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Primary Editor |
Giorgio Cangioli, PhD Consultant, HL7 Italy giorgio.cangioli@gmail.com
|
Primary Editor |
Rob Hausam Hausam Consulting LLC rob@hausamconsulting.com
|
Primary Editor |
Dr Kai U. Heitmann Heitmann Consulting and Services, HL7 Germany, ART-DECOR Open Tools GmbH info@kheitmann.de |
Primary Editor |
François Macary Phast francois.macary@phast.fr |
Contributor |
Dr Philip Scott HL7 UK philip.scott@uwtsd.ac.uk |
Contributor |
Dr Christof Geßner Gematik christof.gessner@gematik.de |
Contributor |
Dr Stefan Sabutsch ELGA, HL7 Austria stefan.sabutsch@elga.gv.at |
Contributor |
Gary Dickinson CentriHealth gary.dickinson@ehr-standards.com |
Contributor |
Catherine Chronaki HL7 International Foundation chronaki@gmail.com |
Contributor |
Dr Stephen Chu HL7 Australia chuscmi88@gmail.com |
Contributor |
Didi Davis The Sequoia Project ddavis@sequoiaproject.org |
Other Contributors |
Alexander Berler (a.berler@gnomon.com.gr) ; Carina Seerainer (carina.seerainer@elga.gv.at); John Roberts (John.A.Roberts@tn.gov); Julie James (julie_james@bluewaveinformatics.co.uk); Mark Shafarman (mark.shafarman@earthlink.net); Fernando Portilla (fportila@gmail.com); Ed Hammond (william.hammond@duke.edu); Steve Kay (s.kay@histandards.net) |
Introduction
Responsible: Philip Scott
In Review
The International Patient Summary (IPS) is a minimal and non-exhaustive patient summary, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.
Please Note
Missing some explanation about the actual meaning of “specialty-agnostic, condition-independent”: not specialty or condition filtered PS, focused on actual situation and not the patient history
non-exhaustive - not reproduce content of EHR... (Kai)
Purpose
The goal of this Implementation Guide is to identify the required clinical data, vocabulary and value sets for an international patient summary.
The international patient summary is specified as a templated document using HL7 CDA R2.
The primary use case is to provide support for cross-border emergency and unplanned care.
This specification aims to support:
- Cross-jurisdictional patient summaries (through adaptation/extension for multi-language and realm scenarios, including translation).
- Emergency and unplanned care in any country, regardless of language.
- Where possible, value sets based on international vocabularies that are usable and understandable in any country.
- Data and metadata for document-level provenance.
Project Background
This Implementation Guide has drawn upon the results of multiple previous projects on patient summaries (including but not limited to epSOS, ONC, Trillium Bridge, Sequoia eHealth Exchange), rules and recommendations for vocabularies and value sets (in multilingual settings) and templates for the implementation of international patient summary documents.
The idea of the International Patient Summary has been one of the main results of the 2010 EU/US Memorandum of Understanding through its two operational arms: the European project Trillium Bridge and the Interoperability of EHR work group formed under the ONC Standards and Interoperability Framework (ONC S&I) EU/US eHealth Cooperation Initiative[1].
These initiatives identified the need for common templates and vocabularies for the patient summary.
The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization has initiated the standard sets project with patient summary as its pilot; and the IPS became one of the main subjects of the new EU / US roadmap , having as declared goal “to enable a standardized international patient summary (IPS) to be in use by 2020”[2].
The first standardization activity concerning the IPS was initially promoted in April 2014 by ONC within HL7 International. The project was called “INTernational PAtient Summary (INTERPAS)”. In May 2016, the European Commission Granted an Agreement with CEN/ TC 251, recognizing the need to effectively support the leadership and active participation in IPS standardization activities. Thanks to the new boost from both the European Commission (EC) and ONC a revision of the HL7 project was started in May 2016, as well as the standardization activities in CEN/TC 251 for the European standards on Patient Summaries.
Since the beginning of this new phase, the initiatives were envisaged as a single common IPS project supported by different organizations; where the CEN/TC 251 and the HL7 teams worked together, taking in account the inputs of the JIC Standard Sets initiative on Patient Summary, with the common intent of developing coherent set of standards to support the International Patient Summary concept.
To expedite progress it was also agreed to set up an informal collaboration, promoting a continuous alignment process between the two SDO-specific projects, thanks also to a cross-participation in the project teams. Overlaps have thus been minimized: the CEN/TC 251 activities have been focused on the IPS dataset, formalized by the CEN/TC 251 European standard (EN) "The Patient Summary for Unscheduled, Cross-border Care" (the CEN/TC 251 EN PS in [Figure 1]); the HL7 ones on its implementation based on HL7 CDA R2 - this guide - and hopefully on FHIR (the HL7 IPS IGs in [Figure 1]). The figure shows how the products of these standardization activities are placed in the HL7 SAIF Interoperability Matrix.
[Figure 1] Standards in the HL7 SAIF Interoperability Matrix
A formal agreement between HL7 International and CEN/TC 251 has been finally signed in April 2017 in which these organizations established “in order to further the care for citizens across the globe <…> to collaborate on a single, common International Patient Summary (IPS) specification”); and that “the IPS specification shall focus on a minimal and non-exhaustive Patient Summary, which is specialty-agnostic and condition-independent, but still clinically relevant.”.
Scope
to be written
Responsible: Kai Heitmann
...a minimal and non-exhaustive patient summary, which is specialty-agnostic and condition-independent, but still clinically relevant.
...global use
General Principles for this Specification
With the formal agreement signed on April 2017 HL7 International and CEN/TC 251 expressed their intent to collaborate under the following principles for the IPS.
[Figure 2]The IPS Principles
- The standards specification for the IPS will be implementable
- Promote (the evolution and convergence of) existing standards
- Rely on solutions that are already implemented or ready for implementation
- Consider new or additional solutions as they become available
- The standards specification for the IPS will be applicable for global use
- Strive for global accessibility of standards for free
- Strive for a core set of globally accessible and usable terminologies and value sets
- Include free text in addition to the structured codes as needed
- Do not include local solutions in the core specification that are not available in other jurisdictions
- The standards specification will be extensible and open to future use cases and solutions
- The IPS provides common content that can be extended and specialized for other use cases, or localized for specific jurisdictional needs
- The IPS is open to emerging solutions for unresolved issues or improvements
- The standards specifications and their implementation must be sustainable through:
- A robust maintenance and update process for the IPS
- A process to ensure clinical validity of the IPS, meeting:
- clinical requirements (including workflow)
- clinical documentation requirements
- information quality requirements
Moreover HL7 International and CEN/TC 251 will manage the expectations of the IPS standards specifications among stakeholders, by
- stipulating the role of the IPS as a foundation for others to extend
- justifying the inclusion of items in the IPS within the limited context of unplanned (cross-border) care.
The more relevant consequences of these principles in the template design are:
- The adoption of a meet in the middle approach in the templates’ design to balance the need of maximizing the reuse of existing implemented templates (epSOS, C-CDA CCD; IHE PCC…) and facilitate implementers;with that of optimizing the fitness for purpose within the IPS scope. All this trying to avoid a pure technical exercise of templates harmonization; or, on the other hand, an academic exercise that does not take in account what is already implemented.
[Figure 3]The IPS meet-in-the-middle approach
- Cooperate with the HL7 Terminology Authority and the organizations that own the used code systems (e.g. SNOMED International) to make available a set of free value sets that could be globally usable when the IPS would be implemented.
- When global identifiers are not (or not yet) available, as in the case of the medicinal products, enhance the model proposed for that element with relevant identifying and descriptive attributes that could help the global identification of that element.
- Select a set of reference global terminologies, leaving however space for the inclusion of the locally used terminologies.
- Do not choose solutions (e.g. identifiers, terminologies, standards) , even promising in the resolution of some of the well-known issues (as the medicinal product identification), that are not yet available for concrete global use. When possible, the IPS has been however already designed in order to be ready when these solutions will be made available for real use (e.g. the IDMP identifiers) or to support since now the parts of those solutions that could be used today.
- Within the scope of the IPS and of the “implementable” principle, attempt to be enough generic in the design of the templates in order that the IPS templates might be hopefully extensible to support new scenarios; or specific specialties or conditions; through templates specialization or adaptation mechanisms.
Structuring Choices
The International Patient Summary is specified as a templated document using HL7 CDA R2. The specification has taken account of how FHIR represents equivalent concepts and in some cases has followed a FHIR style of representation rather than a conventional CDA style. The variations from CDA R2 are explained in the relevant detail sections. The mechanism for negation, unknown data and known absent data does not follow the CDA conventions and is explained here.
To be universally exchangeable, a patient summary must rely on multilingual international reference terminologies. The International Patient Summary defines SNOMED CT as a primary terminology (the meaning of "primary terminology" is explained in a later section) and it is used for the majority of value sets. Other primary terminologies used by this specification are LOINC for observations (e.g., laboratory tests) and document sections, UCUM for units of measure and EDQM for dose forms and routes.
This specification adopts ART-DECOR® as the specification platform for this Implementation Guide and uses the HL7 template exchange format. This tool and format are increasingly used by several regions, including European countries, and have been adopted by the EU eHealth Digital Service Infrastructure (eHDSI) project for the operational deployment of the EU cross-borders patient summary and ePrescription services.
Ballot Status of the Document
This Implementation Guide is STU with the intention to go normative.
Audience
The audience for this Implementation Guide includes:
Public
- Citizens who want to carry or access their healthcare data for emergency care purposes.
Regulatory
- Policy makers such as healthcare payers or government agencies.
- Healthcare information governance authorities and regulatory bodies.
Clinical
- Healthcare providers that offer unscheduled and emergency care.
- Healthcare providers that populate regional and national patient summaries.
Technical
- Vendors of EHRs unplanned care system, personal health records and mobile health data applications.
- System integrators.
- Organizations that manage regional and national patient summaries.
Relationships with other projects and guidelines
Responsible: Giorgio Cangioli
In Review
This guide is one of the products of the International Patient Summary project (see the Project Background section for details).
This project relates to a other projects and products as:
- The European Commission CEN/TC 251 Grant Agreement “The International Patient Summary Standards Project” (SA/CEN/GROW/EFTA/000/2015-16).
This project has as one of its goal “to participate in the creation of an International Patient Summary specification, at a global level, and turn this into a European standard, in line with the Guidelines on Minimum/Nonexhaustive Patient Summary Dataset for Electronic Exchange as adopted by the European eHealth Network"
Under this project two other standard work items have been promoted under CEN/TC 251:
- The CEN/TC 251 “prEN: The Patient Summary for Unscheduled, Cross-border Care”.
Its goal is to “formalise the dataset required to share information about the medical background and history of a patient …. It uses the European guidelines (version 2, November 2016) as an official source for the requirements….”
Even if it is an European standard it is designed to be applicable in a wider global context.
- The CEN/TC 251 “prTS: The International Patient Summary: Guidance for European Implementation Technical Specification.
Its goal is to “ ….provide implementation guidance to support the use of the International Patient Summary dataset in a European context….”
This document is focused on the European cross-country services.
[Figure 3]The European Commission CEN/TC 251 Grant Agreement
- The European eHealth Network Guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU. Release 2. (https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf).
This Guideline, together with the general guidelines for the electronic exchange of health data under Cross-Border Directive 2011/24/EU, document the clauses agreed among the European Countries to support the exchange of Patient Summary data for unscheduled care.
The relationships among these standards are shown in the figure included in the section Conformance clause below.
- The HL7 Consolidated CDA (C-CDA) implementation guide was developed and produced through the joint efforts of HL7, two Sub-Work Groups of the Office of the National Coordinator (ONC) Standards and Interoperability (S&I) Framework — Longitudinal Care Plan (LCP) and Long-Term Post-Acute Care (LTPAC) Transition) — and through the SMART C-CDA Collaborative hosted by ONC and Harvard Medical School. It provide a library of CDA templates for implementing a set of CDA documents.
This is one of the primary sources for this Implementation Guide.
- The IHE Patient Care Coordination (PCC) Cross-Enterprise Sharing of Medical Summaries (XDS-MS) – “defines a mechanisms to automate the sharing process between care providers of Medical Summaries, a class of clinical documents that contain the most relevant portions of information about the patient intended for a specific provider or a broad range of potential providers in different settings.”[ IHE Patient Care Coordination (PCC) 5 Technical Framework].
This is one of the primary sources for this Implementation Guide.
- eHealth Digital Service Infrastructure (eHDSI) Patient Summary Service. This European initiative operationalizes the work done by the epSOS and EXPAND projects for the implementation of European Cross-border services for the exchange of patient summaries and ePrescriptions. eHDSi specification are available at https://ec.europa.eu/cefdigital/wiki/display/EHOPERATIONS/Specifications.
This is one of the primary sources for this Implementation Guide.
- The Data Provenance is a ONC S&I Initiative addressing the “source data” challenge so that trust in the authenticity of the data can help inform decision making. The HL7 CDA® Release 2 Implementation Guide: Data Provenance, Release 1 is one of the products as result of joint efforts of Health Level Seven (HL7), and the Office of the National Coordinator (ONC) Standards and Interoperability Standards and Interoperability Framework-Data Provenance Initiative.
How to read this document
- Kai to write a paragraph
- Balloter instructions
Responsible: Kai Heitmann
Responsible: Kai Heitmann, Giorgio Cangioli
IPS Technical Background
Design conventions and principles
Responsible: Rob Hausam, François Macary
How to use terminologies (preferred binding)
As stated above, to be universally exchangeable the International Patient Summary must rely on international multilingual reference terminologies. To that effect, each codeable element of the international patient summary template is bound to a Value Set built upon an international reference terminology, such as SNOMED CT, LOINC, UCUM, EDQM Standard Terms. These reference terminologies have been selected to provide the preferred bindings for the codeable elements of the patient summary. They are the primary terminologies of this specification.
Nethertheless, it is anticipated that in some situations, a system producing an instance of patient summary might not support one or the other of these primary terminologies, supporting only a local inteface terminology instead. Similarly, it is also anticipated that the receiving system might in some cases not be able to use a code in a patient summary, either because this code belongs to a primary terminology that the receiving system does not support or because this code belongs to an interface terminology specific to the country of the producing system.
In order to maximize the international scope and usability of patient summaries, and also to accommodate the exceptional situations listed above, this specification makes these requirements:
- The Primary Code of a codeable element should be populated.
- If populated, the Primary Code of a codeable element shall be chosen from the primary terminology assigned to the value set bound to this element.
- The Display Name of the Primary Code shall be populated with a term representing this same code in the primary terminology, in the language chosen for the current instance of the patient summary.
- When the Primary Code is not populated, the Original Text shall be populated with a textual expression representing the meaning for the producer.
- One or more Alternate Codes from a local interface terminology may be provided, each with its associated Display Name.
Primary Code
In the data type for codeable elements (CD constrained by the CD.EPSOS template), the Primary Code is represented by the attributes @code, @displayName, @codeSystem, @codeSystemName, @codeSystemVersion.
Alternate Code
In the data type for codeable elements (CD constrained by the CD.EPSOS template), an Alternate Code is carried in a "translation" sub-element.
Original Text
In the data type for codeable elements (CD constrained by the CD.EPSOS template), the Original Text is provided in the "originalText" sub-element.
Representing "known absent" and "not known"
In Review
Responsible: Philip Scott, Giorgio Cangioli, Kai Heitmann, Francois Macary
In line with the properties of minimalism and non-exhaustiveness for the IPS (see the IPS definition above), and benefiting from the experience acquired with the European cross-borders services, this guide explicitly addresses two general situations:
- condition or activity unknown;
- condition or activity known absent.
Other kinds of negations such as: (a) the negation of an allergy to a specific agent; (b) the absence of a particular disease; or (c) the fact that a specific vaccination has not been performed; have been considered beyond the set of essential data for an IPS, even if it is not precluded to provide them.
This specification represents this core set of negations (“condition/activity unknown” and “condition/activity known absent” ) by leveraging the expressiveness of SNOMED CT to use explicit coded elements rather than relying on specific mechanisms of the underlying syntactical standard (such as nullFlavor and negationInd attributes for CDA).
The main reasons for this choice are:
- @negationInd in CDA has been superseded in V3 later by two other negation indicators: @actNegationInd and @valueNegationInd.
- To have a representation of the clinical content of the patient summary which is less dependent on a particular format or syntax, enabling a more practical path to transforming and exchanging data from one standard format (e.g., CDA R2) to another (e.g., FHIR).
- to provide one single method to express either the presence or absence of a particular condition (e.g., an allergy) or activity (e.g., an immunization), or the lack of knowledge regarding this kind of condition or activity, resulting in a more robust and easily implementable specification.
In some cases this required the creation of new SNOMED CT concepts. For example, a known absent Allergy/Intolerance would be represented by "716186003 |No known allergy (situation)|" (or any combination of its descendants), whereas no information about Allergy/Intolerance would be represented by a code with the meaning "Allergic disposition not known (situation)". For these cases an HL7 extension to SNOMED CT has been created, working for their future inclusion in the SNOMED CT International Release.
For the other kinds of negations, not explicitly mentioned in this guide, it is suggested to apply – where possible – the same approach.
Future versions of this guide may extend the number of cases covered and include new coded concepts for supporting them.
Uncoded information
An IPS originator may not be able to value a coded element with an appropriate coded concepts, but only with textual information.
This may happen for two reasons:
- the originator is not able to express the concept in the reference value sets;
- the originator is not able to express the concept in any known terminology.
The first case, assuming that the coding strength is CNE (coded, no extensions), is represented in this guide with the following assertion:
<code codeSystem=”2.16.840.1.113883.6.96” nullFlavor=”OTH” >
<originalText><reference value='#ref1'/></originalText>
</code>
That is expressing that there are no codes applicable in the referred code system (in the example SNOMED CT). Please note that according to this guide the text is documented in the section narrative and only referenced by the coded element.
Note: datatype R1 doesn't allow to specify that there are no codes applicable in the referred value set, as instead possible with datatype R2. Future versions of this guide may consider to extend the datatype to better support this situation.
The second case, that applies both to CNE and CWE (coded with extensions) coding strengths, is instead here represented valuing the coded element with the most generic nullFlavor “NI” (No Information) and pointing the text in the section narrative:
<value xsi:type=”CD” nullFlavor=”NI”>
<originalText><reference value='#ref1'/></originalText>
</value>
Note: the most proper nullFlavor to be used here would be "UNC" (Uncoded) but this code is not part of the nullFlavors foreseen by the CDA R2 standard.
Unmapped Coded Concepts
In several real world situations the records used as source for the Patient Summaries may use locally adopted terminologies mapped into the reference value sets. When the original coded concept cannot be mapped in one of the coded concepts included in the reference value sets, is recommended that the original code is reported in the IPS instance as well as the indication that the mapping didn’t occur. (See also the Concept code mapping in the functional requirements section.)
Two circumstances are here considered: the case in which the coding strength is CNE and when it is CWE.
In the case of coding strength CNE the following statement can be used to express that no appropriate target coded concepts were found:
<value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" nullFlavor=”OTH”>
[ <originalText><reference value='#ref1'/></originalText>]
<translation code="A02.9" codeSystem="2.16.840.1.113883.6.3" displayName="Infezioni da Salmonella non specificate"/>
</value>
The square brackets [ ] are used to indicate that the originalText element may or may not be present
Note: It may happen that a mapping would be possible in the target code system, but not in the target value set; datatype R1 doesn't allow to specify this difference, that is that there are no codes applicable in the reference value set, as instead possible with datatype R2. Future versions of this guide may consider to extend the datatype to better support this situation.
Even if, in case of CWE coding strength, it would be allowed to leave the orginal code as the primary code, this guide suggests that to highlight that a mapping to the reference value set was attempted and no suitable target codes were identified, it is reccomended to represent the original code in the <translation> sub-element and value with a nullFlavor the main coded element.
<value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" nullFlavor=”NI”>
[ <originalText><reference value='#ref1'/></originalText>]
<translation code="A02.9" codeSystem="2.16.840.1.113883.6.3" displayName="Infezioni da Salmonella non specificate"/>
</value>
The square brackets [ ] are used to indicate that the originalText element may or may not be present
Mapped coded concepts
As mentioned above in several circumstances an original coded concept is mapped into the reference value sets. When this happens both the original and the reference codes should be reported in the IPS instance.
Other conditions that should be considered are described in the Concept code mapping in the functional requirements section, and refer to the multiple coding; the preservation of the link to the original text; the mapping between a same code system.
All those aspects are considered in this section.
The simplest situation is the case of a single code mapped into a reference one, with original and reference codes belonging to different code systems. Hereafter the way to represent it:
<value xsi:type=”CD” code="42338000" codeSystem="2.16.840.1.113883.6.96" displayName="Salmonella gastroenteritis">
[ <originalText><reference value='#ref1'/></originalText>]
<translation code="003.0" codeSystem="2.16.840.1.113883.6.103" displayName="Gastroenterite da Salmonella"/>
</value>
The square brackets [ ] are used to indicate that the originalText element may or may not be present
The second example is the case in which the originator provides a multiple mapping. In this case if the primary code is one belonging to the reference value set noting should be done.
If not, as in the example below, all the original primary and alternate coded concepts are represented in a nested translation element, as described by the following example:
<value code="422479008" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, STAGE 2" xsi:type="CD">
<originalText><reference value="#problem4name"/></originalText>
<translation code="code-example" codeSystem="1.999.999" codeSystemName="this is only an example" displayName="FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, STAGE 2">
<translation code="174.9" codeSystem="2.16.840.1.113883.6.103" codeSystemName="ICD-9CM" displayName="Malignant neoplasm of breast (female), unspecified"/>
<translation code="C50.919" codeSystem="2.16.840.1.113883.6.90" codeSystemName="ICD-10-CM"displayName="Malignant neoplasm of unspecified site of unspecified female breast"/>
</translation>
</value>
The third case is when the original and the reference coded concepts belong to the same code system (distinct codes). This may be the result of a different level of granularity between the original and the reference value sets.
<code code="60591-5" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Patient Summary">
<translation code="60592-3 " codeSystem="2.16.840.1.113883.6.1" displayName="Patient summary unexpected contact "/>
</code>
Note: the R1 datatype definition identifies the <translation> as “a set of other concept descriptors that translate this concept descriptor into other code systems.”; there is however a common understanding that it “may be more than on representation in a single code system where code systems allow multiple representations, such as Snomed-CT”. Datatype R2 extended in fact the possibility to provide translations also in the same code system.
Translation of designations
The capability of recording one or more designations, in different languages, for the exchanged Patent Summary is one of the functional requirements requested for “safety and liability reasons” by the European Cross-border services (see Designations’ Translation under the Functional requirements and high-level use cases for more details).
It is known that there is not a “native” way to convey this kind of information using the coded descriptor (and derived) datatypes, in fact the @displayName attribute has cardinality 0..1 and the <translation> was designed for the coding translation, “that is to translate this concept descriptor into other code systems” and not for the translation of designations.
Note for balloters:
two options has been discussed and reported in this ballot version of this guide to collect feedback from ballotters.
- The first one is base on an optional extension to the CD datatype ;
- The second one doesn't require extensions, but some flexibility in the use of the <translation> element.
these two options are not mutually exclusive.
The first solution is based on an optional extension to the CD datatype ; A description of the extended CD and CE datatypes is provided in the Datatypes section.
Hereafter some examples of possible use of this extension in case of
No code mapping
<code code="60591-5" codeSystem="2.16.840.1.113883.6.1"codeSystemName="LOINC" displayName="Patient Summary">
<ips:designation lang=”it-IT” value="Profilo Sanitario Sintetico" />
<ips:designation lang=”fr-FR” value="Patient Summary" />
<ips:designation lang=”en” value="Patient Summary" />
</code>
Codes mapping
<value xsi:type=”CD” code="42338000" codeSystem="2.16.840.1.113883.6.96" displayName="Salmonella-gastroenterit">
<ips:designation lang=”da-DK” value=" Salmonella-gastroenterit" />
<ips:designation lang=”en” value="Salmonella gastroenteritis (disorder)" type=”FSN” />
[ <originalText><reference value='#ref1'/></originalText>]
<translation code="003.0" codeSystem="2.16.840.1.113883.6.103" displayName="Gastroenterite da Salmonella"/>
</value>
The second one doesn't require extensions, but it some flexibility in the use of the <translation> element.
In this case the language code can be declared.
No code mapping
<code code="60591-5" codeSystem="2.16.840.1.113883.6.1"codeSystemName="LOINC" displayName="Patient Summary">
<translation code="60591-5" codeSystem="2.16.840.1.113883.6.1"codeSystemName="LOINC" displayName="Profilo Sanitario Sintetico" />
</code>
Codes mapping
<value xsi:type=”CD” code="42338000" codeSystem="2.16.840.1.113883.6.96" displayName="Salmonella-gastroenterit">
[ <originalText><reference value='#ref1'/></originalText>]
<translation code="42338000" codeSystem="2.16.840.1.113883.6.96" displayName="Salmonella gastroenteritis">
<translation code="003.0" codeSystem="2.16.840.1.113883.6.103" displayName="Gastroenterite da Salmonella"/>
<translation />
</value>
Narrative Translations
With “narrative translation” is meant both the translation of the original narrative text, that can be human curated or automatically performed; and the generation of a translated narrative based on the coded entries.
The functional requirements associated to this process are described in the Designations’ Translation under the Functional requirements and high-level use cases section, and can be summarized in two main points : (a) language identification and (b) distinguishable original and translated narratives.
It would be moreover good if the methodology applied for the narrative translation (e.g. derived from the coded entries; translated by a generic service;..) should be recognizable.
Considering that only one <text> element is allowed for section, the solution suggested by this guide is to document the narrative translations into subordinate sections (one for translation) as described by the template 2.16.840.1.113883.10.22.3.15.
Hereafter an example:
<section>
<templateId root="2.16.840.1.113883.3.1937.777.13.10.5"/>
<id root="1.2.3.999" extension="--example only--"/>
<code code="48765-2" codeSystem="2.16.840.1.113883.6.1" displayName="Allergies and adverse reactions"/>
<title>Allergies and Intolerances</title>
<text>No known Allergies</text>
<!-- OMISSIS -->
<component>
<section>
<!-- subordinate section carrying a translation of the parent section -->
<title>Allergie ed Intolleranze</title>
<text>Nessuna Allergia Nota</text>
<languageCode code="it-IT"/>
</section>
</component>
</section>
Medicinal Product Identifications
In Review
Responsible: Giorgio Cangioli
The identification of medicinal products – that in general is quite-easily solved within a single jurisdiction relaying on local drugs databases – is instead one of the major still open issue for cross-jurisdictional services.
The set of ISO standards call IDMP [ref] - designed initially for the regulatory scopes, but hopefully extensible to other domains- are the most promising solution for solving this known issue as also highlighted by the European project OpenMedicine [ref]. The completion of the IDMP implementation guides; the deployment of the needed supporting services; the development of some companion standards that will allow the seamless flow of the IDMP identifiers and attributes from the regulatory space to the clinical world (and back) are however still in progress. Some further years are needed before these identifiers and attributes will be available for actual use.
Following therefore the IPS principles of “implementability” and “openness and extensibility” the solution here proposed will not then rely on the IDMP identifiers; being however already suitable for representing the IPS relevant IDMP identifiers and attributes: e.g. Pharmaceutical Product Identifiers (PhPIDs); Medicinal Product Identifier (MPID); Medicinal Product Package Identifier (PCID).
Note for ballotters: IPS members had no access to the latest version of the IDMP implementation guides; any indication that may help the alignment with those standards would be appreciated.
Note: IDMP Medicinal Product (MPID) and Medicinal Product Package (PCID) identifiers depends on the market authorization, the “same” product might therefore have different IDs if different authorizations have been required in different countries (the PhPID should be however the same). For the purpose of the IPS it might be useful if in future standards will be defined new global product identifiers that are independent by the drug registration process (as the Virtual Medicinal Product in SNOMED CT) and related to the IDMP identifiers.
Thus, in absence of a global identification system for products, the solution here proposed is based on the approach initially adopted by the European cross-border services (epSOS and currently by the eHDSI project), then reused by the IHE Pharmacy templates and more recently adopted (for specific cases) also by the HL7 Pharmacy Medication statement templates. The main idea is in fact that of integrating possible local drug identifiers (e.g. product codes) with all the relevant identifying and descriptive attributes that may help the receiver to understand the type of product the sender is referring to, e.g.: active ingredients; (administrable) dose forms; strengths; route of administration; package description.
Medicines data are usually represented in the CDA Templates using the class manufacturedMaterial, that includes a code and a name used for describing any level of product: packaged product, medicinal product, classes or clusters or products, and so on. This information is not however sufficient for covering the defined needs.
[Figure 4] Representation of medicines in CDA
Hence, in order to be able to describe these attributes an extension of the CDA model needs to be applied and this was done in epSOS enhancing the Manufactured Product and Material classes from the CDA model with the attributes and relationships derived from the Medication and Medicine classes from the R_Medication CMET.
The same design approach has been followed for this guide adopting the Common Product Model (R_ProductListed) instead.
This choice has been made:
- considering the expected use of this model (“The common product model is used to improve the alignment between the different representations of products used within the body of HL7 Version 3 models. One goal of this effort is to make it possible for there to be a single such representation, which could then be used as a common message element type (CMET) across those models.”)
- to eventually have a common implementable solution to represent the future IDMP identifiers and attributes in the IPS and in other document based standards (as SPL).
[Figure 5] shows how the CDA model has been enhanced with the Common Product Model: the relationship and classes of the CPM manufactured material (Product) class has been added as extensions to that of the CDA model (Material); the same has been done for the ManufacturedProduct classes.
[Figure 5] CDA model and the Common Product Model
Medication Statement
Responsible: Giorgio Cangioli, Kai Heitmann
Provenance
Responsible: Philip Scott; Gary Dickinson
In Review
In the development of this Implementation Guide, consideration was given to the HL7 CDA® Release 2 Implementation Guide: Data Provenance, Release 1 - US Realm Draft Standard for Trial Use (December 2015). That guide provides a matrix offering a thorough and systematic analysis of provenance characteristics of electronic health records. Given the agreed scope principle that the IPS be minimal and implementable, and the variable maturity and operational methods of existing national patient summaries, the proposal is that this first version should not attempt to require the full detail of that provenance specification.
The approach proposed for this version of the IPS is to:
- Require document-level, not section level, provenance.
- Define IPS document provenance as one of two types: human-curated or software-assembled.
- The classification is based on whether the IPS document is constructed by a human or an automated process, regardless of whether the IPS contains some content of both kinds.
- Require the IPS source system to identify the IPS document provenance type and "author".
- The "author" shall be a human, if the IPS provenance type is "human-curated", or a device or system if the IPS provenance type is "software-assembled".
- In the case of a "software-assembled" IPS that is then verified by a human, the document provenance type shall be "software-assembled" and the author shall be the device or system that constructed the IPS document, but an additional "verifier" identity shall name the human who performed this check. For the avoidance of doubt, this is not the same as legalAuthenticator. However, in cases where the verifying person intentionally wishes to sign the document, this shall be recorded as a legalAuthenticator.
- Allow optional section level author, provenance type, verifier and informant identification, for IPS source systems that can support this.
- Not attempt to implement the US Realm CDA data provenance templates.
The discussions with the EHR work group suggest that a possible future project should be an IPS functional profile, once there is greater clarity and operational experience of using the IPS.
General Implementation Guidance
Responsible: Kai Heitmann
- How to populate IDs in an CDA XML instance, e.g. ClinicalDocument.id, setId
- Where I can get IDs
- Relevant times for a patient summary
- Description of the different status definitions (condition, concern, observation) --> Giorgio
- (Authorship is probably a part to go to Provenance)
Conformance clause
Responsible: Stephen Kay, Giorgio Cangioli
In Review
This section references the requirements, criteria, or conditions to be satisfied in order that a product (tangible) or a service may claim conformance about this guide, and how other artefacts may claim compliance with it. (Note: The concept of conformance and compliance are used coherently with the HL7 Service-Aware Interoperability Framework: Canonical Definition Specification, Release 2[3]. The fulfilment of these clauses indirectly assure that a product that is subject of a “conformity assessment” satisfies the business or the design requirements this specification complies to. It should be however clear that the compliance with specified business or the design requirements, for example in the future with the CEN prEN IPS, doesn’t imply that the compliant implementations are technically interoperable. A “conformity assessment” is a process that assesses that any proposition that is true in a given specification, it is also true in the service or product that implements it. In most real-world cases conformance testing objects are used to technically validated the products. These objects provide a great help in the validation of the instances, even if it is not often these kind of validation is not self-sufficient to guarantee the functional/ semantic conformity: many real-life examples can be made about instances that are technically valid, but not clinically meaningful or correct.
[Figure 6] below depicts how this concept applies to the business requirements, the current and hopefully future IPS projects standards (CEN/TC 251 and HL7) and other related artefacts involved in this assessment chain. (see section Relationships with other projects and guidelines for a description of the standards developed by the CEN/TC 251 IPS project )
[Figure 6]The IPS World
The "rules" and processes for refining the standard through constraint and extension, including which standard artifacts are subject to constraint or extension; the definition of constraint and localization profiles; the criteria for establishing a conformance statement; and the principles guiding who may define extensions to the standards and under what circumstances that applies to the CDA standards are defined in § 1.3 CDA Conformance of the CDA and detailed in the HL7 V3 Refinement, Constraint and Localization section. (See the CDA R2 Standard[4])
There are no additional requirements to be applied for this guide for what concern the Recipient and the Originator Responsibilities.
The formal representation used in this implementation guide for expressing the conformance statement is described in section ZZZ of this guide and makes use of a tabular representation that may include also computable or textual constraints. The template rules are formalized using the computable format defined by the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1[5] in order to facilitate also the automatic generation of consistent testing objects.
This standard (i.e. the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 ) defines also how derived templates may relate to the templates defined in this guide for example:
- Specialization: “A specialized template is a narrower, more explicit, more constrained template based on a “parent” template.
- Adaptation: “The adapted template is “based on” the original template which means it can be an extension or a specialization (restriction) of the original template design.”
- Equivalency: “two templates have the same purpose and the same design; however, their governance and/or metadata and/or details of their design may be different.”
Based on this the following way to use this guide may be considered :
- IPS as a document: the conformance is asserted at the document level, all the rules defined by this guide, or by an IPS specialized document level template, are fulfilled. Implementers may take advantage of the template openness to better support specific cases, “extended” parts may be however not interoperable among them.
- IPS as a library: the conformance is asserted at the section or the entry level. The templates are used as a library to build, for example, new cross-border documents. For example the immunization section may be used to build an electronics implementation of the WHO yellow card for vaccinations; or the used section to send back a cross border encounter report after the Patient Summary has been used. Implementers may take advantage of the template openness to better support specific cases, “extended” parts may be however not interoperable among them.
- IPS as a reference: the implementation is conformant with templates that are adaptation or equivalent to those defined by this guide. In this case some of the rules defined by this guide are not fulfilled and the conformance cannot be asserted. However differences may be limited and the effort required to achieve the harmonization be not so huge. Typical examples are templates in which alternatives vocabularies are used.
Jurisdiction may also decide to impose the closure of the template in order to limit the implementation optionality, this should be carefully evaluated in term of flexibility of the solution.
Functional requirements and high-level use cases
Responsible: Giorgio Cangioli
In Review
Several cases may be identified for the International Patient Summary within its scope (“specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care”). Section Examples (in progress) provides examples of some real world user stories for the cross-border care developed by the Trillium Bridge Project and by the S&I EU-US eHealth Cooperation Initiative in the scope of the EU/US Roadmap initiative.
The cross-border care is not however the only expected usage scenario for the IPS: some European countries have already manifested their interest on the IPS work for their future national Patient Summary for unscheduled care.
As shown by the user stories there are several possible options for the IPS in term of creation, sharing and usage of an IPS, for example:
- an IPS could be a created when requested and used (before or during a care episode); or can be asynchronously generated and made available for future usage (e.g. store and retrieve).
- the IPS can be retrieved using a document exchange infrastructure; transported by the patient ; or shared using a cloud-services.
- the IPS may be subject of a transformation process, that may include syntactical conversions; coded concepts mappings and coded concept designation or free text translations. This transformation process may be performed in the creation phase; during the transmission or after the reception for example using an external service.
- Finally, the received CDA may be expected to be displayed using a common CDA stylesheet; may be used to extract some relevant information to be displayed by the EHR-S or to be incorporated into the receiver’s EHR; or a specialized viewer may be adopted to enable the display of the translated content.
Moreover for cross-organizations/jurisdictions exchange the IPS could be used as :
- shared format among jurisdictions (case A): jurisdictions originate and use IPS conformant documents;
- pivot document among existing summaries / data formats (case B): for example as intermediate format between the US C-CDA CCD (Please note that the CCD scope differs from that of the IPS) and the European eHDSI Patient Summary for a Transatlantic Patient Summary exchange.
- Or in a mixed mode (Case C): either the originator or the consumer are expected to use an IPS conformant document.
[Figure 7]Examples of IPS usage
Considering all those possible combinations and additional business requirements agreed by jurisdictions, the are several technical infrastructures and services that may be designed to support these requirements.
It is out of scope of this standard to provide any indication about solutions and strategies for the IPS creation, sharing, syntactical and semantic mapping, translation, use.
Having said that an International Patient Summary may be characterized by :
- being the result of an automatic assembling (assembled IPS) or of a human summarization act (human curated IPS)
- having one or more EHR sources
- document information from a single or multiple jurisdictions/organizations
- being the result of a single or multiple encounters
A clear determination of such a kind of contextual information helps the comprehension and the trustiness on the received IPS. Most of these aspects are related to the data provenance, introduced in section Provenance above.
Even if in many jurisdictions require that only one active Patient Summary for unscheduled care would be made available; no constraints on this purpose are imposed by this guide being this strongly dependent on the case for which this template is used.
Moreover it is also out of scope for this guide to :
- provide guidance on how to determine the relevancy of data for their inclusion in a IPS;
- define selection or composition rules for facing potential inconsistencies from multiple sources in case of automatic collection.
Code mappings and multilinguistic support
The capability of managing locally used coded concepts and reference terminologies, and that of providing receiving providers with human readable information in a language that can be understood by them, are critical aspects to be taken in account for the cross-border sharing of documents.
This section summarizes some of the requirements related to these aspects, including also additional needs derived from the European cross-border services and some lessons learned by the EU/US Trillium Bridge Project.
The European cross-border services (eHDSI see link to eHDSI) use a business to business exchange infrastructure based on a network of countries’ gateways that hide the national infrastructures; the eHDSI Patient Summary (eHDSI PS) is used as a “pivot” document for the cross-country exchange: local data/document formats are in fact remapped into the eHDSI PS; the document exchanged is processed each time it passes through one of these a gateway applying the needed syntactical transformations; codes mapping; codes designations’ translation; finally, in the current practice the received PSs are displayed using specialized display tools, that build a human readable representation of the PS in the target language using the translated designations reported in the coded entries.
The adoption of translated narratives in the received document has been one of the indications received by the Trillium Bridge Project. This in fact allows to extend the multi-linguistic support for the cross-border patient summaries to a wider set of potential consumers (EHR-Systems), without requiring specialized viewers as applied in the European services.
Concept code mapping
In several real world cases the records used as source for the Patient Summaries may use locally adopted terminologies that – when possible – are remapped into the reference value sets; or may be able in some cases to provide only uncoded information.
This leads to a series of requirements for the IPS that will be discussed in the Design conventions and principles section.
- When the original coded concept is mapped in one of the coded concepts included in the reference value sets (called hereafter reference code/coded concept), both the original and the reference codes should be reported in the IPS instance.
- When the original coded concept is not mapped in one of the coded concepts included in the reference value sets, the original code should be reported in the IPS instance as well as the indication that the mapping didn’t occur.
- When the original record, for a specific coded element, is not able to provide coded but only textual information, this information should be preserved in the IPS instance.
Moreover it should be taken in account that:
- The original record may support multiple coding, so that the IPS instance should be able to distinguish if the additional codes belong to the original content or they are the result of a coded concepts mapping.
- The original record may include references to the pieces of text the coding was derived from, if present, the IPS instance should preserve this link between the original code and the referred text.
- It may happen that distinct original and the reference coded concepts belong to the same code system. This may be the result of a different level of granularity between the original and the reference value sets; or of a format transformation (e.g. a CCD document is used as input for generating an IPS). Also for these cases the requirement of recording both coded concepts should be applied.
Note: in some jurisdiction (as the European Cross-border services) some of these should may be turned into a shall.
Multilinguistic support
The debate on the multi linguistic support for the IPS could be split in two distinct subjects:
- The translation of coded concept designations (displayName)
- The translation of the narrative
In both cases several options may be identified depending also on the use cases considered:
- The translation in the receiving country language: an IPS is prepared before a planned travel; a foreign provider retrieves a translated copy of the IPS from the patient country of affiliation;…
- The translation into a commonly agreed language: an English version of the IPS is prepared;..
- The predefined set of translations is included in the shared IPS.
Is out of the scope of this guide to suggest any of these solutions, all of them should be supported by this standard.
Designations’ Translation
Basically, the requirements related to the translation of the designations derive from the European Cross-border services imposing as functional requirements that for “safety and liability reasons” that all the terms (designations, displayName) associated to the original codes in the original language shall be recorded in the exchanged documents; together with the English and the receiving country language terms (designations, displayName) associated to the reference codes. The designations translated in the receiving country language are used for generating the human readable content shown to the receiving provider. No free text translation is applied in this case.
In order to accomplish this need, the IPS should have the capability of recording one or more designations, possibly indicating the language used.
Narrative Translation
With the term narrative translation two different concepts are covered:
- The translation of the original narrative text. This can be in principle:
- Human curated
- Automatically performed (e.g. using specialized or generic translation services)
- The creation of a new translated narrative based on the coded entries.
Different levels of quality and liability can be obtained depending on the solution adopted and on the translation service used.
It is out of the scope of this guide to suggest any of these solutions, in all the cases however:
- the language of the narrative should be identifiable
- the original and the translated narrative should be clearly distinguished
- the methodology applied for the narrative translation (e.g. derived from the coded entries; translated by a generic service;..) should be recognizable
Reading Guide
Responsible: Kai Heitmann
Description of formalisms used, symbols, icons, how to read ART-DECOR artefacts
CDA Document Level Templates
International Patient Summary
Id | 2.16.840.1.113883.10.22.1.1 | Effective Date | 2020‑07‑14 16:08:21 |
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Status | Draft | Version Label | 2021 |
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Name | HL7-IPS | Display Name | International Patient Summary |
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Description | The International Patient Summary is a "Minimal and non-exhaustive Patient Summary, specialty-agnostic, condition-independent, but readily usable by all clinicians for the unscheduled (cross-border) care of a patient." The IPS templates aim to: Serve for both
cross-jurisdictional (through adaptation/extension for multi-language and realm scenarios, including translation) and national (through localization) patient summaries. Support emergency care and unplanned care in any country (home and foreign), regardless of language Define value sets based on international vocabularies that are usable and
understandable in any country
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Context | Pathname / |
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Classification | CDA Document Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 21 templates | Used by | as | Name | Version |
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hl7ips-transaction-2 | Transaction | IPS Created (2020) | 2017‑04‑07 11:10:54 | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.2.1 | Include | IPS CDA recordTarget (2021) | DYNAMIC | 2.16.840.1.113883.10.22.2.2 | Include | IPS CDA author (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.2.3 | Include | IPS CDA custodian (2021) | DYNAMIC | 2.16.840.1.113883.10.22.2.4 | Include | IPS CDA legalAuthenticator (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.2.5 | Include | IPS Patient Contacts (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.2.6 | Include | IPS CDA documentationOf (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.2.7 | Include | IPS CDA relatedDocument (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.1 | Containment | IPS Medication Summary Section (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.2 | Containment | IPS Allergies and Intolerances Section (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.3.3 | Containment | IPS Problems Section (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.4 | Containment | IPS History of Procedures Section (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.5 | Containment | IPS Immunizations Section (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.6 | Containment | IPS Medical Devices Section (2021) | DYNAMIC | 2.16.840.1.113883.10.22.3.14 | Containment | IPS Results Section (STU1) | DYNAMIC | 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2 | Containment | IHE Coded Vital Signs Section (2014) | DYNAMIC | 2.16.840.1.113883.10.22.3.7 | Containment | IPS History of Past Illness Section (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.8 | Containment | IPS Functional Status Section (TI-2020) | DYNAMIC | 2.16.840.1.113883.10.22.3.9 | Containment | IPS Plan of Care Section (TI-2020) | DYNAMIC | 2.16.840.1.113883.10.22.3.10 | Containment | IPS Social History Section (TI-2020) | DYNAMIC | 2.16.840.1.113883.10.22.3.11 | Containment | IPS History of Pregnancy Section (TI-2020) | DYNAMIC | 2.16.840.1.113883.10.22.3.12 | Containment | IPS Advance Directives Section (TI-2020) | DYNAMIC |
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Relationship | Version: template 2.16.840.1.113883.10.22.1.1 International Patient Summary (2020‑05‑08 12:30:59) Version: template 2.16.840.1.113883.10.22.1.1 International Patient Summary (2017‑04‑11) Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.1.3 epSOS-Patient Summary (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.12.1 CDA ClinicalDocument (2005‑09‑07) ref ad1bbr- |
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Example | Example | <ClinicalDocument> <realmCode code="ES"/> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <templateId root="2.16.840.1.113883.10.22.1.1"/> <id root="2.16.724.4.8.10.200.10" extension="PSCTD0160f274530a031"/> <code displayName="Patient Summary" code="60591-5" codeSystem="2.16.840.1.113883.6.1"/> <title>Patient Summary</title> <effectiveTime value="20111113125600+0200"/> <confidentialityCode code="N" displayName="normal" codeSystem="2.16.840.1.113883.5.25"/> <languageCode code="es-ES"/> <setId root="2.16.724.4.8.10.200.10" extension="PSCTD0160f274530a031S"/> <versionNumber value="2"/> <!-- include template 2.16.840.1.113883.10.22.2.1 'IPS CDA recordTarget' (dynamic) 1..1 M --> <!-- include template 2.16.840.1.113883.10.22.2.2 'IPS CDA author' (dynamic) 1..* M --> <!-- include template 2.16.840.1.113883.10.22.2.3 'IPS CDA custodian' (dynamic) 1..1 M --> <!-- include template 2.16.840.1.113883.10.22.2.4 'IPS CDA legalAuthenticator' (dynamic) 0..1 R --> <!-- include template 2.16.840.1.113883.10.22.2.5 'IPS Patient Contacts' (dynamic) 0..* O --> <!-- include template 2.16.840.1.113883.10.22.2.6 'IPS CDA documentationOf ' (dynamic) 1..1 M --> <!-- include template 2.16.840.1.113883.10.22.2.7 'IPS CDA relatedDocument' (dynamic) 0..* R --> <component> <structuredBody classCode="DOCBODY"> <component> <!-- template 2.16.840.1.113883.10.22.3.1 'IPS Medication Summary Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.2 'IPS Allergies and Intolerances Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.3 'IPS Problems Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.4 'IPS History of Procedures Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.5 'IPS Immunizations Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.6 'IPS Medical Devices Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.7 'IPS History of Past Illness Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.14 'IPS Results Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.8 'IPS Functional Status Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.9 'IPS Plan of Treatment Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.10 'IPS Social History Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.11 'IPS History of Pregnancy Section' (dynamic) --> </component> <component> <!-- template 2.16.840.1.113883.10.22.3.12 'IPS Advance Directives Section' (dynamic) --> </component> </structuredBody> </component></ClinicalDocument> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | CDA header | (HL7-IPS) | | hl7:realmCode
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| CS | 0 … 1 | R | | (HL7-IPS) | | hl7:typeId
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| II | 1 … 1 | M | The clinical document typeId identifies the constraints imposed by CDA R2 on the content, essentially acting as a version identifier.
| (HL7-IPS) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.1.3 | | | @extension
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| st | 1 … 1 | F | POCD_HD000040 | | Example | <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> | | hl7:templateId
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| II | 1 … 1 | M | | (HL7-IPS) | | | @root
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| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.1.1 | | hl7:id
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| II | 1 … 1 | M | Unique identifier of this instance of the Patient Summary. | (HL7-IPS) | | hl7:code
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| CE.IPS | 1 … 1 | M | Determines the document type that is the "Patient Summary" document | (HL7-IPS) | | | @displayName
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| | 1 … 1 | R | | | | @code
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| CONF | 1 … 1 | F | 60591-5 | | | @codeSystem
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| 1 … 1 | F | 2.16.840.1.113883.6.1 (LOINC) | | Example | <code code="60591-5" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Patient Summary"/> | | | hl7:translation
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| CD.IPS | 0 … * | R | This element can be here used either to provide the originally used document code if this IPS is the result of a transformation. | (HL7-IPS) | | hl7:title
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| ST | 1 … 1 | M | ClinicalDocument/title is used for display purposes. | (HL7-IPS) | | Example | <title>Patient Summary</title> | | Example | <title>Profilo Sanitario Sintetico</title> | | hl7:effectiveTime
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| TS.IPS.TZ | 1 … 1 | M | Time of creation of the Patient Summary | (HL7-IPS) | | Example | <effectiveTime value="20111113125600+0200"/> | | hl7:confidentialityCode
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| CE.IPS | 1 … 1 | R | | (HL7-IPS) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16926 HL7 BasicConfidentialityKind (DYNAMIC) |
| | Example | <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="normal"/> | | hl7:languageCode
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| CS | 1 … 1 | M | Document Language Code | (HL7-IPS) | | Constraint | The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC) |
| | Example | <languageCode code="en-GB"/> | | Example | <languageCode code="fil-PH"/> | | Schematron assert | role | error | | | test | matches(@code,'[a-z]{2,3}-[A-Z]{2,3}') | | | Message | The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code) | | | hl7:setId
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| II | 0 … 1 | R |
This attribute “represents an identifier that is common across all document revisions”.
In the case the IPS instance is generated as result of one or more transformations (translation/transcoding) the setId is supposed to remain unchanged across all those transformations.
Implementers are recommended to use this attribute.
| (HL7-IPS) | | hl7:versionNumber
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| | 0 … 1 | R | | (HL7-IPS) | Included | 1 … 1 | M | from 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget (DYNAMIC) | | hl7:recordTarget
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| | 1 … 1 | M | | (HL7-IPS) | | | @typeCode
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| cs | 0 … 1 | F | RCT | | | @contextControlCode
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| cs | 0 … 1 | F | OP | | Example | <recordTarget typeCode="RCT" contextControlCode="OP"> <patientRole classCode="PAT"> <id root="1.2.3.999" extension="__example only__"/> <addr> <streetAddressLine>HSE M CASSAR STR</streetAddressLine> <city>ISLA</city> <country>MT</country> </addr> <telecom use="HP" value="tel:+356124567891"/> <telecom use="WP" value="mailto:elif@foo.too.mt"/> <patient> <name> <family>BORG</family> <given>TANIA</given> </name> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <birthTime value="19430130"/> <!-- Optional guardian information ; see example below--> <!-- Optional languageCommunication information see example below --> </patient> </patientRole></recordTarget> | | | hl7:patientRole
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| | 1 … 1 | M | | (HL7-IPS) | | | hl7ips-dataelement-2.1 | Patient Attributes | CEN/TC 251 prEN 17269 |
| | cs | 0 … 1 | F | PAT | | II | 1 … * | R | Patient Identifiers: Primary Patient Identifier (Regional/National Health Id), Secondary Patient Identifier (Social/Insurance Number) | (HL7-IPS) | | | hl7ips-dataelement-202 | Healthcare related Identifiers | CEN/TC 251 prEN 17269 | hl7ips-dataelement-7 | Insurance identifier | CEN/TC 251 prEN 17269 |
| | AD.IPS | 1 … * | R | The patient address. | (HL7-IPS) | | | hl7ips-dataelement-162 | Address | CEN/TC 251 prEN 17269 |
| | Constraint | When used for cross-border exchange the country address part has to be provided. | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (HL7-IPS) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's Country. | (HL7-IPS) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | TEL | 1 … * | R | Patient’s telecom information : e.g. telephone number, e-mail address. | (HL7-IPS) | | | hl7ips-dataelement-100 | Telecoms | CEN/TC 251 prEN 17269 |
| | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | Example | <telecom use="HP" value="tel:+356124567891"/> | | Example | <telecom use="WP" value="mailto:elif@foo.too.mt"/> | | Example | <telecom nullFlavor="NI"/> | | | 1 … 1 | M | | (HL7-IPS) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | Example | Japanese example (Person Name) <patient> <name use="IDE"> <family>木村</family> <given>通男</given> </name> <name use="SYL"> <family>きむら</family> <given>みちお</given> </name> <name use="ABC"> <family>KIMURA</family> <given>MICHIO</given> </name> <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1" displayName="Male"/> <birthTime nullFlavor="UNK"/></patient> | | PN | 1 … * | M | Patient Name | (HL7-IPS) | | | hl7ips-dataelement-3 | Patient's name | CEN/TC 251 prEN 17269 |
| | Constraint | The Alphabetic representation of the name SHALL be always provided | | | 1 … * | R | Patient's Family Name/Surname | (HL7-IPS) | | | 1 … * | R | Patient's Given Name | (HL7-IPS) | | | | | hl7:administrativeGenderCode
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| CE.IPS | 1 … 1 | R | Patient's Gender | (HL7-IPS) | | | hl7ips-dataelement-4 | Administrative gender | CEN/TC 251 prEN 17269 |
| | cs | 0 … 1 | F | UNK | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.1 Administrative Gender (HL7 V3) (DYNAMIC) |
| | Example | <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"> <translation code="2" codeSystem="2.16.840.1.113883.3.129.1.2.21" codeSystemName="Cinsiyet" displayName="Kadın"/></administrativeGenderCode> | | TS | 1 … 1 | R | Patient's Date of Birth. The patient date of birth may be a partial date such as only the year. | (HL7-IPS) | | | hl7ips-dataelement-5 | Date of birth | CEN/TC 251 prEN 17269 |
| | | 0 … * | R |
The guardians of a patient.
Other patient contacts are described using the /ClinicalDocument/participant structure. The <associatedEntity> element defines the type of contact.
| (HL7-IPS) | | cs | 1 … 1 | F | GUARD | | Example | <guardian classCode="GUARD"> <code code="AUNT" displayName="tante" codeSystem="2.16.840.1.113883.5.111"/> <addr nullFlavor="NI"/> <telecom use="MC" value="tel:+33-12345678"/> <guardianPerson> <name> <family>Curie</family> <given>Marie</given> </name> </guardianPerson></guardian> | | CD.IPS | 0 … 1 | R | The relationship between the patient and the guardian or other contact may be recorded in the element. | (HL7-IPS) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19563 PersonalRelationshipRoleType (DYNAMIC) |
| | AD.IPS | 1 … * | R | | (HL7-IPS) | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.
| Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (HL7-IPS) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's Country. | (HL7-IPS) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | TEL | 1 … * | R | Guardian’s telecom information: e.g. telephone number; e-mail address. | (HL7-IPS) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | | 1 … 1 | R | | (HL7-IPS) | | PN | 1 … * | R | Patient Guardian's Name | (HL7-IPS) | | ENXP | 1 … * | R | Patient Guardian's Family Name/Surname | (HL7-IPS) | | ENXP | 1 … * | R | Patient Guardian's Given Name | (HL7-IPS) | | | | | hl7:languageCommunication
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| | 0 … * | R | | (HL7-IPS) | | CS | 1 … 1 | R | Patient’s language | (HL7-IPS) | | | hl7ips-dataelement-135 | Patient’s preferred language | CEN/TC 251 prEN 17269 |
| | Constraint | The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC) |
| | Example | British English <languageCode code="en-GB"/> | | Example | Amurdak (Australia) <languageCode code="amg-AU"/> | | Schematron assert | role | error | | | test | matches(@code,'[a-z]{2,3}-[A-Z]{2,3}') | | | Message | The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code) | | Included | 1 … * | M | from 2.16.840.1.113883.10.22.2.2 IPS CDA author (DYNAMIC) | | hl7:author
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| | 1 … * | M | | (HL7-IPS) | | | @typeCode
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| cs | 0 … 1 | F | AUT | | | @contextControlCode
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| cs | 0 … 1 | F | OP | | Example | <author> <time value="201212290600+0100"/> <assignedAuthor> <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/> <addr use="WP"> <streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country> </addr> <telecom use="WP" value="tel:+39-051-34343434"/> <assignedPerson> <name> <given>Paolo</given> <family>Rossi</family> </name> </assignedPerson> </assignedAuthor> <representedOrganization> <!-- template 'IPS CDA Organization' (dynamic) --> </representedOrganization></author> | | | hl7:functionCode
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| CE.IPS | 0 … 1 | R | | (HL7-IPS) | | | hl7:time
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| TS.IPS.TZ | 1 … 1 | R | The author/time element represents the start time of the author’s participation in the creation of the clinical document. | (HL7-IPS) | | Example | <time value="201212290600+0100"/> | | | hl7:assignedAuthor
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| | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | F | ASSIGNED | | II | 1 … * | R | Author Identifier(s) | (HL7-IPS) | | cs | 0 … 1 | | | | CE.IPS (extensible) | 0 … 1 | R | A code, which identifies the profession/competence/specialty of the author when it is a person. | (HL7-IPS) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) |
| | Example | <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors"/> | | AD.IPS | 1 … * | R | | (HL7-IPS) | | Example | <addr use="WP"> <streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country></addr> | | TEL.IPS | 1 … * | R | | (HL7-IPS) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | url | 0 … 1 | | | | Example | <telecom use="WP" value="tel:+39-051-34343434"/> | | Example | <telecom nullFlavor="NI"/> | Choice | 1 … 1 | | Elements to choose from:- hl7:assignedPerson
- hl7:assignedAuthoringDevice
| | | 0 … 1 | C | | (HL7-IPS) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the person (e.g. the Healthcare Professional) authoring this document | (HL7-IPS) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | | (HL7-IPS) | | | 1 … * | R | | (HL7-IPS) | | | | | hl7:assignedAuthoringDevice
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| | 0 … 1 | C | | (HL7-IPS) | | Example | <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/></assignedAuthoringDevice> | Included | | | from 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) | | cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (HL7-IPS) | | | | | | hl7:manufacturerModelName
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| SC | 0 … 1 | | | (HL7-IPS) | | SC | 0 … 1 | | | (HL7-IPS) | | | | hl7:representedOrganization
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| | 0 … 1 | R | | (HL7-IPS) | Included | | | from 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) | | cs | 1 … 1 | F | ORG | | cs | 1 … 1 | F | INSTANCE | | II | 1 … * | R | | (HL7-IPS) | | cs | 0 … 1 | | | | ON | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | | | | TEL | 1 … * | R | | (HL7-IPS) | | set_cs | 1 … 1 | R | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | | | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | AD.IPS | 1 … 1 | R | | (HL7-IPS) | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (HL7-IPS) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's Country. | (HL7-IPS) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | Included | 1 … 1 | M | from 2.16.840.1.113883.10.22.2.3 IPS CDA custodian (DYNAMIC) | | hl7:custodian
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| | 1 … 1 | M | | (HL7-IPS) | | | @typeCode
|
| cs | 0 … 1 | F | CST | | Example | <custodian typeCode="CST"> <assignedCustodian classCode="ASSIGNED"> <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE"> <!-- template 'IPS CDA Organization' (dynamic) --> </representedCustodianOrganization> </assignedCustodian></custodian> | | | hl7:assignedCustodian
|
| | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | F | ASSIGNED | | | | hl7:representedCustodianOrganization
|
| | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | F | ORG | | cs | 0 … 1 | F | INSTANCE | | II | 1 … * | R | | (HL7-IPS) | | cs | 0 … 1 | | | | ON | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | | | | TEL | 1 … 1 | R | | (HL7-IPS) | | set_cs | 1 … 1 | R | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | | | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | AD.IPS | 1 … 1 | R | | (HL7-IPS) | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (HL7-IPS) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's Country. | (HL7-IPS) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | Included | 0 … 1 | R | from 2.16.840.1.113883.10.22.2.4 IPS CDA legalAuthenticator (DYNAMIC) | | hl7:legalAuthenticator
|
| | 0 … 1 | R | | (HL7-IPS) | | Example | <legalAuthenticator> <time value="20111013150937-0800"/> <signatureCode code="S"/> <assignedEntity> <id extension="admin" root="2.16.17.710.780.1000.903.1.1.3.3"/> <assignedPerson> <name> <given>John</given> <family>Español Smith</family> </name> </assignedPerson> <representedOrganization> <name>Healthcare Facility's name</name> <addr> <country>NL</country> <streetName>Duinweg</streetName> <houseNumber>23</houseNumber> <postalCode>7364 RX</postalCode> <city>Amsterdam</city> </addr> </representedOrganization> </assignedEntity></legalAuthenticator> | | | hl7:time
|
| TS.IPS.TZ | 1 … 1 | M | Time of signing the document | (HL7-IPS) | | | hl7:signatureCode
|
| CS | 0 … 1 | R | Signature code | (HL7-IPS) | | CONF | 0 … 1 | F | S | | | hl7:assignedEntity
|
| | 0 … 1 | R | The entity that is responsible for the legal authentication of the CDA document | (HL7-IPS) | | | 1 … * | R | Unique identification of legal authenticator | (HL7-IPS) | | AD.IPS | 1 … * | R | | (HL7-IPS) | | TEL.IPS | 1 … * | R | | (HL7-IPS) | | | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the legal authenticator | (HL7-IPS) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | HP Family Name/Surname | (HL7-IPS) | | | 1 … * | R | HP Given Name | (HL7-IPS) | | | | hl7:representedOrganization
|
| | 1 … 1 | M | Organization the legal authenticator is acting for Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) | (HL7-IPS) | Included | 0 … * | | from 2.16.840.1.113883.10.22.2.5 IPS Patient Contacts (DYNAMIC) | | hl7:participant
|
| | 0 … * | R | Patient contacts or the Preferred Health Professional to contact in case of emergency. | (HL7-IPS) | where [hl7:templateId/@root='2.16.840.1.113883.10.22.2.5'] | | | | hl7ips-dataelement-154 | Patient’s Address Book | CEN/TC 251 prEN 17269 | hl7ips-dataelement-163 | Preferred Healthcare providers | CEN/TC 251 prEN 17269 |
| | | @typeCode
|
| cs | 1 … 1 | F | IND | | Example | <participant typeCode="IND"> <templateId root="2.16.840.1.113883.10.22.2.5"/> <associatedEntity classCode="NOK"> <addr> <streetAddressLine>Promenade des Anglais 111</streetAddressLine> <city>Lyon</city> <postalCode>69001</postalCode> <country>FR</country> </addr> <telecom value="tel:(+33)555-20036" use="WP"/> <associatedPerson> <name> <given>Martha</given> <family>Mum</family> </name> </associatedPerson> </associatedEntity></participant> | | | hl7:templateId
|
| II | 1 … 1 | M | | (HL7-IPS) | | uid | 1 … 1 | F | 2.16.840.1.113883.10.22.2.5 | | | hl7:functionCode
|
| | 0 … 1 | C | The <functionCode> element may be used to indicate that this participant is the preferred Health Professional to contact in case of emergency.</functionCode> | (HL7-IPS) | | CONF | 0 … 1 | F | PCP | | 0 … 1 | F | 2.16.840.1.113883.5.88 (Participation Function) | | | hl7:associatedEntity
|
| | | R | The <associatedEntity> element identifies the type of contact. </associatedEntity> | (HL7-IPS) | | cs | 1 … 1 | R | | | CONF | The value of @classCode shall be drawn from value set 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes (DYNAMIC) |
| | Example | <associatedEntity classCode="ECON"> <addr> <streetAddressLine>Karl Strasse</streetAddressLine> <city>Freiberg</city> <postalCode>09599</postalCode> <country>DE</country> </addr> <telecom value="tel:+49-761-11110000" use="WP"/> <associatedPerson> <name> <given>Arzt</given> <family>Guter</family> </name> </associatedPerson></associatedEntity> | | CV.IPS | 0 … 1 | R | This element indicates the relationship between the patient and this participant. | (HL7-IPS) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.54 IPS Personal Relationship (DYNAMIC) | or | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) |
| | Example | <code code="AUNT" displayName="θεία" codeSystem="2.16.840.1.113883.5.111"/> | | AD.IPS | 1 … * | R | Patient Contact's / Preferred HP's Address | (HL7-IPS) | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (HL7-IPS) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (HL7-IPS) | | ADXP | 0 … 1 | C | Subject's Country. | (HL7-IPS) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | TEL | 1 … * | R | Patient Contact's / Preferred HP's/Legal Organization telephone or e-mail <telecom> element is required.</telecom> | (HL7-IPS) | | | hl7ips-dataelement-169 | Telecoms | CEN/TC 251 prEN 17269 | hl7ips-dataelement-174 | Telecoms | CEN/TC 251 prEN 17269 |
| | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present
| | Example | <telecom use="WP" value="tel:+45 20 7025 6161"/><telecom use="HP" value="mailto:jsmith@myprovider.co.uk"/> | Choice | 1 … 2 | | Elements to choose from:- hl7:associatedPerson
- hl7:scopingOrganization
| | | 0 … 1 | C | Or the associatedPerson, or the scopingOrganization, or both elements shall be provided | (HL7-IPS) | | | hl7ips-dataelement-165 | Healthcare Provider (person) | CEN/TC 251 prEN 17269 |
| | PN | 1 … * | R | Patient Contact's Name / Preferred HP's Name | (HL7-IPS) | | | hl7ips-dataelement-121 | Name | CEN/TC 251 prEN 17269 |
| | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | Patient Contact's Family Name/Surname / Preferred HP's Family Name/Surname | (HL7-IPS) | | | 1 … * | R | Patient Contact's Given Name / Preferred HP's Given Name | (HL7-IPS) | | | 0 … 1 | C | Or the associatedPerson, or the scopingOrganization, or both elements shall be provided | (HL7-IPS) | | | hl7ips-dataelement-166 | Healthcare Provider (organisation) | CEN/TC 251 prEN 17269 |
| | ON | 1 … * | R | Organization's Name | (HL7-IPS) | | | hl7ips-dataelement-172 | Organisation’s Name | CEN/TC 251 prEN 17269 |
| Included | 1 … 1 | M | from 2.16.840.1.113883.10.22.2.6 IPS CDA documentationOf (DYNAMIC) | | hl7:documentationOf
|
| | 1 … 1 | M | The documentationOf relationship in an International Patient Summary contains the representation of providers who are wholly or partially responsible for the safety and well-being of a subject of care. | (HL7-IPS) | | | @typeCode
|
| cs | 0 … 1 | F | DOC | | Example | <documentationOf> <serviceEvent classCode="PCPR"> <effectiveTime> <low nullFlavor="NI"/> <high value="20110308"/> </effectiveTime> <performer typeCode="PRF"> <!-- See example below --> </performer> </serviceEvent></documentationOf> | | | hl7:serviceEvent
|
| | 1 … 1 | R | The main activity being described by a IPS is the provision of healthcare over a period of time. This is shown by setting the value of serviceEvent/@classCode to “PCPR” (care provision) and indicating the duration over which care was provided in serviceEvent/effectiveTime. Additional data from outside this duration may also be included if it is relevant to care provided during that time range (e.g., reviewed during the stated time range).
For example if the IPS is generated by a GP based on information recorded in his/her EHR-S, then the low value should represent the date when the treatment relationship between the patient and the GP started; and the high value the date of the latest care event. | (HL7-IPS) | | cs | 1 … 1 | F | PCPR | | cs | 1 … 1 | F | EVN | | II | 0 … * | R | | (HL7-IPS) | | IVL_TS | 1 … 1 | R | | (HL7-IPS) | | TS | 1 … 1 | R | | (HL7-IPS) | | TS | 1 … 1 | R | | (HL7-IPS) | | | 0 … * | R | It represents the healthcare providers involved in the current or pertinent historical care of the patient. Preferably, the patient’s key healthcare providers would be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors | (HL7-IPS) | | cs | 1 … 1 | R | | | CONF | The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19601 x_ServiceEventPerformer (DYNAMIC) |
| | Example | <performer typeCode="PRF"> <assignedEntity> <id assigningAuthorityName="MEF" displayable="false" extension="DVLMMG57R07F205G" root="2.16.840.1.113883.2.9.4.3.2"/> <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors"> <translation codeSystem="2.16.840.1.113883.2.9.5.1.111" code="MMG" displayName="Medico di Medicina Generale"/> </code> <addr nullFlavor="NI"/> <telecom nullFlavor="NI"/> <assignedPerson> <name> <family>DVALUNO</family> <given>MMG</given> </name> </assignedPerson> <representedOrganization> <id assigningAuthorityName="A.S.L. DELLA PROVINCIA DI LECCO" extension="030305" root="2.16.840.1.113883.2.9.4.1.1"/> <name>A.S.L. DELLA PROVINCIA DI LECCO</name> <telecom nullFlavor="NI"/> <addr> <state>LECCO</state> <city>LECCO</city> <country>IT</country> <postalCode>23900</postalCode> <streetAddressLine>CORSO CARLO ALBERTO,120</streetAddressLine> </addr> </representedOrganization> </assignedEntity></performer> | | CE.IPS | 0 … 1 | R | | (HL7-IPS) | | IVL_TS.IPS.TZ | 0 … 1 | R | | (HL7-IPS) | | | 1 … 1 | M | | (HL7-IPS) | | II | 1 … * | R | Healthcare provider ID number | (HL7-IPS) | | CE.IPS (extensible) | 0 … 1 | R | It describes the professional role of the healthcare provider involved in the current or pertinent historical care of the patient. | (HL7-IPS) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) |
| | AD.IPS | 1 … * | R | | (HL7-IPS) | | TEL.IPS | 1 … * | R | | (HL7-IPS) | | | 0 … 1 | | | (HL7-IPS) | Included | | | from 2.16.840.1.113883.10.22.9.3 IPS CDA Person (DYNAMIC) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | | (HL7-IPS) | | | | | | hl7:representedOrganization
|
| | 0 … 1 | | Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) | (HL7-IPS) | Included | 0 … 2 | R | from 2.16.840.1.113883.10.22.2.7 IPS CDA relatedDocument (DYNAMIC) | | Constraint | A conformant CDA document can have:
- a single relatedDocument with typeCode "APND"; OR
- a single relatedDocument with typeCode "RPLC"; OR
- a single relatedDocument with typeCode "XFRM"; OR
- a combination of two relatedDocuments with typeCodes "XFRM" and "RPLC"; OR
- a combination of two relatedDocuments with typeCodes "XFRM" and "APND".
No other combinations are allowed.
| | hl7:relatedDocument
|
| | 0 … 2 | R | | (HL7-IPS) | | | @typeCode
|
| cs | 1 … 1 | R | | | CONF | The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.11610 x_ActRelationshipDocument (DYNAMIC) |
| | | hl7:parentDocument
|
| | 1 … 1 | R | | (HL7-IPS) | | cs | 0 … 1 | F | DOCCLIN | | cs | 0 … 1 | F | EVN | | II | 1 … * | R | | (HL7-IPS) | | CD.IPS | 0 … 1 | R | | (HL7-IPS) | | CONF | 0 … 1 | F | 2.16.840.1.113883.6.1 (LOINC) | | ED | 0 … 1 | R | | (HL7-IPS) | | II | 0 … 1 | R | | (HL7-IPS) | | INT | 0 … 1 | R | | (HL7-IPS) | | hl7:component
|
| | 1 … 1 | M | | (HL7-IPS) | | | hl7:structuredBody
|
| | 1 … 1 | M | Note: the proposed order of the sections hereafter indicated is not mandatory | (HL7-IPS) | | cs | 0 … 1 | F | DOCBODY | | | 1 … 1 | M | Contains 2.16.840.1.113883.10.22.3.1 IPS Medication Summary Section (DYNAMIC) | (HL7-IPS) | | | 1 … 1 | M | Contains 2.16.840.1.113883.10.22.3.2 IPS Allergies and Intolerances Section (DYNAMIC) | (HL7-IPS) | | | 1 … 1 | M | Contains 2.16.840.1.113883.10.22.3.3 IPS Problems Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | R | Contains 2.16.840.1.113883.10.22.3.4 IPS History of Procedures Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | R | Contains 2.16.840.1.113883.10.22.3.5 IPS Immunizations Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | R | Contains 2.16.840.1.113883.10.22.3.6 IPS Medical Devices Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | R | Contains 2.16.840.1.113883.10.22.3.14 IPS Results Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | R | Contains 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2 IHE Coded Vital Signs Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.7 IPS History of Past Illness Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.8 IPS Functional Status Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.9 IPS Plan of Care Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.10 IPS Social History Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.11 IPS History of Pregnancy Section (DYNAMIC) | (HL7-IPS) | | | 0 … 1 | | Contains 2.16.840.1.113883.10.22.3.12 IPS Advance Directives Section (DYNAMIC) | (HL7-IPS) |
|
IPS CDA author
Id | 2.16.840.1.113883.10.22.2.2 | Effective Date | 2017‑04‑11 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSCDAauthor | Display Name | IPS CDA author |
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Description | A CDA document shall have at least one author. Authors could be either human (ClinicalDocument/author/assignedAuthor/assignedPerson) either devices (ClinicalDocument/author/assignedAuthor/assignedAuthoringDevice). For definition “The author element represents the creator of the clinical document. If the role of the actor is the entry of information
from his or her own knowledge or application of skills, that actor is the author. If one actor provides information to another actor who filters, reasons, or algorithmically creates new information, then that second actor is also an author, having created information from his or her own knowledge or skills.” [From Implementation Guide for CDA Release 2: Imaging Integration – UV Realm, March 2009]. According to this definition, not any device that generates the electronic document has to be considered as an author: - a spider collecting and filtering information from different repositories, according to defined rules and policies, for the scope of creating a Patient Summary is definitely a document
author (and in some cases the only one );
- an application that transforms a Patient Summary record into this CDA format may not be an author;
- For cross-border exchange purposes, a device, which modifies the concepts conveyed (e.g. applying code system mappings), should appear as one of the authors. In this case (document generated through a transformation
process) the authors of the parent (original) patient summary should appear as authors as well.
Further to this, authorship can give information about the nature of Patient Summary : - if there is a person author only, then the Patient Summary is the result of a practitioner clinical act;
- if there are device authors only, the summary was
automatically generated according to well defined rules defined by the responsible organization.
The CDA standard allows to provide detailed information about what was authored by whom in the Patient Summary, allowing the specification of authorship at the whole document level, at the section level and also at the entry level. In any case it is not required to repeat this information for each of the mentioned levels, taking advantage of the context conduction propriety. In fact “context that is specified on an outer tag holds true for all nested tags, unless overridden on a nested tag. Context specified on a tag within the CDA body always overrides context propagated from an outer tag. For instance, the specification of authorship at a document section level overrides all authorship propagated from outer tags.” (HL7 CDA R2 Standard). |
|
Classification | CDA Header Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 2 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.9.2 | Include | IPS CDA Device (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.9.1 | Include | IPS CDA Organization (STU1) | DYNAMIC |
|
|
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.102 CDA author (2005‑09‑07) ref ad1bbr- |
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Example | Human Author | <author> <time value="201212290600+0100"/> <assignedAuthor> <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/> <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medico"/> <addr use="WP"> <streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country> </addr> <telecom use="WP" value="tel:+39-051-34343434"/> <assignedPerson> <name> <given>Paolo</given> <family>Rossi</family> </name> </assignedPerson> <representedOrganization> <!-- template 'IPS CDA Organization' (dynamic) --> </representedOrganization> </assignedAuthor></author> |
|
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Example | Device Author | <author> <time value="201212290600+0100"/> <assignedAuthor> <id root="1.2.3.999" extension="__example only__"/> <addr use="WP"> <state>Castilla-La Mancha</state> <city>Toledo</city> <precinct>Toledo</precinct> <country>ES</country> <postalCode>45071</postalCode> <streetAddressLine>Av. Río Guadiana, 4</streetAddressLine> </addr> <telecom nullFlavor="NI"/> <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/> </assignedAuthoringDevice> <representedOrganization classCode="ORG" determinerCode="INSTANCE"> <id root="1.2.3.999" extension="__example only__"/> <name>SESCAM</name> <telecom use="WP" value="tel:+34925274100"/> <addr use="WP"> <state>Castilla-La Mancha</state> <city>Toledo</city> <precinct>Toledo</precinct> <country>ES</country> <postalCode>45071</postalCode> <streetAddressLine>Av. Río Guadiana, 4</streetAddressLine> </addr> </representedOrganization> </assignedAuthor></author> |
|
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Item | DT | Card | Conf | Description | Label |
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| | 1 … * | R | | (IPS...hor) | | @typeCode
|
| cs | 0 … 1 | F | AUT | | @contextControlCode
|
| cs | 0 … 1 | F | OP | | Example | <author> <time value="201212290600+0100"/> <assignedAuthor> <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/> <addr use="WP"> <streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country> </addr> <telecom use="WP" value="tel:+39-051-34343434"/> <assignedPerson> <name> <given>Paolo</given> <family>Rossi</family> </name> </assignedPerson> </assignedAuthor> <representedOrganization> <!-- template 'IPS CDA Organization' (dynamic) --> </representedOrganization></author> | | hl7:functionCode
|
| CE.IPS | 0 … 1 | R | | (IPS...hor) | | hl7:time
|
| TS.IPS.TZ | 1 … 1 | R | The author/time element represents the start time of the author’s participation in the creation of the clinical document. | (IPS...hor) | | Example | <time value="201212290600+0100"/> | | hl7:assignedAuthor
|
| | 1 … 1 | R | | (IPS...hor) | | | @classCode
|
| cs | 0 … 1 | F | ASSIGNED | | | hl7:id
|
| II | 1 … * | R | Author Identifier(s) | (IPS...hor) | | cs | 0 … 1 | | | | | hl7:code
|
| CE.IPS (extensible) | 0 … 1 | R | A code, which identifies the profession/competence/specialty of the author when it is a person. | (IPS...hor) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) |
| | Example | <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors"/> | | | hl7:addr
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| AD.IPS | 1 … * | R | | (IPS...hor) | | Example | <addr use="WP"> <streetAddressLine>Viale della Cristallina 3</streetAddressLine> <city>Bologna</city> <state>BO</state> <postalCode>40121</postalCode> <country>IT</country></addr> | | | hl7:telecom
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| TEL.IPS | 1 … * | R | | (IPS...hor) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | url | 0 … 1 | | | | Example | <telecom use="WP" value="tel:+39-051-34343434"/> | | Example | <telecom nullFlavor="NI"/> | Choice | 1 … 1 | | Elements to choose from:- hl7:assignedPerson
- hl7:assignedAuthoringDevice
| | | 0 … 1 | C | | (IPS...hor) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the person (e.g. the Healthcare Professional) authoring this document | (IPS...hor) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | | (IPS...hor) | | | 1 … * | R | | (IPS...hor) | | | | hl7:assignedAuthoringDevice
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| | 0 … 1 | C | | (IPS...hor) | | Example | <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/></assignedAuthoringDevice> | Included | | | from 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) | | cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (IPS...hor) | | | | | hl7:manufacturerModelName
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| SC | 0 … 1 | | | (IPS...hor) | | SC | 0 … 1 | | | (IPS...hor) | | | hl7:representedOrganization
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| | 0 … 1 | R | | (IPS...hor) | Included | | | from 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) | | cs | 1 … 1 | F | ORG | | cs | 1 … 1 | F | INSTANCE | | II | 1 … * | R | | (IPS...hor) | | cs | 0 … 1 | | | | ON | 1 … 1 | R | | (IPS...hor) | | cs | 0 … 1 | | | | TEL | 1 … * | R | | (IPS...hor) | | set_cs | 1 … 1 | R | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | | | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | AD.IPS | 1 … 1 | R | | (IPS...hor) | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...hor) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...hor) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...hor) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...hor) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...hor) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. |
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IPS CDA custodian
Id | 2.16.840.1.113883.10.22.2.3 | Effective Date | 2021‑08‑04 12:13:07Other versions this id: - IPSCDAcustodian as of 2017‑04‑11
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Status | Draft | Version Label | 2021 |
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Name | IPSCDAcustodian | Display Name | IPS CDA custodian |
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Description |
The custodian element represents the organization that is in charge of maintaining and is entrusted with the care of the document.
This information is required by the CDA R2 standard and shall be recorded in the ClinicalDocument/custodian/assignedCustodian/ representedCustodianOrganization element.
There is only one custodian per CDA document. Allowing that a CDA document may not represent the original form of the authenticated document, the custodian represents the steward of the original source document. The custodian may be the document originator, a health information exchange, or other responsible party.
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Classification | CDA Header Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.11 | Include | IPS Address (STU1) | DYNAMIC |
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Relationship | Version: template 2.16.840.1.113883.10.22.2.3 IPS CDA custodian (2017‑04‑11) Adaptation: template 2.16.840.1.113883.10.12.104 CDA custodian (2005‑09‑07) ref ad1bbr- |
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Example | Example | <custodian typeCode="CST"> <assignedCustodian classCode="ASSIGNED"> <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE"> <!-- template 'IPS CDA Organization' (dynamic) --> </representedCustodianOrganization> </assignedCustodian></custodian> |
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Item | DT | Card | Conf | Description | Label |
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| | 1 … 1 | R | | (IPS...ian) | | @typeCode
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| cs | 0 … 1 | F | CST | | Example | <custodian typeCode="CST"> <assignedCustodian classCode="ASSIGNED"> <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE"> <!-- template 'IPS CDA Organization' (dynamic) --> </representedCustodianOrganization> </assignedCustodian></custodian> | | hl7:assignedCustodian
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| | 1 … 1 | R | | (IPS...ian) | | | @classCode
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| cs | 0 … 1 | F | ASSIGNED | | | hl7:representedCustodianOrganization
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| | 1 … 1 | R | | (IPS...ian) | | cs | 0 … 1 | F | ORG | | cs | 0 … 1 | F | INSTANCE | | II | 1 … * | R | | (IPS...ian) | | cs | 0 … 1 | | | | ON | 1 … 1 | R | | (IPS...ian) | | cs | 0 … 1 | | | | TEL | 1 … 1 | R | | (IPS...ian) | | set_cs | 1 … 1 | R | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | | | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | AD.IPS | 1 … 1 | R | | (IPS...ian) | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...ian) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...ian) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...ian) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...ian) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...ian) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. |
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IPS CDA documentationOf
IPS CDA legalAuthenticator
IPS CDA Organization
IPS CDA Person
Id | 2.16.840.1.113883.10.22.9.3 | Effective Date | 2017‑04‑12 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSCDAPerson | Display Name | IPS CDA Person |
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Description | Person name |
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Classification | CDA Header Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07) ref ad1bbr- |
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Item | DT | Card | Conf | Description | Label |
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| cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | | (IPS...son) |
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IPS CDA recordTarget
Id | 2.16.840.1.113883.10.22.2.1 | Effective Date | 2021‑09‑02 12:10:24Other versions this id: - IPSCDArecordTarget as of 2020‑07‑14 16:56:08
- IPSCDArecordTarget as of 2017‑04‑11
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Status | Draft | Version Label | 2021 |
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Name | IPSCDArecordTarget | Display Name | IPS CDA recordTarget |
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Description | The recordTarget records the administrative and demographic data of the patient whose health information is described by the clinical document; each recordTarget must contain at least one patientRole element. |
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Classification | CDA Header Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 9 concepts | Id | Name | Data Set |
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hl7ips-dataelement-100 | Telecoms | CEN/TC 251 prEN 17269 | hl7ips-dataelement-135 | Patient’s preferred language | CEN/TC 251 prEN 17269 | hl7ips-dataelement-162 | Address | CEN/TC 251 prEN 17269 | hl7ips-dataelement-2.1 | Patient Attributes | CEN/TC 251 prEN 17269 | hl7ips-dataelement-202 | Healthcare related Identifiers | CEN/TC 251 prEN 17269 | hl7ips-dataelement-3 | Patient's name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-4 | Administrative gender | CEN/TC 251 prEN 17269 | hl7ips-dataelement-5 | Date of birth | CEN/TC 251 prEN 17269 | hl7ips-dataelement-7 | Insurance identifier | CEN/TC 251 prEN 17269 |
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.11 | Include | IPS Address (STU1) | DYNAMIC |
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Relationship | Version: template 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget (2020‑07‑14 16:56:08) Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.100 epSOS CDA recordTarget (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.12.101 CDA recordTarget (2005‑09‑07) ref ad1bbr- |
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Example | Example | <recordTarget typeCode="RCT" contextControlCode="OP"> <patientRole classCode="PAT"> <id root="1.2.3.999" extension="__example only__"/> <addr> <streetAddressLine>HSE M CASSAR STR</streetAddressLine> <city>ISLA</city> <country>MT</country> </addr> <telecom use="HP" value="tel:+356124567891"/> <telecom use="WP" value="mailto:elif@foo.too.mt"/> <patient> <name> <family>BORG</family> <given>TANIA</given> </name> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <birthTime value="19430130"/> <!-- Optional guardian information ; see example below--> <!-- Optional languageCommunication information see example below --> </patient> </patientRole></recordTarget> |
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Item | DT | Card | Conf | Description | Label |
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| | 1 … * | R | | (IPS...get) | | @typeCode
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| cs | 0 … 1 | F | RCT | | @contextControlCode
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| cs | 0 … 1 | F | OP | | Example | <recordTarget typeCode="RCT" contextControlCode="OP"> <patientRole classCode="PAT"> <id root="1.2.3.999" extension="__example only__"/> <addr> <streetAddressLine>HSE M CASSAR STR</streetAddressLine> <city>ISLA</city> <country>MT</country> </addr> <telecom use="HP" value="tel:+356124567891"/> <telecom use="WP" value="mailto:elif@foo.too.mt"/> <patient> <name> <family>BORG</family> <given>TANIA</given> </name> <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/> <birthTime value="19430130"/> <!-- Optional guardian information ; see example below--> <!-- Optional languageCommunication information see example below --> </patient> </patientRole></recordTarget> | | hl7:patientRole
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| | 1 … 1 | M | | (IPS...get) | | | hl7ips-dataelement-2.1 | Patient Attributes | CEN/TC 251 prEN 17269 |
| | | @classCode
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| cs | 0 … 1 | F | PAT | | | hl7:id
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| II | 1 … * | R | Patient Identifiers: Primary Patient Identifier (Regional/National Health Id), Secondary Patient Identifier (Social/Insurance Number) | (IPS...get) | | | hl7ips-dataelement-202 | Healthcare related Identifiers | CEN/TC 251 prEN 17269 | hl7ips-dataelement-7 | Insurance identifier | CEN/TC 251 prEN 17269 |
| | | hl7:addr
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| AD.IPS | 1 … * | R | The patient address. | (IPS...get) | | | hl7ips-dataelement-162 | Address | CEN/TC 251 prEN 17269 |
| | Constraint | When used for cross-border exchange the country address part has to be provided. | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...get) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...get) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...get) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...get) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...get) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | | hl7:telecom
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| TEL | 1 … * | R | Patient’s telecom information : e.g. telephone number, e-mail address. | (IPS...get) | | | hl7ips-dataelement-100 | Telecoms | CEN/TC 251 prEN 17269 |
| | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | Example | <telecom use="HP" value="tel:+356124567891"/> | | Example | <telecom use="WP" value="mailto:elif@foo.too.mt"/> | | Example | <telecom nullFlavor="NI"/> | | | hl7:patient
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| | 1 … 1 | M | | (IPS...get) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | Example | Japanese example (Person Name) <patient> <name use="IDE"> <family>木村</family> <given>通男</given> </name> <name use="SYL"> <family>きむら</family> <given>みちお</given> </name> <name use="ABC"> <family>KIMURA</family> <given>MICHIO</given> </name> <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1" displayName="Male"/> <birthTime nullFlavor="UNK"/></patient> | | PN | 1 … * | M | Patient Name | (IPS...get) | | | hl7ips-dataelement-3 | Patient's name | CEN/TC 251 prEN 17269 |
| | Constraint | The Alphabetic representation of the name SHALL be always provided | | | 1 … * | R | Patient's Family Name/Surname | (IPS...get) | | | 1 … * | R | Patient's Given Name | (IPS...get) | | | | hl7:administrativeGenderCode
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| CE.IPS | 1 … 1 | R | Patient's Gender | (IPS...get) | | | hl7ips-dataelement-4 | Administrative gender | CEN/TC 251 prEN 17269 |
| | cs | 0 … 1 | F | UNK | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.1 Administrative Gender (HL7 V3) (DYNAMIC) |
| | Example | <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"> <translation code="2" codeSystem="2.16.840.1.113883.3.129.1.2.21" codeSystemName="Cinsiyet" displayName="Kadın"/></administrativeGenderCode> | | TS | 1 … 1 | R | Patient's Date of Birth. The patient date of birth may be a partial date such as only the year. | (IPS...get) | | | hl7ips-dataelement-5 | Date of birth | CEN/TC 251 prEN 17269 |
| | | 0 … * | R |
The guardians of a patient.
Other patient contacts are described using the /ClinicalDocument/participant structure. The <associatedEntity> element defines the type of contact.
| (IPS...get) | | cs | 1 … 1 | F | GUARD | | Example | <guardian classCode="GUARD"> <code code="AUNT" displayName="tante" codeSystem="2.16.840.1.113883.5.111"/> <addr nullFlavor="NI"/> <telecom use="MC" value="tel:+33-12345678"/> <guardianPerson> <name> <family>Curie</family> <given>Marie</given> </name> </guardianPerson></guardian> | | CD.IPS | 0 … 1 | R | The relationship between the patient and the guardian or other contact may be recorded in the element. | (IPS...get) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19563 PersonalRelationshipRoleType (DYNAMIC) |
| | AD.IPS | 1 … * | R | | (IPS...get) | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.
| Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...get) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...get) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...get) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...get) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...get) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | TEL | 1 … * | R | Guardian’s telecom information: e.g. telephone number; e-mail address. | (IPS...get) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.
| | | 1 … 1 | R | | (IPS...get) | | PN | 1 … * | R | Patient Guardian's Name | (IPS...get) | | ENXP | 1 … * | R | Patient Guardian's Family Name/Surname | (IPS...get) | | ENXP | 1 … * | R | Patient Guardian's Given Name | (IPS...get) | | | | hl7:languageCommunication
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| | 0 … * | R | | (IPS...get) | | CS | 1 … 1 | R | Patient’s language | (IPS...get) | | | hl7ips-dataelement-135 | Patient’s preferred language | CEN/TC 251 prEN 17269 |
| | Constraint | The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC) |
| | Example | British English <languageCode code="en-GB"/> | | Example | Amurdak (Australia) <languageCode code="amg-AU"/> | | Schematron assert | role | error | | | test | matches(@code,'[a-z]{2,3}-[A-Z]{2,3}') | | | Message | The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code) | |
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IPS CDA relatedDocument
IPS Patient Contacts
Id | 2.16.840.1.113883.10.22.2.5 | Effective Date | 2017‑04‑12 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSCDAContacts | Display Name | IPS Patient Contacts |
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Description | The IPS may record several kinds of patient contacts, including parents, relatives, caregivers, and others related in some way to the patient. A patient contact may be an individual or an organization with a relationship to the patient, including health provider (person or organization) to be contacted in case of emergency.
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Classification | CDA Header Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 8 concepts | Id | Name | Data Set |
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hl7ips-dataelement-121 | Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-154 | Patient’s Address Book | CEN/TC 251 prEN 17269 | hl7ips-dataelement-163 | Preferred Healthcare providers | CEN/TC 251 prEN 17269 | hl7ips-dataelement-165 | Healthcare Provider (person) | CEN/TC 251 prEN 17269 | hl7ips-dataelement-166 | Healthcare Provider (organisation) | CEN/TC 251 prEN 17269 | hl7ips-dataelement-169 | Telecoms | CEN/TC 251 prEN 17269 | hl7ips-dataelement-172 | Organisation’s Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-174 | Telecoms | CEN/TC 251 prEN 17269 |
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.11 | Include | IPS Address (STU1) | DYNAMIC |
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.108 CDA participant (DYNAMIC) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.2.4 IHE Patient Contacts (DYNAMIC) ref IHE-PCC- |
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Example | Contact person | <participant typeCode="IND"> <templateId root="2.16.840.1.113883.10.22.2.5"/> <associatedEntity classCode="NOK"> <addr> <streetAddressLine>Promenade des Anglais 111</streetAddressLine> <city>Lyon</city> <postalCode>69001</postalCode> <country>FR</country> </addr> <telecom value="tel:(+33)555-20036" use="WP"/> <associatedPerson> <name> <given>Martha</given> <family>Mum</family> </name> </associatedPerson> </associatedEntity></participant> |
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Example | Preferred Health Professional for emergency contact | <participant typeCode="IND"> <templateId root="2.16.840.1.113883.10.22.2.5"/> <functionCode code="PCP" codeSystem="2.16.840.1.113883.5.88"/> <time value="20070213"/> <associatedEntity classCode="ECON"> <addr> <streetAddressLine>Karl Strasse</streetAddressLine> <city>Freiberg</city> <postalCode>09599</postalCode> <country>DE</country> </addr> <telecom value="tel:(+49)761-11110000" use="WP"/> <associatedPerson> <name> <given>Arzt</given> <family>Guter</family> </name> </associatedPerson> </associatedEntity></participant> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | Patient contacts or the Preferred Health Professional to contact in case of emergency. | (IPS...cts) | where [hl7:templateId/@root='2.16.840.1.113883.10.22.2.5'] | | | | hl7ips-dataelement-154 | Patient’s Address Book | CEN/TC 251 prEN 17269 | hl7ips-dataelement-163 | Preferred Healthcare providers | CEN/TC 251 prEN 17269 |
| | @typeCode
|
| cs | 1 … 1 | F | IND | | Example | <participant typeCode="IND"> <templateId root="2.16.840.1.113883.10.22.2.5"/> <associatedEntity classCode="NOK"> <addr> <streetAddressLine>Promenade des Anglais 111</streetAddressLine> <city>Lyon</city> <postalCode>69001</postalCode> <country>FR</country> </addr> <telecom value="tel:(+33)555-20036" use="WP"/> <associatedPerson> <name> <given>Martha</given> <family>Mum</family> </name> </associatedPerson> </associatedEntity></participant> | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...cts) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.2.5 | | hl7:functionCode
|
| | 0 … 1 | C | The <functionCode> element may be used to indicate that this participant is the preferred Health Professional to contact in case of emergency.</functionCode> | (IPS...cts) | | | @code
|
| CONF | 0 … 1 | F | PCP | | | @codeSystem
|
| 0 … 1 | F | 2.16.840.1.113883.5.88 (Participation Function) | | hl7:associatedEntity
|
| | | R | The <associatedEntity> element identifies the type of contact. </associatedEntity> | (IPS...cts) | | | @classCode
|
| cs | 1 … 1 | R | | | CONF | The value of @classCode shall be drawn from value set 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes (DYNAMIC) |
| | Example | <associatedEntity classCode="ECON"> <addr> <streetAddressLine>Karl Strasse</streetAddressLine> <city>Freiberg</city> <postalCode>09599</postalCode> <country>DE</country> </addr> <telecom value="tel:+49-761-11110000" use="WP"/> <associatedPerson> <name> <given>Arzt</given> <family>Guter</family> </name> </associatedPerson></associatedEntity> | | | hl7:code
|
| CV.IPS | 0 … 1 | R | This element indicates the relationship between the patient and this participant. | (IPS...cts) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.54 IPS Personal Relationship (DYNAMIC) | or | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) |
| | Example | <code code="AUNT" displayName="θεία" codeSystem="2.16.840.1.113883.5.111"/> | | | hl7:addr
|
| AD.IPS | 1 … * | R | Patient Contact's / Preferred HP's Address | (IPS...cts) | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | Included | | | from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) | | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...cts) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...cts) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...cts) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...cts) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...cts) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. | | | hl7:telecom
|
| TEL | 1 … * | R | Patient Contact's / Preferred HP's/Legal Organization telephone or e-mail <telecom> element is required.</telecom> | (IPS...cts) | | | hl7ips-dataelement-169 | Telecoms | CEN/TC 251 prEN 17269 | hl7ips-dataelement-174 | Telecoms | CEN/TC 251 prEN 17269 |
| | set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) |
| | cs | 0 … 1 | F | NI | | Constraint | If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present
| | Example | <telecom use="WP" value="tel:+45 20 7025 6161"/><telecom use="HP" value="mailto:jsmith@myprovider.co.uk"/> | Choice | 1 … 2 | | Elements to choose from:- hl7:associatedPerson
- hl7:scopingOrganization
| | | 0 … 1 | C | Or the associatedPerson, or the scopingOrganization, or both elements shall be provided | (IPS...cts) | | | hl7ips-dataelement-165 | Healthcare Provider (person) | CEN/TC 251 prEN 17269 |
| | PN | 1 … * | R | Patient Contact's Name / Preferred HP's Name | (IPS...cts) | | | hl7ips-dataelement-121 | Name | CEN/TC 251 prEN 17269 |
| | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | Patient Contact's Family Name/Surname / Preferred HP's Family Name/Surname | (IPS...cts) | | | 1 … * | R | Patient Contact's Given Name / Preferred HP's Given Name | (IPS...cts) | | | 0 … 1 | C | Or the associatedPerson, or the scopingOrganization, or both elements shall be provided | (IPS...cts) | | | hl7ips-dataelement-166 | Healthcare Provider (organisation) | CEN/TC 251 prEN 17269 |
| | ON | 1 … * | R | Organization's Name | (IPS...cts) | | | hl7ips-dataelement-172 | Organisation’s Name | CEN/TC 251 prEN 17269 |
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CDA Section Level Templates
IPS Advance Directives Section
IPS Allergies and Intolerances Section
IPS Functional Status Section
IPS History of Past Illness Section
IPS History of Pregnancy Section
IPS History of Procedures Section
IPS Immunizations Section
IPS Medical Devices Section
IPS Medication Summary Section
IPS Plan of Care Section
IPS Problems Section
IPS Results Section
Id | 2.16.840.1.113883.10.22.3.14 | Effective Date | 2017‑04‑30 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSResultsSection | Display Name | IPS Results Section |
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Description | This section assembles relevant observation results collected on the patient or produced on in-vitro biologic specimens collected from the patient. Some of these results may be laboratory results, others may be anatomic pathology results, others, radiology results, and others, clinical results. The structured, machine-processable content of this section is sorted out between as many Result Organizer entries as needed. One Result Organizer entry groups results, which have a common context of production: - common specialty (imaging, bacteriology, serology, chemistry, surgical pathology, clinical, radiology ...),
- common overall interpretation, (which interprets the set of results of the Organizer),
- common
biologic specimen for in vitro diagnostic observations,
- common associated illustrative image.
The optional author and informant elements of the section are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header. In case this section assembles results from multiple authors (e.g.; results authored by a clinical laboratory, and results produced by a radiology center), the authors are listed in the section, and each Result Organizer of the section indicates its own author(s). |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.3.14 |
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Classification | CDA Section Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 3 concepts | Id | Name | Data Set |
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hl7ips-dataelement-126 | Observations results list | CEN/TC 251 prEN 17269 | hl7ips-dataelement-142 | Result Description | CEN/TC 251 prEN 17269 | hl7ips-dataelement-19 | Results | CEN/TC 251 prEN 17269 |
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Uses | Uses 4 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.14 | Include | IPS Body Author (STU1) | DYNAMIC | 2.16.840.1.113883.10.12.319 | Containment | CDA Informant (Body) | DYNAMIC | 2.16.840.1.113883.10.22.4.9 | Containment | IPS Result Organizer (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.3.15 | Containment | IPS Translation Section (2021) | DYNAMIC |
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- |
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Example | Example | <section classCode="DOCSECT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.3.14"/> <id root="1.2.3.999" extension="__example only__"/> <code code="30954-2" codeSystem="2.16.840.1.113883.6.1" displayName="Relevant diagnostic tests/laboratory data Narrative"/> <title>MOST SIGNIFICANT RESULTS</title> <text> <!-- some clinical laboratory results and some surgical pathology results presented to the human reader --> </text> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director --> </author> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 2nd author: a pathologist --> </author> <entry typeCode="COMP" contextConductionInd="true"> <!--- 1st Organizer: chemistry observations on blood serum specimen produced and interpreted by a clinical laboratory --> <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="18719-5" displayName="Chemistry studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - common blood serum specimen --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of chemistry results --> </component> </organizer> </entry> <entry> <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="18723-7" displayName="Hematology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - venous blood total specimen --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of hematology results --> </component> </organizer> </entry> <entry> <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="11529-5" displayName="Surgical pathology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 2nd author: a pathologist --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.11 'IPS Pathology Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - excised tissue specimen --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - pathologist's interpretation --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative slide image --> </component> </organizer> </entry></section> |
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Item | DT | Card | Conf | Description | Label |
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| | | | | (IPS...ion) | | | hl7ips-dataelement-19 | Results | CEN/TC 251 prEN 17269 |
| | @classCode
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| cs | 0 … 1 | F | DOCSECT | | @moodCode
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| cs | 0 … 1 | F | EVN | | hl7:templateId
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| II | 1 … 1 | R | | (IPS...ion) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.3.14 | | hl7:id
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| II | 0 … * | R | | (IPS...ion) | | hl7:code
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| CE.IPS | 1 … 1 | M | | (IPS...ion) | | | @code
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| CONF | 1 … 1 | F | 30954-2 | | | @codeSystem
|
| 1 … 1 | F | 2.16.840.1.113883.6.1 (LOINC) | | hl7:title
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| ST | 1 … 1 | M | | (IPS...ion) | | hl7:text
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| SD.TEXT | 1 … 1 | M | | (IPS...ion) | | | hl7ips-dataelement-142 | Result Description | CEN/TC 251 prEN 17269 |
| Included | 0 … * | | from 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) | | hl7:author
|
| | 0 … * | | | (IPS...ion) | | | hl7:templateId
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| II | 1 … 1 | M | | (IPS...ion) | | uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.14 | | | hl7:time
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| TS.IPS.TZ | 1 … 1 | R | | (IPS...ion) | | | hl7:assignedAuthor
|
| | 1 … 1 | M | | (IPS...ion) | | II | 1 … * | R | | (IPS...ion) | | | 0 … 1 | R | | (IPS...ion) | Choice | 0 … 1 | | Elements to choose from:- hl7:assignedPerson
- hl7:assignedAuthoringDevice
| | | 0 … 1 | C | | (IPS...ion) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the person (e.g. the Healthcare Professional) authoring this document | (IPS...ion) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | | (IPS...ion) | | | 1 … * | R | | (IPS...ion) | | | | | hl7:assignedAuthoringDevice
|
| | 0 … 1 | C | | (IPS...ion) | | Example | <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/></assignedAuthoringDevice> | Included | | | from 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) | | cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (IPS...ion) | | | | | | hl7:manufacturerModelName
|
| SC | 0 … 1 | | | (IPS...ion) | | SC | 0 … 1 | | | (IPS...ion) | | | | hl7:representedOrganization
|
| | 0 … 1 | | | (IPS...ion) | | II | 0 … * | | | (IPS...ion) | | | 0 … * | | | (IPS...ion) | | TEL | 0 … * | | | (IPS...ion) | | AD | 0 … * | | | (IPS...ion) | | hl7:informant
|
| | 0 … * | | Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) | (IPS...ion) | | hl7:entry
|
| | 1 … * | M | Contains 2.16.840.1.113883.10.22.4.9 IPS Result Organizer (DYNAMIC) | (IPS...ion) | | | hl7ips-dataelement-126 | Observations results list | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | R | | | CONF | The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) |
| | | @contextConductionInd
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| bl | 0 … 1 | F | true | | hl7:component
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| | 0 … * | | Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) | (IPS...ion) |
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IPS Social History Section
IPS Translation Section
CDA Entry Level Templates
IPS Allergy and Intolerance Concern
Id | 2.16.840.1.113883.10.22.4.5 | Effective Date | 2024‑08‑04 10:09:24Other versions this id: - IPSAllergyAndIntoleranceConcern as of 2016‑11‑11
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Status | Draft | Version Label | STU2 |
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Name | IPSAllergyAndIntoleranceConcern | Display Name | IPS Allergy and Intolerance Concern |
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Description | This template reflects an ongoing concern on behalf of the person that placed the allergy on a patient’s allergy list. A concern may refer to one or more allergies or intolerances. There are different kinds of status that could be related to an allergy, or more in general to a condition:
- The status of the concern (active, inactive,..)
- The status of the condition (e.g. active, inactive, resolved,..)
- The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…)
Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition).
As long as the underlying condition is of concern to the author (i.e., as long as the allergy, whether active or resolved, is of ongoing concern and interest to the author), the statusCode is “active”.
In case the clinician deems that there is no longer any need to track the underlying conditions then the concern is inactive and the statusCode is set to "completed". The effectiveTime/low of the Allergy Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient's chart. The effectiveTime/high asserts when the concern became inactive, and it is present if the statusCode of the concern act is "completed"
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.5 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.1 | Containment | IPS Allergy or Intolerance (STU2) | DYNAMIC |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.5 IPS Allergy and Intolerance Concern (2016‑11‑11) Adaptation: template 2.16.840.1.113883.10.12.301 CDA Act (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.3 IHE Allergy and Intolerance Concern Entry (2013‑12‑20) ref IHE-PCC- |
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Example | Example | <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.5"/> <id root="1.2.3.999" extension="__example only__"/> <code code="CONC" codeSystem="2.16.840.1.113883.5.6"> <statusCode code="active"/> <effectiveTime> <low value="..."/> <high value="..."/> </effectiveTime> <entryRelationship typeCode="SUBJ" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.1 'IPS Allergy or Intolerance' (dynamic) --> </entryRelationship> </code></act> |
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Item | DT | Card | Conf | Description | Label |
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| | 0 … * | R | | (IPS...ern) | | @classCode
|
| cs | 1 … 1 | F | ACT | | @moodCode
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| cs | 1 … 1 | F | EVN | | hl7:templateId
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| II | 1 … 1 | M | | (IPS...ern) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.5 | | hl7:id
|
| II | 0 … * | R | | (IPS...ern) | | hl7:code
|
| CD | 1 … 1 | M | | (IPS...ern) | | | @code
|
| CONF | 1 … 1 | F | CONC | | | @codeSystem
|
| 1 … 1 | F | 2.16.840.1.113883.5.6 (HL7ActClass) | | hl7:statusCode
|
| CS | 1 … 1 | R | As long as the underlying conditions are of concern to the author (i.e., as long as allergies, whether active or resolved, is of ongoing concern and interest to the author), the statusCode is “ active ”. The concern is tracked by the author.
Only when the underlying allergies are no longer of concern then the statusCode is set to “ completed ”. The author is no more tracking this concern and no further actions are expected. | (IPS...ern) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) |
| | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | R | | (IPS...ern) | | | hl7:low
|
| IVXB_TS | 1 … 1 | R | This element asserts when the concern became active. This equates to the time the concern was authored in the patient's chart and the author started tracking this concern. | (IPS...ern) | | | hl7:high
|
| IVXB_TS | 0 … 1 | C | This element asserts when the clinician deemed there is no longer any need to track the underlying conditions. | (IPS...ern) | | Constraint | If statusCode/@code="completed" Completed, then effectiveTime *SHALL* contain [1..1] high | | Schematron assert | role | error | | | test | not(../hl7:statusCode[@code='completed']) or hl7:high | | | Message | If statusCode/@code="completed" Completed, then effectiveTime *SHALL* contain [1..1] high | | | hl7:entryRelationship
|
| | 1 … * | R | Contains 2.16.840.1.113883.10.22.4.1 IPS Allergy or Intolerance (DYNAMIC) | (IPS...ern) | | | @typeCode
|
| cs | 1 … 1 | F | SUBJ | | | @inversionInd
|
| bl | 0 … 1 | F | false |
|
IPS Allergy Certainty Observation
{{: 2.16.840.1.113883.10.22.10/dynamic}}
IPS Allergy or Intolerance
Id | 2.16.840.1.113883.10.22.4.1 | Effective Date | 2024‑08‑04 09:48:50Other versions this id: - IPSEntryAllergyOrIntolerance as of 2016‑11‑10
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Status | Draft | Version Label | STU2 |
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Name | IPSEntryAllergyOrIntolerance | Display Name | IPS Allergy or Intolerance |
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Description | This template reflects a discrete observation about a patient's allergy or intolerance. Because it is a discrete observation, it will have a statusCode of "completed".
The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient.
For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago.
The effectiveTime of the Allergy - Intolerance Observation gives an indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present.
If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". It is recommended that the agent responsible for an allergy or adverse reaction would be used for describing the allergy, however the possibility that pre-coordinate codes (e.g. "allergy to nuts") will be used has been here also considered. The agent responsible for an allergy or adverse reaction it is not always a manufactured material (for example, food allergies), nor is it necessarily consumed; however the playingEntity classCode = "MMAT" for all agents, manufactured or not is expected to be used. This choice depends on thecharacteristics of the base CDA R2 specification.
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.1 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 12 concepts | Id | Name | Data Set |
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hl7ips-dataelement-173 | Agent | CEN/TC 251 prEN 17269 | hl7ips-dataelement-182 | Allergies/Intolerances Content Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-184 | Allergy/Intolerance | CEN/TC 251 prEN 17269 | hl7ips-dataelement-185 | Diagnosis | CEN/TC 251 prEN 17269 | hl7ips-dataelement-186 | Clinical Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-187 | Onset date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-188 | End Date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-189 | Criticality | CEN/TC 251 prEN 17269 | hl7ips-dataelement-190 | Certainty | CEN/TC 251 prEN 17269 | hl7ips-dataelement-191 | Type of propensity | CEN/TC 251 prEN 17269 | hl7ips-dataelement-192 | Reaction | CEN/TC 251 prEN 17269 | hl7ips-dataelement-196 | Agent code | CEN/TC 251 prEN 17269 |
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Uses | Uses 4 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.6 | Containment | IPS Reaction Manifestation (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.18 | Containment | IPS Criticality Observation (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.10 | Containment | IPS Allergy Certainty Observation (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.21 | Containment | IPS Allergy Status Observation (STU1) | DYNAMIC |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.1 IPS Allergy or Intolerance (2016‑11‑10) Adaptation: template 2.16.840.1.113883.10.20.1.18 Alert observation (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.6 eHDSI Allergies And Intolerances (DYNAMIC) ref epsos- |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.1"/> <id root=" " extension=" "/> <!-- This is the code that shows what kind of allergy or intolerance --> <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"> <text> <reference value="#ref1"/> </text> <statusCode code="completed"/> <effectiveTime> <low value="20170701"/> </effectiveTime> <!-- This is the allergen - the substance that caused the allergy --> <participant typeCode="CSM"> <participantRole classCode="MANU"> <playingEntity classCode="MMAT"> <code code=" " codeSystem=" "> <originalText> <reference value="#substance"/> </originalText> </code> <name>...</name> </playingEntity> </participantRole> </participant> <!-- This is how the allergy manifests itself --> <entryRelationship typeCode="MFST" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.6 'IPS Reaction Manifestation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.18 'IPS Criticality Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="REFR" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.21 'IPS Allergy Status Observation' (dynamic) --> </entryRelationship> </code></observation> |
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Example | No Known Allergies | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.1"/> <code code="allergy" displayName="Allergy" codeSystem="2.16.840.1.113883.4.642.1.122"> <statusCode code="completed"/> <effectiveTime> <low nullFlavor="UNK"/> </effectiveTime> <value code="X-NoKnownAllergy" displayName="No known allergy" codeSystem="2.16.840.1.113883.5.1150.2"/> </code></observation> |
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Example | No Information available about allergies or intolerances | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.1"/> <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"> <statusCode code="completed"/> <effectiveTime> <low nullFlavor="NA"/> </effectiveTime> <value code="no-allergy-info" displayName="No information about allergies" codeSystem="2.16.840.1.113883.5.1150.1"/> </code></observation> |
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Example | Minimum Set (active propensity; agent known) | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.1"/> <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"> <statusCode code="completed"/> <effectiveTime> <low nullFlavor="UNK"/> </effectiveTime> <participant typeCode="CSM"> <participantRole classCode="MANU"> <playingEntity classCode="MMAT"> <code code="13577000" codeSystem="2.16.840.1.113883.6.96" displayName="Nut"/> </playingEntity> </participantRole> </participant> </code></observation> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | | (IPS...nce) | | | hl7ips-dataelement-184 | Allergy/Intolerance | CEN/TC 251 prEN 17269 |
| | @classCode
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| cs | 1 … 1 | F | OBS | | @moodCode
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| cs | 1 … 1 | F | EVN | | hl7:templateId
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| II | 1 … 1 | M | | (IPS...nce) | | | @root
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| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.1 | | hl7:id
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| II | 0 … * | R | | (IPS...nce) | | hl7:code
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| CD.IPS | 1 … 1 | M | This element describes whether this condition refers to an allergy, non-allergy intolerance, or unknown class of intolerance (not known to be allergy or intolerance). | (IPS...nce) | | | hl7ips-dataelement-191 | Type of propensity | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.2 Allergy or Intolerance Type (DYNAMIC) |
| | hl7:text
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| ED | 0 … 1 | R | The text element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.</reference>
| (IPS...nce) | | | hl7:reference
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| TEL | 1 … 1 | M | | (IPS...nce) | | url | 1 … 1 | R | When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:statusCode
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| CS | 1 … 1 | M | A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.</statusCode>
| (IPS...nce) | | | @code
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| cs | 1 … 1 | F | completed | | hl7:effectiveTime
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| IVL_TS | 1 … 1 | M | The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago. The effectiveTime of the Allergy - Intolerance Observation may give an indication of whether or not the underlying allergy/intolerance is resolved. The <low> and <high> values should be no more precise than known, but as precise as possible. | (IPS...nce) | | | hl7:low
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| IVXB_TS | 1 … 1 | R | The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active. | (IPS...nce) | | | hl7ips-dataelement-187 | Onset date | CEN/TC 251 prEN 17269 |
| | | hl7:high
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| IVXB_TS | 0 … 1 | C | The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". | (IPS...nce) | | | hl7ips-dataelement-188 | End Date | CEN/TC 251 prEN 17269 |
| | Constraint | If this condition is known to be resolved, then the effectiveTime/high would be present. | | hl7:value
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| CD.IPS (preferred) | 0 … 1 | | | (IPS...nce) | | | hl7ips-dataelement-185 | Diagnosis | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.10 IPS Allergy or Intolerance Conditions (DYNAMIC) |
| | hl7:participant
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| | 0 … 1 | C | The substance that causes the allergy or intolerance should be specified in the <participant> structure. This is the preferred way an allergy is supposed to be expressed. However it is recognized that in some contexts a controlled vocabulary is used for describing the allergy to a substance; or for asserting known absence or unavailability of information. In this case the <participant> structure shall be omitted. The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent, i.e., use playingEntity classCode = "MMAT" for all agents, manufactured or not. | (IPS...nce) | | | hl7ips-dataelement-173 | Agent | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | F | CSM | | Constraint | IF the observation/value element is present and valued with a code derived form the 2.16.840.1.113883.11.22.9 Absent or Unknown Allergies value set THEN the observation/participant element used to describe the agent SHALL be omitted. | | | hl7:participantRole
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| | 1 … 1 | R | | (IPS...nce) | | cs | 1 … 1 | F | MANU | | | 1 … 1 | R | | (IPS...nce) | | cs | 1 … 1 | F | MMAT | | CD.IPS (preferred) | 1 … 1 | R | Code for the substance causing the allergy or intolerance. | (IPS...nce) | | | hl7ips-dataelement-196 | Agent code | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.65 IPS Allergy or Intolerance Substances (DYNAMIC) |
| | hl7:entryRelationship
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| | 0 … * | R | The contained entry describes the reactions that are manifestations (typeCode='MFST') of the reported allergy or intolerance. Contains 2.16.840.1.113883.10.22.4.6 IPS Reaction Manifestation (DYNAMIC) | (IPS...nce) | | | hl7ips-dataelement-192 | Reaction | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | F | MFST | | | @inversionInd
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| bl | 1 … 1 | F | true | | hl7:entryRelationship
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| | 0 … 1 | R | Criticality
The contained entry describes the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual. Contains 2.16.840.1.113883.10.22.4.18 IPS Criticality Observation (DYNAMIC) | (IPS...nce) | | | hl7ips-dataelement-189 | Criticality | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | F | SUBJ | | | @inversionInd
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| bl | 1 … 1 | F | true | | hl7:entryRelationship
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| | 0 … 1 | R | Certainty or Verification Status
The contained entry describes the certainty associated with a propensity, or potential risk, of a reaction to the identified substance. Contains 2.16.840.1.113883.10.22.10 IPS Allergy Certainty Observation (DYNAMIC) | (IPS...nce) | | | hl7ips-dataelement-190 | Certainty | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | F | SUBJ | | | @inversionInd
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| bl | 1 … 1 | F | true | | hl7:entryRelationship
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| | 0 … 1 | R | Status of the Allergy or Intolerance
The contained entry describes the current status of the allergy or intolerance, for example, whether it is active, in remission, resolved, and so on ... Contains 2.16.840.1.113883.10.22.4.21 IPS Allergy Status Observation (DYNAMIC) | (IPS...nce) | | | hl7ips-dataelement-186 | Clinical Status | CEN/TC 251 prEN 17269 |
| | | @typeCode
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| cs | 1 … 1 | F | REFR | | | @inversionInd
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| bl | 1 … 1 | F | false |
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IPS Allergy Status Observation
Id | 2.16.840.1.113883.10.22.4.21 | Effective Date | 2017‑05‑24 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSAllergyStatusObservation | Display Name | IPS Allergy Status Observation |
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Description | This subordinated observation used by the allergy observation records information about the current status of an allergy or intolerance, for example, whether it is active, in remission, resolved, et cetera. |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.21 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 1 concept | Id | Name | Data Set |
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hl7ips-dataelement-186 | Clinical Status | CEN/TC 251 prEN 17269 |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (DYNAMIC) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.1.1 IHE Problem Status Observation (2013‑12‑20) ref IHE-PCC- |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.21"/> <templateId root="2.16.840.1.113883.10.22.4.20"/> <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" displayName="Status"/> <text> <reference value="#cstatus-2"/> </text> <statusCode code="completed"/> <value code="active" displayName="Active" codeSystem="2.16.840.1.113883.4.642.3.155"/></observation> |
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IPS Body Author
IPS CDA Device
Id | 2.16.840.1.113883.10.22.9.2 | Effective Date | 2017‑04‑12 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSCDADevice | Display Name | IPS CDA Device |
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Description | This template provides basic information about a device |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.315 CDA Device (2005‑09‑07) ref ad1bbr- |
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Item | DT | Card | Conf | Description | Label |
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| cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (IPS...ice) | hl7:manufacturerModelName
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| SC | 0 … 1 | | | (IPS...ice) | | SC | 0 … 1 | | | (IPS...ice) |
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IPS Certainty Observation
IPS Criticality Observation
IPS Immunization
IPS Immunization Medication Information
IPS Internal Reference
Id | 2.16.840.1.113883.10.22.4.31 | Effective Date | 2017‑05‑02 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSEntryInternalReference | Display Name | IPS Internal Reference |
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Description | This template is used to reference (point to) information contained in other entries within the same document. |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Relationship | Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.4.1 IHE Internal Reference Entry (2013‑12‑20) ref IHE-PCC- |
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Example | Reference to an uncoded element | <act classCode="ACT" moodCode="cs"> <templateId root="2.16.840.1.113883.10.22.4.31"/> <id root="1.2.3.999" extension="__example only__"/> <code nullFlavor="NA"/></act> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | | (IPS...nce) | | @classCode
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| cs | 1 … 1 | F | ACT | | @moodCode
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| cs | 1 … 1 | R | The @moodCode of the reference SHALL match the @moodCode of the referenced element | | Variable let | Name | refMoodCode | | | Value | @moodCode | | | Variable let | Name | refID | | | Value | concat(hl7:id[1]/@root,'#',hl7:id[1]/@extension) | | | Variable let | Name | refCode | | | Value | concat(hl7:code[1]/@code,'#',hl7:code[1]/@codeSystem) | | | Variable let | Name | reffedObject | | | Value | (ancestor::hl7:ClinicalDocument//*:id[concat(@root,'#',@extension)=$refID][not(preceding-sibling::hl7:templateId/@root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1')]/parent::*)[1] | | | Schematron assert | role | error | | | test | not(exists($reffedObject)) or $reffedObject[@moodCode=$refMoodCode] | | | Message | The @moodCode of the reference SHALL match the @moodCode of the referenced element | | | Schematron assert | role | error | | | test | exists($reffedObject) | | | Message | The root and extension attributes SHALL identify an element defined elsewhere in the same document. | | | Schematron assert | role | error | | | test | not(exists($reffedObject)) or ($reffedObject[not(*:code/@code)] and hl7:code[@nullFlavor='NA']) or $reffedObject/*:code[concat(@code,'#',@codeSystem)=$refCode] | | | Message | The code of the reference SHALL match the code of the referenced element | | | hl7:templateId
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| II | 1 … 1 | M | | (IPS...nce) | | | @root
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| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.31 | | hl7:id
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| II | 1 … 1 | R | This element shall be present. The root and extension attributes shall identify an element defined elsewhere in the same document. | (IPS...nce) | | hl7:code
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| CD | 1 … 1 | R | This element shall be present. It shall be valued when the internal reference is to element that has a <code> element, and shall have the same attributes as the <code> element in the act it references. If the element it references does not have a <code> element, then the nullFlavor attribute should be set to "NA". | (IPS...nce) | | | @nullFlavor
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| cs | 0 … 1 | F | NA |
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IPS Laboratory Result Observation
Id | 2.16.840.1.113883.10.22.4.13 | Effective Date | 2024‑08‑04 11:10:20Other versions this id: - IPSLaboratoryResultObservation as of 2017‑03‑21
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Status | Draft | Version Label | STU2 |
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Name | IPSLaboratoryResultObservation | Display Name | IPS Laboratory Result Observation |
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Description | This template constrains the results of a clinical laboratory observation. The result observation includes a statusCode to allow recording the status of an observation. “Pending” results (e.g., a test has been run but results have not been reported yet) should be represented as “active” ActStatus. |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.13 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 2 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.14 | Include | IPS Body Author (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.22 | Containment | IPS Comment Activity (STU1) | DYNAMIC |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation (2017‑03‑21) Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (2017‑03‑02) |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.13"/> <id root="1.2.3.999" extension="--example only--"/> <code codeSystem="2.16.840.1.113883.6.1" code="41995-2" displayName="Hemoglobin A1c [Mass/volume] in Blood"> <statusCode code="completed"/> <effectiveTime> <low value="20171113173215"/> </effectiveTime> <value xsi:type="PQ" value="4.8" unit="%"/> <interpretationCode code="H" displayName="High" codeSystem="2.16.840.1.113883.5.83"/> <author> <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) --> </author> <referenceRange> <observationRange> <value xsi:type="IVL_PQ"> <low value="1.5" unit="%"/> <high value="4.5" unit="%"/> </value> <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/> </observationRange> </referenceRange> <entryRelationship typeCode="COMP"> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' (dynamic) --> </entryRelationship> </code></observation> |
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IPS Manufactured Material
Id | 2.16.840.1.113883.10.22.4.3 | Effective Date | 2024‑08‑04 10:47:30Other versions this id: - IPSMedMaterial as of 2021‑08‑02 16:52:27
- IPSMedMaterial as of 2016‑11‑10
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Status | Draft | Version Label | STU2 |
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Name | IPSMedMaterial | Display Name | IPS Manufactured Material |
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Description | This entry provides details about the medicinal product.
Due to the current absence of global product identifiers the product is described through a set of identification and descriptive attributes (e.g. active substances, strength, unit of presentation,...) that may be used to integrate jurisdictional product codes.
This shortage will be likely overcome when the ISO IDMP identifiers will be available for concrete usage in the next years, as well as the globally used value sets for products attributes agreed by the ISO IDMP implemention guides. (e.g. GInAs for substances).
Even though there is a quite common consensus about the attributes that should be provided in order to describe a medicine in the context of the international patient summary (e.g. the list of active substances, the strength(s); the administrable pharmaceutical forms;..), this template doesn't require any of them, recommending, above all for cross-borders services, to provide
all the available information that could be helpful for the identification of medications
Jurisdictions could specialize this template making some ofthese attributes required.
It is also recognized that in many contexts structured information about the product, might not be available, and only textual information for describing products (e.g. the product scientific name "amoxicillin 400mg/5mL suspension”) or some of their attributes (e.g. textual strength "875 mg + 125 mg" ; "amoxycillin and clavulanic acid") could be used.
This template attempts to provide a solution that takes in account this current complexity being also ready for including the future IDMP-based solution as soon as they will become available for concrete use.
Since the CDA R2.0 model support only a very limited set of information about the products, extensions based on the R_ProductList (Common Product Model) CMET have been used for conveying such information, aiming to align this solution with that that will be likely used for the IDMP implementation Guide.
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 4 concepts | Id | Name | Data Set |
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hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 | hl7ips-dataelement-117 | Brand Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-171 | Product Common Name (and Strength) | CEN/TC 251 prEN 17269 | hl7ips-dataelement-227 | Pharmaceutical dose form | CEN/TC 251 prEN 17269 |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (2021‑08‑02 16:52:27) Adaptation: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (2016‑05‑10 22:43:03) ref epsos- |
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Example | Example | <manufacturedMaterial> <!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other product attributes (e.g. ingredients, ATC Code, strengths) --> <templateId root="2.16.840.1.113883.10.22.4.3"/> <code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA"> <name>Medicinal Product Name</name> <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/> <asContent> <!-- Packaged Medicinal Product (PC) --> <containerPackagedProduct> <!-- PC ID--> <code codeSystem=" " code="PCID" displayName=" "> <name>...</name> <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="" displayName="" CodeSystemName="EDQM"/> </code> </containerPackagedProduct> </asContent> <asSpecializedKind classCode="GRIC"> <!-- Pharmaceutical Substance (ATC Code)--> <generalizedMaterialKind classCode="MMAT"> <!-- Pharmaceutical Substance (ATC Code)--> <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </generalizedMaterialKind> </asSpecializedKind> <asSpecializedKind> <!-- Pharmaceutical Product (PhP)--> <generalizedMaterialKind classCode="MMAT"> <code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA"> <name>....</name> </code> </generalizedMaterialKind> </asSpecializedKind> <!-- list of active ingredients --> <ingredient classCode="ACTI" determinerCode="KIND"> <quantity> <!-- strength --> <numerator type="PQ" value="20" unit="mg"/> <denominator type="PQ" value="1" unit="{tablet}"/> </quantity> <ingredientSubstance> <code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS"> <name>...</name> </code> </ingredientSubstance> </ingredient> </code></manufacturedMaterial> |
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Example | Example | <manufacturedMaterial classCode="MMAT" determinerCode="KIND"> <templateId root="2.16.840.1.113883.10.22.4.3"/> <code code="..." codeSystem="1.2.3.999"> <name>name</name> <formCode code="10101000" displayName="Oral drops, solution" codeSystem="0.4.0.127.0.16.1.1.2.1"/> <asContent classCode="CONT"> <containerPackagedProduct classCode="CONT" determinerCode="KIND"> <code> <name/> <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/> <capacityQuantity value="..." unit="..."/> <asContent classCode="CONT"> <containerPackagedProduct classCode="CONT" determinerCode="KIND"> <code> <name/> <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/> <asContent classCode="CONT"> <containerPackagedProduct classCode="CONT" determinerCode="KIND"> <code> <name/> <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/> </code> </containerPackagedProduct> </asContent> </code> </containerPackagedProduct> </asContent> </code> </containerPackagedProduct> </asContent> <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <code code="..." codeSystem="2.16.840.1.113883.6.73"> <name/> </code> </generalizedMaterialKind> </asSpecializedKind> <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <code> <name/> </code> </generalizedMaterialKind> </asSpecializedKind> <ingredient classCode="ACTI" determinerCode="KIND"> <quantity> <numerator value="20" unit="mg"/> <denominator value="100" unit="mL"/> </quantity> <ingredientSubstance> <code> <name/> </code> </ingredientSubstance> </ingredient> </code></manufacturedMaterial> |
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Item | DT | Card | Conf | Description | Label |
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hl7:manufacturedMaterial
|
| | 0 … * | R | | (IPS...ial) | | @classCode
|
| cs | 0 … 1 | F | MMAT | | @determinerCode
|
| cs | 0 … 1 | F | KIND | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...ial) | | | @root
|
| oid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.3 | Choice | 0 … 1 | | Elements to choose from:- hl7:code
- hl7:code[@codeSystem='2.16.840.1.113883.6.96']
| | | hl7:code
|
| CE.IPS | 0 … 1 | R | This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. | (IPS...ial) | | | hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 |
| | | hl7:code
|
| CE.IPS | 0 … 1 | R | Non IDMP codes from SNOMED CT value set | (IPS...ial) | where [@codeSystem='2.16.840.1.113883.6.96'] | | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC) |
| | hl7:name
|
| EN | 0 … 1 | R | This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.
| (IPS...ial) | | | hl7ips-dataelement-117 | Brand Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-171 | Product Common Name (and Strength) | CEN/TC 251 prEN 17269 |
| | pharm:formCode
|
| CE.IPS | 0 … 1 | R | Administrable Pharmaceutical Dose Form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.
| (IPS...ial) | | | hl7ips-dataelement-227 | Pharmaceutical dose form | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC) |
| | Example | <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> | | pharm:asContent
|
| | 0 … * | | This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package.
If the package has a brand name, it can be described in the <pharm:name> element.
The <pharm:capacityQuantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging.
In the latter case, the most inner (nested) item represents the most outer package item.
For example the case
\--Box
\-----2 blisters
\--------20 tablets
is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box.
The most inner package represents the Packaged Medicinal Product.
When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
| (IPS...ial) | | | @classCode
|
| cs | 1 … 1 | F | CONT | | Example | Packaged Medicinal Product with multiple layers packaging <asContent> <containerPackagedProduct> <!-- Inner Package --> <code codeSystem="..." code="..." displayName="..."> <asContent> <containerPackagedProduct> <!-- Intermediate Package --> <asContent> <containerPackagedProduct> <!-- Outer Package / Packaged Medicinal Product --> </containerPackagedProduct> </asContent> </containerPackagedProduct> </asContent> </code> </containerPackagedProduct></asContent> | | Example | Packaged Medicinal Product with formCode <asContent> <containerPackagedProduct> <!-- Packaged Medicinal Product --> <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"> <name>100 MIRACLE PILLS(TM)</name> <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/> </code> </containerPackagedProduct></asContent> | | | pharm:quantity
|
| PQ | 0 … 1 | | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the most inner Package Item or the Packaged Medicinal Product. | (IPS...ial) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | | 0 … 1 | | If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...ial) | | ST | 0 … 1 | | It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...ial) | | Example | <name>AMOXIFEN(R) 20 compresse 20 mg</name> | | CE.IPS | 0 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ial) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | Example | <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> | | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product.
| (IPS...ial) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product | (IPS...ial) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | If this is also the most inner <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...ial) | | ST | 0 … 1 | R | It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...ial) | | Example | <name>...</name> | | CE.IPS | 1 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ial) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
| (IPS...ial) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (IPS...ial) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage). | (IPS...ial) | | ST | 0 … 1 | R | When present, it can be used for the representing the brand name. | (IPS...ial) | | CE.IPS | 1 … 1 | R | When present, it encodes the type of the outer package.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ial) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ial) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | pharm:asSpecializedKind
|
| | 0 … 1 | R | This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.
The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
| (IPS...ial) | where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] | | | | @classCode
|
| cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <!-- Pharmaceutical Substance (ATC Code)--> <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </generalizedMaterialKind></asSpecializedKind> | | | pharm:generalizedMaterialKind
|
| | 1 … 1 | M | | (IPS...ial) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | The <code> element contains the ATC code of this medicine. | (IPS...ial) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC) |
| | Example | <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> | | | 0 … * | | | (IPS...ial) | | pharm:asSpecializedKind
|
| | 0 … * | R | The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element. | (IPS...ial) | | | @classCode
|
| cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"> <name/> </code> </generalizedMaterialKind></asSpecializedKind> | | | pharm:generalizedMaterialKind
|
| | | R | | (IPS...ial) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id.
The level and the stratum of the PhPID will be distiguished by the OID of the code system.
| (IPS...ial) | | | 0 … * | R | | (IPS...ial) | | pharm:ingredient
|
| | 0 … * | R | This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
| (IPS...ial) | | | @classCode
|
| cs | 1 … 1 | R | | | CONF | The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) |
| | | pharm:quantity
|
| | 1 … 1 | M | The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity>
| (IPS...ial) | | Example | <quantity>...</quantity> | | PQ | 1 … 1 | R | | (IPS...ial) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) |
| | | 1 … 1 | R | | | PQ | 1 … 1 | R | | (IPS...ial) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) |
| | | 1 … 1 | R | | | | pharm:ingredientSubstance
|
| | 1 … 1 | R | | (IPS...ial) | | cs | 1 … 1 | F | MMAT | | cs | 1 … 1 | F | KIND | | CD.IPS (extensible) | 0 … 1 | C | The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS. | (IPS...ial) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC) |
| | ED | 0 … * | | | (IPS...ial) | | TEL | 0 … * | | | (IPS...ial) | | CD | 0 … * | | This element can be used to provide alternative identifications for the described substance. | (IPS...ial) | | | 0 … 1 | C | Name of the substance | (IPS...ial) | | Schematron assert | role | error | | | test | pharm:code or pharm:name | | | Message | Either the name or the code of the substance (or both) shall be provided | |
|
IPS Medical Device
Id | 2.16.840.1.113883.10.22.4.26 | Effective Date | 2017‑04‑11 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSMedicalDevice | Display Name | IPS Medical Device |
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Description | The medical devices entry content module describes the kind of device that is, or has been used by the patient |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.26 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 6 concepts | Id | Name | Data Set |
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hl7ips-dataelement-150 | Use end date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-218 | Device content Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-57 | Device | CEN/TC 251 prEN 17269 | hl7ips-dataelement-58 | Device Type | CEN/TC 251 prEN 17269 | hl7ips-dataelement-59 | Use start date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-60 | Device Identifier | CEN/TC 251 prEN 17269 |
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Relationship | Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.5 Medical Devices (2013‑12‑20) ref epsos- |
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Example | Example | <supply moodCode="EVN" classCode="SPLY"> <templateId root="2.16.840.1.113883.10.22.4.26"/> <id root="2.16.840.1.113883.19.811.3"/> <text> <reference value="#dev_1"/> </text> <effectiveTime xsi:type="IVL_TS"> <low value="20070728"/> </effectiveTime> <participant typeCode="DEV"> <participantRole classCode="MANU"> <id/> <playingDevice classCode="DEV" determinerCode="INSTANCE"> <code code="304184000" displayName="Ankle joint implant" codeSystem="2.16.840.1.113883.6.96"/> </playingDevice> </participantRole> </participant></supply> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | The <supply> element shall be present. The moodCode attribute shall be EVN to reflect that a medical device has been provided.</supply> | (IPS...ice) | | @classCode
|
| cs | 1 … 1 | F | SPLY | | @moodCode
|
| cs | 1 … 1 | F | EVN | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...ice) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.26 | | hl7:id
|
| II | 0 … * | R | This optional element identifies the provision of the device (e.g. implant procedure) | (IPS...ice) | | hl7:text
|
| ED | 0 … 1 | R | | (IPS...ice) | | | hl7:reference
|
| TEL | 1 … 1 | M | | (IPS...ice) | | url | 1 … 1 | R | Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | R |
This element provides the interval of time corresponding to the device usage by/presence in the patient.
| (IPS...ice) | | | @xsi:type
|
| st | 1 … 1 | F | IVL_TS | | | hl7:low
|
| TS | 1 … 1 | R | The lower bound of the interval represents the start date/time. | (IPS...ice) | | | hl7ips-dataelement-59 | Use start date | CEN/TC 251 prEN 17269 |
| | | hl7:high
|
| TS | 0 … 1 | C | The upper bound represents the end date/time. If it is not present, the device is still used by or present in the patient. | (IPS...ice) | | | hl7ips-dataelement-150 | Use end date | CEN/TC 251 prEN 17269 |
| | hl7:participant
|
| | 1 … * | R | The device is represented as a participant in the supply structure. The following descriptions apply to the device structure. | (IPS...ice) | | | hl7ips-dataelement-57 | Device | CEN/TC 251 prEN 17269 |
| | | @typeCode
|
| cs | 1 … 1 | F | DEV | | Example | <participant typeCode="DEV"> <participantRole classCode="MANU"> <id root="1.2.3.999" extension="__example_only__"/> <playingDevice classCode="DEV" determinerCode="INSTANCE"> <code code="" codeSystem=""/> <!-- ... --> </playingDevice> </participantRole></participant> | | Example | Presence of implanted device not known (situation) <participant typeCode="DEV"> <participantRole classCode="MANU"> <playingDevice> <code code="000000" codeSystem="2.16.840.1.113883.6.96" displayName="Presence of implanted device not known (situation)"/> </playingDevice> <scopingEntity> <id root="2.16.840.1.113883.3.3719"/> </scopingEntity> </participantRole></participant> | | Example | No implant in situ (situation) <participant typeCode="DEV"> <participantRole classCode="MANU"> <playingDevice> <code code="000000" codeSystem="2.16.840.1.113883.6.96" displayName="No implant in situ (situation)"/> </playingDevice> <scopingEntity> <id root="2.16.840.1.113883.3.3719"/> </scopingEntity> </participantRole></participant> | | | hl7:participantRole
|
| | 1 … 1 | R | | (IPS...ice) | | cs | 1 … 1 | F | MANU | | II | 0 … * | R |
The device ID, e.g. using UDI, is represented by the id element of the participant role. This element is optional, as not all production identifiers (e.g., serial number, lot/batch number, distinct identification number) may be known to the provider or patient.
| (IPS...ice) | | | hl7ips-dataelement-60 | Device Identifier | CEN/TC 251 prEN 17269 |
| | Example | UDI GS1: DeviceIdentifier 00844588003288, Serial# 10987654d321, Lot# 7654321D <id root="2.16.840.1.113883.3.3719" extension="{01}00844588003288{17}141120{10}7654321D{21}10987654d321"/> | | Example | UDI ICCBBA: DeviceIdentifier 00844588003288 <id root="2.16.840.1.113883.3.3719" extension="A9999XYZ100T0474"/> | | Example | UDI HIBCC: Serial# XYZ456789012345678, Lot# LOT123456789012345 <id root="2.16.840.1.113883.3.3719" extension="+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C"/> | | | 1 … 1 | R | The playingDevice element describes the device instance. | (IPS...ice) | | cs | 1 … 1 | F | DEV | | cs | 1 … 1 | F | INSTANCE | | CE.IPS (preferred) | 1 … 1 | R | The device code describes the type of device (e.g. arm prosthesis, arterial stent). | (IPS...ice) | | | hl7ips-dataelement-218 | Device content Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-58 | Device Type | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.23 IPS Medical Devices (DYNAMIC) | or | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.61 Absent or Unknown Devices (DYNAMIC) |
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IPS Medication Information (detail)
Id | 2.16.840.1.113883.10.22.4.2 | Effective Date | 2024‑08‑04 10:45:46Other versions this id: - IPSManufacturedProduct as of 2016‑11‑10
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Status | Draft | Version Label | STU2 |
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Name | IPSManufacturedProduct | Display Name | IPS Medication Information (detail) |
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Description | This entry describes the consumable subject of the medication statement. All the information about the medication is provided in the included IPS Manufactured Material template. |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 1 concept | Id | Name | Data Set |
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hl7ips-dataelement-2 | Medicinal Product | CEN/TC 251 prEN 17269 |
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.3 | Include | IPS Manufactured Material (STU2) | DYNAMIC |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.2 IPS Medication Information (detail) (2016‑11‑10) Adaptation: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07) ref ad1bbr- Specialization: template 2.16.840.1.113883.10.21.4.11 UV Medication Information (detail) (DYNAMIC) ref pharmcda- |
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Example | Example | <manufacturedProduct classCode="MANU"> <templateId root="2.16.840.1.113883.10.22.4.2"/> <!-- include template 2.16.840.1.113883.10.22.4.3 'IPS Manufactured Material' (dynamic) 1..1 R --> </manufacturedProduct> |
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Item | DT | Card | Conf | Description | Label |
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| | 0 … * | R | | (IPS...uct) | | | hl7ips-dataelement-2 | Medicinal Product | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 0 … 1 | F | MANU | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...uct) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.2 | Included | 1 … 1 | R | from 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC) | | hl7:manufacturedMaterial
|
| | 1 … 1 | R | | (IPS...uct) | | | @classCode
|
| cs | 0 … 1 | F | MMAT | | | @determinerCode
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| cs | 0 … 1 | F | KIND | | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...uct) | | oid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.3 | Choice | 0 … 1 | | Elements to choose from:- hl7:code
- hl7:code[@codeSystem='2.16.840.1.113883.6.96']
| | CE.IPS | 0 … 1 | R | This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. | (IPS...uct) | | | hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 |
| | CE.IPS | 0 … 1 | R | Non IDMP codes from SNOMED CT value set | (IPS...uct) | where [@codeSystem='2.16.840.1.113883.6.96'] | | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC) |
| | | hl7:name
|
| EN | 0 … 1 | R | This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.
| (IPS...uct) | | | hl7ips-dataelement-117 | Brand Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-171 | Product Common Name (and Strength) | CEN/TC 251 prEN 17269 |
| | | pharm:formCode
|
| CE.IPS | 0 … 1 | R | Administrable Pharmaceutical Dose Form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.
| (IPS...uct) | | | hl7ips-dataelement-227 | Pharmaceutical dose form | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC) |
| | Example | <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> | | | pharm:asContent
|
| | 0 … * | | This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package.
If the package has a brand name, it can be described in the <pharm:name> element.
The <pharm:capacityQuantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging.
In the latter case, the most inner (nested) item represents the most outer package item.
For example the case
\--Box
\-----2 blisters
\--------20 tablets
is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box.
The most inner package represents the Packaged Medicinal Product.
When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
| (IPS...uct) | | cs | 1 … 1 | F | CONT | | Example | Packaged Medicinal Product with multiple layers packaging <asContent> <containerPackagedProduct> <!-- Inner Package --> <code codeSystem="..." code="..." displayName="..."> <asContent> <containerPackagedProduct> <!-- Intermediate Package --> <asContent> <containerPackagedProduct> <!-- Outer Package / Packaged Medicinal Product --> </containerPackagedProduct> </asContent> </containerPackagedProduct> </asContent> </code> </containerPackagedProduct></asContent> | | Example | Packaged Medicinal Product with formCode <asContent> <containerPackagedProduct> <!-- Packaged Medicinal Product --> <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"> <name>100 MIRACLE PILLS(TM)</name> <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/> </code> </containerPackagedProduct></asContent> | | PQ | 0 … 1 | | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the most inner Package Item or the Packaged Medicinal Product. | (IPS...uct) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | | 0 … 1 | | If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...uct) | | ST | 0 … 1 | | It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...uct) | | Example | <name>AMOXIFEN(R) 20 compresse 20 mg</name> | | CE.IPS | 0 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...uct) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | Example | <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> | | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product.
| (IPS...uct) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product | (IPS...uct) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | If this is also the most inner <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...uct) | | ST | 0 … 1 | R | It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...uct) | | Example | <name>...</name> | | CE.IPS | 1 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...uct) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
| (IPS...uct) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (IPS...uct) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage). | (IPS...uct) | | ST | 0 … 1 | R | When present, it can be used for the representing the brand name. | (IPS...uct) | | CE.IPS | 1 … 1 | R | When present, it encodes the type of the outer package.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...uct) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...uct) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | pharm:asSpecializedKind
|
| | 0 … 1 | R | This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.
The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
| (IPS...uct) | where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] | | | cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <!-- Pharmaceutical Substance (ATC Code)--> <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </generalizedMaterialKind></asSpecializedKind> | | | | pharm:generalizedMaterialKind
|
| | 1 … 1 | M | | (IPS...uct) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | The <code> element contains the ATC code of this medicine. | (IPS...uct) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC) |
| | Example | <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> | | | 0 … * | | | (IPS...uct) | | | pharm:asSpecializedKind
|
| | 0 … * | R | The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element. | (IPS...uct) | | cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"> <name/> </code> </generalizedMaterialKind></asSpecializedKind> | | | | pharm:generalizedMaterialKind
|
| | | R | | (IPS...uct) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id.
The level and the stratum of the PhPID will be distiguished by the OID of the code system.
| (IPS...uct) | | | 0 … * | R | | (IPS...uct) | | | pharm:ingredient
|
| | 0 … * | R | This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
| (IPS...uct) | | cs | 1 … 1 | R | | | CONF | The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) |
| | | 1 … 1 | M | The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity>
| (IPS...uct) | | Example | <quantity>...</quantity> | | PQ | 1 … 1 | R | | (IPS...uct) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) |
| | | 1 … 1 | R | | | PQ | 1 … 1 | R | | (IPS...uct) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) |
| | | 1 … 1 | R | | | | | pharm:ingredientSubstance
|
| | 1 … 1 | R | | (IPS...uct) | | cs | 1 … 1 | F | MMAT | | cs | 1 … 1 | F | KIND | | CD.IPS (extensible) | 0 … 1 | C | The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS. | (IPS...uct) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC) |
| | ED | 0 … * | | | (IPS...uct) | | TEL | 0 … * | | | (IPS...uct) | | CD | 0 … * | | This element can be used to provide alternative identifications for the described substance. | (IPS...uct) | | | 0 … 1 | C | Name of the substance | (IPS...uct) | | Schematron assert | role | error | | | test | pharm:code or pharm:name | | | Message | Either the name or the code of the substance (or both) shall be provided | |
|
IPS Medication Statement
Id | 2.16.840.1.113883.10.22.4.4 | Effective Date | 2024‑08‑04 10:41:54Other versions this id: - IPSMedicationStatement as of 2021‑09‑02 12:17:54
- IPSMedicationStatement as of 2016‑11‑11
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Status | Draft | Version Label | STU2 |
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Name | IPSMedicationStatement | Display Name | IPS Medication Statement |
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Description | An IPS Medication entry describes a medication statement, that is a substance administration that has actually occurred (e.g., pills ingested or injections given) or are intended to occur (e.g., "take 2 tablets twice a day for the next 10 days"). Medication activities in "INT" mood are reflections of what a clinician
intends a patient to be taking. For example, a clinician may intend that a patient to be administered Lisinopril 20 mg PO for blood pressure control. If what was actually administered was Lisinopril 10 mg., then the Medication activities in the "EVN" mood would reflect actual use.
The source of this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay, but it could be derived from the medications information recorded into a GP's EHR-system, in form of prescribed medication, or
administration statements.
The medication information may come from sources such as the patient's memory, from a prescription bottle, or from a list of medications the patient, clinician or other party maintains.
A medication statement is usually less specific than an a prescription or a medication administration record.
This entry is composed by a main substanceAdministration act and a subordinate substanceAdministration act, unless it is asserted that there are no medications data.
The first conveys information as the product, the period of administration and the route of administration; the latter is used to provide dosage information as the frequency of intakes or the amount of the medication given.
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.4 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 3 concepts | Id | Name | Data Set |
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hl7ips-dataelement-102 | Route of administration | CEN/TC 251 prEN 17269 | hl7ips-dataelement-104 | Medication | CEN/TC 251 prEN 17269 | hl7ips-dataelement-220 | Medication Summary content status | CEN/TC 251 prEN 17269 |
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Uses | Uses 4 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.21.9.1 | Include | UV Use Period (2023) | DYNAMIC | 2.16.840.1.113883.10.22.4.2 | Include | IPS Medication Information (detail) (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.14 | Include | IPS Body Author (STU1) | DYNAMIC | 2.16.840.1.113883.10.21.4.6 | Containment | UV Subordinate Substance Administration (2023) | DYNAMIC |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.4 IPS Medication Statement (2021‑09‑02 12:17:54) Version: template 2.16.840.1.113883.10.22.4.4 IPS Medication Statement (2016‑11‑11) Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.4 Medication Item (2013‑12‑20) ref epsos- Specialization: template 2.16.840.1.113883.10.21.4.7 UV Medication Statement (DYNAMIC) ref pharmcda- |
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Example | Example | <substanceAdministration classCode="SBADM" moodCode="INT"> <templateId root="2.16.840.1.113883.10.22.4.4"/> <code code="DRUG" codeSystem="2.16.840.1.113883.5.4" displayName="Drug"> <statusCode code="active"/> <effectiveTime> <width value="2" unit="wk"/> </effectiveTime> <consumable typeCode="CSM"> <!-- template 'IPS ManufacturedProduct' (dynamic) --> </consumable> <entryRelationship typeCode="COMP"> <substanceAdministration classCode="SBADM" moodCode="EVN"> <statusCode code="active"/> <effectiveTime xsi:type="PIVL_TS" institutionSpecified="true"> <period value="12" unit="h"/> </effectiveTime> <doseQuantity value="2" unit="{puff}"/> <consumable> <manufacturedProduct> <manufacturedMaterial nullFlavor="NA"/> </manufacturedProduct> </consumable> </substanceAdministration> </entryRelationship> </code></substanceAdministration> |
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Example | No medication infos | <substanceAdministration classCode="SBADM" moodCode="INT"> <templateId root="2.16.840.1.113883.10.22.4.4"/> <code code="no-medication-info" codeSystem="2.16.840.1.113883.5.1150.1" displayName="No information about medications"> <statusCode code="completed"/> <effectiveTime nullFlavor="NA" xsi:type="IVL_TS"/> <consumable> <manufacturedProduct> <manufacturedMaterial nullFlavor="NA"/> </manufacturedProduct> </consumable> </code></substanceAdministration> |
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Item | DT | Card | Conf | Description | Label |
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hl7:substanceAdministration
|
| | | R | | (IPS...ent) | | | hl7ips-dataelement-104 | Medication | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 1 … 1 | F | SBADM | | @moodCode
|
| cs | 1 … 1 | R | If the statement refers to a prescribed medication then a <substanceAdministration> intent (moodCode='INT') is used; otherwise, to record medications which are stated to have taken, the moodCode shall be set to 'EVN'.</substanceAdministration>
| | CONF | The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC) |
| | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...ent) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.4 | | hl7:id
|
| II | 0 … * | R | | (IPS...ent) | | hl7:code
|
| CD.IPS | 1 … 1 | R | The <code> element is valorized with the Substance Administration ACT code "DRUG" unless it is used for asserting the known absence of medication treatments or no information about them.
| (IPS...ent) | | | hl7ips-dataelement-220 | Medication Summary content status | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.14 DRUGActCode (DYNAMIC) | or | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.79 IPS No Medications (DYNAMIC) |
| | hl7:text
|
| ED | 0 … 1 | R | The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication.
In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication.
| (IPS...ent) | | | hl7:reference
|
| TEL | 1 … 1 | M | | (IPS...ent) | | url | 1 … 1 | R | Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:statusCode
|
| CS | 1 … 1 | M | | (IPS...ent) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended (DYNAMIC) |
| | Example | <statusCode code="active"/> | Included | 1 … 1 | R | from 2.16.840.1.113883.10.21.9.1 UV Use Period (DYNAMIC) | Choice | 1 … 1 | | The effectiveTime element encodes the use period of the medication, it is always expressed as an interval of time. It may be expressed using the low and high OR with the width element. The first is used to indicate a specified interval (e.g. from march 15th, 2017); the latter for indicating a 'floating' period (e.g. 2 weeks). Elements to choose from:- hl7:effectiveTime[hl7:low | hl7:high][not(hl7:width)]
- hl7:effectiveTime[hl7:width][not(hl7:low|hl7:high)]
- hl7:effectiveTime[hl7:low | hl7:width][not(hl7:high)]
| | | hl7:effectiveTime
|
| IVL_TS | 0 … 1 | C | Case 1: specified interval
The low and high values of the first effectiveTime element represent the start and stop times for the medication. The low value represents the start time, and the high value represents the stop time. If either the low or the high value is unknown, this shall be recorded by setting the nullFlavor attribute to UNK.
In case of unbounded period (continuous therapy) the high element will be valued with the nullFlavor attribute to NA.
The high value records the end of the medication regime according to the information provided in the prescription or order. For example, if the prescription is for enough medication to last 30 days, then the high value should contain a date that is 30 days later then the low value. The rationale is that a provider, seeing a prescription that has not been refilled would normally assume that the medication is no longer being taken, even if the intent of the treatment plan is to continue the medication indefinitely. | (IPS...ent) | where [hl7:low or [not(hl7:width)] | | | cs | 0 … 1 | | | | Example | Known Interval <effectiveTime type="IVL_TS"> <low value="20130321"/> <high value="20140321"/></effectiveTime> | | Example | Information not available about the period <effectiveTime type="IVL_TS" nullFlavor="NI"/> | | Example | Unknown end date <effectiveTime type="IVL_TS"> <low value="20130321"/> <high nullFlavor="UNK"/></effectiveTime> | | Example | continous therapy <effectiveTime type="IVL_TS"> <low value="20130321"/> <high nullFlavor="NA"/></effectiveTime> | | IVXB_TS | 1 … 1 | R | | (IPS...ent) | | IVXB_TS | 0 … 1 | R | | (IPS...ent) | | | hl7:effectiveTime
|
| IVL_TS | 0 … 1 | C | Case 2: 'floating' period:
The width element is used to specify a period of (actual or intended) administration that is not anchored to any specific date (e.g. a two weeks therapy) | (IPS...ent) | where [hl7:width] [not(hl7:lowor hl7:high)] | | | Example | 2 week period <effectiveTime type="IVL_TS"> <width value="2" unit="w"/></effectiveTime> | | | | NP | | (IPS...ent) | | | | NP | | (IPS...ent) | | | | NP | | (IPS...ent) | | PQ | 1 … 1 | R | | (IPS...ent) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC) |
| | | hl7:effectiveTime
|
| IVL_TS | 0 … 1 | C | Case 3: anchored period:
The width element is used to specify a period of (actual or intended) administration anchored to a specific date (e.g. a two weeks therapy starting today) | (IPS...ent) | where [hl7:low or [not(hl7:high)] | | | Example | 2 week period starting on 2013-03-21 <effectiveTime type="IVL_TS"> <low value="20130321"/> <width value="2" unit="w"/></effectiveTime> | | IVXB_TS | 0 … 1 | C | | (IPS...ent) | | PQ | 1 … 1 | R | | (IPS...ent) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC) |
| | hl7:routeCode
|
| CE.IPS | 0 … 1 | R | The <routeCode> element specifies the route of administration using the EDQM route of administration vocabulary.
A code must be specified if the route is known.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are also used for this concept domain, as NCI or SNOMED CT.
Official NCI and EDQM maps for the route of administration are available from the EDQM site.
| (IPS...ent) | | | hl7ips-dataelement-102 | Route of administration | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.33 IPS Medicine Route of Administration (DYNAMIC) |
| | hl7:doseQuantity
|
| IVL_PQ | | NP | | (IPS...ent) | | hl7:rateQuantity
|
| IVL_PQ | | NP | | (IPS...ent) | | hl7:administrationUnitCode
|
| CE | | NP | | (IPS...ent) | | hl7:consumable
|
| | 1 … 1 | M | | (IPS...ent) | | | @typeCode
|
| cs | 1 … 1 | F | CSM | Included | | | from 2.16.840.1.113883.10.22.4.2 IPS Medication Information (detail) (DYNAMIC) | | | hl7:manufacturedProduct
|
| | 0 … * | R | | (IPS...ent) | | | hl7ips-dataelement-2 | Medicinal Product | CEN/TC 251 prEN 17269 |
| | cs | 0 … 1 | F | MANU | | II | 1 … 1 | M | | (IPS...ent) | | uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.2 | Included | 1 … 1 | R | from 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC) | | | | hl7:manufacturedMaterial
|
| | 1 … 1 | R | | (IPS...ent) | | cs | 0 … 1 | F | MMAT | | cs | 0 … 1 | F | KIND | | II | 1 … 1 | M | | (IPS...ent) | | oid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.3 | Choice | 0 … 1 | | Elements to choose from:- hl7:code
- hl7:code[@codeSystem='2.16.840.1.113883.6.96']
| | CE.IPS | 0 … 1 | R | This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. | (IPS...ent) | | | hl7ips-dataelement-105 | Product Code | CEN/TC 251 prEN 17269 |
| | CE.IPS | 0 … 1 | R | Non IDMP codes from SNOMED CT value set | (IPS...ent) | where [@codeSystem='2.16.840.1.113883.6.96'] | | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.71 IPS Medications Products (DYNAMIC) |
| | EN | 0 … 1 | R | This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction.
The name may be applicable in one or more country/language combinations.
| (IPS...ent) | | | hl7ips-dataelement-117 | Brand Name | CEN/TC 251 prEN 17269 | hl7ips-dataelement-171 | Product Common Name (and Strength) | CEN/TC 251 prEN 17269 |
| | CE.IPS | 0 … 1 | R | Administrable Pharmaceutical Dose Form.
This code represents the form of the medication (e.g. tablet, capsule, liquid)
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration.
It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT.
| (IPS...ent) | | | hl7ips-dataelement-227 | Pharmaceutical dose form | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 IPS Medicine Doseform (DYNAMIC) |
| | Example | <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> | | | 0 … * | | This structure describes the packaging of the medication.
The <pharm:formCode> element provides the code for the particular package.
If the package has a brand name, it can be described in the <pharm:name> element.
The <pharm:capacityQuantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging.
In the latter case, the most inner (nested) item represents the most outer package item.
For example the case
\--Box
\-----2 blisters
\--------20 tablets
is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box.
The most inner package represents the Packaged Medicinal Product.
When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID.
| (IPS...ent) | | cs | 1 … 1 | F | CONT | | Example | Packaged Medicinal Product with multiple layers packaging <asContent> <containerPackagedProduct> <!-- Inner Package --> <code codeSystem="..." code="..." displayName="..."> <asContent> <containerPackagedProduct> <!-- Intermediate Package --> <asContent> <containerPackagedProduct> <!-- Outer Package / Packaged Medicinal Product --> </containerPackagedProduct> </asContent> </containerPackagedProduct> </asContent> </code> </containerPackagedProduct></asContent> | | Example | Packaged Medicinal Product with formCode <asContent> <containerPackagedProduct> <!-- Packaged Medicinal Product --> <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"> <name>100 MIRACLE PILLS(TM)</name> <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/> </code> </containerPackagedProduct></asContent> | | PQ | 0 … 1 | | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the most inner Package Item or the Packaged Medicinal Product. | (IPS...ent) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | | 0 … 1 | | If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...ent) | | ST | 0 … 1 | | It represents the Name of the Package Item or of the Packaged Medicinal Product.
If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...ent) | | Example | <name>AMOXIFEN(R) 20 compresse 20 mg</name> | | CE.IPS | 0 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ent) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | Example | <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> | | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the "2 blisters"
In the case of
\--Box
\-----5 vials
it represents the Packaged Medicinal Product.
| (IPS...ent) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | It represents the intermediate Package Item or the Packaged Medicinal Product | (IPS...ent) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | If this is also the most inner <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).
The presence of the PCID indicates that that element represents the "Packaged Medicinal Product".
| (IPS...ent) | | ST | 0 … 1 | R | It represents the Name of the Package Item or of the Packaged Medicinal Product
If this is also the most inner <pharm:containerPackagedProduct> than this element can be used for the brand name.
| (IPS...ent) | | Example | <name>...</name> | | CE.IPS | 1 … 1 | R | This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ent) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … * | R | In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product.
For example in the case
\--Box
\-----2 blisters
\--------20 tablets
it describes the Packaged Medicinal Product.
| (IPS...ent) | | cs | 1 … 1 | F | CONT | | PQ | 0 … 1 | R | The quantity which specified how many inner packaged content entities are in an outer packaging container entity.
| (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | Example | <quantity value="20" unit="{tablet}"/> | | Example | <quantity value="10" unit="mL"/> | | | | | | | | | | pharm:containerPackagedProduct
|
| | 1 … 1 | R | When present, it represents the Packaged Medicinal Product | (IPS...ent) | | cs | 1 … 1 | F | CONT | | cs | 1 … 1 | F | KIND | | CD.IPS | 0 … 1 | | When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage). | (IPS...ent) | | ST | 0 … 1 | R | When present, it can be used for the representing the brand name. | (IPS...ent) | | CE.IPS | 1 … 1 | R | When present, it encodes the type of the outer package.
Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. | (IPS...ent) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) |
| | PQ | 0 … 1 | | It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. | (IPS...ent) | | cs | 0 … 1 | | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) |
| | | 1 … 1 | R | | | | 0 … 1 | R | This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System.
The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry.
| (IPS...ent) | where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] | | | cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <!-- Pharmaceutical Substance (ATC Code)--> <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/> </generalizedMaterialKind></asSpecializedKind> | | | | | | pharm:generalizedMaterialKind
|
| | 1 … 1 | M | | (IPS...ent) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | The <code> element contains the ATC code of this medicine. | (IPS...ent) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 IPS WHO ATC (DYNAMIC) |
| | Example | <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> | | | 0 … * | | | (IPS...ent) | | | 0 … * | R | The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified.
When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element. | (IPS...ent) | | cs | 1 … 1 | F | GRIC | | Example | <asSpecializedKind classCode="GRIC"> <generalizedMaterialKind classCode="MMAT"> <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"> <name/> </code> </generalizedMaterialKind></asSpecializedKind> | | | | | | pharm:generalizedMaterialKind
|
| | | R | | (IPS...ent) | | cs | 1 … 1 | F | MMAT | | CD.IPS | 1 … 1 | R | When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id.
The level and the stratum of the PhPID will be distiguished by the OID of the code system.
| (IPS...ent) | | | 0 … * | R | | (IPS...ent) | | | 0 … * | R | This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present.
The classCode of "ACTI" indicates that this is an active ingredient.
| (IPS...ent) | | cs | 1 … 1 | R | | | CONF | The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) |
| | | 1 … 1 | M | The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity>
| (IPS...ent) | | Example | <quantity>...</quantity> | | PQ | 1 … 1 | R | | (IPS...ent) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) |
| | | 1 … 1 | R | | | PQ | 1 … 1 | R | | (IPS...ent) | | cs | 1 … 1 | R | | | CONF | The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) |
| | | 1 … 1 | R | | | | | | | pharm:ingredientSubstance
|
| | 1 … 1 | R | | (IPS...ent) | | cs | 1 … 1 | F | MMAT | | cs | 1 … 1 | F | KIND | | CD.IPS (extensible) | 0 … 1 | C | The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances. The Global Ingredient Archival System (GInAS) will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS. | (IPS...ent) | | CONF | The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 IPS Medicine Active Substances (DYNAMIC) |
| | ED | 0 … * | | | (IPS...ent) | | TEL | 0 … * | | | (IPS...ent) | | CD | 0 … * | | This element can be used to provide alternative identifications for the described substance. | (IPS...ent) | | | 0 … 1 | C | Name of the substance | (IPS...ent) | | Schematron assert | role | error | | | test | pharm:code or pharm:name | | | Message | Either the name or the code of the substance (or both) shall be provided | | Included | 0 … * | | from 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) | | hl7:author
|
| | 0 … * | | | (IPS...ent) | | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...ent) | | uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.14 | | | hl7:time
|
| TS.IPS.TZ | 1 … 1 | R | | (IPS...ent) | | | hl7:assignedAuthor
|
| | 1 … 1 | M | | (IPS...ent) | | II | 1 … * | R | | (IPS...ent) | | | 0 … 1 | R | | (IPS...ent) | Choice | 0 … 1 | | Elements to choose from:- hl7:assignedPerson
- hl7:assignedAuthoringDevice
| | | 0 … 1 | C | | (IPS...ent) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the person (e.g. the Healthcare Professional) authoring this document | (IPS...ent) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | | (IPS...ent) | | | 1 … * | R | | (IPS...ent) | | | | | hl7:assignedAuthoringDevice
|
| | 0 … 1 | C | | (IPS...ent) | | Example | <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/></assignedAuthoringDevice> | Included | | | from 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) | | cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (IPS...ent) | | | | | | hl7:manufacturerModelName
|
| SC | 0 … 1 | | | (IPS...ent) | | SC | 0 … 1 | | | (IPS...ent) | | | | hl7:representedOrganization
|
| | 0 … 1 | | | (IPS...ent) | | II | 0 … * | | | (IPS...ent) | | | 0 … * | | | (IPS...ent) | | TEL | 0 … * | | | (IPS...ent) | | AD | 0 … * | | | (IPS...ent) | | hl7:entryRelationship
|
| | 0 … * | C | Subordinate Substance Administration Statement as a component of the overall medication statement.
Unless medications are unknown or known absent, at least one subordinated <substanceAdministration> has to be present to convey information about dosages (dose, frequency of intakes,..).
Subordinated <substanceAdministration> elements can be also used either to handle split dosing, or to support combination medications.
Contains 2.16.840.1.113883.10.21.4.6 UV Subordinate Substance Administration (DYNAMIC) | (IPS...ent) | | | @typeCode
|
| cs | 1 … 1 | F | COMP | | Constraint | At least one subordinate <substanceAdministration> element SHALL be present unless medications are unknown or known absent. </substanceAdministration>
| | Example | <hl7:entryRelationship typeCode="COMP"> <!-- component: Subordinate Substance Administration Statement. --> <hl7:substanceAdministration classCode="SBADM" moodCode="EVN"> <hl7:templateId root="2.16.840.1.113883.10.22.4.33"/> <!-- .. --> </hl7:substanceAdministration> <hl7:sequenceNumber value="1"/></hl7:entryRelationship> | | | hl7:sequenceNumber
|
| INT | 0 … 1 | | Sequence number of the Subordinate Substance Administration | (IPS...ent) |
|
IPS ObservationMedia
IPS Pathology Result Observation
Id | 2.16.840.1.113883.10.22.4.11 | Effective Date | 2024‑08‑04 11:10:42Other versions this id: - IPSPathologyResultObservation as of 2017‑03‑21
|
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Status | Draft | Version Label | STU2 |
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Name | IPSPathologyResultObservation | Display Name | IPS Pathology Result Observation |
---|
Description | This template constrains the results of an anatomic pathology observation. The result observation includes a statusCode to allow recording the status of an observation. “Pending” results (e.g., a test has been run but results have not been reported yet) should be repnresented as “active” ActStatus. |
|
Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.11 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 2 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.14 | Include | IPS Body Author (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.22 | Containment | IPS Comment Activity (STU1) | DYNAMIC |
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|
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation (2017‑03‑21) Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (2017‑03‑02) |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.11"/> <id root="1.2.3.999" extension="__example only__"/> <code code="44638-5" codeSystem="2.16.840.1.113883.6.1" displayName="Histologic type in Breast tumor by CAP cancer protocols"> <statusCode code="completed"/> <effectiveTime> <low value="20171210085407"/> </effectiveTime> <value xsi:type="CD" code="399935008" displayName="Ductal carcinoma in situ - category (morphologic abnormality)" codeSystem="2.16.840.1.113883.6.96"/> <methodCode code="104157003" displayName="Light microscopy" codeSystem="2.16.840.1.113883.6.96"/> </code></observation> |
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IPS Pregnancy Expected Delivery Date Observation
Id | 2.16.840.1.113883.10.22.4.29 | Effective Date | 2024‑08‑04 11:02:42Other versions this id: - IPSPregnancyExpectedDeliveryDateObservation as of 2017‑04‑13
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Status | Draft | Version Label | STU2 |
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Name | IPSPregnancyExpectedDeliveryDateObservation | Display Name | IPS Pregnancy Expected Delivery Date Observation |
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Description | This observation records the Pregnancy Expected Delivery Date for pregnant patients, expressed as a time stamp. The code reflects the method (operationalisation) of how the date was determined, e.g. clinically estimated, estimated from last menstruation date or last ovulation date.
|
|
Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.29 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 1 concept | Id | Name | Data Set |
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hl7ips-dataelement-213 | Expected delivery date | CEN/TC 251 prEN 17269 |
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|
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.29 IPS Pregnancy Expected Delivery Date Observation (2017‑04‑13) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.13.5 Pregnancy Observation (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.33 Social history observation (DYNAMIC) ref ccd1- |
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Example | Example | <observation typeCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.29"/> <code code="11778-8" codeSystem="2.16.840.1.113883.6.1" displayName="Delivery date estimated (clinical)" codeSystemName="LOINC"> <text> <reference value="#xxx"/> </text> <statusCode code="completed"/> <effectiveTime value="20160819"/> <value xsi:type="TS" value="20170414"/> </code></observation> |
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IPS Pregnancy Outcome Observation
IPS Pregnancy Status Observation
IPS Problem Concern Entry
Id | 2.16.840.1.113883.10.22.4.7 | Effective Date | 2021‑08‑04 08:49:27Other versions this id: - IPSProblemConcernEntry as of 2017‑02‑15
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Status | Draft | Version Label | 2021 |
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Name | IPSProblemConcernEntry | Display Name | IPS Problem Concern Entry |
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Description |
This template reflects an ongoing concern on behalf of the provider that placed the concern on a patient’s problem list. The purpose of the concern act is that of supporting the tracking of a problem or a condition.
There are different kinds of status that could be related to a condition:
- The status of the concern (active, inactive,..)
- The status of the condition (e.g. active, inactive, resolved,..)
- The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…)
Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition).
So long as the underlying conditions are of concern to the provider (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”. Only when the underlying conditions are no longer of concern is the statusCode set to “completed”.
The effectiveTime reflects the time that the underlying condition was felt to be a concern; it may or may not correspond to the effectiveTime of the condition (e.g., even five years later, the clinician may remain concerned about a prior heart attack). The effectiveTime/low of the Problem Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient's chart. The effectiveTime/high asserts when the concern become inactive, and it is present if the statusCode of the concern act is "completed".
A Problem Concern Act can contain many Problem Observations.
The many Problem Observations nested under a Problem Concern Act reflect the change in the clinical understanding of a condition over time. For instance, a Concern may initially contain a Problem Observation of “chest pain”:
- Problem Concern 1
--- Problem Observation: Chest Pain
Later, a new Problem Observation of “esophagitis” will be added, reflecting a better understanding of the nature of the chest pain. The later problem observation will have a more recent author time stamp.
- Problem Concern 1
--- Problem Observation (author/time Jan 3, 2012): Chest Pain
--- Problem Observation (author/time Jan 6, 2012): Esophagitis
Many systems display the nested Problem Observation with the most recent author time stamp, and provide a mechanism for viewing prior observations.
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.7 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Uses | Uses 1 template | Uses | as | Name | Version |
---|
2.16.840.1.113883.10.22.4.8 | Containment | IPS Problem Entry (2021) | DYNAMIC |
|
|
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Relationship | Version: template 2.16.840.1.113883.10.22.4.7 IPS Problem Concern Entry (2017‑02‑15) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.1 IHE Concern Entry (DYNAMIC) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.20.1.27 Problem act (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.2 eHDSI Problem Concern (DYNAMIC) ref epsos- |
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Example | Active Concern with several conditions | <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.7"/> <id root="1.2.3.999" extension="__example only__"/> <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/> <statusCode code="active"/> <effectiveTime> <low value="20170309"/> </effectiveTime> <entryRelationship typeCode="SUBJ" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) --> <!-- A condition could be active, inactive,.... --> </entryRelationship> <entryRelationship typeCode="SUBJ" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) --> </entryRelationship></act> |
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Example | Concern no longer tracked | <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.7"/> <id root="1.2.3.999" extension="__example only__"/> <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/> <statusCode code="completed"/> <effectiveTime> <low value="20161210"/> <low value="20170309"/> </effectiveTime> <entryRelationship typeCode="SUBJ" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) --> </entryRelationship></act> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | | (IPS...try) | | @classCode
|
| cs | 1 … 1 | F | ACT | | @moodCode
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| cs | 1 … 1 | F | EVN | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...try) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.7 | | hl7:id
|
| II | 0 … * | R | | (IPS...try) | | hl7:code
|
| CD | 1 … 1 | M | | (IPS...try) | | | @code
|
| | 1 … 1 | F | CONC | | | @codeSystem
|
| | 1 … 1 | F | 2.16.840.1.113883.5.6 | | hl7:statusCode
|
| CS | 1 … 1 | R | So long as the underlying conditions are of concern to the provider (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”.
Only when the underlying conditions are no longer of concern is the statusCode set to “completed”. | (IPS...try) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) |
| | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | M | | (IPS...try) | | | hl7:low
|
| IVXB_TS | 1 … 1 | R | This element asserts when the concern became active. This equates to the time the concern was authored in the patient's chart and the author started tracking this concern. | (IPS...try) | | | hl7:high
|
| IVXB_TS | 0 … 1 | C | This element asserts when the clinician deemed there is no longer any need to track the underlying conditions. | (IPS...try) | | Constraint | If the statusCode is completed this element is required | | hl7:entryRelationship
|
| | 1 … * | R | Contains 2.16.840.1.113883.10.22.4.8 IPS Problem Entry (DYNAMIC) | (IPS...try) | | | @typeCode
|
| cs | 1 … 1 | F | SUBJ | | | @inversionInd
|
| bl | 0 … 1 | F | false |
|
IPS Problem Entry
Id | 2.16.840.1.113883.10.22.4.8 | Effective Date | 2024‑08‑04 11:06:03Other versions this id: - IPSProblemEntry as of 2021‑08‑04 08:52:52
- IPSProblemEntry as of 2017‑02‑15
|
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Status | Draft | Version Label | 2021 |
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Name | IPSProblemEntry | Display Name | IPS Problem Entry |
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Description | This template reflects a discrete observation about a patient's problem. Because it is a discrete observation, it will have a statusCode of "completed". The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the
clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago.
The effectiveTime of the Problem Observation is the definitive indication of whether or not the underlying condition is resolved. If the problem is known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".
|
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.8 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 12 concepts | Id | Name | Data Set |
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hl7ips-dataelement-101 | Problem type | CEN/TC 251 prEN 17269 | hl7ips-dataelement-115 | Problem content status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-127 | Onset date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-128 | Severity | CEN/TC 251 prEN 17269 | hl7ips-dataelement-131 | Diagnosis | CEN/TC 251 prEN 17269 | hl7ips-dataelement-136 | Severity | CEN/TC 251 prEN 17269 | hl7ips-dataelement-140 | Problem | CEN/TC 251 prEN 17269 | hl7ips-dataelement-209 | Health condition / Problem | CEN/TC 251 prEN 17269 | hl7ips-dataelement-210 | Problem Type | CEN/TC 251 prEN 17269 | hl7ips-dataelement-32 | Onset Date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-34 | Date resolved | CEN/TC 251 prEN 17269 | hl7ips-dataelement-36 | Diagnosis | CEN/TC 251 prEN 17269 |
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Uses | Uses 3 templates | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.25 | Containment | IPS Severity Observation (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.19 | Containment | IPS Certainty Observation (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.20 | Containment | IPS Problem Status Observation (STU1) | 2017‑03‑29 |
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.8 IPS Problem Entry (2021‑08‑04 08:52:52) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc- |
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Example | Active Problem | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.8"/> <id root="1.2.3.999" extension="__example only__"/> <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"> <text> <reference value="#problem-1"/> </text> <statusCode code="completed"/> <effectiveTime> <low value="20100507"/> </effectiveTime> <value code="38341003" displayName="Hypertensive disorder, systemic arterial (disorder)" codeSystem="2.16.840.1.113883.6.96"/> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="REFR" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.20 'IPS Problem Status Observation' (2017-03-29T00:00:00) --> <!-- this referred observation should report that the condition is still active --> </entryRelationship> </code></observation> |
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Example | Closed Problem (resolution date known) | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.8"/> <id root="1.2.3.999" extension="__example only__"/> <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"> <statusCode code="completed"/> <effectiveTime> <low value="2010"/> <high value="2015"/> </effectiveTime> <value code="38341003" displayName="Hypertensive disorder, systemic arterial (disorder)" codeSystem="2.16.840.1.113883.6.96"/> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) --> </entryRelationship> <entryRelationship typeCode="REFR" inversionInd="false"> <!-- template 2.16.840.1.113883.10.22.4.20 'IPS Problem Status Observation' (2017-03-29T00:00:00) --> <!-- this referred observation should report that the condition is resolved --> </entryRelationship> </code></observation> |
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Example | Known absent problems | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.8"/> <id root="1.2.3.999" extension="__example only__"/> <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"> <statusCode code="completed"/> <effectiveTime> <low nullFlavor="NI"/> </effectiveTime> <value code="no-known-problems" displayName="No known problems" codeSystem="2.16.840.1.113883.5.1150.1"/> </code></observation> |
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Item | DT | Card | Conf | Description | Label |
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| | | R | | (IPS...try) | | | hl7ips-dataelement-140 | Problem | CEN/TC 251 prEN 17269 | hl7ips-dataelement-209 | Health condition / Problem | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 0 … 1 | F | OBS | | @moodCode
|
| cs | 1 … 1 | F | EVN | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...try) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.8 | | hl7:id
|
| II | 0 … * | R | | (IPS...try) | | hl7:code
|
| CD.IPS | 1 … 1 | R | This element describes the type of condition this observation is referring to. | (IPS...try) | | | hl7ips-dataelement-101 | Problem type | CEN/TC 251 prEN 17269 | hl7ips-dataelement-210 | Problem Type | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.16 IPS Problem Type (DYNAMIC) |
| | Example | <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"/> | | hl7:text
|
| ED | 0 … 1 | R | The <text> element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.</reference>
</text>
| (IPS...try) | | Example | <text> <reference value="#problem-1"/></text> | | | hl7:reference
|
| TEL | 1 … 1 | M | | (IPS...try) | | url | 1 … 1 | R | When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:statusCode
|
| CS | 1 … 1 | M | A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.</statusCode>
| (IPS...try) | | | @code
|
| CONF | 1 … 1 | F | completed | | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | M | The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago.
The <low> and <high> values should be no more precise than known, but as precise as possible.
| (IPS...try) | | Example | Known onset date (active condition) <effectiveTime> <low value="20100507"/></effectiveTime> | | Example | Unknown onset date (active condition) <effectiveTime> <low nullFlavor="UNK"/></effectiveTime> | | Example | Unknown resolution date <effectiveTime> <low value="2010"/> <high nullFlavor="UNK"/></effectiveTime> | | Example | Known resolution date <effectiveTime> <low value="201007"/> <high value="201703"/></effectiveTime> | | | hl7:low
|
| IVXB_TS | 1 … 1 | R | The effectiveTime/low (a.k.a. "onset date") asserts when the condition became biologically active. | (IPS...try) | | | hl7ips-dataelement-127 | Onset date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-32 | Onset Date | CEN/TC 251 prEN 17269 |
| | | hl7:high
|
| IVXB_TS | 0 … 1 | C | The effectiveTime/high (a.k.a. "resolution date") asserts when the condition e became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". | (IPS...try) | | | hl7ips-dataelement-34 | Date resolved | CEN/TC 251 prEN 17269 |
| | Constraint | If this condition is known to be resolved, then the effectiveTime/high would be present.
| | hl7:value
|
| CD.IPS (preferred) | 1 … 1 | M | The <value> is the condition that was found. It may a coded or an un-coded string, but its type is always coded. The coded form shall be used also to indicate known absent conditions or the nonavailability of information about them. | (IPS...try) | | | hl7ips-dataelement-115 | Problem content status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-131 | Diagnosis | CEN/TC 251 prEN 17269 | hl7ips-dataelement-36 | Diagnosis | CEN/TC 251 prEN 17269 |
| | | @xsi:type
|
| | 0 … 1 | F | CD | | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.73 IPS Problems (DYNAMIC) |
| | Example | Multiple Coding <value code="302231008" displayName="Salmonella infection" codeSystem="2.16.840.1.113883.6.96"> <translate code="A02.9" displayName="Infezioni da Salmonella non specificate" codeSystem="2.16.840.1.113883.6.3"/></value> | | Example | Local code not mappable in the reference terminology <value nullFlavor="OTH"> <translate code="12345" displayName="Not in the reference value set" codeSystem="1.2.3.999" codeSystemName="--example only--"/></value> | | Example | Textual Information <value nullFlavor="NI"> <originalText> <reference value="#value_as_text"/> </originalText></value> | | Example | Known absent problems <value code="160245001" displayName="No current problems or disability" codeSystem="2.16.840.1.113883.6.96"/> | | | hl7:originalText
|
| ED | | R | The <originalText> element within the <code> element described above is used as follows: the <value> contains a <reference> to the <originalText> in order to link the coded value to the problem narrative text (minus any dates, comments, et cetera). The <reference> contains a
URI in value attribute. This URI points to the free text description of the problem in the document that is being described.
| (IPS...try) | | TEL | 0 … 1 | R | The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains
the complete text describing the medication. </reference>
</reference>
| (IPS...try) | | Example | <reference value="#value_as_text"/> | | | hl7:qualifier
|
| CR | 0 … * | | | (IPS...try) | | | hl7:translation
|
| CD.IPS | 0 … * | | The translation element may be used to transmit a set of other concept descriptors, using for example ICD-10 or other international or jurisdictional code systems. | (IPS...try) | | hl7:entryRelationship
|
| | 0 … 1 | R | Severity
The contained entry describes a subjective assessment of the severity of the condition as evaluated by the clinician. Contains 2.16.840.1.113883.10.22.4.25 IPS Severity Observation (DYNAMIC) | (IPS...try) | | | hl7ips-dataelement-128 | Severity | CEN/TC 251 prEN 17269 | hl7ips-dataelement-136 | Severity | CEN/TC 251 prEN 17269 |
| | | @typeCode
|
| cs | 1 … 1 | F | SUBJ | | | @inversionInd
|
| bl | 1 … 1 | F | true | | hl7:entryRelationship
|
| | 0 … 1 | R | Certainty or Verification Status
The contained entry describes the certainty associated with a condition. Contains 2.16.840.1.113883.10.22.4.19 IPS Certainty Observation (DYNAMIC) | (IPS...try) | | | @typeCode
|
| cs | 1 … 1 | F | SUBJ | | | @inversionInd
|
| bl | 1 … 1 | F | true | | hl7:entryRelationship
|
| | 0 … 1 | R | Status of the Problem The contained entry describes the current status of the condition, for example, whether it is active, in remission, resolved, and so on ... Contains 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (2017‑03‑29) | (IPS...try) | | | @typeCode
|
| cs | 1 … 1 | F | REFR | | | @inversionInd
|
| bl | 0 … 1 | F | false |
|
IPS Problem Status Observation
Id | 2.16.840.1.113883.10.22.4.20 | Effective Date | 2021‑09‑02 11:41:28Other versions this id: - IPSProblemStatusObservation as of 2017‑03‑29
|
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Status | Draft | Version Label | 2021 |
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Name | IPSProblemStatusObservation | Display Name | IPS Problem Status Observation |
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Description | This subordinated observation used by the problem observation records information about the current status of a condition, for example, whether it is active, in remission, resolved, et cetera. |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.20 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Relationship | Version: template 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (2017‑03‑29) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.1.1 IHE Problem Status Observation (2013‑12‑20) ref IHE-PCC- |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.20"/> <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" displayName="Status"/> <text> <reference value="#example"/> </text> <statusCode code="completed"/> <value code="active" displayName="Active" codeSystem="2.16.840.1.113883.4.642.3.155"/></observation> |
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IPS Procedure Entry
Id | 2.16.840.1.113883.10.22.4.17 | Effective Date | 2024‑08‑04 11:08:35Other versions this id: - IPSProcedureEntry as of 2020‑07‑14 16:35:58
- IPSProcedureEntry as of 2017‑03‑27
|
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Status | Draft | Version Label | STU2 |
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Name | IPSProcedureEntry | Display Name | IPS Procedure Entry |
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Description | The procedure entry is used to record procedures that have occurred, or which are planned for in the future. |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.17 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 5 concepts | Id | Name | Data Set |
---|
hl7ips-dataelement-216 | Body site | CEN/TC 251 prEN 17269 | hl7ips-dataelement-44 | Procedures Content Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-47 | Procedure | CEN/TC 251 prEN 17269 | hl7ips-dataelement-48 | Procedure date | CEN/TC 251 prEN 17269 | hl7ips-dataelement-49 | Procedure code | CEN/TC 251 prEN 17269 |
|
|
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Uses | Uses 1 template | Uses | as | Name | Version |
---|
2.16.840.1.113883.10.22.4.31 | Containment | IPS Internal Reference (STU1) | DYNAMIC |
|
|
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry (2020‑07‑14 16:35:58) Version: template 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry (2017‑03‑27) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.19 IHE Procedure Entry (2016‑09‑28 10:37:28) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.12.306 CDA Procedure (2005‑09‑07) ref ad1bbr- |
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Example | Example | <hl7:procedure classCode="PROC" moodCode="EVN"> <hl7:templateId root="2.16.840.1.113883.10.22.4.17"/> <hl7:id root="1.2.3.999" extension="--example only--"/> <hl7:code/> <hl7:text> <hl7:reference value="value"/> </hl7:text> <hl7:statusCode code="completed"/> <hl7:effectiveTime> <hl7:low value="20200714163551"/> </hl7:effectiveTime> <hl7:targetSiteCode/> <hl7:entryRelationship typeCode="COMP" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.31 'IPS Internal Reference' (2017-05-02T00:00:00) --> </hl7:entryRelationship></hl7:procedure> |
|
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Item | DT | Card | Conf | Description | Label |
---|
| | | | | (IPS...try) | | | hl7ips-dataelement-47 | Procedure | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 1 … 1 | F | PROC | | @moodCode
|
| cs | 1 … 1 | R | | | CONF | The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC) |
| | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...try) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.17 | | hl7:id
|
| II | 0 … * | R | | (IPS...try) | | hl7:code
|
| CD.IPS (preferred) | 1 … 1 | R | | (IPS...try) | | | hl7ips-dataelement-44 | Procedures Content Status | CEN/TC 251 prEN 17269 | hl7ips-dataelement-49 | Procedure code | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.35 IPS Procedures (DYNAMIC) |
| | hl7:text
|
| ED | 0 … 1 | R | The <text> element if present points to the text describing the data being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the element (problem, procedure,...) in the document that is being described.</reference>
</text>
| (IPS...try) | | | hl7:reference
|
| TEL | 1 … 1 | M | | (IPS...try) | | url | 1 … 1 | R | When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:statusCode
|
| CS | 1 … 1 | M | | (IPS...try) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.22 ActStatusActiveCompletedAbortedCancelled (DYNAMIC) |
| | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | R | | (IPS...try) | | | hl7ips-dataelement-48 | Procedure date | CEN/TC 251 prEN 17269 |
| | hl7:targetSiteCode
|
| CD.IPS (preferred) | 0 … * | | | (IPS...try) | | | hl7ips-dataelement-216 | Body site | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.55 IPS Body Site (DYNAMIC) |
| | hl7:participant
|
| | 1 … * | R | The device is represented as a participant in the procedure structure. The following descriptions apply to the device structure. | (IPS...try) | | | @typeCode
|
| cs | 1 … 1 | F | DEV | | Example | <participant typeCode="DEV"> <participantRole classCode="MANU"> <id root="1.2.3.999" extension="__example_only__"/> <playingDevice classCode="DEV" determinerCode="INSTANCE"> <code code="" codeSystem=""> <!-- ... --> </code> </playingDevice> </participantRole></participant> | | | hl7:participantRole
|
| | 1 … 1 | R | | (IPS...try) | | cs | 1 … 1 | F | MANU | | II | 0 … * | R | The device ID, e.g. using UDI, is represented by the id element of the participant role. This element is optional, as not all production identifiers (e.g., serial number, lot/batch number, distinct identification number) may be known to the provider or patient.
| (IPS...try) | | Example | UDI GS1: DeviceIdentifier 00844588003288, Serial# 10987654d321, Lot# 7654321D <id root="2.16.840.1.113883.3.3719" extension="{01}00844588003288{17}141120{10}7654321D{21}10987654d321"/> | | Example | UDI ICCBBA: DeviceIdentifier 00844588003288 <id root="2.16.840.1.113883.3.3719" extension="A9999XYZ100T0474"/> | | Example | UDI HIBCC: Serial# XYZ456789012345678, Lot# LOT123456789012345 <id root="2.16.840.1.113883.3.3719" extension="+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C"/> | | | 1 … 1 | R | The playingDevice element describes the device instance. | (IPS...try) | | cs | 1 … 1 | F | DEV | | cs | 1 … 1 | F | INSTANCE | | CE.IPS (preferred) | 1 … 1 | R | The device code describes the type of device (e.g. arm prosthesis, arterial stent). | (IPS...try) | | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.23 IPS Medical Devices (DYNAMIC) | or | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.61 Absent or Unknown Devices (DYNAMIC) |
| | hl7:entryRelationship
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.31 IPS Internal Reference (DYNAMIC) | (IPS...try) | | | @typeCode
|
| cs | 1 … 1 | F | COMP | | | @inversionInd
|
| bl | 1 … 1 | F | true |
|
IPS Radiology Result Observation
IPS Reaction Manifestation
Id | 2.16.840.1.113883.10.22.4.6 | Effective Date | 2024‑08‑04 10:18:47Other versions this id: - IPSAdverseReactionMFST as of 2016‑11‑15
|
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Status | Draft | Version Label | STU2 |
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Name | IPSAdverseReactionMFST | Display Name | IPS Reaction Manifestation |
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Description | This clinical statement represents the response to an undesired symptom, finding, etc. due to administered or exposed substance. This reaction may be an undesired symptom, finding, etc. or it could be a desired response to a treatment. A reaction can be defined with respect to its severity, and can have been treated by one or
more interventions. |
|
Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.6 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 2 concepts | Id | Name | Data Set |
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hl7ips-dataelement-193 | Manifestation of the reaction | CEN/TC 251 prEN 17269 | hl7ips-dataelement-194 | Severity | CEN/TC 251 prEN 17269 |
|
|
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Uses | Uses 1 template | Uses | as | Name | Version |
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2.16.840.1.113883.10.22.4.25 | Containment | IPS Severity Observation (STU1) | DYNAMIC |
|
|
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Relationship | Specialization: template 2.16.840.1.113883.10.22.4.6 IPS Reaction Manifestation (2016‑11‑15) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc- |
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Example | Example | <observation classCode="OBS" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.6"/> <id root="1.2.3.999" extension="__example only__"/> <code code="404684003" displayName="Clinical finding" codeSystem="2.16.840.1.113883.6.96"> <text> <reference value="#ref1"/> </text> <statusCode code="completed"/> <effectiveTime> <low value="201611"/> </effectiveTime> <value xsi:type="CD" code="1985008" displayName="Vomitus" codeSystem="2.16.840.1.113883.6.96"> <originalText> <reference value="#ref2"/> </originalText> </value> <entryRelationship typeCode="SUBJ" inversionInd="true"> <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) --> </entryRelationship> </code></observation> |
|
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Item | DT | Card | Conf | Description | Label |
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| | | R | | (IPS...FST) | | @classCode
|
| cs | 0 … 1 | F | OBS | | @moodCode
|
| cs | 1 … 1 | F | EVN | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...FST) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.6 | | hl7:id
|
| II | 0 … * | R | | (IPS...FST) | | hl7:code
|
| CD.IPS | 1 … 1 | R | This element describes the type of condition this observation is referring to.
| (IPS...FST) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.16 IPS Problem Type (2017‑04‑07) |
| | hl7:text
|
| ED | 0 … 1 | R | The <text> element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.
| (IPS...FST) | | | hl7:reference
|
| TEL | 1 … 1 | M | | (IPS...FST) | | url | 1 … 1 | R | When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 | | hl7:statusCode
|
| CS (required) | 0 … 1 | R | A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.
| (IPS...FST) | | | @code
|
| CONF | 0 … 1 | F | completed | | hl7:effectiveTime
|
| IVL_TS | 1 … 1 | M | The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago.
The <low> and <high> values should be no more precise than known, but as precise as possible.
| (IPS...FST) | | | hl7:low
|
| IVXB_TS | 1 … 1 | R | The effectiveTime/low (a.k.a. "onset date") asserts when the condition became biologically active. | (IPS...FST) | | | hl7:high
|
| IVXB_TS | 0 … 1 | C | The effectiveTime/high (a.k.a. "resolution date") asserts when the condition e became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". | (IPS...FST) | | Constraint | If this condition is known to be resolved, then the effectiveTime/high would be present.
| | hl7:value
|
| CD.IPS (preferred) | 1 … 1 | R | The <value> is the condition that was found. While the value may be a coded or an un-coded string, the type is always a coded value. If uncoded, it shall contain a <reference> to the <originalText> in the narrative where the reaction is described.
| (IPS...FST) | | | hl7ips-dataelement-193 | Manifestation of the reaction | CEN/TC 251 prEN 17269 |
| | | @xsi:type
|
| | 1 … 1 | F | CD | | CONF | The value of @code comes preferably from value set 2.16.840.1.113883.11.22.3 IPS Allergy Reaction (DYNAMIC) |
| | | hl7:originalText
|
| | 0 … 1 | R | The <originalText> element within the <code> element described above is used as follows: the <value> contains a <reference> to the <originalText> in order to link the coded value to the problem narrative text (minus any dates, comments, et cetera). The <reference> contains a
URI in value attribute. This URI points to the free text description of the problem in the document that is being described.
| (IPS...FST) | | | 0 … 1 | R | The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains
the complete text describing the medication. </reference></reference> | (IPS...FST) | | Example | <reference value="#AdvReaction_1"/> | | | hl7:translation
|
| CD | 0 … * | | | (IPS...FST) | | hl7:entryRelationship
|
| | 0 … 1 | R | Severity
The contained entry describes a subjective assessment of the severity of the condition as evaluated by the clinician. Contains 2.16.840.1.113883.10.22.4.25 IPS Severity Observation (DYNAMIC) | (IPS...FST) | | | hl7ips-dataelement-194 | Severity | CEN/TC 251 prEN 17269 |
| | | @typeCode
|
| cs | 1 … 1 | F | SUBJ | | | @inversionInd
|
| bl | 1 … 1 | F | true |
|
IPS Result Observation
IPS Result Organizer
Id | 2.16.840.1.113883.10.22.4.9 | Effective Date | 2017‑03‑02 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSResultOrganizer | Display Name | IPS Result Organizer |
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Description | This template provides a mechanism for grouping result observations. It contains information applicable to all of the contained result observations. The Result Organizer code categorizes the contained results into one of several commonly accepted values (e.g., “Hematology”, “Chemistry”, “Nuclear Medicine”). If any Result Observation within the organizer has a statusCode of "active", the Result Organizer must also have a statusCode of "active". However, the results selected for a patient summary are most often final results, with status "completed". So in most cases, the statusCode of the Organizer is "completed". The result observations contained within the organizer may use
either of these templates: - Laboratory Result Observation
- Radiology Result Observation
- Pathology Result Observation
- Result Observation (most generic template used whenever none of the above is applicable)
One Result Organizer entry groups results, which have a common context of production: - common specialty (imaging, bacteriology, serology, chemistry, surgical pathology, clinical, radiology ...),
- common overall interpretation, (which interprets the set of results of the Organizer),
- common biologic specimen for in vitro diagnostic observations,
- common associated illustrative
image (ObservationMedia).
The ultimate choice for sorting out results between Organizer entries belongs to the authoring person or system of the section. |
|
Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.9 |
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 6 concepts | Id | Name | Data Set |
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hl7ips-dataelement-106 | Observation Result | CEN/TC 251 prEN 17269 | hl7ips-dataelement-143 | Date of observation | CEN/TC 251 prEN 17269 | hl7ips-dataelement-144 | Observation Type | CEN/TC 251 prEN 17269 | hl7ips-dataelement-146 | Performer | CEN/TC 251 prEN 17269 | hl7ips-dataelement-177 | Observer | CEN/TC 251 prEN 17269 | hl7ips-dataelement-23 | Observation Result | CEN/TC 251 prEN 17269 |
|
|
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Uses | Uses 9 templates | Uses | as | Name | Version |
---|
2.16.840.1.113883.10.12.323 | Containment | CDA Performer (Body) | DYNAMIC | 2.16.840.1.113883.10.22.4.14 | Include | IPS Body Author (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.13 | Containment | IPS Laboratory Result Observation (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.12 | Containment | IPS Radiology Result Observation (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.11 | Containment | IPS Pathology Result Observation (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.10 | Containment | IPS Result Observation (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.30 | Containment | IPS Specimen Collection (STU2) | DYNAMIC | 2.16.840.1.113883.10.22.4.22 | Containment | IPS Comment Activity (STU1) | DYNAMIC | 2.16.840.1.113883.10.22.4.23 | Containment | IPS ObservationMedia (2021) | DYNAMIC |
|
|
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Relationship | Adaptation: template 2.16.840.1.113883.10.12.305 CDA Organizer (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.1 Result Organizer (V3) (2015‑08‑01) ref ccda- |
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Example | Example | <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="11529-5" displayName="Surgical pathology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a pathologist --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.11 'IPS Pathology Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - excised tissue specimen --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - pathologist's interpretation --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative slide image --> </component></organizer> |
|
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Example | Example | <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="18719-5" displayName="Chemistry studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a clinical laboratory director --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - common blood serum specimen --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of chemistry results --> </component></organizer> |
|
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Example | Example | <organizer classCode="BATTERY" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.22.4.9"/> <code code="18748-4" displayName="Diagnostic imaging study" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/> <satusCode code="completed"/> <author> <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a radiologist --> </author> <component> <!-- template 2.16.840.1.113883.10.22.4.12 'IPS Radiology Result Observation' --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative image --> </component> <component> <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - overall interpretation --> </component></organizer> |
|
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Item | DT | Card | Conf | Description | Label |
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| | | | | (IPS...zer) | | | hl7ips-dataelement-106 | Observation Result | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 1 … 1 | R | | | @moodCode
|
| cs | 1 … 1 | F | EVN | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...zer) | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.9 | | hl7:id
|
| II | 0 … * | | | (IPS...zer) | | hl7:code
|
| CD.IPS | 1 … 1 | R | | (IPS...zer) | | | hl7ips-dataelement-144 | Observation Type | CEN/TC 251 prEN 17269 |
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.37 IPS Results Organizer (DYNAMIC) |
| | hl7:statusCode
|
| CS | 1 … 1 | M | | (IPS...zer) | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) |
| | hl7:effectiveTime
|
| IVL_TS | 0 … 1 | | | (IPS...zer) | | | hl7ips-dataelement-143 | Date of observation | CEN/TC 251 prEN 17269 |
| | | hl7:low
|
| IVXB_TS | 0 … 1 | | | (IPS...zer) | | | hl7:high
|
| IVXB_TS | 0 … 1 | | | (IPS...zer) | | hl7:performer
|
| | 0 … * | R | When present, this element represents the organization who performed the set of observations grouped under this organizer.
Contains 2.16.840.1.113883.10.12.323 CDA Performer (Body) (DYNAMIC) | (IPS...zer) | | | hl7ips-dataelement-146 | Performer | CEN/TC 251 prEN 17269 |
| Included | 0 … * | R | from 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) | | | hl7ips-dataelement-177 | Observer | CEN/TC 251 prEN 17269 |
| | hl7:author
|
| | 0 … * | R | | (IPS...zer) | | | hl7:templateId
|
| II | 1 … 1 | M | | (IPS...zer) | | uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.14 | | | hl7:time
|
| TS.IPS.TZ | 1 … 1 | R | | (IPS...zer) | | | hl7:assignedAuthor
|
| | 1 … 1 | M | | (IPS...zer) | | II | 1 … * | R | | (IPS...zer) | | | 0 … 1 | R | | (IPS...zer) | Choice | 0 … 1 | | Elements to choose from:- hl7:assignedPerson
- hl7:assignedAuthoringDevice
| | | 0 … 1 | C | | (IPS...zer) | | cs | 0 … 1 | F | PSN | | cs | 0 … 1 | F | INSTANCE | | PN | 1 … * | R | Name of the person (e.g. the Healthcare Professional) authoring this document | (IPS...zer) | | Example | <name> <given>John</given> <family>Español Smith</family></name> | | | 1 … * | R | | (IPS...zer) | | | 1 … * | R | | (IPS...zer) | | | | | hl7:assignedAuthoringDevice
|
| | 0 … 1 | C | | (IPS...zer) | | Example | <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE"> <softwareName displayName="Turriano"/></assignedAuthoringDevice> | Included | | | from 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) | | cs | 0 … 1 | F | DEV | | cs | 0 … 1 | F | INSTANCE | | CE | 0 … 1 | | | (IPS...zer) | | | | | | hl7:manufacturerModelName
|
| SC | 0 … 1 | | | (IPS...zer) | | SC | 0 … 1 | | | (IPS...zer) | | | | hl7:representedOrganization
|
| | 0 … 1 | | | (IPS...zer) | | II | 0 … * | | | (IPS...zer) | | | 0 … * | | | (IPS...zer) | | TEL | 0 … * | | | (IPS...zer) | | AD | 0 … * | | | (IPS...zer) | Choice | 1 … * | | Elements to choose from:- hl7:component containing template 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.12 IPS Radiology Result Observation (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.30 IPS Specimen Collection (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC)
- hl7:component containing template 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia (DYNAMIC)
| | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation (DYNAMIC) | (IPS...zer) | | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.12 IPS Radiology Result Observation (DYNAMIC) | (IPS...zer) | | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation (DYNAMIC) | (IPS...zer) | | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.10 IPS Result Observation (DYNAMIC) | (IPS...zer) | | | hl7ips-dataelement-23 | Observation Result | CEN/TC 251 prEN 17269 |
| | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.30 IPS Specimen Collection (DYNAMIC) | (IPS...zer) | | Constraint | An IPS Specimen Collection SHALL be present only if the organizer carries anatomic pathology or microbiology laboratory observations, which need to be associated with the specific anatomic site the specimen was collected from. | | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) | (IPS...zer) | | Constraint | An IPS Comment Activity SHALL contain a general comment applying to the whole set of observations present in the organizer | | | hl7:component
|
| | 0 … * | | Contains 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia (DYNAMIC) | (IPS...zer) |
|
IPS Severity Observation
IPS Social History Alcohol Use
IPS Social History Tobacco Use
IPS Specimen Collection
IPS Subordinate SubstanceAdministration
Id | 2.16.840.1.113883.10.22.4.33 | Effective Date | 2017‑06‑15 |
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSSubordinateSubstanceAdministration | Display Name | IPS Subordinate SubstanceAdministration |
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Description | This entry is used by a main substanceAdministration act to provide dosage information as the frequency of intakes or the amount of the medication given. |
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Context | Parent nodes of template element with id 2.16.840.1.113883.10.22.4.33 |
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Label | IPSSubordSBADM
|
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Classification | CDA Entry Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Associated with | Associated with 3 concepts | Id | Name | Data Set |
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hl7ips-dataelement-119 | Dose Instruction | CEN/TC 251 prEN 17269 | hl7ips-dataelement-223 | Number of units per intake | CEN/TC 251 prEN 17269 | hl7ips-dataelement-224 | Frequency of intake | CEN/TC 251 prEN 17269 |
|
|
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Relationship | Specialization: template 2.16.840.1.113883.10.21.4.6 UV Subordinate Substance Administration (DYNAMIC) ref pharmcda- |
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Example | Example | <hl7:substanceAdministration classCode="SBADM" moodCode="EVN"> <hl7:templateId root="2.16.840.1.113883.10.22.4.33"/> <hl7:statusCode code="active"/> <!-- choice: 1..1 element hl7:effectiveTime[@value or @nullFlavor] element hl7:effectiveTime[@xsi:type='PIVL_TS'] element hl7:effectiveTime[@xsi:type='EIVL_TS'] element hl7:effectiveTime[@xsi:type='SXPR_TS'] --> <hl7:effectiveTime xsi:type="PIVL_TS" institutionSpecified="true"> <hl7:period value="12" unit="h"/> </hl7:effectiveTime> <hl7:doseQuantity xsi:type="IVL_PQ" value="2" unit="{puff}"/> <hl7:consumable> <hl7:manufacturedProduct> <hl7:manufacturedMaterial nullFlavor="NA"/> </hl7:manufacturedProduct> </hl7:consumable></hl7:substanceAdministration> |
|
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Item | DT | Card | Conf | Description | Label |
---|
hl7:substanceAdministration
|
| | | | | IPSS...BADM | | | hl7ips-dataelement-119 | Dose Instruction | CEN/TC 251 prEN 17269 |
| | @classCode
|
| cs | 1 … 1 | F | SBADM | | @moodCode
|
| cs | 1 … 1 | R | If the statement refers to a prescribed medication then a <substanceAdministration> intent (moodCode='INT') is used; otherwise, to record medications which are stated to have taken, the moodCode shall be set to 'EVN'.</substanceAdministration> | | CONF | The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC) |
| | Constraint | The moodCode of this subordinate <substanceAdministration> SHALL be the same of the parent <substanceAdministration> .
| | hl7:templateId
|
| II | 1 … 1 | M | | IPSS...BADM | | | @root
|
| uid | 1 … 1 | F | 2.16.840.1.113883.10.22.4.33 | | hl7:statusCode
|
| CS | 1 … 1 | M | | IPSS...BADM | | Constraint | The statusCode of this subordinate <substanceAdministration> SHALL be the same of that of the parent <substanceAdministration>.
| | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended (2017‑03‑30) |
| | Example | <statusCode code="active"/> | Choice | 1 … 1 | | Elements to choose from:- hl7:effectiveTime[@value or @nullFlavor]
- hl7:effectiveTime[@xsi:type='PIVL_TS']
- hl7:effectiveTime[@xsi:type='EIVL_TS']
- hl7:effectiveTime[@xsi:type='SXPR_TS']
| | | hl7:effectiveTime
|
| TS | 0 … 1 | C | This required element describes the frequency of intakes. If not known it shall be valued with the nullflavor "UNK" | IPSS...BADM | where [@value or @nullFlavor] | | | | hl7ips-dataelement-224 | Frequency of intake | CEN/TC 251 prEN 17269 |
| | Example | Once (known date) <effectiveTime value="20170404"/> | | Example | Unknown <effectiveTime nullFlavor="UNK"/> | | | hl7:effectiveTime
|
| PIVL_TS | 0 … 1 | C | | IPSS...BADM | where [@xsi:type='PIVL_TS'] | | | | hl7ips-dataelement-224 | Frequency of intake | CEN/TC 251 prEN 17269 |
| | Example | Every 4 hours <effectiveTime xsi:type="PIVL_TS" institutionSpecified="false"> <period value="4" unit="h"/></effectiveTime> | | Example | Twice a day <effectiveTime xsi:type="PIVL_TS" institutionSpecified="true"> <period value="12" unit="h"/></effectiveTime> | | | hl7:effectiveTime
|
| EIVL_TS | 0 … 1 | C | | IPSS...BADM | where [@xsi:type='EIVL_TS'] | | | | hl7ips-dataelement-224 | Frequency of intake | CEN/TC 251 prEN 17269 |
| | Example | After meal <effectiveTime xsi:type="EIVL_TS"> <event code="PC" codeSystem="2.16.840.1.113883.5.139"/></effectiveTime> | | Example | One hour before breakfast <effectiveTime xsi:type="EIVL_TS"> <event code="ACM" codeSystem="2.16.840.1.113883.5.139"/> <offset> <low value="1" unit="h"/> </offset></effectiveTime> | | EIVL.event | 0 … 1 | C | | IPSS...BADM | | cs | 0 … 1 | | | | CONF | The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.10706 TimingEvent (DYNAMIC) |
| | | hl7:effectiveTime
|
| SXPR_TS | 0 … 1 | R | | IPSS...BADM | where [@xsi:type='SXPR_TS'] | | | | hl7ips-dataelement-224 | Frequency of intake | CEN/TC 251 prEN 17269 |
| | hl7:doseQuantity
|
| IVL_PQ | 0 … 1 | R | The <doseQuantity> describes the amount of the medication given (the dosage).
If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high> bounds are specified in their respective elements; otherwise only one physical quantity is specified (e.g. 2 drops)
The dose can be in some known and measurable unit, such as grams, milligrams,or described in "administration" units (unit of presentation, such as capsules).
If the dose is in countable items (tablets, caplets, "eaches"), then the unit could be omitted or valorized using the UCUM annotations for describing the type of countable items (e.g. .{tablet}, {puff},..).
The unit attribute – when expresses unit of measures- shall be derived from the UCUM code system. The used elements should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document. | IPSS...BADM | | | hl7ips-dataelement-223 | Number of units per intake | CEN/TC 251 prEN 17269 |
| | | @unit
|
| cs | 0 … 1 | | | | Example | Not pre-coordinated consumable <doseQuantity value="25" unit="mg"/> | | Example | Pre-coordinated consumable - Dose Range <doseQuantity> <low value="1" unit="{tablet}"/> <high value="2" unit="{tablet}"/></doseQuantity> | | Example | Pre-coordinated consumable <doseQuantity value="2" unit="{puff}"/> | | Example | Pre-coordinated consumable with text reference <doseQuantity value="2" unit="{puff}"> <translation> <originalText> <reference value="#text-ref-1"/> </originalText> </translation></doseQuantity> | | Example | Textual dosage <doseQuantity nullFlavor="OTH"> <translation> <originalText> <reference value="#text-ref-1"/> </originalText> </translation></doseQuantity> | | hl7:rateQuantity
|
| IVL_PQ | 0 … 1 | | | IPSS...BADM | | hl7:consumable
|
| | 1 … 1 | R | | IPSS...BADM | | | hl7:manufacturedProduct
|
| | 1 … 1 | R | | IPSS...BADM | | | | hl7:manufacturedMaterial
|
| | 1 … 1 | R | | IPSS...BADM | | cs | 1 … 1 | F | NA |
|
HL7 V2/V3 Datatype Level Template
IPS Address
Id | 2.16.840.1.113883.10.22.11 | Effective Date | 2018‑04‑04 15:41:36Other versions this id: - IPSAddress as of 2018‑04‑04 15:42:34
- IPSAddress as of 2018‑04‑04 15:41:43
|
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Status | Under pre-publication review | Version Label | STU1 |
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Name | IPSAddress | Display Name | IPS Address |
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Description | Reusable address template |
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Classification | HL7 V2/V3 Datatype Level Template |
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Open/Closed | Open (other than defined elements are allowed) |
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Relationship | Adaptation: template 2.16.840.1.113883.10.20.22.5.2 US Realm Address (AD.US.FIELDED) (2015‑08‑13) ref ccda- |
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Example | Example | <addr use="HP"> <country>TR</country> <city>Ankara</city> <streetAddressLine>Silikon Blok Kat:1</streetAddressLine></addr> |
|
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Example | Example | <addr use="WP"> <state>FI</state> <city>FIRENZE</city> <country>IT</country> <postalCode>50122</postalCode> <streetAddressLine>Palazzo Vecchio, Piazza della Signoria</streetAddressLine></addr> |
|
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Example | Example | <addr nullFlavor="NI"/> |
|
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Item | DT | Card | Conf | Description | Label |
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| set_cs | 0 … 1 | | | | CONF | The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) |
| | cs | 0 … 1 | F | NI | | Constraint | SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. | | Schematron assert | role | error | | | test | @nullFlavor or hl7:* | | | Message | If addr is not nullflavored at least one sub element has to be provided | | | ADXP | 0 … * | C | Subject's or Organization's Street Address Line | (IPS...ess) | | Schematron assert | role | error | | | test | hl7:streetAddressLine and (hl7:city or hl7:postalCode) | | | Message | If the address line is included either the city or the zip code has to be provided | | | ADXP | 0 … 1 | C | Subject's or Organization's City | (IPS...ess) | | ADXP | 0 … 1 | C | Subject's or Organization's Postal Code | (IPS...ess) | | ADXP | 0 … 1 | C | Subject's or Organization's State or Province | (IPS...ess) | | ADXP | 0 … 1 | C | Subject's Country. | (IPS...ess) | | Constraint | The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300 DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. |
|
Appendix
Responsible: NN
Acronyms and abbreviations
Glossary
Compliance: Compliance of one standard or specification is compliant with another standard or specification if all propositions true in the initial standard are also true in the complying standard. The target artifact is compliant with the source artifact if and only if all conformant implementations of the target are also conformant with the source. (RM-ODP). The term compliance is also used to state expectations as to how certain specifications need to satisfy possible legislative or regulatory constraints or requirements.
Conformance: Conformance relates an implementation to a standard. Any proposition that is true of the specification must be true in its implementation. (ISO, 2010).
Conformance Assessment: A process whereby a given implementation instance is evaluated to determine which f its various Conformance Assertions are valid implementations of a given specification’s Conformance Statements.
Conformance Statement : A conformance Statement is a statement that identifies testable requirements at a specified Conformance Point within a specification, explicitly defining the behavior which must be satisfied at these points. Conformance Statements will only occur in standard which are intended to constrain some feature of a real implementation, so that there exists, in principle, the possibility of testing.
Conformance assertion: Conformance assertion is a testable, verifiable statement made about a specific implementation instance against a corresponding Conformance Statement.
Conformance points: Conformance points are the evaluation of conformance at specific points in the implementation or specification. See Conformance.
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)[6] or info@ihtsdo.org
- Logical Observation Identifiers Names & Codes (LOINC): Regenstrief Institute
- International Classification of Diseases (ICD) codes: World Health Organization (WHO)
Integrated examples
Responsible: Kai Heitmann
- links to example instances in the publication package
Validation artifacts
Responsible: Kai Heitmann
- links to xsd
- links to schematrons
Operational information
Responsible: Kai Heitmann
- share the ips HL7 email list address
- also offer info at international-patient-summary.net email address for inquiries regarding the specification
- actual endpoints or user interfaces for testing/validation
FAQ’s
How to reuse this template
List of all artifacts used in this guide
Responsible: Autogenerated, assisted by Kai Heitmann
CDA Templates
Value Sets
System OIDs / IDs
Code systems
Datatypes
Responsible: Kai Heitmann
(This will be a list from ART-DECOR)
Examples (in progress)
( a set of link with explanations)
Responsible: Stephen Chu, Giorgio Cangioli (Translation), Kai Heitmann (Translation)
Plan:
- Create one or more storyboards (Stephen?)
- Turn the storyboards into real IPS example CDA instances
- Allow for multilingual CDA (Italian, German)
- Offer all XSD in the publication package
- include schematrons (generated by ART-DECOR)
References
Literature
Links
- ↑ Memorandum of Understanding between the United States Department of Health and Human Services and the European Commission on Cooperation Surrounding Health Related Information and Communication Technologies http://ec.europa.eu/newsroom/dae/document.cfm?doc_id=1784
- ↑ Transatlantic eHealth/health IT Cooperation Roadmap http://ec.europa.eu/newsroom/dae/document.cfm?doc_id=12123
- ↑ HL7 Service-Aware Interoperability Framework: Canonical Definition Specification, Release 2 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=3
- ↑ CDA R2 Standard http://www.hl7.org/implement/standards/product_brief.cfm?product_id=7
- ↑ HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 http://www.hl7.org/implement/standards/product_brief.cfm?product_id=377
- ↑ Get SNOMED CT http://www.ihtsdo.org/snomed-ct/get-snomed-ct
Figures
- ↑ 1.0 1.1 1.2 Standards in the HL7 SAIF Interoperability Matrix
- ↑ The IPS Principles
- ↑ 3.0 3.1 The IPS meet-in-the-middle approach Cite error: Invalid
<ref>
tag; name "ipsmeetinthemiddle" defined multiple times with different content
- ↑ Representation of medicines in CDA
- ↑ 5.0 5.1 CDA model has been enhanced with the Common Product Model
- ↑ 6.0 6.1 The IPS World
- ↑ Examples of IPS usage