Food and Drug Administration

New Orleans District

6666 Plaza Drive, Suite 406

New Weans, LA 70127

October 15, 2002

VIA FEDERAL EXPRESS

FACILITY ID #1118174

James T. Moss, Chief Executive Officer

Jackson-Madison County General Hospital

708 W. Forest Avenue

Radiology Department

Jackson, TN 38301

Warning Letter No. 03-NSV-01

Dear Mr. Moss:

Your facility was inspected on September 11, 2002 by a representative of the State of Tennessee acting on behalf of the Food and Drug Administration (FDA). This inspection revealed a serious compromise in the quality of the mammography services offered by your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. 236b, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The recent inspection at your facility revealed the following Level 2 Repeat finding:

Level 2 (Repeat)

• 3 of 5 random reports reviewed did not contain an acceptable assessment category for site Jackson-Madison County General Hospital - 27 CFR 900.12(c)(1)

This specific deficiency noted above appeared on your MQSA Post Inspection Report which was sent to your facility by the state inspector along with instructions on how to respond to this findings. Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, this represents violations 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 Direct Plan of Correction, charging your facility for the cost of on-site monitoring seeking civil money penalties up to $10,000 for each failure to substantially comply with MQSA standards, seeking suspension or revocation of your facility?s FDA certificate, or seeking a court injunction against further mammography. [See 42 U.S.C. 263b(h)(j)]

In addition, you should also address the following deficiency that was also listed on the inspection report:

Level 2

•  Phantom QC records were missing for at least two weeks but less than four weeks for unit 2, [redacted] DMR, Room L - 21 CFR 900.12(e)(2)

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 actions.

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. Your response should include:

- The specific steps you have taken to comet the Level 2 Repeat and Level 2 violations as outlined in this letter;

- Each step your facility is taking to prevent the recurrence of similar violations;

- Sample records that demonstrate proper record-keeping procedures relating to quality control or any other records that are appropriate to the noncompliance finding (NOTE: Patient names or identification should be deleted from any copies submitted).

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 the technical aspects of this letter or concerning MQSA standards, you may call Karen Smallwood, Radiation Specialist, at 615-781-5380, extension 144.

Sincerely,

/s/

Carl E. Draper

Director, New Orleans District