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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Perkins County Health Services 27-Jun-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

Food and Drug Administration
SOUTHWEST REGION
Office of the Regional
Food and Drug Director
7920 Elmbrook Drive, Suite 102
Dallas, TX 75247-4982
TELEPHONE: 214-655-8100
FACSIMILE: 214-655-8130

June 27, 2001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
01-SWR-WL-59/0
RE: Inspection ID ?2244150001

Carol Abbuhl
Administrator
Perkins County Health Services
900 Lincoln Avenue
Grant, NE 69140

Dear Carol Abbuhl,

On June 20, 2001, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious regulatory problem involving the mammography at your facility.

The Mammography Quality Standards Act of 1992 requires your facility to meet specific standards. These requirements help protect the health of worn en by assuring that a facility can perform quality mammography. The inspection revealed the following level 1 findings at your facility:

Level 1: Processor QC records were missing 6 out of 13 days of operation in month 12/2000. Processor QC records missing 46%,for processor 1, Kodak, RP X-OMAT.

Level 1: Phantom QC records were missing for 6 weeks for unit 1, Lorad Medical Systems Inc.

Level 1: The system to communicate results is not adequate for site because:

-There is no system in place to provide timely lay summaries.

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

Level 1 findings may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility. They represent a serous violation of the law which may re suit 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 finding that was listed on the inspection report provided to you at the close of the inspection. The inspection revealed the following level 2 finding:

Level 2: 1 of 5 random reports reviewed did not contain an assessment category.

It is necessary for you to act on this matter immediately. You are required to respond to this office in writing within fifteen (15) working days horn receipt of this letter. Please address the following:

- 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.

- 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).

Please submit your response to:

Deborah M. McGee, Radiation Specialist
Food and Drug Administration
7920 Elmbrook Drive, Suite 102
Dallas, TX 75247-4982

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 Deborah M McGee at (214) 655-8100 ext. 138.

Sincerely yours,

/s/
Darryl E. Brown for Gary L. Pierce
Regional Food and Drug Director