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  3. Mammography Quality Standards Act (MQSA) and MQSA Program
  4. Facility Accreditation and Certification
  1. Mammography Quality Standards Act (MQSA) and MQSA Program

Facility Accreditation and Certification

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 number of MQSA-certified mammography facilities operating in the United States can be found on the MQSA National Statistics page.

Accreditation

Before a facility can be certified, it must first be accredited by a federally approved private nonprofit or State accreditation body. If a facility desires to become accredited, it would need to apply to an FDA-approved accreditation body.  The MQSA regulations require an FDA-approved accreditation body to review a mammography facility's equipment, personnel (interpreting physicians, radiologic technologists, and medical physicists), clinical image quality, and practices. The FDA-approved accreditation body will accredit the facility if its review establishes that the mammography facility meets the federal quality standards established under the MQSA and its implementing regulations. (21 CFR 900.4).

As part of a facility maintaining its accreditation, the facility will undergo periodic review of its clinical images (21 CFR 900.4(c)), must have an annual survey conducted by a medical physicist or under the direct supervision of a medical physicist (21 CFR 900.4(e) and 900.12(e)(10)), and must continue to meet federally developed quality standards, including those for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting (21 CFR 900.4(b) and 21 CFR 900.12).  Additionally, the facility must be inspected at least annually by a certified MQSA inspector (42 U.S.C. 263b(g)(1)(E)). 

The FDA-approved accreditation bodies (AB) are:

American College of Radiology
1891 Preston White Dr.
Reston, VA 20191
1-800-227-6440

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

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

Under MQSA regulations, a facility located in a State approved by the FDA as an accreditation body (AB) may be accredited either by the State AB or by the American College of Radiology (ACR).

A facility that has not completed the accreditation process prior to the expiration of an MQSA certificate, must cease performing mammography (see 21 CFR 900.11(a)).  A facility may apply for and receive reinstatement of the facility’s MQSA certificate (21 CFR 900.11(c)).  A facility that fails to become accredited after three consecutive attempts must wait 1 year from the date of the most recent accreditation failure before applying to any accreditation body. (21 CFR 900.4(a)(6)(ii)).

Certification

Certification means the process of approval of a facility by FDA or by an SAC to provide mammography services. (21 CFR 900.2(i)). In other words, a mammography facility that receives MQSA certification has shown it is capable of providing quality mammography. Certification is issued by the FDA or, for facilities located in the States in which the State is a SAC, by that SAC.

A facility that is certified has either: 

  • Full Certification: A fully certified facility has completed the accreditation review process and has been issued an MQSA certificate that is valid for three years. (42 U.S.C. 263b(c)(1); 21 CFR 900.11(b)(1)).
  • Provisional Certification: A provisionally certified facility has had its application accepted by an FDA-approved accreditation body, the accreditation body has decided that the facility has submitted the required information, and FDA or an SAC has issued a provisional certificate to enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process (see 21 CFR 900.11(b)(2)). A provisional certificate is valid for up to six months. During the six-month provisional period, the facility must collect clinical images and other data needed for completion of the accreditation process (within the accreditation body required timeframes) and adhere to all requirements of the accreditation body (21 CFR 900.11(b)(2)(ii)). If the facility has not completed the accreditation process prior to the expiration of the provisional MQSA certificate, it must cease performing mammography (see 21 CFR 900.11(a)). A facility may apply for and receive reinstatement of the facility’s MQSA certificate (21 CFR 900.11(c)). Alternatively, a facility that meets certain criteria may qualify for a one-time 90-day extension of the provisional MQSA certificate. (21 CFR 900.11(b)(3)).

States as Certifiers (SAC)

Subpart C of the MQSA Final Regulations (Title 21, Code of Federal Regulations, Part 900) contains a provision that authorizes the FDA to delegate many aspects of the MQSA certification program to qualified states that have been approved as certifying agencies. Under the SAC program, the following primary responsibilities are delegated to these states:

  • Issuance, renewal, denial, suspension, and revocation of certificates to mammography facilities within the State (Under 21 CFR 900.21(d), FDA may limit the scope of certification authority delegated to the State in accordance with MQSA. To date, FDA has not granted certification authority to a State for Federal facilities.). 
  • Annual facility inspections of facilities.

Currently, the FDA and the States of Illinois, Iowa, South Carolina, and Texas are certifying agencies. 

State Certifying Agency Contact Information

State of Illinois
Office of Radiation Safety
Division of Registration and Certification
1035 Outer Park Drive
Springfield, IL 62704
217-785-9923

State of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
321 East 12th Street, 5th Floor
Des Moines, IA 50319
515-281-3478

State of South Carolina
Department of Health and Environmental Control
Bureau of Radiological Health
2600 Bull Street
Columbia, SC 29201
803-545-4400

State of Texas
Texas Department of State Health Services
Mammography Certification Program
P.O. Box 149347, Mail Code 1986
Austin, Texas 78714-9347
512-834-6688, Extension 2247



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