u. charoonruangrit md. deputy director national blood center, thai red cross society

U. Charoonruangrit MD.Deputy DirectorNational Blood Center, Thai Red Cross Society

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Thailand Experience on Haemovigilance: HIS Brussels, 20-22 Feb 2013

General Country InformationArea:514,000 square kilometers lie in the middle of mainland Southeast Asia.WHO SEAR countries: 11 Member States: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, Timor-Leste.Economy*: Income level: Upper middle incomeGDP = 373.3 bil.USD [2012F] GDP per capita = 5497.3 bil.USD [2012F] Population: 201165.9 millionDensity 132.1/km2F = 51%, M = 49%Age eligible donor [17-60yr] about 65%

** NESDB Economic Outlook, May 2012;Bank of Thailands Monthly Report 31 May 2012, for April 2012.Division of Economic Information Department of International Economic Affairs

Age yr0-1415-59>60Total 10019.5%67.5%13.0%

Thailand Report: WHO Global Consultation on Haemovigilance 20-22 Nov 2012 Dubai, UAE


Blood Services in ThailandNational Blood Center BKK (TRC)VNRBDCore Area :running the National Blood Program as designated by the Royal Thai Government to the Thai Red Cross National Blood Centre. Vision : Procuring adequate and quality blood supply according to international standards at the excellent regional level.

*National Blood Center , Head Quarter Bangkok



Blood Services in ThailandRegional Red Cross Chapter (TRC)Donor recruitment activities 12 Regional Blood centers (TRC)Central lab testing by standard WHO serological IDMs8 of 12 Regional Blood Centers start blood collection VNRBD in 20088 NAT regional centersGovernment Hospitals :6 Branches in BKK and 157 Provincial HospitalsVNRBDFamily /replacement donation in the hospitals


Blood Services in Thailand65,900,000 populationAround 1,800,000 WB collection per year for the whole country Over all 2% of AE population donated blood100% testing by mandatory WHO serological IDMs Nearly 80% NAT testing [project to 100% by Policy]>90% blood components preparationNo paid blood donationNo private blood collection center

*Phuket Regional Blood Centerat Phuket Province


*Blood donationBlood components prepDonor blood testing labStandard Reagents preparationHLA Stem cell/Cord blood labPlasma fractionation plantMobile blood driveInventory and distribution



Whole country Blood collection*



National Blood Policy 2010 Correlation to HaemovigilancePurpose 3To provide safe blood for patients in accordance with the principles of the World Health Organization by recruiting blood donations from a low-risk group of population, screening blood donors, testing all units of blood with standard and conducting a compatibility test for ensuring the safe transfusionPurpose 4To provide the effective blood services in every process at all levels Purpose 5To appropriately utilize blood with common procedure and standard

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National Blood Policy 2010: Purpose 3To provide safe blood for patients in accordance with the principles of the World Health Organization by recruiting the blood from a low-risk group of population, screening blood donors, testing all units of blood with standard and conducting a compatibility test for ensuring the safe transfusionIndicator: The ratio of infectious patients from a transfusion and the ratio of the patients who receives wrong blood groupThe hospitals are responsible for reporting the complication through the blood donation and the complication through the blood transfusion at the blood service center as the country database;

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National Blood Policy 2010: Purpose 4 To provide the effective blood services in every process at all levelsIndicator: The percentage of the blood services units accredited by the quality assurance system The National Blood Center, in cooperation with professional organizations and experts, is responsible for setting the standard, guidelines and the manual including arranging the training courses and the assessment for ensuring all processes of blood services with quality as follows:Recruiting and Drawing Laboratory Testing Components SegregatingStoring Distributing and Transferring

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National Blood Policy 2010: Purpose 5 To appropriately utilize the blood with common procedure and standardIndicator: The ratio of compatibility test against the actual blood usage and the ratio of using the blood components Setting the information technology system for all blood services units in order to monitoring against the blood usage indicator in all hospitals*



Development of blood screening*



By 2002*



*



2009-2012*



Research and StudyPerformance Evaluation Blood bank Elecsys HBsAg II Elecsys Anti-HCV II Elecsys HIV combi PT on Elecsys e.Performance Evaluation of Cobas Taq Screen MPX Test version 2.0 Study on Prevalence of HTLVI&II among blood donors in ThailandComparison of the Syphilis Serology Test between Elecsys Syphilis on Elecsys cobas e and Architect Syphilis TP on Architect i6000 for Blood Donor Screening*



% of positive TTI in blood collections : Whole country 2007 - 2011*


Safety Measures*Blood donorsDonated bloodBlood and blood components for transfusionDonor care, counselingMedical InstitutesSource plasmaFor HBIG, HRIG

Recovered plasma for albumin , HTFDCPooled plasmaPlasma productsVNRBD, promotion health education,donor self selection,Interview, History, data baseHealth checking, Hb testInitial flow diversion 70%Serological test 100%NAT 80% (target to 100%)Leukocyte reduction 80%Inventory hold =>3 mthHeat inactivationNano filtration on studyingQC and national assayRepository samples => 1 yrsAdverse reaction/infectious reportLook back studyPost donation information, problemsNational Blood Policy 2010,Standard for Blood Bank and Transfusion Services,Donor Selection guidelines,Physician Handbook for Appropriate use of Blood and Blood Components



National Blood Center Haemovigilance system2001-2008Initiated by NBC Reported incidence since 2001-2008 Reporting system: voluntary filled out questionnaires with response rate of 20-40%, data was annually collected and analyzedScope: mainly on adverse effect of the blood recipientsReporting categoriesTx of ABO incompatibleAcute hemolysisDeadDHTRNear miss incidenceTx of TTI positive unit by errorPost Tx infectionThe program was discontinued

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SUMMARY OF SHOT 2001 2004 P.Chiewsilp et.al. National Blood Center TRCs*Post transfusion infection by blood in window period. (all units were negative for anti-HIV, HIV-Ag, anti-HCV and HBsAg)

Total units transfused (WB and blood components)= 1,416,520



SUMMARY OF SHOT 2005 2008 P.Chiewsilp et.al. National Blood Center TRCs*Post transfusion infection by blood in window period. (all units were negative for anti-HIV, HIV-Ag, anti-HCV and HBsAg)



SUMMARY OF SHOT 2005 2008 P.Chiewsilp et.al. National Blood Center TRCs*



Donor vigilance Aug-Nov 2011 P.Chiewsilp et.al. National Blood Center TRCsCharacteristics of Blood DonorsResponders: Total 2,789/12,000= 23.24%Female 1479= 12.33%Age 17-65 yrsMale 1310= 10.92%Age 18-65 yrsDonation times= 1-389 [ including hemapheresis]

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*Donor vigilance Aug-Nov 2011 P.Chiewsilpet.al. National Blood Center TRCs















Observation and recommendation*



Forcing to re-try HV

Establish haemovigilance systems for improved blood safetyProvide guidelines, tools and technical support for the establishment of national haemovigilance systems.Foster and support the creation of a Global Haemovigilance, Surveillance and Alert Network

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Workshop on HaemovigilanceMarch 2011 Richmond Hotel, NonthaburiNational Blood Center TRCDr. P. Flanagan, NZ Blood Service, Auckland23 Members from: NBC, Hospital Blood bank Directors, Universities, PhysiciansInternational Standards and network for HVNZ model, Thai HV experienceGroup work*



Key to achieve National HV*



International perspectives on HV: WHODraft Aide-Memoire for Ministry of Health (MOH)*



Core components of a national HV system*



2012: HV Committee*



Action plan for HV*



Proportion and number of hospitals in the country*



Plan Capture data target groups*



Thank youDr J.C. FaberDr Neelam DhingraDr P. FlanaganIHS SponsorWHO consultation Members HV Seminar in DubaiNational Blood Center staffDr Soisaang PhikulsodDr Phimol Chiewsilp

Thank you for your attention

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Good Afternoon , distinguish delegates

I am very please to be invited to the 15th International Hemovigilance Seminar and thank you for giving opportunity to present Thailand Experience in Implementing Haemovigilance.*Here is the general information of Thailand.

It is in the middle of the mainland of Southeast Asia occupying 5 hundred and 14 thousand square kilometers and has been one of the 11 members states of World Health Organization Southeast Asia Region.

Thailand economy is classified as a level of upper middle income with GDP per capita of 5 thousand 4 hundred and 97 billion USD by 2012

The population is about 65.9 million , the population density is around one 132 people per square kilometer. Females are some more than males. This data show the percentage of population structure by age which estimates population of age eligible blood donor from 17 to 60 yr are about 65%

*National Blood Centre (NBC), the Thai Red Cross Society was established in 1969 with its mission designated by the Royal Thai Government to run national blood program in procuring safe, adequate blood supply for the country use.

National Blood Center HQ located in Bangkok mainly activities are donor recruitment, blood collection from VNRBD, laboratory blood processing, preparing the blood components, inventory and delivery , quality management and training both for the delegates in the country and from abroad. So it was designated by World Health Organization as The Collaborating Centre for Training in Blood Transfusion Medicine since 2004

It is also responsible for National Stem cell Registry and HLA lab testing to provide unrelated stem cells for transplantation to the hematologic patients.For production side NBC has its own blood bag factory, anti-sera and red cell reagents production and a small scale plasma fractionation plant.

*Thailand has 76 provinces .In each province The Regional Red Cross Chapter under Thai Red Cross takes responsibility to run donor recruitment activities .

In order to standardize laboratory testing system to ensure blood safety for the patients in rural areas, 12 Regional Blood Centers were set up nationwide as shown in this map. Now 8 from 12 RBC collected blood also.

8 of RBC which located in most appropriate logistics are also served as regional NAT Lab centers.

Apart from Thai Red Cross, 6 Government hospitals in Bangkok and 157 in the provinces still play role on blood collection for their own supply. There are both voluntary and family replacement blood donation. Most of the hospital blood banks send the donors blood sample to do regular blood testing at the RBC lab which include NAT testing.**

Number of blood collection of the whole country is around 18 million per year which is about 2% of the population ,which means insufficient supply , so family/replacement blood donation is still needed in the hospitals.

NAT testing is rapidly increase by covering nearly 80% of all blood collectionAnd no paid donation in Thailand right nowThis show the data of blood collection of the country. Some increasing of Total collection from 18 million units in 2011 to 19 million units in 2012Family and replacement donation is still needed for 6.3 to 6.7 %of total blood donation.

The overall positive infectious markers is a little decrease from 2.3 to 2.2 and expire rate is around 3%.*By the yr 2010 NBC in cooperated with the Government and University Hospital and Professional Organizations created the current version of National Blood Policy. The Policy was endorsed by the Cabinet since then.

Correlation to HV are indicated in Policy Purpose 3: To provide safe blood for patients in accordance with the principles of the World Health Organization by recruiting blood donations from a low-risk group of population, screening blood donors, testing all units of blood with standard and conducting a compatibility test for ensuring the safe transfusionPurpose 4: To provide the effective blood services in every process at all levels Purpose 5: To appropriately utilize blood with common procedure and standard

*For more details the indicator of Policy Purpose3 is that The ratio of infectious patients from a transfusion and the ratio of the patients who receives wrong blood group and the key practice point is that The hospitals are responsible for reporting the complication through the blood donation and the complication through the blood transfusion at the blood service center as the country database*the indicator of Policy Purpose4 is that The percentage of the blood services units accredited by the quality assurance system

Practical point is that The National Blood Center, in cooperation with professional organizations and experts, is responsible for setting the standard, guidelines and the manual including arranging the training courses and the assessment for ensuring all processes of blood services with quality*And indicator for Purpose5 is that The ratio of compatibility test against the actual blood usage and the ratio of using the blood components

Practical point is that Setting the information technology system for all blood services units in order to monitoring against the blood usage indicator in all hospitals

*This diagram shows the development of qualification laboratory testing for donated blood from the beginning aroud 1966 starting with syphilis and HBsAg test by counter immuno-electrophoresis and continually develop to chemiluminescence using the PRISM ABBOTT analyzer.For Red cell grouping and antibody screening were tested on the autoanalyzer PK7200 together with anti-human globulin test by solid phase micro-plate technique.*By the yr 2002 there were many advanced technology and changes impact on our work as shown here such as:Donor self screening questionnaires Syphilis VDRLHIV-p24Ag ABBOTT/COULTERAnti-HCV and HBsAg Anti-HIV Chemiluminescent PRISMABO, Rh, RBC antibody screening AHG PK7200 / 3 machines [home-made reagentslab results from PRISM Interfacing to computerized system AS400

*Between 2003 to 2008 Nucleic acid amplification test or NAT TMA technique was implemented in 2006 which finally changed to Real time PCR pool of 6 sample.For serological infectious marker screening We also moved to HIV-Ag/Ab combination test.

*From 2009 to current Red cell auto-analyzer were develop to version PK7300 National Policy 3th edition was endorsed in 2010 which indicated 100% of NAT test for all units of donated blood All Serological infectious markers are on Architect i6000. HBsAg using Architect ABBOTT Qualitative II version followed by Neutralization test for the positive cases

We have reviewed and established new versions of Standards and guide book such as:Guideline for Syphilis testDonor Selection Guideline 5th editionPhysician Handbook on Appropriate Use of Blood and Blood ComponentsStandards for Blood bank and Transfusion Services 3rd edition

*This show the percentage of each positive infectious marker in total blood collection. All markers are decrease .By the yr 2011 positive for syphilis is 0.37%, HBsAg 1.17% anti-HCV 0.45% and HIV is 0.17%.*This flow diagram summarizes the safety measure for blood and transfusion practice*Haemovigilance program (HVP) in Thailand is initiated by Scientific Subcommittee, NBC since 2001.

The system is that the hospital blood banks in Bangkok and provinces voluntarily fill out questionnaires which was sent out every one or two years from National Blood Center. The response rate were only 20-40% of the original distributing number. The data back in NBC was collected and analyzed by manual annually.

The scope of surveillance was mainly on adverse effect of the blood recipients such as Tx of ABO incompatibleAcute hemolysisDeadDHTRNear miss incidenceTx of TTI positive unit by errorPost Tx infection

The program was discontinue since 2008

*The summary of serious hazard on blood transfusion form 2001-2008 reorted by Dr Pimol Ch. Showed Post transfusion infection by blood in window period for HIV in 2001 and 2004 about 1 in 1.4 mil of transfusionsHCV were about 1 in 500 thousand of transfusionHBV was 1 in 200 thousand and we still had malaria from transfusion of about 1 in 15 mil of transfusionFor bacterial contamination was reported in 2002 for 1 in 143 thousand transfusiuon*During 2005-2008 HIV Post transfusion infection by blood in window period were reported periodically around 1 in 400 thousand transfusion to 1 in 1.1 mil of blood transfusionThere're some report of HCV, HBV and post transfusion sepsis by bacteria

*This data showed post transfusion immune complications We found the events of transfusion ABO incompatible blood units from 1 in 80 thousand to 1 in 50 thousand units of transfusionAmong these , the adverse reaction of acute hemolysis were reported from 1 in 33 thousand to 1 in 10 thousand units of transfusion We found dead case in 2007 Delayed type were reported in various proportion And some of the near mis were also detectd

*National blood center also concern in donor care issue so we set up a pilot project to follow up the donor adverse events in terms of Donor Vigilance during August to November 2001We collected data of the immediate adverse events in the blood center and sent out the questionnaire to the donors to report themselves back after 7 days of their blood donations.

The data was collected analyses by Dr Pimol Ch as following :Responders were = 23% of 12 thousand original distributions12% were Female and 11 were MaleAge group were from 17-65 yrsDonation times were varied from 1-389 including apheresis*These are the findings:Total of 24% of the responders had experience on post donation complications7.9% found Weakness4.8% were VVR9% of hematoma1.43% were complaint on symptoms indicated Nerve injuryAnd 0.86% of local allergy*Focusing on VVR female were affected 4 times more than male

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the relationship between times of donation and VVR. The most were around 2-5 times of donation

Adverse event of VVR were found mostly immediate and before leaving donation site

VVR found occurring between 31-40 yrs old in female and 21-30 yrs old in male

*For adverse local injuryWe found 251 cases reported hematoma, 40 cases reported symptoms of nerve injury and 24 cases of local allergy*There were 26% indicated the previous history of donor reaction while 77% had no reactions before

Nevertheless 81% of them were willing to donate blood again regularly every 3 month-period while 5 of them denied to donate blood anymore*By observation we found the weakness of the system such as:

-Reporting categories and definition of adverse reaction were not international standardized-Voluntary reporting system may not indicated the true figure or under reported-Limitation in recognizing other adverse events: TRALI, GVHD, TACO, etc-The program was initiated by the Scientific Committee of NBC by a small working group , it was not recognized at the National Level which the Ministry of Public Health should take a major role to facilitate the program in all transfusion practices in hospitals.

*What is driving the effort to carry out the following tasks is the movement of global organization on haemivigilance program with a clear direction.

ISBT working party on HV proposed the standard definitions for surveillance of non infectious adverse transfusion reactions which is simple and precise enough to be able to classify most transfusion events. In my opinion this is especially important in the beginning of the HV work.

WHO strategies between 2008-2015 indicated the importance of HV Establish haemovigilance systems for improved blood safetyProvide guidelines, tools and technical support for the establishment of national haemovigilance systems.Foster and support the creation of a Global Haemovigilance, Surveillance and Alert Network

For regional Blood Network Thailand join the Asia Pacific Blood Network as a founder member. Every year we are asked about the progress of HV program

At the National level, National Blood Policy is clearly defined focusing on blood transfusion safety by security surveillance on the patients adverse events. *One of the important step we moved on was in March 2011 , National Blood Center had set up HV workshop in the Annual Scientific meeting and was honored by Dr Peter Flanagan to conduct the conference.

There were 23 members from: NBC, Hospital Blood bank Directors, Universities and Physicians. We discussed on International Standards and network for HV , we studied NZ model and exchange Thai HV experience which was started in the past before NZ but unfortunately died first and we did the group work for brain storm.

*Finally the workshop identified the key success steps including

Extract the target persons to built up a core working groupFind out the leaderGiving the information to relevant people and organizationsClarify all definitions at all levelsSet up hamovigilance committee to achieve national level

**By the end of October 2012 Secretary General of the Thai Red Cross signed an order appointing a Committee of National Haemovigillance including Medical professionals involved such as from MOPH, Hospital under Universities and the Ministry of Defensefor example.

The first meeting was arranged about 3 weeks ago. The sequence of operations will beTo survey the status of Hemovigilance activities in the secondary to tertiary care hospitals and high level medical centers concerning with blood transfusion practices.Set up 2 subcommittees including 1. Documents 2. Data managementSettle the agreement on definition of adverse eventsInform all medical and health care organizations to recognized HV at a National ProgramFind out the reporting and analyzing systemInitiative phase: Create time line, proposed outcome, identify target hospitals to implement HV system (should be tertiary care hospitals and high level medical centers first)Extension HV Implementation to hospitals in different levels according to the time frame covered by.Find out strategies to sustain HV program.

It can be seen that this HV program is not easy because it involves multiple groups, requires extensive cooperation and sustainability.However, we must demonstrate that the project will benefit the patients including the development of quality on blood transfusion services and health care system.

*Currently we have set up action plan for HV as showed by the chart

To survey HV status in Target and Pilot group Hospitals by crating a set of questionnaires to distribute in February and back for analyzing in March

We also consider a set of documents from HV Dubai congress Nov last year named WHO Recommendation at Hospital level [2012] and adapt for hospitals self assessment tool

The experts physicians in sub-committee members will take responsibility to set up the definitions relevant to HV based on 3 origins : ISBT definition SHOT UK and Standard for Surveillance of Complications Related to Blood DonationThis task will be finished in April

After that the Committee will established the workflow process together with creating the report forms in paper and will develop the IT system to support reporting system in the next steps

Training is considered that of importance for implementing and making sustainability of the system

*There are more than 1 thousand 4 hundred hospitals,This diagram shows the proportion of types of the hospitals They are: 25 provincial tertiary care level hospital69 general hospitals736 community hospitals58 other under min of health 111 under other ministries such as the University hospital , the hospital of the Army, Navy, Air force, and Police deparment for examplesAnd 322 private hospitals

more than 80% of these provide blood transfusion to the patients *So the data capturing should be planned stepwise in phases as followed:Phase 1) 1st 2nd yr Medical InstitutesProvincial Tertiary care HospitalsHospitals under Department of Medical Service Phase 2) 3rd yr-4thGeneral Hospitals over 300 bedsPhase 3) After 5 yrsall General Hospitals

*Finally, I would like to thank you Dr Faber for the honor of inviting me to come and support. He is also well known as a famous person who provide support for the development of Blood services system in many countries of Asia.

Dr Neelam Dhingara who worked hard to establish SAFE BLOOD of the world.

Dr P. Flanagan who spent his precious time with us and help us from the beginning step

International Hemavigilance Seminar Sponsor who take care of my long journey here

WHO consultation Members on HV, Dubai Seminar who shared knowledge and also the wonderful slide presentations which some of them I could follow

The most important ones are our team in National Blood Center, the Thai Red Cross Society such as Dr Soisaang Phikulsod the Director and Dr Phimol Ch who provided all HV data

And our National Blood Center staff who work together with the strong mission on safe and sufficient blood supply for the our nation.

Thank you very much.

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u. charoonruangrit md. deputy director national blood center, thai red cross society

Documents

blood donations

safe blood

country blood collection

blood collection vnrbd

national blood program

national blood policy

blood components preparationno

quality blood supply