201 KAR 20:057. Scope and standards of practice of advanced
practice registered nurses.
RELATES
TO: KRS 218A.205(3)(a), 314.011(7), 314.042, 314.193(2), 314.196
STATUTORY
AUTHORITY: KRS 218A.205(3)(a), 314.131(1), 314.193(2)
NECESSITY,
FUNCTION, AND CONFORMITY: KRS 218A.205(3)(a) requires the Board of Nursing to
establish by administrative regulation mandatory prescribing and dispensing
standards for licensees authorized to prescribe or dispense controlled substances.
KRS 314.131(1) authorizes the board to promulgate administrative regulations
necessary to enable it to carry into effect the provisions of KRS Chapter 314.
KRS 314.193(2) authorizes the board to promulgate administrative regulations
establishing standards for the performance of advanced practice registered
nursing to safeguard the public health and welfare. This administrative regulation
establishes the scope and standards of practice for an advanced practice
registered nurse.
Section
1. Definitions. (1) "Collaboration" means the relationship between
the advanced practice registered nurse and a physician in the provision of
prescription medication, including both autonomous and cooperative
decision-making, with the advanced practice registered nurse and the physician
contributing their respective
expertise.
(2)
"Collaborative Agreement for the Advanced Practice Registered Nurse's
Prescriptive Authority for Controlled Substances" or "CAPA-CS"
means the written document pursuant to KRS 314.042(10).
(3)
"Collaborative Agreement for the Advanced Practice Registered Nurse's
Prescriptive Authority for Nonscheduled Legend Drugs" or
"CAPA-NS" means the written document pursuant to KRS 314.042(8).
Section
2. (1) The practice of the advanced practice registered nurse shall be in
accordance with the standards and functions defined in scope and standards of
practice statements adopted by the board in subsection (2) of this section.
(2)
The following scope and standards of practice statements shall be adopted:
(a)
AACN Scope and Standards for Acute Care Nurse Practitioner Practice;
(b)
AACN Scope and Standards for Acute and Critical Care Clinical Nurse Specialist
Practice;
(c)
Neonatal Nursing: Scope and Standards of Practice;
(d)
Nursing: Scope and Standards of Practice;
(e)
Pediatric Nursing: Scope and Standards of Practice;
(f)
Psychiatric-Mental Health Nursing 2nd Edition: Scope and Standards of Practice;
(g)
Scope of Practice for Nurse Practitioners;
(h)
Standards of Practice for Nurse Practitioners;
(i)
Scope of Nurse Anesthesia Practice;
(j)
Standards for Nurse Anesthesia Practice;
(k)
Standards for Office Based Anesthesia Practice;
(l)
Standards for the Practice of Midwifery;
(m)
Statement on the Scope and Standards of Oncology Nursing Practice: Generalist
and Advanced Practice; and
(n)
The Women's Health Nurse Practitioner: Guidelines for Practice and Education.
Section
3. In the performance of advanced practice registered nursing, the advanced
practice registered nurse shall seek consultation or referral in those
situations outside the advanced practice registered nurse's scope of practice.
Section
4. Advanced practice registered nursing shall include prescribing medications
and ordering treatments, devices, and diagnostic tests which are consistent
with the scope and standard of practice of the advanced practice registered
nurse.
Section
5. Advanced practice registered nursing shall not preclude the practice by the
advanced practice registered nurse of registered nursing practice as defined in
KRS 314.011(6).
Section
6. (1) A CAPA-NS and a CAPA-CS shall include the name, address, phone number,
and license number of both the advanced practice registered nurse and each
physician who is a party to the agreement. It shall also include the specialty
area of practice of the advanced practice registered nurse.
(2)(a)
To notify the board of the existence of a CAPA-NS pursuant to KRS
314.042(8)(b), the APRN shall file with the board the Notification of a
Collaborative Agreement for the Advanced Practice Registered Nurse’s
Prescriptive Authority for Nonscheduled Legend Drugs (CAPA-NS).
(b)
To notify the board that the requirements of KRS 314.042(9) have been met and
that the APRN will be prescribing nonscheduled legend drugs without a CAPA-NS,
the APRN shall file the Notification to Discontinue the CAPA-NS After Four
Years.
(c)
To notify the board of the existence of a CAPA-CS pursuant to KRS 314.042(10)(b),
the APRN shall file with the board the Notification of a Collaborative
Agreement for the Advanced Practice Registered Nurse's Prescriptive Authority
for Controlled Substances (CAPA-CS).
(3)
For purposes of the CAPA-NS and the CAPA-CS, in determining whether the APRN
and the collaborating physician are qualified in the same or a similar
specialty, the board shall be guided by the facts of each particular situation
and the scope of the APRN's and the physician's actual practice.
(4)(a)
An APRN with a CAPA-CS shall report all of his or her United States Drug
Enforcement Agency (DEA) Controlled Substance Registration Certificate numbers
to the board when issued to the APRN by mailing a copy of each registration
certificate to the board within thirty (30) days of issuance.
(b)
Any change in the status of a DEA Controlled Substance Registration Certificate
number shall be reported in writing to the board within thirty (30) days.
Section
7. Prescribing medications without a CAPA-NS or a CAPA-CS shall constitute a
violation of KRS 314.091(1), except when a CAPA-NS has been discontinued
pursuant to KRS 314.042(9) or the provisions of KRS 314.196(4)(b) apply.
Section
8. The board may make an unannounced monitoring visit to an advanced practice
registered nurse to determine if the advanced practice registered nurse's
practice is consistent with the requirements established by 201 KAR Chapter 20,
and patient and prescribing records shall be made available for immediate inspection.
Section
9. Prescribing Standards for Controlled Substances. (1)(a) This section shall
apply to an APRN with a CAPA-CS if prescribing a controlled substance other
than a Schedule II controlled substance or a Schedule III controlled substance
containing hydrocodone.
(b)
The APRN shall practice according to the applicable scope and standards of
practice for the APRN’s role and population focus.
(2)
This section shall not apply to:
(a) An APRN prescribing or administering a controlled substance
immediately prior to, during, or within the fourteen (14) days following an
operative or invasive procedure or a delivery if the prescribing or
administering is medically related to the operative or invasive procedure or
the delivery and the medication usage does not extend beyond the fourteen (14)
days;
(b) An APRN prescribing or administering a controlled substance
necessary to treat a patient in an emergency situation; or
(c) An APRN prescribing a controlled substance:
1. For administration in a hospital or long-term-care
facility with an institutional account, or an APRN in a hospital or facility
without an institutional account, if the hospital, long-term-care facility, or
licensee queries KASPER for all available data on the patient or resident for
the twelve (12) month period immediately preceding the query within twelve (12)
hours of the patient's or resident's admission and places a copy of the query
in the patient's or resident's medical records during the duration of the
patient's stay at the facility;
2. As part of the patient's hospice or end-of-life
treatment;
3. For the treatment of pain associated with cancer or with
the treatment of cancer;
4. In a single dose to relieve the anxiety, pain, or
discomfort experienced by a patient submitting to a diagnostic test or
procedure;
5. Within seven (7) days of an initial prescribing pursuant
to subsection (1) of this section if the prescribing:
a. Is done as a substitute for the initial prescribing;
b. Cancels any refills for the initial prescription; and
c. Requires the patient to dispose of any remaining
unconsumed medication;
6. Within ninety (90) days of an initial prescribing
pursuant to subsection (1) of this section if the prescribing is done by
another licensee in the same practice or in an existing coverage arrangement,
if done for the same patient for the same medical condition;
7. To a research subject enrolled in a research protocol approved
by an institutional review board that has an active federal-wide assurance
number from the United States Department of Health and Human Services, Office
for Human Research Protections if the research involves single, double, or
triple blind drug administration or is additionally covered by a certificate of
confidentiality from the National Institutes of Health;
8. During the effective period of any disaster or situation
with mass casualties that have a direct impact on the APRN’s practice;
9. Administering
or prescribing controlled substances to prisoners in a state, county, or
municipal correctional facility;
10.
Prescribing a Schedule IV controlled substance for no longer than three (3) days
for an established patient to assist the patient in responding to the anxiety
of a nonrecurring event; or
11. That has been classified as a Schedule V controlled substance.
(3)
The APRN shall, prior to initially prescribing a controlled substance for a
medical complaint for a patient:
(a)
Obtain the patient’s medical history and conduct an examination of the patient
and document the information in the patient’s medical record. An APRN certified
in psychiatric/mental health shall obtain a medical and psychiatric history,
perform a mental health assessment, and document the information in the
patient’s medical record;
(b)
Query KASPER for all available data on the patient;
(c)
Make a written treatment plan stating the objectives of the treatment and
further diagnostic examinations required;
(d)
Discuss with the patient, the patient’s parent if the patient is an
unemancipated minor child, or the patient’s legal guardian or health care
surrogate:
1.
The risks and benefits of the use of controlled substances, including the risk
of tolerance and drug dependence;
2.
That the controlled substance shall be discontinued when the condition
requiring its use has resolved; and
3.
Document that the discussion occurred and that the patient consented to the
treatment.
(4)
The treatment plan shall include an exit strategy, if appropriate, including
potential discontinuation of the use of controlled substances.
(5)
For subsequent or continuing long-term prescriptions of a controlled substance
for the same medical complaint, the APRN shall:
(a)
Update the patient’s medical history and document the information in the
patient’s medical record;
(b)
Modify the treatment plan as clinically appropriate; and
(c)
Discuss the risks and benefits of any new controlled substances prescribed with
the patient, the patient’s parent if the patient is an unemancipated minor
child, or the patient’s legal guardian or health care surrogate, including the
risk of tolerance and drug dependence.
(6)
During the course of treatment, the APRN shall query KASPER no less than once
every three (3) months for all available data on the patient before issuing a
new prescription or a refill for a controlled substance.
(7)
These requirements may be satisfied by other licensed practitioners in a single
group practice if:
(a)
Each licensed practitioner involved has lawful access to the patient’s medical
record;
(b)
Each licensed practitioner performing an action to meet these requirements is
acting within the scope of practice of his or her profession; and
(c)
There is adequate documentation in the patient’s medical record reflecting the
actions of each practitioner.
(8)
If prescribing a controlled substance for the treatment of chronic, noncancer
pain, the APRN, in addition to the requirements of this section, shall obtain a
baseline drug screen or further random drug screens if the APRN:
(a)
Finds a drug screen to be clinically appropriate; or
(b)
Believes that it is appropriate to determine whether or not the controlled
substance is being taken by the patient.
(9)
If prescribing a controlled substance for the treatment of a mental health
condition, the APRN shall meet the requirements of this section.
(10)
If prescribing a controlled substance for a patient younger than sixteen (16)
years of age, the APRN shall obtain and review an initial KASPER report. If
prescribing a controlled substance for an individual sixteen (16) years of age
or older, the requirements of this section shall apply.
(11)
Prior to prescribing a controlled substance for a patient in the emergency
department of a hospital that is not an emergency situation as specified in
subsection (2) of this section, the APRN shall:
(a)
Obtain the patient’s medical history, conduct an examination of the patient and
document the information in the patient’s medical record. An APRN certified in
psychiatric/mental health shall obtain a medical and psychiatric history,
perform a mental health assessment, and document the information in the
patient’s medical record;
(b)
Query KASPER for all available data on the patient;
(c)
Make a written treatment plan stating the objectives of the treatment and
further diagnostic examinations required;
(d)
Discuss the risks and benefits of the use of controlled substances with the
patient, the patient’s parent if the patient is an unemancipated minor child,
or the patient’s legal guardian or health care surrogate, including the risk of
tolerance and drug dependence, and document that the discussion occurred and
that the patient consented to the treatment.
Section
10. Prescribing Standards for Controlled Substances from Schedule II and
Schedule III Containing Hydrocodone. (1)(a) This section shall apply to an APRN
with a CAPA-CS if prescribing a controlled substance from Schedule II or
Schedule III controlled substance containing hydrocodone.
(b)
The APRN shall practice according to the applicable scope and standards of
practice for the APRN’s role and population focus.
(2)
This section shall not apply to:
(a) An APRN prescribing or administering a controlled substance
immediately prior to, during, or within the fourteen (14) days following an
operative or invasive procedure or a delivery if the prescribing or
administering is medically related to the operative or invasive procedure or
the delivery and the medication usage does not extend beyond the fourteen (14)
days;
(b) An APRN prescribing or administering a controlled substance
necessary to treat a patient in an emergency situation; or
(c) An APRN prescribing a controlled substance:
1. For administration in a hospital or long-term-care
facility with an institutional account, or an APRN in a hospital or facility
without an institutional account, if the hospital, long-term-care facility, or
licensee queries KASPER for all available data on the patient or resident for
the twelve (12) month period immediately preceding the query within twelve (12)
hours of the patient's or resident's admission and places a copy of the query
in the patient's or resident's medical records during the duration of the
patient's stay at the facility;
2. As part of the patient's hospice or end-of-life
treatment;
3. For the treatment of pain associated with cancer or with
the treatment of cancer;
4. In a single dose to relieve the anxiety, pain, or
discomfort experienced by a patient submitting to a diagnostic test or
procedure;
5. Within seven (7) days of an initial prescribing pursuant
to subsection (1) of this section if the prescribing or dispensing:
a. Is done as a substitute for the initial prescribing;
b. Cancels any refills for the initial prescription; and
c. Requires the patient to dispose of any remaining
unconsumed medication;
6. Within ninety (90) days of an initial prescribing
pursuant to subsection (1) of this section if the prescribing is done by
another licensee in the same practice or in an existing coverage arrangement,
if done for the same patient for the same medical condition; or
7. To a research subject enrolled in a research protocol approved
by an institutional review board that has an active federal-wide assurance
number from the United States Department of Health and Human Services, Office
for Human Research Protections if the research involves single, double, or
triple blind drug administration or is additionally covered by a certificate of
confidentiality from the National Institutes of Health.
(3) Prior to the initial prescribing of a Schedule II
controlled substance or a Schedule III controlled substance containing hydrocodone
to a human patient, an APRN shall:
(a) Obtain a medical history and conduct a physical or
mental health examination of the patient, as appropriate to the patient's
medical complaint, and document the information in the patient's medical
record;
(b) Query the electronic monitoring system established in
KRS 218A.202 for all available data on the patient for the twelve (12) month
period immediately preceding the patient encounter and appropriately utilize
that data in the evaluation and treatment of the patient;
(c) Make a written plan stating the objectives of the
treatment and further diagnostic examinations required;
(d) Discuss the risks and benefits of the use of controlled
substances with the patient, the patient's parent if the patient is an
unemancipated minor child, or the patient's legal guardian or health care
surrogate, including the risk of tolerance and drug dependence; and
(e) Obtain written consent for the treatment.
(4)(a) An APRN prescribing an additional amount of a
Schedule II controlled substance or Schedule III controlled substance containing
hydrocodone for the same medical complaint and related symptoms shall:
1.
Review the plan of care at reasonable intervals based on the patient's
individual circumstances and course of treatment;
2.
Provide to the patient any new information about the treatment; and
3.
Modify or terminate the treatment as appropriate.
(b)
If the course of treatment extends beyond three (3) months, the licensee shall:
1.
Query KASPER no less than once every three (3) months for all available data on
the patient for the twelve (12) month period immediately preceding the query;
and
2.
Review that data before issuing any new prescription or refills for the patient
for any Schedule II controlled substance or a Schedule III controlled substance
containing hydrocodone.
(5) For each patient for whom an APRN prescribes a Schedule
II controlled substance or a Schedule III controlled substance containing
hydrocodone, the licensee shall keep accurate, readily accessible, and complete
medical records, which include, as appropriate:
(a) Medical history and physical or mental health
examination;
(b) Diagnostic, therapeutic, and laboratory results;
(c) Evaluations and consultations;
(d) Treatment objectives;
(e) Discussion of risk, benefits, and limitations of
treatments;
(f) Treatments;
(g) Medications, including date, type, dosage, and quantity
prescribed;
(h) Instructions and agreements; and
(i) Periodic reviews of the patient's file.
Section
11. Incorporation by Reference. (1) The following material is incorporated by
reference:
(a)
"AACN Scope and Standards for Acute Care Nurse Practitioner Practice",
2012 Edition, American Association of Critical-Care Nurses;
(b)
"AACN Scope and Standards for Acute and Critical Care Clinical Nurse
Specialist Practice", 2010 Edition, American Association of Critical-Care
Nurses;
(c)
"Neonatal Nursing: Scope and Standards of Practice", 2013 Edition,
American Nurses Association/National Association of Neonatal Nurses;
(d)
"Nursing: Scope and Standards of Practice", 2010 Edition, American
Nurses Association;
(e)
"Pediatric Nursing: Scope and Standards of Practice", 2008 Edition,
American Nurses Association/Society of Pediatric Nursing/National Association
of Pediatric Nurse Practitioners;
(f)
"Psychiatric-Mental Health Nursing 2nd Edition: Scope and Standards of
Practice", 2014, American Nurses Association/American Psychiatric Nursing
Association;
(g)
"Scope of Practice for Nurse Practitioners", 2013 Edition, American
Association of Nurse Practitioners;
(h)
"Standards of Practice for Nurse Practitioners", 2013 Edition,
American Association of Nurse Practitioners;
(i)
"Scope of Nurse Anesthesia Practice", 2013 Edition, American
Association of Nurse Anesthetists;
(j)
"Standards for Nurse Anesthesia Practice", 2013 Edition, American
Association of Nurse Anesthetists;
(k)
"Standards for Office Based Anesthesia Practice", 2013 Edition,
American Association of Nurse Anesthetists;
(l)
"Standards for the Practice of Midwifery"; 2011 Edition, American
College of Nurse-Midwives;
(m)
"Statement on the Scope and Standards of Oncology Nursing Practice:
Generalist and Advanced Practice", 2013 Edition, Oncology Nursing Society;
(n)
"The Women's Health Nurse Practitioner: Guidelines for Practice and
Education", 2008 Edition, Association of Women’s Health, Obstetric and
Neonatal Nurses/Nurse Practitioners in Women’s Health;
(o)
"Notification of a Collaborative Agreement for the Advanced Practice
Registered Nurse's Prescriptive Authority for Controlled Substances
(CAPA-CS)", 12/2014, Kentucky Board of Nursing;
(p)
"Notification of a Collaborative Agreement for the Advanced Practice
Registered Nurse’s Prescriptive Authority for Nonscheduled Legend Drugs
(CAPA-NS)", 12/2014, Kentucky Board of Nursing; and
(q)
"Notification to Discontinue the CAPA-NS After Four Years", 12/2014,
Kentucky Board of Nursing.
(2)
This material may be inspected, copied, or obtained, subject to applicable
copyright law, at the Kentucky Board of Nursing, 312 Whittington Parkway, Suite 300, Louisville, Kentucky 40222, Monday through Friday, 8
a.m. to 4:30 p.m. (13
Ky.R. 2168; eff. 7-2-87; Am. 14 Ky.R. 231; eff. 9-10-87; 19 Ky.R. 2666; 20
Ky.R. 303; eff. 8-6-93; 3218; eff. 8-4-94; 22 Ky.R. 305; eff. 9-20-95; 23 Ky.R.
3606; 4176; 24 Ky.R. 62; eff. 6-18-97; 27 Ky.R. 819; eff. 11-17-2000; 29 Ky.R.
2120; 2449; eff. 4-11-03; 2943; eff. 8-13-03; 32 Ky.R. 285; eff. 10-19-05; 33
Ky.R. 511; 1069; eff. 10-18-06; 34 Ky.R. 1783; 2184; 2278; eff. 5-2-2008; 35
Ky.R. 2790; eff. 8-12-2009; 37 Ky.R. 421; eff. 10-20-2010; 38 Ky.R. 1361; 1549;
eff. 3-21-2012; 39 Ky.R. 535; 1185; 1385; eff. 2-1-2013; 39 Ky.R. 2191; 40
Ky.R. 13; eff. 7-17-2013; 2599; 41 Ky.R. 19; eff. 7-16-2014; 1854; 2070; eff.
5-1-2015.)
