Inspections, Compliance, Enforcement, and Criminal Investigations
Park Nicollet Health Systems 01-Nov-02
Department
of Health and Human Services Public
Health Service
Food and Drug Administration
Minneapolis District
240 Hennepin Avenue
Minneapolis MN 55401-1699
Telephone: 612-3344100
November 1, 2002
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 03 - 03
David Wessner
Chief Executive Officer
Park Nicollet Health Systems
5600 Excelsior Boulevard
St. Louis Park, Minnesota 55426
Dear Mr. Wessner:
On October 10, 2002, a representative of the State of
Minnesota, acting on behalf of the Food and Drug Administration (FDA),
inspected your mammography facility at Park Nicollet Medical Center-Bloomington
Clinic, 5320 Hyland Greens Drive, Bloomington, MN (FDA Certificate # 166421).
This inspection revealed a serious regulatory problem involving the mammography
at your facility.
Under the Mammography Quality Standards Act of 1992
(MQSA), 42 U.S.C. 263b, 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
that your site presented at the time of the inspection, the following repeat
non-compliance was noted 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] Mammography room, ACR
?
This is a required weekly test under Title 21, Code of Federal
Regulations, Section 900.12(e)(2). Title 21, Code of Federal Regulations,
Section 900.12(e)(8)(ii)(A) requires that the failing test condition be
corrected before resuming clinical practice. Note: Acceptable practice includes
written documentation of corrective action and the performance of a re-test
that indicates that the failed parameter is in compliance, prior to producing clinical
images.
A non-compliance is designated a ?repeat? if it was also
cited during the prior inspection.
The specific problem noted above appeared on your MQSA
Post Inspection Report which was issued to your facility following the close of
the inspection. Because this violation may be symptomatic of serious underlying
problems that could compromise the quality of mammography at your facility, FDA
may take additional actions including, but not limited to, placing your
facility under a Directed Plan of Correction, charging your facility for the
cost of on-site monitoring, seeking civil money penalties of up to $10,000 for
each failure to substantially comply with, or each day of failure to
substantially comply with, the MQSA standards, seeking a suspension or
revocation of your facility?s FDA certificate, or seeking a court injunction against
further mammography.
You should respond in writing to FDA within 15 working
days from the date you
- 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.
Finally, you should understand that there are many FDA
requirements pertaining
you have under the law. You may obtain general information
about all of FDA?s
21045-6057 (l-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
Sincerely,
/s/
Annette Byrne
Acting Director
Minneapolis District
