The work group convened by the Board of PA Registration to look at this issue has acknowledged that PAs are members of physician-led multidisciplinary teams who need to legally perform procedures using radiation and fluoroscopic guidance. This concept is not uncommon; as of August 2008, eight states exempt PAs from needing an RT license to use ionizing radiation. In the 13 jurisdictions that do not currently regulate RTs, PAs are not prohibited by law from using ionizing radiation if delegated to do so by a supervising physician. Five states have provisions allowing PAs who have received additional training to perform x-rays and fluoroscopy. Four states permit PAs with additional training to perform x-rays.

Apart from exempting PAs from needing an RT license in order to perform physician-delegated radiological and fluoroscopic-guided procedures, there are two regulatory options the Board could follow with regard to this matter. The first option would be an agency-based model of regulation, similar to the Radiological Health Branch of the California Department of Public Health.  Another example, modeled after recent changes to the Minnesota rules regulating the use of radiation by health care professionals, is facility-based in its focus. This plan is similar to what is already in place for non-radiologist physicians and physician residents in Massachusetts.

Regulatory-Agency Based Plan

The California Radiological Health Branch (RHB) of the Department of Public Health regulates the medical imaging profession, specifically radiological technologists (RTs). California law outlines the requirements for RT licensure and exempts “licentiates of the healing arts” from needing an RT license in order to perform those procedures. Regulations implementing the RT laws require evidence of radiation safety training and continuing education in order for those licentiates to perform radiological procedures. In order to meet these requirements, the RHB has developed a series of “licentiate permits” in the categories of radiography, fluoroscopy, dermatology, and radiology.

The regulatory-agency based plan involves a two-step process: licentiates must first become certified in these categories and are then eligible to register for licentiate permits. In order to apply for a radiography and fluoroscopy supervisor and operator permit (also known as “licentiate permits”), physicians, dentists, and podiatrists must first pass department-approved certification exams in 1) radiography radiation protection and safety and use and supervision of use of radiography and ancillary equipment; and 2) fluoroscopy radiation protection and safety and use and supervision of use of fluoroscopy and ancillary equipment.

The RHB provides free online syllabi for the radiography and fluoroscopy certification exams. Self-study time is approximated at four to six hours for each exam. While we do not have copies of the exams, information provided by those who have taken the exams suggests that licentiates who study the syllabi are able to pass the exams on the first try. Once the licentiates pass the exams, they are eligible to apply for a permit. Permits are renewed every two years. Licentiate permittees must earn 10 hours of RHB-approved CME within those two years. The total cost of the exam and the permit run less than $200.

Facility-Based Plan

The Minnesota Department of Health recently revised its regulations to permit physician-delegated PA performance of radiological procedures, including radiography and fluoroscopy. Section 4732.0825(2) of the Minnesota X-Ray Operator regulations require all individuals using fluoroscopy (except for physicians, dentists, podiatrists, veterinarians, and chiropractors) to be trained in the aspects of the use of fluoroscopy, which include:

A. x-ray generation and control;

B. x-ray dosimetry;

C. image formation;

D. image acquisition;

E. image processing and management;

F. radiation effects;

G. patient dose-management fundamentals;

H. staff radiation safety;

I. professional standards and regulatory requirements; and

J. other miscellaneous items appropriate to site-specific use.

These rules were implemented in September 2007. In early 2008, the Mayo Clinic Radiation Safety office polled the PAs in the institution to identify who was using fluoroscopy and then gave a one-hour training session to all the PAs who responded to the poll. The Radiation Safety office gave its own slide show of training materials and also required those taking the training session to read Minimizing Risks from Fluoroscopic X Rays, by LK Wagner and BR Archer (4th ed 2004, Partners in Radiation Management, Ltd., 281-362-0861).

Mayo plans to require PAs who have taken the safety course to take an open book exam to document compliance with the state rules. The state does not require evidence of passage of an exam.

Possible Regulatory Solutions

The state will ultimately need to choose, upon the recommendation of the Board’s workgroup, how involved it wants to be in the regulation of PA performance of radiological and fluoroscopic-guided procedures. The following two options represent potential regulatory scenarios that may occur if the state chooses either the regulatory-based plan or facility-based plan.

Regulatory Options

If the state wishes to heavily regulate PAs who are delegated radiological and fluoroscopic-guided procedures, it could follow the regulatory-agency based plan. This would require extensive changes to the radiation safety regulations and the PA regulations. These changes would likely include the creation of provisions for state certification of PAs who pass a state-mandated safety training course and exam. The Board or the state Radiation Control Program would have to implement the program and determine how to document certification and approve continuing education.

Facility-Based Options

The other option is to follow the facility-based plan. This may be a more reasonable regulatory scenario for Massachusetts since most elements of this plan are already in place for physician residents and non-radiology physicians in Massachusetts. Implementation of this plan would require less regulatory change, and would not require the Board of PA Registration or the State Radiation Control Program to implement a new training program for PAs delegated radiological and fluoroscopic-guided procedures. Suggested language (in bold) in 105 CMR-120.405(K)(5) would require facilities to:

“ensure that all non-radiologist physicians using fluoroscopy equipment and physician assistants who have been delegated by a supervising physician the performance of radiological procedures including fluoroscopy obtain annual training in Radiation Safety/Radiation Protection and maintain all records relating to compliance with this training requirement for five years.”

Keep in mind that the suggested language above would require PAs who are delegated all procedures, including fluoro, to obtain annual training in radiation safety and protection.  Additionally, the following language (in bold) could be added to the RT Practice Act, Chapter 111: Section 5L:

“Nothing in this section shall be construed as preventing or restricting the practice, services or activities of:

(i) any person licensed in the commonwealth by any other statute from engaging in the profession for which he is licensed, or

(ii) any person employed as a radiologic technologist by the government of the United States or any agency of it, if such person provides services solely under the direction or control of the organization by which he is employed; or

(iii). a physician assistant registered under MGL Chapter 112, section 9C, who has been delegated by a supervising physician the performance of radiological procedures including fluoroscopy and has completed a safety course as prescribed by 105 CMR - 120.405.”

The Board of PA Registration could amend section 5.04(3) of the board’s regulations to read:

“Nothing contained herein shall be construed to allow a physician assistant to:

(b) Perform any procedure involving ionizing radiation, unless the procedure is performed under the supervision of a licensed physician, and the physician assistant has completed a radiation safety course as prescribed by 105 CMR - 120.405.  Physician assistants delegated the performance of ionizing radiation procedures may not administer therapeutic doses of radiation, and may not make a final interpretation of diagnostic radiological exams.”

Again, this language requires a PA delegated any procedure using ionizing radiation, including fluoro, to obtain additional radiation safety training.  Since 105 CMR-120.405(K)(5) does not specify the number of training hours a non-radiologist physician must complete, the Board of PA Registration, in consultation with the work group assigned to address PA use of ionizing radiation, could determine the number of hours of annual safety training required for PAs practicing under these standards. For example, the board could require an annual 3-hour radiation safety course and post-test for PAs, to be offered at the facility. This plan would use existing training programs already in place for physician residents at Massachusetts health care facilities.  For those PAs who do not practice at facilities, PAs could still receive the necessary training by attending facility-sponsored programs that are open to all Masschusetts PAs needing this trainining. 

Another advantage to a facility-based plan is that the safety standards maintain uniformity with changes to technology, patient safety education, and federal nuclear safety regulations. A key reason why the Minnesota Department of Health had to change its regulations was due to almost a decade of advances in radiation safety regulation at the federal level. 

Conclusion

PAs are increasingly being utilized to perform procedures. Demand for PAs to perform diagnostic or therapeutic radiological procedures and fluoroscopy-guided procedures increases as these procedures become more commonplace. When PAs aren’t able to complete a physician-delegated task, patient care is diminished.

Not every PA needs to use ionizing radiation. PAs seeking the ability to perform radiological procedures legally don’t want to change professions, but want to preserve a patient’s access to care and the safety of the care provided. While full exemption from a state’s RT practice laws for PAs is ideal, each state regulates the regulation of ionizing radiation in the health care setting differently. The focus remains on protecting the public from unnecessary exposure to radiation.

You’re in the best position to decide what the Board, and ultimately the state, will accept as a suitable safety training program for PAs who are delegated radiological and fluoroscopic-guided procedures in Massachusetts. MAPA may choose elements from both proposed plans to customize a solution that is unique to Massachusetts, or decide to go another route all together. Please let us know if you have additional questions or need more information.