Radiation-Emitting Products

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?

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No. Partial providers (groups such as yours that provide only part of the services required for mammography) are certified as part of a "system" for producing, processing, and interpreting mammograms. The provider of some component of the system that performs mammography must take the lead in obtaining an MQSA certificate.

FDA expects that, in most cases, the owner of an x-ray unit or units will apply for accreditation and receive an MQSA certificate. However, anyone interested in providing mammography services may apply for accreditation leading to an MQSA certificate. Under the facility accreditation process, partial providers, such as your group practice, are included in the required documentation provided to the accreditation body. The application for accreditation must show that all components of the system used to produce, process, and interpret mammograms meet MQSA requirements. These components do not have to be in the same location. If one or more of the facilities for which you interpret (or wish to interpret) mammograms is applying for accreditation and certification (or reaccreditation and recertification), you will need to provide them with information documenting that the physicians in your group meet MQSA quality standards requirements for interpreting physicians.

When the MQSA certificate is issued or renewed, all such partial providers are covered as providing services through that facility. Each partial provider must meet the MQSA quality standards that apply to its part of the mammography process. Each partial provider must provide adequate documentation to the certificate holder that the quality standards are met. Any partial provider providing services for more than one MQSA certified facility will be covered separately under each facility’s MQSA certificate. Conversely, if one of the facilities for which you interpret mammograms is not certified, it would be unlawful for that facility to continue to produce mammograms and for your group to interpret mammograms produced by them.

Your group practice could apply for accreditation and receive the MQSA certificate, as part of a system. In that case, your practice would be responsible for assuring not only that your practice meets MQSA quality standards for interpreting physicians, but also that the providers that produce and process the mammograms for your interpretation meet the quality standards that apply to them. Your practice would also be responsible for passing the review of clinical images from each facility that produces images for your interpretation, and for meeting the other requirements for accreditation. Finally, as an MQSA certificate holder, you would be responsible for paying an annual MQSA inspection fee.

In summary, the MQSA certificate holder is ultimately responsible for assuring that all MQSA requirements are met.

 

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Page Last Updated: 08/08/2014
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