N6817119Q0110_LIMITED_SOURCE_JUSTIFICATION_(LSJ).pdf

NAVSUPINST 4200.85D, Encl (1) 1 of 3

LIMITED SOURCE JUSTIFICATION (Simplified Acquisitions <$250K)

The supplies listed for Purchase Request (PR) N6609620RCLC003A are limited to being supplied solely by the authorized sources indicated below:

Restricted to the following sources (dealers):

Manufacturer:

Becton Dickinson Italia S.p.A.

Manufacturer Point of Contact (POC):

Mirella Anastasia Contracts and Pricing Clerk Phone: (+39) 024-824-0203 E-mail: Mirella.Anastasia@bd.com

Giulia Cerfeda Sales Application Specialist (+39) 344-149-7252 Giulia.Cerfeda@bd.com

Manufacturer Address:

Via Enrico Cialdini, 16 20161 Milano, Italia

Dealer:

Biomerieux Italia S.p.A.

Dealer POC:

Dr. Renzo Polato Phone: (+39) 335-651-7570 E-mail: Renzo.Polato@biomerieux.it

Tiziano Cipressa Phone: (+39) 335-651-7565 E-mail: Tiziano.Cipressa@biomerieux.it

Dealer Address:

Via di Campigliano 58 50012 Grassina (FI), Italia

Dealer:

Bioservice Italia S.p.A.

Dealer POC:

Phone: (+39) 038-652-2111 E-mail: info@bioservicegroup.it mailto:Mirella.Anastasia@bd.com mailto:Giulia.Cerfeda@bd.com mailto:Renzo.Polato@biomerieux.it mailto:Tiziano.Cipressa@biomerieux.it mailto:info@bioservicegroup.it

NAVSUPINST 4200.85D, Encl (1) 2 of 3

Dealer Address:

46025 Poggio Rusco, Italia

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

The U.S. Navy Hospital (USNH) requires material consumable supplies, media plates/reagents for the Government performance of microbiology testing. The materials are used to perform pathological organism identification and distinguish an appropriate selection of antibiotics for patients to ensure treatment success. The microbiology testing is mission critical to the USHN and that the required products must be maintained at strict temperature control and standards.

The anticipated period of performance (POP) is one (12-month) base year plus four (12-month) option years as indicated below.

Base Year 1 Oct 2019 – 30 Sept 2020

Option Year 1 1 Oct 2020 – 30 Sept 2021 Option Year 2 1 Oct 2021 – 30 Sept 2022 Option Year 3 1 Oct 2022 – 30 Sept 2023 Option Year 4 1 Oct 2023 – 30 Sept 2024

Below is the summary of the items required:

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

NAVSUPINST 4200.85D, Encl (1) 3 of 3

The microbiology media plates and reagents are for specific equipment and usage and will serve as direct replacements of the existing just-in-time inventory. A local supplier is required to maintain the just-in-time deliveries in a set quantity and delivered the first week of every month to accommodate an inventory with a short shelf life.

The microbiology media plates and reagents must be delivered on schedule and maintained at a constant refrigerated temperature of between two to eight degrees Celsius to meet quality control standards and ensure lot sequestration.

All the microbiology media plates and reagents need to be refrigerated maintaining strict temperature control and standards taken from the same lot every two consecutive shipments. Due to their short shelf life, a rapid and punctual delivery is required.

The Contractor shall validate that the microbiology media plates and reagents requested comply with Food and Drug Administration (FDA) standards and are revalidated internally by the USNH laboratory passing a stringent quality control before being utilized for testing. The Contractor shall comply with Clinical & Laboratory Standards Institute (CLSI) / National Committee for Clinical Laboratory Standards (NCCLS) Document M22-A3 (quality assurance for commercially prepared microbiological culture media) and shall document that quality control activities meet the CLSI/NCCLS guidelines.

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

There are no other known sources that can satisfy agency requirements and only the OEM is capable of manufacturing the items. Becton Dickinson Italia S.p.A. brand microbiology media plates and reagents are the only products available in Italy that are in compliance with FDA standards, USNH laboratory quality control, and in accordance with the quality assurance guidelines for commercially prepared microbiological culture media enumerated in Clinical & Laboratory Standards Institute (CLSI)/National Committee for Clinical Laboratory Standards (NCCLS) Document M22 approved standard Third Edition (Wayne, PA: NCCLS, 2004). Therefore, only authorized dealers/distributors are limited to reselling Becton Dickinson Italia S.p.A. brand products.

__N/A__ A patent, copyright, or proprietary data limits competition.

__X__ These are direct replacements for parts/components on existing equipment.

SOURCES SOUGHT NOTICE

The NAVSUP Fleet Logistics Center Sigonella (FLCSI) Naples Detachment office intends to solicit a limited source award for a 2-in-1 supply/service, non-competitive commercial contract at firm fixed prices (FFP) to Becton Dickinson Italia S.p.A. or one of its authorized distributors in support of U.S. Navy Hospital (USNH) Naples’ Materials Management Department and laboratory. The anticipated award will provide consumable microbiology media plates and reagents for the Government performance of microbiology testing the USNH laboratory. The materials are used to perform pathological organism identification and distinguish an appropriate selection of antibiotics for patients to ensure treatment success affecting future patient outcomes. The microbiology testing is mission critical to the USHN and the required products must be maintained at strict temperature control and standards.

The requirement is for a full year of consumables with four additional option years. The microbiology media plates and reagents are for specific equipment and usage and will serve as direct replacements of the existing just-in-time inventory. A local supplier is required to maintain the just-in-time deliveries in a set quantity and delivered the first week of every month to accommodate an inventory with a short shelf life.

The microbiology media plates and reagents must be delivered on schedule and maintained at a constant refrigerated temperature of between two to eight degrees Celsius to meet quality control standards and ensure lot sequestration.

All the microbiology media plates and reagents need to be refrigerated maintaining strict temperature control and standards taken from the same lot every two consecutive shipments. Due to their short shelf life, a rapid and punctual delivery is required. As a result, a local distributor is required to maintain the quality control standards.

Under the authority of FAR 6.302-1, there is a limited number of responsible sources, the original equipment manufacturer (OEM), Becton Dickinson Italia S.p.A., and two authorized dealers, Biomerieux Italia S.p.A. and Bioservice Italia S.p.A. There are no other known sources that can satisfy agency requirements and only the OEM is capable of manufacturing the items. Becton Dickinson Italia S.p.A. brand microbiology media plates and reagents are the only products available in Italy that are in compliance with FDA standards, USNH laboratory quality control, and in accordance with the quality assurance guidelines for commercially prepared microbiological culture media enumerated in Clinical & Laboratory Standards Institute (CLSI)/National Committee for Clinical Laboratory Standards (NCCLS) Document M22 approved standard Third Edition (Wayne, PA: NCCLS, 2004). Therefore, only authorized dealers/distributors are limited to reselling Becton Dickinson Italia S.p.A. brand products.

The solicitation number is N68171-19-Q-0110. The applicable North American Industry Classification System (NAICS) code is 339112. The Product Service Code (PSC) is 6515. The taxonomy of supplies is Surgical and Medical Instrument Manufacturing. The anticipated period of performance (POP) is 1 October 2019 to 30 September 2024. It is anticipated an award will be made either directly to Becton Dickinson Italia S.p.A or to one of its authorized distributors on or before but no later than (NLT) 30 September 2019. Inspection and acceptance will be at destination by the Government. Standard commercial packaging and marking will be required. The delivery location is Materials Management Department Laboratory, USNH Naples, Localita Boscariello, 81030 Gricignano di Aversa (CE), Italia.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, all quotations received by the closing response date will be considered by the Government. A determination by the Government not to compete this proposed solicitation based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. In doing so, interested sources must submit technical capabilities, pricing, and other information that demonstrates their ability to fulfill the requirement in accordance with the Statement of Work (SOW). The points of contact (POC) are the Contract Specialist, Alfonso Porras, whom may be reached at Alfonso.Porras@eu.navy.mil or the Contracting Officer, Ms. Jennifer Lee whom may be reached at Jennifer.Lee@eu.navy.mil. Submissions shall be received no later than (NLT) 1200 Central European Time (CET) on 20 September 2019; all responding vendors must be registered in the System of Award Management (SAM) at https://www.sam.gov, have an active CAGE code, and be issued a Dunn and Bradstreet (DUNS) number.

Contracting Office Address:

mailto:Alfonso.Porras@eu.navy.mil mailto:Jennifer.Lee@eu.navy.mil https://www.sam.gov/

Naval Supply Systems Command (NAVSUP) Fleet Logistics Center Sigonella (FLCSI) Naples Detachment Office Regional Contracting Department (Code 200)

PSC 817 BOX 50

FPO, AE 09622

STATEMENT OF WORK (SOW)

BACKGROUND: The U.S. Navy Hospital (USNH) requires material consumable supplies, media plates/reagents for the Government performance of microbiology testing. The materials are used to perform pathological organism identification and distinguish an appropriate selection of antibiotics for patients to ensure treatment success. The microbiology testing is mission critical to the USHN and that the required products must be maintained at strict temperature control and standards.

SCOPE: A local supplier is required to maintain the just in time deliveries in a set quantity and delivered the first week of every month to accommodate an inventory with a short shelf life. The media plates/reagents must be delivered on schedule and maintained at a constant refrigerated temperature of between two to eight degrees Celsius to meet quality control standards and ensure lot sequestration.

REQUIREMENT: The Contractor shall validate that the microbiology media plates/reagents requested comply with the Food and Drug Administration (FDA) standards and are revalidated internally by the USNH laboratory passing a stringent quality control before being utilized for testing. The Contractor shall comply with Clinical and Laboratory Standards Institute (CLSI)/National Committee for Clinical Laboratory Standards (NCCLS) document M22-A3 (quality assurance for commercially prepared microbiological culture media) or equivalent and shall document that quality control activities meet the CLSI/NCCLS guidelines or equivalent.

TECHNICAL SPECIFICATIONS:

The Contractor shall have the ability to supply the microbiology media plates to meet the below:

1) FDA standards (Volume 4, Section 2 of FDA Office of Regulatory Affairs):

https://www.fda.gov/media/73551/download

2) Quality assurance guidelines enumerated in CLSI/NCCLS Document M22, CLSI/NCCLS

3) Quality control for commercially prepared microbiological culture media; approved standard Third Edition CLSI/NCCLS document M22-A3 (Wayne, PA: NCCLS, 2004)

4) Products maintained and delivered within required temperature between two (2) to eight (8) degrees Celsius

5) Lot sequestration must be ensured

6) Delivery shall be made in a set quantity and must be delivered the first week of every month

7) Materials must not expire prior to receipt of subsequent shipment

Below are the anticipated delivery dates and quantities of the listed products based on the yearly subscription.

https://www.fda.gov/media/73551/download

The anticipated estimated delivery schedule is subject to change. Items shall be delivered on the first week of every month.

PERIOD OF PERFORMANCE (POP):

The POP shall be one (12-month) base year plus four (12-month) option years as indicated below:

Base Year 1 Oct 2019 – 30 Sept 2020

Option Year 1 1 Oct 2020 – 30 Sept 2021

Option Year 2 1 Oct 2021 – 30 Sept 2022

Option Year 3 1 Oct 2022 – 30 Sept 2023

Option Year 4 1 Oct 2023 – 30 Sept 2024

DELIVERY ADDRESS:

Materials Management Department Laboratory USNH Naples Localita Boscariello 81030 Gricignano di Aversa (CE), Italia

INVOICES AND PAYMENT:

(a) Invoices shall be marked with the contract number listed in block 2.

The Contractor shall mail invoices to:

Materials Management Department Laboratory USNH Naples

PSC 827 BOX 09MM

DESCRIPTION ITEM ID

O

C

T

N

O

V

D

E

C

J

A

N

F

E

B

M

A

R

A

P

R

M

A

Y

J

U

N

J

U

L

A

U

G

S

E

P

T

TOTAL

ANNUAL

QUANTITY

CHOCOLATE II AGAR+ISOV 254060 3 4 3 4 3 3 3 4 3 3 2 3 38

COLUMBIA C.N.A. +5% S.M. 254007 2 3 2 3 2 2 2 3 2 2 2 2 27

MARTIN LEWIS AGAR 254029 2 2 2 2 2 2 2 2 2 2 2 2 24

T.S.A. + 5% S.M. 254053 16 16 16 16 16 16 16 16 16 16 16 16 192

MAC CONKEY AGAR 254025 3 3 3 3 3 3 3 3 3 3 3 3 36

T.S.A. II 5% S.M./MAC CONKEY II 221290 12 12 12 12 12 12 12 12 12 12 12 12 144

CDC 5% S.M. + PEA; BD 221739 3 4 3 4 3 3 3 4 3 3 4 3 40

SALMONELLA SHIGELLA AGAR 254047 2 2 2 2 2 2 2 2 2 2 2 2 24

CAMPYLOBACTER S.A. 10% S.M 254001 2 2 2 2 2 2 2 2 2 2 2 2 24

Gas Pak Anaerobe Pouch System 260683 2 2 2 2 2 2 2 2 2 2 2 2 24

GasPak EZ Container Sachets with indicator (20 / box) 260001 1 1 1 1 1 1 1 1 1 1 1 1 12

Gas Pak Campy Pouch System 260685 2 2 2 2 2 2 2 2 2 2 2 2 24

Provette THIOGLYCOLLATE MEDIUM 221195 4 4 4 4 4 4 4 4 4 4 4 4 48

Provette SELENITE F BROTH 221020 2 2 2 2 2 2 2 2 2 2 2 2 24

Provette TODD HEWITT with GM e NA 299486 1 1 1 1 1 1 6

Gram stain 212539 1 1 1 1 1 1 1 1 1 1 1 1 12

Indole 261185 1 1 1 1 1 1 1 1 1 9

Oxidase 261181 1 1 1 1 1 1 1 1 1 9

Potassium hydroxide 10% 261191 1 1 1 1 1 1 1 6

ImmunoCard STAT! Strep A 755250 3 3 3 3 2 3 1 18

ThermoScientific Strep Grouping PathoDXTRA DR0700M 1 1 1 1 1 1 1 7

FPO AE 09617-09MM

(b) Invoices shall conform to the Contract Line Item Number (CLIN) structure of this contract.

(c) Invoices shall be in the name of the Contractor and not any agent or subcontractor.

(d) The Contractor shall maintain original paid invoices and other related records for the length of the contract plus one year. Contractor shall make historical invoicing data available to the Government within ten (10) business days of a formal request. Archived information shall be provided in a mutually acceptable format.

(e) Payment will be made after delivery and acceptance of supplies or performance and acceptance of services. The Government will only pay for those supplies and services, or portions thereof, which have been accepted. Invoices not in compliance with these instructions are not considered to be proper invoices and may be rejected.

(f) Upon receipt of accepted and certified invoices, payment will be made by:

Commercial Bill Paying Office (CPBO) Naples (+39) 081-568-6649