LAB-QM-POC-001 — Point-of-Care Testing (POCT) Governance, Training, and Quality Control Policy

1.0 Purpose

This policy establishes the governance, administrative oversight, operator training, competency evaluation, analytical verification, quality control, and clinical reporting standards for all Point-of-Care Testing (POCT) conducted within Tarangnan Community Hospital (TCH). It ensures that diagnostic testing performed at or near the bedside meets the same quality, accuracy, safety, and regulatory benchmarks as testing performed within the central Clinical Laboratory.

2.0 Scope

This policy applies to all clinical locations, patient care units (including Inpatient Wards, Emergency Room, and Outpatient Department), clinical supervisors, and non-laboratory healthcare personnel (primarily nursing staff) who handle, supervise, or perform point-of-care examinations outside the physical premises of the Clinical Laboratory.

At present, Capillary Blood Glucose (CBG) testing is TCH's only active bedside POCT program, utilizing dedicated hospital-owned glucometers. Standard laboratory urinalysis is performed centrally within the Clinical Laboratory; standby procedures for bedside urine dipstick screening are defined herein for rapid activation if clinical exigencies dictate.

3.0 Definitions

• Point-of-Care Testing (POCT) — Diagnostic testing performed at or near the site of patient care (bedside testing), outside the physical environment of the central Clinical Laboratory.
• POCT Test Site — A designated clinical ward, emergency unit, or outpatient clinic authorized by hospital administration and the Clinical Laboratory to perform approved bedside tests.
• Test Site Manager (TSM) — The clinical supervisor or Head Nurse of a patient care unit responsible for immediate administrative oversight, equipment security, supply custody, and daily quality control enforcement at the bedside testing site.
• POCT Coordinator — A designated Medical Technologist (or the Chief Medical Technologist / Laboratory Quality Manager) assigned written responsibility for the overall administration, technical supervision, training, quality control audit, and regulatory compliance of the hospital-wide POCT program per DOH Administrative Order No. 2021-0037.
• POCT Operator — A healthcare professional (typically a registered nurse or trained clinical personnel) who has completed mandatory training, successfully passed competency check-off, and is authorized to perform bedside testing.
• POCT Master List — The centralized controlled register maintained by the Clinical Laboratory documenting all authorized POCT operators, active testing sites, approved analytical devices, and registered reagent lots.
• Operator Competency Assessment — The structured evaluation through which an operator's theoretical knowledge, practical analytical technique, quality control compliance, and safety adherence are formally verified and documented prior to independent testing and annually thereafter.

4.0 Responsibility

4.1 Hospital Director

• Exercises executive authority and institutional leadership over the hospital POCT program, ensuring necessary material, equipment, and staffing resources per Organization and Governance.
• Approves institutional POCT policies, multidisciplinary committee terms of reference, and formal service agreements.

4.2 Pathologist

• Provides clinical and technical oversight for all point-of-care testing across TCH, ensuring medical necessity and analytical integrity per Organization and Governance.
• Approves the selection of POCT devices, analytical methods, reference intervals, and clinical critical-value action limits.

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Maintains overall operational accountability for the POCT quality management system, conducting annual policy reviews and regulatory audits per Document Control Policy and Internal Audit.
• Designates the POCT Coordinator in writing and reviews monthly quality control submissions, device evaluations, and non-conformance escalations.
• Convenes the periodic multidisciplinary POCT review in coordination with clinical leadership.

4.4 POCT Coordinator

In accordance with DOH Administrative Order No. 2021-0037, Annex A Section II.D, the POCT Coordinator:

• Recommends policies and technical protocols that ensure the reliability and clinical quality of bedside testing, in consultation with the Pathologist;
• Ensures all POCT devices, instruments, and testing supplies are properly calibrated, maintained, and operated in accordance with manufacturer specifications;
• Exercises technical supervision over bedside testing operations across all clinical departments;
• Coordinates initial training and conducts periodic operator competency assessments (Section 5.5);
• Verifies implementation of daily quality control protocols, reviewing monthly test-site logs and investigating analytical variances (Section 5.6);
• Maintains and continuously updates the centralized POCT Master List (Section 5.8).

4.5 Medical Technologists

• Provide analytical guidance, technical troubleshooting, and reagent/strip lot verification to bedside testing units.
• Perform prompt central laboratory confirmatory testing for critical, extreme, or clinically discordant POCT results.
• Assist the POCT Coordinator during practical competency demonstrations and technical audits.

4.6 Laboratory Aides

• Assist in receiving, inspecting, and cataloging incoming POCT reagent strips, quality control solutions, and consumable supplies within the laboratory stockroom.
• Assist in preparing and issuing verified POCT consumable packs to designated clinical test sites per approved requisitions.

4.7 Director of Nursing / Clinical Unit Heads

• Enforce full departmental adherence to this policy across all patient care wards and nursing units.
• Ensure nursing staff complete mandatory initial training and annual competency assessments before operating POCT instruments.
• Participate in the annual multidisciplinary POCT review and support corrective action when testing deficiencies arise.

4.8 Test Site Managers (Head Nurses)

• Oversee day-to-day bedside testing operations within their respective patient care units.
• Ensure that only certified, currently authorized operators perform testing on patients.
• Mandate and verify that daily quality control is successfully run and recorded prior to patient testing on each day of use.
• Collate and submit completed monthly quality control and maintenance logs to the Clinical Laboratory within five (5) working days following the end of each calendar month.

4.9 POCT Operators

In accordance with DOH Administrative Order No. 2021-0037, Annex A Section II.E, POCT Operators:

• Adhere strictly to standardized patient identification, specimen collection, and analytical procedures;
• Maintain, clean, and store POCT devices, test strips, and control solutions in accordance with approved protocols;
• Perform and document quality control testing at least once each day of patient testing, or more frequently if specified by the manufacturer;
• Cease patient testing immediately when a control result falls outside acceptable limits or an instrument malfunction occurs, implementing troubleshooting steps and notifying the Clinical Laboratory;
• Immediately report any untoward clinical incident, adverse device error, or testing discrepancy to the Test Site Manager and the POCT Coordinator.

5.0 Policy / Procedure

5.1 POCT Governance and Operational Framework

• Central Laboratory Oversight: All point-of-care testing conducted across Tarangnan Community Hospital operates under the direct administrative, clinical, and quality oversight of the Clinical Laboratory. No clinical department, ward, or external project may introduce, purchase, or operate a bedside testing device without prior written approval from the Chief Medical Technologist / Laboratory Quality Manager and the Pathologist.
• Authorized Test Scope: TCH's active bedside testing program is strictly restricted to Capillary Blood Glucose (CBG) monitoring. Routine urinalysis, hematology, and serology remain centralized within the Clinical Laboratory. Standby provisions for bedside urine dipstick testing (Section 5.4) remain unactivated unless formally authorized by the Hospital Director and Pathologist.
• Operator Validation Prerequisite: No hospital employee may operate an analytical bedside device or enter POCT results into a patient medical record without possessing an active competency certification recorded on the POCT Master List.
• Integration with Central Laboratory: Bedside testing is designed to supplement, not replace, central laboratory diagnostic examinations. Whenever a bedside test produces an indeterminate result, an unexpected critical value, or an analytical reading discordant with the patient's clinical presentation, a venous specimen shall be drawn immediately and dispatched to the Clinical Laboratory for definitive confirmation (see Figure 1).

Figure 1 — Point-of-care testing operator authorization, daily QC, and critical value flow

5.2 Device Selection and Method Implementation

Before any new POCT device, method, or strip brand is procured or deployed within TCH, the Clinical Laboratory shall perform a formal technical and operational evaluation evaluating:

• Analytical Comparability: Correlation of bedside test results with the central laboratory reference method across normal, low, and elevated pathological ranges to ensure clinical equivalence.
• Regulatory Approval: Verification that all candidate instruments, reagents, test kits, and strips hold valid Certificates of Product Registration (CPR) from the Philippine Food and Drug Administration (FDA) per Purchasing Receipt and External Provider Management Policy.
• Operational Reliability and Simplicity: Robustness of device construction, battery life, resistance to environmental fluctuations, ease of disinfection, and minimization of manual calculation or operator error (e.g., preference for code-free strip technology).
• Supply Chain Continuity: Dependable local availability of compatible test strips, calibration keys, control solutions, lancets, and authorized technical repair services.
• Biosafety and Infection Control: Compatibility with hospital disinfection agents and alignment with institutional biosafety mandates under Laboratory Safety Policy and Hand Hygiene Policy.

Evaluation findings and validation data shall be documented and submitted to the Pathologist and Chief Medical Technologist for formal approval prior to acquisition.

5.3 Active POCT Procedure: Capillary Blood Glucose (CBG) Testing

Bedside blood glucose testing is performed across designated clinical units using the hospital-standardized Sinocare Safe-Accu 2 Blood Glucose Monitoring System.

5.3.1 Instrument Principle and Specifications

The Sinocare Safe-Accu 2 system utilizes electrochemical biosensor technology based on the Glucose Dehydrogenase Flavin Adenine Dinucleotide (GDH-FAD) enzymatic reaction. The system is code-free, automatically recognizing calibrated test strip lots without manual code-chip insertion.

The system requires a micro-sample volume of 0.6 µL of fresh capillary whole blood and delivers quantitative glucose concentrations within ten (10) seconds across an analytical measuring range of 20 mg/dL to 600 mg/dL (1.1 mmol/L to 33.3 mmol/L).

5.3.2 Reagents, Test Strips, and Quality Control Solutions

• Handling and Storage: Test strip vials and control solutions shall be stored strictly between 1°C and 30°C (34°F to 86°F) with relative humidity below 85%, protected from direct heat, freezing, and direct sunlight. Strips must never be refrigerated or stored in damp environments.
• Vial Integrity: The strip vial must remain tightly capped immediately after removing a test strip. Desiccant within the vial cap protects active enzyme pads from atmospheric degradation; test strips exposed to humidity or left uncapped must be discarded.
• Dating and Expiration: Operators shall write the opening date and calculated open-vial expiration date on the vial label upon initial opening. Test strips must be discarded ninety (90) days after opening or upon the manufacturer's printed expiration date, whichever comes first. Expired strips shall be discarded immediately.

5.3.3 Equipment Care and Maintenance

• Cleanliness: Glucometers shall be inspected daily and kept free of blood, dust, and moisture. Clean the exterior housing using a lint-free cloth lightly dampened with 70% isopropyl alcohol or approved hospital disinfectant wipes. Liquid must never enter the test strip port, code port, or battery compartment.
• Battery and Physical Integrity: When the low battery icon appears, replace batteries promptly to prevent analytical failure. If a meter is dropped or subjected to mechanical impact, perform physical inspection and run high and low quality controls before resuming patient testing.
• Maintenance Logging: Daily inspection, battery replacements, and corrective cleanings shall be documented in the POCT quality control and maintenance log (electronic workbook registered under F-QM-002-B-V0).

5.3.4 Specimen Requirements and Collection

• Acceptable Sample Type: Fresh capillary whole blood obtained via skin puncture (fingertip in adults and children; plantar heel surface in neonates and non-walking infants). Venous whole blood collected without anticoagulant or with lithium/sodium heparin may be analyzed within 30 minutes of collection.
• Prohibited Samples: Fluoride-preserved blood (gray-top tubes) or EDTA blood must not be used, as additives interfere with enzymatic biosensor activity. Serum or plasma samples are strictly prohibited.
• Skin Preparation: Cleanse the puncture site with 70% isopropyl alcohol and allow the site to air dry completely. Residual alcohol causes hemolysis, dilutes the sample, and causes falsely elevated or erratic glucose readings.

5.3.5 Stepwise Patient Testing Workflow

• Patient Verification: Confirm patient identity using at least two independent identifiers (e.g., full name and hospital/MRN number verified against patient wristband). Explain the procedure to the patient.
• Preparation: Wash hands and don clean examination gloves per Hand Hygiene Policy. Remove one test strip from the vial and close the vial cap tightly immediately.
• Meter Activation: Insert the contact bar of the test strip firmly into the meter's test port. The meter powers on automatically and displays the flashing blood drop symbol, indicating readiness.
• Skin Puncture: Perform a quick skin puncture using a sterile single-use auto-disabling safety lancet. Dispose of the used lancet immediately into a rigid sharps container.
• Sample Application: Wipe away the very first drop of blood using a clean dry gauze pad to eliminate tissue fluid contamination. Gently encourage a second rounded drop of blood (do not milk or vigorously squeeze the puncture site, which introduces interstitial fluid). Touch the reaction tip of the test strip to the blood drop. The capillary sample port draws blood automatically by capillary action.
• Analytical Run: Ensure the reaction zone fills completely (0.6 µL). The meter beeps and displays a 10-second countdown.
• Hemostasis and Disposal: Apply clean dry gauze with gentle pressure to the patient puncture site until bleeding stops. Eject the used test strip directly into a yellow biohazard waste bin.
• Result Verification: Read and record the digital glucose concentration displayed on the screen.

5.3.6 Quality Control Protocol and Non-Conformance Handling

• Testing Frequency: Quality control using manufacturer-supplied Sinocare Glucose Control Solutions (Level 1 Low and Level 2 High) shall be performed: - At least once every calendar day before analyzing patient specimens; - Whenever opening a new vial or new lot of test strips; - Whenever an unexpected patient result contradicts the clinical condition; - If a meter has been dropped, mechanically shocked, or exposed to excessive heat/moisture; - Whenever a test strip vial was left unsealed or open.
• Acceptable Criteria: Control results must fall strictly within the target acceptable range printed on the active test strip vial label.
• Out-of-Control Corrective Action: If a control value falls outside the target range: - Do not test patient samples. - Verify that strips and control solutions are within expiration dates and have been stored correctly. - Invert the control bottle gently 5 times, discard the first drop, wipe the tip, and re-test with a fresh strip. - If the second control run remains out of range, tag the glucometer as "Defective — Out of Order", quarantine the unit from clinical use, and notify the POCT Coordinator or Clinical Laboratory immediately. - The operator and Test Site Manager shall document the out-of-control incident, investigation, and corrective action in the POCT out-of-control investigation and corrective action record (electronic workbook registered under F-QM-002-B-V0).

5.3.7 Result Review, Recording, and Critical Value Notification

• Medical Record Entry: All bedside glucose results shall be documented promptly in the patient's permanent medical chart (or designated bedside monitoring sheet), indicating the date, exact time, measured glucose value in mg/dL, glucometer serial number, and operator initials.
• Reference Intervals: Adult fasting capillary blood glucose: 70–99 mg/dL (3.9–5.5 mmol/L); normal postprandial/random: <140 mg/dL (<7.8 mmol/L).
• Critical Value Notification: - Adult and Pediatric (>1 month): Glucose ≤50 mg/dL (≤2.8 mmol/L) or ≥450 mg/dL (≥25.0 mmol/L). - Neonatal (≤1 month): Glucose ≤30 mg/dL (≤1.7 mmol/L) or ≥300 mg/dL (≥16.7 mmol/L).
• Critical Value Verification Workflow: - For suspected critical hypoglycemia (≤50 mg/dL): Re-test immediately on a second meter or with a fresh fingerstick. Initiate immediate bedside clinical intervention per physician standing orders while notifying the attending physician. - For suspected critical hyperglycemia (≥450 mg/dL or meter display "HI"): Inform the attending physician immediately and collect a venous blood sample for urgent stat plasma glucose verification in the Clinical Laboratory per Reporting Critical Values Policy. - All critical verbal notifications must follow the mandatory "read-back" confirmation protocol and be recorded in F-QM-POST-002-A-V0.

5.3.8 Safety, Universal Precautions, and Biohazard Disposal

• All capillary blood punctures shall be treated as potentially infectious for bloodborne pathogens (HIV, Hepatitis B, Hepatitis C) per Hand Hygiene Policy.
• Operators shall wear fresh disposable gloves for each patient puncture. Gloves must be removed and hands sanitized between patient contacts.
• Lancets must be single-use safety-engineered devices with automatically retracting needles. Lancets must never be reused or left exposed on bedside trays.
• Contaminated gauze, cotton swabs, and used test strips are classified as pathological biohazard waste and must be placed into yellow infectious waste bags for collection per hospital healthcare waste protocols.

5.3.9 Analytical and Clinical Limitations

• Hematocrit Interference: Extremes in patient hematocrit significantly affect capillary glucose readings. Severe anemia (hematocrit <20%) may cause falsely elevated glucose results; severe polycythemia (hematocrit >60%) may cause falsely decreased readings. Central laboratory plasma glucose testing is required for patients with extreme hematocrit levels.
• Peripheral Hypoperfusion: Capillary fingerstick blood does not accurately reflect systemic glucose in patients experiencing severe dehydration, diabetic ketoacidosis, hyperosmolar hyperglycemic state, peripheral vascular collapse, cardiogenic shock, or severe hypotension. Venous blood testing must be ordered for critically ill patients.
• Severe Edema: In patients with severe peripheral edema, interstitial fluid contamination may dilute capillary blood samples, yielding falsely low readings.
• Meter Display Ranges: The meter displays numerical values between 20 mg/dL and 600 mg/dL. Values below 20 mg/dL display as "LO"; values above 600 mg/dL display as "HI". Both conditions represent life-threatening emergencies requiring immediate clinical intervention and laboratory confirmation.

5.4 Standby POCT Operational Framework: Urine Dipstick Testing

Standby provisions for semi-quantitative bedside urine chemical screening (evaluating specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and occult blood) are established as follows:

• Activation Requirement: Standard urinalysis remains centralized within the Clinical Laboratory. Bedside testing by nursing staff shall be activated only upon formal administrative approval for designated rapid-screening environments (such as triage in the Emergency Room).
• Specimen Collection: Fresh, clean-catch midstream urine or catheterized urine collected in a sterile, dry container without preservatives. Testing must be performed within one (1) hour of voiding; unpreserved specimens delayed beyond one hour must be refrigerated at 2°C to 8°C and returned to room temperature before testing.
• Analytical Procedure: A multi-parameter reagent strip is dipped into the uncentrifuged urine for exactly one (1) second, drawn against the container rim to remove excess liquid, and held horizontally to prevent reagent runover. Color changes on each test pad are read against the manufacturer's visual bottle comparison chart at strictly timed intervals (60 seconds for routine pads; 120 seconds for leukocyte esterase).
• Quality Control: Two levels of commercial liquid urine controls (negative and abnormal) must be tested on each open canister every day of clinical use and whenever a new canister is opened.
• Standby Documentation: If activated, all operator validations, QC results, and maintenance records shall be logged in the POCT electronic records registered under F-QM-002-B-V0.

5.5 POCT Training and Operator Competency Assessment

• Mandatory Initial Training: Every prospective POCT operator must complete formal training conducted by the POCT Coordinator or designated Medical Technologist before performing independent testing. Training curricula comprise: - Clinical rationale, analytical principles, and clinical limitations of bedside testing; - Specimen collection technique, skin preparation, and post-puncture care; - Instrument calibration, strip handling, and test execution; - Quality control rationale, testing protocol, and out-of-control troubleshooting; - Result recording, reference ranges, and critical value reporting workflows; - Universal precautions, personal protective equipment, and healthcare waste segregation.
• Initial Competency Evaluation: Operators must demonstrate practical competence by: - Achieving 100% on a written/oral theoretical examination; - Successfully performing three (3) directly observed test runs (including daily QC and patient testing) witnessed and scored by the POCT Coordinator.
• Annual Re-Assessment: Operator competency shall be re-evaluated at least annually. Re-assessment includes direct observation of routine testing, review of quality control documentation, and verification of critical value reporting compliance.
• Certification Record: Successful completion of initial and annual competency evaluations is recorded in the POCT operator training and competency record (electronic workbook registered under F-QM-002-B-V0) and entered into the POCT Master List. Operators failing competency evaluation shall have bedside testing privileges suspended until remedial training is completed.

5.6 Quality Control Review, Escalation, and Non-Conformance Handling

• Monthly QC Collation: Test Site Managers shall collate all daily quality control sheets, maintenance records, and corrective action forms for their unit and submit the physical or electronic records to the POCT Coordinator within five (5) working days following the conclusion of each month.
• Laboratory Review and Analysis: The POCT Coordinator shall review submitted QC logs for completeness, outlier trends, unresolved deviations, and testing compliance.
• Escalation of Non-Conformances: - Failure to run daily QC prior to patient testing, failure to document corrective action for out-of-range controls, or testing performed by uncertified personnel constitutes a quality non-conformance. - Minor infractions result in written notification to the Test Site Manager and required remedial retraining of involved operators. - Three-Strike Suspension Rule: If a single test site accumulates three (3) uncorrected non-conformances within a rolling 12-month period, the Chief Medical Technologist / Laboratory Quality Manager shall immediately suspend bedside testing authorization for that unit, repossess the testing devices, and notify the Director of Nursing and Hospital Director. Testing shall not resume until root-cause analysis is completed per Corrective and Preventive Action Policy.

5.7 Performance Improvement and Quality Indicators

The POCT program shall track designated quality and performance indicators on a monthly and quarterly basis per Continual Improvement and Performance Improvement Program Policy, including:

• Operator competency currency rate (percentage of active operators with current annual certification; target: 100%);
• Daily QC compliance rate (percentage of testing days with verified QC logged prior to patient testing; target: ≥95%);
• QC outlier resolution rate (percentage of out-of-control events with documented corrective action; target: 100%);
• Critical value read-back documentation rate (target: 100%).

Performance data shall be reviewed during internal quality meetings and summarized for executive management review per Management Review.

5.8 POCT Master List

The Clinical Laboratory shall establish and maintain a centralized, up-to-date POCT Master List comprising two core sections:

• Authorized Operators Register: Documenting operator full name, professional PRC license number, hospital employee ID, assigned clinical ward/unit, authorized POCT test categories, initial qualification date, and most recent competency re-assessment date.
• Devices, Instruments, and Reagents Register: Documenting each glucometer's brand name, model, serial number, assigned ward location, commissioning date, FDA Certificate of Product Registration number, current test strip brand and lot number, strip open-vial expiration date, and control solution lot numbers.

The POCT Coordinator shall update the register immediately upon qualifying new operators, commissioning or retiring meters, or releasing new reagent strip shipments.

5.9 Periodic Multidisciplinary POCT Assessment

A multidisciplinary POCT Committee comprising the Hospital Director (or executive designee), Clinical Pathologist, Chief Medical Technologist / Laboratory Quality Manager, POCT Coordinator, Medical Staff Representative, and Director of Nursing shall conduct a formal program assessment at least once each calendar year (and ad hoc upon introduction of new testing sites or major adverse occurrences).

The multidisciplinary committee shall review:

• Accuracy and completeness of the POCT Master List;
• Annual quality control performance, outlier logs, and unresolved technical issues;
• Staff competency compliance across all clinical departments;
• Review of clinical critical value reporting compliance and adverse patient incidents;
• Relevance of current POCT test menus and evaluation of requests for new bedside diagnostic technologies.

Minutes, evaluation findings, and time-bound action plans shall be recorded and submitted as structured inputs to the institutional Management Review under Management Review.

6.0 Records

POCT records are maintained electronically — in device memory, the LIS, and dedicated electronic workbooks registered under F-QM-002-B-V0 (Decision D5); no separate paper POCT form is maintained. The records cover five areas:

• Area 1: POCT Master List (Operators, Devices, and Reagents Register);
• Area 2: POCT Operator Training and Competency Assessment Record;
• Area 3: Daily Quality Control and Maintenance Log;
• Area 4: Out-of-Control Investigation and Corrective Action Record;
• Area 5: Annual Multidisciplinary POCT Committee Assessment Minutes.

7.0 References

• DOH QMS Tool for Clinical Laboratories (2024), Section 3 — Service Delivery (Point-of-Care Testing)
• DOH Administrative Order No. 2021-0037, Annex A Sections II.D, II.E, V.A.2, V.B.11, VI.C; Annex B1 Items 23, 33 — Requirements for Point-of-Care Testing
• ISO 15189:2022, Clauses 5.3.1, 6.4.2, 6.6.5, 6.7.2, 7.3.7.4, and Annex A "Additional requirements for Point-of-Care Testing (POCT)"
• JCI Accreditation Standards for Hospitals, AOP.5.1.1 — Oversight and Supervision of the Point-of-Care Testing Program
• Sinocare Safe-Accu 2 Blood Glucose Monitoring System User Manual and Package Inserts (Sinocare Inc.)

Companion policies:

• Document Control Policy — control of laboratory policies, procedures, and forms
• Reporting Critical Values Policy — critical-value escalation and reporting protocols
• Hand Hygiene Policy — infection prevention, standard precautions, and healthcare waste segregation

Controlled visual annex:

• IG-17 — POCT Governance and QC — one-page visual annex to this policy, controlled under Document Control Policy Section 5.2.6 and registered in F-QM-002-B-V0. Master files: infographics/IG-17-POCT-Governance-and-QC-LAB-QM-POC-001.png (PNG, print PDF, and editable HTML).