P03. JA VISN 23 Abbott iSTAT testing cartridges_rev 9.10.23_signed_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C263-23-AP-2879

(1) Contracting Activity: Department of Veterans Affairs, Network 23 Contracting Office, 1303 5th St. Suite 300, Coralville, IA 52241.

Organization Activity: VA Midwest Healthcare Network, 2805 Dodd Road, Suite 250, Eagan, MN 55121.

(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/NAC Contract Number: 36F79721D0233

Name of Proposed Contractor: Abbott Laboratories Inc.

Street Address: 100 Abbott Park Rd.

City, State, Zip: Abbott Park, IL 60064-3500 Phone: 928-853-4670

(3) Description of Supplies or Services:

The estimated value of the proposed action is: $

The term of this BPA will be 2-years - base year plus 1 option year. The anticipated award date is September 20, 2023.

The VA VISN 23 Medical Facilities own and use the Abbott iSTAT system of portable blood analyzers that utilize the iSTAT test cartridges/reagents which are the subject of this requirement. The Abbott iSTAT portable blood analyzers and system allows healthcare providers to test a patient’s blood in a few easy steps while at the patient’s side. The system’s software allows the portable units to integrate seamlessly with the VA network, patient records and lab software.

The test cartridges/reagents required are commercial items available from only one source, the OEM, and are on FSS Schedule by the OEM. This is a follow-on contract.

Effective Date: 02/01/2022 Page 2 of 4

Item List:

Item # Description/Part Number* 03P86-25 ACTc Cartridge 03P85-51 CG4+ Cartridge 03P88-25 CG8+ Cartridge 09P31-26 CHEM8 Cartridge 03P84-25 CREA Cartridge 03P76-25 EG7+ Cartridge 03P78-50 G3+ (EUA) Cartridge 03P83-25 Glucose Cartridge 03P89-24 PT Cartridge 03P90-25 Troponin I Cartridge 06F15-01 Calibration Verification 06F12-01 Level 1 Aqueous Control 06F13-01 Level 2 Aqueous Control 06F14-01 Level 3 Aqueous Control 06P17-15 Level 1 Coagulation Control 06P17-16 Level 2 Coagulation Control

06P17-13 PT CTL LV1

06P17-14 PT CTL LV2

06P17-09 i-STAT cTnl Control Level 1 06P17-10 i-STAT cTnl Control Level 2 06P17-11 i-STAT cTnl Control Level 3 06P17-12 i-STAT cTnl Calibration Verification 1-3 06F12-14 CHEM8+ Level 1b 05P71-01 TriControls Control Level 1 (10x1.7ml ampule) 05P72-01 TriControls Control Level 2 (10x1.7ml ampule) 05P73-01 TriControls Control Level 3 (10x1.7ml ampule) 05P70-01 Set Levels 1-5 (4 ea, 5 lvl x 1.7ml ampules/box) 06F1711 Printer Paper

(4) Identify the Authority and Supporting Rationale:

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 Abbott iSTAT system is currently being employed by the VA across VISN 23 and is proprietary to Abbot Laboratories, Inc. who is the Original Equipment Manufacturer (OEM).

The OEM does not allow other parties to distribute the required items and the system cannot utilize equipment produced by any other brand. A sole source letter was obtained from the OEM. Due to the proprietary nature of the Abbot iSTAT system, the OEM is the only source that can provide the test cartridges for the Abbott iSTAT blood analyzers.

(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 requirement is available via the Abbott Laboratories, Inc. FSS contract 36F79721D0233, which has been determined to be fair and reasonable. In accordance with FAR 8.405-4, the Government will request a price reduction.

Effective Date: 02/01/2022 Page 3 of 4

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

Research to find more sources or more sources on schedule were unsuccessful. VA SAC contracts were searched and produced no results. These testing cartridges are not the kind of items found on AbilityOne or UNICOR. An Intent to Sole Source was posted from 8/6/23 – 8/16/23 which produced no sources other than the OEM. Market research revealed the required equipment is available on FSS/NAC by one source, Abbott Laboratories, Inc. the OEM.

The SBA VetCert Database was searched using NAICS 325413 which resulted in 83 SD/VOSBs.

However, due to the reasons stated above, businesses other than the OEM cannot provide the necessary equipment and services.

(7) Any Other Facts Supporting the Justification:

According to the terms of FSS contract 36F79721D0233 all schedule items are produced in the U.S. or Canada which is a trade agreement compliant country. The OEM’s equipment is approved by the CLIA (Clinical Laboratory Improvement Amendments), FDA, College of American Pathologists. FSS pricing is considered fair and reasonable. The OEM has good past performance. Replacing the entire iSAT system with the system of a different brand would cause duplication of cost not expected to be recovered through competition.

(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:

All VA VISN 23 facilities use the Abbott iSTAT system and its proprietary testing cartridges.

When and if the Government procures a new system for portable blood analyzers, further market research will be conducted, and fair opportunity given to potential alternate sources.

(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.

Chasity Vigliotti Date VISN 23 Pathology & Laboratory Medicine Health Systems Specialist.

VISN 23 Pathology & Laboratory Medicine

CHASITY

VIGLIOTTI

Digitally signed by

CHASITY VIGLIOTTI

Date: 2023.09.07 10:29:06 -05'00' 9/7/23

Effective Date: 02/01/2022 Page 4 of 4

(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.

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.

Date

Date

Contract Officer Network 23 Contracting Office (NCO 23)

Curt LaRose Branch Chief Network 23 Contracting Office (NCO 23)

JOSEPH

BENNETT

Digitally signed by

JOSEPH BENNETT

Date: 2023.09.10 18:05 27 -05'00'

09/10/2023

09/11/2023

CURT

LAROSE

Digitally signed by CURT

LAROSE

Date: 2023.09.11 07:23:19 -05'00'