Sole Source Justification_Ceres Nano.docx (1).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: Wastewater Surveillance Testing Vendor name: Ceres Nanoscience Vendor Address: 9460 Innovation Dr. Manassas, VA 20110 Select one: ☐ Original X Modification CORE Vendor ID: VC00000000478782 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)

Ceres Nanotrap Microbiome Particles are proprietary magnetic hydrogel particles designed to capture and concentrate low-abundance microbes (including bacteria, viruses, and fungi) from complex environmental, wastewater, and clinical samples, improving detection sensitivity across downstream workflows. These particles are used for our wastewater workflow as part of verified testing process.

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

FY24 Straight Pay $2,524 & PO 2024*3748 $44530; 6/13/24-Current Sole Source PO 2024*12064 $59,140.

Term of agreement:

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

Start Date 06/07/2024 End Date 06/07/2029

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

$1.5M

If a modification, complete the following:

Amount Increased

$2.0M Revised Total

$3.5M

If a modification, state the reason(s):

We are revising the dollar amount to cover the current Quartzy request in response to increase in testing.

This increase is in response to special projects, outbreaks, and the activation of emergency sentinel surveillance and in response to a price increase on the product pertaining to the vendor changing the volume format of the reagent. The volume format change supports more streamlined use and minimizes contamination potential. Current Quartzy requests total $1.3M. The additional funding is to account for additional spending for the remaining life of the contract.

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

Sole Source Justification 1 Version A2021

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 ☐ No X

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)…

Ceres Nanoscience is the only vendor that manufactures and supplies microbiome A&B particles for both viral and bacterial targets. No other vendor provides the proprietary magnetic hydrogel particles designed to capture and concentrate low-abundance microbes (including bacteria, viruses, and fungi) from complex environmental wastewater samples. They only ship directly and do not use any third party agreements to distribute. The ceres nanotrap reagents are compatible with the current automation infrastructure and allow us to maintain our sensitive and specific, verified routine testing workflow as well as plays a key role in our special projects workflow.

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

Ceres nanosciences is the only supplier that provides sensitive and specific Microbiome Particles are proprietary magnetic hydrogel particles designed to capture and concentrate low-abundance microbes (including bacteria, viruses, and fungi) from complex environmental, wastewater samples, such that the beads allow for a 35mL sample to be concentrated down to 200uL, without loosing pathogen material. It is then able to be extracted for downstream workflow processing and testing. It is also the only reagent marketed for both concentration and extraction while also being compatible with our existing verified automated extraction infrastructure.

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 procured?

This vendor has licenses and certification to distribute the required microbiome particles with all relevant lot and QA/QC information. Ceres is an ISO 3001:2015 Certified Lab. Ceres provides use protocols and all relevant training guidance for use of their materials. All staff has been trained and maintains a use competency for this reagents and its application in the current workflow.

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

The program has revisited the current market to look at existing and emerging protocols to determine if a

Sole Source Justification 2 Version A2021 competitor has emerged in the wastewater space. To date there is not an equivalent product that meets the needs of the workflow or existing infrastructure.

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 X No

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"?

Although Ceres is the only vendor to supply proprietary magnetic hydrogel particles designed to capture and concentrate low-abundance microbes (including bacteria, viruses, and fungi) from complex environmental, wastewater samples, other generic (non-specific) magnetic beads exist and the prices are in line with the Ceres beads. Program also verified that change in volume format that has led to a price increase has not changed the unit price per uL of beads and that over the period for which we have done business with ceres that the per year cost to account for inflation has not exceeded 5% per year, our increase in dollars allocated has been a result of throughput.

Yes X No

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

Division: Lab Service Division

Program: Genomic Surveillance Program, Wastewater Unit

Program Contact Name: Alexandria Rossheim

Phone: 408-529-7406

Program Manager: Shannon Matzinger

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

Comments:

Sole Source Justification 3 Version A2021

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: