Statement of Work Template Template ALL Ventana Ultra 2022.pdf

US Department of Agriculture (USDA)

Statement of Work

Contents Project General Information

1.0 Scope of Work ................................................................................................................................... Error! Bookmark not defined.

2.0 Background

Contractor Requirements

3.0 Technical Requirements / Tasks

4.0 Government Furnished

5.0 Deliverables / Schedule

6.0 Travel

7.0 Contractor’s Key Personnel

8.0 Security Requirements

9.0 Data Rights

10.0 Section 508 – Electronic and Information Technology Standards Attachment

Project Purchase Ventana Discovery Ultra Immunohistochemistry Stainer, Roche Diagnostics Corporation, Indianapolis, IN

General Information The NVSL Pathology Laboratory requires replacement of a Ventana Discovery XT IHC slide stainer obsoleted by the vendor in 2018 used to support USDA Programs for scrapie eradication and chronic wasting disease (CWD) control. The NVSL is the reference laboratory and provides oversight to NAHLN Partner Laboratories performing like testing for the USDA. The Ventana Discovery Ultra, an IHC platform currently used by the NVSL and other NAHLN IHC Laboratories, is specified in SOP and other Quality Documents of the NVSL and the NAHLN.

Only the Roche Diagnostics Corporation, 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250 can supply this instrument as they are the exclusive manufacturer, sales point and support system for the Ventana Discovery Ultra, necessary reagents, and service required.

2.0 Background

Pathology Section Quality documents at the NVSL specify using the NVSL validated IHC prion protocol for scrapie and CWD on the Ventana Discovery Ultra with Ventana reagents and uses this instrumentation for diagnostic testing in support of USDA Scrapie and CWD Programs. There are currently two Discovery Ultras in use at the NVSL laboratory.

Another stainer the Ventana Discovery XT currently utilized at the NVSL has been obsoleted by the vendor and must be replaced to ensure staining capability is sufficient to meet demands of the USDA programs. Proprietary software, reagent formulas, instrumentation specifications and service protocols are not available from any other source.

Contractor Requirements

3.0 Technical Requirements / Tasks

The NVSL has tested and validated protocols for scrapie and CWD evaluation on the Ventana Discovery Ultra specified in current SOPs and Quality Documents for the NVSL and NAHLN Partner Laboratories.

Salient characteristics of the Ventana Discovery Ultra required for this prion testing include: pre-packaged reagent kits with bar-coded dispenses to insure accurate and precise protocol staining and reduce preparation errors, 30 individual experiments, each with it’s own protocol, heat supplied individually to each slide for greater control of reactions, can run fully automated and manual applications simultaneously, and has bulk reservoirs to increase staining capacity without replenishing bulk tank reagents and allows for addition of bulk reagents while the system continues to operate, enhancing workflow.

The vendor must be able to supply instrumentation, reagents and service specific to the requirements of the USDA validated protocols and specifications.

4.0 Government Furnished

List any government-furnished support, data, property or facilities. Describe government responsibility for reviewing and approving reports and final products generated under the contract. If the contractor will require access to government facilities, identify the facility location and specific area. Identify any federal holidays or other times when access may be restricted.

Insert Government Furnished Here

5.0 Deliverables / Schedule

All written deliverables shall be phrased in layperson language.

• Where a written milestone deliverable is required draft format, indicate a completion time for review of the draft formatted deliverable, e.g. within ___ calendar days from date of receipt. The agency shall also indicate the number of business days the contractor has to deliver the final deliverable from date of receipt of the government’s comments.

• To the maximum extent possible, state requirements in terms of (a) functions to be performed; (b) performance required; or

(c) essential physical characteristics. Define in terms that encourage Offerors to supply commercial items, or, to the extent that commercial items suitable to meet the agency’s need are not available, non-developmental items. Allow the contractor to devise and propose one or more solutions to satisfy the requirements.

• Sample Text - Tasks and Associated Deliverables: Timely submission of deliverables is essential to successful completing this requirement. Schedules for deliverables are specified in Exhibit B. All deliverables shall be prepared and submitted according to format, content, and schedule described in the SOW. All “hard copy” deliverables will be submitted on recycled content paper and printed double-sided.

• Sample Text - Reporting Requirements: The contractor is required to provide written progress reports {insert frequency, e.g. monthly} for the period {specify contract period or project duration}. The original and {specify number} copies are required. The progress report shall cover all work completed during the specified period and shall present the work to be accomplished during the subsequent period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation.

Example 1

Key Deliverables Item No. Deliverable Objective Due 1 Proposed Project Plan Defining the responsibilities, timeline, risks and milestones of contract objectives. Ref. Subtask 4.1.3 No later than five (5) business days after contract award

2 Weekly Status Report Report documenting tasks & issues weekly. Ref Task 5.1

Weekly, every Friday, by 3:00 PM EDST until the contract expires

Example 2

Key Deliverables Item No.

Deliverable / Item Title

Description Frequency Reference Delivery Format

Due By

1 Monthly Status Report

Monthly report documenting tasks and issues identified during the month

Once per month

Ref. SOO, Page 3, Section 4.2.1, Functional Tasks

Via email to

COR

The 5th day of each month after contract award

2 Monthly Cumulative BPA Call Order Report

Monthly cumulative of all BPA Calls issued since date of contract award

Once per month

Ref. SOO, Page 6, Section 5.1.3, Call Order Report Details

Via email to

COR

The 10th day of each month after contract award

Insert Deliverables / Schedule Here

6.0 Travel

Identify any travel requirements, locations involved, number of trips (if known), and duration of anticipated travel. Specify responsibility for travel reimbursement, e.g., the contractor or the Government. If the travel will be reimbursed by the Government, discuss the method of reimbursement, e.g., in accordance with Federal/agency travel regulations. State the Government official authorized to approve contractor travel, e.g., the Contracting Officer or Contracting Officer Representative.

Insert Travel Here

7.0 Contractor’s Key Personnel

Describe positions which are considered key to successful performance of the contract and the information required to support key personnel qualifications, e.g., experience which correlates to SOW requirements, education, and past performance on similar projects. Specify if resumes are required and provide resume format if appropriate.

Insert Contractor’s Key Personnel Here

8.0 Security Requirements

Specify security requirements that apply to the contract performance. Specify the level of clearances required and identify positions that are applicable.

Insert Security Requirements Here

9.0 Data Rights

If data is to be produced, furnished, acquired, or used in meeting contract requirements, delineate the respective rights and obligations of the government and the contractor regarding the use, production, and disclosure of that data.

Insert Data Rights Here

10.0 Section 508 – Electronic and Information Technology Standards When information technology is to be acquired, include language describing Section 508 requirements.

Insert Section 508 Here

Attachment If applicable, include an Attachment stating Evaluation Factors and significant Subfactors representing the key areas of importance and emphasis to be considered in the source selection decision.