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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fair Oaks Hospital Medical Plaza 07-Nov-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Baltimore District Office

6000 Metro Drive

Suite 100

Baltimore, MD 21215-3215

Telephone: (410) 773-5464

 

CFN: 1124339

Facility ID:159947

InspectionID#1599470008

02-BLT-02

November 7,200l

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Herman East, Diagnostic Radiology Manager

Fair Oaks Hospital Medical Plaza

3700 Joseph Siewick Drive

Suite 408

Fairfax, Virginia 22033

Dear Mr. East:

A representative of the Food and Drug Administration (FDA) inspected your facility on October 23, 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 1 finding:

  • Your facility failed to document that phantom image testing was performed for the weeks of September 2, 2001, September 9, 2001, September 16, 2001, September 23, 2001, September 30, 2001, and October 7, 200l on you m mammography machine.

The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. This problem is identified as a Level 1 finding because it identifies 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 that processor quality control tests were performed on October 10, 2001, October 11, 2001, October 12, 2001, and October 15, 200l;

Your facility failed to document at least once that corrective action was performed when your processor exceeded preset operating limits; and

Your facility failed to perform an annual medical audit and outcome analysis.

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.

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

Your response should be submitted to: Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, to the attention of Ms. 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 (l-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) 779-5441.

Sincerely,

Lee Bowers

Director, Baltimore District