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U.S. Department of Health and Human Services

Radiation-Emitting Products

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MQSA Alternative Standard #13: System Artifact Testing at Remote Mobile Mammography Sites Where Film Processing Takes Place Using Processors Permanently Located at the Site

This alternative standard was approved and became effective on December 14, 2004. It has no time limit. It covers the system artifact testing at remote sites where mobile mammography facilities utilize processors that are permanently located at those sites. The approved alternative permits a specially trained quality control technologist to make system artifact films and phantom images at remote processor sites used by mobile mammography facilities and submit them to the facility medical physicist for evaluation. This relieves the facility from the need to have the medical physicist visit each remote processing location as a part of the annual survey.

Although this request was approved for a specific mobile facilities operator, it has been extended to cover any other mobile facility that elects to apply it and meets the conditions described below.

The original standard states:

21 CFR 900.12(e)(5)(ix): System Artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.

The above is required to be performed annually by a qualified mammography medical physicist under the following:

21 CFR 900.12(e)(9)(i): At least once a year each facility shall undergo a survey by a medical physicist or an individual under the direct supervision of a medical physicist. At a minimum, the survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section.

The granted alternative is:

21 CFR 900.12(e)(9)(i): At least once a year each facility shall undergo a survey by a medical physicist or an individual under the direct supervision of a medical physicist. At a minimum, the survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section. For mobile facilities using remote site processing, a mammography technologist at the facility will be trained by the medical physicist to produce the processor artifact test images at each remote site and will provide them to the medical physicist for evaluation during the annual survey.

Conditions of this alternative requirement are:

The medical physicist will train the mammography technologist in the procedures as outlined in the American College of Radiology (ACR) Mammography Quality Control Manual, 1999. The training will include the direct supervision of that mammography technologist while she carries out these procedures at a mobile mammography site. The medical physicist will also carry out the identical procedures at that site. These procedures are:

  1. Expose and process two mammography films according to the artifact test procedure described in the 1999 ACR Manual in accordance with the medical physicist’s instructions.
  2. Expose and process a phantom image.

The medical physicist will evaluate and compare all these test films produced by the mammography technologist and by the medical physicist. If the results are comparable and the medical physicist reaches the same conclusions after reading the films produced by the mammography technologist that would be reached reading the physicist’s films, then the mammography technologist is considered to be capable of producing adequate films for this test without direct supervision.

At least once a year, the physicist will perform all required annual survey items including the phantom image and artifact test at one location serviced by the medical physicist and will use the technologist’s ACR phantom and absorber materials to perform the on-site testing.Prior to this annual visit, the mammography technologist will take two artifact films using four cm of absorber provided by the physicist at each remote processing site. The films will be developed according to the procedures in the 1999 ACR manual. The artifact test procedures will be repeated for each target/filter combination and each processor used clinically at each site. The mammography technologist will also take a phantom image at each site using the facility’s ACR phantom. The images taken by the mammography technologist at the remote sites will be brought to the chosen annual survey site for evaluation by the medical physicist during the annual survey. Applicable records for the physicist’s “Evaluation of Site’s Technologist’s QC Program” as described in the 1999 ACR Mammography Quality Control Manual, will also be provided from each remote site for the physicist’s review.

 

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