Inspections, Compliance, Enforcement, and Criminal Investigations
Kaiser Permanente - 20th Avenue Medical Center 9/25/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| Southwest Regional Office|
4040 North Central Expressway
Dallas, Texas 75204
September 25, 2012
UPS NEXT DAY AIR
Re: MQSA Inspection ID # 118869
Ginny Me Lain
Vice President of Operations
10350 East Dakota Avenue
Denver, CO 80247
Dear Ms. Me Lain,
On August 14, 2012, a representative of the Food and Drug Administration (FDA) conducted 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.
The manufacturer recommended QC procedures for the monthly monitor viewing conditions for the review workstations (RWS) located in the biopsy room at the Kaiser Permanente Franklin facility were not followed. [See 21 CFR 900.12(e)(6)
On September 4, 2012, your facility responded by letter to the noncompliances found during this investigation as referenced in this Warning Letter. Based on your response, your facility has implemented a correction that addresses the documented noncompliances.
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.
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) 253-4.935.
Dennis E. Baker
Regional Food and Drug Director
Southwest Regional Office
Brian Vamvakias, Unit Leader
Xray and Mammography Unit
Colorado Department of Public Health
4300 Cherry Creek Drive South
South Denver, CO 80246
Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs,
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091