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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Evanston Regional Hospital 15-Nov-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Southwest Regional Office
4040 North Central Expressway
Suite 900
Dallas, Texas 75204




WARNING LETTER

November 15, 2006

Via Federal Express - Next Day

Re: MQSA Inspection ID # 174672
FE1# 1000517628

2007-SWR-02

Ben Quinton
Chief Executive Officer
Evanston Regional Hospital
190 Arrowhead Drive
Evanston, WY 82930-9266

Dear Mr. Quinton,

On October 18, 2006, a representative of the Food and Drug Administration (FDA) conducted an investigation at your facility which revealed a serious problem involving the conduct of mammography. Under the Mammography Quality Standards Act of 1992 ("MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), you must meet specific requirements to practice mammography. These requirements serve to protect the health of women by assuring that a facility can perform quality mammography.

The problem identified during this investigation constitutes a violation of the MQSA as identified below.

Phantom QC records were missing for at least 4 weeks for the [redacted] unit located in the mammography room. [See 21 CFR 900.12(e)(2)].

On October 18, 2006, you responded by letter to the noncompliances found during the investigation as referenced in this Warning Letter. The corrective actions you have implemented will be evaluated during your next inspection.

Because these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

  • requiring your facility to undergo an Additional Mammography Review

  • placing your facility under a Directed Plan of Correction

  • charging your facility for the cost of on-site monitoring

  • requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information

  • seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards

  • seeking to suspend or revoke your facility's FDA certificate

  • seeking a court injunction against your facility

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility and does not necessarily address other obligations you 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/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M . McGee, M.S., Southwest Regional Compliance Officer, by telephoning (214) 253-4935.

Sincerely yours,

/S/

Dennis E . Baker
Regional Food and Drug Director
Southwest Regional Office