WW_LSA_Illumina NovaSeq and MiSeqs Sole Source.docx

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: Illumina NovaSeq and MiSeqs Instrument Service Vendor name: Illumina, Inc.

Vendor Address: 5200 Illumina Way, San Diego, CA 92122 Select one: X Original ☐ Modification CORE Vendor ID: VC00000000106635 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)

This vendor provides authorized service to the following equipment (Model and Serial Number):

This will be a pay in advance contract for ongoing preventive maintenance, unplanned repair services, and/or any other provisions as it pertains to a service contract. The vendor listed is the manufacturer of the equipment and therefore is the only authorized party to provide the parts, service, and certified engineers to perform maintenance and repairs.

This instrumentation is used by and within the Wastewater (WW) Unit, for Wastewater Matrix sequencing.

The NovaSeq is used as the instrumentation that supports the wastewater matrix metagenomics pilot program and is not meant to support clinical sample sequencing within our current workflow based on the instruments capacity, run time, and specific reagent ranges.

The MiSeqs are also used to support the testing of wastewater matrix and are non-redundant instruments in our workflow as they are part of the ISC flu project. The MiSeqs are the only instrument validated by CDC to support seasonal flu sequencing. This instrument is also validated for non-mixed NBS samples. These instruments are integrated into our low throughput scalable capacity for sequencing within our current workflow based on the instruments capacity, run time, and specific reagent ranges.

Because these instruments support non-redundant testing workflows based on their capacity, run time, and specific reagent ranges, maintaining the service and functionality concurrently and consistently is paramount to maintaining testing.

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)

amount $275,000

Increased

Revised Total

If a modification, state the reason(s):

A. Criteria: Answer both 1 and 2.

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?

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)…

The specialized equipment that has been procured, implemented and maintained by the state as fit to purpose in the existing testing infrastructure and workflows is proprietary to the vendor; under the purchase agreement the defined instrumentation is not eligible or able to be maintained by a third party and can only be serviced by the manufacturer’s certified and trained engineers, with their certified parts. Therefore there is only one entity, the manufacturer, which is capable of providing service on/for the defined equipment. If a distributor of the equipment does not have a two-party agreement allowing for the distributor to act on behalf of the manufacturer to support service, or a three-party agreement where the distributor has an agreement with the manufacturer and CDPHE, the customer to act on our behalf to facilitate direct, non-third or second party service, then only the manufacturer is eligible to provide the necessary service plan to maintain operational equipment.

The scope of work included in the service agreement, which includes preventative maintenance (PM) at a minimum cadence of annually, unplanned service to maintain functionality, and any technical support remote or in person that may arise during the life of the instrument, needs to be performed by the manufacturing vendor of the instrument to meet the quality control metrics required for performing testing. When service lapses, the PM is not performed, the instrument is broken and requires service to be operational or any such circumstance planned or unplanned that would call into question the functionality or integrity of the instrument, we are unable to continue the operation of the equipment until the instrument can be recertified and deemed operational by the manufacturer.

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

The instruments as defined in the above table under the project description section, requires specialized preventative maintenance services and in often cases unplanned maintenance that needs to be performed by the vendor who manufactured the proprietary instrument. The manufacturer has been identified as the entity, that has the specialized knowledge, training and certified engineers required to perform service work, as well as the allocated resources to first hand obtain the new, certified parts, and repair the instrument in a timely manner, as needed by the nature of the work performed in the laboratory environment. These services and parts meet the requirements for our Quality management requirements to perform the testing required by our funding deliverables.

E. 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?

The manufacturer staff the field engineers that are trained and certified with the specialized knowledge and have direct access to non-catalog parts for the instruments as defined in the above table under the project description section. The manufacturer is also required to provide liability insurance for the work performed under the service agreements.

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

The vendor is the manufacturer of the instruments and parts. The vendor has established the required preventive maintenance schedules and repair criteria for the instruments. The vendor trains and certifies the technicians to perform this work to guarantee proper operation.

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.

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

The price for service for the defined instruments has remained consistent over the life of the instrument accounting for inflation that impacts tech travel and parts. There have not been undefined changes to the price of service. Once the service contract is signed, there are no hidden or added charges as long as the scope of work is followed.

If No to #3 above:

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

Division: CDPHE Laboratory Services Division Program: Genomic Surveillance Program, Wastewater Unit Program Contact Name: Alexandria Rossheim Phone: 408-529-7406 Program Manager: Shannon Matzinger --------------------------------------------------------------------------------------------------------------------------------------------------------------------- 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