Mammography Facility Inspections - Attachment F
Guidance for Evaluating a Facility Response
Facility Responses and Follow-Up Inspections
You will find additional guidance on facility responses is provided in section A. 1. c. of Part V. Since the adequacy of the facility response may trigger a Warning Letter or follow-up inspection, you should also review section A. 2. in Part V on Warning Letters and section B. in Part III on compliance and follow-up inspections.
Evaluating a Facility Response
You will find that most facilities will respond to the inspections observations and provide adequate information. In those cases where information is missing, a phone call or follow-up letter may resolve the situation. The Policy Guidance Help System usually spells out the specific criteria FDA will use to evaluate whether a facility complies with a specific section of the regulations. You should consult these criteria when evaluating a response.
A facility response should include all of the following items:
- How the facility has corrected or plans to correct the problems observed
- The date(s) corrections will take place, if the facility hasn't corrected all of the problems when it responds
- How the facility will prevent recurrence of the problems
- For problems involving equipment, equipment test results, including equipment settings and technique factors, raw test data, and calculated final results
- If the observations relate to quality control or other records, sample records showing compliant recordkeeping (patient names or identification should be omitted from any copies of records submitted)
- For personnel qualifications, one of the following:
- documentation that the personnel meet the requirements,
- an indication that the personnel are no longer providing mammography services at the facility (services would be defined as interpreting physicians reading and interpreting mammograms, radiologic technologists performing mammography, or medical physicists conducting medical physicist surveys)
- an indication that personnel have been placed under the direct supervision of a qualified physician, technologist, or physicist, as appropriate.
- For medical records, the corrective action might include changes to procedures. These procedures would specify what steps must be taken to prepare the records correctly and assure that reports and letters are provided within appropriate time frames. In the case of mammography reports, the facility should provide sample reporting formats to demonstrate that required information is included.
- Other areas where revised procedures usually need to be sent to FDA include medical outcomes audit, consumer complaints, and infection control.
- For level 1 observations for a mammography x-ray unit, the unit needs to be brought into compliance before it can be used for mammograms. For a film processor, it must be brought into compliance before mammograms are processed. For level 2 observations under 21 CFR 900.12(b), the facility does not have to stop using the equipment immediately, but needs to correct the problem in a timely manner. "In a timely manner" might mean within 30 days, but longer if parts must be ordered or a new x-ray unit or processor must be installed. For level 2 observations under 21 CFR 900.12(e), consult §900.12(e)(8)(ii) for additional information on when the facility must take corrective action.
- For level 1 observation(s) for an interpreting physician, the facility must provide documentation that the physician is licensed and is board certified or had two/three months training in mammography. Usually these physicians are able to provide documentation to the facility. However, if the facility cannot provide documentation, you should refer to Attachment G for a possible AMR.
NOTE: If the x-ray system noncompliance is a manufacturer or assembly problem, refer to CP 7382.003.
Facility Responses from Facilities with Violative Histories
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, you should consider it inadequate and schedule a follow-up inspection before sending a Warning Letter.
Inspection Observations Disputed by Facility
If a facility disputes inspection observations and believes that the inspection report is incorrect, the district should work with the inspector to resolve the dispute. If the inspector works with the State, the district should consult with the RRHR. For guidance on disputed observations, go the Policy Guidance Help System at http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm (check under Inspection/Report/Inspection Findings Disputed by Facilities).
Assistance with Facility Responses
If the district would like assistance when evaluating facility responses, it should refer to Attachment A for contacts.