75N97020R00016 Statement of Work.pdf

LOINC SOW_ COVID19_August 2020 1

Statement of Work

PROJECT TITLE: Creation, Maintenance, and Distribution of the Logical Observation Identifiers Names and Codes® (LOINC®) Related to COVID-19

I. Introduction

In Fiscal Year (FY) 2019 NLM awarded a five-year follow up contracts to the Regenstrief Institute, Inc. to ensure the continued maintenance, expansion, and free public distribution of LOINC. This contract will be supplemental to the current FY2019 LOINC contract (75N97019C00012) to help facilitate creation of LOINC codes and related resources needed to assist in the rapid and thorough public health response to the COVID-19 pandemic.

II. 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.

The Logical Observation Identifiers Names and Codes (LOINC), developed and copyrighted by the Regenstrief Institute, Inc., is a coding system for laboratory test and other clinical measures and documents used in electronic transactions between independent computer systems. The development of LOINC was initiated and is directed by the Regenstrief Institute, which leads the LOINC Committee of volunteers from academia, industry, and government who maintain the coding system.

The Department of Health and Human Services (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, the research community, and public health reporting mechanisms. The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act, Section 18115 requires standardized reporting of laboratory testing and analysis relating to COVID-19 in a standard manner as designated by HHS. LOINC is one of the coding standards listed in the CARES Act.

The National Institutes of Health (NIH) established the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) effort in 2020 to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines to fight COVID-19. Use of standardized reporting of laboratory testing and analysis relating to COVID-19 will help NIH and the research community in the fight against COVID-19.

III. Purpose

The purpose of this procurement is the creation and addition of COVID-19-related laboratory test codes to LOINC and development of associated guidelines and training materials for standardized usage.

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IV. Specific Tasks

The contractor shall:

1. LOINC Code Development – work with Federal Agencies, including HHS, CDC, and FDA to create and update LOINC codes, panels, and terms related to COVID-19.

2. Collaborate with SDOs – in conjunction with the appropriate standards development organizations develop a mapping from/to LOINC and to/from another standard to facilitate use of the two standards for reporting and analyzing COVID-19 data. For example, working with HL7 and affiliated organizations to create mappings of LOINC to FHIR and CDA implementations of COVID-19 for clinical and case reporting.

3. Tooling Development – Augment existing or develop new tooling to address specific functional requirements of the LOINC user community related to COVID-19.

V. Quality Control

The following quality control procedures will be used:

1. Proposed changes to existing policies and procedures will be vetted in discussion with the LOINC Committee.

2. A short (1-2 page), monthly report will be submitted to NLM including:

a. For each task listed above provide:

i. A brief description of the work conducted in the previous month

ii. Indication of percentage of work completed to date

b. Summarize proposed changes to existing LOINC policies, procedures, or logical structure and format including proposed timeframes for implementation. Include a summary of the LOINC Committee’s discussion of the topic and how any issues, risks, or concerns raised by the LOINC Committee will be addressed.

c. Notice, including a short summary of other federal agreements (grants, contracts, etc.)

beyond this contract that include funding for enhancements to LOINC or development of additional content related to COVID-19.

VI. Section 508 Compliance

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. (This includes development of Web sites and training materials.) This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508:

The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards

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The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov/index.cfm?FuseAction=Content&ID=13.

The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

The contractor must submit a GPAT (Government Product / Service Accessibility Template) with its proposal to demonstrate its commitment to 508 compliance. A copy of the GPAT that the government intends on using for this requirement is listed in the attachment section. NLM has indicated which sections of the GPAT the Offeror must address via “yes” or “maybe” responses in the applicable column.

Whenever there is a “yes” or “maybe”, the Offeror must fill out the last two columns of the appropriate row.

It is anticipated that the contract will consist of a Base Year of August 2020 through August 2021, with one successive 12-month Option Period:

Base Year: August 2020 – August 2021

Option Year: August 2021 – August 2022.

http://www.acquisition.gov/ http://www.section508.gov/index.cfm?FuseAction=Content&ID=13