1.2.17 Corrective action 1.2.18 Signature/initials of individual responsible? 1.2.19 Are control data organized and presented so they can be evaluated daily by technical staff to detect problems, trends, etc.? 1.2.20 Is lot number change of quality control material documented on the quality control record? 1.2.21 Are quality control records retained for at two years? 1.2.22 Are quality control statistics (ie. SD and CV) calculated at specified intervals to define analytical imprecision? 2.0 Procedure Manual 2.1 Is a current procedure manual available for laboratory staff? 2.2 Is the procedure manual maintained as per the documented procedure? 2.3 Are the following included for each procedure: (if applicable) 2.3.1 Purpose 2.3.2 Specimens (type, source, amount, storage) 2.3.3 Equipment and Materials required 2.3.4 Preparation and storage of reagents, standards and controls 2.3.5 Procedure – including Step by step instructions 2.3.6 Directions for calibration 2.3.7 Derivation of results (ie. mathematical calculations, dilutions) 2.3.8 Quality control 2.3.9 Linearity limits 2.3.10 Precision 2.3.11 Reference ranges 2.3.12 Clinical Significance 2.3.13 Critical values 2.3.14 Reporting results (units, stats, critical values) 2.3.15 Safety 2.4 Is there documentation of annual review of the procedure manual by the laboratory director or designate? 2.5 Is documentation of annual review of the procedure manual by the laboratory staff?
accuracy and reproducibility, and results recorded? 6.12 Is the temperature of water baths and/or heat blocks checked on days of use? 6.13 Is the temperature of refrigerators and temperature dependent equipment documented daily: 6.13.1 Room temperature 6.13.2 Freezer 6.13.3 Refrigerator 6.14 Is there evidence of active review of results of instrument maintenance and temperature? 6.15 Is there a procedure available if acceptable temperature ranges are exceeded? 6.16 Is this review documented? 6.17 Glassware 6.17.1 Are there appropriate documented procedures for handling and cleaning glassware, including methods for testing for detergent removal? 6.18 Microscopes 6.18.1 Are there an adequate number of microscopes for the workload? 6.18.2 Are all microscopes clean, well maintained and suitable for their intended use? 6.18.3 Is there an adequate selection of objective lenses for the specimens examined? 6.18.4 Is there a procedure for Koehler illumination? 6.19 Centrifuges 6.19.1 Is there a schedule for maintenance of all centrifuges? 6.19.2 Are operating speeds checked and documented? 6.20 Balances 6.20.1 Are balances mounted on vibration-free benches? 6.20.2 Are balances and regularly serviced? 6.20.3 Are NIST/Equivalent reference weights available and used for checking accuracy? 6.21 Autoclaves 6.21.1 Is the autoclave monitored weekly for proper functioning? 6.22 Pipettes 6.22.1 Does your laboratory check pipettes for calibration? 6.23 Thermometers
10.1.6 date and time of report release 10.1.7 conditions of specimen that may adequacy of testing 10.1.8 name of laboratory performing the test(s) 10.1.9 specimen source 10.1.10 specimen collected by 10.2 Are established criteria for immediate notification of critical test results? 10.3 Is there documentation of notification to the proper clinical individual of results of all critical values? 10.4 Does the laboratory have a policy regarding “read back” of critical values that are communicated verbally or by phone? 10.5 Is confidentiality ensured for laboratory results received and distributed by the laboratory via: 10.5.1 Fax 10.5.2 Electronic Mail 10.5.3 Mail 10.5.4 Delivery 10.6 Is there a procedure to identify and trace late/lost reports? 10.7 Is there a policy for retention of patient reports? 10.8 Does the laboratory promptly notify clinical personnel and issue a corrected report when errors are detected in patient test reports? 10.9 Is there a documented system to ensure that all revised reports for previously reported incorrect patient results are identified as amended on all forms of patient reports? 10.10 Is there a policy regarding the communication and documentation of reportable diseases? 10.11 Are all patient results reported with reference ranges? 10.12 Are references ranges verified or established by the laboratory for the population being tested? 10.13 Is there a stat list in place? 10.14 Are stat results available within a reasonable time? 10.15 Are routine results available within a reasonable time? 10.16 Is the referral laboratory identified on the final report, if specimens are referred out? 10.17 Do reports for laboratory-developed assays contain a description of the method, a statement