RFQ-NIAID-24-2218371 - Attachment 2 - Statement of Work (SOW).pdf

STATEMENT OF WORK (SOW)

TITLE: MID-THROUGHPUT NEXT GENERATION SEQUENCING (NGS) SYSTEM

AND MAINTENANCE AGREEMENT – BRAND NAME OR EQUAL

August 2, 2024

1.0 INTRODUCTION/OVERVIEW

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports applied research to better understand, treat and ultimately prevent infectious, immunologic, and allergic diseases. NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats. Within NIAID, the Vaccine Immunology Program (VIP) of the Vaccine Research Center (VRC) is an intramural research component that is dedicated to translating the latest concepts in disease pathogenesis and immunology into new vaccine strategies by conducting basic, translational, and clinical research dedicated to improving public health through discovery, design, and development of vaccines of public health importance. VRC scientific staff have expertise in immunology, virology, structural biology, pathogenesis, laboratory animal medicine, regulatory science, clinical research, bioengineering, and vaccinology. While the Center's primary focus is to develop vaccines and broadly neutralizing antibodies protecting against HIV/AIDS, the VRC also performs basic, translational, and clinical research to develop vaccine candidates for biodefense and emerging and re-emerging infectious diseases of public health importance. This includes vaccines for Ebola/Marburg, influenza, respiratory syncytial virus (RSV), malaria, tuberculosis (TB), Chikungunya and other alphaviruses, Zika virus, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) coronaviruses. In the effort to achieve their research goals and improve the efficiency of critical experiments, the VIP is seeking to acquire a mid-throughput next generation sequencing (NGS) system and a service plan option, which may be exercised upon completion of the 12-month warranty included with the purchase of the system.

2.0 BACKGROUND INFORMATION

The VIP provides state-of-the-art clinical trial research that helps guide determinations of effectiveness as well as providing insight into complex interactions down to the single cell level of the immunological response. Sequencing and genomic work that helps characterize and clarify these complex interactions is essential to a better understanding of the fundamental questions of vaccine effectiveness. The ability to provide these answers in sequencing and genomics using a platform that allows multiple samples of a specific trial over several time points is a key component of our mission to provide this insight while finding ways to reduce the time and cost as technology changes. To carry out parts of its mission, the VIP regularly seeks to purchase highly complex equipment and service agreements to maintain its functionality during use. As one of our laboratory locations has this instrumentation, we are seeking to purchase additional units for capacity.

3.0 OBJECTIVE

The purpose of this acquisition is to purchase a mid-throughput NGS system and an optional service plan which may be exercised upon completion of the 12-month warranty associated with the purchase of the instrument. These services are necessary to ensure the sequencing instrument is maintained in optimal condition as it will be used widely by VRC staff.

4.0 SCOPE

The scope of this effort includes providing the mid-throughput NGS system as well as the resources necessary to perform preventative, remedial maintenance and repair services to maintain the NGS system in optimal operating condition in accordance with the equipment manufacturer’s specifications.

5.0 CONTRACTOR REQUIREMENTS:

The technical requirements of the mid-throughput NGS system include:

• The Mid-Throughput NGS instrument has have at least eleven flowcell options with a minimum of 100M reads on a single flowcell and have a 600-cycle or greater kit option.

• The instrument must incorporate a design to avoid sample cross-contamination within the fluidics.

• The instrument must incorporate an onboard bioinformatics server with BCL to FASTQ conversion, lossless data compression, and secondary analysis pipelines.

• The instrument must not be larger than 23.6” x 23.6” x 25.6” (HxWxD) and weigh no more than 145kg.

• A 12-months warranty, installation, and training must be included with the system.

Training must be onsite on the NIH Bethesda, MD campus for up to 5 personnel.

The technical requirements for the service plan option include:

• Full coverage for Original Equipment Manufacturer (OEM) replacement parts, labor, and travel. Coverage includes all fees associated with repairs (labor and replacement parts) for any service or repairs performed. Only OEM parts will be accepted for all repairs and services.

• Service support must include reagent replacement upon hardware failure.

• Priority scheduling and onsite response for all repairs during the period of performance.

Priority is defined as giving priority scheduling equal to a direct contract and guaranteeing the equivalent manufacturer’s priority onsite response. OEM Trained Certified Technicians required.

• At least one (1) Preventive Maintenance Inspection to be performed during a twelve-month period to ensure the instruments are performing to factory specifications.

• 48-hour priority response time after receipt of service call

• Instrument control software and hardware proprietary updates (can occur during scheduled firmware updates upon request, and in conjunction with a scheduled Preventive Maintenance or Corrective Maintenance visit), including software revision.

Provide End User License Agreement (EULA) if applicable.

• Unlimited service visits during normal business days and hours, excluding Federal holidays.

• Unlimited telephone support for instruments and applications and Remote Technical Support during business hours.

• Field service representative trained to provide service in biosafety level 2 (BSL-2).

6.0 CONTRACTOR SUPPLIED MATERIALS

The Contractor shall provide all necessary parts and equipment necessary to perform remedial repair and planned maintenance on the equipment.

7.0 GOVERNMENT FURNISHED MATERIALS

No Government furnished materials are provided under this contract.

8.0 REPORTING REQUIREMENTS AND DELIVERABLES

Technical support, remedial repair (as needed), and one (1) annual planned preventative maintenance along with the delivery and installation of the new mid-throughput NGS instrument.

9.0 PERIOD OF PERFORMANCE

The warranty will run for 12-months from when the sequencing system has been installed. The optional service plan will take place for 12-months upon completion of the 12-month warranty.

10.0 PLACE OF PERFORMANCE

NIH/NIAID

40 Convent Drive Bethesda, MD 20814

11.0 INSPECTION AND ACCEPTANCE

a) All work will be inspected and approved by a VIP representative at the completion of any repairs and at the completion of the annual maintenance.

b) All work will be completed in accordance with industry standards.