GMPIMPLEMENTATIONSTRATEGIES-MALAYSIA

DrNorya5AbuAminDirector,Na5onalBloodCentre

Na5onalHeadTransfusionMedicineService,MOH

Outline•  Countrybackground•  DevelopmentofBTSincludingqualitysysteminMalaysia

•  Na5onalBloodPolicy•  Na5onalsta5s5csonBTS•  Lessonslearnt•  Priorityforac5on

• Popula5on:30million• Dualhealthsystem-publicandprivate• Healthsystemchallenges-NCDincreasing,emergingandreemergingofinfec5onsandagingpopula5on-sustainabilityofthesystem• Rateofdona5ons:23per1000• Collec5on2015>700,000units• NoofRecipients>388,000(MOH)• Adequateforfreshcomponentsneeds• Seasonalshortages-responsivepublic• Plasmaforfrac5ona5on>32,000kg

COUNTRYBACKGROUND

OverviewoftheMalaysianHealthSystem

77%:23%60%:40%

(NHMS2015–onlymedicalvisit)

Public&PrivateSectorResourcesandWorkload(2014&2015)

Source:HealthInformaRcsCenter(HIC),FamilyHealthDevelopmentDivision,NHMS2015,MNHAPrelim(2014)

26.4

29,895

16,622,744

43,822

150

57,069,523

768

23.9

12,290

3,873,935

13,797

291

37,939,354

6,978

0% 20% 40% 60% 80% 100%

Health Expenditure RM Billion (2014)

Doctors(excl. Houseman) (2014)

Bed Days (NHMS 2015)

Hospital Beds (2014)

No. of Hospitals (2014)

Outpatient visits (NHMS 2015)

Health clinics (with doctors) (2014)

Public Private

10%

60%

34% 66%

40%

90%

76%

81%

24%

19%

71%

52%

29%

48%

Currentorganiza5onstructureofBTS

•  1950s:Bloodbankingac5vitybeganinGHKL•  1972:NBTSlaunched,hospitalbasedblood

banks•  1974:allhospitalsprovidedwithinstruc5on

bookletsontheprocedures-reques5ngofblood,transportandstorageofbloodinwards,thetransfusionofbloodandtherepor5ngandmanagementoftransfusionreac5ons.

•  EstablishedtheearliestQualityManagementprinciplesinthelaboratoryandatcri5calpointsbetweentherequestforabloodcomponentandtheactualtransfusionincludingrecordsfromdonorstopa5ents

DevelopmentofBTSinMalaysia(1)

DevelopmentofBTSinMalaysia(2)•  Standardizedprin5ngoflabelsandrecordformsforall

transfusionproceduresforallhospitalsinthecountry.•  Centralpurchasingandsupplyofconsumables,reagents

andsta5onarycarriedoutbytheCentralMedicalStoreinGHKualaLumpuranddistributedna5onwide.

•  1980-newstandardizedproceduresfortransfusionservice

DevelopmentofBTSinMalaysia(3)•  Na5onalindicatorssince1980’s•  Proficiencytes5ng:na5onalEQA

programmesince80’s•  1991:Ini5a5onofcontractfrac5ona5on

andbeginningofqualitymanagement,includingGMPinBTS-ongoingauditbyCSL5lltoday

•  ISOcer5fica5onsince1995•  1997:Blueprintforana5onally

coordinatedbloodtransfusionservice•  1998:Re-organiza5onandplanfor

regionaliza5onapproved•  2000:EstablishmentoftheNa5onalBlood

Centreandconsolida5onofac5vi5es

32

DevelopmentofBTSinMalaysia(4)•  Haemovigilancesince2003

•  NATAAccredita5onoftheNa5onalBloodCentrein2004•  Implementa5onofNa5onalQualityManagementProgramme

inBTS–ongoingawareness,training,auditbyNBC•  2006:EstablishmentofTransfusionMedicineMMed

Programme•  Accredita5onofhospitallaboratoriesbyDepartmentof

StandardsMalaysiasince2009forISO15189•  Accredita5onofhospitalsbyMSQH•  2007:NATimplementa5on,currentlycovering60%of

collec5on•  Consolida5onofac5vi5es-–  145MOHhospitalsandins5tu5ons-bloodcollec5onin128hospitals,

componentprocessingin20hospitalsandTTIscreeningin15hospitals–  Transfusionlaboratory(XM)in349hospitalsincludingprivate

Na;onalBloodPolicy-2008•  S5pulategovt.support&commitment•  Definesprinciples&ethics

–  Procurementofbloodfromvoluntarynon-remuneratedblooddonors

–  Mandatoryscreeningtest:HIV,HBV,HCVandSyphilis.–  Onlyscreenedbloodtobetransfused–  Allbloodbanksshouldbeundertheperviewof–  amedicalprac55oner.–  Blooddonorcriteria;regularreviewofcriteria,no

discrimina5onofanykind–  Qualitymanagementsystem/GoodManufacturingPrac5ces

employedinallprocessandprocedure•  Sourceoffunding•  Clearlydefineroles&responsibili5es•  Na5onalguidelinesisbeingupdatedandprinted

•  2014:Upgradingof22centresaspartofna5onalfrac5ona5onprogrammeandtheGMPinspec5onof22bloodcentresbyNPRA

•  2015:2regionalcentresapprovedunder10thMalaysianPlan–SabahandKedah

•  Recogni5onofTransfusionMedicineasadis5nctspecialty,2016-nowwith34gazeiedTransfusionMedicineSpecialists

•  Broadbasedmul5disciplinaryspecialtywith3mainareas:1.   Blooddona;onandsupply

•  Behavioural,socialsciences&marke5ng,Epidemiology&PublicHealth,Forecas5ng,Inventory&Logis5cmanagement

2.   Manufacturing•  Immunohematologyandtransfusionmicrobiologytes5ng,component

processingandcontractfrac5ona5on3.   Clinicaltransfusionandlaboratorymedicine

•  Bloodbanking,immunologyandlinkageswithInternalMedicine,Surgery,Paediatrics,O&Getc

•  Importanceofqualitysystemthroughoutthetransfusionprocessanddesigna5onofQualityManagersinbloodcentres

DevelopmentofBTSinMalaysia(5)

Bloodcollec;on,MOH,2007-15

507,808527,898

565,604590,517

627,518646,890 653,124

675,315706,408

-

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

2007 2008 2009 2010 2011 2012 2013 2014 2015

KPIforTransfusionService:60%regulardona5ons

0

5000

10000

15000

20000

25000

30000

35000

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014Penang 0 0 0 0 0 0 0 0 0 0 0 0 0 0 618 504 462 672 648 292 598 115 266 280

Malacca 0 0 0 0 0 0 0 0 0 0 0 0 0 0 353 1352 2402 2660 2638 967 3266 2148 1410 2775

PDN 865 2630 0 4693 5275 6668 7241 9014 11786 12721 14125 18301 20214 22754 24801 27439 27474 27270 22844 25281 28326 19844 30674 30055

Berat(kg)

Year

VolumeofPlasmaforContractFrac;ona;on1991-2014

33,11032,350

22,107

32,190

26,54026,130

30,60230,338

29,295

25,772

22,754

20,214

18,301

14,125

12,72111,786

9,0147,241

6,668

5,2754,693

2,630

865

0.7%0.86%

30%

30%

1.%

4.50%

18%

0%

5%

10%

15%

20%

25%

30%

35%

1970 1980 1990 2000 2004 2005 2006

% of

repl

acem

ent d

onor

FAMILY REPLACEMENT DONORS - MALAYSIA

A dramatic drop in replacement donors between 1980 to 2006

0

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0

5

10

15

20

25

30

35

40

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014Seroconvert Prevalence(%)

Prevalence

SeroconvertNo.

Year

Seroprevalence of HIV & no of seroconvert among PDN’s blood donors

0

0.02

0.04

0.06

0.08

0.1

0.12

0

1

2

3

4

5

6

7

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Seroconvert Prevalence(%) Year

Sero

conv

ert N

o.

Prev

alenc

e (%

)

Seroprevalence of HCV & no of seroconvert among PDN’s blood donors

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0

2

4

6

8

10

12

14

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Ser

ocon

vert

No.

Seroconvert Prevalence(%)

Prev

alen

ce (%

)

Year Prev

alen

ce(%)

Seroprevalence of HBsAg & no of seroconvert among PDN’s blood donors

0

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0.08

0.09

0

5

10

15

20

25

30

35

40

45

50

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Seroconvert Prevalence(%)

Year

SeroconvertNo.

Prevalence(%)

Year

Seroprevalence of Syphillis & no of seroconvert among PDN’s blood donors

HIVRNA+,an5-HIV+concordant

NoHIVRNA–,an5-HIV+elitecontrollerswerefound

HIV-RNA An5-HIV

HIVinfec;onsofID-NATscreeningof1,722,885dona;onsCentralRegion(PDN,Selangor,WestPahang,NegeriSembilan)

(2008to2015)

694(95.7%)

HIVRNA+,an5-HIV–windowperiod

31(4.3%)

725 HIV infections (prevalence 0.04%) 31 HIV WP NAT yields (1:55,577)

ResidualTransmissionRisk:2.11permilliondona5ons@1in473,539dona5ons(ID50 (Virion):3.16)

HCVRNA+an5-HCV+

1374(86.7%)

HCVRNA+an5-HCV–15(0.95%)

HCVRNA–an5-HCV+196(12.37%)

HCV-RNA An5-HCV

1,585HCVinfec;ons(prevalence0.09%)15HCVWPNATyields(1:114,859)

HCVinfec;onsofID-NATscreeningof1,722,885dona;onsCentralRegion(PDN,Selangor,WestPahang,NegeriSembilan)

(2008to2015)

ResidualTransmissionRisk:0.18permilliondona5ons@1in5,592,957dona5ons

HBVDNA+HBsAg+

3,802(84.79%)

HBV-DNA+HBsAg–294(6.56%)

HBV-DNA–HBsAg+388(8.65%)

HBV-DNA HBsAg

4,484HBVinfec;ons(prevalence0.26%)104acutephaseWPNATyields(1:16,566)

190chronicOBINATyields(1:9,067)

HBVinfec;onsofID-NATscreeningof1,722,885dona;onsCentralRegion(PDN,Selangor,WestPahang,NegeriSembilan)

(2008to2015)

Es5matedResidualTransmissionRisk:5.50permilliondona5on@1in181,750dona5ons

Lessonslearnt

•  Evolu5onofGMPimplementa5on-topdownapproachinthebeginningwithstrongleadershipwithinMOHandBTS

•  Withdevelopmentofcri5calmassofspecialistsandHR-ownershipandimplementa5onofQMPatstateanddistrictlevel

•  CultureofqualityindifferentcategoriesBTSstaff•  Strategyandplanneedtobeinplace

Priorityforac5on•  Productqualityandsafety-expansionofNATtocoverallblooddona5onandstrengtheningtheimplementa5onofQSincludingGMPinbloodcentres

•  Pa5entsafetyduringtransfusionprocessandPa5entBloodManagement

•  Blooddonorsafetyandsa5sfac5onfordonorreten5on•  Increasingeffec5veness,efficiencyandreducingwastage

•  Strengtheningofsystem–coordina5on,consolida5on,M&E,sustainabilityofopera5onalbudget,HRetc

AcknowledgementMOH

StaffofNa5onalBloodCentre,pastandpresent