BY ORDER OF THE SECRETARY OF THE AIR FORCE AIR FORCE

BY ORDER OF THE

SECRETARY OF THE AIR FORCE

AIR FORCE INSTRUCTION 44-105

10 JANUARY 2019

Medical

THE AIR FORCE BLOOD PROGRAM

COMPLIANCE WITH THIS PUBLICATION IS MANDATORY

ACCESSIBILITY: Publications and forms are available on the e-Publishing website at

www.e-Publishing.af.mil for downloading or ordering.

RELEASABILITY: There are no releasability restrictions on this publication.

OPR: AFMOA/SGBL

Supersedes: AFI 44-105,

6 November 2014

Certified by: AFMOA/CC

(Brig Gen James H. Dienst)

Pages: 29

This Air Force Instruction (AFI) implements Air Force Policy Directive 44-1, Medical Operations,

and Department of Defense (DoD) Instruction 6480.4, Armed Services Blood Program

Operational Procedures and is consistent with Air Force Manual (AFMAN) 41-111_IP, Standards

for Blood Banks and Transfusion Services. This publication provides the standardized procedures

for management and operation of the Air Force Blood Program (AFBP) in alignment with

requirements set forth by the AABB, the Armed Services Blood Program, the College of American

Pathologists, Assistant Secretary of Defense for Health Affairs (ASD(HA)), and the Food and

Drug Administration (FDA). It applies to all individuals assigned to Air Force (AF) blood

missions, including Air Force Reserve and Air National Guard personnel upon mobilization. This

instruction may be supplemented at any level, but all supplements must be routed to the Air Force

Medical Operations Agency (AFMOA) Air Force Blood Program Division for coordination prior

to certification and approval. Refer recommended changes and questions about this publication to

the AFBP using AF Form 847, Recommendation for Change of Publication. Route AF Forms 847

from the field through the appropriate functional chain of command. Ensure that all records

created as a result of processes prescribed in this publication are maintained in accordance with

AFMAN 33-363, Management of Records, and disposed of in accordance with the AF Records

Disposition Schedule located in the AF Records Information Management System. This

Instruction requires the collection and or maintenance of information protected by the Privacy Act

of 1974 authorized by 5 U.S.C. 552a, 42 U.S.C. 290dd-2, and DoD Health Information Privacy

Regulation (DoD 6025.18-R). The applicable System of Records Notice (SORN), EDHA 07,

2  AFI 44-105  10 JANUARY 2019 
Military  Health  Information  System  (November  18,  2013,  78  FR  69076)  is  available  at:  
http://dpclo.defense.gov/Privacy/SORNs.aspx.    The  authorities  to  waive  wing/unit  level 
requirements in this publication are identified with a Tier number (T-0, T-1, T-2, T-3) following 
the  compliance  statement.    See  Air  Force  Instruction  (AFI)  33-360,  Publications  and  Forms 
Management,  for  a  description  of  the  authorities  associated  with  the  Tier  numbers.    Submit 
requests  for  waivers  through  the  chain  of  command  to  the  appropriate  Tier  waiver  approval 
authority, or alternately, to the requestors commander for non-tiered compliance items.  The use 
of the name or mark of any specific manufacturer, commercial product, commodity, or service in 
this publication does not imply endorsement by the AF. 
SUMMARY OF CHANGES 
The revision of this publication updates the new AF Surgeon General (AF/SG) signature block; 
removes uncommon and underutilized acronyms; removes the requirement for the Base Blood 
Program Officer to establish a donor recognition program; removes the limit to 500 credits for 
blood  products  from  civilian  collections;  and  clarifies  additional  expectations  of  civilian 
Memoranda  of  Understanding  for  credits.    Attachment  2  was  updated  as  follows:  the  366th 
Medical Group at Mountain Home Air Force Base (AFB) was deleted and 39th Medical Group at 
Incirlik Air Base, Armed Services Blood Banking Center-San Antonio at Joint Base San Antonio 
and Air Force Special Operations Command were added. 
 
Chapter 1— Program Overview, Roles, and Responsibilities    4 
1.1.   Overview.   ..............................................................................................................   4 
1.2.   Program Organization.   ..........................................................................................   4 
1.3.   Air Force Blood Program Elements.   .....................................................................   4 
1.4.   Responsibilities. ......................................................................................................   4 
Chapter 2— Blood Donor Center Operations    11 
2.1.   Overview.   ..............................................................................................................   11 
2.2.   Product Distribution.   .............................................................................................   11 
2.3.   Walking Donor Program.   ......................................................................................   12 
Chapter 3— Transfusion Service Operations    14 
3.1.   Overview.   ..............................................................................................................   14 
Table  3.1.   Air Force Blood Program Notification to the Food and Drug Administration. ......   14 
3.2.   Inventory Management ...........................................................................................   15 
3.3.   Procurement of Blood Products ..............................................................................   15 
3.4.   Distribution of Excess Blood Products.   ................................................................   16 

AFI 44-105  10 JANUARY 2019  3 
Chapter 4— Regulatory and Administrative Processes for Blood Program Operations    17 
1.   Inventory Accountability.  ......................................................................................   17 
2.   Quality Assurance (QA) Program. ..........................................................................   17 
3.   Infectious Disease Lookback Program. ..................................................................   17 
4.   Non- Food and Drug Administration Compliant Blood Products. .........................   18 
5.   Food and Drug Administration Licensure and Registration Program. ...................   18 
6.   AABB Inspections. .................................................................................................   18 
7.   Computerization and Information Management. ....................................................   19 
8.   Required Reports. ...................................................................................................   19 
Chapter 5— Sharing Agreements and Contract Requirements    20 
1.   Overview.   ..............................................................................................................   20 
2.   Civilian Blood Donor Centers Collecting Blood on Military Installations. ............   20 
3.   Recovered Blood Product Programs. ......................................................................   21 
4.   Other DoD Blood Donor Centers Collecting Blood on AF installations. ...............   21 
5.   Contracts for Blood Product Purchasing. ................................................................   22 
6.   Contracts for Donor Infectious Disease Testing.   ..................................................   22 
7.   Wartime Contract Restrictions ................................................................................   22 
Chapter 6— Air Force Blood Program Readiness Functions    23 
1.   Overview.   ..............................................................................................................   23 
2.   Blood Readiness Elements/Functions .....................................................................   23 
Attachment 1— GLOSSARY OF REFERENCES AND SUPPORTING INFORMATION    25 
 
   

4 AFI 44-105 10 JANUARY 2019

Chapter 1

PROGRAM OVERVIEW, ROLES, AND RESPONSIBILITIES

1.1. Overview. This publication provides the standardized procedures for management and

operation of the AFBP in alignment with requirements set forth by the AABB, the Armed Services

Blood Program, the College of American Pathologists, Assistant Secretary of Defense for Health

Affairs, and the FDA. The AFBP provides safe, cost-effective, quality blood products and services

in support of the Department of Defense’s wartime and peacetime medical missions. The AFBP

ensures that collection, manufacturing, storage, distribution and transfusion of blood products to

military personnel adhere to the FDA Current Good Manufacturing Practices and regulations

published by the FDA in Title 21 of the Code of Federal Regulations, Parts 200-299 and Parts 600-

680 and to the standards of national accrediting agencies. The AFBP operates per direction of the

Air Force Surgeon General by authority granted under Biologics License Number 610, issued by

the FDA.

1.2. Program Organization. The primary focus of the AFBP is to provide leadership, direction

and guidance for all elements of the AFBP in support of expeditionary and peacetime medical

missions. The AFBP is an integral part of the Armed Services Blood Program. The Armed

Services Blood Program is under the responsibility of the Assistant Secretary of Defense for Health

Affairs. The Secretary of the Army is the Department of Defense Executive Agent for the Armed

Services Blood Program. The Armed Services Blood Program is an integrated blood products

system composed of the Military Services’ and Combatant Commands’ blood programs, and is

coordinated by the Armed Services Blood Program Office. This program provides blood products

to Department of Defense military treatment facilities for both peacetime and wartime use. The

readiness posture of the program is maintained through an active voluntary donor program, blood

collection, blood product manufacturing, quality assurance (QA), logistics, and transfusion

training programs. The program also actively participates in joint exercises and responds to

homeland defense contingencies and public health emergencies when directed by government

authorities.

1.3. Air Force Blood Program Elements. The AFBP is composed of various operational,

manufacturing and shipping elements including Blood Donor Centers, Transfusion Services,

Armed Services Whole Blood Processing Laboratories, Expeditionary Blood Transshipment

Centers, Expeditionary Blood Support Centers, and Frozen Blood Product Teams. Each element

contributes to a tri-service blood distribution system that supports military treatment facilities in

the Continental United States (CONUS) and outside the Continental United States (OCONUS)

during peacetime and wartime. All the CONUS military treatment facilities and blood donor

centers are registered or licensed with the FDA and maintain accreditation by the AABB. All

OCONUS military treatment facilities, with the exception of the 673d Medical Group, must be

registered with the FDA and are highly encouraged to follow AABB standards. The 673d Medical

Group at Joint Base Elmendorf-Richardson, Alaska, will maintain AABB accreditation and FDA

registration.

1.4. Responsibilities.

1.4.1. The Assistant Secretary of the Air Force for Manpower and Reserve Affairs (SAF/MR)

serves as an agent of the Secretary of the Air Force and provides guidance, direction, and

AFI 44-105 10 JANUARY 2019 5

oversight for all matters pertaining to the formulation, review, and execution of plans, policies,

programs, and budgets addressing the AFBP. SAF/MR will:

1.4.1.1. Provide funds, facilities, and support personnel, as required, to maintain the Blood

Donor Centers and the Armed Services Whole Blood Processing Laboratories.

1.4.1.2. Fund transportation of AF-collected and processed blood products and incidental

expenses associated with their delivery to the first CONUS destination.

1.4.1.3. Provide, as the DoD Executive Agent for the Armed Services Whole Blood

Processing Laboratories, Expeditionary Blood Transshipment Centers, Expeditionary

Blood Support Centers, and Frozen Blood Product Teams appropriate support personnel,

facilities, and budgetary resources, as required to maintain at least two Armed Services

Whole Blood Processing Laboratories in active status.

1.4.2. The Air Force Surgeon General will:

1.4.2.1. Serve as the authorized agent for the Air Force Biologics License Number 610,

issued by the FDA. This authority may be delegated to the Chief and/or Deputy Chief,

AFBP.

1.4.2.2. Exercise control over all matters relating to compliance with FDA requirements

as detailed in 21 CFR Parts 200-299 and 600-680. Ensure all AFBP elements gain FDA

registration or licensure, as appropriate, and comply with FDA regulations.

1.4.2.3. Ensure appropriate action is taken to correct and prevent recurrence if the FDA

issues a Form FDA 483, Inspectional Observations, to an AFBP element.

1.4.2.4. Ensure the FDA’s Director, Office of Compliance, Center for Biologics

Evaluation and Research, receives notification within 24 hours in the event of a

transfusion-related fatality or when the post-transfusion cause of death is unknown and

could possibly be related to transfusion.

1.4.2.4.1. Ensure FDA / Center for Biologics Evaluation and Research receives

notification of reportable biological product deviations.

1.4.2.4.2. Provide continuing education programs for clinical laboratory officers and

QA staff to ensure they are current in current Good Manufacturing Practices and

matters of FDA compliance and regulation.

1.4.2.5. Appoint the Chief, AFBP, from candidates provided by the Chief Consultant to

the Surgeon General for Medical Laboratory.

1.4.3. Air Force Medical Operations Agency will:

1.4.3.1. Support the AFBP and ensure adequate resources are available to meet blood

missions.

1.4.3.2. Provide consultation to Major Commands (MAJCOMs) for any blood-related

matters via the AFBP.

1.4.3.3. Ensure blood program funds received from the Armed Services Blood Program

are distributed according to requirements and budget plan. Ensure that military treatment

facilities with blood services funding requirements identify and request appropriate source

funding.

6 AFI 44-105 10 JANUARY 2019

1.4.4. The Chief, Air Force Blood Program will:

1.4.4.1. On behalf of the AF/SG, manage the AF Biologics License Number 610, issued

by the FDA. Coordinate AF policies to ensure compliance with AABB, Armed Services

Blood Program, FDA, Assistant Secretary of Defense for Health Affairs and other

regulatory or accrediting agencies, to include fatality reporting, deviation reporting and

coordination of the infectious disease lookback program.

1.4.4.2. Serve as authorized agent to the FDA and appoint AFBP staff as authorized

agents, as appropriate.

1.4.4.3. Coordinate and manage all AF blood matters, including operational, research,

training and QA issues. Provide operational guidance to MAJCOMS, military treatment

facilities and readiness sections. Assist in determining training and manning requirements

for enlisted laboratory technicians and laboratory officers serving in operational blood

missions.

1.4.4.4. Serve as liaison between military treatment facilities and the FDA. The AFBP is

the only agency authorized to interact with the FDA (except when the military treatment

facility is undergoing on-site FDA inspections). All FDA license/registration applications

and biological product deviations must be coordinated through, approved by and submitted

by the AFBP. (T-2).

1.4.4.5. Serve as the consultant to the Manpower and Equipment Force Packaging

Responsible Agencies for blood-related Unit Type Codes, Allowance Standards and pilot

units. Ensure readiness functions are appropriately identified, staffed and funded.

1.4.4.6. Perform regulatory evaluations of the AF FDA–licensed and registered facilities

to provide guidance and ensure compliance with all applicable regulations and standards.

(T-2).

1.4.4.7. Direct the actions of the QA managers to ensure compliance with regulations and

accreditation standards. Guide military treatment facilities in appropriate investigation,

corrective action and submission of all FDA–reportable deviations.

1.4.4.8. Monitor any reports of suspected transfusion-transmitted diseases submitted to the

AFBP as required by the FDA reporting system and lookback regulations.

1.4.4.9. Establish AF blood product quotas for Department of Defense contingencies and

identify blood mobilization requirements.

1.4.4.10. Coordinate the activities of AF Blood Donor Centers to meet the Armed Services

Blood Program Office quota requirements and monitor blood distribution network

effectiveness during peacetime and wartime.

1.4.4.11. Ensure AFBP elements appropriately fund the peacetime component of their

blood missions using the Program Objective Memorandum (POM) process at their attached

military treatment facility.

1.4.4.12. Contact the Armed Services Blood Program Office to identify and obtain

appropriate funding when the AFBP mission is expanded due to war, contingency or

emergency.

AFI 44-105 10 JANUARY 2019 7

1.4.4.13. Provide the Armed Services Blood Program Office with accurate requirements

for forecasting and sourcing the types and quantities of blood products to be procured for

peacetime use, homeland defense, wartime and contingencies.

1.4.4.14. Compile AFBP QA statistics for process improvement initiatives, and coordinate

with the Armed Services Blood Program Office to establish program performance metrics

and standards.

1.4.4.15. Assist in the development, deployment and maintenance of information

technology initiatives in support of the AFBP and Armed Services Blood Program.

1.4.4.16. Supervise the Directors of the Armed Services Whole Blood Processing

Laboratories and Air Force-led Armed Services Blood Banking Centers.

1.4.5. The Medical Consultant, AFBP, will:

1.4.5.1. Serve in a consultative role to the Armed Services Blood Program Office and

AFBP on donor acceptability, review of FDA reports, updating deferral lists and readiness

issues. May also serve as medical advisor on DoD committees and other Federal

Committees.

1.4.5.2. Be a transfusion medicine trained pathologist, preferably board certified in

transfusion medicine.

1.4.6. Installation Commanders will:

1.4.6.1. Encourage donors at the frequency and in the quantity necessary to enable AF

Blood Donor Centers to meet peacetime and contingency needs for blood products. (T-2).

1.4.6.2. Encourage cooperation between subordinate commanders to support the AFBP

mission and to minimize interruption of work and training schedules while soliciting blood

donors during normal duty hours. (T-2).

1.4.6.3. Ensure DoD-affiliated Blood Donor Centers, where available, have priority access

to donors over civilian blood collecting organizations in order to meet DoD healthcare

requirements. (T-1).

1.4.6.4. Establish Memoranda of Understanding (MOU) with all civilian blood collection

agencies that are granted access to DoD donors on military installations in accordance with

(IAW) ASD(HA) Policy 04-015, Revised Policy Regarding Standardization of Infectious

Disease Reporting Requirements for Civilian Blood Agencies Collecting Blood on Military

Installations, at Military Leased Facilities or Aboard Ships; ASD(HA) Policy 04-019,

Revised Policy Regarding Civilian Blood Collections on Military Installations, Leased

Facilities, and Aboard Ships; and this instruction. (T-1).

1.4.6.5. Provide necessary support to enable the Armed Services Blood Program, Blood

Donor Centers, and/or civilian blood collection agencies with MOUs to perform blood

drives. (T-1).

1.4.6.6. Ensure the Military Personnel Section (MPS) provides the requesting military

Blood Donor Center with a base personnel roster of active component members by unit

and ABO group and Rh blood type. Refer to Paragraph 2.1.3 for further information. (T-

2).

8 AFI 44-105 10 JANUARY 2019

1.4.6.7. Appoint in writing, an officer, senior NCO, or civilian employee (GS-7 or higher)

who will be able to dedicate sufficient time to serve as the Base Blood Program Officer.

For bases with AF Blood Donor Centers, the Blood Donor Center recruiter will serve as

the Base Blood Program Officer. The Blood Donor Center recruiter does not require

appointment. (T-2).

1.4.7. The Base Blood Program Officer:

1.4.7.1. May develop a program of continuing donor education and motivation to

recognize people for their donations.

1.4.7.2. Develops a system with points-of-contact for each installation unit to provide

donors for installation-sponsored blood drives. (T-3).

1.4.7.3. Updates the installation commander, at least annually, on donor program activities

and unit blood collection statistics. (T-3).

1.4.7.4. Ensures that MOUs are accomplished with each civilian agency collecting donors

on the installation. (T-3).

1.4.7.5. Works in consultation with the AFBP and local military treatment facility’s

laboratory when developing an MOU. (T-3).

1.4.8. The Military Treatment Facility Commander or Director:

1.4.8.1. Ensures compliance with AABB, Armed Services Blood Program, FDA,

ASD(HA) and other accrediting agency standards, to include fatality reporting, deviation

reporting and the infectious disease lookback program. (T-0).

1.4.8.2. Ensures the necessary corrective actions are taken to ensure compliance with FDA

regulations and notifies the AFBP of any unresolved problems. (T-0).

1.4.8.3. Appoints a qualified Medical Director to direct the local Transfusion Service

and/or Blood Donor Center. (T-1).

1.4.8.3.1. Ensures the QA Officer is for the local Blood Donor Center is separate from

operational responsibility and will not be supervised by the Blood Donor Center

management. (T-1).

1.4.8.3.2. Ensures the QA Officer is for the local Transfusion Service is separate from

operational responsibility, as much as possible. (T-1).

1.4.9. The Air Force Blood Program Elements: (See paragraph 1.3.)

1.4.9.1. Comply with directives, regulations and standards of AABB, Armed Services

Blood Program, FDA, ASD(HA) and other accrediting agencies to include fatality

reporting, deviation reporting and the infectious disease lookback program. (T-0).

1.4.9.2. Develop and maintain a QA program. (T-3).

1.4.9.3. Contact the AFBP to route questions to the FDA. (T-0).

1.4.9.4. Ensure the AFBP receives notification in the event of a transfusion-related fatality

or when the post-transfusion cause of death is unknown and could possibly be related to

transfusion; notification must occur no later than 24 hours after discovery. (T-0).

AFI 44-105 10 JANUARY 2019 9

1.4.9.5. Initiate all infectious disease lookback functions as required by the FDA.

Possible, suspected and confirmed cases of transfusion-transmitted disease requiring

lookback investigation will be reported to the AFBP as a biological product deviation. (T-

0).

1.4.9.6. Initiate peacetime funding requests through the supporting Resource Management

Office of the local military treatment facility with the POM process in alignment with the

AF POM schedule.

1.4.9.7. Coordinate funding for expanded missions due to contingency or emergency

through the AFBP.

1.4.9.8. Prepare for continuous operation at the maximum tasking noted in AFI 44-118,

Operational Procedures for the Armed Services Blood Program Elements. (T-3).

1.4.9.9. Ship, as directed, existing stock from Blood Donor Center inventory in support of

contingencies within 24 hours of notification. (T-3).

1.4.9.10. Participate in the Armed Services Blood Program frozen blood program as

directed and funded.

1.4.9.11. Establish minimum, target and maximum blood product inventory levels. (T-3).

1.4.10. The Inventory Manager:

1.4.10.1. Monitors blood inventory levels to keep inventory near established target level.

(T-3).

1.4.10.2. Maintains account with the DoD CONUS Blood Management Tool. (T-3).

1.4.10.3. Procures and distributes excess blood products for routine day-to-day military

treatment facility use via methods that offer the greatest overall advantage to the AF (refer

to paragraph 3.4). (T-3).

1.4.11. The Quality Assurance unit will:

1.4.11.1. Be responsible for the QA program to ensure compliance with AABB, Armed

Services Blood Program, FDA, ASD(HA) and other accrediting agencies, to include

fatality reporting, deviation reporting and the infectious disease lookback program. (T-3).

1.4.11.2. Retain authority to cease production of blood products if problems with Current

Good Manufacturing Practices (cGMP) are identified.

1.4.11.3. Submit data to the AFBP for inclusion in the annual FDA report. (T-2).

1.4.12. The Armed Services Whole Blood Processing Laboratories (ASWBPLs) will:

1.4.12.1. Receive and maintain a contingency reserve of blood products and act as a central

repository for forward shipment of blood products to operational units. (T-2).

1.4.12.2. Perform ABO and Rh confirmation testing on Red Blood Cell units. (T-2).

1.4.12.3. Pack, ice and prepare blood products for shipment to the theater. (T-2).

1.4.12.4. Prepare for continuous operation at the maximum tasking noted in AFI 44-118.

(T-2).

10 AFI 44-105 10 JANUARY 2019

1.4.12.5. Distribute excess blood products to the Service Blood Programs, to Veterans

Affairs (VA) facilities or other locations as directed by Armed Services Blood Program

Office via the Chief, AFBP. (T-2).

1.4.12.6. Provide support to exercises (real-world blood support and simulated blood), as

directed by the Armed Services Blood Program Office via the AFBP. (T-2).

1.4.12.7. When directed and funded by the AFBP, maintain equipment, supplies and an

adequate number of trained personnel for freezing, deglycerolization and training purposes

in support of the Armed Services Blood Program frozen blood program. (T-2).

1.4.12.8. Provide daily inventory reports, weekly compliance reports and other reports as

directed to the AFBP. (T-2).

AFI 44-105 10 JANUARY 2019 11

Chapter 2

BLOOD DONOR CENTER OPERATIONS

2.1. Overview. Blood Donor Centers are FDA-licensed CONUS-based facilities that serve vital

peacetime and wartime missions supporting the Military Health Service with blood products in the

CONUS and worldwide. The three AF Blood Donor Centers are located at Keesler AFB,

Mississippi; Joint Base San Antonio, Texas; and Wright-Patterson AFB, Ohio. Blood will only be

collected from United States citizens, to include military members, DoD civilians or contractors,

or beneficiaries.

2.1.1. Voluntary Donations. All blood donations will be voluntary (per FDA Compliance

Policy Guide Sec. 230.150, Blood Donor Classification Statement, Paid or Volunteer Donor)

and will comply with FDA and AABB requirements. (T-0). The AF encourages its employees

to volunteer as blood donors. A civilian employee may be excused for a maximum time of

four hours to support volunteer blood donation IAW AFI 36-815, Absence and Leave. Military

commanders may authorize time-off incentive (special pass) for active duty personnel. Terms

of a contract outline how contractor time is accounted for when donating blood.

2.1.2. Donor Nourishment. Refreshments (such as cookies, water and fruit juice) should be

provided as a provision of medical care to donors to minimize adverse reactions to blood

donation. Subsistence items should be purchased through Medical Logistics using Operation

and Maintenance (O&M) funds at sites with attached AF Blood Donor Centers. Note:

Civilian organizations operating blood drives on base will furnish their own nourishment items

for donors.

2.1.3. Donor Recruitment. Recruiting should target specific blood types and products to meet

local and contingency requirements. Indiscriminate collections of unrequested blood types

should be avoided in order to reduce outdate rates and avoid waste of government resources

for collection, testing and distribution. Close coordination with installation command

personnel is critical to the provision of adequate donors to ensure that specific numbers and

blood types are provided on request. Blood Donor Centers should request active duty alpha

rosters from the Military Personnel Flight as needed.

2.1.4. Donor Motivation. Reasonable incentives and recognition, such as T-shirts, coffee

mugs, or pens, may be offered for recruitment and retention of donors to encourage continued

donations, ensuring support and success of the AFBP mission IAW AFI 65-601V1, Budget

Guidance and Procedures. Note: Civilian organizations will furnish their own donor incentive

items.

2.1.5. Aircrew. Aircrew and Special Operational Duty members who donate blood (200 mL

or more) may be disqualified from flying up to 72 hours IAW AFI 48-123, Medical

Examinations and Standards. This restriction includes donation of whole blood,

plasmapheresis and plateletpheresis.

2.2. Product Distribution. Products manufactured by AF Blood Donor Centers will be

distributed in the following descending priority: (T-1)

2.2.1. Contingency requirements, including support of Armed Services Blood Program Office

–levied quotas.

12 AFI 44-105 10 JANUARY 2019

2.2.2. Military Health Systems requirements at AF military treatment facilities.

2.2.3. Military Health Systems requirements at other DoD military treatment facilities.

2.2.4. Requests from other institutions such as Veteran’s Affairs or Public Health Services.

2.2.5. Other civilian exchange programs.

2.3. Walking Donor Program. Walking Donor Programs are intended for OCONUS facilities

where the local blood supply may not be equivalent to FDA standards, or where the local supplier

may not be able to provide enough blood products during contingency situations. These involve

the emergent collection of non-FDA compliant blood products in support of disaster and

contingency demand. All OCONUS military treatment facilities should incorporate the demand

for blood into their contingency response plans and determine when a Walking Donor Program

may be required. The use of blood collected under emergency conditions may be required to save

life or limb during mass casualty events or combat operations.

2.3.1. Military treatment facilities that identify a need to establish a Walking Donor Program

should coordinate with their respective MAJCOM/SG and Area Blood Program Officer for

approval and guidance.

2.3.2. The military treatment facility is responsible for funding the Walking Donor Program.

2.3.3. To the greatest extent possible, military treatment facilities with Walking Donor

Programs will establish and maintain rosters of pre-infectious disease tested donors (HBsAg,

Anti-HBc, Anti-HCV, HCV RNA, Anti-HIV 1/2, HIV-1 RNA, Anti-HTLV I/II, WNV RNA,

Syphilis, Chagas and Zika virus) and will repeat prescreening at regular intervals not to exceed

90 days. (T-3).

2.3.4. When emergency blood collections are required, donors will be selected in the

following descending priority:

2.3.4.1. Donors who have been prescreened within the last 90 days with the full panel of

FDA –licensed donor infectious disease tests and found to be negative for all tests. Note:

Any donor with a positive test result will not be listed as an approved, prescreened donor

and must not be collected.

2.3.4.2. Donors who report donating in the past and have not been deferred for transfusion-

transmitted disease.

2.3.4.3. Donors who have not been prescreened with FDA –licensed tests, nor have been

blood donors in the past.

2.3.5. On the day of donation, prospective donors will be screened for eligibility using

approved donor history screening protocols and be tested for infectious diseases using Armed

Services Blood Program Office –approved rapid screening tests. As much as possible, rapid

screening tests should be performed before issuing the product.

2.3.6. When emergency blood units are collected:

2.3.6.1. Each unit and its corresponding infectious disease samples will be labeled with a

unique donor identification number. The identification number should be International

Society of Blood Transfusion-compliant, if possible. Products must be labeled “For

Emergency Use Only” IAW 21 CFR Part 610.40(g). (T-3).

AFI 44-105 10 JANUARY 2019 13

2.3.6.2. The blood samples will be sent to an FDA –licensed donor testing laboratory for

retrospective testing.

2.3.6.3. All collection information and the results of all rapid screening and retrospective

sample testing will be maintained locally and entered into the operational blood

management system. (T-3).

2.3.6.4. Follow-up notification and counseling will be provided to any donor who tests

positive/reactive on either a prescreen, rapid or retrospective infectious disease test.

Appropriate medical treatment referrals will be accomplished. (T-1).

14 AFI 44-105 10 JANUARY 2019

Chapter 3

TRANSFUSION SERVICE OPERATIONS

3.1. Overview. Transfusion of human blood products carries a small, but genuine risk of adverse

events and transmission of infectious agents. Alternative interventions, such as the transfusion of

synthetic factor concentrates or products that have undergone viral-inactivation procedures (e.g.

albumin, other plasma derivatives and substitutes) should be considered for use in lieu of blood

products when possible.

3.1.1. Informed Consent. Clinicians will accomplish and document informed consent IAW

AFI 44-102, Medical Care Management. (T-3).

3.1.2. Blood Component Requests. Standard Form 518, Blood or Blood Component

Transfusion (SF 518), suitable Enterprise Blood Management System –Transfusion form or

local form shall be completed for each component request. (T-3). Note: The SF 518 does not

represent the physician’s order to transfuse a blood product, but may be used to document the

transfusion event within the recipient’s medical record.

3.1.3. Military Treatment Facility Instruction. Each military treatment facility that operates

a Transfusion Service shall have a military treatment facility instruction that establishes and

governs the transfusion-related activities in the facility. (T-3).

3.1.3.1. The military treatment facility policy will address blood component

administration to include the use of infusion devices, compatible fluids, ancillary

equipment, transfusion and blood utilization monitoring; blood administration shall be

consistent with the AABB Circular of Information for the Use of Human Blood and Blood

Components, AABB standards and FDA regulations. (T-0).

3.1.3.2. Patients may refuse transfusion of blood products for religious reasons. The

military treatment facility instruction should address how the provider will obtain patient

consent in this situation and how the facility manages these patients’ blood requirements.

3.1.4. Transfusion Reaction. Investigation of suspected transfusion reactions should use AF

Form 1224, Blood Transfusion Reaction Investigation or an equivalent locally developed form.

3.1.5. Transfusion-Related Fatality. The AFBP (DSN 969-9941 or 9928; Commercial 210-

395-9941 or 9928) must be notified within 24 hours of a transfusion-related fatality or when

the post-transfusion cause of death is unknown and could possibly be related to transfusion.

(T-2). The military treatment facility is required to begin a root cause analysis and forward a

report to the AFBP within five calendar days of the event. (T-2). The military treatment facility

will ensure they inform their chain of command to include the MAJCOM/SG office. (T-3).

The AFBP will inform the AF/SG and submit the final report within seven days of the event

to the FDA at the address in Table 3.1. (T-0).

Table 3.1. Air Force Blood Program Notification to the Food and Drug Administration.

Method

Contact Details

E-mail

[email protected]

Telephone/voice-mail

240-402-9160

AFI 44-105 10 JANUARY 2019 15

Fax

301-827-0333, Attn: CBER Fatality Program Manager

Express mail

US Food & Drug Administration

Center for Biologics Evaluation and Research,

c/o Document Control Center

10903 New Hampshire Ave

W071, G112

Silver Spring, MD 20993-0002

3.2. Inventory Management . Effective management of blood resources is vital to maintaining

sufficient blood products to meet all requirements. The Transfusion Service must efficiently

manage and monitor several key areas of control. (T-3).

3.2.1. Establish minimum, target and maximum levels of each blood product by blood type

and maintain stock levels near the target threshold to ensure maximum coverage with minimum

outdating. (T-3).

3.2.2. Monitor the inventory levels and expiration dates of all blood products to ensure

minimal outdating and minimal loss of blood products. (T-3).

3.2.3. Avoid maintaining stock levels above the established target level.

3.2.4. Monitor and evaluate blood ordering and usage practices in the military treatment

facility blood utilization committee or function. (T-3).

3.2.5. Establish maximum time periods for holding cross-matched blood. (T-3). Consider

enacting policy to return cross-matched blood units to the general inventory prior to the three-

day expiration if it appears the patient will not need the blood.

3.2.6. Establish a maximum surgical blood ordering schedule to identify which surgical

procedures require only a type and screen and which procedures warrant a type and crossmatch.

(T-3). The maximum surgical blood ordering schedule should be developed based on

historical records of blood use and in coordination with surgical subject matter experts.

3.2.7. Use the type and screen in lieu of type and crossmatch in concert with the maximum

surgical blood ordering schedule and whenever the likelihood for blood usage is low. (T-3).

3.2.8. Utilize outdated blood products and waste byproducts of blood collection (e.g.

Recovered Plasma) for training and research or recover through Recovered Blood Product

agreements before discarding opting to discard. (T-3). Refer to Paragraph 5.3 of this

instruction for requirements related to Recovered Blood Product programs.

3.3. Procurement of Blood Products . Procurement methods for routine day-to-day military

treatment facility blood product support will be those which offer the greatest overall advantage

to the AF.

3.3.1. Procurement sources should be used in the following descending priority unless doing

so hinders patient care activities:

3.3.1.1. AF Blood Donor Center or military treatment facility sources.

3.3.1.2. Armed Services Blood Program suppliers via the Blood Management Tool or

direct contact.

16 AFI 44-105 10 JANUARY 2019

3.3.1.3. Resource sharing with the VA.

3.3.1.4. MOUs with civilian exchange programs or regional blood centers with which

military treatment facilities have established credit balances.

3.3.1.5. When above mechanisms are exhausted, purchase products from community

sources.

3.3.1.6. ASWBPLs may be contacted to determine availability of excess products prior to

requesting approval to procure the products through the Armed Services Blood Program

Office. Blood products maintained by the ASWBPLs are considered a DoD joint blood

inventory for contingency or emergency operations, and military treatment facilities should

not routinely depend on these inventories as a primary source of blood product support.

3.3.2. Emergent blood procurement is not governed by the above procurement sourcing rules.

The life-saving nature of blood products necessitates that there will be times when products

will need to be purchased due to urgent needs or special blood attributes.

3.3.3. Inter-facility shipments may be made by commercial transportation with associated

expenses charged to the receiving military treatment facility’s O&M account.

3.4. Distribution of Excess Blood Products. Excess blood products will be distributed

according to the following descending priority: (T-2)

3.4.1. Establishes support arrangements with other AF Transfusion Services.

3.4.2. Posts excess inventory to the Blood Management Tool for AF disbursement for one

day.

3.4.3. Posts excess inventory to the Blood Management Tool for DoD disbursement for one

subsequent day.

3.4.4. Makes available any remaining excess not distributed via above methods to the other

Federal, State and local agencies or through blood exchange systems with which appropriate

MOUs/Memoranda of Agreement (MOA) have been established.

3.4.5. Provides blood support to civilian treatment facilities pursuant to a request for AF

logistical support IAW DoD 5500.07-R, The Joint Ethics Regulation section 3-211. Such

assistance should be provided on a no impact to AF mission, minimal expense to government

basis. Accordingly, the civilian facility must arrange for transportation of blood products.

3.4.6. Due to the short shelf-life of platelets, these products may be distributed outside of the

above priority list if necessary.

3.4.7. Note: If a facility has a MOA whereby blood products are provided in exchange for

human resources, excess inventory may be distributed to the facility providing human

resources at a higher priority if necessary to meet the terms of the MOA.

AFI 44-105 10 JANUARY 2019 17

Chapter 4

REGULATORY AND ADMINISTRATIVE PROCESSES FOR BLOOD PROGRAM

OPERATIONS

4.1. Inventory Accountability.

4.1.1. Inventory management processes shall include frequent, documented determinations

that all blood components have a proper disposition and that there are no misplaced blood

products. (T-3).

4.1.2. Facilities maintaining an inventory of blood products shall have a policy to reconcile

every blood product listed in the Enterprise Blood Management System current inventory, line-

by-line, with the blood products in physical inventory. (T-3). Transfusion Services and Blood

Donor Centers must accomplish this reconciliation on a monthly basis at a minimum. (T-3).

ASWBPLs must establish inventory control practices and a periodic reconciliation schedule

that allows for accurate tracking of products and must perform a 100% reconciliation no less

than annually. (T-3).

4.1.3. AFBP elements will also perform a reconciliation of all products in a status of

“Expired,” “Issued,” or “Quarantined” on a weekly basis at a minimum. (T-3).

4.1.4. Sites shall utilize reports generated from the Enterprise Blood Management System

when reconciling blood product inventory. (T-3).

4.1.5. Discrepancies shall be resolved and documented in a timely manner. Discrepancies that

cannot be resolved will be reported to the AFBP. (T-3).

4.2. Quality Assurance (QA) Program.

4.2.1. The QA program will address each AABB Quality System Essential as defined in

regulatory standards and will include tracking of metrics where possible and applicable. (T-1).

4.2.2. The QA unit will conduct assessments through surveys, audits and review of FDA

deviation and inspection reports. (T-3). The QA unit will recommend quality improvements

to the AFBP element management. (T-3). The QA unit is responsible for review of all FDA

reportable deviations and inspection responses before submission to the AFBP and will ensure

corrective actions are appropriate. (T-3).

4.2.3. The QA unit is responsible for suspending blood product production if problems with

cGMPs are identified. The QA unit will notify senior management at any point that a patient

safety concern is evidenced. (T-3).

4.3. Infectious Disease Lookback Program.

4.3.1. Previously donated blood from donors who currently test positive for infectious diseases

(e.g. Human Immunodeficiency Virus, Hepatitis B, Hepatitis C, Human T-cell Lymphotropic

Virus) must be tracked to inform those recipients of the increased risk of disease. Notify the

AFBP of any suspected transfusion-transmitted disease lookback cases within 72 hours of

discovery.

4.3.2. All facilities that collect, store, ship or transfuse blood products must maintain all blood

product collection, transfusion, testing, shipping and/or disposition records to support present

18 AFI 44-105 10 JANUARY 2019

and future transfusion transmitted disease lookback issues as required by regulatory agencies.

(T-3).

4.3.3. Records must be maintained in a manner which provides physical and environmental

protection. (T-3).

4.3.4. AFBP elements will use the approved Enterprise Blood Management System to

determine disposition of suspect units of blood. (T-3).

4.4. Non- Food and Drug Administration Compliant Blood Products.

4.4.1. The transfusion of non- FDA compliant blood products may be required to save life or

limb. Examples of non- FDA compliant blood products include products collected by a foreign

country or products collected under emergency conditions during mass casualty events or

combat operations (e.g. using Walking Donor Programs) and transfused before FDA –

approved blood donor tests are completed.

4.4.2. Military treatment facilities that engage in the transfusion of non- FDA compliant blood

products will have policies in place to comply with recipient notification and follow-up

requirements as outlined in ASD(HA) Policy 10-002, Policy On the Use of Non-U.S. FDA

Compliant Blood Products. (T-0).

4.4.3. Military treatment facilities will track all patients who receive non-FDA compliant

blood products so they may be tested for evidence of transfusion-transmitted diseases, ideally

prior to transfusion and at three, six, and 12 months post-transfusion. (T-3). Note: Recipients

of blood products from Armed Services Blood Program Office –determined equivalent

countries are exempt from this requirement. Contact the AFBP for a list of countries currently

designated for exemption.

4.5. Food and Drug Administration Licensure and Registration Program.

4.5.1. An MOU between the DoD and the FDA requires each military department, through its

SG, to operate its own blood program in accordance with FDA requirements. The MOU

requires FDA registration of all military sites maintaining blood products in inventory.

4.5.2. All active Blood Donor Centers must be licensed by the FDA for each product that is

manufactured and shipped interstate. (T-0).

4.5.3. The FDA, at their discretion, inspects licensed and registered facilities to monitor

compliance with regulations. Facility FDA inspections generally occur every 2-3 years.

4.5.4. Compliance with FDA regulations is required by civil law and provides recognition that

AFBP elements operate under nationally accepted standards of blood product quality and

safety. FDA licensure allows the AF to freely exchange licensed blood products with military

and civilian blood banks across state lines as necessary.

4.5.5. All communication between sites and the FDA must be coordinated through the AFBP.

Sites are not authorized to directly communicate with the FDA.

4.6. AABB Inspections.

4.6.1. The AABB accreditation program is a peer review and educational program motivating

its members to strive for the highest level of performance in all aspects of donor collection,

component manufacturing and transfusion medicine.

AFI 44-105 10 JANUARY 2019 19

4.6.2. AABB accreditation is mandatory for all AF Blood Donor Centers and the CONUS

Transfusion Services.

4.6.3. AABB accreditation is highly encouraged for all OCONUS Transfusion Services.

OCONUS Transfusion Services should follow AABB standards as closely as possible even if

not AABB-accredited.

4.7. Computerization and Information Management.

4.7.1. AFBP elements will use the approved standard Enterprise Blood Management System

real-time as the system of record to perform all operational processes. (T-3).

4.7.2. Utilizing the Enterprise Blood Management System real-time maximizes critical safety

checks and allows facilities to promptly and accurately track each blood unit and product from

creation to final disposition as required by the AABB and FDA.

4.7.3. Each facility must publish a Continuity of Operations Plan to be followed whenever the

approved Enterprise Blood Management System is not available for use. (T-3). If the

approved Enterprise Blood Management System is expected to be unavailable for an extended

time, the facility should notify the AFBP.

4.7.4. Electronic and manual records must be maintained for the time periods established by

the AABB and FDA in an environment that provides physical and privacy protection and

allows records to be retrieved within one week. (T-0).

4.8. Required Reports.

4.8.1. Each FDA-registered facility must submit data for the annual FDA report to the AFBP.

(T-3).

4.8.2. Each FDA-registered facility must review and submit updates to its FDA registration to

the AFBP annually. (T-0).

4.8.3. When requested, each Transfusion Service and blood donor center must submit

operational data to the AFBP. (T-3).

4.8.4. Annual Armed Services Blood Program funding requests and accountability reports

must be submitted to the AFBP. (T-3).

20 AFI 44-105 10 JANUARY 2019

Chapter 5

SHARING AGREEMENTS AND CONTRACT REQUIREMENTS

5.1. Overview. The main purposes for entering into MOUs are: (1) to earn credits for civilian

Blood Donor Center collections on military installations, (2) to exchange excess or expired blood

products and (3) to formalize blood support agreements with other DoD Blood Donor Centers.

Facilities may also establish contracts for blood product purchasing and donor infectious disease

testing.

5.2. Civilian Blood Donor Centers Collecting Blood on Military Installations.

5.2.1. Since the government expends resources (e.g. work-hours and utility/maintenance

costs) when civilian blood agencies collect blood in AF facilities or on federal installations,

MOUs must include a provision requiring the civilian agency to grant credits per donor

collected. The credits can be exchanged for blood products or services, at no cost to the AF,

in exchange for access to donors and facilities. Blood products or services obtained through a

MOU may be used within the Military Health Service or provided to the VA IAW Paragraph

1.4.10.

5.2.2. Each civilian blood agency must have a MOU in order to collect blood donors on an AF

installation. MOUs for civilian blood drives will be coordinated through and approved by the

Installation Commander, the Base Blood Program Officer, and the AFBP. (T-1). The civilian

collection agency must be registered with the FDA as a legal blood collecting organization.

5.2.3. The Base Blood Program Officer should contact the AFBP early in the MOU process

so that guidance, standardized template and a checklist may be provided.

5.2.4. If more than one civilian blood collecting agency requests access to a military base, the

civilian agencies will be granted equal access.

5.2.5. When multiple civilian agencies and/or military Blood Donor Centers are performing

blood drives at an installation, the blood drive schedules must be de-conflicted and priority

must be given to the military Blood Donor Center.

5.2.6. MOUs must include the requirements from ASD(HA) Revised Policy Letters 04-015

and 04-019. The MOUs do not need to include components of these policies that are already

addressed in FDA regulations.

5.2.7. The MOU must be reviewed, approved and signed by the AFBP. The MOU should be

sent to the AFBP for review prior to routing for official signature.

5.2.8. MOUs should be reviewed and negotiated to obtain the best return rate for the AF. The

desired accumulation rate for credit-based MOUs is a ratio of no greater than one credit for

every five donors collected. Facilities may develop other agreements (e.g. standing blood

product shipment or other arrangements) as long as the value to the AF approximates the

desired one-to-five ratio.

5.2.9. If MOUs are established on a credit basis:

5.2.9.1. MOUs should address credit management so as to avoid high credit balances.

AFI 44-105 10 JANUARY 2019 21

5.2.9.2. The MOU should attempt to establish mutually agreeable credit balances and

define outlets for credit use to keep the credit balances at or below the established level.

Refer to Paragraph 3.4 of this instruction for distribution priorities.

5.2.9.3. The MOU should address annual carry-over of credits, specifying the balance

permitted to carry-over.

5.2.9.4. Credits will only be used to obtain blood products, blood bank reference

laboratory services or autologous/therapeutic collection services.

5.2.9.5. Terms of the MOU will allow one year expiration of outstanding credits following

termination or expiration of the MOU.

5.2.10. These MOUs will not be used to barter for equipment, donor recruitment incentives

nor education or training expenses.

5.2.11. The military treatment facility will track civilian collection numbers, credits earned,

credits used and/or appropriate delivery of standing shipments IAW the agreement and local

policy for accountability.

5.2.12. MOUs will be reviewed annually by the Base Blood Program Officer and the civilian

agencies to ensure terms remain acceptable. Documentation of the review should be performed

in accordance with local base policy and maintained locally.

5.3. Recovered Blood Product Programs.

5.3.1. Recovered Blood Product programs must be operated under a Memorandum of

Agreement (MOA) with the military treatment facility commander or director and the AFBP

as signatories.

5.3.1.1. The MOA must include a statement that the facility is not obligated to ship

recovered blood products to the vendor.

5.3.1.2. The MOA should be reviewed periodically to compare the reimbursement rate to

industry standard to ensure best value.

5.3.2. The facility will establish and maintain a documented system to track all recovered

blood product shipments and appropriate vendor reimbursement.

5.3.3. Vendor payments will be mailed to the Blood Donor Center or Transfusion Service.

The Blood Donor Center or Transfusion Service will deliver the check to the military treatment

facility budget office for deposit in the Responsibility Center/Cost Center that generated the

funds.

5.3.3.1. When funds are generated by a Blood Donor Center, the first priority for

expenditure should be to support the mission of the Blood Donor Center through purchase

of blood donor incentive items (e.g. T-shirts, coffee mugs, pens).

5.3.3.2. Procurement of donor incentive items is authorized in AFI 41-209, Medical

Logistics Support.

5.4. Other DoD Blood Donor Centers Collecting Blood on AF installations.

5.4.1. Army or Navy Blood Donor Centers should request permission to collect donors on AF

installations where regional AF Blood Donor Centers are not able to collect donors. The

22 AFI 44-105 10 JANUARY 2019

request should go through the AFBP first to ensure the Blood Donor Center is not adversely

competing with a regional AF Blood Donor Center. Installation commanders must allow DoD-

affiliated Blood Donor Centers to have priority over civilian blood collecting organizations to

meet DoD healthcare requirements. DoD Blood Donor Centers should coordinate with the

local Base Blood Program Officer to de-conflict blood donation schedules.

5.4.2. The CONUS military treatment facilities located near Army, Navy or Air Force Blood

Donor Centers are encouraged to negotiate formal agreements for blood inventory support.

When primary blood product support is rendered by another service, the AF base donor

population should be made available to the supporting facility. Support agreements must be

reviewed and signed by the AFBP.

5.5. Contracts for Blood Product Purchasing.

5.5.1. Blood product costs specified in the contract should be no greater than the prevailing

rates charged in the local community.

5.5.2. When a military treatment facility has a MOU whereby blood credits are accrued for

donations by military members, those credits should be expended prior to purchasing blood

products from civilian facilities.

5.5.3. Facilities remain accountable to the procurement priorities outlined in Paragraph 3.3 of

this instruction.

5.6. Contracts for Donor Infectious Disease Testing.

5.6.1. To support increased economies of scale and overall decreased cost to the AF, before a

Blood Donor Center enters a contract with a civilian laboratory for donor infectious disease

marker testing, the contracted cost-per-donor should be compared to the AF donor testing

reference laboratory’s cost-per-donor (per current published cost-per-donor charge) and also

to other civilian laboratories to ensure best value for the AF.

5.6.2. The contracted testing laboratory must be FDA-licensed and AABB-accredited.

5.6.3. The contract should specify the maximum result turnaround time to ensure that collected

blood will be available for priority shipment to Armed Services Whole Blood Processing

Laboratories or immediate local use.

5.7. Wartime Contract Restrictions . It is not permitted to use contractual or any other

arrangements made by individual facilities with civilian sector organizations to provide blood

products in support of the emergency, mobilization and wartime blood program unless approved

by the AFBP and supported by a signed MOU.

AFI 44-105 10 JANUARY 2019 23

Chapter 6

AIR FORCE BLOOD PROGRAM READINESS FUNCTIONS

6.1. Overview. The AFBP supports war and contingency blood product requirements. The

AFBP also responds to homeland defense contingencies and public health emergencies by

supporting civilian authorities when directed by authorized government authorities within the DoD

chain of command.

6.1.1. Detailed information related to AFBP readiness operations can be found in DoDD

6480.4 and AFI 44-118.

6.1.2. The Federal Emergency Management Agency created the National Blood Program to

meet the nation’s need for blood, blood components, derivatives and plasma expanders in the

event of mobilization or national emergency. The AFBP will coordinate AF Blood Donor

Centers support of the National Blood Program and national emergencies when directed by the

Armed Services Blood Program Office.

6.1.3. The Armed Services Blood Program Office is responsible for activation of contingency

blood product, equipment and supply procurement contracts when necessary to support

increased mission requirements or when the need for blood products exceeds DoD’s ability to

supply required products.

6.2. Blood Readiness Elements/Functions . Additional details for these functions can be found

in AF Tactics, Techniques and Procedures 3-42.711, Blood Support Operations

6.2.1. Blood Donor Centers provide blood and blood products in support of peacetime and

wartime contingencies. Blood Donor Centers can collect, manufacture, and ship red blood

cells; Fresh Frozen Plasma; Cryoprecipitate; Plasma Frozen within 24 hours of phlebotomy;

Apheresis Platelets; Apheresis Fresh Frozen Plasma; and Red Blood Cells destined for

freezing. The Blood Donor Center is typically a fixed facility under the operational control of

the military treatment facility commander or director at the installation where the Blood Donor

Center is located.

6.2.2. Armed Services Whole Blood Processing Laboratories (ASWBPLs). The ASWBPLs

serve as the central receiving and shipment points in the CONUS for blood shipments from the

Blood Donor Centers. There are two: one located at Joint Base McGuire-Dix-Lakehurst, New

Jersey (ASWBPL –East), and one at Travis AFB, California (ASWBPL –West), to facilitate

blood shipments to military treatment facilities in CONUS and around the world. They are

operationally controlled by the AFBP and are capable of expanding operations to meet blood

support requirements as necessary.

6.2.3. Expeditionary Blood Support Centers. The Expeditionary Blood Support Center is a

deployable laboratory team that must be co-located with an AF Theater Hospital or equivalent

Joint Deployed Medical Facility. The Expeditionary Blood Support Center cannot operate in

a stand-alone environment. The Expeditionary Blood Support Center team expands blood

support capabilities for emergency trauma situations by manufacturing apheresis platelets and

fresh whole blood units. The team is operationally controlled by the AF Theater Hospital /Joint

Deployed Medical Facility commander.

24 AFI 44-105 10 JANUARY 2019

6.2.4. Expeditionary Blood Transshipment Centers. The Expeditionary Blood Transshipment

Center provides the capability to receive, store and ship blood products in a theater of

operation. They are normally located at major airfields, with one or more assigned within a

Combatant Command. Expeditionary Blood Transshipment Centers are operationally

controlled by the Combatant Command Joint Blood Program Officer.

6.2.5. Frozen Blood Product Teams. The Frozen Blood Product Team provides coverage to

support the processing of pre-positioned frozen blood stocks. When liquid red blood cells are

unavailable or below minimum advisable inventory levels, the team thaws and deglycerolizes

stockpiled frozen red blood cells for mass casualty, disaster relief or humanitarian assistance

operations. The deglycerolized liquid red blood cells produced are suitable for transfusion for

14 days and provide the blood units needed to sustain patient care until the liquid pipeline is

fully operational.

6.2.6. Transfusion Services. Transfusion Services are part of the military treatment facility’s

Laboratory operations. During times of disaster or contingencies, Transfusion Services should

follow guidelines outlined in their local medical contingency response plan.

DOROTHY A. HOGG

Lieutenant General, USAF, NC

Surgeon General

AFI 44-105 10 JANUARY 2019 25

Attachment 1

GLOSSARY OF REFERENCES AND SUPPORTING INFORMATION

References

AFI 36-815, Absence and Leave, 8 July 2015

AFI 41-209, Medical Logistics Support, 6 October 2014

AFI 44-102, Medical Care Management, 17 March 2015

AFI 44-118, Operational Procedures for the Armed Services Blood Program Elements, 1

September 2007

AFI 48-123, Medical Examinations and Standards, 5 November 2013

AFI 65-601V1, Budget Guidance and Procedures, 16 August 2012

AFMAN 41-111_IP, Standards for Blood Banks and Transfusion Services – 31

Edition, 1 April

2018

AFPD 44-1, Medical Operations, 9 June 2016

AFTTP 3-42.711, Blood Support Operations, 19 April 2013

DoD 5500.07-R, The Joint Ethics Regulation, Logistical Support of Non-Federal Entity Events,

30 October 2012

DoD Instruction 6480.4, Armed Services Blood Program Operational Procedures, 13 August

2012

FDA Compliance Policy Guide, Blood Donor Classification Statement, Paid, or Volunteer

Donor Sec. 230.150, 1 November 2011

ASD(HA) Revised Policy 04-015, Standardization of Infectious Disease Reporting Requirements

for Civilian Blood Agencies Collecting Blood on Military Installations, at Military Leased

Facilities or Aboard Ships, 21 June 2004

ASD(HA) Revised Policy 04-019, Regarding Civilian Blood Collections on Military

Installations, Leased Facilities and Aboard Ships, 10 August 2004

ASD(HA) Policy 10-002, On the Use of Non-U.S. Food and Drug Administration Compliant

Blood Products, 19 March 2010

Title 21, Code of Federal Regulations, Parts 200-299 and Parts 600-680

Prescribed Forms

Standard Form 518, Blood or Blood Component Transfusion Request, Sep 92

AF Form 1224, Blood Transfusion Reaction Investigation, 20040819 V1

Adopted Forms

AF Form 847, Recommendation for Change of Publication

26 AFI 44-105 10 JANUARY 2019

Abbreviations and Acronyms

AF—Air Force

AFB—Air Force Base

AFI—Air Force Instruction

AFBP—Air Force Blood Program

AFMAN—Air Force Manual

AFPD—Air Force Policy Directive

AF/SG—Air Force Surgeon General

AFTTP—-Air Force Tactics, Techniques and Procedures

ASD(HA)—Assistant Secretary of Defense for Health Affairs

ASWBPL—Armed Services Whole Blood Processing Laboratory

CFR—Code of Federal Regulations

cGMP—Current Good Manufacturing Practices

CONUS—Continental United States

DoD—Department of Defense

DoDD—Department of Defense Directive

FDA—Food and Drug Administration

IAW—In Accordance With

MAJCOM—Major Command

MOU—Memorandum of Understanding

MPS—Military Personnel Section

O&M—Operational and Management

POM—Program Objective Memorandum

QA—Quality Assurance

SAF/MR—Secretary of the Air Force for Manpower and Reserve Affairs

SF—Standard Form

SG—-Surgeon General

VA—Department of Veterans Affairs

Terms

AABB—A scientific and technical group, formerly named the American Association of Blood

Banks, that establishes policy and standardizes procedures for the field of blood banking, including

donor collections and transfusion services. Membership and inspections recognize high technical

AFI 44-105 10 JANUARY 2019 27

and administrative competence. AABB represents the “gold standard” of quality patient care and

customer service.

Air Force Blood Program (AFBP)—The Blood Program operated for the Air Force Surgeon

General. This function is located within the Air Force Medical Operations Agency. The Chief,

Air Force Blood Program directs the peacetime and wartime operation of the program worldwide.

Area Blood Program Office—A tri-service staffed office responsible for joint blood product

management in an assigned geographic area within a unified command.

Armed Services Blood Banking Center—A tri-service staffed facility responsible for collecting

and processing blood products. The Air Force is the executive agent for the Armed Services Blood

Banking Center located at Joint Base San Antonio.

Armed Services Blood Program—The combined military blood programs of the individual

services including unified and specified commands in an integrated blood products support system.

Armed Services Blood Program Office—A tri-service staffed DoD field operating agency

responsible for coordinating the military blood programs and related blood activities of the military

departments, the unified and specified commands, various federal, civilian, and allied military

agencies. Armed Services Blood Program Office is chartered by the DoD to monitor the policies

established by the Assistant Secretary of Defense for Health Affairs.

Armed Services Whole Blood Processing Laboratory (ASWBPL)—A tri-service staffed

facility that is responsible for receipt and reprocessing of blood products from the CONUS blood

donor centers, and shipment of these products to designated unified command blood transshipment

centers. The Air Force is the executive agent for all ASWBPLs.

Blood Donor Center—Component staffed the CONUS agencies responsible for collecting and

processing of blood products. Processed blood will be shipped from the Blood Donor Center to

the ASWBPL. Blood Donor Centers may be collocated within a blood bank.

Food and Drug Administration—The FDA Division of Blood and Blood Products establishes

blood banking regulations and requirements for use by blood banks involved in interstate

commerce (shipping blood and blood products across state lines), and grants licenses to blood

banks that comply with those standards. The FDA considers blood as a manufactured drug. The

military departments comply with these standards and each service Surgeon General holds an FDA

license for the respective service’s blood banks.

FDA-Biological Product Deviation—Reportable errors occur when an event takes place during

the collection, processing, testing and/or labeling of blood products that affect the safety, purity or

potency of the blood product and the blood product was distributed (“distributed” is further defined

as “the biological product has left the control of the licensed manufacturer or unlicensed blood

establishment”).

Fresh Frozen Plasma—Plasma is the straw colored liquid obtained when separating red blood

cells from whole blood. In peacetime, blood banks freeze and store this product for no more than

one year at -18C or colder. For contingencies, military blood banks extend the shelf life to three

years.

Joint Blood Program Office—A tri-service staffed office responsible for overall joint blood

product management in a unified command theater of operations.

28 AFI 44-105 10 JANUARY 2019

Maximum Surgical Blood Ordering Schedule—A hospital approved list of recommended blood

ordering practices by procedure based on national blood use averages. Adherence to the Maximum

Surgical Blood Ordering Schedule prevents over utilization of limited blood bank resources and

better manages blood inventory for when it is truly is needed.

Medical Treatment Facility—A facility established for the purpose of furnishing medical and/or

dental care to eligible individuals.

Memorandum of Agreement (MOA)—A type of intra-service, intra-agency, or inter-agency

agreement between two or more parties, which includes specific terms that are agreed to, and

commitment by at least one party to engage in action. It includes either a commitment of resources

or binds a party to a specific action.

Memorandum of Understanding (MOU)—A type of intra-service, intra-agency, or inter-agency

agreement between two or more parties, which includes only a general understanding between the

parties. It neither includes commitment of resources nor binds a party to a specific action.

Platelet Concentrates—Platelets are cellular fragments in the blood that assist in blood clotting.

Platelet concentrates are separated from whole blood by centrifugation and are stored at room

temperature for up to five days with gentle agitation, or at -80C for two years.

Red Blood Cells—Red Blood Cells are the oxygen carrying component of whole blood. Red

Blood Cells are separated from whole blood by centrifugation or sedimentation and removal of

residual plasma.

Type and Crossmatch—A blood bank procedure to determine the ABO and Rh groups of a

patient and the serologic compatibility test with a donor unit of red cells to ensure safe transfusion.

A Type and Crossmatch procedure is used when the probability of actual blood usage is high.

Type and Screen—A blood bank procedure to determine ABO and Rh groups of a patient and the

antibody screen to determine if the patient has any unusual antibodies that might complicate

finding a compatible unit of red blood cells. A Type and Screen procedure is used when the

probability of actual blood usage is low.

Attachment 2—FACILITY FDA REGISTRATION AND LICENSE NUMBERS

Table A2.1—Facility FDA Registration and License Numbers. Refer to this information to

determine the manufacturer of a specific blood product or the site specific FDA registration

number. The Air Force Blood Program FDA license number is 610.

Facility or Unit Name

International

Society of Blood

Transfusion-128

Facility Code

Food and Drug

Administration

Registration

Number

81st Medical Group

Keesler AF, MS

W0017

1077548

Armed Services Blood Banking Center-San Antonio

Joint Base San Antonio TX

W0013

1677552

88th Medical Group

Wright Patterson AFB OH

W0016

1577551

AFI 44-105 10 JANUARY 2019 29

ASWBPL-East

Joint Base McGuire-Dix-Lakehurst NJ

W0001

2277553

ASWBPL-West

Douglas B. Kendrick Blood Processing Laboratory

Travis AFB CA

W0002

2951520

Air Force Special Operations Command

(For Low Titer Whole Blood Program)

W0029

N/A

59th Medical Wing

Joint Base San Antonio TX

N/A

3012374081

779th Medical Group

Joint Base Andrews MD

N/A

1177549

673d Medical Group

Joint Base Elmendorf-Richardson AK

N/A

3020816

60th Medical Group

Travis AFB CA

N/A

2977555

99th Medical Group

Nellis AFB NV

N/A

2951185

96th Medical Group

Eglin AFB FL

N/A

1052138

633d Medical Group

Langley AFB VA

N/A

1177774

432nd Medical Group

Misawa AB, JA

N/A

9612293

51st Medical Group

Osan AB ROK

N/A

9613030

48th Medical Group

RAF Lakenheath UK

N/A

9612214

374th Medical Grp

Yokota AB JA

N/A

9612177

31st Medical Grp

Aviano AB Italy

N/A

9614827

39th Medical Group

Incirlik AB Turkey

N/A

3012251962