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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

NHS Clarkson West Medical Center 21-Oct-08

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

Public Health Service
Food and Drug Administration

 

Southwest Regional Office
4040 North Central Expressway
Suite 900
Dallas, Texas 75204


WARNING LETTER

October 21, 2008

Via Federal Express - Next Day

Re: MQSA Inspection ID # 163204

2009-SWR-01

FEI# 1000510799
Clarkson West Medical Center
2727 South 144th Street, Suite 120 Clarkson West
Omaha, Nebraska 68144

Glen Fosdick
President and CEO
The Nebraska Medical Center
987400 Nebraska Medical Center
Omaha, NE 68198-7400

Dear Mr. Fosdick,

On June 26, 2008 and August 28, 2008, 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 problem identified during this investigation constitutes a violation of the MQSA as identified below.

Failed to produce documents verifying that the radiologic technologist (b)(6) met the continuing experience requirement of having performed 200 mammography examinations in 24 months. [See 21 CFR 900.12(a)(2)(iv)(A)].

Because this violation 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/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 Deborah M. McGee, M.S., Southwest Regional Compliance Officer, by telephoning (214) 253-4935.

Dennis E. Baker

/S/

Dennis E. Baker
Regional Food and Drug Director
Southwest Regional Office

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