Sole Source Justification 2026 Life Technologies.pdf
PDF 286 KB Posted
- Solicitation number
- NPSS1 FHKA 2027000027 1
- Issued by
- Arapahoe County, Denver City, Colorado
About this file
This is a Sole Source Justification Form submitted by the Colorado Department of Public Health and Environment (CDPHE), Laboratory Services Division, specifically the Colorado Newborn Screening Program, for the continuation of maintenance and repair services for Life Technologies instruments. The procurement seeks to modify an existing agreement with Life Technologies Corp (Vendor ID: VC00000000010970) located at 12088 Collection Center Drive, Chicago, IL 60693. Life Technologies will provide maintenance, repair, and preventative services for laboratory instruments that are subject to Clinical Laboratory Improvement Amendments (CLIA) regulations, which mandate regular vendor-authorized maintenance and repairs to maintain CLIA certification for patient testing laboratories. The agreement term extends from August 15, 2022, through August 14, 2027, with the modification increasing the scope due to additional instruments purchased to expand laboratory capacity.
The estimated dollar amount for the life of the project is $1,135,000.00, representing an increase of $135,000.00 from the original contract value to accommodate additional instruments requiring vendor services. Previous procurement history with Life Technologies includes PO 20182979 for $498,068.86, PO 20233426 for $455,026.98, and PO 2024*3404 for $537,389.27. The justification for sole source procurement is based on Life Technologies being the manufacturer and authorized distributor of the instruments, maintaining exclusive certified parts inventory and authorized service technicians necessary to comply with CLIA requirements. No conflict of interest has been disclosed. The program has reviewed regulatory requirements and manufacturer specifications to support this determination, and the Procurement Director's approval is required before proceeding with contract development.
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Sole Source Justification Guidance
1 Version A 05.2026
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: Life Technologies service, maintenance, and repairs Vendor name: Life Technologies Corp Vendor Address: 12088 COLLECTION CENTER DRIVE CHICAGO, IL 60693 Select one: ☐Original XModification CORE Vendor ID: VC00000000010970 PO or Contract Number (if this is a modification): PO 2023*3426
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) Life Technologies will provide maintenance and repair services for instruments. Vendor is the manufacturer and/or distributor of the instruments thus maintains staff and parts to readily provide this service. A number of these instruments are required by the Clinical Laboratory Improvement Amendments (CLIA) to have regular preventative maintenance and vendor authorized repairs. CLIA regulates patient testing and these laboratories are required to maintain a CLIA certification. This vendor meets all these requirements.
List dates, agreement numbers and dollar amounts for any previously procured products or services from this vendor related to this project: PO 2018*2979 - $498,068.86, PO 2023*3426
$455,026.98 & PO 2024*3404 $537,389.27
Term of agreement:
(If multi-year, indicate the full term up to 5 years)
Start Date 8/15/2022 End Date 8/14/2027
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
$1,000,000.00
If a modification, complete the following:
Amount Increased
135,000.00 Revised Total
1,135,000.00
If a modification, state the reason(s): Additional instruments were purchased to expand capacity that also require service by this vendor. The quote for the service contract increased to accommodate these additional instruments.
A. Criteria: Answer both 1 and 2.
1. There is only one Good or Service that will meet the needs of the State. Yes ☐ No ☐
2. There is only one Vendor that can supply that Good or Service. Yes ☐ No ☐
If “NO” to either 1 or 2, answer 3 and 4, below.
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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 ☐ No ☐
Yes ☐ No ☐
4. A sole supplier’s item is needed for trial use or testing. Yes ☐ 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)…
C. What makes this good or service unique to meeting your needs?
D. Is the Good or Service Proprietary (product or technology entirely owned by the individual/company and usually protected by trademark or copyright)?
Yes ☐ No ☐
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?
F. What research has the program conducted to justify this sole source?
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 ☐
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 ☐
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 ☐
3. Did you conduct a cost/price analysis? (If “Yes”, attach documentation) Yes ☐ No ☐
If No to #3 above:
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4. Do you know if the cost is "fair and reasonable"? Yes ☐ No ☐
Demonstrate how you determined fair and reasonable prices/rates: Attach additional pages if required.
Division:
Program:
Program Contact Name:
Phone:
Program Manager:
**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 ☐ N o ☐ 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.
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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
5 Version A 05.2026 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, 6 Version A 05.2026 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.
SOLE SOURCE JUSTIFICATION GUIDANCE
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| Posted on VSS Yes: Off |
| N o: Off |
| If Yes Please Explain This space is limited please provide additional documentation if applicable: |
| F What research has the program conducted to justify this sole source: Program has reviewed regulatory requirements and manufactures requirements. |
| 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: Vendor is certified to perform maintenance and repair on these instruments. Vendor maintains certified parts for these instruments. Vendor is authorized for warranty work on these instruments. |
| C What makes this good or service unique to meeting your needs: |
| 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: This is the only vendor that can meet the State’s needs for this service. The instruments addressed in this sole source are manufactured by the vendor. The vendor maintains authorized parts and service technicians |
| Text5: Gregory Bonn |
| Text1: Laboratory Services Division |
| Text2: Colorado Newborn Screening Program |
| Text3: Kendra (Jones) Croak |
| Text4: 303-692-3675 |
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