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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Borgess at Woodbridge Hills 18-Oct-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 48207-3179
Telephone: 313-226-6260

CERTIFIED MAIL
Detroit District
RETURN RECEIPT REQUESTED
WARNING LETTER
2002-DT-07
October 18, 2001

J. Thomas Jones, M.D.
Radiologist
Borgess at Woodbridge Hills
7901 Angling Road
Portage, MI 49024

Dear Dr. Jones:

We are writing you because on October 8, 2001, your facility was inspected by a representative of the State of Michigan acting in behalf of the Food & Drug Administration (FDA). The inspection revealed a serious regulatory problem involving the mammography at your facility.

Under a United Stales 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. Mammograms were processed in your film processor when it was outside of control limits on at least five (5) 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 your staff at the close of the inspection. These level 2 findings are:

1. Corrective actions for processor QC failures were not documented at least once for your mammography film processor.

2.Corrective action before further exams, for a failing image score or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for your Instrumentarium X-ray machines in all three of your mammography rooms.

3. The phantom QC for the [redacted] unit with registration number 40629 was not adequate because the operating level for background density was less than 1.20 optical density (O.D.) units.

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 Michigan 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.0. 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.

Sincerely yours,
David M. Kaszubski for
Joann M. Givens
District Director
Detroit District Office