Blood Products_Testing PWS.docx

Department of Defense Defense Health Agency Performance Work Statement

Blood Testing Services & Products

60th Medical Group David Grant Medical Center Travis AFB, California

Date: 01 April 2025

TABLE OF CONTENTS

Section

1. General Information

2. Definitions/Acronyms/Publications/HIPAA

3. Government Furnished Property/Equipment/Services

4. Contractor Furnished Property/Equipment/Services

5. Specific Tasks

6. Attachments/Technical Exhibits

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Blood Testing Services and Blood Products for David Grant Medical Center, Travis AFB.

1.2 Description of Services/Introduction: The Contractor shall provide Blood Testing Services & Products as required for Government beneficiaries at David Grant Medical Center (DGMC), Travis AFB. DGMC is the largest Blood Transfusion Service Center in the Air Force. The Contractor shall arrange transportation of blood and/or components and services (special testing for blood products as required) that have been tested as required by the Food and Drug Administration (FDA), as well as tests currently performed under Investigational New Drug (IND) protocols as mandated by the Air Force Blood Program Office. Performance shall be according to this Performance Work Statement (PWS), professional standards of the American Association of Blood Banks (AABB) and FDA guidelines and regulations (CFR Title 21 Parts 600-799). The terms “must,” “shall” and “will” denote mandatory actions in this PWS. This includes all direct and indirect resources.

1.3 Background: David Grant Medical Center has a need for Blood Testing Services and Blood Products. Travis Air Force Base is the largest Blood Transfusion Service Center in the Air Force. These products and services are required to support the mission and beneficiaries that DGMC supports.

1.4 Objectives: The Contractor shall provide Blood Testing Services and Products along with meeting all other requirements as listed in this PWS.

1.5 Scope: The contractor shall furnish all supplies, materials, equipment, facilities and services required to perform work listed in this PWS.

1.6 Period of Performance (PoP):

Base Year: 1 Apr 2025 – 30 Sep 2025 Option Year 1: 1 Oct 2025 – 30 Sep 2026 Option Year 2: 1 Oct 2026 – 30 Sep 2027 Option Year 3: 1 Oct 2027 – 30 Sep 2028 Option Year 4: 1 Oct 2028 – 30 Sep 2029

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at David Grant Medical Center, Travis AFB.

1.7.2 Recognized Federal holidays: Contractor is required to perform services on Recognized Federal Holidays.

Independence Day

1.7.3 Hours of operation: DGMC Transfusion/Blood Bank Department operates 24/7, 365 Days a year including being required to provide services on the above Federal/Observed Holidays.

1.7.4 Point of Contact: All information regarding testing will be coordinated with the Chief of the DGMC Transfusion Services element.

1.7.5 The contractor shall create and maintain Privacy Act data IAW AFI 33-129, Transmission of Information Via the Internet, paragraphs 7.4, 8.2.3, 16 and 17 and supplements; AFI 33-201, Communications Security (COMSEC), Table 1; AFI 33-332, Air Force Privacy Act Program, Privacy Act systems of records notice(s), which are posted on the internet at (http://www.defenselink.mil/privacy/notices/usaf). The contractor shall not create or maintain a Privacy Act system of records prior to public notice. If the contractor receives a Privacy Act request, the contractor shall be responsible for searching for the records and providing those records to the government official who, as authorized official, will make the decision on releasing government records.

1.7.6 If the contractor receives a FOIA request the contractor shall immediately hand-carry it to the base FOIA manager for processing. The FOIA manager will task a government official. When tasked, the Contractor shall be responsible for searching for the records and providing those records to a government official who, as the authorized official, will make the decision on releasing government records.

1.7.7 Patient lists, no matter how developed, shall be treated as privileged information. Add the following to the bottom of all patient lists: "FOR OFFICIAL USE ONLY. This document contains information exempt from mandatory disclosure under the Freedom of Information Act (FOIA)., Title 5 U.S.C 552(b)(2) High and (b)(6) apply." Lists and/or names of patients shall not be disclosed or revealed in any way for any use outside the MTF without prior written permission by the Chief of Hospital Services.

1.7.8 The Government will evaluate the Contractor's professional, as differentiated from administrative, performance under this contract using the FDA Code of Federal Regulations (CFR) Parts 200-299, Current Good Manufacturing Practices.

1.7.9 The Contractor shall release medical information obtained during this contract to MTF staff involved in the care and treatment of that individual patient only.

1.7.10 A written request for DoD records that does not cite either the FOIA or Privacy Act may be received from any person (including a member of the public), or organization, or a business. The contractor shall be responsible for searching for the records and providing those records to a government official who, as the authorized official, will make the decision on releasing government records.

1.7.11 Records: The Contractor shall create and maintain Government-owned/ contractor held records, regardless of media, in accordance with (IAW) AFI 33-119. Electronic Mail (E-Mail) Management and Use; AFI 33-202, Computer Security; AFI 33-322, Records Management Program; AFMAN 37-123, Management of Records. Segregate the governing-owned records from the company-owned records. Background electronic data and records specified for delivery to the contracting agency must be accompanied by sufficient technical documentation to permit the Air Force to use the data. Upon completion of the contract, all government-owned/ contractor-held records (regardless of media) received, created, maintained, or provided by the government and/or generated for the government in the performance of this statement of work shall be turned over to the government. In the event of default or non-performance, the government will have access to all records in order to ensure mission support is not interrupted.

1.8 Quality

1.8.1 Quality Control (QC): The Contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The Contractor’s QC program is the means by which the work complies with stated requirements. The Contractor’s QCP must be delivered to the CO within 30 days after contract is awarded. After acceptance of the Quality Control Plan (QCP) the Contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 6, Attachment 4 - CDRL A001.

1.8.2 Quality assurance (QA): The government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.8.3 The Contractor's standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure nonperformance and continual repeat of defective service does not occur.

1.8.4 The Quality Assurance Personnel will ensure that standards of delivery and quality of services are maintained in accordance with the PWS.

1.9 Reporting

1.9.1 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.9.2 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.10 Mission Essential

1.10.1 In accordance with DFARs 252.237-7023 Continuation of Essential Contractor Services, David Grant Medical Center has confirmed the services outlined in this PWS are considered mission/emergency essential. Inability to secure services in a timely manner can cause compliance violations and impair the provision of patient care. These services are in direct support of mission essential functions for DGMC, Travis AFB.

1.10.2 Performance of Services During Crisis Declared By The National Command Authority Or Overseas Combatant Commander: DGMC Transfusion/Blood Bank Services is required to meet readiness requirements during war or peacetime crisis in accordance with DoDI 3020.37. Contractor will endeavor to provide services sufficient to meet DGMC’s needs during war or peacetime crisis, consistent with the terms of the Contract, provided only that Contractor is limited by the availability of Blood Products and its need to balance the demands of all hospital customers. The Contractor will be notified by phone when a crisis is declared.

1.10.3 Continuity of Services: Contractor will promptly notify David Grant USAF Transfusion Services if Contractor is unable provide an ordered product or service. The David Grant USAF Transfusion Services retains the right to seek these services elsewhere should services not be provided by the Contractor.

1.11 DGMC Blood Bank Service’s Responsibilities

1.11.1 The David Grant USAF Transfusion Services element will remain licensed, registered and/or accredited by the FDA, AABB and other regulatory agencies as required.

1.11.2 The David Grant USAF Transfusion Services element will agree to follow approved Investigational New Drug (IND) protocols established by the Contractor for testing of blood donor samples.

1.11.3 The David Grant USAF Transfusion Services element agrees to collect and process samples for testing in accordance with Contractor established protocols.

1.11.4 Except for those items or services specifically stated to be Government furnished, the Contractor shall furnish everything required to perform this contract in accordance with all of its terms.

1.11.5 The Contractor shall ensure service providers under his/her supervision maintain open and professional communication with members of the MTF. Complaints validated by the Functional Commander shall be reported in writing to the contract administrator and the Contractor for action. Failure of the Contractor to correct the validated complaints rose by the Functional Commander will be considered a failure to perform.

1.11.6 Upon written request, and as required by Section 952 of U.S. Public Law 96-499 and the FDA CFR Parts 600 799, the Contractor shall make available to the Blood Bank Element Chief, the Food and Drug Administration, or any of their duly authorized representatives, any and all documents and records. This will occur if required by the cited law and regulations of those regulations.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.2 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.3 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.5 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc.

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the PWS. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS INSTRUCTIONS/DIRECTIVES

DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework

AIR FORCE INSTRUCTIONS/MANUALS

Publications Code:

AFI--Air Force Instruction AFMAN--Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☐ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.2 Facilities: The Government:

☐ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.3 Utilities: The Government:

☐ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.4 Equipment: The Government:

☐ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

3.5 Materials: The Government:

☐ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☐ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below in 4.2 General:

4.2 General: The contractor shall furnish all supplies, materials, equipment, facilities and services required to perform work listed under Part 5 and Part 6 Attachment 2/3/4 of this PWS.

PART 5

5.0 SPECIFIC TASKS

5.1 Products or services shall be available for acquisition 24 Hours a Day, 365 Days a year.

5.2 Products or services shall be packed and ready for shipment within one (1) hour for STAT request, within four (4) hours for ASAP request and within 24 to 48 hours for routine request. Contractor will endeavor to coordinate prompt transfer of product to the courier for shipment or transit and delivery.

5.3 Contractor is required to provide services on Federal/Observed Holidays as noted in Section 1.7.2 and 1.7.3 of the PWS.

5.4 Contractor will promptly notify DGMC Transfusion Services if they are unable to provide an ordered product or service. The DGMC Transfusion Services retains the right to seek these services elsewhere should services not be provided by Contractor.

5.5 Reports or reference laboratory testing data shall be submitted in English.

5.6 The testing site shall meet or exceed all applicable FDA current Good Manufacturing Practice Guidelines and be in good standing with the FDA and Investigational New Drug (IND) Protocol.

5.7 The Contractor shall be, and shall remain, licensed by the FDA and the state in which they are located (if required by state law) and shall be accredited by the AABB to operate as a blood center.

5.8 The Contractor is responsible for ensuring personnel performing testing possess required credentials commensurate with testing difficulty in compliance with the Clinical Laboratory Improvement Act (CLIA) of 1988. And remain compliant should an updated version be released.

5.9 The Contractor shall provide proof of licensure/accreditation as requested by the DGMC Transfusion Services element.

5.10 In the event of a natural disaster or crisis, Contractor, by and through its third-party testing services provider, shall use best efforts to serve as an alternative testing site for allogeneic donor blood that is FDA and IND compliant. Contractor, through its third-party testing services provider, agrees to provide those tests that are required by the FDA, AABB, and the Air Force Blood Program to include nucleic acid testing and tests which may be under an IND protocol.

5.11 The Contractor shall perform procedures compatible with the Air Force Blood Program's FDA requirements. New medical procedures/services shall not be introduced without prior recommendation to, and approval of the medical facility's Commander or authorized representative.

5.12 The Contractor shall arrange for transportation of samples. If transportation of shipped samples for testing is by Air delivery, Contractor must have a mechanism in place to ensure testing is completed and delivered in accordance with the timeline listed in this PWS should air traffic be grounded due to a crisis.

5.13 Confirmation tests performed on a routine schedule will be included as part of the services.

5.14 There shall be a mechanism, between specified or appropriate divisions or departments of the Contactor's testing center and the David Grant USAF Transfusion Services element, for transmission of results of all testing within 48 hours of receipt by the Contractor.

5.15 The contractor shall provide testing services for Autologous (Seit) donations. These donations can be performed at any of the contractor donation facilities and must be coordinated with the David Grant USAF Transfusion Services' element.

5.16 A list of all initial or repeat reactive units shall be faxed or electronically transmitted daily to the David Grant USAF Transfusion Services element by unit number and by test immediately after review and validation. Initially reactive units are repeat tested on the next testing day.

5.17 The Contractor shall serve as a Reference Lab with the ability to provide ABO/Rh typing, antibody screening, and the wide range of reference lab services included in Part 5 Attachments/Technical Exhibit Listing.

5.18 Contractor shall provide blood products to include whole blood, packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate AHF. Contractor shall have the means to provide products that are irradiated, leukocyte reduced, pooled, washed, obtained by aphaeresis, antigen specific or a combination of the characteristics listed upon request by the David Grant USAF Transfusion Services element.

5.19 Contractor shall provide Transportation containers during pick-up and drop-off to the MTF.

PART 6

6.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

PART 6, ATTACHMENT 1

PERFORMANCE REQUIEREMENTS SUMMARY

Performance Objective

Threshold Method of Surveillance Procedure

PRS # 1

Provide blood products and testing 24 hours a day, 365 days a year.

*STAT: Not more than 1 hour from the time an order is received by the blood center to the time it is ready to be shipped from the blood center.

Contractor will endeavor to coordinate prompt transfer of product to the courier for shipment/transit and delivery.

**ASAP: Not more than 4 hours from the time an order is received by the blood center to the time it is ready to be shipped from the blood center.

Contractor will endeavor to coordinate prompt transfer of product to the courier for shipment/transit and delivery.

PWS

Part 5,

5.1 & 5.2

PRS # 2

Provide donor specimen.

testing in the event of a natural disaster or crisis within 48 hours

PWS

Part 5, 5.10

PRS # 3

Properly maintain and dispose of records.

PWS Part 1, 1.7.11

PRS # 4

The Contractor will maintain required certification with the FDA and AABB.

PWS Part 5, 5.7

PART 6, ATTACHMENT 2

BLOOD PRODUCTS AND SERVICES

Whole Blood

PediPak

Autologous

Red Blood Cells

Leukocytes Reduced

Irradiated

Leukocytes Reduced, Irradiated

Washed

Leukocytes Reduced, Washed

PediPak (Leukocytes Reduced)

Autologous

Frozen (Leukocytes Reduced)

Deglycerolized

Rejuvenated

Platelets, Single Donor by Apheresis

Leukocytes Reduced

Irradiated

Leukocytes Reduced, Irradiated

Apheresis (HLA Matched))

Low Count

Plasma, Fresh Frozen

PediPak

Plasma, Frozen Plasma, Cryo-depleted Cryoprecipitate

Pooled (5 units)

Granulocytes by Apheresis

Additional Processing Services

Leukocyte reduction by filtration RSC

Washing

Freezing

Deglycerolization

Irradiation

CMV antibody negative

Hemoglobin S negative

Sterile Docking

Transfer bag

Per PediPak

Special Donations

Whole Blood

Autologous

Red Blood Cell

Autologous freezing in advance of surgery

Freezing storage 1st year

Freezing storage each additional year

Autologous surcharge (all other components)

Designated Donation Surcharge

Immunohematology Services

ABO Grouping

ABO/Rh (Includes weak D when indicated)

Adsorption (Auto)

Adsorption (Allo)

Adsorption (RESt)

Antibody Screen Cell

Separation

Chloroquine/Glycine

HCI Compatibility Test

Direct Antiglobulin Test

Polyspecific Direct

Antiglobulin Test

Monospecific DNA

Genotyping

Donor Compatibility

Donor Units Negative for Antigens (per antigen)

Drug Study

Elution

Neutralization

Red Cell Panel (Initial)

Red Cell Panel (Each Additional)

Red Cell Panel (Rare)

Red Cell Phenotype

Rh Phenotype (5 antigens)

Titration

DTT Treatment

Enzyme Treatment

Confirmed Antigen Negative Units (per antigen)

Historically Antigen Negative Units (per antigen)

Platelet Immunology

PLA Typing

Recruitment for crossmatch of identified donor

Platelet Crossmatch

*Item listing represents most commonly ordered products, modifications and services and is not exhaustive.

PART 6, ATTACHMENT 3

BLOOD SERVICES

PRODUCT/SERVICE

RED BLOOD CELLS

Red Blood Cells Leukocytes Reduced

PLATELET COMPONENTS

Large Volume Delayed Sampling

Pathogen Reduction Technology (PRT Platelet Products)

PLASMA COMPONENTS

Fresh Frozen Plasma/FP24

CRYO COMPONENTS

Cryoprecipitate AHF

Cryoprecipitate AHF Pooled

MODIFICATIONS/SERVICES

CMV Unit Test

Irradiation

STAT Delivery

ASAP Delivery

STAT/ASAP Delivery by Third Party

*Item listing represents most commonly ordered products, modifications and services and is not exhaustive.

PART 6, ATTACHMENT 4

LAB SERVICES

Rh(D):C,c,E,e.

antigen. Example: RH/FY/JK/K/MNS.

Excluding Rh(D): K, Fya, Fyb, Jka, Jkb, S,s.

bound to patient red blood cells. One charge for poly then if applicable one for anti-IgG and one charge for complement.

reagent red cells.

patients own red cells) or allogeneic adsorption (using donor red cells of known phenotype).

Examples: EGA/CHL/DTT/WARM/ZZAP.

antibody identification testing.

Contract.

must be done in order to utilize electronic crossmatching.

determine common and rare red cell antigens using multiplex PCR and microarray analysis. Includes DNA extraction and purification.

determine common Human Platelet Antigens, using multiplex PCR and microarray analysis. Includes DNA extraction and purification.

units, per antigen

typing per antigen. Example: RH/FY/JK/K/MNS. A charge is incurred for each test performed.

hours, weekends and holidays).

upon sample receipt in lab).

sample receipt in lab).

*Item listing represents most commonly ordered products, modifications and services and is not exhaustive.

PART 6, ATTACHMENT 4

DELIVERABLES SCHEDULE

CDRL A001 – Quality Control Plan

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