#06-5558 Accrd Manual V7 - COLA

IMMUNOHEMATOLOGY & TRANSFUSION SERVICES>Does the written transfusion reaction investigation procedure and associated documentation:TS 75 RInclude checking for errors in the identification of the recipient or in the records?TS 76 RRequire that a new blood sample be drawn?TS 77 RRequire that all infusion materials be collected?TS 78 RInclude checking for hemolysis of the newly collected blood sample?TS 79 RInclude a repeat direct antiglobulin test (DAT) that is compared to the initial sample?TS 80 RInclude culturing for potential contamination, if clinically indicated?TS 81 RRecommend changes to transfusion procedures in response to identified errors?TS 82 RInclude taking remedial action to prevent future transfusion reactions?TS 83 RInclude a report-back mechanism to testing or collecting facility if results of adverse transfusion reactions wereattributable to them?TS 84 EDoes the laboratory have a procedure for the immediate notification of the FDA and COLA in the case of transfusionrelated fatalities?The transfusing facility must notify the FDA by phone or telegraph as soon as possible, and in writing within7 days of all transfusion-related fatalities.Record Keeping and DocumentationTS 85 EDoes the record keeping system in use trace all units from source to disposition, facilitating the investigationof adverse reactions and facilitate recall if needed?TS 86 RDoes the record keeping system in use identify the persons responsible at each step in the transfusion process?Does the record keeping system in use include:TS 87 RA record of all reagents used when testing donor units that includes the manufacturer’s name, lot number, andexpiration date?TS 88 RThe disposition of rejected reagents?TS 89 RA dispensing log of plasma derivatives such as Rh immune globulin, Factor VIII, Factor IX, and albumin indicatingrecipient and lot number?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org75