902 KAR 20:370 - Operations and services; private duty nursing agencies
RELATES TO: KRS 2.015, 216B.020, 314.041, 314.051, 45 C.F.R. Parts 160, 164, 42 U.S.C. 1320d-2 - 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 and establish licensure standards to ensure safe, adequate, and efficient health facilities and health services. This administrative regulation establishes minimum licensure requirements for the operation of and services provided by private duty nursing agencies.
Section 1.
Definitions.
(1) "Private duty nursing
agency" means a public or private organization, including any partnership,
corporation, or other legal entity, that provides or arranges for the provision
of private duty nursing services.
(2) "Private duty nursing services" means the
delivery of skilled nursing services as defined by subsection (3) of this
section.
(3) "Skilled nursing
services" means the delivery of nursing care to a patient of a private duty
nursing agency that:
(a) Exceeds the level of
routine health monitoring;
(b) Is
clinically appropriate;
(c) Is
provided on a continuous basis or as part-time or short-term nursing
care;
(d) Is subject to:
1. A nursing reassessment no less than every
ninety (90) days; and
2. Frequent
changes in the plan of treatment;
(e) Is based on the expectation that the
service will improve, restore, or maintain function, or slow the patient's
decline of the disease or functional ability; and
(f) Includes skilled interventions provided
directly by a licensed nurse. Examples of skilled interventions may include:
1. Bowel and bladder care;
2. Administering medications or
oxygen;
3. Furnishing infusion
therapy services;
4. Medication
setups;
5. Treating decubitus
ulcers, skin breakdown, or other types of wound care; or
6. Ventilation care.
Section 2. Scope.
(1) Private duty nursing services shall be:
(a) Ordered and directed by the treating,
licensed practitioner or specialist after a face-to-face evaluation of the
patient, which may be provided as a telehealth encounter;
(b) Provided by:
1. A registered nurse (RN) licensed in
accordance with
KRS
314.041; or
2. A licensed practical nurse (LPN) licensed
in accordance with
KRS
314.051; and
(c) Provided to a patient in his or her
temporary or permanent place of residence or other community-based setting,
including:
1. The patient's home; or
2. Outside of the patient's home, as
necessitated by normal life activities.
(2) A private duty nursing agency shall not
include:
(a) A registered nurse who provides
nursing services as an independent practitioner; or
(b) An entity that seeks certification under
Title XVIII of the Social Security Act.
Section 3. Administration.
(1) The licensee shall be legally responsible
for:
(a) The operation of the private duty
nursing agency; and
(b) Compliance
with federal, state, and local laws and administrative regulations pertaining
to the operation of the agency.
(2) The licensee shall:
(a) Establish lines of authority;
(b) Designate an administrator who shall be
responsible for the daily operation of the agency;
(c) Establish and implement written
administrative policies covering all aspects of operation, including:
1. A description of the agency's
organizational structure, staffing, and allocation of responsibility and
accountability;
2. Policies and
procedures for the evaluation of personnel performance; and
3. A narrative describing in detail:
a. The services offered by the agency; and
b. Qualifications of personnel
involved in the delivery of services;
(d) Establish procedures for the handling and
administration of drugs and biologicals; and
(e) Maintain policies regarding the delivery
and supervision of patient care that shall:
1.
Be developed by a group of professional health providers, including at least
one (1) physician or one (1) registered nurse; and
2. Include the following:
a. A description of the services
provided;
b. A requirement for a
written plan of treatment for each patient who receives private duty nursing
services;
c. Guidelines to ensure
coordination of treatment with other health facilities and practitioners that
deliver services to patients of the agency;
d. Guidelines for the medical management of
health problems, including conditions that require medical consultation or
patient referral;
e. Procedures for
the annual review and evaluation of the services provided;
f. Guidelines for patient and environment
assessment; and
g. Guidelines to
ensure that a patient is receiving adequate services for assistance with daily
living activities.
Section 4. Personnel.
(1) Each private duty nursing agency shall
have:
(a) A clinical director who is:
1. A Kentucky-licensed physician or advanced
practice registered nurse with specialized training and experience in the range
of services provided by the agency; and
2. Responsible for overseeing the clinical
activities of the agency; and
(b) Adequate staffing to provide for
effective patient care in accordance with the terms and conditions of the
contract with the patient.
(2) Each private duty nursing agency's
written personnel policies shall be:
(a)
Available to each employee;
(b)
Reviewed on an annual basis; and
(c) Revised as necessary.
(3) There shall be a written job
description for each position that shall be reviewed and revised as
necessary.
(4) There shall be an
employee health and infection control program, including tuberculosis screening
and testing in accordance with
902 KAR
20:205.
(5) The private duty nursing agency shall
maintain a current personnel record for each employee, including:
(a) Evidence of each employee's current
registration, certification, or licensure, if applicable;
(b) Documentation of the employee's training
and experience;
(c) Evidence of an
annual performance evaluation;
(d)
Documentation of compliance with the agency's health and infection control
program;
(e) A preemployment
background check in which the agency shall not employ an individual in a
position that involves providing direct services if the individual:
1. Is listed on the:
a. Nurse aide or home health aide abuse
registry pursuant to
906
KAR 1:100;
b. Caregiver misconduct registry pursuant to
922 KAR 5:120; or
c. Child abuse
and neglect central registry pursuant to 922 KAR 1:470; or
2. Has a conviction of, or a plea of guilty,
an Alford plea, or a plea of nolo contendere to:
a. A felony offense that is related to:
(i) Theft;
(ii) Abuse, possession, or sale of illegal
drugs;
(iii) Abuse, neglect, or
exploitation of a child or an adult; or
(iv) A sexual crime; or
b. A misdemeanor offense related to abuse,
neglect, or exploitation of an adult or child; and
(f) Evidence of orientation and,
if needed, on-the-job training related to the employee's job
responsibilities.
(6) An
employee with direct patient care responsibilities shall have current
cardiopulmonary resuscitation (CPR) certification from the American Heart
Association, American Red Cross, or equivalent.
(7) Each licensed nurse of a private duty
nursing agency shall provide services that:
(a) Are commensurate with the nurse's
educational preparation and clinical competence;
(b) Address the nursing needs of the patient;
and
(c) Are delivered in accordance
with the patient's plan of treatment.
Section 5. Patient Records.
(1) Each private duty nursing agency shall
maintain a clinical record for each patient that includes:
(a) Pertinent past and current medical,
nursing, and social history, including information obtained from other
providers;
(b) Name of the
referring physician, or other ordering practitioner, if any, acting within the
statutory scope of practice;
(c)
Orders of the referring physician, or other ordering practitioner, if any,
acting within the statutory scope of practice;
(d) Description of each contact, including
the:
1. Condition or reason necessitating
contact;
2. Assessment;
3. Service provided;
4. Medication and treatment prescribed;
and
5. Disposition made;
and
(e) Documentation of
referrals made, including:
1. Reason for
referral;
2. To whom the patient
was referred; and
3. Information
obtained from a referral source.
(2) Ownership.
(a) Medical records shall be the property of
the private duty nursing agency.
(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.
(3)
Confidentiality and Security: Use and Disclosure.
(a) The agency shall maintain the
confidentiality and security of patient 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.
(b) The private duty nursing agency may use
and disclose patient 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.
(c) A private duty
nursing 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.
(d)
Retention of records. After a patient's death or discharge, the completed
medical record shall be placed in an inactive file and:
1. Retained for six (6) years; or
2. Three (3) years after the patient reaches
the age of majority in accordance with
KRS
2.015, whichever is longer.
(4) The agency shall:
(a) Designate a specific location for the
maintenance and storage of the agency's medical records;
(b) Have provisions for storage of medical
records in the event the agency ceases to operate; and
(c) Safeguard the record and its content
against loss, defacement, or tampering.
Section 6. Private Duty Nursing Services.
(1) A private duty nursing agency shall
develop a plan of treatment for each patient receiving private duty nursing
services.
(2) The plan of treatment
shall be developed in consultation with the:
(a) Prescribing practitioner;
(b) Agency personnel; and
(c) Patient, patient's family member, or
patient's responsible party.
(3) The plan of treatment shall be reviewed:
(a) By the ordering practitioner in
consultation with:
1. Agency personnel;
and
2. The patient, patient's
family member, or patient's responsible party; and
(b) At intervals as the severity of the
patient's illness requires or at least once every two (2) months.
(4) Services shall be nonabusive
and provided in a manner that ensures the greatest amount of safety and
security for the patient.
(5)
Private duty nursing agency personnel shall ensure that medical waste generated
as a result of a service shall be removed from a patient's home and disposed of
properly.
Section 7.
Licensure. Within ninety (90) days from the most recent effective date of this
administrative regulation, the cabinet shall:
(1) Convert any licensed home health agency
that is not certified under Title XVIII of the Social Security Act to a
licensed private duty nursing agency;
(2) Not require approval of a new certificate
of need to convert an existing home health agency license to a private duty
nursing license; and
(3) Require a
home health agency that converts its license to a private duty nursing license
to comply with the accreditation requirements of Section 8(1)(b) of this
administrative regulation.
Section
8. Accreditation.
(1) A private
duty nursing agency shall be accredited by the Joint Commission, Community
Health Accreditation Program, Accreditation Commission for Health Care, or an
accrediting body with equivalent standards within one (1) year from the date
of:
(a) Initial, provisional licensure;
or
(b) The most recent effective
date of this administrative regulation.
(2)
(a) If a
private duty nursing agency has not obtained accreditation in accordance with
subsection (1) of this section, the agency may request an extension to complete
the accreditation process.
(b) A
request for extension shall:
1. Be submitted
in writing to the Office of Inspector General at least sixty (60) days prior to
the:
a. Date of the licensee's first annual
renewal; or
b. One (1) year
anniversary from the most effective date of this administrative
regulation;
2. Include
evidence that the agency:
a. Has initiated the
process of becoming accredited within sixty (60) days of the:
(i) Date of provisional licensure;
or
(ii) Most recent effective date
of this administrative regulation; and
b. Is continuing its efforts to obtain
accreditation; and
3.
Include an estimated timeframe by which approval of accreditation is
anticipated, not to exceed two (2) years from the:
a. Date of provisional licensure; or
b. Most recent effective date of
this administrative regulation.
(3) A licensee's provisional licensure status
shall end on the date that the agency obtains accreditation.
(4) Proof of accreditation shall be provided
to the Office of Inspector General:
(a) Upon
receiving accreditation; and
(b)
Yearly at the time of annual renewal.
(5) If a private duty nursing agency loses
its accreditation or becomes accredited by a different accrediting
organization, the licensee shall notify the Office of Inspector General no
later than thirty (30) days from the date that:
(a) The licensee's accreditation was
terminated; or
(b) Accreditation by
a different organization that meets the requirements of subsection (1) of this
section took effect.
(6)
The cabinet shall revoke a license if a private duty nursing agency fails to
meet one (1) of the following requirements:
(a) Become accredited in accordance with
subsection (1) of this section;
(b)
Request an extension in accordance with subsection (2) of this
section;
(c) Achieve accreditation
within two (2) years from the:
1. Date of
provisional licensure, if a request for extension is submitted; or
2. Most recent effective date of this
administrative regulation, if a request for extension is submitted;
or
(d) Maintain
accreditation.
Notes
STATUTORY AUTHORITY: KRS 216B.042(1)
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