RELATES TO:
KRS
13B.040,
13B.050,
13B.080,
13B.090,
13B.110,
13B.130,
216.510
- 216.525, 216.555 - 216.567, 216.577, 216A.010(3),
42 C.F.R. 483.10,
45 C.F.R. Part 160, Part 164,
42
U.S.C. 1320d-2
-
1320-8
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216.563 requires the Cabinet for Health and
Family Services to promulgate administrative regulations setting forth the
criteria and, where feasible, the specific acts that constitute Type A and B
violations as specified by
KRS
216.537 to
216.590.
This administrative regulation establishes the criteria for Type A and B
violations in long-term care facilities and the process for appeal of any
decision on citations or penalties as required by
KRS
216.567(1).
Section 1. Definitions.
(1) "Cabinet" is defined by
KRS
216.510(3).
(2) "Citation" means written notification of
a Type A or Type B violation.
(3)
"Long-term care administrator" is defined by
KRS
216A.010(3).
(4) "Long-term care facility" means the same
as "long-term care facilities" defined by
KRS
216.510(1).
(5) "Resident" is defined by
KRS
216.510(2).
(6) "Type A violation" means a violation, as
described by
KRS
216.557(1), by a long-term
care facility of the administrative regulations, standards, and requirements
established by the cabinet pursuant to
KRS
216.563 or the provisions of
KRS
216.510 to
216.525, or
applicable federal laws and regulations that present an imminent danger to any
resident of a long-term care facility and creates substantial risk that death
or serious mental or physical harm to a resident will occur.
(7) "Type B violation" means a violation, as
described by
KRS
216.557(2), by a long-term
care facility of the administrative regulations, standards, and requirements
established by the cabinet pursuant to
KRS
216.563 or the provisions of
KRS
216.510 to
216.525, or
applicable federal laws and regulations that present a direct or immediate
relationship to the health, safety, or security of any resident, but which does
not create an imminent danger.
Section 2. Written Citations and Imposition
of Penalties.
(1) The cabinet's finding of a
Type A or Type B violation shall be:
(a)
Communicated to the long-term care facility at the exit conference of an onsite
survey; and
(b) Issued as a written
citation in the statement of deficiencies, including:
1. The nature of the violation;
2. The statutory provision or administrative
regulation alleged to have been violated pursuant to
KRS
216.555; and
3. Notice of the right to appeal the:
a. Citation; and
b. Proposed assessment of the civil
penalty.
(2) The cabinet shall issue the citation and
statement of deficiencies as soon as practicable to the licensee, long-term
care administrator, or designated representative by:
(a) Certified mail, return receipt
requested;
(b) Personal service;
or
(c) Other method of delivery,
which may include electronic service.
(3) If the cabinet sends notice of a citation
and statement of deficiencies to a long-term care facility electronically, the
cabinet shall request that the facility reply immediately upon receipt to
confirm that the facility received the citation.
(4) If a long-term care facility fails to
reply to the cabinet within one (1) business day after the cabinet sends a
citation and statement of deficiencies electronically, the cabinet:
(a) Shall contact the licensee, long-term
care administrator, or administrator's designee by telephone to determine
receipt; and
(b) May deliver the
citation and statement of deficiencies by certified mail or personal service if
a second attempt to send the citation electronically is not
successful.
(5) The date
of the exit conference shall be day one (1) of the time period specified for
abatement of a Type A or Type B violation.
(6) The cabinet shall consider the factors
established in
KRS
216.565 in determining the amount of the
initial penalty to be imposed for a Type A or Type B violation.
Section 3. Criteria for Finding a
Type A Violation.
(1) The following specific
acts or circumstances shall constitute a Type A violation:
(a) The cabinet determines that one (1) or
more violations related to resident care or physical plant standards:
1. Resulted in actual harm to a resident;
or
2. Represent an imminent danger
and create a substantial risk that death or serious mental or physical harm to
a resident will occur;
(b) The facility fails to implement a regular
program to prevent pressure sores with emphasis on the following:
1. Procedures to maintain clean linens for
each resident;
2. Procedures to
assure that clothes and linens are cleaned each time the bed or clothing is
soiled;
3. Procedures to assure
adherence to nationally recognized clinical practice guidelines or
recommendations that shall be in writing and available to direct care
staff;
4. Documentation that direct
care staff have received training on nationally recognized pressure ulcer
guidelines;
5. Procedures to assist
the resident in being up and out of bed as much as the resident's condition
permits, unless medically contraindicated; and
6. If a resident is bedfast or unable to
relieve pressure, procedures that require staff to assist the resident to
change positions as often as necessary, but no less than every (2) hours to:
a. Stimulate circulation;
b. Prevent pressure areas, contractures, and
decubitus; and
c. Promote the
healing of any pressure sores;
(c) The facility fails to ensure that a
resident who is admitted to the facility without pressure sores does not
develop pressure sores, unless the individual's clinical condition demonstrates
that they were unavoidable;
(d) If
a resident has pressure sores, the facility fails to provide necessary
treatment and services to:
1. Promote
healing;
2. Prevent infection;
and
3. Prevent new sores from
developing;
(e) The
facility knowingly admits or retains an individual whose needs exceed the
facility's capability to care for the resident;
(f) The facility fails to disclose to a
resident a serious preventable adverse event that affected the
resident;
(g) The cabinet finds a
violation of a resident's rights, pursuant to
KRS
216.515 to
216.520
or
42 C.F.R.
483.10,
that presents an imminent danger to any resident and creates substantial risk
that death or serious mental or physical harm will occur;
(h) The facility fails to consult a physician
if a resident experiences a serious accident or illness;
(i) The facility fails to follow the written
instructions of an attending physician, or in case of emergency, verbal order
given by the physician or licensed practitioner acting within the physician or
practitioner's scope of practice during use of a physical restraint or
pharmaceutical agent that restricts a resident's movement;
(j) The facility fails to advise the
attending physician if an error in medication occurs, the error is not recorded
in the resident's file, and correction is not made within one (1) day of the
date of discovery;
(k) The facility
fails to store all drugs and biologicals in locked compartments under proper
temperature controls;
(l) The
facility fails to comply with a resident's medically prescribed special diet or
dietary restriction, except for special days or celebrations in which the
restriction has been lifted and is medically approved;
(m) The facility fails to maintain no less
than a three (3) day supply of food in the facility; or
(n) The facility fails to maintain a written
fire control and evacuation plan in which staff present and responsible for
supervision are familiar.
(2) A long-term care facility that fails to
correct a Type A violation within the time specified for correction by the
cabinet shall be subject to at least one (1) of the actions established in
KRS
216.577.
Section 4. Criteria for Finding a Type B
Violation. The following specific acts or circumstances shall constitute a Type
B violation:
(1) The cabinet finds one (1) or
more violations related to resident care or physical plant standards that:
(a) Present a direct or immediate
relationship to the health, safety, or security of any resident;
(b) Do not create an imminent
danger;
(c) May be isolated or
occasional; and
(d) Do not
represent a pattern or widespread practice throughout the facility;
(2) The facility maintains or
admits more residents to a long-term care facility than the maximum capacity
permitted under the license, except in an emergency as documented by the
facility in a contemporaneous notice to the cabinet;
(3) The facility fails to maintain an active
program of pest control for all areas of its physical plant;
(4) The facility fails to serve at least
three (3) meals per day with not more than fourteen (14) hours between the
evening meal and breakfast, unless an exception is allowed pursuant to the
applicable administrative regulations under 902 KAR Chapter 20;
(5) The facility fails to meet the
nutritional needs of residents by not complying with the physician's
orders;
(6) The facility fails to
make between meal and bedtime snacks available, unless medically
contraindicated;
(7) The facility
fails to maintain a complete medical record for each resident with all entries
current, dated, and signed;
(8)
Except for a long-term care facility with an integrated heating, ventilation
and air conditioning system (HVAC system), the facility fails to maintain
screens on windows;
(9) The
facility fails to offer a nutritional substitute to a resident who refuses food
served;
(10) The facility fails to
modify the texture or change the consistency of food served based upon a
resident's need;
(11) The facility
fails to 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
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;
(12) Except in family care homes, the
facility fails to assure that cold water and hot water is available for
resident use;
(13) The facility
fails to assure that the maximum water temperature available for use by a
resident does not exceed 110 degrees Fahrenheit;
(14) The facility fails to provide
substitutions of equal nutritive value if changes in the menu are necessary;
or
(15) The facility fails to have
an administrator on staff who is responsible for the operation of the facility,
or who fails to delegate responsibility if absent.
Section 5. Penalties.
(1) Civil penalties shall be trebled in
accordance with the provisions of
KRS
216.560(3).
(2) The amount of the initial penalty shall
be determined with consideration given to the factors established in
KRS
216.565.
Section 6. Appeals.
(1) Within twenty (20) days of the receipt of
the citation and statement of deficiencies established in Section 2 of this
administrative regulation, the licensee may file a written request for a
hearing with the cabinet secretary.
(2) Upon receipt of the written request for a
hearing, the secretary shall designate a hearing officer in accordance with
KRS
216.567(2).
(3) A hearing shall be scheduled and
commenced as soon as practicable after receipt of the request for
hearing.
(4) Notice of the hearing
shall:
(a) Be served on the party pursuant to
KRS 13B.050(1)
and (2); and
(b) Include the information required by
KRS
13B.050(3).
(5) The hearing officer may hold a
prehearing conference in accordance with
KRS
13B.070.
(6) The hearing shall be conducted pursuant
to
KRS 13B.080
and
13B.090.
(7) Within sixty (60) days of the closing of
the record or hearing, the hearing officer shall make written findings of fact,
conclusions of law, and a final decision based upon the official record of the
proceeding.
(8) In addition to the
requirements of
KRS
13B.130, the official record of the hearing
shall include:
(a) The notice of citation
within the statement of deficiencies or penalty assessed;
(b) Any staff reports, memoranda, or
documents prepared by, or for the cabinet regarding the matter under review as
introduced at the hearing;
(c) Any
information provided by the parties as introduced at the hearing;
(d) Any other evidence admitted during the
hearing with respect to the matter under review; and
(e) Upon its completion, the prehearing
orders, if any, and the report of the hearing officer containing the:
1. Findings of fact;
2. Conclusions of law; and
3. Final decision.
(9) Any party aggrieved by the
final decision may appeal that decision to the Franklin Circuit Court in
accordance with
KRS
216.567(3).
(10) An appeal of a Type A or Type B
violation shall not be construed to limit the authority of the cabinet to act
pursuant to
KRS
216.573 or
KRS
216.577 for failure to correct the violation
in a timely manner.
(11) In
addition to the grounds for disqualification established by
KRS
13B.040(2)(b), a hearing
officer shall not participate in a hearing involving a long-term care facility
if the hearing officer has, within the twelve (12) month period preceding the
hearing, had any ownership interest, employment, staff, fiduciary, contractual,
creditor, or consultative relationship with the facility.