LSJ FAR 8 Cobas 6 Month Bridge Final.pdf

VHAPG Part 808.405-6

Limited Sources Justification, AP 36C24722AP4940

Effective Date: 02/01/2022 Page 1 of 3

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C24722AP4940

(1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 07, located at Charlie Norwood VA Medical Center, 1 Freedom Way, Augusta GA 30904.

(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). Charlie Norwood VA Medical

Center (CNV AMC) Augusta, GA currently uses two Roche Cobas 8000 configurations along with pre-and post-analytical automation to perform clinical chemistry testing through established

VA delivery order VA24717F2263. The current delivery order will expire September 30, 2022. A replacement delivery order, 36C24722F0199 was awarded in April of 2022 to allow a six month

POP overlap for phase-in/phase/out of the equipment. However, delivery under that contract has been delayed until sometime in the first quarter of FY23.

This is a bridge delivery order that will effectively extend the current service that is provided under VA24717F2263 for six months with a POP of 1 Oct 2022 – 31 Mar 2023. No extension of the current order is supported by federal and VA acquisition regulations.

Order against: FSS Contract Number: V797P-7347A

Name of Proposed Contractor: Roche Diagnostics

Street Address: 9115 Hague Rd

City, State, Zip: Indianapolis IN 46256

Phone: 1-800-346-8606, Ext. 13302

(3) Description of Supplies or Services:

The estimated value of the proposed action is $708,984.46

The contractor shall provide the Charlie Norwood Veterans' Hospital (VA), Pathology and Laboratory

Medicine Service an FDA approved automated integrated track system, including chemistry analyzers, immunoassay analyzers, 2 centrifuges, decapper, and input module. In order to reduce the risk of paying additional "add-on" costs associated with a bundle price when test volumes increase, the VA requires vendor proposals to be structured as follows:

* CPT to include reagents, controls, calibrators, consumables and accessories.

* Fixed rental for instruments, all automation components and middleware, complete system installation and integration, on-going service for each and water system hardware and service, complete https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

Effective Date: 02/01/2022 Page 2 of 3 training for personnel for the term of the agreement. In addition, the contractor shall provide an integrated system and deionized water system for Charlie Norwood Veterans' Hospital to be included in this agreement.

(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; The current delivery order 36C24722F0199 was solicited competitively in Mar of 2022.

Three quotes were received. However, only Roche was found to be technically acceptable. It is unlikely that competition under this acquisition would expand the vendor pool given that only Roche was found acceptable less than six months ago. More importantly, the currently installed system is the property of

Roche Diagnostics and changing to another vendor at this time is not feasible, prudent, nor cost effective and would result in the certain interruption of patient care.

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. 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..

(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: The Roche system is currently installed and in use. This order will serve to extend that use for an additional six months in order to allow time for the new system that was awarded under 36C24722F0199 to be delivered and installed.

Considering price, special features, administrative costs, any alternate acquisition strategy would result in duplication of cost and effort.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was conducted by speaking to the lab and to the vendor about the delays in delivery of the new equipment under

36C24722F0199, POP 1 April 2022 – 31 Mar 2027. Roche Diagnostics is both the outgoing

VA24717F2263, and incoming 36C24722F0199 contractor for this requirement. It was determined that the best approach is to cut a bridge order with Roche to cover the labs testing needs until the new equipment can be delivered and installed.

https://www.acquisition.gov/far/part-8#FAR_8_405_6

Effective Date: 02/01/2022 Page 3 of 3

(7) Any Other Facts Supporting the Justification: None

(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. A competitive award was made for this equipment in Mar of 2022.

The equipment delivery has subsequently been delayed however due to the global supply issues.

(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.)

Jasmine Cage

Medical Technologist/COR

(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.

Jason Compton

Contracting Officer NCO7

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Millicent Ball

Branch Chief, NCO7 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx