1 Foreword 前言 2
2 Introduction 临床检验结果共享系统交互性规范引论 4
2.1 Overview 概述 4
2.2 Problem Story Board 本规范的情节展板 4
2.3 Solution Concept 本规范的解决方案概念 4
3 Standards References 本规范中引用的标准 4
3.1 List of Base Standards 基础标准列表 4
3.2 List of Composite Standards 复合标准列表 4
3.3 Standards Gaps 现有标准的裂缝 4
4 Interoperability Requirements 系统交互性要求 4
4.1 Lab Test Results Sharing Interoperability Model 临床检验结果共享系统交互性模型 4
4.1.1 Scenario Overview 场景概述 4
4.1.2 Lab Test Result Report Publishing 临床检验结果报告发布 4
4.1.2.1 Pre-conditions 前置条件 4
4.1.2.2 Process Flow 流程 4
4.1.2.3 Post-conditions后置条件 4
4.1.3 Lab Test Result Report Locating and Retrieving 临床检验结果报告搜索和获取 4
4.1.3.1 Pre-conditions前置条件 4
4.1.3.2 Process Flow流程 4
4.1.3.3 Post-conditions 后置条件 4
4.1.4 Lab Test Result Report Availability Notification 临床检验结果报告就绪通知 4
4.1.4.1 Pre-conditions前置条件 4
4.1.4.2 Process Flow 流程 4
4.1.4.3 Post-conditions后置条件 4
4.1.5 Lab Test Result Report Revision临床检验结果报告重版 4
4.1.5.1 Pre-conditions 前置条件 4
4.1.5.2 Process Flow流程 4
4.1.5.3 Post-conditions 后置条件 4
4.2 List of EHR-SC Transaction Packages 交易包列表 4
4.3 List of EHR-SC Independent Transactions 独立交易列表 4
4.4 List of EHR-SC Component 元件列表 4
4.5 Dependencies 相关性 4
4.6 Constraints 制约性 4
5 Use Case Actions and Events 用例动作和事件 4
6 Conformance Requirements 相容性要求 4
7 Appendix 附录 4
7.1 HER-SC Technical Framework for Standard Harmonization 电子病历委员会标准协调技术框架 4
7.2 Glossary 术语 4
7.3 Audience 技术框架读者 4
7.4 Conventions技术框架文体凡例 4
7.5 Copyright Permission 引用标准版权声明 4
1 Foreword 前言
[This is a fixed text copied into all documents, to state the HER-SC mission, team, and approach. This should be short (hopefully less than one page). It also includes a high level description of the Technical Framework document structure (Interoperability Profiles, Transaction Packages, Transactions, Components, Composite and Base Standards, and possibly also others in the future, e.g., test plan, test tools).]
The EHR Steering Committee (EHR SC) has been initiated by a group of healthcare providers, professional societies, government agencies and healthcare IT vendors, with the purpose of facilitating electronic health record (HER) applications in China for interchange and access of patient longitudinal clinical information by promoting the industry standards based interoperability across healthcare information systems. The EHR SC is led by the MOH standard organization. Currently, there are more than a dozen of healthcare providers and vendors participating in the activities of the EHR SC.
The EHR SC is not a standard making group. It adopts a standard harmonization process to select and profile existing healthcare IT standards for the specification of Interoperability Profile (IP) in particular domains and for specific applications.
The EHR SC approach of developing IP consists of a number of steps:
• Identifies the key use cases of interchange and access of patient clinical information with a high impact on the patient value and business needs in Chinese healthcare delivery system and its reform
• Refines these identified use cases into a number of tasks for healthcare information interchange and interoperability, where tasks are modeled from the entire healthcare universal, and therefore can be shared / reused in different use cases as well as in use cases developed in the future.
• Selects the exiting healthcare IT standards for resolution of the information interchange and access problems in each task, and develop corresponding extensions and constraints of application of these standards in the particular task context
• Specify the IP by referencing the task solutions involved in the target use case and defining the interconnection of these task solutions in the IP context in the unified technical framework.
An EHR SC Interoperability Profile documents specifies the entire solution to the interoperability problem(s) identified in the target use case. The IP document is comprised from one or more Transactions or other Interoperability Profile Building Blocks (IPBB) which define the task solutions required in the use case. The IP document explains the interrelationship of these IPBB and how they work together to provide a complete solution to the use case. The IP document references the IPBB it uses, but does not describe the technical details of these IPBB. An IPBB is documented in its own specification.
An IPBB is not restricted into the context of any particular IP. An IPBB is designed to solve a generic problem, and constructed in a modular manner, to plug into each other for addressing a bigger, perhaps more specific problem in an IP.
An IPBB can be a piece of specification based on an industry standard (called Base Standard in this document, e.g., HL7 V3, DICOM, SNOMED CT, etc.) or a piece of information interchange, and access or other interoperability specification in some derived standards (called Composite Standard in this document, e.g., HL7 or other standards Implementation Guides, IHE, etc.). The EHR SC IPBB documents will document these (base or composite) standard pieces, and their profiled specifications in the HER SC technical framework. The following examples provide more information about the format and content of an IPBB:
• Examples of base standard IPBB include a profiled message content (payload carried on in a message transaction), a set of codes drawn from an industry standard vocabulary system, an arrangement of security context, etc.
• Examples of composite standard IPBB include a transaction of an IHE Integration Profile, a group of transactions in one or more IHE Integration Profiles. Etc.
The EHR SC specifies its IPBB only by reference to the base / composite standards. It does not duplicate these exiting standards for its own specifications. The specification added by the EHR SC technical framework includes the use-case-specific application context of these standard IPBB, and additional extensions and constraints developed to the base / composite standards to satisfy the use case context.
2 Introduction 临床检验结果共享系统交互性规范引论
[This section provides a high level description of the Interoperability Profile, the problem it attempts to address and the solution concept it specifies.]
This document specifies an Interoperability Profile for healthcare systems to interchange clinical laboratory test results report, to satisfy the EHR SC Use Case Lab Test Results Sharing [Ref].
This IP has been focusing on dissemination of the lab results reports to different receipts for various application purposes. This includes the results of currently performed lab tests as well as the longitudinal historical records of the previous lab test results. Lab test related workflow issues (like lab order, specimen management and track, order fulfilling, etc.) are not covered in the IP.
This IP provides a document-based specification of lab test results sharing among various parties. This does not cover all interchange and access scenarios of clinical lab test results. In case of interchanging individual pieces of results of a lab test order, messaging-based approach has been widely used in the healthcare practice. Instead, the document-based approach as specified in this IP is devoted to interchange complete report of a lab test order (or even aggregated results of more than one order) as a persistent object, although the report can be either preliminary or final.
[Explain what a clinical document can be … it could be fully structural … provide all the descrete pieces of information which are typically convey in a message]
2.1 Overview 概述
[This section describes the EHR-SC Interoperability Profile methodology, including business goals, technical approach, and EHR-SC organization. This should be a short text and will be duplicated in all Interoperability Profiles.]
This document lists all IPBB referenced in the IP and specifies their interrelationships to form a complete solution to the problem described in the EHR SC use cases.
While the IPBB will be described in their own documents, the IP document defines the context where these IPBB are applied, their particular application purposes (in the context), and their interconnection (data and control flows connecting them for the IP specification). Constraints may be specified in the IP context, in addition to the constraints and extensions against the original standards defined in the IPBB.
2.2 Problem Story Board 本规范的情节展板
[This section outlines the interoperability problem to be addressed with a narrative story board. This is can be duplicated from the use case document with modification. It should answer the question of what this Interoperability Profile addresses, in a concise manner. If the problem(s) are related to other problem(s) addressed in other Interoperability Profiles, this relationship needs to be described.]
The problem of interchange of lab test results has been discussed in detail in the EHR SC Lab Test Results Sharing Use Case. The interoperability solution defined in this IP address the following problems:
• Patient John Doe was referred by Dr. xx (his primary care provider) to Dr. Smith in Hospital Well Health. Dr. Smith placed a Complete Blood Count (CBC) test order for John Doe, and requested that Dr. xx should receive the test report when it is available. The order management system of Hospital Well Health routed the order to Precision Laboratory, which performed the test.
Using the test results data, the Precision Laboratory created the lab results report. Since the data had been verified by a lab technician but not yet by a staff physician, the report was marked as Preliminary Report. The Precision Laboratory published the Preliminary Report for sharing across providers under the local security and administration policies. In addition, Dr.
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