F-QM-002-B-V0 — Master Document Register, Retention Schedule, and Staff Reading Acknowledgment
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-002 — Document Control Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-002-B-V0-master-document-and-records-control-register.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-002-B-V0 | Parent Document | LAB-QM-002 — Document Control Policy |
|---|
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Part 1 — Controlled Policies & Standard Operating Procedures Master Register
Maintained by the Chief Medical Technologist / Laboratory Quality Manager as the master inventory of all 37 contiguous active policies and technical SOPs:
| Document No. | Document Title | Section / Discipline | Current Ver. | Effective Date | Next Review Date | Author / Owner | Primary Controlled Storage Location | Status |
|---|---|---|---|---|---|---|---|---|
| LAB-QM-001 | Quality Management Manual | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-002 | Document Control Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-003 | Continual Improvement and Performance Improvement Program Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-004 | Scope of Service and Laboratory User Information Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-005 | Confidentiality Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-006 | Internal Laboratory Rules and Regulations Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-007 | Control of Records | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-008 | Organization and Governance | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-009 | Risk Management | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-010 | Occurrence Management Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-011 | Corrective and Preventive Action Policy | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-012 | Internal Audit | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-013 | Management Review | General QM | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Master Quality Binder / Lab Drive | Active (Draft) |
| LAB-QM-PRE-001 | Specimen Collection Policy | Pre-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Specimen Receiving / Lab Drive | Active (Draft) |
| LAB-QM-PRE-002 | Referral Laboratory Policy | Pre-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Specimen Receiving / Lab Drive | Active (Draft) |
| LAB-QM-PRE-003 | Specimen Handling, Packaging and Transportation Policy | Pre-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Specimen Receiving / Lab Drive | Active (Draft) |
| LAB-QM-ANA-001 | Quality Control Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-002 | Reagent Management Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-003 | Method Validation Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-004 | Proficiency Testing Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-005 | Equipment and Temperature Monitoring Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-006 | Calibration and Verification of Ancillary Measuring Devices and Labware Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-ANA-007 | Purchasing, Receipt and External Provider Management Policy | Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Testing Benches / Lab Drive | Active (Draft) |
| LAB-QM-POST-001 | Laboratory Reporting Policy | Post-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Result Releasing / Lab Drive | Active (Draft) |
| LAB-QM-POST-002 | Reporting Critical Values Policy | Post-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Result Releasing / Lab Drive | Active (Draft) |
| LAB-QM-POST-003 | Turnaround Time and STAT Testing Policy | Post-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Result Releasing / Lab Drive | Active (Draft) |
| LAB-QM-POST-004 | Laboratory Retention Schedule Policy | Post-Analytic | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Result Releasing / Lab Drive | Active (Draft) |
| LAB-QM-POC-001 | Point-of-Care Testing Policy | POCT | V0 | MM-DD-YYYY | Annual | Chief Med Tech | POCT Sites / Lab Drive | Active (Draft) |
| LAB-QM-HR-001 | Orientation Policy | Human Resources | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Personnel File / Lab Office | Active (Draft) |
| LAB-QM-HR-002 | Competency Assessment Policy | Human Resources | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Personnel File / Lab Office | Active (Draft) |
| LAB-QM-HR-003 | Recruitment, Qualification and Appointment Policy | Human Resources | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Personnel File / Lab Office | Active (Draft) |
| LAB-QM-HR-004 | Personnel Records Policy | Human Resources | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Personnel File / Lab Office | Active (Draft) |
| LAB-QM-SAF-001 | Laboratory Safety Policy | Safety & Biorisk | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Safety Station / Lab Drive | Active (Draft) |
| LAB-QM-SAF-002 | Facilities and Environmental Conditions | Safety & Biorisk | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Safety Station / Lab Drive | Active (Draft) |
| LAB-QM-IC-001 | Hand Hygiene and Infection Control Policy | Infection Control | V0 | MM-DD-YYYY | Annual | Chief Med Tech | IPC Station / Lab Drive | Active (Draft) |
| LAB-QM-IT-001 | Laboratory Information Management and Security Policy | Information Tech | V0 | MM-DD-YYYY | Annual | Chief Med Tech | IT Office / Lab Drive | Active (Draft) |
| LAB-QM-IT-002 | Computer and Power Downtime and Disaster Recovery Plan | Information Tech | V0 | MM-DD-YYYY | Annual | Chief Med Tech | IT Office / Lab Drive | Active (Draft) |
| SOP-P-001 | Phlebotomy Section Reception, Unacceptable Specimen Management, and Adverse Reaction First Aid SOP | Phlebotomy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Phlebotomy Station / Lab Drive | Active (Draft) |
| SOP-P-002 | Adult and Pediatric Venipuncture Procedure SOP | Phlebotomy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Phlebotomy Station / Lab Drive | Active (Draft) |
| SOP-P-003 | Capillary (Skin Puncture) and Neonatal Heel-Stick Blood Collection Procedure SOP | Phlebotomy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Phlebotomy Station / Lab Drive | Active (Draft) |
| SOP-H-001 | Hematology Section Workflow, Quality Control, Interference Management, and Result Validation SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-H-002 | HORIBA ABX Pentra XL 80 Complete Blood Count (CBC), 5-Part Differential, and Analyzer Maintenance SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-H-003 | Peripheral Blood Smear Preparation, Wright-Giemsa Staining, Manual Differential, and Reticulocyte Count SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-H-004 | Erythrocyte Sedimentation Rate (ESR — Modified Westergren Method) SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-H-005 | ABO and Rh(D) Blood Typing (Slide and Tube Method) SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-H-006 | Bleeding Time and Clotting Time (Capillary and Slide Method) Procedure SOP | Hematology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Hematology Bench / Lab Drive | Active (Draft) |
| SOP-S-001 | Serology Section Workflow, Specimen Processing, Quality Control, and Result Reporting SOP | Serology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Serology Bench / Lab Drive | Active (Draft) |
| SOP-S-002 | Hepatitis B Surface Antigen (HBsAg) Rapid Qualitative Immunoassay and Confirmatory Referral SOP | Serology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Serology Bench / Lab Drive | Active (Draft) |
| SOP-S-003 | Syphilis Rapid Qualitative Treponemal Antibody and RPR Screening Procedure SOP | Serology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Serology Bench / Lab Drive | Active (Draft) |
| SOP-S-004 | Dengue Duo (NS1 Ag and IgM/IgG) and Salmonella typhi (IgM/IgG) Rapid Immunoassay SOP | Serology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Serology Bench / Lab Drive | Active (Draft) |
| SOP-S-005 | Serum Qualitative Beta-hCG Pregnancy Test SOP | Serology SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Serology Bench / Lab Drive | Active (Draft) |
| SOP-CM-001 | Clinical Microscopy Section Workflow, Specimen Acceptance, Quality Control, and Result Reporting SOP | Clinical Microscopy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Microscopy Bench / Lab Drive | Active (Draft) |
| SOP-CM-002 | Routine Urinalysis (Physical Examination, Sysmex UC-1000 / MEDITAPE UC-10S Chemical Strip and Visual Backup, and Microscopic Sediment Examination) SOP | Clinical Microscopy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Microscopy Bench / Lab Drive | Active (Draft) |
| SOP-CM-003 | Routine Fecalysis (Macroscopic Inspection and Direct Fecal Smear — Saline and Lugol's Iodine Wet Mount) SOP | Clinical Microscopy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Microscopy Bench / Lab Drive | Active (Draft) |
| SOP-CM-004 | Urine Qualitative Beta-hCG Pregnancy Test SOP | Clinical Microscopy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Microscopy Bench / Lab Drive | Active (Draft) |
| SOP-CM-005 | Stool Rapid Immunochromatographic Tests (Helicobacter pylori Stool Antigen and Qualitative Fecal Occult Blood Test / FOBT) SOP | Clinical Microscopy SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Microscopy Bench / Lab Drive | Active (Draft) |
| SOP-C-001 | Clinical Chemistry Section Workflow, Pre/Post-Examination, Quality Control, and Result Validation SOP | Clinical Chemistry SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Chemistry Bench / Lab Drive | Active (Draft) |
| SOP-C-002 | Mindray BS-240 Clinical Chemistry Analyzer Operation, Calibration, and Maintenance SOP | Clinical Chemistry SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Chemistry Bench / Lab Drive | Active (Draft) |
| SOP-C-003 | Routine Photometric Chemistry Procedures on Mindray BS-240 (Glucose, Lipid Profile, Renal Panel, and Liver Enzymes) SOP | Clinical Chemistry SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Chemistry Bench / Lab Drive | Active (Draft) |
| SOP-C-004 | Serum Electrolytes (Sodium, Potassium, and Chloride) Testing on Sensa Core ISE Electrolyte Analyzer SOP | Clinical Chemistry SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Chemistry Bench / Lab Drive | Active (Draft) |
| SOP-C-005 | Glycated Hemoglobin (HbA1c) Testing on Wondfo Finecare FIA Meter SOP | Clinical Chemistry SOP | V0 | MM-DD-YYYY | Annual | Chief Med Tech | Chemistry Bench / Lab Drive | Active (Draft) |
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Part 2 — Controlled Laboratory Blank Forms & Logs Master Inventory
Controlled register of active blank form masters, worksheets, and logs in clinical use:
| Form No. | Form Title | Parent Policy | Current Ver. | Point-of-Use Location | Retention Category | Status |
|---|---|---|---|---|---|---|
| F-QM-001-A-V0 | Laboratory Strategic & Quality Master Plan | LAB-QM-001 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-002-A-V0 | Document Change, Annual Review, and Disposal Request Form | LAB-QM-002 | V0 | Quality Office / Lab Drive | Permanent | Active (Draft) |
| F-QM-002-B-V0 | Master Document Register, Retention Schedule, and Staff Reading Acknowledgment | LAB-QM-002 | V0 | Quality Office / Lab Drive | Permanent | Active (Draft) |
| F-QM-003-A-V0 | Quality Indicator Register, CQI Schedule, and Performance Improvement Log | LAB-QM-003 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-003-B-V0 | Continuous Quality Improvement (CQI) Project Charter and Committee Minutes | LAB-QM-003 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-004-A-V0 | Client Feedback, Satisfaction Survey, and Complaint Log | LAB-QM-004 | V0 | Reception / OPD / Lab Drive | 3 Years | Active (Draft) |
| F-QM-005-A-V0 | Confidentiality Agreement Form | LAB-QM-005 | V0 | Personnel Files / Quality Binder | 5 Years | Active (Draft) |
| F-QM-007-A-V0 | Laboratory Department Personnel Audit Trail and Signature Register | LAB-QM-007 | V0 | Reception / Testing Benches | 5 Years | Active (Draft) |
| F-QM-008-A-V0 | Clinical Laboratory Organizational Chart | LAB-QM-008 | V0 | Laboratory Office Bulletin Board | 5 Years | Active (Draft) |
| F-QM-008-B-V0 | Official Delegation of Duties, Authority & Leave Coverage Form | LAB-QM-008 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-009-A-V0 | Laboratory Risk Register, Assessment, and Treatment Plan | LAB-QM-009 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-010-A-V0 | Incident, Occurrence, and Deviation Report & Log | LAB-QM-010 | V0 | All Testing Areas / Lab Drive | 5 Years | Active (Draft) |
| F-QM-011-A-V0 | Corrective and Preventive Action (CAPA) Record & Master Log | LAB-QM-011 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-012-A-V0 | Annual Internal Audit Schedule, Plan, Report & Follow-Up Log | LAB-QM-012 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-013-A-V0 | Management Review Record & Action Follow-Up Log | LAB-QM-013 | V0 | Quality Office / Lab Drive | 3 Years | Active (Draft) |
| F-QM-PRE-001-A-V0 | Clinical Laboratory Request Form | LAB-QM-PRE-001 | V0 | Reception / OPD / Wards | 5 Years | Active (Draft) |
| F-QM-PRE-002-A-V0 | Referral Laboratory Register, Annual Evaluation & Send-Out Log | LAB-QM-PRE-002 | V0 | Specimen Dispatch / Lab Drive | 5 Years | Active (Draft) |
| F-QM-PRE-003-A-V0 | Specimen Receipt, Transport, Rejection & Recollection Log | LAB-QM-PRE-003 | V0 | Specimen Receiving Station | 5 Years | Active (Draft) |
| F-QM-ANA-004-A-V0 | Proficiency Testing Survey Master Packet & Alternative Assessment Register | LAB-QM-ANA-004 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-ANA-005-A-V0 | Critical Equipment List and Downtime Log | LAB-QM-ANA-005 | V0 | Testing Areas / Lab Drive | 5 Years | Active (Draft) |
| F-QM-POST-001-A-V0 | Laboratory Reporting, Validation, and Correction Record | LAB-QM-POST-001 | V0 | Result Release / Lab Drive | 5 Years | Active (Draft) |
| F-QM-POST-002-A-V0 | Critical Values and Notifiable Disease Notification Log | LAB-QM-POST-002 | V0 | Releasing / All Benches | 5 Years | Active (Draft) |
| F-QM-POST-003-A-V0 | Turnaround Time Exception and Verbal Orders Documentation Sheet | LAB-QM-POST-003 | V0 | Releasing / All Benches | 3 Years | Active (Draft) |
| F-QM-HR-001-A-V0 | Personnel Orientation and Safety Training Checklist | LAB-QM-HR-001 | V0 | Personnel Files / Lab Office | 5 Years | Active (Draft) |
| F-QM-HR-002-A-V0 | Staff Competency Assessment Record and Development Plan | LAB-QM-HR-002 | V0 | Personnel Files / Lab Office | 5 Years | Active (Draft) |
| F-QM-HR-002-B-V0 | Personnel Authorization Matrix and Staff Roster | LAB-QM-HR-002 | V0 | Quality Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-HR-003-A-V0 | Position Descriptions — Clinical Laboratory Positions | LAB-QM-HR-003 | V0 | Personnel Files / Lab Office | 5 Years | Active (Draft) |
| F-QM-HR-003-B-V0 | Workload and Staffing Review / Additional Manpower Request Record | LAB-QM-HR-003 | V0 | Quality Office / Lab Office | 5 Years | Active (Draft) |
| F-QM-HR-004-A-V0 | Personnel Dossier Verification, Appointment, and Exit Checklist | LAB-QM-HR-004 | V0 | Personnel Files / Lab Office | Duration + 5 Yrs | Active (Draft) |
| F-QM-SAF-001-A-V0 | Chemical Inventory & SDS Master Register | LAB-QM-SAF-001 | V0 | Safety Station / Lab Drive | 5 Years | Active (Draft) |
| F-QM-SAF-001-B-V0 | Safety Inspection Checklist, Drill Attendance, and Recall Record | LAB-QM-SAF-001 | V0 | Safety Station / Lab Drive | 5 Years | Active (Draft) |
| F-QM-SAF-002-A-V0 | Daily Facility, Environment, and Safety Check Log | LAB-QM-SAF-002 | V0 | Safety Station / Testing Areas | 3 Years | Active (Draft) |
| F-QM-SAF-002-B-V0 | Facility Maintenance Request and Visitor Access Record | LAB-QM-SAF-002 | V0 | Reception / Lab Office | 3 Years | Active (Draft) |
| F-QM-IC-001-A-V0 | Infection Prevention & Control Audit Checklist and Spill Response Log | LAB-QM-IC-001 | V0 | Safety Station / IPC Area | 3 Years | Active (Draft) |
| F-QM-IT-001-A-V0 | Laboratory IT Systems Maintenance, Backup, and Recovery Log | LAB-QM-IT-001 | V0 | IT Office / Lab Drive | 5 Years | Active (Draft) |
| F-QM-IT-002-A-V0 | Computer and Power Downtime Pending-Work Log | LAB-QM-IT-002 | V0 | Testing Areas / Releasing | 5 Years | Active (Draft) |
| F-H-002-A-V0 | HORIBA ABX Pentra XL 80 Hematology Analyzer Maintenance Checklist | SOP-H-002 | V0 | Hematology Bench | 5 Years | Active (Draft) |
| F-C-002-A-V0 | Mindray BS-240 Clinical Chemistry Analyzer Maintenance Checklist | SOP-C-002 | V0 | Chemistry Bench | 5 Years | Active (Draft) |
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Work Instructions & Posted Bench Aids (WI-* — 16 Active Visual Aids)
Controlled master register of 16 active visual work instructions and posted bench aids displayed at laboratory testing stations and phlebotomy areas:
| Work Instruction Code | Title | Parent Document | Location |
|---|---|---|---|
| WI-P-002-A-V0 | BD Vacutainer Order of Draw, Tube Additives & Inversion Chart | SOP-P-002 | illustrations/SOP-P-002/ |
| WI-P-003-A-V0 | Capillary Finger-Stick & Neonatal Heel-Stick Safe Puncture Card | SOP-P-003 | illustrations/SOP-P-003/ |
| WI-H-002-A-V0 | HORIBA ABX Pentra XL 80 Daily Startup, Difftrol QC & Shutdown Card | SOP-H-002 | illustrations/SOP-H-002/ |
| WI-H-003-A-V0 | Peripheral Blood Smear Wedge, Wright-Giemsa Staining & Reticulocyte Card | SOP-H-003 | illustrations/SOP-H-003/ |
| WI-H-005-A-V0 | ABO & Rh(D) Slide and Immediate-Spin Tube Reaction Grading Card | SOP-H-005 | illustrations/SOP-H-005/ |
| WI-CM-002-A-V0 | Sysmex UC-1000 / MEDITAPE UC-10S Operation, Visual Backup & Sediment Card | SOP-CM-002 | illustrations/SOP-CM-002/ |
| WI-CM-004-A-V0 | Abbott Bioline hCG Urine & Serum Pregnancy Test Rapid Bench Card | SOP-CM-004 | illustrations/SOP-CM-004/ |
| WI-CM-005-A-V0 | Stool Rapid Tests (RightSign H. pylori Antigen & Immunochemical FOBT) Card | SOP-CM-005 | illustrations/SOP-CM-005/ |
| WI-C-002-A-V0 | Mindray BS-240 Daily Startup, Calibration, IQC & Special Wash Bench Card | SOP-C-002 | illustrations/SOP-C-002/ |
| WI-C-004-A-V0 | Sensa Core ISE Electrolyte Analyzer Operation & Daily Cleaning Bench Card | SOP-C-004 | illustrations/SOP-C-004/ |
| WI-C-005-A-V0 | Wondfo Finecare FIA Meter HbA1c Testing & ID Chip Verification Bench Card | SOP-C-005 | illustrations/SOP-C-005/ |
| WI-S-002-A-V0 | HBsAg Rapid Qualitative Immunoassay & Confirmatory Referral Bench Card | SOP-S-002 | illustrations/SOP-S-002/ |
| WI-S-003-A-V0 | Syphilis Rapid Treponemal Cassette & RPR Flocculation Card Bench Aid | SOP-S-003 | illustrations/SOP-S-003/ |
| WI-S-004-A-V0 | Dengue Duo (NS1 Ag + IgM/IgG) & Typhoid IgM/IgG Rapid Test Bench Card | SOP-S-004 | illustrations/SOP-S-004/ |
| WI-QM-POST-002-A-V0 | Critical Value Panic Thresholds & 15-Minute Read-Back Wall Chart | LAB-QM-POST-002 | illustrations/LAB-QM-POST-002/ |
| WI-QM-SAF-001-A-V0 | Biological Spill Response & Sharps/Splash First Aid Wall Poster | LAB-QM-SAF-001 | illustrations/LAB-QM-SAF-001/ |
Visual Annexes — Infographics (IG-* — 27 Controlled Annexes to Parent Policies)
Controlled register of the Laboratory's 27 infographics. Each infographic is a visual annex of its parent policy under LAB-QM-002 Section 5.2.6 — it carries no independent document number, is approved, revised, and retired together with its parent, and contains no requirement beyond the parent's text. Master files (PNG, print PDF, and editable HTML) are stored in infographics/ and cited in each parent policy's Section 7.0:
| Annex Code | Title | Parent Document | Location |
|---|---|---|---|
| IG-01 | QMS at a Glance | LAB-QM-001 | infographics/ |
| IG-02 | Quality Indicators at a Glance | LAB-QM-003 | infographics/ |
| IG-03 | Do Not Accept — Specimen Rejection | LAB-QM-PRE-001 | infographics/ |
| IG-04 | Test Menu | LAB-QM-004 | infographics/ |
| IG-05 | Waste Segregation | LAB-QM-IC-001 | infographics/ |
| IG-06 | Specimen Handling and Transport | LAB-QM-PRE-003 | infographics/ |
| IG-07 | Occurrence to CAPA | LAB-QM-010 and LAB-QM-011 | infographics/ |
| IG-08 | The Quality Year | LAB-QM-012 and LAB-QM-013 | infographics/ |
| IG-09 | Who Does What | LAB-QM-008 | infographics/ |
| IG-10 | Risk Matrix | LAB-QM-009 | infographics/ |
| IG-11 | Hand Hygiene and PPE | LAB-QM-IC-001 | infographics/ |
| IG-12 | Turnaround Times | LAB-QM-POST-003 | infographics/ |
| IG-13 | Keep It How Long — Retention at a Glance | LAB-QM-POST-004 | infographics/ |
| IG-14 | Notifiable Results | LAB-QM-POST-002 | infographics/ |
| IG-15 | Records Done Right | LAB-QM-007 | infographics/ |
| IG-16 | IQC Westgard Troubleshooting | LAB-QM-ANA-001 | infographics/ |
| IG-17 | POCT Governance and QC | LAB-QM-POC-001 | infographics/ |
| IG-18 | Sharps Injury & Exposure Response | LAB-QM-SAF-001 | infographics/ |
| IG-19 | LIS & Power Downtime | LAB-QM-IT-002 | infographics/ |
| IG-20 | NEQAS Proficiency Testing Cycle | LAB-QM-ANA-004 | infographics/ |
| IG-21 | Amended Reports | LAB-QM-POST-001 | infographics/ |
| IG-22 | Competency Assessment | LAB-QM-HR-002 | infographics/ |
| IG-23 | Equipment Tagout & Return to Service | LAB-QM-ANA-005 | infographics/ |
| IG-24 | Referral Specimens | LAB-QM-PRE-002 | infographics/ |
| IG-25 | Reagent Receiving & Lot Release | LAB-QM-ANA-007 | infographics/ |
| IG-26 | Method Verification | LAB-QM-ANA-003 | infographics/ |
| IG-27 | New Staff Onboarding | LAB-QM-HR-001 | infographics/ |
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Part 3 — Authorized Personnel for Document Preparation, Review, and Approval
| Document Category | Authorized Author / Originator | Authorized Technical Reviewer | Authorized Approver |
|---|---|---|---|
| Quality Management Manual (QM-001) | Chief Medical Technologist / LQM | Pathologist / Head of Laboratory | Hospital Director |
| Laboratory Policies (LAB-QM-###) | Chief Medical Technologist / Assigned RMT | Pathologist / Head of Laboratory | Hospital Director |
| Technical SOPs (Analytical & Sectional) | Registered Medical Technologist (RMT) | Chief Medical Technologist / LQM | Pathologist / Head of Laboratory |
| Laboratory Controlled Forms & Logs | Registered Medical Technologist (RMT) | Chief Medical Technologist / LQM | Pathologist / Head of Laboratory |
| Equipment Manuals & External Standards | Equipment Manufacturer / DOH / HFSRB | Chief Medical Technologist / LQM | Pathologist / Head of Laboratory |
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Part 4 — Records Retention Schedule & Archiving Rules
Retention periods follow DOH Department Circular No. 2021-0226 (which superseded D.C. No. 70 s.1996), DOH A.O. 2021-0037, and ISO 15189:2022 Clause 8.4.3 per Laboratory Retention Schedule Policy:
| Record Classification | Record Title / Description | Mandatory Retention Period | Archiving & Storage Method | Authorized Disposal Method |
|---|---|---|---|---|
| Patient Test Reports (General) | Routine CBC, Clinical Microscopy, Clinical Chemistry | 2 Years for issued reports; 5 Years for laboratory-held result records | Electronic Lab-LIS database + Printed copy | Secure confidential shredding / Electronic purge |
| Serology & Transmissible Disease Records | HBsAg, Syphilis, Dengue, infectious disease results | 5 Years for laboratory-held result records; results filed in the patient chart follow chart retention (in-patient 10 years after discharge) | Electronic Lab-LIS + Sealed annual archive | Secure confidential shredding |
| Quality Control (IQC) Data | Daily LJ charts, calibration logs, control run sheets | 2 Years | QC Binder / Digital Excel archive | Shredding after review |
| External Quality Assessment (EQAP / PT) | NEQAS survey packets, evaluation reports, certificates | 5 Years | Dedicated EQAP binder per program | Secure shredding after Pathologist approval |
| Maintenance & Service Records | Calibration certificates, service work orders, PM logs | 2 Years after the equipment is declared unserviceable | Equipment Master File | Retained while instrument operational |
| Personnel Training & Competency | Orientation, annual competency, CEU certificates | 3 Years after the employee's last day of employment | Individual Personnel Dossier (F-QM-HR-004-A) | Archiving / Controlled destruction |
| Quality System Documents (Obsolete) | Superseded policies, SOPs, forms, audit reports | 2 Years from date of obsolescence | Obsolete Document Archive (Stamped OBSOLETE) | Controlled destruction |
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Part 5 — Staff Reading and Training Acknowledgment Sign Page
5.1 Document Details
| Field | Description |
|---|---|
| Document Number | |
| Document Title | |
| Version Number | Effective Date: YYYY-MM-DD |
| Section / Applicable Scope | [ ] All Staff [ ] Hematology [ ] Microscopy [ ] Chemistry [ ] Serology |
5.2 Staff Acknowledgment and Undertaking
I confirm that I have read the controlled document above and received orientation on it. I understand it and will follow its requirements and procedures in my laboratory duties.
| No. | Staff Name | Designation (MT / Laboratory Aide) | Date Read & Understood | Staff Signature | Orientation Conducted By (Initials) |
|---|---|---|---|---|---|
| 1 | |||||
| 2 | |||||
| 3 | |||||
| 4 | |||||
| 5 | |||||
| 6 | |||||
| 7 | |||||
| 8 |
5.3 Verification by Chief Medical Technologist / Laboratory Quality Manager
I verify that all staff in the section who must use this document have read and acknowledged it before it is implemented.
Signature: ____________________________________ Date: ________________________
