N6817119Q8010_SOLE_SOURCE_JUSTIFICATION_(SSJ).pdf

NAVSUPINST 4200.85D, Encl (1) 1 of 2

JUSTIFICATION FOR SOLE SOURCE (Simplified Acquisitions <$250K)

The supplies listed on Purchase Request (PR) N6609620RCLC001 can only be provided by one source (and there are no known substitutes available) thus competition is precluded for reasons indicated below.

Restricted to the following source:

Manufacturer:

Biomerieux Italia S.p.A.

Manufacturer Point of Contact (POC):

Dr. Renzo Polato

Phone: (+39) 335-651-7570

E-mail: Renzo.Polato@biomerieux.it

Manufacturer Address:

Via di Campigliano 58

50012 Grassina (FI), Italia

Dealer:

Dealer POC:

Tiziano Cipressa

Phone: (+39) 335-651-7565

E-mail: Tiziano.Cipressa@biomerieux.it

Dealer Address:

Via di Campigliano 58

50012 Grassina (FI), Italia

_X__ Description of the item or service required, the estimated cost, and required delivery date.

The U.S. Navy Hospital (USNH) Naples requires the consumable supplies of laboratory reagents and supplies

(blood culture bottles) required to perform blood testing via the Government-owned VITEK@2 Compact and

BacT/ALERT@ 3D equipment. The requirement is for one (12-month) base year plus four (12-month) option years.

USNH will keep a drop ship inventory due to the shelf-life expiration of the reagents. Deliveries of the consumables shall be within a mutually agreed upon schedule between the Contractor and the Government.

Period of Performance (POP)

Base Year 1 Oct 2019 – 30 Sep 2020

Option I 1 Oct 2020 – 30 Sep 2021

Option II 1 Oct 2021 – 30 Sep 2022

Option III 1 Oct 2022 – 30 Sep 2023

Option IV 1 Oct 2023 – 30 Sep 2024 mailto:Renzo.Polato@biomerieux.it mailto:Tiziano.Cipressa@biomerieux.it

NAVSUPINST 4200.85D, Encl (1) 2 of 2

__X_ Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.

As per FAR 6.301-1, there is only one responsible source, the original equipment manufacturer (OEM), Biomerieux

Italia S.p.A., capable and authorized to fulfill the requirement. There are no other known or authorized supplies or services that will satisfy agency requirements other than the responsible source and OEM. Biomerieux Italia S.p.A.

is the manufacturer of the specialized blood testing equipment (Vitek@2 Compact and BacT/Alert@ 3D) which are

Government owned and provide factory direct support for any repairs, upgrades, software updates and equipment modifications. Biomerieux Italia S.p.A. also manufactures the consumable reagents and specialized blood culture bottles which are the only compatible supplies designated for use with the Vitek@2 Compact and

BacT/ALERT@3D equipment.

_X__ The requested material or service represents the minimum requirements of the Government.

In order to successfully perform the blood testing and maintain the performance of the Vitek@2 Compact and

BacT/Alert@ 3D and be within the terms of the existing warranty, it is required for the consumable reagent and blood sample bottles required to be updated and compliant in accordance with manufacturer specifications.

CHECK & FILL IN ALL APPLICABLE BLANKS BELOW

_X_ The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

The requirement is to maintain a drop ship inventory for the consumables that are for the form, fit, and function as specified by the manufacturer in compliance with the Vitek@2 Compact and BacT/Alert@ 3D warranties. Other reagents from various vendors would cause instrument failure. Any repairs that void the warranty, may cause remedial repairs outside the maintenance agreement that would lead to increased costs and suspended the laboratory processing of blood tests. In addition, the reagents and blood culture bottles comply with Federal Drug

Administration (FDA) and USNH laboratory quality control for the specific equipment and usage.

_X_ A patent, copyright or proprietary data limits competition.

The proprietary data for the Vitek@2 Compact and BacT/Alert@ 3D is wholly owned by the manufacturer. The manufacturer patent, copyright, and proprietary data on the machines and bottles will limit competition.

Competition is also limited by the manufacturer warranty specific to the use reagents and blood culture bottles produced by the manufacturer.

_X_ These are “direct replacements” parts/components for existing equipment.

The required supplies are direct replacements to the current consumable reagents and blood culture bottles. This requirement is to maintain the drop ship inventory already being utilized by USNH Naples.