Inspections, Compliance, Enforcement, and Criminal Investigations
Aurora Medical Group 27-Nov-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
240 Hennepin Avenue
Minneapolis, MN 55401-1999
November 27, 2001
RETURN RECEIPT REQUESTED
Refer to MIN 02-15
Elliott J. Huxley, M.D.
Aurora Medical Group
3000 West Montana
Milwaukee, Wisconsin 53215
Dear Dr. Huxley:
On November 20, 2001, a representative of the State of Wisconsin, acting on behalf of the Food and Drug Administration (FDA), inspected your mammography facility (Aurora Medical Group, 1575 N. River Center Drive, Suite 144, Milwaukee, WI 53212, FDA Certificate #127365). This inspection revealed a serious regulatory problem involving the mammography at your facility.
Under a United States Federal law, the Mammography Quality Standards Act of 1992, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. Based on the documentation your site presented at the time of the inspection, the following non-compliances were documented at your facility:
Repeat Level 2 Non-Compliance:
1. Phantom QC records were missing for at least two weeks but less than four weeks for your mammography unit ( [redacted] Mammography room, ACR unit designation 2).
This is designated as a "repeat" because this non-compliance was also cited during the previous (10/27/00) inspection.
Level 2 Non-Compliance:
2. Corrective actions for processor QC failures were not documented at least once for your mammography film processor ( [redacted] Mammography room).
3. Mammograms were processed in your mammography film processor ( [redacted] Mammography room) when it was out-of-limits on at least two but less than five days.
4. Failure to produce documents verifying that Radiologic Technologist [redacted] met the continuing experience requirement of having performed 200 mammography examinations in 24 months.
Note: Individuals failing to meet either the "Initial" and/or "Continuing" MQSA requirements must immediately cease performing mammography independently. Requirements for re-qualification are listed in the Final Regulation that became effective on April 28, 1999. Conditions for direct Supervision of unqualified personnel are specified in regulation and formal FDA policy. Policy references may be found at the Internet address below.
The specific problems noted above appeared on your MQSA Post Inspection Report which was issued to your facility following the close of the inspection.
Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent a serious violation of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the Standards, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography.
It is necessary for you to act on this matter immediately. Please explain to this office in writing within 15 working days from the date you received this letter:
- the specific steps you have taken to correct all of the violations noted in thisletter;
- each step your facility is taking to prevent the recurrence of similar violations;
- equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
- sample records that demonstrate proper record keeping procedures if the findings relate to quality control or other records.
Please submit your response to Thomas W. Gamin, Radiological Health Specialist, Food and Drug Administration, 2675 N. Mayfair Road, Suite 200, Milwaukee, WI 53226-1305.
Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection 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 specific questions about mammography facility requirements or about the content of this letter please feel free to phone Mr. Garvin at (414) 771-7167 ext. 12.Sincerely,
James A. Rahto