part - II DETAILED checklist: HEMATOLOGY INSPECTION CHECKLIST Requirement (Doc. Ref. / Clause No.) assessment COMPLIANCE Y/N/NA NOTES 1.0 HEMATOLOGY INSPECTION CHECKLIST 1.1 Is a specimen collection manual available at all collection sites? 1.2 Does the specimen collection manual include: 1.2.1 Patient preparation 1.2.2 Specimen type and amount 1.2.3 Proper handling 1.2.4 Labelling instructions 1.3 Are there written criteria for specimen rejection? 2.0 Quality Control 2.1 Are controls run and documented on each day of use? 2.2 Are control specimens tested in the same manner and by the same personnel as patient samples? 2.3 Is quality control data reviewed at least monthly by the laboratory director or designate and is this review documented? 2.4 Are the day of use control results verified for acceptability before reporting patient results? 2.5 Are tolerance limits established for the controls run on each day of use? 2.6 Are criteria for referral of “out of control” results to the supervisor and/or senior staff identified? 2.7 Is evidence of documented corrective action taken when controls on day of use exceed defined tolerance limits? 2.8 Does the documentation include: 2.8.1 What was out of control? 2.8.2 Why the analysis was out of control? 2.8.3 Corrective action taken? 2.8.4 Signature/initials of individual responsible
2.9 Is lot number change of quality control material documented on the quality control record? 2.10 Are quality control records retained for at least two years? 2.11 Are quality control statistics (ie. SD and CV) calculated at specified intervals to define analytical imprecision? 2.12 Are control data organized and presented so they can be evaluated daily by technical staff to detect problems, trends, etc.? 3.0 Procedure Manual 3.1 Is a current procedure manual available for laboratory 3.2 Is the procedure manual maintained as per the documented procedure? 3.3 Are the following included for each procedure: (if applicable) 3.3.1 Purpose 3.3.2 Specimens (type, source, amount, storage) 3.3.3 Equipment and Materials required 3.3.4 Preparation and storage of reagents, standards and controls 3.3.5 Procedure – including Step by step instructions 3.3.6 Directions for calibration 3.3.7 Derivation of results (ie. mathematical calculations, dilutions) 3.3.8 Quality control 3.3.9 Linearity limits 3.3.10 Precision 3.3.11 Reference ranges 3.3.12 Critical values 3.3.13 Reporting results (units, stats, critical values) 3.3.14 Safety 3.4 Is documentation of annual review of the procedure manual by the laboratory director or designate? 3.5 Does the laboratory have a system documenting review of procedure manuals by personnel, relevant to their scope of testing? 3.6 Are all changes in methodology signed and dated by authorized staff?
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
19.6 For differentials, are stains always used to facilitate classification of nucleated cell types? 19.7 Are slides with suspected malignant reviewed by a pathologist or other qualified physician before final results reporting? 19.8 For samples counted using a hemocytometer, is each body fluid sample counted in duplicate? 20.0 SEMEN ANALYSIS 20.1 Does your laboratory perform semen analysis as part of a fertility investigation? 20.2 If yes, is a full assessment made to include: 20.2.1 Volume 20.2.2 Viscosity 20.2.3 pH 20.2.4 Motility 20.2.5 Abnormalities of liquefaction 20.2.6 Viability 20.2.7 Morphology 20.3 Is testing performed within one hour? 20.4 Is each sample counted in duplicate? 20.5 Is a pathologist, supervisor or experienced technologist available for consultation?