Policy, Standards, and Guidelines for Hemoglobin Testing

1. Policy
· Objective: Ensure accurate, reliable hemoglobin (Hb) measurements to inform clinical
decisions.
· Commitments:
o Adherence to regulatory standards (CLIA, ISO 15189).
o Use of validated methods and certified equipment.
o Staff competency through regular training and assessments.
o Patient safety, data confidentiality, and ethical sample handling.
o Continuous quality improvement and error correction protocols.
2. Standards
· Analytical Methods:
o Primary: Spectrophotometry (e.g., cyanmethemoglobin method) or automated
hematology analyzers.
o Calibration: Traceable to international standards (e.g., ICSH).
· Quality Control:
o Daily internal controls (normal/abnormal ranges).
o Participation in external proficiency testing (e.g., CAP).
· Sample Handling:
o Anticoagulant: EDTA tubes; avoid hemolysis.
o Stability: Test within 6 hours at 20–25°C or 24 hours at 4°C.
· Equipment:
o Regular maintenance per manufacturer guidelines.
o Documented calibration and troubleshooting.
3. Guidelines
· Pre-Analytical:
o Patient Preparation: Note fasting status, posture, recent transfusions, or
altitude exposure.
o Collection: Use proper venipuncture to prevent hemolysis; label samples
immediately.
· Analytical:
o Interference Checks: Lipemia, leukocytosis, hemoglobinopathies may require
method adjustment.
o SOPs: Follow step-by-step protocols; validate new methods.
· Post-Analytical:
o Reference Ranges: Adjust for age, sex, and altitude (e.g., adult males
13.5–17.5 g/dL).
o Critical Values: Report Hb <7 g/dL or >20 g/dL immediately.
o Clinical Context: Interpret results with patient history; suggest follow-up (e.g.,
iron studies for anemia).
· Documentation & Safety:
o Record all steps, QC results, and personnel.
o Use PPE; dispose of biohazard waste safely.
4. Continuous Improvement
· Training: Annual competency assessments and updates on guidelines (CLSI, WHO).
· Audits: Internal/external reviews of compliance and accuracy.
· Delta Checks: Flag significant deviations from prior results.
· Incident Reporting: Analyze errors to refine protocols.

5. Ethical & Legal Considerations

· Confidentiality: Secure patient data per HIPAA/GDPR.
· Chain of Custody: Essential for forensic or transfusion cases.
Quality Policy, Vision, Mission, and Goals for Hemoglobin Testing
Aligned with Policy, Standards, and Guidelines (PSG) to Ensure Accurate and Reliable Results

Vision
"To be the benchmark of excellence in hemoglobin diagnostics, delivering precise and
actionable insights that empower optimal patient care worldwide."

Mission
"To determine the true hemoglobin value in patient blood through standardized, evidence-based
methodologies, rigorous quality assurance, and continuous innovation, ensuring every result is
reliable, timely, and clinically meaningful."

Quality Policy
We are committed to:
1. Accuracy: Deliver hemoglobin values that reflect the true physiological state of the
patient, validated by traceable calibration and adherence to international standards
(e.g., ICSH, CLSI).
2. Reliability: Eliminate pre-analytical, analytical, and post-analytical errors through
robust protocols, staff competency, and advanced technology.
3. Patient-Centricity: Prioritize patient safety, confidentiality, and ethical practices in all
testing processes.
4. Continuous Improvement: Foster a culture of learning, innovation, and
accountability through audits, feedback, and technology upgrades.
5. Compliance: Meet or exceed regulatory requirements (CLIA, ISO 15189) and
participate in external proficiency testing (e.g., CAP).

Goals
1. Analytical Precision
o Achieve ≤3% coefficient of variation (CV) in internal quality control (IQC) for
hemoglobin measurements.
o Ensure 100% compliance with CLIA and ISO 15189 standards for method
validation.
2. Pre-Analytical Excellence
o Reduce pre-analytical errors (e.g., hemolysis, mislabeling) by 95% through staff
training and standardized collection protocols.
3. Staff Competency
o Certify 100% of laboratory staff in hemoglobin testing competency annually,
with bi-annual refresher training.
4. Technology & Infrastructure
o Maintain 100% uptime for hemoglobin analyzers through preventive
maintenance and prompt calibration.
5. Clinical Relevance
o Ensure 100% of critical results (Hb <7 g/dL or >20 g/dL) are communicated to
clinicians within 15 minutes of verification.
 6. Data Integrity
o Secure 100% compliance with HIPAA/GDPR for patient data confidentiality and
traceability.
7. Continuous Improvement
o Achieve ≥95% scores in external proficiency testing programs annually.
o Implement corrective actions for all non-conformities within 48 hours of
identification.

Alignment with PSG

· Policy: Reflects commitments to accuracy, compliance, and patient safety.
· Standards: Embodies ICSH guidelines for methods, CLIA/ISO for quality control, and
WHO recommendations for clinical interpretation.
· Guidelines: Operationalizes pre-analytical, analytical, and post-analytical best
practices (e.g., sample stability, delta checks, clinical context).

Outcome: This framework ensures that every hemoglobin result is a true reflection of the
patient’s condition, driving informed clinical decisions and fostering trust in laboratory services.
QUALITY MANAGEMENT SYSTEM (QMS) MANUAL
FOR HEMOGLOBIN EXAMINATION IN A CLINICAL LABORATORY

1. Introduction
This QMS Manual outlines the systematic approach to ensure accurate, reliable, and clinically
relevant hemoglobin (Hb) testing in alignment with international standards (ISO 15189, CLIA)
and institutional policies. It integrates quality control, staff competency, and continuous
improvement to deliver results that reflect the true hemoglobin value in patient blood.

2. Scope
Applies to all processes involved in hemoglobin testing, including:
· Pre-analytical (patient preparation, sample collection, handling).
· Analytical (methodology, calibration, quality control).
· Post-analytical (result reporting, interpretation, and storage).

3. Quality Policy
"To deliver hemoglobin results with uncompromising accuracy, reliability, and timeliness,
ensuring patient safety and trust through adherence to global standards, staff excellence, and
continuous improvement."

4. Organizational Structure and Responsibilities

4.1 Laboratory Director
· Oversee compliance with QMS and regulatory standards.
· Approve SOPs and ensure resource allocation.
4.2 Quality Manager
· Monitor QMS implementation, audits, and corrective actions.
· Manage proficiency testing and non-conformance investigations.
4.3 Laboratory Technologists
· Perform Hb testing per SOPs.
· Conduct daily QC, equipment maintenance, and error reporting.
4.4 Phlebotomists
· Ensure proper patient identification, sample collection, and labeling.

5. Personnel Competency and Training

· Initial Training: Certification in Hb testing methods (e.g., spectrophotometry,
automated analyzers).
· Annual Competency Assessment: Practical exams, theoretical tests, and review of
error rates.
· Continuing Education: Updates on Hb variants, interference management, and
ISO/CLIA guidelines.

6. Pre-Analytical Phase
6.1 Patient Preparation
· Document factors affecting Hb (e.g., fasting status, recent transfusions).
 · Use standardized questionnaires to identify confounding variables (e.g.,
high-altitude residence).
6.2 Sample Collection
· Anticoagulant: EDTA tubes (lavender top).
· Procedure: Avoid hemolysis via proper venipuncture; mix tubes gently.
· Labeling: Patient ID, time, and date on all samples.
6.3 Sample Transport and Storage
· Stability: Process within 6 hours (room temperature) or 24 hours (2–8°C).
· Rejection Criteria: Hemolyzed, clotted, or mislabeled samples.

7. Analytical Phase
7.1 Methodology
· Primary Method: Automated hematology analyzers (e.g., Sysmex, Beckman
Coulter) or cyanmethemoglobin spectrophotometry.
· Calibration: Traceable to ICSH reference standards; performed quarterly or
after major maintenance.
7.2 Quality Control (QC)
· Internal QC:
o Run normal and abnormal controls daily.
o Accept if within ±2 SD of mean.
· External QC: Participate in CAP or WHO proficiency testing biannually.
7.3 Interference Management
· Common Interferences:
o Lipemia: Use blank correction or ultracentrifugation.
o High WBC (>50 x 10³/μL): Centrifuge sample and re-test plasma.
o Hemoglobinopathies: Validate with HPLC if needed.

8. Post-Analytical Phase
8.1 Result Reporting
· Reference Ranges:
o Adult males: 13.5–17.5 g/dL.
o Adult females: 12.0–15.5 g/dL.
o Adjust for pediatric/geriatric patients and altitude.
· Critical Values: Escalate Hb <7 g/dL or >20 g/dL to clinicians immediately.
8.2 Clinical Interpretation
· Annotate results with context (e.g., iron deficiency, polycythemia).
· Suggest follow-up tests (e.g., reticulocyte count, ferritin).
8.3 Data Retention
· Store electronic records for 10 years; maintain audit trails for modifications.

9. Equipment Management
· Calibration: Documented before use and after maintenance.
· Maintenance: Daily cleaning; monthly performance checks.
· Troubleshooting: Log errors and corrective actions in equipment records.
10. Document Control
· SOPs: Version-controlled, reviewed annually, and accessible to all staff.
· Forms: Standardized templates for sample rejection, QC logs, and incident reports.

11. Non-Conformance and Corrective Action

· Incident Reporting: Document deviations (e.g., QC failures, mislabeled samples).
· Root Cause Analysis: Use 5 Whys or Fishbone diagrams.
· Corrective Action Plan: Implement within 48 hours; monitor effectiveness.

12. Safety and Ethics

· PPE: Gloves, lab coats, and eye protection mandatory.
· Biohazard Waste: Dispose of sharps and blood samples in designated containers.
· Confidentiality: Adhere to HIPAA/GDPR for patient data.

13. Continuous Improvement

· Internal Audits: Quarterly reviews of QMS compliance.
· Management Reviews: Biannual meetings to assess KPIs (e.g., turnaround time, error
rates).
· Feedback Loop: Incorporate clinician and patient input into process refinements.

14. Appendices
· Appendix A: Hb Testing SOPs.
· Appendix B: QC Log Templates.
· Appendix C: Reference Ranges by Age/Sex.
· Appendix D: Incident Report Form.
Appendix A: Hb Testing SOPs
Example: Excerpt from the Hemoglobin Testing SOP
Section 1.0: Automated Hb Testing Using Sysmex XN Analyzer
Procedure:
1. Power On: Allow analyzer to complete self-check.
2. Load QC Materials:
o Run Normal Control (12–15 g/dL) and Abnormal Control (6–8 g/dL).
3. Load Patient Samples:
o Mix EDTA tubes gently; ensure no clots or hemolysis.
4. Run Analysis:
o Select "Hb" test mode; input patient ID.
5. Review Results:
o Flagged results (e.g., Hb <7 g/dL) trigger repeat testing.
Scenario:
A sample with Hb 6.5 g/dL is flagged. The technologist repeats the test using a manual
cyanmethemoglobin method to confirm.

Appendix B: QC Log Templates

Daily QC Log for Hemoglobin Testing
Date Control Lot Expected Observed Acceptable? Technician Action
Type Number Range Value (Y/N) Initials Taken
(g/dL) (g/dL)
2023- Normal QC123 12.0–15.0 13.8 Y JD None
10-20
2023- Abnormal QC456 6.0–8.0 6.2 Y JD None
10-20
2023- Normal QC123 12.0–15.0 16.1 N AL Recalibrat
10-21 ed
analyzer;
repeated
QC.
Scenario:
On 2023-10-21, the normal control exceeded the range. The technician recalibrated the
analyzer, repeated QC, and documented the corrective action.

Appendix C: Reference Ranges by Age/Sex

Hemoglobin Reference Intervals
Population Hb Range Notes
(g/dL)
Adult Males 13.5–17.5 Adjust for smokers (+0.5–1.0 g/dL).
 Adult Females 12.0–15.5 Lower during menstruation (-1.0–2.0 g/dL).

Children (1–12 yrs) 11.0–14.0 Varies by age; use pediatric-specific charts.

Infants (6–12 mos) 10.0–14.0 Iron deficiency common; interpret with

ferritin.
Pregnancy (3rd ≥11.0 Physiological hemodilution lowers Hb.
Trimester)
Notes:
· Altitude Adjustment: Add +1.0–2.0 g/dL for elevations >1,500 meters.
· Critical Values:
o Hb <7 g/dL: Risk of cardiac failure; urgent transfusion evaluation.
o Hb >20 g/dL: Risk of thrombosis; investigate polycythemia vera.

Appendix D: Incident Report Form

Non-Conformance Report (NCR) Template
Incident Date / Reported Description Root Corrective Effectiveness Closed
ID Time By Cause Action Check By/Date
NCR-202 2023-10 John Doe Mislabeled Phleboto Retrain No repeat Jane Smith
3-101 -22 sample: mist phlebotomis errors in 30 /
10:15 Patient ID skipped t on SOP; days. 2023-11-22
AM mismatch ID check. implement
between dual-signoff
requisition for labeling.
form and
EDTA tube.

Scenario:
A mislabeled sample led to a near-miss patient ID error. The phlebotomist was retrained, and a
dual-signoff protocol was introduced.

Key Notes for Implementation:

1. Customization: Adapt templates to your lab’s workflows (e.g., add altitude-specific
reference ranges).
2. Integration: Link appendices to main SOPs (e.g., reference ranges in Appendix C
guide post-analytical reporting).
3. Compliance:
o SOPs must align with CLSI EP28-A3c (Reference Intervals).
o Incident reports follow CLSI QMS02-A6 (Nonconforming Event Management).

These templates standardize Hb testing processes, minimize errors, and ensure patient safety
through systematic documentation.
Approval
Laboratory Director Signature: ___________________________
Date: ___________________________

This QMS Manual ensures hemoglobin testing aligns with the highest standards of accuracy,
reliability, and patient care. Regular updates will reflect advancements in technology and
regulations.
TECHNICAL STANDARD OPERATING PROCEDURE (SOP)
FOR HEMOGLOBIN TESTING IN A CLINICAL LABORATORY

1. Purpose
To standardize the procedure for accurate and reliable measurement of hemoglobin (Hb) in
blood samples, ensuring results reflect the true physiological value for clinical
decision-making.

2. Scope
Applies to all laboratory personnel performing Hb testing using:
· Automated Hematology Analyzers (e.g., Sysmex XN-series, Beckman Coulter DxH).
· Manual Spectrophotometric Methods (e.g., cyanmethemoglobin method).

3. Responsibilities
· Lab Technologists: Execute testing, QC, and equipment maintenance.
· Quality Officer: Verify compliance with SOPs and QC protocols.
· Phlebotomists: Ensure proper sample collection and labeling.

4. Equipment and Reagents

4.1 Equipment
· Automated hematology analyzer (calibrated and validated).
· Spectrophotometer (for manual method).
· Centrifuge, micropipettes, vortex mixer, and glass cuvettes.
· PPE: Gloves, lab coats, safety goggles.
4.2 Reagents
· Automated Method: Manufacturer-specific Hb reagent kits (e.g., lytic reagent).
· Manual Method: Drabkin’s reagent (potassium ferricyanide, potassium cyanide,
sodium bicarbonate).
· Quality control materials (normal/abnormal Hb levels).

5. Pre-Analytical Procedure
5.1 Patient Preparation
· Document patient factors affecting Hb (fasting, recent transfusions, altitude
exposure).
5.2 Sample Collection
· Anticoagulant: EDTA (lavender-top tube).
· Procedure:
o Perform venipuncture avoiding hemolysis.
o Mix tube gently by inverting 8–10 times.
· Labeling: Patient ID, date, time, and collector’s initials.
5.3 Sample Acceptance/Rejection Criteria
· Accept: Well-mixed, no clots, no visible hemolysis.
 · Reject: Hemolyzed, clotted, or mislabeled samples. Document rejection in
LIMS.

6. Analytical Procedure
6.1 Automated Hematology Analyzer
1. Power On: Warm up analyzer per manufacturer instructions.
2. Load Reagents: Ensure sufficient volume and no expired batches.
3. Run QC:
o Process normal and abnormal controls.
o Verify results fall within ±2 SD of expected ranges.
4. Load Samples:
o Mix EDTA tubes gently before loading.
o Input patient ID into the analyzer.
5. Run Analysis: Follow on-screen prompts.
6. Review Flags: Address interferences (e.g., turbidity, high WBC).
6.2 Manual Cyanmethemoglobin Method
1. Prepare Drabkin’s Reagent:
o Mix 200 mg potassium ferricyanide, 50 mg potassium cyanide, and 1 g
sodium bicarbonate in 1 L distilled water.
2. Lyse Blood:
o Add 20 μL whole blood to 5 mL Drabkin’s reagent. Incubate 10 minutes.
3. Centrifuge: Spin at 3000 rpm for 5 minutes if turbid.
4. Measure Absorbance:
o Read at 540 nm wavelength using spectrophotometer.
5. Calculate Hb:
o Hb (g/dL)=Absorbance of testAbsorbance of standard×Concentration of
standardHb (g/dL)=Absorbance of standardAbsorbance of
test×Concentration of standard.

7. Quality Control (QC)

· Daily QC: Run normal and abnormal controls with patient samples.
· Acceptance Criteria:
o Automated: CV ≤3%.
o Manual: ±5% of target value.
· QC Failure Action:
1. Repeat QC.
2. Recalibrate if repeated failure.
3. Document and escalate to Quality Officer.

8. Interference Management
· Lipemia: Use blank correction (automated) or ultracentrifuge (manual).
· High WBC (>50 x 10³/μL): Centrifuge sample, use plasma for manual method.
· Hemoglobin Variants (e.g., HbS): Confirm with HPLC if results are inconsistent.
9. Post-Analytical Procedure
9.1 Result Reporting
· Reference Ranges:
o Males: 13.5–17.5 g/dL.
o Females: 12.0–15.5 g/dL.
o Adjust for age, altitude, and pregnancy.
· Critical Values:
o Hb <7 g/dL (severe anemia) or >20 g/dL (polycythemia): Notify
clinician immediately.
9.2 Documentation
· Record results in LIMS with operator ID, date/time, and QC status.
· Archive raw data (printouts/electronic files) for 10 years.

10. Safety and Waste Disposal

· PPE: Mandatory during testing.
· Chemical Waste: Dispose of Drabkin’s reagent (cyanide-containing) in labeled
hazardous containers.
· Biohazard Waste: Autoclave blood samples before disposal.

11. Troubleshooting
Issue Resolution
Erratic QC Results Recalibrate analyzer; check reagent expiration.
Clogged Analyzer Run cleaning cycle; inspect aspiration probe.
Absorbance Out of Verify spectrophotometer calibration; remake
Range reagent.

12. References
· CLSI Guidelines H03-A6 (Hemoglobin Testing).
· ICSH Recommendations for Hb Measurement.
· Manufacturer’s analyzer operation manuals.

13. Revision History

Version Date Changes Approved By
1.0 [Insert Date] Initial Release Lab Director

Approval
Laboratory Director: ___________________________
Quality Officer: ___________________________
Date: ___________________________

This SOP ensures standardized, precise, and reliable hemoglobin testing. Review
annually or after significant procedural changes.
ADMINISTRATIVE STANDARD OPERATING PROCEDURE (SOP)
FOR HEMOGLOBIN TESTING IN A CLINICAL LABORATORY
Aligned with CLSI QSE (Quality System Essentials) Framework

1. Purpose
To establish administrative processes that support accurate hemoglobin (Hb) testing by
addressing CLSI’s 12 Quality System Essentials (QSEs): Organization, Personnel,
Equipment, Purchasing, Process Control, Documents, Records, Occurrence
Management, Assessments, Process Improvement, Customer Service, and Facilities &
Safety.

2. Scope
Applies to administrative activities governing Hb testing, including staff management, resource
procurement, document control, incident response, and compliance monitoring.

3. Organization
3.1 Roles and Responsibilities
· Laboratory Director:
o Oversee QSE implementation and regulatory compliance (CLIA, ISO
15189).
o Approve budgets, staffing, and SOPs.
· Quality Manager:
o Monitor adherence to QSEs, conduct audits, and manage corrective
actions.
· Lab Supervisors:
o Ensure daily workflow alignment with QSEs and troubleshoot
administrative barriers.
3.2 Organizational Chart
· Include in Appendix A.

4. Personnel
4.1 Training and Competency
· Initial Training:
o CLSI-based Hb testing protocols, safety, and ethics.
o Documented in Training Log (Appendix B).
· Competency Assessment:
o Annual evaluations using direct observation, written tests, and review of
error rates.
· Continuing Education:
o Quarterly updates on Hb testing guidelines (e.g., CLSI H03-A6).

5. Equipment Management
5.1 Procurement and Validation
 · Select Hb analyzers/reagents validated per CLSI EP05-A3 (Evaluation of
Precision).
· Maintain vendor qualification records (Appendix C).
5.2 Maintenance and Calibration
· Schedule monthly preventive maintenance.
· Document calibration dates and outcomes in Equipment Log (Appendix D).

6. Purchasing and Inventory

6.1 Supplier Evaluation
· Vet suppliers for Hb reagents/equipment using criteria: ISO certification, delivery
reliability, and technical support.
6.2 Inventory Control
· Track reagent lot numbers, expiration dates, and storage conditions.
· Use a First-Expired-First-Out (FEFO) system.

7. Process Control
7.1 Workflow Mapping
· Define Hb testing workflow from sample collection to result reporting (Appendix
E).
7.2 Key Performance Indicators (KPIs)
· Turnaround time (<1 hour for STAT Hb tests).
· Pre-analytical error rate (<2% of total samples).

8. Document and Record Control

8.1 SOP Management
· Version-controlled Hb testing SOPs stored electronically with restricted access.
· Annual review by Quality Manager.
8.2 Record Retention
· Retain Hb test records for 10 years (electronic/hardcopy).
· Secure patient data per HIPAA/GDPR.

9. Occurrence Management
9.1 Incident Reporting
· Document errors (e.g., mislabeling, QC failures) using Non-Conformance
Form (Appendix F).
9.2 Root Cause Analysis (RCA)
· Apply 5 Whys or Fishbone diagrams for critical incidents.
9.3 Corrective Actions
· Implement within 48 hours; track effectiveness for 30 days.

10. Assessments
10.1 Internal Audits
· Quarterly audits of Hb testing processes using QSE Audit Checklist (Appendix
G).
 10.2 Proficiency Testing (PT)
· Biannual participation in CAP surveys; investigate outliers per CLSI GP27-A.

11. Process Improvement

11.1 Continuous Improvement Plan
· Address audit findings, PT gaps, and clinician feedback.
· Annual review of KPIs by management.

12. Customer Service

12.1 Clinician Communication
· Escalate critical Hb results (<7 g/dL or >20 g/dL) within 15 minutes.
12.2 Feedback Mechanism
· Distribute quarterly satisfaction surveys to clinicians; address gaps in 14 days.

13. Facilities and Safety

13.1 Environmental Controls
· Monitor temperature (20–25°C) and humidity (30–60%) in testing areas.
13.2 Safety Protocols
· PPE (gloves, lab coats) mandatory during Hb testing.
· Biohazard waste disposed per OSHA standards.

14. Appendices
· Appendix A: Organizational Chart.
· Appendix B: Training Log Template.
· Appendix C: Vendor Qualification Form.
· Appendix D: Equipment Maintenance Log.
· Appendix E: Hb Testing Workflow Diagram.
· Appendix F: Non-Conformance Report Form.
· Appendix G: QSE Audit Checklist.

15. References
· CLSI QMS01-A4 (Quality Management System: Organization and Personnel).
· CLSI GP26-A3 (Quality Management: A Risk-Based Approach).

16. Revision History

Version Date Changes Approved By
1.0 [Insert Date] Initial Release Lab Director

Approvals
Laboratory Director: ___________________________
Quality Manager: ___________________________
Date: ___________________________
This SOP ensures administrative processes align with CLSI QSEs to uphold the integrity
and reliability of hemoglobin testing.

Below are detailed examples and illustrations for each appendix referenced in the
Administrative SOP for Hemoglobin Testing, aligned with CLSI QSE guidelines. These
templates are designed to ensure clarity, compliance, and consistency in laboratory operations.

Appendix A: Organizational Chart

Provide sample chart

Appendix B: Training Log Template

Purpose: Track staff training, competency assessments, and continuing education.
Employee Training Date Training Competency Trainer Next Review
Name Topic Method Assessment Signature Date
(Pass/Fail)
John Doe Hb Testing 2023- Classroom Pass Jane Smith 2024-10-01
SOP 10-01 + Practical
Alice Lee Interference 2023- E-Learning Pass Mark 2024-10-05
Management 10-05 Brown
Scenario:
John Doe completed training on the hemoglobin testing SOP, including hands-on practice with
the Sysmex analyzer. His competency was assessed via a written test (score: 95%) and direct
observation of sample processing.

Appendix C: Vendor Qualification Form

Purpose: Evaluate and approve suppliers of Hb testing reagents/equipment.
Vendor Product / Service ISO Certification Delivery Technical Approval
Name (Yes/No) Reliability Support Status
(1–5) (1–5)
LabSupplie Drabkin’s Reagent Yes 4 3 Approved
s Inc.
MedTech Sysmex XN Yes 5 5 Approved
Corp. Analyzer
Scoring Criteria:
· Delivery Reliability: 1 (Poor) to 5 (Excellent).
· Technical Support: 1 (Unresponsive) to 5 (24/7 Support).
Scenario:
MedTech Corp. scored 5/5 for delivering the Sysmex analyzer on time and providing immediate
technical assistance during installation.

Appendix D: Equipment Maintenance Log

Purpose: Document preventive maintenance and calibration of Hb analyzers.
 Equipment Date Maintenance Performed Next Due Issues Signature
ID Type By Date Identified
Sysmex-XN- 2023-1 Calibration John Doe 2024-01- None John Doe
001 0-10 10
Centrifuge-0 2023-1 Cleaning Alice Lee 2023-11- Loose rotor Alice Lee
02 0-12 12
Scenario:
During monthly maintenance, Alice Lee identified a loose rotor in Centrifuge-002. The issue was
resolved before the next use.

Appendix E: Hb Testing Workflow Diagram

Purpose: Visualize end-to-end Hb testing process.
Workflow Steps:
1. Pre-Analytical:
o Patient ID verification → Sample collection (EDTA tube) → Labeling →
Transport to lab.
2. Analytical:
o Sample acceptance check → Load into analyzer → Run QC → Result
validation.
3. Post-Analytical:
o Report critical values → Archive data → Dispose of biohazard waste.
Visual Example:
[Insert flowchart created using software like Lucidchart or Microsoft Visio, showing arrows
connecting each step with decision points (e.g., "Sample rejected if hemolyzed").]

Appendix F: Non-Conformance Report Form

Purpose: Document deviations (e.g., QC failure, mislabeling).
Incident Date Description Root Corrective Effectiveness Closed By
ID Cause Action Check
NC-2023 2023-1 QC failure (Hb Expired Replaced QC passed on Jane Smith
-101 0-15 control = 14.8 g/dL reagent reagent; retest
vs. expected 15.5 batch retrained staff
g/dL)
Scenario:
A QC failure occurred due to an expired reagent. The batch was replaced, and staff were
retrained on reagent inventory checks.

Appendix G: QSE Audit Checklist

Purpose: Assess compliance with CLSI’s 12 Quality System Essentials.
QSE Audit Question Yes/No Comments Corrective
Category Action
 Personnel Are all staff competency Yes Annual N/A
records up to date? assessments
completed.
Equipment Is the Sysmex analyzer No Calibration Scheduled for
calibration documented? overdue by 5 2023-10-20
days.
Scenario:
An audit revealed overdue calibration for the Sysmex analyzer. The lab supervisor scheduled
immediate calibration and updated the maintenance log.

Key Notes for Implementation:

1. Customization: Tailor templates to your lab’s workflows (e.g., add/remove columns).
2. Digital Tools: Use LIMS (Laboratory Information Management System) for automated
logs and audit trails.
3. CLSI Alignment: Cross-reference with CLSI QSE guidelines (e.g., QMS01-A4 for
documents, GP26-A3 for risk management).