15.0 Platelet Function Studies Are blood specimens for platelet aggregation 15.1 and initial platelet function studies handled at room temperature before testing? If platelet aggregation studies are performed by an optical aggregation methodology using 15.2 platelet rich plasma (PRP), is there a defined optimal platelet concentration? Are platelet aggregation studies completed 15.3 within 4 hours of collection? 16.0 D-dimer Are the limitations of the methodology or the 16.1 cut off value for exclusion of VTE included with the patient report? Does the laboratory report D-dimer in FEU 16.2 g/L? Is documentation of annual verification 16.3 of calculated results? Has the D-dimer method been evaluated for 16.4 the exclusion of venous thromboembolism? Abnormal Hemoglobin Detection 17.0 Are controls containing at least three known major hemoglobins, including both a sickling 17.1 and a non-sickling hemoglobin applied with the patient specimen(s) and are separations satisfactory? Are all samples with hemoglobin variants migrating in , positions on “non-A” “non-S” 17.2 alkaline electrophoresis, isoelectric focusing or HPLC further defined with electrophoresis at acid pH or other acceptable methods? Are samples that appear to have Hb S in the 17.3 primary screening further examined to confirm the presence of Hb S by: Performing a second procedure, or 17.3.1 Indicate on report, specimen referred for 17.3.2 confirmation Are all samples that have Hb S as the 17.4 predominant band by the primary method and confirmed as sickling further examined to
15.0 Platelet Function Studies 15.1 Are blood specimens for platelet aggregation and initial platelet function studies handled at room temperature before testing? 15.2 If platelet aggregation studies are performed by an optical aggregation methodology using platelet rich plasma (PRP), is there a defined optimal platelet concentration? 15.3 Are platelet aggregation studies completed within 4 hours of collection? 16.0 D-dimer 16.1 Are the limitations of the methodology or the cut off value for exclusion of VTE included with the patient report? 16.2 Does the laboratory report D-dimer in FEU g/L? 16.3 Is documentation of annual verification of calculated results? 16.4 Has the D-dimer method been evaluated for the exclusion of venous thromboembolism? 17.0 Abnormal Hemoglobin Detection 17.1 Are controls containing at least three known major hemoglobins, including both a sickling and a non-sickling hemoglobin applied with the patient specimen(s) and are separations satisfactory? 17.2 Are all samples with hemoglobin variants migrating in “non-A” , “non-S” positions on alkaline electrophoresis, isoelectric focusing or HPLC further defined with electrophoresis at acid pH or other acceptable methods? 17.3 Are samples that appear to have Hb S in the primary screening further examined to confirm the presence of Hb S by: 17.3.1 Performing a second procedure, or 17.3.2 Indicate on report, specimen referred for confirmation 17.4 Are all samples that have Hb S as the predominant band by the primary method and confirmed as sickling further examined to
cra-f-05-15189-s-11-hematology%20inspection%20checklist.docx