ATTACHMENT 1 - Terminology PWS_.docx

ATTACHMENT 1

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Office of Health Informatics (OHI) Knowledge Based Systems (KBS)

Project Title: Terminology Standards Support Date: January 27, 2020 PWS Version Number: 18.1 Table of Contents

Table of Contents

1.0 BACKGROUND

The Veterans Health Administration (VHA) Office of Health Informatics (OHI), Clinical Informatics and Data Management Office (CIDMO), Knowledge Based Systems (KBS) provides subject matter expertise, policy and terminology guidance and strategic recommendations regarding health standards implementation for Department of Veterans Affairs Information Technology (IT) systems.

KBS provides expertise for the terminology lifecycle. Their efforts contribute towards establishing and evolving a common framework for functional and semantic interoperability built upon standard terminologies. KBS teams work to discover, represent and implement VA requirements for achieving intelligent, reusable health information. KBS subject matter experts engage in VA project teams, such as the next generation electronic health records; VA DOD data sharing to validate technical specifications; and business requirements to ensure that VA’s needs are met and terminology standards are properly implemented. The KBS team works with business owners to establish well-defined requirements, select appropriate standards, and constrain them accordingly to meet VA clinical use cases. The KBS team also makes recommendations to external VA offices and teams on how to incorporate terminology standards and models into current and planned activities.

KBS engages with the HIT community beyond VA. KBS Terminology gathers information about industry-wide healthcare information technology trends and initiatives and identifies related terminology standards requirements. KBS actively participates in and establishes leadership roles within various Standards Development Organizations (SDOs) and Standards Related Organizations (SROs) to engage, influence, and become early adopters of emerging terminology standards/profiles. KBS reviews and makes recommendations on artifacts produced by various SDOs/SROs and other federal health service entities to ensure that VA requirements are represented and that it is compatible with the existing or future, planned state architecture.

KBS collaborates with VA partners such as the Office of Information and Technology (OI&T) and external partners such as the National Information Exchange Model (NIEM), Office of the National Coordinator (ONC) which oversees the Electronic Health Record (EHR) Meaningful Use Certification Program and the Federal Health Architecture (FHA) office which oversees the Federal Health Information Model (FHIM) initiative. KBS also supports open-source efforts and intersects with health information modeling and health standards architecture.

KBS has two highly aligned teams working in the terminology arena: Terminology Standards and Informatics Architecture

Terminology: Provides expert clinical terminology consultation, terminology creation, matching, and modeling to support semantic interoperability and reasoning capabilities in health records.

Informatics Architecture: Defines VA strategy and architecture for the use and integration of Terminologies and related methods to support clinically meaningful and highly interoperable representations of patient-specific clinical data and knowledge within VA health information systems. Develops information science-based terminology methodologies to process data for patient care, quality assurance, and secondary uses.

KBS - Additional Core Competencies

Clinical Decision Support: Provides subject matter expertise on Clinical Decision Support (CDS) to internal and external collaborators and supports modeling and implementation of VHA’s current and future CDS strategy by identifying and exploring CDS capabilities needed to optimally support patient care.

Standards and Interoperability: Provides expert health standards analysis, creation, engagement and consultation, contributing to a common framework for functional and semantic interoperability by sharing VA requirements and supporting solutions to achieve intelligent health information exchange that extends to enhanced patient care.

KBS covers the full spectrum of the terminology lifecycle, including:

Terminology Functional Categories

Functional Categories are defined by:

A. Terminology Products

B. Unified Development Processes to Create Terminology Products

Terminology Products

A. Content Terminology content creation is the construction, maintenance, and general curation of terminology systems in a manner consistent with the VHA Informatics Architecture. It includes several activities:

Creation of Terminology Content and Relationships - New content is created as needed to support VA use cases. Content includes the concepts themselves as well as appropriate modeling of inter-concept relationships consistent with terminology modeling guides such as the Systematized Nomenclature of Medicine -- Clinical Terms (SNOMED CT) modeling guide.

1. Terminology versioning, evolution and maintenance - All terminology systems are subject to release of successive versions that must be curated. As both the underlying systems and VA needs change, maintenance activities are of high priority.

2. Terminology matching and harmonization - Various VA systems require matchings from their native data representations to standard codes. VA systems will be modified to internally adopt and better harmonize with Federally approved terminology standards in order to meet the demands for interoperability.

3. Structural and Semantic Integration across terminologies - Harmonize SNOMED, LOINC, RxNorm, CDC CVX Codes, and related priority meaningful use standards by using Modular Description-Logic Extensions (MODLEs) per the Informatics Architecture Roadmap.

4. Terminology configuration and specialization - Terminology systems do not exist merely as databases of standard code sets, but must be extensively orchestrated for interdependencies, adapted to, and extended to serve the needs of VA systems today and future systems such as HealthShare, Cerner’s HealtheIntent and Millennium.

5. Publication - VA Terminology content is to be published and exposed by means of services to a spectrum of users, ranging from clinicians to terminologist and analysts.

6. Submission - VA anticipates substantial contributions to Standards organizations, such as the LOINC and SNOMED International. For example, VA contributed Ebola-related concepts to the National Library of Medicine National Release Center, and these have been approved by the SNOMED IHTSDO for international release.

B. Standards - Terminology standards will include SNOMED, LOINC, and RxNorm and other selected standards that are approved by the National Coordinator for Health IT and VA

1. Terminology Standards - Terminology standards include examples such as the SNOMED-CT. They also include some VA-specific code sets that may not yet be completely harmonized with or replaced by terminology standards such as SNOMED CT. Yet these VA internal standards are still critical to operations and must be maintained.

2. Integration with related Standards such as Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) - Terminology products VA produces must harmonize with messaging and modeling standards such as those provided by HL7. Alignment of the FHIR standard in the VA enterprise is needed so that we are not on different versions of the standard and so that interoperability is enhanced.

C. Consultation for each product - Consultation shall be an essential activity for Terminology. Various VHA and VA technical business stakeholders must be brought together to understand how to best use clinical terminology in VA applications and services. Generally, this consultation occurs by product line, such as “Pharmacy” or “Lab package”. However, consultation also occurs with service lines such as “Decision Support” or “Performance Measures Department”’

1. Content:

(a) Terminology application, implementation and integration with Health Information Technology (HIT). It is critical that clinical thoughts be accurately and, as much as possible, completely captured in key clinical applications by means of high-quality terminologies that comply with the Informatics Architecture.

(b) Terminology reuse for CDS and secondary uses - If the Informatics Architecture is applied then the clinical data thereby encoded can be aggregated, decomposed, and otherwise managed to support a variety of purposes including Clinical Decision Support, clinical registries, management dashboards, and other useful applications.

2. Standards - A large number of VA, Veterans Benefits Administration (VBA), and VHA user groups require periodic assistance and consultation, in order to understand the terminology landscape and how it applies to their particular clinical, technical, or administrative processes.

Unified Development Process for Terminology Products

Inception - The primary objective is to scope terminology product adequately as a basis for validating initial costing and budgets. In this phase the business case which includes business context, and success factors is established. To complement the business case, a basic use case model, project plan, initial risk assessment and project description (the core project requirements, constraints and key features) are generated. After these are completed, the project is checked against the following criteria:

A. Stakeholder concurrence on scope definition and cost/schedule estimates.

B. Requirements understanding as evidenced by the fidelity of the primary use cases.

C. Credibility of the cost/schedule estimates, priorities, risks, and creation process.

D. Depth and breadth of any architectural prototype that was created.

E. Establishing a baseline by which to compare actual expenditures versus planned expenditures.

Inception Activities conducted include but are not limited to:

A. Needs Assessment - Create and document an understanding of the terminology related needs of a particular use-case, project, program or enterprise activity.

B. Analysis of Alternatives - Create and document an analysis of potential terminology solutions including positive and negative components of each candidate.

C. Gap Analysis - Need versus Existing Content and Structure

D. Initial Requirements Analysis and Documentation

Elaboration - The elaboration phase is where the project starts to take shape. In this phase the problem domain analysis is made, and the architecture of the project gets its basic form.

Construction - The primary objective is to build the product. In this phase, the main focus is on the creation of components and other features of the system. This is the phase when the bulk of the coding takes place.

Transition - The primary objective is to 'transit' the system from creation of the content to implementing the content in a production system, making it available to and understood by the end user. The activities of this phase include training the end users and maintainers and beta testing the system to validate it against the end users' expectations. The product is also checked against the quality level set in the Inception phase.

VA aims to continue to actively participate in terminology standards activities in order to continue to understand how our efforts can inform and be informed by terminology standards so that maximum interoperability can be achieved. VA SDO/SRO participation includes but is not limited to the follow health standards organizations:

A. National Library of Medicine (NLM)

B. Health Level Seven (HL7)

C. International Health Terminology Standards Development Organization (IHTSDO)

D. Logical Observation Identifiers, Names, and Codes (LOINC)

E. National Council for Prescription Drug Programs (NCPDP)

F. Object Management Group (OMG)

G. United States Technical Advisory Group (US TAG) to International Standards Organization (ISO) Technical Committee (TC) 215

H. National Drug File – Reference Terminology (NDF-RT) Interagency Expert Panel (IEP)

I. Health IT Standards Committee/ONC Federal Advisory Committee (FACA)

2.0 SCOPE OF WORK

The contractor shall provide non-personal enterprise support services for Terminology related activities. The Contractor shall not be developing, building, or deploying any software application or code as part of this contract effort. No software will be developed or delivered as part of the effort.

There are at least two separate funding streams for this work. The first is the Clinical and Data Management Office (CIDMO) Program Management Office (PMO). The second is the Electronic Health Record Modernization (EHRM) Program Management Office (PMO). Specific Tasks Orders will be released at the time of award specific for EHRM so that the funding streams are easily distinguished.

The Contractor shall primarily support the KBS terminology teams but may be involved in collaborative activities within OHI, CIDMO, KBS, as well as with entities outside of the VA such as the Health Level 7, Logica (formerly HSPC), the Electronic Health Record Modernization (EHRM), the Department of Defense, and other governmental agencies collaborating on common projects. The contractor shall conduct, coordinate and collaborate on terminology-related activities within and beyond VA including knowledge management, creating, organizing, integrating, maintaining and harmonizing perpetually licensed or open source healthcare terminologies. The Contractor shall be able to rapidly deploy a team with specialized terminology related experience across multiple workstreams as described below. The purpose is to enable computational capability, and to contribute to a framework that provides cognitive and decision support for Veteran’s health, research, quality improvement, public health and long-range planning activities.

This PWS provides general requirements (i.e., not defined) and specific requirements (i.e., predefined). Specific requirements are described in Section 5.0. General requirements are described in Section 6.0 and shall be further defined within individual task orders. Although this IDIQ contains specific requirements and some defined general requirements, this does not limit the scope of this IDIQ. Requirements shall fall within the areas described in Sections 5.0 & 6.0; however, this IDIQ covers all activities related to the terminology life cycle. Furthermore, as the general requirements become further defined as a result of future Task Order awards, they may be incorporated into this IDIQ on an as needed basis to facilitate future ordering.

3.0 APPLICABLE DOCUMENTS

Applicable documents are listed below. Additional documents may be listed in individual Task Orders.

A. 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002” B. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements for Cryptographic Modules” C. FIPS Pub 201, “Personal Identity Verification of Federal Employees and Contractors,” March 2006 D. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974” E. Public Law 109-461, Veterans Benefits, Health Care, and Information Technology Act of 2006, title IX Information Security Matters F. 10 U.S.C. § 2224, "Defense Information Assurance Program" G. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964” H. Department of Veterans Affairs (VA) Directive 0710 Personnel Security and Suitability Program dated May 18, 2007 (https://www.voa.va.gov/) I. Department of Veterans Affairs (VA) Directive 6102 (Internet/Intranet Services) (https://www.voa.va.gov/) J. Department of Veterans Affairs (VA) Handbook 6102 (Internet/Intranet Services) (https://www.voa.va.gov/) K. Health Insurance Portability and Accountability Act (HIPAA); 45 CFR Part 160, 162, and 164; Health Insurance Reform: Security Standards; Final Rule dated February 20, 2003 L. VHA Security Handbook 1600.01, Business Associate Agreements (https://www.voa.va.gov/) M. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003 N. Office of Management and Budget Circular A-130, “Management of Federal Information Resources’, November 28, 2000 O. U.S.C. Section 552a, as amended P. Title 32 CFR 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)” Q. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008 R. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. Section § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998 S. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004 T. Department of Veterans Affairs (VA) Directive 6500, “Managing Information Security Risk: VA Information Security Program,” September 20, 2012” U. VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015 V. VA Handbook 6500.1, “Electronic Media Sanitization,” March 22, 2010.

W. VA Handbook 6500.2, “Management of Data Breaches Involving Sensitive Personal Information (SPI)”, January 6, 2012 X. VA Handbook 6500.3, “ASSESSMENT, AUTHORIZATION, AND CONTINUOUS MONITORING OF VA INFORMATION SYSTEMS,” February 3, 2014.

Y. VA Handbook, 6500.5, Incorporating Security and Privacy in System Development Lifecycle,” March 22, 2010 Z. VA Handbook 6500.6, “Contract Security,” March 12, 2010 AA. Office of Information and Technology (OI&T) ProPath Process Methodology (https://www.voa.va.gov/) NOTE: In the event of a conflict, OI&T ProPath takes precedence over other processes or methodologies.

BB. National Institute of Standards and Technology (NIST) Special Publication 800-53, “Recommended Security Controls for Federal Information Systems and Organizations” (https://www.voa.va.gov/) CC. Project Management Accountability System (PMAS) portal (https://www.voa.va.gov/) DD. Federal Travel Regulation (FTR) (www.gsa.gov/federaltravelregulation) EE. Technical Reference Model (TRM) (http://trm.oit.va.gov/TRMHomePage.asp) FF. Federal Segment Architecture Methodology (FSAM) v1.0, December 2008 GG. National Institute Standards and Technology (NIST) Special Publications 800 series HH. VA Directive 6508, Implementation of Privacy Threshold Analysis and Privacy Impact Assessment, October 15, 2014 II. VA Directive 6300, Records and Information Management, February 26, 2009 JJ. VA Directive 6300, Records and Information Management, February 26, 2009 KK. VA Handbook, 6300.1, Records Management Procedures, March 24, 2010 LL. OMB Memorandum, “Transition to IPv6”, September 28, 2010

4.0 GENERAL REQUIREMENTS

The Contractor shall provide and/or acquire the services, hardware, and software required by individual Task Orders pursuant to the general requirements specified below.

4.1 Contract Type

It has been determined that a single award, firm-fixed price (FFP), Indefinite-Delivery Indefinite-Quantity (IDIQ) contract is appropriate.

4.2 Period of Performance

The proposed contract will include a five (5) year ordering period and one (1) 12-month optional period exercisable under a substantially similar clause to the clause at FAR 51.217-9. The period of performance identified on each task order will vary based on the type of terminology services required. Task orders may include optional periods exercisable under FAR 52.217-9. The requested start date for this requirement is September 30, 2020, effective upon contract award.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

4.3 Place of Performance

The place of performance shall be identified in individual Task Orders. Locations will be Government or Contractor sites within the continental United States (CONUS) and/or outside the continental United States (OCONUS).

4.4 Travel

Travel shall be in accordance with individual Task Order requirements. Travel details must be provided to and approved by the Contracting Officer’s Representative (COR) or the Government designee prior to the commencement of travel. All travel shall be in accordance with the Federal Travel Regulations (FTR) and may be on a direct- reimbursable basis or FFP basis. OCONUS travel may require additional authorization and approvals as specified in the individual Task Order and in accordance with Joint Federal Travel Regulations (JTFR).

4.5 Materials, Equipment and Facilities

The Government will provide office space, telephone service and system access when authorized contract staff work at a Government location as required in order to accomplish the Tasks associated with this PWS. All procedural guides, reference materials, and program documentation for the project and other Government applications will also be provided on an as-needed basis.

The Contractor shall request other Government documentation deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact. The Contractor shall consider the COR as the final source for needed Government documentation when the Contractor fails to secure the documents by other means. The Contractor is expected to use common knowledge and resourcefulness in securing all other reference materials, standard industry publications, and related materials that are pertinent to the work.

VA may provide remote access to VA specific systems/network in accordance with VA Handbook 6500, which requires the use of a VA approved method to connect external equipment/systems to VA’s network. Citrix Access Gateway (CAG) is the current and only VA approved method for remote access users when using or manipulating VA information for official VA Business. VA permits CAG remote access through approved Personally Owned Equipment (POE) and Other Equipment (OE) provided the equipment meets all applicable 6500 Handbook requirements for POE/OE. All of the security controls required for Government furnished equipment (GFE) must be utilized in approved POE or OE. The Contractor shall provide proof to the COR for review and approval that their POE or OE meets the VA Handbook 6500 requirements and VA Handbook 6500.6 Appendix C, herein incorporated as Addendum B, before use. CAG authorized users shall not be permitted to copy, print or save any VA information accessed via CAG at any time. VA prohibits remote access to VA’s network from non-North Atlantic Treaty Organization (NATO) countries. The exception to this are countries where VA has approved operations established (e.g. Philippines and South Korea). Exceptions are determined by the COR in coordination with the Information Security Officer (ISO) and Privacy Officer (PO).

This remote access may provide access to VA specific software such as Veterans Health Information System and Technology Architecture (VistA), ClearQuest, PAL, Primavera, and Remedy, including appropriate seat management and user licenses, depending upon the level of access granted. The Contractor shall utilize government-provided software development and test accounts, document and requirements repositories, etc. as required for the development, storage, maintenance and delivery of products within the scope of this effort. The Contractor shall not transmit, store or otherwise maintain sensitive data or products in Contractor systems (or media) within the VA firewall IAW VA Handbook 6500.6 dated March 12, 2010. All VA sensitive information shall be protected at all times in accordance with VA Handbook 6500, local security field office System Security Plans (SSP’s) and Authority to Operate (ATO)’s for all systems/LAN’s accessed while performing the tasks detailed in this PWS. The Contractor shall ensure all work is performed in countries deemed not to pose a significant security risk. For detailed Security and Privacy Requirements (additional requirements of the contract consolidated into an addendum for easy reference) refer to ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED and ADDENDUM B - VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE.

4.5.1 Government-Furnished

Government Furnished Property (GFP) which includes Government Furnished Material (GFM), Government Furnished Information (GFI), and Government Furnished Equipment (GFE) may be provided and shall be identified in the individual Task Order.

VA may provide VA specific software as appropriate and required in individual Task Orders. The Contractor may utilize VA provided software development and test accounts, document and requirements repositories and others as required for the creation, storage, maintenance and delivery of enterprise terminology content.

Contractors shall comply with VA security policies and procedures with respect to protecting sensitive data. See Section 10.0 for detailed security requirements.

4.5.2 Contractor-Acquired

The Contractor shall acquire and/or provide any hardware and/or software required to accomplish each Task Order that is not provided as GFP. Software integrity shall be maintained by the Contractor within the licensing agreement of the producer until such software is delivered to the Government, or otherwise disposed of in accordance with Government direction. See Section 10.0 for detailed security requirements.

4.5.3 Non-Developmental Items and Commercial Processes

Non-Developmental Items (NDI), Commercial-Off-The-Shelf (COTS) and Government-Off-The-Shelf (GOTS) products shall be used to the maximum extent. The Contractor shall apply commercially available and industry best processes, standards and technologies to the maximum extent.

4.5.4 Connectivity

VA will provide the Contractor use of Virtual Private Network (VPN) as appropriate. The Contractor will bear the cost to provide connectivity to VA through VPN, and VA will provide the required account access accordingly. Other connectivity to VA systems may be authorized as appropriate in individual Task Orders.

4.5.5 Facilities

Work may be performed at either a Government or Contractor facility. Each Task Order shall delineate the facility requirements.

4.5.5.1 Government Facilities

Certain Government office or laboratory space may be made available for performance of individual Task Orders. Contractors may be required to establish operations and support Government facilities and shall comply with VA and/or Federal certification and accreditation requirements. Such facilities shall be specified in the individual Task Order.

4.5.5.2 Contractor Facilities

Personnel may perform at a Contractor facility or remote locations. Contractors may be required to establish operations and support Contractor facilities and shall comply with VA and/or Federal certification and accreditation requirements. Such facilities shall be specified in the individual Task Order.

4.5.6 Warranty

Items acquired under this contract may require warranty protection. Commercial warranties shall be transferred to the Government. The type of warranty and extent of coverage shall be determined on an individual Task Order basis.

4.5.7 Marking, Handling, Storage, Preservation, Packaging, & Shipping The Contractor shall establish/maintain procedures for handling, storage, preservation, packaging, and shipping to protect the quality of products and prevent damage, loss, deterioration, degradation or substitution of products.

4.5.8 Export Control

The Contractor shall comply with all applicable laws and regulations regarding export-controlled information and technology and shall not use, distribute, transfer or transmit technology (even if incorporated into products, software or other information) except in compliance with such laws and regulations. In addition, the Contractor shall plan for, obtain, and maintain any and all export licensing required to satisfy individual Task Order requirements.

4.6 Safety and Environmental

Safety and environmental procedures shall be identified in individual Task Order requirements.

The Contractor shall comply with the Office of Federal Procurement Policy Green Acquisition initiatives as identified in individual Task Orders in accordance with the policies referenced

4.7 Enterprise and IT Framework

4.8 Enterprise Product Teams

The Contractor may be required to serve as a member of, or provide Subject Matter Expertise to Integrated Product Teams (IPTs) or Integrated Business Teams (IBTs) within the VA. Their role(s) will be identified in individual Task Orders. IPTs and IBTs are cross-functional teams that work collaboratively to create strategies and approaches to meet particular objectives. IPTs and IBTs bring together the principal stakeholders and focus efforts on establishing critical elements of all phases of the acquisition lifecycle.

4.9 Transition and Orientation Support

The Contractor shall perform transition and orientation services (e.g. create Phase-In/Phase-Out Transition Plan) to ensure continuity of services as specified in the individual Task Order. Transition and orientation support may include transitioning to Government or Contractor personnel.

5.0 SPECIFIC REQUIREMENTS (i.e., predefined)

The tasks and deliverables described below are specific in nature (i.e., predefined). Individual task orders may encompass more than one specific requirement listed below. Tasks under this section will be ordered by simply applying the quantity the government requires to the predetermined, firm-fixed-prices outlined in the price schedule of the Basic IDIQ (not-to-exceed travel costs will be included as determined necessary). Specific requirements listed below will not be redefined at the task order level. Reporting, management, and meeting requirements (i.e., project management) may be required and will be specified as additional tasks on each task order; however, it will be included as a “not separately priced (NSP) line item. The costs associated with project management type requirements shall be included, as appropriate, in the firm-fixed unit prices outlined in the price schedule of the basic IDIQ.

5.1 Terminology Matching

5.1.1 Background

Terminology impacts virtually all clinical data either via direct data representation, by reference to the data element or both. For years, adequate terminology standards did not exist, and clinical data was named and collected in various and inconsistent ways. Today, terminology standards exist and are required for EHR certification for key domains, such as drug names and lab names. Yet, standards implementation for newly acquired data is incomplete and remediation of existing data is relatively uncommon.

One approach to address the different data naming and representation paradigms is via matchings between the components of the underlying terminological systems. In the simplest sense, matching concepts in source and target terminology systems are discovered and documented by a combination of algorithmic and human expert driven processes. More complex challenges, such as one to many matchings and incomplete matches as well as consistent application of heuristics are often encountered. The current state of VA data and our need to share that data within and beyond the VA necessitates the generation and maintenance of terminology matches between various terminologies.

An example of a terminology matching project would be matching content in Health Practice Patterns (HPPs) to a standardized health vocabulary. An HPP is a general service design that accommodates specific information, tools, and processes for a set of related clinical processes.

5.1.2 Scope

The Contractor shall perform terminology matching to align government supplied source terminology data sets with the target terminology data sets. Upon completion of the matching efforts the Contractor shall prepare the completed and matching data sets for deployment by VA and provide final reports to the government. All data relevant to electronic health records and the delivery of health care are in scope for this functional area. Terminology matching tasks are expected to follow a standard process including quality assurance. The contractor shall utilize terminology content creation environments approved for use by the VA (for example open source tools or databases, etc.). The contractor will need to understand the various terminology creation tools and tool sets used within VA.

Matching tasks can vary in intensity depending on the circumstances detailed below. When issuing a task order the government will, within its ability, describe the task.

A. Matching involves a variety of factors, which include (at least) 1) the type and pay grade of any required Subject Matter Experts (SME), 2) the ease of access to source terminologies from VA, 3) the amount of lexical normalization and processing required prior to matching, 4) the tractability of automated tools for normalizing and matching in any particular domain, 5) the amount and difficulty of quality review required—especially for patient safety critical domains, 6) prior contractor experience with the particular domain and associated standards, and 7) the spread of fixed costs (e.g., acquiring domain expertise) over the anticipated number of matchings.

Matching task: This type of task usually requires terminology informatics subject matter experts to make matching decisions. The source (and/or matched-to) concepts involved are highly specific and granular. Getting VA source materials may be hard, requiring the contractor to gain approved access VistA systems, partner with internal VA resources with system access, and to have personnel with expertise in M (Mumps), VistA Fileman, and VistA routines. Some sources contain multitudinous local term variants that require extensive lexical normalization. The domain may be highly patient safety related (e.g., related to medications). A quality assurance plan (required for all matchings) must take that into account and involve a high degree of over-sampling and dual review. The contractor’s prior experience with the domain may be low, requiring internal training and skills development. Fixed costs, for example to acquire a standard from the Standards Development Organization, may be incurred even if the actual number of matchings is low. Matching of supply item names to an as-yet incomplete SDO standard (that requires extension), where each local VistA system has idiosyncratic and often cryptic names for their supplies, would be an example.

Obtaining the VistA data might be complex, and the source and matched-to concepts may be finely granular and specific. Extensive lexical normalization may be needed, but the tools to do this (e.g., National Library of Medicine NORM routines) are free of cost and highly applicable. A Quality Assurance (QA) plan is needed for each domain and requires vetting with the relevant VA national program office. Laboratory result matching to LOINC is another matching example. The domain is well understood, and local variants are largely straightforward. In other domains such as Immunizations that match to the Centers for Disease Control (CDC) immunization standard few local variants are present, or if present are straightforward.

A. Domain Novelty

1. New Domains: New domains will require the creation of acceptable standard operating procedures (SOPs) prior to pilot matching. Pilot matching must be presented and reviewed prior to execution of the body of the matching task.

2. Established Domains: Established domains will require the review of established matching plan (s). Proposed changes will be presented for government approval prior to execution of the body of the matching task.

5.1.3 Tasks

A. Terminology matching, medical safety analysis, and quality assurance plan for each domain. This shall be delivered for government approval within 10 business days of the initiation of a funded order for matching. It shall be updated quarterly as appropriate.

B. Delivery of matchings and quality assured matchings. The contractor shall deliver matchings and quality assurance results continuously. Matchings shall be delivered in a mutually agreed electronic format suitable for the particular domain (e.g., SNOMED RF2 for SNOMED matchings).

C. The contractor shall address quality issues raised by government either at the time of matching delivery or when subsequently discovered (e.g., in the field).

D. The contractor shall summarize the delivered matchings and quality assurance work in a monthly report.

E. The Contractor shall perform matchings and validations for the Government furnished data, including, but not limited to, review and update of existing matches, and defining new matches. The Contractor shall integrate quality assurance methods into the process. The contractor shall conduct monthly status briefings and provide interim matching results and a written status report to the government program office. Meetings shall be conducted in a virtual online meeting format F. The Contractor shall, during evaluation of the Government supplied data, separate the data into categories of data that can be matched and data to be represented via modeling. The Contractor shall send the latter data set to the Government within 60 days of contract award.

G. The Contractor shall load the data sets for each domain into Government approved tools. The following tools and tool sets are currently in use including the NLM Unified Medical Language System routines, Microsoft Structured Query Language (MS SQL) Server, Oracle, Microsoft Access, spreadsheets, and the VHA Enterprise Terminology Server (VETS). In all cases the tools and functionalities proposed for use must be currently approved for use within VA.

H. Within 30 days after all matching is complete, the Contractor shall prepare the domain matching data sets produced under this effort for uploading to various VHA IT systems such as VETS and VistA, which may require the transformation of the data into multiple file formats with each being tailored for its intended end use. Examples of file formats that might be required include, but are not limited to:

1. Spreadsheets analogous to the GFI which include the matched terms and additional data resulting from the terminology matching process and described prior to terminology matching efforts

2. Electronic files which adhere to the SNOMED RF2 ReFset standard, with the exception that Target system identifiers may be used in the delivered file where SNOMED identifiers would normally be per the IHTSDO SNOMED RF2 refset standard. Additional formats such as tab delimited text files, XML and JSON may also be required.

I. With 30 days after all matching is complete, the contractor shall prepare a final report describing approaches, findings and results and lessons learned. The final report shall be a white paper with an accompanying Power Point briefing. The contractor shall present the final report via virtual online meeting format.

J. The Contractor shall define (for new domains) or review and update (for previously mapped domains) a Terminology Matching Process (i.e., matching plan) that will contain major sections to address key aspects of the Matching process (e.g., matching procedure, style guide, workflow diagram, matching table update events, and a matching checklist). The terminology matching plan must at a minimum address every type of data that is within the data set and include summary statistics. Additionally the matching plan shall identify all types of data; all steps in the matching process, including, but not limited to review and update existing matches, define new matches, apply quality assurance methods, summary statistics, and create plans for resolving unclear matchings; methods to review the results, accuracy, reliability and inter-rater reliability of the results; and methods to review and adjudicate difficult, incomplete, broader or non-match term matchings. The terminology matching plan will be reviewed and by the government before terminology matching work proceeds within ten (10) business days or 14 calendar days. The contractor shall modify their terminology matching plan as required based on government feedback within seven (7) calendar days.

K. For new domains - For one (1) month after approval of the matching plan the contractor shall perform pilot matching and pilot validation of Government furnished data to matching target for all elements occurring more than one (1) time where such matching is possible. The contractor shall generate an initial written report regarding pilot matching and validation efforts and sample data of partial results after one (1) month of effort, including problems encountered and proposed resolutions with follow up via virtual conference with VA-identified personnel to formulate working agreements about how to resolve any encountered problems. The initial pilot report and briefing will be reviewed by the government before matching and validation work proceeds within ten (10) business days or 14 calendar days. The contractor shall modify their terminology matching and validation plan as required based on government feedback within seven (7) calendar days.

L. Following approval of the pilot matching and pilot validations and the revised matching and validation plan, the contractor shall perform matchings and validations for the remaining Government furnished data. Monthly the contractor shall conduct monthly status briefings and provide interim matching results and a written status report to the government program office. Meetings shall be conducted in a virtual online meeting format.

5.1.4 Task Order Procedures:

The Government will include the complexity of the terminology matching work and whether or not the matching work is a new or established domain. Task orders for new and established domains will require a monthly report to be provided to the COR and Program Manager.

5.1.5 Deliverables

The contractor shall include in the Monthly Report any and all tasks the contractor performs for all tasks and efforts related to this task order. The Contractor shall provide a monthly summary of activities and learnings included in the Monthly Report. The contractor shall include within the deliverable the following information:

a) Initial Matching and QA Plan, monthly updates thereafter, when applicable

b) Initial written report and briefing, monthly updates thereafter, when applicable

c) Monthly status briefings and interim matching results in an agreed upon format (i.e. Excel)

d) Matching files Final written Report and briefing

e) At the completion of the task, provide a final quality report, a written summary of task observations, a project briefing, and the RefSets and edited concepts.

5.2 Terminology Concept Modeling

5.2.1 Background

The KBS office has engaged in a series of clinical terminology projects. These projects include terminology knowledge creation and management, creating terminology related requirements and services, and terminology implementation projects with internal/external partners.

An example of an information model with clinical terminology binding is an Analysis Normal Form (ANF) model.