HL7 working draft V6 1/1/2006
Working document
Order Set Publication Standard
I. Project Identification
a) Project Identifier
b) Project Name
Order Set Publication Specification: A functional and structural standard for structured documents sharing order set content
c) Project Description
Order sets are an integral feature of daily clinical healthcare, multidisciplinary care plans, guideline execution paradigms and publication of clinical care protocols. The purpose of this project is to support a standard for:
1) publication, sharing and maintenance of order sets by authors and authoring institutions
2) distribution of interoperable order set content to providers and institutions who seek to support and standardize care
3) importation and localization of order set knowledge structures into Computerized Physician Order Entry (CPOE) and Care Planning software
4) presentation of order sets for effective clinical deployment in guidelines and care plans
5) organization of order sets as knowledge tools which may be employed as components of executable, interoperable guidelines.
Out of scope: This project is NOT meant to develop or promote messaging standards for HL7 compliant orders nor to specify operations or functions for manipulation of the orders sets developed by this publication specification.
d) Project Classification
Type of product: Specification for a knowledge-based structured document supporting order sets as clinical care plan elements.
Type of development: New development
Scope of participation: Sponsored by Clinical Decision Support TC; in collaboration with Patient Care, Structured Documents and Orders/Observations
Source of resources: HL7 volunteer effort
II. Requirements
Introduction
Order sets can organize and structure complex health care plans into useful units of work for clinicians. An order within an order set can request any clinical activity including referrals (requests for encounters), acts, supplies, procedures and observations among others. Structured observations and goal setting can also be supported from the order set. The sharing of care protocols and regimes authored as phased order sets has a much broader audience for work on error reduction, standardization of care and quality improvement. Order sets in this context can be envisioned as action elements within a care plan, allowing a clinician to organize and request a step in a larger protocol. Definition of the structure and function of orders and order sets for integration into an HL7 RIM compliant medical recordis a central issue in development of interoperable functionality necessary to shared guidelines. (The application program interface to this record is conceptually denoted the vMR (virtual medical record) with the standard guideline model.) This document proposes a multi-layered standard that supports the publication and maintenance of order set libraries, the sharing of order sets between collaborating institutions, the structuring of order sets to support effective clinical use, and the importing andinteroperation of order sets within advanced clinical guideline and care planning software. The proposal assumes that organizations employing this standard may deploy the depth of specification appropriate to their enterprise needs and the capabilities of their clinical systems architecture and performance.
Use Cases
Layer I
a) Publication and maintenance of order sets
The AmericanCollege of Physicians desires to develop a repository of problem-based order sets to be used by its members. This parallels comparable guidelines activities by national and international professional organizations as well as private, content-development companies and those developed by academic organizations. Typically, these order sets will be distributed as text documents, to be employed in a large variety of hospital and office-based clinical information systems (CIS). In order to maintain a library of order sets in an organized, up-to-date, and accessible fashion; the order sets should be maintained in a document repository with appropriate descriptive metadata. The electronic documents (order sets) should support computer processing as well as being readable by humans in order to support import procedures into Clinical Information Systems (CIS).
Metadata should support browsing across order sets, understandable context for identifying orders sets for appropriate clinical use, web link to external knowledge sources for expanded “help”, editing and review time stamps, editorial staff responsible for content, designated target populations, acuity flag for clinical classification, version number and diagnoses for application of content. The organization and content of the order sets themselves will assist ACP members in understanding and following standard care protocols and meeting performance measure standards (the Pay 4Performance program) promoted by the College quality care activities. The ACP repository is designed to be compliant with HL7 phase I standards which allows them to manage and track the editorial needs of their initiativeas well as organize and maintain the clinical content.
Layer II
b) Distribution and localization of content
Multiple institutions wish to share order sets with ACP to support their efforts to implement computerized physician order entry (CPOE). Although they have different order master tables and order processing systems, their individual CPOE software supports order set definition from the orders created in their order master table. Furthermore, each platform will also include textual alerts linked with individual orders which can inform the clinician at the time of order processing. The clinical practice committees at each institution download order sets for sharing in compliance with HL7 layer I/II order set standards from the AmericanCollege of Physicians. (See Appendix B for exemplar order set) At the time that an order set is imported into the recipient institution, each order in the set is compared with the order master and a new master table entry is created if necessary. Alerting text from phase II standards allows the recipient institution to enhance their order master with clinically useful warnings and text alerts linked to orders which may have risk or require clinical evaluation at order processing . For ease of review and browsing, orders are grouped by functional or administrative category. Order sets may be identified as employed by a single clinician, or for general clinical use.
Layer III
c) Order set presentation and clinical use
Order set presentation standards are important to physicians and other clinical users who may need to use CPOE systems from multiple vendors across multiple settings of care. Major software vendor have developed order processing software for CPOE in compliance with HL7 layer I-III standards. For example, as an initiative to support implementation of CPOE in small rural hospitals, a vendor has contracted with a clinical middleware company to provide starter order sets for these organizations. These will be deployed on the vendor order platform which is web-based software employing low cost presentation tools. The middleware vendor maintains a library of current clinically reviewed orders sets employing HL7 layer I standards to manage the content. Layer III standards control clinical presentation features which are integral to the clinical utility of the order sets.
Order sequencing specified by the middleware vendor, along with default pre-selection of common orders and logical grouping of order actions (orders which must be selected all at once, and orders which are mutually exclusive when selected) all make the order set more clinically useful and attractive for the clinician. Embedded alerts from layer II standards enhance the understanding and proper selection of orders appropriate for the clinical scenario. Hot links by order allow for an expanded web-based help function relevant to each order when used in the clinical setting.
Layer IV
d) Interoperation
The SAGE consortium has developed an interoperable model for the sharing of executable clinical guidelines between SAGE compliant vendor systems. This model employs a number of guideline action features, including the employment of dynamic, problem-oriented order sets to support protocol work sessions.
The order sets are prepared in (order) sessions as multi-disciplinary templates, including nursing, medical, pharmacy and allied health actions items. The order sets have been professionally reviewed and are a component of problem oriented care plans, wherein each order set serves to organize one session or phase of the overall plan of care. Problem and session encoding of order sets assure that order sets are employed in relevant clinical contexts and care plans, and the order sessions may be merged when multiple guidelines apply to a single patient
In addition to library, sharing and presentation features, SAGE order sets employ embedded decision logic features which may turn orders “default on or off” within the set at the time of order processing (sanction logic) Order items within the set may specify an order for a medication or service, allow confirmation and recording of clinical observations or setting of a goal. Goal setting within a care plan allows for later determination of clinical outcomes and determination of variance from care standards.
Service coding of each order item within the order set and order master allows the guideline software to determine whether an instance of an order is already active (supporting alerts for orders already issued), an observation is already recorded or a goal is already set, and to manage merging of order sets to eliminate duplication. Level of recommendation flags allow dynamic prioritization of orders within sets by SAGE decision support features, so that multiple treatment options may be placed in perspective for the clinician. Order collectives defined within layer III allow groups of order items to be manipulated as a block by the SAGE decision engine for purposes of alerting, prompting and changing default actions for the clinical user. SAGE order sets are distributed as guideline knowledge constructs compliant with HL7 level I-IV standards on the SAGE guideline CD.
III. Definitions
Order set
“An order set is a pre-filled ordering template, or electronic protocol that is derived from evidence based best practice guidelines.” (1)
In the article proposing this definition, the authors provide a cursory description of their methodology and data structure.
“Once a guideline is accepted, the contents of the guidelines are translated into a workflow that can then be adapted into one or more order sets and automated through the computerized provider order entry (CPOE) system.”
“Each record in the table represents one order and contains all high level information about the order such as, order description, department, type of order, frequency, dose, order entry date, etc. This table also houses essential, frequently used attributes needed in order set analysis such as order set name, ordering health care professional, the patients current clinical service and patient location at the time the order set was placed.”
The electronic health record interest group of HL-7 has recently published a proposed electronic health record functional description[]. They state order sets “supports delivery of effective healthcare,” improve efficiency, facilitate management of chronic conditions, and improve patient safety[]. They provide the following functional description of order sets:
“Order sets allow a care provider to choose common orders for a particular disease state or circumstance according to best practice criteria for assembling the order set without having to generate each order individually. The EHR may recommend order sets in certain conditions or as the result of other clinical information being entered into the EHR. Or the order sets may simply be available for use by the ordering care provider.”
An order set is not merely a collection of orders. The collection of proposed acts within the order set has been developed and edited to promote consistent and effective organization of health care activity.
Acuity is a metadata string which denotes the chronicity of the setting for order set employment. Options include “Acute”, “Chronic”, and “Emergency”
A Care plan is an ordered assembly of expected or planned Acts (in Definitional mood), including observations, services, appointments, procedures and setting of goals, usually organized in phases or sessions, which have the objective of organizing and managing health care activity. Care plans are often focused upon on or more health care problems, with the expectation of one or more favourable outcomes. Care plans may include orders sets as actionable elements, usually supporting a single session or phase
MESH (1968, NLM): N 04.590.233.624 Patient care planning - “Usually a written medical and nursing care program designed for a particular patient.”
Creation date [xml: CreationDate]is the date the order set was created
Date of Last Review [Lastreview]: is the date of last order set review for content
Date Valid Until [ValidUntil]: the order set is valid for use until this date
Date last edited is the date the order set was last reviewed or modified
Boolean collective [BooleanCollective; AND, OR, XOR supported] is a feature of order set specification layer III which identifies named sets of orders (collectives) to be manipulated and controlled at time of order set presentation. This supports menu options which may enforce exclusivity/concurrency of order set item at the time of order session processing.
The implicit assumption of order set construction is that all order items by default may be selected by the clinician as independent choices. Hence the usual case is that each order item within an order set is linked by an “inclusive OR” (any item or no item may be selected). Boolean collectives may override this default at order selection and allows adjacent order items within the order set to be required for selection as a group, or individually. All order set items flagged as “AND” will be required to be selected as a unit or not at all. All items flagged as “XOR” will require selection of at most of a single item from the group at time of order selection.
When employed by decision enabled (layer IV) systems, this feature supports the identification of a set of order items from the order set which serve a common purpose for clinical decision support. All order items within a collective may be manipulated ‘en bloc’, supporting alerts, manipulation of pre-selection flags, and other presentation features which enhance the decision support features of order sets.
Is Personal is a data flag indicating whether the order set is institutional (Boolean false) or owned by an individual (Boolean true)
Order display group: a textual category linked to each order set item; vendor software employs these tags to organize and display orders with similar actions or intent within an order set for ease of clinical browsing and to aid understanding and order selection. They may express intent, such as “Diagnostic” or “Treatments”, or be organizational in nature, such as “Laboratory” or “Radiology”.
Order set item [Orderitem]: is the recurring element of the order body consisting of the order, observation or goal embedded within order specification, management and logic layers.
Order set management layer (layer III) consists of the order sequence number, full text order, Boolean collective and pre-selection keys, and comprises the information designed to help manage the order session for maximum clinical utility.
Order set Header: Each order set has a single header which identifies the order set, specifies the patient population for whom the order set is useful, links the order set to the guideline problem of focus, identifies the protocol session whose management this supplements, and contains editorial information for authorship and proper maintenance.
Order set key [OSKey] uniquely defines an order set and may be employed to nest an order set as an order set item within another order set
Full text order [FullItemText] will be a complete textual description of the order, observation or goal including purpose, instructions, frequency, priority, repetitions, etc. All order set items with full text description but a “null” order set specification layer will be considered non-actionable by the order session and will be descriptive only and function as comments to the user when an order set is displayed.
Order specification layer consists of the RIM specification fields for the order, medication order, observation or goal, permitting a decision engine to identify the coded subject of the order item, the dose, route, frequency, repetition and other structured elements which are needed for guideline decision logic.
Order set item [OrderItem] consists of thefull RIM compliant definition of an Order, Medication order, Observation or Goal to be set. It may also be a pointer to an order set, allowing the nesting of order sets within order sets.
Order logic layer consists of all those elements of the order set item which are employed to dynamically alter order set content by order sanctioning or to enhance clinical order information employing alerting text.
Order alerting text [OrderAlertText] is a text message which is displayed as an informational item with an order set item at the time of the order session. The alerting text may be a static element of the order set or may be dynamically populated at the initiation of the order session by a decision support program.