Centers that interpret mammograms but do not perform the actual imaging need not be accredited under the Mammography Quality Standard Act of 1992, the FDA has ruled.Under a draft guidance recently issued by the agency, such partial providers are covered
Centers that interpret mammograms but do not perform the actual imaging need not be accredited under the Mammography Quality Standard Act of 1992, the FDA has ruled.
Under a draft guidance recently issued by the agency, such partial providers are covered under the certification of the system that hires them for interpretation.
Facilities that interpret mammograms may apply for certification if they wish. However, they would have to pay certification fees and could incur additional legal responsibilities.
The additional responsibilities would include providing assurance that interpreting facilities and those that produce and process the mammograms meet the MQSAs stringent quality control standards. Payment of an annual MQSA inspection fee would also be required.
The provider of some component of the system that performs mammography must take the lead in obtaining an MQSA certificate, the draft said. The FDA expects that in most cases the owner of an x-ray unit or units will apply for accreditation and receive a certificate. If one or more of the facilities for which you interpret mammograms is applying for accreditation and certification, your responsibility will be to provide them with information documenting that the physicians in your group meet MQSA requirements for interpreting physicians.
Several other issues were also addressed in the lengthy document. The draft indicated that for accreditation purposes, certification by the American Registry of Radiologic Technologists is sufficient proof of training in breast anatomy and physiology, positioning and compression, quality control and assurance techniques, and the imaging of patients with breast implants.
A masters degree or higher in physics (for physicists) is adequate documentation that the required number of semester hours has been achieved, the FDA said.
This exemption is designed to loosen requirements on physicians who interpret exams only, freeing them from many of the application processes and requirements that (are involved in) MQSA certification, said Dr. Douglas P. Beall, director of interventional services at Sheppard Air Force Base in Wichita Falls, TX.
Beall is something of an expert on mammography quality. He spent eight weeks last year working to improve the radiologic techniques at a medical center in Tanzania.
This loosens unnecessary restrictions and will, we hope, encourage more widespread interpretation of exams by those radiologists qualified to do it under the MQSA standards for interpretation, Beall said.