PHARM Templates Implementationguide

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This document contains: Implementation Guide Pharmacy Templates (0.90). The text materials belong to category cdapharm.

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HL7 CDA® R2 Implementation Guide: Pharmacy Templates, Release 1

Pharmacy Templates

Implementation Guide

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Terminology	Owner/Contact
Current Procedures Terminology (CPT) code set	American Medical Association https://www.ama-assn.org/practice-management/cpt-licensing
SNOMED CT©	SNOMED CT® International http://www.snomed.org/snomed-ct/get-snomed-ct or info@ihtsdo.org
Logical Observation Identifiers Names & Codes (LOINC©)	Regenstrief Institute, Inc.
International Classification of Diseases (ICD) codes	World Health Organization (WHO)
NUCC Health Care Provider Taxonomy code set	American Medical Association. Please see www.nucc.org. AMA licensing contact: 312-464-5022 (AMA IP services)

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Co-Chair, Primary Editor	Melva Peters Jenaker Consulting melva@jenakerconsulting.com
Co-Chair, Primary Editor	John Hatem jnhatem@hotmail.com
Co-Chair	Scott Robertson PharmD scott.m.robertson@kp.org
Co-Chair	Jean Duteau jean@duteaudesign.com
Contributor	Dr Kai U. Heitmann Heitmann Consulting and Services, ART-DECOR Open Tools GmbH, HL7 Germany info@kheitmann.de
Contributor	Giorgio Cangioli, PhD Consultant, HL7 Italy giorgio.cangioli@gmail.com
Contributor	Tom de Jong VZVZ, HL7 The Netherlands tom@nova-pro.nl
Contributor	Dr Christof Geßner Gematik GmbH, HL7 Germany christof.gessner@gematik.de

Introduction

This Implementation Guide provides templates for Medication Order and Medication Statement that can be used by HL7 standards developers and external projects to develop models for pharmacy related content. The implementation guide is intended to provide consistency of pharmacy related models across all uses regardless of the method of transport by:

• creating a library of Universal pharmacy templates that can be used by other Work Groups to derive constrained versions.

Purpose

Background

Historically multiple HL7 Work Groups have developed specifications for pharmacy related content and as a result, there is inconsistency in the models that exist in HL7 V2, V3, CDA and FHIR. The Pharmacy Work Group often receives questions as to how to model pharmacy related content but in some cases, the use case cannot be met with the existing models.

This Implementation Guide provides a library of pharmacy templates that can be used by HL7 Work Groups or external projects to derive constrained versions of models for pharmacy related content.

Scope

The scope of the Implementation Guide is limited to Medication Order and Medication Statement. The content was developed by aligning and harmonizing the existing specifications for Consolidated CDA (C-CDA Release 2.1).

Future releases of the Implementation Guide will include Medication Dispense and Medication Administration.

Ballot Status of the Document

The Implementation Guide is being balloted as Informative with the intention to go to Standard for Trial Use (STU) and then to Normative.

Audience

• Clinical and Public Health laboratories
• Immunization Registries
• Pharmaceutical Vendors
• EHR/PHR vendors
• Clinical Decision Support Systems
• HIS Vendors
• Emergency Services Providers
• Healthcare Institutions
• Pharmacists
• Physicians and other Clinicians

Relationships with other projects and guides

• Consolidated CDA (C-CDA)
• HL7 Version 3 Pharmacy Models
• HL7 FHIR® Pharmacy Resources

Principles and background

Please Note

Nothing in here yet. Do we want to report about

• the new method to represent normal, split and tapered dose information in CDA Substance Administrations?
• do we want to tell people that we reduced the richness of the original Pharmacy V3 templates drastically to ease implementation?
• do we want to mention FHIR profile work that influenced heavily the development of the CDA templates?
• And/or more general other design principles?

Technical Background

In Review

What is a CDA

CDA R2 is "… a document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange” [CDA R2, Section 1.1]. Clinical documents, according to CDA, have the following characteristics:

• Persistence
• Stewardship
• Potential for authentication
• Context
• Wholeness
• Human readability

CDA defines a header for classification and management and a document body that carries the clinical record. While the header metadata are prescriptive and designed for consistency across all instances, the body is highly generic, leaving the designation of semantic requirements to implementation.

Templated CDA

CDA R2 can be constrained by mechanisms defined in the “Refinement and Localization” section of the HL7 Version 3 Interoperability Standards. The mechanism most commonly used to constrain CDA is referred to as “templated CDA”. This specification created a set of artefacts containing modular CDA templates (and associated value sets) for the purpose of the International Patient Summary, and the templates can be reused across any number of CDA document types.

There are different kinds of templates that might be created. Among them, the most common are:

• CDA Document Level Templates constrain fields in the Clinical Document Architecture (CDA) header, and define containment relationships to CDA sections.
  For example, a History-and-Physical document-level template might require that the patient’s name be present, and that the document contain a Physical Exam section.
• CDA Header Level Templates constrain fields for parts of the CDA header, like the patient (record target), the author, participations or the service event.
• CDA Section Level Templates constrain fields in the CDA section, and define containment relationships to CDA entries.
  For example, a Physical-exam section-level template might require that the section/code be fixed to a particular LOINC code, and that the section contain a Systolic Blood Pressure observation.
• CDA Entry Level Templates constrain the CDA clinical statement model in accordance with real world observations and acts.
  For example, a Systolic-blood-pressure entry-level template defines how the CDA Observation class is constrained (how to populate observation/code, how to populate observation/value, etc.) to represent the notion of a systolic blood pressure.

Open and Closed Templates

Open templates permit anything to be done in the underlying standard that is not explicitly prohibited. This allows templates to be built up over time that extend and go beyond the original use cases for which they were originally designed.

Closed templates only permit what has been defined in the template, and do not permit anything beyond that. There are good reasons to use closed templates, sometimes having to do with local policy. For example, in communicating information from a healthcare provider to an insurance company, some information may need to be omitted to ensure patient privacy laws are followed. Most templates developed for CDA are of the open sort.

Template versioning

Template versioning is needed to enable template designs to evolve over time.

Template versioning enables template designers to control and shape the conformances that make up a template’s design over time tailoring the design to fit the template’s intended purpose.

Each template version is associated with a particular template. The template – as a whole – has a mandatory globally unique, non-semantic, identifier. The identifier serves as the identifier of the original intent of the template and as the identifier of the set of versions that represent the template over time.

Template versions have a mandatory timestamp (date and optional time), called the “effective date”. The date can be seen as the point in time when the template version “came into being”, i.e. was recognized as existent by the governance group. Use of the template prior to this date would be considered an invalid use of the template.

For further information on Templates, Template Versions and related topics refer to the HL7 Templates Standard.

Identifiers for Templates and Value Sets

This specification uses the following OIDs for the artefacts that are registered at the HL7 OID registry.

• The root OID for templates is 2.16.840.1.113883.10.21
  • Document Level Templates are sub branch .1, e.g. 2.16.840.1.113883.10.21.1.1 XXXXXX
  • Header Level Templates are summarized under 2.16.840.1.113883.10.21.2, e.g. 2.16.840.1.113883.10.22.2.1 XXXXXX
  • Section Level Templates are summarized under 2.16.840.1.113883.10.21.3, e.g. 2.16.840.1.113883.10.22.3.1 XXXXXX
  • Entry Level templates are summarized under 2.16.840.1.113883.10.21.4, e.g. 2.16.840.1.113883.10.22.4.19 XXXXX
  • “other” assistance templates are summarized under 2.16.840.1.113883.10.21.9, e.g. 2.16.840.1.113883.10.22.9.2 XXXXX
• The root OID for Value Sets is 2.16.840.1.113883.11

The sub branches for templates follow the recommendations of HL7 International and ISO 13582

How to read this document

This is a ballot document. The provided text is subject to comments.

All artefacts (templates, value sets etc.) listed with the status Draft or Pending are subject to ballot comments.

Artefatcs with other status information, especially Final or Active are not (directly) part of the ballot and some artefacts are actually even used coming from different sources (references artefacts, indicated by the symbol

ref

). These references artefacts are also not subject to the ballot, as they might be balloted elsewhere already.

The PDF version contains a ruler on the left side of the page. A ruler has the page number on top of it and allows locating a line at the page by simply specifying the number at the scale tick. This is more precise and allows also commenting on graphics and pictures.

For example if you have a comment on page 29 because of a typo (see figure), you simply specify the error with its location p0029-04.

Of course you can also refer by classical chapter and section numbers. The use of the ruler has the ballot team's preference though.

To locate a typo on page 29 as a ballot comment, simply specify the location p0029-04.

Functional requirements and high-level use cases

The following use cases are relevant to the pharmacy domain for both community and institutional settings:

• Prescribing a medication (aka Prescription or Order or Request)
• Dispensing a medication
• Recording the administration of a medication
• Recording the use of a medication (in the past, current or future)

The following definitions are relevant to this Implementation Guide:

• “Prescribing” is an activity that can be performed by a variety of healthcare professionals and involves a variety of orderable items (see glossary entry). For the purposes of the following Implementation Guide, prescribing is defined as the act of prescribing a medication in either an ambulatory or an institutional setting. This could include initiating a new medication order or making all kinds of modifications to existing orders.
• “Dispensing” is an activity undertaken to fulfill the logistical requirements of a prescription. It supplies the materials needed to perform the prescribed actions by those who will perform them. Examples of dispensing include eyeglasses, contact lenses and medications. For the purposes of the following ballot material, dispensing is defined as supplying a medication in fulfillment of a prescription or medication order. While dispensing in these circumstances would usually be performed by a pharmacist, other health care providers such as nurses or physicians might also dispense medications.
• “Administration” is an activity undertaken to give medication to the patient. In the community, this process is usually not recorded, since the majority occurs in the patient's home; only administrations undertaken by a healthcare professional, such as vaccination, tend to be formally documented. Administration of medication in the institutional setting is usually recorded on a dose-by-dose basis, and may be messaged on that basis, or a summary of all the administrations occurring during an inpatient stay may be described.

Templates

Root Entry Level Templates

Entry Level Templates

Id	2.16.840.1.113883.10.21.5	Effective Date	valid from 2017‑01‑02
Status	Draft	Version Label
Name	SubstitutionPermission	Display Name	UV Substitution Permission
Description	Information about a substitution permission for this adminstration.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.21.5
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Used by / Uses	Used by 0 transactions and 1 template, Uses 0 templates Used by as Name Version 2.16.840.1.113883.10.21.1 Containment UV Medication Order 2015‑10‑07 17:53:30
Relationship	Specialization: template 2.16.840.1.113883.10.12.300 (2005‑09‑07)
Example	Example <act classCode="ACT" moodCode="DEF" negationInd="false">   <templateId root="2.16.840.1.113883.10.21.5"/>  <code code="TE" codeSystem="2.16.840.1.113883.5.1070" displayName="therapeutic alternative"/>  <entryRelationship typeCode="RSON">     <act classCode="ACT" moodCode="EVN">       <!-- Reason no substitution -->     </act>  </entryRelationship></act>
Item DT Card Conf Description Label hl7:act 1 … 1 M (Substit… @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F DEF @negationInd bl 0 … 1   Used to convey that the specified type of substitution is not allowed. hl7:templateId II 1 … 1 M (Substit… @root uid 1 … 1 F 2.16.840.1.113883.10.21.5 hl7:code CE 1 … 1 The type of substitution that this permission relates to. (Substit…   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16621 ActSubstanceAdminSubstitutionCode (DYNAMIC) hl7:entryRelationship 0 … 1 C Used when substitution is not allowed and may indicate the reason for why substitution is not allowed. (Substit… @typeCode cs 1 … 1 F RSON   Example <entryRelationship typeCode="RSON">   <code code="PAT" codeSystem="2.16.840.1.113883.5.8" displayName="Patient request">     <originalText>Patient objects</originalText>  </code></entryRelationship> hl7:act 1 … 1 (Substit… @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F EVN hl7:code CD 1 … 1 (Substit…   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19719 SubstanceAdminSubstitutionNotAllowedReason (DYNAMIC)   Schematron assert role  error     test not(hl7:entryRelationship[@typeCode='RSON']) or (@negationInd='true')     Message Only if substitution is not allowed indicate the reason for why substitution is not allowed

Appendix (Informative)

Acronyms and abbreviations

C-CDA Consolidated CDA
CDA Clinical Document Architecture
DSTU Draft Standard for Trial Use
EDQM European Directorate for the Quality of Medicines & Healthcare
EHR Electronic Healthcare Record
HL7 Health Level Seven
HP Healthcare Professional
IDMP IDentification of Medicinal Products (ISO Standard)
IHE Integrating the Healthcare Enterprise
ISO International Organization for Standardization
JIC Joint Initiative Council on SDO Global Health Informatics Standardization
LOINC Logical Observation Identifiers Names & Codes
MPID Medicinal Product Identifier
PCID Medicinal Product Package Identifier
PhPID(s) Pharmaceutical Product Identifier(s)
SDO Standard Developing Organization
STU Standard for Trial Use
UCUM Unified Code for Units of Measure

Glossary

• Prescribing is an activity that can be performed by a variety of healthcare professionals and involves a variety of orderable items (see glossary entry). For the purposes of the following Implementation Guide, prescribing is defined as the act of prescribing a medication in either an ambulatory or an institutional setting. This could include initiating a new medication order or making all kinds of modifications to existing orders.
• Dispensing is an activity undertaken to fulfill the logistical requirements of a prescription. It supplies the materials needed to perform the prescribed actions by those who will perform them. Examples of dispensing include eyeglasses, contact lenses and medications. For the purposes of the following ballot material, dispensing is defined as supplying a medication in fulfillment of a prescription or medication order. While dispensing in these circumstances would usually be performed by a pharmacist, other health care providers such as nurses or physicians might also dispense medications.
• Administration is an activity undertaken to give medication to the patient. In the community, this process is usually not recorded, since the majority occurs in the patient's home; only administrations undertaken by a healthcare professional, such as vaccination, tend to be formally documented. Administration of medication in the institutional setting is usually recorded on a dose-by-dose basis, and may be messaged on that basis, or a summary of all the administrations occurring during an inpatient stay may be described.

Integrated examples

The Medication on CDA specification releases are published at Project Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances. A set of use cases have been defined and represented in Medication on CDA format.

It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Validation artifacts

You can test your implementation (instances) against the Medication on CDA specification. To download materials to your computer for local testing and validation consider...

• ...the W3C schemas (actually valid for any CDA specification) located at the Project Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances.
• ..the ISO schematron, automatically generated by the tool. These are files to do validation locally by associating IPS CDA instances with the main schematron using an XML editor or to use the derived XSLT conversions and apply the according XSLT derivation to your local IPS CDA instance.

For further information you can follow the documentation.

Operational information

• The original specification is hosted on one of the ART-DECOR main servers, the project is reachable at the Live Project Landing Page.
• Any Medication on CDA specification release in HTML format resides at Project Publication Page. It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Licenses

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

• SNOMED CT: SNOMED International (formerly know as International Healthcare Terminology Standards Development Organization IHTSDO) or info@ihtsdo.org
• Logical Observation Identifiers Names & Codes (LOINC): The Regenstrief Institute, Inc.
• Unified Code for Units of Measure (UCUM) : Regenstrief Institute, Inc. and the UCUM Organization
• EDQM Standard Terms  : European Directorate for the Quality of Medicines & Healthcare (EDQM)

List of all artifacts used in this guide

CDA Templates

• 2.16.840.1.113883.10.21.1.1 xxxxx

Value Sets

• 2.16.840.1.113883.11.21.2 xxxxx
• 2.16.840.1.113883.11.22.3 xxxxy

References

Literature

• Keith W. Boone: The CDA TM Book. Springer 2011, ISBN 978-0-85729-336-7