JA Reagent_Redacted.pdf

CUI

SOURCE SELECTION INFORMATION – SEE FAR 2.101 AND 3.104

Abaxis 11009131E Chemistry Control LvL 1 Piccolo Xpress/Blood Chemistry

Analyzer

Abaxis 11009132E Chemistry Control LvL 2 Piccolo Xpress/Blood Chemistry

Analyzer ABBOTT LABS 02R2901 Total ß-hCG Control Lv 1 i-STAT Point of Care Analyzer ABBOTT LABS 02R2902 Total ß-hCG Control Lv 2 i-STAT Point of Care Analyzer ABBOTT LABS 02R2903 Total ß-hCG Control Lv 3 i-STAT Point of Care Analyzer

ABBOTT LABS 02R2901

cTnI Calibration Verification 1-3 i-STAT Point of Care Analyzer

ABBOTT LABS 03P8325

REAGENT ANALYZER

GLUCOSE CARTRIDGE F/ I

STAT i-STAT Point of Care Analyzer

ABBOTT LABS 03P8550 CG4+ i-STAT Point of Care Analyzer ABBOTT LABS 05P71-01 CONTROL BLOOD CHEMIST i-STAT Point of Care Analyzer ABBOTT LABS 06F14-01 CONTROL BLOOD CHEMIST i-STAT Point of Care Analyzer ABBOTT LABS 06P17-03 CTRL ISTAT LEV3 1ML 6S i-STAT Point of Care Analyzer ABBOTT LABS 06F15-01 REF STD KIT BLD CHEM i-STAT Point of Care Analyzer ABBOTT LABS 03P78-50 TEST PACK PH PARTIAL i-STAT Point of Care Analyzer ABBOTT LABS 03P84-25 TEST CARTRIDGE CREATI i-STAT Point of Care Analyzer ABBOTT LABS 03P83-25 TEST CARTRIDGE GLUCOS i-STAT Point of Care Analyzer ABBOTT LABS 03P80-25 CARTRIDGE I-STAT 25S i-STAT Point of Care Analyzer ABBOTT LABS 03P82-25 TEST PACK SODIUM HEMA i-STAT Point of Care Analyzer ABBOTT LABS 06P17-14 CONTROL LEVEL 2 PT 10S i-STAT Point of Care Analyzer ABBOTT LABS 06P17-13 CONTROL LVL 1 PT 10S i-STAT Point of Care Analyzer ABBOTT LABS 09P31-26 CARTRIDGE TEST BLOOD i-STAT Point of Care Analyzer ABBOTT LABS 03P79-25 CARTRIDGE BLD A TEST i-STAT Point of Care Analyzer ABBOTT LABS 03P76-25 TEST PACK SODIUM K IO i-STAT Point of Care Analyzer ABBOTT LABS 06F13-01 CONTROL BLOOD CHEMIST i-STAT Point of Care Analyzer ABBOTT LABS 03P89-24 CARTRIDGE COAGULATION i-STAT Point of Care Analyzer ABBOTT LABS 06P17-10 CONTROL LVL 2 1ML 6S i-STAT Point of Care Analyzer ABBOTT LABS 06P17-11 CONTROL LVL 3 1ML 6S i-STAT Point of Care Analyzer ABBOTT LABS 06P17-09 CONTROL LVL 1 1ML 6S i-STAT Point of Care Analyzer ABBOTT LABS 05P70-01 SET CALIB LEVEL 1-5 1S i-STAT Point of Care Analyzer ABBOTT LABS 05P71-01 TRICONTROL LEVEL 1 1S i-STAT Point of Care Analyzer ABBOTT LABS 05P5825 ISTAT HCG CART 25S i-STAT Point of Care Analyzer ABBOTT LABS 05P72-01 TRICONTROL LEVEL 2 1S i-STAT Point of Care Analyzer ABBOTT LABS 03P9025 CARTRIDGE CARDIAC TES i-STAT Point of Care Analyzer ABBOTT LABS 06F12-01 CONTROL BLOOD CHEMIST i-STAT Point of Care Analyzer ABBOTT LABS 03P8825 CARTRIDGE TEST CG8 25S i-STAT Point of Care Analyzer ABBOTT LABS 9P31-25 CARTRIDGE CHEM 8+ 25S i-STAT Point of Care Analyzer

Accriva Diagnostics 000J201 PT CUVETTES Hemochron Signature Elite

Accriva Diagnostics DCJCPT-N

DIRECTCHECK PT/APTT

Normal Hemochron Signature Elite

Accriva Diagnostics DCJAPTT-A

DIRECTCHECK APTT

ABNORMAL Hemochron Signature Elite

Accriva Diagnostics DCJPT-A DIRECTCHECK PT ABNORMAL Hemochron Signature Elite

ALERE 88753 CONTROL BLOOD CHEMIST Triage Meter Pro

BECKMAN

COULTER 8448350 ACT RINSE DIL 500ML 1S Beckman Coulter DxH500

BECKMAN

COULTER B36880 CALIBRATOR DXH SER 1S Beckman Coulter DxH500

BECKMAN

COULTER B36845 DILUENT FOR DXH 500 1S Beckman Coulter DxH500

BECKMAN

COULTER B36872 CONTROLS DXH 500 1S Beckman Coulter DxH500

BECKMAN

COULTER B36846 LYSE FOR DXH 500 1S Beckman Coulter DxH500

BECKMAN

COULTER B36868 CLEANER DHX SERIES 1S Beckman Coulter DxH500

BIOFIRE

DIAGNOSTICS 423742

Respratory Panel 2.1 (RP2.1) Panel BioFire Filmarray system

BIOFIRE

DIAGNOSTICS NGDS-ASY-0017 PANEL,SENTINEL BioFire Filmarray system BIOMERIEUX 423740 KIT RESPIR PAN 2.1 30S BioFire Filmarray system BIOMERIEUX RFIT-ASY-0116 KIT BIOFIRE GI PAN 30S BioFire Filmarray system

BIOSITE 21V88754 CONTROL 5TOTAL LVL2 5S Triage Meter Pro

Cepheid

CEPRSARSCOV2

DOD RT-PCR TEST CEPHD 10S Cepheid Gene Xpert Cepheid GXCT/NG-10 RT-PCR TEST CT/NG Cepheid Gene Xpert

Cepheid

XP3COV2/FLU/

RSV-10

Xpert® Xpress CoV- 2/Flu/RSV plus Cepheid Gene Xpert

Cepheid NATFRC-ERC

NATtrol Flu/RSV/SARS-CoV-2 External Run Control (6 x 0.5mL Vials) Cepheid Gene Xpert

MAINE

MOLECULAR

QUALITY

CONTROLS INC M315 PANEL CNTRL 12 TUBE 1S BioFire Filmarray system

MAINE

MOLECULAR M441 PANEL CTRL FILMARR 12S BioFire Filmarray system

QUALITY

CONTROLS INC

MMQCI MQCM210V11 Respratory Panel 2 (PR2), QC BioFire Filmarray system MMQCI MQCM238 GastrointestinaI (GI), QC BioFire Filmarray system

ORTHO CLINICAL

DIAGNOSTICS 719810 CONTROL COOMBS TEST Ortho Confidence System

ORTHO CLINICAL

DIAGNOSTICS 716980 COOMBS TEST REAGENT

Ortho Hematology microplate Bioclone

ORTHO CLINICAL

DIAGNOSTICS 719610 REAGENT SET ANTIBODY Ortho Selectogen

ORTHO CLINICAL

DIAGNOSTICS 719100 ANTI-BODY DETECTION Ortho Surgiscreen

ORTHO CLINICAL

DIAGNOSTICS 719210 TEST KIT REVERSE BLD

Ortho Vision or Ortho Vision Max

ORTHO CLINICAL

DIAGNOSTICS 6902096 CONTROL KIT BLOOD GRP

Ortho-Clinical Confidence system

Quidel 98000XREU TRIAGE BNP XR TEST 25S Triage Meter Pro Quidel 97300EU PANEL SOB TRI PROF 25S Triage Meter Pro

Quidel 98100EU Triage Multi-Analyte Control Level 1 Triage Meter Pro

Quidel 97000HS Cardiac Panel Cartridge Triage Meter Pro Quidel 94614 Tox Drug Screen Controls Lv 2 Triage Meter Pro Quidel 94613 Tox Drug Screen Controls Lv 1 Triage Meter Pro Quidel 94600 Drug Screen Panel Cartridge Triage Meter Pro

Siemens 3536597 Multistix 10 SG (urine dip stick) CLINITEK Advantus

SYSMEX

SYS-024-

0971-4

REAGENT POCH DILUENT 2L

100I HEMATOLOGY

XP-300, pocH-100i, pocH100iV Diff

SYSMEX PPL-200A POCH-PACK L

XP-300, pocH-100i, pocH100iV

Diff

SYSMEX 217685 Poch Calibrator SCS - 1000 1S XP-300, pocH-100i, pocH100iV

Diff

SYSMEX 99900517 EIGHTCHECK-3WP 4.6 1S

XP-300, pocH-100i, pocH100iV

Diff

SYSMEX SYE83401621 Cell Clean XP-300, pocH-100i, pocH100iV

Diff

SYSMEX 140-3004-0 CONTROL EIGHTCHECK 12S

XP-300, pocH-100i, pocH100iV

Diff

Werfen 87177 Kova Liqua-Trol w/micro, Abnormal, Control urine Lv1 CLINITEK Advantus

Werfen DCJPT-A CONTROL COAGULATION Hemochron Signature Elite purchases are currently supported by DLA’s OCONUS Electronic Catalog (ECAT) contracts, Blanket Purchase Agreements (BPAs) administered by the Regional Health Contracting Office – Europe, and Government Payment Card purchases made by USAMMCE. The supplies ordered are brand-name reagents purchased direct from manufacturers or through authorized distributors.

The brand-names available under the ECAT contracts include Abaxis, Abbott Diagnostics, Alere, Biofire Diagnostics LLC, Biomerieux, Becton Dickinson, Cepheid, Immucor, Microbiologics, Quidel, Siemens, Sifin Diagnostics Berlin, Streck Labs, and Thermo Fisher Scientific.

No other supplies will satisfy the agency’s requirements for the items listed above because reagents are not interchangeable or compatible between manufacturers and use of third-party reagents on brand-name analyzers could render the analyzer inoperable and/or invalidate terms of service and manufacturer warranty.

The current laboratory analyzer and reagent marketplace consists of manufacturers who develop proprietary machines and in vitro diagnostic (IVD) tests in tandem to ensure accuracy of each test being performed. IVD tests consist of one or more reagents prepacked in assay tubes in which the biological sample is analyzed. Tests performed using the required reagents include, but are not limited to, disease diagnosis such as HIV, SARS, COVID, cholera and malaria and, blood chemistry analysis such as thyroid, cholesterol, hemoglobin, insulin and calcium levels.

Manufacturers design, test, and certify their reagent materials to work solely with the analyzer they produce. Both are proprietary technology that cannot function independently and are not compatible with other manufacturer’s products. For example, each manufacturer designs the analyzer and reagents based on a defined quantity of the relevant biological sample for testing such as blood, saliva, or urine. One manufacturer may design their product to require 2 mLs of a sample while another may only use 0.2 mLs to provide the same test/result. Therefore, reagents may perform the same test but are not interchangeable because of the original design. Although reagents may be developed for the same biological sample size the composition of the reagent and how it extracts, reacts with, or otherwise interacts with the samples is manufacturer specific.

The form, fit, and function of each reagent and test is unique to its analyzer and not designed for interchangeability across manufacturers or brand-names. Reagents developed with an analyzer are the only ones authorized for use by the manufacturer. Use of third-party reagents invalidates analyzer warranties and could degrade equipment performance or cause damage or defects to the analyzer to the detriment of patient care.

6. A sources sought notice was posted on February 24, 2023, to Contract Opportunities, at www.SAM.gov, to identify sources for the required items who can meet the required three (3) business day Required Delivery Date (RDD). The notice also asked interested vendors to provide a list of any manufacturer approved alternates for the brand-name items on the required items list. The notice closed on March 27, 2023, with ten vendors expressing interest in the solicitation. However, none of the vendors notified DLA of manufacturer approved alternates nor could any single manufacturer or distributor provide consumables for every brand-name analyzer.

A pre-solicitation notice for this requirement will be published in the Contract Opportunities at www.SAM.gov to notify potential sources of DLA’s intent to solicit a variety of reagents with direct delivery to USAMMC-SWA. The solicitation will be synopsized in the same location. In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c). The Request for Quotes will include the list of all required brand-name items to ensure quotes are solicited from as many manufacturers and authorized distributors as possible.

7. As the Contracting Officer, I hereby determine that the anticipated prices will be fair and reasonable based on a favorable comparison to commercial pricing and previous prices paid by the government. Negotiations will be conducted, as necessary, to obtain fair and reasonable prices and favorable discounts.

8. Market Research was conducted with current vendors and USAMMC-SWA’s technical experts to inquire about the nature of the laboratory analyzer and reagent market. This research confirmed that each manufacturer’s analyzers and associated reagents and tests are unique and proprietary to each manufacturer. On April 25, 2023, the Contracting Officer sent a market survey to the current ECAT contract holders, BPA holders, manufacturers of the required items, and interested vendors identified during the sources sought with a list of the reagents routinely purchased. Those who responded could provide some, but not all the required products, because manufacturers cannot produce and sell other brands’ reagents and distributors need licensing agreements with each manufacturer to sell their products. Finally, recent reagent contracts awarded are indicative of the commercial market. The current OCONUS ECAT contracts, exclusively for use by USAMMCE, were awarded January 16, 2023, after DLA solicited quotes for thirty (30) days on www.SAM.gov. The solicitation, SPE2DS-22-Q-0083, was also for brand-name only reagents, controls, and test kits in accordance with FAR 6.302-1. During that solicitation, DLA did not identify sources offering other than brand-name reagents. Thirty-five of the reagents listed in Paragraph 3, above, were included in the previous solicitation and awarded on the resulting contracts.

9. There are no other facts supporting the use of other than full and open competition.

10. The following sources expressed an interest in this acquisition in writing:

i. Austability

ii. B&S World Supply DMCC

iii. MediTrade Medical Trading Gmbh

iv. SR-Services Gmbh

v. Jamal Al Mansour Company for General Supplies & Contracting

vi. Shalaal Balad Company

vii. Ali Al Suwadi Trading EST

viii. Coutinued Tender Company

ix. Green Diamond Company

x. QuidelOrtho

11. The barriers to competition were not imposed by this agency. Unlike other industries, analyzer and reagent product selection is not primarily based on price. Non-price factors such as compatibility, efficacy, and warranty of the products are more important than price once an analyzer is in use. The proprietary nature of the brand-name items does not allow for use of third-party versions of the same. Failure to procure the required brand-name items invalidates warranty protections and may render the devices inoperable which jeopardizes timely and