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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Columbia/San Jose Breast Care Center 22-Aug-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: 510-337-6700

August 22, 2001
via Federal Express
MQSA Facility ID: 153585
Inspection ID: 1535850007
FDA Reference #: 2951916

William J. Morse, Director of Radiology
Columbia/San Jose Breast Care Center
707 East Santa Clara Street
San Jose, CA 95112

Dear William J. Morse:

We are writing to you because on June 20,2001, your facility was inspected by a representative of the State of California, acting in 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 repeat level 2 finding at your facility:

1. The facility has not specified adequate written procedures for collecting and resolving consumer complaints or did not follow them when required at site Columbia/San Jose Breast Care Center (R)

The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection.

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, MQSA 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 performed annually at site Columbia/San Jose Breast Care Center

2. Medical audit and outcome analysis was not done separately for each individual at site Columbia/San Jose Breast Care Center

3. Medical audit and outcome analysis was not done for the facility as a whole at site Columbia/San Jose Breast Care Center

4. A medical physicist's survey has not been conducted for x-ray unit 2, [redacted] room Mammo Room 2 within the last 14 months.

5. 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 unit 2, [redacted] room Mammo Room 2

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days horn 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 which also address patient notification Please submit your response to:

Russell A. Campbell, Compliance Officer
San Francisco District
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

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 more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Russell A. Campbell at 510-337-6861.

Sincerely yours,

Dennis K. Linsley

District Director