| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesApril 22, 2011
WARNING LETTER NO 2011-NOL-13
UNITED PARCEL SERVICE
Delivery Signature Requested
FACILITY ID 193219
Mike Marshall, Chief Executive Officer
Tombigbee Healthcare Authority operating under
Bryan W. Whitfield Memorial Hospital (BWWMH)
105 Highway 80 East
Demopolis, Alabama 36732
Dear Mr. Marshall:
Your facility was inspected on September 30, 2010, by a representative of the State of Alabama, Department of Public Health, Office of Radiation Control, under contract to the U.S. Food & Drug Administration (FDA). This inspection revealed your facility failed to comply with the Mammography Quality Standards Act of 1992 (MQSA) as codified in Section 263b(f) of Title 42 of the United States Code [42 USC 263b(f)] and Title 21, Code of Federal Regulations, Part 900.12 (21 CFR 900.12). On January 31, 2011, a representative of the FDA conducted an inspection at your facility which revealed serious problems involving the conduct of mammography at your facility. Under MQSA, 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 violations which were noted on the MQSA Facility Inspection Report and the document “Important Information about Your MQSA Inspection” the inspector provided your facility on January 31, 2011.
The violations noted are identified below:
Level 2: The phantom image score (using an FDA-approved mammography phantom) is at least 2 but is less than 3 speck groups for (b)(4) [See 21 CFR 900.12(e)(2)(iii)].
The FDA inspector was unable to discern the speck groups expected to be visualized on your facility’s phantom, imaged and processed on your quality control (QC) film, as part of the inspectional elements. Too many other speck-like artifacts appeared on your facility's QC film, making it difficult to read the film correctly. The phantom image is representative of your facility’s mammography image quality. While other (QC) tests are designed to ensure certain parts of the imaging chain function consistently over time, the phantom image test ensures the entire imaging system (x-ray unit, processor, darkroom, and image receptor) functions properly and consistently as a whole, over time. When an entire system test is performed, a failed phantom image necessitates checking every component of the imaging chain to determine the cause of failure. From a regulatory standpoint, such failure requires the facility to correct the problem causing the failure prior to conducting any clinical examinations using the part of the system which caused the phantom image to fail.
Additionally cited during the inspection was the following noncompliance item:
Level 3: The fixer retention QC is not adequate for processor (b)(4) at site Tombigbee Healthcare Authority Operating BWWMH because:
- The fixer retention QC tests were not done at the required frequency.
Because this 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 $11,000 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 whether each problem at your facility has been corrected.
You should respond in writing to FDA within fifteen (15) working days from the date you received 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; and,
3. sample phantom films to demonstrate proper image quality procedures.
Please submit your written response to the above issues to the attention of Cynthia R. Gibson, Compliance Officer, New Orleans District, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. Please submit a copy of your response to this letter to:
Beverly Jo Carswell
Office of Radiation Control
Alabama Department of Public Health
P.O. Box 303017
Montgomery, AL 36130-3017
Finally, you should understand there are many requirements pertaining to mammography operations. 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 through the Internet at: http://www.fda.gov/Radiation-EmittingProducts/MammographyQuality StandardsActandProgram/default.htm.
Should you have questions concerning the content of this letter, please direct your questions to Cynthia R. Gibson, Compliance Officer, telephone number 251-344-8208 ext. 105.
Sincerely,
/s/
Laurie C. Farmer
Acting District Director
New Orleans District
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