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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Oaklawn Hospital 04-Mar-03

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

WARNING LETTER

2003-DT-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED

March 4, 2003

Robert J. Zick, M.D.
Mammography Supervisor
Oaklawn Hospital
200 North Madison
Marshall, MI 49068

Dear Dr. Zick:

We are writing you because on February 19, 2003, your facility was inspected by a representative of the State of Michigan acting on behalf of the Food & Drug Administration (FDA). The inspection revealed a serious deficiency in the quality of the mammography services offered by your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. 263b, 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 recent inspection at your facility revealed the following Repeat Level 2 finding:

1. Two (2) of six (6) medical records, that were randomly selected for review, did not contain an acceptable assessment category. This is in violation of Title 21 Code of Federal Regulations 900.12(c)(1)(iv).

The specific violation noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which your facility received at the close of the inspection. This problem is identified as a Repeat Level 2 because it identifies a failure to meet a significant MQSA requirement and indicates failure by your facility to implement permanent correction of the same problem found during your previous inspection.

This condition may be symptomatic of serious underlying problems that could compromise the quality of mammography 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, suspending or revoking your facility?s FDA certificate, or obtaining a court injunction against performing further mammography.

It is necessary for you to act on this matter immediately. Please provide 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 Repeat Level 2 violation noted in this letter;
  • each step your facility is taking to prevent the recurrence of similar violations;

Please submit your response to:

Mr. David M. Kaszubski

Director Compliance Branch

U. S. Food & Drug Administration

300 River Place, Suite 5900

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 of your response 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.

There are many FDA requirements pertaining to mammography. This letter only ccncerns the findings of your recent 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/mammograohy.

If you have any questions regarding this letter or how to ensure that you are meeting MQSA standards, please call Mr. Dennis E. Swartz, Radiological Health Expert, at 313-393-8156.

Sincerely yours,

/s/

Joann M. Givens

District Director

Detroit District Office