Attachment 2_SOW.pdf

2022 1

Statement of Work

Date: 5/10/2022

PROJECT TITLE: SNOMED CT AND RELATED SERVICES

I. Background

In support of its statutory mission to “aid the dissemination and exchange of scientific and other information important to the progress of medicine and to the public health” [42 USC 286], the National Library of Medicine (NLM) actively participates in government-wide efforts to establish health data standards and expands and enhances the Unified Medical Language System® (UMLS®) Metathesaurus® and related UMLS components to improve their utility for creating, retrieving, and aggregating health data.

SNOMED CT® is a comprehensive, multi-axial, controlled terminology suitable for use in patient, public health, and health research data and it is one of the vocabularies included in the National Library of Medicine’s Unified Medical Language System® Metathesaurus®. SNOMED CT is a proprietary product originally owned by the College of American Pathologists, which developed successive versions of the terminology over 35 years to maintain relevance to current medical knowledge. In April 2007 the International Health Terminology Standards Development Organisation (IHTSDO;

trading as SNOMED International) acquired the intellectual property rights to SNOMED CT and all previous versions of the terminology from the College of American Pathologists.

HHS has a legislative mandate to designate national standard code sets for use in electronic health transactions that promote interoperability of electronic health records used by health professionals, hospitals, and the research community. The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Revitalization Act, requires HHS select existing code sets currently in use in the health care industry whenever possible. To be workable and meet legislative requirements, standards designated by HHS must be updated regularly and be readily available to the health care industry at low or no cost. SNOMED, due to NLM’s membership in the IHTSDO, meets these requirements.

The National Institutes of Health also has growing interest in health data standards, including code sets for clinical observations. Researchers are increasingly making use of clinical data drawn from electronic health records to better understand the progress of disease and the effectiveness of various interventions. NIH recently encouraged NIH researchers to explore the use of the Fast Healthcare Interoperability Resources (FHIR®) standards to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data. The availability of data in standard formats is essential to such work. In addition, NIH’s All of Us Research Program aims to gather data from one million or more people living in the United States to accelerate research and improve health. The program combines participants medical record data with additional data from surveys to include data about family medical history, lifestyle, and community information to develop a complete picture of participants health. Clinical

2022 2 observations recorded using SNOMED CT codes are an especially important and rich source of data in this program.

Over a period of years, various U.S. federal agencies, including the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the National Institutes of Health, the Department of Defense, and the Veterans Administration, determined that SNOMED CT can assist in improving the quality of patient, public health, and health research data that Federal agencies create, collect, exchange, or analyze, both within the Federal government and in conjunction with state and local governments or private organizations. SNOMED CT has repeatedly been recognized as the best available standard for recording clinical information in health care systems over the past 20+ years. Highlights include:

• NCVHS – The National Committee on Vital and Health Statistics (NCVHS), a

Federal Advisory committee with responsibility for advising the Secretary of HHS on matters related to health data, recommended SNOMED CT as one of a “core set” of U.S. standards for collecting and exchanging patient medical record information

• CHI – SNOMED CT was adopted as a U.S.-government wide standard by the interagency Consolidated Health Informatics Initiative (CHI; active 2001 – 2007) for use in U.S. Federal Government systems for the electronic exchange of clinical information

• HITSP – SNOMED CT was specified as a required standard in several U.S.

Interoperability Specifications released by the Healthcare Information Technology Standards Panel (HITSP; active 2005 - 2010) and recommended for U.S. wide adoption by the Secretary of HHS

• HITECH - In 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Revitalization Act, was passed. HITECH established the Office of the National Coordinator for Health Information Technology (ONC) in law and created two new federal advisory committees, to advise the National Coordinator and the Secretary of HHS on matters related to standardization, certification, adoption, and implementation of electronic health record (EHR) systems. Upon the advice of both advisory committees, SNOMED CT was designated as a national standard for several purposes (problem list, public health reporting) in the initial certification criteria for EHRs issued by the Office of the National Coordinator for Health Information Technology. Subsequent recommendations from the two advisory committees specified use of SNOMED CT as the U.S. national standard for additional categories of information in EHRs and for additional health information exchange transactions.

• 21st Century Cures Act - required development by ONC of a Trusted Exchange Framework and Common Agreement to set common principles, terms, and conditions to facilitate trust between disparate health information networks. This led to the publication, and annual updates, of the Interoperability Standards Advisory and the US Core Data for Interoperability (USCDI) contained therein, both identify SNOMED CT as a core standard.

SNOMED CT has been chosen as the standard for selected data elements in international genetic information resources, including a Genetic Testing Registry and database of

2022 3 clinically significant human variations under development at NIH. It is also being used in an increasing number of clinical research studies.

II. Purpose

The purpose of this procurement is to obtain the rights to use and distribute the international release of SNOMED CT conferred by membership in the International Health Terminology Standards Development Organisation.

III. Specific Tasks

The contractor shall:

1. Provide at least twice-yearly updated versions to the international release of

SNOMED CT, including the English and Spanish editions under the terms of the Articles of Association of the International Health Terminology Standards Development Organisation.

2. As requested, provide services to help NLM manage and author SNOMED CT content for the US Edition of SNOMED CT, so it is fully aligned with the International Release of SNOMED CT.

IV. Quality Control

1. The project officer will monitor the deliverables (English and Spanish versions of

SNOMED CT) to determine that updated versions are delivered in accordance with the specifications outlined in the Articles of Association for the International Health Terminology Standards Development Organisation.

2. The project officer will work with UMLS staff to review the deliverables to ensure the files are complete and have the appropriate content and format.

V. Period of Performance

The period of performance is as follows:

Base year (6 months) 07/01/2022 - 12/31/2022

Option Year 1 01/01/2023 - 12/31/2023

Option Year 2 01/01/2024 - 12/31/2024

Option Year 3 01/01/2025 - 12/31/2025

Option Year 4 01/01/2026 - 12/31/2026