Current through Register Vol. 51, No. 3, September 1, 2024
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
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).
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:
1. Provides assisted living services,
including basic health and health-related services directly to its residents;
and
2. 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:
1. Planned opening;
or
2. 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:
1. Living units, including features that meet
the requirements of KRS
194A.703(1);
2. Central dining area;
3. Laundry facility; and
4. 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)
1. 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.
2. 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.
Number of Units |
Initial and Annual Fee |
<25 |
$500 + $40 per unit |
25-49 |
$1,000 + $40 per unit |
50-74 |
$1,500 + $40 per unit |
75-99 |
$1,750 + $40 per unit |
100 or more |
$2,000 + $40 per unit |
(3)
(a)
Name change. An ALC, ALC-BH, or ALC-DC shall:
1. 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
2. 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.
1. 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.
2. 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.
1. 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.
2. 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.
1. 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.
2. 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:
1. 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
2. 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)
1. 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.
2. 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.
3. 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.
4. 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)
1. 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.
2. 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.
3. 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.
4.
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:
1. Provide the locks on the
unit;
2. 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
3. Not lock a resident in the
resident's unit;
(j)
Develop and implement a staffing plan for determining staffing levels that:
1. Includes an evaluation conducted at least
twice a year of the appropriateness of staffing levels in the
facility;
2. 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
3. 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:
1. Available twenty-four (24) hours per
day, seven (7) days per week; and
2. 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:
1. Medical and social services
appointments;
2. Shopping;
and
3. 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:
1.
Residents remain connected to their traditional lifeways; and
2. 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:
1. Office of Inspector General, Division
of Health Care; and
2. 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:
1. The prevention of disease transmission;
and
2. 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:
1. Nursing tasks in accordance with
201 KAR 20:400; or
2. 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:
1.
Maintained for at least two (2) years; and
2. 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:
1. Accept a power-of-attorney from
a resident for any purpose or accept appointment as a guardian or conservator;
or
2. 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:
1. Provide to the resident, resident's legal
representative, or resident's designated contact person a final statement of
account;
2. Provide any refunds
due; and
3. 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:
1. Substitutions shall provide equal
nutritive value;
2. The changes
shall be recorded on the menu; and
3. 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:
1. Prepared by methods that conserve
nutritive value, flavor, and appearance; and
2. 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:
1. Contains a plan for evacuation,
including the written policy required by Section 7(4)(c) of this administrative
regulation and KRS
194A.717(5);
2. 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;
3. Identifies temporary relocation sites;
and
4. 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:
1. Provide
emergency and disaster training to all staff during the initial staff
orientation and annually; and
2.
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:
1. Have a criminal record check performed
pursuant to KRS
216.789(3);
2. 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;
3. 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;
4. Not have a criminal conviction or plea of
guilty to a felony or misdemeanor offense related to abuse, neglect, or
exploitation of a child;
5. In
accordance with KRS
209.032, not be listed on the caregiver
misconduct registry established by
922 KAR 5:120; and
6. 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:
1. Criminal background check upon initial
hire and no less than every two (2) years thereafter; and
2. 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:
1. Licensed entity; or
2. 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)
1. A
nurse in an ALC-BH or ALC-DC may delegate tasks in accordance with
201 KAR 20:400.
2. 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:
1. Be trained
in the proper methods to perform the tasks; and
2. 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:
1. Verify that the work is being performed
competently; and
2. 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:
1. Have the
authority, skills, and ability to provide the supervision of unlicensed
personnel;
2. Can implement changes
as needed; and
3. Can train
staff.
(c) Supervision
may include:
1. Direct observation of an
unlicensed staff person while the unlicensed staff person is providing the
services; and
2. 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:
1. Delegated
nursing tasks shall be supervised by a nurse pursuant to the requirements of
201 KAR 20:400, Section 4;
or
2. 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:
1. Shall be provided by a nurse or
appropriately licensed health professional; and
2. 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:
1.
Requesting and receiving prescriptions for medications;
2. Preparing and giving
medications;
3. Verifying that
prescription drugs are administered as prescribed;
4. Documenting medication management
activities;
5. 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;
6. Monitoring
and evaluating medication use;
7.
Resolving medication errors;
8.
Communicating with the prescriber, pharmacist, resident, and if applicable,
designated contact person or legal representative;
9. Disposing of unused medications;
and
10. 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:
1. Resident's name;
2. Name of the drug;
3. Strength;
4. Name of the pharmacy;
5. Prescription number;
6. Date;
7. Prescriber's name; and
8. 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:
1. Indications for medications;
2. Side effects;
3. Contraindications; and
4. 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:
1. Resident;
2. Resident's designated contact person or
legal representative; or
3. 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:
1. A statement describing the
medication management services that will be provided to the resident;
2. 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;
3. Documentation of specific instructions
relating to the administration of medications to the resident;
4. Identification of persons responsible for
monitoring medication supplies and ensuring that medication refills are ordered
on a timely basis;
5.
Identification of medication management tasks that may be delegated to
unlicensed personnel;
6. Procedures
for staff to notify a nurse or appropriate licensed health professional if a
problem arises with medication management services; and
7. 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:
1. 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
2. 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:
1. Specified, in writing, specific
instructions for each resident and documented those instructions in the
resident's records; and
2.
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:
1. 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.
2. Medication name, dosage, date, and time
administered; and
3. Method and
route of administration.
(c) The staff person shall document the:
1. Reason why medication administration was
not completed as prescribed, if applicable;
2. 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
3. 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:
1.
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.
2. 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:
1. Provide the resident with written
information on medications, including any special instructions for
administering or handling the medications;
2. Place the medications in a medication
container or containers appropriate to the provider's medication system;
and
3. 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:
1. Not be set up for later administration;
and
2. 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:
1. The resident's service plan ends;
or
2. 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:
1.
That are discontinued or expired; or
2. 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:
1.
The medication's name, strength, prescription number as applicable, and
quantity;
2. How the medication was
disposed of or to whom the medications were given;
3. Date of disposition; and
4. 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:
1. The medication has been prescribed and
labeled in a container for a specific resident;
2. The nurse assesses the resident, in person
or virtually, prior to administration of the PRN controlled
substance;
3. The nurse assesses
the resident, in person or virtually, following the administration of the PRN
controlled substance; and
4. 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:
1. Name of the
resident;
2. Date, time, kind,
dosage, and method of administration of each controlled substance;
3. Name of the practitioner who prescribed
the medications; and
4. 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:
1. Schedule II controlled substances count
daily; and
2. 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:
1. After expiration of the medication;
or
2. From the date the medication
was discontinued.
(h) If
controlled substances are destroyed on-site:
1. The method of destruction shall render the
drug unavailable and unusable;
2.
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
3. 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:
1. Requirement for licensed personnel
established by
201 KAR 2:370, Section
2(4)(i);
2. Requirements for
storage and administration established by
902 KAR 55:070, Section 2(2),
(5), and (7) through (9); and
3.
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:
1.
Requirement for licensed personnel established by
201 KAR 2:370, Section 2(4)(i);
and
2. 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:
1. Investigate any known
loss or unaccounted for prescription drugs;
2. Document the investigation in required
records; and
3. 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:
1.
KRS
194A.700 through
194A.729,
216.532, or
216.789; or
2. 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:
1. The Application for License to Operate an
Assisted Living Community; or
2.
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:
1. Is
convicted of a felony or gross misdemeanor that relates to the operation of the
facility or directly affects resident safety or care; or
2. 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.
STATUTORY AUTHORITY:
KRS
194A.707(1), (9),
216B.042(1)