Mammography Facility Inspections - Part II: Implementation

PART II - IMPLEMENTATION

1. Objective

   This compliance program provides guidance for:

   1. Inspections and investigations of mammography facilities under MQSA.
   2. Actions that FDA may take to ensure that mammography facilities are in compliance with MQSA.

2. Program Management Instruction

   1. Resource Instruction

      MPRIS Web is a vital part of the program. It allows immediate access to and update of information on mammography facilities. All MQSA inspectors and compliance officers, who work with violative MQSA facilities, should have access to MPRIS Web, including exchange of information and updating capabilities. State inspectors also have access to their State's inspections, as well as other information, regarding facility certification status.

      The FDA's RRHRs, along with the Division of Mammography Quality and Radiation Programs (DMQRP) and the Division of Human Resource Development in ORA, are responsible for training and oversight of FDA and State inspectors. These and other functions are described in Part VII A. (DMQRP responsibilities). DMQRP staff will train MQSA inspectors. Only certified MQSA inspectors can perform MQSA inspections (see section 354(g)(1)(D) of the MQSA (42 U.S.C. 263b(g)(1)(D)).

      FDA districts without a certified FDA MQSA inspector or auditor should work with their RRHR to arrange for a certified inspector or MQSA auditor from the regional office or other districts to perform MQSA inspections and audit functions.

      All MQSA inspectors should follow FDA inspection procedures provided by DMQRP (http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm). FDA inspectors should wear personnel dosimeters (radiation badges) distributed by the Radiation Safety Officer ((781) 729-5700 x713) at WEAC if they perform inspections or accompany an inspector. State contract inspectors should wear the personnel dosimeter normally provided by the State. All FDA and State inspectors must present identification (provided only to MQSA-certified inspectors) to facility personnel prior to the start of each inspection. This identification is required by MQSA (section 354(g)(1)(B) of the MQSA (42 U.S.C. 263b(g)(1)(B))). Official FDA credentials issued to investigators should not be used as a substitute.

   2. Planning Instructions

      Each District (or Regional Radiological Staff, where appropriate) should develop a strategy:

      1. To work with the RRHR to have State Radiation Programs inspect certified facilities annually under the terms of its contract, and
      2. To encourage voluntary compliance of facilities and, where necessary, send Warning Letters, conduct follow-up or compliance inspections, or recommend regulatory actions to bring violative facilities into compliance.

      District Office or Regional Radiological Staff should work through the RRHR to assure that State contract inspections are done in accordance with FDA policy and contract requirements (Refer to Part II B.9. - RRHR Management Activities).

   3. States as Certifiers (SAC) Program

      FDA may approve States to certify mammography facilities under MQSA. Under section 354(q) of the MQSA (42 U.S.C. 263b(q)), FDA may authorize a State to carry out specific responsibilities, which include:

      1. Issuing MQSA certificates to mammography facilities
      2. Conducting inspections of mammography facilities
      3. Sending letters and evaluating responses from mammography facilities in violation of MQSA standards and regulations
      4. Taking regulatory actions under MQSA, where appropriate, against mammography facilities

      This authorization does not allow States to carry out the following responsibilities under MQSA, which must be carried out by FDA:

      5. Conducting MQSA inspection audits of State inspectors
      6. Developing MQSA facility standards

      States approved as a SAC State would perform most of the functions currently performed by FDA field offices for facilities in their State. An exception would be inspection audits, which would still be performed by approved FDA auditors. Also, while the Act allows the State to take regulatory action against facilities, FDA still has the authority to also take action, when necessary (section 354(q)(3)(B) of the MQSA (42 U.S.C. 263b(q)(3)(B)).

      FDA final regulations for State certification became effective on May 7, 2002 (21 CFR 900.20 through 900.25). Go to http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/ucm049115.htm for a current list of SAC States.

      Field Office Guidance: With the exception of inspection audits and SAC oversight functions, field offices will not normally be responsible for assessing compliance of mammography facilities in SAC States. There are several exceptions. The first is where FDA and the State decide to work together to bring a facility into compliance. Another exception is that FDA certifies and inspects federal facilities in SAC States.

   4. Veterans Health Administration (VHA) Inspections

      Mammography facilities operated by VHA, which is part of the U.S. Department of Veterans Affairs, are exempt from the requirements of MQSA (see 354(a)(3)(A) of the MQSA (42 U.S.C. 263b(a)(3)(A)). The law does not require that these facilities be certified or inspected by FDA. However, to assure that the quality of mammography at their facilities is equivalent to certified facilities, VHA requires all their mammography facilities be accredited by the American College of Radiology and meet VHA standards that are equivalent to FDA standards.

      Under an interagency agreement (IAG) with VHA, FDA inspects VHA facilities. Their facilities are evaluated against the same requirements as FDA certified facilities. FDA inspects these facilities using the same procedures and software (FISS) as certified facilities. FDA provides the inspection reports to the VHA which is responsible for assuring compliance of their facilities with VHA standards. Under the IAG, VHA reimburses FDA for the costs for these inspections. FDA shouldn't direct facility personnel to respond to FDA regarding the inspection observations nor should it evaluate responses for these observations.

   5. Inspection Follow-up and Regulatory Action

      Facilities should be informed of adverse observations during the inspections in one of several ways. The most common method is for the inspector to leave a printed inspection report at the close of the inspection (some States may mail this report to the facility after State supervisory review).

      FDA may use various advisory, regulatory, and other actions for a facility that fails to comply with the standards and regulations under MQSA. These include:

      1. Warning Letter - formal notification to the facility regarding serious violations that could result in regulatory action, if not corrected.

      2. Additional Mammography Review (AMR) - under 21 CFR 900.12(j)(1), FDA may require additional mammography review to investigate whether violative conditions at a facility may have seriously affected the quality of mammography (see Attachment G). Should this AMR show that the quality of mammography represents a serious risk to human health, FDA may require patient and physician notification, as well as other regulatory actions. An AMR may consist of a review of mammograms to assess the clinical image quality of mammography at a facility. In some instances, the review could include mammography reports to assess the quality of mammographic interpretations.

         Note: AMR isn't a regulatory action, but may be combined with other actions where serious violations have been found.

      3. Directed Plan of Correction - a specific set of requirements imposed to assure that the facility performs mammography in compliance with MQSA and allows monitoring of the facility's continued compliance (section 354(h)(1)(A) of the MQSA (42 U.S.C. 263b(h)(1)(A)).

      4. Civil Money Penalties - fines imposed for violations of MQSA (section 354(h)(3) of the MQSA (42 U.S.C. 263b(h)(3)).

      5. Patient and Physician Notification (wording in MQSA is "Patient Information") - FDA required notification for patients and physicians when the mammography at the facility has been found to be a serious risk to human health (section 354(h)(2) of the MQSA (42 U.S.C. 263b(h)(2)).

      6. Suspension or revocation (of the facility's MQSA certificate) - action taken to stop a facility from performing mammography in violation of MQSA (section 354(i) of the MQSA (42 U.S.C. 263b(i)).

      7. Action under 21 CFR 900.13(a) (certificate determined to be no longer in effect) - if a facility's accreditation has been revoked by its accreditation body, FDA may determine that its certificate is no longer in effect. This action is equivalent to suspension of the facility's certificate prior to a hearing. A facility whose certificate is no longer in effect must stop performing mammography.

      8. Injunction - court order which stops a facility from performing mammography where continued operation may represent a serious risk to human health or when a facility continues to perform mammography without a certificate (section 354(j) of the MQSA (42 U.S.C. 263b(j)).

   6. Scheduling Inspections

      In most cases, a facility gets its 6 month provisional certificate and then goes on to get its full 3 year certificate. This facility should be inspected within 10-14 months of its initial provisional certification date and then every 10-14 months from its most recent inspection. However, there are exceptions to this general policy that can be found under section 2.1.2 Routine Annual Facility Inspections - When should a facility be inspected? in the MQSA inspection procedures (http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm).

   7. Inspection Priorities

      1. Highest Priority

         1. Immediate inspections to investigate allegations of serious risk to human health, performing mammography without a certificate, continuing serious violations, or fraud
         2. Follow-up inspections for facilities with a history of serious violations (facility failed to respond or provided inadequate response after violative inspection, facilities under Directed Plans of Correction, facilities considered for regulatory actions with no recent inspection)
         3. Compliance inspections (inspections to follow up on a Warning Letter)

      2. Moderate Priority - Inspections under moderate priority should be scheduled ahead of facilities with lesser problems, but still within 10 to 14 months after the previous inspection. The scheduling of these inspections should also take into account the location of the facility, as well as travel costs, availability of personnel, and other constraints.

         1. Inspections of facilities with a history of violations not serious enough for highest priority (example: repeat level 1, level 1 and/or repeat level 2 observations, but response to last annual inspection was adequate)
         2. Inspections of facilities with violations under State regulations that parallel MQSA requirements, but not serious enough for highest priority
         3. Facilities that have complaints against them concerning quality standards (including complaints from accreditation bodies), but not serious enough for highest priority
         4. Facilities that have "reinstated for accreditation" and have never been inspected (section 2.1.2 Routine Annual Facility Inspections - When should a facility be inspected? in the MQSA inspection procedures for more information about when to inspect reinstated facilities, http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm))

            Note: Reinstatement for accreditation is a process that allows facilities that are no longer accredited and certified to apply for accreditation to have the certificate reinstated. This facility may then be considered a new facility and eligible for a provisional certificate. Reinstatement applies to any facility that:

            1. let its certificate expire
            2. withdrew its accreditation
            3. was denied accreditation or reaccreditation
            4. had its accreditation suspended or revoked
            5. had its certificate suspended

            In situations 3-5 above, the facility must have corrected its problems to the satisfaction of the accreditation body before being reinstated (see 21 CFR 900.11(c)(1)(iii)). After receiving the provisional certificate, the facility may resume performing mammography while completing the requirements for certification (21 CFR 900.11(c)(3)).

      3. Normal Priority - see section 7 of this Part for further information on scheduling these inspections.

      4. Low Priority - new provisionally certified facilities (inspection of these facilities should be delayed, if possible, until 10-14 months after their initial provisional certification date. The only time a new provisionally certified facility should be high priority is when serious MQSA violations and/or mammography quality problems are suspected).

   8. RRHR Management Activities

      The RRHR should coordinate and supervise agency contracts with States performing MQSA inspections, including the following:

      1. Work with contract States to have each facility within the State inspected following the guidance under sections 7 and 8 of this Part and to expedite submission of the inspection results for those facilities to the MPRIS to ensure timely follow-up action by FDA.
      2. Monitor annual inspection audits of State and FDA personnel by qualified MQSA auditors to ensure that proper procedures and techniques are used during inspections.
      3. Administer tests and practical examinations to inspectors who are training for MQSA inspector certification.
      4. Monitor State and FDA inspection workload and manpower resources and give periodic assessments to DMQRP/CDRH.
      5. Coordinate and supervise MQSA inspection contracts with States.
      6. Coordinate with States for the performance of special inspections (e.g., follow-up inspections, special assignment inspections).
      7. Authorize a State to inspect a facility without prior notification.
      8. Authorize a State to release information regarding an MQSA facility inspection (unless information is required to be released under State law).

      RRHRs should be copied on all correspondence with State programs, including State inspectors, as well as all facility correspondence.