Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)

The FDA issued a final rule on March 10, 2023, to amend the MQSA regulations (“2023 MQSA Final Rule”). Enforcement of the MQSA regulations as amended by the 2023 MQSA Final Rule began on September 10, 2024. Facilities subject to the MQSA, must now comply with all applicable requirements, including the breast density notification.

Access the 2023 MQSA Final Rule in its entirety at Federal Register: Mammography Quality Standards Act.

MQSA Inspections

During a facility’s annual MQSA inspection, inspectors will review documentation that relates to whether the facility is meeting the requirements of the MQSA. As of September 10, 2024, the MQSA regulations have certain additional requirements, including:

Mammography Reports

• Name and location of the facility performing the exam, (at a minimum the city, State, ZIP code, and telephone number).
• An overall final assessment of findings, classified into one of the following categories: 
  • Negative
  • Benign
  • Probably Benign
  • Suspicious
  • Highly Suggestive of Malignancy
  • Known-Biopsy-Proven Malignancy
  • Post-Procedure Mammogram for Marker Placement. 
  • In cases where no final assessment category can be assigned due to incomplete work-up, the report should indicate:  
    • Incomplete: Need additional imaging evaluation
    • Incomplete: Need prior mammograms for comparison.
• An overall assessment of breast density, classified in one of the following categories: 
  • "The breasts are almost entirely fatty." 
  • "There are scattered areas of fibroglandular density." 
  • "The breasts are heterogeneously dense, which may obscure small masses." 
  • "The breasts are extremely dense, which lowers the sensitivity of mammography."

Patient Lay Summaries

• The patient's name, and the name, address, and telephone number of the facility performing the exam.
• Depending on whether the patient's breast density is dense or not dense, as indicated by the mammography report, the patient lay summary must include one of the following notification statements:
  • Not dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation." 
  • Dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."

Communication of Results

When the exam has a final assessment category of "Suspicious" or "Highly Suggestive of Malignancy," the mammography report is provided to the health care provider and the patient lay summary is provided to the patient within 7 calendar days of the date the mammogram was interpreted. When the exam has an assessment of "Incomplete: Need prior mammograms for comparison," the facility issued a follow-up report with a final overall assessment within 30 calendar days of the initial report, regardless of whether comparison views are obtained.

Medical Outcomes Audit

The annual medical outcomes audit includes the positive predictive value, cancer detection rate, and recall rate for each interpreting physician as well as for the facility as a whole.

Additional Information About the MQSA Final Rule

This information is not an exhaustive list of everything contained in the 2023 MQSA Final Rule. As always, facilities are required to comply with all mammography requirements applicable to them under the MQSA and its implementing regulations. Below is an overview and/or excerpts of some of the additional requirements of the 2023 MQSA Final Rule. It is important to note that the FDA may take enforcement action for noncompliance with the MQSA regulations, whether observed during an annual inspection or determined by other means.

Accreditation Failures

If a facility has failed to become accredited after three consecutive attempts, no accreditation body must accept an application for accreditation from the facility for a period of 1 year from the date of the most recent accreditation failure.

(21 CFR 900.4(a)(6)(ii))

Equipment

All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use. (21 CFR 900.12(b)(2)(i))

Personnel Records

To comply, facilities must: 

• Maintain records of training and experience
• Ensure records are relevant to their qualification under MQSA
• Include records for personnel working or who have worked at the facility as:
  • Interpreting physicians
  • Radiologic technologists
  • Medical physicists 

Records must be available for review by MQSA inspectors.

Records of personnel no longer employed by the facility must be maintained for no less than 24 months from the date of the departure of the employee, and these records must be available for review at the time of any annual inspection occurring during those 24 months.

The facility must provide copies of these personnel records to current interpreting physicians, radiologic technologists, and medical physicists upon their request. 

Facilities must provide personnel records to former employees if the former employees communicate their request within 24 months of the date of their departure. 

(21 CFR 900.12(a)(4))

Recordkeeping

Facilities must maintain the original mammograms and mammography reports in a permanent medical record of the patient for the longest of the following:

• a period of not less than 5 years, 
• a period of not less than 10 years if no additional mammograms of the patient are performed at the facility, or 
• a period, if longer, mandated by State or local law. 

Facilities must implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained in retrievable form in the mammographic modality in which they were produced.  They cannot be produced by copying or digitizing hardcopy originals. 

(21 CFR 900.12I(4)(i))

Transfer of Records or Release of Copies

Transfers of mammograms and mammography reports, or release of copies, must take place within 15 calendar days of the facility receiving the request. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred or released for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically. Additionally, before a facility closes or ceases to provide mammography services, it must make arrangements for access by patients and healthcare providers to their mammographic records. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.

(21 CFR 900.12(c)(4)(ii), (iii), (v))

Facility Responsibility to Self-Referred Patients

Each facility that accepts patients who do not have a healthcare provider must maintain a system for referring such patients to a healthcare provider when clinically indicated, which must include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy.

(21 CFR 900.12(c)(2)(ii))

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Questions?

Please direct any questions to the MQSA Hotline at MQSAhotline@versatechinc.com or 1-800-838-7715.