Inspections, Compliance, Enforcement, and Criminal Investigations
Beaver Dam Community Hospital 22-Oct-02Department of Health and Human Services Public Health Service
Food and Drug Administration
240 Hennepin Avenue
Minneapolis MN 55401-1999
October 22, 2002
RETURN RECEIPT REQUESTED Refer to MIN 03 - 01
John R. Landeck
Chief Executive Officer
Beaver Dam Community Hospital
707 S. University Avenue
Beaver Dam, Wisconsin 53916
Dear Mr. Landeck:
On October 1, 2002, a representative of the State of Wisconsin,
acting on behalf of the Food and Drug Administration (FDA), inspected
your mammography facility (FDA certificate #102848). This inspection revealed
a serious regulatory problem involving the mammography at your facility.
Under a United States law, the Mammography Quality
Standards Act of 1992
Level 1 Non-Compliance:
1. The system to communicate results is not adequate
because there is no
Your policy entitled ?Mammography will be performed by
self requesting and
Communication of mammography results to the patients.
Each facility shall send each patient a summary of the mammography report
written in lay terms within 30 days of the mammographic examination. If
assessments are ?Suspicious? or ?Highly suggestive of malignancy,?
the facility shall make reasonable attempt to ensure that the results are
Level 2 Non-Compliances:
2. The medical physicist?s survey for x-ray unit 2 (
[redacted] model CONT, Mammo room), is incomplete because the following
tests were inadequate or not done:
No artifact evaluation.
No recommendations for failed items were given.
No evaluation of the Technologist?s QC tests:
No processor QC.
No analysis of fixer retention.
No uniformity of screen speed.
Numerical results were not given.
Title 21, Code of Federal Regulations, Part 900.12(e)(5)
details the required annual quality control tests. Note: All mammography
processors must be evaluated. All film cassettes must be evaluated for
artifacts during the Screen Uniformity test.
3. Failure to produce documents verifying that the
medical physicist, [redacted] met the continuing experience requirement of
having surveyed at least two mammography facilities and a total of at
least six mammography units in 24 months.
Title 21, Code of Federal Regulations, Part 900.12(a)(3)(iv)(B)
details the physicist?s continuing experience requirement. Note:
Individuals failing to meet either the ?Initial? and/or ?Continuing?
MQSA requirements must immediately cease performing surveys independently.
The specific problems noted above appeared on your MQSA
Facility 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. 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, seeking civil
money penalties 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
It is necessary for you to act on this matter
immediately. Please explain to this
. the specific steps you have taken to correct all of the
violations noted in this
. 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,
Finally, you should understand that there are many FDA
If you have specific questions about mammography facility
requirements, or about
Cheryl A. Bigham