Inspections, Compliance, Enforcement, and Criminal Investigations
Aspen Medical Group 14-Jan-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
240 Hennepin Avenue
Minneapolis, MN 55401-1999
January 14, 2002
RETURN RECEIPT REQUESTED Refer to MIN 02 - 20
Chief Executive Officer
Aspen Medical Group
102 1 Bandana Boulevard
St. Paul, Minnesota 55108
Dear Mr. Holets:
On December 20, 2001, a representative of the State of Minnesota, acting on behalf
of the Food and Drug Administration (FDA), inspected your Aspen Medical Group
facility located at 1850 Beam Avenue, Maplewood, Minnesota 55109, FDA Certificate #221235. 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 (MQSA), 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. Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for the mammography unit [redacted] PROF; Mammography room, ACR unit designation = 1).
Additionally, please respond to the following non-compliance:
Repeat Level 3 Non-Compliance:
2. The freer retention QC is inadequate for the mammography film processor
([redacted] because the fixer retention QC tests were not done at the required frequency.
The specific problems noted above appeared on your MQSA Post Inspection Report
which was issued to your facility following the close of the inspection. Additional
Level 3 issues were also documented. A non-compliance is identified as a "repeat"
if it was cited during the previous 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 this letter;
- 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. Garvin, Radiological Health Specialist,
Food and Drug Administration, 2675 No. Mayfair Road, Suite 200, Milwaukee, WI
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
David R. Yost