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U.S. Department of Health and Human Services

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Enforcement Actions

St. Joseph's Candler-Mobile Mammography 12-Mar-07

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 Eighth Street, NE
Atlanta, GA 30309

Telephone: 404/253-1161
FAX: 404/253-1201


March 12, 2007

VIA FEDERAL EXPRESS

Re: MQSA Inspection ID # 2277980005

Robert K. Myers, MD
Medical Director
St. Joseph's Candler-Mobile Mammography
5353 Reynolds Street
Savannah, GA 31405

WARNING LETTER
(07-ATL-07)

Dear Dr. Myers:

On February 5, 2007, a representative of the U.S. Food and Drug Administration (FDA) inspected your facility. 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 that a facility can perform quality mammography.

The inspection revealed violations of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector left with Ms. Julie Swartz, Cancer Screening Coordinator at your facility on February 8, 2007. The violations are again identified below.

Level 1: Processor Quality Control records in the month of 04/2006 were missing for at least 30% of operating days, for processor 1, [redacted] located in the darkroom at site St. Joseph's Candler-Mobile Mammography [21 CFR 900.12(e)(1)].

Level 1: Processor Quality Control records were missing at least 5 consecutive days for processor 1, [redacted] located in the darkroom at site St. Joseph's Candler-Mobile Mammography [21 CFR 900.12(e)(1)].

Level 1: Phantom Quality Control records were missing for at least 4 weeks for unit 1, [redacted] located at site St. Joseph's Candler-Mobile Mammography. [21 CFR 900.12(e)(2)].

Level 2: A performance verification test was not conducted after each move for mobile unit 1, [redacted] [21 CFR 900.12(e)(7)].

Level 3: The medical physicist's survey for x-ray unit 1 described above is incomplete because the following tests were inadequate or not done: No uniformity of screen speed, numerical results were not given [21 CFR 900.12(e)(9)(ii)].

On February 16, 2007, we received your response to the MQSA Facility Inspection Report. Your response was inadequate in that it failed to address management's oversight of the problems that were noted during our inspection. Without that management oversight and commitment, there is no assurance that similar or related violations will not recur.

Because the continued failure to resolve these violations may be indicative of serious underlying problems that 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
• 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

See 42 USC 263b(h) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that 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;
3. equipment settings (including technique factors), raw test data, and calculated final results;
4. sample records that demonstrate proper record keeping procedures.

Please submit your response to this letter to Serene N. Ackall, Compliance Officer, at the address in the letterhead. Please send a copy of your response to:

Ms. Jeannie Arnold, State of GA
Department of Human Resources
Office of Regulatory Services
Healthcare Section, Room 19
2 Peachtree Street
Atlanta, GA 30303-3167

Finally, you should understand that 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 and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet 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 Serene N. Ackall at 404-253-1296.

Sincerely,

/S/

Mary H. Woleske, Director
Atlanta District

cc: Ms. Jeannie Arnold
State of Georgia
Department of Human Resources
Office of Regulatory Services
Healthcare Section, Room 19
2 Peachtree Street
Atlanta, GA 30303-316 7

Ms. Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091