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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Delta Medical Center 20-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

New Orleans District Office

6600 Plaza Drive, Suite 400

New Orleans, LA 70127

February 20, 2002

Warning Letter No. 02-NSV-14

VIA FEDERAL EXPRESS

FACILITY ID #176370

Craig Watson, C.E.O.

Delta Medical Center

3000 Getwell Road

Memphis, TN 38125

Dear Mr. Watson:

Your facility was inspected on January 15, 2002 by a representative of the State of Tennessee on contract to the Food and Drug Administration (FDA). This inspection revealed that your facility failed to comply with the Quality Standards for Mammography Standards as specified in Title 21, Code of Federal Regulation (CFR), Part 900.12, as follows:

Level 1

The system to communicate results is not adequate for site Delta Medical Center because:

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

Level 2

Phantom QC records were missing for at least two weeks but less than four weeks for unit 1, [redacted] Room : Mammography.

Failed 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.

1 of 6 random reports reviewed did not contain an acceptable assessment category for site Delta Medical Center.

Medical audit and outcome analysis was not performed annually at site Delta Medical Center.

There is no designated audit (reviewing) interpreting physician for site Delta Medical Center.

These specific deficiencies appeared on the Post Inspection Report, which was given to your facility by the state inspector at the close of your inspection, with instructions on how to respond to these findings. These deficiencies may be symptomatic of serious that could compromise the quality of mammography at your facility and potentially overexpose both involved with mammography.

It is your responsibility to ensure adherence of the Mammography Quality Standards Act of 1992 (MQSA) and FDA?s regulations. You are responsible for investigating and determining the cause of these deficiencies as identified and to promptly initiate permanent corrective action.

If you fail to properly address 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 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.

Within 15 working days after receiving this letter, you should notify FDA in writing of each step your facility is taking to prevent the recurrence of any similar violations.

If your facility is unable to complete these corrective actions within 15 working days, you should state the reason for the delay and the time within which the corrections will be completed.

Your reply should be directed to Joseph E. Compliance Officer, Food and Drug Administration, 297 Plus Park Boulevard, Nashville, Tennessee 37217, 615-781-5389, extension 125, with a copy to the State of Tennessee. Should you have questions letter or MQSA standards, you may call Karen Smallwood, Radiation Specialist, at 615-781-5380, extension 144.

Sincerely,

Carl E. Draper

Director, New Orleans District