Medical Physicist Overview

In order to independently conduct surveys of mammography facilities and provide oversight of a facility’s equipment-related quality assurance program, one must qualify as a medical physicist. 21 C.F.R. 900.12(a)(3).

 

Because the duties of the medical physicist encompass more than just the physics survey, FDA expects the facility to be able to call on the services of the medical physicist throughout the year. Therefore, the facility must be able to identify its qualified medical physicist at the time of the MQSA inspection or it will be subject to citation. 21 C.F.R. 900.12(a)(3).

 

To qualify under the initial qualifications of the regulations, a medical physicist must document all of the following requirements:

 

1. Be State licensed or approved or have certification.

2. Have a master's degree or higher in a physical science with no less than 20 semester hours in physics.

3. Have 20 contact hours of specialized training in conducting mammography facility surveys.

4. Have the experience of conducting surveys of at least l mammography facility and a total of at least 10 mammography units.

 

OR

 

To qualify under the alternative initial qualifications of the regulations, a medical physicist must document all of the following requirements:

 

1. Have qualified as a medical physicist under the interim regulations and maintained active status of any licensure, approval, or certification required under the interim regulations.

2. Prior to April 28, 1999 have:

1. A bachelor’s degree or higher in a physical science with no less than 10 semester hours in physics.

2. Forty contact hours of documented specialized training in conducting surveys of mammography facilities and,

3. Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 20 mammography units. The training and experience requirements must be met after fulfilling the degree requirement.

 

Having once met the initial qualifications, all medical physicists (whether they initially qualified under the interim or final regulations) must meet the continuing qualifications:

 

1. Continuing education (15 CEU's/36 months).

2. Continuing experience (2 facilities and 6 units/24 months).

3. Maintain a valid State license, State approval, or certification.

Medical physicists failing to maintain the continuing requirements must requalify prior to independently conducting surveys of mammography facilities.

1. Continuing education: Must bring total up to 15 CEU's/3 years.

2. Continuing experience: Must bring total up to 2 facilities and 6 units/24 months under direct supervision.

 

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Medical Physicist Qualification Worksheet This worksheet may be used by facilities to help ensure that their personnel meet all applicable  requirements prior to providing mammography services
Initial Qualifications (FINAL)	Alternative Initial Qualifications (FINAL)
Need one of the following:	Obtained one of the following before 4/28/99 and maintained it:
___ ABR or ABMP certification ___ State licensed ___ State approved	___ ABR or ABMP certification ___ State licensed ___ State approved
Need all of the following:	Need all of the following:
___ Masters degree or higher with no less than 20 semester hours in physics, in: Physics Chemistry Engineering Radiation Science (including Health Physics or Medical Physics)	___ Bachelors degree or higher (obtained prior to 4/28/99) with no less than 10 semester hours in physics, in: Physics Chemistry Engineering Radiation Science (including Health Physics or Medical Physics)
___ 20 contact hours of training in surveys	___ 40 contact hours of training in surveys
___ Surveys of one facility and 10 mammography units (under direct supervision after 4/28/99)	___ Surveys of one facility and 20 mammography units (training and surveys completed after degree and prior to 4/28/99)
START DATE ___________________________ (The later of 10/1/94 or date the last initial qualification was completed)
___ 8 hours initial training in additional mammographic modality used (if applicable) DATE COMPLETED ____________________________
Continuing Qualifications All of the following: ___ Surveys of two facilities and 6 units in the 24 months prior to the current date (applicable 24 months after start date) ___ 15 CMEs in the 36 months prior to the current date (applicable 36 months after start date)

 

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