6 Microscope and Examination 10.3.4 10.7 6.1 Instructions for ocular and Kohler adjustments? 3.22.10 Requirement 10.3.6 10.8 6.2 That all measurements must be recorded to the 15.2.2.3 15.2.2.4 3.22.5 Requirement nearest 0.5 micron? 15.2.3.3 15.2.3.4 6.3 Microscope cleaning procedures? 10.4 10.9 3.22.11 Requirement 6.4 The recording of coordinates of all cysts and oocysts on the worksheet for future reference; and - - - Recommendation slide orientation on the microscope stage to standardize coordinate recording? 6.5 The examination and acceptance of positive and 5.4.6 negative staining controls before proceeding with 15.2.1 15.2.1 Requirement 5.4.7 examination of field samples? 6.6 That each analyst characterizes 3 oocysts and 3 cysts on the positive staining control at each 15.2.1.1 15.2.1.1 5.4.6 Requirement examination session? 6.7 Corrective actions if positive and/or negative - - 5.4.8 Recommendation staining controls are not acceptable? 15.2.2 5.4.9 6.8 The criteria for organism identification? 15.2.2 Requirement 15.2.3 5.4.10 6.9 Every positive organism in a field sample is 15.2.2.1 5.4.9.1 15.2 Requirement characterized and recorded? 15.2.3.1 5.4.10.1 6.10 Acceptable microscope and examination Requirement procedures, including issues not noted in items 6.1 GLP through 6.9? 7 Reagents 7.1 Procedures for the preparation of all essential 7.0 7.0 4.2 Critical chemicals and reagents? 7.2 That expiration are specified for all reagents - - 4.2.2 Critical prepared by the laboratory?
6 Microscope and Examination 6.1 Instructions for ocular and Kohler adjustments? 10.3.4 10.3.6 10.7 10.8 3.22.10 Requirement 6.2 That all measurements must be recorded to the nearest 0.5 micron? 15.2.2.3 15.2.3.3 15.2.2.4 15.2.3.4 3.22.5 Requirement 6.3 Microscope cleaning procedures? 10.4 10.9 3.22.11 Requirement 6.4 The recording of coordinates of all cysts and oocysts on the worksheet for future reference; and slide orientation on the microscope stage to standardize coordinate recording? - - - Recommendation 6.5 The examination and acceptance of positive and negative staining controls before proceeding with examination of field samples? 15.2.1 15.2.1 5.4.6 5.4.7 Requirement 6.6 That each analyst characterizes 3 oocysts and 3 cysts on the positive staining control at each examination session? 15.2.1.1 15.2.1.1 5.4.6 Requirement 6.7 Corrective actions if positive and/or negative staining controls are not acceptable? - - 5.4.8 Recommendation 6.8 The criteria for organism identification? 15.2.2 15.2.2 15.2.3 5.4.9 5.4.10 Requirement 6.9 Every positive organism in a field sample is characterized and recorded? 15.2 15.2.2.1 15.2.3.1 5.4.9.1 5.4.10.1 Requirement 6.10 Acceptable microscope and examination procedures, including issues not noted in items 6.1 through 6.9? Requirement GLP 7 Reagents 7.1 Procedures for the preparation of all essential chemicals and reagents? 7.0 7.0 4.2 Critical 7.2 That expiration are specified for all reagents prepared by the laboratory? - - 4.2.2 Critical
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