1. JOFOC SCC ver. Sept. 2025 Signed and REDACTED.pdf

steps and others in special cases automates a formerly manual process.

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

This integrated information processing system serves the three departments and creates the opportunity to share important medical test data, supporting the fulfillment of the NIH Clinical Center’s primary mission of supporting scientific research involving human patients.

Soft Computer Corporation (SCC) has been the incumbent since the initial install of the software and due to its proprietary nature they have performed the ongoing maintenance and support on the system.

The following is a listing of the awards since the original award in 1996 through the current award, associated award numbers, the period of performance and the amounts of the individual awards.

Multiple awards were made over the years, and all of the awards made to this day 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 [now under FAR 6.103-1], and FAR 13.501 sole source under simplified acquisitions.

More recent Purchase orders were awarded on a sole source basis, and expires 9/26/2025. These were all awarded on a sole basis due to the proprietary nature of the LIS Software.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. “Hardware, Software, and Interface maintenance and support of the Soft Computer Systems and modules that make up the Clinical Center Laboratory Information System (LIS)”

b. Project description:

• 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: 09/27/2025 – 02/28/2026

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) 6.103-1 (c)(2). Also see: FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements and FAR 13.501 sole source under simplified acquisitions.

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 Lab system/LIS software system created by SCC’s proprietary software and systems is critical asset for the CC and is integrated into the NIH’s clinical processes as well as compatibility with CRIS and other clinical systems. This 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. The current NIH systems run on SCC propriety software and code that is not offered to outside vendors or resellers. Other potential vendors would 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 run on SCC’s proprietary software as they did not have authorization to use SCC’s proprietary software and systems. The Lab system created by SCC’s proprietary software and systems is critical asset for the CC and is integrated into the NIH’s clinical processes as well as compatibility with CRIS and other clinical systems. The Clinical Center also has an investment in clinical and technical staff that have been trained and certified to support the system.

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.

Switching to a different system from a different vendor would be a substantial duplication of cost and effort where time, money & resources, etc are required. The Clinical Center also has an investment in clinical and technical staff that have been trained and certified to support the system. The NIH would have to abandon the current system being used and retrain the staff, which would take additional time and resources. For example, 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.

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.

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. A sole source notification was posted on SAM.gov under

NOI-CC-25-008398.

7.

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

This will be a firm fixed price requirement. No cost analysis will be needed.

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.

Program evaluated Sources Sought SS-CC-25-008398 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.

SCC also sent us a letter stating that their software is proprietary and they are the sole organization authorized to provide support and maintenance.

Thus, these other vendors cannot perform work on the system that is currently run on SCC’s proprietary software as they did not have authorization to use SCC’s proprietary software and systems.

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. This was reiterated by SCC in a sole source letter.

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

No other sources responded (besides the ones already mentioned above).

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.