Mammography Facility Inspections - Part V: Regulatory / Administrative Strategy

PART V - REGULATORY / ADMINISTRATIVE STRATEGY

1. Regulatory Philosophy and Strategy

   1. Inspection Observations

      There are three levels of observations, from level 1, which is the most severe, to level 3 (see Attachment E). The type of follow-up should depend on the level of the noncompliance. The post inspection printout, called the "MQSA Facility Inspection Report" should identify all of the inspection observations.

      1. Levels of Inspection Observations

         Highest Level of Observation	Action by Facility
         Level 1 - repeat observation	Response from facility within 15 working days
         Level 1	Response from facility within 15 working days
         Level 2 - repeat observation	Response from facility within 15 working days
         Level 2	Response from facility within 30 working days
         Level 3 - repeat observation	Response from facility within 30 working days
         Level 3	Follow up during next annual inspection

      2. Repeat Inspection Observations

         The following list identifies characteristics pertaining to repeat inspection observations:

         1. Uncorrected from previous inspection or has recurred
         2. Generates the same standard statement from the FISS inspection software as for the previous inspection
         3. Can be for a different individual in a facility within the same professional category (physician, technologist, or physicist), a different x-ray system, or a different film processor
         4. Response from the facility should include how it intends to correct all repeat observations, regardless of level

      3. Facility Responses

         Facilities should send all responses to inspection observations to the district office (or Regional Radiological Staff, where appropriate). It does not matter whether the inspection was conducted by a State or an FDA MQSA inspector. Facilities should be directed, however, to send a copy of letters they send FDA to the State. FDA recommends that contract States be consulted on the adequacy of facility responses, since State inspectors usually conduct MQSA inspections and have useful information about the facility and the inspection. In addition, the district should copy the State program for all letters sent to facilities, as well as minutes of meetings with facilities. Attachment F contains guidance on reviewing responses.

         Before reviewing a facility response, the district should read Attachment F for guidance. If a facility doesn't respond to level 1 or repeat level 2 inspection observations when requested or doesn't respond adequately, the district should consider a follow-up inspection or Warning Letter. The district should review section D under Part III before scheduling the follow-up inspection or sending a Warning Letter.

         DMQRP has provided access to all district and regional offices to MPRIS Web. MPRIS Web contains information on facility inspection data, results, and compliance information. The district should update MPRIS Web when the response to the letter has been evaluated. A letter should be sent to the facility when the responses are found to be adequate (see Attachment J) and no follow-up inspection or further action is indicated.

   2. Warning Letters

      Facilities will be asked to respond to repeat level 1, level 1 and repeat level 2 inspection observations within 15 working days after the inspection and level 2 and repeat level 3 inspection observations within 30 working days. Inspectors have been instructed to explain to facility management how to respond to the inspection observations and to provide them with a revised version of the Important Information about Your MQSA Inspection document (see Attachment L). If the facility adequately responds to inspection observations, the District should send a close-out letter to the facility. If the facility fails to respond within the appropriate time frame or the response is inadequate, the District should communicate with the facility to remind it of its obligations and encourage an adequate response to the observations within a reasonable timeframe.

      If, after communicating with the District, a facility, with repeat level 1, level 1 or repeat level 2 inspection observations, still fails to respond, or its response is inadequate, the district should send a Warning Letter. If the District finds that the facility's proposed corrections appear adequate, but based on the facility's past history and capabilities require further verification, the district should conduct a follow-up (fee based) inspection (rather than a Warning Letter). If similar violations are again found during the follow-up (fee based) inspection, the District should send a Warning Letter.

      Note: Districts retain direct reference authority to send Warning Letters for repeat level 1, level 1 and/or repeat level 2 observations. When sending Warning Letters, Districts must follow their standard procedures, including the need for OCC clearance. CDRH concurrence is required for Warning Letters where the most significant observation is either level 2 or repeat level 3.

      If, after communicating with the District, a facility with level 2 or repeat level 3 inspection observations still fails to respond, or its response is inadequate, the District should conduct a follow-up inspection. If similar violations are again identified during the follow-up (fee based) inspection, the District should send a Warning Letter.

      In all cases Warning Letters should be sent to the most responsible individuals, not necessarily the contact people at the locations. The district should copy all contract states for all Warning Letters sent to facilities located in their states and to the facility's accreditation body (for a list of the current accreditation bodies, go to http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/ucm049115.htm), in addition to the normal distribution.

   3. Additional Mammography Review (AMR)

      If the district suspects that the mammography quality at a facility has been compromised and may present a serious risk to human health, it should recommend that the facility undergo AMR. Under an AMR, the facility must provide clinical images and other relevant information (which may include mammography reports), for review by the facility's accreditation body or by an interpreting physician not associated with the facility (21 CFR 900.12(j)(1)). The AMR review will help FDA determine whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.

      FDA has written guidance defining situations where AMR may be needed, as well as procedures to follow for AMR. FDA may request AMR even if it does not have evidence of violations for a Warning Letter. Several complaints from other facilities about mammographic quality would be an example of this type of situation.

      1. Information the district should include with an AMR recommendation

         Submit the following documents (by e-mail or fax; if you submit films, use overnight carrier) to the Division of Mammography Quality and Radiation Programs (DMQRP):

         1. Recommendation memorandum summarizing facts
         2. Establishment Inspection Report (EIR), if one is written
         3. Documentation, copies of correspondence, exhibits, and other materials

         Note: Level 1 observations (either the phantom image test or the qualifications of the interpreting physician), by themselves, may warrant an AMR recommendation (see Attachment G). For most inspections, you may only have a State inspection. If FDA did not conduct the inspection and you don't need a follow-up inspection to further document facility problems, just submit the memorandum. In this case, you can reference the Facility ID and the date of the uploaded inspection in the memorandum.

      2. Checklist for inspection documentation (see Appendix 3 of the MQSA inspection procedures; http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm):

         1. Level 1 phantom image scores from inspection confirmed through a second review by the MQSA auditor or an FDA MQSA inspector (or by the State, if the State has a thorough phantom image quality assurance (QA) program in place)
         2. Inspector has re-scored the facility's QC phantom images and recorded any failed scores in inspection record (including dates of failed facility images to help determine AMR time frame)
         3. Medical physicist survey phantom image scores recorded by inspector
         4. Time frame for interpreting physician's reading and interpretation of mammograms documented by inspector
         5. Actual qualifications of interpreting physician documented (or facility could not document physician's qualification)

         Note: The district should not consider recommending an AMR for a lack of qualifications for an interpreting physician unless it has made reasonable attempts to assure that the physician truly lacks these qualifications. In many cases, documentation may have been missing at the time of the inspection and missing documents may have caused the inspector to cite the facility. At a later date, the facility submitted the documents that indicated that the physician was qualified at the time of the inspection. When the inspection observation is a documentation issue, the district should not consider recommending an AMR for the facility.

      3. AMRs and regulatory actions

         When districts find violations significant enough to consider regulatory action, it should also consider recommending AMR. The recommendation for AMR may be included in the recommendation for regulatory action, rather than as a separate memorandum.

      4. How AMR recommendations are approved

         All requests for AMRs require DMQRP approval, regardless of the type of problem(s) that resulted in the recommendation to request an AMR from the facility. DMQRP must also approve the plan for the AMR, including the selection of the reviewing interpreting physician(s) (if not selected by the accreditation body) and the number and timeframe of the exams reviewed. DMQRP will use the results of the AMR to determine whether to require Patient and Physician Notification by the facility. DMQRP will update the district of the status of AMRs.

   4. Regulatory Actions under MQSA

      1. General sanctions information

         Note: Whenever the district finds serious conditions at a facility where the reliability, clarity, and accuracy of interpretation of mammograms may be suspect, it should consider AMR for the facility, in addition to considering a regulatory action. It should not delay an AMR while considering regulatory action.

         Generally, the district should have at least repeat level 1, level 1, and/or repeat level 2 observations from the most recent inspection and have prior notice before considering regulatory action for a facility (usually a Warning Letter; see Chapter 10 of the Regulatory Procedures Manual for other examples of prior notice). Before considering regulatory action, the district should usually have done a follow-up or compliance inspection to document current problems. While a single inspection may indicate the need for some type of regulatory action, it would be a rare situation.

         Factors to consider prior to recommendations for regulatory action

         1. Prior Notice: FDA may take regulatory action without prior notice if the situation presents a danger to health or constitutes intentional, gross, or flagrant violations. When the district finds the above conditions, it should contact DMQRP and the RRHR to discuss options for regulatory action.

         2. Corrections and History: The district should also consider the facility's commitment to correct the problems, including corrections made during the inspection, and the inspection history of the facility. The district should review all relevant information and evidence, including any information and recommendations from the inspector.

         3. Follow-Up and Compliance Inspections: The district should consider a follow-up or compliance inspection by an FDA MQSA inspector before recommending regulatory action. In most cases, you should conduct an inspection to show that violations continue and to gather sufficient documentation.

         There are a variety of sanctions or regulatory actions that FDA may impose under MQSA, including Directed Plan of Correction (DPC), Patient and Physician Notification (PPN), Civil Money Penalties (CMP), and suspension or revocation of a facility certificate. FDA may also seek injunctions against facilities in federal district court. Of these actions, the DPC, PPN, and suspension can be implemented fairly quickly.

      2. Directed Plan of Correction (DPC)

         Under section 354(h)(1)(A) of the MQSA (42 U.S.C. 263b(h)(1)(A)), FDA may impose "Directed plans of correction which afford a facility an opportunity to correct violations in a timely manner." FDA is not limited in the problems or types of violations the DPC can address, nor is FDA restricted by MQSA for what a DPC may require of a facility. FDA, therefore, has options we can require of the facility to correct problems.

         The district may decide that the DPC works best for many situations, since it can prevent continued use of specific personnel, procedures, or equipment, without FDA suspending their certificate. FDA may limit the DPC to address a particular problem at a facility. An effective DPC would require a facility to immediately address significant observations and allow FDA to monitor corrections under the plan.

         The following are examples of conditions or requirements the district may include in a DPC:

         1. The facility would cease using a mammographic x-ray system with poor performance until the system repairs showed acceptable improvement in image quality.
         2. The facility would have a qualified medical physicist evaluate specific problems with a follow-up report to FDA.
         3. The facility could not use unqualified interpreting physicians to read and interpret mammograms or radiologic technologists to perform mammograms. FDA can maintain this prohibition until the personnel meet the MQSA requirements (21 CFR 900.12).
         4. The facility would have to undergo AMR.

         If FDA requires a facility to discontinue use of specific equipment or personnel as part of a DPC, the facility need not stop performing mammography. A facility may have only one x-ray system or employ one interpreting physician, but the facility may bring in a mobile unit or temporary personnel. In this manner, they can continue to operate until they correct problems.

         FDA should require monitoring of the facility under DPC. The district will be responsible for monitoring compliance with the DPC. Monitoring under a DPC could include, but is not limited to, the following:

         1. Submission of copies of records to the district office, such as quality control (QC) charts, on a regular schedule to demonstrate appropriate record keeping.
         2. A survey by a qualified medical physicist, regardless of whether the facility is due for its annual survey.
         3. Follow-up inspections by FDA or the State.
         4. A site visit to the facility by the accreditation body.

      3. Payment for the Cost of On-Site Monitoring

         Under section 354(h)(1)(B) of the MQSA (42 U.S.C. 263b(h)(1)(B)), FDA may require the facility to pay for on-site monitoring of the facility.

         Monitoring could include routine inspections by FDA or State MQSA inspectors to monitor continued compliance by the facility. FDA would choose an inspection frequency based on how often we may need to check on facility compliance. FDA could adjust the frequency of the inspections, based on the results of previous inspections.

      4. Patient and Physician Notification (PPN)

         FDA has authority to require PPN when the quality of mammography at a facility represents a significant risk to individual or public health. This authority can be found under 21 CFR 900.12(j)(2) and 354(h)(2) of the MQSA (42 U.S.C. 263b(h)(2)) (wording in the Act is "Patient Information").

         FDA would usually consider PPN after finding serious problems with mammographic quality at a facility through an AMR. The notification to the patients and/or their referring physicians may be that the quality of the mammograms was inadequate, the interpretation of the mammogram by the interpreting physician was inadequate, or both.

      5. Civil Money Penalties (CMP)

         A CMP is a fine levied against the facility and/or individuals by the FDA for violations of MQSA after FDA has given the facility an opportunity for an administrative hearing. The most likely situations where FDA might want to assess CMP would be where violations were serious, but were not continuing. As an example, we may find that a facility is performing mammography without a certificate, but agrees to stop when discovered. We may decide to assess CMP in this situation.

         A facility may be subject to CMP up to $10,000 for failure to obtain a certificate (section 354(h)(3)(A) of the MQSA (42 U.S.C. 263b(h)(3)(A)) and up to $10,000 for failure to notify a patient of risk (section 354(h)(3)(C) of the MQSA (42 U.S.C. 263b(h)(3)(C)). Other violations may also be subject to CMP (354(h)(3)(B), (D) of the MQSA (42 U.S.C. 263b(h)(3)(B), (D)).

         Before assessing a CMP, FDA would notify the facility by letter of our intent to assess a penalty and provide instructions for requesting a hearing. FDA has specific regulations for CMP hearing procedures at 21 CFR Part 17.

      6. Suspension

         Suspension of the facility's certificate prevents them from performing mammography (section 354(i) of the MQSA (42 U.S.C. 263b(i)). For this reason, FDA normally would not consider this sanction, unless one or more of the following conditions are present:

         1. Lesser sanctions, such as a DPC, have failed to bring the facility into compliance.
         2. The facility has refused to permit inspection.
         3. The conditions at the facility represent a serious risk to human health.
         4. Violations at the facility were intentional.

         FDA has two different ways in which suspension could occur:

         1. FDA would notify the facility by letter that we intend to suspend the facility's certificate and that they may request a hearing. Only after the facility waives their right to a hearing, or after a hearing, would we suspend the certificate.
         2. FDA would notify the facility by letter that we have suspended their certificate and that they may request a hearing. Either conditions 3 or 4 above would be required to suspend a certificate prior to a hearing. We would normally hold a hearing to allow the facility to contest the suspension or present their views on whether we should lift the suspension.

         FDA may employ one or more of the following factors in deciding whether to suspend a facility's certificate prior to holding a hearing:

         1. Failure to comply with the required standards presents a serious risk to human health.
         2. There is reason to believe that the violative acts were intentional or otherwise rise to a level that presents a threat to public health.

         In the event that the facility requests a hearing, FDA will use the process outlined in 21 CFR Part 16.

      7. Revocation

         Revocation of a certificate is an action taken by the FDA that prohibits a facility from operating, with the expectation that it will not be operating in the future. We may seek to revoke a facility's certificate for the same violations mentioned under suspension of a certificate. Unlike suspension, if we revoke a facility's certificate, the owner or operator of the facility may not operate that facility or any other facility for two years after the date of revocation (section 354(i)(3) of the MQSA (42 U.S.C. 263b(i)(3)). We intend suspension to be a temporary action to encourage a facility to comply with the quality standards. We would generally revoke a certificate of a facility that cannot or will not comply with the regulations. We may seek revocation when a facility continues to operate after suspension of its certificate. In some circumstances, we may suspend a certificate without a prior hearing, but revocation actions always require an opportunity for a hearing. We would use the same process under 21 CFR Part 16 for hearings that are employed for suspension.

      8. Injunction

         An injunction under MQSA is a court order prohibiting a facility from continuing any activity related to the provision of mammography that would constitute a serious risk to human health or to stop a facility from performing mammography without a certificate (section 354(j) of the MQSA (42 U.S.C. 263b(j)). Violation of the order can result in criminal contempt sanctions. FDA would normally use this mechanism when other FDA actions, including other sanctions, have failed to bring a facility into compliance or to stop a facility from performing mammography without a certificate. Under certain circumstances, where continued operation of a facility constitutes a serious hazard to the public health, we may choose this as a course of action.

   5. Violations under State Law for Mammography Facilities

      Many States have mammography facility requirements that overlap with MQSA requirements. In some cases, the State may have different or more stringent requirements than FDA. States may also decide to take regulatory action against a facility for violations that would normally not result in similar action by FDA.

      For these reasons, States should copy FDA on letters they send to facilities pertaining to mammography requirements or violations. Under State contracts, the State must report to the RRHR or other designated field contact any adverse action taken against a facility under State authority within ten working days of the event in instances where a significant violation has occurred that would result in FDA taking action under MQSA.

2. Case Guidance

   1. General Information

      Preliminary contacts with DMQRP: When the district finds that specific facility problems may be serious enough for regulatory action, it should send an e-mail to DMQRP prior to submission of a recommendation package. This e-mail should include:

      1. A summary of the facts relating to the facility's violative operation, including information obtained from inspections and investigations.
      2. A brief history of the facility's prior violations, if present, and whether prior notice was given and when.
      3. A description of why this would be a candidate for regulatory action, versus trying to get the facility to voluntarily comply.

      After the e-mail is sent, the district may want a conference call with DMQRP and other headquarters units to discuss the merits of the case.

      Recommendation package: After consultation with DMQRP, the district may submit a recommendation to DMQRP. The district should include the following with the recommendation memorandum:

      1. Establishment Inspection Reports and reports for any investigations.
      2. Exhibits and documentation (affidavits, photographs, copies of facility records).
      3. Copies of correspondence, including Warning Letters.
      4. Draft documents for approval (see specific documents mentioned below pertaining to specific actions).

      The district should submit all recommendations for regulatory action to DMQRP. For any documents or records that are in electronic format, please submit these documents by electronic mail or on disc. You do not have to submit copies of inspection reports from the inspections uploaded into MPRIS, unless the inspection could not be uploaded and only a paper report is available.

   2. Directed Plan of Correction (DPC)

      Draft documents to submit: DPC letter

      Approval official: Director, Division of Mammography Quality and Radiation Programs, OCER, CDRH

      FDA headquarters units involved in the review process: DMQRP (review of DPC letter by Office of the Chief Counsel (OCC))

      Appeal process for facility: 21 CFR 10.75 - Request for appeal to the Director of the Office of Communication, Education, and Radiation Programs, CDRH

   3. Civil Money Penalties (CMP)

      Draft documents to submit: Draft Notice of Opportunity of Hearing (for CDRH Director's signature) and draft complaint (for OCC attorney's signature) (see 21 CFR 17.5)

      Approval official: Director, CDRH

      FDA headquarters units involved in the review process: CDRH, ORA/OE/DCMO, OCC

      Appeal process for facility: 21 CFR 17 - Hearing before FDA administrative law judge

   4. Suspension and/or Revocation

      Draft documents to submit: Draft Notice of Intent to Suspend (or Revoke) or Notice of Suspension letter (for Office of Communication, Education, and Radiation Programs Director's signature)

      Approval official: Director, Office of Communication, Education, and Radiation Programs, CDRH

      FDA headquarters units involved in the review process: CDRH, OCC

      Appeal process for facility: 21 CFR 16 - Regulatory hearing before FDA-appointed presiding officer

   5. Injunction

      Draft documents to submit: see Chapter 6 of the Regulatory Procedures Manual

      Approval official: United States District Judge

      FDA headquarters units involved in the review process: CDRH, OCC

      Appeal process for facility: Hearing before the United States District Judge signing the order