SOW - Polarize - NOI Sole Source.docx

STATEMENT OF WORK

TITLE

Preventive Maintenance Services for One (1) SpinAligner Hyperpolarizer

BACKGROUND

The Urologic Oncology Branch (UOB) and a series of other laboratories at the Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), study the effect of mutations that can directly impact cancer metabolism and DNA repair, and thus diagnosis, treatment, and outcomes of cancer patients. The rapid uncontrolled growth of cancer cells requires a different metabolism than the steady, controlled growth of normal cells. Detecting this abnormal metabolism provides both a way to improve cancer diagnosis and a new potential avenue for treatment.

In support of this metabolic cancer research, the Radiation Biology Branch (RBB) acquired a magnetic resonance hyperpolarizer platform, SpinAligner, in fiscal year 2019. The instrument, designed/developed and sold by Polarize ApS, allows NCI and NIH researchers to conduct metabolic studies by distinguishing various endogenous molecules and metabolic products at extraordinary high sensitivity. The SpinAligner is based on dissolution Dynamic Nuclear Polarization (dDNP) technology. It is equipped with a superconducting dry magnet, cooled by a pulse-tube coldhead and compressor, and has a closed-cycle, continuous helium circulation system. Dynamic Nuclear Polarization is achieved by irradiation with microwaves. The proprietary control system of the SpinAligner includes pulse sequence library, hyperpolarize sequence/procedure, and coils. Proper maintenance service of this hyperpolarizer is critical for a series of preclinical and clinical research projects conducted at the NCI and the NIH to ensure peak performance of this heavily used equipment.

SCOPE

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

· One (1) SpinAligner ApS Hyperpolarizer, S/N SA9.

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.

SPECIAL ORDER REQUIREMENTS

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

PREVENTIVE MAINTENANCE

The Contractor shall perform one (1) planned preventive maintenance during the contract period. Technically qualified factory-trained personnel shall perform this service. 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. This shall include adjustment of the magnetic field, cleaning of the probe and the char coal trap, pumping the enclosure vacuum, and electronic and mechanic maintenance and calibration of the pressure gauge sensors (airlock and DNP probe) and the needle valve.

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. Fees for labor, travel, and preventative maintenance replacement components shall be included at no additional cost to the Government.

EMERGENCY SERVICE

Up to two 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 two (2) business days, and an on-site response within (14) business days 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.

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 be new and meet original equipment manufacturer (OEM) specifications. Upon identification of required parts, they shall be delivered within four business days, or the following business day should the request fall on a Friday, or preceding a Federal Holiday. If parts will take longer than four business days 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.

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. 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.

TECHNICAL SUPPORT SERVICES

The Contractor shall provide unlimited toll-free technical telephone and email support at no additional cost to the Government.

FIELD SERVICE REPORTS

The contractor shall provide an electronic Field Service Report (FSR) by email to NCI’s Technical Point of Contact (TPOC, see Section 9.0) within three (5) business days of completion of any services performed on equipment or software covered under this requirement. The FSR shall include at a minimum the following information:

a) Contractors Name;

b) Equipment Model and Serial Number;

c) Technician’s name, telephone number, and signature;

d) Date and Time at which services were performed;

e) Summary of work performed;

f) As applicable: summary of malfunction/issue; malfunction that occurred, the repair efforts, and the duration that was required to restore the equipment to operation;

g) As applicable: reason for software updates, and any effect it may have on equipment operation;

h) Certification that equipment is fully operational.

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

SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water. Should damage occur as a result of the aforementioned events, the Government reserves the right to obtain repairs needed as a result of such events via a modification to the purchase order, under a separate purchase order, or any other method deemed appropriate and in accordance with Federal Acquisition Regulations.

PERSONNEL QUALIFICATIONS

The Contractor shall provide technically qualified, OEM-trained, and authorized service personnel to perform service on the SpinLab at NIH, as covered by this purchase order. The technicians shall be specifically trained on covered equipment, associated accessories, system components, and software. This shall include training on cryogenic handling and on very strong magnetic fields. Technicians must have access to the latest official instrument documentation, system specifications, software, and components necessary to maintain and repair equipment to normal operating conditions in accordance with the OEM’s most recent service guidelines.

TYPE OF ORDER

This shall be a firm fixed-price purchase order.

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.

PERIOD OF PERFORMANCE

The Period of Performance (PoP) shall be for twelve (12) months, with four (4) 12-month option periods as follows:

PLACE OF PERFORMANCE

Onsite services shall be performed at the following location:

NIH/NCI

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).

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 (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.

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:

Main TPOC (RBB)

TBD:

Alternate TPOC (UOB)

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.

PAYMENT

Payment shall be made quarterly, in arrears. Payment shall be made in its entirety upon completion and acceptance of all deliverables. 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

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.

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)