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)
each other at least twice a year for correlation of results? 5.9 Are there defined tolerance limits for result agreement of inter-instrument assays? 5.10 Does the laboratory have a procedure for evaluating automatic pipette systems for carryover? 5.11 Are pipettors, microtiter or automatic dispensers checked at annually for accuracy and reproducibility, and results recorded? 5.12 Is the temperature of baths and/or heat blocks checked on days of use? 5.13 Is the temperature of refrigerators and other temperature dependent equipment documented daily: 5.13.1 Room temperature 5.13.2 Freezer 5.13.3 Refrigerator 5.13.4 Incubators 5.14 Is there evidence of active review of temperature records? 5.15 Are reviews documented? 5.16 Is there a procedure available if acceptable temperature ranges are exceeded? 5.17 Is there documentation that anaerobic systems (eg. jars, chambers, bags) are checked for adequate anaerobic conditions with: 5.17.1 indicator strips 5.17.2 fastidious anaerobic organisms 5.17.3 Are CO2 incubators checked daily for adequate CO2 levels, with recording of results 5.18 Biological Safety Cabinets 5.18.1 Is a biological safety cabinet used for handling all specimens or organisms considered to be contagious by airborne routes? 5.18.2 Does the biological safety cabinet meet minimum requirements for the work performed in it, as described in the Health Canada Laboratory Biosafety Guidelines? 5.18.3 Type of biological safety cabinet used: Class I – protect operator 5.18.4 Class II – protect operator plus specimen 5.18.5 Class III – protect operator plus specimen, airtight 5.18.6 Is the biological safety cabinet certified annually (and documented)? 5.18.7 Is the cabinet appropriately situated to avoid/minimize air turbulence?
7.1.6 CSF: 7.1.7 Wound: 7.1.8 Genital: 7.1.9 7.1.10 Throats: 7.1.11 (specify): 7.2 Media 7.2.1 Are there instructions to indicate the number and types of media and method of inoculation required? 7.2.2 Does the laboratory have documentation that its media supplier carries out the quality assurance guidelines as per CLSI document M22-A3? 7.2.3 Does the laboratory have documentation that the purchased media that are not listed in M22-A3 as exempt from testing is checked for each of the following: Ability to support growth by means of stock cultures or by parallel testing with previous batches? 7.2.4 Biochemical reactivity (where appropriate)? 7.2.5 For media prepared in-house, is there documentation that it is checked for each of the following: Sterility (following introduction of additives after sterilization)? 7.2.6 Ability to support growth by means of stock cultures or by parallel testing with previous batches? 7.2.7 Biochemical reactivity (where appropriate)? 8.0 GYNECOLOGICAL SPECIMENS 8.1 Are B streptococcus screens collected and cultures from pregnant women in accordance with current guidelines? 9.0 DETECTION OF SEXUALLY TRANSMITTED PATHOGENS 9.1 Are culture conditions optimal for isolation of Neisseria gonorrhoeae? 9.2 If Neisseria gonorrhoeae isolated, is being tested and reported? 9.3 Are culture facilities or NAAT methods available locally or via a reference laboratory for the detection of Chlamydia trachomatis?