Inspections, Compliance, Enforcement, and Criminal Investigations
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
September 6, 2001
Via Federal Express
Our Reference: 2952023
MQSA Facility ID: 174813
Inspection ID: 1478130009
E.James McLaughlin, M.D.
Medical Director Radiology
Sierra Kings District Hospital
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
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 athttp://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.
Dennis K. Linsley