Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.

1. QUALITY CONTROL
IN CLINICAL LABORATORY
DR RAJESH V BENDRE
MD(PATH), DNB(PATH), DPB
CHIEF PATHOLOGIST, HEAD LABORATORY & BLOOD BANK SERVICES
JASLOK HOSPITAL & RESEARCH CENTER

2. Introduction- what is Quality?

3. INTRODUCTION- JOURNEY OF QUALITY MANAGEMENT SYSTEM - STANDARDS
ISO 15189: 2007 & 2012

4. NABL
INRODUCTION- JOURNEY OF QUALITY MANAGEMENT SYSTEM – Individual Lab

5. Introduction- Why Quality for Individual Lab?
Consequences of Poor Quality-
 Inappropriate action
 Over-investigation
 Over-treatment
 Mistreatment
 Inappropriate inaction
 Lack of investigation
 No treatment
 Delayed action
 Loss of credibility of
laboratory
 Legal action
Objectives of Quality-
Support provision of high
quality healthcare
 Reduce morbidity
 Reduce mortality
 Reduce economic loss
 Ensure credibility of lab
 Error proof & Generate
confidence in lab results
 Consistency
 Accuracy
 Precision
 Right result
 First time
 Every time
 Invisible when GOOD
 Impossible to ignore when BAD

6. Laboratory Errors

7. Laboratory Errors

8. Sample Collection
 Anticoagulant of choice 3.8% or 3.2% Sodium
Citrate?
 3.2 % Preferred as the standard measure due
to stability and closeness to the plasma
osmolality
 Anticoagulant/blood ratio is critical (1:9)
 CLSI guideline is +/- 10 % of fill line
 Order of Draw- special emphasis in collections post
blood culture
Sample transport-
Separated citrated plasma at 2 to 6^C – upto 24hrs for
PT but within 4hrs for aPTT & other coagulation assays
OR frozen, ensure that specimen is not in direct contact
with ice.
Pre-preanalytical variables- Coagulation

9. 9
21-May-2018 13:45
Cell Analyser- Daily Background Check
WBC 0.05 x 10^3/L PASS
RBC 0.00 x 10^6/L PASS
Hgb 0.00 x g/dl PASS
Plt 10.0 x 10^3/U FAILED
Pre-Analytical Example
Within Lab-
For Coagulation- Platelet Poor Plasma
• Recommended centrifugation to remove platelets to a count of
less than 10 x 10^9/L (10,000/µL).
For Automated Cell Counters
• Daily Instrument Function checks- Background Counts
Within Lab-
For Urine Chemistry(24hrs)-
• Recommended check for Urine PH &
appropriate correction before testing,
especially for Urinary calcium & Uric acid

10. ANALYTICAL- QUALITY CONTROL PROGRAMME

11.  It includes all QC methods which are performed every day by the laboratory personnel with the
laboratory’s materials and equipment. It checks primarily the precision (repeatability or
reproducibility) of the method.
INTERNAL QUALITY CONTROL
Test Calibration- Using company provided traceable
calibrators at defined frequency as per manufacturer & as
required following preventive maintenance or as part of
corrective action for IQC outlier
Control materials- are all the materials which can be used
for error detection in SQC methods.
• Control samples are pools of biological fluids (serum,
whole blood, urine or other materials) with known values
of analytes of interest.(Assayed controls)
• Guidelines recommendation to use Third Party Assayed
controls as far as possible.
• Before control samples are assayed for SQC methods,
each laboratory has to estimate their own control limits.
(Lab Mean & Lab SD)
• To Increase the stability of controls – they are lyophilized,
requiring reconstitution with diluent water (HPLC grade,
sterile), alliquoted & frozen(as applicable)
Instrument Calibration-
• For Analytical instruments- Use company
provided defined protocols & frequency
• For Non-Analytical instruments- like centrifuge &
pipettes- the frequency should twice yearly or more
as defined by laboratory
Instrument Maintenance-
Using company provided defined protocols &
frequency
Maintain log for daily, weekly, monthly instrument
function checks & periodic preventive maintenance as
per company defined protocol.
Guideline recommendations for Instrument Labels
mentioning- date of installation, date of calibration
(performed & due), date of preventive maintenance
(performed & due)

12. INTERNAL QUALITY CONTROL

13. INTERNAL QUALITY CONTROL
• Patient Data as Alternate Quality Control-
- Correlation of test results Across patients-
- Trends in patient results
- Average of Normal
- Correlation of test results within same patient
- With clinical findings eg- ammonia levels
with altered sensorium
- With Other tests eg- BUN & creatinine
- With same test but alternate method eg-
Infectious Serology, Tumour markers
- Delta check- Reference Change Value (RCV) for
chemistry & immunoassay analytes based on
equation: RCV = 2½ × Z × [CVA
2 + CVI
2]½ where
Z=1.96, CVA is Analytical variance ,
CVI is intra-individual biological variance

14. Choice of External Quality Control Programme-
ISO 17043
• Accreditation of the PT provider
• Adequate PT event frequency and number of
samples
• Clinically relevant targets used in the PT
samples
• Faster PT results delivered.
• PT sample/analyte stability- liquid based /
lyophilised
• PT evaluation, often uses peer group means
which fails to identify systematic bias, in
cases with several instruments or methods,
which can have substantial implications for
quality of results & patient care.
Idealistic- Accuracy Based Surveys
• Cost effective

15.  PT samples must be tested along with the laboratory's regular patient sample.
 PT samples must be tested the same number of times that patients' samples
are tested routinely.
 Laboratories should not send PT samples to another laboratory for analysis.
 Laboratories must document all steps of processing for PT samples.
The NABL/CAP/NABH/JCI standards for handling proficiency testing
specimens are as follows:

16.  Quantification of the analytical performance of each participant is done by using Scoring methods which
converts participant’s raw result into a standard form that adds judgemental information about performance.
 The Z score or Standard deviation Index(SDI) are frequently advised as such performance indicators. When
the distribution of results of participating labs is Gaussian, classical Z Score – same as SDI .
PT Evaluation - Statistics
Interpretation – SDI or Z score
Value 0.0, Excellent, there is no difference between the laboratory mean and the consensus group mean.
Any value < 2 is considered Satisfactory performance.
Any value 2.0 or greater, is Questionable & deserves some special concern, shows a systematic drift & in near future, this bias
might lead to unacceptable results.
Any value > 3 is Unacceptable result.

17. Step wise approach to resolve "Proficiency Testing" failure in clinical laboratory –
Step 1: Look for clerical, computer entry, or scanning errors
Step 2: Review Specimen Handling
Step 3: Review Testing Process
Step 4: Evaluate Test Kit/Instrument Performance
Step 5: Review Internal Quality Control
Step 6: Retesting of PT samples, depending on analyte stability or
perform interlaboratory comparison with patient samples
Step 7: Note Number of Samples Failing and any Patterns of
Failure- positive or negative trend.
PT Failure Evaluation – Algorithm -1

18. PT Failure Evaluation – Algorithm- 2 CAP-SDI

19. Source: CLSI EP-23A.
Root Cause Analysis for PT Outlier

20. PT Outlier Investigation Form - 1 Proficiency Testing Approved Guideline GP 27-A Aug1999 NCCLS

21. PT Outlier Investigation Form - 2

22. Unsatisfactory Analytical Performance
 About 75% can be attributable to Random Error
(instability of analytical system) (50%) or
Systematic Error (calibration drift or bias near
limits of reportable range) (25%)
 While 25% of the investigations often are
Indeterminate, which further can be subcategorized
as inherent method bias (14%) or as event with no
explanation(11%).
PT Failure- Reasons
Detection of Laboratory Problems by Proficiency Testing, Hoeltge et al, Arch Pathol Lab Med;Vol 129, Feb 2005

23. Proficiency Testing Monitoring by Accreditation Program

24. • Today’s competitive environment
leaves no room for error. This is why
six sigma quality must be a part of our
culture.
• What is six sigma- It is a process that
helps us focus on developing and
delivering near perfect products and
services.
• Sigma = (Tea – bias)/cv
Tea = tolerable error or allowable total
error (determined by CLIA, Ricos-2014)
Bias = inaccuracy, CV= imprecision
Six Sigma metrics- For Analytical Performance

25. Chemistry
Test or Analyte
CLIAAcceptable
Performance
Five-Sigma
Precision
Six-Sigma
Precision
Glucose
6 mg/dL
or 10% (greater)
1.2 mg/dL
or 2.0%
1.0 mg/dL
or 1.7%
Iron, total 20% 4.0% 3.3%
LDH 20% 4.0% 3.3%
Magnesium 25% 5.0% 4.2%
Potassium 0.5 mmol/L 0.1 mmol/L 0.08 mmol/L
Sodium 4 mmol/L 0.8 mmol/L 0.67 mmol/L
Total protein 10% 2.0% 1.7%
Urea Nitrogen
2 mg/dL
or 9% (greater)
0.4 mg/dL
or 1.8%
0.33 mg/dL
or 1.5%
Uric acid 17% 3.4% 2.8%
Six Sigma Performance Goals

26. Hematology Test or Analyte
Test or Analyte
CLIA
Acceptable
Performance
Five-
Sigma
Precision
Six-Sigma
Precision
Erythrocyte count 6% 1.2% 1.0%
Hematocrit 6% 1.2% 1.0%
Hemoglobin 7% 1.4% 1.2%
Leukocyte count 15% 3.0% 2.5%
Platelet count 25% 5.0% 4.2%
Fibrinogen 25% 5.0% 4.2%
Partial thromboplastin time 15% 3.0% 2.5%
Prothrombin time 15% 3.0% 2.5%
Six Sigma Performance Goals

27.  Manufacturer controlled- are
letter or symbol that appears to tag
the result.
 Aspiration,
 Linearity
 LOD
 Interference
27
Post Analytical Phase-
Laboratory controlled
Critical ranges
Decision rules for retest,
alternate / other tests
 Reportable ranges
Interpretative Medical Remarks
 Advisory comments for further
workup or confirmatory tests
• Flags-
• Report the above accurately generated result in a timely manner by:
Using an electronic process allowing for acceptable results to be transmitted electronically via an
‘interface’ between the analyzer and lab information system(LIS) and then via another ‘interface’
between the LIS to the clinician / EMR / MRD / patient.

28. Post Analytical Example –Instrument Flags
 Laboratory Results
 WBC - 8,900/uL
 RBC - 4,460,000/uL
 Hgb -13.4 g/dl
 HCT- 40.7%
 Platelets - 56,000/ul
 MCV - 91.1.1fl
 MCH - 29.9pg
 MCHC - 32.8g/dl
 RDW - 23.1%
 Instrument Differential
 Neutrophil % - 52.5%
 Lymphocyte % - 35.2%
 Monocyte % - 10.4%
 Eosinophil % - 1.4%
 Basophil % - 0.5%
 Flags
 WBC interference (*)
 Micro/Fragmented RBC
 Giant Platelets
 R (Review)-code on Platelets
 Platelet Clumps

29.  Laboratory Results
 WBC - 8,500/uL
 RBC - 4,870,000/uL
 Hgb - 16.4 g/dl
 HCT - 43.5%
 Platelets - 356,000/ul
 MCV - 89.5 fl
 MCH - 23.6 pg
 MCHC - 37.7 g/dl
 RDW -12.5%
 Instrument Differential
 Neutrophil% - 60.9%
 Lymphocyte % - 28.7%
 Monocyte % - 8.2%
 Eosinophil% - 2.0%
 Basophil% - 0.2%
 Flags
 H-H difference check
 Alert (aH) on the MCHC
Post Analytical Example –Instrument Flags

30. Implementation of Total Quality Management
 There is no single approach to the implementation of TQM.
 Oakland Model that is based on-
Three Cs (culture, communication and commitment) &
Four Ps, which are:
 Planning: The development and deployment of policies and
strategies; setting up appropriate partnerships and resources; and
designing in quality.
 Performance: Establishing a performance measurement
framework; carrying out self-assessment, audits, reviews and
benchmarking.
 Processes: Understanding, management, design and redesign;
quality management systems; continuous improvement.
 People: Managing the human resources; culture change;
teamwork; communications; innovation and learning.
Each organization needs to develop a programme that is suited to its
own needs, taking into account its stage of organizational
development, resources available, organizational culture, and
customer requirements.
Quality System Elements-
PDCA Model -Deming
PLAN
Quality officer
Quality manual
DO
Standard operating procedures (SOP's)
Management of documents
Infrastructural requirements
Human resources requirements
Equipment requirements
Reagents & standards requirements
CHECK
Quality Indicators
Internal audit
External audit
ADJUST
Remedial actions (CAPA)

31. 31
Continuing
Education
Training
Job
Descriptions
Orientation
Competency
Assessment
Job
Qualifications
Personnel
Management

32. Orientation
Competency Assessment
Task-specific Training
Competency Recognition
Job Description
Qualified Technician/Doctor
Retraining
6monthly
for 1st year
& atleast
Annually
thereafter for all

33. Competency Assessment Methods
 Direct Observation
 checklists
 Indirect Observations
 monitoring records
 re-testing
 case studies
 Give previously analyzed specimens for
testing
 Provide written exercises to assess:
• Problem solving skills
• Knowledge
• Interpretation
Technologist Name Technologist Title
Procedure for
Evaluation
Evaluation Date Evaluator
Procedure item Accept Partial No Comment
Read procedure
manual
Equipment set up
appropriately
Work area neat
Reagent preparation
Perform task
accurately
Perform task timely
Other: Specify

34. QUALITY AS LAB CULTURE- IS A REPORTING CULTURE-
As Quality Journey Continues……
Blame Culture Just Culture
Focus on Fault
Finding exercise
Focus on Process
& system
improvement
Lack/poor Quality
awareness at all
levels
Improved Quality
awareness at all
levels
Reactive Proactive
Decentrailized
quality leadership
centrailized
quality leadership
High COPQ Low COPQ
Compliance
Focussed
Best Practice
Focussed
Lab Centric Clinician/Patient
centric

35. QUALITY INDICATORS
 As stated by the ISO 15189:2012, Technical Requirements-
“The laboratory shall establish QIs to monitor and evaluate performance
throughout critical aspects of pre-examination, examination and post examination
processes”
 The Working Group on Laboratory Errors and Patient Safety (WG-LEPS) of the
International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
developed consensus QI (2014, 2017)-
 Testing process- 53 QIs - 28 preanalytical , 6 analytical & 11 postanalytical phases.
 Support process- 5 QIs – 2 Employee competence, 2 clinical relationship, 1
Laboratory Information system
 Outcome measures- 3 QIs

36. QUALITY INDICATORS LABORATORY Bench Mark
TESTING PROCESS-
Pre Analytical Misidentification errors
Incorrect sample type
Incorrect sample quality- hemolysed, clotted,contaminated(Microbiology)
Inappropriate time in sample collection
0.08%
0.05%
1-2%
0.05%
Analytical Test with inappropriate/outlier IQC performances
Test uncovered by an EQA-PT control Performances
Unacceptable performances in EQA-PT schemes
2-3%
RCA compliance100%
RCA compliance 100%
Post Analytical Data transcription errors
Notification of critical values
Interpretative comments
Inappropriate turnaround times
0.02%
Time- within15mins 100%
Testwise compliance 100%
Testwise TAT compliance 95%
SUPPORT PROCESS-
Employee competence Training followed by competency assessment as per schedule 100%
Customer Satisfaction Surveys for both clinicians & patients RCA 100%
LIMS/IT Efficacy System Downtime, Interface errors No unplanned events
OUTCOME MEASURES-
Sample recollection Total including lab & clinician/patient reasons 2%
Incorrect laboratory reports Total including lab & clinician/patient reasons RCA compliance 100%

37. THANK YOU