1. Update: Inspection Demonstration Program Helen J. Barr, M.D. Deputy Director, Division of Mammography Quality and Radiation Programs

2. Mammography Quality Standards Reauthoriztion Act (MQSRA) MQSRA enacted October 1998 Reauthorized MQSA until October 2002 New requirements & authorizations - Written lay summary of exam results for patients - Inspection of uncertified facilities - Inspection Demonstration Program

3. MQSRA Inspection Demonstration Program Program may not be implemented before 4/1/01 Selected facilities get less frequent inspection(s) Facilities included must be substantially free of incidents of non-compliance Number of facilities provide a statistically significant sample Inspection frequency will reasonably assure compliance with standards

4. Demonstration Program Goals Comply with MQSRA Initiate a pilot to evaluate if we can : –Reduce MQSA inspection frequency for high performance facilities, and –Maintain assurance of quality

5. Demonstration Program Approach Consulted with –States/Conference of Radiation Control Program Directors –National Mammography Quality Assurance Advisory Committee –FDA Regional Radiological Health Representatives

6. Demonstration Program Approach continued - Other Offices: The Center for Devices and Radiological Health Office of Surveillance and Biometrics Developed program plan and schedule

7. Demonstration Program Plan Include States and facilities using established criteria Include study and control groups Conduct biennial inspections for study group Conduct annual inspections for control group

8. State Criteria For a State to participate in the inspection demonstration program, the State shall: Have no State laws/regulations/policy which require annual inspections of mammography facilities (units and records) Agree to participate in the inspection demonstration program Inspect participating facilities at the frequency designated by FDA

9. State Criteria continued Accept modifications in the State contract based on the number of facilities to be inspected Notify FDA of potential serious public health risks, of which they become aware, at any of the participating facilities

10. State Participation - Solicited participation from all 50 States (plus DC, NYC, PR) - Received agreement from 14 of the 53 to participate AR, DC, FL, MS, NYC, NY, OH, OK, PA, PR, SD, WA, WI, WY

11. State Participation continued Limit participation to no more than 10% of the State’s facilities (5% study group, 5% control group) Include eligible federal facilities

12. Facility Criteria For a facility to be eligible to participate in the inspection demonstration program, the facility shall: Maintain full accreditation/certification throughout the inspection demonstration program Anticipate providing mammography services throughout the inspection demonstration program Undergo at least two annual inspections under the final regulations

13. Facility Criteria continued Receive no citations during the two most recent annual inspections under the final regulations Receive no regulatory action (i.e., compliance action), nor have been considered for regulatory action, nor currently be considered for such an action by FDA Be selected by FDA to participate

14. Program Limitations Limited number of States - Ability to participate ( no State laws, regulations or policy that require yearly inspections) -Voluntary participation - Self selection bias

15. Program Limitations continued Limited number of facilities (about 300) - Facilities must meet the inclusion criteria - No more than 5% of the State’s facilities will participate in the study group - Eligible facilities are restricted to participating States

16. Program Limitations continued Not statistically valid Significance of descriptive statistics Applicability of results nationwide

17. Timeline 10/2001 - Provide states with the names of the first 50% of facilities selected 10/2001 - Distribute letters of notification of selection to the facilities (first 50%) 5/2002 - Provide states with the names of the second 50% of facilities selected 5/2002 - Distribute letters of notification of selection to the facilities (second 50%) 5/2002 - Implement the demonstration program