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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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East Georgia Regional Medical Center 28-Mar-2002

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Atlanta District office

60 Eighth Street. N.E.

Atlanta, Georgia 30309

March 28, 2002

VIA FEDERAL EXPRESS

Inspection ID: 1604160007

WARNING LETTER

(02-ATL-23)

Tony Taylor

Radiation Safety Officer

East Georgia Regional Medical Center

1499 Fair Road

Statesboro, GA 30458

Dear Mr. Taylor:

Your facility was inspected on 3/13/02 by a representative of the Georgia Department of Human Resources, Division of Radiation Protection, acting on behalf of the Food and Drug Administration (FDA). This inspection revealed that your facility failed to

comply with the Mammography Quality Standards Act of 1992 (MQSA)

and certain Quality Standards for Mammography as specified in Title 21, Code of Federal Regulations (CFR), Part 900.12, as follows:

Repeat Level 2 Non-Compliance:

1. Failure to produce documents verifying that the interpreting physician, [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.

2. Failure to produce documents verifying that the interpreting physician, [redacted] met the continuing education requirement m of having taught or completed at least 15 category I continuing medical education units in mammography in 36 months (0 CME's in 36 months).

The specific deficiencies noted above appeared under the Level 2 heading on your MQSA Facility Inspection Report, which was issued at the close of the inspection. These deficiencies were repeat findings from the previous inspection of your facility on 3/7/01.

Because these conditions 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.

If you fail to promptly correct these deficiencies, FDA may, without further notice, initiate regulatory action. Under MQSA, FDA may:

impose civil money penalties on a facility of up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the Standards.

suspend or revoke a facility's FDA certificate for failure to comply with the Standards.

seek an injunction in federal court to prohibit any mammography activity that constitutes a serious risk to human health.

place your facility under a Directed Plan of Correction (DPC).

It is your responsibility tie ensure adherence to each requirement of the MQSA and FDA's regulations. You are responsible for investigating and determining the causes of the deficiencies that the inspection identifies and promptly initiating permanent

corrective actions.

Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA's. When you plan your corrective action(s); therefore, you should consider the more stringent State requirements, if any.

Within 15 working days after receiving this letter, you should notify FDA in writing of:

  • 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; and
  • sample records that demonstrate proper record-keeping H procedures, if the non-compliances that were found relate to quality control or other records. (Note: Patient names or identification should be deleted from any copies submitted.)

If your facility is unable to complete the corrective action within 15 working days, you should state the reason for the delay and the time within which corrections will be completed. Please send the original copy of your response to:

Serene A. Kimel, Compliance Officer

U.S. Food and Drug Administration

60 Eighth St., NE

Atlanta, GA 30309

With a copy to:

Georgia Department of Human Resources

Division of Radiation Protection

2 Peachtree St.

Suite 33-285

Atlanta, GA 30303

and

Thomas Clarida

U.S. Food and Drug Administration

5701 Executive Center Drive, Suite 104

Charlotte, NC 28212

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 (l-800-838-7715) or through the Internet at

http://www.fda.gov/cdrh/mammography/index.html.

You may choose to address both FDA and state requirements in your response. If you have any questions regarding this letter or how to ensure you are meeting MQSA standards, please feel free to call Thomas Clarida at 704-344-6116.

Sincerely yours,

Ballard H. Graham, Director

Atlanta District