PERFORMANCE WORK STATEMENT.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 Agency, Defense Health Agency, AABB, and other regulatory agency 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 tests for each individual blood donation:

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. Zika Nucleic Acid Test – Single Testing

14. Babesia NAT by IDT

15. Confirmatory

Standard Test Panel in accordance with the Food and Drug Administration regulations and includes the following tests:

• ABO/Rh (including weak-D testing

• Red Cell Alla-Antibody Screen

• Standard Test for Syphilis (STS)

• HBsAg

• Anti-HBc

• Anti-HCV

• Anti-HIV-1/HIV-2

• Anti-Cytomegalovirus

• Anti-HTLV-I/II

• WNV-NAT*

• HIV-NAT

• HCV-NAT

• HBV-NAT

• Chagas Disease Testing

• Zika-NAT*

• Babesia NAT*

The following assays are performed on select donations as requested by US Naval Hospital Guam:

• HLA Ab (TRALI)

• Anti-A/ Anti-B Titers

• Licensed Phenotype Screening - E,e,C,c, and Kell antigens (selective testing is scheduled 1 to 2 times per week.)

• Hemoglobin S performed by the Transfusion Services Laboratory within 24 hours of receipt of sample.

• The MosaiQ COVID-19 Antibody test is an in vitro diagnostic test for the qualitative detection of total (lgM and lgG) antibodies to the SARS-CoV-2 in human serum and EDTA plasma collected in CLIA certified laboratories and/or by healthcare workers at the point-of-care. This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS- CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The MosiaQ COIVD-19 Antibody Assay should not be used to diagnose acute SARS-CoV-2 infection.

• The MosaiQ COVID-19 Antibody test is only for use under the Food and Drug Administration's Emergency Use Authorization.

Confirmatory testing will consist of individually run tests as follows:

• HBsAg Neutralization

• Anti-HCV Confirmatory Testing, Repeat HCV IDT-NAT, if negative then run on Anti-HCV Alternate Manufacturer EIA methodology

• Anti-HIV-1 Western Blot (Bio-Rad) performed at Innovative Blood Resources until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Laboratory.

• Anti-HIV-2 EIA until Bio-Rad Geenius™ is made available at the Bloodworks Donor Testing Lab.

• Bio-Rad Geenius™ HIV-1/-2 Supplemental Testing

• Abbott ESA Chagas (Testing performed at Creative Testing Solutions, a qualified sub-contractor)

• HTLV-1/II Blot Confirmatory Testing

• FTA-ABS (Testing performed at Quest Diagnostics, a qualified sub-contractor)

• Vitalant Research Institute (VRI) SARS-CoV-2 Reporter Viral Particle Neutralization (RVPN) testing is performed when the qualitative Anti-SARS-CoV-2 screening test is reactive, to help determine the specificity and relative neutralizing capability of the antibody. The RVPNs represent a safe and rapid way of quantitatively measuring neutralization, by using SARS-CoV-2 Spike glycoprotein pseudotyped onto a rhabdovirus reporter virus. The assay is performed by mixing serial dilutions of serum with constant concentrations of reporter viruses, in equal volumes. The mixture is then added to cell culture monolayers to assess antibody presence.

Inhibited reporter virus growth in the cell culture monolayers is indicative of the presence of neutralizing antibody in serum. The SARS-CoV-2 RVPN detects the presence of neutralizing antibody directed against the virus but there is still a potential that cross reactivity with other coronavirus species may occur. FDA recommends neutralizing antibody titration for CCP qualification.

This requirement 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's to be determined. This may include an up loadable format or a printable paper copy of the results as required.

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

LT Ananou, Akakpossa Area Joint Blood Program Officer Guam Head, Blood Bank/Donor Center, USNH Guam 671-344-9763

DSN: 315-344-9391

Ananou, Akakpossa B LT USN NAVHOSP GU (USA) akakpossa.b.ananou.mil@mail.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 48 hours of shipment time.

NOTE: Results must be available within 48 hours of shipment time.

mailto:akakpossa.b.ananou.mil@mail.mil http://www.militaryblood.dod.mil/

1.4 Period of Performance: 28 November 2020 to 27 November 2021.The period of this service performance shall not exceed more than one year.

1.6 General Information

1.6.1 Quality Control (QC) (Not applicable):

1.6.1.1 Quality Control Reports: N/A

1.6.2 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.

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.

1.6.3 Recognized Holidays: N/A

1.6.4 Hours of Operation: The contractor is responsible for conducting business 24/7. Each testing run may be delayed for logistical and planning processes that include other reasonable obligations of the contractor to include organ transplant testing and other lifesaving testing. These delays should not be greater than the original stated 48 hour turnaround time for result receipt.

1.6.5 Place of Performance: Contractor’s Address

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

1.6.7 Security Requirements: N/A

1.6.7.1 PHYSICAL Security: N/A

1.6.7.2 Key Control: Not Applicable

1.6.7.2.1. N/A

1.6.7.2.2. N/A

1.6.7.3 Lock Combinations: Not Applicable

1.6.8 Special Qualifications: N/A

1.6.9 Post Award Conference/Periodic Progress Meetings: N/A

1.6.10 Contracting Officer Representative (COR): N/A

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

1.6.12 Identification of Contractor Employees: Not applicable

1.6.13 Contractor Travel Not Applicable

1.6.14 Other Direct Costs Not Applicable.

1.6.15 Data Rights Not Applicable

1.6.16 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

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

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER (CO). A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the Government. Note:

The only individual who can legally bind the Government. A Contracting Officer is the only person authorized to make changes to the terms and conditions of a contract.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract, and shall obtain written approval of any changes from the KO.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non- manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS.

When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.13. WORK WEEK. 24/7 Monday-Monday.

2.2. ACRONYMS:

ACOR Alternate Contracting Officer's Representative

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska, Hawaii & Guam) COR Contracting Officer Representative

COTR Contracting Officer's Technical Representative

COTS Commercial-Off-the-Shelf

DON Department of the Navy

DD250 Department of Defense Form 250 (Receiving Report)

DD254 Department of Defense Contract Security Requirement List

DFARS Defense Federal Acquisition Regulation Supplement

DOD Department of Defense

FAR Federal Acquisition Regulation

KO Contracting Officer

NMCARS Navy Marine Corps Acquisition Regulation Supplement OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska, Hawaii & Guam) PIPO Phase In/Phase Out

POC Point of Contact

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Program

TE Technical Exhibit

WAWF Wide Area Work Flow

PART 3

APPLICABLE PUBLICATIONS

3. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

3.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.