2014 Meeting of Mid-Atlantic States

Radiation Control Programs

March 25, 2014

Digital Mammography QC

◦ The manufacturer recommended printer QC

procedures for digital unit were not followed

Survey Report

◦ The time period between the previous and current

surveys exceeds 14 months

Technologists

◦ Failed to produce documents verifying that the

radiologic technologist met the continuing experience requirement of having performed 200 mammography examinations in 24 months

Interpreting Physicians

◦ Failed to produce documents verifying that the

interpreting physicina met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months

Technologists

◦ Failed to produce documents verifying that the

radiologic technologist met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months

Digital Mammography QC

◦ The manufacturer recommended QC procedures for

the monitor for digital unit were not followed

Interpreting Physicians

◦ Failed to produce documents verifying that the

interpreting physician met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months

Digital Mammography QC

◦ The FFDM manufacturer QC (excluding monitor &

printer QC) procedures for digital unit were not followed

Summary

◦ The required personnel qualification documents

were not available during the inspection

Medical Records

◦ Reports reviewed did not contain an acceptable

assessment category

Copy facility records relating to inspection observations and explain their observations in the appropriate “Remarks” section of the inspection software.

By providing this information, FDA can compare facilities’ responses to specific inspection observations and records you have provided.

Be sure remarks can be understood by non-mammography personnel (lay person).

Document that mammograms were performed during the time frame of noncompliance ◦ Example: Phantom image QC was not performed for

3 weeks. Copy both the phantom QC chart as well as procedure log showing mammograms were performed during that timeframe.

If nothing available, obviously nothing to copy!

If problems detected with a facility’s records, copy them and send them to FDA auditor after completion of the inspection.

Record all relevant information regarding the inspection observations in the “Remarks” section.

Copy all relevant QC records (if available). For processor and phantom QC, make sure to

copy all charts with missing or noncompliant data since the last inspection.

In situations where the software does not

capture information you feel important, use the “Remarks” section to document observations (for example, problems with a facility’s test equipment, or procedures).

When citing FFDM unit, printer, or RWS, document which QC manual the facility is using.

Daily testing

If facility failed to perform test (or failed to take corrective action for failed test) once for a given test during a month: do not cite the facility; record that noncompliance in the remarks.

If facility failed to perform test (or failed to take corrective action for failed test) more than once for a given test during a month: cite the facility using the appropriate unit/monitor/printer question.

Weekly testing

If facility failed to perform test (or failed to take corrective action for failed test) once for a given test during a 12 week period: do not cite the facility; record that noncompliance in the remarks.

If facility failed to perform test (or failed to take corrective action for failed test) more than once for a given test during a 12 week period: cite the facility using the appropriate unit/monitor/printer question.

Monthly testing

If facility failed to perform test (or failed to take corrective action for failed test) once for a given test during a 12 month period: do not cite the facility; record that noncompliance in the remarks.

If facility failed to perform test (or failed to take corrective action for failed test) more than once for a given test during a 12 month period: cite the facility using the appropriate unit/monitor/printer question.

Ordinarily, only need to make copies of specific pages with questionable tests.

For survey reports with numerous problems, however, may need to copy the entire report.

Copy mammography reports, letters, or procedures that indicate problems.

Ensure patient-specific information (patient names, addresses, and telephone numbers) is removed from the copies before removing the copies from the facility or sending them to the FDA field office.

Explain the problems observed with a facility’s procedures, reports, or letters in the ‘Remarks” section.

Inspectors have the authority to inspect and copy patient records for MQSA purposes under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 regulations. You can view the privacy rules in HIPAA at: http://www.hhs.gov/ocr.

Copy records showing problems with medical audit, infection control, and consumer complaint procedures.

Explain why facility was cited for these problems with their procedures in the “Remarks” section.

Clarify between a comment and actual citation in the remarks.

Let me repeat…..

An inspector should not routinely cite a facility for Level 2 or Level 3 non-compliant observation(s) that occurred since the last inspection and were then corrected before the current inspection.

These corrected problems could be in any part of the inspection. The most likely areas where this policy could be applied would be for quality control testing or personnel qualifications.

Use the printable Remarks Section to record the problematic observation(s) and verify that it had been CBI.

During the exit interview remind facility personnel that the noncompliance should not be allowed to recur.

The historical record entered into the Remarks Section(s) and the discussion during the exit interview is important, should the facility have serious problems later and FDA considers action against the facility in the future.

The Corrected Before Inspection policy does not apply to Level 1 observations. Level 1 observations, even if corrected before the inspection, should still be cited.

Seven Level 2 noncompliances were cited during 4/29/13 inspection ◦ QC not adequately performed for the unit, monitors

and printer; incomplete medical audit and outcome analysis; failure to present documentation on new mammographic modality training for radiologist.

Facility did not respond to noncompliances, despite numerous attempts by FDA.

Unannounced follow-up fee based inspection performed on 1/6/14 by FDA resulted in seven Level 2 REPEAT noncompliances.

Warning letter to facility issued on 1/28/14.

ACR agreed to perform a Limited Additional Mammography Review on 3/7/14.

ACR initiated a full AMR based on ACR reviewer comments during the accreditation review process. ◦ Poor positioning, poor compression, detector

artifacts and noise.

Facility also received a Level 2 noncompliance during 7/16/13 MQSA inspection for the sole interpreting physician not meeting the continuing experience requirement.

11/8/13: ACR issued a Mammography Accreditation Deficiency Report with AMR request letter.

11/15/13: FDA received acceptable documentation for IP continuing experience.

11/20/13: ACR issued a Delinquent AMR Case Selection letter to facility.

11/26/13: MQSA certificate expired.

12/20/13: Clinical images for the AMR were received by ACR.

1/14/14: ACR issued an AMR Report to the facility. Facility failed the AMR at a level that “posed a serious risk to health”. Only 4 of 30 clinical cases reviewed by ACR were acceptable. ◦ Poor positioning, poor contrast, etc.

1/24/14: DMQS issued a PPN (patient/physician notification) letter to facility.

3,318 patients and their referring healthcare providers affected.

3/5/14: DMQS denied the facility’s request to use their proposed patient notification letter. The letter template by the facility minimized the seriousness of the risk to public health.

Status: Mailings to the referring healthcare providers are in progress.

3/25/10: state investigation revealed a non-qualified individual performed mammography.

07/2010: ACR performed full AMR at the request of FDA. 30 of 30 cases reviewed by ACR failed at a level that posed a “serious risk to human health”.

8/31/10: ACR revoked accreditation, FDA removed facility’s certification.

FDA required facility to conduct a PPN. Facility did not notify all at risk physicians and patients.

3/10/11: FDA posted a Safety Notification on FDA webpage

3/22/11: ACR reinstated facility from revocation following facility’s completion of a Corrective Action Plan.

7/1/11: Facility failed post-reinstatement AMR at a level that posed a “serious risk to human health”. ACR accreditation denied.

7/29/11: FDA issued PPN letter to facility. Facility did not complete PPN.

FDA informed facility it would be required to submit to an Oversight Interpreting Physician Compliance Agreement prior to FDA issuing a new provisional certificate in the future.

Agreement was signed by facility but not executed because facility was banned from performing mammography by the state.

10/31/13: Facility applied for reinstatement. FDA requested facility to submit credentials of the Outside Interpreting Physician for review and approval because of the amount of time that had lapsed since signing the agreement.

11/29/13: Facility submitted adequate physician information.

State will not issue the facility a state license to perform mammography because facility failed to acknowledge the prior ACR accreditation revocation on application. State considers the omission to be a fraudulent statement by the facility.

State investigation will delay state of the FDA requested on-site AMR.

3/10/14: Facility re-submitted state application. State will notify FDA of the results of their review.

#1: ACR revoked accreditation of facility following an FDA requested AMR. Facility successfully completed PPN on 1/24/14. Facility must undergo a post-revocation AMR (30 cases).

#2: Facility performed mammography without MQSA certificate from 6/8/11-9/6/12. At least 1,900 patients imaged. Facility has failed accreditation twice. FDA posted Safety Notification on website. FDA investigated (on-site) on 12/3/13 and determined facility is no longer performing mammography. Mammo unit has been sold to another facility but that facility as yet to apply for ACR accreditation.