OS260858 US Realm- JOFOC_Approved.pdf

management and methodology structures necessary for the US Realm focused standards development."4 Consequently, the USR-SC is a critical governance body with a significant influence on HL7 standards development and implementation activities within the US Realm. No standards impacting the US Realm can proceed through the HL7 balloting process without approval from the committee.

HL7 provides the intellectual property, governance, oversight, and ability to manage the HL7 standards development process that no other organization can provide. HL7 facilitates a large and highly engaged standards development community, which is both necessary for an open and trusted standards development process and would require significant time and resources to replicate. HL7 standards are used by a vast number of health IT systems and products for a wide variety of clinical and operational use cases; attempting to rely on other standards would require wholesale redevelopment by much of the health IT industry and regulatory changes on the part of federal agencies like

ONC.

HL 7 is uniquely situated in the health care industry and is a critical partner in ONC's mission to support the adoption of health IT and promote nationwide interoperability. ONC believes that a well-organized US Realm is vital to enabling high-quality, low-cost, and effective health care delivery in the United States, and that HL7 is the only organization that can successfully perform this work.

7. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Pre-solicitation notice was published to FedBizOpps as required by FAR Subpart 5.2 on 8/17/2020 closing on 9/1/2020. To date, only one response was received asking if this was a new or follow-on requirement.

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

This acquisition is being conducted as a commerical item under FAR Pat 12 in accordance with Acquisition Alert 2020-06 COVID Guidance c.Treating certain items as commercial. Therefore, certified cost and pricing data is not required in accordance with FAR 15.403-1(c)(3). Other than certified cost and pricing data will be requested in accordance with FAR 15.403-3(c) Commercial items. Additionally this acquisition is subject to the Service Contract Labor Standard Act, as such, the applicable wage determination (WD) will be provided in the solicitation and subsequent contract. Price reasonableness will be evaluated and found fair and reasonable by comparison with the WD and will utilize methods allowed in FAR Part 15.403-3(c) as necessary.

4 hm>s://confluence.hl7 .org/display/USR/US+ Realm+Steering+Committee

Updated December 2015 6

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

ONC has familiarity with health IT standards development and implementation activities, including the role played by HL7, from many years of engagement with the standards development community. For example, ONC has funded cooperative agreements with HL7, sponsored the development, balloting, and publication of HL7 standards, and participated at HL7 Workgroup Meetings and "connectathons."

ONC reviewed the NSI accreditation process and identified other health care

SDOs, such as Integrating the Healthcare Enterprise {IHE). Although there are other health care SDOs, the standards under the governance of each SDO are unique to that SDO. Therefore, modifying or publishing a given standard is only possible through the SDO that is responsible for that standard. Any modifications or changes to a standard conducted outside of the SDO that "owns" the standard would not be interoperable with the official standard approved by the SDO.

ONC staff regularly engage with stakeholders in the standards development community to better understand the needs of the health IT community and set priorities for future health IT standards development and implementation activities.

For example, ONC staff regularly attend meetings of the USR-SC and other HL7 workgroups.

To help identify priorities for organizing and managing the US Realm, ONC staff met with representatives of the USR-SC to understand issues and obstacles that impede the efficient approval and oversight of standards development in the US Realm. A co-chair of the committee, for example, noted that HL7 lacks a centralized tracking system for tracking the status of standards development projects. Likewise, tracking the standards development activities associated with a single HL7 workgroup requires many hours of effort, and there are more than 40 workgroups to monitor. As a result, the USR-SC, whose members participate on a volunteer basis, simply lacks the capacity to provide more than cursory tracking of standards development in the US Realm.

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

N/A

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

N/A

12 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 reasons cited in this document and the unique position of SDOs, ONC does not plan to undertake any further actions to overcome barriers to competition. However, ONC continues to support health IT standards development and implementation activities conducted by other SDOs. ONC relies on market surveillance, stakeholder engagement, and participation in the standards development process itself to understand and assess the maturity health IT standards and the readiness of the health care industry to implement and use them. ONC believes that HL7 will continue to operate as a highly influential SDO and that the health care industry will continue to frequently adopt and use HL7 standards for the foreseeable future.

Updated December 2015 7

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Requiring Activity Tracy H. Okubo Tracy H. Digitally signed by Tracy H. Okubo -S 06/17/2020

POC

DN: c=US, o=U.S. Government, ou=HHS, ou=OS, ou=People, cn=Tracy H. Okubo-

Senior Program Analyst Okubo-S s,

0.9.2342. 19200300, 100, 1. 1=2001035641

Date: 2020.06.17 10:57:06 -04'00'

POC Immediate Sherilyn Z. Pruitt Sherilyn Z. Digitally signed by 06/17/2020

Supervisor Sherilyn Z. Pruitt -5

Branch Chief Pruitt-S Date: 2020.06.17 15:13:07

-04'00'

Head of the Christopher Muir Christophe Digitally signed by 06/17/2020 Sponsoring Christopher 0. Muir -S

Program Office Division Director r 0. Muir -S Date: 2020.06.18

08:56:01 -04'00'

14. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature

Contracting Digitally signed by Debbie L.

Officer Debbie L. Hope -5 Hope-5

Date: 2020.08.17 09:39:43 -06'00' Debbie L. Hope

15. Competition Advocate and Head of the Procuring Activity approval. (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)

Official Name & Title

Susan Cortes-Shrank, Competition Advocate

Competition Advocate

16. HHS Senior Procurement Executive approval.

Updated December 2015 8

Signature

Date

08/17/2020

Date

13. Program office certification.