1 Armed Services Blood Program Armed Services Blood Program - Transformation - CDR Michael C. Libby Director, Armed

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Armed Services Blood Program

www.militaryblood.dod.mil UNCLASSIFIED

Armed Services Blood Program- Transformation -

CDR Michael C. Libby

Director, Armed Services Blood Program Office

12 Feb 08

Society of Armed Forces Medical Laboratory Scientists

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To provide thoughts on what might be ahead for the ASBP in order to be far more efficient in using available resources.

To get people to start thinking about the big picture of the certain business change.

To raise a broad suggestion about where the Armed Services Blood Program is going over the long term and what are the underlying forces creating transformation.

To succeed we need to operate beyond the edge of knowledge where time honored rules of thumb might not apply in the organization.

Purpose

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To put the transformation in proper perspective, the ASBP will be described in a history capsule from 2001 to 2008.

Where we have been. Where we are now Where are we going…

We are on the verge of a historic shift… a National Blood Program?

Accelerated technological and business changes are in the foreseeable future and will bring similar gov’t agencies together.

Briefing Outline

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Senior Military Medical Advisory Committee

Blood ProgramBusiness Case Analyses

Toward a Future StateMarch 2003

Blood ProgramBusiness Case Analyses

Toward a Future StateMarch 2003

( A STEP BACK IN TIME!)

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- ASBPO Convened SME Panel 24-27 April 2001• Lt Col Ruth Sylvester, USAF, Chair• Lt Col Fabrizio Saraceni, USAF; CDR Brenda Bartley,

USN; LCDR Michael Libby, USN; Maj Donna Whittaker, USA; Maj Ken Pell, USA

- ASBPO Convened SME Panel 21-22 June 2001• Lt Col Ruth Sylvester, USAF, Chair• Lt Col Fabrizio Saraceni, USAF; CDR Brenda Bartley,

USN; LCDR Michael Libby, USN; Lt Col (P) Gary Norris, USA; Ms Kathleen Elder, USA

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2001: Why A Strategic Plan Based on a BCA?

• ASD(HA) tasked ASBPO to develop plan to deal with vCJD deferral looming over horizon (Mar 01)* GOAL – – maintainmaintain contingency/peacetime needs.

• Tasking two-fold • Short term (3-6 mo) plan of action (POA) to deal w/ vCJD deferral criteria (over 25% expected)• Long term strategic plan for ASBP to meet peacetime/wartime blood needs in efficient, cost effective and regulatory compliant manner•Support w/ POAPOA, , milestonesmilestones, , timelinetimeline & & BCABCA

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• Make up estimated 25% vCJD donor deferral– Obtain donor recruitment resources

• Eliminate non-productive screening of ineligible donors

• Minimum of 16 recruiters needed

– Obtain additional phlebotomy resources• Place at select CONUS BDCs at training sites• Minimum 10 phlebotomists needed

2001: Short Term Recommendations

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• Hire contractor to conduct BCA to validate panel findings and to:

– Determine optimum number of BDCs & testing centers

– Determine optimum locations for assets– Develop long term strategic plan based upon

outcome of BCA

2001: Long Term Recommendations

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March 2003Blood Program Mission

1. Mission is to collect blood in CONUS to support the warfighter overseas

2. One output of this program is a cost effective peacetime blood supply 3. Blood products collected were not linked to an established mission to

support peacetime needs of the Region or MHS

ASWBPL East shipments OCONUS

ASWBPL West shipments OCONUS

(1)(1)



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March 2003Define Peacetime Mission of ASBP

• Establish goal of DoD blood supply self sufficiency in peacetime needs

• Staff and resource to meet peacetime blood needs– Transfusion, ASWBPL quotas, and normal shelf inventory

and expiration – Total program goal: 85,000 usable units/year (150,000/year

in 2005-08)– Requires 106,000 total donors/year (180,000/year)

• Build in flexibility for surge expansion

Existing cost data show that a peacetimeblood mission based on these criteria would be cost effective

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DoD Readiness $ 68

DoD Peacetime Acquisition $ 143

(Average Total Cost $ 211 Range) $ 175 – 300)

Civilian Acquisition ~$ 210

(Range $ 175 – 250)

Cost Comparison

DoD acquisition cost for blood in peacetime is considerablylower than civilian acquisition cost but there is wide variation in both.

DoD transfusion costs appear higher than civiliantransfusion costs but the source of variation is not clear.

DoD Transfusion $ 635Civilian Transfusion $ 500

Cost per unit of blood acquired

Cost per unit of blood transfusedDoD Readiness $ 68



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March 2003: ASBP Annual External / Internal Exchange

More units of RBCs are transferredOUTSIDE the ASBP (to / from civilian

agencies, VA) than are transferred between Services inside the Program

NAVY19,118 donations

12,332transfusions

ARMY51,218 donations

30,176 transfusions

AIR FORCE18,933

donations12,780

transfusions

ASWBPLs

Civilian BloodPrograms

3661

3583

4062

12,404 to Civilian10,258 from Civilian



1,254 to Army1,555 to Navy

529 to Army2,933 to AF

656 to AF632 to Navy

VA Hospitals

3,400 to VA48 from VA



CY00 data. Frozen blood, manufacture of blood products omitted for clarity



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March 2003: Command, Control, and Funding• Blood Program has responsibility but no authority for resources • Blood donor centers compete with health care delivery for funds and staffing

BloodDonation Center

Ancillary Services

MedicalTreatment

Facility

Chief

MTF CO

ServiceSurgeonGeneral

ServiceBlood Program

Officer

Armed ServicesBlood Program

Office

HealthAffairs

Line(Installation Commander)

Service-specific Medical

Typical reporting structureSome BDCs are stand-alone or use other staffing arrangements

BloodTransfusion Center

OIC

FDA Licensed Program


JCS J4(HSSD)

COCOMS

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Mar 03: Short-Term Improvements to Increase Efficiency

• Increase recruiters, phlebotomists, & MLTs, to optimize collection/production of blood products

• Move to a data-driven management process• Develop a needs and inventory visibility system• Develop targeted quarterly communications for

overall program & donor communities• Optimize blood credit system across Services

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• Optimize BDC site location• Redefine peacetime mission requirements for BDCs

– 100% of DoD needs (125K annually)– Contingency (2100 units/day)

• Create mechanisms to balance blood inter-regionally and inter-Service in peacetime

• Separate blood manufacturing program from health care delivery to align authority with accountability

– Separate budget for BDCs from core medical budget– Separate staff for BDCs from MTF laboratory – Successful models – ASBBCs, Ft Hood & Ft Knox

• Implement incentive based funding

Mar 03: Improvements Discussed Long-Term

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Recommended ProgramRationalize and

Consolidate BDC Site Locations

Administrative management of inventoryRedefine

Peacetime Mission

BDC staff report to SBPOs

BDC

SG

SBPO

MTF

BDCs are Multi-Service Staffed as

Appropriate

Separate budget for BDCs

BDC

SG

SBPO

MTF

Maintain ServiceFDA Licenses

ARMY

NAVY

AIRFORCE

Standardize datareporting and

leverageexisting systems

SG SG SG

BDCs BDCs BDCs

SBPO SBPO SBPO

Standardized Data



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- GWOT/OIF OEF Years - National Security and Emergency Preparedness

The 2003 to 2008 Gap in Executing a Business Plan

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The 2003 to 2008 Gap in Executing a Business Plan

• ASBP Strategic Planning Workshops were held in 2003 to 2004.

• ASBP Workshops On Developing Capabilities and Strategic Planning held each year from 2005 to present. In 2008, the Workshop have representatives from NATO and an executive session with J4 and ASD(HA)FHP&R.

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Blood Products for OEF/OIF as of 27 May 03

0

5000

10000

15000

20000

25000

30000

OEF OIF

OEF (11 Sep 01-20 Mar 03) 2,021 u. OIF (21 Mar 03 - 27 May 03) 1,438 u.

RBCs SHIPRBCs TXND

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OIF Transfused Blood ProductsArmed Services Blood Program


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• Improve the mortality and morbidity of battlefield casualties by developing products that can be used by medics and physicians far-forward of a field hospital.

• American forces in the Iraq and Afghanistan conflict are experiencing the highest casualty survival rate in U.S. history.

• Mitigate the risk of emergent battlefield blood product transfusion to trauma casualties that include post-deployment medical care.

Vision Tenet: War FocusedOperation Iraqi Freedom and Operation Enduring Freedom

Global War on Terrorism/Operations

Tomorrow’s Science for Today’s Warfighters

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• Changing doctrine in tracking post-transfusion patients and creating tracking systems– The recipients of our transfusion services:

• US Military• Civilians from multiple nations • Coalition military partners• NATO military partners• US Gov’t Civilians• US Citizens (contractors, others)

– US Citizens receiving blood products from non-US hospitals

Challenges

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Blood Product Transfusions by Nationality

46,927

6,083

17,011

82,788

U.S.

Other

Iraqi

Afghan

69% of blood products are transfused to non-U.S. forces

54% 4%

31%

11%

As of 31 August 2007


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Challenges



The physician practice of collecting and transfusing “fresh” whole blood and apheresis platelets supports aggressive hemostatic resuscitation techniques performed in parallel with aggressive surgical control of bleeding.

•Develop blood products to support damage control resuscitation in lieu of fresh whole blood.•Develop rapid screening field tests for transfusion transmitted diseases, ABO Rh, and patient-donor compatibility.

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Transfusion practices in CENTCOM arise:- RBC age effect on massive transfusion in trauma.- Use of deglycerolized RBC in massively transfused

patients.- Component therapy vs whole blood transfusions.- RBC to FFP ratios (use of AB plasma vs A plasma).

Issues in the US:- Convalescent plasma- TRALI- DBL RBC collections - ETC, ETC

Challenges – Transfusion Medicine

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2005: ASBPO partners with US Government

A vital component of US medical support

DHS: Provides Funding

DOD: Provides Patient

Movement

Definitive Care

VA: Provides Definitive Care

HHS: Provides Response

Teams


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Defense Support to Civilian Assistance Process

NORTHCOM Responds

(when directed) JTF et al

Secretary of Defense authorizes

DoD support

DHS requests DoD

support

DHS implements National

Response Plan

President declares major disaster or

emergency

Governor requests Presidential Disaster Declaration through

DHS

City requests aid from state

Local first responders react

Disaster Occurs

Disaster Occurs


ASBP engaged in scenario planning/Execution of NRP.

28TRANSFORM THE FORCE/UNITY OF EFFORT

National Response

Plan

CDC

Department of Defense Dept, Health and Human Services

ASBPO

ASD(HA) FHP&RP2

Homeland Defense ASPR

JCS J4 HSSD

NORTHCOM


NIH

FDA

Homeland Security

ASH

QDR MRR

Strategy for Homeland Defense and Civil Support National Infrastructure

Protection Plan

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Quadrennial Defense Review

Roadmap for

Medical

Transformation15 June 2006


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QDR 3: Homeland Defense and Medical Civil-Military Operations

Objective: Align MHS capabilities to meet the requirements of DoD Homeland Defense, civil support, and medical civil-military operations.

Task 2: In FY 2007, use Joint Capabilities Integration and Development System (JCIDS) to conduct a capabilities-based analysis to determine the MHS “DOTMLPF” requirements.

* ASBPO is a member of the JS War Eagles, a JCIDS advisory group to Force Health Protection Board / Functional Capabilities Board (Ms Embrey). Provide the Joint Force with the capabilities needed to perform across the range of military operations and challenges.

Achieving Unity of Effort: All gov’t agencies to integrate their efforts into a unified strategy.


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Ensure medical capability for homeland defense and civil support missions. Driven by:

Strategy for Homeland Defense and Civil Support Hurricane Katrina Lessons Learned DoD Quadrennial Defense Review (QDR) MHS

Initiative #3Fulfill DOD responsibilities under National Response

Plan (NRP) DOD is a supporting agency to all Emergency

Support Functions (ESFs), including ESF #8 (Public Health and Medical Services)

Engage the interagency in transforming our national capacity to manage the public health and medical aspects of catastrophic domestic events

Position the Emergency Medical System to surge into a “Disaster Medical System” when needed.

*2008, CIVILIAN BLOOD COLLECTION AGENCIES ARE NOT MENTIONED IN ESF #8. INCREASES RELIANCE ON DOD BLOOD PROGRAM AS A GOV’T ASSET.

MHS: Homeland Defense and Civil Support

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Need a process to create a National system to understand population(s) at risk and determine the requirement(s) for medical countermeasures.

Necessarily includes Federal, state, and local governments, as well as national pharmaceutical manufacturing base and biologics (blood, tissues, stem cells, cord cells)

Requirements modeling DOD using Institute of Defense Analysis (IDA)

Only Government Agencies are part ofthis modeling effort.

MHS Preparedness – Way Ahead

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• National Infrastructure Protection Plan (2006) – Michael

Chertoff, Sec DHS

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Defense Infrastructure Sector Assurance Plan (DISAP) v. 2.1 LMI


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DISAP Topics

• National Critical Infrastructure Program

• DoD Critical Infrastructure Program

• DoD Health Sector CIP Program

• Information Systems Support

• Capability Area Working Documents

• Vulnerability Assessment Protocols


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Biodefense for the 21st Century:

1. Threat Awareness / Anticipation of Future Threats

2. Prevention and Detection

3. Surveillance and Detection

4. Response and Recovery

Capabilities required for response based on interagency-agreed scenarios derived from plausible threat assessments

Mass Casualty Care

Risk Communication

Decontamination

MEDICAL COUNTERMEASURE DEVELOPMENT

“…a blueprint for our future biodefense program…that fully integrates the sustained efforts of the national and homeland security, medical, public health, intelligence, diplomatic, and law enforcement communities.” George W. Bush

April 28, 2004

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• Blood, stem cells, tissue, and organs are a critical medical counter measure

• Local planning and national participation with monitoring systems – BASIS/BRAMS

• National Blood Reserve (Agree with it or not)• Frozen products as backfield

– Frozen RBC– Frozen Platelets– Fresh Frozen Plasma

• Hemostatic agents– Chitosan-dressing– Celox – arterial bleeding


ASBP - DHHS Partnership Initiatives

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ASBP - DHHS Partnership Initiatives

• Efficacy studies of whole blood v. component therapy

• Efficacy studies of age of blood• Rapid Testing to support initial screening “walking

donors”• Hemoglobin based Oxygen Carriers (HBOC)• Novo-Seven or “cocktail”• Platelet Substitutes• Pathogen inactivation• Blood pharming - rbc and platelets


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- MTS Boxes (Logistics)- Non-FDA Licensed Blood Product Transfusions- Golden Hour Box Validations- Technology Implementation

- Leuko-reduction- DBL RBC Collections- DBL Plasma Collections- RBCXL- Convalescent Plasma

- Information Blood Systems- Transfusion Medicine Experts- Blood Research and Development- Managing DOD CONUS Blood Inventories

Multiply Blood Program Offices – Lack Ability to Plan Efficiently and Execute

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- Secretary of Defense- Under Secretary of Defense for Personnel

and Readiness- Assistant Secretary of Defense (ASD) for

Health Affairs- ASD (HA) Force Health Protection and

Readiness- ASD (HA) Clinical Plans and Policy

ASBPO held directly accountable for events and outcomes it has no authority or control over.

Who Answers for the ASBP?

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Feb 08 (same): Command, Control, and Funding• Blood Program HQ Offices has responsibility but no authority for resources • Blood donor centers compete with health care delivery for funds and staffing

BloodDonation Center

Ancillary Services

MedicalTreatment

Facility

Chief

MTF CO

ServiceSurgeonGeneral

ServiceBlood Program

Officer

Armed ServicesBlood Program

Office

HealthAffairs

Line(Installation Commander)

Service-specific Medical

Typical reporting structureSome BDCs are stand-alone or use other staffing arrangements

BloodTransfusion Center

OIC

FDA Licensed Program


JCS DHHS

COCOMS

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The Transformation

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• Service Blood Programs operating independently, resulting in:– Operational redundancies– Disparate chains of command– Inability to generate efficient, positive change

• Disparate governance and authority over policy• Disjointed and inefficient use of enterprise technology, data, and

information• Objective:

– Improve governance and authority of a central blood program office over ASBP organizational resources, business processes, information, and technologies

– Reduce redundancies and inefficiencies which have developed over time among the Service Blood Programs

– Define and implement business processes, information, data, and technology

Drivers of Enterprise Transformation for the Armed Services Blood Program

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Under Secretary of Defense for Personnel and Readiness or Assistant Secretary of Defense for Health Affairs, with Joint Staff concurrence, signs “directive” or charters Force Health Protection and Readiness to execute a study of the ASBP on “as is”, “what it should be”, and “how to get there.”

BLUF: “The current ASBP organization must be changed based on patient safety alone.”

Transformation: Getting There

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Transformation concept and study implementation plan approved by:

- JSC J4 (HSSD)- ASD(HA)FHP&R- OTSG (as ASBPO EA)

Study is funded and pending contract execution.

Transformation

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Transformation• The study begins with meeting the needs of

the stakeholders/customers:– COCOMs– JCS (J4 HSSD)– ASD(HA)FHP&RP2

– ASD(HA)CPP– Dept Homeland Defense– Dept Health and Human Services (via MOU)


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• Duplicate processes, information, data, and systems will be unified under a single ASBP Business Enterprise Architecture (BEA)

• ASBP goals will be aligned with those of MHS; misalignments will be identified and resolved

• All Service Blood Programs will work as a single cohesive unit, while retaining service affiliation.

• ASBP goals will be aligned with those of DHHS; eliminate redundancies in R&D, improve command and control, and logistics of a national proportion.

Transformation Benefits

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• Utilize the mandated and best practice Department of Defense Architecture Framework (DoDAF)

• Analysis of current state ASBPO architecture (“Where we are”)• Define future state ASBPO architecture (“Where we want to

be”)• Define and implement transition activities (“How we will get

there”)• Identify vision of future state Concept of Operations (ConOps)• Develop operational detail of how vision will be realized in

terms of organizational, management, technology governance, budget, and other terms.

• Create transition plan detailing how to take ASBPO from current state to future state of operations.

Transformation Approach

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Libby’s Transformation Future Vision

• Establish one blood program agency (Defense Agency or part of JFCOM)– Single FDA License– Single Command and Control

• Civilian staff – continuity of experience and knowledge• Establish a Transfusion Medicine Branch• Join with DHHS / Homeland Security – Homeland Defense

– PHS Officers/staff (Indian reservations, US Territories, Prisons)– Need a National Blood Program for disaster preparedness (all

countries of the world have a national program)

• Veterans Affairs partnership • Oversight of tissue and organs• Cost effective


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