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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Women's Diagnostic Imaging Center 17-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 98021-4421

Telephone: 425-486-8788

FAX: 425-483-4996

December 17, 2001

VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Reference: Warning Letter SEA 02 ? 22

Inspection ID: 1477690008

WARNING LETTER

Ms. Karen MacInerney, Manager

Women?s Diagnostic Imaging Center

1221 Madison Street, Suite 520

Seattle, Washington 98104

Dear Ms, MacInerney:

We are writing to you because on December 6, 2001, your facility was inspected by Mr. Bill Van Pelt, a representative of the State of Washington, 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, 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 inspection revealed the following level 1 findings at your facility:

1. Phantom QC records were missing for at least 4 weeks for unit 6, General Electric Co. (GE Medical Systems), DMR, room 1.

2. Phantom QC records were missing for at least 4 weeks for unit 5, General Electric Co. (GE Medical Systems), DMR, room 2.

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. These problems are identified as Level 1, because they identify a failure to meet a significant MQSA requirement. 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.

In addition, your response should address the Level 2 findings that were listed on the inspection report provided to you at the close of the inspection, These Level 2 findings are:

1. Medical audit and outcome analysis was not done separately for each individual.

2. Failure to produce documents verifying that [redacted], Radiologic Technologist, met the continuing experience requirement of having performed 200 mammography examinations in 24 months.

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 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 (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 (1-800-838-7715) or through the Internet at http://www.fda.gov.

Sincerely,

Charles M. Breen

District Director