SON_autoMACS_DRAFT.pdf

STATEMENT OF NEED (SON)

SS-75N91024Q00045 1

1.0 TITLE

Procurement of One (1) Brand Name or Equal Miltenyi Biotec autoMACS NEO Separator & MACS MiniSampler S

2.0 BACKGROUND

The Clinical Immunotherapy Section (CIS) of the Laboratory of Molecular Biology (LMB) at the Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH), conducts research to understand basic genetic changes causing initiation and development of Hairy Cell Leukemia (HCL) and Hairy Cell Leukemia variant (HCLv) diseases.

As part of this research, CIS requires a cell separator for sorting leukemic cells from patient peripheral blood samples. These leukemic cells can be further used for DNA, RNA and protein purification, followed by whole exome and total RNA sequencing and transcriptome analysis.

The CIS/LMB previously utilized an autoMACS Pro Separator instrument for this purpose.

CIS/LMB seeks a benchtop instrument capable of automated immunomagnetic cell separation.

Therefore, CIS/LMB requires one (1) Brand Name or Equal Miltenyi Biotec autoMACS NEO Separator & MACS MiniSampler S to allow ongoing research to continue without disruption.

3.0 TYPE OF ORDER

This shall be a Firm Fixed-Price Purchase Order.

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following minimum product features/characteristics are required:

1. Shall be a compact benchtop instrument with a touchscreen user interface.

2. Must be fully compatible with Miltenyi Biotec MACS MiniSampler S to position tubes and reagent racks during automated processing of one or multiple samples.

3. Shall be able to process different sample volumes in 5 ml, 15 ml, and 50 ml tubes, thereby allowing flexibility in sample volumes.

4. Shall be able to process different sample types, such as whole blood, dissociated tissue and bone marrow.

5. Shall be capable of automated labeling of multiple samples.

6. Shall include maintenance service.

The following products by Miltenyi Biotec fulfills these requirements:

• autoMACS NEO Separator, Material No. 130-120-327

• MACS MiniSampler S, Material No. 130-123-093

• autoMACS NEO Essential Service, Material No. 160-003-401

SS-75N91024Q00045 2

4.2 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 final installation 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.

4.3 DELIVERY / INSTALLATION

Delivery shall be within four (4) weeks of the purchase order award. All shipping/handling (including FOB Destination) and delivery/installation fees shall be included in the quote. Upon delivery, the Contractor shall notify the respective NCI Technical Point of Contact to schedule installation dates and times. Installation shall occur within fourteen (14) calendar days of delivery and shall be performed by, or under the direct supervision of, a certified operator.

The contractor shall deliver and install the equipment at the following address:

Center for Immuno-Oncology/Laboratory of Molecular Biology National Institutes of Health/NCI 9000 Rockville Pike Bethesda, MD 20892

Technical Point of Contact: [to be provided upon award]

4.3.1 DELIVERY GUIDANCE

The Contractors shall communicate and follow instructions from the Technical Point of Contact (TPOC) to coordinate delivery and installation.

The Contractor shall direct all courier and delivery services – including those not operated by the Contractor (e.g. FedEx, USPS, UPS) – to follow the instructions in this section.

All companies delivering to the NIH main campus must comply with Commercial Vehicle Inspection Facility (CVIF) access procedures. Upon arrival, the CVIF will provide a list of buildings and loading docks to delivery personnel.

Deliveries will be logged in at the loading dock, and the loading dock contractor or Government personnel will attempt to contact the TPOC listed on the package. In the event that the TPOC is unable to accept the package, the delivery shall not be left at the loading dock station. The delivery must be returned to the Contractor, and the Contractor must coordinate with the TPOC to deliver on another date at no additional cost.

Deliveries can only be made between 6:00 a.m. and 4:00 p.m. EST, Monday – Friday, excluding federal holidays.

SS-75N91024Q00045 3

4.4 INSPECTION AND ACCEPTANCE

Pursuant to FAR Clause 52.212-4, all items to be delivered in relation to this Purchase Order are subject to final inspection and acceptance by an authorized representative of the Government.

The authorized representative of the Government is the TPOC who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

4.5 TRAINING

Training is not required for this equipment.

5.0 PAYMENT

Payment shall be made in full after the successful delivery, installation, and acceptance of equipment by the NCI Technical Point of Contact (TPOC). Payment authorization requires submission and approval of invoices to the NCI 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

SS-75N91024Q00045 4

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 (Technical Point of Contact):

Approving Official: Technical Point of Contact Name- Email Address-

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.

https://www.ipp.gov/

SS-75N91024Q00045 5

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 (MAR 2023)

(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) http://www.ipp.gov/