6640--VISN 6 Vitek ID-AST

Simplified Acquisition Procedures for Certain Commercial Items

VHAPG Part 813.5 36C246-22-AP-3749

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-22-AP-3749

Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 6 on behalf of the Asheville, Fayetteville, Hampton, Richmond, Salem, and Salisbury VA Medical Centers. Their respective Purchase Request Numbers are 637-23-1-167-0006, 565-23-1-049- 0002, 590-23-1-023- 0012, 652-23-1-096-0072, 658-23-1-039-0016, and 659-23-1-064-0013

Nature and/or Description of the Action Being Processed: Network Contracting Office 6 intends to awarded a new firm-fixed-price, indefinite-delivery indefinite-quantity sole source contract to BioMerieux Inc. for VITEK MS Automated Mass Spectrometry Microbial Identification System, VITEK 2 Microbial ID/AST Testing System, supplies and support. The use of these microbiological analyzers in the Asheville, Fayetteville, Hampton, Richmond, Salem, and Salisbury VA Medical Center laboratories allows for continued rapid identification and susceptibility testing of pathological microorganisms found in Veteran beneficiaries served at these medical center facilities. This justification is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

Description of Services/Supplies Required to Meet the Agency s need: The Asheville, Fayetteville, Hampton, Richmond, Salem, and Salisbury VA Medical Center laboratories require the continued use previously installed Vitek microbiological analyzers, the installation of two additional analyzers, testing supplies and annual service agreements.

The VITEK MS automated mass spectrometry microbial identification system uses Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) bacterial/microbial identification technology and Antimicrobial Sensitivity (AST) to provide single-

choice identifications at the species, genus, or group level. The VITEK 2 uses unique ID and AST cards to conduct testing to provide identification and susceptibility with a testing capacity of 60 cards and the VITEK 2 XL has increased testing capacity with 120 cards. The VITEK microbial identification systems allow the clinicians to receive quick information to adjust therapy for better overall Veteran beneficiaries care and outcomes and the MALDI-TOF technology reduces time for bacterial Identification by 24-48 48 hours, allowing Veteran beneficiaries to be treated for life threating infections in an expeditious manner. The MALDI-TOF and AST platforms, must include middle-ware software for connectivity which allows the two systems to communicate test information with the already installed BioMerieux Myla middleware software at each of the Medical Center Laboratories. The middleware promotes efficient retrieval of microbial/antimicrobial data and statistics in an integrated process between BioMerieux platforms in order to expedite testing. The vendor shall provide testing supplies, installation of new equipment, technical support to assist laboratory personnel with middleware connectivity

issues, training, instrument service/repair and routine maintenance. The total estimated cost for five years is as follows:

Base Period October 1, 2022 to September 30, 2023

$1,027,791

Option 1 October 1, 2023 to September 30, 2024

$1,105,497

Option 2 October 1, 2024 to September 30, 2025

$1,160,408

Option 3 October 1, 2025 to September 30, 2026

$1,220,565

Option 4 October 1, 2026 to September 30, 2027

$1,286,485

Estimated 5-year Total

$5,800,746

The total estimated quantity supplies, equipment and services for five years includes:

Description

TOTAL

ACCESSORY KIT VTK2 PIP/DIL

698

GN TEST KIT VTK2

1526

GP TEST KIT VTK2

1153

YST TEST KIT VTK2

176

NH TEST KIT VTK2

105

ANC ID

149

KIT DENSICHEK Plus Standards

71

PIPETTE TIPS 0.5 - 250UL

193

VITEK-2 0.45% Sodium Chloride Bags

56

AST-ST02 Test Kit

550

AST-GP67 Test Kit

392

AST-GP75 Test Kit

2101

AST-GN69 Test Kit

1243

AST-GN84 Test Kit

1201

AST-GN95 Test Kit

1857

AST-XN09 Test Kit

99

AST-Yeast YS-09 Test kit

88

Vitek MS-FA Formic Acid MS FA

124

Vitek MS-CHCA matrix

590

Vitek MS Liquid Myco Supplemental Kit

0

Vitek MS Mycobacterium/Nocardia Kit IVD

0

Vitek MS Mould Kit IVD

0

Vitek MS Specimen Racks

11

Disposable Target Slides

650

Vitek Pickme Pen

112

Vitek MC Orange Gel

330

Vitek pick me Nibs

227

UNSENSITIZED TUBES 1X2000

189

0.45% SALINE 12 X 1000 ML

77

0.45% SALINE (18X500ML)

6

Vitek-2 Analyzer Lease (Asheville, Fayetteville, Hampton, Salem, Salisbury Medical Centers)

5

Vitek-2 XL Analyzer Lease (Richmond Medical Center)

0

Vitek-MS Analyzer Lease (Hampton, Salem Medical Centers)

2

RUO Database

2

MYLA Upgrade

5

Vitek-2 Annual Service Agreement

21

Vitek2-XL Service Annual Service Agreement

5

Vitek-MS Annual Service Agreement

28

Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Require the Use of the Authority Cited Above (applicability of authority):

The VITEK 2 and VITEK MS Systems are intended for the automated identification and susceptibility testing of most clinically significant organisms, such as bacteria and yeast, routinely isolated in a microbiology laboratory. This requirement will continue to provide testing supplies and service to the ten currently installed and in use VITEK microbial testing systems; five of which are owned by the Government and provide advanced testing by the installation of two additional systems. The VITEK Systems are only intended to be used with the proprietary VITEK identification (ID) and susceptibility (AST) test cards, reagents, and testing kits. VITEK 2 testing requires a saline suspension of organism be inoculated into a test panel of biochemicals and a test panel of antibiotics. These panels, referred to as cards, are single-use disposables that are inoculated according to the procedure set out in the VITEK 2 Systems Product Information. The VITEK MS reagents and test kits are made especially and solely for use with the for VITEK MS System. BioMerieux, Inc. is the sole source provider for the VITEK instruments, reagents, consumables, and support. A proprietary letter has been received from the vendor. Failure to provide the required maintenance and supplies could potentially cause failure of the system and lead to diminished care to the Veteran beneficiaries served at the identified medical centers.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source was posted to SAM on July 5, 2022. No responses were received.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The requirement is in support of laboratory instrumentation that was previously procured and is currently on site and validated for use in patient care. The equipment in this requirement and equipment previously procured at participating VISN-6 laboratories function as an integrated system through the use of BioMerieux Myla software to produce patient results for the treatment and care of patients. The Myla software is validated and in use at participating VISN-6 laboratories with interface to the VA s IT network. Validation of laboratory instrumentation is labor intensive and consumes considerable time and financial resources. The continued use of the current integrated system is in the best interest of the government financially and the continuity of patient care.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research was not Conducted: Market research included speaking with the Fayetteville VAMC s Laboratory Manager, speaking with BioMerieux, and conducting an internet search for the required equipment and supplies. The Fayetteville Lab Manager, Penny Creech confirmed that no other vendors can meet the test menu, test methodology and turn around testing times required by the Fayetteville NC VA Coastal Healthcare System. Therefore, BioMerieux solution is the only equipment that will interface the labs other existing equipment. The BioMerieux Regional Sales Director provided documentation confirming the proprietary nature of the required items. The VA Rule of Two cannot be met because there are no Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Business (VOSB) sellers authorized to distribute the BioMerieux Vitek systems, supplies, reagents and support.

Any Other Facts Supporting the Use of Other than Full and Open Competition: None

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Once all associated components reach the end of their life cycle, market research will be conducted to determine if a competitive acquisition of the entire system is appropriate. The Government will continue to conduct thorough market research to gauge the commercial marketplace capabilities for future requirements. No actions can be taken to increase competition due to the manufacturer is the sole distributor.

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 and belief. Awarded contract 36C24623D0015 to BIOMERIEUX INC for 1430451.10000000 on 2022-10-01.