LOGO. Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University & Thai Society of Clinical Pathology

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1 LOGO Improvement of Coagulation Lab Practice in Thailand via Thailand NEQAS for Blood Coagulation : 4-year Experience Nisarat Opartkiattikul MD,PhD Panutsaya Tientadakul, MD. Department of Clinical Pathology, Faculty of Medicine, Mahidol University & Thai Society of Clinical Pathology

2 Background Department of Clinical Pathology, Faculty of Medicine,, Mahidol University has been a member of WHO International External Quality Assessment Scheme for Blood Coagulation (WHO IEQAS) for > 30 years Encourage participants to set up NEQAS within their own country, where not already initiated

3 Our lab has been accredited by ISO since March 2005

4 A Survey of Coagulation Laboratory Practice in Thailand: the First Step to Establish a National External Quality Assessment Scheme (NEQAS) for Blood Coagulation J Med Assoc Thai 2007; 90 (12):

5 Survey Results (May 2005) 112 out of 220 hospitals responded 43 labs still using 3.8% sodium citrate 73 labs still reported normal control with patients results Only 47 labs established their own reference range Sources of denominators used for calculation of PT/INR & APTT ratio not derived from healthy population Only 7 labs participated EQA (AQUAS,UK NEQAS)

6 Objective of Thailand NEQAS for Blood Coagulation To test the competence of individual laboratory by analysis of the degree of agreement between one laboratory s results and other participants. To EDUCATE and HELP To improve laboratory performance and finally optimal patient care.

7 Thailand NEQAS for Blood Coagulation Scope of Test : PT, PT/INR, APTT, APTT ratio Survey material : commercial control plasma, Stability check for 20 & 30 days at 2-8 o C and non-air conditioned 1 st -2 nd year : artificial plasma 3 rd year : artificial & patients plasma 4 th year : patients plasma only Distribution : 4 times/year by express mail (March, June, September, December) 3 samples (1 normal, 2 abnormal) Member fee : 2000 bath (60 US) Result submit : registration letter, Fax, Evaluation : Derived from WHO IEQAS

8 Thailand NEQAS Data Entry Recheck Members perform tests Distribute survey samples Overall Data %deviation (Consensus) median Basic std criteria? Overall median within ±15% outwith Upto 10 or more? Reagent specific

9 Basic standard criteria Establish their own reference range & mean (at least 20 fresh normal plasmas) Preston FE: Quality control and oral anticoagulation, Thrombosis & Haemostasis. 74(1):515-20, 1995 Jul.

10 Example of Report (adopted from WHO) Sample Number 7/07 8/07 9/07 Your result of PT (Secs) Your normal range (lower upper) Your INR Median Your % deviation Your assessment against reagent reagent reagent Your performance (Consensus) within within within Your interpretation abnormal abnormal abnormal Overall interpretation Normal Borderline Abnormal

11 Education Comment for possible of errors Instruction sheet Cooperate with GAP program of WFH to organize workshop Direct communication by phone,

12 Education : Comment for possible of errors Suspected systemic error 2/3 outwith Positive/ negative bias Pre-analytic problem: dilution error Matrix effect, calculation error Not appropriate reference range Not appropriate denominator

13 Education Instruction sheet Recommend appropriate conc. of citrate, ISI How to establish reference range, denominators for PT & APTT

14 Education Cooperate with GAP program of WFH to organize workshop Quality Improvement of Laboratory Investigation for Bleeding Disorders since times / year Labs from all over country Lec & wet workshop

15 Education Direct communication eg. Appropriate use of bleeding time, Thrombin Time How to establish reference range Lab result not correlate with clinical

16 Questionnaire To observe any improvement Questionnaires were sent to our members Once a year

17 Results Number of members Response rate Quality improvement

18 Number of members Hospital size (total number) University hospital (12) Regional hospital (25) Provincial hospital (70) Private hospital (298) Public hospital in Bangkok (24) Total

19 Response rate No. of survey No. of Participants No. of responses Response rate(%) 1(trial) (trial)

20 Response rate

21 Certificate of Participation For 100% response 2006 : 98 labs 2007 : 107 labs 2008 : 113 labs

22 Opportunity for Improvement Pre-analytical phase Analytical phase Post-analytical phase

23 Arch Pathol Lab Med Vol 133, January 2009

24 Quality Improvement : Pre-analytic Number of lab that use 3.2% sodium citrate 2005 : 69/ : 99/ : 111/ : 148/148

25 Quality Improvement Number of labs that establish their own reference range (data from the beginning survey of each year) Number of Particip pants responder establish ref range do every change of lot 0 1 (trial) 3 (first) 7 (second) 11 (third) 15 (fourth) Number of Survey

26 Number of control plasmas performed in the lab N=119 42, 35% Sep 07 1, 1% , 64% 58, 39% 2, 1% March 09 2, 1% N=148 86, 59% NO IQC 1 level 2 level 3 level

27 Quality Improvement : Analytical Performance Characteristic indicated by All-method Coefficient of Variation (CV) High precision : <11% Intermediate : % Low : 21-30% Cunningham MT, Brandt JT, Chandler WL et al. Quality assurance in hemostasis: the perspective from the College of American Pathologists proficiency testing program. Semin Thromb Hemost. 2007;33:250-8.

28 QI : Precision CV : Normal control normal PT/INR % 15 High precision survey 1 survey 2 survey 3 survey 4 survey 5 survey 6 survey 7 survey 8 survey 10

29 QI : Precision CV : Normal control % survey 1 survey 2 survey 3 survey 4 normal APTT High precision survey 5 survey 6 survey 7 survey 8 survey 10

30 QI : Precision CV : Abnormal control abnormal PT (INR ~ 3) Intermediate precision % Survey.sample

31 QI : Precision CV : Abnormal control 15 % 10 5 abnormal APTT, test/normal ratio ~ Intermediate precision Survey.sample

32 Summary 4 year old Thailand NEQAS 168 Members : Almost all of large labs Improvement of lab coag. practice

33 Future plan Website : submit results Ask for ISO accreditation Extend scope : POCT of diabetic care

34 LOGO