Attachment_6.docx

Attachment 6 Continuing Experience Policy for Mammography Quality Standards Act (MQSA) Certified Inspectors (January 2013)

PURPOSE AND GOAL

The purpose and goal of this policy is to ensure proficiency, accuracy and reliability of MQSA-certified inspectors in performing MQSA inspections, the Food and Drug Administration (FDA) has established a continuing experience policy requiring inspectors to perform a minimum number of inspections to maintain their status as an MQSA inspector.

BACKGROUND

In 1996, FDA Headquarters and Regional Radiological Health Representatives (RRHRs) extensively discussed instituting a minimum number of inspections, depending on an inspector’s status (general, backup or supervisory) an inspector must complete on an on-going basis to reasonably assure inspector proficiency. Likewise, FDA surveyed State and FDA MQSA inspectors to elicit their input on requirements for a minimum number of inspections per year. The findings resulted in recommendations to require from zero to over 50 inspections per year. Some States felt that there should be a single minimum number while others preferred different minimums for different categories of inspectors. FDA also considered the complexity of the MQSA inspection procedures and the necessity for an inspector to stay current with evolving inspection policies in developing a continuing experience policy. From this analysis, FDA established a minimum requirement of twelve (12) inspections per year for an MQSA inspector to remain active.

In Spring 1997, FDA contracted with a private consulting firm to conduct “A Customer Service Survey Among Mammography Facilities - An Assessment of Facility Experiences and Opinions.” In this survey, FDA randomly polled 1,000 mammography facilities concerning their experiences with MQSA inspections. The survey examined four components of the MQSA inspection: pre-inspection preparation (e.g., educational materials), the actual inspection process, inspector performance, and inspection results. Of the 674 surveys returned, data revealed, among other things, that facility satisfaction with an inspection significantly depended on the number of inspections an inspector had performed. Facilities expressed greater satisfaction with the inspection process with an inspector who had performed more than 10 previous inspections, with no correlation of practical significance between satisfaction and compliance findings. Therefore, FDA believes that a specified minimum number of inspections is necessary for an inspector to maintain his/her expertise.

POLICY

Minimum Inspections Required to Maintain Active Status

Following the second anniversary date of certification and annually thereafter, all MQSA-certified inspectors shall have performed an average of 24 MQSA inspections during the 24 months immediately preceding the date of the inspector’s annual MQSA audit or the last day of the calendar quarter preceding the audit, or any date in between the two. The inspector will choose one of these dates to determine the 24-month period that the MQSA FDA auditor will use to confirm that his/her continuing experience requirements were met. The inspector may change the 24-month period assessed each year.

Acceptable Inspection Types

The following inspection types count toward meeting the continuing experience requirement:

· Basic annual certified facility inspections (includes federal facilities, comprising U.S. federal, VHA** and U.S. foreign military facilities)

· Joint (J) Audit inspections (count for both the inspector and FDA auditor) – To obtain credit for the audit, the inspector should select a “J” (for Joint inspection) in the MPRIS system and identify the auditor’s inspector number in the “Facility Inspections” screen.

· Mentored (M) inspections (count for both the mentored State/FDA inspector and accompanying FDA/State inspector). To obtain credit for the mentored inspections, the inspector should select “M” for “Mentored” in the annual inspection type screen and select the appropriate accompanying inspector.

NOTE: Follow-up or headquarters initiated inspections, which are normally conducted by FDA inspectors and typically examine only limited items, will not count toward meeting the continuing experience requirement **A VHA inspection is one in which an FDA inspector conducts an inspection for the VHA under an Interagency Agreement (IAG).

Acceptable Documentation of Continuing Experience

At an inspector’s annual audit, the auditor will verify the number of inspections performed as outlined above (Reference Minimum Inspections Required to Maintain Active Status) and document the number of inspections performed by the inspector in his/her audit report. The auditor can verify the number of inspections performed by accessing reports in the Mammography Program Reporting and Information System (MPRIS). To minimize facility disruption, auditors will assess the inspector’s records just prior to or following the audit inspection. Although tracked by the MQSA FDA Auditor, it is the individual inspector’s responsibility to ensure compliance with the continuing experience requirement. An inspector should be prepared at his/her annual audits to provide his/her auditor with documentation to confirm the number of mentored, joint audit, and VHA inspections they performed because this information is not easily accessed by the auditor. This information should include the inspection dates, the facility identification number(s), the facility name(s), and the types of inspections: Mentored, joint audit, and Veterans Administration (VHA) inspections.

· A Mentored inspection is one in which an inspector is mentoring another inspector.

· A Joint Audit inspection is one in which a FDA auditor and an inspector receive credit for the conduct of the inspection.

· A VHA inspection is one in which an FDA inspector conducts an inspection for the VHA under an Interagency Agreement (IAA).

An inspector participating in the above-listed types of inspections are responsible for providing supporting documentation to his/her auditor at the time of the annual audit because none of these categories are included in the participating inspector’s official counts and are, thus, not easily accessed by the auditor.

Steps for Reestablishing Qualifications for Certification

DMQS will consider an inspector who does not meet the continuing experience requirement to be inactive and ineligible to perform independent inspections. In order to be reactivated, an inspector must:

· perform the balance number of inspections needed to meet the continuing experience requirements or three inspections, whichever is less, within the six months immediately prior to resuming independent inspections. These inspections for reestablishing qualifications must be under the direct mentoring of an MQSA-certified inspector. The mentoring inspector will be designated after consultation with the appropriate FDA Regional Radiological Health Representative(s) (RRHRs). The inspector being mentored should provide documentation of his/her mentoring and associated results to his/her auditor at the time of the next audit.

After meeting the requirements, an inspector is still responsible for maintaining his/her 24 inspections in the 24-month period preceding an audit. Further, the date on which an inspector was initially certified as an MQSA inspector does not change due to taking time off or not meeting the continuing experience requirement.

If an inspector is not meeting his/her continuing experience requirements because there are not enough facility inspections available for him/her to perform, inspectors may not automatically implement re-qualification procedures. Instead, the State or FDA District Office must contact the RRHR to discuss this issue. The RRHR will work with the FDA’s Division of Mammography Quality and Radiation Programs to resolve the situation.