SOW NovaSeq 6000.pdf

STATEMENT OF WORK

1.0 TITLE

Preventative Maintenance, Emergency Service, support, and coverage for Illumina NovaSeq 6000 Sequencing System

2.0 BACKGROUND

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center of Cancer Research (CCR), Laboratory of Pathology utilizes a Government owned NovaSeq 6000 (Illumina Inc.) for NGS assays requiring high throughput and depth including Whole Exome Sequencing (WES), Whole Genome Sequencing (WGS), Transcriptome Sequencing (RNAseq) and/or comprehensive cancer Panel. These clinical sequencing assays are used for the patient enrolment in NCI clinical protocols and 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 accreditation. This maintenance contract is required for our facility to remain accredited and continue to serve the NIH patient population to the benefit of the Government.

3.0 SCOPE

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

1. Illumina Inc. – NovaSeq 6000 Sequencing System – Asset No.: A01064

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturers (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 maybe 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:

4.1 PREVENTIVE MAINTENANCE

The Contractor shall perform one (1) planned preventive maintenances during the contract period. Service shall be performed by Technically qualified factory-trained personnel. 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. 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. 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 such as, a Word or PDF file.

4.2 EMERGENCY SERVICE

On-site, emergency repair services 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 a four (4) hour initial response with a seventy-two (72) hour on-site response a qualified factory-trained 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 and travel will be included.

Within three (3) days of the completion of any emergency repair services performed, the contractor shall provide a brief report to the TPOC stating the equipment malfunction that occurred, the repair efforts performed, and the duration that was required to restore the equipment to operation. The report shall be provided in electronic format such as, a 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 OEM specifications. Upon identification of required parts, they shall be delivered within 48 hours, or the following business day should the request fall on a Friday or proceeding a Federal Holiday. If parts will take longer than 48 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 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, 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. Defective software shall be replaced at no additional cost to the government.

Installation of any software/updates shall be performed by a factory trained and certified technician. The Contractor shall provide an electronic report to the TPOC per the within one (1) day after successful performance of software updates. This report must also include the reason for the updates, and any effect it may have on equipment operation.

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 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. These repairs shall be the subject of a separate purchase order and shall not be performed under this contract.

4.7 PERSONNEL QUALIFICATIONS

Technically qualified factory-trained personnel shall perform service to Illumina NovaSeq 6000 sequencing system, including its configured PC, and supporting software as covered by this contract. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the equipment covered by this contract.

5.0 TYPE OF ORDER

This is a firm-fixed-priced purchase order for severable services.

6.0 PLACE OF PERFORMANCE

Onsite services shall be performed at the following location:

NIH, NCI, CCR

Laboratory of Pathology

10 Center Drive Bldg. 10, Room 4A22 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).

7.0 PERIOD OF PERFORMANCE

The tentative Period of Performance (PoP) shall consist of one (1) twelve (12) month base period, and one

(1) twelve (12) month option period as follows:

Base Period: July 30th, 2022 – July 29th, 2021 Option Period 1: July 30th, 2023 – July 29th,2023

Option period will be executed in accordance with FAR Clause 52.217-9 (Option to Extend the Term of the Contract).

8.0 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 the Government. The authorized representative of the Government is the NCI Technical Point of Contact (TPOC T.B.D upon award) 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/accessibility-checklists/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.

9.0 DELIVERABLES AND DELIVERY SCHEDULE

All written deliverable products shall be submitted in draft format for review, comment and approval by the TPOC. Final copies of approved drafts shall be delivered to the TPOC by the specified due dates in the table below.

Reports shall be delivered in Microsoft Office 2013 or newer Word formats or Adobe PDF, unless prior approval for another format has been obtained from the TPOC.

DELIVERABLE REQUIRED FORMAT DUE DATE

Preventative 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

Software Updates/Revisions (Section 4.4)

Electronic, Word or PDF format 1 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 PAYMENT

Payment shall be made in quarterly in arrears. Payment authorization requires submission and approval of invoices to the Technical Point of Contact and NIH OFM, in accordance with the payment provisions listed below:

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 taken into account 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. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the System for Award Management (SAM).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a Contractor does not have a DUNS 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.

B. 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.

C. The Contractor shall submit invoice to the National Institutes of Health (NIH)/Office of Financial

Management (OFM) via email at invoicing@nih.gov with a copy to the approving official, as directed below. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files. The invoice shall be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF). The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official Technical Point of Contact:

Technical Point of Contact

Name- (TBD at Award) Email Address- (TBD at Award)

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@incontactemail.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday – Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

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 (December 2013)

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, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)