1. Department of Health and Human Services Office of the Assistant Secretary for Health (ASH) BLOOD AND TISSUE ELEMENTS OF NATIONAL ALL-HAZARDS RESPONSES Jerry Holmberg, Ph.D. Senior Advisor for Blood Policy August 2011

2. 1 Objectives Provide an overview of the Department of Health and Human Services responsibilities in Emergency Support Function (ESF) #8 of the National Response Framework Present projection of blood and tissue needs in a high-consequence mass-casualty scenario Convey surge capacity assumptions and implications for regulatory considerations

3. ASH is Blood Safety Officer and coordinates all Public Health issues concerning blood Points to consider in National response ─No National Blood Policy ─Non-federalized blood supply (ARC, ABC, BCA, AABB) ─Responsible for commissioned Public Health Service Corps ─OASH’s Mission Essential Functions include coordination of blood and vaccines availability Office of the Assistant Secretary for Health (OASH)

4. Office of the Assistant Secretary for Preparedness and Response (ASPR) Under the Pandemic and All Hazards Preparedness Act, HHS is the lead agency for the National Response Framework (NRF) for Emergency Support Function 8 (ESF). Pandemic and All Hazards Preparedness ActNational Response Framework (NRF) The Secretary of HHS is responsible for ESF #8 and coordinates principally through the Assistant Secretary for Preparedness and Response (ASPR) for health and medical services. ESF 8 resources can be activated through the Stafford Act or the Public Health Service Act. 3

5. OS HHS Org Chart RHA REC

6. ESF 8 Public Health and Medical Services ESF #8 – Public Health and Medical Services provides the mechanism for coordinated Federal assistance to supplement state, tribal, and local resources in response to the following: 1.Public health and medical care needs, including behavioral health 2.Veterinary and/or animal health issues in coordination with the U.S. Department of Agriculture (USDA) 3.Potential or actual incidents of national significance ESF #8 involves supplemental assistance to state, tribal, and jurisdictional governments in identifying and meeting the public health and medical needs of victims of major disasters or public health and medical emergencies.

7. ESF 8 Public Health and Medical Services Assessment of public health/medical needs Public health surveillance Medical care personnel Medical equipment and supplies Patient movement Hospital care Outpatient services Victim decontamination Safety and security of human drugs, biologics, medical devices, veterinary drugs, etc. Blood products and services Food safety and security Agriculture feed safety and security Worker health and safety All hazard consultation and technical assistance and support Mental health and substance abuse care Public health and medical information Vector control Potable water/wastewater and solid waste disposal, and other environmental health issues Victim identification/mortuary services Veterinary services. Federal public health and medical assistance consists of medical materiel, personnel, and technical assistance. A developing potential health and medical situation This support is categorized in the following functional areas:

8. Blood, Organs, and Tissues ESF #8 may task HHS components and request assistance from other ESF #8 partner organizations to monitor and ensure the safety, availability, and logistical requirements of blood, organs, and tissues. This includes the ability of the existing supply chain resources to meet the manufacturing, testing, storage, and distribution of these products.

9. ESF #8 Action Confidentially monitors blood and blood product supplies throughout the year using the Blood Availability and Safety Information System as baseline data for ESF #8 activation. Liaisons with the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism (i.e., AABB TF) to assist in logistical requirements and to coordinate a national public blood announcement message for the need to donate. Monitors blood and blood product shortages and reserves, including the safety and availability of the blood supply.

10. SOC contact points: Primary: Office of Blood Safety and Availability Incident Hospital Affected Blood Collector HHS’ s Blood Issues handled by the ASH’s Office of Blood Safety and Availability through Secretary’s Operation Center BASIS Data Activate Critical Infrastructure Protection Plans Supplies Electricity Communication Water Local EMA State EOC DoD ASBPO CDCFDA HRSACMS HHS Response AABB ABC, BCA, ARC

11. 10 Scenario-Based Planning Scenario: Improvised Nuclear Device (IND) Concepts of Operations Assumptions for model Multiple Scenarios to Scope Consequence/Demand Projections Products/Treatments For RBCs, Plasma, Platelets ─Baseline Assumptions ─Gap over Time ─Associated Considerations Supply Surge Considerations ─Regulatory Implications

12. 11 The Threat: Improvised Nuclear Device Primary incident is local Severe to moderate damage within one mile Light damage potentially to several miles Dangerous fallout widespread; caution beyond Blast effects: Overpressure and wind – destruction and trauma Thermal energy – burns Prompt radiation – radiation injury Fallout – radiation injury Miles from ground-zero 2- 1- 0- 3- 4- 9- 8- 7- 6- 5- 10 kT Large 1 kT Medium 0.1 kT Small Dangerous Fallout Light Damage Moderate Damage Severe Damage

13. 12 Concepts of Operations: RTR system Radiation TRiage, TReatment, and TRansport RTR 1 RTR 2 RTR 3 AC (Assembly Centers) MC (Medical Care Sites) Evacuation Centers

14. 13 Model Assumptions “Ideal realistic” CONOPs ─Severe Damage Zone: no access, resources destroyed Details dependent on target city ─Local area resources (remaining) available on incident day ─Hospital beds represent care resources (city-specific) ─Resources to people and people to resources ( 40 km/d rate) ─Immediate and expectant fatalities removed in model Citizen response ─Stay in place 2 h, then shelter-in-place for 24 h, then evacuate

15. 14 Analysis: Multiple Scenarios to Scope Consequence/Demand Projections Based on DHS, HHS, BTWG assessments of scenarios of particular concern Starting point: DHS National Planning Scenario #1 ─10-kT ground burst in a large metropolitan area Risk assessments for 2008, 2010: wide-ranging approach with multiple scenarios in various Urban Area Security Initiative (UASI) cities ─6 cities ─5 yields: 0.01 to 100 kT ─Various heights of burst BTWG added two non-coastal cities with different resource availability geometry Total: 239 scenarios analyzed

16. 15 Blood & Tissue Products as MCMs Biological Products ─Supplied by donors ─Constrained storage conditions ─Short shelf life ─Labor-intensive use CONOPs of use are important ─Collected and distributed by private organizations With particular interests (compare pharmaceutical industry) Artificial alternatives could be useful ─May relax above constraints

17. 16 Products/Treatments Red blood cells ─Trauma (blood loss), surgery, burn & radiation treatment Cryoprecipitate ─High blood-loss trauma – supplies fibrinogen & clotting factors Plasma ─Trauma (clotting & intravascular volume), burns (volume) IV fluids ─Trauma, burns, radiation – intravascular volume; IV access Platelets ─Trauma, thrombocytopenia due to ARS – clotting capability Hematopoietic Syndrome Treatment  Potential HSC transplant ─Acute Radiation Syndrome-associated Skin ─Thermal burns - grafting

18. 17 Baseline Supply Assumptions RBC o Daily number of RBC units collected in US assumed at least 40,000 o Modeled 5 days of supply on hand initially o Over 2 weeks ramp up period to 5-times normal rate Plasma o Daily number of Plasma units collected in US assumed at least 16,000 o Modeled 5 days of supply on hand initially o Over 2 weeks ramp up period to 5-times normal rate Platelets o Daily number of Platelets units collected in US assumed at least 28,000 o Modeled 2 days of supply on hand initially o Ramp up in capacity over 2 weeks to twice normal rate

19. 18 RBC Gap Analysis over Time Given surge to 5x normal supply rate under assumptions, supply is sufficient after first two days First two days  Gap in local/regional supplies and capability RBC Gap (U) -300,000 -200,000 -100,000 0 100,000 200,000 110100 Day City A – 10 kT City A – 1 kT City B – 10 kT

20. 19 Plasma Gap Analysis over Time Given surge to 5x normal supply rate under assumptions, supply is sufficient after first two days First two days  Gap in local/regional supplies and capability Plasma Gap (U) -200,000 -150,000 -100,000 -50,000 0 50,000 100,000 110100 Day City A – 10 kT City A – 1 kT City B – 10 kT

21. 20 Platelets Gap Analysis over Time Early AND late gaps under assumptions  surge supply particularly critical Platelet Gap (U) -600,000 -500,000 -400,000 -300,000 -200,000 -100,000 0 100,000 110100 Day City C – 100 kT City B – 10 kT City A – 1 kT

22. 21 Blood Products Associated Considerations Operational capability Resources (people and supplies) to administer City-specific demand Supply capacity Surge capacity: ─To five or more times the normal collection and supply rate for blood donations within the first two weeks after a detonation Rate of facility and resource availability ─Availability of facilities and resources to patients at distances from the detonation site increasing at a rate of at least 40 km per day

23. Immediate Supply Surge Considerations Mass effects of blast ─Building collapse (crush injuries) ─Shrapnel (glass, metal) ─Accidents associated with flash blindness (did not contribute to demand in model) ─Secondary explosions (model did not consider) Infrastructure damaged ─Ability to move blood/tissue products into area of need or surrounding area ─Transportation (road and air) ─Restricted areas Limited medical resources ─Health care providers/beds/scarce resources ─Healthcare system overwhelmed by concerned citizens 22

24. Thoughts to Consider Today Response is dependent on preparedness ─Are cities prepared? ─Will mobilization of blood and tissue from other parts of the country be possible? Gaps will be in first 2 days for most blood products Cryoprecipate demand may be primarily first 2 days Platelet gaps are early and late ─Acute radiation syndrome impact on hematopoietic system ─Current dependency is on apheresis platelets may want to consider WBDP Surge in volunteer donations is expected and increasing by 5 times the normal rate may be possible 23