SOW - Illumina - NOI SS.pdf

STATEMENT OF WORK

1.0 TITLE

Preventive Maintenance Services For One Illumina Microarray Scanner (iScan/RoMa) and Two Illumina Sequencers (NextSeq 550Dx)

2.0 BACKGROUND

The Laboratory of Pathology (LP) at the National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), uses one Illumina iScan system and two Illumina NextSeq 550Dx sequencing instruments for high-throughput, diagnostic assays and multiplex human genotyping microarrays for whole-genome, targeted genome, and exome analyses. These clinical assays are used for patient enrollment in NCI clinical protocols and for patient treatments. Scheduled maintenance and proactive service of diagnostic equipment are requirements for all clinical laboratories performing and reporting complex assays on human materials, to maintain Clinical Laboratory Improvement Advisory (CLIA) and College of American Pathologists (CAP) accreditations and continue to serve the NIH patient population.

3.0 SCOPE

The Contractor shall provide all labor, material and equipment necessary to maintain and provide preventive maintenance for the following equipment, including configured software:

• One (1) Illumina Microarray Scanner, consistent of:

o One (1) iScan, Serial Number (S/N) N0948 o One (1) RoMa (robotic module), S/N 1803000025

• Two (2) Illumina NextSeq 550Dx, S/N NDX550199 and S/N NDX550200

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturer’s (OEM) most current standard commercial maintenance practices. Onsite and emergency services shall be provided during standard business hours (defined as 8:00 am – 5:00 pm EST, Monday through Friday, excluding Federal Holidays found at www.opm.gov/policy-data-oversight/pay-leave/federal-holidays and extended hours (5:00 pm – 9:00pm EST, Monday through Friday) for any issues not able to be resolved remotely, or during normal business hours.

Software updates/services may be provided remotely as applicable. All travel, labor, materials, and related charges shall be included in the purchase order price.

4.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall provide all labor, materials, and equipment required to perform the following tasks:

4.1 PREVENTIVE MAINTENANCE

The Contractor shall perform one (1) planned preventive maintenance visit during each contract period of performance. Technically qualified factory-trained personnel shall perform this service.

The service shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all equipment in accordance with the manufacturer’s latest established service procedures. The http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays

Contractor shall perform calibration, alignment, verification and validation for each module of the instrument according to manufacturer’s lastest established maintenance protocol. All equipment shall be operationally tested through at least one (1) complete operating cycle at the end of the preventive maintenance inspection to assure optimum and efficient performance. The Laboratory of Pathology will then validate the performance of the equipment using a series of quality control materials.

All reagents used for failed runs resulting from hardware malfunctions shall be replaced by the Contractor at no additional cost to the Government.

Deliverable:

A report indicating the work performed shall be provided to NCI’s Technical Point of Contact (TPOC) within three (3) business days of completion. The report shall be provided in electronic format (Word or PDF file).

4.2 EMERGENCY SERVICE

On-site, emergency repair service visit shall be provided during the term of this contract at no additional cost to the Government. Emergency service shall be provided during normal working hours, Monday through Friday excluding Federal Holidays (see Section 3.0). Upon receipt of notice that any part of the equipment is not functioning properly, the Contractor shall provide an initial response within one (1) hour, and an on-site response within fourty-eight (48) business hours a qualified service representative to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition.

Emergency service calls shall not replace the necessity for planned preventative maintenance.

All labor, travel, and OEM parts shall be included. All reagents used for failed runs resulting from hardware malfunctions shall be replaced by the Contractor at no additional cost to the Government

Deliverable:

Within three (3) days of the completion of any emergency repair services performed, the contractor shall provide a brief emergency service report to the TPOC stating the equipment malfunction that occurred, the repair efforts, and the duration that was required to restore the equipment to operation. The emergency service report shall be provided in electronic format (Word or PDF file).

4.3 REPLACEMENT PARTS

The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. All parts shall meet original equipment manufacturer (OEM) specifications. Upon identification of required parts, they shall be delivered within 24 hours, or the following business day should the request fall on a Friday, or preceding a Federal Holiday.

Deliverable:

If parts will take longer than 24 hours to be delivered for any reason, the Contractor must provide the TPOC with a notification stating the reason and estimated delivery timeframe immediately upon identification of delivery delay.

4.4 SOFTWARE AND HARDWARE UPDATES/SERVICE

The Contractor shall provide Software Service and updates in accordance with the manufacturer’s latest established service procedures, to include telephone access to technical support for use of program software and troubleshooting of the operating systems, and on-site applications support, at no additional cost to the Government. The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government.

Software service shall include all major software versions, upgrades, updates and mandatory safety releases, installing the most recent version of the covered software. Software service shall include all maintenance release/service pack updates. Defective software shall be replaced at no additional cost to the Government. Hardware updates required to support updated software, software revisions, or newer software versions, shall be included at no additional cost to the Government.

4.5 TECHNICAL PHONE SUPPORT

The Contractor shall provide at no additional cost to the Government unlimited clinical technical telephone support during standard business hours and extended standard business hours for troubleshooting for the instrument and clinical application support (8am – 9pm Monday through Friday), excluding Federal holidays.

4.6 SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water.

4.7 PERSONNEL QUALIFICATIONS

Only technically qualified factory-trained personnel shall perform service on the Illumina iScan microarray scanner and the Illumina NextSeq sequencing equipment at NIH/NCI/CCR/LP, as covered by this purchase order. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the equipment covered under this purchase order.

5.0 TYPE OF ORDER

This shall be a firm fixed-price purchase order.

5.1 SEVERABLE SERVICES

The services acquired under this purchase order are severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods.

6.0 PERIOD OF PERFORMANCE

The base period of performance shall be for twelve (12) months from July 1, 2025 to June 30, 2026.

Note: the Base Period of Performance for the the NextSeq 550Dx (S/N NDX550199) and NextSeq550DX (S/N NDX550200) shall begin on July 20, 2025.

7.0 PLACE OF PERFORMANCE

Onsite services shall be performed at the following locations:

iScan microarray scanner: Rm. 3S253 NextSeq550DX sequencers: Rm. 3S255

NIH/NCI/CCR

Laboratory of Pathology Bethesda, MD 20892

Note that access to the NIH campus is restricted. As such all contractor personnel will be required to access campus via designated entrances where they are subject to security screening.

Also, due to the current COVI-19 Pandemic there maybe additional access restrictions. Please refer to the NIH Security and Access site for more details: (www.nih.gov/about-nih/visitor-information/campus-access-security).

8.0 TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all work in relation to this requirement, and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual.

The TPOC for this requirement is: TBD

Note: The TPOC has limited authority as defined within this Statement of Work. They do not have the authority to commit or obligate Government funds or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.

9.0 DELIVERABLES AND DELIVERY SCHEDULE

DELIVERABLE REQUIRED FORMAT DUE DATE

Preventive Maintenance

Service Report (Section 4.1) Electronic, Word or PDF format 3 business days after completion of service

Emergency Maintenance Service Report (Section 4.2)

Electronic, Word or PDF format

3 business days after completion of service

Delayed Delivery Notification (Section 4.3)

Electronic, Word or PDF format

Immediately upon identification of delayed deliveries

10.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of https://www.nih.gov/about-nih/visitor-information/campus-access-security https://www.nih.gov/about-nih/visitor-information/campus-access-security the Government. The authorized representative of the Government is the NCI Technical Point of Contact (POC) who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/making-files-accessible/create-accessiblepdfs/index.html.

Federal Government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

Note: The TPOC has limited authority as defined within this Statement of Work. They do not have the authority to commit or obligate Government funds, or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.

11.0 PAYMENT

Payment shall be made quarterly in arrears. The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9.

If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Purchasing Agent) and Technical Point of Contact:

Approving Official: Purchasing Agent

TBD: Name Email

Technical Point of Contact

TBD: Name Email https://www.ipp.gov/

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (November 2021)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause)