P03 LSJ - Cepheid VA-20-00081740 15 20 Dmc OVER SAT -.pdf

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:__VA-20-00081740______________

(1) Contracting Activity: Department of Veterans Affairs, VISN 01, VA Boston Medical Center.

This request is for the purchase of 4new Cepheid analyzers to handle the increased testing of Covid-19 within the VISN 1.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

Order against: FSS Contract Number: GS-07F-0597T exp 9/14/22__________________________

Name of Proposed Contractor: Cepheid US

Street Address: 904 Caribbean Dr.

City, State, Zip: Sunnyvale, CA 94089

Phone: 774-437-9133 Steven Cook

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 587,225.00. This request for a2 new 16 module Cepheid GeneXpert analyzers for Bedford and Newington and 2 new 4 module GXIV systems for VA Togus and VA West Haven to increase the capacity of Covid-19 testing within VISN 1.

Cepheid is the sole supplier of this instrumentation and can be considered the gold standard for PCR (Polymerase Chain Reaction) testing. No Substitutes allowed. Please see Salient Characteristics for greater detail.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: The COVID-19 Pandemic necessitates the need for additional equipment to perform testing of this virus.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Unified Covid-19 testing must be maintained to ensure all results can be compared to one another. This helps with the “comparing apples to apples” analogy. There will be no method comparison studies necessary. This saves time and money by not wasting cepheid cartridges on studies and using these cartridges where they are needed, for patients.

(5) Describe Why You Believe the Order Represents the Best Value. This product is offered with GSA contract pricing. This is an average %15 decrease from open market pricing. GSA pricing under contract GS-07F-0597T is pre negotiated and considered to be fair and reasonable for the purchases being made.

(6) Describe the Market Research Conducted . : Cepheid has been providing quality PCR testing for VA Boston and the rest of the country for many years. This new equipment will help the VISN 1 Network keep up with the current volume of Covid-19 testing and the testing anticipated with the second wave of the virus. There are newer companies coming out with their own platforms, but Cepheid has proven itself for almost 10 years in the VA. Some of these new companies have rushed getting their product to market and further evaluation has found these vendors not having the needed sensitivities and specificities to detect the Covid-19 virus .

With the Cepheid GeneXpert equipment, a negative patient will show negative and a positive patient will give positive results. Results are obtained in about 1 hour.

(7) Any Other Facts Supporting the Justification: Past experience with the Cepheid platform has proven to be reliable and accurate. With the Covid-19 virus, there is no room for mistakes.

A negative patient cannot have an instrument error positive result and a positive patient cannot be reported as a mistaken negative. There is a tremendous impact on those receiving invalid test results. Incorrect results jeopardize the patient’s health and could also impact the health of many other people . You cannot afford to have a false positive result and that patient be sent to ward with COVID -19 patients. This patient would sure become infected then. A false negative result allows for the patient to go to a ward of non-infected patients and exposing all of these patients to the virus. Cepheid is considered the gold standard of PCR testing.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: N/A

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

____7/15/20_

SIGNATURE DATE

David McElwee Program Support VISN 1 NCL Lab Service

NAME TITLE SERVICE LINE/SECTION

VA Brockton

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

NAME AND TITLE FACILITY/NCO/PCO

David G.

McElwee 142454

Digitally signed by David G.

McElwee 142454 Date: 2020.08.26 09:50:04 -04'00'