Kentucky Administrative Regulations
Title 906 - CABINET FOR HEALTH AND FAMILY SERVICES
Chapter 1 - Office of Inspector General
Section 906 KAR 1:110 - Critical access hospital services
Universal Citation: 906 KY Admin Regs Service 1:110
Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS 205.639(3), 211.842-211.852, 216.378, 216.379, 216.380, 216B.015(6), 216B.040(1)(c), (2)(b), 216B.105, 216B.153, 216B.165, 216B.990, Chapter 311, 315.035, 333.030, 42 C.F.R. 485.601-42 C.F.R. 485.647, 45 C.F.R. Part 160, Part 164, 42 U.S.C. 1320d-2-1320 d-8, 42 U.S.C. 1395i-4(c)(2)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 216.380(14) requires the Cabinet for Health and Family Services to promulgate administrative regulations necessary to implement a program for the licensure of critical access hospitals. 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 quality of care and licensure standards for critical access hospitals.
Section 1. Definitions.
(1) "Cabinet" is defined by
KRS
216B.015(6).
(2) "Licensee" means the entity that has been
issued and holds a valid critical access hospital license from the
cabinet.
Section 2. Requirements for Critical Access Status.
(1)
An applicant for initial licensure of a critical access hospital shall provide
documentation to the cabinet verifying that the hospital:
(a) Complies with the requirements of
KRS
216.380 and this administrative regulation;
and
(b) Qualifies for state
designation under 42 U.S.C.
1395i-4(c)(2).
(2) In accordance with
42 U.S.C.
1395i-4(c)(2)(B), a critical
access hospital that was certified by the secretary of the cabinet as a
necessary provider of services prior to January 1, 2006, may be relicensed as a
critical access hospital if the requirements of this administrative regulation
are met.
(3)
(a) If an application for initial licensure
of a critical access hospital is denied by the cabinet, the applicant shall be
entitled to an administrative hearing pursuant to
KRS
216B.040(1)(c) and (2)(b),
and KRS
216B.105.
(b) Licensure hearings shall follow the
procedures established by
900 KAR 6:040.
Section 3. Administration and Operation.
(1) The
licensee shall be legally responsible for the operation of the critical access
hospital and for compliance with federal, state, and local laws and
administrative regulations pertaining to the operation of the critical access
hospital.
(2) A critical access
hospital shall be under the medical direction of a physician licensed to
practice medicine or osteopathy in Kentucky.
(3) The licensee shall:
(a) Establish written policies and lines of
authority; and
(b) Designate an
administrator as the person principally responsible for the daily operation of
the critical access hospital.
(4) The licensee shall develop patient care
policies with the advice of a group of healthcare professionals identified by
the licensee.
(a) Pursuant to
42 C.F.R.
485.635(a)(2), the advisory
group shall include:
1. At least one (1)
Kentucky-licensed doctor of medicine or doctor of osteopathic medicine;
and
2. One (1) or more physician
assistants, advanced registered nurse practitioners, or clinical nurse
specialists.
(b) The
patient care policies shall include:
1. A
description of services that the critical access hospital furnishes, including
services provided through a contractual agreement;
2. A written program narrative describing in
detail the:
a. Services offered;
b. Methods and protocols for service
delivery;
c. Qualifications of
personnel involved in the delivery of services; and
d. Outcomes expected to be attained through
the delivery of specified services;
3. Guidelines for the medical management of
health problems, including:
a. Criteria for
determining if a case requires medical consultation;
b. Patient referral procedures; and
c. Maintenance of health records;
4. Procedures for the proper
storage, handling, and administration of drugs and biologicals;
5. Procedures establishing annual review and
evaluation of services provided;
6.
Procedures that assure compliance with
KRS
216B.165; and
7. A surgical smoke safety and control policy
that shall be available to staff if the hospital offers any surgical procedure
that is likely to produce surgical smoke.
(5) A critical access hospital shall
establish written policies regarding patient rights and responsibilities to
assure that each patient is:
(a) Informed of:
1. Patient rights;
2. Rules and regulations governing patient
conduct and responsibilities; and
3. The procedure for handling a patient
grievance;
(b) Informed
of services available and related charges, including charges not covered by
Medicare, Medicaid, or other third-party payor;
(c) Informed of the patient's:
1. Medical condition, unless medically
contraindicated as documented in the patient's medical record;
2. Right to participate in planning his or
her medical treatment; and
3. Right
to refuse to participate in experimental research;
(d) Assisted in understanding his or her
patient rights;
(e) Provided
confidential treatment of his or her records in accordance with subsection (9)
of this section;
(f) Treated with
consideration, respect, and recognition of the patient's dignity and
individuality, including privacy in treatment and care of personal health
needs; and
(g) Informed of the
procedure for filing a grievance or a recommendation to change a policy or
service. The policy shall establish a time frame within which critical access
hospital personnel shall determine what corrective action to take.
(6) Personnel.
(a) Staffing shall be maintained in
accordance with KRS
216.380(9).
(b) A physician shall:
1. Be responsible for all medical aspects of
the critical access hospital;
2.
Provide direct medical services in accordance with KRS Chapter 311;
3. Be present to provide medical direction,
supervision, and consultation to staff at least once in every two (2) week
period, unless no patient has been treated since the last visit;
4. Participate with other medical personnel
in developing, executing, and periodically reviewing written policies and
services;
5. Review and sign
patient records during the site visit; and
6. Provide medical orders and medical care
services to patients in accordance with the critical access hospital's
protocols.
(c) A
registered nurse or licensed practical nurse shall be on duty if a patient has
been admitted for overnight stay.
(7) The critical access hospital shall have
transfer and linkage contracts in accordance with
KRS
216.380(11) and
(12).
(8) Medical records.
(a) A critical access hospital shall maintain
a complete, comprehensive, accurate, and legible medical record for each
patient. The record shall include the following information:
1. The names of the patient's immediate
family members;
2. Medical and
social history, including information obtainable from other
providers;
3. Description of each
medical visit or contact, including:
a.
Condition or reason necessitating visit or contact;
b. Assessment;
c. Diagnosis;
d. Services provided;
e. Medications and treatments prescribed;
and
f. Disposition made;
4. Reports of laboratory, x-ray,
and other test findings; and
5.
Documentation of referrals, including:
a.
Reason for the referral;
b. To whom
patient was referred; and
c.
Information obtained from the referral source.
(b) Confidentiality of individual patient
records shall be maintained in accordance with subsection (9)(b) of this
section.
(c) Transfer of records.
The critical access hospital shall:
1.
Establish systematic procedures to assist with continuity of care if a patient
transfers to another licensed level of care; and
2. Upon proper release, transfer medical
records or an abstract upon request.
(d) Retention of records. Medical records
shall be retained for at least:
1. Six (6)
years from the date of discharge; or
2. If the patient is a minor, three (3) years
after the patient reaches the age of majority under state law, whichever is the
longest.
(9)
(a) Ownership.
1. Medical records shall be the property of
the critical access hospital.
2.
The original medical record shall not be removed from the critical access
hospital except by court order or subpoena.
3. Copies of a medical record or portions of
the record may be used and disclosed. Use and disclosure shall be as
established by paragraph (b) of this subsection.
(b) Confidentiality and Security: Use and
Disclosure.
1. The critical access 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.
2. The critical access 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.
3. A
critical access 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.
(10) Utilization review and
medical audit. In order to determine the appropriateness of services delivered,
there shall be a written plan for utilization review that specifies the
frequency of reviews and composition of the body conducting the
review.
(11) Quality assessment and
performance improvement program.
(a) Pursuant
to KRS
216.380(10), a critical
access hospital shall have a program to ensure continuous and effective
mechanisms for:
1. Review and evaluation of
patient care; and
2. Corrective
action.
(b) The quality
assessment and performance improvement program shall:
1. Be approved by the licensee;
2. Establish responsibility for the
monitoring and evaluation of services;
3. Delineate the scope of care;
4. Identify specific aspects of care to be
provided;
5. Establish and document
clinical criteria used to monitor care and services;
6. Systematically evaluate the standard of
care to identify problems and recommend corrective action or alternatives to
improve the standard of care;
7.
Establish criteria to assess the effectiveness of corrective action taken to
improve care; and
8. Require
documentation of improvements in the standard of care subsequent to corrective
action taken.
(12) Contract[ services. The critical access
hospital shall assure that a service provided under contract is properly
licensed or certified in accordance with applicable local, state, and federal
regulations and statutes.
Section 4. Provision of Services.
(1) A
critical access hospital shall provide services in accordance with
KRS
216.380(5).
(2) Laboratory services.
(a) A critical access hospital shall provide
basic laboratory services essential to the immediate diagnosis and treatment of
each patient.
(b) If the critical
access hospital provides laboratory services directly, the hospital shall
comply with
902 KAR 20:016, Section
4(4).
(c) If the critical access
hospital contracts for laboratory services, the laboratory shall be licensed
pursuant to KRS
333.030.
(d) The following services shall be provided:
1. Chemical examination of urine, including
ketone measurement, by stick or tablet method, or both;
2. Microscopic examination of urine
sediment;
3. Hemoglobin or
hematocrit;
4. Blood
glucose;
5. Examination of stool
specimens for occult blood;
6.
Pregnancy tests; and
7. Primary
culturing for transmittal to a hospital laboratory or licensed
laboratory.
(3) Emergency services.
(a) A critical access hospital shall:
1. Provide medical emergency procedures as a
first response to common lifethreatening injuries and acute illness;
2. Have available drugs and biologicals
commonly used in life-saving procedures, such as analgesics, local anesthetics,
antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids;
and
3. Provide examination services
in accordance with
902 KAR 20:012.
(b) There shall be a physician,
nurse practitioner, or physician assistant with training or experience in
emergency care:
1. On-call and immediately
available by telephone or radio contact; and
2. Available on site within thirty (30)
minutes on a twenty-four (24) hour per-day basis.
(c) A registered nurse shall be on duty at
the hospital to provide immediate emergency care on a twenty-four (24) hour per
day basis.
(4) Pharmacy
services.
(a) In accordance with
KRS
216.380(5)(b), a critical
access hospital shall provide basic pharmacy services essential to the
treatment of the patient.
(b) If
the critical access hospital provides pharmacy services directly, the hospital
shall comply with
902 KAR 20:016, Section
4(5).
(c) If the critical access
hospital contracts for pharmacy services, the pharmacy shall have a permit to
operate in accordance with
KRS
315.035.
(5) Radiology services.
(a) In accordance with
KRS
216.380(5)(b), a critical
access hospital shall provide basic radiology services essential to the
immediate diagnosis and treatment of the patient.
(b) If the critical access hospital provides
radiology services directly, the hospital shall comply with
902 KAR 20:016, Section
4(6).
(c) If the critical access
hospital contracts for radiology services, the radiology facility shall be
currently licensed or registered pursuant to
KRS
211.842 to
211.852.
(6) Dietary services. Pursuant to
KRS
216.380(5)(b), the critical
access hospital shall provide dietary services directly or by contract in
accordance with
902 KAR 20:016, Section 4(3) to
each patient who is admitted to the hospital and remains for more than twelve
(12) hours.
(7) Psychiatric units.
A critical access hospital that provides inpatient psychiatric services in a
distinct part unit in accordance with
KRS
216.380(7)(a) shall comply
with 902 KAR 20:180.
(8) Rehabilitation units. A critical access
hospital that provides inpatient rehabilitation services in a distinct part
unit in accordance with
KRS
216.380(7)(b) shall comply
with the requirements of
902 KAR 20:240.
(9) Surgical services.
(a) If a critical access hospital provides
surgical services, the hospital shall comply with
42 C.F.R.
485.639.
(b)
1. In
accordance with KRS
216B.153, a critical access 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.
2. 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).
Section 5. Physical and Sanitary Environment. A critical access hospital shall maintain the condition of the physical plant and hospital's overall environment in accordance with 902 KAR 20:016, Section 3(10).
Section 6. Facility Requirements. A critical access hospital shall comply with the applicable structural specifications and physical plant requirements established by 902 KAR 20:009 for services offered.
STATUTORY AUTHORITY: KRS 216.380(14), 216B.042(1)(a), (c)
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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