Blood Safety and Sustainability in the Asia Pacific: An...

___________________________________________________________________________

2014/LSIF/PD/005

Blood Safety and Sustainability in the Asia Pacific: An Overview of Blood Systems in the Asia Pacific

Submitted by: Pan American Health Organization (PAHO)

Policy Dialogue and Workshop on Attaining a Safe and Sustainable Blood Supply Chain

Manila, Philippines30 September – 1 October 2014

APEC POLICY DIALOGUE AND WORKSHOP ON ATTAINING A SAFE AND SUSTAINABLEBLOOD SUPPLY CHAINAPEC LIFE SCIENCE INOVATION FORUM

BLOOD SAFETY AND SUSTAINNABILITY IN THE ASIA PACIFIC:

AN OVERVIEW OF BLOOD SYSTEMS IN THE ASIA PACIFIC

Geni Neumann

Consultant, Blood and Transplants Services

Tel: +1 202 9743044

[email protected]

Unit of Medicines and Health TechnologiesDepartment of Health Systems and Services

Topics WHO initiatives.

Important issues:

Universal Access to Safe blood

National Blood System

Blood Transfusion services

PAHO initiatives

Regional Plan 2005-2010 - evaluation

Blood safety status in the Region.

Haemovigilance in Latin America.

Plan of Action for Universal Access to Safe Blood 2014-2019

WHO INITIATIVES

Since 1975, the World Health Assembly (WHA)and the WHO Executive Board have considered variousdocuments and adopted numerous resolutions relatedto universal access to safe blood:

WHA28.72 [1975], EB79.R1 [1987], WHA40.26 [1987],WHA45.35 [1992], WHA48.27 [1995], WHA53.14[2000], WHA55.18 [2002], WHA56.30 [2003],WHA58.13 [2005], WHA63.12 [2010], WHA63.18[2010], and WHA63.20 [2010].

IMPORTANT ISSUES

UNIVERSAL ACCESS TO SAFE BLOOD

Blood transfusion contributes to saving millions oflives every year, improves life expectancy and the quality oflife of patients suffering from life-threatening conditions,and supports complex medical and surgical procedures.

Every country should put in place policies, systemsand structures to ensure the safety, quality, accessibilityand timely availability of blood and blood products to meet

the needs of all patients who require transfusion.

WHO: Developing a National Blood System. 2011.

IMPORTANT ISSUESUNIVERSAL ACCESS TO SAFE BLOOD

Policies should be supported by appropriatelegislation to promote uniform implementation ofstandards and consistency in the quality and safety ofblood and blood products.

All activities related to blood collection, testing,processing, storage and distribution should becoordinated at the national level through effectiveorganization and management.

WHO/World-Blood-Donor-Day/2014.1, http://www.who.int/campaigns/world-blood-donor-day/2014/en/

IMPORTANT ISSUESNATIONAL BLOOD SYSTEM

Leadership and governanceFormulate and oversee the implementation of the national

blood policy and strategic plan.Define the roles, responsibilities and accountability of

institutions and organizations that comprise the national blood system.Set national standards for blood and blood products, services,

processes and systemsEstablish regulatory mechanisms for the registration, licensing,

operation and inspection of blood transfusion services.


Coordination and CollaborationThe national blood system should be organized and coordinatedat national level (MOH)in a manner that ensures the mostefficient and cost-effective use of all resources.

IMPORTANT ISSUESBLOOD TRANSFUSION SERVICES

To perform their functions efficiently, BTS should have:…Adequate number of qualified, skilled and experiencedpersonnel in human resource management, finance andadministration, quality systems, transfusion medicine, blooddonor program, laboratory testing and blood processing.

…Efficient inventory management system for optimum bloodstocks and minimal wastage.

… Local transfusion committees with responsibility forimplementing transfusion guidelines and monitoringtransfusion practices.


Strategies for achieving safe blood transfusion

National guidelines - Guidance on the development of bloodordering schedule and standard operating procedures at hospital level.

Education and training - Training of clinicians, nurses and BTS/blood bank staff in: Undergraduate and postgraduate programs,in-service training and continuing medical education.

Hospital transfusion committees- Effective implementation of nationalguidelines, monitoring and evaluation at hospital level.

Monitoring and evaluation - Traceability of blood and blood products,patterns of blood usage and transfusion practice and adverse events.

http://www.who.int/bloodsafety/clinical_use/AM_CUB_English.pdf?ua=1

Important Issues

PAHO INITIATIVES

Since 1999, several resolutions on this matter have alsobeen adopted by PAHO in the Region of the Americas:CD41.R15 (1999), CD46.R5 (2005), CE142.R5 (2008),

and CD48.R7 (2008).

• 2000 -2004 - Regional initiative - PAHO/WHO and GatesFoundation.

Objectives:• 100% blood tested to HIV, HBsAg, HVC, sífilis and T. cruzi .• 100% BS participation in EQAP for sorology and

imunohematology• 50 % voluntary donnors.

Initiative for Safe blood Transfusion and Regional Plan 2005-2010

PAHO/WHO 46th Directing Council, Sept 2005

Purpose: to contribute to the reduction of mortality and theimprovement of patient care in LA and the Caribbean by making safeblood for transfusion available in a timely manner for all patients whoneed it.

Objectives:

• 1. Assure appropriate collection and preparation of blood components insufficient quantities to treat the patients who need blood transfusions.

• 2. Assure timely access to blood components in the patients who needblood transfusions.

• 3. Assure the highest level of safety of blood products to avoid thetransmission of infectious diseases and other untoward effects associatedwith transfusions.

• 4. Promote the appropriate clinical use of blood.

• 5. Improve the efficiency of national resources.PAHO: Supply of Blood for Transfusion in Latin American and Caribbean Countries 2010 and2011. (2013)

Strategies

1) Planning andmanagement of the

national bloodnetwork system.

2) Promotion ofvoluntary blood

donation

3) Qualityassurance

4) Appropriate useof blood and blood

components.

Initiative for Safe blood Transfusion and Regional Plan 2005-2010

Regional Plan 2005-2010 Evaluation*

Key remarks

• 12% increase in units colected.

• 26% increase voluntarydonation.

• Increase in no. blood unitsscreened to HIV, HBC, HCV &syphilis (99.6% in 2010).

• Regional EQAP in Sorology andImunoheamtology.

• In 18 of 19 LA countries - Bloodcoordination at MOH level and 16specific law/regulation for blood.

• 8/23 CA countries - Bloodcoordination at MOH level andspecific law/regulation for blood .

• Technical guides and capacitybuilding.

• Annual data report on supply ofblood for transfusion in LA andCaribean Countries (2000-2010).

*”Evaluación del Plan Regional de la OPS para laSeguridad de las Transfusiones 2006-2010”

Main recomendations to Countries

• Consolidate blood services from collection to screening andprocessing.

• Achieve 100% voluntary non remunerated donation, mostlyregular or repeated.

• Implement quality assurance programs.

• Improve rational use of blood and components.

Regional Plan 2005-2010 Evaluation*

*”Evaluación del Plan Regional de la OPS para la Seguridad delas Transfusiones 2006-2010”

BLOOD SAFETY STATUS IN THE REGION

Blood Units Officially Reported by Latin American andCaribbean Countries, 2011

4/40 countries concentrate 75% (6,936,710 / 9,275,91) of allblood units reported in the Region in 2011

Argentina 1,101,438Brazil 3,356,382Mexico 1,768,065Colombia 710,825

Organización Panamericana de la Salud. Suministro de sangre para transfusiones en los paísesde Latinoamérica y del Caribe 2010 y 2011. Washington, DC : OPS, 2013.

Organization of the National Blood System LAC, 2012

Country Specific Law Responsible Unit

Specific

Budget

National

Policy

National

Comission

ARG YES YES YES YES YES

BOL YES YES YES YES YES

BRA YES YES YES YES YES

CHI PARTIAL YES YES YES YES

COL YES YES YES YES YES

COR NO NO NO NO NO

CUB YES YES NO YES YES

ECU YES YES YES YES NO

ELS NO YES NO YES NO

GUT YES YES YES NR PARTIAL

HON PARTIAL YES YES PARTIAL PARTIAL

MEX YES YES YES YES YES

NIC YES YES YES YES YES

PAN YES NO NO NO YES

PAR YES YES YES YES NO

PER YES YES YES YES NO

DOR YES YES NO YES YES

URU YES NR NR NR NR

VEN YES PARTIAL YES NO PARTIAL


CountryReference

Centre

National

Plan

Donor

Norms

Operation

Norms

Clinical

Guidelines

Blood Service

Registration

ARG No Yes Yes Yes Yes Partial

BOL Yes Yes Yes Yes Yes Yes

BRA No No Yes Yes Yes Yes

CHI Yes Yes Yes Yes Yes Yes

COL Yes Yes Yes Yes Yes Yes

COR Yes No No Partial No Partial

CUB Yes Yes Yes Yes Yes Yes

ECU Yes No Yes Yes Yes Yes

ELS Yes Yes Yes Yes Yes Yes

GUT Yes Yes Yes Yes Yes Yes

HON No No Partial Partial Yes No

MEX Yes Yes Yes Yes Yes Yes

NIC Yes Yes Yes Yes Yes Yes

PAN Yes No Yes Yes Yes No

PAR Yes Yes Yes Yes Yes Yes

PER No No Yes Yes Yes Yes

DOR No Yes Yes Yes No Yes

URU NR NR Yes Yes NR NR

VEN NO Yes Yes Yes Partial Partial


Country

Quality

Assurance

Policy

National

Quality

Assurance

Program

External

Evaluation

Serology-TTI

External

Evaluation

Immunohematology

Inspection

Program

Continued

Education

ARG Partial Yes Yes Partial Partial Yes

BOL Yes Yes Yes Yes Yes Yes

BRA Yes Yes Yes Yes Yes Yes

CHI Yes Yes Yes Yes Yes Partial

COL Yes Yes Yes Yes Yes Yes

COR No No Partial Partial No No

CUB Yes Yes Yes Yes Yes Yes

ECU No Yes Yes No No No

ELS No Yes Yes Yes Partial SI

GUT No No No No SI SI

HON No No No No No No

MEX Yes Yes Yes Yes Yes Yes

NIC Yes Yes No No Yes Yes

PAN No No No No Yes No

PAR Yes Yes No No Yes SI

PER Yes No Yes Yes Yes No

DOR Yes Yes Yes No Yes No

URU NR NR Yes NR NR NR

VEN Partial Partial Yes No Partial Yes


Country Staff Certification

Service Accreditation

ARG No Yes

BOL Yes Yes

BRA Yes Yes

CHI Yes Yes

COL Yes Yes

COR No No

CUB Yes Yes

ECU No No

ELS No No

GUT Yes No

HON No No

MEX Yes Yes

NIC Partial Partial

PAN No No

PAR No Yes

PER No No

DOR No No

URU No NR

VEN No No

Country

Number of

units

collected

Number ofCollecting

Centers

Number ofProcessing

Centers

Annual Processingper Bank

Daily Processingper Bank

(260 Days)

ARG 1056710 282 222 4760 18.31

BOL 83391 18 18 4633 17.81

BRA 3335035 544 530 6293 24.20

CHI 233165 46 19 12272 47.20

COL 746059 85 85 8777 33.76

COR 70182 34 30 2339 8.99

CUB 401575 168 46 8730 33.58

ECU 83680 0 19 4404 16.94

ELS 94494 42 36 2725 10.48

GUT 113041 62 62 1823 7.01

HON 66518 18 17 3912 15.05

MEX 1768862 779 556 3181 12.24

NIC 72988 5 2 36494 140.36

PAN 55083 27 27 2040 7.85

PAR 62154 46 5 12430 47.81

PER 166049 NR NR NR NR

DOR 106291 65 65 1635 6.29

URU 104342 74 34 3069 11.80

VEN 445957 319 316 1411 5.43

Efficiency of Blood Processing, 2012

Blood Units Officially Reported to PAHO/WHO2009 -2012

Year Latin America Chile Mexico Peru

2009 4,937,275 NR 1,602,071 221,266

2010 8,883,339 227,301 1,699,885 234,566

20119,141,157

230,308 1,768,065 141,202

2012 9,062,749 233,165 1,768,862 166,049

Blood Donation Rate per 1,000 Population2010 - 2012

YearLatin

AmericaChile Mexico Peru

2010 15.60 13.26 15.36 7.95

2011 15.90 13.33 15.40 4.80

2012 15.21 13.88 15.22 5.58

RemuneratedReplacementVoluntary

0

10

20

30

40

50

60

70

2009 2010 2011 2012

Type of Allogeneic Donor in Latin America, 2009 – 2012(%)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Voluntary Replacement Remunerated

Blood Collection Ranked from Greatest to Least byVoluntary Donations, Latin America, 2012

LA 99.95 99.94 99.95 99.90 99.51 99.97

Countries HIV HBsAg HCV Syphilis T. cruzi HTLV I-II Anti-HBc

ARG 100 100 100 100 100 100 100

BOL 100 100 100 100 100 NR NR

BRA 100 100 100 100 100 100 100

CHI 100 100 100 100 100 100 NR

COL 100 100 100 100 100 70.53 71.20

COR 100 100 100 100 100 100 100

CUB 100 100 NR 100 NR NR 100

ECU 100 100 100 100 100 11.05 15.29

ELS 100 100 100 100 100 NR NR

GUT 100 100 100 100 100 NR 77.41

HON 100 100 100 100 100 94.03 95.65

MEX 98.43 98.36 98.47 98.20 90.69 NR NR

NIC 100 100 100 100 100 NR NR

PAN 100 100 100 100 100 97.89 99.56

PAR 100 100 100 100 100 100 100

PER 100 100 100 100 100 100 100

DOR 100 100 100 100 NR 100 NR

URU 100 100 100 100 100 100 100

VEN 100 100 100 100 100 100 100

Coverage of Screening for Infectious Markers, 2012 (Percentage)

HIV HBsAg HCV SYPHILIS T. CRUZI HTLV I-II

0.26 0.56 0.40 1.05 0.78 0.42

Proportion of Reactive/Positive Units in Latin America, 2012

HIV HBsAg HCV Syphilis T. cruzi HLTV I-II

MEX 0.25 0.15 0.57 0.59 0.45 NR

PER 0.19 0.41 0.47 1.12 0.61 0.98

CHI 0.03 0.01 0.03 0.83 0.14 0.12

Blood discard in LAC in 2011

799.738 RBC units were discarded for due datecriteria waitage of US$ 44,785,328 (averagecost US$56/unit).

Recomendation to countries:

• Implement in every country, a system of inventorymanagement and daily update of all bloodcomponents, at a national level. This scheme willfacilitate the full utilization of the available units,thus reducing the discard.

PAHO Regional Plan for Transfusion Safety 2006-2010

Indicator of progress:

100% of the countries will have established ahaemovigilance program to assess the impact oftransfusions on patients’ health.

Haemovigilance in Latin American Countries

PAHO: Supply of Blood for Transfusion in Latin American and Caribbean Countries 2010 and2011. (2013)

Torres O.W., León de Gonzalez G.: LA HEMOVIGILANCIA EN AMÉRICA LATINA.Blood Transfus 12, Supplement no. 2, February 2014

Survey: quest form was sent to the 19 LA countries

Feed-back from 13/19 (68.42%)13/13 – MOH <-> data of BS activities on regular basis

8/13 - standardized electronic format.

Blood Services informing in regular basis :100 % BS in 5/12 countries80 – 99% BS in 3/12 countries40% BS in 1/12 countries


• Brazil (2006) and Colombia (2009) have a national HV system.• Cuba: regional pilot plan (2003), in nationwide expansion .• Chile, Guatemala, Venezuela and Mexico: mandatory to notify HV

data, but few institutions send information regularly.• Chile: improving its communication network to extend it

nationwide.• Venezuela: the official agency showed no interest in developing a

national plan presented by the Scientific Society in 2011.• Mexico: mandatory since 2012, but only some institutions do HV.• Argentina and Honduras record some data voluntarily.• Costa Rica, Ecuador and Peru: not mandatory. Only some

institutions record HV data.



Conclusions… General interest in HV is present in the Region and HV activities areemerging in many LA countries.

… It is necessary to change some paradigms in many countries: HV willnot lead to a punitive action .

… PAHO, Scientific Societies and professionals have to work jointly inorder to demonstrate and persuade health authorities about theimportance of HVS for transfusion safety .



PLAN OF ACTION FOR UNIVERSAL ACCESS TO SAFE BLOOD

2014-2019

Goal:

• To promote universal access to safe bloodthrough voluntary non-remunerateddonations to help save lives and improve thehealth of patients who need them.

Strategic Lines of Action

1. Effective and sustainable integration of national blood programsand services into the national health system to achieve blood self-sufficiency, safety, efficiency, availability, and universal access toblood and blood products.

• Objective 1.1. Strengthen planning, implementation, monitoring,and evaluation processes in national blood programs.

• Objective 1.2. Include the issue of safe blood in national health plansin order to ensure resources and intersectoral support.

• Objective 1.3. Organize and consolidate an integrated blood servicesnetwork within the health services network, tailored to the needs ofeach country.

•


2. Self-sufficiency in safe blood and blood productsthrough 100% voluntary non-remunerateddonations.

• Objective 2.1. Calculate the country’s need for bloodand blood products to achieve self-sufficiency in safeblood

• Objective 2.2. Reach blood self-sufficiency throughnon-remunerated voluntary blood donations.


3. Quality management in the national blood system andscreening for transfusion-transmitted infections.

• Objective 3.1. Establish, monitor, and evaluate thequality management system in the blood services network,which includes screening for HIV, HBV, HCV, syphilis, andT. cruzi (the latter in endemic areas).

• Objective 3.2. Adopt the necessary mechanisms toincrease the availability and appropriate use of blood andblood products.


4. Health surveillance, haemovigilance, risk management,monitoring, and evaluation.

• Objective 4.1. Strengthen the national blood system so thathealth surveillance is included in blood services.

• Objective 4.2. Strengthen the national blood system tointegrate haemovigilance in blood services.

• Objective 4.3. Establish a mechanism to enable countries tomonitor the implementation of their national plan.

• Objective 4.4. Draft risk management plans based on theinformation generated by the haemovigilance system.

Thank you!www.paho.serviciosdesangre.org

Date post:	22-Jul-2018
Category:	Documents
Upload:	hoangnhan
View:	216 times
Download:	0 times

Blood Safety and Sustainability in the Asia Pacific: An...

Documents