2015/LSIF/FOR/006. Blood Safety Program. Submitted by: United States

Transcription

1 2015/LSIF/FOR/006 Blood Safety Program Submitted by: United States 2 nd APEC Blood Supply Chain Policy Forum Anaheim, United States 23 October 2015

2 Blood Safety Program LCDR Frederick Matheu, MSC, USN Joint Blood Program Officer US PACOM J0741 (808) (V) (904) (Cell) October 2015 USPACOM Blood Safety Program Enduring program of Blood Safety in Lao PDR, Vietnam and Cambodia since 2009 (maybe earlier) 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 UNCLASSIFIED 1

3 Why U.S. DoD Involvement? Defense Security Cooperation Agency Overseas Humanitarian Disaster and Civic Aid Program Makes available non-lethal excess property; medical, dental, veterinarian Allows minor construction projects; repair of roads, schools, clinics; well digging, and flood control In coordination with US Embassies and concurrence with USAID using a Whole of Government Approach 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 2

4 Execution It takes years to see results Divide the country geographically in centers of excellence using train the trainer approach Build capacity in the centers of excellence for Host Nation to extend the services to the provinces Continue assessments, policy development and training Recruit more organizations to help to reach the final goal US PACOM Blood Safety Program timeline 2009: Initial Planning Phase Meetings with Ministry of Health and National Blood Transfusion Center : Blood Safety Workshops in Lao P.D.R and Cambodia 2012: Equipment needs identified, equipment purchased and turnover to Lao P.D.R 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 3

5 US PACOM Blood Safety Program timeline cont 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. Lao P.D.R. will be used as pilot program for the region. Promoting Interagency and Regional Cooperation 2014: Blood Safety Workshop in Da Nang, Vietnam for Senior Military Medical Department Leaders. Workshop focused on standardized blood safety policy development. Ministry of Health was invited to discuss common challenges in blood safety 2014: Blood Safety Workshop in Phnom Penh, Cambodia for Ministry of Health, Ministry of Defense and Lao P.D.R. delegation 4

6 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) Equipment Needs 5

7 Equipment Needs New Equipment 6

8 Blood Donor Center Constructions 2014: Coordination with US Army Corps of Engineers, US Center of Disease Control, Australian Red Cross and Cambodian Ministry of Health to design and build Regional Blood Donor Centers in Cambodia using World Health Organization Guidelines Cambodia Ground Breaking Ceremony 7

9 UNCLASSIFIED Cambodia Ground Breaking Ceremony UNCLASSIFIED UNCLASSIFIED Future National Blood Transfusion Center 8

10 Luang Prabang Center Provincial Training in New Building 9

11 Blood Safety Program Assessment Tool Capability None Minimal Moderate Significant End State Doctrine/ Policy Organization No legislation and/or regulatory framework No national standards for manufacturing/admin No quality assurance plan No BTC 100% paid donors Little specific legislative and/or regulatory framework Developing standards for manufacturing, QA, & admin Hospital/Clinic collection No NBTC/ Transfusion Committee No comp/standardized screening or lookback 75% remunerated donors Training No training program No standardized trng prog No trainers Materiel Leadership & Education Personnel No functional refrigerators No functional centrifuges No testing No PPE None trained in blood safety Not aligned w/technical schools Not aligned w/medical & nursing schools Staff works 100 hours/wk No qualified personnel 0% Hep B vaccinated <50% functional refrigerators <50% functional centrifuges No plasma expresser No collection beds <50% sterile connectors All rapid testing Lab coats only 25% trained blood safety 25% of Regl ctrs aligned w/technical schools 25% of Regl ctrs aligned w/medical & nursing schools Staff works 75 hours/week 25% qualified personnel 25% Hep B vaccinated Partially specific legislative & regulatory framework Developing standards for manufacturing/admin/qa plan Local HV System Developing NBTC, Transfusion Committee Delegation to NGO Developing comp/standardized screening and lookback 50% remunerated donors Developing trng program Developing trainers >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 50% trained blood safety 50% of Regl ctrs aligned w/technical schools 50% of Regl ctrs aligned w/medical & nursing schools Staff works 60 hours/week 50% qualified personnel 50% Hep B vaccinated Specific legislation & regulations Natl blood policy & strategic plan Natl manufacturing/admin standard Established QA plan Regional HV System Have NBTC & Developing RBTC Have Transfusion Committee Have comp/standardized screening Lookback program 25% remunerated donors Have a standardized trng program Have trainers 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 80% trained blood safety 75% of Regl ctrs aligned w/technical schools 75% of Regl ctrs aligned w/medical & nursing schools Staff works 50 hours/week 75% qualified personnel 75% Hep B vaccinated Compliance with international standards National Surveillance & Hemo Vigilance System 100% TTI testing NBTC tasked with overseeing blood safety, managed by competent clinical authority trained in blood bank with adequate funding 100% voluntary unpaid donors Regional training provider HIV, HCV, HBV, Malaria, Syphilis testing 100% trained in WHO guidelines, blood admin, donor/recipient counseling All Regl ctrs aligned w/schools 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 Blood Safety Program Status Doctrine/ Policy Organization Training Materiel Leadership & Education Personnel Facilities Lao P.D.R. -Specific legislation & regulations -No quality assurance plan -Natl manufacturing/admin standards -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 trng program -Developing trainers -<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 -25% trained blood safety -All Regional Centers aligned w/schools -Staff works 60 hours/week -100% graduated from course -25% Hep B vaccinated -Lab Coats and Gloves only 25% WHO design 25% aligned by region 50% floor centrifuge <25% cold chain management 50% emerg generator Cambodia -Partially Specific legislation & regulations -No quality assurance plan -Developing manufacturing/admin standards -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 -Developing trng program -Developing trainers -<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 25% trained blood safety -All Regional Centers aligned w Lab schools -No Regional Center aligned with Med/Nursing School -Staff works 60 hours/week -100% graduated from course -75% Hep B vaccinated -Lab Coats and Gloves only 25% WHO design 100%aligned by region 50% floor centrifuge 75% cold chain management 75% emerg generator 10

12 Challenges Financial Support from Ministries of Health Blood Donor Centers unaware or little control over National Budget for Blood Safety NBTC leaders are given the responsibility to improve the Blood System without extra financial support from MOH Sustainment; MOH relies on external donors and organizations to maintain the Blood Bank capacity Change Management Some NBTC Staff reluctant to change current practices Process Improvements are seeing as more work for the same pay Needs buy in from Country Blood Bank Authorities. Stroke that Ego!! APEC Opportunities Create awareness at the Prime Minister Level Influence Ministries of Finance to include a dedicated budget on the National Budget for Blood Bank Capacity Building Influence Ministries of Health to recognize the need to improve Blood Bank Systems and meet international accreditation standards New equipment is not the answer. Develop a Sustainable System! Influence Ministries of Education to update educational materials to meet current international practices Include the Defense Ministry. They have hospitals and use blood 11

13 Questions? 12