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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sierra Kings District Hospital 06-Sep-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

September 6, 2001

Via Federal Express

Our Reference: 2952023

WARNING LETTER

MQSA Facility ID: 174813

Inspection ID: 1478130009

E.James McLaughlin, M.D.

Medical Director Radiology

Sierra Kings District Hospital

Radiology Department

372 W. Cypress Avenue

Reedley, CA 93654

Dear Dr. McLaughlin:

We are writing to you because on August 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 level 1 finding at your facility:

  • Phantom QC records were missing for 5 weeks for unit 1 [redacted] room mammography.

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 k 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 S10,000 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 corrective actions should address the 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 of 6 random reports reviewed did not contain an assessment category for site Sierra

Kings District Hospital.

We acknowledge receipt of Joe Torres?, R.T. Supervisor, letter dated August 29,2001

responding to the Level 1 and Level 2 findings discussed above. Mr. Torres? response

appears to adequately address both the Level 1 and Level 2 findings. YOU corrective

actions will be verified during the next inspection.

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://wwv.fda.gov.

If you have more specific questions about mammography facility requirements, or about

the content of this letter, please feel bee to contact Russell A. Campbell, Compliance

Officer, at 510-337-6861.

Sincerely yours,

Dennis K. Linsley

District Director