Sole Source Justification_TubeWriter 5.19.23ver3 8.15.23_BAM.pdfsigned.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

PPLB/DVD/NCIRD

Roybal Campus Building 17/6011 H17-6 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Polio and Picornavirus Laboratory Branch

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: TubeWriter 400 - Direct High-Speed Alphanumeric Printing System for Labware sold by TubeWriter, LLC.

b. Procurement Request (PR) Number (if available): Click here to enter text.

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: TubeWriter, LLC. 6500 River Place Blvd, Bldg 2, Suite 100, Austin, TX 78730

b. Estimated Procurement Amount: $To be advertised

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency ☐ Exclusive licensing agreements/Proprietary data ☐ Brand name required ☐ Industrial mobilization ☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency ☐ Only One Source ☐ Logical Follow Up ☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The TubeWriter Alphanumeric Printing System for Labware will be used in the labeling of thousands of unique laboratory specimens and specimen aliquots and derivatives generated by the Vaccine Development Laboratory. Currently the laboratory labels vials by hand, which creates bottlenecks in work processes and is very labor intensive. The features below make TubeWriter printing system unique compared to other laboratory printing devices: Specialized Printing Technology: The TubeWriter utilizes a proprietary printing technology specifically designed for labware.

It ensures accurate and high-resolution alphanumeric printing on various types of laboratory tubes, vials, and other lab containers. This technology enables clear and durable labeling that remains intact even in harsh laboratory conditions. Versatile Compatibility: The TubeWriter is compatible with a wide range of labware materials, including plastic, glass, and metal. It can print on tubes of different sizes and shapes, accommodating various laboratory applications. This versatility allows the use the system with existing labware inventory without the need for costly replacements.

Rev. 5/14/19

Easy and Intuitive Operation: The system is user-friendly and easy to operate, featuring a simple and intuitive interface that require minimal training to use effectively. Lab personnel can quickly and efficiently print alphanumeric characters, symbols, and barcodes onto labware, reducing labeling errors and saving valuable time. Permanent and Resistant Markings: The TubeWriter uses specialized ink that creates permanent and resistant markings. These markings withstand common lab procedures such as freezing, thawing, autoclaving, and exposure to chemicals or solvents. By ensuring long-lasting labels, the system helps maintain sample integrity and traceability throughout the entire lab workflow. Integration with Laboratory Information Systems: The TubeWriter can be integrated with Laboratory Information Systems (LIS) and Microsoft Excel, enabling automated data transfer and sample tracking, streamlining laboratory processes and reducing manual data entry errors.

By integrating with existing laboratory software, the TubeWriter enhances overall efficiency and productivity and integrates with existing Quality Management Systems.

b. What other products/services were considered and why did they not meet the need?

Other laboratory printing systems did not meet all the requirements listed in part 2a, like the Scinomix Sci-Print VX2. Specifically, other printing systems did not have integration with current inventory system or flexible data entry interphase, permanent ink that cannot be removed by laboratory solvents, and flexibility to label a wide array of laboratory specimen vials..

3. Program Office efforts to seek potential offerors:

Researched and contacted vendors that carry other printing systems including the Scinomix Sci-Print VX2. Unfortunately, the other laboratory printing systems did not have all the features highlighted in part 2a that make the TubeWriter the best option.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: Bernardo Mainou

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a date.

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.