Sole Source Justification_Qiagen.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: Qiagen Vendor Address: 19300 Germantown Road, Germantown, MD, 20874 Select one: ☐Original X Modification CORE Vendor ID: VC00000000070984 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 sole source covers the procurement of two QIAGEN QIAcuity digital polymerase chain reaction (dPCR) instruments as well as the service, reagents and supplies required with the instruments. Also including the 5 year service agreement renewal for the original QIAcuity instrument.

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

The previous sole source agreement with QIAGEN covered the date ranges 07/01/2013 to 6/30/2018 and was for an estimated dollar amount of $155,000. There is a QIAGEN sole source currently that covers unit DLM0 that covers from 04/13/2023-04/13/2025 for the amount of $600,000. This new agreement covers the procurement of 2x QIAGEN QIAcuity dPCR instruments and the associated reagents and consumables for the 5 year date period stated below, that will be used by the wastewater surveillance unit at the CSPHL. This agreement also covers the original QIAcuity dPCR instrument for service coverage for 5 years.

Term of agreement:

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

Start Date 12/15/2023 End Date 12/14/2028

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

$1.64M

If a modification, complete the following:

Amount Increased

$1.5M Revised Total

$3.14M

If a modification, state the reason(s):

We have an increased in testing volume and this necessitates additional funding to support reagents needed to respond to increasing testing throughput. The current requests in Quartzy amount to $950K, which exceeds the current estimated dollar amount.

A. Criteria: Answer both 1 and 2.

Sole Source Justification 1 Version A2021

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). Although QIAGEN is not the only vendor that offers dPCR options it is the only vendor on the market that specifically complies with the verified parameters of existing internal and external protocols, which allows consistent comparison of historical and new data being derived both in-house and via our external federal, state, and academic partners. (2) Additionally, to maintain our existing agreements with QIAGEN it is required that we continue our procurement directly through QIAGEN because QIAGEN does not market, sell or option its trademarked, proprietary equipment, consumables or reagents through any third party vendors. (3). By procuring our consumable and reagent needs directly from QIAGEN for use on our verified and maintained QIAGEN equipment we maintain the reliability of the results coming off the instrument and have assurance of the compatibility of the certified analysis software with kits being used to generate outputs. (4) QIAGEN is well established in the functionality and capacity of the lab and therefore only requires reagents and consumables to be maintained to continue our existing workflow.

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

QIAGEN provides equipment, goods, and services that align with the existing capacity for the wastewater surveillance unit projects ongoing at the lab, in that there are established protocols as well as implemented automation that utilizes the equipment, reagents and consumables for QIAGEN platform. Further, lab staff has invested in specialized trainings on QIAGEN specific assays including the wastewater pathogen quantification which is only possible through QIAGENs line of dPCR platform. Additionally, our academic, federal, and local public health partnerships including our public health dashboard data requires that we utilize QIAGEN such that our data is comparable across groups and time points, as QIAGEN remains the gold standard platform within a diverse range of protocols. Additionally, the offerings QIAGEN has in terms of equipment, service and reagents are the only vendors on the market offering FDA approved options that fit the current laboratory needs, protocols, and partnerships. By maintaining QIAGEN equipment, service and reagents in the lab and making the upgrade as new kits and models become available we are remaining competitive in our testing capacity and mitigating potential equipment challenges

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

Sole Source Justification 2 Version A2021

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?

We currently hold the service agreement for a QIAGEN QIAcuity that is considered proprietary, and are considered experts with this instrumentation. Also, the lab staff have undergone specialized trainings and competencies specific to protocols verified on these instruments.

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

Through communications with the vendor, our academic, federal, and local partners, as well as by conducting a cursory literature and market search, it is clear that QIAGEN remains the gold standard for equipment and consumables used by the wastewater unit and is therefore the only viable option for maintaining our current processes as expected.

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 ☐ No X

3. Did you conduct a cost/price analysis? (If “Yes”, attach documentation)

There have been no major price increases and the prices for dPCR are equitable to other PCR technologies

Yes X No

If No to #3 above:

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

The existing QIAGEN equipment maintained in the wastewater unit along with their respective consumables do not have a comparable alternative that is reasonably interchangeable with current internal standard operating procedures, verifications, and testing requirements, nor are there. There have been no major increases in prices.

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, Wastewater 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: