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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Boscobel Area Health Care 02-Jan-02

   

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

Food and Drug Administration
Minneapolis District
240 Hennepin Avenue
Minneapolis, MN 55401-1999
Telephone: 612-334-4100

January 2, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 16

Gary Bezucha
Facility Administrator
Boscobel Area Health Care
205 Parker Street
Boscobel, Wisconsin 53805

Dear Mr. Bezucha:

On November 29, 2001, a representative of the State of Wisconsin, acting on behalf of the Food and Drug Administration (FDA), inspected your facility (Facility ID = 180018). This 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. Based on the documentation your site presented at the time of the inspection, the following Level 1 and Level 2 findings were documented at your facility:

Level 1 Non-Compliance

  • Phantom QC records were missing for at least four weeks for your mammography unit ( [redacted] Mammography room, ACR unit designation = 1).

Level 2 Non-Compliance:

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 mammography unit ([redacted] Mammography room, ACR unit designation = 1).

The specific problems noted above appeared on your MQSA Facility Inspection Report which was issued to your facility following the close of the inspection. Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent a serious violation of the 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, or each day of failure to substantially comply with, the Standards; suspension or revocation of your facility? s FDA certificate; or obtaining a court injunction against further mammography.

It is necessary for you to act on this matter immediately. Please explain to this office in writing within 15 working days from the date you received this letter:

  • the specific steps you have taken to correct all of the 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.

Please submit your response to Thomas W. Garvin, Radiological Health Specialist,
Food and Drug Administration,
2675 N. Mayfair Road, Suite 200,
Milwaukee, WI 53226-111305.

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 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 specific questions about mammography facility requirements, or about the content of this letter, please feel free to phone Mr. Garvin at (414) 771-7167 ext. 12.

Sincerely,
James A. Rahto
Director
Minneapolis District