Inspections, Compliance, Enforcement, and Criminal Investigations
Unimed Physician's Complex 30-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Ministration
240 Hennepin Avenue
Minneapolis MN 55401-1999
July 30, 2001
RETURN RECEIPT REQUESTED
Refer to MIN 01-70
Chief Executive Officer
Unimed Physician?s Complex
One Burdick Expressway West
Minot, North Dakota 58701
Dear Mr. Hoff:
We are writing to you because on July 25, 2001, your facility was inspected by a
representative of the State of North Dakota acting on behalf of the Food and Drug
Administration (FDA). 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. The inspection revealed the following noncompliance
at your facility:
Level 1 Non-Compliance
1. Failure to produce documents verifying that interpreting physician [redacted]
met the initial requirement of being certified in the appropriate specialty by a FDA-approved board or having two months of initial training in the interpretation of mammograms prior to April 28, 1999.
The specific problem noted above appeared on your MQSA Facility Inspection
Report (copy enclosed) which was issued to your facility at the close of the
inspection. This problem is identified as Level 1 because it identifies a failure to
meet a significant MQSA requirement.
Because this condition may be symptomatic of serious underlying problems that
could compromise the quality of mammography at your facility, it represents 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, MQSA Standards, suspension or revocation of your facility?s FDA certificate,
or obtaining a court injunction against further mammography.
In addition, your response should address the Level 2 findings that were listed on
the inspection report provided to you at the close of the inspection. These Level 2
Level 2 Non-Compliances
2. Medical audit and outcome analysis was not performed annually at Unimed
3. Medical audit and outcome analysis was not done separately for each
Interpreting Physician at Unimed Physician's Complex.
4. Medical audit and outcome analysis was not done for the facility as a whole
at Unimed Physicians Complex.
5. Failure to produce documents verifying that interpreting physician [redacted] met the initial experience requirement of having interpreted or multi-read
240 mammograms in six months.
6. Failure to produce documents verifying that Radiologic Technologist [redacted]
met the initial requirement of having 40 contact hours training
specific to mammography.
7. Failure to produce documents verifying that interpreting physician [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.
8. Failure to produce documents verifying that interpreting physician [redacted] met the initial requirement of having 40 hours of medical education in mammography prior to April 28, 1999.
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. (Note: Patient names or identification should be deleted from any copies submitted.)
Please submit your response to Compliance Officer Thomas P. Nelson, 240
Hennepin Avenue, Minneapolis, MN 55401.
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.
If you have more specific questions about mammography about the content of this letter, please feel free to contact facility requirements, or Mr. Nelson at (612) 334-4100 ext.177.
James A. Rahto
Web page created by god July 2001