Current through Register Vol. 51, No. 3, September 1, 2024
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
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.
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:
1. Self-care;
2. Receptive and expressive
language;
3. Learning;
4. Mobility;
5. Self direction;
6. Capacity for independent living;
or
7. 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:
1. Communication;
2. Self-care;
3. Home living;
4. Social or interpersonal skills;
5. Use of community resources;
6. Self-direction;
7. Functional academic skills;
8. Work;
9. Leisure; or
10. 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:
1. In a patient's home;
or
2. 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:
1. Services offered;
2. Methods and protocols for service
delivery;
3. Qualifications of
personnel involved in the delivery of the services; and
4. 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:
1. Be responsible for all
medical aspects of the clinic and provide direct medical services in accordance
with the Medical Practice Act, KRS Chapter 311;
2. Provide medical direction, supervision,
and consultation to the staff;
3.
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;
4. Periodically review the clinic's patient
records, provide medical orders, and provide medical care services to patients
of the clinic;
5. 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
6. 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 instate
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:
1. KRS Chapter 209;
2. KRS Chapter 218A;
3.
KRS 507.020,
507.030,
and
507.040;
4. KRS Chapter 509;
5. KRS Chapter 510;
6. KRS Chapter 511;
7. KRS Chapter 513;
8.
KRS
514.030;
9. KRS Chapter 530;
10. KRS Chapter 531;
11.
KRS
508.010,
508.020,
508.030,
and
508.032;
12. A criminal statute of the United States
or another state similar to subparagraphs 1 to 11 of this paragraph;
or
13. 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:
1.
Thorough job orientation for new personnel;
2. Regular in-service training
programs;
3. Behavior management
procedures and techniques;
4.
Training in the detection and reporting of suspected abuse or neglect of a
child or adult;
5. Training in the
field of intellectual and developmental disabilities; and
6. 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:
1. Date of the
visit;
2. Condition or reason for
the visit;
3. Name of health care
practitioner providing the service;
4. Description of the services provided;
and
5. 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.
1. Personnel performing physical examinations
shall have adequate training and be currently licensed, registered, or
certified in accordance with applicable Kentucky statutes and administrative
regulations.
2. 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:
1. 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;
2. 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;
3. 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;
4. 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;
5. 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
6. 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
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, 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.
STATUTORY AUTHORITY:
216B.042