Equip Texas FAQs
Mammography Quality Standards Act Enhancing Quality Using the Inspection Program Frequently Asked Questions
– Adapted to Texas Regulations
Texas, like several other states have mammography regulations that are more specific and detailed than the FDA MQSA regulations. In some cases, following the FDA recommendations could lead a facility to violate state regulations, as was the case with these FAQs as originally written by FDA. This document has been edited so that all questions are answered in ways that demonstrate acceptable methods of complying with both state and FDA regulations.
The purpose of this document is answer questions facilities may have about the EQUIP inspection questions. The three questions, and their sub-questions, that the inspector will be answering during the annual inspection, as well as the compliance pathway, are outlined below and followed by FAQs.
Quality Assurance — Clinical Image Corrective Action
Clinical Image Quality
- During the initial year of implementation facilities will not be cited for violations of the Clinical Image Quality Review (CIQR) requirements
- MQSA Inspection Year Two: Facilities will receive Level 2 citations for deficiencies noted by MQSA inspectors in the area of CIQRs. The facility will be required to provide a written response to the Texas DSHS within 30 days of the Notice of Violation
- MQSA Inspection Year Three: A repeat violation of the CIQRs will be cited as a Level 2 repeat violation. The facility will be required to provide a written response to the Texas DSHS within 30 days of