1. LCDR Frederick Matheu Applying a DOTMLPF Scorecard to a Blood Safety Program Global Health Engagement 1 Dec 2015 Overall Classification of this Brief is: USPACOM Blood Safety Program

2. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 2 FDO#7778 Disclosures The presenter has no financial relationships to disclose. This continuing education activity is managed and accredited by Professional Education Services Group in cooperation with AMSUS. Neither PESG,AMSUS, nor any accrediting organization support or endorse any product or service mentioned in this activity. PESG and AMSUS staff has no financial interest to disclose. Commercial support was not received for this activity.

3. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 3 FDO#7778 Learning Objectives: At the conclusion of this activity, the participant will be able to: Overview of US PACOM Blood Safety Program Understand how to apply DOTMLPF construct in HA/DR projects Understand how to select Industry/Field benchmark indicators Overview of the US PACOM Blood Safety Assessment Tool

4. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 4 FDO#7778 USPACOM Blood Safety Program Enduring program of Blood Safety in Lao PDR, Vietnam and Cambodia since 2009 Purpose: Builds host nation biosecurity and a sustainable blood program capacity in support of disaster response Brings together civilian and military blood program stakeholders in Partner Nations, paving the way for further civilian and military coordination Program progression to include frozen blood products, nursing training, and link with Blood Bank construction Partners

5. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 5 FDO#7778 Project Overview Blood Safety Systems Blood Donor Selection Blood Collection Infectious Disease Screening Blood Component Manufacturing Compatibility Testing National Guidelines for Blood Administration Adverse Blood Transfusion Events (identification, counseling and treatment) Donor and Recipient notification of positive infectious disease test results Blood Products Recall Equipment and Building Constructions

6. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 6 FDO#7778 2015 Accomplishments Lao P.D.R. Developed a National Blood Administration Guidelines and SOP for Nurses on Blood Transfusion, Identification and Treatment of Adverse Transfusion Events Developed a National Blood Safety Training Team to educate Provinces and Districts Transferred DoD Blood Bank Excess Equipment to support 2016 ASEAN Chairmanship. Lao will host more than 300 international meetings next year Developed Frozen Blood program capability. Lao will receive DoD Frozen Red Cells to support the meetings Cambodia U.S. Whole of Government Approach and International partnership with Australian Red Cross for Policy Development and Infrastructure capacity building Expanding from Lao to Cambodia the National Blood Administration Guidelines and SOP for Nurses on Blood Transfusion, Identification and Treatment of Adverse Transfusion Events Establishment of First Military Hospital based Blood Product Depot (Transfusion Services)

7. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 7 FDO#7778 New Equipment

8. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 8 FDO#7778 Construction Projects

9. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 9 FDO#7778 Assessment Tool Blood Safety Program Goals  Builds host nation biosecurity and a sustainable blood program capacity in support of disaster response  Increase Host Nation Blood Safety, measured by WHO Guidelines and monitored via DoD Blood Safety Index (BSI). Not FDA Guidelines  Develop a program that can be interoperable with U.S. Armed Services Blood Program to support Exercise, HA/DR events and Operations What can U.S. “whole of government” influence?  Doctrine/Policy: Policy Development  Organization: Support NBTC Development  Training: Train the Trainer approach to develop Blood Safety training teams  Materiel: Purchase Blood Safety equipment to build capacity  Leadership/Education: Align training with MED/NURSE/Lab schools to develop future generation  Personnel: Limited influence. Mentor and provide concepts for improvement  Facilities: Work with U.S. Army Corps of Engineers to build WHO approved Blood Centers. Supports application for Global Fund grants

10. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 10 FDO#7778 Sources for Benchmark Points World Health Organization Guidelines Blood Safety Index Analysis Guide AABB Accreditation Guidelines (international accreditation track)

11. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 11 FDO#7778 Blood Safety Program Assessment Tool Capability None End StateMinimalSignificantModerate 01234 Doctrine/ Policy No legislation and/or regulatory framework No national standards for manufacturing/admin No quality assurance plan Little specific legislative and/or regulatory framework Developing standards for manufacturing, QA, & admin Partially specific legislative & regulatory framework Developing standards for manufacturing/admin/QA plan Local HV System Specific legislation & regulations Natl blood policy & strategic plan Natl manufacturing/admin standard Established QA plan Regional HV System Compliance with international standards National surveillance & HV System 100% TTI testing Organization No BTC 100% paid donors Hospital/Clinic collection No NBTC/ Transfusion Committee No comp/standardized screening or lookback ≥75% remunerated donors Developing NBTC, Transfusion Committee Delegation to NGO Developing comp/standardized screening and lookback ≤50% remunerated donors Have NBTC & Developing RBTC Have Transfusion Committee Have comp/standardized screening Lookback program ≤25% remunerated donors NBTC tasked with overseeing blood safety, managed by competent clinical authority trained in blood bank with adequate funding 100% voluntary unpaid donors Training No training programNo standardized trng prog No trainers Developing trng program Developing trainers Have a standardized trng program Have trainers Regional training provider Materiel No functional refrigerators No functional centrifuges No testing No PPE <50% functional refrigerators <50% functional centrifuges No plasma expresser No collection beds <50% sterile connectors All rapid testing Lab coats only >50% functional refrigerators >50% functional centrifuges 2 expressers per Regl center 1 bed per phlebotomist >50% sterile connectors Combination of ELISA & rapid testing with confirmatory test Lab coats & gloves only 100% functional refrigerators 100% functional centrifuges 5 expressers per Regl center 2 beds per phlebotomist 100% sterile connectors Elisa testing per Regl center with confirmatory testing Lab coats, gloves, eye protection HIV, HCV, HBV, Malaria, Syphilis testing Leadership & Education None trained in blood safety Not aligned w/technical schools Not aligned w/medical & nursing schools 25% trained blood safety 25% of Regl ctrs aligned w/technical schools 25% of Regl ctrs aligned w/medical & nursing schools 50% trained blood safety 50% of Regl ctrs aligned w/technical schools 50% of Regl ctrs aligned w/medical & nursing schools 80% trained blood safety 75% of Regl ctrs aligned w/technical schools 75% of Regl ctrs aligned w/medical & nursing schools 100% trained in WHO guidelines, blood admin, donor/recipient counseling All Regl ctrs aligned w/schools Personnel Staff works 100 hours/wk No qualified personnel 0% Hep B vaccinated Staff works 75 hours/week 25% qualified personnel 25% Hep B vaccinated Staff works 60 hours/week 50% qualified personnel 50% Hep B vaccinated Staff works 50 hours/week 75% qualified personnel 75% Hep B vaccinated Staff works 40 hours/week 100% graduated from course 100% Hep B vaccinated Facilities ≤25% WHO design <25% aligned by region <25% floor centrifuge <25% cold chain mgmt <25% emerg generator ≥25% WHO design 25% aligned by region 25% floor centrifuge 25% cold chain mgmt 25% emerg generator ≥50% WHO design 50% aligned by region 50% floor centrifuge 50% cold chain mgmt 50% emerg generator ≥75% WHO approved design 75% aligned by region 75% floor centrifuge 75% cold chain mgmt 75% emerg generator 100% WHO approved design All regions hub & spoke aligned Floor centrifuge (s) available All Regl ctrs cold chain mgmt All Regl ctrs have emerg power UNCLASSIFIED

12. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 12 FDO#7778 Score Card

13. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 13 FDO#7778 Score Card Cont…. CapabilityAssessmentValue Doctrine National Legislative and regulatory frameworkPartially specific (Value 2)2 National Standards for manufacturing and administrationHave Standards (Value 3)3 National Quality Assurance ProgramNo QA Plan (Value 1)1 Total Value 6 Organization Centralized System: National Blood Transfusion Center (NBTC) tasked with overseeing blood safety managed by competent clinical authority trained in blood bank and adequately fundedNBTC Established and managed by competent Clin Authority (Value 3)3 Transfusion CommitteeDeveloping Transfusion Committee (Value 2)2 Donor Availability75% Vol Unpaid Blood Donor (Value 3)3 Donor ScreeningDeveloping Comprehensive, standardized Donor Screening (Value 2)2 Lookback programNo Program (Value 1)1 Total Value 11

14. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 14 FDO#7778 Blood Safety Program Status Lao P.D.R. (May 2015)Cambodia (July 2015) Doctrine/ Policy -Specific legislation & regulations -No quality assurance plan -Natl manufacturing/admin standards -Partially Specific legislation & regulations -No quality assurance plan -Developing manufacturing/admin standards Organization -NBTC tasked with overseeing blood safety, managed by competent clinical authority -No NBTC/ Transfusion Committee - 75% Vol Donors -Have comp/standardized screening -No Lookback Program -Developing the NBTC to be tasked with overseeing blood safety, managed by competent clinical authority -No NBTC/ Transfusion Committee -50% Vol Donors -Have comp/standardized screening -No Lookback Program Training -Developing trng program -Developing trainers -Developing trng program -Developing trainers Materiel -<50% functional refrigerators -<50% functional centrifuges -2 beds per phlebotomist -<50% sterile connectors -2 expressers per Regional Center -Combination of ELISA and Rapid Test at Reg Centr -<50% functional refrigerators ->50% functional centrifuges -1 bed per phlebotomist -<50% sterile connectors -2 expressers per Regional Center -Combination of ELISA and Rapid Test at Reg Centr Leadership & Education -25% trained blood safety -All Regional Centers aligned w/schools 25% trained blood safety -All Regional Centers aligned w Lab schools -No Regional Center aligned with Med/Nursing School Personnel -Staff works 60 hours/week -100% graduated from course -25% Hep B vaccinated -Lab Coats and Gloves only -Staff works 60 hours/week -100% graduated from course -75% Hep B vaccinated -Lab Coats and Gloves only Facilities≥25% WHO design 25% aligned by region 50% floor centrifuge <25% cold chain management 50% emerg generator ≥25% WHO design 100%aligned by region 50% floor centrifuge 75% cold chain management 75% emerg generator

15. Defending America’s Interests in the Indo-Asia-Pacific Lead Rebalance Operationalize Theater C2 Drive Activities in TCO Fight Tonight Organizational Coherence/Climate Defend the Homeland 15 FDO#7778 Questions?