Blood bank receives back-to-back 483s for donor suitability criteria.

Siouxland Community Blood Bank, Sioux City, IA, Lenexa, KS District

Siouxland Community Blood Bank, Sioux City, IA, received consecutive 483s within 30 days for failing to ensure that plasmapheresis donors met suitability criteria, and for failure to submit biological product deviation reports in a timely manner. The EIR was not available at press time.

Investigator David Miser from the Lenexa, KS, District Office wrote both reports. He noted in the first inspection that Siouxland received an approval letter dated March 27, 2003, for a supplement to its biologics license application to include the manufacture of fresh frozen plasma (FFP) every 28 days or less frequently, concurrently with plateletpheresis using the firm's Haemonetics MCS Plus LN9000. "However, your firm has been collecting FFP concurrently with plateletpheresis with each donation of plateletpheresis since Feb. 2, 2003."

Next, the firm was cited by Miser for "failure to test each month four units prepared from different donors at the end of the storage period for platelet count, pH of not less than 6.0 measured at the storage temperature of the unit, and actual plasma volume." Specifically, Siouxland conducted quality control testing on plateletpheresis at the time of collection, not at the end of the unit's storage period.

The second 483 noted that the facility submitted a biological product deviation report in the applicable timeframe, "but was incomplete because information regarding the fatality associated with the platelet product unit at 1845575 at [undisclosed] was not included in the report to FDA."

The report also cited Siouxland because it did not maintain quality control records. "Specifically, periodic checks of sterile technique do not include an objective evaluation of microbial contamination. Two units of platelets...were found contaminated with Staphylococcus epidermidis and Staphylococcus aureus, respectively."

Janet Twait, the facility's CEO, said in a May 5 interview: "FDA was correct in their notation about plasmapheresis donors not meeting suitability criteria. We had a short period where we collected fresh plasma concurrently. We have made the correction and are in compliance. We stopped producing FFP until we were in compliance."

Regarding testing, she said: "We modified our process so that we were testing not just at time of release, but to ensure we fulfilled all testing obligations. We weren't doing this consistently before. We know we have to do testing now at release and sometimes after outdate."

Twait also commented on an unreported serious adverse event: "We notified the hospital to report it but we didn't realize that our facility also needed to do it. We are making a process change, so that when the hospital reports the adverse event, we will do so, as well," Twait said.

Siouxland Community Blood Bank, Sioux City, IA, 6/17-20/03, Doc. 109714M, $3 plus retrieval.