19-00011-ss-fbo.sow.doc

Statement of Work PROJECT TITLE: Creation, Maintenance, and Distribution of the Logical Observation Identifiers Names and Codes® (LOINC®)

I. Background The 1993 NIH Revitalization Act created a National Information Center on Health Services Research and Health Care Technology (NICHSR) at the National Library of Medicine (NLM) to improve “the collection, storage, analysis, retrieval, and dissemination of information on health services research, clinical practice guidelines, and on health care technology, including the assessment of such technology.” One of the overall goals of the NICHSR is to contribute to the information infrastructure needed to foster patient record systems that can produce useful health services research data as a by-product of providing health care. In support of this goal, NICHSR/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. LOINC development has been partially supported by a private foundation, the Agency for Health Care Policy and Research, and the Regenstrief Institute. The NLM has supported research and development projects to test the use of LOINC in a metropolitan health network linking multiple hospitals, laboratories, clinics, and public health facilities. LOINC is distributed free via the Internet and is also included in NLM’s UMLS Metathesaurus.

In 1996, Congress passed the Health Insurance Portability and Accountability Act (HIPAA). HIPAA contains Administrative Simplification provisions that require the establishment of national standards for administrative health data transactions, including the code sets used in such transactions. LOINC will be designated as a HIPAA standard code set for use in claims attachments which will lead to additional expansion of its content. LOINC has been specified as one of the standards for the National Electronic Disease Surveillance System (NEDSS) initiative developed by the Centers for Disease Control and Prevention. LOINC was recommended as a U.S standard by the National Committee on Vital and Health Statistics. LOINC was adopted as a U.S.-government wide standard by the interagency Consolidated Health Informatics E-Government Initiative (CHI; active 2001 – 20017) for the electronic exchange of clinical health information. LOINC specified as a required standard in 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 the Department of Health and Human Services (HHS).

In 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Revitalization Act, established Office of the National Coordinator for Health Information Technology (ONC) in law; created two new federal advisory committees, the Health Information Technology Policy Committee and the Health Information Technology Standards Committee, 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; and established programs to encourage the meaningful use of EHRs by health professionals and hospitals that serve the Medicare and Medicaid populations. The advisory committees used the output of both CHI and HITSP as a starting point for formulating their recommendations for standard terminologies. Upon the advice of both advisory committees, LOINC was designated as a national standard for several purposes (lab orders and results and submission of lab results to public health agencies) in the initial certification criteria for EHRs issued by ONC. Subsequent recommendations from the two advisory committees specified use of LOINC as the U.S. national standard for additional categories of information in EHRs and for additional health information exchange transactions.

The 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 LOINC as a core standard.

In FY 1999, NLM awarded a three-year contract for the continuing development and free public distribution of LOINC to the Regenstrief Institute for Health Care, Indiana University, on behalf of HHS, VA, and DOD. In FY 2003, FY 2008, and again in FY 2014 NLM awarded five-year follow up contracts to the Regenstrief Institute, Inc. to ensure the continued maintenance, expansion, and free public distribution of LOINC.

II. Purpose The purpose of this project is to ensure the continued maintenance of LOINC as a freely available and openly developed source of standard identifiers, names and codes for the electronic exchange of clinical and laboratory observations, measurements, and documents.

III. Specific Tasks The contractor shall:

1. LOINC Production - Produce LOINC through editing and enhancing the terminology based upon:

a. Legitimate individual requests from current and future users of LOINC.

b. Requirements arising from the gradual extension of federal regulations that specify use of LOINC in healthcare standards. This includes but is not limited to regulations relating to HIPAA claims attachments, meaningful use, clinical quality measures, certification of EHR technology (including the HITECH act), and those arising from the 21st Century Cures Act.

c. Requirements arising from collaborations with other standards development organizations to:

i. Facilitate implementation of LOINC and improve interoperability of healthcare systems (e.g. Health Level 7 (HL7), HL7 Fast Healthcare Interoperability Resources (FHIR), Institute of Electrical and Electronics Engineers, Inc. (IEEE), Accredited Standards Committee X12 (ASC X12)).

ii. Facilitate consolidation of overlapping standards to reduce duplication and improve interoperability of healthcare systems (e.g. Radiological Society of North America (RSNA)).

d. Additional and emerging test areas, including but not limited to molecular pathology, clinical genetic testing, patient reported outcomes, data collection, and validated survey instruments (surveys).

2. Software Tooling - Maintain and ensure the usability of software tooling:

a. For editing and enhancing the LOINC terminology and,

b. To enable users to search the LOINC terminology and, where appropriate, map local codes to LOINC codes in order to facilitate implementation of LOINC.

Systems reliability expectations will be outlined in published service level agreements or similar instruments available to the user community of the software tooling.

3. LOINC Dissemination - Disseminate LOINC free-of-charge via the Internet on a published schedule. At a minimum the contractor will provide:

a. The entire current coding system,

b. Sets of changes and updates, in a format that supports automated updating of systems that contain the previous version of LOINC, and

c. Updated versions of the coding system to NLM for inclusion in the UMLS.

4. Reporting - Quarterly reports to NLM will include at a minimum:

a. Details on additions and changes to LOINC over the past quarter. Highlight any additions or changes that do not conform with the current policies, procedures, or logical structure and format of LOINC explaining why the deviation was necessary.

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. Information on the reliability of the software tooling and adherence to the service level agreements. Proposed tooling enhancements should be described at a high level including why it is needed and how it will benefit the user community.

5. Optional Task 1: Federal Agency Requests - As requested, assist Federal agencies in implementation of LOINC through:

a. Mapping local vocabularies and code sets to LOINC or;

b. Creation of new codes for specific purposes or to cover specific domains.

6. Optional Task 2: Collaborate with SDOs – As requested, in conjunction with the appropriate standards development organization, develop a mapping from/to LOINC and to/from another recognized standard terminology to facilitate use of these two standards that are generally used together.

7. Optional Task 3: Tooling Development – As requested, augment existing or develop new tooling to address specific functional requirements of the LOINC user community.

IV. Quality Control

Quality control will primarily be achieved through quarterly reports to NLM as described in Task 4 above. Additionally:

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

2. Quality control procedures for mapping local vocabularies and code sets to LOINC will be negotiated at the time specific mapping tasks are assigned. (See Task 5)

3. Quality control procedures for creating mappings from/to LOINC and other recognized standard terminologies will be negotiated as part of the strategy development. (See Task 6) V. 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.

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 attachments sections. 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.

LOINC SOW – June 2019