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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Union County General Hospital - 1/11/01

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Southwest Region
7920 Elmbrook Drive
Suite 102
Dallas, TX 75247-4982
Telephone: 214-655-8100
FAX: 214-655-8130

January 11,2001

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

01-SWR-WL- 17/7

Steve Campbell
Union County General Hospital
301 Harding
Clayton, NM 88415

RE: Inspection ill - 1978140006

Dear Steve Campbell,

On 12/5/2000, 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 women by assuring that a facility can perform quality mammography. The inspection revealed the following level 1 finding at your facility:

Level 1: The system to communicate results is not adequate for site Union County General Hospital because: There is no system in place to provide timely medical reports.

The specific problem 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 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, 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: The interpreting physician did not meet the requirement of having initial experience in mammography (read or interpreted 240 patient examinations in a 6 month period)

Level 2: The interpreting physician did not meet the requirement of having read a minimum of 40 CM credit hours of initial training in mammography:

Level 2: There were no examples of nor attempts to get biopsy results for site Union County General Hospital.

 

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 from 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 fmdings relate to quality control or other records (Note: Patient names or identification should be deleted from any copies submitted).

We have received documentation that addresses the Level 1 non-compliance. We have also received documentation for Dr. Linver's initial 40 hours of training in mammography and the newly established procedure for obtaining biopsy results. We have not yet received the documentation for Dr. Linver's initial experience in mammography.

Please submit your response to:
Deborah M. McGee, Radiation Specialist
Food and Drug Administration
7920 Elmbrook Drive, Suite 102
Dallas, Texas 75247-4982

This letter pertains only to findings of your inspection and does not necessarily address other obligation 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 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,
Garv L. Pierce
Regional Food and Drug Director