Is lot number change of quality control 2.9 material documented on the quality control record? Are quality control records retained for at 2.10 least two years? Are quality control statistics (ie. SD and CV) 2.11 calculated at specified intervals to define analytical imprecision? Are control data organized and presented so 2.12 they can be evaluated daily by technical staff to detect problems, trends, etc.? Procedure Manual 3.0 Is a current procedure manual available for 3.1 laboratory Is the procedure manual maintained as per the 3.2 documented procedure? Are the following included for each 3.3 procedure: (if applicable) Purpose 3.3.1 Specimens (type, source, amount, storage) 3.3.2 Equipment and Materials required 3.3.3 Preparation and storage of reagents, standards 3.3.4 and controls Procedure including Step by step – 3.3.5 instructions Directions for calibration 3.3.6 Derivation of results (ie. mathematical 3.3.7 calculations, dilutions) Quality control 3.3.8 Linearity limits 3.3.9 Precision 3.3.10 Reference ranges 3.3.11 Critical values 3.3.12 Reporting results (units, stats, critical values) 3.3.13 Safety 3.3.14 Is documentation of annual review of the 3.4 procedure manual by the laboratory director or designate? Does the laboratory have a system 3.5 documenting review of procedure manuals by personnel, relevant to their scope of testing? Are all changes in methodology signed and 3.6 dated by authorized staff?
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?
cra-f-05-15189-s-11-hematology%20inspection%20checklist.docx