900.12(e)(8)(i),(ii)(A)(B): Use of test results.
(i) After completion of the tests specified in paragraphs (e)(1) through (e)(7) of this section, the facility shall compare the test results to the corresponding specified action limits; or, for nonscreen-film modalities, to the manufacturer's recommended action limits; or, for post-move, preexamination testing of mobile units, to the limits established in the test method used by the facility.
(ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:
(A) Before any further examinations are performed or any films are processed using the component of the mammography system that failed any of the tests, described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;
(B) Within 30 days of the test date for all other tests described in paragraph (e) of this section.
Approved Alternative Standard:
- Amendment to GE SenographeTM 2000D Full Field Digital Mammography (FFDM) system alternative standard originally approved on June 27, 2002.
- Correction Period When Components of the Selenia Full Field Digital Mammography System Fail Quality Control Tests
- Correction Period When Components of the SenographeTM 2000D Full Field Digital Mammography (FFDM) System Fail Quality Control Tests
For tests done as part the facility's quality assurance program, the following identify the time requirements for correcting the failure.
Before any further examinations are performed or any films are processed using a component of the mammography system that failed:
The processor quality control test
The phantom image quality test
The darkroom fog test
The screen-film contact test
The compression device performance test
The average glandular dose test
All "other modality" tests except those that have been allowed a 30 day correction period under an approved alternative requirement
The post-move performance test of a mobile unit
Within 30 days of the test date:
The fixer retention in film test
The automatic exposure control performance test
The kilovoltage peak accuracy and reproducibility tests
The focal spot condition test
The beam quality and half value layer test
The breast entrance air kerma and AEC reproducibility tests
The X-ray field/light field/image receptor/compression paddle alignment tests
The uniformity of screen speed test
The system artifacts test
The radiation output test
The automatic decompression capability test
The above information applies to the tests done as part the facility's quality assurance program. The situation is different if the test is done as part of an MEE. In that case 21 CFR 900.12(e)(10) requires that all problems must be corrected before the new or changed equipment is put into service for examinations or film processing. No 30 day alternative is provided for failures of any tests that are part of the MEE.
- How can the facility correct within 30 days a problem that may be found as a result of an annual test that is done by a physicist as part of the annual survey if the report is not provided to the facility before the 30 days are up (since the physicist has up to 30 days to provide the report)?
- How should a facility document the corrective actions that have been taken in response to quality control tests that fall outside the action limits and how should it document the effectiveness of those actions?
- What is the facility required to do if a test result falls outside the limits defined in the regulations?
- We perform a required quality assurance test more frequently than stated in the regulations. If the results of this test lie outside the regulatory action limits, must we take corrective actions based on this test or can we wait until the test is repeated at its regularly scheduled time?