Question:

What are the proposed changes to MQSA?

Answer:

Among the proposed changes by the Food and Drug Administration are:

  • “Expressly stating that the FDA can directly notify patients and their health care professionals, should facilities be unwilling or unable to do so, that mammography at a facility did not meet quality standards and that reevaluation or repeat of the mammogram at another certified facility may be needed
  • Requiring that only digital accessory components specifically FDA approved or cleared for mammography be used, or that facilities use components that otherwise meet the requirements under the rule;
  • Strengthening record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.”

This question was answered in an edition of our Radiology Compliance Manager. For more hot topics relating to radiology services, please visit our store or call us at 1.800.252.1578, ext. 2.

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