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This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E23Q0114 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-02.

This requirement will be made using a cascading set-aside under the associated NAICS code 485991 Special Needs Transportation with a small business size standard of $16.5M.

Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of lowest price technically acceptable.

STATEMENT OF WORK
CSP2017 Pivotal POP Study

I. Background

The VA Boston Cooperative Studies Program (CSP) is sponsoring a study to test the safety and efficacy of an implantable skeletal prosthetic for Veterans with above the knee amputation. The study will require participants to travel from various locations within the United States to VA approved research sites in Richmond, VA, Tampa Bay, FL, Salt Lake City, UT, Seattle, WA, Minneapolis, MN and a site to be determined (TBD). The intent is to completely fund round trip airfare, ground transportation, per-diem and lodging for study participants.

This will be a prospective, open label, randomized multi-center study. Subjects will be recruited within the United States who have experienced lower limb loss, at least 24 months prior to consent.

II. General Description of Service

The Boston Cooperative Studies Program Coordinating Center (CSPCC) Study Project Manager (PM) or designee shall contact the vendor and provide them with the minimum necessary participant information required to arrange transportation. Only minimal information will be provided to the vendor to facilitate transportation and the information will be supplied by secure, VA approve methods to protect participant PHI and PII.

The vendor shall coordinate with the participant to arrange for reservations for travel while accommodating for participant s mobility limitations. from the participants home of record (HOR) to and from the participating VA Medical Center via common carriers (air/train/bus). Travel may encompass airfare, ground transportation, lodging accommodations & per diem. Due to the limited mobility of the participants as related to above the knee amputation, the vendor shall ensure that travel arrangements are made in accordance with the Americans with Disabilities Act. However, first class travel will be prohibited due to VA travel restrictions and regulations.

Travel may originate from anywhere within the United States and be provided to one of six VA Medical Centers located in Richmond, VA; Tampa Bay, FL; Salt Lake City, UT; Seattle, WA, Minneapolis, MN; and one other site TBD. It is anticipated that 147 participants will be enrolled in the study and will be expected to travel to a study site a minimum of seven times. In addition to the 147 participants, there will be two (2) occasions where a caregiver will be allowed to travel with the participant to the research site. Caregiver travel and accommodations shall be arranged in the same manner as participants.

The vendor shall communicate all participant travel information via secure method which meets VHA privacy and security requirements to the Boston Cooperative Studies Program Coordinating Center (CSPCC) Study Project Manager (PM) or designee prior to booking. The Study PM or designee will review and provide approval for the participant travel to be scheduled and purchased in advance.

Additionally, the vendor shall provide an emergency contact number for all travelling participants to contact in emergencies, the emergency number shall be staffed during participant travel.

The vendor shall submit invoices monthly to the Boston CSPCC once services have been rendered.

III. Work Requirements

A. Itinerary
Itinerary: A copy of the final itinerary including record locator(s) shall be sent by the vendor to the Boston CSPCC PM, or designee, and a member of the study team will relay the information to the study participant.

Costs should be limited to essential travel and limited to government rate or similar, but with the ability to exceed, if justified (e.g., for ADA compliance reasons).

B. Training
Vendor employees involved in itinerary planning and/or interacting with veterans shall be required to take Privacy and HIPAA Training, VA Privacy and Information Security Awareness and Rules of Behavior (WBT), and VA Core Values Training (I CARE Commitment). The I CARE values are VA regulations and are expected to be incorporated in all interactions with veterans.

Information made available to the vendor by VA for the performance and administration of this contract shall be used only for those purposes required to complete contract requirements and shall not be used in any other way, unless the contractor receives prior written agreement from the VA. The vendor shall receive, gather, store, maintain, use, disclose and dispose of VA assets only in compliance with the terms of the contract.

IV. Performance Period and Contract Type

The intended contract type is an Indefinite Delivery/Requirements contract with Firm-Fixed price task orders.

Period of performance will be five (5) years from contract award. Individual periods of performance will be awarded by task orders, when services are required and based on attached price list.

Delivery FOB Destination to:
US Department of Veterans Affairs
Research
150 S. Huntington Ave
Boston, MA 02130
Additional contract requirement(s) or terms and conditions determined by the contracting officer:

Set Aside Cascading set-aside procedures.

Any award resulting from this solicitation will be made using a cascading set-aside order of precedence as follows:

1. In accordance with FAR Subpart 19.1405 and VAAR Subpart 819.7005, any award under this solicitation will be made on a competitive basis first to an eligible Service Disabled Veteran Owned small business [SDVOSB] concern provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States.

2. If there is inadequate competition for award to an SDVOSB concern, the SDVOSB set-aside shall be withdrawn and cascaded to the next contracting order of priority in accordance with VAAR 819.7004, which is Veteran Owned Small Businesses (VOSB) and conducted in accordance with the procedures set forth in VAAR 819.7006 provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States.

3. If there continues to be inadequate competition between SDVOSB and VOSB concerns, the cascading will continue through the contracting order of priority in accordance with VAAR 819.7004 and FAR 19.203. If the contracting officer determines that offers from small business concerns do not meet the solicitation requirements in terms of technical acceptability, past performance, and fair market price, the small business set-aside[s] will be withdrawn and award will be made on the basis of full and open competition.

Adequate competition:

Adequate competition shall be deemed to exist if At least two competitive offers are received from qualified, responsible business concerns at the set-aside tier under consideration; and Award could be made at fair market price as determined in accordance with FAR 19.202-6.

The VA contracting officer reserves the right to consider competitive proposals submitted from all responsible offerors (including large businesses) in determining the fair market price.
Due date and submission of quotes:

The quotes are due on 8/22/2023 at 10:00 AM EST and shall be directed electronically to Michael.haydo@va.gov. Quotes shall be marked with the solicitation number.
Information regarding the solicitation can be addressed to the Contracting Officer, Michael Haydo, michael.haydo@va.gov

Attachments:

Att 1 Applicable Provisions and Clauses
Att 2 System and Information Security Requirements
Att 3 Pricing Schedule

Attachments/Links

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