Two inspections for blood bank net clean report, 1-item 483.Blood Bank of San Bernardino San Bernardino, city, United States San Bernardino (săn bûr'nədē`nō), city (1990 pop. 164,164), seat of San Bernardino co., S Calif., at the foot of the San Bernardino Mts.; inc. 1854. and Riverside Counties, San Bernardino, CA, Irvine, CA, District The Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, was not cited for any 483 violations following a 2003 inspection, but did receive a one-item 483 in 2005 because SOPs for the collection and processing of blood and blood components for homologous homologous /ho·mol·o·gous/ (ho-mol´ah-gus) 1. corresponding in structure, position, origin, etc. 2. allogeneic. ho·mol·o·gous adj. 1. transfusion and autologous transfusion autologous transfusion Autologous blood transfusion Transfusion medicine The collection and re-infusion of the Pt's own blood and/or blood products; the volume of blood available for AT can be ↑ with recombinant erythropoietin and iron supplements; AT is most were not always followed. Both inspections were performed by Investigator Timothy LaFave from the Irvine, CA, District Office. In the first audit, 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) noted that the blood bank operates four fixed satellite donor sites in Upland, Ontario, Riverside and Hesperia, as well as mobile whole blood collection operations at various locations. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. wrote: "Donor records, quality control records, equipment maintenance and service records, training records, storage records, blood product deviation reports and computer records were reviewed since the last inspection with no significant problems noted." The report stated that two mobile operations were checked during this inspection. One was located at a strip mall parking lot in a large motor home with five donor beds and two donor history- and screening- booths. The other was operated in a hotel in a large room with six beds. "Both mobiles collected only allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically whole blood, which was stored in validated coolers after collection, then transported back to the main facility for processing," the EIR noted. LaFave reviewed 10 donor records at each location with no significant problems noted. Also, "approximately 10 donations were observed at each location and no problems noted." In the second inspection, LaFave noted that the donor sign-in SOP stated on page five: "At each donation, ask donor to present some form of recent picture identification," and "make certain that the donor matches the name and picture on his/her ID," the EIR stated. This was not performed by any staff observed. The facility's management agreed that this was a problem and would make corrections, including retraining re·train tr. & intr.v. re·trained, re·train·ing, re·trains To train or undergo training again. re·train of staff. The facility was contacted by Inspection Monitor, but an update could not be obtained before deadline. Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, 7/14-18/03, 1/11-18/05, Doc. 109804M, $11 plus retrieval. |
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