Armed Services Blood Program Blood Safety Support CAPT Roland L. Fahie, MSC, US Navy Director, Armed Services Blood Program International Blood Safety Forum Global Healing March 20, 2015 www.militaryblood.dod.mil

Armed Services Blood Program Established by Executive Order in 1952 DoDD 6000.12 – Health Services and Operational Readiness DoDI 6480.4 – Armed Services Blood Program (ASBP) Operational Procedures Implements policy, assigns responsibilities, and prescribes procedures to carry on the responsibilities of the ASBP during peacetime, contingency (includes humanitarian), and wartime operations

The Armed Services Blood Program (ASBP) Coordination for Global Engagements Armed Services Blood Program Office Navy Blood Program Office Air Force Blood Program Office Army Blood Program Office COCOM Joint Blood Program Offices

Blood Program Contacts ASBPO – (703) 681-8024 Combatant Command Joint Blood Program Officers USEUCOM– Major Matthew Swingholm, Landstuhl, GE 011-49 6371868176 USAFRICOM - Major Matthew Swingholm, Landstuhl, GE USPACOM – LCDR Frederick Matheu, Camp Smith, HI (808) 477-7895 USSOUTHCOM – Mr. Walt Diaz, Miami, FL (305) 437-4287 / 1330

Provide blood safety support via DoD PEPFAR Theater Security Cooperation Programs in COCOMS Many Partners

Countries Receiving Assistance Cambodia Ethiopia Indonesia Laos Mozambique Thailand Ukraine Vietnam

UNCLASSIFIED Blood Safety Program Enduring program of Blood Safety in Lao P.D.R., Vietnam, and Cambodia since 2007 Purpose Builds host nation for a sustainable blood program in support of care, treatment and disaster response Program progression to include frozen blood products, administrative, technical, physician, and nursing training, and linkages to humanitarian assistance construction projects for Blood Banks Brings together civilian and military blood programs stakeholders in host nations to support the country Partners: DoS, US CDC, USAID, National Blood Transfusion Center, Ministry of Health, US PEPFAR, Australian Red Cross, Laos Red Cross, World Health Organization, US Army Corps of Engineers and Armed Services Blood Program UNCLASSIFIED

Goals and Benefits of ASBP Global Engagements Promotes and strengthen partnerships with host nations, partners, and NGOs Improves response to disease and natural or manmade disasters Improves general healthcare commodities Fosters quality systems improvement Assists with developing good governance and democracy “Global Force for Good” Helps nations to strengthen and take ownership of its own programs and initiatives Gives nations more confidence with sustaining programs of their own

Types of Assistance

Blood Safety Assistance UNCLASSIFIED Blood Safety Assistance National Policy for Blood – commitment, responsibility, and accountability Blood Donor Selection Blood Collection Infectious Disease Screening Blood Component Manufacturing Compatibility Testing National Guidelines for Blood Administration Appropriate Use of Blood Products Adverse Blood Transfusion Events (identification, counseling and treatment) UNCLASSIFIED

Blood Safety Assistance Donor and recipient notification of positive infectious disease test results Blood products recall Equipment and building construction Build capacity in the centers of excellence and extend the services to the provinces Assessments Policy and SOP development Technical Assistance

Blood Safety Assistance UNCLASSIFIED Blood Safety Assistance Designing Quality Assurance Programs focusing on the goal of accreditation Divide the country regions in centers of excellence using “train the trainer approach” Build capacity in the centers of excellence and extend the services to the provinces Training at the hospitals and blood centers Regional workshops UNCLASSIFIED

Blood Center Designing What do we do? Blood Center Designing

Five Blood Safety Centers - Vietnam Military Hospital 103 – Hanoi Military Hospital 175 – Ho Chi Minh City Military Hospital 17 – DaNang Military Hospital 121 – Cantho Military Hospital 87 – Nha Trang Robust blood safety program. Collaborates and lead country in the Pacific and partners for training. Implementing frozen blood technology.

Hospital Ship – Blood Bank Training

US PACOM Blood Safety Program UNCLASSIFIED US PACOM Blood Safety Program Coordinate with US Army Corps of Engineers and country team to design and build Regional Blood Donor Centers in Laos and Cambodia using World Health Organization Guidelines UNCLASSIFIED

US PACOM Blood Safety Program UNCLASSIFIED US PACOM Blood Safety Program 2013: Center of Excellence identified in Luang Prabang, Lao P.D.R., building finalized and turned over to Ministry of Health. Training performed at new Donor Center to integrate Ministry of Health and Ministry of Defense personnel in Northern provinces 2009: Initial Planning Phase Meetings with Ministry of Health and National Blood Transfusion Center 2010 – 2011: Blood Safety Workshops in Lao P.D.R and Cambodia 2012: Equipment needs identified, equipment purchased and turnover to Lao P.D.R UNCLASSIFIED

US PACOM Blood Safety Program UNCLASSIFIED US PACOM Blood Safety Program 2014: Blood safety Workshop in Pakse, Lao P.D.R. to integrate Ministry of Health and Ministry of Defense personnel in Southern provinces 2014: Meeting in Vientiane, Laos P.D.R. with Nurses and Doctors to discuss development of National Blood Administration Guidelines. Vientiane will be used as pilot program. UNCLASSIFIED

Cambodia Ground Breaking Ceremony UNCLASSIFIED Cambodia Ground Breaking Ceremony UNCLASSIFIED

Cambodia Ground Breaking Ceremony UNCLASSIFIED Cambodia Ground Breaking Ceremony UNCLASSIFIED

National Blood Transfusion Center UNCLASSIFIED National Blood Transfusion Center UNCLASSIFIED

UNCLASSIFIED Equipment UNCLASSIFIED

UNCLASSIFIED New Equipment UNCLASSIFIED

Training in the Centers UNCLASSIFIED Training in the Centers UNCLASSIFIED

Blood Program Assessment UNCLASSIFIED Blood Program Assessment Capability None End State Minimal Significant Moderate 1 2 3 4 Doctrine 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 Hospital/Clinic collection No NBTC/ Transfusion Committee No comp/standardized screening or lookback Developing NBTC, Transfusion Committee Delegation to NGO Developing comp/standardized screening and lookback Have NBTC & Developing RBTC Have Transfusion Committee Have comp/standardized screening Lookback program NBTC tasked with overseeing blood safety, managed by competent clinical authority trained in blood bank with adequate funding Training No training program No standardized trng prog No trainers Developing trng program Developing trainers Have a standardized trng program Have trainers Regional training provider Material 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 100% paid donors Staff works 75 hours/week 25% qualified personnel 25% Hep B vaccinated ≥75% remunerated donors Staff works 60 hours/week 50% qualified personnel 50% Hep B vaccinated ≤50% remunerated donors Staff works 50 hours/week 75% qualified personnel 75% Hep B vaccinated ≤25% remunerated donors Staff works 40 hours/week 100% graduated from course 100% Hep B vaccinated 100% voluntary unpaid donors 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 BTC = Blood Transfusion Center CME = Continuing Medical Education ELISA = Antibody-capture Enzyme-linked Imunosorbent Assay HBV = Hepatitis B Virus HCV = Hepatitis C Virus HIV = Human Immunodeficiency Virus HV = Haemovigilance NBTC = National Blood Transfusion Center NBTS = National Blood Transfusion Service NGO = Non-Governmental Organization PBTC = Province Blood Transfusion Center PPE = Personal Protective Equipment QA = Quality Assurance RBTC = Regional Blood Transfusion Center TTI = Transfusion-Transmissible Infections WHO = World Health Organization UNCLASSIFIED

Ethiopia Facility Scope of Service Armed Forces General Hospital (Addis Ababa) Transfusion Service Bahrdar (northwest Ethiopia) Bella Blood Bank (Addis Ababa) Blood Donor Collections Donor Testing Laboratory Blood Distribution Center Harar Transfusion Service (eastern Ethiopia) Mekelle Blood Bank (northern Ethiopia) Mekelle Transfusion Service (northern Ethiopia) Shire Transfusion Service (northern Ethiopia)

New Bella Facility Addis Ababa Bella Defense Blood Bank Center THE RESULTS – THE BELLA DEFENSE BLOOD BANK CENTER

Blood Safety Challenges in Countries Donor population – Who are your donors? Paid vs Volunteer Education level of the staff and equivalency Staff turnover due to military training or just not retaining qualified staff Lack of knowledge of donor and patient age (older donors) etc.. Unique identifiers No such thing as a medical record number Managing funds in the country Dependency – Mutual agreed exit strategy and sustainment plan

Blood Safety Challenges Uneducated Beliefs such as catching HIV from donating blood How does the government (MOD) and civilian (MOH) work? Are they working together? Religion and Culture Holidays Internet connection weak or regulated Language barrier (having someone on your team) Technology (bringing technology that cannot be sustained)

Blood Safety Challenges Time zone (years) Logistics and Terrain Communication – translators Country Power and Equipment Requirements (220v vs 110v) Consistent training and application Honest Technical Assistance Retaining key personnel after investing in training Training together (MDs with Nurses with Admin with Techs)

Challenge Food

Courtesy of the USAF

In Conclusion

QUESTIONS?