Limited Sources Justification_Lantana_02.01.22_FE.pdf

1. Identification of the agency and contracting activity.

a. Federal Agency and Contracting Activity Department of Health and Human Services, National Institutes of Health (NIH)

b. Sponsoring Organization Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Maternal and Pediatric Infectious Disease Branch (MPIDB)

c. Contracting Officer’s Representative (COR) Information.

(1) COR name: John Moye, Jr., MD.

(2) Mailing address: 6710B Rockledge Drive, Rm. 2130, Bethesda, MD 20892-7510

(3) Email address: john.moye@nih.hhs.gov

(4) Telephone number: 301-594-8624

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

a. Acquisition purpose and objectives.

This Limited Sources Justification (LSJ) is to modify the existing Task Order Number 75N94021F00041 issued under the General Service Administration (GSA) Contract Number 47QTCA21D001V with the purpose to encourage widespread adoption of the implementation guidance (IG) being developed under the existing task order and to pilot the standards using automation and standards tooling for research data acquisition

NICHD anticipates three key outputs from the pilot:

1. Final report/pilot assessment and recommendations for future implementations

2. List of required updates to the Longitudinal Maternal & Infant Health Information for Research IG based on robust testing and feedback collected during the pilot

3. Develop a stable, open-source application (MaternalHealthLink) that stakeholders can customize and use for their own research.

i. Current Contractor: Lantana Consulting Group, LLC

ii. Period of Performance: 03/24/2021 – 03/23/2023

iii. Total dollar amount obligated to date: $806,883.90

iv. The original order was placed on a competitive basis in accordance with the applicable

Federal Supply Schedule ordering procedures

b. Project background.

The purpose of the NICHD project that the current acquisition supports the development of a standardized approach to link electronic data on maternal and infant health for use in research studies.

Currently, the United States lacks consistent ways to collect and share data needed to analyze how a pregnant woman’s longitudinal medical history and basic socioeconomic and demographic characteristics affect outcomes for both the mother and the infant.

LIMITED SOURCES JUSTIFICATION

This project under the current ongoing will produce an HL7® FHIR® (Fast Healthcare Interoperability Resources) Implementation Guidance document encompassing pregnancy, pregnancy outcomes, and pregnancy-related conditions, co-morbidities, and procedures, and link maternal to infant health records (for purpose of this action the term “pregnancy” shall be understood to include the one-year postpartum period).

The HL7® FHIR® I shall provide researchers with the ability to identify the full range of risk factors, pre-existing conditions, and causes of severe maternal morbidity and pregnancy-related mortality, including longitudinal medical history and basic socioeconomic and demographic characteristics, that affect pregnancy outcomes, birth outcomes, and related aspects of maternal and infant health.

This proposed modification addresses the challenges researchers face accessing clinical information to support research studies: the need for linked mother/child records beyond a single healthcare provider, a desire to tap into data aggregation centers, and the need for a solution that will support future research questions. The customization of the MaternalHealthLink—an automated, measure-based tool —will provide a simple user interface and the flexibility to address researchers’ data needs.

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

Project Title: “Severe Maternal Morbidity and Mortality Electronic Health Record (EHR) Data Infrastructure.”

Project Description: Specific tasks under the proposed modification include the following:

Task 1: Development of MaternalHealthLink

The Contractor will develop MaternalHealthLink, an automated, measure-based data aggregation and evaluation tool that acquires and reports on maternal/infant health data. To create the MaternalHealthLink, the Contractor will customize the NHSNLink, an open-source FHIR application for public health reporting developed by Lantana Consulting Group LLC for the Center for Disease Control and Prevention’s National Healthcare Safety Network (NHSN). Through an extensible, configurable query engine, NHSNLink’s multi-component architecture connects securely to EHR systems via a standard, open application programming interface (API). The application extracts data, evaluates the data using pre-defined measures, generates measure and line-level reports, and submits data directly to the NHSN. Lantana shall perform the following customizations of the NHSNLink under this modification.

The include but are not limited to integration with Health Information Exchanges (HIEs) rather than EHRs, transforming Consolidated Clinical Document Architecture (C-CDA) data to FHIR, and creating measures to automate the Longitudinal Maternal & Infant Health Information for Research project data collection and the reporting process.

Task 2: Pilot Project Management

The Contractor will perform these project management activities over the duration of the pilot:

1. Coordinate and lead the pilot kickoff meeting

2. Draft and maintain a pilot project management plan (PMP)

3. Coordinate weekly internal pilot project calls

4. Lead monthly pilot-specific, one-hour client meetings

5. Oversee pilot task and risk management activities

Task 3: Conduct the MaternalHealthLink Pilot

Working with HHS, Office of the National Coordinator for Health Information Technology (ONC), and CDC project stakeholders, the Contractor shall identify and recruit an HIE or comparable data source organization for the MaternalHealthLink pilot. This work shall encompass:

Defining pilot site criteria, such as availability of a community-wide Master Patient Index Assessing, identifying, and recruiting a pilot site Defining and negotiating business and legal agreements with pilot site administrators Leading technical implementation planning and training sessions:

FHIR training for researchers accessing the data Technical training for information technology professionals who will administer the application

Performing initial data collection to assess data quality and completeness prior to subsequent pilot data collection. The Contractor will use synthetic test data only. Protected health information (PHI) or personally identifiable information (PII) will not be used during any phase of the pilot.

Providing technical support through pilot launch and test.

Collecting feedback on the IG and incorporating changes before publishing.

Provide a final pilot report that summarizes lessons learned and recommendations for future implementations.

Task 4: Supportive Pilot Tooling - MaternalHealthLink

MaternalHealthLink development and implementation tasks will include:

Leveraging the measure specification and Clinical Quality Language (CQL) logic developed under the current .

Implementing pilot integration:

Setting up the sandbox test environment—this will be a dedicated HAPI FHIR3 server loaded with measure and test data for measure evaluation. HAPI FHIR is a complete implementation of the HL7 FHIR standard for healthcare interoperability used to add FHIR capability to applications.

Setting up user authentication processes—the Contractor will use an OAuth2 server such as KeyCloak4 (OAuth2 is the industry standard protocol for user authentication management.)

Ha

Accessing an HIE’s Integrating the Health Enterprise5 (IHE) XD* endpoint. The Contractor will provide a connection to an HIE’s XD* interface to query and retrieve C-CDA-based clinical documents to be converted to FHIR data.

Setting up the MaternalHealthLink application development environment and build processes in a GitHub6 repository. This will provide source code control and the ability to compile and deploy

MaternalHealthLink as updates are made, providing a continuous integration environment.

Using C-CDA to FHIR transforms to convert mother/child data linkages and other data to FHIR format and to access mother/child C-CDA clinical data in this FHIR-based solution. EHR systems use C-CDA documents to meet certification requirements; these documents often contain more clinical content than is available via FHIR data interfaces, thus providing a richer data set. Since MaternalHealthLink’s measure resources and CQL logic use the FHIR data model, non-FHIR data must first be transformed before evaluation.

Creating a Representational State Transfer (RESTful) endpoint to receive patient individual identifications (IDs). This is the FHIR interface for defining the categories of data (aka FHIR Resources) to exchange. The Contractor may explore other options for gathering patient IDs using Clinical Decision Support (CDS) hooks, an interface that invokes clinical decision support from within a clinician's workflow. The Contractor will work with the pilot organization to determine the mechanism for sending IDs to MaternalHealthLink.

Demonstrating basic Microsoft Power BI query and visualization functionality using acquired data and the Power BI FHIR Connector.

i. Requirement type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ____________________

ii. Type of action.

New requirement Follow-on (logical follow-on to an original GSA competitive task order) Other (specify):

iii. Proposed contract/order type.

Firm-fixed-price Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________

iv. Acquisition identification number.

GSA Contract No.: 47QTCA21D001V, Order: 75N94021F00041 (Modification No. P0001)

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

Total Estimated Cost: $310,161 – Period of Performance – 0 / /2022 - 03/23/3023

4. Identification of the justification rationale [see 8.405-6(a) and (b)] and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

This acquisition is conducted under the authority of the Multiple Award Schedule Program.

Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation (FAR) 8.405-6(a)(1):

Authority: 8.405-6(a)(1)(C): “In the interest of economy and efficiency, the new work is a logical follow-on 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 order or BPA must not have been previously issued under sole-source or limited-sources procedures”.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer as provided in FAR 8.405-6(a)(2)

5. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Name and address of the proposed contractor.

Lantana Consulting Group, Inc.

P.O. Box 177 East Thetford, Vermont 05043-0177

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

The purpose of the current task order issued to the Lantana Consulting Group, LLC’s (Lantana) under the General Service Administration (GSA) contract number 47QTCA21D001V is to create HL7® FHIR® I to develop a standardized approach to link maternal and infant electronic health data for research.

This proposed modification is to add additional work to encourage timely widespread adoption of the IG by electronic health record systems (EHRs), health information exchanges (HIEs), and other health data source organizations so that it would allow researchers and other stakeholders to gain access to this vital data. To accomplish this, an open-source, measure-based application— MaternalHealthLink— will be developed to provide data access and the flexibility to address researchers’ data needs over time. With the award of this modification, the Government will leverage ongoing development of the Longitudinal Maternal & Infant Health Information for Research IG to define input and output requirements by conducting a pilot to test this linkage.

Defined data requirements will be mapped into two measure definitions for use by the MaternalHealthLink application to request linked, longitudinal clinical data from data source organizations and deliver detailed, accurate reports to researchers.

Given that the IG will use HIEs as the data source, it is critical to test the IG for real world use in this case. Real world implementations of newly developed IT tools are very difficult for the end user developing a tool to perform a particular task while developing the IG for the specific task will make the tool more useful. Health Information Exchanges using this tool will be able to bridge that gap that now exists between the linkage of the mother and baby’s health records. This feedback from health exchanges as the tool is customized and the IG is being developed will make the IG more useful to researchers.

To create the MaternalHealthLink tool, Lantana will customize the NHSNLink, an open-source FHIR application for public health reporting developed by Lantana for the Center for Disease Control and Prevention ’s National Healthcare Safety Network (NHSN). The customization of this NHSNLink will provide clinical data derived directly from the process of care is the clearest, most complete path to understanding, analyzing, and evaluating that process of care as it removes the distortion introduced with data developed for different purposes – for reimbursement or administrative management. This proposed customization of th MaternalHealthLink will enable data reuse of the EHRs.

Since Lantana it is currently in the midstream in developing the IG under the current they are in a unique position to develop and pilot the MaternalHealthLink. The overall strategy is to modify and/or tailor the existing tool (NHSNLink) developed by Lantana to support the longitudinal maternal & infant health information for research use cases developed under the current . This will leverage the production system that is working well for reporting hospital-acquired infections to the CDC for public health reporting and monitoring as well as Lantana’s expertise and knowledge the existing tool.

Lantana, under the current ongoing GSA is funded to use electronic data to support continuity of care, public health, quality reporting, and research, and is contracted to develop standards for HL7 FHIR into an IG. Therefore, Lantana has the existing infrastructure in place to customize the link and incorporate the improvements to the IG concurrently. Any information gleaned by the pilot will be incorporated into the IG (as deem appropriate) as the IG is being developed. For this reason, Lantana is in a unique position to accomplish the work more efficiently and effectively.

With this modification, the Government will save time and money. another contractor will require additional time for the new team to become familiar with the existing application to be able to customize the existing tool, and will take additional effort to coordinate between contractors which will also cause delays in the process. It is estimated that another contractor to develop the link and conduct the pilot would take the Government approximately an additional 3 to 4 months to complete the work. On the contrary, Lantana will be able to perform the tooling and piloting building on the work that is currently underway and, at the same time, informing and enhancing the final IG to customize the link within the same current contract’s performance period.

In conclusion, in view of all the above, award to any other source would result in additional cost and time to the Government that is not expected to be recovered through competition.

Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

GSA has already determined that Lantana Consulting Group, LLC’s fixed hourly labor rates offered under the schedule are fair and reasonable. The original award was placed on a competitive basis in accordance with 8.405-2(c)(3)(ii) and (iii) resulting in adequate competition through the original solicitation. All responses received were reviewed using the evaluation criteria included in the solicitation and NICHD found that Lantana’s total price was reasonable within FAR 8.405-2(d) for the number of hours proposed which were determined to be commensurate with the work required. NICHD has evaluated the level of effort and the mix of labor proposed by Lantana to perform the work under this modification and considered them adequate and the total price was determined to be reasonable.

Therefore, based on the previously stated, the CO has concluded that the proposed modification to the existing order represents the best value to the Government and the lowest overall cost alternative.

Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

The Request for Quotation on the GSA Federal Supply Schedule was competitive, and the resulting awarded to Lantana competitively. The Government recognizes there are other FSS contractors that possess the overall capabilities to fulfill the requirement; however, as explained above, the ongoing project infrastructure in place under the current and the significant direct technical expertise and experience that Lantana Consulting Group LLC brings to the “Severe Maternal Morbidity and Mortality Electronic Health Record (EHR) Data Infrastructure” project, makes it operationally and economically beneficial and technically advantageous to the Government. For that reason, it has been determined that awarding to any other vendor will cause delays in the execution of the project and will result in higher pricing to the overall work.

Any other facts supporting the justification.

Increasing competition would not result in better pricing as it would cause delays in the execution of the necessary scientific progress on the Research IG, resulting in time delays estimated at 3 to 4 months.

This would be due to a learning curve for personnel from another Contractor to gain the experience necessary to familiarize themselves with the health link application and then customize and coordinate with Lantana in implementing enhancements to the IG and the MaternalHealthLink. Through this modification, Lantana will be piloting and customizing the MaternalHealthLink using their expertise, knowledge and prior experience. This will save the Government time and money as it will make possible the rapid initiation and completion of the work

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

N/A

Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

The MaternalHealthLink to be developed under this modification is an open-source FHIR application. The project under the current ongoing will produce an HL7® FHIR® (Fast Healthcare Interoperability Resources) IG document encompassing pregnancy, pregnancy outcomes, and pregnancy-related conditions, co-morbidities, and procedures, and link maternal to infant health records.

This guidance will be available to Health Information Exchanges, researchers and the general public.

Therefore, is anticipated that any future actions will be competitive.

Program office certification.

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 or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title Signature/Date

Contracting Officer’s Representative

John Moye, Jr., MD

Contracting Officer’s Immediate Supervisor

Sonia Lee, PhD

Head of the Sponsoring Program Office

Rohan Hazra, MD

13. 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

Contracting Officer Elizabeth Osinski

John H. Moye Jr -S

Digitally signed by John H.

Moye Jr -S Date: 2022.01.27 14:38:48 -05'00'

Elizabeth J.

Osinski -S

Digitally signed by Elizabeth J.

Osinski -S Date: 2022.01.28 08:48:49 -05'00'

Sonia Lee Digitally signed by Sonia Lee Date: 2022.01.28 11:09:30 -05'00'

Rohan Hazra Digitally signed by Rohan Hazra Date: 2022.01.28 11:43:57 -05'00'

Signature/Date

Team Leader and Contracting Officer

Alice Pagan Pereira

Branch Chief, Contract Management Branch

Daniel Federline

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title

Acting Chief of the Contracting Office, NICHD Office of

Acquisitions

Marlene Mireles

Head of the Contracting Activity

N/A

15. Competition Advocate signature. The designated OPDIV Competition Advocate (CA), upon acceptance of the rationale provided in the LSJ, shall complete the information required below and sign in the block provided as the approving official for any LSJ over $750,000 but not exceeding $15 million.

However, if the CA does not meet the requirements of FAR 8.405-6(d)(3)(ii) for an LSJ over $ million, but not exceeding $75 million, an individual other than the CA shall exercise the approval authority.

The signature of the CA, or that of an individual meeting FAR 8.405-6( )(3)(ii) requirements for an LSJ over $ million, but not exceeding $ million, shall serve as concurrence on any LSJ over $ million that requires the approval of the HHS Senior Procurement Executive (SPE).

Official Name & Title Signature Date

Competition Advocate N/A

16. HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the LSJ, shall complete the information required below and sign in the block provided as the approving official for any LSJ exceeding $75 million1.

Official Name & Title Signature Date

HHS Senior Procurement Executive

N/A

1This dollar range is current as of the date of issuance of interim acquisition policy memorandum No. 2008-03 but is subject to change – see FAR 8.405-6(h)(4). See HHSAR 308.405-6(h)(4) for additional information regarding SPE approval of an LSJ in this dollar range.

Signature/Date

Alice M. Pagan Pereira - S

Digitally signed by Alice M. Pagan Pereira -S Date: 2022.01.31 23:39:53 -05'00'