Putnam Diagnostic Imaging Center 27-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

555 Winderley PI., Ste. 200

Maitland, FL 32751

VIA FEDERAL EXPRESS

WARNING LETTER

FLA-02-35

March 27, 2002

FACILITY ID # 218644

David Taylor, Administrator

Putnam Diagnostic Imaging Center

6905 Old Wolf Bay Road

Palatka, Florida 32177

Dear Mr. Taylor:

We are writing to you because, on February 15, 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 a United States Federal law, the Mammography Quality Standards Act of

1992, 42 U.S.C. 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 February 15,

2002 inspection revealed the following violations at your facility:

1. Failure to adjust and maintain film processors used to develop mammograms

to meet the technical development specifications for the mammography film in

use. A processor performance test is required to be performed on each day

that clinical films are processed before any clinical films are processed that

day. The test shall include an assessment of base plus fog density, mid-

density, and density difference as required by 21 CFR 900.12(e)(l)(i), (ii), (iii).

For example, mammograms were processed when the X-OMAT Kodak

processor (Mammo Room) was out of limits on twenty- three days.

Specifically, the speed and contrast indices were out of limits from April 26

through May 30, 2001 and new AIMS were repeatedly established without

documenting that the facility physicist was consulted.

2. Failure to identify and correct the source of problems discovered during the

comparison of the test results, for the tests specified in 21 CFR 900.12(e)(l)

through (7) to the corresponding specified action limits, or to the

manufacturer?s recommended action, before further exams or within thirty

days, as required by 21 CFR 900.12 (e)(8)(i) and ii(A). For example,

corrective actions were not documented for: (1) processor QC failures at least

once for processor 01, Kodak, RP X-OMAT M6B, 6AN, Mammo room; and (2)

for a failing image score, a phantom background optical density, or a density

difference outside the allowable regulatory limits before further exams were

performed for unit 1, Bennett X-Ray Corp., CONT., Mammo room. More

specifically, phantom QC contrast index was out of limits on March 1, 8, 10,

13, and 17, 2001. Phantom QC specks score failed on July 20, and 27, 2001.

Mammograms were performed on these days and no corrective actions were

documented.

The specific problems noted above appeared on your MQSA Facility Inspection

Report, which was issued to your facility at the close of the inspection. Because

these conditions may be symptomatic of serious underlying problems that could

compromise the quality of mammography at your facility, they represent 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.

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;

• 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 Timothy J. Couzins, Compliance Officer, U.S.

Food & Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida

32751, (407) 475-4728. 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/cdrh/mammography.

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 at

561-338-5236 ext 23.

Sincerely,

Donna Langne

Emma R. Singleton

Director, Florida District