Amendment 0001 Attachment - Revised FAR 52.212-1 Instructions to Offerors.pdf

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

Offerors shall provide the following information and documentation with their proposal submissions:

1. Cover Letter/Executive Summary (limited to no more than 2 pages).

2. Evidence of completion of Food and Drug Administration (FDA) 510(k) process and FDA clearance for each product solution proposed.

3. Evidence of validation by Oracle Health’s CareAware Platform to support medical device integration for applicable pumps. If validation by Oracle Health’s CareAware Platform cannot be provided, include evidence of validation in progress. If validation is in progress, then the evidence of validation must be provided in response to the fair opportunity competitions for evaluation prior to award of delivery orders (see Paragraph I in the Statement of Work).

4. Product brochures, technical specification sheets, and information for each proposed product solution, which shall include, but not be limited to, the following:

a. For hardware evaluation: operating manual and device specifications including configuration options, cleaning instructions, and maintenance guides.

b. For software evaluation: drug library build information.

c. For reporting evaluation: training materials, basic and advanced analyst guides, implementation guide, data dictionary, and drug library distribution reference guide.

d. Complete list of consumables and supplies required for startup and operation.

5. Project/implementation plan, including, but not limited to:

a. A narrative (limited to no more than 10 pages) describing the offeror’s plan to comply with the requirements in Paragraph C of the Statement of Work to deliver, install, and implement its proposed infusion pump system for use at a VA medical facility. Describe specific steps the offeror will take, as well as the key milestones necessary to fully implement the offeror’s proposed implementation plan to replace the entire fleet of existing infusion pump equipment at a VA medical facility. The narrative must address any schedule risks that the offeror has identified regarding activation and describe the steps the offeror plans to take to mitigate those risks.

6. Training plan, including, but not limited to:

a. A narrative (limited to no more than 10 pages) describing the offeror’s plan to deliver training in accordance with the requirements in Section E of the

SOW.

7. Completed VA Directive 6550 Appendix A for each proposed product solution

(reference Attachment C – VA Directive 6550 – Appendix A). If 802.11 wireless networking is utilized and the Federal Information Processing Standard (FIPS) 140-2 or 140-3 certificate number cannot be provided, include evidence of certification in progress. If FIPS certification is in progress, then the FIPS certification number must be provided in response to the fair opportunity competitions for evaluation prior to award of delivery orders (see Paragraph I in the Statement of Work).

8. Completed MDS2 Worksheet for each proposed product solution (reference

Attachment B - NEMA MDS2 Worksheet).

9. Standard Commercial Warranty: Information shall be included in proposal package and shall include a minimum of one (1) year parts and labor from the time of acceptance (for each system) for defects in material and workmanship.

10. Completed Attachment A – Pricing Worksheet: Offeror shall submit a firm-fixed pricing structure. Offeror shall submit all (if any) assumptions upon which the price proposal is based upon. The Government understands different manufacturers’ solutions involve unique configurations and supplemental equipment that may not be listed currently on the Attachment A

- Pricing Worksheet. Therefore, offerors may substitute their own format for the Pricing Worksheet as long as they propose all requested quantities for the LVP, Syringe, and PCA Infusion Systems and all requested services and support items needed for the infusion systems to be fully operational and operate as intended. The offeror agrees to hold the prices in its offer firm for 60 calendar days from the date specified for receipt of offers.

11. SDVOSB/VOSB Subcontracting Plan. In accordance with VAAR clause

852.215-70, non-SDVOSB and non-VOSB offerors proposing to use SDVOSBs and/or VOSBs as subcontractors in support of this effort must state in their proposals the names of the SDVOSBs and VOSBs with whom they intend to subcontract and provide a brief description of the proposed subcontracts and the approximate dollar values of the proposed subcontracts.

In addition, the proposed SDVOSB and VOSB subcontractors must be registered and verified in the VetCert SBA database.

(End of Addendum to 52.212-1)