters the state. The notice shall include the type of radiation machine; the name of the individual in charge; the nature, duration, and scope of use; and the exact location where the radiation machine is to be used. If for a specific case the two (2) day period imposes an undue hardship on the person, he may, upon application to the cabinet, obtain permission to proceed sooner. In addition, the out-of-state person shall:
(a) Comply with applicable administrative regulations of the cabinet; and
(b) Supply the cabinet with other information as the cabinet may reasonably request.
(7) No radiation producing machines shall be operated without a valid registration as stipulated in these administrative regulations.
Section 4. Vendor Obligation.
(1) The distributor, retailer or other agent who sells, leases, transfers, lends, or installs radiation producing machines shall apply for registration of these services with the cabinet within thirty (30) days following the effective date of these administrative regulations or, thereafter, prior to furnishing or offering to furnish these services. Registration under this section shall contain the following information and other information as may be required:
(a) Name and address of the person having responsibility for the business' operations.
(b) Name and address of the business' operation if different from paragraph (a) of this subsection.
(c) Designation of the categories of equipment in which the business deals (dental, medical, industrial or other).
(d) Date of application and signature.
(2) Vendor registration certificates shall expire on the last day of the month, one (1) year after the date of issuance.
(3) Vendor registration renewals shall be submitted to the cabinet within forty-five (45) days of the renewal notification date.
(4) The vendor shall notify the cabinet within thirty (30) days of a change which would render the information contained in the application for registration no longer accurate. A change of ownership of the business shall terminate the registration.
(5) Vendor services shall not be rendered without a valid registration as stipulated in these administrative regulations.
(6) Vendor services shall only be rendered at a preregistered or registered facility.
(7) No vendor in an advertisement shall refer to the fact that his business is registered with the cabinet and no vendor shall state or imply that an activity under his registration has been approved by the cabinet.
(8) The vendor shall be subject to applicable requirements of these administrative regulations.
(9) The vendor shall notify the cabinet within fifteen (15) days after the end of each month of:
(a) The names and addresses of persons who have received these machines;
(b) The manufacturer, model, and serial number of each machine transferred;
(c) The date which the machine(s) were sold, leased, transferred, or loaned; and
(d) The preregistration or registration number of persons who have received these machines.
(10) No vendor or person shall make, sell, lease, transfer, lend or install x-ray equipment or the supplies used in connection with the equipment unless the supplies and equipment, if placed in operation and used, shall meet the requirements of these administrative regulations.
Section 5. Exemptions.
(1) No person shall be required to register due to the ownership or possession of the following:
(a) Electronic equipment that produces radiation incidental to its operation for other purposes provided the dose equivalent rate averaged over an area of ten (10) square centimeters does not exceed five-tenths (0.5) mrem per hour at five (5) cm from an accessible surface of the equipment. The production, testing, or factory servicing of such equipment shall not be exempt.
(b) Radiation producing machines while in transit or storage incident thereto.
(2) Domestic television receivers are exempt from the requirements of this administrative regulation.
(3) No registrant, or his estate, shall be required to comply with the provisions of Section 4 of this administrative regulation except Section 4(10) of this administrative regulation if the radiation producing machines had been previously obtained for his sole use.
Section 6. Radiation Safety Officer.
(1) The registrant or his duly authorized representative shall designate a radiation safety officer or may personally assume the radiation safety responsibility.
(2) The person responsible for radiation safety shall:
(a) Be qualified by training and experience to assume the responsibilities of appraising himself of all hazards and precautions involved in handling the radiation machine(s) for which he is responsible.
(b) Give instructions concerning hazards and safety practices to persons who may be occupationally exposed to radiation.
(c) Provide reasonable assurance that other provisions as required by these administrative regulations are carried out.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to regulate the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide for the registration of radiation producing machines and vendors in Kentucky.
- History: 1 Ky.R. 411; eff. 2-5-1975; 12 Ky.R. 1391; eff. 3-4-1986; 18 Ky.R. 1544; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:115 Diagnostic x-ray {#sec-902-kar-100-115 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:115}
Section 1. Applicability. This administrative regulation shall apply to diagnostic x-ray systems in relation to the healing arts, to persons, equipment and materials used in connection with the possession, use or operation of the systems.
Section 2. Warning Label. The control panel containing the main power switch shall bear the following warning statement or an equivalent statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."
Section 3. Battery Charge Indicator. On battery-powered x-ray 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.
Section 4. Leakage Radiation from the Diagnostic Source Assembly. The leakage radiation from the diagnostic source assembly measured at distances of one (1) meter from the source shall not exceed 100 milliroentgens in one (1) hour if the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than twenty (20) centimeters.
Section 5. Radiation from Components other than the Diagnostic Source Assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed two (2) milliroentgens in one (1) hour at five (5) centimeters from accessible surfaces of the component if it is operated in an assembled x-ray system under conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than twenty (20) centimeters.
Section 6. Beam Quality.
(1) The half-value layer (HVL) of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following table:
(2) If it is necessary to determine the half-value layer at an exposure tube potential which is not listed in the table above, linear interpolation or extrapolation may be made;
(3) The above HVL criteria is considered to have been met if it can be demonstrated that the aluminum equivalent of the total filtration in the primary beam is not less than that shown in the following table:
(4) X-ray tubes with beryllium windows shall have a minimum of five-tenths (0.5) mm aluminum equivalent filtration permanently mounted in the useful beam;
(5) For capacitor energy storage equipment, compliance shall be determined with the maximum quantity of charge per exposure; and
(6) The required minimal aluminum equivalent filtration shall include the filtration contributed by materials which are always present between the focal spot of the tube and the patient (e.g., a tabletop if the tube is mounted "under the table" and inherent filtration of the tube).
Section 7. Filtration Controls. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filter(s) which prevents an exposure unless the minimum required amount of filtration is in the useful beam for the given kVp which has been selected.
Section 8. Mechanical Support of the Tube Head. The tube housing assembly supports shall be adjusted so that the tube housing assembly remains stable during an exposure unless the tube housing movement is a designed function of the x-ray system.
Section 9. Technique and Production Indicators.
(1) The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated.
(2) The requirement of technique indicators may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.
(3) A means shall be provided which gives positive indication of the production of x-rays if the x-ray tube is energized.
(4) On machines certified under the federal performance standard; and
(a) A visual indication of the production of x-rays and an audible signal indicating the exposure is terminated shall be provided; and
(b) Deviation of technique factors from indicated values shall not exceed the limits specified for that system by its manufacturer.
Section 10. Timers. Timers shall meet the following requirements:
(1) A means shall be provided to automatically terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses, or a preset radiation exposure of the image receptor;
(2) Automatic termination of the exposure shall cause automatic resetting of the timer to its initial setting or to zero, except for dental panoramic systems. The timer shall not be capable of making an exposure if the timer is set to a zero or off position if either is provided;
(3) If four (4) timer tests are performed at identical timer settings, the average time period (Tave) shall be greater than five (5) times the maximum period (Tmax) minus the minimum period (Tmin), (Tave) greater than five (5) (Tmax minus Tmin).
Section 11. Exposure Switch. The exposure switch shall be of the dead man type.
Section 12. Exposure Reproducibility. The exposure produced shall be reproducible so that if technique factors are held constant, the coefficient of variation shall not exceed one-tenth (0.1). This requirement shall be deemed to have been met if, four (4) exposures at identical technique factors are made, the value of the average exposure (Eave) is greater than five (5) times the maximum exposure (Emax) minus the minimum exposure (Emin), (Eave) greater than five (5) (Emax minus Emin). If the diagnostic x-ray system is certified, the estimated coefficient of variation of radiation exposures shall be no greater than 0.05 for specific combination of selected technique factors.
Section 13. Technique Chart. In the vicinity of each x-ray system's control panel a chart shall be provided which specifies for examinations which are performed by that system a list of information for each projection within that examination. The chart shall include but not be limited to the following:
(1) The patient's anatomical size versus technique factors to be utilized;
(2) The type and size of the film or film-screen combination to be used;
(3) The type and focal distance of the grid to be used, if used;
(4) The source to image receptor distance to be used; and
(5) The type and location of gonadal shielding to be used, if used.
Section 14. Personnel in X-ray Room. Except for patients who cannot be moved out of the room, only staff and ancillary personnel required for the medical procedure or training shall be in the room during the radiographic exposure. The patients and personnel shall be protected as follows:
(1) Other than the patient being examined, individuals in the x-ray room shall be positioned so that no part of the body not protected by five-tenths (0.5) mm lead equivalent, is struck by the useful beam.
(2) Staff and ancillary personnel shall be protected from direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 mm lead equivalent;
(3) Patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 mm lead equivalent or shall be so positioned that the nearest portion of the body is at least two (2) meters from both the tube head and the nearest edge of the image receptor; and
(4) If a portion of the body of staff or ancillary personnel is potentially subjected to stray radiation which results in that individual receiving one-quarter (1/4) of the maximum permissible dose as defined in these administrative regulations, additional protective devices may be required by the cabinet.
Section 15. Examination Information. Each facility shall maintain written records of each examination. The records shall include but not be limited to the following:
(1) Appropriate patient identification data, including name, Social Security number, age and sex;
(2) Date of examination;
(3) A description of the examination or treatment given by routine or local title as denoted on the technique chart;
(4) Deviation from standard procedure or technique, including repeat exposures, as denoted in the technique chart;
(5) The x-ray system used, if there is more than one (1) system per facility;
(6) the name of the person who performed the exam;
(7) the name of the individual who ordered the exam; and
(8) The name of the human holder.
Section 16. Image Interpretation. Each image (film, film set, etc.) shall be interpreted by a licensed practitioner, and a permanent record shall be made of the interpretation of the total examination.
Section 17. Gonadal Shielding. Gonadal shielding of not less than 0.25 millimeter lead equivalent shall be used for patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the beam except for cases in which this would interfere with the diagnostic procedure.
Section 18. Procedures and Ancillary Equipment. Procedures and ancillary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized. The procedures and equipment shall include but not be limited to the following:
(1) The speed of the film or film and screen combination shall be the fastest consistent with the diagnostic objective of the examination;
(2) Portable and mobile equipment shall be used only for examinations if it is impractical to transfer the patient to a stationary radiographic installation; and
(3) Radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.
Section 19. Multiple Tubes. If two (2) or more radiographic tubes are controlled by one (1) exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide requirements for the possession, use, and operation of diagnostic x-ray systems in relation to the healing arts.
- History: 1 Ky.R. 412; eff. 2-5-1975; 3 Ky.R. 553; eff. 3-2-1977; 12 Ky.R. 1392; eff. 3-4-1986; 18 Ky.R. 1546; eff.1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:120 General diagnostic radiography {#sec-902-kar-100-120 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:120}
Section 1. Applicability. This administrative regulation shall apply to radiographic x-ray systems used in relation to the healing arts, except dental intra-oral, fluoroscopic, veterinary radiographic, or computed tomography and to persons, equipment and materials used in connection with the possession, use or operation of the systems.
Section 2. Permanent Structural Shielding. Permanent structural shielding and protective barriers shall be used as necessary to insure that no person other than the patient receives a dose equivalent in excess of the limits specified in these regulations.
Section 3. Beam Limitation. The useful beam shall be limited to the area of clinical interest as follows:
(1) General purpose stationary and mobile x-ray systems.
(a) A means shall be provided for stepless adjustment of the size of the x-ray field. The minimum field size at an SID of 100 centimeters shall be equal to or less than five (5) by five (5) centimeters;
(b) No dimension of the x-ray field, measured in the plane of the image receptor, shall exceed the corresponding dimension of the image receptor by more than two (2) percent of the source to image receptor distance (SID) measured if the plane of the image receptor is perpendicular to the primary ray of the x-ray field; and
(c) A method shall be provided for visually defining the perimeter of the x-ray field. 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 (2) percent 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.
(d) The cabinet may grant an exemption as provided by 902 KAR 100:015 Section 7(1) on noncertified x-ray to the requirements of paragraphs (a) and (c) of this subsection for equipment registered prior to the effective date of this administrative regulation.
(2) In addition to the requirements of subsection (1) of this section, stationary general purpose x-ray systems, both certified and noncertified, shall meet the following requirements:
(a) A method shall be provided to indicate if 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 (2) percent of the SID and to indicate the SID to within two (2) percent.
(b) The beam limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted; and
(c) Indication of field size dimensions and SID's shall be specified in inches or centimeters, so 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 (2) percent of the SID if the beam axis is indicated to be perpendicular to the plane of the image receptor.
(3) Radiographic equipment designed for only one (1) 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 (2) percent of the SID, or shall be provided with means to both size and align the x-ray field so that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.
(4) Radiographic systems designed only for mammography and general purpose radiographic systems, if special attachments for mammography are in service, shall be provided with means to limit the useful beam so 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 (2) percent of the SID. This requirement can be met with a system which performs as prescribed in subsection (5)(c) of this section. If 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 subsection (5)(c) of this section shall be the maximum SID for which the beam limiting device or aperture is designed. In addition, each image receptor support intended for installation on a system designed only for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.
(5) For x-ray systems other than those described in subsections (1), (2), (3), (4) and (5) of this section:
(a) Means shall be provided to limit the x-ray field in the plane of the image receptor so that the field does not exceed each dimension of the image receptor by more than two (2) percent of the SID if the axis of the x-ray beam is perpendicular to the plane of the image receptor and align the center of the x-ray field with the center of the image receptor to within two (2) percent of the SID, or means shall be provided to both size and align the x-ray field so that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor; or
(b) Shall meet the requirements for a general purpose x-ray system as specified in subsection (1) of this section; or
(c) If alignment means are also provided, 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 with each device having clear and permanent markings to indicate the image receptor size and SID for which it is designed or 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.
Section 4. Field Limitation and Alignment on General Purpose X-ray Systems.
(1) For stationary, general purpose x-ray systems which contain a tube housing assembly, an x-ray control, and, for those systems so equipped, a table, certified in accordance with 21 CFR 1020.30(c), positive beam limitation shall be provided if 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 each less than fifty (50) centimeters;
(c) The x-ray beam axis is within plus or minus three (3) degrees of vertical and the SID is ninety (90) centimeters to 130 centimeters inclusive or the x-ray beam axis is within plus or minus three (3) degrees of horizontal and the SID is ninety (90) centimeters to 205 centimeters inclusive;
(d) The x-ray beam axis is perpendicular to the plane of the image receptor to within plus or minus three (3) degrees;
(e) Neither tomographic nor stereoscopic radiography is being performed; and
(f) The positive beam limitation (PBL) system has not been intentionally overridden in accordance with subsection (3) of this section.
(2) PBL shall prevent the production of x-rays if;
(a) Either the length or width of the x-ray field in the plane of the image receptor differs, except as permitted by subsection (5) of this section, from the corresponding image receptor dimensions by more than three (3) percent of the SID; or
(b) The sum of the length and width differences as stated in paragraph (a) of this subsection without regard to sign exceeds four (4) percent of the SID.
(3) If a means of overriding the PBL system exists, that means:
(a) Shall be designed for use only in the event of PBL system failure or if the system is being serviced;
(b) Shall require that a key be utilized to defeat the PBL, that the key or key remain in place during the entire time the PBL system is overridden and that the key switch be clearly and durably labeled "For X-ray Field Limitation System Failure" if the means of overriding the PBL system is in a position that the operator would consider it part of the operational controls or if it is referenced in the operator's manual or in other materials intended for the operator; and
(c) Shall be used only for that period of time necessary for the repair or service of the system.
(4) Compliance with subsection (2) of this section shall be determined if the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of subsection (1) of this section are met. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor.
(5) The positive beam limitation system shall be capable of operation, at the discretion of the operator, so that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at an SID of 100 centimeters shall be equal to or less than five (5) by five (5) centimeters.
(6) The PBL system shall be designed so that if a change in image receptor does not cause an automatic return to PBL function as described in subsection (2) of this section, then any change of image receptor size or SID shall cause the automatic return.
Section 5. X-ray Control (Exposure Switch).
(1) A control shall be incorporated into each x-ray system so such that an exposure can be terminated instantly except for exposures of one-half (1/2) second or less, or during serial radiography a means shall be provided to permit completion of a single exposure of the series in process.
(2) The location of x-ray exposure controls on stationary x-ray systems shall be regulated as follows:
(a) Stationary x-ray systems shall be required to have the x-ray control permanently mounted in a protected area so that the operator is required to remain in that protected area during the entire exposure; and
(b) The exposure controls shall be behind a window of lead equivalent glass equal to that required by the adjacent barrier or an appropriate viewing system shall be provided so that the operator can see the patient without having to leave the protected area during the exposure.
(3) Mobile and portable x-ray systems which are used for one (1) week or more in one (1) location (one (1) room or suite), shall be considered stationary for the purposes of this administrative regulation and these systems shall meet the requirements of subsection (2) of this section.
(4) Mobile and portable x-ray systems which are used for greater than one (1) hour and less than one (1) week in one (1) location (one (1) room or suite) shall meet the requirement of subsection (3) of this section or be provided with a protective barrier one and nine-tenths (1.9) meters in height having a window of lead equivalent glass equal to that required of the barrier and placed at least one and eight-tenths (1.8) meters from the tube housing assembly and at least one and eight- tenths (1.8) meters from the patient.
(5) Mobile and portable x-ray systems which are used for one (1) hour or less in one (1) location (one (1) room or suite) shall meet the requirement of subsection (3) or (4) of this Section or be provided with a method of x-ray control that permits the operator to be at least three and six-tenths (3.6) meters from the tube housing assembly during an exposure.
Section 6. Automatic Exposure Controls (Phototimers). If an automatic exposure control is utilized, the following requirements shall be met:
(1) An indicator shall be provided on the control panel to indicate if this mode of operation is selected;
(2) If the x-ray tube potential is equal to or greater than fifty (50) 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;
(3) The minimum exposure time for equipment other than that specified in subsection (2) of this section shall be equal to or less than one-sixtieth (1/60) second or a time interval required to deliver five (5) mAs, whichever is greater;
(4) The product of peak x-ray tube potential, current, and exposure time shall be limited to not more than sixty (60) kWs per exposure or the product of x-ray tube current and exposure time shall be limited to not more than 600 mAs per exposure except if the x-ray tube potential is less than fifty (50) kVp in which case the product of x-ray tube current and exposure time shall be limited to not more than 2000 mAs per exposure; and
(5) A visible signal shall indicate that an exposure has been terminated at the limits described in subsection (4) of this section, and manual resetting shall be required before further automatic time exposures can be made.
Section 7. Source to Skin or Image Receptor Distance.
(1) All mobile or portable radiographic x-ray systems shall be provided with a durable, securely-fastened means to limit the source to skin distance to not less than thirty (30) centimeters.
(2) Radiographic x-ray systems shall be equipped with a device or reference, other than a collimator light localizer, which shall indicate reference, or measure the selected source to receptor distance to within two and five-tenths (2.5) centimeters.
Section 8. Standby Radiation from Capacitor Energy Storage Equipment. Radiation emitted from the x-ray tube if the exposure switch or timer is not activated shall not exceed a rate of two (2) milliroentgens per hour at five (5) centimeters from an accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.
Section 9. Personnel Monitoring. Personnel monitoring shall be required for individuals operating portable or mobile x-ray systems.
Section 10. Linearity. On x-ray systems certified under the federal performance standard, if the equipment allows a choice of x-ray tube current settings and is operated on a power supply as specified by the manufacturer in accordance with the requirements of applicable federal standards, for a fixed x-ray tube potential within the range of forty (40) to 100 percent of the maximum rating, the average ratios of exposure to the indicated milliampere-seconds product obtained at two (2) consecutive tube current settings shall not differ by more than one-tenth (0.1) times their sum X1 - X2 < 0.10 (X1 + X2).
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide special requirements for the possession, use, and operation of radiographic x-ray systems used in relation to the healing arts, except systems used for dental intra-oral or veterinary radiography.
- History: 1 Ky.R. 412; eff. 2-5-1975; 3 Ky.R. 555; eff. 3-2-1977; 12 Ky.R. 1395; eff. 3-4-1986; 18 Ky.R. 1550; eff.1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:125 Fluoroscopic x-ray except for computed tomography x-ray systems {#sec-902-kar-100-125 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:125}
Section 1. Applicability. This regulation shall apply to fluoroscopic x-ray systems and to persons, equipment and materials used in connection with the possession and use or operation of these such systems.
Section 2. Equipment. Fluoroscopic x-ray systems shall meet the following requirements:
(1) The tube housing assembly shall be of the diagnostic type;
(2) Cones or shutters used to restrict the size of the useful beam shall provide the same degree of attenuation as required of the tube housing; and
(3) Fluoroscopic imaging devices used for optical viewing which are not mechanically linked to the x-ray tube shall not be utilized.
Section 3. Protective Barrier and Field Size.
(1) The fluoroscopic tube shall not be capable of producing x-rays unless the primary protective barrier is in position to intercept the entire useful beam.
(2) The entire cross-section of the useful beam shall be intercepted by the primary protective barrier of the fluoroscopic image assembly at every SID (e.g., source to image receptor distance).
Section 4. Limitation to the Imaging Surface. The x-ray field shall be restricted so that the following requirements are met:
(1) On nonimage-intensified fluoroscopic x-ray systems, the x-ray field shall not extend beyond the entire visible area of the image receptor. This requirement applies to field size during both fluoroscopic procedures and spot filming procedures. In addition:
(a) Means shall be provided for stepless adjustment of the field size;
(b) The minimum field size at the greatest SID shall be equal to or less than five (5) by five (5) centimeters;
(c) Equipment manufactured after February 25, 1978, if the angle between the image receptor and the beam axis of the x-ray beam is variable, shall be provided with the means to indicate if the axis of the x-ray beam is perpendicular to the plane of the image receptor; and
(d) Compliance with this subsection shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.
(2) On image-intensified fluoroscopic systems with manual shutter controls, the x-ray beam shall not exceed the area of the largest image receptor, if measured with the fluoroscopic image assembly positioned thirty-five and five-tenths (35.5) centimeters from the table top or panel surface, and with the manual shutter controls opened to the fullest extent. Collimators located between the image receptor and patients shall not be used to fulfill this requirement. Means shall be provided to reduce the x-ray field size to five (5) by five (5) centimeters or less at the maximum SID; or
(3) For image-intensified fluoroscopic equipment, neither the length nor 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 (3) percent of the SID. The sum of the excess length and width shall be no greater than four (4) percent of the SID.
(a) 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.
(b) Means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or a visible area of greater than 300 square centimeters shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and a visible area of 300 square centimeters or less shall be provided with stepless adjustment of the x-ray field or with means to further limit the x-ray field size at the plane of the image receptor to 125 square centimeters or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of five (5) by five (5) centimeters or less.
(c) For equipment manufactured after February 25, 1978, if the angle between the image receptor and beam axis is variable, means shall be provided to indicate if the axis of the x-ray beam is perpendicular to the plane of the image receptor.
(4) Spot film devices which are certified components shall meet the following additional requirements:
(a) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the film to the size of the portion of the film which has been selected on the spot film selector. This adjustment shall be automatically accomplished except if the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option;
(b) It shall be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, five (5) by five (5) centimeters;
(c) The center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within two (2) percent of the SID; and
(d) 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 if 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.
(5) If a means exists to override the automatic x-ray field size adjustments required in this section, that means:
(a) Shall be designed for use only if the system fails:
(b) Shall incorporate a signal visible at the fluoroscopist's position which shall indicate if the automatic field size adjustment is overridden; and
(c) Shall be clearly and durably labeled as follows: "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE".
Section 5. Activation of the Fluoroscopic Tube. X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of an exposure. If recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposures, but means may be provided to permit completion of a single exposure of the series in process.
Section 6. Exposure Rate Limits. The entrance exposure rate allowable limits and requirements are as follows:
(1) The exposure rate at the point where the center of the useful beam enters the patient shall not exceed ten (10) roentgens per minute, except during recording of fluoroscopic images or if provided with optional high level control;
(2) If provided with optional high level control, the equipment shall not be operable at a combination of tube potential and current which results in an exposure rate in excess of five (5) roentgens per minute at the point where the center of the useful beam enters the patient unless the high level control is activated.
(a) Special means of activation of high level controls shall be required. The high level control shall only be operable if continuous manual activation is provided by the operator.
(b) A continuous signal audible to the fluoroscopist shall indicate that the high level control is being employed.
(3) Certified systems which do not incorporate an automatic exposure control shall not be operable at a combination of tube potential and current which results in an exposure rate in excess of five (5) roentgens per minute at the point where the center of beam enters the patient except during recording of fluoroscopic images or if provided with an optional high level control;
(4) Compliance with the entrance exposure rate limits shall be determined as follows:
(a) Movable grids and compression devices shall be removed from the useful beam during the measurement;
(b) If the source is below the table, exposure rate shall be measured one (1) centimeter above the tabletop or cradle;
(c) If the source is above the table, the exposure rate shall be measured at thirty (30) centimeters above the tabletop with the end of the beam limiting device or spacers positioned as closely as possible to the point of measurement;
(d) C-arm fluoroscopes, both stationary and mobile, shall meet the entrance exposure rate limits in subsections (1), (2) and (3) of this section thirty (30) centimeters from the input surface of the fluoroscope imaging assembly with the source positioned at an available SID if the end of the spacer assembly or beam-limiting device is not closer than thirty (3) centimeters from the input surface of the fluoroscopic imaging assembly.
(5) Periodic measurements of the exposure rate shall be made. An adequate period for these measurements shall be annually or after maintenance of the system which might affect the exposure rate;
(a) Results of these measurements shall be posted where a fluoroscopist has ready access to them while using that fluoroscopic x-ray system and in the records required by these administrative regulations. Results of the measurements shall include the exposure rate in roentgens per minute, as well as the physical factors used to determine the data, the name of the person who performed the measurements, and the date the measurements were performed;
(b) Conditions of periodic measurement of entrance exposure rate are as follows:
-
The kVp shall be the kVp typical of clinical use of the x-ray system;
-
The measurement shall be made under the conditions of subsection (4) of this section;
-
Fluoroscopic x-ray system(s) that incorporate automatic exposure control (e.g., automatic brightness control) shall have sufficient material placed in the useful beam to produce a milliamperage typical of the use of the fluoroscopic x-ray system; and
-
Fluoroscopic x-ray system(s) that do not incorporate automatic exposure control shall utilize a milliamperage typical of the clinical use of the fluoroscopic x-ray system. Materials (e.g., an attenuation block) shall be placed in the useful beam to protect the imaging system.
Section 7. Radiation Rate Limits Transmitted Through the Primary Barrier. The exposure rate due to transmission through the primary protective barrier with the attenuation block in the useful beam, combined with radiation from the image intensifier, if provided, shall not exceed two (2) milliroentgens per hour at ten (10) centimeters from accessible surfaces of the fluoroscopic imaging assembly beyond the plane of the image receptor for each roentgen per minute of entrance exposure rate. The transmitted exposure rate shall be measured so that the following requirements are met:
(1) The exposure rate due to transmission through the primary protective barrier combined with radiation from the image intensifier shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than twenty (20) centimeters;
(2) If the x-ray source is below the table top, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty (30) centimeters above the table top;
(3) If the x-ray source is above the table top and the SID is variable, the measurement shall be made with the end of the beam limiting device or spacer as close to the table top as it can be placed, except that it shall not be closer than thirty (30) centimeters;
(4) Movable grids and compression devices shall be removed from the useful beam during the measurement; and
(5) The attenuation block shall be positioned in the useful beam ten (10) centimeters from the point of measurement of the entrance exposure rate and between this point and the input surface of the fluoroscopic imaging assembly.
Section 8. Indication of Tube Potential and Current. During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated on the control panel or within view of the fluoroscopist.
Section 9. Source to Skin Distance. The source to skin distance shall not be less than:
(1) Thirty-eight (38) centimeters on stationary fluoroscopes certified under the federal performance standard;
(2) Thirty-five and five-tenths (35.5) centimeters on stationary fluoroscopes which are not certified under the federal performance standard;
(3) Thirty (30) centimeters on mobile fluoroscopic x-ray systems; or
(4) Twenty (20) centimeters for image-intensified fluoroscopes used for specific surgical applications. The written safety procedures shall provide precautionary measures to be adhered to during the use of this device.
Section 10. Fluoroscopic Timer. A means shall be provided to preset the cumulative on-time of the fluoroscopic x-ray system. The fluoroscopic x-ray system shall not be able to be activated without this timer also being activated. The end of the predetermined period of irradiation shall be indicated by an audible signal. The audible signal shall continue until the timing device is reset. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting.
Section 11. Mobile Fluoroscopes. Mobile fluoroscopic systems shall be provided with image intensification. It shall be impossible to operate mobile fluoroscopic systems unless the useful beam is intercepted by the image intensifier.
Section 12. Control of Scattered Radiation.
(1) Fluoroscopic table designs combined with procedures utilized shall expose no unprotected part of staff or an ancillary person's body to unattenuated scattered radiation which originates from under the table. The attenuation required shall not be less than 0.25 mm lead equivalent; and
(2) Equipment configuration design combined with procedures shall expose no portion of staff or an ancillary person's body, except the extremities, to the unattenuated scattered radiation emanating from above the tabletop unless that individual:
(a) Is at least 120 cm from the center of the useful beam, or
(b) The radiation has passed through not less than 0.25 mm lead equivalent material (e.g., leaded drapes, Bucky slot cover panel, or self supporting leaded curtains) in addition to lead equivalency provided by protective aprons.
(3) Exceptions to subsection (2)(a) and (b) of this section may be made in some special procedures if a sterile field does not permit the use of the normal protective barriers. If the use of prefitted sterilized covers for the barriers is practical, the cabinet shall not permit an exception.
Section 13. Operating Procedures and Auxiliary Equipment. The following operating procedures and auxiliary equipment shall be utilized, if applicable, in the operation of a fluoroscopic x-ray system:
(1) Fluoroscopy performed by technologists shall be under the direction of a radiologist and be exclusively for localization purposes;
(2) Spot film images shall be obtained only by a licensed practitioner of the healing arts;
(3) Protective gloves of at least 0.25 mm lead equivalent shall be readily available to the fluoroscopist during every examination;
(4) The eyes of the fluoroscopist shall be adequately dark-adapted before using nonimage-intensified fluoroscopic x-ray systems;
(5) Extraneous light that interferes with the fluoroscopic examination shall be eliminated;
(6) Hand-held fluoroscopic screens shall not be used;
(7) Protective aprons of at least 0.25 mm lead equivalence shall be worn by the fluoroscopist and by persons in the fluoroscopic room except the patient during each examination;
(8) Fluoroscopic x-ray systems designed strictly for fluoroscopy shall not be used for spot filming or radiography; and
(9) Dental fluoroscopic x-ray systems without image intensification shall not be used.
Section 14. Radiation Therapy Simulation Systems. Radiation therapy simulation systems shall be exempt from the requirements of Sections 4, 6, and 10 of this administrative regulation if:
(1) Systems are designed and used in a manner that no individual other than the patient is in the x-ray room if the system is producing x-rays; and
(2) Systems which do not meet the requirements of Section 10 of this administrative regulation are provided with a means of indicating the cumulative time that an individual patient has been exposed to x-rays. Procedures shall require in these cases that the timer be reset between examinations.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide special requirements for the possession, use, and operation of fluoroscopic x-ray systems in the healing arts.
- History: 1 Ky.R. 413; eff. 2-5-1975; 3 Ky.R. 557; eff. 3-2-1977; 12 Ky.R. 1397; eff. 3-4-1986; 18 Ky.R. 1554; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:130 Dental {#sec-902-kar-100-130 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:130}
Section 1. Applicability. This administrative regulation shall apply to dental intraoral radiographic x-ray systems and to persons, equipment, and materials used in connection with the possession, use, or operation of these systems.
Section 2. Source to Skin Distance. Each radiographic x-ray system designed for use with an intraoral image receptor shall be provided with a means to limit the source to skin distance to not less thaneighteen (18) centimeters.
Section 3. Field Limitation. Each radiographic x-ray system designed for use with an intraoral image receptor shall be equipped with a means to limit the x-ray beam.
(1) If the minimum source to skin distance is eighteen (18) centimeters or more, the x-ray field shall be containable in a circle having a diameter of no more than seven (7) centimeters.
(2) Circular beams are permitted, but the cabinet recommends the use of rectangular collimation.
(3) The useful beam shall be limited to the area of clinical interest.
Section 4. Operator and Public Protection.
(1) Except for hand-held x-ray systems with integral shields, each installation shall be provided with a protective barrier for the operator or shall be arranged so that the operator can conveniently stand at least six (6) feet from the patient, the tube housing assembly, and outside the path of the useful x-ray beam while making an exposure.
(2) If six (6) feet cannot be maintained, a barrier shall be provided, with the ability to view the patient, while making the exposure.
(3) The operator shall monitor and secure the area prior to making an exposure near public areas.
(4) In dental facilities using a large, multi-patient open-bay design, a patient in proximity to another patient being radiographed shall be treated as a member of the public.
(5) All public areas shall comply with the applicable requirements of 902 KAR 100:019.
Section 5. Operating Procedures. In performing intraoral dental radiography, the rules as established in this section shall apply.
(1) Patient and image receptor film holding devices shall be used if technique permits.
(2) Except for units designed to be hand-held, the tube housing and position indicating device shall not be hand-held during an exposure.
(3) An individual shall not be used routinely to hold the image receptor or patient during a radiation exposure.
(4)
(a) The registrant shall restrict the presence of individuals in the area where the patient is being radiographed.
(b) Parents or guardians may accompany a child or person with special needs.
(c) Those persons present in the area where the patient is being radiographed shall be:
-
Positioned so that no part of their body is exposed to the primary beam; and
-
Protected from secondary radiation by protective lead shielding to not less than 0.25 millimeter lead equivalent material.
(5) A sufficient number of protective apparel (e.g., aprons, gloves, thyroid collars) and auxiliary shields shall be available to provide the necessary radiation protection for all patients and personnel who are involved with x-ray operations.
(a) All protective apparel and auxiliary shields shall be evaluated annually for integrity and clearly labeled with their lead equivalence.
(b) Shielding shall be provided for patients if it will not interfere with the examination.
(c) In accordance with guidance from a qualified expert, registrants implementing dose reduction technologies (e.g., position-indicating device twenty (20) – thirty (30) centimeters, rectangular collimation, fast digital image receptors) and procedures, may develop and submit to the cabinet for approval their own policies and procedures regarding human patient protection, exposure of pregnant patients, patient shielding, and patient education.
(6) The registrant shall annually review their radiation protection program in accordance with 902 KAR 100:019, Section 2.
(7) The registrant shall maintain and make available safe operating procedures to include written safety procedures and techniques required for the safe use of the x-ray system.
(8) Image receptors of speeds slower than the American National Standards Institute (ANSI) speed group E/F or D speed shall not be used for intraoral radiography.
(9) Dental fluoroscopy without image intensification shall not be used.
(10) Technique factors and selection criteria shall be appropriate to the age and size of the patient.
(11) The registrant shall maintain a quality control program that complies with 902 KAR Chapter 100.
Section 6. Beam Quality. The half-value layer of the useful beam shall:
(1) Not be less than the value specified in 21 C.F.R. 1020.30(m), Table 1; and
(2) Meet requirements specified in 21 C.F.R. 1020.30(m)(1).
Section 7. Leakage Radiation. The leakage radiation from the diagnostic source assembly shall be measured in accordance with 21 C.F.R. 1020.30(k).
Section 8. Kilovolt Peak (kVp) Accuracy. The kVp accuracy shall be within plus or minus ten (10) percent of its indicated value.
Section 9. Coefficient of Variation. The coefficient of variation for timing, radiation exposure, and reproducibility shall not exceed 0.05 in four (4) consecutive exposures.
Section 10. Maintaining Compliance. Diagnostic x-ray systems and their associated components used on humans and certified pursuant to the Federal X-Ray Equipment Performance Standards for Ionizing Radiation Emitting Products, 21 C.F.R. Part 1020, shall be maintained in compliance with applicable requirements of that standard.
Section 11. Additional Requirements. Dental intraoral x-ray systems shall:
(1) Provide a visual and audible indication that x-rays are being produced;
(2) Utilize a "dead-man" exposure switch;
(3) Provide a means to terminate the exposure at a preset:
(a) Time interval;
(b) Product of current and time;
(c) Number of pulses; or
(d) Radiation exposure to the image receptor;
(4) Display their technique factors prior to exposure:
(a) If automatic exposure controls are used, the technique factors, which are set prior, shall be indicated; or
(b) May be met by permanent display of markings on x-ray systems using fixed technique factors;
(5) Have tube housing assembly supports so that the tube housing assembly remains stable during the exposure unless tube housing movement is a designed function of the x-ray system; and
(6) Not be operated at less than fifty (50) kVp.
Section 12. Hand-held Devices. In addition to the standards in 902 KAR Chapter 100, the following standards established within this section apply specifically to intraoral hand-held devices.
(1) Any dental intraoral hand-held x-ray system used shall be cleared by the Federal Food and Drug Administration prior to use.
(2) The hand-held x-ray system shall be equipped with a backscatter shield of not less than (0.25) millimeter lead equivalent.
(3) The registrant shall maintain documentation that each operator has completed training as specified by the manufacturer and to ensure the operator is competent in the safe use of the x-ray system.
(4) The training required by subsection (3) of this section shall, at a minimum, contain:
(a) The basics of x-ray production and scatter;
(b) The As Low as Reasonably Achievable (ALARA) principle and basic protective measures to include time, distance, and shielding; and
(c) Instruction on the proper positioning of the patient and operator, location and orientation of the handheld device, and operator's hand positioning on the device.
(5) If the hand-held x-ray system is not in use, then it shall be secured and stored so that it is not accessible to members of the public.
(6) The registrant shall provide personal dosimeters for all new hand-held x-ray system operators to determine if further monitoring is required pursuant to 902 KAR 100:019, Section 3.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4), 21 C.F.R. Part 1020
- STATUTORY AUTHORITY: KRS 194A.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of any sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes the requirements for the possession, use, and operation of intraoral dental radiographic x-ray systems.
- History: 902 KAR 100:130. 1 Ky.R. 415; eff. 2-5-1975; 3 Ky.R. 560; eff. 3-2-1977; 12 Ky.R. 1401; eff. 3-4-1986; 18 Ky.R. 1557; eff. 1-10-1992; Crt eff. 8-16-2019.; 52 Ky.R. 629, 1136; eff. 1-22-2026.
902 KAR 100:136 Therapeutic systems below one (1) MeV {#sec-902-kar-100-136 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:136}
Section 1. Applicability. This administrative regulation shall apply to therapeutic x-ray systems which operate at energies below one (1) MeV and to persons, equipment and materials used in connection with the possession, use or operation of the systems.
Section 2. Leakage Radiation. If the x-ray system is operated at its leakage technique factors, the leakage radiation shall not exceed the value given below:
(1) For contact therapy systems the leakage radiation shall not exceed 100 milliroentgens per hour measured five (5) cm anywhere from the tube housing;
(2) For systems operating between zero and 150 kVp and which are registered prior to March 2, 1977, the leakage radiation shall not exceed one (1) roentgen in one (1) hour at one (1) meter from the source;
(3) For systems operating between zero and 150 kVp and which are registered after March 2, 1977, the leakage radiation shall not exceed 100 milliroentgens in one (1) hour at one (1) meter from the source;
(4) For systems operating between 151 and 500 kVp the leakage radiation shall not exceed one (1) roentgen in one (1) hour at one (1) meter from the source; or
(5) For systems operating between 501 and 999 kVp the leakage radiation at one (1) meter from the source shall not exceed one-tenth (0.1) percent of the useful beam one (1) meter from the source.
Section 3. Permanent Beam Limiting Devices. Permanent fixed diaphragms or cones used for collimating the useful beam shall provide the same or higher degree of protection as required by the tube housing assembly.
Section 4. Removable Beam Limiting Devices. Removable beam limiting devices shall, for the portion of the useful beam to be blocked by these devices, transmit not more than one (1) percent of the useful beam at the maximum kilovoltage and maximum treatment filter. This requirement does not apply to auxiliary blocks or materials placed in the useful beam to shape the useful beam to the individual patient.
Section 5. Adjustable Beam Limiting Devices. Adjustable beam limiting devices shall meet the following requirements:
(1) Devices installed after March 2, 1977 shall, for the portion of the useful beam to be blocked by these devices, transmit not more than one (1) percent of the original beam at the maximum kilovoltage and maximum treatment filter; or
(2) Devices installed before March 2, 1977, shall for the portion of the useful beam to be blocked by these devices, transmit not more than five (5) percent of the original beam at the maximum kilovoltage and maximum treatment filter.
Section 6. Filter System. The filter system shall be designed to meet the following requirements:
(1) The filters cannot be accidentally displaced at possible tube orientation;
(2) Each filter shall be marked as to its material of construction and its thickness and, for wedge filters, the wedge angle shall appear on the wedge or wedge tray; and
(3) The radiation at five (5) centimeters from the filter insertion slot opening does not exceed thirty (30) roentgens per hour under operating conditions.
Section 7. Focal Spot Marking and Assembly Immobilization. The tube housing assembly shall be marked so that it is possible to determine the location of the focal spot to within five (5) millimeters and the marking shall be readily accessible for use during calibration procedures. In addition the assembly shall be capable of being immobilized during stationary treatments.
Section 8. Contact Therapy Beam Block. Contact therapy tube housing assemblies shall have a removable shield of at least five-tenths (0.5) mm lead equivalent material at 100 kVp that can be positioned over the entire useful beam port during periods that the beam is not in use.
Section 9. Beam Monitor System. Therapy x-ray systems registered after March 2, 1977 which are capable of operating above 150 kVp shall be provided with a beam monitoring system which meets the following requirements:
(1) The beam monitoring system shall have a detector interlock to prevent incorrect positioning;
(2) The beam monitoring system shall have a display at the control panel from which the dose at a reference point in soft tissue can be calculated;
(3) The control panel display shall maintain the administered dose reading until intentionally reset to zero;
(4) If a system malfunctions or electrical power failure occurs the dose administered to a patient prior to the system's malfunction or power failure can be accurately determined;
(5) The beam monitoring system shall not allow irradiation until a preselected value of exposure has been made at the treatment control panel;
(6) The beam monitoring system shall be capable of independently terminating irradiation if the preselected exposure has been reached; and
(7) The control panel display shall not have scale multiplying factors and shall utilize a design that displays increasing dose by increasing numbers.
Section 10. Timers. Therapeutic x-ray systems shall be provided with timers which meet the following requirements:
(1) The timer shall have a display at the control panel with a preset time selector and an elapsed time indicator;
(2) The timer shall be a cumulative timer which activates with the production of radiation and retains its reading after irradiation is interrupted or terminated. It shall be necessary to zero the elapsed time indicator after irradiation is terminated and before irradiation can be reinstated.
(3) The timer shall terminate irradiation after a preselected time has elapsed if a dose monitoring system present has not previously terminated irradiation.
(4) The timer shall permit accurate presetting and determination of exposure times as short as one (1) second and shall not permit an exposure if set at zero; and
(5) The timer shall not activate until the shutter is open if the irradiation is controlled by a shutter mechanism.
Section 11. Control Panel. The control panel, in addition to other display requirements of this administrative regulation, shall meet the following requirements:
(1) The control panel shall indicate the presence of electrical power, the possibility of tube activation, the production of x-rays, and the actual kilovoltage and current across the tube;
(2) A means shall be provided for terminating an exposure at once;
(3) A locking device shall be provided which prevents unauthorized use of the x-ray system; and
(4) A display shall be provided on systems registered after March 2, 1977 which indicates specific filter(s) in the useful beam.
Section 12. Control Panels Which Control More Than One (1) Tube. If a control panel may energize more than one (1) x-ray tube then the following requirements shall be met:
(1) Only one (1) x-ray tube may be activated at one (1) time;
(2) The control panel shall indicate which x-ray tube is energized; and
(3) Each x-ray tube shall indicate whether that tube is energized.
Section 13. Source-to-skin Distance. A means shall be provided to determine the source-to-skin distance to within one (1) centimeter.
Section 14. Shutter Control. Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five (5) seconds, the entire useful beam shall be automatically attenuated by a shutter having a lead equivalency not less than that of the tube housing. Systems using shutter control shall meet the following requirements:
(1) The shutter shall be electrically controlled by the operator from the control panel; and
(2) An indication of shutter position shall appear at the control panel. The control panel shall indicate whether the shutter is open or closed.
Section 15. Facility Design and Shielding Requirements for X-ray Systems Capable of Operating Above Fifty (50) kVp. In addition to the shielding adequate to meet the requirements of 902 KAR 100:105, the following requirements shall also be met:
(1) Provision shall be made for two (2) way aural communication with the patient from the control room; however, if excessive noise levels make aural communication impractical other methods of communication shall be used;
(2) Windows, mirror systems, or closed-circuit television viewing screens or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator may see the patient and the control panel from the same position. If the primary viewing system is by electronic means (e.g., television) an alternate viewing system shall be available as a back-up if electronic failure occurs;
(3) The therapy room shall be so constructed that persons may be able to escape from within; and
(4) Facilities which contain an x-ray system which may be operated above 150 kVp shall meet the following requirements:
(a) Protective barriers shall be fixed barriers, except for entrance doors or beam interceptors.
(b) The control panel shall be located outside the treatment room;
(c) Doors of the treatment room shall be electrically connected to the control panel so that x-ray production cannot occur unless the door is closed;
(d) Doors referred to in paragraphs (a) and (c) of this subsection, shall be interlocked electrically so that they are closed before treatment can be initiated or continued. If the irradiation is interrupted by a door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and
(e) If a door referred to in paragraph (d) of this subsection is opened while the x-ray tube is activated, the exposure at a distance of one (1) meter from the source shall be reduced to less than 100 milliroentgens per hour.
Section 16. Surveys and Calibrations. New facilities and existing facilities not previously surveyed, shall have a radiation protection survey made by or under the direction of a qualified expert. A survey shall also be conducted after changes in the facility which might cause a significant increase in a radiation hazard.
(1) The registrant shall obtain a written report of this survey from the qualified expert and a copy of this report shall be transmitted by the registrant to the cabinet within thirty (30) days of receipt of the report. The survey and report shall indicate instances where the installation, in the opinion of the qualified expert, is in noncompliance of applicable administrative regulations.
(2) The calibration of an x-ray system shall be performed at intervals not to exceed one (1) year and after changes or replacement of components which are likely to change the radiation output. This calibration shall be performed by or under the direction of a qualified expert who is physically present at the facility during the calibration. Calibration of the radiation output shall be performed with a calibrated dosimetry system which is directly traceable to national standards and which shall have been calibrated within the preceding two (2) years. Records of calibrations shall be maintained by the registrant for five (5) years. The calibration shall include at least the following determinations:
(a) Verification that the system is operating in compliance with the design specifications;
(b) The exposure rate as a function of field size, technique factors, filter, and treatment distance used;
(c) The congruence between the radiation field and field indicated by the localizing device if localizing devices are used for radiation therapy; and
(d) The uniformity of the largest radiation field used.
(3) The calibration determinations prescribed in subsection (2) of this section shall be performed in a manner that the dose at a reference point in soft tissue can be calculated within plus or minus five (5) percent of the intended absorbed dose.
(4) A copy of the most recent x-ray system calibration shall be available at or in the area of the control panel.
(5) Therapeutic x-ray systems capable of operation at greater than 150 kVp shall also have spot checks performed which meet the following:
(a) The spot check procedures shall specify the frequency at which tests or measurements are to be performed. The spot check procedures shall specify that the spot check shall be performed during the calibration specified in subsection (2) of this section. The acceptable tolerance for each parameter measured in the spot check compared to the value for that parameter determined in the calibration specified in subsection (2) of this section shall be stated;
(b) The spot check methods shall be in writing and shall have been designed by a qualified expert. A copy of the procedures shall be submitted to the cabinet prior to its implementation;
(c) If a qualified expert does not perform the spot check measurement, the results of the spot check measurements shall be reviewed by a qualified expert within fifteen (15) days;
(d) If a spot check indicates a significant change in the operating characteristics of a machine, the machine shall be recalibrated as required by subsection (2) of this section;
(e) Records of spot check measurements shall be maintained for two (2) years after completion of the spot check measurements and necessary corrective actions;
(f) The spot check procedures shall specify the frequency at which tests of measurements are to be performed the spot check procedures shall specify that the spot check shall be performed during the calibration specified in subsection (2) of this section shall be stated;
(g) The cause for a parameter exceeding a tolerance set by the qualified expert shall be investigated and corrected before the system is used for patient irradiation; and
(h) If a spot check involves a radiation measurement, the measurement shall be obtained using a system satisfying the requirements of subsection (2) of this section or which has been intercompared with a system meeting those requirements within the previous year.
Section 17. Operating Procedures. Therapeutic x-ray systems shall be operated so the following requirements are met:
(1) The facility shall be operated in compliance with any limitations indicated by the radiation protection survey which have been approved by the cabinet;
(2) The x-ray system shall not be used in the administration of radiation therapy unless the requirement of Section 16 of this administrative regulation has been met;
(3) Therapeutic x-ray systems shall not be left unattended unless the locking device required by Section 10(3) of this administrative regulation is set to prevent activation of the useful beam;
(4) If a patient is required to be held in position for radiation therapy, mechanical supporting or restraining devices shall be used;
(5) The tube housing assembly shall not be held by hand during operation unless the system is designed to require holding and the potential difference of the system does not exceed fifty (50) kVp. In this instance the holder shall wear protective gloves and apron of not less than five-tenths (0.5) mm lead equivalency at 100 kVp;
(6) No individual other than the patient shall be in the treatment room unless the individual is protected by a barrier sufficient to meet the requirements of 902 KAR 100:020. No individual other than the patient shall be in the treatment room during exposures from x-ray systems operating above 150 kVp; and
(7) The x-ray system shall not be used in the administration of radiation therapy unless the requirements of subsections (2) and (5)(d) of this section have been met.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling, and disposal of radioactive waste. The purpose of this administrative regulation is to provide special requirements for the possession, use, and operation of therapeutic x-ray systems which operate at energies below one (1) MeV.
- History: 3 Ky.R. 570; eff. 3-2-1977; 12 Ky.R. 1402; eff. 3-4-1986; 18 Ky.R. 1559; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:137 Therapeutic systems above one (1) MeV {#sec-902-kar-100-137 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:137}
Section 1. Applicability. This administrative regulation shall apply to therapeutic x-ray and electron systems which operate at energies of one (1) MeV and above and to persons, equipment and materials used in connection with the possession, use or operation of these systems.
Section 2. Leakage Radiation to the Patient Area.
(1) Systems registered after March 2, 1977 shall meet the following requirements:
(a) For operating conditions producing maximum leakages the absorbed dose in rads due to leakage radiation (including electrons, x-rays and neutrons) at a point in a circular plane of radius two (2) meters centered on and perpendicular to the central axis of the beam at the isocenter or normal treatment distance and outside the maximum useful beam shall not exceed one-tenth (0.1) percent of the maximum absorbed dose in rads of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the plane surface. Measurements, excluding those for neutrons, shall be averaged over an area up to but not exceeding 100 square centimeters at the position specified. Measurements of the portion of the leakage radiation dose contributed by neutrons shall be averaged over an area up to but not exceeding 200 square centimeters; and
(b) The registrant shall determine or obtain from the manufacturer, for each system, the leakage radiation existing at the points specified in paragraph (a) of this subsection for specified operating conditions. Records of radiation leakage shall be maintained at the installation.
(2) Systems registered before March 2, 1977, shall meet the following requirements:
(a) For operating conditions producing maximum leakage radiation, the absorbed dose rate in rads due to leakage radiation (excluding neutrons) at a point on the area specified in subsection (1)(a) of this section shall not exceed one-tenth (0.1) percent of the maximum absorbed dose in rads of the unattenuated useful beam dose rate at one (1) meter from the source, for its operating conditions. Measurements shall be averaged over an area up to but not exceeding 100 square centimeters; and
(b) The registrant shall determine or obtain from the manufacturer for each system the leakage radiation existing at the points specified in subsection (1)(a) of this section for the specified operating conditions. Records of radiation leakage shall be maintained at the installation.
(3) If neutron leakage may be a hazard the cabinet may, by specific order, impose upon a user additional requirements, as it deems appropriate or necessary to protect health and minimize danger to life or property. If imposing additional requirements, the cabinet shall give due consideration to accepted standards of safe practice.
Section 3. Leakage Radiation Outside the Patient Area. The leakage radiation outside the patient area shall meet the following requirements:
(1) The absorbed dose in rads due to leakage radiation, except in the area defined in Section 2(1)(a) of this administrative regulation, measured at one (1) meter from the path of the charged particle, before the charged particle strikes the target or window, shall not exceed one-tenth (0.1) percent for x-ray leakage, nor .05 percent for neutron leakage of the maximum absorbed dose in rads of the unattenuated useful beam measured at the point of intersection of the central axis of the beam and the circular plane specified in Section 2(a) of this administrative regulation; and
(2) The registrant shall determine or obtain from the manufacturer the actual leakage radiation existing at the points specified in Section 2(1)(a) of this administrative regulation for specific operating conditions. Measurements, excluding neutrons, shall be averaged over an area up to but not exceeding 100 square centimeters. Neutron measurements shall be averaged over an area up to but not exceeding 200 square centimeters.
Section 4. Beam Limiting Devices. Adjustable or interchangeable beam limiting devices shall be provided so that the following requirements are met:
(1) Adjustable or interchangeable beam limiting devices shall transmit no more than two (2) percent of the useful beam at the normal treatment distance for the portion of the useful beam which is to be attenuated by the beam limiting device. Neutrons are not included in this requirement;
(2) If the beam limiting device on existing equipment does not meet the requirements of subsection (1) of this section the cabinet may accept auxiliary equipment or methods for accomplishing attenuation; and
(3) Dose equivalent measurements shall be averaged over an area up to but not exceeding 100 square centimeters at a distance of one (1) meter from the target. If overlapping beam limiting devices are present, the leakage through each set shall be measured independently.
Section 5. Filters. Filters shall be provided so that the following requirements are met:
(1) If the absorbed dose rate information provided in Section 17 of this administrative regulation relates exclusively to operation with a field flattening or beam scattering filter in place, then the filter shall be a permanent filter only removable by the use of tools; and
(2) In therapy systems which use a system of wedge filters or interchangeable field flattening filters or beam scattering filters the following requirements shall be met:
(a) Irradiation shall not be possible until a selection of filter has been made at the control panel;
(b) An interlock system shall be provided to prevent irradiation if the filter is not in the correct position; and
(c) A display shall be provided at the control panel showing the filter(s) (or zero filter) in use.
Section 6. Beam Quality. The beam quality for therapy systems shall meet the following requirements:
(1) The absorbed dose, from x-ray stray radiation in the useful electron beam, on the central axis of the beam at a depth ten (10) cm further than the practical range shall not exceed the following limits:
(a) Three (3) percent of the maximum absorbed dose for electron beam energies to fifteen (15) MeV;
(b) Five (5) percent of the maximum absorbed dose for electron beam energies in the range fifteen (15) to thirty-five (35) MeV;
(c) Ten (10) percent of the maximum absorbed dose for electron beam energies in the range thirty-five (35) MeV to fifty (50) MeV;
(d) Twenty (20) percent of the maximum absorbed dose for electron beam energies fifty (50) MeV or greater; and
(e) Linear interpolation shall be used for values not stated.
(2) The measurements required by subsection (1) of this section shall be made at electron beam maximum size not exceeding fifteen (15) by fifteen (15) cm in a phantom whose cross-sectional dimensions exceed the measurement radiation field by at least five (5) cm and whose depth is sufficient to perform the required measurement. The incident surface of the phantom shall be at the normal treatment distance and normal to the central axis of the beam.
(3) At the largest field size available, the absorbed dose from electron stray radiation in the useful x-ray beam, at the surface during x-ray irradiation on the central axis of the beam shall not exceed the following limits;
(a) Eighty (80) percent of the maximum absorbed dose for x-ray beam maximum energies in the range of one (1) to two (2) MeV;
(b) Seventy (70) percent of the maximum absorbed dose for x-ray beam maximum energies in the range of two (2) to five (5) MeV;
(c) Sixty (60) percent of the maximum absorbed dose for x-ray beam maximum energies in the range of five (5) to fifteen (15) MeV;
(d) Fifty (50) percent of the maximum absorbed dose for x-ray beam maximum energies in the range of fifteen (15) to thirty-five (35) MeV;
(e) Forty (40) percent of the maximum absorbed dose for x-ray beam maximum energies in the range of thirty-five (35) through fifty (50) MeV; and
(f) Linear interpolation shall be used for values not stated.
(4) The measurements required by subsection (3) of this section shall be made using a phantom of size and placement which meet the requirements of subsection (2) of this section. An instrument which allows extrapolation to the surface absorbed dose shall be used. Beam modifying devices which are removed without the use of tools, except beam scattering or field flattening filters, shall be removed from the useful beam.
(5) The registrant shall determine, or obtain from the manufacturer, the maximum percentage absorbed dose in the useful beam due to neutrons, excluding stray neutron radiation for specified operating conditions.
Section 7. Beam Monitors. Systems registered after March 2, 1977 shall be provided with two (2) radiation detectors in the radiation head. The two (2) detectors shall be incorporated into two (2) dose monitoring systems. Systems registered before March 2, 1977 shall be provided with at least one (1) radiation detector in the radiation head. This detector shall be incorporated into a primary dose monitoring system. Beam monitoring systems shall meet the following requirements:
(1) The detectors shall be removable only with tools and shall be interlocked to prevent incorrect positioning.
(2) Each detector shall be capable of independently monitoring, interrupting, and terminating the useful beam;
(3) Each detector shall form part of a dose monitoring system from whose readings in dose monitor units the absorbed dose at a reference point in the treatment volume can be calculated;
(4) For systems registered after March 2, 1977 the design of the dose monitoring systems of subsection (4) of this section shall ensure that the malfunctioning of one (1) system shall not affect the correct functioning of the second system. In addition the failure of an element which may be common to both systems shall terminate the useful beam; and
(5) Each dose monitoring system shall have a legible display at the control panel. Each display shall also meet the following requirements:
(a) Maintain a reading until intentionally reset to zero;
(b) In the event of power failure, have the capability of retrieving the information displayed in at least one (1) system for twenty (20) minute period of time after failure occurs;
(c) On systems registered after March 2, 1977 the display shall have only one (1) scale and no scale multiplying factors; and
(d) A design shall be utilized so that increasing dose is displayed by increasing numbers and shall be so designed that in the event of an overdosage of radiation the absorbed dose may be accurately determined.
Section 8. Beam Symmetry. The useful beam shall be symmetrical within the following requirements:
(1) For systems registered after March 2, 1977 and inherently capable of producing useful beams with a symmetry exceeding five (5) percent. The asymmetry of the radiation beam in two (2) orthogonal directions shall be monitored before the beam passes through the beam limiting device. Means shall be provided so that, if the difference in the dose rate between one (1) region and another region symmetrically displaced from the central axis of the beam exceeds five (5) percent of the central axis dose rate, indication of this condition is made at the control panel; and if this difference exceeds ten (10) percent, the irradiation is terminated; and
(2) On systems registered before March 2, 1977 if the cabinet has determined that beam symmetry is inadequate the use of an automatic beam asymmetry warning system shall be required.
Section 9. Selection and Display of Dose Monitor Units. Irradiation shall not be possible until a selection of a number of dose monitor units has been made at the control panel. In addition dose monitor units shall also meet the following requirements:
(1) After the useful beam terminates it shall be necessary to reset the preselected dose monitor units before treatment can be reinitiated;
(2) The preselected number of dose monitor units shall be displayed at the control panel until manually reset for the next irradiation; and
(3) For systems registered after March 2, 1977, it shall be necessary to manually reset the preselected dose monitor units before radiation can be initiated.
Section 10. Termination of Irradiation by the Dose Monitoring System or Systems During Stationary Beam Therapy. Each of the required dose monitoring systems shall terminate irradiation when the preselected number of dose monitor units has been detected by the system. Dose monitoring systems shall also meet the following requirements:
(1) Each primary system shall terminate irradiation when the preselected number of dose monitor units has been detected by the system.
(2) If the original design of the equipment included a second dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen (15) percent of forty (40) dose monitor units above the preselected number of dose monitor units set at the control panel has been detected by the second dose monitoring system; and
(3) For systems registered after March 2, 1977 the beam shall terminate automatically when the secondary system detects more than ten (10) percent or twenty-five (25) dose monitor units above the preset dose monitor units and indicators on the central panel shall show which system has terminated the beam.
Section 11. Termination Switches. It shall be possible to terminate irradiation and equipment movement or to go from an interruption condition to termination conditions at once from the control panel.
Section 12. Interruption Switches. It shall be possible to interrupt irradiation and equipment movements at once from the control panel. Following an interruption if shall be possible to restart irradiation by operator action without reselection of operating conditions. If a change is made of a preselected value during interruption the system shall go to termination condition.
Section 13. Timers. A timer shall be provided, have a display at the control panel, a preset time selector and an elapsed time indicator. The timer shall be a cumulative timer which switches on and off with the irradiation and retains its reading after irradiation is interrupted or terminated. If shall be necessary to zero the elapsed time indicator after irradiation is terminated. To guard against failure of the dose monitoring systems, the timer shall terminate irradiation when a preselected time has elapsed.
Section 14. Selection of Radiation Type. In systems capable of both x-ray and electron therapy the following requirements shall be met:
(1) Irradiation shall not be possible until a selection of radiation type (x-ray or electrons) has been made at the control panel;
(2) An interlock system shall be provided to ensure that the system can emit only the radiation type which has been selected;
(3) An interlock system shall be provided to prevent irradiation if selected operations carried out in the treatment room do not agree with the selected operations carried out at the control panel;
(4) An interlock system shall be provided to prevent irradiation with x-ray except to obtain a port film if electron applicators are fitted and irradiation with electrons if accessories specific for x-ray therapy are fitted; and
(5) The radiation type shall be displayed at the control panel before and during irradiation.
Section 15. Selection of Energy. In systems capable of generating radiation beams of different energies the following requirements shall be met:
(1) Irradiation shall not be possible until a selection of energy has been made at the control panel;
(2) An interlock system shall be provided to prevent irradiation if selected operations carried out in the treatment room do not agree with the selected operations carried out at the control panel;
(3) The nominal energy value selected shall be displayed at the control panel before and during irradiation; and
(4) For equipment registered after the effective date of these administrative regulations, an interlock system shall be provided to terminate irradiation if the energy of the electrons striking the x-ray target or electron window deviates by more than twenty (20) percent or three (3) MeV, whichever is smaller, from the selected nominal energy.
Section 16. Selection of Stationary Beam Therapy or Moving Beam Therapy. In systems capable of both stationary and moving beam therapy the following requirements shall be met:
(1) Irradiation shall not be possible until a selection of stationary or moving beam therapy has been made at the control panel;
(2) An interlock system shall be provided to ensure that the system can operate only in the mode which has been selected;
(3) An interlock system shall be provided to prevent irradiation if selected operations carried out in the treatment room do not agree with the selected operations carried out at the control panel;
(4) The mode of operation shall be displayed at the control panel;
(5) For equipment registered after the effective date of this administrative regulation, an interlock system shall be provided to terminate irradiation if movement of the gantry occurs during stationary beam therapy or movement of the gantry stops during moving beam therapy unless stoppage is a preplanned function.
(6) Moving beam therapy shall be controlled to obtain the selected relationships between incremental dose monitor units and incremental angle of movement. Additionally for units registered after the effective date of this administrative regulation:
(a) An interlock system, shall be provided to terminate irradiation if the number of dose monitor units delivered in ten (10) degrees of arc differs by more than twenty (20) percent from the selected value; and
(b) Where gantry angle terminates the irradiation in arc therapy, the dose monitor units shall differ by less than five (5) percent from the value calculated from the absorbed dose per unit angle relationship.
(7) Where the dose monitor system terminates the irradiation in arc therapy, the termination of irradiation shall be required by Section 10 of this administrative regulation.
Section 17. Absorbed Dose Rate. In systems registered after March 2, 1977 a system shall be provided from whose readings the absorbed dose rate at a reference point in the treatment volume can be calculated. The radiation detectors specified in Section 7 of this administrative regulation may form part of this system. In addition the following requirements shall be met:
(1) The dose monitor units shall be displayed at the control panel; and
(2) If the system can deliver an absorbed dose rate at the normal treatment distance more than twice the maximum value specified by the manufacturer for machine parameters utilized, a device shall be provided which terminates irradiation if the dose rate exceeds a value not more than twice the specified maximum. The value at which the irradiation is terminated shall be a record maintained by the registrant.
Section 18. Location of Virtual Source and Beam Orientation. The registrant shall determine or obtain from the manufacturer the location with reference to an accessible point on the radiation head the following points:
(1) The x-ray target or the virtual source of x-rays; and
(2) The electron window or the virtual source of electrons if the system has electron beams capabilities.
Section 19. System Checking Facilities. Facilities shall be provided so that radiation safety interlocks can be checked. If preselection of operating conditions requires action in the treatment room and at the control panel, selection at one (1) location shall not give a display at the other location until the requisite selected operations in both locations have been completed.
Section 20. Auxiliary Support of Patients. If a patient is required to be held in position for radiation therapy, mechanical supporting or restraining devices shall be used. No person other than the patient shall be in the treatment room during irradiation.
Section 21. Facility and Shielding Requirements. In addition to shielding adequate to meet the requirements of 902 KAR 100:105, the following requirements shall be met:
(1) Except for entrance doors and beam interceptors the required barriers shall be fixed barriers;
(2) The control panel shall be located outside the treatment room;
(3) Windows, mirror systems, closed-circuit television viewing screens or other equivalent viewing systems shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator may see the patient and the control panel from the same position. If the viewing system is by electronic means (e.g., television) an alternate viewing system shall be provided for use in the event of failure of the primary system;
(4) Provision shall be made for two (2) way aural communication with the patient from the control station. However, if excessive noise levels or treatment requirements make aural communication impractical, other methods of communications shall be used;
(5) The treatment room shall be so constructed that persons may be able to escape from within;
(6) Treatment room entrances to which access is possible through more than one (1) entrance, shall be provided with warning lights in a readily observable position near the outside of access doors, which indicate if the useful beam is "on." These warning lights shall be accompanied by an appropriate sign as specified in 902 KAR 100:020, Section 12; and
(7) Interlocks shall be provided so that entrance doors shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by a door opening, it shall be possible to restore the machine to operation only by closing the door and reinitiating exposure by manual action at the control panel.
Section 22. Protection Survey. New facilities, and existing facilities not previously surveyed, shall have a radiation protection survey made by, or under the direction of a qualified expert. The survey shall also be conducted after a change in the facility which might produce a radiation hazard.
(1) The registrant shall obtain a written report of the survey and a copy of the report shall be transmitted by the registrant to the cabinet within thirty (30) days of receipt of the report.
(2) The survey and report shall indicate instances where the facility in the opinion of the qualified expert is in violation of the applicable therapy radiation administrative regulations and shall cite the sections violated.
Section 23. Calibrations. The output of each therapeutic x-ray system shall be calibrated by a qualified expert, before it is first used for medical purposed. Calibrations shall be repeated at least once every twelve (12) months and after changes which might significantly increase radiation hazards. Calibration of the therapy beam shall be performed with a measurement instrument having a calibration factor for cobalt - sixty (60) gamma rays, and which shall have been calibrated within the preceding two (2) years and after servicing that may have affected its calibration. Records of calibrations shall be maintained by the registrant for five (5) years after completion of the full calibration. The records shall be in sufficient detail that the dose at a reference point in soft tissue may be calculated to within an uncertainty of five (5) percent. A copy of the latest calibration shall be available in the area of the control panel. The calibration shall include at least the following determinations:
(1) Verification that the system is operating in compliance with the design specifications concerning the light localizer, the side light and back-pointer alignment with the isocenter, if applicable, variation in the axis of rotation for the table, gantry, and jaw system, and beam flatness and symmetry at the specific depths;
(2) The absorbed dose rate at various depths of water for the range of and field sizes used and for each effective energy that verifies the accuracy of the dosimetry of therapy procedures utilized with that therapy beam;
(3) In uniformity of the radiation field an its dependence upon the direction of the useful beam;
(4) Verification that existing depth-dose data and isodose charts applicable to the specific machine continue to be valid or are updated to existing machine conditions; and
(5) Verification of transmission and electron buildup factors for accessories, i.e., wedges, shadow trays and compensators.
Section 24. Spot Checks. A spot check shall be made monthly and shall include carefully selected representative or indicative measurements which demonstrate the consistency of relevant system operating characteristics, or lack of same. Spot checks shall meet the following requirements:
(1) The spot check methods shall be in writing, shall have been designed by a qualified expert and a copy of the procedure shall be submitted to the cabinet prior to its implementation;
(2) If a qualified expert does not perform the spot check measurements, the results of the spot check measurements shall be reviewed by the qualified experts within fifteen (15) days;
(3) The spot check procedures shall specify the frequency at which tests or measurements are to be performed and the acceptable tolerance for each parameter measured in the spot check when compared to the value for that parameter determined in the calibration;
(4) At intervals not to exceed one (1) week, spot checks shall be made of absorbed dose measurements at a minimum of two (2) depths in a phantom;
(5) If a spot check indicates a significant change (as specified in the qualified experts spot check design) in the operating characteristics of a system, the system shall be recalibrated as required by Section 23 of this administrative regulation;
(6) If a system has a built in device which provides a self-check of parameters during irradiation, the measurement shall not be utilized as a spot check measurement;
(7) The course for a parameter exceeding a tolerance set by the qualified expert shall be investigated and corrected before the system is used for patient irradiation;
(8) Records of spot check measurements shall be maintained by the registrant for a period of two (2) years after completion of the spot check measurements and necessary corrective actions; and
(9) If a spot check involves a radiation measurement, the measurement shall be obtained using a system meeting the requirements of Section 23 of this administrative regulation or which has been intercompared with a system meeting those requirements within the previous year.
History
- RELATES TO: KRS 211.842-211.850, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide special requirements for the possession, use and operation of therapeutic x-ray and electron systems which operate at energies of one (1) MeV and above.
- History: 3 Ky.R. 573; eff. 3-2-1977; 12 Ky.R. 1406; eff. 3-4-1986; 18 Ky.R. 1563; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:140 Veterinarians {#sec-902-kar-100-140 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:140}
Section 1. Applicability. This administrative regulation shall apply to radiographic x-ray systems for veterinary medicine and to persons, equipment, and materials used in connection with the possession, use or operation of these systems.
Section 2. Equipment. Veterinary radiographic x-ray systems shall meet the following requirements:
(1) The protective tube housing assembly shall be of the diagnostic type;
(2) The primary beam shall be restricted by cones, shutters, diaphragms, or adjustable collimators. No dimension of the x-ray field, measured in the plane of the image receptor, shall exceed the corresponding dimension of the image receptor by more than two (2) percent of the source to image receptor distance (SID) measured if the plane of the image receptor is perpendicular to the primary ray of the x-ray field. This paragraph shall not be construed to require enlarging the x-ray field size if the x-ray field size is less than the size of the image receptor.
(3) A means shall be provided to align the center of the x-ray field with the center of the image receptor to within two (2) percent of the source to image receptor distance;
(4) A device shall be provided to terminate the exposure after a preset time or exposure; and
(5) A dead man type of exposure switch shall be provided, together with an electrical cord of sufficient length, so that the operator can conveniently stand at least one and eight-tenths (1.8) meters from the tube housing assembly, the animal, and the useful beam during x-ray exposures if the exposure to the operator is within the limits provided by 902 KAR 100:020, Section 20.
Section 3. Structural Shielding. Wall, ceiling, and floor areas shall be equivalent to or provided with applicable protective barriers as required by 902 KAR 100:105, Section 2(2)(i).
Section 4. Operating Procedures. In the operation of a veterinary radiographic x-ray system the following requirements shall be met:
(1) The operator shall stand well away from the useful beam and the animal during radiographic exposures. No individual other than the operator shall be in the x-ray room while exposures are being made unless an individual's assistance is required; and
(2) If an animal is held in position during radiography, mechanical supporting or restraining devices shall be available and used if possible. If an animal is held by an individual, that individual shall be protected with appropriate shielding devices (protective gloves and apron), and shall be so positioned that no part of his body shall be struck by the useful beam. In addition, the exposure of an individual used for this purpose shall be monitored and no individual shall routinely be used to hold animals.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide special requirements for the possession, use, and operation of radiographic x-ray systems for veterinary medicine purposes.
- History: 1 Ky.R. 416; eff. 2-5-1975; 3 Ky.R. 561; eff. 3-2-1977; 12 Ky.R. 1410; eff. 3-4-1986; 18 Ky.R. 1569; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:142 Licenses and radiation safety requirements for well logging {#sec-902-kar-100-142 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:142}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 39 except as established in subsections (1) through (3) of this section.
(1) The licensee shall not be subject to the following:
(a) 10 C.F.R. 39.5;
(b) 10 C.F.R. 39.8;
(c) 10 C.F.R. 39.11;
(d) 10 C.F.R. 39.101; or
(e) 10 C.F.R. 39.103.
(2) Each application for a specific license shall be filed pursuant to 902 KAR 100:040.
(3) Reference to the "Commission", "NRC", or an agreement state shall be deemed to be a reference to the "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", the NRC, or an agreement state.
(4) Notifications required by 10 C.F.R. 39.77 shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502)564-1492: Facsimile;
(c) (502)564-3700: Telephone, Monday through Friday from 8 a.m. to 4:30 p.m.; or
(d) (800)255-2587: Telephone, for hours outside of those in paragraph (c).
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 39, 42 U.S.C. 2021
- STATUTORY AUTHORITY: KRS 194.050(1), 211.090(3), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.844 requires the Cabinet for Health and Family Services to promulgate administrative regulations for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation provides the requirements for the issuance of a license authorizing the use of licensed materials including sealed sources, radioactive tracers, radioactive markers, and uranium sinker bars in well logging in a single well..
- History: 5 Ky.R. 293; eff. 11-1-1978; 12 Ky.R. 1069; eff. 1-3-1986; 16 Ky.R. 2556; eff. 6-27-1990; 21 Ky.R. 2311; eff. 4-19-1995; 38 Ky.R. 850; 1142; eff. 12-7-2011; 41 Ky.R. 953; 1642; eff. 2-5-2015; 45 Ky.R. 550, 1288, 1667; eff. 12-12-2018; Crt eff. 5-19-2025.
902 KAR 100:145 Cabinet systems {#sec-902-kar-100-145 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:145}
Section 1. Applicability. This administrative regulation shall apply to persons who possess, use or operate cabinet x-ray systems. This administrative regulation does not apply to microscopic analytical x-ray systems.
Section 2. For cabinet x-ray systems installed prior to April 10, 1975, the systems shall:
(1) Have the radiation machine and objects exposed thereto, within a permanent enclosure, within which no person is permitted to remain during the generation of x-radiation.
(2) Have adequate interlocks provided so that if doors or panels to the enclosure are opened, the radiation-producing machine is shut off automatically. After shutoff, it shall be possible to restore the machine to full operation only from the control panel outside the room.
(3) If the enclosure is of a size or is so arranged that the operator cannot readily determine whether the enclosure is unoccupied, there shall be provided:
(a) Audible or visible warning signals within the enclosure which are required to be activated before irradiation can be started.
(b) Suitable means of exit, so that a person who accidentally may be shut in can leave the enclosure without delay, or effective means within the enclosure for preventing or quickly interrupting the irradiation, and which cannot be reset from outside the enclosure.
(4) Except as provided in subsection (5) of this section, the exposure at accessible regions two (2) inches from the outside surface of the enclosure cannot exceed five-tenths (0.5) milliroentgen in one (1) hour.
(5) If the registrant has submitted operating and safety procedures, and the cabinet has approved the procedures, which can show that an individual cannot receive a radiation dose in excess of the limits specified in these administrative regulations, the radiation levels specified in subsection (4) of this section may be exceeded. However, cabinet x-ray systems under this subsection shall not exceed the limits specified below:
(a) The exposure at accessible and occupied areas one (1) foot from the outside surface of the enclosure shall not exceed ten (10) milliroentgens in one (1) hour.
(b) The exposure at accessible and normally unoccupied areas one (1) foot from the outside surface of the enclosure shall not exceed 100 milliroentgens in one (1) hour.
(6) Operating procedures.
(a) Before a new installation is placed in routine operation, a radiation protection survey shall be made. This shall also be done after changes in an existing installation which might affect its radiation safety.
(b) A copy of each radiation protection survey shall be signed and dated by the surveyor, and kept on file by the individual in charge of the installation.
(c) The installation shall be operated in conformance with recommendations of the protection survey.
(d) The registrant shall designate a competent employee as the radiation safety officer.
Section 3. For cabinet x-ray systems installed on or after April 10, 1975, systems shall:
(1) Have the radiation machine and objects exposed thereto, within a permanent enclosure, within which no person is permitted to remain during the generation of x-radiation.
(2) Be so constructed that radiation emitted from the cabinet x-ray system shall not exceed an exposure of five-tenths (0.5) milliroentgen in one (1) hour at points five (5) centimeters outside the external surface.
(3) Have a permanent floor. Support surfaces to which a cabinet x-ray system is permanently affixed may be deemed the floor of the system.
(4) Be so constructed that the insertion of part of the human body through ports or apertures shall not be possible.
(5) Be so constructed that each door of a cabinet x-ray system has a minimum of two (2) safety interlocks. One (1), but not both of the required interlocks, shall be configured in a manner that door opening results in physical disconnection of the energy supply circuit to the high-voltage generator, and this disconnection shall not be dependent upon moving parts other than the door.
(6) Be so constructed that each access panel shall have at least one (1) safety interlock.
(7) Following interruption of x-ray generation by the functioning of a safety interlock, use of a control provided in accordance with subsection (10)(b) of this section shall be necessary for resumption of x-ray generation.
(8) Be so constructed that failure of a single component of the cabinet x-ray system shall not cause failure of more than one (1) required safety interlock.
(9) Be so constructed that a ground fault shall not result in the generation of x-rays.
(10) For systems to which this section is applicable, there shall be provided:
(a) A key-actuated control to insure that x-ray generation is not possible with the key removed.
(b) A control or controls to initiate and terminate the generation of x-rays other than by functioning of a safety interlock of the main power control.
(c) Two (2) independent means which indicate if and only if x-rays are being generated, unless the x-ray generation period is less than one-half (1/2) second, then the indicators shall be activated for one-half (1/2) second, and which are discernible from points at which initiation of x-ray generation is possible. Failure of a single component of the cabinet x-ray system shall not cause failure of both indicators to perform their intended function. One (1), but not both, of the indicators required by this paragraph may be a milliammeter labeled to indicate x-ray tube current. Other indicators shall be legibly labeled "X-RAY ON."
(d) Additional means other than milliammeters which indicate if and only if x-rays are being generated, unless the x-ray generation period is less than one-half (1/2) second then the indicators shall be activated for one-half (1/2) second, to insure that at least one (1) indicator is visible from each door, access panel, and port, and is legibly labeled "X-RAY ON."
(11) For cabinet x-ray systems designed to admit humans, there shall also be provided:
(a) A control within the cabinet for preventing and terminating x-ray generation, which cannot be reset, overridden or bypassed from the outside of the cabinet.
(b) No means by which x-ray generation can be initiated from within the cabinet.
(c) Audible and visible warning signals within the cabinet which are activated for at least ten (10) seconds immediately prior to the first initiation of x-ray generation after closing doors designed to admit humans. Failure of a single component of the cabinet x-ray system shall not cause failure of both the audible and visible warning signals.
(d) A visible warning signal within the cabinet which remains actuated if and only if x-rays are being generated, unless the x-ray period is less than one-half (1/2) second then the indicators shall be activated for one-half (1/2) second.
(e) Signs indicating the meaning of the warning signals specified in subsection (11)(c) and (d) of this section and containing instructions for the use of the control specified in subsection (11)(a) of this section. These signs shall be legible, accessible to view, and illuminated if the main power control is in the "on" position.
(f) The designated operator(s) shall have a copy of the manufacturer's operating procedures and maintenance manual for the equipment being used and shall have been instructed in the proper techniques of equipment utilization.
(g) Tests for proper operation of interlock and door seal systems shall be conducted and recorded at intervals not to exceed one (1) month.
(12) Have permanently affixed or inscribed on the cabinet x-ray system at the location of controls which can be used to initiate x-ray generation, a clearly legible and visible label bearing the statement: "CAUTION: X-RAYS PRODUCED WHEN ENERGIZED."
(13) Have permanently affixed or inscribed on the cabinet x-ray system adjacent to each port a clearly legible and visible label bearing the statement: "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."
(14) Additional requirements for x-ray baggage inspection systems. X-ray systems designed primarily for the inspection of carryon baggage at airline, railroad, and bus terminals, and at similar facilities, shall be provided with means specified in paragraphs (a) and (b) of this subsection, to insure operator presence at the control area in a position which permits surveillance of the ports and doors during generation of x-radiation.
(a) During an exposure or preset succession of exposures of one-half (1/2) second or greater duration, the means provided shall enable the operator to terminate the exposure or preset succession of exposures at once.
(b) During an exposure or preset succession of exposures of less than one-half (1/2) second duration, the means provided may allow completion of the exposure in progress but shall enable the operator to prevent additional exposures.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to regulate the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide requirements for the possession, use or operation of cabinet x-ray systems.
- History: 1 Ky.R. 417; eff. 2-5-1975; 12 Ky.R. 1412; eff. 3-4-1986; 18 Ky.R. 1570; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:150 Microscopic analytic x-ray {#sec-902-kar-100-150 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:150}
Section 1. Applicability. The requirements in this administrative regulation shall apply to the use of microscopic analytical x-ray machines. The provisions of this administrative regulation are in addition to, and not in substitution for, other applicable provisions for these administrative regulations.
Section 2. Equipment.
(1) A label bearing essentially the words "CAUTION - RADIATION - THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" shall be placed near a switch which energizes a tube. Labels shall use the conventional colors (magenta or purple on yellow background) and bear the conventional radiation symbol.
(2) A sign bearing the words "CAUTION - HIGH INTENSITY X-RAY BEAM" shall be placed in the area immediately adjacent to each tube housing. The sign shall be so located that it is clearly visible to a person operating, aligning or adjusting the unit or handling or changing a sample.
(3) An apparatus utilized in beam alignment procedures shall be designed in a way that excessive radiation shall not strike the operator. Particular attention shall be given to viewing devices, in order to ascertain that lenses and other transparent components attenuate the beam to an acceptable level.
(4) Open beam configurations shall be provided with a readily discernible indication of:
(a) X-ray tube "on-off" status located near the radiation source housing, if the primary beam is controlled in this manner; or
(b) Shutter "open-closed" status located near each port on the radiation source housing, if the primary beam is controlled in this manner.
(c) Warning devices shall be labeled so their purpose is easily identified. On equipment installed after July, 1986, warning devices shall have fail-safe characteristics.
(5) A device which prevents entry or a portion of an individual's body into the primary beam or causes the primary beam to be shut off, shall be provided on open-beam configurations. A registrant may apply to the cabinet for an exemption from the requirement of a safety device. The application shall include:
(a) A description of the various safety devices that have been evaluated;
(b) The reason each evaluated device cannot be used; and
(c) A description of the alternative methods that are to be employed to minimize the possibility of an accidental exposure, including procedures to assure that operators and others in the area are informed of the absence of safety devices.
(6) If a shutter mechanism is used to control the primary beam, a shutter status (open or closed) indication shall be provided in the area adjacent to the tube head so that the position of the shutter is readily discernible.
(7) If an interlock device turns off the x-ray beam, it shall not be possible to resume operation without resetting the beam "ON" switch at the control panel.
(8) The tube housing leakage radiation at a distance of five (5) centimeters from accessible points on the surface of the tube housing shall not exceed two and five-tenths (2.5) mR per hour at each maximum specified tube rating. This measurement shall be made with a monitoring instrument appropriate for the energy range generated by the x-ray equipment, and shall be made with beam ports blocked off.
(9) Unused ports on radiation source housings shall be secured in the closed position in a manner which prevents casual opening.
(10) On open-beam configurations installed after July 1, 1986, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
Section 3. Administrative Responsibilities.
(1) An individual at each facility shall be designated to be responsible on behalf of the registrant for maintaining radiation safety. This individual, designated the radiation safety officer, shall be responsible for the following:
(a) Establishing and maintaining operation procedures so that the radiation exposure of each worker is kept as far below the maximum permissible dose as is practical;
(b) Instructing personnel who work with or near radiation machines in safety practices;
(c) Maintaining a system of personnel monitoring;
(d) Arranging for establishment of radiation control areas, including placement of appropriate radiation signs and devices;
(e) Providing for radiation safety inspection of radiation machines on a routine basis;
(f) Reviewing modifications to x-ray apparatus, including x-ray tube housing, cameras, diffractometers, shielding, and safety interlocks;
(g) Investigating and reporting to proper authorities cases of excessive exposure to personnel and taking remedial action; and
(h) Being familiar with applicable administrative regulations for control of ionizing radiation.
(2) No individual shall be permitted to act as an operator of a particular machine until an individual has received training in radiation safety as it applies to that machine and is approved by the radiation safety officer. The registrant shall assure that operators shall be responsible for:
(a) Keeping radiation exposure to himself and to others as low as is practical;
(b) Being familiar with safety procedures as they apply to each machine;
(c) Wearing of personnel monitoring devices, if applicable; and
(d) Notifying the radiation safety officer of known or suspected excessive radiation exposures to himself or others.
Section 4. Operating Procedures.
(1) Written emergency procedures pertaining to radiation safety shall be established for each x-ray producing apparatus by the radiation safety officer, and posted in a conspicuous location. These shall list the telephone number(s) of the radiation safety officer and shall include the following actions to be taken if a known, or suspected, accident involving radiation exposure occurs:
(a) Notify radiation safety officer; and
(b) Arrange for medical examination. Important: Notify examining physician that exposure to low energy x-rays may have occurred.
(2) Normal operating procedures shall be written and available to analytical x-ray equipment workers. No individual shall be permitted to operate analytical x-ray equipment in a manner other than specified in the procedures unless the individual has obtained written approval of the radiation safety officer.
(3) Only properly trained maintenance personnel shall be permitted to install, repair, or make other than routine modifications to the x-ray generating apparatus and the tube housing apparatus complex.
(4) If possible, x-ray diffraction and spectrographic equipment shall be placed in a room separate from other work areas.
(5) If it is necessary to temporarily, intentionally alter safety devices (e.g., bypassing interlocks or removing shielding) this action shall be:
(a) Specified in writing and posted near the x-ray tube housing so that other persons know the existing status of the machine; and
(b) Terminated as soon as possible.
(c) When a safety device or interlock has been bypassed, a readily discernible sign bearing the words "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed on the radiation source housing.
(6) Unused tube head ports shall be secured in the closed position and shall be checked prior to use if the machine has been left unattended.
(7) Personnel film badges or other monitoring devices shall be worn on the finger or wrist, rather than on the body. Finger or wrist dosimetric devices shall be provided to and shall be used by:
(a) Analytical x-ray equipment workers using systems having an open-beam configuration and not equipped with a safety device; and
(b) Personnel maintaining analytical x-ray equipment if the maintenance procedures require the presence of a primary x-ray beam when a local component in the analytical x-ray system is disassembled or removed.
(c) Reported dose values shall not be used for the purpose of determining compliance with 902 KAR 100:020 unless evaluated by a qualified expert.
(8) Analytical x-ray equipment shall not be left unattended while the tube is energized unless:
(a) An interlock device is provided to prevent accidental entry into the primary beam; and
(b) The stray radiation at accessible points at a distance of ten (10) inches from the tube housing or its containment, as measured with a monitoring instrument appropriate for the energy range generated, is no greater than two (2) milliroentgen per hour.
(9) Safety devices shall be tested at intervals not to exceed one (1) month.
(10) Records of personnel monitoring results and safety devices shall be maintained for inspection by the cabinet.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by regulation for the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide radiation safety requirements for microscopic analytical x-ray equipment and operation.
- History: 1 Ky.R. 418; eff. 2-5-1975; 12 Ky.R. 1414; eff. 3-4-1986; 18 Ky.R. 1572; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:155 Particle accelerator {#sec-902-kar-100-155 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:155}
Section 1. Applicability. The requirements in this administrative regulation apply to the use of particle accelerators by persons registering the machines under the provisions of these administrative regulations. The requirements of this administrative regulation are in addition to, and not in substitution for, other applicable provisions of these administrative regulations.
Section 2. Equipment.
(1) A label bearing essentially the words "CAUTION - RADIATION - THIS MACHINE PRODUCES RADIATION WHEN ENERGIZED" shall be placed near switches which energize portions of the machine. Labels shall use the conventional colors (magenta or purple on yellow background) and bear the conventional radiation symbol.
(2) Apparatus utilized in beam alignment procedures shall be designed in a way that radiation greater than limits prescribed in 902 KAR 100:020 shall not strike the operator.
(3) A switch or device which may cause the radiation machine to produce radiation if actuated shall be located on a control panel or console, and shall cause a warning light immediately adjacent to the switch or device to light; this light shall remain lit if, and only if, the associated control circuit is energized.
(4) Locations designated as high radiation areas, and entrances to the locations shall be equipped with easily observable flashing or rotating red or magenta warning lights that operate automatically if, and only if, radiation is being produced or may be produced.
(5) Each entrance into a target room or other high radiation area shall be provided with a safety interlock designed to terminate radiation production for the possible modes of machine operation under conditions of barrier penetration.
(6) Only a device on the accelerator control console shall be used to turn the accelerator beam on and off. The safety interlock system shall not be used to turn off the accelerator beam, except in an emergency. If the interlock system does turn off the accelerator, it shall not be possible to resume operation without resetting the accelerator "ON" device at the control console.
(7) Safety interlocks shall not be dependent upon the operation of a single circuit; i.e., they shall be of redundant or fail-safe design. Each safety interlock shall be on a circuit which shall allow it to operate independently of other safety interlocks.
(8) A scram button or other emergency power cutoff switch shall be located and easily identifiable in high radiation areas. The cutoff switch shall include a manual reset, so that the accelerator cannot be restarted from the accelerator console without resetting the cutoff switch.
(9) Circuit diagrams of the accelerator and the associated interlock systems shall be kept current and maintained for inspection by the cabinet and shall be available to the operator.
(10) A lock shall be provided on the control panel or console.
(11) Instrumentation, readouts, and controls on the particle accelerator control console shall be clearly identified and easily discernible.
(12) Safety interlocks shall be designed so that a defect or component failure in the safety interlock system prevents operation of the accelerator.
Section 3. Administrative Responsibilities.
(1) A person at each facility shall be appointed as the radiation safety officer, and shall be delegated responsibility for ensuring the following:
(a) Establishing and maintaining operational procedures so that the radiation dose received by a person is as low as reasonably achievable and below the maximum permissible dose as is practical;
(b) Instructing personnel who work with or near radiation producing machines, in radiation safety practices;
(c) Maintaining a system of personnel monitoring;
(d) Arranging for establishment of radiation control areas, including placement of appropriate radiation warning signs and devices;
(e) Providing for radiation safety inspection of radiation producing machines on a routine basis;
(f) Reviewing modifications to apparatus, shielding, and safety interlocks;
(g) Investigating and reporting to proper authorities excessive exposure to personnel and taking remedial action;
(h) Being familiar with applicable administrative regulations for the control of ionizing radiation;
(i) Terminating operations at the facility because of radiation safety considerations; and
(j) Maintaining records of these actions to document compliance with these administrative regulations.
(2) No individual shall be permitted to act as an operator of an accelerator until the person has:
(a) Received training in radiation safety and has been approved by the radiation safety officer; and
(b) Demonstrated competence to use the accelerator, related equipment, and radiation survey instruments to be employed.
(3) The registrant shall ensure that each operator shall:
(a) Keep radiation exposure to himself and to others as low as practical;
(b) Be familiar with safety procedures as they apply to each machine;
(c) Wear personnel monitoring devices, if applicable; and
(d) Notify the radiation safety officer of conditions or situations which may have resulted in, or threatens to result in, unnecessary radiation exposure.
(4) The registrant shall establish a radiation safety committee to approve in advance, proposals for uses of particle accelerators, if deemed necessary by the cabinet.
(5) A registrant authorized to use a particle accelerator in the healing arts shall:
(a) Appoint a medical committee of at least three (3) members to evaluate proposals for research, diagnostic, and therapeutic use of a particle accelerator if deemed necessary by the cabinet. Membership of the committee shall include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in depth dose calculations and protection against radiation;
(b) The individuals designated as users have substantial training and experience in deep therapy technique, or in the use of particle accelerators to treat humans; and
(c) An individual designated as a user is a physician.
(6) The radiation safety committee or the radiation safety officer shall have the authority to terminate the operations at a particle accelerator facility if this action is deemed necessary to minimize danger to public health and safety or property.
Section 4. Operating Procedures.
(1) Written operating procedures pertaining to radiation safety shall be established for each accelerator facility.
(2) Written emergency procedures pertaining to radiation safety shall be established and posted in a conspicuous location. These shall list the telephone number(s) of the radiation safety officer and shall include the following actions to be taken if a known, or suspected, accident involving radiation exposure occurs:
(a) Notifying radiation safety officer; and
(b) Arrange for medical examination.
(3) The registrant shall assure that operators and other appropriate personnel are familiar with and have been given a copy of the written operating and emergency procedures pertaining to radiation safety. Each operator shall demonstrate an understanding of these procedures and the applicable requirements of 902 KAR 100:020 and 902 KAR 100:165. These procedures shall be maintained at the accelerator control panel.
(4) Particle accelerators shall be secured if not in operation to prevent unauthorized use.
(5) The registrants shall assure that personnel do not expose a part of their body to the radiation beam.
(6) If it is necessary to intentionally alter safety devices, e.g., bypassing interlocks or removing shielding action shall be:
(a) Specified in writing and posted on the control console and at each entrance requiring a safety interlock as required by this administrative regulation so that other persons know the existing status of the machine;
(b) Terminated as soon as possible; and
(c) Authorized by the radiation safety committee or radiation safety officer.
(7) Accelerators shall not be left unattended while energized.
(8) Safety devices shall be tested for proper operation at intervals not to exceed three (3) months.
(9) Records of personnel monitoring results and safety device tests shall be maintained for inspection by the cabinet.
(10) Appropriate, portable radiation monitoring equipment shall be available at the accelerator facility, properly maintained and calibrated, and sensitive to those radiations being monitored. The monitoring equipment shall be tested for proper operation and calibrated at intervals not to exceed one (1) year and after each servicing and repair.
(11) Radiation levels in high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the accelerator control and safety interlock systems and capable of providing a readout at the control panel. Area monitors shall be calibrated at intervals not to exceed one (1) year and after each servicing and repair.
(12) Personal radiation dosimeters that measure the expected radiations and are of sufficient range to be useful under normal and accident conditions shall be worn by persons designated by the radiation safety officer.
(13) Before a new installation is placed in routine operation, a radiation protection survey shall be made by a qualified expert.
(14) A radiation protection survey shall be performed by a qualified expert if changes have been made in shielding, operation, equipment, or occupancy of adjacent areas, and periodically to check for unknown changes and malfunctioning equipment.
(15) Records of radiation protection surveys, inspections, and maintenance performed on the accelerator and related components shall be kept current and on file at each accelerator facility, and maintained for inspection by the cabinet.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide radiation safety requirements for particle accelerator operations.
- History: 1 Ky.R. 419; eff. 2-5-1975; 12 Ky.R. 1416; eff. 3-4-1986; 18 Ky.R. 1574; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:160 Plan review {#sec-902-kar-100-160 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:160}
Section 1. Applicability. This administrative regulation shall apply to persons who construct or modify radiation producing machine installations.
Section 2. Plan Review. Prior to construction or modification of an x-ray facility, the plans and specifications for construction or modification shall be evaluated by a qualified expert. A report of his evaluation shall be submitted to the cabinet for review and approval. This evaluation report shall become a part of the registrant's permanent record with the cabinet. The plans shall show, as a minimum, the following:
(1) The normal location of the radiation- producing equipment's radiation port; the port's travel and traverse limits; general direction(s) of the radiation beam; locations of any windows and doors; the location of the operator's booth; and the location of the equipment's control console.
(2) Structural composition and thickness or lead equivalent of walls, doors, partitions, floor, and ceiling of the room(s) concerned.
(3) The dimensions of the room(s) concerned.
(4) The type of occupancy of adjacent areas inclusive of space above and below the room(s) concerned. If there is an exterior wall, the distance to the closest area(s) where it is likely that individuals may be present.
(5) The make and model of the radiation- producing equipment including the maximum energy output.
(6) The type of examination(s) or treatment(s) to be performed with the equipment (e.g., dental, orthodontal, chest, gastrointestinal, fluoroscopic, podiatry, fixed therapy, rotational therapy, or other).
(7) Information on the anticipated workload.
(8) The facility preregistration or registration number.
Section 3. Qualified Expert's Report. A copy of the qualified expert's report shall be submitted with the plans. This report shall show basic assumptions (i.e., workload, occupancy and use factors, distance, etc.) used to determine the shielding requirements.
Section 4. Approval. The approval by the cabinet of these plans shall not preclude the requirement of additional modifications if a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in 902 KAR 100:020.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS 194.050, 211.090, 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: The Cabinet for Human Resources is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and to regulate the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide requirements for the review by the cabinet of radiation producing machine installation, construction and modification plans.
- History: 1 Ky.R. 420; eff. 2-5-1975; 12 Ky.R. 1418; eff. 3-4-1986; 18 Ky.R. 1577; eff. 1-10-1992; Crt eff. 8-16-2019; Crt eff. 4-21-2026.
902 KAR 100:165 Notices, reports, and instructions to employees {#sec-902-kar-100-165 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:165}
Section 1. Posting of Notices to Workers.
(1) A licensee or registrant shall post current copies of the following documents relating to standards for protection against radiation:
(a)
-
This administrative regulation;
-
902 KAR 100:019, as applicable for users other than radioactive materials users; and
-
902 KAR 100:185 as applicable for radioactive material users;
(b) The license, certificate of registration, conditions or documents incorporated into the license by reference, and amendments to the license;
(c) The operating procedures for work under the license or registration; and
(d) A notice of violation involving radiological working conditions, proposed imposition of civil penalty, or order issued as authorized by 902 KAR 100:170, and responses from the licensee or registrant.
(2) If posting of a document specified in subsection (1)(a), (b), or (c) of this section is not practical, the licensee or registrant shall post a notice that describes the document and states where it may be examined.
(3) Cabinet form KR-441, Notice to Employees, incorporated by reference in 902 KAR 100:070, shall be prominently posted by a licensee or registrant.
(4) Documents, notices, or forms posted as required by this section shall:
(a) Appear in a sufficient number of places to permit an individual engaged in work under the license or registration to observe them on the way to or from a particular work location to which the document applies;
(b) Be conspicuous; and
(c) Be replaced if defaced or altered.
(5)
(a) Cabinet documents posted as required by subsection (1)(d) of this section shall be posted within two (2) working days after receipt of the documents from the cabinet;
(b) The licensee's or registrant's response shall be posted within two (2) working days after dispatch from the licensee or registrant; and
(c) The documents shall remain posted for a minimum of five (5) working days or until action correcting the violation has been completed, whichever is later.
Section 2. Instructions to Workers.
(1) An individual who is likely to receive in a year, during the course of employment, an occupational dose in excess of 100 millirems (one (1) mSV) shall be:
(a) Kept informed of the storage, transfer, or use of sources of radiation in the licensee's or registrant's workplace;
(b) Informed of potential health risks to the individual and potential offspring, associated with exposure to radioactive material or radiation, and instructed in precautions or procedures to minimize exposure and in the purposes and functions of protective devices employed;
(c) Instructed in, and instructed to observe, to the extent within the worker's control, the applicable requirements of 902 KAR Chapter 100 and licenses issued under this chapter for the protection of personnel from exposures to radiation or radioactive material;
(d) Instructed of their responsibility to report promptly to the licensee or registrant a condition that may lead to or cause a violation of the Kentucky Radiation Control Act of 1978, as established in KRS 211.840; 902 KAR Chapter 100; or license conditions, or unnecessary exposure to radiation or radioactive material;
(e) Instructed in the appropriate response to warnings made in the event of an unusual occurrence or malfunction that may involve exposure to radiation or radioactive material; and
(f) Informed of the radiation exposure reports that workers may request as authorized by Section 3 of this administrative regulation.
(2) In determining the individuals subject to the requirements of this section, a licensee or registrant shall take into consideration assigned activities during normal and abnormal situations involving exposure to radioactive material or radiation that can reasonably be expected to occur during the life of a licensed or registered facility. The extent of the instructions shall be commensurate with potential radiological health protection problems in the workplace.
Section 3. Notifications and Reports to Individuals.
(1) Radiation exposure data for an individual and the results of any measurements, analyses, and calculations of radioactive material deposited or retained in the body of an individual, shall be reported to the individual as specified in this section.
(2) The information reported shall include data and results obtained in accordance with 902 KAR Chapter 100, orders, or license conditions as shown in records maintained by the licensee or registrant.
(3) Each notification and report shall:
(a) Be in writing;
(b) Include appropriate identifying data:
-
The name of the licensee or registrant;
-
The name of the individual; and
-
The individual's identification or Social Security number;
(c) Include the individual's exposure information; and
(d) Contain the following statement: "This report is furnished to you under the provisions of the Kentucky Cabinet for Health and Family Services' radiation administrative regulation, 902 KAR 100:165. You should preserve this report for further reference."
(4) Each licensee or registrant shall make dose information available to workers as shown in records maintained by the licensee or registrant under the provisions of 902 KAR 100:185.
(5) The licensee or registrant shall provide an annual report to each individual monitored under 902 KAR Chapter 100 of the dose received in that monitoring year if:
(a) The individual's occupational dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue; or
(b) The individual requests his or her annual dose report.
(6) At the request of a worker formerly engaged in licensed activities controlled by the licensee or registrant, each licensee or registrant shall furnish to the worker a report of the worker's exposure to radiation or to radioactive material. The report shall:
(a) Be furnished within thirty (30) days from the time the request is made, or within thirty (30) days after the exposure of the individual has been determined by the licensee or registrant, whichever is later.
(b) Cover the period of time the worker's activities involved exposure to radiation from radioactive material licensed by the cabinet; and
(c) Include the dates and locations of licensed activities in which the worker participated during this period.
(7) If a licensee or registrant is required to report to the cabinet an exposure of an individual to radiation or radioactive material, the licensee or the registrant shall also provide the individual a report on the exposure data included in the report to the cabinet. The reports shall be transmitted to the individual at a time not later than the transmittal to the cabinet.
(8)
(a) At the request of a worker who is terminating employment with the licensee or registrant that involved exposure to radiation or radioactive material during the current year, the licensee or registrant shall provide to the worker, or to the worker's designee, at termination a written report regarding the radiation dose received by that worker from operations of the licensee or registrant during the current year or fraction of the year.
(b) If the most recent individual personnel monitoring results are not available at the time of termination, a written estimate of the dose shall be provided.
(c) Estimated doses shall be clearly indicated as estimated doses.
Section 4. Presence of Representatives of Licensees or Registrants and Workers during Inspection.
(1) A licensee or registrant shall afford to the cabinet at all reasonable times opportunity to inspect materials, machines, activities, facilities, premises, and records required by 902 KAR Chapter 100.
(2) During an inspection, cabinet inspectors may consult privately with workers as specified in Section 5 of this administrative regulation. The licensee or registrant may accompany cabinet inspectors during other phases of an inspection.
(3) If, during the inspection, an individual has been authorized by the workers to represent them during cabinet inspections, the licensee or registrant shall notify the inspectors of the authorization and shall give the workers' representative an opportunity to accompany the inspectors during the inspection of physical working conditions.
(4) The workers' representative shall be routinely engaged in work under control of the licensee or registrant and shall have received instructions as specified in Section 2 of this administrative regulation.
(5) Different representatives of licensees or registrants and workers may accompany the inspectors during different phases of an inspection if there is no resulting interference with the conduct of an inspection. However, only one (1) workers' representative at a time may accompany the inspectors.
(6) With the approval of the licensee or registrant and the workers' representative, an individual who is not routinely engaged in work under control of the licensee or registrant, for example, a consultant to the licensee or registrant or to the workers' representative, shall be afforded the opportunity to accompany cabinet inspectors during the inspection of physical working conditions.
(7) A cabinet inspector shall refuse to permit accompaniment by an individual who deliberately interferes with a fair and orderly inspection.
(8) Unless specifically authorized, an individual accompanying an inspector shall not have access to an area containing information classified by an agency of the U.S. government as a national security interest.
(9) Unless previously authorized by the licensee or registrant, a worker's representative shall not have access to an area containing proprietary information.
Section 5. Consultation with Workers during Inspection.
(1) If necessary to conduct an effective and thorough inspection, a cabinet inspector may consult privately with a worker concerning a matter of occupational radiation protection or other matter related to 902 KAR Chapter 100, licenses, or registrations.
(2) During the course of an inspection, a worker may bring to the attention of the inspectors, either orally or in writing, a past or present condition that he or she has reason to believe may have contributed to or caused a violation of the Act, 902 KAR Chapter 100, or license condition, or an unnecessary exposure of an individual to radiation from licensed radioactive material or a registered radiation machine under the licensee's or registrant's control. Any written notice shall comply with the requirements of Section 6(1) of this administrative regulation.
(3) The requirements of subsection (2) of this section shall not be interpreted as authorization to disregard instructions required by Section 2 of this administrative regulation.
Section 6. Requests by Workers for Inspections.
(1)
(a) A worker or representative of workers who believes that a violation of the Act, 902 KAR Chapter 100, or a license condition exists, or has occurred in work under a license or registration with regard to radiological working conditions in which the worker is engaged, may request an inspection by giving notice of the alleged violation to the Cabinet for Health and Family Services, Radiation Health Branch.
(b) The notice shall:
-
Be in writing;
-
Set forth the specific grounds for the notice; and
-
Be signed by the worker or representative of the workers.
(c) A copy shall be provided to the licensee or registrant by the cabinet no later than at the time of inspection. If the worker giving the notice requests, his or her name and the name of individuals referred to in the notice shall not appear in the copy or on a record published, released, or made available by the cabinet, except for good cause shown.
(2) In accordance with 10 C.F.R. 19.16, if, upon receipt of the notice, the Manager, Radiation Health Branch, determines that the complaint meets the requirements established in subsection (1) of this section, and that there are reasonable grounds to believe that the alleged violation exists or has occurred, the manager of the Radiation and Health Branch shall cause an inspection to be made as soon as practicable, to determine if the alleged violation exists or has occurred. An inspection authorized by this section may not be limited to matters referred to in the complaint.
(3) A licensee, registrant, contractor, or subcontractor of a licensee or registrant, shall not discharge or discriminate against a worker because the worker has:
(a) Filed a complaint;
(b) Instituted or caused to be instituted a proceeding under 902 KAR 100:170;
(c) Testified or is about to testify in a proceeding; or
(d) Exercised an option on behalf of himself, herself, or others afforded by this administrative regulation.
Section 7. Inspections not Warranted; Informal Review.
(1)
(a) If the Cabinet for Health and Family Services, Radiation Health Branch determines, with respect to a complaint under Section 6 of this administrative regulation, that an inspection is not warranted because there are no reasonable grounds to believe that a violation exists or has occurred, the cabinet shall notify the complainant in writing of the determination.
(b) The complainant may obtain a review of the determination by submitting a written statement of position with the commissioner, Department for Public Health. The commissioner shall provide the licensee or registrant with a copy of the statement by certified mail excluding, at the request of the complainant, the name of the complainant.
(c) The licensee or registrant may submit an opposing written statement of position with the commissioner, who shall provide the complainant with a copy of the statement by certified mail.
(2) Upon the request of the complainant, the commissioner shall hold an administrative conference in accordance with 902 KAR 1:400.
(3) If the Radiation Health Branch determines that an inspection is not warranted because the requirements of Section 6(1) of this administrative regulation have not been met, the complainant shall be notified, in writing, of the determination. The determination shall be without prejudice to the filing of a new complaint meeting the requirements of Section 6(1) of this administrative regulation.
Section 8. Employee Protection.
(1) Discrimination by a cabinet licensee; an applicant for a cabinet license; a registrant, or a contractor, or subcontractor of a cabinet licensee, registrant, or applicant against an employee for engaging in protected activities shall be prohibited. Discrimination shall include discharge and other actions that relate to compensation, terms, conditions, or privileges of employment.
(a) The protected activities shall include in part:
-
Providing the cabinet or his or her employer information about alleged violations or possible violations of requirements of 902 KAR Chapter 100;
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Refusing to engage in a practice made unlawful under these requirements, if the employee has identified the alleged illegality to the employer;
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Requesting the cabinet to institute action against his or her employer for enforcement of these requirements;
-
Testifying in a cabinet proceeding, before Congress, or at a federal or state proceeding regarding a provision, or proposed provision, of 902 KAR Chapter 100; and
-
Assisting or participating in, or preparing to assist or participate in, a protected activity.
(b) A protected activity shall retain its protected status even if no formal proceeding is initiated as a result of the employee assistance or participation.
(c) This section shall not be applied to an employee alleging discrimination who, acting without direction from his or her employer or the employer's agent, deliberately causes a violation of the Kentucky Radiation Control Act of 1978 or 902 KAR Chapter 100.
(2) An employee who believes that he or she has been discharged or discriminated against for engaging in a protected activity may seek a remedy through an administrative proceeding in the Department of Labor.
(a) If an aggrieved employee files a complaint, it shall be filed within 180 days after the occurrence of the alleged violation with the Kentucky Education and Labor Cabinet, Workplace Standards, Division of Wages and Hours, at https://labor.ky.gov/standards/Pages/Wages-and-Hours.aspx.
(b) If warranted by the evidence presented, the Division of Wages and Hours may order reinstatement, back pay, and compensatory damages as appropriate to the case.
(3) A violation of subsections (1) or (5) of this section or Section 1(3) of this administrative regulation by a cabinet licensee, an applicant for a cabinet license, or a contractor or subcontractor of a cabinet licensee or applicant shall constitute grounds for:
(a) Denial, revocation, or suspension of the license;
(b) Imposition of a penalty; or
(c) Other enforcement action in accordance with 902 KAR 100:170.
(4)
(a) An action taken by an employer or others that adversely affects an employee shall be predicated upon nondiscriminatory grounds.
(b) The prohibition applies if the adverse action occurs because the employee has engaged in a protected activity.
(c) An employee's engagement in a protected activity does not automatically render him or her immune from discharge or discipline for legitimate reasons, or from adverse action dictated by nonprohibited considerations.
(5) An agreement affecting the compensation, terms, conditions, or privileges of employment, including an agreement to settle a complaint filed by an employee with the Kentucky Education and Labor Cabinet, shall not contain a provision that has the potential to prohibit, restrict, or discourage an employee from participating in protected activity, including providing information to the cabinet or to his or her employer on alleged violations or other matters within cabinet's regulatory responsibilities.
Section 9. Deliberate Misconduct.
(1) This section applies to:
(a) Licensee;
(b) Registrant;
(c) Certificate of registration holder;
(d) Applicant for a license or certificate of registration;
(e) Employee of any person identified in this section; or
(f) Contractor, including a supplier, consultant, or subcontractor to any person identified in this section.
(2) Any person identified in subsection (1) of this section shall not:
(a) Engage in deliberate misconduct that causes or may have caused, if not detected, a licensee, registrant, certificate of registration holder, or applicant to be in violation of the Kentucky Radiation Control Act of 1978, administrative regulation, order, term, condition, or limitation of a license issued by the cabinet; or
(b) Deliberately submit information to the cabinet, a licensee, registrant, certificate of registration holder, an applicant, or subcontractor of a licensee, certificate holder, or applicant that the person knows to be incomplete or inaccurate in some respect material to the cabinet.
(3) A person who violates subsection (2) of this section shall be subject to enforcement action in accordance with the procedures in 902 KAR 100:170.
(4) For the purposes of subsection (2)(a) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows:
(a) May cause a licensee, registrant, certificate holder, or applicant for a license, registration, or certificate to be in violation of the Kentucky Radiation Control Act of 1978, regulation, order or a term, condition, or limitation of a license, registration, or certificate issued by the cabinet; or
(b) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, registrant, certificate holder, applicant, or the contractor or subcontractor of any of them.
History
- RELATES TO: KRS 211.842 - 211.852, 211.990(4), 10 C.F.R. Part 19
- STATUTORY AUTHORITY: KRS 13B.170, 194A.050(1), 211.844
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844 requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes notices, instructions, and reports for the protection of workers who may be exposed to radiation in their employment.
- History: 1 Ky.R. 420; eff. 2-5-1975; 3 Ky.R. 170; eff. 9-1-1976; 12 Ky.R. 1073; eff. 1-3-1986; 18 Ky.R. 1578; eff. 1-10-1992; 24 Ky.R. 771; eff. 11-14-1997; 26 Ky.R. 2418; 27 Ky.R. 991; eff. 10-16-2000; 37 Ky.R. 1863; 2651; eff. 6-3-2011; Crt eff. 8-16-2019; 50 Ky.R. 215, 1156; eff. 12-13-2023.
902 KAR 100:170 Proceedings {#sec-902-kar-100-170 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:170}
Section 1. Applicability. The provisions of this administrative regulation shall apply to administrative proceedings involving the use, possession or transfer of radioactive materials or radiation producing machines within Kentucky.
Section 2. Administrative Examination of License Applications. Applications for the issuance of a license, amendment of a license at the request of the holder, transfer of a license and renewal of a license shall be reviewed by the cabinet. The applicant may be required to submit additional information and may be requested to confer informally regarding the application. The cabinet shall give to others notice of the filing of applications as is required under the applicable provisions of these administrative regulations and additional notices as it deems appropriate.
Section 3. Action on License Applications, Hearings.
(1) The cabinet shall, upon request of the applicant or intervenor, and may upon its own initiative, direct the holding of a formal hearing prior to taking action on the application. If no prior formal hearing has been held and no notice of proposed action has been served as provided in subsection (2) of this section, the cabinet shall direct the holding of a formal hearing upon receipt of a request therefor from the applicant or intervenor within thirty (30) days after the issuance of a license or other approval or a notice of denial.
(2) In cases it deems appropriate, the cabinet may cause to be served upon the applicant a notice of proposed action upon his application and shall cause copies thereof to be serviced upon intervenors or others entitled to or requesting notification. The notice shall state the terms of the proposed action. If a formal hearing has not been held prior to the issuance of the notice, the cabinet shall direct the holding of a formal hearing upon the request of the applicant or an intervenor received within fifteen (15) days following the service of the notice.
Section 4. Effect of Timely License Renewal Applications. If at least thirty (30) days prior to the expiration of an existing license authorizing activity of a continuing nature, a licensee files an application for a renewal or for a new license for the activity so authorized, the existing license shall not be deemed to have expired until the application has been finally determined.
Section 5. Notice of Violation.
(1) Prior to the institution of proceedings for alleged violation of provisions of these administrative regulations, the Act, or the conditions or terms of a license or registration, the licensee, registrant, or other person as appropriate shall be served with a written notice of violation, except as specified in subsection (2) of this section. The notice of violation shall state the alleged violation and shall require that the licensee submit, within fifteen (15) days of the date of the receipt of the notice or other time as specified in the notice, a written explanation or statement in reply including:
(a) Corrective steps which have been taken by the licensee or registrant and the results achieved;
(b) Corrective steps to be taken;
(c) The date when correction and compliance will be achieved; and
(d) An admission or denial of the violation and the reason(s) for the violation(s) if admitted and required in the notice.
(2) If in the opinion of the cabinet the public health, interest, or safety so requires, or the violation is willful, the notice provided in this section may be omitted.
Section 6. Failure to Respond to Notice of Informal Hearing.
(1) In the event the person to whom the notice of violation has been issued fails to respond within the prescribed time, the Secretary for Health Services, or his designee, may set the matter down for an informal hearing as described in Section 15 of this administrative regulation.
(2) Failure of the person to whom the notice was sent to appear at the informal hearing may result in:
(a) The registration or license of the person being modified, suspended or revoked;
(b) The recapture, quarantine or seizure of the radiation source;
(c) The inactivation of radiation producing machines; or
(d) Other appropriate action deemed necessary by the cabinet to protect public health and safety.
(3) Any person aggrieved by the action of the cabinet under this section may, within thirty (30) days after receipt of notice of the action, request a formal hearing before the secretary or his designee.
Section 7. Notices and Orders. In a case described in Section 5 of this administrative regulation, the cabinet may issue the licensee, registrant, or other person as appropriate a notice to comply with the administrative rules and administrative regulations of the cabinet or an order issued by the cabinet. The terms of the notice or order may be effective immediately or at a time specified in the notice or order. The notice or order shall apprise the licensee or registrant that he has the right to request a hearing within thirty (30) days by making a written request therefor to the cabinet. In the event a request for a hearing is received by the cabinet within the time specified, a notice of hearing shall be issued by the cabinet in accordance with Section 5 of this administrative regulation.
Section 8. Emergency Notices and Orders. If the cabinet finds that a condition exists requiring immediate action to protect the public health or welfare, the cabinet may issue a notice or an order reciting the existence of the condition and requiring that action be taken as is deemed necessary by the cabinet to protect the public health and welfare. The notice or order may be issued by the Manager, Radiation Control, on behalf of the cabinet. The notice or order shall be effective immediately. Persons to whom a notice or an order is directed shall comply therewith immediately, but applicants for hearings to the cabinet shall be afforded a hearing in accordance with 902 KAR 1:400. On the basis of a hearing, the cabinet shall continue, revoke, or modify a notice or order.
Section 9. Enforcement of Obedience to Orders. If the failure on the part of a person to comply with a lawful order of the cabinet or with process or if the refusal of a witness to testify concerning a matter on which he may be lawfully interrogated, the circuit court or a judge thereof having jurisdiction may, on application of the cabinet, compel obedience by proceedings as in contempt cases as provided by KRS 211.230.
Section 10. Recapture, Quarantine, or Seizure of Sources of Radiation. If a case of extreme importance to the health and safety of the public, the cabinet may, without prior notice of hearing, recapture, quarantine, or seize a source of radiation, if as promptly as possible and not later than ten (10) days from the recapture, quarantine, or seizure, the cabinet shall serve upon the person from whom the sources were recaptured, quarantined, or seized an appropriate order depriving that person of possession or use of the sources together with a notice which shall give that person the right to request a hearing, concerning the order depriving him of the use of the sources and the restoration of the sources to him pursuant to 902 KAR 1:400.
Section 11. Filing Papers. Unless otherwise specified, papers required to be filed with the cabinet shall be filed with the Manager, Radiation Control, Cabinet for Health Services, 275 East Main Street, Frankfort, Kentucky 40621. Papers required to be filed with the cabinet shall be deemed filed upon actual receipt by the cabinet at the place specified accompanied by proof of service upon the parties required to be served as described in Section 14 of this administrative regulation. Unless otherwise specified, the filing if by mail or telegram shall upon actual receipt be deemed complete as of the date of deposit in the mail or with the telegraph company. Papers may be filed in person at the cabinet's offices, 275 East Main Street, Frankfort, Kentucky 40621.
Section 12. Computation of Time. In computing a period of time prescribed or allowed by an applicable rule or administrative regulation, notice or order, the provisions of KRS 446.030 shall apply.
Section 13. Extension of Time.
(1) Extensions of time for filing or performing an act required or allowed to be done, and continuances of a proceeding or hearing, may be granted in the discretion of the cabinet upon application and good cause shown by a party, or upon the initiative of the cabinet or stipulation of the parties.
(2) If a hearing officer has been designated for hearing, the discretion in granting extensions of time and continuances in matters relating to the hearing shall rest with the hearing officer in accordance with KRS Chapter 13B.
Section 14. Intervention. A person whose interests may be affected by a proceeding may file a petition to intervene pursuant to KRS 13B.060.
Section 15. Informal Hearing Procedure. The procedure to be followed in informal hearings shall be as best serve the purpose of the hearing. An informal hearing may consist of the submission of written data, views, or arguments with or without oral argument, or may partake of the nature of a conference or may assume some of the aspects of a formal hearing in which the subpoena of witnesses and the production of evidence may be permitted or directed.
Section 16. Administrative Hearings. All administrative hearings shall be conducted in accordance with 902 KAR 1:400.
Section 17. Answer.
(1) Within the time allowed by the notice of hearing for filing and serving an answer, the answer of a licensee, applicant or registrant shall fully advise the cabinet and other parties of the nature of the defense or other position of the answering party, the issues he proposes to argue and those he does not argue, and whether or not he proposes to appear and present evidence. If facts are alleged, the answer shall admit or deny specifically each allegation of fact; or if knowledge is lacking, the answer may so state and the statement shall serve as a denial. Allegations of fact not denied shall be deemed to be admitted. Matters alleged as affirmative defenses or positions shall be separately stated and identified and, in the absence of a reply, shall be deemed to be argued. The answer of an intervenor shall fully advise the cabinet and other parties of his position and whether he proposes to appear and present evidence.
(2) If a party does not oppose an order or proposed action of the cabinet embodied in or accompanying the notice of hearing or does not wish to appear and give evidence at the hearing, the answer shall so state. In lieu of appearing, the party may, if he chooses, submit a statement of reasons why the proposed order or sanction shall not be issued or shall be different than proposed, and the cabinet shall attribute weight as it deems deserving to the written reasons.
Section 18. Reply. In appropriate cases the cabinet may file and serve a reply to the answer or, if the answer affects other parties to the proceeding, the cabinet or the hearing officer may permit these parties to file and serve a reply.
Section 19. Admissions. After an answer has been filed, a party may file and serve upon the opposing side a written request for the admission of the genuineness and authenticity of relevant documents described in or attached to the request or for the admission of the truth of relevant matters of fact stated in the request. Each matter for which an admission is requested shall be deemed admitted unless within the time designated in the request, but not less than ten (10) days after service thereof or further time as the hearing officer may allow upon motion and notice, the party to whom the request is directed serves upon the requesting party a sworn statement either denying the matters upon which the admission is requested or setting up the reasons why he cannot truthfully admit or deny the matters.
Section 20. Waiver of Procedures. The parties to a hearing may agree to waive one (1) or more of the procedural steps which would otherwise precede the reaching of a final decision by the cabinet.
Section 21. Public Records: Exceptions. Except as specified in this section records shall be deemed public records and shall be open to inspection by the public. The following are not to be considered public records which are available for public inspection:
(1) Documents relating to personnel matters and medical and other personnel information, which, under general governmental personnel practices, are not normally made public.
(2) Intra-agency and interagency communications including memoranda reports, correspondence, and staff papers prepared cabinet personnel, or by other government agency for use within the cabinet or within the executive branch of the government.
(3) Documents classified as restricted data under the Atomic Energy Act of 1954 or classified under Executive Order of the President of the United States as restricted data.
(4) Correspondence received in confidence by the cabinet relating to an alleged or possible violation of a statute, rule, administrative regulation, order, license or permit.
(5) Other documents involving matters of internal cabinet management.
(6) Other matters required by law to be kept confidential or not available to public inspection.
(7) Names of individuals who have received exposures to radiation.
(8) The cabinet may withhold documents or parts thereof 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. This withholding from public inspection shall not, however, affect the right of persons properly and directly concerned to inspect the document. Persons requesting that documents or information therein be withheld from public disclosure shall make prompt application identifying the material and giving the reasons. If the applicant is responsible for the preparation of the document. he shall insofar as is possible segregate in separate paper the information for which the special treatment is requested. The cabinet may honor the request upon a finding that public inspection is not required in the public interest and would adversely affect the interest of the persons concerned. If the request is denied, the applicant shall be notified thereof with a statement of the reasons.
Section 22. Hearings: Formal and Informal.
(1) Formal hearings shall be held adjudication of rights.
(2) Informal hearings shall normally be held for the purpose of obtaining necessary or useful information, including but not limited to cases as described in Section 6 of this administrative regulation.
History
- RELATES TO: KRS 211.842-211.852, 211.990(4)
- STATUTORY AUTHORITY: KRS Chapter 13B, 194.050, 211.090, 211.844, EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Department for Public Health and its programs under the Cabinet for Health Services. The Cabinet for Health Services is authorized by KRS 211.844 to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. The purpose of this administrative regulation is to provide for the conduct of proceedings before the cabinet involving the possession, use, and transfer of radioactive materials and radiation producing machines.
- History: 1 Ky.R. 421; eff. 2-5-1975; 2 Ky.R. 481; eff. 4-14-1976; 12 Ky.R. 1419; eff. 3-4-1986; 18 Ky.R. 1581; eff. 1-10-1992; 23 Ky.R. 2490; eff. 8-1-1996; Crt eff. 8-16-2019; TAm eff. 3-20-2020; Crt eff. 4-21-2026.
902 KAR 100:180 Technologically Enhanced Naturally Occurring Radioactive Material related to oil and gas development {#sec-902-kar-100-180 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:180}
Section 1. Definitions.
(1) "Activity concentration" means the rate of disintegration (transformation) or decay of radioactive material per unit of dry mass.
(2) "Oil and gas development":
(a) Means the drilling, operation, and closure of a well permitted and regulated pursuant to KRS Chapter 353, including:
-
A stratigraphic test well;
-
An oil or gas production well;
-
A well drilled or used for enhanced recovery or for disposal of oil or gas-related wastes; or
-
A related production and storage facility; and
(b) Includes gathering lines, but does not include subsequent transmission or processing of produced oil or gas not permitted or regulated pursuant to KRS Chapter 353.
(3) "Technologically Enhanced Naturally Occurring Radioactive Material" or "TENORM" is defined by KRS 211.862(13).
(4) "Well operator" is defined by KRS 353.010(20).
Section 2. Applicability.
(1) This administrative regulation shall apply to a person who receives, owns, possesses, uses, processes, transfers, transports, distributes, arranges for the disposal of, or disposes of TENORM with an activity concentration greater than five and zero-tenths (5.0) picocuries per gram of combined radium-226 (Ra-226) and radium-228 (Ra-228).
(2) This administrative regulation shall apply only to TENORM related to oil and gas development.
(3) Each person subject to this administrative regulation shall manage and dispose of waste containing TENORM:
(a) Pursuant to Section 6 of this administrative regulation; or
(b) In accordance with an alternate method authorized by the cabinet upon written request or upon the cabinet's initiative in accordance with this administrative regulation and administrative regulations of the Energy and Environment Cabinet.
(4) Exemptions to this administrative regulation are established in Section 3 and are not considered a hazard to public health based on scientific and health rationale.
Section 3. Exemptions. The following shall be exempt from the requirements of this administrative regulation:
(1) Background activity concentrations upon specific request and the written approval of the cabinet;
(2) Drill cuttings and associated residual pit fluids from wells permitted pursuant to KRS Chapter 353 and managed in accordance with the requirements of that chapter; and
(3) Water produced from or utilized during oil or gas well development or production operations, including produced water and water flowed back following hydraulic fracturing operations that is disposed of in injection wells that are regulated and permitted in accordance with KRS 353.590 through 353.593 and 353.992; 805 KAR 1:110; and, if applicable, the Safe Drinking Water Act, 42 U.SC. 1421 throught 1443 and 40 C.F.R. Parts 144 through 147, and Underground Injection Control Program.
Section 4. Sample Collection and Analysis.
(1) All sample collection pursuant to this section shall be conducted so as to be representative of the entire waste load or container.
(2) Sample collection and analysis of the TENORM-containing waste shall take place prior to disposal as established in paragraphs (a) through (e) of this subsection.
(a)
-
At least five (5) representative samples taken randomly from within the load or container shall be composited into one (1) sample and analyzed; or
-
For tubing, a representative sample shall be taken every 500 feet.
(b) Analysis of TENORM waste proposed to be transported off-site for management or disposal shall be conducted by a laboratory accredited by the National Environmental Laboratory Accreditation Conference to perform radiological analysis.
(c) Each sample analyzed by an accredited laboratory shall be analyzed for the activity concentration of combined Ra-226 and Ra-228;
(d) For TENORM waste being disposed of downhole pursuant to Section 6(4) of this administrative regulation, sample collection and analysis shall be performed:
-
Pursuant to paragraphs (a) through (c) of this subsection; or
-
At the election of the well operator, by measuring the highest on-contact radiation exposure rate or radiation dose rate reported in microroentgen per hour (µR/hr) or microrem per hour (µrem/hr) through the use of a portable radiation detector that is:
a. Appropriate for the radiation being measured; and
b. Calibrated at least annually.
(e) The cabinet may require additional testing if another progeny is considered to be of primary concern.
(3) For the purpose of determining disposal method pursuant to Section 6 of this administrative regulation, sample collection and analysis meeting the requirements of subsection (2) of this section may additionally occur after the waste has been prepared or treated for disposal as long as the waste is not treated beyond the minimum required for disposal.
Section 5. Transporting TENORM Waste for Management or Disposal.
(1) TENORM waste being transported for management or disposal shall be:
(a) Accompanied by a waste profile or manifest document pursuant to Section 8 of this administrative regulation;
(b) Covered and contained during transportation in accordance with general standards of the U.S. Department of Transportation and KAR Title 601; and
(c) Packaged or stabilized as needed to prevent dispersion during transportation or landfill placement.
(2) Other than TENORM wastes stored on-site prior to disposal in conjunction with an oil or gas operation permitted pursuant to KRS Chapter 353 and those materials awaiting return transportation following rejection at the disposal facility in accordance with Section 6(6)(c) of this administrative regulation, the storage or treatment of TENORM waste is allowed only if licensed pursuant to 902 KAR 100:040.
Section 6. Disposal of Waste.
(1) TENORM waste with an activity concentration greater than five and zero-tenths (5.0) and less than or equal to 100 pCi/g of combined Ra-226 and Ra-228 shall be disposed in a:
(a) Landfill meeting the design and construction standards of a contained landfill as established by the Energy and Environment Cabinet that:
-
Possesses a current permit demonstrating compliance with the requirements of KRS 224 and 401 KAR Chapters 47 and 48; and
-
Ensures the disposal is in accordance with statutory provisions of KRS 224 and regulatory provisions of KAR Title 401 that apply specifically to the disposal of TENORM waste in such a facility;
(b) Well that is regulated and permitted for disposal pursuant to the requirements of subsection (4) of this section; or
(c) Landfill meeting the requirements of subsection (2)(a) or (2)(b) of this section.
(2) TENORM waste with an activity concentration greater than 100 and less than or equal to 200 pCi/g of combined Ra-226 and Ra-228 shall be disposed of in a:
(a) Landfill located in Kentucky specifically permitted by the Energy and Environment Cabinet to accept TENORM wastes for disposal or located in Illinois as specified under the terms and conditions of the Central Midwest Interstate Low-Level Radioactive Waste Compact pursuant to KRS 211.859;
(b) Licensed low-level radioactive waste disposal facility as established in 902 KAR 100:021; or
(c) Well that is regulated and permitted for disposal pursuant to the requirements of subsection (4) of this section.
(3) TENORM waste with an activity concentration greater than 200 pCi/g of combined Ra-226 and Ra-228 shall be disposed of in a:
(a) Licensed low-level radioactive waste disposal facility as established in 902 KAR 100:021; or
(b) Well that is regulated and permitted for disposal pursuant to the requirements of subsection (4) of this section.
(4) The downhole disposal of TENORM waste into a well located on the same lease, pool, or unit from which the TENORM waste was generated shall be allowed if:
(a) The well is permitted by the Energy and Environment Cabinet;
(b) Disposal is done in accordance with 805 KAR 1:060; and
(c) The radioactivity is analyzed pursuant to Section 4(2)(d) of this administrative regulation and reported to and maintained by the Energy and Environment Cabinet.
(5)
(a) TENORM waste imported from outside of Kentucky or Illinois shall not be disposed of in Kentucky pursuant to KRS 211.859.
(b) The disposal of TENORM waste with an activity concentration greater than 200 pCi/g of combined Ra-226 and Ra-228 in a landfill in Kentucky shall be prohibited.
(6) Prohibited TENORM waste that is delivered to a landfill for disposal shall be rejected. The owner or operator of the landfill shall:
(a) Record the:
-
Source;
-
Amount;
-
Generator; and
-
Other identifying information about the rejected waste; and
(b) Notify the cabinet by telephone, fax, or electronic mail within one (1) business day of the rejection, impoundment, and quarantine of the material. Contact telephone numbers are established in 902 KAR 100:040, Section 15(3); and
(c) Impound and quarantine the waste load until the cabinet determination on the disposition of the waste if the impounding and quarantining of the waste by the owner or operator of the landfill shall not constitute storage or cause the owner or operator of the landfill to become responsible under law for the further management or disposition of the waste.
(7) Records of disposal, including waste profiles and manifests, shall be maintained by the owner or operator of the landfill for thirty (30) years after closure of the facility.
Section 7. Material or Real Property Containing TENORM.
(1) The transfer of TENORM not exempt pursuant to Section 3 shall be authorized if the equipment and facilities contaminated with TENORM shall be used by the recipient for the same purpose.
(2) Transfers made pursuant to subsection (1) of this section do not relieve the person making the transfer from the responsibilities of assessing the extent of TENORM contamination or material present, informing the person receiving the TENORM of these assessments, and maintaining records required by this administrative regulation.
(3) The transfer of TENORM products not exempt in Section 3 shall be authorized provided the requirements of this section are met and the product is accompanied by a waste profile or manifest document pursuant to Section 8.
(4) The remediation of material contaminated with TENORM shall be performed only if licensed to do so pursuant to 902 KAR 100:040.
Section 8. Record Keeping Requirements.
(1) A person in possession of TENORM waste with an activity concentration greater than five and zero-tenths (5.0) pCi/g and less than or equal to 100 pCi/g of combined Ra-226 and Ra-228 being transported for management or disposal shall maintain and provide to the off-site treatment or disposal facility receiving waste a waste profile or manifest containing information as required by KRS 224.43-335.
(2) A person in possession of TENORM waste with an activity concentration greater than 100 pCi/g and less than or equal to 200 pCi/g of combined Ra-226 and Ra-228 being transported shall maintain a copy of the TENORM Manifest, form RPS 180. The manifest shall contain the:
(a) Name and signature of any:
-
Generating facility owner or operator;
-
Transporter company; and
-
Receiving facility owner or operator;
(b) Identity and business contact information of the accredited laboratory that analyzed the samples;
(c) Type, amount, activity concentration, and source of TENORM being transported; and
(d) Unique tracking number established by the generator.
(3) A person in possession of TENORM waste with an activity concentration greater than 200 pCi/g of combined Ra-226 and Ra-228 activity concentration being transported shall maintain records in accordance with 902 KAR 100:021.
Section 9. Worker Training and Safety.
(1) A landfill approved for the disposal of TENORM waste pursuant to Section 6(2) shall implement a worker training program and safety program to meet the requirements of 902 KAR 100:019.
(2)
(a) A landfill permitted to accept TENORM waste pursuant to Section 6(2) shall monitor individuals for exposure to radiation and radioactive material as required by 902 KAR 100:019, Section 13, for at least two (2) years.
(b) Personnel dosimeters shall meet the requirements of 902 KAR 100:019, Section 12.
(c) If the average result is less than 200 millirems (2.0 mSv) per year, suspension of individual monitoring may be requested and approved in writing by the cabinet.
Section 10. Violations.
(1) A violation of this administrative regulation shall be subject to KRS 211.869(1) and (3) and KRS 211.990(2) and (4).
(2) A violation of an Energy and Environment Cabinet regulation referenced in this administrative regulation shall not be subject to the provisions of KRS 211.869 or KRS 211.990.
Section 11. Incorporation by Reference.
(1) Form RPS 180, "TENORM Manifest", 10/2017, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Department for Public Health, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
History
- RELATES TO: KRS 189.150, 211.842-211.990, 216B.050(22), Chapters 224 and 353, 40 C.F.R. Parts 144 - 147, 42 U.S.C. 1421 - 1443
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1)(a), 211.842, 211.844(1), 211.863(6), 211.865, 211.893(2)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to protect, develop, and maintain the health, personal dignity, integrity, and sufficiency of Kentucky citizens and to operate programs and fulfill the responsibilities vested in the cabinet. KRS 211.893(2) authorizes the cabinet to exercise its regulatory authority to ensure the proper management of oil- and gas-related wastes containing technologically enhanced naturally occurring radioactive material (TENORM). This administrative regulation establishes radiation protection standards for the possession, use, transport, transfer, and disposal of TENORM related to oil and gas development.
- History: 44 Ky.R. 477, 1029, 1350; eff. 12-7-2017; Cert eff. 10-9-2024.
902 KAR 100:185 Standards for protection against radiation from radioactive materials {#sec-902-kar-100-185 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:185}
Section 1. Definitions.
(1) "Agreement state" means a state with which the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
(4) "Person" is defined by KRS 216B.015(22).
Section 2. Applicability. This administrative regulation shall apply to a licensee. The licensee shall comply with 10 C.F.R. Part 20 except as established in subsections (1) through (5) of this section.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 20.1003, Definition for licensee;
(b) 10 C.F.R 20.1007;
(c) 10 C.F.R. 20.1009;
(d) 10 C.F.R. 20.1406(b);
(e) 10 C.F.R. 20.1905(g);
(f) 10 C.F.R. 20.2203(c);
(g) 10 C.F.R. 20.2206(a)(1), (a)(3), (a)(4), and (a)(5);
(h) 10 C.F.R. 20.2401; and
(i) 10 C.F.R. 20.2402.
(2)
(a) Except for the definition of special nuclear material in 10 C.F.R. 20.1003, reference to the "Commission" or "NRC" shall be deemed to be a reference to the "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch".
(b) Reference to the "Commission" or an agreement state shall be deemed to be a reference to the "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", the commission, or an agreement state.
(3) Reference to "NRC Form 313, Application for Material License" shall be deemed to be a reference to "Application for Radioactive Material License" RPS-7, incorporated by reference in 902 KAR 100:040.
(4) Reference to the violations under 10 C.F.R. 20.2401 shall be deemed to be a reference to 902 KAR 100:170.
(5) Reference to the criminal penalties under 10 C.F.R. 20.2402 shall be deemed to be a reference to KRS 211.990.
Section 3. Annual Report of Waste Generated.
(1) A licensee issued a specific license, pursuant to 902 KAR 100:040, shall file an Annual Low Level Radioactive Waste (LLRW) Report with the cabinet.
(2) The report shall be filed regardless of whether the licensee was a waste generator during the reporting period, except for a licensee that is authorized for only sealed radioactive sources and has leak test results indicating no leakage or damaged sources.
(3) The report shall:
(a) Contain information regarding low-level radioactive waste associated with activities authorized by the license for a period of one (1) calendar year;
(b) Contain the types and amounts of generated waste, and estimates of future wastes to be generated; and
(c) Be filed no later than January 15 of the following year.
Section 4. Reporting of Events and Notifications. The reporting of events and notifications required by 10 C.F.R. Part 20 shall be directed to the manager, Radiation Health Branch, at:
(1) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(2) (502) 564-1492: Facsimile;
(3) (502) 564-3700: Telephone, Monday through Friday from 8 a.m. to 4:30 p.m.; or
(4) (800) 255-2587: Telephone, for hours outside of those in subsection (3) of this section.
Section 5. Incorporation by Reference.
(1) "Annual Low Level Radioactive Waste (LLRW) Report", 05/2023, is incorporated by reference.
(2) This material may be inspected, copied, or obtained, subject to applicable copy right law, at Department for Public Health, Radiation Health Branch, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
(3) This material is available on the agency's Web site at https://www.chfs.ky.gov/agencies/dph/dphps/rhb/Documents/LLRWReportForm1.pdf.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 216B.015(22), 10 C.F.R. Part 20, 42 U.S.C. 2021(b)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary to promulgate, administrative regulations necessary to implement programs mandated by federal law, to qualify for the receipt of federal funds, and to cooperate with other state and federal agencies. KRS 211.844(1) requires cabinet to provide by administrative regulation for the licensing of the possession or use of sources of ionizing and the handling and disposal of radioactive waste. This administrative regulation establishes the standards for protection of the user and general public against radiation exposure, the standards for protection against ionizing radiation resulting from activities conducted by persons issued licenses or registrations by the cabinet, and the standards to control the receipt, possession, use, transfer, and disposal of sources of radiation by a person, or licensee.
- History: 50 Ky.R. 282, 1161; eff. 12-13-2023.
902 KAR 100:195 Licensing of special nuclear material {#sec-902-kar-100-195 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:195}
Section 1. Definitions.
(1) "Agreement state" means a state that the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.).
(2) "Cabinet" is defined by KRS 194A.005(1).
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. Except as established in subsections (1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 70.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 70.1(c), (d), and (e);
(b) 10 C.F.R. 70.4 Definitions:
-
Commencement of Construction (2); and
-
Construction (9)(ii);
(c) 10 C.F.R. 70.5;
(d) 10 C.F.R.70.8;
(e) 10 C.F.R. 70.13;
(f) 10 C.F.R. 70.14;
(g) 10 C.F.R. 70.20a;
(h) 10 C.F.R. 70.20b;
(i) 10 C.F.R. 70.21(a)(1), (c), (f), (g), and (h);
(j) 10 C.F.R. 70.22(b), (c), (f), (g), (h), (i), (j), (k), (l), (m), and (n);
(k) 10 C.F.R. 70.23(a)(6), (a)(7), (a)(8), (a)(9), (a)(10), (a)(11), (a)(12), and (b);
(l) 10 C.F.R. 70.23a;
(m) 10 C.F.R. 70.24;
(n) 10 C.F.R. 70.25(a)(1);
(o) 10 C.F.R. 70.31(c), (d), and (e);
(p) 10 C.F.R. 70.32(a)(1), (a)(4), (a)(5), (a)(6), (a)(7), (b)(1), (b)(3), (b)(4), (c), (d), (e), (f), (g), (h), (i), (j), and (k);
(q) 10 C.F.R. 70.37;
(r) 10 C.F.R. 70.40;
(s) 10 C.F.R. 70.42(b)(6);
(t) 10 C.F.R. 70.44;
(u) 10 C.F.R. 70.52;
(v) 10 C.F.R. 70.55(c);
(w) 10 C.F.R. 70.59;
(x) 10 C.F.R. 70.60;
(y) 10 C.F.R. 70.61;
(z) 10 C.F.R. 70.62;
(aa) 10 C.F.R. 70.64;
(bb) 10 C.F.R. 70.65;
(cc) 10 C.F.R. 70.66;
(dd) 10 C.F.R. 70.72;
(ee) 10 C.F.R. 70.73;
(ff) 10 C.F.R. 70.74;
(gg) 10 C.F.R. 70.76;
(hh) 10 C.F.R. 70.82; and
(ii) 10 C.F.R. Appendix A to Part 70.
(2)
(a) Reference to the NRC, the Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch.
(b) As used in 10 C.F.R. 70.19(a)(1) and 70.19(c)(3), reference to the "Commission" or "Atomic Energy Commission" shall remain and shall not be deemed to reference the cabinet.
(c) As used in 10 C.F.R. 70.42(b)(1) reference to "Department" shall be deemed to reference the U.S. Department of Energy.
(3) Each application for a specific license shall be filed pursuant to 902 KAR 100:0195.
(4) Notifications, reports, and correspondence required by 10 C.F.R. 70 shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 255-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 70, 42 U.S.C. 2021(b)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844(1) requires the Cabinet for Health and Family Services to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes procedures, criteria, terms, and conditions upon which the cabinet issues licenses for special nuclear material.
- History: 50 Ky.R. 284, 1163; eff. 12-13-2023.
902 KAR 100:200 Licenses and radiation safety requirements for irradiators {#sec-902-kar-100-200 omnilex-key=us-ky-regs-official--title-902--902 KAR 100:200}
Section 1. Definitions.
(1) "Agreement state" means a state that the United States Nuclear Regulatory Commission (NRC) or the United States Atomic Energy Commission has entered into an effective agreement under subsection 274 b. of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2021(b) et seq.)
(2) "Cabinet" is defined by KRS 194A.005(1)
(3) "Licensee" means a person who holds:
(a) A specific license issued by the cabinet pursuant to 902 KAR 100:040 and this administrative regulation;
(b) A specific license issued by the U.S. Nuclear Regulatory Commission or an agreement state; or
(c) A general license pursuant to 902 KAR 100:050 or equivalent regulations of the U.S. Nuclear Regulatory Commission or an agreement state.
Section 2. Applicability. This administrative regulation shall apply to a licensee. Except as established in subsections (1) through (4) of this section, the licensee shall comply with 10 C.F.R. Part 36.
(1) The licensee shall not be subject to:
(a) 10 C.F.R. 36.2, Definitions:
-
Commencement of Construction (2); and
-
Construction (9)(ii);
(b) 10 C.F.R. 36.8;
(c) 10 C.F.R. 36.91; and
(d) 10 C.F.R. 36.93.
(2)
(a) Reference to the NRC, the Commission, or an agreement state shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch.
(b) Reference to "NRC" or "agreement state" shall be deemed to be a reference to "Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch", the "NRC", or "agreement state".
(3) Each application for a specific license shall be filed pursuant to this administrative regulation.
(4) Notifications, reports, and correspondence required by 10 C.F.R. 36 shall be directed to the manager, Radiation Health Branch, at:
(a) 275 East Main Street, Mailstop HS1-C-A, Frankfort, Kentucky 40621;
(b) (502) 564-1492: Facsimile;
(c) (502) 564-3700: Telephone, Monday through Friday, 8 a.m. to 4:30 p.m.; or
(d) (800) 255-2587: Telephone, for hours except those established in paragraph (c) of this subsection.
History
- RELATES TO: KRS 194A.005(1), 211.180(1), 211.842-211.852, 211.990(4), 10 C.F.R. Part 36, 42 U.S.C. 2021(b)
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.844(1)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194A.050(1) requires the secretary of the Cabinet for Health and Family Services to promulgate administrative regulations necessary to operate the programs and fulfill the responsibilities vested in the cabinet. KRS 211.844(1) requires the cabinet to provide by administrative regulation for the registration and licensing of the possession or use of sources of ionizing or electronic product radiation and the handling and disposal of radioactive waste. This administrative regulation establishes procedures, criteria, terms, and conditions upon which the cabinet issues licenses for special nuclear material.
- History: 50 Ky.R. 286, 1165; eff. 12-13-2023.
Chapter 115 Water Fluoridation
902 KAR 115:010 Water fluoridation for the protection of dental health {#sec-902-kar-115-010 omnilex-key=us-ky-regs-official--title-902--902 KAR 115:010}
Section 1. Definitions.
(1) "Cabinet" is defined by KRS 194A.005(1).
(2) "Consecutive supply" means a supply that purchases its water from another water system.
Section 2. Community Implementation. The population served by a water system includes its own population and the population served by its consecutive supplies.
(1) A water system serving a community population of 3,000 or more, including consecutive supplies, shall adjust fluoride-deficient waters to protect the dental health of the people served by the supply.
(2) A water system serving a population between 1,500 and 3,000 shall provide supplemental fluoridation only if adequate fluoride feed equipment is available from the cabinet, Department for Public Health.
(3) Although not required to provide supplemental fluoridation, a water system serving a population of less than 1,500 that chooses to provide supplemental fluoridation shall do so only if:
(a) Adequate fluoride feed equipment is available from the cabinet, Department for Public Health; and
(b) There are competently trained or certified personnel at the water system.
Section 3. Approval. A water system shall obtain the written approval of the cabinet before adding fluoride to a public water system, pursuant to Section 5 of this administrative regulation.
Section 4. Equipment, Facilities, and Services. The equipment, facilities, and services shall meet the requirements set forth in this section.
(1) Feeding. Feeding equipment with an accuracy within five (5) percent shall be provided to feed the optimal dosage of fluoride.
(a) The rate of feed shall give a fluoride content operating tolerance range between six-tenths (0.6) ppm and one and two-tenths (1.2) ppm in the treated water, with an optimal concentration of seven-tenths (0.7) ppm.
(b) The point of application shall be selected so that fluoride is evenly mixed with the water leaving the treatment plant.
(2) Method of measurement.
(a) Saturator tanks. If solution feed equipment is used, the water plant shall have a corrosion-resistant solution tank and an accurate means for weighing the stock chemical (fluoride) available. A metering device for measuring the water for the solution shall also be used.
(b) Dry feed hoppers. Dry feed hoppers shall be mounted on scales.
(c) Acid systems (H2SiF6). Scales shall be available to measure the weight loss each day or a volumetric method of measuring the amount of acid being used each day shall be used.
(3) Protection of operator. Precautions shall be taken to protect the operators. Precautions shall include:
(a) An approved respirator;
(b) Approved rubber gloves;
(c) An eye shield;
(d) An apron; and
(e) An exhaust or ventilation system for all fluoride feeding equipment.
(4) Storage. Separate storage areas shall be used for all fluoride chemicals.
(5) Laboratory facilities. Laboratory facilities shall be used for the determination of the fluoride content of the water by personnel in accordance with the current standards published by the American Public Health Association, the American Water Works Association, and the Water Pollution Control Federation.
(6) Samples. Raw water and plant tap water samples shall be examined at least once per day and the results shall be included on the monthly operation report submitted to the Energy and Environment Cabinet in accordance with 401 KAR 8:020.
(a) Additional finished water samples shall be analyzed by a laboratory certified by the Energy and Environment Cabinet in accordance with 401 KAR 8:040 for fluoride determination, with the results being forwarded by the water system to the cabinet, Department for Public Health.
(b) This sampling shall be at a rate of two (2) samples per month.
(c) The first sample shall be collected from the plant tap during the first week of the month and the second sample collected from the distribution system, at a point of maximum retention, during the third week of the month.
(7) Siphon breakers. Fluoride feeders shall be equipped with siphon breakers to prevent back siphonage of concentrated fluoride solution into the distribution system.
(8) Notification of cabinet when fluoride begins. The cabinet shall be notified of the date on which fluoridation is to commence in order that a representative of the cabinet may be present to calibrate and check the fluoridation equipment and instruct the operating personnel concerning tests, records, operation, and safety precautions.
(9) Notice when fluoride is interrupted. The owner or operator of the water plant shall immediately notify the cabinet of any interruption to the addition of fluoride to the water supply.
Section 5. Procedure for Obtaining Approval. A system shall submit to the cabinet:
(1) Detailed plans showing the method and point of application of fluoride and storage facilities for stock chemicals;
(2) Information concerning technical supervision of the treatment process;
(3) Information on the provisions for laboratory facilities; and
(4) Evidence that the plant facilities and operation will provide for:
(a) Control and supervision;
(b) Safe operation and maintenance;
(c) The keeping of operational records; and
(d) Compliance with this administrative regulation and 401 KAR 8:010 through 401 KAR 8:700 relating to public water systems.
History
- RELATES TO: KRS Chapter 211
- STATUTORY AUTHORITY: KRS 194A.050(1), 211.090(3), 211.180(1), 211.190(11)
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.190(11) requires the Cabinet for Health and Family Services to provide public health services that include water fluoridation programs for the protection of dental health. This administrative regulation establishes the requirements for the programs.
- History: 21 Ky.R. 816; eff. 9-21-1994; Am. 42 Ky.R. 145; 719; eff. 9-16-2015; Cert. eff. 11-12-2021.
902 KAR 115:020 Enforcement of Water Fluoridation Program {#sec-902-kar-115-020 omnilex-key=us-ky-regs-official--title-902--902 KAR 115:020}
Section 1. Notice of Violation.
(1) If the Cabinet for Health Services has reasonable grounds to believe that a violation of 902 KAR 115:010 has occurred, it shall serve the alleged violator with a "Notice of Violation" (DH-36).
(2) The "Notice of Violation" shall state:
(a) The violation;
(b) Measures required to be taken to correct the violation;
(c) The date by which the corrective measures shall be completed;
(d) That the alleged violator has the right to request a hearing which shall be conducted in accordance with 902 KAR 1:400; and
(e) That the alleged violator may file an appeal in accordance with 902 KAR 1:400.
Section 2. Hearing. An administrative hearing shall be conducted in accordance with 902 KAR 1:400.
Section 3. Incorporation by Reference.
(1) Form DH-36, "Notice of Violation (4/96 Edition), Cabinet for Health Services, is incorporated by reference.
(2) This form may be inspected, copied, or obtained at the Office of the Commissioner for Public Health, 275 East Main Street, Frankfort Kentucky, 8 a.m. to 4:30 p.m., Monday through Friday.
History
- RELATES TO: KRS 211.190(11)
- STATUTORY AUTHORITY: KRS 13B.170, 194.050(1), 211.090(3), EO 96-862
- NECESSITY, FUNCTION, AND CONFORMITY: KRS 194.050(1) and 211.090(3) authorize the cabinet to promulgate administrative regulations to protect the health and welfare of the citizens. This administrative regulation establishes the procedures for the enforcement of the Cabinet for Health Services Water Fluoridation Programs as directed by KRS 211.190(11). Executive Order 96-862, effective July 2, 1996, reorganizes the Cabinet for Human Resources and places the Department for Public Health and the Dental Health Program under the Cabinet for Health Services.
- History: 902 KAR 115:020. 21 Ky.R. 3106; 22 Ky.R. 292; eff. 7-26-1995; 23 Ky.R. 1785; 2524; eff. 11-20-1996; eff. 4-5-2019; Crt eff. 1-7-2026.
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