PWS - Blood Donor Testing.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:

LCDR Apolinar Ortiz Head, Blood Bank/Donor Center, USNH Guam 671-344-9763 Apolinar.ortiz3.mil@health.mil www.militaryblood.dod.mil

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 Dec 2025 to 14 Dec 2030.

1.5 General Information

1.5.1 Quality Assurance: The contractor is responsible for maintaining any applicable state and mailto:.mil@health.mil http://www.militaryblood.dod.mil/ 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.

Testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract must meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

1.5.2 Place of Performance: 701 SW 39th St., Renton WA, 98057 with the exception of the following low-volume confirmatory and supplemental testing that are not economical to perform on-site.

1.5.3 Type of Contract: The government will award a Firm Fixed Price Contract.

1.5.4 Key Personnel: The follow personnel are considered key personnel by the government:

1.5.5 Organizational Conflict of Interest (OCI): This requirement is not applicable to this contract.

Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interest as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI

1.6 Labor Standards: The contractor will ensure compliance with all US labor laws.

Test/Panel Quantity Standard Panel 1400 Anti-Cytomegalovirus 1400 Anti-Trypanosoma cruzi (Chagas) 1400 WNV NAT by IDT 1400 Babesia NAT by IDT* 1400 HLA Testing for TRALI Mitigation 100 Anti-A/Anti-B Titer Testing 250 Licensed phenotyping (Selective) 50

Red Cell Phenotyping (Licensed) 50 ABO Discrepancy (Cold Panel or Cold Agglutinin Investigation) 50 Hemoglobin S 300

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

Performance Requirements Summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

(The Service required—usually a shall statement)

Standard Performance Threshold (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

PRS # 1.

The contractor shall provide results of routine blood screening test (including standard panel) within 24 hour of sample receipt.

100% of results are transferred before 48 hours from shipment time. (exempt from shipment errors outside of their control)

There will be zero deviations from the standard

100% inspection

PRS # 2

The contractor shall provide results for all listed tests required.

100% results of samples sent are required. (results may include indeterminate results for specific tests)

There will be zero deviations from the standard

100% inspection

NOTE: YOU MAY ALSO IDENTIFY ANY SURVEILLANCE METHOD USED IN THE

COMMERCIAL MARKET TO SURVEY THE REQUIRED SERVICE. (THIS WILL BE

DISCOVERED WHEN MARKET RESEARCH IS CONDUCTED