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 plasmapheresis, see apheresis. donors met suitability criteria, and for failure to submit biological product deviation reports in a timely manner. The EIR EIR n. popular acronym for environmental impact report, required by many states as part of the application to a county or city for approval of a land development or project. (See: environmental impact report) 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 fresh frozen plasma
n. Abbr. FFP
Blood plasma frozen within 6 hours of collection.
fresh frozen plasma (FFP FFP - Formal FP. A language similar to FP, but with regular sugarless syntax, for machine execution.
See also FL.
["Can Programming be Liberated From the von Neumann Style? A Functional Style and Its Algebra of Programs", John Backus, 1977 Turing Award Lecture, CACM ) 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 Platelet Count Definition
A platelet count is a diagnostic test that determines the number of platelets in the patient's blood. Platelets, which are also called thrombocytes, are small disk-shaped blood cells produced in the bone marrow and involved in , 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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ."
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 microbial
pertaining to or emanating from a microbe.
the breakdown of organic material, especially feedstuffs, by microbial organisms. contamination. Two units of platelets...were found contaminated with Staphylococcus epidermidis and Staphylococcus aureus, respectively."
Janet Twait, the facility's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , 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 out·date
tr.v. out·dat·ed, out·dat·ing, out·dates
To replace or make obsolete or old-fashioned. ."
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.