RELATES TO: KRS Chapter 13B, 209.032, 216.935, 216.937,
216.9375, 216B.010-216B.130, 216B.990, 311.840(3), 314.011(8), 314.042(8),
319A.010(3), 327.010(2), 334A.020(3), 45 C.F.R. Part 160, 164, 42 U.S.C.
1320d-1320d-8
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.042(1) requires the
Cabinet for Health and Family Services to promulgate administrative regulations
necessary for the proper administration of the licensure function, which
includes establishing licensure standards and procedures to ensure safe,
adequate, and efficient health facilities and health services. KRS
216.9375(11)(a) requires the cabinet to promulgate administrative regulations
to implement, monitor, and enforce compliance with dementia-specific training
requirements for home health aides. This administrative regulation establishes
the minimum licensure requirements for the operation of and services provided
by home health agencies.
Section 1.
Definitions.
(1) "Coordination agreement"
means an agreement to coordinate health care services within the service area
of the agency.
(2) "Home health
agency" is defined by
KRS
216.935(4).
(3) "Home health aide" is defined by
KRS
216.935(3).
(4) "Home health aide services" is defined by
KRS
216.935(5).
(5) "Medical social worker" means an
individual who:
(a) Has a baccalaureate degree
in social work, psychology, sociology, or other field related to social
work;
(b) Has at least one (1) year
of social work experience in a health care setting; and
(c) Is licensed by the Kentucky Board of
Social Work.
(6)
"Occupational therapist" is defined by
KRS
319A.010(3).
(7) "Physical therapist" is defined by
KRS
327.010(2).
(8) "Qualified medical social worker" means
an individual who:
(a) Has a master's degree
from a school of social work accredited by the Council on Social Work
Education;
(b) Has social work
experience in a hospital, outpatient clinic, medical rehabilitation, medical
care, or mental health program; and
(c) Is licensed by the Kentucky Board of
Social Work.
(9)
"Speech-language pathologist" is defined by
KRS
334A.020(3).
Section 2. Scope. A home health
agency shall provide part-time or intermittent health and health related
services to a patient in his or her place of residence, either singly or in
combination as required by a plan of care prescribed by a licensed physician,
advanced practice registered nurse, or physician assistant.
Section 3. Administration and Operation.
(1) The licensee shall be legally responsible
for:
(a) The operation of the home health
agency; and
(b) Compliance with
federal, state, and local laws and administrative regulations pertaining to the
operation of the service.
(2) The licensee shall establish policies for
the administration and operation of the service. The policies shall include the
following:
(a) Acceptance of patients. The
policy shall assure that the acceptance of patients is based on medical,
nursing, and social information provided by the:
1. Physician, advanced practice registered
nurse, or physician assistant responsible for the patient's care;
2. Institutional personnel; and
3. Staff of the home health agency.
(b) Establishment and review of
the plan of care. The policy shall assure that services and items provided are
specified under a plan of care:
1.
Established, signed, and reviewed by the physician, advanced practice
registered nurse, or physician assistant who is responsible for the care of the
patient; and
2. Developed by the
physician, advanced practice registered nurse, or physician assistant and
appropriate professional staff acting within the limits of his or her statutory
scope of practice.
(3) Home health services shall be available
to the total population regardless of age, sex, and ethnic
background.
(4)
(a) The status of each patient and the plan
of care shall be reviewed at such intervals as the severity of the patient's
illness requires but no less frequently than every two (2) months, with a
maximum of sixty (60) days, by home health agency staff and the physician,
advanced practice registered nurse, or physician assistant.
(b) Verbal authorization to change the plan
of care shall be:
1. Put in writing, signed,
and dated with the date of receipt by the registered nurse or other appropriate
professional staff responsible for furnishing or supervising the order
services; and
2. Signed by the
physician, advanced practice registered nurse, or physician assistant within
thirty (30) days after the verbal order is issued.
(5) Clinical records.
(a) The home health agency shall maintain a
clinical record for each patient that:
1.
Covers the services the agency provides directly and those provided through
arrangements with another agency; and
2. Contains pertinent past and current
medical, nursing, and social information, including the plan of care.
(b) Ownership.
1. Medical records shall be the property of
the home health agency.
2. The
original medical record shall not be removed except by court order.
3. Copies of medical records or portions
thereof may be used and disclosed in accordance with the requirements
established in this administrative regulation.
(c) Confidentiality and Security: Use and
Disclosure.
1. The agency 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 home health agency may use and
disclose clinical 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. An agency 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.
(6) Original drug orders and changes in
orders. The following shall be signed by the physician or other prescribing
practitioner acting within the statutory scope of his or her license and
incorporated in the patient record maintained by the agency:
(a) The original drug order; and
(b) Changes in orders for the administration
of drugs subject to federal and state controlled substance acts, and other
legend drugs.
(7) Verbal
authorization for an original order for drugs or a change order shall be
reviewed and signed by the same prescribing practitioner within thirty (30)
days after the order is issued.
(8)
Evaluation.
(a) The agency shall have
procedures that provide for a systematic evaluation of the agency's program at
least once every two (2) years.
(b)
The agency staff shall conduct the evaluation.
(c) The program evaluation shall include
measures to determine whether the policies established are followed, including:
1. A review of patient records on a sample
basis to determine that services are being used appropriately and the extent to
which the needs of the patients the agency serves are being met both
quantitatively and qualitatively; and
2. A mechanism for reviewing overall
management aspects of the agency's services to assure economy and efficiency of
operations.
(9)
Planning. Each agency shall develop and annually review a long range plan which
includes:
(a) Assessment of needs for
services in the service area of the agency;
(b) Identification of agency's role in
meeting those needs;
(c) Staff
expansion for a two (2) year period;
(d) Establishment of goals and objectives;
and
(e) Coordination of volunteer
services, community education, and community development activities if these
services are provided by the agency.
(10) Subdivision operating as home health
agency.
(a) If a subdivision of an agency,
including the home care department of a hospital or the nursing division of a
health department, applies for a license, the subdivision shall:
1. Be licensed as a home health agency;
and
2. Maintain records of the
subdivision's activities, ensuring that expenditures attributable to the
services provided are identifiable.
(b) The parent organization shall determine
who:
1. Signs each coordination agreement and
other official documents; and
2.
Receives and disburses funds.
Section 4. Personnel; Supervision and
Training.
(1) Personnel policies. The agency
shall have written policies available to staff concerning qualifications,
responsibilities, and conditions of employment for each type of personnel
(including whether licensure is required by state law). The policies shall
cover:
(a) Wage scales, hours of work,
vacation, and sick leave;
(b) A
plan for a preemployment medical examination and follow-up medical examination
no less than every three (3) years thereafter for agency staff who serve
patients in their place of residence;
(d) Plans for orientation and for on-the-job
training;
(e) Annual evaluation of
employee performance;
(f) Job
descriptions for each category of health personnel which are specific to the
type of activity each may carry out;
(g) Pre-employment abuse registry checks
conducted pursuant to
KRS
216.937 and
KRS
209.032; and
(h) Pre-employment criminal background checks
in which the agency shall not employ an individual in a position that involves
providing direct services if the individual has been convicted of a:
1. Felony offense related to:
a. Theft;
b. Abuse, possession, or sale of illegal
drugs;
c. Abuse, neglect, or
exploitation of a child or an adult; or
d. A sexual crime; or
2. Misdemeanor offense related to abuse,
neglect, or exploitation of an adult.
(2) Agency supervision. The home health
agency shall designate a physician, registered nurse, or physician assistant to
supervise the agency's performance in providing home health services in
accordance with the:
(a) Orders of the
physician, advanced practice registered nurse, or physician assistant
responsible for the care of the patient; and
(b) Plan of care established by the
physician, advanced practice registered nurse, or physician
assistant.
(3)
Supervision of therapy services.
(a) If the
services of aides or other personnel providing supplementary services are
utilized in providing home health services, the staff shall be trained and
supervised by a qualified practitioner responsible for the delivery or
supervision of services within the practitioner's scope of licensure.
(b) If supervision is less than full-time,
the supervision shall:
1. Be provided on a
planned basis; and
2. Assure
adequate review of each individual plan of care and progress.
(4) Supervision of home
health aides.
(a) A registered nurse shall
provide direct supervision as described in this subsection and be readily
available at other times by telephone.
(b) The supervisor shall evaluate the home
health aide closely to ensure the aide's competence in providing care,
including the aide's ability to:
1. Carry out
assigned duties;
2. Relate well to
the patient; and
3. Work
effectively as a member of a team of health workers.
(c) If the patient receives skilled nursing
care or another skilled service, the registered nurse or a qualified
practitioner responsible for the delivery or supervision of services within the
practitioner's scope of licensure shall make a supervisory visit to the
patient's residence at least every two (2) weeks when the aide is:
1. Present to observe and assist;
or
2. Absent to assess
relationships and determine whether goals are being met.
(d) If home health aide services are provided
to a patient who is not receiving skilled nursing care or another skilled
service, the registered nurse shall make a supervisory visit to the patient's
residence at least every sixty (60) days and the supervisory visit shall occur
while the home health aide is providing patient care.
(5) Training of home health aides.
(a) The home health agency shall ensure that
each home health aide successfully completes an aide training and competency
evaluation program, including training in:
1.
Methods of assisting patients to achieve maximum self-reliance;
2. Principles of nutrition and meal
preparation;
3. The aging process
and the emotional problems of illness;
4. Procedures for maintaining a clean,
healthful, and pleasant environment;
5. Awareness of changes in the patient's
condition that should be reported;
6. Work of the agency and the health team;
and
7. Ethics, confidentiality, and
recordkeeping.
(b)
1. In addition to the training and competency
evaluation program required by paragraph (a) of this subsection and within
ninety (90) days from the most recent effective date of this administrative
regulation, a home health aide who provides care to a patient that exhibits
symptoms of Alzheimer's disease or other dementia shall complete at least six
(6) hours of initial training and three (3) hours of annual training in
dementia care pursuant to the requirements established by KRS
216.9375(3).
2. In accordance with
KRS 216.9375(2), a home health aide shall successfully complete the initial
training in dementia care prior to providing services to a patient that
exhibits symptoms of Alzheimer's disease or other dementia.
3. Pursuant to KRS 216.9375(6), a home health
aide who has a lapse of twenty-four (24) months or more providing care to a
patient that exhibits symptoms of Alzheimer's disease or other dementia shall
complete the six (6) hours of initial training within sixty (60) days of
resuming the delivery of care to a patient that exhibits symptoms of
Alzheimer's disease or other dementia.
(c) A home health agency shall:
1. Obtain cabinet approval of the agency's
dementia care training curriculum in accordance with the process established by
910 KAR
4:010;
2. Provide a
certificate of completion pursuant to KRS 216.9375(4) to each home health aide
who successfully completes the initial and annual dementia care training;
and
3. Maintain documentation of
successful completion of dementia care training for each home health aide in
accordance with KRS 216.9375(5).
(d) The cabinet shall impose fines in
accordance with KRS 216.9375(9) and (10).
(e) A home health agency's appeal of any
decision regarding a fine shall be conducted in accordance with KRS Chapter
13B.
Section 5.
Provision of Services.
(1) The home health
agency shall provide:
(a) Part-time or
intermittent skilled nursing services; and
(b) Other services for restoring,
maintaining, and promoting health or rehabilitation with minimum disruption of
daily living, including:
1. At least one (1)
other therapeutic service (physical, speech, or occupational
therapy);
2. Medical social
services; or
3. Home health aide
services.
(2)
Services shall be available five (5) days a week with back-up arrangements for
weekend and emergency services.
(3)
In addition to the services described in subsection (1) of this section, the
agency may provide:
(a) Medical supplies;
or
(b) Equipment
services.
(4) The
following conditions shall be met for the provision of therapeutic and medical
social services:
(a) Physical, speech, or
occupational therapy. An agency that provides or arranges for physical, speech,
or occupational therapy directly or under a contractual arrangement shall
provide the service in accordance with a physician, advanced practice
registered nurse, or physician assistant's written order by or under the
supervision of a therapist defined by Section 1(6), (7), or (9) of this
administrative regulation.
(b)
Respiratory therapy. An agency that provides or arranges for respiratory
therapy directly or under a contractual arrangement shall provide the service
in accordance with a physician, advanced practice registered nurse, or
physician assistant's written order by or under the supervision of a licensed
nurse with experience and training in the field of respiratory
therapy.
(c) Medical social
services. An agency that provides or arranges for medical social services
directly or under a contractual arrangement shall provide the service in
accordance with a physician, advanced practice registered nurse, or physician
assistant's written order by a medical social worker or a qualified medical
social worker as defined by Section 1(5) or (8) of this administrative
regulation.
(5) Home
health aide services. A visit by a home health aide for the provision of
personal care and other related health services shall be:
(a) Ordered by a physician, advanced practice
registered nurse, or physician assistant; and
(b) Included in a plan of care approved by
the physician, advanced practice registered nurse, or physician
assistant.
(6) Services
arranged with another provider. A home health agency that makes arrangements
for the provision of home health services by another agency shall establish a
written agreement that:
(a) Identifies each
service provided under the agreement;
(b) Ensures that the services shall be
provided within the scope and limitations set forth in the plan of
care;
(c) Allows for services to be
altered only upon the specific order of the initiating home health agency as
the result of a change made by the physician, advanced practice registered
nurse, or physician assistant in the patient's plan of care;
(d) Describes how the contracted personnel
shall be supervised;
(e) Requires
contract personnel to record progress notes and observations in the home health
agency records for purposes of planning and evaluating patient care;
(f) Assures that the contract agency's staff
and services meet the requirements established in this administrative
regulation for personnel qualifications, functions, supervision, orientation,
and training; and
(g) Specifies the
period of time the written agreement shall be in effect and how frequently the
agreement shall be reviewed.
(7) Service agreements with other health care
facilities. A home health agency shall establish a coordination agreement
defined by Section 1(1) of this administrative regulation with health care
providers in the agency's service area including hospitals and long-term care
facilities.