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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Capital Medical Center 25-Apr-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-466-8766
FAX: 425-463-4996

April 25, 2002
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Reference: Warning Letter SEA 02-45
Inspection ID: 1054370008
WARNING LETTER

Donald Klein, M.D., Radiologist
Capital Medical Center
3900 Capital Mall Way, S.W.
Olympia, Washington 98502

Dear Dr. Klein:

We are writing to you because on April 10, 2002, your facility was inspected by a representative of the State of Washington, Mark Radonich, acting on behalf of the Food and Drug Administration (FDA). 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 1992,42 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 April 10, 2002 inspection revealed the following level 1 violation at your facility:

Your facility does not have adequate procedures to ensure that results of assessments that are "suspicious" or "highly suggestive of malignancy" are communicated to patients as soon as possible, as required by 21 CFR 900.12(c)(2).

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 Level 1, because it identifies a failure to meet a significant MQSA requirement. Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents 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 fifteen (15) working days from the date you received this letter:

  • the specific steps you have taken to correct all of the violation 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 (Note: patient names or identification should be deleted from any copies submitted). *

*This note is not applicable for letters that also address patient notification.

Please submit your response to U.S. Food & Drug Administration, Attention Thomas S. Piekarski, Compliance Officer, 22201 23rd Drive, SE, Bothell, Washington 98021-4421. 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, Maryland 21045-6057 (l-800-838-7715) or through the Internet at http://www.fda.gov.

Sincerely,

Charles M. Breen

District Director