Medbrook Medical Center 24-Sep-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Baltimore District Office

900 Madison Avenue

Baltimore, MD 21201-2199

Telephone: (410) 962-3396

CFN:1124099

Facility ID:122895

Inspection ID #1228950008

01 -BLT-43

September 24, 200l

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Jackie Brumage, Manager, Diagnostic Services

Medbrook Medical Center

1370 Johnson Avenue

Bridgeport, West Virginia 26330

Dear Ms. Brumage:

A representative from the State of West Virginia under contract to the Food and Drug Administration (FDA) inspected your facility on August 28, 2001. This inspection revealed a serious regulatory problem involving mammography performed at your facility.

Under a United States Federal law, the Mammography Quality Standards Act (MQSA) of 1992, your facility must meet specific requirements for mammography. These requirements help protect the public health by assuring that a facility can perform quality mammography. The inspection revealed the following Level I finding:

• Your facility failed to document that processor quality control was performed for 11 consecutive days in the month of January 2001.

The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. These problems are identified as Level 1 finding because they identify a failure to comply with a significant MQSA requirement.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography performed at your facility, it represents a violation of the law that 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, or each day of 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, the following Level 2 findings were listed on the inspection report provided to you at the close of the inspection:

• Your facility failed to document corrective actions before further patient exams for failing phantom image tests performed on the [redacted] X-Ray machine located in your mammography room:

• Corrective action was not documented at least once when your processor exceeded preset operating limits;

• Five of five random mammographic examination reports reviewed by the inspector did not contain an assessment category.

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 receive this letter:

• The specific steps you have taken to correct the violations noted in this letter; and

• Each step your facility is taking to prevent the recurrence of similar violations.

Your response should be submitted to: Food and Drug Administration, 900 Madison Avenue, Baltimore, Maryland, 21201, to the attention of Anita Richardson, Director, Compliance Branch.

Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection and does not necessarily address other obligations you may have under the 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.

If you have technical questions about mammography facility requirements, or about the content of this letter, please feel free to contact Elizabeth A. Laudig at (410) 962-3591, extension 159.

Sincerely,

Lee Bowers

Director, Baltimore District