P03 LSJ - 36C244-21-AP-4388 - Multi-Site Coaguchek.pdf

36C244‐21‐AP‐4388 ‐ Multi‐Site Coaguchek

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405‐6

Acquisition Plan Action ID: 36C244‐21‐AP‐4388 – Multi‐Site Coaguchek

(1) Contracting Activity: Department of Veterans Affairs, VISN 04, Acquisition, 1010 Delafield Road, Pittsburgh, PA 15215; VA Pittsburgh Healthcare System, Lab & Pathology Service, Pittsburgh, PA 15240.

(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 is a new firm fixed price requirement for single award (5) year FSS BPA.

Order against: FSS Contract Number: _V797P‐5279B________

Roche Diagnostics Corporation 9115 Hague Road, PO Box 50457 Indianapolis, IN 46250‐0457 Phone: (800) 428‐5076 (Customer Service)

(3) Description of Supplies or Services:

The estimated value of the proposed action is: $801,247.25

Base $160,249.45

Option Year 1 $160,249.45

Option Year 2 $160,249.45

Option Year 3 $160,249.45

Option Year 4 $160,249.45

This requirement is for the procurement of an FSS BPA for a one‐year base and four option years. A multi‐station single award is anticipated to Roche Diagnostics for Roche Coaguchek XS Plus analyzers that allow for Point of Care (POC) coagulation testing currently used at the VA Pittsburgh Healthcare System and the Butler, Lebanon, and Wilmington VAMCs.

(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.

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: Roche has proprietary rights to the Coaguchek XS Plus analyzers and reagents.

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.

The requested equipment must be compatible with the RALS middleware.

Only Roche reagents are FDA approved for use on the Roche Coaguchek.

(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: Award of the described delivery order to Roche Diagnostics represents the best value to Government for the following reasons: (1) The price offered by Roche Diagnostics has been determined fair and reasonable by the government as Roches’ Coaguchek XS Plus analyzers and reagents are under FSS GSA schedule V797P‐5279B. (2) Roche Diagnostics has performed satisfactorily over the last five years. 3) The patient care providers that operate the Coaguchek are already trained and competent on its use so there will be no delay in continuing patient care.

(6) Describe the Market Research Conducted: Sources sought notice 36C24421Q1088 was posted on FBO from August 5‐20, 2021. The following companies responded: Roche Diagnostics – a large business and the incumbent contractor for the current contract; After Action Medical and Dental Supply – an SDVOSB company; Wilburn Medical – an SDVOSB company; and Coag‐Sense (unable to identify business size as no Dun & Bradstreet (D&B) number on file).

Coag‐Sense was eliminated from consideration as no D&B number is listed nor did the company’s Sales Rep provide a D&B number when requested.

After Action Medical and Dental and Wilburn Medical were eliminated from consideration for the following reasons: 1) Neither company is listed in BETASAM under NAICS 325413 and 2) After Action Medical and Dental is registered in VETBIZ but not under NAICS 325413.

The Pittsburgh VA Healthcare system currently has a five‐year FSS BPA with Roche Diagnostics under FSS Schedule V797P‐5279B for Coaguchek analyzers and reagents for performing coagulation testing. The current BPA is set to expire January 1, 2022.

No company other than Roche Diagnostics can fulfill the requirement of supplying Coaguchek XS Plus analyzers and reagents as Roche has proprietary rights to this coagulation testing system. Additionally, concerning form, fit, and function, the following stand: 1) Only Roche reagents are FDA approved for use on the Roche Coaguchek; 2) the Coagucheck XS Plus analyzer and reagents are compatible with the RALS middleware (also a Roche product) and are included in this requirement. The RALS middleware allows automatic transmission of patient results which eliminates transcription errors. Last, the patient care providers that operate the Coaguchek are already trained and competent on its use, so there will be no delay in continuing patient care.

As a result, it is in the government’s best interest to award a five‐year FSS BPA to Roche Diagnostics. This ensures continued supply of the required instrumentation, associated support services, and materials needed to continue POC coagulation testing without interruption to patient testing.

(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: Not applicable.

(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.

Jason C. Tedrow, Lead Medical Technologist DATE Pathology VA Pittsburgh Healthcare

(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.

Amanda Saunders, Contracting Officer DATE VA Pittsburgh Healthcare/NCO 04/ PCO

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.

Seth Custer DATE NCO4/ Division Chief, Division 1

c. Director NCO 04 I certify the justification meets requirements for other than full and open competition.

Benjamin Iachini DATE Director of Contracting, NCO 04

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

d. VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Joseph Maletta DATE Executive Director Regional Procurement Office ‐East VHA Head of Contracting Activity (HCA)