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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Southwestern General Hospital 01-Jan-02

DEPARTMENT 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 15, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED 02-SWR-WL-22/7

RE: Inspection ID ? 2138920006

Addie M. Haverfield, R.T.(M)

Director of Radiology

Southwestern General Hospital

1221 N. Cotton Street

El Paso, TX 79902

Dear Ms. Haverfield,

On 1/7/2002, a representative from the state of Texas, acting on behalf 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: Phantom QC records were missing for at least 4 weeks for unit 2, Lorad Medical Systems Inc., ELIT, room Mammo

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.

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 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 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 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 (l-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Angela Moak at (214) 655-8100 ext. 135.

Sincerely yours,

Gary L. Pierce

Regional Food and Drug Director