Redacted LSJ_Redacted.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 6 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C244-21-AP-3952

(1) Contracting Activity: Department of Veterans Affairs, VISN 04, VA Pittsburgh Healthcare System (VAPHS), University Drive C., Pittsburgh, PA 15240. Purchase Request: 646-22-1-080- 0004.

(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).

The VA Pittsburgh Healthcare System (VAPHS) has a new Sole Source requirement for Abbot i- STAT Reagent Analyzers and Reagents. The Government s intent is to award a Base with Two Option Year Contract. The reagents requested are used for Point of Care testing which is used throughout the VAPHS at the Veteran bedside.

Order against: FSS Contract Number: V797P-7322A

Name of Proposed Contractor: Abbott Laboratories, Inc. Point of Care Division

Street Address: 200 Abbott Park Road

Dept 850Q, Bldg. AP 52

City, State, Zip: Abbott Park, IL 60064

Phone: 1-800-366-8020

(3) Description of Supplies or Services:

The i-STAT is lightweight, portable, and easy to use, the i-STAT blood analyzer operates with the advanced technology of single-use i-STAT test cartridges.

needed.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 6 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

The item description of the Government s request is shown below:

Item # Description/Part Number* Qty

I-STAT Analyzers 04P75-01 6

Electronic Simulator 06F11-01 5

I-STAT Serial Downloader 06F23-45 2

Creatinine Cartridges 03P84-25 1500

TriControl Level 1 05P71-01 32

TriControl Level 2 05P72-01 32

TriControl Level 3 05P73-07 32

Tricontrol Cal Verification Kit 05P70-01 4 Troponin Test Cartridges 03P90-25 4500 Cardiac Level 1 Aqueous Control 06P17-09 20 Cardiac Level 2 Aqueous Control 06P17-10 20 Cardiac Level 3 Aqueous Control 06P17-11 20 Cardiac Calibration Verification 06P17-12 12

Chem 8+ Cartridges 09P31-25 4500

CG4+ Cartridges 03P85-25 900

The VAPHS s intent is to award a Base Year Contract with Two Option Year.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a 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

VHAPM Part 808.405-6 Limiting Sources Page 3 of 6 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021 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 eplacem 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 GSA Cost Per Test Contract V797P-7322A is only offered direct through Abbott Point of Care, the distributors cannot provide the structure at the GSA/FSS Cost Per Test contract offered by Abbott.

The i-STAT System features a handheld portable, blood analyzer combined with single-use test cartridges, delivering lab-quality results in minutes.

The i-STAT analyzers provide testing for Veteran s troponin, creatine, chem 8+, and CG4 levels. The testing used with the i-STAT System facilitates real-time decisions in a diverse healthcare system, such as the VAPHS, to optimize Veteran care and healthcare outcomes. As a result of the expedited manner in which i-STAT produces results, the appropriate treatment is accelerated for the Veteran.

VHAPM Part 808.405-6 Limiting Sources Page 4 of 6 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

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

During the Market Research phase, the following results were found:

A Request for Information (RFI) 36C24421Q0972 was posted to SAM.gov on Wednesday, July 14, 2021 to Friday, July 16, 2021. One response was received from Abbott (Large Business), the Original Equipment Manufacturer (OEM), matching the exact requirement. The OEM Abbott confirmed they have authorized distributors: Dove (Woman Owned Small Business), BMK Ventures (Woman Owned Small Business), and TQM (Service Disabled Veteran Owned Small Business). However, these distributors are not authorized to resell the i-STAT Reagents on a Cost Per Test and they cannot provide the structure that the terms of the GSA Contract V797P- 7322A offer.

The Vendor Information Pages (VIP) was searched using keywords i-STAT and NAICS 325412.

This search resulted in one SDVOSB, Nationwide Pharmaceutical LLC, but they are not authorized distributors for the i-STAT Abbott Reagent System.

The Federal Supply Schedules (FSS) were reviewed. The Government s request for the Abbott i- STAT System can be satisfied via FSS Contract V797P-7322A.

The Federal Procurement Data System (FPDS) was searched for historical Contracts awarded to Abbot. The search resulted in 24 pages of procurement history to the Department of Veterans Affairs and several other Federal Agencies. In addition to the historical Contract data found on FPDS, the current Contract in place with the VAPHS was awarded to Abbott by NCO4 on October 01, 2020 in the amount of $114,510.00, however this Contract is for one year only. The Contract number is 36C24421N0025, awarded on a Sole Source basis.

Based on the above information, there is only one source for the Government to satisfy its requirements. Award will be made on a Sole Source basis to Abbott Laboratories, Inc. against GSA Contract V797P-7322A.

(7) Any Other Facts Supporting the Justification: None.