Inspections, Compliance, Enforcement, and Criminal Investigations
University Hospital and Medical Center 11-Feb-02
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751
VIA FEDERAL EXPRESS
February 11, 2002
FACILITY ID # 144428
Jim Cruckshank, Administrator
University Hospital and Medical Center
7201 North University Drive
Tamarac, Florida 33321
Dear Mr. Cruckshank:
We are writing to you because on January 8, 2002 a representative of the State
of FL, acting in behalf of the Food and Drug Administration (FDA) inspected your
facility. 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, 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 REPEAT
level 2 violation(s) at your facility.
Level 2 - REPEAT: Your facility failed to produce documents verifying that the
interpreting physicians [redacted] [redacted], and [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.
Additionally, the medical audit and outcome analysis was not performed annually
at your site.
A finding is considered a repeat finding, if the same type of violation was cited
during the previous inspection, whether or not the finding is associated with the
same piece of equipment (x-ray unit, processor, darkroom) or the same
personnel in any given category.
The specific problem(s) noted above appeared on your MQSA Facility inspection
Report, which was issued to your facility at the close of the inspection. 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,
the Standards, suspension or revocation of your facility? s FDA certificate, or
obtaining a court injunction against further mammography.
We have received and reviewed your letter dated January 23, 2002 signed by
Jacqui Cotterall, Managing Director, and find that your firm? s response addresses
our concerns for the most part. The response, however, does not address the
events that led up to these repeat violations. It is necessary for you to act on this
matter immediately and establish procedures to assure this deficiency is not
Please submit your response to Timothy J. Couzins, Compliance Officer, U.S.
Food & Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida
32751, (407) 4754728.
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 facility requirements, or
about the content of this letter, please feel free to contact D. Janneth Caycedo,
Consumer Safety Officer, Food and Drug Administration, Boca Raton Resident
Post, 1499 W. Palmetto Park Road, Ste. 110, Boca Raton, FL 33486 or call 561-
338-5236, ext 23.
Director, Florida District