CURRENT SITUATION AND PROBLEM OF IQC AND EQC IN INDONESIA Tjan Sian Hwa Jakarta, Oct 29 2016

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

INTERNAL QUALITY CONTROL

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

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

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

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

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

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

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. 2012 Nov; 33(4): 133–139

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

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 www.westgard.com Country based specification: RCPA, Rilibak, Spanish, French Indonesia ???

SIGMA VERIFICATION OF PERFORMANCE www.westgard.com

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

EXTERNAL QUALITY ASSURANCE

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

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

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.

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“

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

IACP EQAS REPORTS HEMATOLOGY HAEMOSTASIS CHEMISTRY Index Deviation = X- mean participants SD SD = Chosen Coefficient of variation (CCV) BIAS INDEX DEVIATION 0.00-0.50 : very good 0.51-1.00 : good 1.01-2.00 : moderate 2.01-3.00 : 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 51-100 : good 101-200: moderate 201-300: poor 301-400 :very poor > 400 : unmeasurable

REPORTS

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)

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

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

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