1. CURRENT SITUATION AND PROBLEM OF IQC AND EQC IN INDONESIA
Tjan Sian Hwa
Jakarta, Oct

2. CLINICAL LABORATORY PRACTICE IN INDONESIA
Clinical Laboratories in Indonesia are heterogen in
Size
Complexity
Personil Competency
Quality Awareness
Harmonization obstacles :
EQAS:
Local : only 2x/ year and limited parameter
International / Third party: Expensive, Material Transfer Agreement Regulation
Heterogenity in Instrument, reagent and method
Inavailability of Quality Standard

3. INTERNAL QUALITY CONTROL

4. INTERNAL QUALITY CONTROL BEST PRACTICE
THIRD PARTY CONTROL
SIMILAR MATRIX AND CLINICALLY SIGNIFICANT RANGE
ASSAYED PARAMETER
CALCULATE LAB’S OWN MEAN AND SD
IQC RULES WITH HIGH ERROR DETECTION AND LOW FALSE REJECTION
COST EFFECTIVENESS
ANALYSIS AND TROUBLE SHOOTING AND CORRECTIVE ACTION

5. INTERNAL QUALITY CONTROL QC MATERIAL
BEST PRACTICE : THIRD PARTY QC MATERIAL
CURRENT PRACTICE : manufacture QC material
CHALLENGES :
MANUFACTURE :
Difficulty in detecting calibrator or reagent missproduct
THIRD PARTY :
No peer group
No specific range for the method used
Not real time comparison
After sales service

6. INTERNAL QUALITY CONTROL
BEST PRACTICE : CALCULATE LAB’S OWN MEAN AND SD
CURRENT PRACTICE: use manufacture mean and SD
CHALLENGES:
Frequent lot variation/changes  Hematology, Haemostasis, Immunology
Methods : rule in outliers or not

7. INTERNAL QUALITY CONTROL FREQUENCY
BEST PRACTICE : min 2 level, frequency based on individual parameter
CURRENT PRACTICE : daily, 1-3 levels

8. IQC RULES IDEAL IQC RULES : high error detection, low false rejetion
cost effective
BEST PRACTICE : Westgard Multi level rules with sigma metric
CURRENT PRACTICE :
Manufactures range
2SD
Westgard 1 level rules
Westgard multilevel rules
Sigma metric

9. IQC : SIGMA METRICS CHALLENGES : WHICH TEA  COMPARABILITY
CALCULATION OF BIAS (reference material, manufacture kit insert mean,manufacture peer group QC, independent EQAS)
AVAILABILITY OF SUITABLE EQAS ( frequency , analyte level)
PEER GROUP ( small populations)
METHOD PERFORMANCE
QC rules for multi level control

10. Analytical Quality Specifications Stockholm Consensus
Agreement of hierarchy of models should be applied to set analytical quality specifications:
I. Evaluation of the effect of analytical performance on clinical outcomes in specific clinical settings
II. Evaluation of the effect of analytical performance on clinical decisions in general:
A. data based on components of biological variation B. data based on analysis of clinicians' opinions
III. Published professional recommendations
A. from national and international expert bodies B. from expert local groups or individuals
IV. Performance goals set by
A. regulatory bodies B. organisers of External Quality Assessment (EQA) schemes
V. Goals based on the current state of the art
A. as demonstrated by data from EQA or Proficiency Testing schemes B. as found in current publications on methodology.
Where available, and when appropriate for the intended purpose, models higher in the hierarchy are to be preferred to those at lower levels.
Clin Biochem Rev Nov; 33(4): 133–139

11. ANALYTICAL QUALITY SPECIFICATION:
Based on effect of analytical performance on clinical outcome / classification
Based on components of biological variation of the measurand
Time intervals, steady state, effect of current illnesses and measurand concentration
Based on state of the art
Highest level of technically achievable

12. QUALITY SPECIFICATION :”LIPID”
CLIA Requirements for Analytical Quality
NCEP Laboratory Standardization Panel and the Working Group on Lipoprotein Measurement
TE (%)
CV (%)
Bias (%)
Total Cholesterol 9 3
Triglyceride 15 5
LDL Cholesterol 12 4
HDL Cholesterol 13
Dr. Carmen Ricos ( 2014)
TE (%)
CV (%)
Bias (%)
Total Cholesterol
9.01
2.98
4.1
Triglyceride
25.99
9.95
9.57
LDL Cholesterol
11.9
3.9
5.46
HDL Cholesterol
11.63
3.65
5.61
Country based specification: RCPA, Rilibak, Spanish, French
Indonesia ???

13. SIGMA VERIFICATION OF PERFORMANCE www.westgard.com

14. SIGMA METRIC ANALYSIS Oct 2016 , Sten Westgard MS www.westgard.com
Traceability, method

15. EXTERNAL QUALITY ASSURANCE

16. FIVE PILLARS OF LABORATORY STANDARDIZATION
reference materials
reference methods
reference laboratories
traceable reference intervals and decision points
external quality assurance (EQA)

17. EXTERNAL QUALITY ASSURANCE SCHEME/ PROFICIENCY TESTING
A program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others. (CLSI GP27-A2 27:8)
....a system of objectively checking laboratory results by means of an external agency... (WHO)
Tools to evaluate and improve analytical performance
Detect equipment faults, identify reagent problems and review staff training
Tool to evaluate methode / instrument performance
Harmonization of different analytical method
Regulatory requirement

18. ISO15189:2012
The laboratory shall participate in inter-laboratory comparisons such as those organised by external quality assessment schemes. Laboratory management shall monitor the results of external quality assessment and participate in the implementation of corrective actions when control criteria are not fulfilled.
EQA should, as far as possible, cover the entire range of tests, and the entire examination process, from sample reception, preparation and analysis to interpretation and reporting.

19. CHOOSING EQAS VENDOR Number of Participants :
Coverage of participants :International, National, Regional,
Parameter/ Menu
Peer Group
Matrix similar to patient sample and stable
Frequency
Analyte Clinically important level
Education and Support
Reports: rapid, detailed and informative
Accredited to ISO/IEC 17043:2010 "Conformity assessment–General requirements for proficiency testing“

20. REPORTS IN EXTERNAL QUALITY ASSURANCE
-What targets are used:
-median of all returned data or of the relevant method groups;
-reference measurements performed on the samples;
- comparison with reference materials; or
-weighed in values for substances such as drugs.
How is the result compared : to all participant, to same instrument, to same
method?
What quality standards : bias and imprecision, SDI, VIS, Ratio to median
How are data expressed: text, histogram, graph etc
What information can we get

21. IACP EQAS REPORTS HEMATOLOGY HAEMOSTASIS CHEMISTRY
Index Deviation = X- mean participants SD
SD = Chosen Coefficient of variation (CCV)
BIAS
INDEX DEVIATION
: very good
: good
: moderate
: need attention
> 3.00 : need instant attention CV
Ratio to median
Ratio Median
To all participants
To reagent group
Bias SD CV
VIS
0-50 : very good
: good
: moderate
: poor
:very poor
> : unmeasurable

22. REPORTS

23. CHALLENGES Availability of test parameters Frequency of EQAS
Duration of EQAs report
Standardization in reports and quality assessment
Low population for instrument or method
Interference
Open system
Traceability ( immunology, hormones)

24. SUMMARY IQC and EQA are important part of quality assurance
IQC and EQA are complimentary
Choose the right IQC Rules to increase error detection, decrease false rejection and cost effectiveness
Choose the suitable EQAS provider
Quality Control will give benefit to laboratory quality and patient safety if result are analysis, trouble shoot and action taken
Quality Control is a Never Ending Act of improvement

27. CHEMISTRY % VARIASI = V= (X-nilai target) x 100 Nilai target
VI = V x 100
CCV
VIS = VI , max 400
OVIS = mean VIS

28. What affect your EQAS result
Reagent
Control material
Calibrator : reference material
Process
Instrument
Software
Transcription error
Man