What are the proposed changes to MQSA?
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.”