#06-5558 Accrd Manual V7 - COLA

IMMUNOHEMATOLOGY & TRANSFUSION SERVICESCOLA Accreditation includes an evaluation of laboratory policies, processes, and records associated with thefollowing:• Laboratory testing performed on potential blood donors (such as hemoglobin and hematocrit)• Laboratory testing performed on blood components (such as ABO& Rh, HIV, hepatitis, etc…)• Laboratory testing of blood products for compatibility with an intended recipient (such as ABO & Rh,Antibody screening, compatibility, etc)• Storage of blood products• Dispensing blood products for intended transfusion• Basic requirements associated with administration of the product to the intended recipient• Investigation of suspected transfusion reactions and associated laboratory testing (such as ABO & Rh, DAT,haptoglobin, etc…).COLA Accreditation does not include evaluation of policies, processes, and procedures associated with donorsuitability, collection of the blood product, manufacturing (processing) the blood product, and recall of bloodproducts or donors.ManagementTS 1 EIs your transfusion service properly registered with the FDA if it is not exempt from FDA registration accordingto 21 CFR 607.65 (f )?Facilities that draw donors and process donor units must be registered with the FDA. Laboratories processingdonor units beyond:• The packing or aliquoting of RBC’s,• Issuing of bedside leukocyte reduction filters,• Thawing FFP,• Pooling Platelets of Cyroprecipitated AHFare not exempt from these regulations.TS 2 RDo you have a written agreement between your facility and other facilities governing the availability, procurement,testing and transfer of blood and blood components that are provided to you by those facilities, and does theagreement meet the needs of the physicians responsible for the diagnosis, management, and treatment ofpatients who are served by your facility?Does the laboratory director:TS 3 EProvide facilities adequate for procurement, safekeeping, and transfusion of blood and blood components asspecified at 21 CFR 606.40?TS 4 EEnsure that procedures are in place for the storage, testing, dispensing and transfusion of blood and bloodcomponents?64. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org