3 CCR 713-1.17 - DELEGATION AND SUPERVISION OF MEDICAL SERVICES TO UNLICENSED PERSONS PURSUANT TO SECTION 12-240-107(3)(l), C.R.S
A.
Basis: The general authority for promulgation of these
Rules by the Colorado Medical Board ("Board") is set forth in sections
12-20-204(1),
12-240-106(1)(a),
and 24-4-103, C.R.S.
B.
Purpose: The
following Rules have been adopted by the Board to clarify the requirements of
section 12-240-107(3)(l),
C.R.S. (the "Delegation Statute"). The Delegation Statute governs the
delegation of medical services to, and personal and responsible direction and
supervision over, a person who is not licensed to practice
medicine or otherwise licensed to perform the delegated medical services. This
Rule does not govern delegation of medical services to physician assistants,
anesthesiologist assistants or those individuals regulated by the Board of
Nursing. Such delegation is governed by Rules 1.15 and 1.16, and the Nurse
Practice Act, section
12-255-101
et
seq., C.R.S., respectively.
C.
Scope of Rules:
These Rules apply to the delegation of services constituting the practice of
medicine to a person who is not licensed to practice medicine, is not qualified
for licensure as a physician, physician assistant or anesthesiologist
assistant, and is not otherwise exempt pursuant to section
12-240-107, C.R.S., from holding a
license to practice medicine.
D.
MEDICAL SERVICES THAT MAY BE DELEGATED UNDER THESE RULES
1. Medical Services
a. "Medical services" are defined by the
Medical Practice Act, section
12-240-107, C.R.S., to include
suggesting, recommending, prescribing, or administering any form of treatment,
operation, or healing for the intended palliation, relief, or cure of any
physical or mental disease, ailment, injury, condition or defect of any
person.
b. "Medical services" also
include holding oneself out to the public as being able to diagnose, treat,
prescribe for, palliate or prevent any human disease, ailment, pain, injury,
deformity, or physical or mental condition. "Medical services" are further
defined by section
12-240-107(1),
C.R.S.
c. "Medical Services"
includes those acts, other than those acts excluded by subsection (D) of this
Section, performed pursuant to physician delegation by unlicensed persons or
licensed healthcare professionals.
2. Medical-Aesthetic Services
a. "Medical-Aesthetic Services" are medical
services in the cosmetic or aesthetic field that constitute the practice of
medicine. Such Medical-Aesthetic Services include, but are not limited to:
(a) the use of a Class IIIb or higher laser,
radio-frequency device, intense pulsed light, or other technique that results
in the revision, destruction, incision or other structural alteration of human
tissue and/or for hair removal; and
(b) the performance of injection(s) of any
substance into the human body except as may be permitted pursuant to subsection
(D) of this Section.
b.
As with all delegated medical services, delegated Medical- Aesthetic Services
must be of the type that a reasonable and prudent physician would find within
the scope of sound medical judgment to delegate. Consequently, delegated
Medical-Aesthetic Services should be routine, technical services, the
performance of which do not require the special skills of a licensed
physician.
c. Off-label use of
medications or devices when performing delegated Medical-Aesthetic Services is
generally prohibited unless:
(1) The
delegating physician has specifically authorized and delegated the off-label
use, and,
(2) The off-label use is
within generally accepted standards of medical practice.
d. Medical-Aesthetic Services must be
delivered within a facility appropriate to the delegated service provided and
listed on the written agreement as set forth in Appendix A.
3. Use of Lasers
a. The revision, destruction, incision, or
other structural alteration of human tissue using laser technology is a medical
service and constitutes the practice of medicine, as defined in section
12-240-107, C.R.S.
b. Use of Class IIIb or higher lasers or
pulse light devices as constitutes the practice of
medicine.
4. Acts That Do
Not Constitute Medical Services
a. The
definition of medical services under the Medical Practice Act does not include
acting as an intermediary by communicating a physician's message or order to
another person, or otherwise carrying out education activities as directed by
the physician. Therefore a person who merely acts as an intermediary to
communicate a physician's message or order to another person is not subject to
these Rules.
b. The definition of
medical services under the Medical Practice Act does not include gathering
data. A person who merely gathers data is not subject to these Rules. For
example, performing phlebotomy, measuring vital signs, and gathering historical
patient information is not subject to these Rules.
c. Tattooing, application of permanent
makeup, superficial exfoliative therapies, such as microdermabrasion, other
superficial skin treatments, and those services regulated by the Barber and
Cosmetologist Practice Act, section
12-105-101, et
seq., C.R.S., are not medical services.
d. The use of Class I, II, and IIIa medical
devices, including Class I, II, and IIIa lasers, does not constitute a medical
service.
e. Monitoring of
medication compliance is not a medical service.
f. Medication administration by Qualified
Medication Administration Personnel (QMAP) who are regulated by the Colorado
Department of Public Health and Environment is not included within the
definition of medical services for purposes of this Rule.
5. Delegated Medical Services Should Not
Require Exercise of Medical Judgment
a. A
physician should not delegate a medical service requiring the exercise of
medical judgment by the delegatee.
b. Delegated medical services should be
limited to routine, technical services that do not require the special skills
of a licensed physician.
6. Medical Services that May Not Be Delegated
a. Prescription Medications
(1) Prescribing of drugs may not be delegated
under section
12-240-107(3)(l),
C.R.S., and these Rules.
(2) The
ordering of a prescription refill by a delegatee does not constitute "the
prescribing of drugs" provided that:
(a) The
prescription refill is ordered at the same dose and for the same medication as
the original prescription for that patient; and
(b) The prescription refill is ordered
pursuant to a written refill protocol developed and authorized by one or more
delegating physicians.
b. Non-Prescription Medications
(1) The recommendation of marijuana as a
therapeutic option may not be delegated under section
12-240-107(3)(l),
C.R.S., and these Rules.
E. RULES GOVERNING INDIVIDUALS WHO CHOOSE TO
DELEGATE MEDICAL SERVICES
1. Who May Delegate
a. Licensed physicians may delegate the
performance of medical services to delegatees, in conformance with these
Rules.
b. To delegate a medical
service, an eligible delegating physician must be:
(1) Qualified by education, training and
experience to perform the medical service;
(2) Actively performing the medical service
as part of his or her medical practice and not exclusively by delegating the
service to a delegatee;
(3) Insured
to perform the medical service; and
(4) Actively practicing medicine and
available in the community where the delegated medical services occur.
(a) To be "available in the community," a
physician must be physically present in the State and able to promptly,
personally consult with or otherwise provide follow up care to the
patient.
(b) A delegating physician
may utilize telehealth technologies, where appropriate, to satisfy the
requirements for prompt personal consultation or follow-up care, but should not
rely exclusively on such telehealth technologies to perform those
services.
(c) Physician assistants
or anesthesiologist assistants may delegate medical services to unlicensed
healthcare providers who are acting under the direct supervision of the
licensed physician assistant or anesthesiologist assistant, where appropriate,
within the scope of the physician assistant's or anesthesiologist assistant's
delegated medical services.
2. Who May Not Delegate
a. Delegated services cannot be re-delegated
to another party by the delegatee.
b. A person who holds a physician training
license pursuant to section
12-240-128, C.R.S., is not
authorized to delegate medical services pursuant to section
12-240-107(3)(l),
C.R.S., and these Rules.
c. Persons
with a limited medical license may not delegate pursuant to these Rules any
medical services for which the licensee is prohibited from
performing.
F.
RULES GOVERNING INDIVIDUALS TO WHOM MEDICAL SERVICES ARE DELEGATED
("DELEGATEES")
1. Persons Who May Serve as
Delegatees
a. Qualified by Education,
Training or Experience
(1) The delegating
physician must evaluate and determine that the delegatee has the necessary
education, training or experience to perform each delegated medical
service.
(2) As part of his or her
evaluation, the delegating physician shall personally assess and review:
(a) Copies of diplomas, certificates or
professional degrees from bona fide training program(s) appropriate to the
specific services delegated; and,
(b) Appropriate credentialing by a bona fide
agency, Board or institution, if applicable.
(c) In any practice which utilizes a
credentialing committee or a human resources department for verification of
credentials, a delegating physician may rely on a credentialing committee or a
human resources department for verification of Section 30.4(A)(1)(b)(1) and
(2).
(3) The delegating
physician shall perform over-the-shoulder direct observation of the delegatee's
performance of any medical service prior to authorizing the delegatee to
perform the medical service outside of the delegating physician's physical
presence. A delegating physician may rely on another Colorado Medical Board
licensee's evaluation of the delegatee's skill to perform medical
services.
b. In the event
that a delegating physician chooses to delegate medical services to a person
holding a license, certificate or registration, and the delegated services are
beyond the scope of that person's license, certificate or registration, the
delegating physician must ensure that the delegatee is qualified by additional
education, training or experience beyond that required for the delegatee's
license, certificate or registration. Any delegation described in this
paragraph must comply with the requirements of this Rule 800.
c. These Rules apply to individuals who are
certified by a national or private body but who do not have Colorado state
licensure, registration or certification.
d. Graduates of physician assistant and
anesthesiologist assistant programs who have not yet taken the certification
examination, and thus, are not qualified for licensure, may perform delegated
medical services pursuant to section
12-240-107(3)(l),
C.R.S., until such time as they have been notified that they have passed the
certification exam and are eligible for a Colorado license. The delegating
physician and the unlicensed physician assistant graduate or unlicensed
anesthesiologist assistant graduate shall comply with the requirements of these
Rules until the physician assistant or anesthesiologist assistant is licensed
and subject to Board Rule 1.15 or 1.16.
e. Medical aesthetic service instructors at
institutions accredited/certified by the Department of Higher Education may
serve as delegatees provided the instructor possesses the necessary education,
training or experience to perform each delegated medical service.
(1) The physician may delegate the medical
service to such Instructor and students at the aforementioned institution to be
performed by the student under the direct supervision of the
instructor.
2.
The delegating physician and the delegatee shall take appropriate measures to
ensure that delegatees are identified in a manner that prevents confusion as to
the delegatees' qualifications and legal authority to provide medical services.
Following are examples of situations in which confusion as to the delegatees'
qualifications and legal authority to provide medical services is likely and in
which the physician and the delegatee shall be responsible for taking effective
measures to prevent such confusion. This list is illustrative and not
exhaustive.
a. A delegatee who is a
"radiology practitioner assistant" uses the acronym "RPA", which is easily
confused with the title of a licensed physician assistant or PA;
b. A delegatee uses the word "licensed" as
part of a title when the delegatee is not licensed, registered, or certified by
the state of Colorado to perform the medical services at issue;
c. A delegatee uses the word "doctor" or the
abbreviation "Dr." when acting as a delegatee; or
d. A delegatee who is an "aesthetician" uses
the word "medical" as part of a title, such as "medical aesthetician", when the
delegatee is not licensed, registered or certified by the state of Colorado to
perform medical services.
3. Persons Not Eligible to Serve as
Delegatees
a. A physician shall not delegate
medical services to any person who is otherwise qualified to be licensed by the
Board as a physician, physician assistant or anesthesiologist assistant but who
is not so licensed, including, but not limited to:
(1) Any physician, physician assistant or
anesthesiologist assistant with an inactive, expired, revoked, restricted,
limited, suspended or surrendered license;
(2) Any physician, physician assistant or
anesthesiologist assistant (other than those physician assistants or
anesthesiologist assistants authorized pursuant to Rule 1.17) who meets all
qualifications for licensure but who is not licensed in Colorado; and
(3) Any physician, physician assistant or
anesthesiologist assistant whose application for licensure in the State of
Colorado has been denied unless the denial is pursuant to section
12-240-120(1)(a),
C.R.S.
b. Medical
services shall not be delegated to any person who holds a physician training
license pursuant to section
12-240-128,
C.R.S.
4. Exceptions
a. These Rules do not apply to a person
performing acts that do not constitute the practice of medicine as defined by
section 12-240-107(1),
C.R.S.
b. These Rules do not apply
to health care providers who are licensed, registered or certified by the state
of Colorado and who are acting within their scope of practice.
c. These Rules do not apply to a registered
nurse (also known as a professional nurse or an RN). Services provided by a
registered nurse, either as an independent nursing function or a delegated
medical function, are governed by the Nurse Practice Act.
d. These Rules do not apply to any person who
is otherwise exempt pursuant to section
12-240-107, C.R.S. from holding a
license to practice medicine and who is acting within the scope of the specific
statutory exemption.
G. RULES GOVERNING THE DELEGATING PHYSICIAN'S
DELEGATION OF AUTHORITY TO PROVIDE MEDICAL SERVICES.
1. Any medical service rendered by the
delegatee must conform to the same standard applicable if the delegating
physician performed the service personally.
H. RULES GOVERNING THE DELEGATING PHYSICIAN'S
REQUIREMENTS FOR SUPERVISION OF DELEGATEES
1.
The delegating physician must:
a. Provide
ongoing inspection, evaluation, advice and control;
b. Make decisions as to the necessity, type,
effectiveness and method of treatment;
c. Provide sufficient on-the-spot inspection
to determine that the physician's directions are regularly being
followed;
d. Monitor the quality of
the services provided by the delegatee; and,
e. Provide personal and responsible direction
and supervision that is consistent with generally accepted standards of medical
practice.
2. The
physician's direction and supervision of the delegatee shall be sufficient to
limit the need for a delegatee to exercise the judgment required of a
physician.
3. Delegated services
must be provided in the context of an appropriate physician/patient
relationship.
4. Ongoing care of a
particular patient without direct physician involvement is inappropriate and
demonstrates insufficient personal and responsible direction and supervision of
a delegatee.
a. Factors establishing the
presence of an appropriate physician/patient relationship include, but are not
limited to, some or all of the following: physician performance of an initial
consultation with the patient, direct observation by the physician of delegated
services rendered by the delegatee, physician review of care rendered to the
patient by the delegatee, physician review of outcomes following the
performance of delegated services, and other active physician involvement in
the provision, review and documentation of services provided by the
delegatee.
5. Except as
otherwise provided in these Rules, a physician must be on the premises and
readily available to provide adequate personal and responsible direction and
supervision.
6. Where a delegatee
is acting pursuant to specific and detailed written protocols and where
adequate written emergency protocols are in place, the presence of the
delegating physician on the premises may not be necessary. However, a
delegating physician must be physically present in the State and available to
promptly, personally attend to the patient. At any time when a delegating
physician is not physically present within the State, the delegating physician
must identify and provide the contact information to delegatees of a covering
physician who is physically present in the State and available to promptly,
personally attend to the patient.
7. At least every two weeks, the delegating
physician must monitor the quality of the services provided by the delegatee
through such means as direct observation, review of care, review of outcomes,
review of equipment, review of protocols and procedures and review of charts.
The monitoring must occur at the site where the delegated services are
performed.
8. On at least an annual
basis, the delegating physician must personally reassess the qualifications and
competence of the delegatee to perform the medical services. This reassessment
must include, but must not be limited to, over-the-shoulder monitoring of the
delegatee's performance of each delegated medical service.
9. The delegating physician must document the
initial assessment and follow-up reassessments of the delegatee's performance
of the delegated medical services. Upon request, the delegating physician must
provide such documentation to the Board.
a. In
a hospital or medical practice, a delegating physician may rely on a
credentialing committee, human resources, or other documented institutional
process/es for verification of this Rule 1.17(H)(6)-(9).
I. DOCUMENTATION REQUIREMENTS
1. Written Procedure Protocols
a. Written procedure protocols are required
to be in place at any time that a delegating physician will not be physically
located on the premises where medical services are provided by a
delegatee.
b. The delegating
physician shall create a comprehensive written protocol for use by the
delegatee for each procedure that the physician delegates to the delegatee. The
delegating physician may not rely upon a written protocol created by the
delegatee to satisfy this requirement.
2. Written Emergency Protocols
a. Written emergency protocols are required
to be in place at any time that a delegating physician will not be physically
located on the premises where medical services are provided by a
delegatee.
b. The delegating
physician shall create a comprehensive written emergency protocol for use by
the delegatee when medical services result in adverse events. The delegating
physician may not rely upon a written protocol created by the delegatee to
satisfy this requirement.
c. As
part of a written emergency protocol, the delegatee shall be required to notify
the delegating physician of all adverse events.
3. Medical Records
a. A delegating physician shall assure that
there is a timely medical record for all patient contacts with either the
delegatee or with the delegating physician. The medical record prepared by a
delegatee shall conform to generally accepted standards of medical practice for
recordkeeping.
b. A delegating
physician shall review the care provided to every patient who is treated by the
delegatee. The delegating physician shall demonstrate that he or she has
reviewed the care provided to the patient by reviewing each entry in the
patient's medical record. The delegating physician shall initial and date the
medical record at the time he or she reviews the record.
c. A delegating physician shall review the
care provided to patients pursuant to his or her delegated authority within
fourteen days of the date that the care was provided.
d. When the delegated medical services by
delegatees occur in the context of a same-day encounter with the delegating
physician and the delegating physician has been personally involved in the care
of the patient, the delegating physician's own documentation of the encounter
shall be adequate to meet the requirements for chart review, and the delegating
physician need not co-sign any entries made by the delegatee.
4. Written Agreement between
Delegating Physician and Delegatee
a. The
delegating physician and the delegatee must have a written agreement
documenting and detailing the relationship. This written agreement is attached
in Appendix A of these Rules. The written agreement as set forth in Appendix A
must be available to the public at the site where the delegated medical
services are performed.
b. The
delegating physician must maintain a list of all delegatees to whom the
physician has delegated medical services. The list must include a comprehensive
and specific list of the delegated medical services that the physician has
authorized the delegatee to perform.
c. Where the delegating physician is on-site
and able to personally direct the delegatee at least 60% of the time, the
requirement for a written agreement may be satisfied through job descriptions,
personnel records or other documents that identify the relationship between the
delegating physician and delegatee.
5. Documentation that the Delegating
Physician or Healthcare Facility Must Maintain
a. The delegating physician or healthcare
facility shall maintain a copy of all documentation required by these Rules,
including but not limited to:
(1) Appendix A
written agreement;
(2) Any
agreement that the delegating physician enters into, in order to serve as a
medical director.
b. The
delegating physician or healthcare facility is required to maintain all
documentation required by these Rules.
c. Upon request, the delegating physician is
responsible to provide all documentation maintained by the physician or
healthcare facility in accordance with these Rules to the Board. The delegating
physician may not rely solely on a medical office or other entity to provide
the requested documents.
6. Disclosure Requirements to Patients
a. Delegating physicians shall ensure that
delegatees adequately disclose that a medical service will be performed by a
delegatee, rather than by the delegating physician. When the delegating
physician is not actively involved in the patient encounter, the disclosure
shall include: the service the patient is receiving is a medical service; the
delegatee of the service is not licensed by the state of Colorado or is acting
beyond the scope of his or her Colorado license, certification or registration;
the delegatee is providing the service pursuant to the delegated authority of a
physician; and, the delegating physician is available personally to consult
with them or provide appropriate evaluation or treatment in relation to the
delegated medical services. Upon request, the delegating physician must timely
and personally provide such consultation, evaluation or treatment, or provide
appropriate follow-up care and/or referrals.
(1) The disclosure requirements may be made
in writing as part of a signed disclosure agreement, an Informed Consent
agreement, or a Consent or Agreement to Treat form.
b. For all delegated medical services
occurring in the context of a bona fide physician-patient relationship, the
delegating physician and the delegatee shall document the disclosure made to
the patient, at the time each medical service is performed.
c. For all offices at which delegated
medical-aesthetic services are provided, the delegating physician shall ensure
that each office conspicuously posts, in the office's reception area, a notice
with the name and contact information for each delegating physician.
d. For all offices at which delegated
medical-aesthetic services are provided, the delegating physician shall create
a written disclosure, identifying the service to be performed, that the
performance of the medical service is delegated to an unlicensed person, the
name of the unlicensed person/delegatee, and the name and contact information
for the delegating physician. The written disclosure shall be signed by the
patient prior to receiving the medical service. The patient shall be given a
copy of each disclosure and a copy shall be retained within the patient's
medical record.
e. The delegating
physician must ensure that each patient receives all information necessary to
give appropriate informed consent or consent or agreement for treatment for any
medical service and that such informed consent or consent or agreement for
treatment is timely documented in the patient's chart.
J. UNPROFESSIONAL CONDUCT
1. It is a violation of these Rules for any
physician to have delegated medical services without complying with the
provisions of these Rules.
2. It is
a violation of these Rules for a licensee to perform delegated medical services
pursuant to these Rules, when such licensee is otherwise restricted from
performing such acts.
3. It is a
violation of these Rules for any person qualified for licensure by this Board
and who later applies for licensure by this Board, to have performed delegated
medical services or to have delegated medical services pursuant to section
12-240-107(3)(l),
C.R.S., prior to licensure in Colorado.
4. Any violation of these Rules may be
determined to be unprofessional conduct pursuant to section
12-240-121(1)(n),
C.R.S.
5. To the extent that
delegatees do not provide delegated medical services within generally accepted
standards of medical practice, the delegating physician may be determined to
have committed unprofessional conduct pursuant to section
12-240-121(1)(j),
C.R.S.
6. To the extent that
delegatees falsify or repeatedly make incorrect essential entries on patient
records, or repeatedly fail to make essential entries on patient records, the
delegating physician may be determined to have committed unprofessional conduct
pursuant to section
12-240-121(1)(v),
C.R.S.
7. In the event that a
delegating physician fails to produce to the Board, upon its request through a
30-day letter, a copy of any document required to be maintained by these Rules,
the Board may determine that the delegating physician has committed
unprofessional conduct pursuant to section
12-240-121(1)(y),
C.R.S.
K. UNLICENSED
PRACTICE OF MEDICINE
1. Pursuant to section
12-240-107(2),
C.R.S., any person who performs any of the acts constituting the practice of
medicine as defined by section
12-240-107(1),
C.R.S., and who is not licensed by the Board to practice medicine or exempt
from licensure requirements by some provision of section
12-240-107, C.R.S., shall be
deemed to be practicing medicine without a license. No person shall be exempt
from medical licensure requirements pursuant to section
12-240-107(3)(l),
C.R.S., unless such person is acting in conformance with these Rules.
2. A person who practices medicine without a
license may be the subject of a cease and desist order pursuant to section
12-240-125, C.R.S. Such person may
also be the subject of injunctive proceedings by the Board in the name of the
People of the State of Colorado pursuant to section
12-20-406, C.R.S. Such person may
also be held criminally liable pursuant to section
12-240-135(1),
C.R.S. Finally, such person may be subject to any other enforcement allowed
under the law.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.