Mammography Facility Inspections - Part I: Background
PART I - BACKGROUND
Breast cancer is a leading cause of cancer death among women and is most treatable in the early stages. Research indicates that, with widespread use of high-quality mammography, breast cancer mortality could be significantly reduced through the identification of early cancerous lesions and early implementation of treatment. However, the quality of mammography at some facilities has been found to be inadequate, resulting in missed diagnosis of early lesions, delayed treatment, and otherwise avoidable increases in mortality. Concerns about mammography quality and breast cancer prompted the establishment of various private, State, and Federal programs for ensuring quality mammography.
Disadvantages of such programs were that they were either voluntary, such as the Mammography Accreditation Program of the American College of Radiology (ACR), or were mandatory but did not apply to all facilities in the United States, such as State programs and programs administered by the Centers for Medicare and Medicaid (CMS) (formerly Health Care Financing Administration (HCFA)). Also, most of these programs lacked important mammography quality evaluation criteria or oversight mechanisms, such as clinical image review and on-site inspections of facilities. Therefore, on a nationwide level, there were no universal mandatory standards for providing safe, accurate, and reliable mammography services.
Congress passed the Mammography Quality Standards Act (MQSA) to set uniform, national quality standards for mammography. The MQSA amended part F of Title III of the Public Health Service Act (the MQSA) (42 U.S.C. 262 et seq.) by adding new section 354 (42 U.S.C. 263b) to require certification and inspection of all mammography facilities by the Department of Health and Human Services. Under the MQSA, only certified facilities that are in compliance with uniform Federal standards for safe, high-quality mammography services may lawfully continue operation after October 1, 1994. Performing mammography after this date requires an MQSA certificate. The requirements under MQSA apply to all facilities producing, processing, or interpreting mammograms for screening or diagnostic purposes, except for facilities of the Department of Veterans Affairs.
FDA was given interim rule authority to establish regulations implementing provisions of section 354(b), (c), (d), (e), and (f) of the MQSA pertaining to certification procedures and quality standards for mammography on December 21, 1993. A more detailed legislative history and rationale for these regulations are provided in the preamble for the accreditation regulations published on December 21, 1993 (58 F.R. 67558).
- A National Mammography Quality Assurance Advisory Committee. Among other things, the advisory committee will advise the Secretary on the appropriate quality standards for the mammography facilities and the accreditation bodies (section 354(n) of the MQSA (42 U.S.C. 263b(n)).
- Standards for interpreting physicians, radiologic technologists, medical physicists, and mammography facility inspectors (section 354(f), (g) of the MQSA (42 U.S.C. 263b(f), (g)).
- Designation of boards or organizations eligible to certify the adequacy of training and experience of particular mammography personnel (section 354(f)(2) of the MQSA (42 U.S.C. 263b(f)(2)).
- Establishment of quality standards for mammography equipment and practices, including quality assurance and quality control programs (section 354(f) of the MQSA (42 U.S.C. 263b(f)).
- Establishment of standards governing record keeping for mammograms (images and paper records), requirements concerning mammography reporting, and notification of results to patients (section 354(f)(1)(G) of the MQSA (42 U.S.C. 263b(f)(1)G)).
- Annual physics survey, consultation, and evaluation of mammography facilities performed by a certified or State-licensed/approved medical physicist (section 354(f)(1)(E) of the MQSA (42 U.S.C. 263b(f)(1)(E)); 21 CFR 900.12(e)(9)).
- Accreditation of mammography facilities by private, nonprofit organizations or State agencies which have met the standards established by the Secretary for accreditation bodies and has been approved by the Secretary. It also requires that, as a part of the overall accreditation process, clinical mammograms from each facility be evaluated for quality (section 354(d)(1)(A)(iv), (e)(1)(B)(i) of the MQSA (42 U.S.C. 263b(d)(1)(A)(iv), (e)(1)(B)(i)).
- Annual inspection of mammography facilities, to be performed by Federally-certified inspectors. The MQSA also requires a Federal audit of inspections conducted by States (section 354(g)(1), (3) of the MQSA (42 U.S.C. 263b(g)(1), (3)).
After October 1, 1994, no mammography facility, whether in a hospital, doctor's office, mobile van, military base, or any other public or private enterprise may operate legally, unless the facility is:
Accredited by an approved accreditation body (currently, the American College of Radiology and the States of Arkansas, Iowa, and Texas) and
Certified by FDA or a State approved by FDA (currently the States of Illinois, Iowa, South Carolina, and Texas).
On October 25, 2004, the president signed into law the Mammography Quality Standards Reauthorization Act of 2004 (Public Law 108-365). The following is a summarized list of the major changes to MQSA from this law:
- Temporary renewal certificate – these certificates allow facilities an additional 45 days to complete the accreditation process which have met the requirements for submission of materials, but the accreditation body is unable to complete the reaccreditation process before the certification expires.
- Limited provisional certificate - these certificates allow facilities to produce mammograms for educational purposes while an onsite visit from an accreditation body is in progress. This certificate is only valid for 72 hours.
- National Mammography Quality Assurance Advisory Committee – added that at least 2 industry representatives with expertise in mammography equipment be included on the committee and changed the frequency of meetings from biannually to annually.
On April 28, 1999, the current MQSA facility regulations went into effect (21 CFR Part 900). Prior to this date, facilities were covered by interim regulations that took effect on October 1, 1994 (21 CFR 900.2(t)).
Veterans Health Administration (VHA): Mammography facilities in the Department of Veteran Affairs are exempt from MQSA. However, VHA has established internal standards equivalent to the MQSA standards. Under an interagency agreement (IAG) with VHA, FDA conducts inspections of VHA facilities. VHA facilities are evaluated against the same requirements as FDA certified facilities. The inspections are conducted using the same procedures and inspection (FISS) software as certified facilities. FDA provides the inspection reports to the VHA who is responsible for assuring compliance of their facilities with VHA standards. Under the IAG, VHA reimburses FDA for the costs for these inspections.
Interventional Mammography: Facilities using mammography equipment exclusively for the purpose of interventional procedures (procedures such as stereotactic breast biopsy, needle localization, fine needle aspiration, or galactography) currently are not required to be accredited or certified and should not be inspected. The exemption for equipment used exclusively for interventional procedures took effect on September 30, 1994 (21 CFR 900.2(aa)(1)).
Investigational Mammography Equipment: There is an exemption in effect for mammography performed as part of a scientific study to evaluate an experimental mammography device conducted in accordance with FDA's investigational device exemption regulations under 21 CFR 812 (see 21 CFR 900.2(aa)(2)).
Once facilities are inspected, they are usually charged a fee for the inspection (section 354(r) of the MQSA (42 U.S.C. 263b(r)). Facilities that qualify as government entities (federal, state, and local) are exempt from inspection fees. Fees are usually collected for annual inspections and follow-up inspections. The total fee for an annual inspection should be based on the FDA's cost for an inspection for a facility. Since follow-up inspections do not usually cover all aspects of the facility's operation, the fee is lower than for the annual inspection. Independent audit and compliance inspections are not charged to the facility (see section A of Part III for an explanation of inspection types). For information on the current fee structure, go to http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm111000.htm.