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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fisherman's Hospital 07-Nov-02

Department of Health and Human ServicesDepartment of Health and Human Services            Public Health Service


Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751

VIA CERTIFIED MAIL
WARNING LETTER
FLA-03-08

November 7, 2002

FACILITY ID # 112789

Wendy Hashly, Director of Imaging
Fishermen?s Hospital
3301 Overseas Highway
Marathon, Florida 33050

Dear Ms. Hashly:

On September 25, 2002 a representative of the State of Florida, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed serious regulatory problems involving the mammography at your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 USC 263b, 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 violations at your facility.

Your facility failed to establish a system to collect and review outcome data for all mammograms performed, including follow up on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician?s mammography report. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. In addition, any cases of breast cancer among patients imaged at your facility that subsequently become known to your facility, shall prompt your facility to initiate follow up on surgical and/or pathology results and to review the mammograms taken prior to the diagnosis of a malignancy as required by 21 CFR 900.12(f)(1). For example, your facility failed to conduct medical audit(s) and outcome analyses for all interpreting physicians both individually and collectively. This is a REPEAT violation identified during the previous inspection of your facility on September 26, 2001.

Your facility failed to conduct an audit analysis, at least once every 12 months, to permit completion of diagnostic procedures and data collection as required by 21 CFR 900.12 (f)(2). For example, no medical audit or outcome analysis has been performed in the 12 months since the last inspection of your facility on September 26, 2001. This REPEAT violation was identified during the previous inspection of your facility on September 26, 2001.

Your facility failed to designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months as required by 21 CFR 900.12(f)(3).

For example, no interpreting physician has been designated to conduct medical audits and outcome analyses at your facility. This is a REPEAT violation that was identified during the previous inspection of your facility on September 26, 2001.

In addition, the optical density of the film in the center of the phantom image should not be less than 1.20 as required by 21 CFR 900.12(e)(5)(i)(C). Operating levels for background density were less than 1.20 in your phantom image.

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection on September 25, 2002.

Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional regulatory actions 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, seeking civil money penalties of up to $10,000.00 for each failure or each day of failure to substantially comply with MQSA Standards, suspending or revoking your facility?s FDA certificate, or seeking a court injunction against further mammography at your facility.

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 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;
  • 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 Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Ste. 200, Maitland, Florida 32751, telephone no. (407) 475-4728.

Finally, you should understand that there are many requirements pertaining to mammography facilities. This letter pertains only to findings related to the recent inspection of your facility and does not necessarily address other obligations you may 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, Maryland 21045-6057, telephone no. (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 contact D. Janneth Caycedo, Boca Resident Post, Food and Drug Administration, Interstate Plaza, 1499 W. Palmetto Park Rd., Ste. 110, Boca Raton, Florida 33486, telephone no. (561) 338-5236, ext. 23.

Sincerely,

/s/

Elizabeth W. Ormond for Emma R. Singleton

Director, Florida District