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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Methodist Healthcare-Mckenzie Hospital 07-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

New Orleans District Office

6600 Plaza Drive, Suite 400

New Orleans, LA 70127

December 7, 2001

VIA FEDER4L EXPRESS

FACILITY ID #124917

Warning Letter No. 02-NSV-06

Robert Miller, Administrator

Methodist Heakhcare ? McKenzie Hospital

161 Hospital Drive

McKenzie, TN 38201

Dear Mr. Miller:

Your facility was inspected on November 15, 2001 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 Regulations (CFR), Part 900.12, as follows:

Level 2 (repeat non-compliance)

Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for unit 1, [redacted] Room: Mammography.

Level 2

Documents fail to verify that the radiologic technologist [redacted] (13 CEU?S in 36 months) met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months.

Documents fail to verify that the radiologic technologist [redacted] met the continuing

experience requirement of having performed 200 mammography examinations.

Medical audit and outcome analysis was not done for the facility as a whole at site Methodist Healthcare - McKenzie Hospital.

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

It is your responsibility to ensure adherence to each requirement 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 tier 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. Hayes, Compliance officer, Food and Drug Administration 297 Plus Park Boulevard, Nashville, Tennessee 37217, telephone 615-781-5389, extension 125, with a copy to the State of Tennessee. Should you have questions regarding this 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

?.