CLASS 09

ERRORS IN A
MEDICAL
LABORATORY
WHAT IS
ERROR IN A
MEDICAL LAB?
Error is the difference between the true
result (or accepted true result) and the
measured result.
Failure of a planned action to be
completed can occur at any part of the
laboratory cycle from ordering
examinations to reporting results and
appropriately interpreting and reacting to
them.
The handling of the specimens is critical
to decreasing the error in the lab results.

Next Page: Types of Error

Classification of
Laboratory Errors

Pre- Analytical Error

Pre-Analytical Error

Analytical Error
Analytical Error
Post- Analytical Errors

Post- Analytical Error

Next Page: Pre- Analytical Error

 Pre- Analytical Error
These errors happen during the pre-analytical
phase of the laboratory testing process — from
the time a test is ordered until the sample is ready
for analysis.

1. Incorrect patient identification

2. Wrong test ordered or request form errors

3. Improper sample collection (e.g., wrong tube,

insufficient volume)

4. Incorrect labeling of specimens

5. Improper handling, storage, or transport (e.g.,

exposure to heat or delay in processing)

6. Poor patient preparation (e.g., not fasting when

required)

Why it matters:
Pre-analytical errors are estimated to account for 60–70% of total
laboratory errors, and they can lead to misdiagnosis, unnecessary
repeat testing, or delayed treatment.

Next Page: How Pre-analytical Error Can be Prevented

Prevention of
Pre- Analytical Error
1. Patient Preparation 5. Communication and Documentation
• Ensure the patient follows pre-test instructions (e.g., fasting, avoiding • Use a Laboratory Information System (LIS) or proper manual logs for
medications). traceability.
• Verify patient identity using at least two identifiers (e.g., name and id number). • Encourage clear communication between clinicians, nurses, and lab staff.
2. Test Requesting • Implement incident reporting systems for continuous improvement.
• Use standardized and complete request forms (electronic or paper). 6. Training and Quality Control
• Confirm that the correct test is ordered. • Provide regular training and competency assessments for all personnel.
• Avoid illegible handwriting or ambiguous abbreviations. • Conduct internal audits and quality checks on pre-analytical procedures.
3. Specimen Collection • Follow international guidelines (e.g., CLSI, ISO 15189).
• Train phlebotomists and staff properly on collection techniques.
• Use correct containers/tubes and observe proper order of draw.
• Ensure adequate sample volume is collected.
• Avoid hemolysis by using the correct needle size and gentle handling.
• Label specimens immediately at the bedside, not afterward.
4. Specimen Handling and Transport
• Maintain proper temperature and storage conditions.
• Minimize delays in transport to the lab.
• Use secure, leak-proof containers.
• Log and track specimens during transit.

Next Page: Analytical Error

Analytical Error
Analytical error is any inaccuracy or problem that
occurs during the measurement process in the
laboratory, leading to an incorrect test result.
Common Causes of Analytical Errors
Instrument malfunction or poor calibration
– Analyzer not properly maintained or calibrated.
Reagent issues
– Expired, contaminated, or improperly prepared reagents.
Operator (technician) error
– Incorrect pipetting, timing, or handling of samples.
Environmental factors
– Temperature, humidity, or electrical fluctuations affecting results.
Interfering substances in the specimen
– Hemolysis, lipemia, or icterus affecting measurement accuracy.
Improper quality control (QC)
– Failure to run or record control samples correctly.

Examples
Glucose analyzer not calibrated → inaccurate blood sugar
readings.
Wrong reagent lot used → erroneous electrolyte levels.
Contaminated pipe e → false infec on markers.

Next Page: How Prevent Analytical Errors

 Prevention of
Analytical Error
1. Use Quality Reagents and Calibrators 6. Proper Sample Handling During Analysis
Verify reagent integrity: Check expiration dates, storage conditions, and lot Avoid contamination: Use clean pipettes, avoid mix-ups, and change tips between
numbers. samples.
Standardize calibration: Use traceable reference materials and calibrate Maintain correct volumes: Follow test-specific pipetting requirements precisely.
instruments regularly. Monitor instrument carryover: Perform wash cycles or blanks between high-value
Lot-to-lot validation: Compare new reagent lots with old ones before switching. samples.
2. Maintain and Validate Equipment 7. Implement Laboratory Information Systems (LIS) Controls
Regular maintenance: Follow the manufacturer’s preventive maintenance Automated data capture: Reduce manual transcription errors.
schedule. Delta checks: Use historical data to flag improbable changes in patient results.
Instrument validation: Validate performance after installation, repair, or Barcode systems: Ensure correct sample identification throughout the analytical
relocation. process.
Environmental control: Maintain stable temperature, humidity, and power 8. Regular Auditing and Continuous Improvement
supply. Internal audits: Review QC logs, instrument records, and test reports.
Root cause analysis: Investigate all QC failures or result discrepancies thoroughly.
3. Implement Robust Quality Control (QC) Programs
Corrective and preventive actions (CAPA): Document and implement
Internal QC: Run control samples daily (or per batch) and document results.
improvements.
Westgard rules: Apply statistical QC rules to detect systematic or random errors.
9. Environmental and Safety Monitoring
External Quality Assessment (EQA): Participate in proficiency testing programs to
Monitor environmental conditions: Especially for temperature-sensitive analyzers
benchmark performance against other labs.
or reagents.
4. Ensure Competent and Trained Personnel Power backups: Use UPS or generators to prevent interruptions during analysis.
Training & certification: Staff should be trained on test principles, instrument Clean workspace: Prevent dust, moisture, or biological contamination.
operation, and troubleshooting.
10. Use of Automation and Error-Detection Technologies
Continuous education: Regular refresher courses on new methods, error
Auto-verification systems: Reduce human bias and detect outliers automatically.
recognition, and safety.
Instrument interfaces: Direct communication between analyzers and LIS
Competency assessment: Periodic evaluations and proficiency testing.
minimizes manual entry errors.
5. Standardize Analytical Procedures Regular software validation: Ensure analytical algorithms and instrument
Standard Operating Procedures (SOPs): Each test should have a clear, up-to-date firmware are updated and validated.
SOP.
Adhere strictly to methods: Avoid “shortcuts” or unapproved modifications.
Cross-checks: Have a second technologist verify critical steps in high-risk analyses.

Next Page: Post Analytical Error

 Post Analytical Errors
1. Incorrect Data Entry or Transcription
Typing or transferring wrong results into the Lab Information System (LIS) or report.
Confusing decimal points (e.g., 10.0 vs 1.00) or units (e.g., mg/dL vs mmol/L).
Manually copying data from instrument printouts incorrectly.

2. Failure to Review or Validate Results

Releasing abnormal or implausible results without verification.
Ignoring delta checks (sudden, unlikely changes compared to previous results).
Skipping manual review for critical or flagged results.

3. Delay in Reporting
Late result validation or transmission to clinicians.
Network or LIS communication failures delaying report delivery.
Poor workflow organization or backlog of unvalidated results.

4. Incorrect or Incomplete Reporting

Missing reference ranges, patient identifiers, or test units.
Mixing up patient reports.
Sending partial results or omitting comments (e.g., “sample hemolyzed,” “retest advised”).

5. Failure to Communicate Critical Results

Not informing clinicians of life-threatening or urgent results (e.g., very high potassium, glucose).
Inadequate documentation of when and to whom results were communicated.

6. Inappropriate Data Storage or Record Keeping

Loss of electronic or paper records due to poor backup systems.
Storing reports in unsecured or disorganized systems.
Violation of confidentiality (HIPAA, GDPR, etc.).

7. Interpretation Errors
Incorrect comments or clinical interpretations attached to results.
Lack of pathologist review for complex or abnormal findings.
Misuse of reference intervals for wrong age, sex, or method. Next Page: How to prevent
Post Analytical error
 Prevention of
Post Analytical Errors
1. Implement a Strong Validation Process 6. Regular Audits and Continuous Quality Improvement
All results should be reviewed by authorized personnel before release. Review report accuracy and turnaround time metrics.
Use auto-verification rules for normal results, but flag critical ones for manual review. Analyze incident reports for root causes.
Apply delta checks and biological plausibility checks. Implement corrective and preventive actions (CAPA).

2. Use a Reliable Laboratory Information System (LIS) 7. Ongoing Staff Training

Automate result transfer from instruments to LIS to avoid transcription errors. Train on result interpretation, LIS operation, and data security.
Ensure proper patient ID linkage using barcodes. Conduct competency assessments periodically.
Maintain system audit trails for accountability. Encourage double-checking before report release.

3. Standardize Result Reporting 8. Effective Communication with Clinicians

Use consistent units and reference intervals. Maintain clear communication channels (phone, email, LIS portal).
Include patient identifiers, sample type, and date/time of collection and release. Provide interpretive comments when relevant.
Clearly mark abnormal and critical values. Offer consultation for abnormal or ambiguous results.

4. Establish a Critical Result Policy

Define what constitutes a critical value for each test.
Set a standard procedure for immediate notification to clinicians (documented with
time, date, and recipient).
Train staff to escalate promptly.

5. Ensure Proper Record Keeping and Data Security

Maintain automatic data backups (daily or weekly).
Secure electronic storage with access control and encryption.
Retain records per legal and accreditation requirements (e.g., CAP, ISO 15189).
 THANK YOU
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