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This is a Justification for Sole Source Procurement document for the CDC's acquisition of software maintenance, technical support, and version upgrades for Rhapsody software from InterOperability Bidco, with an estimated procurement amount of $118,226.37. The procurement is being conducted under FAR 13.106-1(b)(1) for purchases under the simplified acquisition threshold.

The justification explains that InterOperability Bidco is the only viable source as they are the original developer with exclusive proprietary rights to modify and maintain the Rhapsody software, which is critical for CDC's ELIMS Interoperability Project and secure public health data exchange. The document details why alternatives like Mirth Connect, Cloverleaf, and InterSystems were deemed unsuitable, citing issues such as lack of built-in healthcare message support, high complexity, and extensive coding requirements. While the CDC plans to eventually transition to ReportStream (a cloud-based platform), maintaining Rhapsody support is necessary during the multi-year migration period to ensure operational continuity. The procurement is being handled by CDC's Office of Financial Resources, Acquisition Branch 2, Section 2, for the CDC Office of Laboratory Science and Research (CDC/OD/OLSR).

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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:

CDC/OD/OLSR

Centers for Disease Control and Prevention 1600 Clifton Rd Atlanta, GA 30333

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2, Section 2

C. Identification of Requirement:

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

a. Sole source acquisition for ongoing software maintenance, technical support, and version upgrades for Rhapsody software. This action is necessary because only InterOperability Bidco, the original developer and exclusive provider of Rhapsody support services, has the proprietary knowledge and legal rights required to perform these services. No other vendor can legally or technically modify, maintain, or upgrade this software to support the CDC Infectious Diseases Enterprise Laboratories.

b. Procurement Request (PR) Number (if available): TBD

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

a. Proposed Vendor: InterOperability Bidco

b. Estimated Procurement Amount: $118,226.37

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

Rev. 5/14/19

If yes, provide schedule number: N/A

D. Justification:

1. The justification for this non-competitive action is:

☒ 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 InterOperability Bidco Rhapsody product is the preferred solution for the CDC’s ELIMS Interoperability Project due to its unmatched capabilities, proven compatibility, and ability to meet the unique requirements of secure, real-time public health data exchange. Rhapsody has an established track record in healthcare data exchange, supporting industry-standard protocols such as HL7 v2 and HL7 FHIR, and other critical formats for interoperability. Competing solutions lack this comprehensive protocol support, requiring costly and time-intensive custom development.

Furthermore, Rhapsody integrates seamlessly with existing CDC systems, including the STARLIMS Laboratory Information System, and has been successfully deployed across multiple CDC divisions, such as the Division of Healthcare Quality Promotion (DHQP). This deep integration minimizes the need for disruptive system overhauls and ensures operational continuity. The CDC has heavily invested in Rhapsody-based workflows, which are customized to meet the needs of state partners and public health agencies. Transitioning to an alternative integration engine would disrupt these workflows, necessitating extensive retraining, rebuilding historical integrations, and adapting to a new architecture. Such changes would not only introduce significant risks to data integrity and accuracy but also compromise mission-critical operations. Rhapsody also ensures secure data exchange through encrypted transmission channels, meeting stringent healthcare security and privacy regulations, including HHS and CDC standards. Competing products would require extensive testing to achieve similar compliance, adding unnecessary risk and delay.

From a cost perspective, transitioning to a new integration engine is prohibitively expensive. The costs associated with license procurement, customization, data and code migration, and ongoing maintenance would far exceed the value of continuing with Rhapsody. Additionally, such a shift would increase the risk of project delays, data quality issues, and operational inefficiencies, all of which would hinder the CDC’s ability to respond effectively to public health emergencies. While the CDC plans to transition to ReportStream, a modern cloud-based platform, this migration will take several years to complete. Maintaining Rhapsody during this period ensures operational continuity and avoids the additional complexity and disruption that adopting an alternative product would cause. The Rhapsody product meets the CDC’s immediate and long-term needs. Its proven reliability, compatibility, compliance, and cost-effectiveness ensure that critical public health operations continue without disruption. Without Rhapsody, the CDC would face significant challenges in maintaining effective data exchange and meeting HHS Public Health Messaging goals. Due to Rhapsody's proprietary system code, the highly customized messaging workflows currently in use cannot be transferred to another product.

Transitioning to a new integration engine would necessitate developing entirely new workflows from the ground up, requiring extensive time, resources, and expertise.

This redevelopment process risks disrupting established data exchange operations, delaying public health reporting, and impairing the CDC’s ability to respond swiftly and effectively to public health emergencies.

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

1. Mirth Connect:

Mirth Connect was considered as a potential alternative due to its open-source nature and popularity in healthcare data integration. However, it does not meet CDC’s requirements for several reasons. Primarily, Mirth lacks built-in support for standard healthcare message definitions such as HL7 v2/v3, HL7 FHIR, and other critical healthcare data standards. The absence of these built-in message definitions would require custom development and configuration, significantly increasing the time and resources needed to achieve compliance and interoperability. Additionally, Mirth does not offer the same level of technical support, security, and proprietary tools as commercial products, making it an unsuitable choice for CDC’s mission-critical operations that require robust performance, compliance, and 24/7 support.

2. Cloverleaf:

Cloverleaf has several disadvantage including its high complexity, which requires extensive coding skills, including TCL, Java, and Perl, making it challenging for contractor support staff or organizations with limited programming resources. This also increases development time and effort, especially for custom integrations and message transformations.

3. InterSystems

InterSystems is powerful but complex, requiring advanced skills in Cache coding and SQL, which increases implementation time and costs. InterSystems has a steep learning curve, making it less accessible for contract support staff. Customization is more challenging, as even minor configurations need extensive coding. Additionally, specialized training for Cache and IRIS is necessary, complicating support.

4. Transitioning to a CDC’s Enterprise solution, ReportStream

The ELIMS Project is in the process of transitioning our HL7 messaging connections with State Public Health Partners to the CDC’s Enterprise solution, ReportStream—a modern, cloud-based platform for lab data routing and processing. ReportStream enables health departments to efficiently receive, manage, and share data across jurisdictions using an open-source approach to integrate inputs from various sources such as SimpleReport, devices, labs, and hospitals, ensuring timely and accurate data reporting. Given that this migration may take several years to complete, it is necessary to maintain software support for the Rhapsody product to ensure operational continuity until the transition is fully implemented.

3. Program Office efforts to seek potential offerors:

Researched integration engine software through internet searches and consultations with HL7 messaging experts to identify solutions that meet interoperability requirements between the CDC and State Public Health Partners.

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: CDC/OD/OLSR, James Tolson/IT Program Manager

Center/Institute/Office COR/Program Official Signature:

Certification Date:

F. Contracting Office Certification:

Digitally signed by James S. Tolson -S Date: 2025.01.21 10:27:33 -05'00'

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: Eric Lyons

Digitally signed by Eric C. Lyons -S Date: 2025.01.21 12:49:07 -05'00'

Contracting Officer Signature:

Certification Date:

James S. Tolson -S

Eric C. Lyons -S

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