P03 J_A - Part808.405-6_Limiting_Sources_Justification_OVER_SAT.pdf.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C260-20-AP-4241

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 20 (NCO

20) procuring for the Portland VA Medical Center utilizing purchase request 648-20-3-9961- 0206.

(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).

This procurement is for high-throughput molecular laboratory testing platform to test to perform SARS-CoV2, HCV viral load, HIV viral load, quantitative CMV, TV/MG, and HPV.

Material #05524245001 COBAS® 6800 Analyzer. This action will be awarded as a new requirement, Base + 4 option years, Period of Performance to be 10/1/2020 – 9/30/2025 with the potential for a 6-month -8 extension at an estimated total value of $579,925.00.

Order against: FSS Contract Number: V797D-70105

Name of Proposed Contractor: Roche Diagnostics

Street Address: 9115 Hague Road, PO Box 50457

City, State, Zip: Indianapolis, IN 46250

Phone: 336-436-5742

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 579,925.00

The FSS order includes costs covering (a) equipment, (b) training and training travel, (c) LIS interface allowance, (d) validation material allowance, (e) and warranty years.

The Automated Chemistry Immunochemistry Analyzers (Chemistry Analyzers – COBAS 6800’s) for testing at the Department of Veterans Affairs Medical centers in Veterans Integrated Service Network 20 (VISN 20) are used by laboratory staff employees for immunochemistry testing.

This testing is considered essential as it allows the medical staff to test patients’ bodily fluids, assisting providers in diagnosis and in monitoring patients’ health

________________09/29/2020 - 09/28/2025

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(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:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Per Roche Proprietary letter dated August 4, 2020 - “Roche Diagnostics Corporation (RDC) hereby confirms that the Roche Molecular Diagnostics (RMD) products are proprietary to Roche Diagnostics Corporation (RDC) and only available for purchase in the United States directly from RDC. The RMD product portfolio is not available through any Veteran Owned Small Business (VOSB) distributor or any other distributor, regardless of size. The products which make up the RMD portfolio are subject to FDA approval and regulation. Our obligations with respect to our RMD consumables include ensuring the products are properly temperature controlled throughout the entire shipping and storage process in route to a customer site. Failure to comply with these regulations could create potential patient safety issues. Because of potential patient safety issues and other factors, RMD has made the business decision to only sell these products directly to the end-users.”

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

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

A patent, copyright or proprietary data limits competition.

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

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

As an order off of an existing FSS contract (V797D-70105) this has already been determined to represent best value to the government.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

The Roche COBAS 6800 will not only increase capability and preparedness for SARS-CoV2, HCV viral load, HIV viral load, quantitative CMV, TV/MG, and HPV testing but also provide the opportunity perform in-house testing that is currently being sent out. This alone would result in approximately $77K annual cost savings. Additionally, it would provide testing heterogeneity within VISN 20. Currently, the only other site with this testing capability is VA Puget Sound. If their platform or certain assays become inoperable or there is a recall rendering a test unusable the entire VISN is at a disadvantage. Having this heterogeneity would ensure that there will always be testing that is VISN 20 and veteran centrically focused.

Also, in addition to testing for SARS-CoV-2, it will be used to replace the current Roche Ampliprep/Taqman. HCV, HIV, CMV (quant currently sent out), and HPV high risk (currently sent out) in-house testing will be possible on the new instrumentation. The multiple assays have the ability to be performed simultaneously and on one plate which would conserve resources. The platform has a very large throughput for testing, 384 tests per 8-hr shift, and 1,344 tests in 24 hours. Having the Roche COBAS 6800 at the Portland VAMC would reduce the reliance of NCO 20 on the Puget Sound COBAS 6800 system and reduce delays in testing and reporting due to specimen transportation mishaps and limitations on the hours of the testing site. Additionally, it is a fully automated, walkaway system, freeing up technologists to perform other duties.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Limited market research was performed as the Roche 6800 is the only machine capable of meeting the needs of the VA.

(7) Any Other Facts Supporting the Justification:

As of June, the Oregon Health Authority has announced recommendation for coronavirus testing for 6 categories of asymptomatic groups:

Close contacts of a person with a confirmed infection or with a person presumed by public health officials to be infected

People exposed to coronavirus in a congregate setting, such as a nursing home or prison Migrant or seasonal farm workers, when they arrive in Oregon Oregonians who are black, African American, Latino, Latina, Latinx, American

Indian/Alaska Native, Asian, Asian-American or Pacific Islander Oregonians with a disability People whose first language is not English

There are at least 4 of the 6 categories of individuals that VAPORHCS treat. Encouraging testing among some people without symptoms could help identify infections earlier and reduce the spread.

Thus, the current requirement of VAPORHCS mandates us to continue to test for HCV viral load, HIV viral load, bring in-house CMV quant testing, HPV testing, and TV/MG while also adding the

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020 above high throughput SARS-CoV2 testing. In order to fulfill this requirement, there is only one platform that can handle the request.

(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:

None at this time.

(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.)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

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 SIGNATURE DATE

Bethany Ireton, Contracting Officer - APC Branch Chief - NCO 20, Vancouver

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

Kelsey Kiaha 429055 Digitally signed by Kelsey Kiaha 429055 Date: 2020.09.25 16:18:31 -07'00'

Bethany D. Ireton 282396 Digitally signed by Bethany D. Ireton 282396 Date: 2020.09.25 16:59:58 -07'00'

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

SIGNATURE DATE

Peggy Bowen, Division 1 Chief NC0 20, Vancouver

RPO-West JOFOC Tracking Log Number: 2020-09-25T14:56:54

Peggy L. Bowen 1568934 Digitally signed by Peggy L. Bowen 1568934 Date: 2020.09.26 06:42:05 -07'00'