Violation Alerts

      As frequent violations and problem areas are noted across the state, these items of interest will be posted here so that you may avoid such violations at your facility.  Check back often, as mammography is an ever-changing process.

Using ACR 'Suspicious' Subcategories of 4(a), 4(b) and 4(c)

     Since the ACR introduced the new 'Suspicious' subcategories of 4(a), (b) and (c), some facilities have chosen to replace the 'Suspicious' category with one of the new subcategories.  This is not allowed under MQSA regulations.  Both the FDA and the ACR have addressed the situation.

From the FDA website Policy Guidance Help System:

Question 18: The American College of Radiology Breast Imaging Reporting and Data System (BIRADS) suggests that facilities subdivide the “Suspicious” assessment category into one of three subcategories (4A-Low Suspicion for Malignancy, 4B-Intermediate Suspicion for Malignancy, and 4C-Moderate Concern but not Classic for Malignancy). Can facility reports use these subcategories instead of the “Suspicious” assessment category?

No. While the facility has the option of using one of the three subcategories in addition to a final assessment of “Suspicious”, it cannot use the subcategories instead of the “Suspicious” assessment category on the mammography report

    Following are excerpts from the ACR BIRADS frequently asked questions posted on the ACR website:

Q.  We wish to use the ACR's Category 4 subdivisions (4A - Finding needing intervention with a low suspicion for malignancy, 4B - Lesions with an intermediate suspicion of malignancy, and 4C - Findings of moderate concern, but not classic for malignancy).  Can our reports use these subcategories instead of the Category 4 assessment ( Suspicious Abnormality - Biopsy Should Be Considered)?

A.  No.  While you have the option of using one of the 3 subcategories in addition to a final assessment of "Suspicious", the FDA will not allow you to use the subcategories instead of the "Suspicious" assessment category on the mammography report.  (This question and answer was adapted from the FDA's Policy Guidance Help System.)

link to ACR BIRADS FAQ

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Continuing Experience Documentation for Interpreting Physicians Reading at Multiple

 Sites

Comments:

Physicians continuing experience documentation may include the following:

§         A letter, table, or printout from each facility

§         Signed by a responsible facility official

§         Stating that he/she has interpreted a given number of mammograms at the facility in a given time period

The inspector will no longer accept printouts from the interpreting physician’s office that include all sites where they read.

*The only exception to this would be if the ownership of the facilities where the interpreting physicians read is the same person(s) signed by the same responsible facility official. 

For example:  If a radiologist’s office owns 5 different sites where they read and one coordinator who keeps up with their continuing experience for all sites, that coordinator can provide a list documenting their continuing experience. This list must be signed by a responsible facility official who may be the same person if the official is employed by the owner of all of the facilities.

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When a Facility Has More Than One Processor

The annual survey or equipment evaluation requirement for all clinically used mammography processors is addressed in MQSA as 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 by an individual under the direct supervision of a medical physicist.  At a minimum this survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual test described in 900.12(e)(5) and (6) and the weekly phantom image quality test described in 900.12(e)(2). 

21 CFR 900.12(e)(10)  Mammography equipment evaluations.  Additional evaluations of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is dissembled and reassembled at a new location or major components of a mammography unit or processor equipment are changed or repaired.  These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in 900.12(b) and (e).  All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing.  The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.

 Comments:

The annual survey or equipment evaluation must include all processors used clinically, even those at remote sites or back-up processors.  It is the responsibility of the facility to inform the medical physicist prior to introducing a different processor into mammography and at the annual survey.  The equipment evaluation requirement for the processors is the following:

§         Sensitometric testing as described in 900.12(e)(1)

§         Phantom testing as described in 900.12(e)(2)

§         System artifact evaluation as described in 900.12(e)(5)(ix)

§         Dose determination as described in 900.12(e)(5(vi) if clinical techniques increase significantly

§         Verification of the appropriate processing solutions as described in 900.12(b)(13) 

      ****PLEASE BE CERTAIN THAT YOU ARE PERFORMING A WEEKLY PHANTOM ON YOUR SECOND PROCESSOR IF BOTH PROCESSORS ARE USED REGULARLY FOR MAMMOGRAPHY****

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Uniformity of Screen Speed

The uniformity of screen speed requirement is addressed in MQSA as the following:

21 CFR 900.12 (e)(5)(viii):  Uniformity of screen speed of all the cassettes in the facility shall be tested and the difference between the maximum and the minimum optical densities shall not exceed 0.30.  Screen artifacts shall also be evaluated during this test.

Comments:

Please be aware that if the physicist does not document for screen artifacts during this test, the facility will be in violation and cited.

Also, Uniformity of Screen Speed MUST be performed on all NEW screens before they are put into service.  Failure to do so will result in a violation.  This may be performed by the physicist on site, or by physicist oversight.

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Alternative Standards for Processor QC

 Conducting the daily processor QC when the sensitometer is not available. 

On 10-18-1999, FDA approved a request for an alternative to sensitometric-densitometric testing of processor performance that can be used for a period of up to 2 weeks when the facility’s sensitometer is unavailable.

When using the alternative test, processor performance is considered satisfactory if:

1.      The optical density of the film at the center of an image of a standard FDA-accepted phantom is at least 1.20 when exposed under typical clinical conditions.

2.      The optical density of the film at the center of the phantom image changes no more than +/- 0.20 from the established operating level.

3.      The density difference between the background of the phantom and an added test object, used to assess image contrast, is measured and does not vary by more than +/- 0.05 from the established operating level. 

********IN ADDITION******** 

4.      To evaluate base+fog an additional measurement of density must be made either of a shielded portion of the phantom image film or of an unexposed film.  In accordance with 21 CFR 900.12 (e)(1)(i), the base+fog density must be within +0.03 of the established operating level. 

As with the original test, this alternative test must be conducted “each day clinical films are processed, but before processing of clinical films.”  All results must be recorded.  Again, as with the original test, if processor performance fails to meet any part of the alternative test, the problem must be corrected before processing is resumed.  

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