Medical Physicist
Credentials:
The Regulatory Path
Douglas Pfeiffer, MS, DABR
Boulder Community Hospital
Chair, AAPM Governmental and Regulatory Affairs Committee
Outline
• Regulation vs. Licensure
• What the regulatory path is
• What the regulatory path is not
• Steps required
• Sample language
• Problems and Pitfalls
Objective
The level of complexity involved in medical imaging
and radiation therapy is such that it is necessary
that physicists with special training, education, and
experience must be a part of the team providing
these procedures. We believe it is the role of the
medical physicist to oversee the processes
involving the physics of these procedures. … For
the benefit of patients and the general public, it is
essential that the profession of medical physics be
both defined and protected by law.
From JMPLSC FAQ document
Licensure vs. Regulation
• Are they equivalent?
NO!
Licensure
•
A technical definition: a license is a government grant
of specific legal rights and obligations to the licensee.
•
Once a license has been granted, it cannot be
restricted or taken away without notice and a
hearing, with all the attendant legal rights and
appeals.
•
If the State proposes to take some action against a
licensee, the burden of proof rests with the State.
•
Since a license grants a right to do something, it ipso
facto limits or prohibits the ability of others to do
that same activity.
However...
• Not all states are amenable to licensure
• Not enough medical physicists
• Not open to the concept
Licensure is Imperfect
• Board Certification
• New York: Pass ABR Parts I, II
• Texas: Pass Texas exam, not ABR
• Florida: Requires certification
• Local exigencies require departure from
the ideal template
Regulation
• This term is being used as short-hand for a
comprehensive set of regulations governing
the practice of medical physics
• Credentials
• Scope of practice
• Ethics
• Revocation of privileges
Regulation
• Attempts to use existing radiation control
enabling legislation
• Enacted as any other radiation control
regulation
• Should not require legislative involvement
• No formal lobbying
• Much less expensive
Preparation
•
Enabling legislation must allow, and be interpreted to allow,
comprehensive registration
•
Colorado: (1) (a) The state board of health shall formulate, adopt,
and promulgate rules and regulations as provided in subsections
(2) and (2.5) of this section which shall cover subject matter
relative to radioactive materials, including but not limited to
naturally occurring radioactive materials, and other sources of
ionizing radiation. The subject matter of such rules and regulations
shall include, but not be limited to: Licenses and
registration, records, permissible levels of exposure,
notification and reports of accidents, technical qualifications
of personnel, technical qualifications of mammographers,
handling, transportation and storage, waste disposal, posting and
labeling of hazardous sources and areas, surveys, monitoring, and
financial assurance warranties.
•
Interpreted as allowing for comprehensive regulation of MP
Preparation
•
Enabling legislation must allow, and be interpreted to
allow, comprehensive registration
•
Michigan: Sec. 13521.
(1)
The department shall promulgate
rules providing for general or specific licenses or
registration, or exemption from licensing or registration, for
radioactive materials and other sources of ionizing radiation.
The rules shall provide for amendment, suspension, or
revocation of licenses. In connection with those rules, the
department may promulgate rules to establish
requirements for record keeping, permissible levels of
exposure, notification and reports of accidents, protective
measures, technical qualifications of personnel, ...
•
NOT interpreted as allowing for comprehensive regulation of
MP
Michigan Act
•
“The rules shall not limit the intentional exposure of
patients to radiation for the purpose of lawful therapy or
research conducted by licensed health professionals.”
•
Legal advice: “This language clearly and specifically carves
out the power to regulate therapy or research involving
radiation when conducted by licensed health professionals,
such as a medical physicist.”
•
Colorado: “The rules and regulations adopted pursuant to
this part 1 shall never be construed to limit the kind or
amount of radiation that may be intentionally applied to a
person for diagnostic or therapeutic purposes by or under
the direction of a duly licensed practitioner of the healing
arts.”
Lesson
• Establish good, close working relationship
with the regulators
• Give advice and CONSTRUCTIVE
criticism of radiation control regulations
• Ask them questions
• Be available for consultation
• Help regulators see the importance of QMP
Colorado Template
• Growing effort since 1999
• Still sub-optimal, but Department is largely
supportive
• “‘Registered medical physicist’ (RMP)
means an individual who meets the
applicable requirements of Appendix 2B
and has current Department approval to
perform medical physics activities in a
designated specialty” (effective 7/1/10)
PART 2, APPENDIX 2B: REGISTERED MEDICAL PHYSICIST
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non-healing-arts
purposes.
non-healing-arts
purposes.
erate
of an exposure
individual
of
forantraining,
individual
demonstration
for training, or
demonstration
other
or other
arts
who
meets
the training
requirements specified in RH 20.3.2. This provision specifically
!>#$
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s purposes.
prohibits deliberate exposure of an individual for training, demonstration or other
20.3.7
Reserved
20.3.7
Reserved
non-healing-arts
purposes.
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Scope of Practice - Dx
20.3.7.1
20.3.7.3
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24.5
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Registered
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Revocation of Privileges
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•
•
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MODIFICATION AND REVOCATION OF REGISTRATION
!"#"!"H% &'(%*(,61,.+/<(%16%(+<'%:;+3262(9%(M*(,-%+/9G1,%,(820-(,(9%.(92<+3%*'702<20-?%2/%
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While not stated explicitly (yet), current practice is to
review questionable cases with a number of trusted
RMPs.
E!F%
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The burden
of proof is on the registrant to prove its
&'(%)(*+,-.(/-%0'+33%/1-267%-'(%,(820-,+/-%16%+/7%6+23;,(%-1%.((-%+%*(,61,.+/<(%0-+/9+,9%1,%
case
if
someone
makes a claim against the individual.
,(:;2,(.(/-%16%-'(%,(8;3+-21/0%-'+-%20%29(/-262(9%+0%+%,(0;3-%16%-'(%,(=2(A%1,%+;92-"%
!"#"B%
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+9(:;+<7%1,%<1.*(-(/<7%0'+33%@(%9(.1/0-,+-(9"%
!%J%!B%
Ethics
• Not currently explicitly addressed in
Colorado regulation
• Cases of questionable situations have been
brought to the attention of a small group of
RMPs (with anonymity preserved) for
advice
!%>%!;%
Colorado Template
• Lessons
• Many hours sitting at the table with
regulators
• Provide “straw man” language
• Be flexible, but hold onto key elements
CRCPD
• Conference of Radiation Control Program
Directors
• Write Suggested State Regulations (SSR)
Part ZZ
• Part Z is a new section dealing with
credentials
• Part ZZ is that part of Z dealing with QMP
• In DRAFT FORM
• Following are only as suggested by AAPM
liaisons, and have not been accepted by
CRCPD
PART ZZ
REGISTRATION REQUIREMENTS FOR QUALIFIED MEDICAL
PHYSICISTS (QMP)
Sec. ZZ.1 - Purpose and Scope.
This Part provides for the approval and registration of Qualified
Medical Physicists (QMP). Specifically, this Section:
a.
Establishes standards and procedures to be applied by the
Agency for approving individuals as a QMP; and
b.
Establishes standards and procedures to be applied by the
Agency when withdrawing its approval of a QMP.
Sec. ZZ.2 - Certification/Education/Experience
Requirements.
b. An individual shall be considered to be a QMP to
practice one or more of the subfields of Medical
Physics if that individual is certified in that subfield by
any one of the following:
i.
The American Board of Radiology
ii.
The American Board of Medical Physics
iii.
The American Board of Health Physics
iv.
The American Board of Science in Nuclear Medicine
v.
The Canadian College of Physics in Medicine
c.
Grandfather
i.
Individuals that have, prior to the effective date
of these regulations, performed the functions of a
QMP under an existing state rule or regulation, and
have maintained the active status of any required
licensure, approval or certification, within 3 years
from date of enactment may continue to perform
the functions of a QMP, or
ii.
Individuals that do not meet the requirements
specified in ZZ.2.b in one of the subfields, must
meet the requirements of section ZZ.2.b. of this
section within 5 years from date of enactment of
the regulation in order to practice as a QMP.
Sec.ZZ.4 - Suspension and Revocation of
Registration
a.
The Agency may act to suspend or revoke an
individual’s registration as an approved medical
physicist and/or therapeutic radiological physicist
and remove the individual’s name from the
record of approval for any one or a combination
of the following causes: …
i. Misrepresentations on application
ii. Evading or violating an Agency regulation or
order
iii. Significant or repeated incompetence
iv. Providing false or misleading information to
the Agency
v. Signing for an evaluation not performed or
overseen
vi. Failing to repay educational loan
vii.Failing to meet child support orders
b.
If, based upon any of the grounds in subsection (a)
of this Section, the Agency determines that action is
necessary to suspend or revoke the registration of an
approved QMP and to remove the individual’s name
from the record of approved individuals, the Agency
shall first notify the individual of the reason for its
action and the proposed length of a suspension or
revocation and shall provide an opportunity for a
hearing in accordance with (cite appropriate
Administrative Proceedings citation). An opportunity
for a hearing shall be provided before the Agency
takes final action to suspend or revoke an individual’s
registration.
Ethics
• Not explicitly addressed in Part ZZ at this
time
• Liaisons are discussing the options
National Registry of
Medical Physicists
• The national registry is NOT equivalent to
the regulatory approach
• The national registry is a tool that can be
used by states in support of both regulation
and licensure approaches
• It is merely a list of individuals who are
certified by one of the identified boards
Licensure
Component
Regulation
Yes, with caveats
Board Certification
Yes, with caveats
Yes
Stature
No
Yes
Due Process
Yes, with caveats
Yes
Scope of Practice
Yes
Yes
Able to be Revoked
Yes
Possibly
Ethics
Possibly
High
Cost
Low
Yes
Controlled by MP
No
Yes
Defines profession
Not really
Objective
The level of complexity involved in medical imaging
and radiation therapy is such that it is necessary
that physicists with special training, education, and
experience must be a part of the team providing
these procedures. We believe it is the role of the
medical physicist to oversee the processes
involving the physics of these procedures. … For
the benefit of patients and the general public, it is
essential that the profession of medical physics be
both defined and protected by law.
From JMPLSC FAQ document
Objective
The level of complexity involved in medical imaging
and radiation therapy is such that it is necessary
that physicists with special training, education, and
experience must be a part of the team providing
these procedures. We believe it is the role of the
medical physicist to oversee the processes
involving the physics of these procedures. … For
the benefit of patients and the general public, it is
essential that the profession of medical physics be
both defined and protected by law.
From JMPLSC FAQ document
Objective
The level of complexity involved in medical imaging
and radiation therapy is such that it is necessary
that physicists with special training, education, and
experience must be a part of the team providing
these procedures. We believe it is the role of the
medical physicist to oversee the processes
involving the physics of these procedures. … For
the benefit of patients and the general public, it is
essential that the profession of medical physics be
both defined and protected by law.
From JMPLSC FAQ document
Conclusion
• Ideal licensure is the gold standard
• Ideal licensure may not be achievable for a
number of reasons
• Some states will likely never have licensure
• AAPM must develop an appropriate
alternative
Conclusion
• Comprehensive regulatory approach is an
achievable alternative to licensure
• Regulation can achieve many of the goals of
licensure
• Regulation is less costly than licensure
• Regulation must be pursued in parallel with
licensure