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Texas State
Board of Medical Examiners
Standing Delegation Orders
Chapter
193.1-193.11
193.1.
Purpose.
(a) The
purpose of this chapter is to encourage the more effective utilization
of the skills of physicians by establishing guidelines for the
delegation of health care tasks to qualified non-physicians providing
services under reasonable physician control and supervision where such
delegation is consistent with the patient's health and welfare; and to
provide guidelines for physicians in order that existing legal
constraints should not be an unnecessary hindrance to the more effective
provision of health care services. Texas Occupations Code Annotated,
§§164.052 and 164.053, empower the Texas State Board of Medical
Examiners to cancel, revoke or suspend the license of any practitioner
of medicine upon proof that such practitioner is guilty of failing to
supervise adequately the activities of persons acting under the
physician's supervision, allowing another person to use his license for
the purpose of practicing medicine, or of aiding or abetting, directly
or indirectly, the practice of medicine by a person or entity not
licensed to do so by the board. The board recognizes that the delivery
of quality health care requires expertise and assistance of many
dedicated individuals in the allied health profession. The provisions of
this chapter are not intended to, and shall not be construed to,
restrict the physician from delegating administrative and technical or
clinical tasks not involving the exercise of medical judgment, to those
specially trained individuals instructed and directed by a licensed
physician who accepts responsibility for the acts of such allied health
personnel. The board recognizes that statutory law shall prevail over
any rules adopted and that the practice of medicine is, by statute,
defined as follows: "A person shall be considered to be practicing
medicine within the Medical Practice Act:
(1) who
shall publicly profess to be a physician or surgeon and shall
diagnose, treat, or offer to treat, any disease or disorder, mental or
physical, or any physical deformity or injury, by any system or
method, or to effect cures thereof; or
(2) who
shall diagnose, treat, or offer to treat any disease or disorder,
mental or physical or any physical deformity or injury by any system
or method and to effect cures thereof and charge therefor, directly or
indirectly, money or other compensation."
(b)
Likewise, nothing in this chapter shall be construed as to prohibit a
physician from instructing a technician, assistant, or nurse to perform
delegated tasks so long as the physician retains supervision and control
of the technician, assistant, or employee. Nothing in this chapter
should be construed to relieve the supervising physician of the
professional or legal responsibility for the care and treatment of those
persons with whom the delegating physician has established a
physician-patient relationship. Nothing in this chapter shall enlarge or
extend the applicable statutory law relating to the practice of
medicine, or other rules and regulations previously promulgated by the
board.
193.2.
Definitions.
The
following words and terms, when used in this chapter, shall have the
following meanings, unless the contents clearly indicate
otherwise.
(1)
Advanced practice nurse - A registered nurse approved by the Texas
State Board of Nurse Examiners to practice as an advanced practice
nurse on the basis of completion of an advanced educational program.
The term includes a nurse practitioner, a nurse midwife, nurse
anesthetist, and clinical nurse specialist, as defined by Texas
Occupations Code Annotated, §301.152.
(2)
Authorizing physician - A physician or physicians licensed by the
board who execute a standing delegation order.
(3)
Carrying out or signing a prescription drug order - To complete a
prescription drug order presigned by the delegating physician, or the
signing of a prescription by an advanced practice nurse or physician
assistant after being registered with the board by the delegating
physician as a person authorized to sign a prescription. The following
information shall be provided on each prescription: the patient's name
and address; the drug to be dispensed; directions to the patient for
taking the drug; dosage; the intended use of the drug, if appropriate;
the name, address, and telephone number of the physician; the name,
address, telephone number, identification number, and signature of the
physician assistant or advanced practice nurse completing or signing
the prescription drug order; the date; and the number of refills
permitted. This also includes the ability of a physician assistant or
advanced practice nurse to telephone prescriptions in to a pharmacy
under his or her prescriptive authority.
(4)
Controlled substance - A substance, including a drug, an adulterant,
and a dilutant, listed in Schedules I through V or penalty Groups 1,
1-A, or 2 through 4 as described under the Texas Health and Safety
Code, Chapter 481 (Texas Controlled Substances Act). The term includes
the aggregate weight of any mixture, solution, or other substance
containing a controlled substance.
(5)
Dangerous drug - A device or a drug that is unsafe for self medication
and that is not included in the Texas Health and Safety Code,
Schedules I-V or Penalty Groups I-IV of Chapter 481 (Texas Controlled
Substances Act). The term includes a device or a drug that bears or is
required to bear the legend: "Caution: federal law prohibits
dispensing without prescription".
(6)
Health professional shortage area (HPSA) -
(A) An
area in an urban or rural area of Texas (which need not conform to
the geographic boundaries of a political subdivision and which is a
rational area for the delivery of health services) which the
secretary of health and human services determines has a health
manpower shortage and which is not reasonably accessible to an
adequately served area;
(B) a
population group which the secretary determines to have such a
shortage; or
(C) a
public or nonprofit private medical facility or other facility which
the secretary determines has such a shortage as delineated in 42
United States Code Section 254(e)(a)(1).
(7)
Medically underserved area (MUA) - An area or population group
designated by the USDHHS as an area with a shortage of personal health
services. Also includes an area defined by rule adopted by the Texas
Board of Health that is based on demographics specific to this state,
geographic factors that affect access to health care, and
environmental health factors.
(8)
Physician Assistant - A person who is licensed as a physician
assistant by the Texas State Board of Physician Assistant
Examiners.
(9)
Physician's orders - The instructions of a physician for the care of
an individual patient.
(10)
Protocols - Delegated written authorization to initiate medical
aspects of patient care including authorizing a physician assistant or
advanced practice nurse to carry out or sign prescription drug orders
pursuant to the Medical Practice Act, Texas Occupations Code
Annotated, §§157.051-157.060 and §193.6 of this title (relating to the
Delegation of the Carrying Out or Signing of Prescription Drug Orders
to Physician Assistants and Advanced Practice Nurses). The protocols
must be agreed upon and signed by the physician, the physician
assistant and/or advanced practice nurse, reviewed and signed at least
annually, maintained on site, and must contain a list of the types or
categories of dangerous drugs and controlled substances available for
prescription, limitations on the number of dosage units and refills
permitted, and instructions to be given the patient for follow-up
monitoring or contain a list of the types or categories of dangerous
drugs and controlled substances that may not be prescribed. Protocols
shall be defined to promote the exercise of professional judgment by
the advanced practice nurse and physician assistant commensurate with
their education and experience. The protocols used by a reasonable and
prudent physician exercising sound medical judgment need not describe
the exact steps that an advanced practice nurse or a physician
assistant must take with respect to each specific condition, disease,
or symptom.
(11) Site
serving a medically underserved population - A site located in a
medically underserved area; a site located in a health manpower
shortage area; a rural health clinic designated under Public Law
95-210, the Rural Health Clinic Services Act of 1977; a public health
clinic or a family planning clinic operating under contract with the
Texas Department of Human Services or the Texas Department of Health;
a site located in an area in which there exists an insufficient number
of physicians providing services to eligible clients of federal,
state, or locally funded health care programs, as determined by the
Texas Department of Health; or a site that serves a disproportionate
number of clients eligible to participate in federal, state, or
locally funded health care programs, as determined by the Texas
Department of Health.
(12)
Standing delegation order - Written instructions, orders, rules,
regulations, or procedures prepared by a physician and designed for a
patient population with specific diseases, disorders, health problems,
or sets of symptoms. Such written instructions, orders, rules,
regulations or procedures shall delineate under what set of conditions
and circumstances action should be instituted. These instructions,
orders, rules, regulations or procedures are to provide authority for
and a plan for use with patients presenting themselves prior to being
examined or evaluated by a physician to assure that such acts are
carried out correctly and are distinct from specific orders written
for a particular patient, and shall be limited in scope of authority
to be delegated as provided in §193.4 of this title (relating to Scope
of Standing Delegation Orders). As used in this chapter, standing
delegation orders do not refer to treatment programs ordered by a
physician following examination or evaluation by a physician, nor to
established procedures for providing of care by personnel under
direct, personal supervision of a physician who is directly
supervising or overseeing the delivery of medical or health care. Such
standing delegation orders should be developed and approved by the
physician who is responsible for the delivery of medical care covered
by the orders. Such standing delegation orders, at a minimum,
should:
(A)
include a written description of the method used in developing and
approving them and any revision thereof;
(B) be
in writing, dated, and signed by the physician;
(C)
specify which acts require a particular level of training or
licensure and under what circumstances they are to be
performed;
(D)
state specific requirements which are to be followed by persons
acting under same in performing particular functions;
(E)
specify any experience, training, and/or education requirements for
those persons who shall perform such orders;
(F)
establish a method for initial and continuing evaluation of the
competence of those authorized to perform same;
(G)
provide for a method of maintaining a written record of those
persons authorized to perform same;
(H)
specify the scope of supervision required for performance of same,
for example, immediate supervision of a physician;
(I) set
forth any specialized circumstances under which a person performing
same is to immediately communicate with the patient's physician
concerning the patient's condition;
(J)
state limitations on setting, if any, in which the plan is to be
performed;
(K)
specify patient record-keeping requirements which shall, at a
minimum, provide for accurate and detailed information regarding
each patient visit; personnel involved in treatment and evaluation
on each visit; drugs, or medications administered, prescribed or
provided; and such other information which is routinely noted on
patient charts and files by physicians in their offices;
and
(L)
provide for a method of periodic review, which shall be at least
annually, of such plan including the effective date of initiation
and the date of termination of the plan after which date the
physician shall issue a new plan.
(13)
Standing medical orders - Orders, rules, regulations or procedures
prepared by a physician or approved by a physician or the medical
staff of an institution for patients which have been examined or
evaluated by a physician and which are used as a guide in preparation
for and carrying out medical or surgical procedures or both. These
orders, rules, regulations or procedures are authority and direction
for the performance for certain prescribed acts for patients by
authorized persons as distinguished from specific orders written for a
particular patient.
(14)
Submit - The term used to indicate that a completed item has been
actually received and date-stamped by the Board along with all
required documentation and fees, if
any.
193.3. Exclusion
from the Provisions of this Chapter.
The
provisions of this chapter shall not be applicable, nor shall they
restrict the use of pre-established programs of health care, nor shall
they restrict physicians from authorizing the provision of patient care
by use of pre-established programs under the following circumstances
listed in paragraphs (1)-(8) of this section:
(1) where
a patient is institutionalized and the care is to be delivered in a
hospital, nursing home, or other institution which has an organized
medical staff which has authorized or approved standing delegation
orders or standing medical orders;
(2) where
care is rendered in an emergency. Emergency care is that care provided
to a person who is unconscious, ill, or injured, when the reasonable
apparent circumstances require prompt decisions and actions in care
and when the necessity of immediate care is so reasonably apparent
that any delay in the rendering of care or treatment would seriously
worsen the physical condition or endanger the life of the
person;
(3) where
care is rendered as a part of disaster relief and charges for the
services are not made;
(4) where
limitation from civil liability is provided under the Texas Civil
Practice and Remedies Code, §74.001;
(5) where
first aid care is provided at the site of an injury or as an interim
measure prior to transfer of the patient to a medical facility where
medical services are available;
(6) where
care rendered is provided by licensed health professional acting
within the scope of the licensed profession as defined by Texas
Occupations Code Annotated;
(7) where
care is to be delivered in any setting under standing medical orders
as defined in this chapter;
(8) where
care is to be delivered as authorized by the Medical Practice Act,
Texas Occupations Code Annotated, §157.051-157.060, except as provided
in §193.6 of this title (relating to the Delegation of the Carrying
Out or Signing of Prescription Drug Orders to Physician Assistants and
Advanced Practice Nurses).
193.4. Scope of
Standing Delegation Orders.
Providing
the authorizing physician is satisfied as to the ability and competence
of those for whom the physician is assuming responsibility, and with due
regard for the safety of the patient and in keeping with sound medical
practice, standing delegation orders may be authorized for the
performance of acts and duties which do not require the exercise of
independent medical judgment. Limitations on the physician's use of
standing delegation orders which are stated in this section shall not
apply to patient care delivered by physician assistants or advanced
practice nurses, as authorized by the Medical Practice Act, Texas
Occupations Code Annotated, §§157.051-157.060, or §193.6 of this title
(relating to Delegation of the Carrying Out or Signing of Prescription
Drug Orders to Physician Assistants and Advanced Practice Nurses). When
care is delivered under other circumstances, standing delegation orders
may include authority to undertake the following as listed in paragraphs
(1)-(8) of this section:
(1) the
taking of personal and medical history;
(2) the
performance of appropriate physical examination and the recording of
physical findings;
(3) the
ordering of tests appropriate to the services provided under such
orders, such as tuberculin tests, skin tests, VD tests, VDRL tests,
gram stains, pap smears, and serological tests;
(4) the
administration or providing of drugs ordered by direct personal or
voice communication by the authorizing physician who shall assume
responsibility for the patient's welfare, providing such
administration or provision of drugs shall be in compliance with other
state or federal laws and providing further that pre-signed
prescriptions shall not be utilized by the authorizing physician
except under the following conditions shown in subparagraphs (A)-(D)
of this paragraph.
(A) The
prescription shall be prepared in full compliance with the Texas
Health and Safety Code, §483.001(13) except for the inclusion of the
name of the patient and the date of issuance.
(B) The
prescription shall be for one of the following classes or types of
drugs:
(i)
oral contraceptives;
(ii)
diaphragms and contraceptive creams and jellies;
(iii)
topical anti-infectives for vaginal use;
(iv)
oral anti-parasitic drugs for treatment of pinworms;
(v)
topical anti-parasitic drugs; or
(vi)
antibiotic drugs for treatment of venereal
disease.
(C) The
prescriptions may not be issued for any controlled
substance.
(D) The
providing of the drugs shall be in compliance with the Texas
Pharmacy Act and rules adopted by the Texas State Board of
Pharmacy.
(5) the
administration of immunization vaccines providing the recipient is
free of any condition for which the immunization is
contraindicated;
(6) the
providing of information regarding hygiene and the administration or
providing of medications for health problems resulting from a lack of
hygiene, including the institution of treatment for conditions such as
scabies, ringworm, pinworm, head lice, diaper rash and other minor
skin disorders, provided the administration or providing of drugs
adheres to paragraph (4) of this section;
(7) the
provision of services and the administration of therapy by public
health departments as officially prescribed by the Texas Department of
Health for the prevention or treatment of specific communicable
diseases or health conditions for which the Texas Department of Health
is responsible for control under state law;
(8) the
issuance of medications which do not require a prescription (over the
counter medications) for the symptomatic relief of minor illnesses
provided that such medications are packaged and labeled in compliance
with state and federal laws and
regulations.
193.5.
Enforcement.
Any
physician authorizing standing delegation orders or standing medical
orders which authorize the exercise of independent medical judgment or
treatment shall be subject to having his or her license to practice
medicine in the State of Texas revoked or suspended under Texas
Occupations Code Annotated, §§164.052 and 164.053.
193.6. Delegation of the Carrying Out or Signing of
Prescription Drug Orders to Physician Assistants and Advanced Practice
Nurses.
(a) Purpose. The purpose of this section is to provide
guidelines for implementation of the Medical Practice Act (“the Act”),
Texas Occupations Code Annotated, §§157.051-157.060, which provide for
the use by physicians of standing delegation orders, standing medical
orders, physician's orders, or other orders or protocols in delegating
authority to physician assistants or advanced practice nurses at a site
serving medically underserved populations, at a physician's primary
practice or alternate practice site, or at a facility-based practice
site. This section establishes minimum standards for supervision by
physicians when delegating prescriptive authority to physician
assistants and advanced practice nurses at such sites. This section also
provides for the signing of a prescription by an advanced practice nurse
or a physician assistant after the person has been designated by the
delegating physician as a person delegated to sign a prescription which
may be carried out by a physician assistant or advanced practice nurse
according to protocols. Such protocols may authorize diagnosis of the
patient's condition and treatment, including prescription of dangerous
drugs or controlled substances Schedules III-V as provided under
subsection (n) of this section. Proper use of protocols allows
integration of clinical data gathered by the physician assistant or
advanced practice nurse. Neither the Act, §§157.051-157.060, nor these
rules authorize the exercise of independent medical judgment by
physician assistants or advanced practice nurses, and the delegating
physician remains responsible to the board and to his or her patients
for acts performed under the physician's delegated authority. Advanced
practice nurses and physician assistants remain professionally
responsible for acts performed under the scope and authority of their
own licenses.
(b) Delegation of prescriptive authority at site serving
underserved populations.
(1) Acts that may be delegated. At a site serving a
medically underserved population, a physician authorized by the board
may delegate to a physician assistant or an advanced practice nurse
the act or acts of administering, providing, or carrying out or
signing a prescription drug order as authorized through physician’s
orders, standing medical orders, standing delegation orders, or other
orders or protocols as defined by the board. Providing and carrying
out or signing a prescription drug order under this subdivision is
limited to dangerous drugs and controlled substances Schedules III-V
as provided under subsection (n) of this section, and shall comply
with other applicable laws.
(2) Physician supervision at site serving medically
underserved populations. Physician supervision of a physician
assistant or an advanced practice nurse at a site serving a medically
underserved population will be adequate if a delegating physician:
(A) receives a daily status report to be conveyed in
person, by telephone, or by radio from the advanced practice nurse
or physician assistant on any complications or problems encountered
that are not covered by a protocol;
(B) visits the clinic in person at least once every
ten business days during regular business hours during which the
advanced practice nurse or physician assistant is on site providing
care, in order to observe and provide medical direction and
consultation to include, but not be limited to:
(i) reviewing with the physician assistant or
advanced practice nurse the case histories of patients with
problems or complications encountered;
(ii) personally diagnosing or treating patients
requiring physician follow-up; and
(iii) verifying that patient care is provided by
the clinic in accordance with a written quality assurance plan on
file at the clinic, which includes a random review and
countersignature of at least 10% of the patient charts by the
physician;
(C) is available by telephone or direct
telecommunication for consultation, assistance with medical
emergencies, or patient referrals; and
(D) is responsible for the formulation or approval
of such physician’s orders, standing medical orders, standing
delegation orders, or other orders or protocols and periodically
reviews such orders and the services provided to patients under such
orders.
(3) Supervision of clinics. A physician may not
supervise more than three clinics serving medically underserved
populations without approval of the board. A physician may not
supervise any number of clinics with combined regular business hours
exceeding 150 concurrent hours per week without approval of the
board.
(c) Delegation of prescriptive authority at primary
practice site.
(1) “Primary practice site” means:
(A) the practice location where the physician spends
the majority of the physician’s time;
(B) a licensed hospital, long-term care facility, or
adult care center where both the physician and the physician
assistant or advanced practice nurse are authorized to practice;
(C) a clinic operated by or for the benefit of a
public school district for the purpose of providing care to the
students of that district and the siblings of those students, if
consent to treatment at that clinic is obtained in a manner that
complies with the Family Code, Chapter 32;
(D) an established patient’s residence; or
(E) where the physician is physically present with
the physician assistant or advanced practice nurse.
(2) Acts that may be delegated. At a physician's
primary practice site, a licensed physician authorized by the board
may delegate to a physician assistant or an advanced practice nurse
acting under adequate physician supervision the act or acts of
administering, providing, carrying out or signing a prescription drug
order as authorized through physician's orders, standing medical
orders, standing delegation orders, or other orders or protocols as
defined by the board. Providing and carrying out or signing a
prescription drug order under this subdivision is limited to dangerous
drugs and controlled substances Schedules III-V as provided in
subsection (n) of this section, and shall comply with other applicable
laws.
(3) Physician supervision. Physician supervision of
the carrying out and signing of prescription drug orders shall conform
to what a reasonable, prudent physician would find consistent with
sound medical judgment but may vary with the education and experience
of the advanced practice nurse or physician assistant. A physician
shall provide continuous supervision, but the constant physical
presence of the physician is not required.
(4) Additional limitations. A physician's authority to
delegate the carrying out or signing of a prescription drug order
under this subsection is limited to:
(A) three physician assistants or advanced practice
nurses or their full-time equivalents practicing at the physician's
primary or alternate practice site; and
(B) the patients with whom the physician has
established or will establish a physician-patient relationship, but
this shall not be construed as requiring the physician to see the
patient within a specific period of time.
(d) Delegation of prescriptive authority at a
physician’s alternate practice site.
(1) “Alternate practice site” means a site:
(A) where services similar to the services provided
at the delegating physician’s primary practice site are provided;
and
(B) located within 60 miles of the delegating
physician’s primary practice site.
(2) Acts that may be delegated. At a physician’s
alternate practice site, a licensed physician authorized by the board
may delegate to a physician assistant or an advanced practice nurse
acting under adequate physician supervision the act or acts of
administering, providing, carrying out or signing a prescription drug
order as authorized through physician’s orders, standing medical
orders, standing delegation orders, or other orders or protocols as
defined by the board. Providing, carrying out or signing a
prescription drug order under this subsection is limited to dangerous
drugs and controlled substances Schedules III-V as provided in
subsection (n) of this section, and shall comply with other applicable
laws.
(3) Physician supervision is adequate for the purposes
of this subsection if the delegating physician:
(A) is on-site with the advanced practice nurse or
physician assistant at lest 20 percent of the time;
(B) randomly reviews at least 10 percent of the
medical charts of patients seen by a physician assistant or advanced
practice nurse at the site; and
(C) is available through direct telecommunication
for consultation, patient referral, or assistance with a medical
emergency.
(4) A physician may not delegate to a combined number
of more than three physician assistants or advanced practice nurses or
their full-time equivalents at the physician’s primary and alternate
practice sites.
(e) Delegation of prescriptive authority at a
facility-based practice site.
(1) Acts that may be delegated. A licensed physician
authorized by the board shall be authorized to delegate, to one or
more physician assistants or advanced practice nurses acting under
adequate physician supervision whose practice is facility based at a
licensed hospital or licensed long-term care facility, the carrying
out or signing of prescription drug orders if the physician is the
medical director or chief of medical staff of the facility in which
the physician assistant or advanced practice nurse practices, the
chair of the facility's credentialing committee, a department chair of
a facility department in which the physician assistant or advanced
practice nurse practices, or a physician who consents to the request
of the medical director or chief of medical staff to delegate the
carrying out or signing of prescription drug orders at the facility in
which the physician assistant or advanced practice nurse practices.
Providing and carrying out or signing a prescription drug order under
this subdivision is limited to dangerous drugs and controlled
substances Schedules III-V as provided in subsection (n) of this
section, and shall comply with other applicable laws.
(2) Limitations on authority to delegate. A
physician's authority to delegate under this subsection is limited as
follows:
(A) the delegation is pursuant to a physician's
order, standing medical order, standing delegation order, or other
order or protocol developed in accordance with policies approved by
the facility's medical staff or a committee thereof as provided in
facility bylaws;
(B) the delegation occurs in the facility in which
the physician is the medical director, the chief of medical staff,
the chair of the credentialing committee, or a department chair;
(C) the delegation does not permit the carrying out
or signing of prescription drug orders for the care or treatment of
the patients of any other physician without the prior consent of
that physician;
(D) delegation in a long-term care facility must be
by the medical director and the medical director is limited to
delegating the carrying out and signing of prescription drug orders
to no more than three advanced practice nurses or physician
assistants or their full-time equivalents; and
(E) under this section, a physician may not delegate
at more than one licensed hospital or more than two long-term care
facilities unless approved by the board.
(3) Physician supervision. Physician supervision of
the carrying out and signing of a prescription drug order shall
conform to what a reasonable, prudent physician would find consistent
with sound medical judgment but may vary with the education and
experience of the advanced practice nurse or physician assistant. A
physician shall provide continuous supervision, but the constant
physical presence of the physician is not required.
(f) Documentation of supervision. If the physician
assistant or advanced practice nurse is located at a site other than the
site where the physician spends the majority of the physician’s time,
physician supervision shall be documented. The documentation should be
through a log or other method appropriate to the practice. The
documentation will include the names or identification numbers of
patients discussed during the daily status reports, the times when the
physician is on site, and a summary of what the physician did while on
site. Said summary shall include a description of the quality assurance
activities conducted and the names of any patients seen or whose case
histories were reviewed with the physician assistant or advanced
practice nurse. The supervising physician shall sign the documentation
at the conclusion of each site visit. Documentation is not required if
the physician assistant or advanced practice nurse is permanently
located with the physician at a site where the physician spends the
majority of the physician’s time.
(g) Alternate physicians. If a delegating physician will
be unavailable to supervise the physician assistant or advanced practice
nurse as required by this section, arrangements shall be made for
another physician to provide that supervision. The physician providing
that supervision shall affirm in writing that he or she is familiar with
the protocols or standing delegation orders in use at the site and is
accountable for adequately supervising care provided pursuant to those
protocols or standing delegation orders by fulfilling the requirements
for registration as an alternate supervising physician to include
completing and submitting a board approved form.
(h) Prescription forms. Prescription forms shall comply
with applicable rules adopted by the Texas State Board of Pharmacy.
Prescriptions issued pursuant to this section may only be written for
dangerous drugs and controlled substances Schedules III-V as provided in
subsection (n) of this section. A delegating physician is responsible
for devising and enforcing a system to account for and monitor the
issuance of prescriptions under the physician’s supervision.
(i) Waivers.
(1) The board may waive or modify any of the site or
supervision requirements for a physician to delegate the carrying out
or signing of prescription drug orders to an advanced practice nurse
of physician assistant at facilities serving medically underserved
populations, at physician primary and alternate practice sites, and at
facility-based practice sites.
(2) The board may grant a waiver under paragraph (1)
of this subsection if the board determines that:
(A) the practice site where the physician is seeking
to delegate prescriptive authority is unable to meet the
requirements of Chapter 157 of the Act or this section, or
compliance would cause an undue burden without a corresponding
benefit to patient care;
(B) safeguards exist for patient care and for
fostering a collaborative practice between the physician and the
advanced practice nurses and physician assistants; and
(C) if the requirement for which the waiver is
sought is the amount of time the physician is on-site, the frequency
and duration of time the physician is on-site when the advanced
practice nurse or physician assistant is present is sufficient for
collaboration to occur, taking into consideration the other ways the
physician collaborates with the advanced practice nurse or physician
assistant at other sites.
(3) The board may not waive the limitation on the
number of primary or alternate practice sites at which a physician may
delegate the carrying out or signing of prescription drug orders or
the number of advanced practice nurses or physician assistants to whom
a physician may delegate the carrying out or signing of prescription
drugs orders.
(4) Procedure.
(A) In accordance with this section and §157.0542 of
the Act, the board shall appoint an advisory committee to review as
needed applications for waivers and make recommendations to the
board regarding waiver requests.
(B) A physician may apply for a waiver by submitting
a written request to the licensure division of the board via the
agency website, email, or regular mail. The request shall then be
submitted to the waiver committee for review.
(C) An advisory committee recommendation of the
approval of a waiver, with or without modifications, requires a vote
of at least:
(i) three advanced practice nurse committee
members;
(ii) three physician assistant committee members;
and
(iii) three physician committee members.
(D) The Standing Orders Committee of the board shall
review recommendations from the advisory committee and may recommend
to the full board that a waiver be granted, denied or modified.
(E) The board may grant a waiver only if the
advisory committee recommends that the waiver be granted, unless the
board determines good cause exists to grant a waiver the committee
does not recommend.
(F) The advisory committee may recommend that the
board approve a waiver with modifications.
(G) If the board denies a waiver, a written
explanation for the denial shall be given to the physician along
with any recommended modifications that would make the waiver
application acceptable.
(H) The board may revoke, suspend or modify a waiver
previously granted after providing the physician notice and
opportunity for a hearing as provided for by the Administrative
Procedure Act and Chapter 187 of this title (relating to Procedural
Rules).
(j) Violations. Violation of this section by the
delegating physician may result in a refusal to approve supervision
or the cancellation of the physician’s authority to delegate to a
physician assistant or an advanced practice nurse under this
section. Violation of this section may also subject the physician to
disciplinary action as provided by the Act, §164.001, for violation
of §164.051. If an advanced practice nurse violates this section or
the Act, §§157.051-157.060, the board shall promptly notify the
Texas Board of Nurse Examiners of the alleged violation. If a
physician assistant violates this section or the Act,
§§157.051-157.060, the board shall promptly notify the Texas State
Board of Physician Assistant Examiners.
(k) Delegation to certified registered nurse
anesthetists.
(1) In a licensed hospital or ambulatory surgical
center a physician may delegate to a certified registered nurse
anesthetist the ordering of drugs and devices necessary for a
certified registered nurse anesthetist to administer an anesthetic
or an anesthesia-related service ordered by the physician. The
physician's order for anesthesia or anesthesia-related services
does not have to be drug-specific, dose-specific, or
administration-technique-specific. Pursuant to the order and in
accordance with facility policies or medical staff bylaws, the
nurse anesthetist may select, obtain, and administer those drugs
and apply the appropriate medical devices necessary to accomplish
the order and maintain the patient within a sound physiological
status.
(2) This paragraph shall be liberally construed to
permit the full use of safe and effective medication orders to
utilize the skills and services of certified registered nurse
anesthetists.
(l) Delegation related to obstetrical services.
(1) A physician may delegate to a physician
assistant offering obstetrical services and certified by the board
as specializing in obstetrics or an advanced practice nurse
recognized by the Texas State Board of Nurse Examiners as a nurse
midwife the act or acts of administering or providing controlled
substances to the nurse midwife's or physician assistant's clients
during intra-partum and immediate post-partum care. The physician
shall not delegate the use of a prescription sticker or the use or
issuance of an official prescription form relating to the
prescription of Schedule II controlled substance as described
under §481.075 of the Health and Safety Code.
(2) The delegation of authority to administer or
provide controlled substances under this paragraph must be under a
physician's order, medical order, standing delegation order, or
protocol which shall require adequate and documented availability
for access to medical care.
(3) The physician's orders, medical orders,
standing delegation orders, or protocols shall provide for
reporting or monitoring of client's progress including
complications of pregnancy and delivery and the administration and
provision of controlled substances by the nurse midwife or
physician assistant to the clients of the nurse midwife or
physician assistant.
(4) The authority of a physician to delegate under
this paragraph is limited to:
(A) three nurse midwives or physician assistants
or their full-time equivalents; and
(B) the designated facility at which the nurse
midwife or physician assistant provides care.
(5) The administering or providing of controlled
substances under this paragraph shall comply with other applicable
laws.
(6) In this paragraph, "provide" means to supply
one or more unit doses of a controlled substance for the immediate
needs of a patient not to exceed 48 hours.
(7) The controlled substance shall be supplied in
a suitable container that has been labeled in compliance with the
applicable drug laws and shall include the patient's name and
address; the drug to be provided; the name, address, and telephone
number of the physician; the name, address, and telephone number
of the nurse midwife or physician assistant; and the date.
(8) This paragraph does not permit the physician
or nurse midwife or physician assistant to operate a retail
pharmacy as defined under the Texas Pharmacy Act Texas Occupations
Code Annotated Subtitle J.
(A) This paragraph shall be construed to provide
a physician the authority to delegate the act or acts of
administering or providing controlled substances to a nurse
midwife or physician assistant but not as requiring physician
delegation of further acts to a nurse midwife or as requiring
physician delegation of the administration of medications to
registered nurses or physician assistants other than as provided
in this paragraph.
(B) This subsection does not limit the authority
of a physician to delegate the carrying out or signing of a
prescription drug order involving a controlled substance under
subsection (n) of this section.
(m) Liability. A physician shall not be liable for the
act or acts of a physician assistant or advanced practice nurse solely
on the basis of having signed an order, a standing medical order, a
standing delegation order, or other order or protocols authorizing a
physician assistant or advanced practice nurse to perform the act or
acts of administering, providing, carrying out, or signing a
prescription drug order unless the physician has reason to believe the
physician assistant or advanced practice nurse lacked the competency
to perform the act or acts.
(n) Prescription Drug Orders.
(1) Pursuant to the Medical Practice Act, Tex. Occ.
Code Ann. §157.0511, a physician’s authority to delegate the
carrying out or signing of a prescription drug order is limited to:
(A) dangerous drugs; and
(B) controlled substances to the extent provided
in paragraph (2) of this subsection.
(2) A physician may delegate the carrying out or
signing of a prescription drug order for a controlled substance only
if:
(A) the prescription is for a controlled substance
listed in Schedules III, IV, or V as established under Chapter 481
of the Texas Health and Safety Code;
(B) the prescription is for a period not to exceed
30 days;
(C) with regard to the refill of a prescription,
the refill is authorized after consultation with the delegating
physician and the consultation is noted in the patient’s chart;
and
(D) with regard to a prescription for a
child less than two years of age, the prescription is made after
consultation with the delegating physician and the consultation is
noted in the patient’s chart.
193.7.
Delegated Drug Therapy Management.
(a)
Purpose. This section is promulgated to promote the efficient
administration and regulation of the delegation by physicians to
pharmacists of drug therapy management pursuant to the Medical Practice
Act, Texas Occupations Code Annotated, §157.001 (related to Delegation
of Certain Functions).
(b)
Delegation. A physician licensed to practice medicine in Texas may
delegate to a properly qualified and trained pharmacist acting under
adequate supervision the performance of specific acts of drug therapy
management authorized by the physician through the physician's order,
standing medical order, standing delegation order, or other order or
protocol as provided for in this section.
(c) Drug
therapy management. Drug therapy management is the performance of
specific acts by pharmacists as authorized by a physician through
written protocol. Drug therapy management does not include the selection
of drug products not prescribed by the physician unless the drug product
is named in the physician initiated protocol or the physician initiated
record of deviation from a standing protocol. Drug therapy management
may include the following listed in paragraphs (1)-(6) of this
subsection:
(1)
collecting and reviewing patient drug use histories;
(2)
ordering or performing routine drug therapy related patient assessment
procedures including temperature, pulse, and respiration;
(3)
ordering drug therapy related laboratory tests;
(4)
implementing or modifying drug therapy following diagnosis, initial
patient assessment, and ordering of drug therapy by a physician, as
detailed in the protocol;
(5)
generically equivalent drug selection if the physician's signature
does not clearly indicate that the prescription must be dispensed as
written; or
(6) any
other drug therapy related act delegated by a
physician.
(d)
Supervision. Physician supervision shall be considered adequate for
purposes of this section if the delegating physician is in compliance
with this section and the physician:
(1) is
responsible for the formulation or approval of the written protocol
and any patient-specific deviation from the protocol and review of the
written protocol and any patient-specific deviations from the protocol
at least annually and the services provided to a patient under the
protocol on a schedule defined in the written protocol;
(2) has
established and maintains a physician-patient relationship with each
patient provided drug therapy management by a delegated pharmacist and
informed the patient that drug therapy will be managed by a pharmacist
under written protocol;
(3) is
geographically located so as to be able to be physically present daily
to provide medical care and supervision;
(4)
receives, on a schedule defined in the written protocol, a periodic
status report on the patient, including any problem or complication
encountered;
(5) is
available through direct telecommunication for consultation,
assistance, and direction.
(e) Written
protocol. Written protocols for purposes of this section shall mean a
physician's order, standing medical order, standing delegation order, or
other written order.
(1) A
written protocol must contain at a minimum the following listed in
subparagraphs (A)-(E) of this paragraph:
(A) a
statement identifying the individual physician authorized to
prescribe drugs and responsible for the delegation of drug therapy
management;
(B) a
statement identifying the individual pharmacist authorized to
dispense drugs and to engage in drug therapy management as delegated
by the physician;
(C) a
statement identifying the types of drug therapy management decisions
that the pharmacist is authorized to make which shall
include:
(i) a
statement of the ailments or diseases, drugs, and type of drug
therapy management authorized; and
(ii)
a specific statement of the procedures, decision criteria, or plan
the pharmacist shall follow when exercising drug therapy
management authority;
(D) a
statement of the activities the pharmacist shall follow in the
course of exercising drug therapy management authority, including
the method for documenting decisions made and a plan for
communication or feedback to the authorizing physician concerning
specific decisions made. Documentation shall be recorded within a
reasonable time of each intervention and may be performed on the
patient medication record, patient medical chart, or in a separate
log book; and
(E) a
statement that describes appropriate mechanisms and time schedule
for the pharmacist to report to the physician monitoring the
pharmacist's exercise of delegated drug therapy management and the
results of the drug therapy management.
(2) A
standard protocol may be used, or the attending physician may develop
a drug therapy management protocol for the individual patient. If a
standard protocol is used, the physician shall record, what deviations
if any, from the standard protocol are ordered for that
patient.
(f) Review
and revision of protocols.
(1) At
least annually, written protocols shall be reviewed by the physician
and, if necessary, revised.
(2)
Documentation of all services provided to the patient by the
pharmacist shall be reviewed by the physician on the schedule
established in the protocol.
(g)
Construction and interpretation. This section shall not be construed or
interpreted to restrict the use of a pre-established health care program
or restrict a physician from authorizing the provision of patient care
by use of a pre-established health care program if the patient is
institutionalized and the care is to be delivered in a licensed hospital
with an organized medical staff that has authorized standing delegation
orders, standing medical orders, or protocols. This section may not be
construed to limit, expand, or change any provision of law concerning or
relating to therapeutic drug substitution or administration of
medication, including the Texas Pharmacy Act, Article 4542a-1, Vernon's
Texas Civil Statutes, §17(a)(5).
193.8. Delegated
Administration of Immunizations or Vaccinations by a Pharmacist under
Written Protocol.
(a)
Purpose. This section is promulgated to promote the efficient
administration and regulation of the delegation by physicians to
pharmacists of the administration of immunizations or vaccinations under
written protocol pursuant to the Medical Practice Act, Texas Occupations
Code Annotated, §157.001 (related to Delegation of Certain
Functions).
(b)
Delegation. A physician licensed to practice medicine in Texas may
delegate to a properly qualified and trained pharmacist acting under
adequate supervision the administration of immunizations and
vaccinations authorized by the physician through the physician's order,
standing medical order, standing delegation order, or other order or
protocol as provided for in this section.
(c)
Delegated Administration of Immunizations and Vaccinations under Written
Protocol. Administration of Immunizations and Vaccinations does not
include the selection of drug products not prescribed by the physician
unless the drug product is named in the physician initiated
protocol.
(d)
Supervision. Physician supervision shall be considered adequate for
purposes of this section if the delegating physician is in compliance
with this section and the physician:
(1) is
responsible for the formulation or approval of the physician's order,
standing medical order, standing delegation order, or other order or
written protocol and periodically reviews the order or protocol and
the services provided to the patient under the order or protocol on a
schedule defined in the written protocol;
(2) has
established a physician‑patient relationship with each patient under
14 years of age and referred the patient to the pharmacist;
(3) is
geographically located so as to be easily accessible to the pharmacist
administering the immunization or vaccination;
(4)
receives, on a schedule defined in the written protocol, a periodic
status report on the patient, including any problem or complication
encountered; and
(5) is
available through direct telecommunication for consultation,
assistance, and direction.
(e) Written
protocol. Written protocols for purposes of this section shall mean a
physician's order, standing medical order, standing delegation order, or
other written order.
(1) A
written protocol must contain at a minimum the following listed in
subparagraphs (A)‑(F) of this paragraph:
(A) a
statement identifying the individual physician authorized to
prescribe drugs and responsible for the delegation of administration
of immunizations or vaccinations;
(B) a
statement identifying the individual pharmacist authorized to
administer immunizations or vaccinations as delegated by the
physician;
(C) a
statement identifying the location(s) at which the pharmacist may
administer immunizations or vaccinations which may not include where
the patient resides, except for a licensed nursing home or
hospital;
(D) a
statement identifying the immunizations or vaccinations that may be
administered by the pharmacist;
(E) a
statement identifying the activities the pharmacist shall follow in
the course of administering immunizations or vaccinations including
procedures to follow in the case of reactions following
administration; and
(F) a
statement that describes the content of, and the appropriate
mechanisms for the pharmacist to report the administration of
immunizations or vaccinations to the physician issuing the written
protocol within 24 hours of administering the immunization or
vaccination.
(2) A
standard protocol may be used, or the physician may develop an
immunization or vaccination protocol for the individual patient. If a
standard protocol is used, the physician shall record, what deviations
if any, from the standard protocol are ordered for that
patient.
(f) Review
and revision of protocols.
(1) At
least annually, written protocols shall be reviewed by the physician
and, if necessary, revised.
(2)
Documentation of the administration of immunizations or vaccinations
to the patient by a pharmacist shall be reviewed by the physician on
the schedule established in the protocol.
(g)
Construction and interpretation. This section shall not be construed or
interpreted to restrict the use of a pre‑established health care program
or restrict a physician from authorizing the provision of patient care
by use of a pre‑established health care program if the patient is
institutionalized and the care is to be delivered in a licensed hospital
with an organized medical staff that has authorized standing delegation
orders, standing medical orders, or protocols. This section may not be
construed to limit, expand, or change any provision of law concerning or
relating to therapeutic drug substitution or administration of
medication, including the Texas Pharmacy Act, Article 4542a‑1, Vernon's
Texas Civil Statutes, §17(a)(5).
193.9.
Pronouncement of Death.
(a)
Purpose. These rules are promulgated under the authority of the Medical
Practice Act, Section 3.06(d), to allow physicians to receive
information from Texas licensed vocational nurses through electronic
communication for the purpose of making a pronouncement of death.
Electronic communication includes, but is not limited to telephone,
facsimile transmission, or electronic mail.
(b) Do not
resuscitate order. A do not resuscitate (DNR) order must be kept in the
patient's file.
(c)
Required information. In order to make a pronouncement of death through
electronic communication, a physician must receive, at a minimum, the
following information regarding the condition of the patient:
(1)
absence of palpable pulse for a minimum of 60 seconds;
(2)
absence of discernible blood pressure for a minimum of 60
seconds;
(3)
absence of evidence of respiration for a minimum of 60
seconds;
(4)
absence of evidence of heartbeat for a minimum of 60 seconds;
and
(5) other
information as the physician may require.
(d)
Follow-up by physician. If a physician makes a pronouncement of death
based on information received pursuant to subsection (c) of this
section, the physician retains responsibility for all acts related to
this pronouncement.
193.10.
Collaborative Management of Glaucoma.
(a)
Purpose. The purpose of this section is to implement the mandate of the
76th Legislature as it relates to the Optometry Act, Article
4552, §1.02, Vernon’s Texas Civil Statutes, regarding the minimum
standards for the collaborative management of glaucoma.
(b) Minimum
requirements. At a minimum, the treating ophthalmologist should follow
the guidelines outlined in paragraphs (1)–(10) of this
section.
(1) The
ophthalmologist will confirm the diagnosis within 30 days of the
diagnosis of glaucoma made by the optometrist. While the
ophthalmologist may, in his or her discretion, require that the
patient visit the ophthalmologist for a face-to-face visit, such a
face-to-face visit is not mandated. The ophthalmologist may, at the
ophthalmologist’s discretion, rely upon the results of diagnostic
tests performed originally by the optometrist, unless reaffirmation is
needed.
(2) The
ophthalmologist must communicate in written form the confirmation of
the diagnosis within 30 days, as well as the refinement of the
treatment plan as recommended by the optometrist.
(3) A
proper medical record must be generated for each patient by the
ophthalmologist and shall include all correspondence and testing
results. The medical record must also include a written note made in
the record by the ophthalmologist or a copy of the written informed
consent demonstrating that the patient understands that he or she is
participating in a co-management of primary open angle
glaucoma.
(4) The
necessity for follow-up visits will be at the discretion of the
ophthalmologist based on the communication of the patient’s progress
by the optometrist.
(5) The
ophthalmologist must report any irregular behavior of the optometrist
to the Texas State Board of Medical Examiners for referral to the
Texas Optometry Board.
(6) The
ophthalmologist must enter into the patient’s written medical records
that the ophthalmologist has elected to enter into a co-management
agreement with an optometrist.
(7) It is
at the discretion of the ophthalmologist to complete a clinical skills
assessment with each optometrist in which a co-management arrangement
exists. The ophthalmologist will, however, receive written
confirmation and documentation that the co-managing optometrist has
completed all of the requirements of the Optometric Health Care
Advisory Committee to obtain the designation of “optometric glaucoma
specialist.”
(8) A
physician may charge a reasonable consultation fee for a consultation
given when a patient is referred with a diagnosis of primary open
angle glaucoma.
(9) When
a physician examines a patient involved in a co-management
consultation with a therapeutic optometrist for treatment of primary
open angle glaucoma, the physician shall forward to the therapeutic
optometrist, not later than the 30th day following the examination, a
written report on the results of the examination. A physician who, for
a medically appropriate reason, does not return a patient to the
therapeutic optometrist, shall state in the physician’s report to the
therapeutic optometrist the specific medical reason for failing to
return the patient.
(10) In
order to enter into a co-management agreement with an optometrist,
there must be an agreement between the two professionals that,
following each visit, specified information, previously agreed upon by
both the ophthalmologist and the optometrist, about the patient
examined will be forwarded to the other
practitioner.
193.11.
Use of Lasers.
(a)
Purpose. As the use of lasers/pulsed light devices is the practice of
medicine, the purpose of this section is to provide guidelines for the
use of these devices for ablative and non-ablative treatment by
physicians. Nothing in these rules shall be construed to relieve the
supervising physician of the professional or legal responsibility for
the care and treatment of the physician's patients.
(b)
Definitions. For the purpose of this section, the following definitions
will apply.
(1)
Advanced health practitioner--An advanced health practitioner is a
physician assistant or an advanced practice nurse.
(2)
Non-ablative treatment--Non-ablative treatment shall include any
laser/intense pulsed light treatment that is not expected or intended
to remove, burn, or vaporize the epidermal surface of the skin. This
shall include treatments related to laser hair removal.
(3)
On-site supervision--On-site supervision shall mean continuous
supervision in which the individual is in the same building.
(4)
Physician--A physician licensed by the Texas State Board of Medical
Examiners.
(c) Use of
lasers in the practice of medicine.
(1) The
use of lasers/pulsed light devices for the purpose of treating a
physical disease, disorder, deformity or injury shall constitute the
practice of medicine pursuant to §151.002(a)(13) of the Medical
Practice Act.
(2) The
use of lasers/pulsed light devices for non-ablative procedures cannot
be delegated to non-physician delegates, other than an advanced health
practitioner, without the delegating/supervising physician being
on-site and immediately available.
(3) The
use of lasers/pulsed light devices for ablative procedures may only be
performed by a physician.
(d)
Delegation.
(1) If
the physician provides on-site supervision, the physician may delegate
the performance of non-ablative treatment through the use of written
protocols to a properly trained delegate acting under adequate
supervision.
(2) If
the physician does not provide on-site supervision during a
non-ablative treatment, the on-site supervision may be delegated to an
advanced health practitioner.
(3) Prior
to any non-ablative initial treatment, the physician or advanced
health practitioner must examine the patient and sign the patient's
chart.
(e)
Supervision. Supervision by the delegating physician shall be considered
adequate for purposes of this section if the physician is in compliance
with this section and the physician:
(1)
ensures that patients are adequately informed and have signed consent
forms prior to treatment that outline reasonably foreseeable side
effects and untoward complications that may result from the
non-ablative treatment;
(2) is
responsible for the formulation or approval of a written protocol and
any patient-specific deviation from the protocol;
(3)
reviews and signs, at least annually, the written protocol and any
patient-specific deviations from the protocol regarding care provided
to a patient under the protocol on a schedule defined in the written
protocol;
(4)
receives, on a schedule defined in the written protocol, a periodic
status report on the patient, including any problems or complications
encountered;
(5)
remains on-site for non-ablative treatments performed by delegates
consistent with subsection (d)(1) of this section and immediately
available for consultation, assistance, and direction;
(6)
personally attends to, evaluates, and treats complications that arise;
and
(7)
evaluates the technical skills of the delegate performing non-ablative
treatment by documenting and reviewing at least quarterly the
assistant's ability:
(A) to
properly operate the devices and provide safe and effective care;
and
(B) to
respond appropriately to complications and untoward effects of the
procedures.
(f)
Alternate physicians.
(1) If a
delegating physician will be unavailable to supervise a delegate as
required by this section, arrangements shall be made for another
physician to provide that supervision.
(2) The
physician providing that supervision shall affirm in writing that he
or she is familiar with the protocols or standing delegation orders in
use at the site and is accountable for adequately supervising care
provided pursuant to those protocols or standing delegation orders.
(3) An
alternate physician must have the same training in performance of
non-ablative treatments as the primary supervising physician.
(g) Written
protocols. Written protocols for the purpose of this section shall mean
a physician's order, standing delegation order, standing medical order,
or other written order that is maintained on site. A written protocol
must provide at a minimum the following:
(1) a
statement identifying the individual physician authorized to utilize
the specified device and responsible for the delegation of the
performance of the specified procedure;
(2) a
statement of the activities, decision criteria, and plan the delegate
shall follow when performing delegated procedures;
(3)
selection criteria to screen patients for the appropriateness of
non-ablative treatments;
(4)
identification of devices and settings to be used for patients who
meet selection criteria;
(5)
methods by which the specified device is to be operated;
(6) a
description of appropriate care and follow-up for common
complications, serious injury, or emergencies as a result of the
non-ablative treatment; and
(7) a
statement of the activities, decision criteria, and plan the delegate
shall follow when performing delegated procedures, including the
method for documenting decisions made and a plan for communication or
feedback to the authorizing physician concerning specific decisions
made. Documentation shall be recorded within a reasonable time after
each procedure, and may be performed on the patient's record or
medical chart.
(h)
Educational requirements for physicians and advanced health
practitioners. Physicians and advanced health practitioners who are
involved in the performance of non-ablative treatments must:
(1)
complete basic training devoted to the principles of lasers, intense
pulsed light devices and thermal, radiofrequency and other
non-ablative devices, their instrumentation, physiological effects and
safety requirements. For each device, the physician and advanced
health practitioner must attend an initial training program. The
initial training must last at least 24 hours, and include clinical
applications of various wavelengths and hands-on practical sessions
with each device and their appropriate surgical or therapeutic
delivery systems; and
(2)
maintain competence to perform non-ablative procedures and obtain at
least eight hours of documented training annually regarding the
appropriate standard of care in the field of non-ablative procedures.
(i)
Educational requirements for delegates. A physician may delegate
non-ablative procedures to a qualified delegate. The physician must
ensure that the delegate complies with paragraphs (1) - (5) of this
subsection prior to performing the non-ablative procedure in order to
properly assess the delegate's competency.
(1) The
delegate has completed and is able to document clinical and academic
training in the subjects listed in subparagraphs (A) - (G) of this
paragraph:
(A)
fundamentals of laser operation;
(B)
bioeffects of laser radiation on the eye and skin;
(C)
significance of specular and diffuse reflections;
(D)
non-beam hazards of lasers;
(E)
non-ionizing radiation hazards;
(F)
laser and laser system classifications; and
(G)
control measures.
(2) The
delegate has read and signed the facility's policies and procedures
regarding the safe use of non-ablative devices.
(3) The
delegate has received or participated in at least 16 hours of
documented initial training in the field of non-ablative devices.
(4) The
delegate has attended at least eight hours of additional hours of
documented training annually in the field of non-ablative procedures.
(5) The
delegate has completed at least ten procedures of precepted training
for each non-ablative procedure to assess competency.
(j) Quality
assurance. The physician must ensure that there is a quality assurance
program for the facility at which non-ablative procedures are performed
in order for the purpose of continuously improving the selection and
treatment of patients. An appropriate quality assurance program shall
consist of the elements listed in paragraphs (1) - (5) of this
subsection.
(1) A
mechanism to identify complications and untoward effects of treatment
and to determine their cause.
(2) A
mechanism to review the adherence of delegates to standing delegation
orders, standing medical orders and written protocols.
(3) A
mechanism to monitor the quality of non-ablative treatments.
(4) A
mechanism by which the findings of the quality assurance program are
reviewed and incorporated into future standing delegation orders,
standing medical orders, written protocols, and supervising
responsibility.
(5)
Ongoing training to improve the quality and performance of delegates.
(k) The
deadline for compliance with the provisions of this section will be one
year following the final adoption of this
rule.
Effective May
2,
2004. |
