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

WARNING LETTER

FLA-02-28

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

repeated.

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.

Sincerely yours,

Emma Singleton

Director, Florida District