The website said those reviews were based on the technical quality of the mammography images and that "... neither the ACR nor the FDA has indicated that any visible cancer or disease on any image was overlooked."
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In a statement, the practice said it expects the suspension to be temporary. Raleigh Radiology Blue Ridge is working on a Corrective Action Plan to get its accreditation reinstated and on notifying patients who received mammograms between November 7, 2017 and November 6, 2019.
"We are working with the FDA and the ACR to understand their concerns and have begun implementing a Corrective Action Plan," Dr. Laura Thomas, chair of breast imaging for Radiology Raleigh, said in the statement. "We care about our patients' well-being and remain comfortable that Raleigh Radiology offers high-quality, mammography and radiographic services using state-of-the-art equipment. We look forward to continuing to meet our patients' mammography needs and hope to have those services restored soon at Blue Ridge."
Other Raleigh Radiology facilities are unaffected and other imaging services are available at the Blue Ridge location.
Raleigh Radiology statement
The American College of Radiation gave a brief overview of the law which requires these facilities to remain actively accredited for a three-year term.
All mammography facilities accredited by ACR must go through accreditation qualification testing as well as yearly Mammography Quality Standards Act (MQSA) inspections. MQSA requirements for clinical image attributes are detailed in the FDA regulations at 21 CFR 900.4(c)(2) (copied below).
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(2) Requirements for clinical image attributes. The accreditation body shall use the following attributes for all clinical image reviews, unless FDA has approved other attributes:
(i) Positioning. Sufficient breast tissue shall be imaged to ensure that cancers are not likely to be missed because of inadequate positioning.
(ii) Compression. Compression shall be applied in a manner that minimizes the potential obscuring effect of overlying breast tissue and motion artifact.
(iii) Exposure level. Exposure level shall be adequate to visualize breast structures. Images shall be neither underexposed nor overexposed.
(iv) Contrast. Image contrast shall permit differentiation of subtle tissue density differences.
(v) Sharpness. Margins of normal breast structures shall be distinct and not blurred.
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(vi) Noise. Noise in the image shall not obscure breast structures or suggest the appearance of structures not actually present.
(vii) Artifacts. Artifacts due to lint, processing, scratches, and other factors external to the breast shall not obscure breast structures or suggest the appearance of structures not actually present.
(viii) Examination identification. Each image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:
(A) Name of the patient and an additional patient identifier.
(B) Date of examination.
(C) View and laterality. This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by FDA in accordance with 900.3(d) or paragraph (a)(8) of this section shall be used to identify view and laterality.
For more information about the Mammography Quality Standards Act and Program