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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mammography Quality Standards Act Auditor's Guide

 

TABLE OF CONTENTS

 

Introduction Pg 1

 

Auditor's Responsibilities Pg 2

 

Audit Process Pg 2

 

Inspector Quality Assurance Pg 3

 

Joint vs. Independent Audits Pg 3

 

New Inspector Evaluation Pg 4

 

Review of Uploaded Inspection Records Pg 4

 

Conducting Joint Audits Pg 7

 

Documenting the Joint Audit Pg 8

 

Conducting Independent Audits Pg 10

 

Audit Reports Pg 11

 

Audit Tools Pg 12

 

Attachment #1 - Joint MQSA Inspection

 

Audit Report Pg 14

 

Attachment #2 - MQSA Inspection Records Review Report Pg 16

 

Attachment #3 - Sample Cover Letter to

 

State MQSA Program Manager Pg 19

 

 

 

 

INTRODUCTION

 

This guide is being issued to MQSA auditors to provide them with specific guidance in implementing the general audit requirements specified in Field Management Directive (FMD)-76 "Evaluation of Inspectional Performance, Appendix D "Evaluation of MQSA Inspections. It will also assist in overall inspector quality assurance. This guidance document represents the agency's current thinking on MQSA audits.

 

The Guide was written by the Division of Mammography Quality and Radiation Programs, Office of Health and Industry Programs, CDRH and the Office of Regulatory Affairs. If you discover errors in printing or have suggestions for changes which you feel will contribute to the goal of increasing inspector quality and uniformity, please communicate your written comments or suggestions to the Division of Mammography Quality and Radiation Programs (HFZ-240), 1350 Piccard Dr., Rockville, MD 20850 or to Division of Emergency and Investigational Operations (HFC-130), 5600 Fishers Lane, Rockville, MD 20857.

 

The origin of the audit requirement is derived from Section 354(g)(3) of the Mammography Quality Standards Act of 1992 (PL102-539) which states "The Secretary shall inspect annually facilities inspected by State agencies acting on behalf of the Secretary to assure a reasonable performance by such State

 

agencies. The Food and Drug Administration (FDA) has extended the audit requirement to all MQSA inspectors, including FDA personnel, as stated in FMD 144, dated 3/18/96, "Criteria for Qualifying MQSA Auditors.

 

A key goal of our audits will be to attain inspectional uniformity among the MQSA inspectors. Auditor uniformity is also critical to assure that MQSA inspectors are evaluated uniformly nationwide. Uniformity will promote high quality inspections which are an important element in achieving high quality mammography. This guide will provide the basis for auditor uniformity.

 

The auditor will be responsible for evaluating the performance of each of their state and FDA MQSA inspectors. This will be accomplished through a combination of on-site audits, inspection record review, and monitoring of each inspector's general performance through periodic review of inspectional data tabulated through Mammography Program Reporting and Information System (MPRIS). The MQSA audit process is not just an annual evaluation, but an ongoing process.

 

Another important auditor function is to be a resource person for the inspectors. It is important for the auditor to establish a rapport with each inspector and maintain communication lines with them. The auditors should encourage their inspectors to call them whenever they have questions or problems. It is important to call and/or meet new inspectors. This will sow the seeds for a close auditor/inspector relationship. An interactive relationship will allow small problems to be addressed before they become big problems. The inspectors will feel they are an important and respected part of the whole inspection process, promoting better quality inspections.

 

Auditors should establish a good rapport with the State Radiation Program Manager for MQSA and each individual MQSA inspector. They should be diplomatic and professional with their contacts. Good communication is crucial to help foster high quality MQSA inspections.

 

 

AUDITOR'S RESPONSIBILITIES

 

The auditor plays an important role in inspector quality assurance (QA). The auditor evaluates and maintains QA by:

 

1. establishing contact with new inspectors and evaluating their initial four inspections, including mentoring at least one of the initial two, if possible;

 

2. evaluating inspector performance through a combination of on-site audits and ongoing independent inspection record review which will be documented using the forms in this guide;

 

3. establishing and maintaining good communication channels with each inspector and their respective State MQSA Program Managers;

 

4. being diplomatic and professional when dealing with facilities, inspectors, and State program managers;

 

5. encouraging each inspector to contact him or her if they have any questions or problems;

 

6. mentoring or arranging for mentoring of inspectors who were on inactive status and are returning to active status;

 

7. developing an audit plan to complete all audits on a fiscal year basis;

 

8. providing reports on audit activities to State MQSA Program Managers, Division of Mammography Quality and Radiation Programs (DMQRP), and the Regional Radiological Health Representative (RRHR);

 

9. working with the inspectors, State MQSA Program Managers, MQSA facilities, DMQRP, and the RRHR to resolve problems and unusual situations;

 

10. participating in periodic auditor workshops and conference calls as scheduled by DMQRP.

 

In fulfilling these responsibilities, the auditor will follow the procedures established by the RRHR in the region.

 

 

AUDIT PROCESS

 

The auditing of certified MQSA inspectors will consist of three primary parts:

 

1. review and evaluation of the initial four inspections performed by all new inspectors

 

2. periodic inspection record review including films

 

3. annual joint audits of each inspector

 

For item #1, follow the instructions outlined in the "New Inspector Evaluation" section.

 

A joint audit of each inspector will be performed annually with subsequent audits performed 11-13 months after the previous audit. Audits may be scheduled earlier at the auditor's discretion or on request of the inspector or DMQRP. It is the auditor's responsibility to ensure all audits are completed as scheduled. Any problems in meeting the audit schedule should be discussed with the RRHR.

 

As discussed under the section titled "Joint vs. Independent Audits, independent audits will not be conducted on a routine basis. The independent audit will be generally reserved for problem situations after consultation with the RRHR (and DMQRP if needed).

 

 

INSPECTOR QUALITY ASSURANCE

 

The process of assessing the competency and capability of each MQSA inspector in performing acceptable inspections begins when they start performing inspections. The process continues as the inspectors gain experience and as technology and policy evolve. For new inspectors, the first two inspections must be mentored by a certified MQSA inspector. This may be done by any State or FDA certified inspector, however, if possible and practical, the auditor should mentor at least one of the initial two inspections. This will provide an opportunity for the auditor and the inspector to get acquainted.

 

In addition, the auditor will perform an inspection record review of the first four inspections as discussed under section titled "Review of Uploaded Inspection Records. This review will also include an evaluation of all films obtained during the inspection. The New Inspector Evaluation section details these procedures.

 

After the initial evaluation, joint audits and reviews of uploaded inspection records provide a mechanism for evaluating inspector performance. The first joint audit should be scheduled after the inspector has performed at least five independent inspections. Subsequent joint audits will be scheduled on an annual basis. For a variety of reasons, joint audits may be performed more frequently.

 

Review of uploaded inspection reports will be conducted on a continuing basis with reviews performed each quarter. At least 10% of each inspectors reports will be reviewed.

 

In certain situations, independent audits will be performed as discussed in the section "Joint vs. Independent Audits. These will be reserved for situations where serious problems are suspected and will be coordinated with the RRHR (and DMQRP if needed).

 

The auditor, the RRHR and DMQRP will work with inspectors and State MQSA Program Managers to resolve problems through training and/or mentoring. It is not the purpose of the audit program to disqualify inspectors, but to ensure and improve the quality of MQSA inspections. This should be stressed in all audit activities.

 

JOINT VS. INDEPENDENT AUDITS

 

Routine on-site audits will be conducted as joint audits. Joint audits are valuable because they allow an auditor to confirm how measurements are being performed, how records are being reviewed and how the inspector interacts with personnel at the facility and presents his or her findings.

 

Joint audits are also an opportunity to interact with the inspector to determine if they had problems with the performance or use of the test equipment or software. Current policies are also a common item of discussion with the inspector on-site.

 

There may be situations where a personality conflict exists between the inspector and the facility. This does not necessarily indicate that a poor inspection was performed. However, if an inspector does not act professionally and display appropriate conduct during the inspection, it is a serious problem in itself, regardless of the quality of the actual data gathering part of the inspection.

 

Independent audits will create an additional burden on facilities. Thus, they should be reserved for times when the auditor receives information that indicates inspections may have been substandard and/or significant problems may have been missed which would have resulted in a Level 1 or multiple lower Level findings. Independent audits should also be considered when there is a pattern of poor inspectional performance, even if the inspector does a good job during the joint audit. The RRHR concurrence is required before conducting any independent audits. See the sections titled "Conducting Joint Audits" and "Conducting Independent Audits" for further guidance.

 

 

NEW INSPECTOR EVALUATION

 

This section provides guidance on the evaluation of the quality of the inspections being performed by new inspectors.

 

1. Contact each new inspector and discuss the initial evaluation process. Arrange or have them arrange to have at least their first two inspections mentored by a certified MQSA inspector. If possible, it would be desirable for the auditor to mentor at least one of these first two inspections.

 

2. Call the RRHR to get the results of course III for the new inspector. If the new inspector had any weak areas, the "mentor" can then focus on these weak areas during the mentoring inspection.

 

3. Instruct the new inspector to inform you when each of the first four inspections is completed. After each inspection, request that they send you all inspection films obtained. The auditor will review these films along with the detail inspection report as stated under the section titled "Review of Uploaded Inspection Records.

 

4. Contact the inspector(s) who mentored the new inspector to get their impressions.

 

5. The auditor will document the review and evaluation of the initial four (two of which were mentored) inspections on the form "MQSA Inspection Records Review Report, Attachment #2.

 

6. Call the new inspector to discuss your evaluation. Discuss all items observed which deviate from expected inspection requirements, but also reinforce items they handle well.

 

7. If significant problems are observed with your review, contact the RRHR and discuss. Determine if additional mentoring or training is required.

 

 

REVIEW OF UPLOADED INSPECTION RECORDS

 

This section provides guidance for performing the evaluation of the initial four inspections by new inspectors and also for the periodic inspection record review of all inspectors.

 

After the initial evaluation of new inspectors, the auditor will evaluate at least one inspection record per quarter per inspector. This review will be documented on the form titled "MQSA Inspection Records Review Report, Attachment #2. Every other quarter the review will include evaluation of all films taken during the inspection such as the alignment films, phantom images, fog film, and Sensitometric Technique for the Evaluation of Processing (STEP) test film. At the auditor's discretion, additional films for review may be requested if problems are observed in any of the films reviewed.

 

It is recommended that additional inspection records, without films, be reviewed if there are concerns regarding inspector performance or comprehension of inspection procedures or knowledge of DMQRP policies. If problems are observed with any of the films, consider requesting films from additional inspections. Additional record reviews should also be considered when DMQRP issues major changes to the inspection software.

 

If an inspector performs more than 40 inspections per year, additional record reviews, without films, will be required to meet the 10% record review requirement in FMD-76.

 

Use the following guidance when reviewing the uploaded inspection records:

 

1. Perform the inspection record review four times a year covering the quarters, Oct-Dec, Jan-Mar, Apr-Jun, and Jul-Sep. It is preferred that this review be done during the month following each quarter, i.e., Jan, Apr., Jul., and Oct. This will establish a uniform practice among the auditors and also allow DMQRP to ensure that all reviews are being performed as required. However, the inspection record review may be performed during the quarter, if the auditor prefers. Submit the reports for inspection record reviews to DMQRP before the end of the month following each quarter or as completed.

 

If the inspector did not perform any inspections during the quarter, submit a report stating no inspections were performed. Some inspectors are only doing the minimum number of inspections and may only be doing them in one or two quarters per year.

 

Copies of all reports will be distributed to DMQRP, the RRHR, and internal district files.

 

2. Randomly select a facility for review. Selection of the facility for inspection report review can be accomplished by using the Compliance System to query the database for all inspections performed in that quarter for the inspector of interest. See the section titled "Audit Tools" for additional guidance. While in the Compliance System, check upload dates versus the inspection dates. Note on the reporting form if the inspections were not uploaded in a timely manner.

 

3. Download the inspection record of interest using MPRIS and the request for "an inspection record for viewing. Generate and print the detail report and compliance report.

 

4. Call the inspector and request that the films obtained during the selected inspection be sent to you. Return the films after your review, unless they are needed to document any observed problems. Problem films should be retained until any inspector quality issues are resolved. If a delay in uploading the inspection(s) was noted in item #2 above, discuss the reason with the inspector at this time.

 

5. Review the compliance report and the detail report. Document problems on page 2 of the "MQSA Inspection Record Review Report. Your review should cover:

 

a. the compliance report to identify completeness of the equipment test data, and what noncompliances were observed.

 

b. the "Missing Data" report to determine if the missing data is a problem or justified.

 

6. At a minimum the review of the detail report should evaluate the following:

 

a. Use of remarks by the inspector. Details should be provided which summarize the basis for any noncompliances. Remarks should be used to explain items unique to the facility. Inspectors should be encouraged to include remarks where appropriate when problems are noted. Examples of situations involving specific noncompliances which must have additional information in the remarks are: dates when phantom QC not performed, dates when processor QC not performed, dates when mammograms processed when the processor was "out of control, # of training hours if training requirement not met, etc.

 

b. Does the type of processing (extended or standard) make sense with the type of film used (e.g., MinR-M film with extended processing)?

 

c. Did the inspector identify appropriate persons as facility contact and for billing and compliance responsibility? This can only be a general determination, e.g., if the inspector identified an R.T. as the individual responsible for compliance, it is unlikely that this is the correct individual to be recorded for compliance responsibility.

 

d. Was current DMQRP guidance used during the inspection?

 

e. Does the reference step marked for STEP film match the reference step marked on the box of control film used by the inspector? Call the inspector to determine the reference step.

 

f. If a Radiologic Technologist (R.T.) was initially qualified by the experience option and now claims training was obtained, is the training summarized in the remarks?

 

g. If the inspection report includes documents pending, and more than 30 days have passed since the inspection, determine why the documents pending were not resolved.

 

h. Is the on-site inspection time reasonable? Is the on-site time vs. total inspection time reasonable? A difference of more than 2 hours may indicate non-reportable time such as travel was included. Is the on-site time reasonable for the number of machines and personnel at the facility?

 

i. If the report indicates the facility's film processor was used when it was out-of-limits, do the remarks indicate the dates when the processor was operated out-of-limits?

 

j. If records are stored off-site, do the remarks state where films are stored?

 

k. If a physicist is cited for not testing 3 kVp s at 4 cm for the AEC Performance/Tracking test, do the remarks state how many kVp s are used by the facility?

 

l. Check the validity of entered data (e.g., if a physicist is shown as having state license, does that state issue licenses to physicists).

 

m. Is the Employer Identification Number (EIN) obtained? (Note: Federal Facilities may not have an EIN) UPIN s for interpreting physicians? (Note: while the UPIN's may not be critical, they are part of information requested to be obtained. The inspectors should be told to record this information.)

 

List and describe the various deficiencies found during the review of an inspection record(s) on page two of the "MQSA Inspection Records Review Report," Attachment #2. Use page 3 of this form to document any consultations with the inspector. Also, document any consultations with the RRHR and DMQRP including the dates of these discussions and a summary of the resulting recommended follow-up on page 3.

 

Copies of the completed report should be distributed to HFZ-240 (QA Coordinator), HFC-152 (MQSA Contract Specialist), RRHR, and District Audit Files.

 

 

CONDUCTING JOINT AUDITS

 

1. Inform the State MQSA Program Manager that joint audits need to be performed on State inspectors.

 

2. Contact the inspector no less than four weeks in advance of doing the audit to determine a mutually agreeable date to perform the audit. (Preferably at a facility with one mammography machine)

 

3. Inform the facility that the inspection is being conducted as an audit by FDA as part of our internal quality assurance for performance and consistency of the inspections in the MQSA program. When scheduling the joint audit with the MQSA inspector, request that when they schedule the inspection, they should inform the facility that an FDA auditor will be participating in the inspection.

 

4. Observe whether the inspector presents his or her MQSA credentials to the facility as required by MQSA.

 

5. The inspection is the responsibility of the certified inspector and not the auditor. Although the auditor may see something that is set up incorrectly, the auditor should give the inspector an opportunity to correct the situation before correcting the error. If it is obvious that an error will not be detected by the inspector, the auditor should point out the discrepancy to the inspector. Be tactful in pointing out any test method errors. Also, realize that the inspector may use a different sequence to test but that the testing ends up with the same information. Terms such as "I recommend" or "I suggest" go further than "Don't do it that way" or "That's not right." Point out strengths as well as weaknesses. If an inspector does a particularly good job or uses a particularly good technique let him or her know it. Unlike pointing out weaknesses, praising strengths need not be done in private.

 

6. Ask "what if" questions during the inspection, i.e., "what if this record were missing?", "what if the processor isn't functioning?", "what if the phantom fails?", to determine how the inspector would handle problems.

 

7. Be present in the room to observe the collection of data but let the inspector do his or her work without distraction. Try not to assist in the collection of data as this may not result in a reasonable assessment of the inspector's ability and understanding of that particular item or test method.

 

8. Observe the performance of the equipment tests for conformance with the MQSA Inspection Procedures Manual; this includes the equipment tests, the STEP test, and the darkroom fog test.

 

9. Verify that the Equipment Registration information, including the film reference step number, MDH number, and the sensitometer number entered into the laptop computer by the inspector is correct.

 

10. Score the phantom images after the inspector has scored them. Discuss any differences in scoring. If a phantom image fails, it is recommended that recent phantom images taken by the facility be reviewed to see if problems existed with these images.

 

11. During review of the facility's records, it is important to allow the inspector to review the records and come to a determination on compliance. The auditor should review a sample of the records, including the survey by the medical physicist, to see if there are any problems with the facility records. If the inspector determines a noncompliance exists, verification by the auditor is appropriate. If there is disagreement, the auditor should again be tactful in explaining the reason for a different conclusion. The difference may be due to a change in policy that was not understood by the inspector. The auditor should be prepared to show current policy to the inspector or to at least explain the reason for the difference. It is important that discussions with the inspector be done privately, if possible.

 

12. After the inspector has completed all of the appropriate entries in the data fields and has made relevant determination regarding repeat items, the inspector should be observed to see that the appropriate report is printed, that the correct letter is printed and that the facility receives a document on How to Interpret the Inspection Report and Respond to the FDA.

 

Some States require supervisory review of the inspection report prior to issuance to the facility. In this case, ask the inspector to fax or send you a copy of whatever was sent to the facility.

 

13. During the exit interview, the auditor should let the inspector present his or her findings to the facility management/responsible personnel. If possible, discuss the content of the compliance report with the inspector before it is discussed with the facility. This will allow an opportunity to discuss any problems with the observations before they are presented to the facility. The auditor should observe and listen to what is being stated to determine if the findings are being presented appropriately. If the facility has been misled where the auditor believes that compliance will not be pursued as established by FDA guidelines, the auditor should tactfully clarify what may have been misstated or misunderstood. Any pending items should be discussed and a time frame for submission of the missing documents should be established by the inspector with the facility.

 

Where State inspections are conducted concurrently with the MQSA inspection, observe that any State findings are distinguished from MQSA findings.

 

14. If at the conclusion of the inspection, it is obvious that the inspector did an unsatisfactory inspection, additional joint audits or mentored inspections should be considered. Independent audits should also be considered as discussed under the section titled "Joint vs. Independent Audits. Consult with the RRHR to discuss appropriate follow-up.

 

15. See the following section titled "Documenting the Joint Audit" for additional areas to be reviewed during the audit.

 

 

DOCUMENTING THE JOINT AUDIT

 

Attachment #1 "Joint MQSA Inspection Audit Report" is to be used to summarize the joint audit results. The form consists of two pages. The first page has 11 categories that are to be evaluated during the audit. The second page is used to record the overall audit rating and to document any comments/problems/ suggestions.

 

Indicate with a check mark or an "X" whether each category was acceptable, needs improvement, or acceptable with comment. Any category with a "needs improvement" rating, must be fully documented on page two of the report describing the basis for that rating. Also use page two of the report to describe the categories with "acceptable with comment"' rating, if needed.

 

The overall audit rating will be either satisfactory or unsatisfactory. Generally a satisfactory rating will be given if all the categories are marked as "acceptable" or "acceptable with comment. It is also possible for a satisfactory rating to be given if there are one or more categories marked as "needs improvement. This will be true only if the auditor feels the inspector will correct the deficiency after discussing the problem with him or her and that additional mentoring is not required.

 

If an "unsatisfactory rating" is given, the auditor must consult with the RRHR and DMQRP (QA Coordinator) to determine what additional steps must be taken to assist the inspector in performing a higher quality inspection.

 

See the section titled "Distribution of the Audit Report" for guidance on distribution of the audit report.

 

The MQSA Inspection Procedures Manual and current DMQRP policy statements will be used as the basis for determining whether the inspector performed each area of evaluation in an acceptable manner.

 

The following summarizes examples of specific areas to be addressed within each general area of evaluation:

 

1. Inspection Preparation

 

Request a copy of the inspection confirmation notice. This provides a record that it was issued and gives the auditor a record of location of the audit along with important facility contact names and phone numbers. Determine the calibration dates of the inspector's MDH, sensitometer, and densitometer to ensure equipment is being calibrated as required. Was a sensitometer comparison made with another sensitometer as requested by DMQRP? Ask the inspector if he or she is accessing and reviewing current DMQRP policy statements through his/her laptop. Inspectors should have a system to access this information during the inspection if needed. Ask for a copy of the "How to Interpret and Respond to the Inspection Report" document and check if it contains the proper name and address of the FDA contact person to receive the thirty day responses.

 

2. Facility Information

 

Did the inspector identify correctly the facility contact person, the person responsible for compliance, and the person to receive the inspection fee bill? The facility contact person should be the individual who was called to schedule the inspection or who assisted the inspector during the inspection. The person identified for being responsible for compliance should be consistent with DMQRP guidance on this issue. Note that it may not be appropriate to list the R.T. or Chief R.T. as the person responsible for compliance.

 

3. Equipment Testing

 

Observe the performance of the currently required equipment tests to determine compliance with the MQSA Inspection Procedures Manual.

 

4. QA/QC Records Review

 

Observe whether the inspector reviewed the records covering the period from the previous inspection. Did he or she evaluate the records in sufficient detail to determine compliance by the facility?

 

5. Physicist Survey Report Review

 

Determine if the inspector reviewed the medical physicist survey report using the guidelines contained in the DMQRP document dated March 29, 1996 "Medical Physicist's Annual Survey Requirements" and any updates to this guideline. The auditor should review the medical physicist report to see if the inspector evaluated the survey correctly. Some state inspectors will request the facility to fax the medical physicist survey to them before the inspection. The auditor should determine if any deficiencies were noted and also review the survey report to see if the inspector s evaluation was correct.

 

6. Personnel Qualifications Review

 

Are all personnel included on the inspection record? Did the inspector accept proper documentation for determining compliance with the personnel requirements? If attestations were used, did the attestation provide specific details, and are they used only for pre 10/1/94 information? General statements such as I have 40 hours of training in mammography or I read 240 mammograms in 6 months are not acceptable. The attestation should state what, when, and where.

 

7. Medical Records and Medical Audits Review

 

Did the inspector review the medical records, which includes the mammography films, as required? Did he or she adequately question the facility to determine the adequacy of their medical audit system? If records are stored off-site, is the off-site location identified in the remarks?

 

8. Exit Interview

 

See section "Auditor Conduct During Joint Audits. Note that if a final compliance report is not issued, a "pending" report should be printed and discussed with the facility. The inspector should get a commitment from the facility as to when the "documents claimed" will be obtained. If a final report is issued, did the inspector also issue the appropriate copy of Dr. Houn's Letter and a copy of the "How to Interpret and Respond to the Inspection Report" document?

 

9. Communication Skills

 

Observe whether the inspector interacted with the facility in a professional manner and treated facility personnel with respect. This is a critical area and if unprofessional conduct, is observed early in the inspection, the auditor should privately discuss the situation with the inspector.

 

10. Post-Inspection Items

 

The inspection process is not completed until the inspector uploads a completed inspection record to DMQRP. The auditor should determine when the inspection was uploaded and whether time frames were followed. If the inspection record contains documents pending items, the items should be resolved within 30 days. Inspections should be uploaded within 5 working days of the inspection unless unusual circumstances exist. If an inspection has a "documents pending" item(s) which involves a potential level 1 item, the inspector must, whenever possible, get an agreement from the facility to provide the documents ASAP so that the inspection data can be uploaded within 5 working days after the inspection. If a level 1 is found during the inspection, the inspector should upload the inspection within 5 working days whether the facility has responded to the claimed items or not. If a final report was not issued before leaving the facility, determine if the inspector sent the facility a copy of the final report when finalized. Note that some states require supervisory review of inspections before the report is issued to the facility.

 

After the inspection is uploaded, retrieve the inspection record for viewing and generate the compliance report, missing data report, and detail report. Review the missing data report to see if any valid items were missed. Review the detail report to see if the type of inspection was entered as a J "joint inspection" and if the detail report is acceptable.

 

 

CONDUCTING INDEPENDENT AUDITS

 

Independent audits should be reserved for problem situations and should only be conducted after consultation with the RRHR. A diplomatic approach must be used when scheduling the inspection. Inform the facility that as part of FDA's quality assurance oversight of MQSA inspectors, the auditor needs to perform an independent inspection to verify inspector performance. Make it clear that your purpose is to assure the overall quality of the program and that you have no reason to believe that the facility has any serious problems. Also, tell them that they will not be billed for this inspection.

 

If the facility is reluctant or adamant against having you perform the inspection, consider choosing another facility to do the audit. It is important that the facility is receptive to the idea of having a second inspection performed. Good communication skills are important and will increase the likelihood of the facility agreeing to your request to do an independent audit. However, the facility should understand that if new problems are discovered during your independent audit, the facility will be cited and the problem would have to be corrected.

 

On-site, reassure the facility that you are not there because of anything that they have done. Explain that the purpose is to verify the ability of the previous inspector and that you want to assure that only truly noncompliant

 

items are cited. Refer the facility to the RRHR if they have questions or concerns that you are unable to resolve.

 

Prior to conducting the inspection, download the inspection data uploaded by the inspector. Generate the compliance and detail reports and review. Identify any weak or problem areas in the report.

 

Conduct the inspection as efficiently as possible. Use "I" for the inspection type in the inspection software. Review records covering the same time period as the previous inspector. Thoroughly cover any areas in which the inspector is weak or is suspected of being weak. When performing equipment tests, do not expect to exactly duplicate the previous results. However, results should be reasonably comparable.

 

During the closeout discussion, ask the facility for their impression of the previous inspector. Were there any areas they felt were not adequately inspected or where they felt the inspector was not performing the inspection properly? Be aware that, in some cases, facility personnel may be reluctant to adversely comment on the inspector. Assure them that all comments will be kept confidential and that your intention is to improve the quality of the MQSA inspection program and ultimately the quality of mammography. Their input could be useful to identify additional training needs.

 

Discuss your inspectional findings with the facility. Avoid discussing your evaluation of the previous inspector with the facility. Where there are serious differences between your findings and those of the previous inspector, explain that the purpose of this inspection was to identify areas where the previous inspector may not have identified problems or may have incorrectly identified problems and that this program will attempt to reduce the incidence of that occurring in the future. However, the facility is responsible for correcting any noncompliance items that you found which were not observed during the previous inspection.

 

Thank the facility for their cooperation and remind them that they may call you or the RRHR at any time if they have any questions or comments on the inspection process.

 

 

AUDIT REPORT

 

After each audit is completed, the auditor will send a cover letter to the State MQSA Program Manager which explains that an audit was performed and where, and summarizes the overall audit rating. A sample letter is attached as Attachment #3. A copy of the "Joint Audit Inspection Audit Report" should be attached to the cover letter.

 

Copies of these letters with attachments should be distributed to: the inspector, RRHR, HFZ-240 (QA Coordinator), HFC-152 (MQSA Contract Specialist), and internal district files.

 

If the inspector is an FDA investigator, a memorandum should be written to the investigator's supervisor with a copy of the audit report form instead of the letter.

 

For Independent Audits, write a narrative report, following the format of the "Joint MQSA Inspection Audit Report" (Attachment #1). Address each item, indicating if it was an area of concern prior to the inspection, and if it is an area of concern now. Be as specific as possible in describing problem areas. Also propose suggested corrective actions which should be taken such as: repeat course III, additional mentoring, additional training, etc. Send your report to the RRHR and DMQRP. Following RRHR/DMQRP review, the RRHR will discuss the report with the State MQSA Program Manager or FDA Supervisor, and will arrange for appropriate follow-up.

 

 

AUDIT TOOLS

 

Use of the following audit tools is strongly recommended to assist the auditor in the overall evaluation of their inspectors:

 

1. Data Integrity Check Report

 

This report contains all data discrepancies by inspector, for all inspections conducted from the beginning of the fiscal year to the date of the report. It is used to assist the auditor in finding problem areas from inspections conducted by the inspector being audited. The report will initially be generated by DMQRP and sent to the auditors monthly. The data should be reviewed to determine if there are any glaring problem areas. This information can be used to help select the inspection record(s) to be reviewed quarterly. It can also suggest that an additional inspection record review is required beyond the one inspection record per quarter requirement.

 

2. MPRIS Compliance System

 

The MPRIS Compliance System is a multi-functional database application which allows, in part, the user to query the inspectional database to obtain information on noncompliances associated with a particular inspection and also generate various types of noncompliance reports. Refer to the "MPRIS Compliance Application User's Guide" for more details on the exact capabilities of the system and instructions for use. The auditors are encouraged to explore the Compliance System to review the various report options.

 

The following are two reports which will be used routinely to assist the auditor in the evaluation of their inspectors:

 

a. Claimed Item Condition Report

 

This report will generate a listing of all inspections that have documents pending items by inspector ID and the number of days each inspection has been in this status. The inspectors must resolve all documents pending within 30 days of the inspection.

 

It is suggested that the auditor generate this report monthly or bimonthly to determine that these inspections are being resolved in a timely manner, i.e., less than 30 days. Contact the inspector if any inspections are more than 30 days overdue, to determine why the documents pending items have not been resolved.

 

b. Inspection Summary Report

 

This report will list all inspections performed by the inspector and will list the facility ID, Inspection ID, Inspection Date, EIN, Facility Name and Address, and the number of level 1, 2, or 3 observations found during each inspection.

 

Use this report to generate a list of inspections performed and uploaded within the selected time frame and by selected inspector. This list can be used to help select the facility for the quarterly inspection record review or additional record review if required. Once a facility is selected for review, use FISS to download the report for viewing as described below.

 

3. FCS

 

FCS (Facility Communication System) provides a communication link to the inspection database, which allows the user to download for viewing the inspection data for any inspection of interest. Once the inspection data is downloaded, use FISS to generate the Compliance Report and the Detail Report. These reports will be used to do the quarterly inspection record review.

 

 

JOINT MQSA INSPECTION AUDIT REPORT ATTACHMENT #1

 

 

 

Name of Inspector ____________________________ Inspector ID# ___________ Name of Auditor ____________________________ Auditor ID# ___________ Inspection ID ____________________________ Date of Audit ___________

 

 

 

Check the box which appropriately reflects the inspector s performance in each of the following areas. Use page 2 for all comments.

 

 

 

Acceptable

 

Needs

 

Improvement

 

Acceptable

 

with Comments

 

1. Inspection Preparation

 

     

2. Facility Information

 

     

3. Equipment Testing

 

     

4. QA/QC Records Review

 

     

5. Physicist Survey Report Review

 

     

6. Personnel Qualifications Review

 

     

7. Medical Records Review

 

     

8. Medical Audits Review

 

     

9. Exit Interview

 

     

10. Communication Skills

 

     

11. Post-Inspection Items

 

     

 

JOINT MQSA INSPECTION AUDIT REPORT - PG 2 ATTACHMENT #1

 

 

 

Name of Inspector ____________________________ Inspector ID# ___________ Name of Auditor ____________________________ Auditor ID# ___________ Inspection ID ____________________________ Date of Audit ___________ ___________________________________________________________________________

 

COMMENTS: (Attach additional sheets as needed)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

___________________________________________________________________________

 

Overall Audit Rating ______ Satisfactory ______ Unsatisfactory

 

If unsatisfactory, recommended follow-up: ________ additional mentoring________ areas to be mentored (1-11)

 

________ consult with RRHR/DMQRP

 

Auditor Signature ________________________ Date _________________

 

MQSA INSPECTION RECORDS REVIEW REPORT ATTACHMENT #2

 

Name of Inspector ___________________________ Inspector ID #__________

 

Name of Auditor ___________________________ Auditor ID #__________

 

Date of Review ___________________________

 

 

 

CHECK BOX WHICH APPLIES:

 

___________________________________________________________________________

 

New Inspector Review of First Four Inspections

 

Mentor of First Inspection ____________________

 

Mentor of Second Inspection ____________________

 

Inspection Records Reviewed

 

Inspection ID

 

     

Inspection

 

Date

 

     

 

___________________________________________________________________________

 

Quarterly Review for FY ______ 1ST 2ND 3RD 4TH

 

Number of Inspections Performed during the Quarter _________

 

Number of Inspection Records to be Reviewed _________

 

Inspection Records Reviewed

 

Inspection ID

 

     

Inspection

 

Date

 

     

 

 

 

Monthly Data Integrity Check received for this inspector? Y N

 

(Note: Every inspector should have at least one inspection reviewed per quarter including review of all inspection films. If the inspector performed more than ten inspections during the quarter, perform one additional record review (w/o films) for each group of ten inspections above the ten performed, i.e. for 11-20 inspections completed, perform one additional inspection record review, for 21-30 inspections, do two additional inspection record reviews)

 

MQSA INSPECTION RECORDS REVIEW REPORT - PG 2 ATTACHMENT #2

 

Name of Inspector ___________________________ Inspector ID #__________

 

Name of Auditor ___________________________ Auditor ID #__________

 

Date of Review ___________________________

 

___________________________________________________________________________

 

COMMENTS: (Attach additional sheets if needed)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

___________________________________________________________________________

 

Consultation with inspector required? Y N

 

Date consultation completed: ____________

 

Problems suggest consult with RRHR/DMQRP

 

to discuss mentoring/auditing options? Y N

 

Use pg 3 to document summary of all consultations with the inspector and results of consultation with RRHR/DMQRP

 

Distribution: HFZ-240 (QA Coordinator); HFC-152 (MQSA Contract Specialist); RRHR; District Audit Files

 

MQSA INSPECTION RECORDS REVIEW REPORT - PG 3 ATTACHMENT #2

 

Name of Inspector ___________________________ Inspector ID #__________

 

Name of Auditor ___________________________ Auditor ID #__________

 

Date of Review ___________________________

 

___________________________________________________________________________

 

Consultation Summary:

 

 

 

SAMPLE COVER LETTER TO STATE MQSA PROGRAM MANAGER ATTACHMENT #3

 

Date

 

 

 

Name & Title of State MQSA Program Manager

 

Address

 

City, State, Zip Code

 

 

 

Dear Mr./Ms.:

 

On date of audit, I conducted a joint audit inspection with name of inspector (inspector ID#) as stipulated in your contract with FDA to conduct MQSA inspections of certified mammography facilities. The joint audit inspection was performed at:

 

Name of MQSA Facility (ID# XXXXXX)

 

Address

 

City, State, Zip Code

 

Attached is an inspection audit report for Mr./Ms. last name. The first page is a list of the various items covered during the joint audit inspection. The second page contains my written comments/suggestions/problems regarding the inspection conducted by Mr./Ms. last name.

 

**** paragraph if satisfactory performance (includes acceptable w/ comment areas) ****

 

In summary, Mr./Ms. last name performed a thorough inspection and interacted with the staff at the facility in a professional manner. My audit of Mr./Ms. last name was satisfactory. If you have any questions, please call me at your phone number

 

**** paragraph if unsatisfactory performance or if there are items which need to be

 

addressed ****

 

My audit found summarize in a clear concise manner the item or items which were a problem. Discuss the proposed recommended follow-up. If the inspector requires follow-up beyond additional mentoring, advise the manager that the RRHR will be sending him/her a letter which will describe the required corrective action.

 

 

 

Sincerely yours,

 

Auditor's Name

 

Title

 

District

 

 

 

Attachment: MQSA Audit Report - Name of inspector

 

cc: Audited Inspector

 

bcc: HFC-152 (MQSA Contract Specialist)

 

HFZ-240 (DMQRP QA Coordinator)

 

RRHR

 

District Audit Files

 

 

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