Inspections, Compliance, Enforcement, and Criminal Investigations
St. Vincent Clay Hospital 10-Apr-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
1560 East Jefferson Avenue
Detroit, MI 48207-3179
April 10, 2002
RETURN RECEIPT REQUESTED
Mr. Rich Johansen, CEO
St. Vincent Clay Hospital
1206 E. National Avenue
Brazil, IN 47894
Dear Mr. Johansen:
We are writing you because on March 26, 2002, your facility was inspected by a
representative of the State of Indiana acting on behalf of the Food & Drug
Administration (FDA). The inspection revealed a serious compromise in the
quality of the mammography services offered by your facility.
Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C.
236b, 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.
The recent inspection at your facility revealed the following Repeat Level 2
1. There was no documentation to show that technologist [redacted] met the
minimum requirement of having taught or completed at least 15 CEU?s of
continuing education units in mammography in the previous 36 month period.
This is a violation of Title 21 Code of Federal Regulations section 900.12 (a)
The specific problem noted above appeared on your MQSA Facility Inspection
Report, which your facility received at the dose of the inspection. This problem
is identified as a Repeat Level 2 because it identifies a failure to meet a
significant MQSA requirement and indicates failure by your facility to implement
permanent correction of the same problem found during your previous
Since this condition may be symptomatic of a serious underlying problem that
could compromise the quality of mammography at your facility, it represents a
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, suspension or revocation of
your facility?s FDA certificate, or obtaining a court injunction against performing
In addition, you should also address the following Level 2 findings that were
listed on the inspection report provided to your staff at the close of the inspection.
Your facility does not have adequate written procedures for the collection and
resolution of consumer complaints including the resolution of serious complaints
and reporting or referral of serious complaints to the American College or
Radiology. This is in violation of Title 21 Code of Federal Regulations section
There is no designated audit (reviewing) interpreting physician to review the
medical audit outcome data at least once every 12 months. This is in violation of
Title 21 Code of Federal Regulations section 900.12 (f)(3).
Your facility has not established adequate procedures for the collection of biopsy
results when patients do not have a biopsy performed at your facility following a
positive mammogram performed and interpreted by your facility. The outcome
data also does not correlate the disposition of positive mammograms with
pathology results. This is in violation of Title 21 Code of Federal Regulations
section 900.12 (f)(l).
It is necessary for you to act on this matter immediately. Please explain to this
office in writing within fifteen (15) working days from the date you receive this
- the specific steps you have taken to correct the Repeat Level 2 and Level 2 violations noted in this letter;
- each step your facility is taking to prevent the recurrence of similar violations;
- the sample records that demonstrate proper record keeping procedures, if the findings relate to quality control or other records (Note: Patient names or identification should be deleted from any copies submitted).
Please submit your response to:
Mr. David M. Kaszubski
Director Compliance Branch
U. S. Food & Drug Administration
1560 East Jefferson Ave.
Detroit, MI 48207-3179
Please note that FDA regulations do not preclude a State from enforcing its own
State mammography laws and regulations. In some cases, these requirements
may be more stringent than FDA?s. When you plan your corrective actions, you
should consider the more stringent State requirements, if any. You should also
send a copy of your response to the State of Indiana radiation control office that
conducted the inspection referenced in this letter. You may choose to address
both the FDA and any additional State requirements in your response.
There are many FDA requirements pertaining to mammography. This letter only
concerns the findings of your recent 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 (l-800-838-7715) or through the Internet
If you have any questions regarding this letter or how to ensure that you are
meeting MQSA standards, please call Mr. Dennis E. Swartz, Radiological Health
Expert, at 313-226-6260 Ext. 155.
Joann M. Givens
Detroit District Office