1.0 Introduction

As an introduction to the HITSP Electronic Health Records (EHR) Laboratory Results Reporting Interoperability Specification, this section provides a high level overview of the information sharing scenario enabled by following this specification, provides a document map of the construct relationships for the Interoperability Specification, acknowledges the copyright protections that pertain, and provides a list of key reference documents and background material. If you are already familiar with this information, proceed to Section 2.0 Interoperability Requirements.

1.1 Interoperability Specification Overview

This section provides a high level definition of this Interoperability Specification and background information about the underlying Use Case that it is based upon.

The purpose of this Interoperability Specification is to describe the top-level specification for the American Healthcare Information Community (AHIC) Electronic Health Records (Laboratory Result Reporting) Use Case. This Use Case comprises two scenarios that describe the entities and interactions that would be needed to implement an electronic EHR or other clinical data system with a laboratory interface. The goals supported by this Interoperability Specification are stated in the Use Case:

Transmission of complete, preliminary, final and updated laboratory results to the EHR system (local or remote) of the ordering clinician

Transmission of complete, preliminary, final and updated laboratory result (or notification of laboratory result) to the EHR system (local or remote) or other clinical data system of designated providers of care (with respect to a specific patient)

Obstacles

The EHR (Laboratory Result Reporting) Use Case notes that there are obstacles to achieving the stated goals. In particular, the following obstacle is delineated:

Lack of harmonization among data interoperability standards including vocabulary, laboratory and other messaging standards

This specification is the result of an assessment of the current practices in electronic laboratory results reporting and the requirements of the Use Case. The Provider Perspective Technical Committee chose a combination of standards that meet the requirements of the Use Case and reflect both current practice and future directions for healthcare information sharing.

1.2 Interoperability Specification Document Map

Each HITSPInteroperability Specification (IS)is comprised of a suite of constructs that, taken as a whole, define how to integrate and constrain existing standards and specifications to satisfy the requirementsimposed by a given Use Case. TheIS groups specific actions and actors to describe the relevant context(s) for the use ofHITSP constructs that further identify and constrain standards where necessary. In addition to ISs, there are three other types of HITSP constructs called Transaction Packages (TP), Transactions (T), andComponents (C). The document map depicted in Figure 1-1 identifiesthe HITSP constructs used to meet the IS requirements. Implementers should read the documents that describe the constructs depicted in the diagram for their details and specific uses.

Figure 1-1 Interoperability Specification Document Map

EHR Lab Results Reporting Interoperability Specification Document Map.jpg

1.2.1 List of Constructs

The following table lists and describes the HITSP constructs that are shown in the Unified Modeling Language (UML) diagram above and are used by the Interoperability Specification. All references to HITSP specifications are to the current, and Panel approved Released for Implementation versions of the specifications.

Table 1-1 List of Constructs

Related Documents

Document Description

HITSP/C19 - Entity Identity Assertion Component

The Entity Identity Assertion Component provides the mechanisms to ensure that an entity is the person or application that claims the identity provided. An example of this Component is the validation and assertion of a consumer logging on to a Personal Health Record (PHR) system

HITSP/C35 - Lab Result Terminology Component

This document defines the vocabulary for either message-based or document-based laboratory results reporting

HITSP/C36 - Lab Result Message Component

This document describes the use of a constrained Health Level Seven (HL7) Version 2.5.1 ORU Unsolicited Observation Message for electronic laboratory results reporting

HITSP/C37 - Lab Report Document Component

This Component prescribes the use of the standard Clinical Document Architecture Release 2 (CDA R2), as in the HL7 V3 2006 normative edition profiled by IHE LAB TF-3 for:

Transmission of complete, preliminary, final and updated laboratory results to the EHR system (local or remote) of the ordering clinician

Transmission of complete, preliminary, final and updated (or notification) to the EHR system (local or remote) or other clinical data system of designated providers of care (with respect to a specific patient)

Transmit laboratory result data from electronically enabled healthcare delivery and public health systems in standardized and anonymized format to authorized Public Health Agencies with less than one day lag time

HITSP/C44 - Secure Web Connection Component

This Component provides the capability to access documents through a secure web browser

HITSP/T14 - Send Laboratory Result Message Transaction

The functionality supported by this Transaction is for sending laboratory result messages to the ordering clinicians and providers of care, and to receive acknowledgement from authorized recipients

HITSP/T15 - Collect and Communicate Security Audit Trail Transaction

The Collect and Communicate Security Audit Trail Transaction is a means to provide assurance that security policies are being followed or enforced and that risks are being mitigated. This document describes the mechanisms to define and identify security relevant events and the data to be collected and communicated as determined by policy, regulation or risk analysis. It also provides the mechanism to determine the record format to support analytical reports that are needed

HITSP/T16 - Consistent Time Transaction

The Consistent Time Transaction provides a mechanism to ensure that all of the entities that are communicating within the network have synchronized system clocks

HITSP/T17 - Secured Communication Channel Transaction

The Secured Communication Channel Transaction provides the mechanisms to ensure the authenticity, integrity, and confidentiality of Transactions, and the mutual trust between communicating parties. It supports both application and machine credentials, and user machines (user nodes)

HITSP/T18 - View Laboratory Results from a Web Application Transaction

This Transaction allows a user to view a laboratory report through a secure browser. This Transaction uses the HITSP/C44 - Secure Web Connection Component. It may not define all functions, constructs and standards necessary to implement a conforming system in a real world environment. In particular, an implementer must provide the technical infrastructure and security framework necessary to support operations in accordance with law, regulation, best practices and business agreements

HITSP/T23 - Patient Demographics Query Transaction

This PDQ Transaction is intended to provide a list patients and their demographics query / patient(s) and their demographics identified response message pair (QBP^Q22, RSP^K22) for use wherever such needs exist. This Transaction document extracts the Health Level Seven (HL7) Version 2.5 Query and Response data mapping. The underlying basis for this extraction can be found in the Integrating the Healthcare Enterprise IT Infrastructure Technical Framework, Volume 2 (ITI TF-2), Revision 4.0: Patient Demographics Query

HITSP/T29 - Notification of Document Availability Transaction

The NAV Integration Profile introduces a mechanism allowing notifications to be sent point-to-point to systems within a Cross-Enterprise Document Sharing Affinity Domain (See IHE IT Infrastructure Cross-Enterprise Document Sharing (XDS) Integration Profile), eliminating the need for manual steps or polling mechanisms for a Document Consumer to be aware that documents of interest have been registered with an XDS Document Registry Actor

HITSP/TP13 - Manage Sharing of Documents Transaction Package

This Transaction Package supports the sharing of patient records in the form of source attested objects called documents. A healthcare document is a composite of structured and coded health information, both narrative and tabular, that describes acts, observations and services for the purpose of exchange. No assumption is made by this construct in terms of the format and structure of the content of documents shared. This Interoperability Specification specifically references the IHE XDS.b option to support Entity Identity Assertion (SAML support)

HITSP/TP20 - Access Control Transaction Package

The Access Control Transaction Package provides the mechanism to administer security authorizations which control the enforcement of security policies including: role-based access control; entity based access control; context based access control; and the execution of consent directives. In an emergency, this construct supports the capability to alter access privileges to the appropriate level (failsafe/emergency access), which may include override of non-emergency consents

HITSP/TP22 - Patient ID Cross-Referencing Transaction Package

This specification includes by reference the Transactions and Components that comprise the Patient ID Cross-Referencing Transaction Package. Source material is from the IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2). The two transactions within this package are:

The IHE Patient ID Cross-Referencing (PIX) transaction is described in IHE-ITI TF-2 3.9.1

The IHE Patient Identity Feed transaction is described in IHE-ITI TF-2 3.8.1

HITSP/TP30 - Manage Consent Directives Transaction Package

The Manage Consent Directives Transaction Package describes the messages needed to capture, manage, and communicate rights granted or withheld by a consumer to one or more identified entities in a defined role to access, collect, use or disclose individually identifiable health information (IIHI), and also supports the delegation of the patients right to consent. The transactions described in this construct are intended to be carried out by HITSP/TP13 - Manage Sharing of Documents

1.3 Copyright Permissions

COPYRIGHT NOTICE

2008 ANSI. This material may be copied without permission from ANSI only if and to the extent that the text is not altered in any fashion and ANSIs copyright is clearly noted.

ASTM International materials used in this document have been extracted, with permission from the Privilege Management Infrastructure (PMI) Guidelines and the E-2147-01 Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems, copyright ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428. Copies of these standards are available through the ASTM Web Site at www.astm.org.

Certain materials contained in this Interoperability Specification are reproduced from Health Level Seven (HL7) Consent related vocabulary including Confidentiality Codes; HL7 Healthcare Permissions Catalogue; HL7 Version 2.5; HL7 Version 2.5/2.5.1; HL7 Version 2.5.1; HL7 U.S. Realm - Interoperability Specification: Lab Result Message to EHR (ORU^R01) (HL7 Version 2.5.1) September, 2007; HL7 Role Based Access Control (RBAC) Healthcare Permissions Catalog Version 2.0, July 2005; and HL7 Version 3.0 Privacy Consent related specifications including RCMR_RM010001 - Data Consent, RCMR_RM010002 - Shared Secret, and COCT_RM580000 - Data Consent with permission of Health Level Seven, Inc. No part of the material may be copied or reproduced in any form outside of the Interoperability Specification documents, including an electronic retrieval system, or made available on the Internet without the prior written permission of Health Level Seven, Inc. Copies of standards included in this Interoperability Specification may be purchased from the Health Level Seven, Inc. Material drawn from these standards is credited where used.

IHE materials used in this document have been extracted from relevant copyrighted materials with permission of Integrating the Healthcare Enterprise (IHE) International. Copies of this standard may be retrieved from the IHE Web Site at www.ihe.net.

This material includes SNOMED Clinical Terms (SNOMED CT) which is used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT was originally created by The College of American Pathologists.

"SNOMED" and "SNOMED CT" are registered trademarks of the IHTSDO.

OASIS materials used in this document have been extracted from relevant copyrighted materials with permission of the Organization for the Advancement of Structured Information Standards (OASIS). Copies of this standard are available from OASIS at www.oasis-open.org.

1.4 Reference Documents

A list of key reference documents and background material is provided in the table below. These documents can be retrieved from the www.hitsp.org Web Site.

Table 1-2 Reference Documents

Reference Document

Document Description

HITSP Interoperability Specification Overview

Provides background information about the HITSP and its role in the overall U.S. efforts to realize large scale interoperability of health information. The document also provides a description of the HITSP process for healthcare standards harmonization and explains how to use the Interoperability Specifications and other related documents to inform your health IT product development or product refinement

HITSP Conventions List

Describes the conventions that are used to convey the full descriptions and usage of standards in the HITSP specifications

HITSP Acronyms List

Lists and defines the acronyms used in this document

HITSP Glossary

Provides definitions for relevant terms used by HITSP documents

HITSP Harmonization Framework

Describes the current framework within which the Interoperability Specifications are built

Electronic Health Records (Laboratory Result Reporting), March 19, 2006 Use Case

ONC Use Case that is the basis of this Interoperability Specification

TN900 - Security and Privacy Technical Note

Developed as a reference document to provide the overall context for use of the HITSP Security and Privacy constructs. It includes the following:

The scope, reference policy background, and Security and Privacy principles used in the development of the constructs

A detailed description and schematics of the conceptual relationship between the Security and Privacy constructs

A mapping of existing standards and constructs to be used in meeting the stated requirements of the AHIC Use Cases

A list of identified gaps and the recommended approaches to resolving those gaps

A roadmap for how the Security and Privacy constructs will evolve and eventually align with other HITSP Interoperability Specifications

A conceptual framework for Security and Privacy management, including reference information on privacy policies, risk assessment, and risk management

A glossary of terms used in all the Security and Privacy construct documents

A description of the application of the Security and Privacy constructs to the HITSP Interoperability Specifications for the three initial AHIC Use Cases Biosurveillance, Electronic Health Records - Laboratory Results Reporting, and Consumer Empowerment

HITSP will periodically update this Technical Note as required by the introduction of new contexts for use