1. 1 Armed Services Blood Program Update COL Frank Rentas Director, Armed Services Blood Program Office www.militaryblood.dod.milUNCLASSIFIED 2009 Society of Armed Forces Medical Laboratory Scientists Annual Meeting Reno, Nevada 23 March 2009

2. 2  ASBPO Organizational Structure  Service Blood Program Officers  COCOM JBPOs  OIF/OEF Blood Transfusion Statistics  Background- Whole Blood  Background- Platelets  Blood Product Availability  Current Policy/Guidance for HIV, HBV, HCV Screening Prior to Deployment  Transfusion-Transmitted Disease Residual Risk Estimates  Transmission Countermeasures  Current Initiatives  Frozen Blood use in Theater  Improved Rapid Test Kits  DBSS  Fresher Blood in Theater  Non-FDA Compliant Transfusions  Visit to Iraq www.militaryblood.dod.milUNCLASSIFIED Agenda

3. 3 www.militaryblood.dod.milUNCLASSIFIED ASBPO Organizational Structure Director COL Francisco J. Rentas Blood Donor Recruiter Supervisor Mr. Marty Ricker Blood Donor Recruiters Deputy Director, Policy LCDR Corey Jenkins Deputy Director, Operations MAJ David Lincoln NCOIC SFC Peter Maas Deputy Director, Information Technology Mr. Don Dahlheimer Communications and Marketing Ms. Julie Oliveri Marketing Specialist Ms. Melissa Yu Administrative Specialist Ms. Ginger-Rogers Bass # Military: 4 # Civilians: 25 (5 at ASBPO, the rest all over the world)

4. 4 Air Force Blood Program Director: Lt Col Dianne Davis QA Manager: Maj George Hestilow Medical Consultant: Lt Col Joseph P.R. Pelletier Navy Blood Program Director: CDR Brian Williamson QA Manager: Ms. Kathleen Whitlock Medical Consultant: CDR Karin M. Hollis-Perry Army Blood Program Director: LTC Mike Lopatka QA Manager: Ms. Kathleen Elder Assistant QA Manager: Mr. Dave Reiber Medical Consultant: LTC Frank Chiricosta Service Blood Program Officers www.militaryblood.dod.milUNCLASSIFIED

5. 5 COCOM JBPOs www.militaryblood.dod.milUNCLASSIFIED USEUCOM – MAJ Jose Quesada, USA, Landstuhl, GE USPACOM –CDR Roland Fahie, USN, Camp H. M. Smith, HI USCENTCOM – LtCol Richard McBride, USAF, Tampa, FL MAJ Kristine Fumia, USAF, CAOC Qatar USNORTHCOM – LTC Jonathan Branch, USA, JFHQ, Peterson AFB CO USSOUTHCOM – Mr. Walter I. Diaz, DAC, Miami, FL

6. 6 As of 31 December 2008 OIF/OEF Blood Transfusion Statistics OIF - 58% reduction in the monthly average of blood products transfused during the last 12 months as compared to 2007 OEF - 23% increase in the monthly average of blood products transfused as well as a 31% increase in red cells during the last 12 months as compared to 2007 TotalU.S. OnlyNon-U.S. Percent U.S. Only Percent Non-U.S. Transfused Patients20,8294,76216,06722.9%77.1% WB6,7053,5713,13453.3%46.7% RBCs112,73629,49483,24226.2%73.8% Platelets5,5321,8573,67533.6%66.4% FFP59,51616,83742,67928.3%71.7% CRYO14,7745,3419,43336.2%63.8% www.militaryblood.dod.milUNCLASSIFIED

7. 7  Whole blood (WB) has been used extensively to resuscitate casualties in military conflicts since World War I  As of 31 December 2008, 3,571 whole blood units have been transfused in theater to 497 US patients  One documented emergency transfusion associated HCV transmission  76% of WB transfusions have taken place in Level II+ facilities (2006-2008)  WB transfusions are down 81.5%, and 83.4% from 2007 and 2006 respectively  Samples for retrospective testing collected on most donations  Current JTTS CPG on Whole Blood – Updated November 2008  WB is neither intended nor indicated for routine use  WB is to be used only when other blood products are unable to be delivered at an acceptable rate to sustain the resuscitation of an actively bleeding patient or when specific components are not available www.militaryblood.dod.milUNCLASSIFIED Background- Whole Blood

8. 8 www.militaryblood.dod.milUNCLASSIFIED Background- Whole Blood *Includes all transfusions until 31 December 2008 (US and Non-US)

9. 9 www.militaryblood.dod.milUNCLASSIFIED Background- Whole Blood Whole Blood Transfusions 2006-2008 OIF/OEF

10. 10 www.militaryblood.dod.milUNCLASSIFIED Background- Whole Blood Whole Blood Transfusions 2006-2008 OIF

11. 11 www.militaryblood.dod.milUNCLASSIFIED Background- Whole Blood Whole Blood Transfusions 2006-2008 OEF

12. 12  As of 31 December 2008, 1,857 Platelet (PLT) units have been transfused in theater to 744 US patients  Collections in much more controlled environments than WB  All collections at level III facilities  Donors are pre-screened with all FDA-mandated tests before allowed to donate  Donors normally allowed to donate every two weeks  Samples for retrospective testing collected during every donation  HIV, HBV, and HCV Rapid testing of most donations  Products tested for bacterial contamination  84% of PLT transfusions have taken place in Level III facilities (2006-2008)  PLT transfusions are down 46.5%, and 37.2% from 2007 and 2006 respectively  Current JTTS CPG on Damage Control Resuscitation addresses use of PLTs - Updated February 2009  1:6 PLT/RBC ratio memo signed by Army TSG- February 2009 www.militaryblood.dod.milUNCLASSIFIED Background- Platelets

13. 13 www.militaryblood.dod.milUNCLASSIFIED Background- Platelets *Includes all transfusions until 31 December 2008 (US and Non-US)

14. 14 www.militaryblood.dod.milUNCLASSIFIED Background- Platelets Platelets Transfusions 2006-2008

15. 15 www.militaryblood.dod.milUNCLASSIFIED Background- Platelets Platelets Transfusions 2006-2008 OIF

16. 16 www.militaryblood.dod.milUNCLASSIFIED Background- Platelets Platelets Transfusions 2006-2008 OEF

17. 17  Level III MTFs  Red Blood Cells - all blood types but AB  Fresh Frozen Plasma - all blood types  Cryoprecipitate  Platelets  Fresh Whole Blood – as needed for emergencies. Destroyed if not used within 24 hours  Level II+ (18 in OIF, 13 in OEF)  Red Blood Cells – mostly Os  Fresh Frozen Plasma – 12 MTFs in OEF, 10 in OIF, mostly A and AB  Platelets – very limited, 4 in OIF, one in OEF  Fresh Whole Blood – as needed for emergencies. Destroyed if not used within 24 hours  Level II (no surgical capability) and I – No blood products delivered*  * SOF teams have blood available during missions www.militaryblood.dod.milUNCLASSIFIED Blood Product Availability

18. 18  HIV  Current USCENTCOM Individual Protection and Individual/Unit Deployment Policy (MOD Nine, September 2008) requires that HIV screening be performed within 90 days of deployment  HBV  No current policy/guidance for screening prior to deployment. Current USCENTCOM Individual Protection and Individual/Unit Deployment Policy (MOD Nine, September 2008) requires all deploying military personnel to be vaccinated against both Hepatitis A and B  HCV  No current policy/guidance for screening prior to deployment www.militaryblood.dod.milUNCLASSIFIED Current Policy/Guidance for HIV, HBV, HCV Screening Prior to Deployment

19. 19 www.militaryblood.dod.milUNCLASSIFIED Transfusion-Transmitted Disease Residual Risk Estimates US Military Donors Seroprevalence US Military Rapid Screen Residual Risk (New test kits) US FDA-Cleared Testing Residual Risk HIV: Medical Surveillance Report 2008 - Army Active 1:5882 ANG 1:4167 AR 1:2381 Retrospective testing of 17,387 samples from actual donors in theater (caveat sample integrity): No HIV cases identified OraQuick Advance, WB, kit insert Sensitivity =99.6% 1:1,470,500 1:1,041,750 1:595,250 No cases Bihl J Trans Med 2007 1:2,135,000 HCV: Hyams et al. Am J Epi 2001 Military 1:208 Retrospective testing of 17,387 samples from actual donors in theater (caveat sample integrity): Military 1:1932 Axiom, WB, Sensitivity =95.2% 1:4333 1:40,250 Bihl J Trans Med 2007 1:1,930,000 HBsAg: Retrospective testing of 17,387 samples from actual donors in theater (caveat sample integrity): Military 1:2898 First Vue, WB, Sensitivity =84.3% 1:18,458 Bihl J Trans Med 2007 1:277,000

20. 20 www.militaryblood.dod.milUNCLASSIFIED Transmission Countermeasures HIVHCVHBV Force Screen2 years-- Theater Entrance90 days-- VaccinationNot Available Required by all Services Pre-Screens **Yes Retrospective TestingYes Improved Rapid Testing Yes ** For all PLTs and some WB collections

21. 21  HBV seroprevalence/seroincidence study of recently deployed forces to define epidemiology of HBV in deployed force  pending USACHPPM EPICON per CENTCOM SG request to JS  HCV seroprevalence study of recently deployed forces to define epidemiology of HCV in deployed force  pending USACHPPM EPICON per CENTCOM SG request to J4S  Draft HA policy to address rapid testing, pre-screening, retrospective testing, and follow up of recipients  Increasing fresh frozen plasma availability at level II+ facilities  Making improved rapid test kits available at level II+ facilities  Increasing number of facilities collecting apheresis platelets  Deglycerolized RBCs available  Shipments directly from BTC to Kandahar  Navy laboratory technicians assigned to BSD in ATO www.militaryblood.dod.milUNCLASSIFIED Current Initiatives

22. 22 Frozen Blood Use in Theater www.militaryblood.dod.mil  FDA-approved product: 10 year expiration  Tested with all FDA-required tests  Frozen fresh (w/6 days): storage lesion issue  DoD freezing – ASBPO monitoring production/use  Deglycerolized: 14 day expiration  Supplement to liquid red cells  Washed product (↓ leukocytes; removes plasma proteins and cytokines which have been involved recently with ↑ infections in transfused recipients)  Being transfused at all 3-level III trauma centers

23. 23

24. 24 DBSS COTS www.militaryblood.dod.milUNCLASSIFIED Armed Services Blood Program

25. 25 www.militaryblood.dod.milUNCLASSIFIED Fresher Blood to Theater

26. 26 Non-FDA Compliant Transfusions  Past  Thank you for your support.  Present  1096 Individuals in system  20 Countries  7 countries presently linked into the Non-FDA database system  Process on track and monitored closely  Future  Incorporate NATO countries - future conflicts  Establish international agreement for the exchange of transfusion related information.  Incorporate Veterans Administration into system www.militaryblood.dod.milUNCLASSIFIED

27. 27 Balad www.militaryblood.dod.milUNCLASSIFIED Fresher blood (<15 days old) shelf Deglycerolized Red Cell units (frozen red cells)

28. 28 BTC Qatar working nights www.militaryblood.dod.milUNCLASSIFIED

29. 29 Good Luck!! Best Wishes!!

30. 30 Thanks for everything you do to take care of our customers!!