Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO: KRS 216.2925, 216.530, 216B.010, 216B.015,
216B.040, 216B.042, 216B.045-216B.055, 216B.075, 216B.105-216B.131,
216B.990
NECESSITY, FUNCTION AND CONFORMITY: KRS 216B.185 requires that
the cabinet promulgate the necessary administrative regulations to implement
the licensing validation process for hospitals deemed in compliance with
licensure requirements. This administrative regulation implements the licensing
validation process and establishes a procedure for investigating complaints at
deemed hospitals.
Section 1.
Definitions.
(1) "CMS" means the Centers for
Medicare and Medicaid Services.
(2)
"Deemed hospital" means a hospital that is deemed to be in compliance with
licensure requirements pursuant to the provisions of KRS 216B.185.
(3) "Inspecting agency" means the Cabinet for
Health Services, Office of the Inspector General.
(4) "State licensure standard" means an
individual requirement contained within the operations and services regulation
of a deemed hospital.
Section
2. Licensure Validation Inspection.
(1) On an annual basis the inspecting agency
shall select a minimum of five (5) percent and no more than ten (10) percent of
the total number of deemed hospitals and conduct an on-site inspection to
validate that state licensure standards are met.
(2) A deemed hospital that has received a CMS
certification validation survey in the previous twelve (12) months shall not be
selected for a licensure validation inspection.
(3) A deemed hospital that is selected to
receive a licensure validation inspection shall be notified of the inspection
at least seven (7) days before the scheduled inspection date.
(4) The inspecting agency shall conduct
validation surveys in accordance with the provisions contained in Section 4 of
this administrative regulation.
Section 3. Complaint Investigation
Inspection.
(1) If the inspecting agency
receives a complaint or becomes aware from another state agency or through the
media that a deemed hospital may not be in compliance with a state licensure
standard, the inspecting agency shall conduct an investigation of the alleged
noncompliance.
(2) Complaint
investigations shall be unannounced and conducted in accordance with the
procedures in Section 4 of this administrative regulation.
Section 4. Procedures for Conducting
Validation and Complaint Investigations of Deemed Hospitals.
(1) If the inspecting agency determines, as a
result of an on-site licensure validation or compliant investigation
inspection, that a hospital is not in compliance with a state licensure
standard:
(a) At the conclusion of the of the
on-site inspection, the survey staff of the inspecting agency shall conduct an
exit conference to discuss preliminary findings with the hospital administrator
or designee;
(b) The inspecting
agency shall inform the hospital in writing of the violation of the state
licensure standard within ten (10) days of the inspection; and
(c) The hospital shall submit to the
inspecting agency, within ten (10) days of receipt of the written notice, a
written plan for the correction of the violation;
1. The plan 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 that will be
utilized to ensure the violation will not reoccur.
2. Following a review of the plan, the
inspecting agency shall notify the hospital in writing of the acceptability of
the plan.
3. If a portion or all of
the plan is unacceptable:
a. The inspecting
agency shall specify the reasons for the unacceptability; and
b. The hospital shall modify or amend the
plan and resubmit it to the inspecting agency within ten (10) days.
4. Upon receipt of an acceptable
plan of correction, the inspecting agency may conduct a follow-up on-site
inspection to ensure that the violation has been corrected.
(2) The hospital shall
lose its status as a deemed hospital if, as a result of the on-site licensure
validation or complaint investigation inspection, the inspecting agency
determines that a hospital has:
(a) A single
violation of a state licensure standard of sufficient severity that the
violation poses a substantial risk to patient care or patient safety;
or
(b) A substantial number of
violations of state licensure standards.
(3) The hospital shall regain its deemed
status when the inspecting agency determines that the violation or violations
have been corrected.
STATUTORY AUTHORITY: KRS 216B.185