Qiagen Supplies and Service SSJ 2026 MOD (1).docx

Sole Source Justification Guidance

SOLE SOURCE JUSTIFICATION GUIDANCE

SOLE SOURCE JUSTIFICATION FORM:

This completed form is to be submitted to PCU via cdphe_pcs@state.co.us 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: Genomic Surveillance Program, QIAGEN automated Extraction Vendor name: QIAGEN LLC Vendor Address: 19300 Germantown RD, Germantown MD 20874 Select one: ☐Original X Modification CORE Vendor ID: VC00000000530218 PO or Contract Number (if this is a modification): 2027*5027

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 document covers the supplies, reagents, and purchase of two QIAGEN EZ2 Connect automated extraction systems. These systems will be used in the genomic surveillance program to support automated extraction procedures.

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

There have been a few QIAGEN sole sources in the past that have covered the required reagents and consumables. This sole source will only cover the procurement of 2x EZ2 Connects, reagents and consumables solely used on the EZ2 systems.

Term of agreement:

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

amount $350,000

Increased

Total $875,000

If a modification, state the reason(s):

This modification is intended to add additional dollars for reagent expenditure. From 2024 to 2026 we have spent 175k/yr; this amount multiplied by the remaining 3 years of the project adds $525K for a total of $875K over the life of the project.

The expanded cost pertains to the need to support outbreak testing that occurred over the 2026 summer season, in addition to supporting regional state outbreak testing requests while maintaining our routine testing. The new amount covers the increase volume tested in 2026 and multiplies it over the remaining years of the project.

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)…

While QIAGEN is not the only vendor that offers automated extraction 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. Due to space and electrical limitations, sample matrices, and cost determinations this justifies as a sole source since QIAGEN is the only vendor that has an instrument that meets all of these requirements necessary for day-to-day testing at the laboratory, including PulseNet testing. PulseNet is a part of the FoodCORE Program put forth by the CDC to respond to foodborne illnesses. PulseNet as well as being one of the Food Safety Centers of Excellence, Colorado is funded through CDC to continue these testing practices. The QIAGEN EZ2 Connects are the only fully automated, self-contained sealed reagent strip chemistries, and Gdna, mitoDNA, or RNA extraction protocols for multiple samples matrices including raw stool (PulseNet required). If the EZ2 Connects are not procured this could cause a massive delay in sample results that are being distributed to CDC, Local LPHAs, and laboratory clients. Having to verify and support new equipment can cause delays up to 2 months, which could greatly affect patient care, CDC grant funding, and or completing other grant deliverables.

The EZ2 Connects are also the only pieces of equipment that provide the space requirements for the laboratory. Due to the construction process, every piece of equipment has to meet a certain space requirement. The size of the EZ2 connect automated extraction systems are the only extraction system that meet the matrix requirements (Acceptable sample types) and the space requirements which must be 28.35 X 22.6 X 22 or less. The EZ2 Connects meet the space requirements, sample matrices, and are fully automated eliminating the need for extra FTE’s to extract samples.

The EZ2 connects are also valid for In vitro diagnostic use as well as research use. Similar instruments such as the Maxwell RSC48 are only validated for research use, making them incompatible for clinical samples. Using a research use instrument for diagnostic samples can cause the laboratory to lose their accreditation licenses with providers such as CMS.

Overall, the QIAGEN EZ2 Connect automated extraction systems are the only available automated extraction system that meets the needs of the state of Colorado.

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

QIAGEN provides equipment, goods, and services that align with the existing capacity of the genomic surveillance unit. There are established protocols as well as implemented automation that utilizes the equipment, reagents, and consumables of the QIAGEN platform. Additionally, our academic, federal and local public health partnerships including our public 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, including the extraction of samples. 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. As a last point, 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

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?

QIAGEN is the only vendor that manufactures, sells, and maintains the EZ2 Connect automated extraction systems. These instruments are trademark and hence, QIAGEN has the exclusive experience to operate, maintain, and continue servicing these instruments.

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

Through communications with the vendor, 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 within the Genomic surveillance Program workflows and is therefore the only viable option for maintaining our current processes as expected.

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.

If No to #3 above:

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

The existing QIAGEN equipment maintained in the genomic surveillance program do not have a comparable alternative that is reasonably interchangeable with current internal SOPs, verifications and testing requirements, nor are there alternative options established within the existing range of verified assay application required by our external partnerships, grant deliverables, and goals as a public health laboratory. Overall, the costs are reasonable considering there is not a directly comparable alternative on the market at this time.

Division: DCPHR- CSPHL Program: Genomic Surveillance Program Program Contact Name: Aleigha Wellbrock Phone: 3032499288 Program Manager: Shannon Matzinger

**An aggrieved party may file a protest concerning a material issue(s), at any phase of solicitation.

Reference §24-109-102, C.R.S., as amended, and Procurement Rule R-24-109-102-01, et seq.

-------------------------- 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 SUMMARY

Sole Source Procurements are allowed by the Procurement Code when:

• There is only one Good or Service that will meet the need of the State AND There is only one Vendor that can supply that Good or Service.

If a proprietary item is required, a sole source circumstance may exist where:

• The compatibility of equipment, accessories, or replacement parts in the paramount consideration and the items are only available from one vendor

• A sole supplier’s item is needed for trial use or testing

1. A program wishing to purchase proprietary goods in excess of $10,000 or proprietary services in excess of $25,000 must complete the Sole Source Justification Form and submit to the Procurement Director for approval prior to negotiating a contract or purchase order. (Not required for interagency or governmental agencies). Please note: Insufficient time for solicitation of Bids is not an allowable reason to proceed with the “Sole Source” procurement.

2. If the Procurement Director approves the Sole Source Justification Form, the request on the PCU site will be approved and the final documents attached. Once the program has received the approval they can move forward with the next step of contract or purchase order development.

3. The Procurement Director may require the project to be posted as an Intent to Sole Source, or may not agree the Vendor is the sole source, and require competition be solicited. The Procurement Director will indicate the next steps to be taken for the appropriate solicitation method at this time.

INTENT TO SOLE SOURCE

Competition must be solicited if doubt exists whether a Sole Source Procurement is appropriate. In this event, PCU will post a “Notice of Intent to Sole Source (NPSS1) on Vendor Self Service (VSS) to assist in the determination. The request will be posted as “Notice of Intent to Sole Source” to the VSS system for a minimum of 3 business days. The Procurement Director reserves the right to post the notice for a longer period if determined necessary.

After a posting on VSS, if no respondents expressed valid interest in the work, Purchasing will notify the program to proceed with a sole source. The Program will include the completed and approved Sole Source Justification Form and the approved request number in their contract or purchase order packet.

If there are respondents to the “Notice of Intent to Sole Source” that expressed valid interest in the work, Purchasing will notify the program of this interest and discuss a possible need to proceed with the competitive solicitation process.

COST AND PRICE ANALYSIS--AN EXPLANATION

(Parts excerpted from the Florida State University Office of Research Contracts and Grants guidance) Both sole source and emergency procurements require a written determination by the head of a purchasing agency, or a designee, of the basis for the approval. This form is designed for approval of a “sole source,” not an emergency procurement. Consult with your procurement official regarding requirements for emergency procurements.

Normally, price analysis is not done in competitive solicitations where “adequate competition” exists, because the competitive process takes care of the “fairness and reasonableness” of prices. However, in a sole source situation where no price competition exists, some analysis must be done to insure that the requirements of the controller’s statute (Part 2, Title 24, Article 30, C.R.S.) are met, i.e., that prices or rates are “fair and reasonable.”

Some form of price or cost analysis should be performed in connection with every procurement action, regardless of whether the organization is a vendor or a subrecipient. The form and degree of analysis, however, are dependent on the particular subcontract or purchase, and the pricing situation. Determination of price reasonableness through price or cost analysis is required even though the procurement is source-directed by the contracting officer of the sponsoring agency.

In some purchases, price analysis alone will be sufficient; in others, price analysis will be used to corroborate the conclusions arrived at through cost analysis. The form and degree of analysis are dependent on facts surrounding a particular subcontracting or purchasing situation. The scope of price analysis performed and the particular techniques used will depend on whether or not cost analysis is done, as well as on such factors as type of product or service, dollar value, purchase method, and extent of competition. (The words “vendor” and “subrecipient” used herein are interchangeable.)

It is important to remember that the information requested herein is based on Federal and State requirements. Please call PCU if you have questions about this information.

PRICE ANALYSIS

Price Analysis is the process of deciding if the asking price for a product or service is fair and reasonable, without examining the specific cost and profit calculations the vendor used in arriving at the price. It is basically a process of comparing the price with known indicators of reasonableness.

When adequate price competition does not exist, some other form of analysis is required.

Some reasons that could affect adequate price competition are: specifications are not definitive, tolerances are restrictive, or production capacity limits those eligible to bid.

In either case, even though neither historical nor market prices involve the identical service, some analysis can often be done which evaluates the differences in the types of services or goods, and concludes that the nature of the differences warrant the differences in pricing. In other cases, judgments must be made that proprietary aspects of the service or commodity warrant expenditure of the prices or rates in excess of what is customary.

Common methods of price/cost analysis include:

a. Comparison of prices and rates to established catalog prices or market prices. In a sole source situation, there commonly are similar prices or rates, e.g., those on price agreements that can serve as a guide to fairness or prices or rates proposed by a sole source provider. In some cases, e.g., some utilities, prices and rates are set by law or regulation (utility tariff rates).

b. Historical prices or rates for similar items or services procured in the past also serve as a guide to fair and reasonable prices.

Examples of other forms of price analysis information include:

• Analysis of previous prices paid

• Comparison of vendor’s price with the in-house estimate

• Comparison of quotations or published price lists from multiple vendors • Comparisons with official published federal government prices In cases where neither historical nor catalog prices exist, cost analysis must be used.

COST ANALYSIS

Cost analysis is the element-by-element examination of the estimated or actual cost of contract performance to determine the probable cost to the vendor. The goal is to form an opinion on whether the proposed costs are in line with what reasonably economical and efficient performance should cost.

Cost or pricing data, which should be provided by the contractor, are the means for conducting cost analysis. Such data provide factual information about the costs that the contractor says may be incurred in performing the contract. Cost analysis should be performed in those situations where price analysis does not yield a fair and reasonable price.

Cost analysis techniques are used to break down a contractor’s cost or pricing data so as to verify and evaluate each component. Some of the cost elements examined for necessity and reasonableness are materials costs, labor costs, equipment and overhead. These costs can be compared with actual costs previously incurred for similar work, the cost or pricing data received from other vendors, and independent cost estimate breakdowns.

Vendors may be asked to provide summary level detail of materials and labor costs, as well as markups and other indirect cost rates included in the price. Technical judgments concerning labor hours can be applied to labor hour rates to evaluate the reasonableness of the overall price. Reasonable profit, of course, is another element of price. Per 24-103-403 C.R.S., for noncompetitive acquisitions where neither historical nor catalog prices exist, vendors are required to submit cost or pricing data for purposes of conducting a cost analysis.

1 Version A 05.2026