Statement of Work.pdf

STATEMENT OF WORK (SOW)

National Cancer Institute Statement of Work 1

1.0 TITLE

Procurement of Services to Measure Urinary Creatinine and Albumin Concentrations Among Participants in the Biomarkers of Exposure and Effect in Agriculture (BEEA) Study

2.0 BACKGROUND

The Biomarkers of Exposure and Effect in Agriculture (BEEA) study is a molecular epidemiologic sub-cohort within the Agricultural Health Study (AHS) that includes 1,681 male private pesticide applicators (mainly farmers) and 211 non-farming controls. Participants in BEEA completed questionnaires regarding their use of pesticides and other agricultural exposures, and provided biologic specimens (e.g. blood, urine, and buccal cells) than have been stored for future molecular epidemiologic investigations.

These samples are being utilized to elucidate the biologic plausibility and potential mechanisms underlying of the relationships between pesticides and other agricultural exposures, and risk of various cancers and other chronic diseases.

In particular, the National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) is using first morning void urine samples that were collected from nearly all BEEA participants are being used to assess exposure to pesticides by measuring urinary concentrations of pesticides or their metabolites. When using urinary biomonitoring data for pesticides or other exogenous exposures, it is important to account for variable dilutions in urine samples and kidney function in the exposure assessment.

2.1 OBJECTIVE

The primary objective of this effort is to account for urine concentration and kidney function as part of DCEG’s assessment of pesticide exposures using pesticide biomonitoring data for BEEA participants. Accounting for variability in urine concentration and kidney function is a critical element of pesticide exposure assessment based on urinary biomonitoring data.

3.0 SCOPE

The Contractor shall measure levels of creatinine and albumin in urine samples from participants in the Biomarkers of Exposure and Effect in Agriculture (BEEA) study.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall perform the following tasks:

1. Confirm the specifications for urine samples to be delivered (e.g., volume requirements, vial type, labeling/barcoding) and coordinate with NCI personnel for all aspects of delivery and performance.

2. Prepare a template of the Excel file that will be used to report assay results.

National Cancer Institute Statement of Work 2

3. Document the receipt of all urine samples in a MS Excel file with the unique ID of each sample.

4. Perform assays measuring urine levels of creatinine, albumin, and the ACR for each sample submitted.

5. Record assay results, test date, batching information, and quality control data for quality control samples provided by the Government and any quality control performed by the Contractor in the Excel file

6. Provide the NCI Contracting Officer’s Representative (COR) with a copy of the Excel data file upon completion.

5.0 GOVERNMENT RESPONSIBILITIES

The Government technical point of contact (TPOC) will coordinate with the Contractor to deliver samples to the Contractor’s facilities. The Government will be responsible for arranging shipment of samples to and from the Contractor.

Risk of loss or damage to the samples provided under this task order shall remain with the Government until samples have been delivered to the Contractor.

6.0 TYPE OF ORDER

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

7.0 PERIOD OF PERFORMANCE

The period of performance shall be for 12-months from date of award.

8.0 PLACE OF PERFORMANCE

Services shall be provided at the Contractor’s facilities, the facilities of its sub-contractors, and/or facilities authorized by the Contractor.

National Cancer Institute Statement of Work 3

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

All deliverables shall be per the following deliverable schedule:

DELIVERABLE

NO.

DELIVERABLE

DESCRIPTION

FORMAT

REQUIREMENTS DUE DATE

Confirm sample specifications and coordinate with NCI personnel

Confirmation of specifications via e-mail to the NCI COR and teleconference for coordination

10 days after award

2 Template of file for reporting assay results

Microsoft Excel file submitted via e-mail to the

NCI COR

September 29, 3 Samples delivered to the Contractor

Common carrier to be determined at time of award

60-days after award

Receipt of all urine samples with the unique ID of each sample.

Microsoft Excel file submitted via e-mail to the NCI COR upon completion.

10-days after receipt of samples

Urinary creatinine and albumin measurements and the albumin-to-creatinine ratio

Microsoft Excel file submitted via e-mail to the NCI COR upon completion.

15-days prior to expiration of the period of performance

9.0 PAYMENT TERMS

Payment shall be made upon delivery and acceptance of all deliverables.

The NCI will not accept invoices which include items not listed on the Offeror’s initial proposal and incorporated into the schedule of items for the resulting award. Payment authorization requires submission and approval of invoices to the TPOC and NIH OFM, in accordance with the attached 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:

National Cancer Institute Statement of Work 4

9.1 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 SAM.gov.

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. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health

National Cancer Institute Statement of Work 5

Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500

Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

9.2 ELECTRONIC INVOICING PROCEDURES

Effective April 1, 2020 all NIH contractors/vendors invoices should be sent electronically via e-mail to the NIH Office of Financial Management (OFM) and the Contracting Officer (CO) using the electronic submission instructions contained in Attachment #2.

This section shall remain in full force and effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this award.

9.3 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.

9.4 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.

National Cancer Institute Statement of Work 6

9.5 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (DEC 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.

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.