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2015/SOM3/LSIF/SS/009 Agenda item: 6.8

APEC LSIF Blood Supply Chain Initiative Overview

Purpose: Information Submitted by: LSIF PG Chair

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Life Sciences Innovation Forum Special SessionCebu, Philippines

30 August 2015

 

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Overview of the APEC Blood Supply Chain Initiative

Background

The demand for human blood is increasing at a rapid rate throughout the Asia-Pacific region. Growth indemand is driven by rising incidence of disease, attention on maternal and child health, populationgrowth, aging populations, a steadily growing middle-class population with greater access to medicalcare, as well as an increased government focus on improving healthcare infrastructure. Evidence-basedstrategies for blood safety and availability have been successfully implemented in most developedeconomies and in only some developing economies. Across the APEC region, wide disparities in the levelof access to safe blood exist. As of 2013, only 13 of the 21 APEC economies report collecting 100% oftheir blood supplies from voluntary unpaid donors.

Furthermore, the transfusion of infected blood contributes to an ever-widening pool of infection in thegeneral population with far-reaching consequences. The WHO recommends that, at a minimum, blood isscreened for HIV, hepatitis B, hepatitis C, and syphilis. The WHO estimates that the lack of effectivescreening results annually in up to 16 million new infections with hepatitis B, 5 million new infectionswith hepatitis C, and 160,000 cases of HIV infection. It is estimated that annually 5% and 10% of all HIVinfections worldwide are the result of transfusions of contaminated blood and blood products. If theproper steps are taken, such infections can be easily prevented. An unsafe or inadequate blood supply iscostly in both human and economic terms. According to the WHO, the health-related MillenniumDevelopment Goals (MDGs) of reducing child mortality, improving maternal health and combatingHIV/AIDS, malaria and other acute or chronic diseases will be unachievable unless significant attention isfocused on availability, safety and quality of blood products.

Many challenges, such as governance alignment, appropriate resources (i.e., funding, infrastructure) andachievement of international safety/quality standards obstruct APEC economies’ efforts to improve thesafety and sustainability of the blood supply chain. In spite of these challenges, there are clearopportunities for implementation of plans by APEC economies to achieve a well-organized, qualitydriven nationally-coordinated blood transfusion service.

Following the WHO’s 2013 decision to add blood and blood products to its List of Essential Medicines,the APEC Life Sciences Innovation Forum (LSIF) initiated action to develop a comprehensive and multi-sectoral approach to improve access to blood and blood products in the Asia-Pacific region. APECrecognized the need to leverage the collective strength of key stakeholders to help APEC economies,particularly developing economies, to build the capacity of their blood services, infrastructure, andgovernance and promote the achievement of international safety and quality standards.

APEC Blood Supply Chain 2020 Roadmap

In October 2014, APEC representatives convened in Manila, Philippines for the first policy dialogue toshare experiences and develop a path forward for APEC to support blood safety. The meeting convenedrepresentatives from 20 of the 21 APEC Economies, including senior leaders from government, academicinstitutions, the private sector, civil society, and international organizations to identify key blood safetyissues in the region and to discuss how APEC economies can work together to build the capacity of their

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blood services, infrastructure, and governance and promote the achievement of international safety andquality standards for the blood supply chain. APEC representatives subsequently adopted the APECBlood Supply Chain 2020 Roadmap, launching a long-term multi-sectoral effort to address blood safetyin the region that would support the translation of global blood safety policy recommendations andlocal economy blood safety plans into concrete, measurable results.

Facilitating Policy Dialogue

Facilitating high-level, multi-sectoral policy dialogue on blood safety challenges in the Asia-Pacific regionis a key objective of the APEC Blood Supply Chain Initiative. The 2nd APEC High Level Blood SupplyChain Policy Forum: A Critical Time for Policy Action, Leadership, and Investment in Blood Safety will beheld on Friday, 23 October 2015 in Anaheim, California, United States.

The Policy Forum will convene senior blood safety leaders to develop and identify strategies to ensurethe APEC Roadmap’s successful implementation. The forum will focus in particular on securing politicalsupport in promoting policy implementation of quality systems as well as making high-impactinvestments, and how accreditation can be used to measure improvements. This meeting is open torepresentatives from APEC economies as well as invited guests from non-APEC countries.

Partnership Training Network (PTN)

APEC representatives further agreed in Manila to establish an APEC LSIF Blood Supply Chain PartnershipTraining Network (PTN) to serve as a long-term sustainable mechanism to support capacity buildingactivities to help APEC economies implement the APEC Roadmap’s recommended actions. The PTN willdevelop and deliver an evolving curriculum that enhances capacity and promotes the achievement ofinternational standards in the blood supply chain. The PTN is not intended to be an actual “bricks andmortar” facility, but instead will build upon existing resources in the region to create a network oforganizations with the capacity to conduct training in international best practices in maintaining safetyand quality in the blood supply chain. The PTN will involve representatives of health ministries, nationalblood services organizations, regulatory agencies, international organizations, academia, the privatesector, and other key stakeholders. The PTN will operate in accordance with a Terms of Referenceapproved by the LSIF.

AABB, the internationally-recognized, independent professional body and standards organization forblood services, was appointed by the LSIF Executive Board as the Secretariat for the PTN in June 2015.Following the 1st Pilot Workshop, the PTN will operate entirely on a self-funded basis with in-kindsupport coming from partner institutions throughout the region and a coalition of relevant privatesector entities managed by AABB.

A PTN Advisory Board, comprised of up to 12 representatives from APEC governments, internationalorganizations, medical associations (AABB, APBN), academic societies (ISBT), and the private sector, iscurrently being established and will provide strategic guidance and oversight over the PTN’s activities.

Working Towards Blood Safety Accreditation throughout the APEC Region

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Progress will be measured over the medium-term by assessing the ability of participating institutions to meetinternational accreditation standards through a tiered approach. Participating institutions (nominated by APECeconomies) in the PTN training programs will be invited to conduct self-assessments and external peer reviewsto assess progress made on strengthening their quality system and operational areas for compliance withinternational standards.

Next Steps

APEC funding has been approved to support two pilot programs - one in Lima, Peru in December 2015 andanother in Southeast Asia in mid-2016. Following the successful completion of the pilot programs, the PTNwill operate entirely on a self-funded basis with in-kind support coming from partner institutions throughoutthe region, government support, and private sector contributions managed by the PTN Secretariat.

Who Should Be Involved in the APEC Blood Supply Chain Initiative?

Governments. The 21 APEC Governments will facilitate the participation of experts from Ministries ofHealth and national regulatory agencies as appropriate in ongoing policy dialogue and in PTN activities.Through the APEC process, policy recommendations and reports on the PTN training activities will bereported to APEC Governments, including Ministers of Health, and APEC Ministers (Foreign) and Leaders asappropriate.

National Blood Services. The PTN’s training and capacity building activities are targeted at managers ofNational Blood Services organizations (both government and non-profit, independent organizations).Securing high-level support from these organizations is critical to the success of the APEC initiative.

Regional and International Organizations. Regional and international organizations will provide strategicinput and advice on training and capacity building programs and activities.

Academia, Medical Associations, and Patient Groups. Academic and non-profit leaders in key areas ofblood safety will be included in APEC’s ongoing policy dialogues and PTN training activities as appropriate.

Private sector. The Private sector will have input into policy dialogues and PTN Training Activities throughthe PTN Secretariat. The private sector’s input will be provided in a transparent manner and without theperception of a conflict of interest.

If you are interested in participating in the APEC Blood Supply Chain Initiative or to request moreinformation, please contact Prof. Maureen Goodenow at apecbloodproject@outlook.com.

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APEC LSIF Blood Supply Chain Initiative

Maureen M. Goodenow, PhD.

APEC SOM 3Cebu, Philippines

August, 2015

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APEC LSIF Blood Supply Chain Initiative

GOALBuilding the capacity of the blood supply chain 

in the Asia‐Pacific region

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APEC: Building the capacity of the blood supply chain in the Asia‐Pacific region

• 2013 Blood and blood products added to WHO List of Essential Medicines

• Wide disparities in level of access to safe blood

– Only 13 of 21 APEC economies collect 100% of blood supply from voluntary unpaid donors.

– Where safe blood is available, supply chain and quality systems may fail to ensure timely access.

• Health-related MDGs and SDGs will be unachievable without significant attention to access to safe blood

• Economic value of safe blood to universal health care systems and to health of populations

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Accomplishments to Date

2013

• June – Initiative proposed at LSIF HAI Workshop in Medan, Indonesia

• August-December – Applied and approved for APEC Project Funding

2014

• January-August – Established APEC Blood Supply Chain Task Force / Network of Economies; drafted Roadmap; worked with the Philippines Dept. of Health to prepare for Policy Dialogue/Workshop

• May-September – Conducted pre-workshop survey

• September 30-October 1 – 1st APEC Blood Supply Chain Policy Dialogue (Manila, Philippines), Developed APEC Blood Supply Chain 2020 Roadmap

• October-February 2015 – Finalized 2020 Roadmap and initiated discussions to establish Partnership Training Network [PTN]

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Accomplishments to Date

2015

• February - Presented Roadmap and updates at SOM1 LSIF meeting; secured support for establishing PTN (Clark, Philippines)

• February - July – Applied and approved for APEC Project Funding for PTN Pilot Workshops

• June - AABB selected to serve as PTN Secretariat by LSIF Executive Board; PTN Terms of Reference developed

• August - Endorsement at SOM3 of final APEC Blood Supply Chain 2020 Roadmap and PTN Terms of Reference (Cebu, Philippines)

APEC LSIF Blood Supply Chain 2020 Roadmap 

The Roadmap calls for:

Step 1: Assessment (2014)- Blood safety gaps and capacity building priorities in APEC

developing economies (Country level assessments).

Step 2: Training (2015 - 2016)- Provide training on quality systems and leadership in blood safety.

Step 3: Assessment of Training (2017)

Step 4: Training to reach the 2020 goal (2017 – 2020) and furtherrecommendations for blood safety improvements

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APEC Policy DialogueAttaining A Safe and Sustainable Blood Supply Chain

September 30 ‐ October  1, 2014

Step 1: Assessment (2014)- Blood safety gaps and priorities in APEC developing economies- High Level Multi-country Assessment

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VENUE:   Asian Institute of Management, Macati, Manila

Co‐CHAIRS:  Dr. Kenneth Hartigan‐Go and Dr. Maureen Goodenow

LSIF Secretariat:  Michael Schmitz

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APEC Policy DialogueAttaining A Safe and Sustainable Blood Supply Chain

PARTICIPANTS• 20 APEC member economies• WHO & other regional/international health organizations• Professional associations• Private sector• Academia

TOPICS• overview of the status of blood systems in the Asia‐Pacific region• challenges to developing safe and sustainable blood systems within their 

economies, including an analysis of aggregated data and information collected from the pre‐workshop surveys.

• key elements of quality blood systems, shared strategies and best practices• explore models for centralizing or regionalizing blood processing and 

testing facilities

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APEC Policy DialogueAttaining A Safe and Sustainable Blood Supply ChainSeptember 30‐ October  1, 2014 Manila, Philippines

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Championed by the United States, the goal for the Blood Supply ChainRoadmap is:

to improve the safety and sustainability of the blood supply in APEC economies through cross-sectoral, multi-disciplinary, coordinated &

collaborative approaches.

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APEC Blood Supply Chain 2020 Roadmap

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APEC Blood Supply Chain 2020 Roadmap

APEC Blood Supply Chain 2020 Roadmap Goals

1. Enhance cross‐sectorial political commitment and national level government leadership for improving the safety and sustainability of the blood supply for the advancement of public health 

2. Strengthen quality systems as an essential foundational element for creating a viable National Blood System or Service that requires full government commitment for long‐term success

3. Increase government awareness that economies of scale are best achieved through centralization and regionalization to provide quality services at the local level

4. Incorporate models such as public‐private partnerships and partnerships with non‐profit organizations to access resources and expertise and identify advocates for advancing blood safety

5. Provide to decision‐makers evidence on the economic value of blood safety policies that facilitate data‐driven decisions for public health 

APEC LSIF Blood Supply Chain 2020 Roadmap 

The Roadmap calls for:

Step 1: Assessment (2014)- Blood safety gaps and capacity building priorities in APEC

developing economies (Country level assessments).

Step 2: Training (2015 - 2016)- Provide training on quality systems and leadership in blood safety.

Step 3: Assessment of Training (2017)

Step 4: Training to reach the 2020 goal (2017 – 2020) and furtherrecommendations for blood safety improvements

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APEC LSIF Blood Supply Chain Partnership Training Network (PTN)

Step 2: Training (2015 - 2016)

- Training will be conducted through the Partnership Training Network (PTN).

- The PTN will develop and conduct in-person and online training programs.

- Training programs will be held at APEC sub-regional levels (i.e. SoutheastAsia, Latin America) to maximize resources and impact.

- The PTN Advisory Board in cooperation with the APEC sub-regions willidentify specific training priorities.

- Activities will be organized by the PTN Secretariat in cooperation with thesub-regional partner institutions.

- The PTN Advisory Board will convene monthly or bi-monthly to providestrategic guidance, report updates on training programs, discuss priorities,and progress with Roadmap implementation.

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Blood Supply Chain – Partnership Training Network

APEC LSIF Blood Supply Chain Partnership Training Network (PTN)

PTN Secretariat (AABB)

APEC Life Sciences Innovation Forum

APEC Ministers and Leaders

PTN Advisory Board

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APEC Blood Safety Industry Coalition

Network of APEC Economies

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Network of APEC Economies

Australia• Australian Red Cross• National Blood Authority, AustraliaCanada• Health CanadaChile• Ministry of HealthChina• National Health and Family Planning Commission• Institute of Blood Transfusion at Chinese Academy of

Medical Sciences Hong Kong, China• Hong Kong Red CrossIndonesia• Ministry of Health• Indonesia National Agency of Drug and Food ControlJapan• Ministry of Health, Labour, and Welfare• Japanese Red Cross SocietyKorea• Korean Red Cross Blood ServicesMalaysia• National Blood Centre, Ministry of Health Mexico• National Center of Blood Transfusion, Ministry of HealthNew Zealand• New Zealand Blood Service

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Papua New Guinea• PNG National Blood Transfusion ServicesPeru• Ministry of HealthPhilippines• Department of Health• Philippine Food and Drug Administration• Philippine Red CrossRussia• Russian Federal Institute for Pediatric Hematology,

Oncology and ImmunologySingapore• Health Sciences AuthorityChinese Taipei• Food & Drug Administration, Ministry of Health and

Welfare• Taiwan Blood Services FoundationThailand• Ministry of Public Health• Thai Red Cross SocietyUnited States • State Department• FDA• Centers for Disease Control and Prevention• AABBViet Nam• National Institute of Hematology and Blood

Transfusion, Ministry of Health

Establishing the Partnership Training Network (PTN) Advisory Board 

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AABB (Co‐Chair) Miriam Markowitz, Chief Executive Officer, AABB

United States (Co‐Chair and Project Overseer)

Maureen M. Goodenow, Ph.D., Senior Advisor, Bureau of East Asian and Pacific Affairs, US Department of State,Professor & Stephany W. Holloway Endowed Chair for HIV/AIDS Research, University of Florida

Asia Pacific Blood Network (APBN) Dr. Kenji Tadokoro, Chair, Asia Pacific Blood Network

World Health Organization TBD 

Pan American Health Organization (PAHO)

María Dolores Pérez‐Rosales, MD, MPH, Regional Advisor Blood Services and Organ Transplants (INVITED)

International Society of Blood Transfusion (ISBT)

Dr. Celso Bianco, MD, President, ISBT

Industry Coalition Representative Dr. Jerry Holmberg, Director, Scientific Business Development, Grifols Diagnostic Solutions Inc.

Industry Coalition Representative TBD

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Establishing the Partnership Training Network (PTN) Advisory Board  (Continued)

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Expert from an APEC Economy (Government or Academia)

Dr. Yuyun SM Soedarmono, PhD, Directorate of Basic Health Care, Ministry of Health, Republic of Indonesia

Expert from an APEC Economy (Government or Academia)

Dr Noryati Abu Amin, Director, National Blood Centre, Ministry of Health, Malaysia (INVITED)

Expert from an APEC Economy (Government or Academia)

Dra. Ina Noelia Perez Huaynalaya, Comité Directivo, GCIAMTRegional Director Southern Americas, ISBT, Clinica Delgado, Peru (INVITED)

Expert from an APEC Economy (Government or Academia)

Dr. Pham Tuan Duong, Deputy Director, National Institute of Hematology and Blood Transfusion, Viet Nam (INVITED)

Expert from an APEC Economy (Government or Academia)

Dr. Maria Victoria Abesamis, OIC Executive Director, Philippine Blood Disease and Transfusion Center, Department of HealthPhilippines (INVITED)

Expert from an APEC Economy (Government or Academia)

Prof. Dr. Liu Zhong, Vice President, Institute of Blood Transfusion, CAMS , Vice Director, Department of Blood Transfusion, PUMC, Editor in Chief, Chinese Journal of Blood Transfusion, People’s Republic of China 

HealthCare Organizations

Citizens

Scope of the Accreditation System

Hospitals & Clinics and

Physicians

Healthy Population(potential donors) Patients

Blood Center & Transfusion

Service

1. Organization2. Resources3. Equipment4. Supplier &

Customer Issues

5. Process Control

Collection & Production of Components

Transfusion Service Activities

Donor Recruitment

DonorAwareness

6. Documents & Records

7. Deviations 8. Assessments9. Process

Improvement10.Facilities & Safety

Unit for Transfusion

Quality Management Systems Foundation

Transfusion Committee

Technical Standards

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Scope of the Accreditation System

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Recruitment VNRBDs Donor Screening Donor Questionnaire Whole Blood Collection Sample Collection Donor Reactions Traceability (Donor, Paper, Blood Bag, Test Tube)

Donor Counseling

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TTI Testing Grouping & Compatibility Testing Test Results Traceability (Test Tube to Results)

Sterile Component Storage (Cold Chain Mgt) Traceability (Test Results to Product) Product labeling Issuing of Product Blood Administration (Traceability of Product to Patient) Transfusion Reactions Hemovigilance

Donor  Sample ‐Product

Product ‐ Patient

Sample –Test 

Results

Donor Vein Patient VeinLaboratory

Scope of the Technical Standards and Feedback Loop

Next Steps and Milestones 

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DATE ACTIVITY

August  APEC SOM3 LSIF Meetings  ‐ Cebu, Philippines 

August ‐ October APEC Blood Safety PTN Membership and Advisory 

Board Recruitment

October 232nd APEC Blood Supply Chain Policy Forum –

Anaheim, California, USA

December 2‐3 1st PTN Pilot Workshop – Lima, Peru

February 2016 APEC SOM1 LSIF Meetings  ‐ Peru

Mid‐2016 2nd PTN Pilot Workshop – TBD (Southeast Asia)

Late 2016 PTN Workshop – location TBD

2017‐2020 2 or more workshops each year

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YOU’RE INVITED… 

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2nd APEC Blood Supply Chain Policy Forum October 23, 2015 ‐ Anaheim, California, USA

Program Topics• Making a Commitment to Quality and Safety

• Panel Discussion: Achieving Sustainable Blood Safety Programs• Securing Political and Financial Support for Blood Safety

• Using Accreditation as an Indicator of Progress• Quality Systems for Blood Safety  (Breakout Groups)

• Looking Ahead • APEC‐AABB Dinner 

Other• PTN Advisory Board – 1st Meeting 

Please fill out and return the enclosed RSVP Form by 1 October 2015to Michael Schmitz at mschmitz@crowell.com. 

SAVE THE DATE…

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1st APEC Blood Supply Chain PTN Pilot Workshop December 2‐3, 2015 ‐ Lima, Peru

If interested in attending, please contact Michael Schmitz at mschmitz@crowell.com.