Justification for Non-Competitive Procurement (JNCP)_Redacted.pdf

1 Template March 2019

JUSTIFICATION FOR NON-COMPETITIVE PROCUREMENT (JNCP)

FOR ACTIONS < SIMPLIFIED ACQUISITION THRESHOLD (SAT)

PR: Click here to enter PR Number Department: Blood Bank Department, NH Guam

1) Agency, Contracting Activity and Purpose: DHACA Healthcare Contracting Division-West, Justification for Other than Full and Open Competition.

2) Description of the Supply or Service being procured, its intended use and anticipated/estimated value

INTERCEPT Platelet Small Volume Processing Set (minimum quantity = 24 Sets)

INTERCEPT Platelet Processing Set with Dual Storage Containers (minimum quantity = 24 Sets)

Annual Maintenance for Illuminator Serial #s V02081701 and V02081702

Preventive maintenance services will be performed twice per fiscal year (October 1 through September 30) at 6-month intervals. Repair services, when needed, will be performed Monday – Friday, between 8:00 am and 4:00 pm Chamorro Standard Time. This service is available only from the incumbent due to the specialized nature, making it highly likely that awarding to another source would result in inefficiencies.

The pathogen reduction system should eliminate the need for bacterial testing of platelet units and allow immediate accessibility of platelet units when used in accordance with the Instructions for Use. The system should enable NBDCs to produce two therapeutic platelet doses from a single INTERCEPT Dual Storage Processing Set and pool two whole-blood derived plasma units to produce three 200 mL dose INTERCEPT Blood System processed plasma units. The system must be FDA approved for use with apheresis platelets, reducing the risk of microbial contamination in blood components, transfusion-transmitted infections (TTIs), and sepsis risk, and reducing T-cells to a level that potentially lowers the risk of TA-GVHD.

Additionally, the system must be FDA approved for use with whole blood-derived or apheresis plasma.

As part of the installation and deployment process, the Contractor will provide a seasoned team to assist NBDCs in transitioning to pathogen reduction, including in-depth training on the INTERCEPT system. The Contractor shall provide all services, materials, and equipment necessary for the repair and preventive maintenance of the Cerus Illuminators as requested by the NBDC to ensure dependable and reliable equipment operation. The scope of work includes furnishing all labor and parts for all repairs on the listed equipment for twelve months, ensuring continued operation at designed efficiency and capacity for the specified period.

3) Possible Authority for Non-Competitive Procurement

a. Sole/Limited Source Procurement ((Sole Source: Only one source exists with no known distributors of the required product or service. Only One Responsible/Capable Source IAW either FAR 8.405-6(a), FAR 13.106-1(b) or FAR 16.505(b)(2)).

b. Brand Name Requirement ((Brand Name: Only one manufacturer with multiple distributors (this justification covers only the portion of the acquisition which is brand name). Item Peculiar to One Manufacturer with multiple distributors/resellers/vendors IAW FAR 8.405-6(b), FAR 13.106-1(b) or FAR 16.505(a)(4)).

4) Reason for Non-Competitive Procurement

An urgent and compelling need exists, and following the procedures would result in unacceptable delay

Unique or highly specialized requirement/Only one source reasonable available Exclusive Licensing Agreements Logical Follow-on to previously competed work

2 Template March 2019

The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed (identify systems and why other products are not compatible)

Patent, copyright, or proprietary data limits competition (identify specifics and corresponding level of Government rights – if any)

Direct replacement parts/components for existing equipment and similar parts/components will not meet Government requirements

End to End Engineering (For example, Command X supports engineering and/or development efforts for Program of Records and supplies are required from OEM.)

Testing (For example, Command X supports laboratory testing that must replicate shipboard/command environment without deviation.)

Software (Either license and maintenance renewals with compatibility and proprietary coding and data warranty requirements.)

5) Provide rationale and justification regarding the above selection. Cerus Corporation is a leading biotechnology company specializing in pathogen reduction technology for blood products. Their INTERCEPT Blood System is FDA approved for use with apheresis platelets and whole blood-derived plasma, significantly reducing the risk of transfusion-transmitted infections (TTIs) and sepsis. The system allows for the production of therapeutic platelet doses and plasma units, enhancing blood safety. Cerus Corporation holds exclusive licensing agreements and has a proven track record of providing highly specialized services that are critical for maintaining blood safety standards. Their unique qualifications make them the ideal choice for fulfilling the contract requirements.

To ensure that offers are solicited from as many potential sources as practicable, a notice of intent to sole source will be posted via SAM.gov. This notice will clearly outline the requirement and the unique qualifications of Cerus Corporation, allowing other potential suppliers to express their interest and capability to meet the requirement. Additionally, outreach efforts will include contacting known suppliers in the industry and leveraging industry networks to identify any potential sources that may be capable of fulfilling the contract requirements.

These efforts will demonstrate due diligence in seeking competition while acknowledging the specialized nature of the supplies and services required.

6) Describe the Market Research conducted. Research of mandatory sources including AbiityOne, UNICOR, GSA Advantage did not yield any results. A dynamic search for additional small business firms also resulted in negatibve results. The market research conducted for this procurement involved several methods to ensure a comprehensive understanding of potential sources. Initially, a secondary reserach was performed, reviewing government publications, industry reports, and commercial data to identify potential supplies with the capability to meet the requirements. Despite these efforts, it was determined that the highly specialized nature of the services required limited the number of potential sources capable of fulfilling the contract requirements. As a result, a notice of intent to sole source will be posted via SAM.gov to ensure transparency and provide an opportunity for any interested parties to express their capability to meet the requirements.

These combined efforts demonstrate due diligence in seeking competition while acknowledging the unique qualifications of Cerus Corporation for this procurement.

7) Any other information of facts supporting the justification to limit competition not described elsewhere on this form (i.e. international agreement). Due to unique qualifications of Cerus Corporation, Cerus Corporation possesses exclusive licensing agreements and proprietary technology that no other vendors can replicate, making them uniquely qualified to provide the INTERCEPT blood system and associated specialized training and maintenance.