Inspections, Compliance, Enforcement, and Criminal Investigations
Jackson Clinic North 09-Nov-01
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
New Orleans District Office
6600 Plaza Drive, Suite 400
New Orleans, LA 70127
November 9, 2001
VIA FEDERAL EXPRESS
FACILITY ID# 212530
Warning Letter No. 02-NSV-03
Carl Rudd, CEO, Administrator
The Jackson Clinic North
2863 Highway 45 Bypass
Jackson, TN 38305
Dear Mr. Rudd:
Your facility was inspected on October 25, 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:
Failed to produce documents verifying that the interpreting physician [redacted], met the initial requirement of being certified in the appropriate specialty by an FDA-approved board or having 2 months of initial training in the interpretation of mammograms prior to 4/28/99.
Level 2 (Repeat)
Failed to produce documents verifying that the radiologic technologist [redacted] (13 CEU?S in 36 months) met the continuing education requirement completed at least 15 continuing education units in mammography in 36 months.
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], Mammography Room
Failed to produce documents verifying that the interpreting physician, [redacted] met the initial experience requirement of having interpreted or multi-read 240 mammograms in 6 months.
Level 2 (continued)
Failed to produce documents verifying that the interpreting physician [redacted] met the initial requirement of having 40 hours of medical education in mammography prior to 04-28-99.
Failed to produce documents verifying that the interpreting physician [redacted] (0 CMES in 36 months) met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.
Failed to produce document verifying that the radiologic technologist , [redacted] met the requirement of having 40 contact hours training specific to mammography.
Medical audit and outcome analysis was not done for the facility as a whole at site The Jackson Clinic North.
Medical audit and outcome analysis was not done separately for each individual at site The Jackson Clinic North.
Medical audit and outcome analysis was not performed- at site The Jackson Clinic North.
There is no designated audit (reviewing) interpreting physician for site The Jackson Clinic North.
Level 3 (Repeat)
Corrective action was not taken when called for in the medical physicist?s survey report for unit 1, [redacted], Mammography Room.
The required personnel qualification documents were not available during the inspection.
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, 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 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. 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