Sole Source Justification_Std Bio Tools.pdf

SOLE SOURCE JUSTIFICATION FORM:

This completed form is to be submitted to PCU via the Request website as the first step in the Sole Source

Process.

Important! Consult the document “Sole Source Justification Guidance” for additional instructions.

TYPE OR CLEARLY PRINT ALL INFORMATION

Project Name: Standard BioTools Equipment, Service, and Reagents Procurement Vendor name: Standard BioTools *Formerly Called “Fluidigm Corporation” Vendor Address: 2 Tower Place, Suite 2000, South San Francisco, CA 94080 USA Select one: ☐Original X Modification CORE Vendor ID: VC00000000422053 PO or Contract Number (if this is a modification):

Describe the products and/or services to be procured and how they meet your needs. (This space is limited – provide a scope of work or specs as additional documentation)

The original and currently owned instrument (the Fluidgm Juno, SN# 130249 ), was purchased as a requirement by the CDC for an APHL grant funded project as the only instrument currently on the market that was capable of performing metagenomics testing directly on raw stool specimens. Since the procurement of this original instrument, the vendor Fluidgm and the Juno model no longer as exists; it has been replaced and rebranded as the Standard BioTools X9. Our project with CDC has continued but will require we upgrade our model, which is still at this point the only available model that both meets the requirements of the CDC project and is capable of metagenomics testing directly on raw stool specimens. We have executed our plan to trade in our discontinued Fluidgm Juno, SN# 130249 for a trade-in credit, and procured two replacement Standard BioTools X9 units, including also procure the five year service agreement at a fixed upfront cost, as well as accept the additional 1 year free factory warranty that comes as a new instrument purchase incentive. Additionally we asked that reagents that are only procurable direct through Standard BioTools also be covered under this sole source. Given the success of this project we need to expand our capacity to include 2 additional X9 units with service that applies to the remaining duration of the contract.

As a result of the expanded capacity we have increased throughput and therefore the need for additional reagents

List dates, agreement numbers and dollar amounts for any previously procured products or services from this vendor related to this project:

Term of agreement:

(If multi-year, indicate the full term up to 5 years)

Start Date 12/13/2023 End Date 12/12/2028

If this is a modification, indicate the revised end date (if applicable). Revised End Date

Estimated dollar amount - life of the project (up to 5 years):

Dollar amount

$1.3M

If a modification, complete the following:

Amount Increased

$1M Revised Total

$2.3M

If a modification, state the reason(s):

We have expanded our testing capacity and require additional reagent budget to accommodate throughput.

Sole Source Justification 1 Version A2021

A. Criteria: Answer both 1 and 2.

1. There is only one Good or Service that will meet the needs of the State. Yes X No

2. There is only one Vendor that can supply that Good or Service. Yes X No

If “NO” to either 1 or 2, answer 3 and 4, below.

3. The compatibility of equipment, software, accessories, or replacement parts is the paramount consideration and the items are only available from one vendor.

a. Is this a software package or other IT system and the existing system now requires only ongoing maintenance and support?

Yes X No

Yes X No

4. A sole supplier’s item is needed for trial use or testing. Yes X No

If “NO” to 1-4, above, this is not a sole source.

STOP

A formal solicitation is required. Complete a Purchasing Determination Form.

Submit all required documents via the PCU Request Site.

B. Explain in terms of 1 through 4, above, the basis for your identifying this as a sole source?

A sole source is justified in the instance that this is the only vendor - not what the program may determine to be the best vendor. Is this the only vendor? Explain (See form instructions

(1) The Standard BioTools, X9 High-Throughput Genomics System is the only unit on the market that is capable of metagenomics testing directly on raw stool specimens. Other unique features that serve the needs of the state have been provided in an attachment.

(2) It is important to note that while standard BioTools is the only manufacturer and certified service provider for the unit, they do work with other distributors for initial procurement of the unit (VWR and Fisher are able to drop ship the unit on behalf of Standard BioTools). However, it is the same unit, sold at the same price, and brokered in collaboration with same sales representatives at Standard BioTools, through VWR and/or Fisher facilitating the shipment and exchange of money. VWR and Fisher cannot and are not distributors of the service agreement and warranty.

(3/4) Beyond its unique capabilities, it is the only direct replacement for our current unit and as such is the unit that is required by the CDC to fulfill the grant deliverables and multiplexed testing needs. We also have staff that have been trained on the instrument and plan to expand training directly provided by the vendor to educate additional staff members.

C. What makes this good or service unique to meeting your needs?

This unit remains the only unit on the market that is capable of metagenomics testing directly on raw stool specimens. This means eliminating culturing, sub-culturing, extraction, cDNA preparation workflows and taking a whole specimen straight to instrument. Further, it comes with software and hardware capabilities for primer designs that negate overlap consideration while creating highly multiplexed reactions, while being flexible to third party enzymes.

D. Is the Good or Service Proprietary (product or technology entirely owned by the individual/company and usually protected by trademark or copyright)?

Yes X No

D. What type of required, specific and exclusive experience, certifications, licenses etc.

are possessed by this vendor that directly relate to the good or service to be

Sole Source Justification 2 Version A2021 procured?

Vendor insurance is attached to the previous modification. Notably, as part of the initial instrument set up, it is required that the lab or selected user will be trained directly by Standard BioTools prior to use, this is outlined in the quote for procurement of the instrument and service.

E. What research has the program conducted to justify this sole source?

We were required by CDC as part of an APHL grant to in conjunction with University of Michigan procure the Fluidigm Juno, for which the Standard BioTools X9 is the direct market replacement. As part of this study, in collaboration with our academic and CDC partners, we worked to field validate its function in its capability to direct metagenomics testing on raw stool. Additionally, Standard BioTools has the sole legal right to commercialize the High-Throughput Genomics System utilizing Dynamic Array and, to the best of our knowledge, Standard BioTools is the only vendor of the X9 High-Throughput Genomics System, and Dynamic Array (that is, Standard BioTools has not licensed other vendors and knows of no vendor that is legally or illegally selling these products outside of their distribution agreements with VWR and Fisher).

G. Do you have an actual or potential conflict of interest in this purchase?

(For example, is an individual from the Department or a family member affiliated with the vendor as an employee, board member, volunteer, etc.?)

Yes ☐ No X

If Yes: Please Explain. (This space is limited – please provide additional documentation if applicable.)

H. This Section is Required – You must answer “Yes” to at least one.

1. Did you compare prices/rates to established catalog prices or market prices? (If “Yes”, attach documentation)

Yes ☐ No X

2. Did you compare prices/rates to historical prices or rates for similar items or services procured in the past? (If “Yes”, attach documentation)

Yes X No

3. Did you conduct a cost/price analysis? (If “Yes”, attach documentation) Yes ☐ No X

If No to #3 above:

4. Do you know if the cost is "fair and reasonable"?

As we previously purchased and maintained service for this instruments previous model (Juno) with Fluidgm before it became Standard BioTools (X9), we believe the price is fair and reasonable as the updated model and service agreement and reagents are relatively the same price as the original model and vendor rate.

Yes X No

Demonstrate how you determined fair and reasonable prices/rates: Attach additional pages if required.

Division: Laboratory Services Division

Program: Genomic Surveillance Program, Sequencing Unit

Program Contact Name: Alexandria Rossheim

Phone: 408-529-7406

Program Manager: Shannon Matzinger

Sole Source Justification 3 Version A2021

-------------------------- Procurement Use Only:------------------

Comments:

Approved: __________________________________________________________________________ Agency Procurement Director or Authorized Representative Signature Date

Posted on VSS? Yes ☐ No ☐ If posted, original Intent to Sole Source VSS# __________________________________________

If not posted or modified, Approved CDPHE Request #: _______________________________________

Sole Source Justification 4 Version A2021

SOLE SOURCE JUSTIFICATION FORM: