Enable Me, the U.S. division of VELA Medical, has analyzed the new Mammography Quality Standards Act and urges mammography facilities to take note of the significant changes and updates before the effective date in September.
TAMPA, Fla., Feb. 29, 2024 /PRNewswire-PRWeb/ -- Enable Me, the U.S. division of international mammography chair manufacturer VELA MEDICAL, today reminds managers and owners of mammography facilities that the deadline for compliance with the new Mammography Quality Standards Act is September 10.
"If you haven't already, you should be taking action now to embrace and begin applying the MQSA 2024 policies and procedures before the effective date to ensure you have them in place," said Mike Laky, President of Tampa-based Enable Me. "Adherence to the new standards will help you maintain your ACR accreditation and MQSA certification."
In analyzing the full text of the 46-page act, with public comment, and in interviews with personnel with the U.S. Food and Drug Administration, which promulgated it, Enable Me has found the new version includes several requirements not present in earlier versions.
Last updated in 2004, here is the FDA's rationale: "We are issuing updates to modernize the regulations by incorporating current science and mammography best practices."
For instance, there is significant focus on breast density reporting requirements. In fact, in examining the full text and public comment, we found "breast density" mentioned 238 times, a major update clinicians will want to become familiar with.
The medical audit in previous versions did not require positive predictive value (PPV). The 2024 version states: "The rule clarifies that positive predictive value, cancer detection rate, and recall rate must be collected during this audit."
Transfer of imaging studies or release of copies to authorized recipients previously was vague, with no time frame. Now, the transfer must occur within 15 calendar days. This is extremely important for facilities to comply with because in medical matters, time is of the essence.
Protection of radiology personnel information, especially with traveler technologists for continuing education purposes, receives significant new focus in that it requires facilities to timely release radiologist experiential data, to wit: "Require facilities to provide personnel with copies of their MQSA qualification records, which are often needed to work at additional or new facilities." And, facilities must protect that information for 24 months.
The act mentions "risk to human health" nine times. Here is one instance: "If FDA or the State certification agency believes that mammographic quality at a facility has been compromised and may present a significant risk to human health, the facility must provide clinical images and other relevant information for review by the accreditation body or the State certification agency."
There are many more new requirements in the act. Please click here for a summary of changes to the act and public discussion and input from the comment period found on The Federal Register.
"It would be wise to have your facility's legal counsel review the new MQSA as well to be certain all new legal requirements are met, in addition to operational, program, communications, patient safety, personnel qualifications and procedural rules," said Laky.
Enable Me recommends radiology unit managers download the PDF version of the act, convert it to Word, search for the above topics and work together to analyze them thoroughly.
Media Contact
Andrew Bowen, Enable Me, 1 4048223309, [email protected], https://enableme.com/vela-mammography/
SOURCE Enable Me
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