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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Kaiser Permanente Medical Center-Vallejo 10-Dec-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

WARNING LETTER

December 10, 2001

Via Federal Express

FDA Reference #: 2952237

MQSA Facility ID: 197533

Inspection ID: 1975330007

Steve Stephens

Director of Diagnostic Imaging

Kaiser Permanence Medical Center - Vallejo

975 Sereno Drive

Vallejo, CA 94589

Dear Mr. Stephens:

We are writing to you because on November 11, 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 findings at your

facility:

1. 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 3 [redacted] room Mammo A

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 unit 4, [redacted] room Mammo B

The specific problems noted above appeared on your MQSA Facility Inspection Report,

which was issued to your facility at 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, 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 other Level 2 finding that was listed on the

inspection report provided to you at the close of the inspection. This Level 2 finding is:

  1. Failed to produce documents verifying that the radiologic technologist [redacted] met the continuing experience requirement of having performed 200 mammography examinations

It is necessary for you to act on this matter immediately. Please explain to this office in

writing within fifteen (15) working days born 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 a 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.

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