part - II DETAILED checklist: HEMATOLOGY INSPECTION CHECKLIST assessment (Doc. Ref. COMPLIANCE Requirement / Clause No.) Y/N/NA NOTES HEMATOLOGY INSPECTION 1.0 CHECKLIST Is a specimen collection manual available at 1.1 all collection sites? Does the specimen collection manual include: 1.2 Patient preparation 1.2.1 Specimen type and amount 1.2.2 Proper handling 1.2.3 Labelling instructions 1.2.4 Are there written criteria for specimen 1.3 rejection? Quality Control 2.0 Are controls run and documented on each day 2.1 of use? Are control specimens tested in the same 2.2 manner and by the same personnel as patient samples? Is quality control data reviewed at least 2.3 monthly by the laboratory director or designate and is this review documented? Are the day of use control results verified for 2.4 acceptability before reporting patient results? Are tolerance limits established for the 2.5 controls run on each day of use? Are criteria for referral of of control” “out 2.6 results to the supervisor and/or senior staff identified? Is evidence of documented corrective 2.7 action taken when controls on day of use exceed defined tolerance limits? Does the documentation include: 2.8 What was out of control? 2.8.1 Why the analysis was out of control? 2.8.2 Corrective action taken? 2.8.3 Signature/initials of individual responsible 2.8.4
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
cra-f-05-15189-s-11-hematology%20inspection%20checklist.docx