(Doc. Ref. assessment COMPLIANCE Clause Requirement / Clause Y/N/NA No. No.) 1.0 Quality Control Are controls run and documented on each 1.1 day of use? Are control specimens tested in the same 1.2 manner and by the same personnel as patient samples? Is quality control data reviewed at least 1.3 monthly by the laboratory director or designate and is this review documented? Are the day of use control results verified 1.4 for acceptability before reporting patient results? Are tolerance limits established for the 1.5 controls run on each day of use? Are criteria for referral of of control” “out 1.6 results to the supervisor and/or senior identified? Is evidence of documented corrective 1.7 action taken when controls on day of use exceed defined tolerance limits? Does the documentation include: 1.8 What was out of control? 1.8.1 Why the analysis was out of control? 1.8.2 Corrective action taken? 1.8.3 Signature/initials of individual 1.8.4 responsible Is lot number change of quality control 1.9 material documented on the quality control record? Are quality control records retained for at 1.10 two years? If the POCT program uses more than one instrument/method to test for a given 1.11 analyte, are the instruments/methods checked against each other at least twice per year for correlation of patient results? Are new lots of controls tested in parallel 1.12 with the lot in use? The following set of questions apply to 1.13 HIV testing only:
Clause No. Requirement (Doc. Ref. / Clause No.) assessment COMPLIANCE Y/N/NA 1.0 Quality Control 1.1 Are controls run and documented on each day of use? 1.2 Are control specimens tested in the same manner and by the same personnel as patient samples? 1.3 Is quality control data reviewed at least monthly by the laboratory director or designate and is this review documented? 1.4 Are the day of use control results verified for acceptability before reporting patient results? 1.5 Are tolerance limits established for the controls run on each day of use? 1.6 Are criteria for referral of “out of control” results to the supervisor and/or senior identified? 1.7 Is evidence of documented corrective action taken when controls on day of use exceed defined tolerance limits? 1.8 Does the documentation include: 1.8.1 What was out of control? 1.8.2 Why the analysis was out of control? 1.8.3 Corrective action taken? 1.8.4 Signature/initials of individual responsible 1.9 Is lot number change of quality control material documented on the quality control record? 1.10 Are quality control records retained for at two years? 1.11 If the POCT program uses more than one instrument/method to test for a given analyte, are the instruments/methods checked against each other at least twice per year for correlation of patient results? 1.12 Are new lots of controls tested in parallel with the lot in use? 1.13 The following set of questions apply to HIV testing only:
CRA-F-05-15189-S-09-Point-of-Care%20Testing%20Inspection%20Checklist.docx