(1) MiSeq-2025-Statement of Work.updated_TD.pdf

Statement of Work

Preventative Maintenance of Illumina MiSeq Next-Generation Sequencing System

Background: The requested services are to provide recertification, annual preventive maintenance, parts, labor, travel for remedial repairs, software updates, and application technical support for one (1) Illumina MiSeq Next-Generation DNA Sequencing System (serial number M07852) (hereafter referred to as the Instrument).

The Instrument is used in support of research conducted by the National Oceanic and Atmospheric Administration (NOAA), National Ocean Service (NOS), National Centers for Coastal Ocean Science (NCCOS) at the Hollings Marine Laboratory (HML) in Charleston, South Carolina. The MiSeq platform supports genomics-based research including environmental DNA (eDNA), microbial community characterization, and molecular diagnostics critical to NCCOS mission objectives.

The Instrument is currently not under manufacturer support and must be recertified by the manufacturer or an authorized service provider prior to initiation of a standard annual service agreement.

Purpose:

1. Recertify the Illumina MiSeq instrument and return it to manufacturer-supported status; and

2. Provide one year of comprehensive annual maintenance coverage, including preventive maintenance, software and hardware updates, application technical support, and full coverage repair services (parts, labor, and travel), for the previously acquired Illumina MiSeq system.

Scope: The Contractor shall furnish all materials, labor, travel expenses, tools, parts, and equipment necessary to recertify and maintain the Instrument in full working order throughout the period of performance.

The scope of work includes:

● One-time instrument recertification which shall include:

• Comprehensive inspection and diagnostics of the Instrument

• Replacement of any non-compliant, worn, or unsupported components as required

• Installation of current manufacturer-approved firmware and software

• Verification of optical, fluidic, and thermal system performance

● Annual preventive maintenance

● Corrective maintenance and emergency repair services

● Software and firmware updates

● Application technical support

● OEM replacement parts

● Replacement of reagents attributable to instrument-related failure

● Telephone and email access to the manufacturer’s application technical support shall be made available.

● All work shall be performed in accordance with the manufacturer’s service manuals and specifications.

● Execution of manufacturer-required validation tests to confirm instrument functionality

● Documentation certifying that the Instrument has been returned to manufacturer-supported status

Preventive Maintenance: The Contractor shall provide one (1) on-site preventive maintenance visit during the period of performance, to include:

● Cleaning and inspection of optical, fluidic, and mechanical components

● Verification and calibration of temperature control systems

● Inspection and testing of fluidics, pumps, valves, and tubing

● System performance verification using manufacturer-approved procedures

● Installation of manufacturer-released software and firmware updates

● Documentation of the preventive maintenance visit, including a service report, shall be provided upon completion.

The preventive maintenance visit shall be coordinated with the Government’s POC at least two

(2) weeks in advance.

Telephone and Email Support

The Contractor shall supply telephone and/or email technical support for resolving hardware, software, application, and system performance issues.

● Support shall be available 18 hours per day, 5 days per week (18×5)

● Qualified, manufacturer-trained personnel shall provide support

● A suitable call-answering or ticketing system shall be available outside of normal support hours

Repairs and Parts

The Contractor shall provide full coverage repair services, including all labor, travel, shipping, and OEM replacement parts, at no additional cost during the period of performance.

● All replacement parts shall be OEM parts and meet or exceed manufacturer specifications

● The Contractor must have and maintain a written agreement authorizing access to manufacturer proprietary parts, tools, and documentation

● Emergency repair service shall have a two (2) business-day on-site response target

● Consumables used in routine operation such as reagents damaged or rendered unusable due to instrument failure shall be replaced by the Contractor at no additional cost.

The Instrument is located at:

NOAA

National Ocean Service Hollings Marine Laboratory (HML) 331 Fort Johnson Road Charleston, SC 29412

Access to the Instrument is limited to normal Government business hours (8:00 AM – 5:00 PM, Monday– Friday, excluding Federal holidays) unless otherwise coordinated with the Government Technical Point of Contact (POC).

Period of Performance: 5/1/26 – 4/30/27

Guarantee of Work

The Contractor shall guarantee all work performed under this contract and agree to remedy, at its own expense, any defects caused by poor workmanship or defective materials.

The deliverables under this contract are intended to:

1. Maintain the Instrument in fully functional and operational condition

2. Minimize instrument downtime through timely repairs and preventive maintenance

3. Ensure access to current manufacturer software and application support

Qualifications and Skills of Assigned Personnel

The Contractor shall provide assurance that factory-trained service engineers are fully qualified, authorized, and certified by Illumina, Inc. to work on the Illumina MiSeq platform.

Service engineers must have:

● Full access to manufacturer technical documentation

● Authorization to install firmware and software updates

● Access to proprietary diagnostic tools and replacement parts

Sufficient personnel shall be assigned to the region to ensure timely response and personnel backup.

Deliverables and Schedule of Deliverables

● All preventive maintenance and repair services shall be performed on site at the Hollings Marine Laboratory.

● The Government agrees to make the Instrument available for service at scheduled times.

● The Contractor shall coordinate all visits with the Government’s POC in advance.

● Emergency repair service shall be available within two (2) business days of notification.

● Any work outside the scope of this statement of work must be pre-approved by the Contracting Officer prior to rendering out of scope services.

Government POC:

NOAA Hollings Marine Laboratory POC: Thomas Greig 331 Fort Johnson Road Charleston, SC 29412 Phone: 843-406-9693 Email: thomas.greig@noaa.gov

IT Security Requirements

The Assessment and Authorization (A&A) requirements of Clause 48 CFR 1352.239-72 do not apply, and a Security Accreditation Package is not required.

The following is a list of relevant information the Department of Commerce (DOC) Information Technology (IT) Security takes into consideration when assessing the security requirements and risk for procuring IT products and services.

a) The Contractor shall only supply Information Technology (e.g., hardware, software, firmware, etc.) and/or product license and shall not require the use of any contractor owned equipment. The contractor will not have remote access to any government owned equipment. The Contractor shall ensure the acquiring Information Technology provided disables “phone home” or similar capabilities.

b) Product support and supporting documentation allows for the sanitization of the acquiring Information Technology and/or product license upon the disposal of the product. Product shall allow the use one of the approved methods for secure destruction of data/information including unclassified but sensitive information. Approved methods include NIST Special Publications 800-88 Guidelines for Media Sanitization (https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-88r1.pdf) or the National Security Agency in the Media Destruction Guidance (https://www.nsa.gov/Resources/Media-Destruction-Guidance/).

mailto:thomas.greig@noaa.gov https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-88r1.pdf) https://www.nsa.gov/Resources/Media-Destruction-Guidance/)

c) The acquiring information technology is engineered for trustworthy and security that is consistent with the engineering-based trustworthy secure solutions as outlined in NIST Special Publication 800-160 Version 1, Revision 1 Engineering Trustworthy Secure Systems (https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-160v1r1.pdf) and NIST Special Publication 800-160, Volume 2, Revision 1 Developing Cyber-Resilient Systems: A Systems Security Engineering Approach (https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-160v2r1.pdf).

d) The acquiring information technology complies with Office of Management and Budget Memorandum M-07-18 Ensuring New Acquisitions Include Common Security Configurations and the Federal Acquisitions Regulations (FAR) 39.101(d) regulations require NIST common security configuration checklists including United States Government Configuration Baseline (USGCB) initiative.

More information is available at National Checklist Program (NCP), (https://nvd.nist.gov/ncp/repository), the U.S. government repository of publicly available security checklists (or benchmarks) that provide detailed low-level guidance on setting the security configuration of operating systems and applications.

The acquiring information technology considers the following requirements:

i. Software procured meets the standard installation, operation, maintenance, updates and/or patching of software shall not alter the configuration settings from the approved USGCB/other secure configuration.

ii. Applications designed for normal end users run in the standard user context without elevated system administration privileges.

iii. Supporting documentation or reference(s) that describes the security capabilities, the design and development processes and the testing and evaluation procedures used by the product or services being provided for this acquisition.

iv. Supporting documentation or reference(s) that describes all product or service updates and enhancements as they are implemented. The product or service supporting documentation could be the user and system administrator guides, which is documents the functional properties of the security controls employed to permit the analysis and testing of the security controls.

e) The acquiring information technology complies with the Homeland Security Presidential Directive 12 (HSPD-12) Policy for a Common Identification Standard for Federal Employees and Contractors requirements from FAR 4.1302 stating: (a) In order to comply with Federal Information Processing Standard (FIPS) 201-3 Personal Identity Verification (PIV) of Federal Employees and Contractors (https://doi.org/10.6028/NIST.FIPS.201-3), agencies must purchase only approved personal identity verification products and services, (b) Agencies may acquire the approved products and services from the GSA, Federal Supply Schedule 70, Special Item Number (SIN) 132-62, HSPD-12 Product and Service Components, in accordance with ordering procedures outlined in FAR Subpart 8.4.

f) The acquiring information technology complies with Internet Protocol Version 6 (IPv6) requirements from FAR part 11.002 requirements that state the agency Chief Information Officer can waive this requirement provided the acquisition requirements documents the appropriate technical capabilities defined in the USGv6 Profile available in the NIST Special Publication (SP) 500-267 (https://www.nist.gov/programs-projects/usgv6-program) and the corresponding declarations of conformance. To meet this requirement each DOC acquisition of IP protocol technology must express requirements for IPv6 capabilities in terms of the USGv6 Profile (i.e., using the USGV6 Capabilities Check List) and vendors must be required to document their product’s support of the requested capabilities through the USGv6 test program (https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1) using the USGv6 Suppliers Declaration of Conformity.

g) The Contractor will only supply manufacturer-approved software and product licenses. The Contractor will not require remote access to Government-owned equipment and will not use contractor-owned equipment connected to Government systems.

https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-160v1r1.pdf) https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-160v2r1.pdf) https://nvd.nist.gov/ncp/repository) https://doi.org/10.6028/NIST.FIPS.201-3) https://www.nist.gov/programs-projects/usgv6-program) https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1) https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1)