BILL ANALYSIS
AB 356
Page 1
Date of Hearing: April 14, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 356 (Fletcher) - As Amended: April 13, 2009
SUBJECT : Radiologic technology: licentiates of the healing
arts.
SUMMARY : Expands the existing category of licentiates of the
healing arts to include a licensed physician assistant (PA) who
practices pursuant to the Radiologic Technology (RT) Act, and
authorizes a physician and surgeon to delegate procedures using
ionizing radiation, including, but not limited to, fluoroscopy,
to a licensed PA, under specified conditions. Specifically,
this bill :
1)Adds a licensed PA who practices under the supervision of a
physician and surgeon, as specified, to the category of
licentiates of the healing arts who practice pursuant to the
RT Act.
2)Allows a physician and surgeon to delegate procedures that use
ionizing radiation, including, but not limited to,
fluoroscopy, to a licensed PA.
3)Requires a physician and surgeon, in order to supervise a PA
in performing the functions authorized by this bill, to either
hold, or be exempt from holding, a certificate or permit
required to perform the functions being supervised.
4)Requires, beginning January 1, 2011, a PA delegated the use of
ionizing radiation to demonstrate successful completion of 40
hours of total coursework, including radiation safety and
protection, provided by an organization or program accredited
by the Accreditation Council for Continuing Medical Education
(ACCME) or by the American Academy of Physician Assistants
(AAPA) using ACCME standards.
5)Specifies that documentation of completed coursework must be
kept on file at the practice site and be available to the
Department of Public Health (DPH).
6)Requires, notwithstanding any other provision of law, DPH to
accept applications for a licentiate supervisor and operator
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permit from a licensed PA who meets the requirements of this
bill.
EXISTING LAW :
1)Establishes the Radiologic Health Branch (RHB) within DPH
which is responsible for licensing of radioactive materials,
registration of X-ray producing machines, certification of
X-ray and radioactive material users, inspection of facilities
using radiation, investigation of radiation incidents, and
surveillance of radioactive contamination in the environment.
2)Establishes the RT Act, administered by DPH, to establish
standards of education, training, and experience for persons
who use radiation on human beings and to prescribe means for
assuring that these standards are met.
3)Establishes the Radiologic Technology Certification Committee
(RTCC) to assist, advise, and make recommendations to DPH for
the establishment of regulations necessary to insure proper
enforcement of radiation control laws in California.
4)Requires DPH to provide for the certification of radiologic
technologists (RTs), provided that applicants submit
satisfactory evidence to DPH that they have satisfactorily
completed a course of study in an approved school for RTs, or
have completed study and training in radiologic technology
that DPH finds equivalent to a course of study from an
approved school.
5)Prescribes, in regulations, the curriculum requirements for an
approved program for RTs in diagnostic and therapeutic X-ray.
Requires an approved diagnostic X-ray program to include
classroom instruction in the following: 50 hours of radiation
protection; 40 hours of physics and electricity; 30 hours in
principles of radiographic exposure; and, 25 hours of
laboratory in radiation protection. Requires an approved
therapeutic X-ray program to include classroom instruction in
the following: 50 hours of radiation protection; 85 hours of
physics in radiation therapy; 25 hours in principles of
radiation therapy; 35 hours in principles of radiography; and,
60 hours of laboratory in radiation protection.
6)Requires DPH to grant limited permits, as may be deemed
appropriate, to persons to conduct radiologic technology
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limited to the performance of certain procedures or the
application of X-rays to specific areas of the human body;
prescribe minimum standards of training and experience for
these persons; and, prescribe procedures for examining
applicants for limited permits.
7)Provides for, in regulations, limited permits for certified
RTs in radiography and fluoroscopy, if specified requirements
are met.
8)Prohibits any person from administering or using diagnostic or
therapeutic X-ray unless that person has been certified by, or
granted a permit from, DPH; is acting within the scope of that
certification or permit; and, is acting under the supervision
of a licentiate of the healing arts (licentiate).
9)Defines a licentiate, for purposes of the RT Act, as a
licensed physician and surgeon, podiatrist, or chiropractor.
10)Requires DPH to provide for certification of licentiates to
supervise the operation of X-ray machines or to operate X-ray
machines, or both; prescribe minimum standards of training and
experience for these licentiates; and, prescribe procedures
for examining applicants for certification.
11)Exempts a licentiate from the prohibition specified in 8)
above if the licentiate is certified and acting within the
scope of that certification.
12)Provides for, in regulations, a licentiate certificate as a
radiology supervisor and operator, and licentiate supervisor
and operator permits in radiography, dermatology, and
fluoroscopy.
13)Requires, in regulations, applicants for a licentiate
supervisor and operator permit to successfully pass a
DPH-administered examination in the permitting category and
pay a specified examination fee. Authorizes, in regulations,
a licentiate supervisor and operator permitholder to supervise
RTs.
14)Requires, in regulations, as a condition of permit or
certificate renewal, RTs to earn 24 approved continuing
medical education (CME) credits every two years in subjects
related to the application of ionizing radiation and
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licentiates to earn 10 CME credits every two years.
15)Provides for the regulation and licensing of PAs by the
Physician Assistant Committee (PAC) of the Medical Board of
California (MBC).
16)Establishes the PAC to prescribe standards and issue licenses
of approval for programs that educate and train PAs; make
recommendations to MBC concerning the scope of practice of
PAs; and, require examinations of applicants for licensure as
a PA who have completed an approved PA training program.
17)Allows a PA to perform those medical services as set forth by
the regulations of MBC when the services are rendered under
the supervision of a licensed physician and surgeon, as
specified.
18)Specifies, in regulations, that a PA may only perform those
medical services which he or she is competent to perform and
which are consistent with the PA's education, training, and
experience, and which are delegated in writing by a
supervising physician who is responsible for the patients
cared for by that PA.
19)Specifies, in regulations, the medical services that a PA may
perform pursuant to a delegated services agreement (DSA) such
as taking a patient history; ordering or transmitting an order
for X-ray; ordering, transmitting an order for, performing, or
assisting in the performance of laboratory, screening, and
therapeutic procedures; instructing and counseling patients;
initiating arrangements for hospital admissions; administering
or providing medication; issuing or transmitting drug orders
as specified; and, performing those surgical procedures
without the personal presence of the supervising physician
that do not require general anesthesia.
20)Requires, in regulations, the orders given and tasks
performed by a PA to be considered the same as if they had
been given and performed by the supervising physician because
PA practice is directed by a supervising physician and a PA
acts as an agent for that physician.
21)Prescribes, in regulations, the curriculum requirements for
an approved program for primary care PAs including instruction
in specified basic education core subjects such as chemistry,
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mathematics, English, anatomy, physiology, microbiology and
psychology; and instruction that includes direct patient
contact in specified clinical science subjects such as mental
health, disease management, common laboratory and screening
techniques, common medical and surgical procedures, and
therapeutics, including pharmacology.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the sponsor, the
California Academy of Physician Assistants (CAPA), existing
law allows supervising physicians to delegate the ordering and
performing of various diagnostic tests to PAs but PAs cannot
explicitly take an X-ray without first being certified as an
RT by DPH. The sponsor believes this restriction is
inconsistent with the scope of practice of PAs, which allows
them to act as the agent of supervising physicians in
performing most other medical services. The sponsor states
that PAs generally need to use ionizing radiation to take a
plain film in a situation where a RT is not available and to
use fluoroscopy for visualization during a medical procedure.
The sponsor asserts this is especially important in rural and
underserved clinics and hospitals where keeping a licensed RT
on staff may not be practical or possible. This bill is
intended to establish a pathway for a licensed PA in
California to perform X-rays or utilize fluoroscopic equipment
without completing an RT program and taking the requisite
fluoroscopic permit exam administered by DPH.
2)BACKGROUND . RHB within DPH is responsible for the oversight
and regulation of the use of radiological equipment in
California. RHB provides public health functions associated
with administering a radiation control program and enforces
the RT Act. The RT Act establishes standards of education,
training, and experience for persons who use radiation on
human beings and RHB ensures that these standards are met.
Among its many functions, RHB certifies personnel in the
supervision and use of diagnostic and therapeutic X-ray,
including licentiates, i.e. physicians and surgeons,
podiatrists, and chiropractors; and, RTs. Individuals who
perform X-ray procedures in radiography (standard X-ray) and
fluoroscopy (live movement X-ray) are required to obtain
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operator permits from DPH, unless they are radiologist
physicians, non-radiologist physician and surgeons,
podiatrists, or chiropractors.
3)LICENTIATE EXEMPTION . Current law exempts licentiates who are
board-certified radiologists from the requirement to obtain an
operator permit and requires them to apply to DPH for a
radiology supervisor and operator certificate if they pay a
specified application fee, provide proof of board
certification, and include a copy of their valid physician and
surgeon state license in the application. Non-radiologist
licentiates are issued a licentiate supervisor and operator
permit in radiography and fluoroscopy if they pay specified
application and examination fees and pass DPH-administered
examinations in the following areas: a) radiography and
fluoroscopy radiation protection and safety; and, b) operation
and supervision of radiography and fluoroscopy and ancillary
equipment. Licentiate supervisor and operator permit holders
may supervise RTs. This bill includes licensed PAs in the
existing category of licentiates under the RT Act.
4)SCOPE OF PRACTICE OF PAs. Current regulations specify that a
PA may only provide those medical services which he or she is
competent to perform, as determined by a supervising
physician; that are consistent with the PA's education,
training, and experience; and, that are delegated in writing
by the supervising physician responsible for the patients
cared for by the PA. The DSA is required to be signed and
dated by the PA and supervising physician. It identifies what
types of services the PA is allowed to perform, how they are
performed, how patient charts will be reviewed and signed, and
what type of medications the PA will transmit on behalf of the
supervising physician. A PA may provide medical services
pursuant to more than one DSA. Every practicing PA is
required to have a DSA and make a copy available upon the
request of the MBC. Failure to have a current DSA constitutes
a violation and grounds for disciplinary action against a PA's
license.
Medical tasks performable by a PA may only be those that are
usual and customary to the supervising physician's practice.
Examples of such medical services include taking patient
histories; ordering or transmitting orders for X-rays;
initiating arrangements for hospital admissions; completing
forms and charts for a patient's medical record; issuing or
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transmitting drug orders under specified conditions; and,
performing surgical procedures that are customarily performed
under local anesthesia. This bill includes procedures using
ionizing radiation, including fluoroscopy, within the medical
services that may be delegated to a PA.
5)FLUOROSCOPY . According to the Center for Devices and
Radiological Health in the federal Food and Drug
Administration (FDA), fluoroscopy is a type of medical imaging
that shows a continuous X-ray image on a monitor. It is used
to diagnose or treat patients by displaying the movement of a
body part or of an instrument or dye (contrast agent) through
the body. During a fluoroscopy procedure, an X-ray beam is
passed through the body. The image is transmitted to a
monitor so that the body part and its motion can be seen in
real time. Some examples of fluoroscopy include viewing
contrast agents moving through the upper gastro-intestinal
tract, examining blood flow to organs, directing the placement
of a catheter during angioplasty, or viewing fractures and
fracture treatment in orthopedic surgery.
The FDA states that management of patient exposure is
particularly important in high-exposure procedures such as
fluoroscopy and computed tomography (CT). According to the
FDA, the two major risks associated with fluoroscopy are
radiation-induced injuries or burns to the skin and underlying
tissues and the small possibility of developing
radiation-induced cancer some time later in life. According
to an April 2008 article in Clinical Cardiology, the risk of a
burn is uncommon and rarely needs discussion before the
procedure but, for patients who have been heavily exposed
during procedures involving extended fluoroscopic time, some
discussion of later skin injury is warranted. The article
states that in rare instances some patients show nearly
immediate signs of skin injury, but the more frequent scenario
is that the patient is discharged with no symptoms of injury,
only to develop a rash days to weeks later. The article
recommends that patients who have been heavily exposed during
fluoroscopy should be advised that injury to the skin may be a
complication of the procedure and be referred to a
dermatologist for immediate diagnosis and treatment of a
radiation injury.
6)RT PERMIT REQUIREMENTS . A certified RT may operate
radiographic and fluoroscopic equipment if he or she has a
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limited permit issued by DPH in radiography and fluoroscopy.
To obtain a fluoroscopy permit, a certified RT is required to
file an application with DPH containing a copy of a
certificate or diploma that indicates successful completion of
a program from an approved fluoroscopy permit school, pay a
specified fee, and pass DPH-administered examinations in
fluoroscopy radiation protection and safety and use of
fluoroscopy and ancillary equipment. DPH specifies that a
program from an approved fluoroscopy permit school must
include classroom instruction in fluoroscopy regulations,
fluoroscopy radiation safety, and fluoroscopy equipment; and
laboratory work in methods of reducing dose to patients during
fluoroscopy procedures and reducing exposure to self and
personnel; performing proper image recording; and, providing
quality control of fluoroscopy equipment.
7)SUPPORT . The sponsor, CAPA, writes in support that California
is in the midst of an access to care crisis and restrictions
in current law that prevent PAs from explicitly taking X-rays
overburden physicians with routine duties that should be
performed by clinically competent PAs. CAPA asserts that
current law creates an undue burden unique to California
since, according to the sponsor, a majority of states allow
PAs to perform X-rays and fluoroscopy and PAs who would like
to provide these functions are forced to leave the state.
CAPA believes that this bill provides a solution by allowing
PAs to comply with requirements set forth for other health
professionals who perform radiological procedures.
8)OPPOSITION . The California Radiological Society (CRS) and the
California Society of Radiologic Technologists (CSRT),
representing radiologists and RTs, object to this bill. They
note in opposition that California has a specific statutory
and regulatory structure that is designed to ensure that, when
the public is exposed to ionizing radiation for medical
purposes, the individuals utilizing the equipment are properly
educated, trained, and experienced in minimizing radiation
exposure. CRS and CSRT maintain that, in most cases,
equipment in California is operated by certified RTs with
fluoroscopy permits under the supervision of a board-certified
radiologist and their training is much greater than the 40
hours that this bill requires of PAs and it extensively covers
multiple types of equipment and procedures used in medical
imaging. CRS contends that this bill superimposes the ability
of a PA to use ionizing radiation without any of the inherent
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safeguards in current law and regulations and would allow a PA
under delegation to perform any procedure that uses ionizing
radiation, including anything from a chest X-ray to a CT scan,
without a sufficient level of training and education. CSRT
adds that this bill inappropriately allows PAs to supervise
RTs because PAs are non-radiology personnel who lack the
education in radiologic sciences and practice in radiologic
procedures that is required of RTs.
9)CONCERNS . The Consumer Attorneys of California (CAOC) writes
in concern that delegating the ability to use ionizing
radiation to a PA may not be in the best interest of patients
as use of such high radiation can raise the risks of cancer.
For this reason, CAOC does not believe that physicians should
delegate high-risk treatments for patients to non-physicians.
10)PRIOR LEGISLATION .
a) AB 623 (Lieu) of 2008, which was held in the Senate
Appropriations Committee, would have required DPH to
provide for the certification of radiology assistants.
b) AB 3 (Bass), Chapter 376, Statutes of 2007, revises
guidelines and protocols governing the practice of PAs.
11)DOUBLE-REFERRAL . This bill is double-referred. Should it
pass out of this committee, it will be referred to the
Assembly Business and Professions Committee.
12)SUGGESTED TECHNICAL AMENDMENT . This bill should be amended
to correctly spell "fluoroscopy."
13)POLICY QUESTIONS & COMMENTS .
a) Different education and training requirements . What is
the rationale for requiring different education and
training requirements for PAs to operate X-ray equipment
than what is required for other permit operators, such as
certified RTs? Currently, certified RTs are required to
complete an approved program accredited by the American
Registry of Radiologic Technologists (ARRT) or the American
College of Radiology (ACR) in diagnostic and therapeutic
X-ray, including classroom instruction in 50 hours of
radiation protection and laboratory work in 25 to 60 hours
of radiation protection, and to complete additional
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education and training from an approved fluoroscopy permit
school to obtain a limited fluoroscopy permit. This bill
requires a PA to complete 40 hours of total coursework that
includes radiation safety and protection accredited by the
ACCME or the AAPA. Should this bill be amended to require,
at a minimum, PAs to earn 24 hours of CME every two years,
similar to CME requirements for certified RTs, rather than
10 as a licentiate? Additionally, since this bill affects
the RT Act, would it be more appropriate to require the
coursework to be accredited by the ARRT or the ACR, which
approve the course of study of RTs?
b) Supervision of RTs . By classifying PAs as licentiates,
this bill would allow PAs to supervise RTs. Although a PA
serves as an agent of the supervising physician, is this
role appropriate for a PA when he or she is supervised by a
non-radiologist physician?
REGISTERED SUPPORT / OPPOSITION :
Support
California Academy of Physician Assistants (sponsor)
Opposition
California Radiological Society
California Society of Radiologic Technologists
Numerous individuals
Analysis Prepared by : Cassie Rafanan / HEALTH / (916)
319-2097