Inspections, Compliance, Enforcement, and Criminal Investigations
Smith County Memorial Hospital
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
October 13, 2009
Via Federal Express - Next Day
Re: MQSA Inspection 10 # 182550
Carolyn K. Hess
Smith County Memorial Hospital
612 South Main Street
Smith Center, Kansas 66967
Dear Ms. Hess,
On September 2, 2009, a representative of the Food and Drug Administration (FDA) performed an investigation at your facility which revealed a serious problem involving the conduct of mammography. Under the Mammography Quality Standards Act of 1992 (MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), you must meet specific requirements to practice mammography. These requirements serve to protect the health of women by assuring that a facility can perform quality mammography.
The problems identified during this investigation constitute a violation of the MQSA as identified below.
Phantom Quality Control records were missing for June 2009 and July 2009 which only represents a portion of the overall missing documentation for the (b)(4) located in the mammography room. [See 21 CFR 900.12(e)(2)].
Processor Quality Control records were missing for June 2009 and July 2009 which only represents a portion of the overall missing documentation for the (b)(4) located at your facility. [See 21 CFR 900.12(e)(1)].
Because 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
• 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
• 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 that each problem at your facility has been corrected.
You should respond in writing to FDA within (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. sample records that demonstrate proper record keeping procedures.
Please submit your response to this letter to:
Deborah M. McGee
Southwest Regional Compliance Officer
U. S. Food and Drug Administration
4040 N. Central Expressway, Suite 900
Dallas, TX 75204
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/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm.
If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M. McGee, M.S., Southwest Regional Compliance Officer, by telephoning (214) 253-4935.
Dennis E. Baker
Regional Food and Drug Director
Southwest Regional Office
Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs,
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091
Cynthia Siemers (mammography contact)
X-Ray Compliance and Registration
Radiation & Asbestos Control Section
Dept. of Health and Environment
Bureau of Air and Radiation
1000 SW Jackson, Suite 310
Topeka, KS 66612-1366