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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Delta Regional Medical Center 09-Nov-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802




November 9, 2006

WARNING LETTER NO. 2007-NOL-02

FEDERAL EXPRESS
OVERNIGHT DELIVERY

FACILITY ID# 158733

L. Ray Humphreys, Chief Executive Officer
Delta Regional Medical Center
1400 E. Union Street
Greenville, MS 38704

Dear Mr. Humphreys:

On September 27, 2006, a representative from the State of Mississippi, under contract for the U .S. Food and Drug Administration (FDA), conducted an inspection at your facility, King's Daughters Hospital West Campus DRMC, located at 300 S. Washington Avenue,
Greenville, Mississippi. This inspection revealed serious problems involving the conduct of mammography at your facility . Under the Mammography Quality Standards Act of 1992 (MQSA), which is codified in Section 263b of Title 42 of the United States Code (USC),
your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring a facility can perform quality mammography procedures.

The inspection revealed a violation of the MQSA at your facility. This violation was noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" provided by our inspector.

The violation noted is identified below:

Level 2 (Repeat): 3 of 7 random results reviewed did not contain an acceptable assessment category for site King's Daughters Hospital West Campus [Title 21, Code of Federal Regulations (CFR) 900.12(c)(1)].

This finding has been noted for the previous two annual inspections, and again during this inspection.

On December 14, 2004, an inspector with the State of Mississippi inspected your facility under contract for FDA. The inspection revealed several Level 2 violations, including the following:

2 of 5 random reports did not contain acceptable assessment categories

Your firm's response, dated December 15, 2004, indicated corrections were made an example Diagnostic Imaging Report was provided. This report correctly identified the mammography conclusion. Subsequently, on January 7, 2005, we corresponded with [redacted] R.T., QC Mammo Tech, at your facility and acknowledged your corrective actions appeared to adequately address our concerns, provided the next inspection proved corrections were in place.

On December 9, 2005, an inspector with the State of Mississippi inspected your facility under contract for FDA. The inspection revealed a Level 2 Repeat violation as follows:

On January 10, 2006, [redacted] responded to the State of Mississippi, indicating corrections were made. No correspondence was received in the FDA office. On March 29, 2006, FDA sent correspondence to [redacted] Radiology Manager, identifying this repeat violation and requesting a written response to address the violation. No response was received by this office.

On October 23, 2006, we received your response to the MQSA Facility Inspection Report dated September 27, 2006. Your response was inadequate because you failed to submit a standard operating procedure for the use of required assessment categories, and Attachment
4 does not include "Incomplete-need additional imaging evaluation", as required.

Because this continued noncompliance may be indicative of serious underlying problems which could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

  • Requiring your facility to undergo an Additional Mammography Review;

  • Placing your facility under a Directed Plan of Correction;

  • Charging your facility for the cost of on-site monitoring;

  • Requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information;

  • Seeking civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards;

  • Seeking to suspend or revoke your facility's FDA certificate; and,

  • Seeking a court injunction against your facility [See 42 USC 263b(h)-(j) and 21 CFR 900.12(j)].

FDA may need to perform a Compliance Follow-up Inspection to determine if each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days from the date you receive this letter. Your response should address the findings listed above and include:

1. The specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps.

2. The specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps.

3. Sample records which demonstrate proper recordkeeping procedures.

Please submit your written response to the above issues to the attention of Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, New Orleans District, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. Please submit a copy of your
response to:

Jimmy Carson
State of Mississippi
Div. of Radiological Health
P.O. Box 1700
Jackson, MS 39215-1700

Finally, you should understand there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility 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 & Drug Administration, P. O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or FDA Internet website at:
http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Karen Smallwood Radiation Specialist, at 615-366-7823.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District'