Inspections, Compliance, Enforcement, and Criminal Investigations
Lake Imaging Center 12-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 48207-3179
RETURN RECEIPT REQUESTED
October 12, 2001
Christine A. Tremper, M.D.
Lake Imaging Center
2520 Lake Avenue
Fort Wayne, IN 46805
Dear Dr. Tremper:
We are writing you because on October 3, 2001, your facility was inspected by a representative of the State of Indiana acting on behalf of the Food & Drug Administration (FDA). The inspection revealed a serious regulatory problem involving the mammography at your facility.
Under a United States Federal law, the Mammography Quality Standards Act Of 1992 MQSA), your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.
The inspection revealed the following Level 1 finding at your facility:
1. Processor QC records were missing at least five (5) consecutive days during the month of May, 2001 and mammograms were processed on those days.
The specific problem noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which was issued at the close of the inspection. This problem is identified as Level 1 because it identifies a failure to meet a significant MQSA requirement.
Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a violation of law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with MQSA standards, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography.
In addition, your response should address the Level 2 findings that were listed on the inspection report provided to you at the close of the inspection. These level 2 findings are:
1.There was no evaluation of the [redacted] mammography system by a qualified medical physicist after replacement of a photocell for automatic exposure control.
2. Processor QC records were missing at least 10% but less than 30% of the days of operation during the month of May, 2001.
3. Phantom image QC records were missing at least two (2) weeks but less than four (4) for the [redacted] mammography system.
4. Phantom image QC records were missing at least two (2) weeks but less than four (4) for the [redacted] mammography system.
It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date you received this letter:
- the specific steps you have taken to correct the Level 1 and 2 violations noted in this letter;
- each step your facility is taking to prevent the recurrence of similar violations;
- equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
- sample records that demonstrate proper record keeping procedures, if the findings relate to quality control or other records. (Note: Patient names or identification should be deleted from any copies submitted)
Please submit your response to:
Mr. David M. Kaszubski
Director Compliance Branch
U.S. Food and Drug Administration
1560 East Jefferson Ave.
Detroit, MI 48207
Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA?s. When you plan your corrective actions, you should consider the more stringent State requirements, if any. You should also send a copy to the State of Indiana radiation control office that conducted the inspection referenced in this letter. You may choose to address both the FDA and any additional State requirements in your response.
Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter only pertains to findings of your inspection and does not necessarily address other obligations you have under law. You may obtain general information about all of FDA?s requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography.
If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Mr. Dennis E. Swartz, Radiological Health Expert, at 313-226-6260 Ext.155.
Joann M. Givens
Detroit District Office