5999-0 bioMerieux Sole Source Memo.pdf

SOLE-SOURCE DETERMINATION MEMO

FOR SUPPLIES AND SERVICES

Date: August 1, 2024 Sole source number: S-10000-00011123

To: Kirk N. Rhoades, Designated Procurement Officer

DHS/OHA Office of Contracts & Procurement

Requestors: Elizabeth Stelle, Contracts Coordinator, PHL

Akiko Saito, Business Director, PHL

Ayodele Ojebode, Virology/Immunology Manager, PHL

Agency/division: Oregon Health Authority / Public Health Division

Program/office: Oregon State Public Health Laboratory (OSPHL)

Contract specialist: Burke Barnett, PCS3

Agency Sole source rule: Sole source authority:

OHA OAR 137-047-0275 ORS 413.033

Estimated total contract value: $500,000 estimated over a five-year period.

Description of goods or services: Purchase BioFire FilmArray Torch PCR Assay System and the associated ongoing annual Preventive Maintenance and Service Agreements, Reagent Kits, Consumables, and Supplies from bioMerieux for a five-year term, with the option to renew for an additional five years, for a maximum cumulative 10-year term.

1. Background:

This sole source determination request applies to the purchase of a BioFire FilmArray

Torch PCR Assay System and the associated ongoing annual Preventive Maintenance and Service Agreements, Reagent Kits, Panels, Consumables and Supplies needed to perform specialized testing on human specimens as part of OSPHL’s continued COVID-

19 response and more general communicable disease surveillance in Oregon. The

Oregon State Public Health Laboratory currently owns a BioFire FilmArray 2.0 System, which is used to detect respiratory and foodborne viruses. bioMerieux is discontinuing the 2.0 model, and OSPHL intends to purchase the newer version of this technology – the BioFire FilmArray Torch System. The Torch System will gradually replace the 2.0

System, and the same reagents, supplies, and consumables are used by both systems.

bioMerieux is the sole manufacturer, distributor, and service provider of the BioFire line of products.

Describe the reasons the agency is seeking this procurement method:

The State of Oregon owns the bioMerieux BioFire FilmArray 2.0 (Serial Number

2FA08378), FilmArray 2.0 HP RP5800 PC Kit (Serial Number KIT-MXL9264DWP) FilmArray

2.0 Kit Printer and Instrument Rack, purchased from bioMerieux in January 2021, under

Emergency Procurement authority while the State was under a Declared Emergency

(Major Disaster Declaration Number DR4499OR).

bioMerieux has discontinued sales of the FilmArray 2.0 System and will discontinue support by 2029. The BioFire FilmArray Torch System is the newer model of this testing platform, and OSPHL intends to purchase the Torch System and gradually phase out the

2.0 System. This will allow for continuity of testing operations and prevent costly validation of new methodology and staff training. OSPHL requires procurement authority to continue purchasing preventative maintenance, annual service agreements and proprietary reagents, panels, consumables, and supplies needed for ongoing instrument operations. bioMerieux is the sole manufacturer, distributor, and service provider for the BioFire FilmArray 2.0 and Torch CPR Assay Instrumentation.

This procurement method is required since there is only one manufacturer, distributor, and service provider for this equipment; there are no competitors providing these goods and services. The procurement authority from a Sole Source Determination will ensure continued use of the bioMerieux BioFire platforms owned by OSPHL. The State has significant financial investment in the purchase of the system, and in staff time and training, to utilize this valuable platform for COVID and other communicable disease testing.

A letter from bioMerieux stating they are the sole proprietary owner and distributor for

BioFire line of products is attached to this Sole Source Determination Memo as

Attachment 2.

2. Prospective contractor/vendor:

Legal entity name: bioMerieux

Address: 515 Colorow Dr., Salt Lake City, UT 84108

Contact person: Lou Banks

Phone: 801-712-1810

Email: Lou.Banks@biomerieux.com

Protests are due by 3:00 PM within seven calendar days after the first date the notice is posted on OregonBuys, the State’s e-Procurement System. Protests must be in writing, sent via email to the following email address:

Protests via telephone will not be accepted.

Agency reserves the right to purchase additional goods and services from bioMerieux, to include but not limited to, additional instruments, ancillary equipment, reagents/kits, panels, consumables, and maintenance and repair services.

3. Written findings of fact (market research):

The findings below must include factual information supporting the determination that meet the sole source requirement in statute.

Pursuant to ORS 279B.075, Agency must conduct market research that supports the assertion that there is only one source that can provide the goods or services.

Market research includes utilization of the internet, trade journals, agency vendor lists, professional organizations, studies, catalogs/industrial periodicals, vendor sources, yellow pages, etc.

For information technology contracts, any ownership or proprietary issues should be fully addressed with written documentation to support facts.

Agency must select at least one of the findings and prepare the determination as it specifically relates to the good or service being procured. More than one finding can be addressed. The findings are as follows:

Pursuant to ORS 279B.075 (2)(a): Provide findings supporting the determination that the efficient utilization of existing goods requires the acquisition of compatible goods or services from only one source.

1) The OSPHL purchased one BioFire FilmArray 2.0 System (Instrument serial number 2FA08378) from bioMerieux in January 2021.

2) The preventative maintenance and repair services, reagents, kits, panels, consumables, and supplies required to maintain and utilize the system are only obtainable through bioMerieux.

3) bioMerieux has discontinued the sale of the BioFire FilmArray 2.0 System and will discontinue support by 2029. OSPHL intends to replace the BioFire FilmArray 2.0

System with the purchase of a BioFire FilmArray Torch system to ensure continuity of testing.

or

Pursuant to ORS 279B.075 (2)(b): Provide findings supporting the determination that the goods or services required for the exchange of software or data with other public or private agencies are available from only one source. N/A or

Pursuant to ORS 279B.075 (2)(c): Provide findings supporting the determination that the goods or services are for use in a pilot or an experimental project. N/A or

Pursuant to ORS 279B.075 (2)(d): Any other findings that support the conclusion that the goods or services are available from only one source.

bioMerieux has provided supporting documentation indicating they are the sole manufacturer, distributor and service provider of the BioFire FilmArray 2.0 and

Torch PCR Assay Systems. Internet research indicates that the goods are not available on the open market from any retail vendor. Conducting a “Statewide

Contract Search” function of OregonBuys indicates that the goods/services are not available on DAS price agreements. Use of any non-bioMerieux BioFire products on the FilmArray 2.0 or Torch PCR Assay Systems or having maintenance and repairs of the system performed by providers other than bioMerieux certified technicians will automatically render the instrument warranty null and void.

APPROVED:

By:

Signed by DPO electronically via OregonBuys

Kirk N. Rhoades, or acting DPO

BRAND NAME DETERMINATION:

If a brand name is involved, Agency must also satisfy the requirements of OAR 125-247-

0691 by completing Attachment 1.

ATTACHMENT 1

DETERMINATION OF BRAND NAME SPECIFICATION

Requestor: Elizabeth Stelle, Contracts Coordinator, PHL

Akiko Saito, Business Director, PHL

Ayodele Ojebode, Virology/Immunology Manager, PHL

Agency/division:

Oregon Health Authority / Public Health Division

Program/office:

Oregon State Public Health Laboratory (OSPHL)

Agency Brand name statute/rule: Brand name authority:

OHA ORS 279B.215 ORS 413.033

1. Brand name to be acquired:

Legal entity name: bioMerieux

Address: 515 Colorow Dr., Salt Lake City, UT 84108

Contact person: Lou Banks

Phone: 801-712-1810

Email: Lou.Banks@biomerieux.com

2. Findings to satisfy required standards:

Use of a brand name specification is unlikely to encourage favoritism in the awarding of public contracts or substantially diminish competition for public contracts because: N/A or

Use of a brand name specification would result in substantial cost savings to the agency or the public because: N/A or

There is only one manufacturer or seller of the product of the quality, performance or functionality required; because: bioMerieux is the sole manufacturer, distributor, and service provider of the BioFire FilmArray 2.0 and Torch PCR Assay Systems.

The reagents, panels, kits, consumables, and supplies required to utilize the system are proprietary and only obtainable from bioMerieux.

or

The efficient utilization of existing goods requires the acquisition of compatible goods or services because: Warranty is void if the consumables specified by bioMerieux are not used exclusively, or if instrument repairs and maintenance are carried out by persons who are not certified and authorized by bioMerieux.

FINDINGS

The findings are accepted, adopted, and incorporated by reference herein.