Paperwork Problems At Payson Blood Bank Irk FDA Regulators

greenspun.com : LUSENET : Y2K discussion group : One Thread

   WASHINGTON -- HCA -- The Healthcare Co. was warned by U.S. regulators about record-keeping problems at a Payson blood bank that could have led to the distribution of impure blood products.
    U.S. Food and Drug Administration inspectors found inconsistencies between different written accounts as to whether some tainted blood was properly incinerated. One set of records said "the salvaged plasma was actually shipped," the FDA said in a letter to the company.
    "There was no evidence that your firm followed up on this error," the FDA said in a May 3 letter about practices at HCA's Mountain View Hospital Blood Bank in Payson. The FDA didn't disclose where the plasma may have been sent.


    Officials at HCA, based in Nashville, Tenn., said the problems stemmed from flawed record-keeping practices, and that no impure blood products were ever distributed. The blood bank had been in the process of changing from manual record-keeping to a computerized system, which is now in place, said Jeff Prescott, a company spokesman.
    "Their concern is strictly with record-keeping and documentation," Prescott said. "The hospital had used a manual system, and they are switching to a computer system -- they are fine now and they are meeting regularly with the FDA."
    Other problems included a donor who tested positive for HIV and then remained on at least one of the blood bank's lists of potential safe donors for about a week, and a donor -- listed as permanently ineligible to donate -- whose name was temporarily listed as eligible after she married and changed her last name.
    The company wasn't as capable as it should have been of tracking the destination of each unit of donated blood product, the letter said. And the problems have persisted in some form or another since a 1999 inspection, according to the letter.

Salt Lake Tribune

-- Anonymous, May 30, 2001


Moderation questions? read the FAQ