Attachment 1 - PWS.pdf

PERFORMANCE WORK STATEMENT (PWS)

Part 1

General Information

1. GENERAL: This is a non-personal services contract to provide Blood Donor Testing. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Airport Expeditor Service as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.1.1 Unless otherwise described in this PWS, the contractor shall use only new materials in the requirement unless otherwise stated in this PWS.

1.2 Background: Blood Donor Testing is a requirement of Food Drug Administration, Defense Health Agency, Association for the Advancement of Blood & Biotherapies (AABB), and other regulatory agencies to provide a safe blood product for transfusions.

1.3 Objectives: This service is to be used for all blood donors at each donation at Naval Hospital Guam Blood Donor Center. This service is set forth to meet time, temperature, and testing requirements to qualify blood products for human transfusions in a clinical setting.

Scope: The scope of this service is to provide the following testing requirements to qualify blood products for human transfusions in a clinical setting.

1. Antibody Screen

2. ABO Rh (Blood Type)

3. Syphilis

4. Hepatitis B Surface Antigen

5. Anti-Human Immunodeficiency Virus 1/2

6. Anti-Hepatitis B Core

7. Anti-Hepatitis C Virus

8. Anti-Cytomegalovirus

9. Nucleic Acid Test testing for Human Immunodeficiency Virus -1 Ribonucleic Acid, Hepatitis C Virus Ribonucleic Acid and Hepatitis B Virus, Deoxynucleic Acid. (Pooled testing is Acceptable with single testing follow up for positive pool)

10. Nucleic Acid Test for West Nile Virus (single testing)

11. Anti-Trypanosoma Cruzi (Chagas)

12. Anti-Human T-Lymphotrophic Virus I/II

13. Babesia NAT by IDT

14. Confirmatory

STANDARD TEST PANEL

Red Cell Allo-Antibody Screen ABO/Rh (including weak-D testing) Standard Test for Syphilis (STS) HBsAg Anti-HBc Anti-HCV Anti-HIV-1/HIV-2 Anti-HTLV-1/11

HIV-NAT

HCV-NAT

HBV-NAT

Anti-Cytomegalovirus* SELECT DONATIONS Chagas Disease Testing* WNV-NAT by IDT* Babesia NAT by IDT* *Included in Standard Panel for an additional charge:

AS REQUESTED

HLA Ab (TRALI) Anti-A/Anti-B Titers.

Licensed Phenotype Screening - E,e,C,c, and Kell antigens Hemoglobin S Antibody Identification ABO/Rh Typing discrepancy resolution Anti-SARS-CoV-2

CONFIRMATORY TESTING

HBsAg Neutralization Anti-HCV Confirmatory-second EIA methodology Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing Abbott ESA Chagas HTLV -I/II Blot Confirmatory Testing STS Confirmatory by Captia Syph G or FTA-ABS WNV Supplemental Testing Zika Supplemental Testing

This will be for 1400 individual donations and will include shipping boxes with return shipping included (of empty boxes with supplies for next shipment). Naval Hospital Guam will be responsible for providing shipping to Bloodwork’s laboratory for testing. It is estimated that 3-5 shipments will be sent per week with an estimated 2-3 small box shipments (platelets) and 1-2 large box shipments (whole blood drives).

Results will be supplied in an electronic format that will be communicated directly to NH Guam via

POC:

This may include an up loadable format or a printable paper copy of the results as required. Results must be available within 24 hours of samples receipt.

1.4 Period of Performance:

15 December 2024 – 14 December 2025

1.5 General Information

1.5.1 Quality Assurance: The contractor is responsible for maintaining any applicable state and federal licenses required to perform testing within state and federal laws. These include FDA 2830 and AABB or CAP certification.

All employees must have the ability to perform the applicable duties consistent with their license and certification, and ensure that all laboratory testing staff complies with minimum Federal, State and local law qualifications/requirements.

PART 2

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT,

AND SERVICES

2. GOVERNMENT FURNISHED ITEMS AND SERVICES:

2.1. Services: The U.S Government will provide a list of names for use of this service 24 hours out or an early as possible.

PART 3

CONTRACTOR FURNISHED ITEMS AND SERVICES

3. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

3.1. General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract.

PART 4

ATTACHMENT/TECHNICAL EXHIBIT LISTING

4. Attachment/Technical Exhibit List:

4.1. Technical Exhibit 1 – Performance Requirements Summary

TECHNICAL EXHIBIT 1