Blood bank received warning letters from FDA

Three letters in the 1990s said Florida Blood Services used improper procedures. The blood bank says problems have been corrected.

By CURTIS KRUEGER, Times Staff Writer
© St. Petersburg Times
published July 19, 2002

ST. PETERSBURG -- Three times in the late 1990s the federal Food and Drug Administration sent "warning letters" to Florida Blood Services about improper procedures, including two letters criticizing its handling of blood being tested for HIV.

But officials with the blood bank, which collects about 200,000 pints a year from 100,000 donors, said Thursday the problems have been corrected. They said the agency is vigilant about searching for impurities in plasma, red blood cells and platelets it sends to 30 hospitals in Pinellas, Hillsborough and Pasco counties.

"I think we do an excellent job," said Don Doddridge, Florida Blood Services' chief executive officer. He said his employees are dedicated and "they don't want to let a bad product out of here."

The FDA said Florida Blood Services did not perform HIV testing properly in one case. In another, it did not properly document how it disposed of HIV-infected blood. In a third, the FDA said a syphilis test was performed incorrectly.

Doddridge stressed, however, that Florida Blood Services did not send out tainted blood in any of those cases.

The FDA routinely inspects blood centers to make sure they are properly testing for infected blood and documenting how they do it.

FDA spokesman Lawrence Bachorik said "a warning letter from the FDA is a serious bit of business." But he added the FDA can take more severe regulatory actions against agencies with more severe problems.

"I'm sure there are blood centers that haven't received three warning letters in five years, but on the other hand there are more extreme remedies" the FDA can impose, he said.

"If the FDA thought they were an imminent threat to the public health they could revoke the license," and do so quickly, Bachorik said.

Blood banks that fail to correct their problems also can be required to sign legally binding "consent decrees," which require them to make improvements, with oversight from a court, he said. The American Red Cross, for example, has operated under a consent decree since 1993.

Florida Blood Services said that after receiving each of its warning letters, it provided written plans to correct the problems cited by the FDA. These plans eventually were approved by the FDA, officials said.

The blood bank was not put under consent decrees after the 1997, 1998 or 1999 letters. It has received no warning letters since then.

In the July 1997 warning letter, FDA officials who inspected a facility on Spectrum Boulevard in Tampa said Florida Blood Services had failed to use proper procedures when testing blood for HIV.

In one case cited by the agency, the blood bank tested a unit of blood and found it to be "reactive," meaning it initially tested positive for HIV. Procedures call for two more tests. The FDA said the blood bank only performed one more test, and then "three unsuitable blood components (red blood cells, platelets and plasma) prepared from this blood unit were released for distribution."

The problem was that an early test did not work properly and, hence, was considered not valid. As a result, the proper number of tests had not been conducted. Florida Blood Services realized the error and conducted further tests before receiving the FDA's letter, Doddridge said.

The FDA's letter said that its findings showed "the procedures in place for supervisory review and quality control are inadequate." But in a followup letter one month later, on Aug. 19, 1997, it said new procedures Florida Blood Services set up to prevent a similar lapse "appear satisfactory."

The warning letter on June 10, 1998, said Florida Blood Services failed to follow the manufacturer's procedures for interpreting a syphilis test. But Florida Blood Services officials said they had consulted with the manufacturer and got instructions somewhat different than the FDA's interpretation. After receiving the FDA letter, they used the FDA's interpretation, and still do.

They said syphilis is not transmitted by blood transfusions, but that the test is important for public health reasons.

The letter on April 30, 1999, said an inspection of a blood bank facility turned up "incomplete, inaccurate and/or nonexistent records for all blood components produced." This included a blood unit which tested positive for HIV. Florida Blood Services officials said this tainted blood was disposed of properly, but the computer program they were using at the time did not reflect that accurately.

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