SON_Thermal Stim.pdf

STATEMENT OF NEED (SON)

1.0 TITLE

Procurement of one (1) QST Lab Thermal Cutaneous Stimulator (TCS II.1.b) System and associated components.

2.0 BACKGROUND

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH), Division of Intramural Research (DIR), Section on Affective Neuroscience and Pain (SANP) is dedicated to exploring complementary and alternative healing practices in the context of rigorous science; educating and training researchers; and disseminating authoritative information to the public and professionals. To fulfill its mission, SANP efforts integrate experimental psychology, neuroimaging, psychophysiology, computational approaches, and other interventions to understand how psychological and contextual factors influence subjective experience. Current projects focus on dissociating components of expectancy (e.g., instructions vs. conditioning;

stimulus vs. treatment expectancies), relating pain with other types of hedonic affective responses, and understanding social influences on pain (e.g., patient-provider interactions;

health disparities). The required equipment is a critical addition to one of the existing shared equipment, Serial number: TC 2020-2.1.b-052 which has CHEPS and CCEPS thermodes and can deliver triggers to other external devices such as the MRI.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for one (1) QST Lab Thermal Cutaneous Stimulator (TCS II.1.b) System and associated components. The equipment shall:

• Have a precise temperature control with a maximum stimulus delivery at any target temperature ramp of 300 degree per second to prevent the device from overheating.

• Include an external touch screen capable of managing the stimulation parameters and the launching of manual stimulations.

o The external touch screen shall include an option to connect to an external computer.

• Be MRI, EEG, and ECG compatible to administer thermal stimulation and the ability to set the intensity of the digital filter on the stimulator. This shall allow the use of existing MRI equipment to generate increased strength of the digital filters.

• Be ultraportable with a maximum weight of 10 Ib, allowing the equipment to move from multiple bedsides and rooms performing testing across the Clinical Center (CC) on different floors. This is to accommodate and minimize the transport of patients who are unable to move from room to room.

• Include two (2) thermal probes, which differ in size and can be set to different types of temperature adjustable from 0 to 3000C per second at five independent stimulation zones.

• Include a temperature/stimulation duration function that integrates four parameters:

the setpoint temperature, the dwell time, the ramp and the return ramp to reach the setpoint temperature to avoid burns on the skin.

• Include a single probe that shall be used to study thermal grill illusion and diffuse noxious inhibitory control pain.

• Allow the user to move the stimulation from one spot to another easily without having to reposition the device.

4.2 DELIVERY / INSTALLATION

The Contractor shall deliver the instrument and associated components within 45 business days of the purchase order award. The equipment shall be fully calibrated prior to delivery. The Contractor shall coordinate delivery and tracking information with the NCCIH Technical Point of Contact (TPOC), TBD at award. All shipping/handling (including FOB) and delivery/installation fees inclusive of parts and labor, shall be included. NCCIH will not be responsible for any shipping charges not listed in the quotation.

Upon delivery, the Contractor shall notify the TPOC to schedule the installation date and time, which shall occur within 5 business days of delivery. Installation shall be performed by the Contractor.

The Contractor shall deliver the equipment to the following address:

ATTN: TBD at Award

NCCIH

10 Center Drive Bldg. 10, Room 4-1741 Bethesda, MD 20892

4.3 TRAINING

The Contractor shall provide video conference virtual training for full instrument operation for up to 8 NCCIH staff members at the above location within five (5) business days of installation of the equipment.

4.4 WARRANTY

In addition to the Implied warranty contained in FAR Clause 52.212-4, the Contractor is encouraged to provide express warranties. At a minimum, the Contractor shall provide a 12-month warranty from date of delivery and Government acceptance on all equipment and associated items provided under, or as a part of this purchase order. The warranty shall include repair and or replacement of parts, including travel, labor, and materials, at no additional cost to the Government. The warranty shall not exclude or limit the Governments rights for an Implied warranty as established in the terms and conditions of clause 52.212-4.

5.0 PAYMENT

Payment shall be made after delivery, inspection, installation, and Government acceptance.

Payment authorization requires submission and approval of invoices to the TPOC 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 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. NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). This award will transition to IPP in the future. It is the Contractor/Vendor’s responsibility to periodically check the OALM IPP website and be prepared to transition to IPP on the designated transition date.

Until the Contractor/Vendor has transitioned to IPP as specified on the OALM IPP website, the Contractor/Vendor 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 and is on the website at https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files Questions concerning the transition to IPP should be directed to NIH-IPPinvoicing@mail.nih.gov. Questions concerning this award should be directed to the NIH Contracting Officer.

If this award is a parent indefinite delivery award or a Blanket Purchase https://oalm.od.nih.gov/IPP https://oalm.od.nih.gov/IPP https://oalm.od.nih.gov/IPP https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files mailto:NIH-IPPinvoicing@mail.nih.gov

Agreement Set-Up, then HHSAR 352.232-71 applies to all task/delivery orders or Blanket Purchase Agreement calls issued under this award.

The Contractor shall submit a copy of the electronic invoice to the following NCCIH TPOC:

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 mailto:ofm_customer_service@incontactemail.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx 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.

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.

http://www.ipp.gov/