Controlled Document Register

Every controlled QMS document — policies, SOPs and forms — parsed live from the actual MASTER-DOCUMENT-INDEX (100 documents), organised by the categories in the document numbers themselves. Policies are grouped by section, SOPs by discipline, and forms by the section of their parent policy or SOP (the parent itself is encoded in the form number and is also shown in the Parent column). Click a category to expand it. Status is shown exactly as it stands: every document is V0, unsigned, effective date “MM-DD-YYYY” — none is approved yet. Click a document number to read it — the document page renders the Word (.docx) file in the browser.

Policies · 37

Core Quality Management — Policies13

Number	Title	Ver	Status	File
LAB-QM-001	Quality Management Manual	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-002	Document Control Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-003	Continual Improvement, Quality Indicators, and Performance Improvement Program Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-004	Scope of Service and Laboratory User Information Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-005	Confidentiality Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-006	Internal Laboratory Rules, Ethics, and Professional Conduct Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-007	Control of Records Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-008	Organization and Governance Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-009	Risk Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-010	Occurrence and Deviation Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-011	Corrective and Preventive Action (CAPA) Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-012	Internal Audit Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-013	Management Review Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Analytical — Policies7

Number	Title	Ver	Status	File
LAB-QM-ANA-001	Quality Control Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-002	Reagent, Water and Consumables Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-003	Method Validation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-004	External Quality Assessment (Proficiency Testing and Alternative Assessment) Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-005	Equipment Management, Calibration, and Temperature Monitoring Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-006	Calibration and Verification of Ancillary Measuring Devices and Labware Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-ANA-007	Purchasing, Receipt and External Provider Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Human Resources — Policies4

Number	Title	Ver	Status	File
LAB-QM-HR-001	Staff Orientation, Training, and Continuing Education Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-HR-002	Competency Assessment and Performance Evaluation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-HR-003	Recruitment, Staffing, Scheduling, and Separation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-HR-004	Personnel Records and Occupational Health Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Pre-examination — Policies3

Number	Title	Ver	Status	File
LAB-QM-PRE-001	Specimen Collection Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-PRE-002	Referral Laboratory Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-PRE-003	Specimen Handling, Packaging and Transportation Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Post-examination — Policies4

Number	Title	Ver	Status	File
LAB-QM-POST-001	Laboratory Reporting Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-POST-002	Reporting of Critical Values and Notifiable Diseases Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-POST-003	Turnaround Time and STAT Testing Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-POST-004	Laboratory Retention Schedule Policy (Specimens, Documents and Records)	V0	DRAFT — UNAPPROVED	Available — open to read

Safety — Policies2

Number	Title	Ver	Status	File
LAB-QM-SAF-001	Laboratory Safety Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-SAF-002	Facilities and Environmental Conditions	V0	DRAFT — UNAPPROVED	Available — open to read

Infection Control — Policies1

Number	Title	Ver	Status	File
LAB-QM-IC-001	Infection Prevention, Hand Hygiene, and Healthcare Waste Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Point of Care Testing — Policies1

Number	Title	Ver	Status	File
LAB-QM-POC-001	Point-of-Care Testing (POCT) Governance, Training, and Quality Control Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Information Management — Policies2

Number	Title	Ver	Status	File
LAB-QM-IT-001	Laboratory Information Management, Data Security, and Backup Policy	V0	DRAFT — UNAPPROVED	Available — open to read
LAB-QM-IT-002	Laboratory Information System Downtime and Disaster Recovery Plan	V0	DRAFT — UNAPPROVED	Available — open to read

SOPs · 24

Hematology — SOPs6

Number	Title	Ver	Status	File
SOP-H-001	Hematology Section Workflow, Quality Control, Interference Management, and Result Validation SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-H-002	HORIBA ABX Pentra XL 80 Complete Blood Count (CBC), 5-Part Differential, and Analyzer Maintenance SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-H-003	Peripheral Blood Smear Preparation, Wright-Giemsa Staining, Manual Differential, and Reticulocyte Count SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-H-004	Erythrocyte Sedimentation Rate (ESR — Modified Westergren Method) SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-H-005	ABO and Rh(D) Blood Typing (Slide and Tube Method) SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-H-006	Bleeding Time and Clotting Time (Capillary and Slide Method) Procedure SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Serology — SOPs5

Number	Title	Ver	Status	File
SOP-S-001	Serology Section Workflow, Specimen Processing, Quality Control, and Result Reporting SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-S-002	Hepatitis B Surface Antigen (HBsAg) Rapid Qualitative Immunoassay and Confirmatory Referral SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-S-003	Syphilis Rapid Qualitative Treponemal Antibody and RPR Screening Procedure SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-S-004	Dengue Duo (NS1 Ag and IgM/IgG) and Salmonella typhi (IgM/IgG) Rapid Immunoassay SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-S-005	Serum Qualitative Beta-hCG Pregnancy Test SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Clinical Microscopy — SOPs5

Number	Title	Ver	Status	File
SOP-CM-001	Clinical Microscopy Section Workflow, Specimen Acceptance, Quality Control, and Result Reporting SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-CM-002	Routine Urinalysis (Physical Examination, Sysmex UC-1000 / MEDITAPE UC-10S Chemical Strip and Visual Backup, and Microscopic Sediment Examination) SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-CM-003	Routine Fecalysis (Macroscopic Inspection and Direct Fecal Smear — Saline and Lugol's Iodine Wet Mount) SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-CM-004	Urine Qualitative Beta-hCG Pregnancy Test SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-CM-005	Stool Rapid Immunochromatographic Tests (Helicobacter pylori Stool Antigen and Qualitative Fecal Occult Blood Test / FOBT) SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Clinical Chemistry — SOPs5

Number	Title	Ver	Status	File
SOP-C-001	Clinical Chemistry Section Workflow, Pre/Post-Examination, Quality Control, and Result Validation SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-C-002	Mindray BS-240 Clinical Chemistry Analyzer Operation, Calibration, and Maintenance SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-C-003	Routine Photometric Chemistry Procedures on Mindray BS-240 (Glucose, Lipid Profile, Renal Panel, and Liver Enzymes) SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-C-004	Serum Electrolytes (Sodium, Potassium, and Chloride) Testing on Sensa Core ISE Electrolyte Analyzer SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-C-005	Glycated Hemoglobin (HbA1c) Testing on Wondfo Finecare FIA Meter SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Phlebotomy — SOPs3

Number	Title	Ver	Status	File
SOP-P-001	Phlebotomy Section Reception, Unacceptable Specimen Management, and Adverse Reaction First Aid SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-P-002	Adult and Pediatric Venipuncture Procedure SOP	V0	DRAFT — UNAPPROVED	Available — open to read
SOP-P-003	Capillary (Skin Puncture) and Neonatal Heel-Stick Blood Collection Procedure SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Forms · 39 (+ 8 referenced with no file, shown under their parent's section)

Core Quality Management — Forms15

Number	Title	Parent	Ver	Status	File
F-QM-001-A-V0	Laboratory Strategic & Quality Master Plan	LAB-QM-001 — Quality Management Manual	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-002-A-V0	Document Change, Annual Review, and Disposal Request Form	LAB-QM-002 — Document Control Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-002-B-V0	Master Document Register, Retention Schedule, and Staff Reading Acknowledgment	LAB-QM-002 — Document Control Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-003-A-V0	Quality Indicator Register, CQI Schedule, and Performance Improvement Log	LAB-QM-003 — Continual Improvement, Quality Indicators, and Performance Improvement Program Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-003-B-V0	Continuous Quality Improvement (CQI) Project Charter and Committee Minutes	LAB-QM-003 — Continual Improvement, Quality Indicators, and Performance Improvement Program Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-004-A-V0	Client Feedback, Satisfaction Survey, and Complaint Log	LAB-QM-004 — Scope of Service and Laboratory User Information Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-005-A-V0	Confidentiality Agreement Form	LAB-QM-005 — Confidentiality Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-007-A-V0	Laboratory Department Personnel Audit Trail and Signature Register	LAB-QM-007 — Control of Records Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-008-A-V0	Clinical Laboratory Organizational Chart	LAB-QM-008 — Organization and Governance Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-008-B-V0	Official Delegation of Duties, Authority & Leave Coverage Form	LAB-QM-008 — Organization and Governance Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-009-A-V0	Laboratory Risk Register, Assessment, and Treatment Plan	LAB-QM-009 — Risk Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-010-A-V0	Incident, Occurrence, and Deviation Report & Log	LAB-QM-010 — Occurrence and Deviation Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-011-A-V0	Corrective and Preventive Action (CAPA) Record & Master Log	LAB-QM-011 — Corrective and Preventive Action (CAPA) Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-012-A-V0	Annual Internal Audit Schedule, Plan, Report & Follow-Up Log	LAB-QM-012 — Internal Audit Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-013-A-V0	Management Review Record & Action Follow-Up Log	LAB-QM-013 — Management Review Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Analytical — Forms9

Number	Title	Parent	Ver	Status	File
F-QM-ANA-004-A-V0	EQAS / NEQAS Enrollment, Result Evaluation, Discordance Investigation & Alternative Assessment Log	LAB-QM-ANA-004 — External Quality Assessment (Proficiency Testing and Alternative Assessment) Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-ANA-005-A-V0	Master Equipment Inventory, Maintenance, Downtime & Temperature Dossier	LAB-QM-ANA-005 — Equipment Management, Calibration, and Temperature Monitoring Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-ANA-001-A-V0	QC Troubleshooting Log — referenced by LAB-QM-ANA-001 §5.9, no file exists	LAB-QM-ANA-001 — Quality Control Policy	—	MISSING	No file exists
F-QM-ANA-001-B-V0	Monthly QC Summary — referenced by LAB-QM-ANA-001, no file exists	LAB-QM-ANA-001 — Quality Control Policy	—	MISSING	No file exists
F-QM-ANA-002-A-V0	Reagent / Stock Register & Lot Verification — referenced by LAB-QM-ANA-002, no file exists	LAB-QM-ANA-002 — Reagent, Water and Consumables Management Policy	—	MISSING	No file exists
F-QM-ANA-003-A-V0	Method Validation Report — referenced by LAB-QM-ANA-003, no file exists	LAB-QM-ANA-003 — Method Validation Policy	—	MISSING	No file exists
F-QM-ANA-003-B-V0	Measurement Uncertainty Log — referenced by LAB-QM-ANA-003, no file exists	LAB-QM-ANA-003 — Method Validation Policy	—	MISSING	No file exists
F-QM-ANA-006-A-V0	Ancillary Device Calibration Record — referenced by LAB-QM-ANA-006, no file exists	LAB-QM-ANA-006 — Calibration and Verification of Ancillary Measuring Devices and Labware Policy	—	MISSING	No file exists
F-QM-ANA-007-A-V0	Approved Provider / Supplier List — referenced by LAB-QM-ANA-007, no file exists	LAB-QM-ANA-007 — Purchasing, Receipt and External Provider Management Policy	—	MISSING	No file exists

Human Resources — Forms7

Number	Title	Parent	Ver	Status	File
F-QM-HR-001-A-V0	Orientation and Training Checklist	LAB-QM-HR-001 — Staff Orientation, Training, and Continuing Education Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-002-A-V0	Competency Assessment Record	LAB-QM-HR-002 — Competency Assessment and Performance Evaluation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-002-B-V0	Personnel Authorization Matrix / Registry	LAB-QM-HR-002 — Competency Assessment and Performance Evaluation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-003-A-V0	Position Description, Qualification Verification & Clearance Record	LAB-QM-HR-003 — Recruitment, Staffing, Scheduling, and Separation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-003-B-V0	Monthly Duty Schedule, Attendance & Workload Log	LAB-QM-HR-003 — Recruitment, Staffing, Scheduling, and Separation Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-004-A-V0	Employee 201 Personnel File, Immunization & Occupational Health Record	LAB-QM-HR-004 — Personnel Records and Occupational Health Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-HR-004-B-V0	List of Personnel with Designations and Area Assignments	LAB-QM-HR-004 — Personnel Records and Occupational Health Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Pre-examination — Forms3

Number	Title	Parent	Ver	Status	File
F-QM-PRE-001-A-V0	Clinical Laboratory Request Form	LAB-QM-PRE-001 — Specimen Collection Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-PRE-002-A-V0	Referral Laboratory Register, Annual Evaluation & Send-Out Log	LAB-QM-PRE-002 — Referral Laboratory Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-PRE-003-A-V0	Specimen Receipt, Transport, Rejection & Recollection Log	LAB-QM-PRE-003 — Specimen Handling, Packaging and Transportation Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Post-examination — Forms3

Number	Title	Parent	Ver	Status	File
F-QM-POST-001-A-V0	Official Laboratory Result Validation, Format Review & Amended/Corrected Report Form	LAB-QM-POST-001 — Laboratory Reporting Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-POST-002-A-V0	Critical Value & Notifiable Disease Notification Log	LAB-QM-POST-002 — Reporting of Critical Values and Notifiable Diseases Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-POST-003-A-V0	STAT / TAT Exception and Verbal/Telephone Order Log	LAB-QM-POST-003 — Turnaround Time and STAT Testing Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Safety — Forms4

Number	Title	Parent	Ver	Status	File
F-QM-SAF-001-A-V0	Chemical Inventory & SDS Master Register	LAB-QM-SAF-001 — Laboratory Safety Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-SAF-001-B-V0	Safety Inspection Checklist, Emergency Drill & Safety Training Record	LAB-QM-SAF-001 — Laboratory Safety Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-SAF-002-A-V0	Daily Facility, Environment & Safety Check Log	LAB-QM-SAF-002 — Facilities and Environmental Conditions	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-SAF-002-B-V0	Facility Maintenance Request and Visitor Access Log	LAB-QM-SAF-002 — Facilities and Environmental Conditions	V0	DRAFT — UNAPPROVED	Available — open to read

Infection Control — Forms1

Number	Title	Parent	Ver	Status	File
F-QM-IC-001-A-V0	Infection Prevention, Hand Hygiene, Cleaning & Biological Spill Log	LAB-QM-IC-001 — Infection Prevention, Hand Hygiene, and Healthcare Waste Management Policy	V0	DRAFT — UNAPPROVED	Available — open to read

Point of Care Testing — Forms1

Number	Title	Parent	Ver	Status	File
F-QM-POC-001-A-V0	POCT Master List (operators/devices/kits) — referenced by LAB-QM-POC-001 §5.8, no file exists	LAB-QM-POC-001 — Point-of-Care Testing (POCT) Governance, Training, and Quality Control Policy	—	MISSING	No file exists

Information Management — Forms2

Number	Title	Parent	Ver	Status	File
F-QM-IT-001-A-V0	Laboratory IT Systems Maintenance & Disaster Recovery Test Log	LAB-QM-IT-001 — Laboratory Information Management, Data Security, and Backup Policy	V0	DRAFT — UNAPPROVED	Available — open to read
F-QM-IT-002-A-V0	Computer and Power Downtime Pending-Work Log	LAB-QM-IT-002 — Laboratory Information System Downtime and Disaster Recovery Plan	V0	DRAFT — UNAPPROVED	Available — open to read

Hematology — Forms1

Number	Title	Parent	Ver	Status	File
F-H-002-A-V0	HORIBA ABX Pentra XL 80 Hematology Analyzer Maintenance Checklist	SOP-H-002 — HORIBA ABX Pentra XL 80 Complete Blood Count (CBC), 5-Part Differential, and Analyzer Maintenance SOP	V0	DRAFT — UNAPPROVED	Available — open to read

Clinical Chemistry — Forms1

Number	Title	Parent	Ver	Status	File
F-C-002-A-V0	Mindray BS-240 Clinical Chemistry Analyzer Maintenance Checklist	SOP-C-002 — Mindray BS-240 Clinical Chemistry Analyzer Operation, Calibration, and Maintenance SOP	V0	DRAFT — UNAPPROVED	Available — open to read