Blood bank outdoes rules, gets praise instead of 483.West Tennessee West Tennessee is one of the three Grand Divisions in the U.S. state of Tennessee. Of the three, it is the most sharply defined geographically. Its boundaries are the Mississippi River on the west and the Tennessee River on the east. Regional Blood Center, Jackson, TN, Nashville District. West Tennessee Regional Blood Center reacted so promptly and strongly to what 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. termed in 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) as "minor isolated discrepancies" that Investigator David Heiar left without issuing a 483 after the May 1996 audit and praised management for its commitment to regulatory compliance. None of the problems wound up on a 483 because the blood bank provided "satisfactory resolution" before the audit ended, the EIR said. For example, Heiar expressed concern about the shipment of an unlicensed product. The product was not shipped out-of-state, but he asked how the blood bank could prevent subsequent interstate shipment by the recipient. Management suggested including an explanatory letter, or perhaps attaching an identifying tag to such products, the EIR said. CBER CB·er n. One that uses a CB radio. backs up blood bank actions The blood bank also won a point when it deferred a decision to CBER. Examining donor re-entry RE-ENTRY, estates. The resuming or retaking possession of land which the party lately had. 2. Ground rent deeds and leases frequently contain a clause authorizing the landlord to reenter on the non-payment of rent, or the breach of some covenant, when the , Heiar questioned whether the blood bank had "deviated slightly" from CBER's protocol for the re-entry of donors deferred due to HBsAG results. The firm did not perform neutralization testing neutralization test n. See protection test. on reactive units, the report said. CEO/Responsible Head Joseph Schifano passed the question on to CBER, which responded with a memo supporting the blood bank's actions. The memo declared that "a sample untested for neutralization neutralization, chemical reaction, according to the Arrhenius theory of acids and bases, in which a water solution of acid is mixed with a water solution of base to form a salt and water; this reaction is complete only if the resulting solution has neither acidic nor would be considered as an 'inconclusive neutralization' result, for which the donor could be re-entered." Some other areas addressed during the inspection included: * A low setting for a refrigerator temperature recorder chart. This resulted in erroneous readings, the EIR said, but manual records showed proper temperatures were maintained. * Unverifiable expiration dates for arm preparation swabs. Schifano told Heiar that development was under way for SOPs for receiving and qualifying supplies and suppliers. He also directed QA staff to check expiration dating on all stocks of disposables. * A donor listed with an incorrect middle initial. Carol Rawlings, director of compliance and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: West Tennessee Regional Blood Center, Jackson, TN, Doc. 107999M, $4 plus handling. |
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