Department of Government Operations Division of Purchasing and General Services 4315 S 2700 W, FL 3, Taylorsville, UT 84129-2128 Phone: 801-957-7160 www.purchasing.utah.gov

Issuing Procurement Unit: Division of Purchasing

Conducting Procurement Unit: Department of Health and Human Services

NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT ENGAGING IN A STANDARD PROCUREMENT PROCESS

The Division of Purchasing is publishing this notice pursuant to the Utah Procurement Code. The Conducting Procurement Unit submitted this form to the Division of Purchasing claiming that it intends to award a contract without competition if it is determined by the Division of Purchasing, in writing, that:

• there is only one source for the procurement item;

• transitional costs are a significant consideration in selecting a procurement item; or

• the award of a contract is under circumstances, described in rules adopted by the applicable rulemaking authority, that make awarding the contract through a standard procurement process impractical and not in the best interest of the procurement unit.

In the subsequent pages the Conducting Procurement Unit has identified its justification for wanting to award a contract without engaging in standard procurement process.

Determination of Other Interested Vendors

If the procurement item identified in this notice is to be awarded as a sole source (only one source for the procurement item), then this notice will help determine if there are any other interested and qualified vendors that meet the specifications of this notice. Any such vendors must submit the following information:

• The name of the contesting person; and

• A detailed explanation of the contest, including documentation showing that there are other competing sources for the procurement item.

In addition, a vendor should include:

• Documentation that your firm can provide a comparable or better procurement item that meets or exceeds the specifications;

• Documentation that your firm can also provide the same proprietary procurement item or an equivalent procurement item; and

• If transitional costs are identified as the justification for this notice, submit a cost comparison of the identified transitional costs with your firm’s anticipated transitional costs.

Regardless of any prior communications with the Division of Purchasing or the State, all vendors interested in responding to this notice must submit a response to this posting containing complete responses to all of the information requested above.

DO NOT CONTACT THE CONDUCTING PROCUREMENT UNIT. Any questions regarding this notice, including obtaining additional information, can be obtained through the Division of Purchasing during the publication period. No action is required if you agree with this notice.

If the purpose of this notice is an intent to award a sole source, after the public notice period has passed, and the Division of Purchasing determines that there are other interested and qualified vendors that meet the specifications of this notice, then the Division of Purchasing will not award a contract pursuant to this notice. An award without competition may still be made even if there are other interested vendors when the basis for the award is due to transitional costs or impracticality as stated above.

If, after the public notice period has passed, no valid contests have been received, then the Division of Purchasing may award a contract to the identified vendor without engaging in a standard procurement process.

Read the entire form very carefully before responding to this notice.

It is anticipated that this procurement will result in a:

RESULT ACTION

Agency Contract

The term of this contract (or extension) will be: 5 and renewal options: .

The agency may not make the procurement until the solicitation process is completed and a contract is written and signed by the agency, the vendor, and the Division of Purchasing.

Purchase Order The agency may not make the procurement until the solicitation process is completed, the purchase order is signed by the Division of Purchasing and delivered to the agency and the vendor.

Description of procurement item to be purchased: Capillary 3 DBS System, Service and Reagents

Estimated value of the contract/purchase order/increase: $219,936.00 annually total agreement $1,099,680

Freight Cost (F.O.B. Destination, Freight Prepaid): $0.00

Vendor Name: Sebia Inc

Explain in detail the service or product to be procured (additional information included in attached Scope of Work):

UPHL is seeking to enter a 5 year agreement to purchase a Capillary 3 DBS System and consumables for screening Hemoglobin disorders using Capillary Electophoresis.

CHECK THE BOX THAT IDENTIFIES WHY A CONTRACT SHOULD BE AWARDED WITHOUT ENGAGING IN A STANDARD

PROCUREMENT PROCESS:

Sole Source - There is only one source for the procurement item. Complete Section A

Transitional Costs - Transitional costs are a significant consideration in selecting a procurement item and the results of a cost-benefit analysis demonstrate that transitional costs are unreasonable or cost-prohibitive, and that the award of a contract without engaging in a standard procurement process is in the best interest of the procurement unit.

Complete Section B

Impracticality - The award of a contract is under circumstances, described in rules adopted by the applicable rulemaking authority, that make awarding the contract through a standard procurement process impractical and not in the best interest of the procurement unit.

Complete Section C

Trial use contract for a new or innovative procurement item, or for a procurement item with a novel or unproven use or application. Complete Section D

Extension of a contract without engaging in a standard procurement process. If extension will result in a request to increase the contract total, then also complete Section F below. Complete Section E

Request to increase total contract amount. Complete Section F

SECTION A: ONLY ONE SOURCE

1. What is unique about this procurement item to justify an award of contract without engaging in a standard procurement process? (Explain in detail why the service, product, etc. is only available from a single supplier.)

1. Proprietary Capillary Electrophoresis Technology Sebia holds proprietary patents and trade secrets surrounding its high-throughput clinical Capillary Electrophoresis (CE) platforms.

True Multi-Capillary Separation: Instruments like the CAPILLARYS 3 series utilize proprietary capillary tube technology, fluidics, and high-voltage power supplies designed exclusively by Sebia.

High-Resolution Separation: Sebia’s CE provides specific protein and hemoglobin fractionations (e.g., precise quantification of 〖"Hb A" 〗_2, "Hb F" , and detection of hemoglobin variants like "Hb S" , "Hb C" , and "Hb Bart's" ) that other standard HPLC (High-Performance Liquid Chromatography) or gel systems cannot duplicate under the same workflow conditions.

2. FDA-Cleared Automated Assays & Reagent Closed Systems

Closed Reagent Loop: Sebia instruments are designed as closed-system analyzers. They rely on proprietary assays, buffer formulations, capillaries, and calibrators specifically engineered and manufactured by Sebia.

Regulatory Compliance: Substituting non-Sebia reagents on a Sebia instrument invalidates FDA clearances (510k), analytical performance guarantees, and manufacturer warranties.

3. Unique Assay Menus & Special Capabilities Immunotyping & Immunofixation Automation: Sebia’s automated Immunotyping on capillary systems is a unique, fully automated alternative to manual Immunofixation Electrophoresis (IFE) for identifying monoclonal proteins (myeloma markers).

Capillary Dried Blood Spot (DBS) Screening: The CAPILLARYS 3 DBS is currently the only high-throughput automated capillary electrophoresis system specially designed for newborn hemoglobinopathy screening from heel-prick dried blood spot cards

2. Could the procurement item be reasonably modified to allow for competition?

No, Consumables and System are exclusive to Sebia INC..

3. Explain the market research performed.

Chief Scientist did extensive research regarding this system and tests.

4. What research have you conducted to ensure the requested procurement item is not available on an existing state cooperative contract?

Searched the State Coopertive Contract Data Base

5. If there is only one source for the procurement item, list the names of other similar vendors contacted, contact person, and a summary of their response.

• No Third-Party Vendors: In many regions (including the United States), Sebia operates as the sole manufacturer, direct seller, and sole authorized service provider for its analyzers, proprietary software, and consumables.

• No Authorized Resellers: Procurement offices cannot source genuine Sebia reagents, replacement parts, or certified field maintenance through generic medical-supply distributors.

SECTION B: TRANSITIONAL COSTS

1. Describe the existing procurement item; include the original purchase price and date of purchase for the existing procurement item.

2. Supply the following:

a. Procurement method used to purchase the existing procurement item: (e.g. IFB, RFP, Sole Source):

b. Solicitation number or RQS/RQM number for the existing procurement item:

c. Contract number for the existing procurement item:

3. Attach the cost-benefit analysis, as required by Utah Code Section 63G-6a-802, that demonstrates that transitional costs are unreasonable or cost-prohibitive.

SECTION C: STANDARD PROCUREMENT PROCESS IMPRACTICAL

1.

Review R33-108-101c and provide supporting justification why awarding the contract through a standard procurement process is impractical and not in the best interest of the procurement unit under the circumstances; including any supporting documentation.

2. Supply the following, if applicable:

a. Procurement method used to purchase existing procurement item (e.g. IFB, RFP, Sole Source):

b. Solicitation number or RQS/RQM number for the existing procurement item:

c. Contract number for existing procurement item:

SECTION D: TRIAL USE CONTRACT

1. Describe how this trial use contract for the new or novel procurement item will benefit your agency.

2. Describe how the procurement item is new or innovative, or how the procurement item has a proposed use/application that is novel or unproven.

3. Describe why a trial use contract exception is necessary for this procurement item at this time as opposed to conducting a standard procurement process to procure the procurement item.

4. What research have you conducted to ensure the requested procurement item is not available on an existing state cooperative contract?

5.

How long does the agency need to test the procurement item and what quantities of the procurement item (if applicable) will be necessary to test this procurement item? Note trial use contracts generally cannot exceed a period of 24 months.

SECTION E: EXTENSION OF CONTRACT WITHOUT ENGAGING IN A STANDARD PROCUREMENT PROCESS The procurement official may extend a contract up to 120 days. For extensions beyond 120 days from the original contract end date, the procurement official may extend the contract after consulting with legal counsel.

Original End Date: Enter date. Current End Date: Enter date.

Proposed End Date: Enter date. Contract Number: Enter text.

1.

Is this request for a contract extension the result of a protest, appeal or court action? If yes, agency does not need to complete items 2-5 below. Provide the solicitation number that resulted in a protest and date of the protest, appeal or court action.

2.

Describe why extending this contract without engaging in a standard procurement process is necessary to avoid a lapse in a critical government service, OR to mitigate a circumstance that is likely to have a negative impact on public health, safety, welfare, or property.

3.

Confirm the procurement unit is currently engaged in a standard procurement process for the procurement item that is subject to the contract extension request and that the standard procurement process is delayed due to an unintentional error.

4.

Justification for Extension: check all that apply:

☐ The standard procurement process is delayed due to an unintentional error.

☐ A change in an industry standard requires one or more significant changes to specifications for the procurement item.

☐ To prevent the loss of federal funds.

☐ To mitigate the effects of a delay of a state or federal appropriation.

☐ To enable the procurement unit to continue to receive a procurement item during a delay in the implementation of a contract awarded pursuant to a procurement that has already been conducted.

☐ To enable the procurement unit to continue to receive a procurement item during a period of time during which negotiations with a vendor under a new contract for the procurement item are being conducted.

5. For the selection(s) above, provide any additional details regarding the circumstances justifying a contract extension.

SECTION F: REQUEST TO INCREASE TOTAL CONTRACT AMOUNT

If the original solicitation type was an ACWESPP (e.g. sole source) and the proposed contract total will exceed $50,000, then public notice is required to increase the contract total. Public notice is not necessary if the procurement official waives the public notice requirement in accordance with R33-108-101e.

Contractor Name: Enter text. Contract Number: Enter text.

Original Contract Total: Enter text. Current Contract Total: Enter text.

Proposed Contract Total: Enter text. % Increase from Original: Enter text.

Solicitation Number: Enter text. Solicitation Type: Enter text.

Product or Service Description: Click to enter text.

Why is the contract total being increased? Check all that apply.

☐ The term of the contract is being extended (also complete Section E above if extending).

☐ The quantity of products or services needed has increased.

☐ The price, rate, or fee for a product or service has increased.

☐ A new or upgraded product or service is needed.

Provide details for the answer that was selected in the previous question. Provide any reasons for the increase.

Click to enter text.