Equipment and Materials required 2.2.3 Preparation and storage of reagents, standards 2.2.4 and controls 2.2.5 Procedure including Step by step instructions – 2.2.6 Directions for calibration (if applicable) Derivation of results (ie. mathematical 2.2.7 calculations, dilutions) Quality control 2.2.8 Linearity limits 2.2.9 Precision 2.2.10 Reference ranges 2.2.11 Clinical Significance 2.2.12 Critical values 2.2.13 Reporting results (units, stats, critical values) 2.2.14 Safety 2.2.15 Is documentation of annual review of the 2.3 procedure manual by the laboratory director or designate? Is there documentation of annual review of the 2.4 procedure manual by the laboratory staff? Are all changes in methodology signed and 2.5 dated by whoever made the changes? Are all new procedures reviewed by the medical 2.6 director or designate? Are discontinued procedures retained for two 2.7 after the procedure is taken out of service? Is a current file on manufacturer’s inserts? 2.8 Are there adequate and up to date reference text 2.9 books available to laboratory staff? Does the laboratory staff have access to current 2.10 and relevant guidelines? 3.0 Specimen Collection Manual Is a specimen collection manual available at all 3.1 collection sites? Are instructions for microbiology specimen 3.2 collection and handling that include all of the following: Method for proper collection of culture 3.2.1 specimens from different sources Proper labelling of culture specimens 3.2.2 Use of transport media when necessary 3.2.3 Procedures for safe handling of specimens 3.2.4 (tightly sealed containers, no external spillage)
2.2.3 Equipment and Materials required 2.2.4 Preparation and storage of reagents, standards and controls 2.2.5 Procedure – including Step by step instructions 2.2.6 Directions for calibration (if applicable) 2.2.7 Derivation of results (ie. mathematical calculations, dilutions) 2.2.8 Quality control 2.2.9 Linearity limits 2.2.10 Precision 2.2.11 Reference ranges 2.2.12 Clinical Significance 2.2.13 Critical values 2.2.14 Reporting results (units, stats, critical values) 2.2.15 Safety 2.3 Is documentation of annual review of the procedure manual by the laboratory director or designate? 2.4 Is there documentation of annual review of the procedure manual by the laboratory staff? 2.5 Are all changes in methodology signed and dated by whoever made the changes? 2.6 Are all new procedures reviewed by the medical director or designate? 2.7 Are discontinued procedures retained for two after the procedure is taken out of service? 2.8 Is a current file on manufacturer’s inserts? 2.9 Are there adequate and up to date reference text books available to laboratory staff? 2.10 Does the laboratory staff have access to current and relevant guidelines? 3.0 Specimen Collection Manual 3.1 Is a specimen collection manual available at all collection sites? 3.2 Are instructions for microbiology specimen collection and handling that include all of the following: 3.2.1 Method for proper collection of culture specimens from different sources 3.2.2 Proper labelling of culture specimens 3.2.3 Use of transport media when necessary 3.2.4 Procedures for safe handling of specimens (tightly sealed containers, no external spillage)
CRA-F-05-15189-S-08-Microbiology%20Inspection%20Checklist.docx