Mammography Facility Inspections - Part III: Inspections

PART III - INSPECTIONS

1. Facility Inspections

   Note: Only FDA and State inspectors who have been certified by FDA may perform MQSA inspections (including follow-up inspections) (see Section 354(g)(1)(D) of the MQSA (42 U.S.C. 263b(g)(1)(D)).

   A facility inspection may consist of equipment testing (x-ray equipment and film processors), a review of quality assurance and quality control records, medical physicist reports, medical audit and outcomes analysis records, personnel records, and medical records. Both test data and inspection observations should be included in each inspection report. The facility should generally be given at least five days notice before the start of the inspection. This notification enables the facility make adjustments to patient scheduling or communicate conflicts or concerns with the proposed inspection date (see Attachment M for a sample confirmation note).

   Note: A Notice of Inspection (form FDA 482) is not required for an MQSA inspection.

   Under some circumstances, where the continued performance of mammography may threaten the public health (mammographic quality is seriously substandard) or where fraud may be suspected (for example, where there is concern that quality control records had been falsified), districts may decide to conduct an unannounced inspection. In the event that districts decide to conduct an unannounced inspection, the inspector should place a memorandum in the facility's establishment file with the reasons why he or she conducted an unannounced inspection. States must get clearance from the RRHR prior to conducting unannounced MQSA inspections (States may conduct unannounced State inspections without FDA authorization when operating under State law).

   FDA MQSA inspectors should inspect all federal facilities, including military. This would include federal facilities in SAC States and military facilities in United States territories and foreign countries. The following are the inspection types that can be selected in the FISS software used for inspections:

   Annual Inspection: The most common type of inspection, which is done 10-14 months after the previous inspection. Inspection fee applies (go to http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm111000.htm for inspection fee information).

   Follow-Up Inspection: An inspection conducted to verify corrective action identified from a facility response or to document ongoing violations prior to taking regulatory action or sending a Warning Letter. Follow-up inspections usually are limited to areas found noncompliant during the previous inspection. Inspection fee applies (go to http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm111000.htm for inspection fee information).

   Compliance Inspection: An inspection conducted as a follow up to a Warning Letter to determine if violations continue. No inspection fee.

   Headquarters-Initiated Inspection: Any inspection requested by CDRH or initiated by a district to investigate complaints about a facility. This inspection type should also be used for any other inspection at a facility that doesn't fall under one of the other types. No inspection fee.

   Joint Audit Inspection: An audit performed by an MQSA auditor simultaneously with an annual inspection by a State or FDA inspector. Since this is an annual inspection, it has an inspection fee (see section C of this Part for more information about audits).

   Guidelines for facility inspections:

   1. Inspectors should follow the MQSA inspection procedures (http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm).

   2. Districts and contract States should select facilities for inspection based on priority (see Inspection Scheduling and Priority in Part II, B.7. and B.8.).

   3. Inspectors should contact the facility by telephone at least five days before the inspection and follow up with a fax or email notice (see Attachment M). If the facility does not have a fax system, then the inspector should mail a notice to the facility. The facility person contacted by phone and notified by fax or letter should be a person in authority and not a clerical employee. Examples of contact individuals would be the chief technologist, lead or other interpreting physician, and quality control technologist. Inspectors should also explain that personnel critical to mammography quality assurance should be notified regarding the time and date of the inspection and be available during the inspection.

      Note: On occasion, when FDA, the State, or an accreditation body is informed of possible serious violations or a risk to health at a facility inspected less than 10 months previously, FDA may need to inspect as soon as possible. For these inspections, the inspector should select an inspection type of "Headquarters Initiated" at download. This inspection type should also be used for other special inspections that aren't annual, follow-up, or independent audits. Inspections uploaded with this inspection type wouldn't normally be billed for an inspection fee.

   4. At the facility, the inspector should:

      1. Wear a personnel radiation dosimeter (thermoluminescent detector (TLD) or film badge) provided either by FDA or the appropriate State Agency when performing the x-ray system testing.

      2. Discuss the inspection with facility personnel about what is involved, prior to conducting any equipment testing or review of facility records, unless this was covered on the telephone prior to the inspection.

      3. During the inspection, enter inspection data into the laptop computer. The inspector should upload the data to MPRIS within five working days after the inspection.

      4. Provide the facility with the MQSA Facility Inspection Report (indicated as "post-inspection report" in the inspection FISS software program), which contains test results and inspection observations (some States may mail this printout to the facility after State supervisory review). The inspector should discuss these observations with the most responsible person at the facility, even when the inspection report is mailed to the facility at a later time. The inspector should also record in the inspection report if the report is left at facility during the inspection or mailed, as well as the person who received or was mailed the report. If the person who was mailed the report is different from the most responsible person at the facility, the most responsible person should also be mailed a copy of the inspection report. When the report is mailed, the date it is mailed should be recorded in the inspection report. It is very important that the inspector make management at the facility aware of the inspection observations and what they need to do in response to these observations. The inspector should identify areas of noncompliance, especially any level 1 and/or repeat observations. See the section 2.8 of the MQSA Inspection Procedures (http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm) for more information on discussing inspection observations with management. In addition to the MQSA Facility Inspection Report, the facility should receive a document entitled Important Information about Your MQSA Inspection, which contains guidance to the facility as to how to interpret its inspection report (see Attachment L). This identifies the different levels of inspection observations and how the facility should respond to FDA, based on the highest level of observation. A check box is present on the form for the inspector to indicate which information pertains to the facility's inspection.

         Note: A new section to this document was recently added which is titled "Your report identified at least one repeat level 1, level 1, or repeat level 2 as the most serious adverse observation and previous inspections have found at least one of these observations at your facility" If a facility has past and current inspection observations of this significance, you should point out the paragraph at the end of this section that discusses the steps it needs to take to prevent the reoccurrence of the problem(s).

      5. Document any x-ray system damage (real or claimed) due to the testing of the x-ray unit or any other facility equipment on FDA form 2766, Claim for Damage to an Electronic Product (refer to Attachment D). Forward this form immediately through the RRHR to DMQRP (without delaying submission or attempting to refute the alleged damages).

         Note: State contract personnel should immediately report any allegations of damage to an x-ray system or other facility equipment to the RRHR. The RRHR should determine what follow up is required (use of FDA form 2766 is not required for State inspections). Under the Federal Tort Claims Act, FDA is not responsible for any damage to facility equipment by State contract employees.

      6. Documentation: Regarding records reviewed during the inspection, the inspector should collect copies of records that show why he or she made a specific inspection observation. This would apply for any level 1, 2, or repeat level 3 observations. Copies of records should also be collected when numerous problems with records may result in a Warning Letter being sent, although no level 1 observations are present. If in doubt, the inspector should collect copies of records. FDA may need documentation or other evidence for a regulatory action (Directed Plan of Correction, Civil Money Penalties, suspension or revocation, or injunction).

         Note: Since FDA jurisdiction depends upon a facility performing mammography when the violations occurred, the inspector should copy records showing that mammography was being performed at the time of the violations. Since the facility can be charged with violating MQSA for each mammogram done while failing to comply, you should document as many mammograms as possible that are associated with specific violations. If it is not possible to document every mammogram, the inspector should record the number of mammograms performed during the time period when the facility was in violation of MQSA regulations. FDA inspectors should also prepare an affidavit tying all records copied to the violations observed and the mammograms done when the violations took place.

         Examples of records that could be collected during an inspection include:

         1. medical physicist reports,
         2. mammography reports or patient letters (patient names and identification must be purged for State inspections; for FDA inspections, names and identification should be purged unless records were copied to support regulatory action),
         3. records concerning personnel qualifications, and
         4. quality control records for film processing, phantom images, and other tests.

         When films such as phantom images, STEP, and FOG tests are produced as part of the equipment testing, these films should remain with the office that conducted the inspection (either the contract State, the FDA district, or FDA regional office), unless specifically requested by the FDA district (or regional office, where appropriate) or DMQRP to be transferred to another location. The inspector should identify records collected with:

         1. name and facility ID number of the facility,
         2. date of the inspection, and
         3. name or initials of the inspector.

         The inspector should forward to the appropriate district or regional office copies of records collected during State inspections for level 1, 2, or repeat level 3 observations (see Attachment E). The State should retain films produced during inspections that show minor or no observations. For level 1 phantom image failures, States may need to send phantom films to the MQSA auditor to confirm the level 1 score (see Appendix 3 of the MQSA inspection procedures; http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm114146.htm).

         Note: No documentation of interstate commerce is necessary for MQSA inspections.

      7. Patient Records: Inspectors may need to collect copies of records, such as mammography reports, mammography logbooks, or letters to patients about mammography results. FDA MQSA inspectors will most likely collect these records when visiting facilities as part of investigations or follow-up inspections, though records may be copied during routine inspections to document medical record violations under 21 CFR 900.12(c).

         In the Policy Guidance Help System, there is a section on the Health Insurance Portability and Accountability Act (HIPAA), a federal law which provides protection for patient information. Under 45 CFR 164.512(b) and (d) of the HIPAA regulations issued by the Department of Health and Human Services, facilities are allowed to release patient information to an MQSA inspector without patient authorization because MQSA inspectors are performing health oversight activities required by law.

         In general, whenever an inspector needs to copy a record containing patient names or other identifying information, he or she also needs to protect patient confidentiality. All inspectors bear a legal and ethical responsibility to prevent unauthorized disclosure of this information. However, FDA also should have accurate documentation of serious violations under MQSA. FDA may need patient names to establish that a violation has occurred, to follow up specific complaints, or to prove that a copy of a record made during an inspection or investigation is a true copy of the original record. The inspector should not purge the copy made during the inspection, if this copy is going to be used as evidence for a potential compliance case (this only applies to FDA inspectors, since FDA contracts with States prohibit State inspectors from making copies without removing patient names or other identifying information). As with any confidential FDA document, the inspector should not disclose these records outside of the FDA or State. The inspector should only share unpurged records containing patient identifiers with other agency or State employees on a "need to know" basis, in accordance with 21 CFR Parts 20 and 21. In addition, FDA advises that if copies of these records are required for use by authorized personnel, inspectors and/or compliance officers should purge additional copies of all patient identifiers whenever there is no need for that particular information to be shared. Patient identifiers would include names, hospital identification numbers, social security numbers, or any other name or code related to a specific patient.

      8. Written Inspection Reports: For inspections or follow-up inspections that reveal serious violations that may result in regulatory action, FDA inspectors should prepare, in addition to the MQSA Inspection computer data that is uploaded to MPRIS, a complete Establishment Inspection Report (see Investigations Operations Manual (IOM), Section 593).

      9. Inspection refusal: In the event that a facility refuses to allow an inspection, the district should contact the Division of Compliance Management and Operations (HFC-210) about getting an inspection warrant (see Regulatory Procedures Manual, Chapter 6). When State inspectors are refused, the inspector or their State supervisor should contact the RRHR.

2. Compliance Follow-Up for Inspections

   The District Office (or Regional Radiological staff, where appropriate) should:

   1. Thoroughly review compliance activity for any facility where regulatory action is being considered. The district's review should include the evaluation of all of the following factors:

      1. Inspection data from MPRIS and copies of facility records
      2. Responses to Warning Letters and copies of any other correspondence with the facility
      3. The results of an Additional Mammography Review (AMR) for a facility (see 21 CFR 900.12(j)(1))
      4. State actions against the facility, under State laws and regulations
      5. Equipment maintenance schedules and service records
      6. Medical physicist reports
      7. Written consumer (patient) complaints, employee complaints, or medical physicist complaints
      8. Written comments or concerns from the inspector

   2. Ensure that whenever corrective actions are evaluated, the MPRIS Web database is updated to reflect the compliance status of a facility.

   3. Monitor inspection results, responses to inspection observations (especially those contained in Warning or Directed Plan of Correction Letters), follow-up inspection data, and identify facilities for possible regulatory follow up.

   4. Prepare and send Warning Letters and perform any follow up associated with the letters.

3. Inspection Quality Assurance Audits and Mentoring

   1. Audits: FDA Auditors should audit all FDA and State MQSA inspectors to ensure they are following FDA procedures and guidance for MQSA inspections. The MQSA Auditor's Guide (http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074895.htm), dated January 1998, provides information on how to conduct audits. Districts should work with the RRHRs if they require assistance in meeting the auditing workplan. Each inspector should be audited at least once during each federal fiscal year. Field Management Directive No. 76 provides general guidance on the MQSA audit program. In addition, the Auditor's Guide contains procedures and policies pertaining to implementation of the audit program. An audit consists of a joint inspection performed by an MQSA auditor simultaneously with an annual inspection by a State or FDA inspector, as well as the review of uploaded inspection records.

   2. Mentoring: mentoring is a requirement for newly-trained MQSA inspectors (those that have passed Course III training) that must be completed before they may begin conducting inspections independently. Mentoring consists of the new inspector being accompanied on an inspection by another experienced inspector. Each newly-trained inspector must be mentored during two inspections within 90 days after passing Course III training before conducting inspections independently. While most State inspectors will be mentored by another experienced State inspector, an FDA auditor or another experienced FDA inspector will usually mentor newly-trained FDA inspectors. FDA auditors or experienced FDA inspectors may also mentor State inspectors, when necessary. Mentoring is also used to re-qualify inactive Federal and State personnel. This includes personnel who retire and are hired back as contractors, or personnel who were involved in the MQSA program in the past and then reassigned to other non-MQSA duties and are now returning to the MQSA program.

4. Follow-Up and Compliance Inspections

   Note: FDA MQSA inspectors should do all follow-up and compliance inspections.

   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 will provide them with a revised version of the Important Information about Your MQSA Inspection document (see Attachment L). If the facility management fails to respond or the response is inadequate to repeat level 1, level 1 or repeat level 2 observations, you should send a Warning Letter to the most responsible individual at the location and also a copy to the most responsible individual, if off site. Typically, this Warning Letter is preceded by a follow-up inspection. A compliance inspection should be performed two to three months following the Warning Letter to ensure that the violations have been corrected. If this inspection shows continuing violations, you should consider regulatory action, such as a Directed Plan of Correction or Civil Money Penalties. These steps are outlined on the flowchart in Attachment H.

   When using the guidance in the paragraph above, there are several things the district should consider:

   1. If facility management fails to respond within 15 (or 30) working days, there may be a reasonable explanation why they haven't responded, such as miscommunication within the facility. Before sending a Warning Letter for repeat level 1, level 1 or repeat level 2 observations, the district should contact them (may be verbal or written) and ask that they respond in writing or come in for a face-to-face meeting. If this fails to resolve the violations, the district should proceed with the follow-up inspection or Warning Letter.

   2. You should always check the facility's inspection history whenever an inspection has repeat level 1, level 1, or repeat level 2 observations. The Inspection History Report in MPRIS Web is convenient for this purpose. If the facility has a violative history, facility management may find it difficult to provide convincing evidence that problems are permanently corrected. If the facility's response contains promises of corrections similar to previous inspections, the district should consider it inadequate and schedule a follow-up inspection for repeat level 1, level 1, or repeat level 2 observations.

   3. If FDA previously sent the facility a Warning Letter for an MQSA inspection, it probably falls under item two above. If a follow-up inspection shows continuing violations, the district should consider regulatory action instead of another Warning Letter.

   4. For certain types of facility problems, such as level 1 observations for phantom image testing by the inspector or level 1 interpreting physician qualifications, we may require the facility to undergo Additional Mammography Review (AMR) under 21 CFR 900.12(j)(1) (see Attachment G). Since the AMR shouldn't be delayed, we may notify the facility about the AMR prior to a follow-up inspection. The Director of the Division of Mammography Quality and Radiation Programs (DMQRP) would usually send an untitled letter to the facility requiring AMR. DMQRP will work closely with the district when requesting AMR and will copy it when results are provided by the accreditation body or other review entity. If the AMR shows that the quality of mammography may represent a serious risk to human health, we can require the facility to notify patients and physicians under 21 CFR 900.12(j)(2). More information about AMR can be found in section A.3. in Part V.

   Follow-up and compliance inspections should take priority over routine, annual inspections. A fee is usually charged for all follow-up inspections, but no fee should be charged for compliance inspections which should occur two to three months after the Warning Letter was sent.

   In violative cases, districts need to obtain adequate documentation of the violations. This means that for violative follow-up inspections, the inspector should prepare a complete narrative report for the inspection (see Investigations Operations Manual (IOM), Section 593), in addition to any information or data recorded in the FISS inspection software.

5. Uncertified Facilities

   1. Background

      FDA may learn that a facility may be performing mammography without a certificate from several sources. A State radiation control program, an accreditation body, consumers, and current or former employees may report the facility.

      A facility that can be shown to be performing mammography without a certificate may be a candidate for regulatory action. However, in most cases, FDA would handle these violations like most level 1 observations. Examples of facilities performing mammography without a certificate could include:

      1. new mammography facilities that fail to apply to an accreditation body (this application is required prior to provisional certification)
      2. facilities that continue to perform mammography after being notified that their certificate has expired, been suspended, been revoked, or no longer is in effect

      Facilities can be assessed civil money penalties or enjoined from operating if they perform mammography without a certificate and have a violative history (see Part V for more information). If the facility performs mammography without a certificate for 90 days or longer, FDA may require AMR.

      Since other violations and problems could support regulatory action by FDA, the district should inspect against all MQSA requirements, if possible.

   2. Facility Investigations and Inspections

      1. If the district becomes aware that a facility may be performing mammography without a certificate, it should inspect the facility as soon as possible. The district should also contact DMQRP prior to the inspection to verify certification status and to obtain any documentation it may have regarding the facility's certification history.

      2. The inspector should conduct a routine MQSA inspection and also document the illegal mammography. The documentation the inspector collects to show illegal mammography should consist of copies of mammography reports (the more recent, the better). Mammography reports are documents that contain the physician's interpretation of the mammogram and should include the date of the mammogram, the date of the interpretation, the facility name, the patient's name or some identification, physician's name, and a written interpretation. For records with patient names or identification, all personnel involved with MQSA should exercise caution to ensure confidentiality and privacy when handling these documents and information (see section A.4.g of this Part for information on the handling of patient records).

      3. If the mammography reports do not contain sufficient information to document that the facility was performing mammography without a certificate, inspectors may need to copy mammography film labels. Mammography films have either a paper label attached or a label imprinted into the film with light. Either of the labels should copy easily on a conventional photocopier. The labels should contain the patient's name, the facility's name, and the date of the mammogram. If the label cannot be photocopied, the inspector may need to photograph the label (on the facility's viewbox if the label was imprinted into the film). However, unless the mammogram has information that can be correlated with the date that the exam was performed, inspectors should not copy information from the films.

      4. Inspectors may find that patient logs or schedules are good sources of information about patients who had mammograms. However, inspectors should make sure that patients listed for mammography on logs or schedules actually had mammograms at the facility. Patients on these documents may have been scheduled, but may not have had the scheduled mammogram. Inspectors may find that the logs or schedules provide indications of volume, but should not be used as a substitute for copies of mammography reports.

         NOTE: Inspectors should always attempt to get a commitment from the uncertified facility to voluntarily stop performing mammography on the day of the inspection. If the facility is not willing to voluntarily stop performing mammography, FDA may need to enjoin the facility from performing mammography without a certificate. In the interim, the State should be contacted. It may have independent authority to stop the facility from performing mammography and FDA may decide to coordinate action with the State against the facility.

6. Possible Criminal Activity at a Facility

   If the district suspects that a facility may have falsified records, has submitted false information to the district, or may have engaged in other possible criminal activity, it should contact the appropriate Office of Criminal Investigations (OCI) field office. The district should coordinate any district follow-up at the facility with this OCI office. However, the district should not delay inspections or investigation of serious problems regarding the quality of mammography (that is, where a possible serious risk to human health may exist) for the purposes of documenting criminal activity, since FDA may need to require AMR at the facility.

7. Mammography Equipment Problems (Non-MQSA)

   If the district suspects that a problem with mammography x-ray unit, film processor, film, cassettes, image processing computers, or other equipment is related to the manufacturer or assembler of the equipment, it should notify the Diagnostic X-Ray Devices Branch, OCER, CDRH and the RRHR. Please refer to CP 7386.003 for guidance regarding x-ray equipment problems.

8. Complaints about Patient Access to Mammograms

   Occasionally, districts may receive complaints from patients, health care providers, facilities, or others that patients cannot get access to their mammograms. Under 21 CFR 900.12(c)(4)(ii), facilities must transfer original mammograms and copies of the patient's reports when requested by, or on behalf of, a patient to a medical institution, or to a physician or health care provider of the patient, or to the patient directly. If you receive complaints of this type, please contact the Inspection and Compliance Branch (see Attachment B for contact information). While facilities that are still operational, whether certified or not, may be the subject of regulatory action for failure to provide mammograms when requested, some may be closed. Even if the facility is closed, the Division of Mammography Quality and Radiation Programs tries to work with patients to locate and obtain their records.