Radiation-Emitting Products

Accreditation and Certification Overview

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Citation:

900.11(a) General. After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in section 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA.

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Discussion:

The Mammography Quality Standards Act (MQSA) requires that before a mammography facility can legally perform mammography, it must be certified. Before a facility can be certified, it must meet applicable MQSA requirements, including those established by its accreditation body to obtain accreditation. To begin the process, the facility must first contact its accreditation body and apply for accreditation.

The FDA-approved accreditation bodies (AB) are:

State of Arkansas
Arkansas Department of Health
4815 W. Markham, Slot 30
Little Rock, Arkansas 72205-3867
1-501-661-2301 

State of Iowa
Mammography Accreditation Program
Bureau of Radiological Health
Iowa Department of Public Health
Lucas State Office Bldg.5th Floor
321 East 12th Street
Des Moines, Iowa 50319
1-515-281-3478

State of Texas
Texas Department of State Health Services
Mammography Accreditation
Machine Source Group
P.O. Box 149347
Mail Code 2835
Austin, TX 78714-9347
1-512-834-6688 extension 2246

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Notes:

Under MQSA regulations, a facility located in a State approved by FDA as an accreditation body (AB) may be accredited by the State AB or by the American College of Radiology (ACR). See 21 CFR 900.4(a)(7). State law may require facilities to meet additional requirements. State requirements are independent of MQSA. See 42 U.S.C. 263b(m). You may want to contact your State about its requirements.

The regulations require the AB to review a mammography facility's equipment, personnel (interpreting physicians, radiologic technologists, and medical physicists), and practices. The AB will accredit the facility if its review establishes that the mammography facility meets the quality standards established under MQSA.21 CFR 900.4.

Certification is a process separate from accreditation. It is administered by a Certifying Agency (FDA or an FDA-approved State Certifying Agency (SCA)). 21 CFR 900.21. FDA generally does not certify facilities located in states that have an FDA-approved SCA. Certifying States only certify facilities within their State borders. The FDA-approved SCAs are:

  State of Illinois
  Office of Radiation Safety
  Division of Registration and Certification
  1035 Outer Park Drive
  Springfield, IL 6270

State of Iowa
Mammography Certification Program
Bureau of Radiological Health
Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
515-281-3478

State of South Carolina
Mammography Certification Program
Department of Health and Environmental Control
Bureau of Radiological Health
2600 Bull Street
Columbia, SC 29201

State of Texas
Texas Department of State Health Services
Mammography Certification Program
Machine Source Group
P.O. Box 149347
Mail Code 2835
Austin, TX 78714-9347
512-834-6688, Extension 2245

Issuance of an MQSA certificate occurs after the AB notifies the Certifying Agency of the facility’s accreditation. Only MQSA certified facilities can lawfully provide mammography services. The Centers for Medicare and Medicaid Services (CMS) will only reimburse for mammography performed at an MQSA certified facility.

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Facilities Waiting for Receipt of their Provisional (6 month) MQSA Certificate (New Facilities)

When the AB accepts the facility’s application for review, the AB will notify FDA or the Certifying State. The Certifying Agency will fax the facility an MQSA provisional certificate or a 45 day interim notice allowing it to begin performing mammography as soon as possible. The facility cannot perform mammography until it receives either of these documents. Facilities with questions about their accreditation/certification status should first contact their AB to see if their application has been accepted and if the Certifying Agency has been notified. If the facility still has not received its MQSA certificate or interim notice, the facility should contact FDA or the Certifying State. FDA may be contacted by fax at 1-410-290-6351 or by phone at 1-800-838-7715. Contact the Certifying State if your MQSA certificate is issued by the State.

During the six month provisional period, the facility must collect clinical images and other data needed for completion of the accreditation process (within the AB required timeframes) and adhere to all requirements of the AB.21 C.F.R. 900.11(b)(2), 42 U.S.C. 263b(c)(2). If the facility has not completed the accreditation process prior to the expiration of the provisional MQSA certificate, it must cease performing mammography or apply for and receive reinstatement of the facility’s MQSA certificate.21 C.F.R. 900.11 (b), (c). Alternatively, a facility that meets certain criteria may qualify for a one-time 90-day extension of the provisional MQSA certificate. Contact your AB for further information regarding reinstatement or a 90-day extension of the MQSA provisional certificate.

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Facilities Waiting for Receipt of their Full (3 year), Reinstatement, or 90 Day Extension MQSA Certificates

Upon AB notification to FDA or the Certifying State that a facility has successfully completed the accreditation process, the Certifying Agency will mail the facility an original MQSA certificate. Because there may be a delay in receipt of the MQSA certificate, the AB may request the Certifying Agency to fax the facility a 45 day interim notice or photocopy of the MQSA certificate allowing continued mammography performance in cases where the facility’s MQSA certificate has or is about to expire. Upon receipt of the interim notice or MQSA certificate, the facility may perform or continue to perform mammography. A facility that has questions about its accreditation status should contact its AB.

Interested parties may find out which mammography facilities are certified as follows:

  • The FDA MQSA Website has a link to "Listing of FDA Certified Mammography Facilities" that lists facilities by selected State or by specified three-digit zip code area. This information is updated weekly.

  • The National Cancer Institute (NCI) provides information regarding breast cancer and mammography, including a list of FDA-certified mammography facilities in a caller’s area through its hotline: 1-800-4-CANCER (1-800-422-6237).

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Questions
  1. What are 45 day interim notices and interim accreditation and when are they used?
  2. What should a facility do if its MQSA certificate expires before it is reaccredited?
  3. Our group practice interprets mammograms sent to us by other facilities under a contractual arrangement. This is the only service that we provide in the mammography area. Does my group practice need an MQSA certificate to interpret mammograms?
  4. What should a facility do if it closes or decides that it will no longer provide mammography services?
  5. If a facility that fails to become accredited and certified continues to perform mammography, what penalties is it subject to? Can the facility be reimbursed by Medicare and insurance companies for mammography services?
  6. Since accreditation and certification are so closely linked, how will FDA or the Certifying State synchronize its certification period with a facility's accreditation period?
  7. By law, MQSA certificates must be prominently displayed in all facilities. Where should they be displayed?
  8. Are Spanish-language MQSA certificates available for facilities providing mammography services to a Spanish-speaking population
  9. Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?
  10. We are a private radiology practice that applied for and became accredited and certified as a mammography facility. We do not own a mammography x-ray unit or employ a radiological technologist qualified to perform mammography. We had applied for accreditation using the x-ray unit and technologist from a certified mobile facility that visits our practice periodically. Do we have to be inspected separately from the mobile facility and who is responsible for correcting any problems found?
  11. Our radiology group has two mammography units at the same location. Can each unit be accredited by a different accreditation body (dual accreditation)?
  12. Now that FDA has approved an FFDM accreditation body, do we have to have our FFDM unit accredited?
  13. We have been using our FFDM unit under FDA’s film-screen certification extension policy. Now that there is an accreditation body for our model FFDM unit, what do we need to do to have the unit accredited? We were keeping our old film-screen-unit just to be eligible for the certification extension policy. Do we still need to keep this film-screen unit?
  14. We have been operating our FFDM unit under FDA’s film-screen certification extension policy by linking our unit with a film-screen facility at a different location. Now that an accreditation body has been approved for our FFDM model unit, must we become accredited and certified as our own independent facility?
  15. Which FFDM units can be accredited by which accreditation bodies?
  16. A mammography facility has contacted our accreditation body (AB) and wants to switch from its current AB. What procedures should the ABs follow to ensure a smooth transition?

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Page Last Updated: 06/18/2014
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