684085947 Document type: matrix Document code: TB 01-01 DOCUMENT MATRIX TB LABORATORY PROCEDURES Confidentiality: none Document title QP code Electronic name Document Matrix - TB Laboratory Procedures TB 01-01 Document Matrix_ TB 01-01_V1.0.doc Overview of Laboratory Procedures TB 01-02 Overview of Procedures_ TB 01-02_V1.0.doc Document Control TB 01-03 Document Control_TB 01-03_V1.0.doc Electronic location Laboratory Quality (TB 01) Document Control List Document Control List_form Archive Log Archive Log_form Document Change Request Document Change Request_form.doc General Procedures (TB 02) General Safety Procedures TB 02-01 General Safety Procedures TB 02-01_1.0.doc Employee Handbook TB 02-02 Employee Handbook TB 02-02_V1.0 Laboratory Access Authorisation Table Laboratory Training Lab Access Authorisation Table_ddMMMyy.doc TB 02-03 Laboratory Training_TB 02-03_V1.0.doc Laboratory Staff Training Plan yyyy Laboratory Staff Training Plan yyyy_form.pdf Laboratory Training Checklist Laboratory Training Checklist_form.doc Health Monitoring of Laboratory Staff TB 02-04 Health Monitoring_ TB 02-03_V1.0.doc This SOP template has been developed by FIND for adaption and use in TB laboratories Release date: ddMMMyy Page 1 of 6 684085947 684085947 Health Monitoring Questionnaire Laboratory Cleaning and Maintenance Health Monitoring Questionnaire_form.doc TB 02-05 Lab Cleaning and Maintenance_TB 02-05_V1.0.doc Laboratory Cleaning and Maintenance Logbook Laboratory Cleaning and Maintenance Logbook_form.xls Laboratory Temperature Monitoring Logbook Laboratory Temperature Monitoring Logbook_form.xls Laboratory Accident Report Laboratory Accident Report_form.doc Spill Sign Spill Sign_form.doc Laboratory Supplies Management TB 02-06 Laboratory Supplies Management_TB 02-06_V1.0.doc Internal Audit TB Laboratory TB 02-07 Internal Audit TB Laboratory_TB 02-07_V1.0.doc Deficiency Report Deficiency Report_form.doc Internal Audit Report TB Laboratory Internal Audit Report TB Laboratory_form.doc Laboratory Fire Safety TB 02-08 Laboratory Fire Safety_TB 02-08_V1.0.doc Decontamination in progress Decontamination in progress_form.doc Stock card Stock card_form.doc Media Preparation TB 02-09 Media Preparation_TB 02-09_V1.0.doc Inter-laboratory testing TB 02-10 Inter-laboratory Testing TB 02-10_V1.0.doc DST Panel Selection MMMyy DST Panel Selection MMMyy_form.doc Inter-Laboratory DST Results Inter-Laboratory DST Results_form.doc Quality Control Middlebrook Media QC Middlebrook Media_form.doc Employee Orientation Form Employee Orientation_form.doc Personal Information Form Personal Information_form.doc Reimbursement Request Form Reimbursement Request_form.doc Standard Leave Form Standard Leave_form.doc Corrective Action Form Corrective Action_form.doc Occurrence Report Form Occurrence Report_form.doc Results Reporting TB 02-11 Results Reporting_TB02-11_V1.0.doc Approved Signatures Form Approved Signatures_form.doc Critical Results Reporting Form Critical Results Reporting_form.doc Page 2 of 6 684085947 684085947 Critical Results Log Form Critical Results Lof_form.doc Specimen Handling (TB 03) Specimen Handling TB 03-01 Specimen Processing Worksheet Specimen Handling_TB 03-01_V1.0.doc Specimen Processing Worksheet_form.doc Specimen Decontamination TB 03-02 Specimen Decontamination_TB 03-02_V1.0.doc Specimen Collection Manual TB 03-03 Specimen Collection Manual_TB 03-03_V1.0.doc NaOH-Sodium Citrate Solution Preparation Logbook NALC-NaOH-Sodium Citrate Solution Preparation Logbook NALC Logbook NaOH-Sodium Citrate Solution Prep Logbook_form.doc 4% NaOH Solution Preparation Logbook 4%NaOH Solution Prep Logbook_form.doc Phosphate buffer pH 6.8 Preparation Logbook Phosphate Buffer Prep Logbook_form.doc NALC-NaOH-Sodium Citrate Solution Prep Logbook_form.doc NALC Logbook_form.doc Microscopy Procedures (04) Ziehl Neelsen Microscopy TB 04-01 ZN Microscopy_TB 04-01_V1.0.doc ZN Stains Preparation Logbook ZN Stains Prep Logbook_form.doc Quality control of ZN Stains QC ZN Stains_form.doc Quality control of Auramine Stains QC Auramine Stains _form.doc ZN Microscopy Worksheet ZN Microscopy Worksheet_form.doc Fluorescence Microscopy TB 04-02 Fluorescence Microscopy_TB 04-02.V1.0.doc Auramine Microscopy Worksheet Auramine Microscopy Worksheet_form.doc Fluorescence Stains Preparation Logbook Fluorescence Stains Prep Logbook_form.doc Microscopy Quality Assurance TB 04-03 Microscopy QA_TB 04-03_V1.0.doc Microscopy Re-checking Results Microscopy Re-checking Results_form.doc Microscopy Re-checking Report Microscopy Re-checking Report_form.doc QC Slides Preparation QC Slides Prep_form.doc Page 3 of 6 684085947 684085947 Culture and Drug Susceptibility Testing (05) Solid Mycobacterial Culture TB 05-01 Solid Culture Worksheet MGIT Culture and Drug Susceptibility Testing Solid Culture_TB 05-01_V1.0.doc Solid Culture Worksheet_form.doc TB 05-02 MGIT Culture and DST_TB 05-02_V1.0.doc Positive MGIT Culture Work-Up Positive MGIT Culture Work-Up _form.doc MGIT 960 Maintenance Logbook MGIT 960 Maintenance_form.xls MGIT First Line DST Work Sheet MGIT First Line DST Worksheet_form.doc Capilia MPT 64 TB assay TB 05-03 Capilia TB Worksheet Mycobacterial Strain Maintenance Capilia TB_05-03_V1.0.doc Capilia TB Worksheet _form.doc TB 05-04 Mycobacterial Strain Maintenance_TB 05-04_V1.0.doc QC Strains Sub-Culture Logbook QC Strains Sub-Culture _form.doc QC Strains Stock Card QC Strains Stock Card_form.doc Clinical Isolate Sub-culture Logbook Clinical Isolate Sub-culture_form.doc Mycobacterial Suspensions & Viable Count Procedure TB 05-05 Mycobacterial Suspensions & Viable Count_TB 05-05_V1.0 Blood Agar QC_form.doc Blood Agar QC QC Strains Stock Card QC Strains Stock Card_form.doc Molecular Methods (06) Genotype MTBDRplus for MDR-TB screening TB 06-01 Genotype MTBDRplus Results Sheet Genotype MTBDRplus_TB 06-01_V1.0.doc Genotype MTBDRplus Results.pdf GT Blot 48 Use and Maintenance TB 06-02 GT Blot TB_06-02_V1.0.doc GeneXpert MTB/Rif TB 06-03 Xpert MTB-Rif_TB 06-03_V1.0.doc Xpert MTB/Rif worksheet Xpert MTB/Rif_form GeneXpert Maintenance Log Xpert Maintenance Log_form Page 4 of 6 684085947 684085947 Equipment Use and Maintenance (07) Equipment Failure Report Equipment Failure Report_form.doc Equipment Failure Notice Equipment Failure Notice_form.doc Biological Safety Cabinet Use and Maintenance Biological Safety Cabinet and Air System Maintenance Logbook Incubator Use and Maintenance TB 07-01 Biological Safety Cabinet_TB 07-01_V1.0.doc BSC and Air System Maintenance_form.doc TB 07-02 Incubator_TB 07-02_V1.0.doc Incubator Temperature Logbook Incubator Temperature_form.xls Fridge Freezer Temperature Logbook Fridge-Freezer Temperature_form.xls Fridge Freezer Use and Maintenance TB 07-03 Fridge Freezer Temperature Logbook Fridge Freezer_TB 07-03_V1.0.doc Fridge Freezer Temperature_form.xls Freezer Use and Maintenance TB 07-04 Freezer_TB 07-04_V1.0.doc Balance Use and Maintenance TB 07-05 Balance_TB 07-05_V1.0.doc Balance Calibration Centrifuge Use and Maintenance Balance Calibration_form.doc TB 07-06 Centrifugation Logbook Centrifuge_TB 07-06_V1.0.doc Centrifugation Logbook_form.doc Sonicator Use and Maintenance TB 07-07 Sonicator _TB 07-07_V1.0.doc Waterbath Use and Maintenance TB 07-08 Waterbath_TB 07-08_V1.0.doc iLED Microscope Use and Maintenance TB 07-09 iLED_TB 07-09_V1,0.doc iLED Maintenance Logbook iLED Maintenance_form.doc PCR Hood Use and Maintenance TB 07-10 PCR Hood_TB 07-10_V1.0.doc Thermal Cycler Use and Maintenance TB 07-11 Thermal Cycler_TB 07-11_V1.0.doc Heat Block Use and Maintenance TB 07-12 Heat Block_TB 07-12_V1.0.doc Air Handling System Use and Maintenance TB 07-13 Air Handling System_TB 07-13_V1.0.doc Pipette Use and Maintenance TB 07-14 Pipette_TB 07-14_V1.0.doc Pipette Calibration Pipette Calibration_form.xls Page 5 of 6 684085947 684085947 Twincubator Use and Maintenance TB 07-15 Twincubator_TB 07-15_V1.0.doc Microcentrifuge Use and Maintenance TB 07-16 Microcentrifuge_TB 07-16_V1.0.doc Equipment Maintenance File Equipment Maintenance File_form.doc -80C Freezer Storage Logbook -80C Freezer Storage_form.doc Incubator Calibration Incubator Calibration-form.doc CHANGE HISTORY New version #/date Old version #/date No. of changes Description of changes Source of change request Page 6 of 6
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