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  1. Mammography Quality Standards Act and 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.

For more detailed information about becoming accredited and certified, refer to the Accreditation and Certification section of the Policy Guidance Help System.

Accreditation

Before a facility can be certified, it must be accredited by a federally approved private nonprofit or State accreditation body.  To be accredited, the facility must apply to an FDA-approved accreditation body; undergo periodic review of its clinical images; have an annual survey by a medical physicist; and meet federally developed quality standards for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting. The facility must also undergo an annual inspection conducted by federally trained and certified Federal or State personnel. 

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 by the State AB or by the American College of Radiology (ACR). However, if state law requires every facility to have state accreditation or state certification, facilities must satisfy those regulations.  These state requirements are independent of MQSA.  
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.

Facilities that fail accreditation must cease providing mammography services. However, once the deficiencies leading to failure have been corrected, a facility may apply for reinstatement to resume the accreditation process.

Certification

Certification means that a mammography facility has been MQSA certified and is capable of providing quality mammography. Certification is issued by the FDA or, for facilities located in the States of Illinois, Iowa, South Carolina, or Texas, by the respective State's FDA-approved Certification Agency. A facility that is certified has either: 1) completed a rigorous review of its practices by an FDA-approved accreditation body (full certification); or 2) is undergoing the process of accreditation by one of the three accreditation bodies (provisional certification). The accreditation bodies are the American College of Radiology, and the States of Arkansas and Texas.  

Full Certification: Fully certified facilities that have completed the accreditation review process and have been issued an MQSA certificate that is valid for three years. 
 
Provisional Certification: Provisionally certified facilities have had their applications accepted by an FDA-approved accreditation body. The quality aspects of the facility remain under review during the six-month period when the provisional certificate is valid.

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 applied for and received FDA approval as a certifying agency. Primary responsibilities delegated under the SAC program include:
issuance, renewal, denial, suspension, and revocation of certificates to non-federal mammography facilities within the State;
annual facility inspections (with the exception of federal facilities); and
all compliance actions for any MQSA inspection findings.

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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