1. JOFOC SCC ver. Sept. 2025 (SIGNED & REDACTED).pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. HHS, National Institutes of Health

b. Sponsoring organization. NIH Clinical Center Department of Clinical Research Informatics

c. Project Officer information.

2. Nature and/or description of the action being approved.

a) Acquisition purpose and objectives. The purpose of this acquisition is to continue to obtain Soft software and hardware license and maintenance services for the IBM hardware and AIX operating system for servers that support the existing Laboratory Information System (LIS). Specifically, the contractor will be required to provide onsite support on the LIS and provide genuine IBM hardware replacement parts as required within 4 hours from notification of failure. The contractor will be required to provide Soft Computer application level support to all the modules that the Clinical Center currently has installed. In addition, the contractor will provide device specific interface support for the laboratory equipment, which communicates with the LIS system. These services and products are to be available to the agency 24 hours a day, 7 days per week, 365 days per year.

b) Project background. Contract No. 263-96-C-0119 was awarded by the Clinical Center in August 1996. The purpose of this contract was to install a new Laboratory Information System (LIS) that supports the information processing requirements of three Clinical Center departments, namely Clinical Pathology (CPD), Anatomic Pathology (AP) and Transfusion Medicine.

This system has outstanding reliability and flexibility and the capacity to accommodate non-standard testing methods and reporting as well as individualized specifications for different NIH Institutes, Centers or Departments ( ), different protocols and changing health and research objectives of NIH researchers. Additionally, this system has the capability to replace human tasks (i.e. entering test request data into test instruments, receiving results electronically, evaluating results electronically, and delivering results to the Medical Information System (MIS)). Each of these steps and others in special cases automates a formerly manual process.

Each instrument that is interfaced to the LIS creates an immediate efficiency.

All of the above awards were made on a sole source basis due to the proprietary nature of the LIS Software and the fact that SCC does not allow third party maintenance for the software. The awards were made under the authority of FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements.

Current bridge order dated expires on 08/31/2025. This was awarded on a sole basis due to the proprietary nature of the LIS Software.

3.

needs (including the estimated value).

a. Project title support of the Soft Computer Systems and modules that make up

b. Project description. Please see the Statement of Work attached hereto (Attachment No. 1) :

Requirement type. :

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action. :

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

POTS 25-008398

c. Total estimated dollar value and performance/delivery period.

Period of Performance:

Base period: 09/01/2025 03/31/2026 Option period: 04/01/2026 03/31/2027

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 1 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Soft Computer Corporation (SCC) 5400 Tech Data drive Clearwater, FL 33760

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The current LIS software system is proprietary to SCC who developed it.

SCC does not permit 3rd party maintenance and will not release their source code to other entities.

As the LIS modules in the Clinical Center are currently handling large volumes of patient data and test and diagnostic results, it is absolutely imperative that there be no interruption in the ongoing operation/functioning of the existing system. Patient safety is of great concern if there is a system failure or interruption in service. Therefore it is critical that the system continues to be maintained by SCC who is the only source capable of providing the necessary maintenance, including making revisions to the source code as circumstances may dictate.

Because the LIS helps support patient diagnosis and care activities, it is deemed a mission critical system for the Clinical Center. The proprietary status of the system to SCC clearly demonstrates that they are the only firm qualified to perform the required maintenance services.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Sources Sought was publicized on August 2, 2011 through August 12, 2011.

Pre-solicitation\Notice of Intent will be posted upon approval of JOFOC by DAPE.

Previous Notice of Intent postings did not result in the finding of any alternative vendors. After the initial award to Soft Computer Consultants, this requirement has been reawarded to them as a sole source requirement ever since the initial award due to the proprietary nature of the software.

For this current requirement, a Sources Sought was posted on SAM.gov under SS-CC-25-008398 on September 1, 2025. Several vendors responded with capability statements, but Program evaluated them and determined them to be not technically capable/insufficient. The current NIH systems run on SCC propriety software and code that is not offered to outside vendors or resellers.

These other potential vendors do not have a Letter of Authorization from SCC to ensure the company can provide the level of services and support for the system.

Thus, these other vendors cannot perform work on the system that is currently proprietary software and systems is critical asset for the CC and is integrated into systems. The Clinical Center also has an investment in clinical and technical staff that have been trained and certified to support the system. The NIH is reliant on the vendor to provide upgrades as well as security patches to ensure the system maintains compliance with NIH security standards. Replacing the system with another system would take considerable planning and funding.

A sole source notification will be posted on SAM.gov after the approval of this acquisition.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

An award will be made only if, during negotiations, it is shown through cost and/or price analysis that the anticipated costs to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Due to the proprietary nature of the software and since the NIH systems run on this software, it was determined that this must be a sole source requirement. Soft Computer Corporation is the only provider of this software.

For this current requirement, a Sources Sought was posted on SAM.gov under SS-CC-25-008398 on September 1, 2025. Several vendors responded with capability statements, but Program evaluated them and determined them to be not technically capable/insufficient. The current NIH systems run on SCC propriety software and code that is not offered to outside vendors or resellers.

These other potential vendors do not have a Letter of Authorization from SCC to ensure the company can provide the level of services and support for the system.

Thus, these other vendors cannot perform work on the system that is currently proprietary software and systems is critical asset for the CC and is integrated into systems. The Clinical Center also has an investment in clinical and technical staff that have been trained and certified to support the system. The NIH is reliant on the vendor to provide upgrades as well as security patches to ensure the system maintains compliance with NIH security standards. Replacing the system with another system would take considerable planning and funding.

9. Any other facts supporting the use of other than full and open competition-

The LIS software provided by SCC is proprietary and cannot be supported or maintained through a 3rd party provider. However, if it was feasible to solicit and recruit an alternate provider the following are the potential risks and cost that would be associated with this action.

First and foremost there would a learning curve for any new service provider that would entail the need to have the current provider and the new provider under contract for a period of four to six months. This would be required due to the critical nature of the software as it relates to patient care and research documentation. There cannot be a lapse in service or downtime for this information system.

The cost if the system was to go down for any period of time is immeasurable due to the lost of research data and the potential risks that the patients may be exposed to due to such down time of the LIS.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition

Please refer to item number 8 on page 5 of this JOFOC.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

Because of the proprietary nature of the Laboratory Information Systems Software, it is highly unlikely that a viable alternative source exists. However, the staff of the Department of Clinical Research Informatics will keep abreast of and monitor new developments in this area of software systems. Should a viable alternative to the provision of technical software support/maintenance services for the Laboratory Information System by SCC becomes available during the contract period of performance, its use would be considered and any subsequent procurement would then be competed.