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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Criteria for Qualifying MQSA Auditors

Subject:
Criteria for Qualifying MQSA Auditors
Area:
Operations Management
Date Revised:
August, 22 1995

 

 

PURPOSE

To establish qualifications, requirements and procedures for nominating personnel to be auditors of state and federal personnel conducting inspections of certified mammography facilities under the authority of the Mammography Quality Standards Act of 1992 (MQSA).

 

BACKGROUND

In 1992, the Mammography Quality Standards Act (P.L. 102-539) was enacted by Congress. The MQSA amends the Public Health Service Act to establish a comprehensive statutory mechanism for certification and inspection of all mammography facilities. Although the Department of Veterans Affairs (VA) facilities were exempt from provisions of the MQSA, the VA has voluntarily agreed to meet the requirements.

Facilities providing mammography services will be required to be certified by the Secretary of Health and Human Services as meeting national, uniform quality and safety standards in the following areas: equipment, personnel and quality assurance.

Section 354 (g)(1)(D) and (E) requires that all facilities be inspected annually by qualified inspectors. The Secretary or state agency acting on behalf of the Secretary will conduct inspections to ensure the facility is in compliance with the quality standards required in the MQSA.

Section 354 (g)(3) requires the Secretary to annually inspect representative facilities, that have been inspected by state agencies acting on behalf of the Secretary, to assure a reasonable performance by such state agencies. Although federal inspectors were not explicitly identified in this section, the audit program will evaluate their performance as well as state inspectors.

 

PROCEDURES

The requirements for qualifying MQSA auditors, to conduct audit inspections for the evaluation of federal and state inspectors' performance, consists of the following:

1. The individual must be recommended in writing by the Regional Radiological Health Representative (RRHR) with concurrence of appropriate District management. A formal recommendation will then be submitted by the Regional Food and Drug Director (RFDD) to the Division of Field Investigations (HFC-130). After establishment of the audit program, the nominee's current MQSA auditor should also concur with individual nominations.

2. The nominee should have completed at least 25 mammography facility inspections. This minimum number of MQSA inspections is required to ensure familiarity with the inspection procedures, standards and policies, and the Mammography Programs Reporting and Information System (MPRIS). In lieu of having completed the minimum number of inspections, consideration may be given to the individual's performance during MQSA training and the combination of training and experience outlined in MQSA Criterion Number 3.

3. The following alternative criteria apply only to nominees having satisfactorily completed a minimum of 10 MQSA facility inspections. No nomination will be considered for a candidate having completed less than 10 MQSA inspections.

a. Experience in testing 45 diagnostic x-ray systems (including stationary general purpose, combination radiographic/fluoroscopic and/or mammography systems) or equivalent experience functioning as an x-ray auditor for a 3 year period; and

Completed 10 federal facility evaluations; or

b. A B.A. or B.S. in radiological sciences, medical physics and/or health physics with documented evidence of continuing education (CEU's) in mammography. A Master's Degree specific to the radiological sciences will be considered equivalent to 3a.

4. Maintenance of Certification. MQSA auditors will be expected to obtain additional training beyond achieving the minimum number of CEU's necessary to maintain their MQSA certificate. This training can be achieved by attending video teleconferences, industry sponsored seminars, the Radiological Society of North America or other professional society conferences/seminars/workshops specific to mammography.

5. Provisional designation of an individual as a MQSA auditor will be considered upon a written request from the RFDD and RRHR. Special considerations include the need for an auditor in a specific location, unexpected loss of staff with experience and training as outlined in Criteria 2 and 3, or other needs as outlined in the written request. This approach shall be considered only for an emergency situation and until the nominee meets provisions of Criteria 2 or 3, this individual should be under the direct oversight of the RRHR. The provisional auditor shall not work in this capacity for more than one year without having met either Criteria 2 or 3. No candidate shall be considered unless they are currently certified as an MQSA inspector.

6. Nominations should be submitted to the Director, Division of Field Investigations, (DFI) (HFC-130) and should include sufficient documentation to show that the nominee, meets the minimum criteria shown above. If acceptable DFI will forward the nomination to the Director, Division of Mammography Quality and Radiation Program (DMQRP), CDRH for their evaluation of the technical competence of the nominee based on the submission and other information available to them. The DMQRP will provide their decision to DFI who will notify the RFDD.