Upload
samuel-richardson
View
219
Download
2
Embed Size (px)
Citation preview
1
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
2
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
3
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
4
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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!)
5
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
- 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
6
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
7
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
8
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
9
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)
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
10
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
11
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
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
12
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
3,915 to Civilian6,846 from Civilian
4,615 to Civilian7,956 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
3,754 to VA78 from VA
1,107 to VA33 from VA
CY00 data. Frozen blood, manufacture of blood products omitted for clarity
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
13
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
Armed Services Blood Program
JCS J4(HSSD)
COCOMS
14
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
15
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
16
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
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
17
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
- GWOT/OIF OEF Years - National Security and Emergency Preparedness
The 2003 to 2008 Gap in Executing a Business Plan
18
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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.
19
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
21
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
22
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
23
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
Armed Services Blood Program
24
Challenges
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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.
25
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
26
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
Armed Services Blood Program
27
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
Armed Services Blood Program
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
Armed Services Blood Program
NIH
FDA
Homeland Security
ASH
QDR MRR
Strategy for Homeland Defense and Civil Support National Infrastructure
Protection Plan
29
Quadrennial Defense Review
Roadmap for
Medical
Transformation15 June 2006
Armed Services Blood Program
30
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.
Armed Services Blood Program
31
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
32
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
33
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• National Infrastructure Protection Plan (2006) – Michael
Chertoff, Sec DHS
35
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
Armed Services Blood Program
36
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
37
• 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
Armed Services Blood Program
ASBP - DHHS Partnership Initiatives
38
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
Armed Services Blood Program
39
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
- 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
40
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
- 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?
41
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
Armed Services Blood Program
JCS DHHS
COCOMS
43
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
44
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
45
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
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
46
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)
Armed Services Blood Program
47
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
48
Armed Services Blood Program
www.militaryblood.dod.mil UNCLASSIFIED
• 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
49
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
Armed Services Blood Program