(Doc. Ref. assessment COMPLIANCE Clause Requirement / Clause Y/N/NA NOTES No. No.) ANATOMIC PATHOLOGY 1.0 Quality Control 1.1 Are control specimens tested in the same 1.1.1 manner and by the same personnel as patient samples? Is quality control data reviewed at least 1.1.2 monthly by the laboratory director or designate? Is this review documented? 1.1.3 Are results of controls verified for 1.1.4 acceptability before reporting results? Are criteria for what is considered to be out 1.1.5 of control available to staff? Are criteria for referral of of control” “out 1.1.6 results to the supervisor and/or senior staff identified? Is there documentation of corrective action 1.1.7 taken when controls exceed defined tolerance limits? Does the documentation include: 1.1.8 1.1.8.1 What was out of control? 1.1.8.2 Why the analysis was out of control? 1.1.8.3 What is Corrective action taken? 1.1.8.4 Signature/initials of individual responsible Are quality control records retained for at 1.1.9 least two years? Quality MANAGEMENT 1.2 Does the anatomic pathology laboratory 1.2.1 utilize documented cancer checklists ? Is the anatomic pathology laboratory enrolled in external proficiency testing for 1.2.2 each area of anatomic pathology? If not, please give justification. Is there documented peer review, involving 1.2.3 either retrospective or prospective review of selected cases, by a second pathologist? Procedure Manual 1.3 Is a current procedure manual available for 1.3.1 laboratory staff?
Clause No. Requirement (Doc. Ref. / Clause No.) assessment COMPLIANCE Y/N/NA NOTES 1.0 ANATOMIC PATHOLOGY 1.1 Quality Control 1.1.1 Are control specimens tested in the same manner and by the same personnel as patient samples? 1.1.2 Is quality control data reviewed at least monthly by the laboratory director or designate? 1.1.3 Is this review documented? 1.1.4 Are results of controls verified for acceptability before reporting results? 1.1.5 Are criteria for what is considered to be out of control available to staff? 1.1.6 Are criteria for referral of “out of control” results to the supervisor and/or senior staff identified? 1.1.7 Is there documentation of corrective action taken when controls exceed defined tolerance limits? 1.1.8 Does the documentation include: 1.1.8.1 What was out of control? 1.1.8.2 Why the analysis was out of control? 1.1.8.3 What is Corrective action taken? 1.1.8.4 Signature/initials of individual responsible 1.1.9 Are quality control records retained for at least two years? 1.2 Quality MANAGEMENT 1.2.1 Does the anatomic pathology laboratory utilize documented cancer checklists ? 1.2.2 Is the anatomic pathology laboratory enrolled in external proficiency testing for each area of anatomic pathology? If not, please give justification. 1.2.3 Is there documented peer review, involving either retrospective or prospective review of selected cases, by a second pathologist? 1.3 Procedure Manual 1.3.1 Is a current procedure manual available for laboratory staff?