A13.SSJ Tecan Maint Signed.pdf

Version 11.24

SINGLE SOURCE JUSTIFICATION IN ACCORDANCE WITH FAR 13.106-1(b) (Over Micro-Purchase Threshold but not exceeding SAT)

1. a. Contracting activity: Centers for Disease Control and Prevention, Office of Acquisition Services.

b. Center/Institute/Office:

2. Description of required supplies or services:

Total estimated value:

3. Rationale for soliciting from single source or brand name:

a. FAR 13.106-1(b), only one responsible source is reasonably available based on the following:

Restrictive Rights – The source has established proprietary rights, limited rights in data, patent rights, etc. for the required item or service.

Exclusive Licensing Agreement – The required item or service is only available from the original equipment manufacturer (OEM) or there is only one authorized distributor/source for the OEM.

Urgency – An urgent and compelling need exists and soliciting from more than one source would result in an unacceptable delay would result in serious injury to the Government.

Brand Name – Required item must be a brand name product particular to one manufacturer.

Other Reasons

b. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

4. Description of market research conducted and results or statement why market research was not conducted:

5. Requirements certification: I certify that the requirement outlined in this justification is a bona fide need of the Centers for Disease Control and Prevention and that the supporting information under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

6. Contracting Officer’s certification: Procurement will proceed in accordance with FAR 13.106-1(b). I certify that the forgoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer

Title:

All services must be performed by factory-trained and certified technicians using OEM-approved procedures, proprietary software, and specialized diagnostic tools. The equipment is integrated into existing laboratory workflows that rely on proprietary Tecan software and validated system configurations, requiring maintenance and calibration to be conducted in strict accordance with manufacturer specifications.

These services are necessary to ensure that the equipment remains fully operational, maintains calibration standards, and continues to support scientifically validated laboratory processes and regulatory compliance requirements.

These services require the use of proprietary software, specialized diagnostic tools, and OEM-certified replacement parts that are exclusively available to Tecan U.S., Inc. The equipment is integrated into existing laboratory workflows that depend on OEM-controlled software and validated system configurations, which cannot be accessed, modified, or supported by non-OEM vendors without compromising system functionality.

Additionally, maintenance and calibration must be performed by factory-trained and certified technicians to ensure compliance with regulatory and quality assurance requirements (e.g., CLIA, FDA, and internal laboratory validation protocols). Use of non-OEM service providers would risk invalidating calibration, disrupting validated research processes, and potentially voiding applicable warranties.

Furthermore, prior third-party support through Remi has been discontinued due to the inability to economically subcontract required OEM services. This confirms that no viable alternative service providers exist that can meet the Government's requirement while maintaining system integrity and compliance.

Accordingly, no other source possesses the unique combination of proprietary access, technical capability, and authorization necessary to perform these services. Use of any non-OEM provider would result in unacceptable performance risk and potential disruption to mission-critical laboratory operations.

Text25: Market research was conducted in accordance with FAR Part 10 to identify potential sources capable of providing preventive maintenance, calibration, and repair services for Tecan plate washers currently in use within CDC laboratories.

The Government reviewed available sources, including the Original Equipment Manufacturer (OEM), Tecan U.S., Inc., and third-party service providers, including the incumbent vendor, Remi, as well as other independent laboratory equipment service vendors. Market research efforts included a review of vendor capabilities, prior procurement history, and publicly available service offerings.

Findings from the market research determined that while third-party vendors may offer general laboratory equipment maintenance services, they lack access to proprietary Tecan software, OEM-certified parts, and specialized diagnostic tools required to perform maintenance and calibration in accordance with manufacturer specifications. Additionally, these vendors are not authorized to perform services that ensure continued compliance with laboratory validation standards and regulatory requirements.

Further, the Government confirmed that the previous third-party provider, Remi, discontinued support due to the inability to economically subcontract required OEM services, reinforcing that no viable non-OEM alternatives are available.

A review of historical procurement actions, including a prior Notice of Intent to Sole Source (Notice ID: 42781) issued by CDC, also supports the determination that Tecan U.S., Inc. is the only responsible source capable of meeting the requirement.

Based on the results of this market research, it was determined that Tecan U.S., Inc. is the only vendor capable of providing the required services without unacceptable risk to system performance, regulatory compliance, and continuity of laboratory operations. No other sources were identified that can meet the Government's requirement.

Text28: Contracting Specialist