Review of C-CDA R1.1 Allergy and Intolerance templates

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1 Review of C-CDA R1.1 Allergy and Intolerance templates Lisa R. Nelson March 26, 2014 This work is copyrighted by Janie Appleseed and made available under the terms of the Creative Commons Attribution-NonCommercial-No Derivs License (CC By-NC-ND 3.0). You are free: to Share to copy, distribute and transmit the work Under the following conditions: Attribution You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Noncommercial You may not use this work for commercial purposes. No Derivative Works You may not alter, transform, or build upon this work. With the understanding that: Waiver Any of the above conditions can be waived if you get permission from the copyright holder. Public Domain Where the work or any of its elements is in the public domain under applicable law, that status is in no way affected by the license. Other Rights In no way are any of the following rights affected by the license: o Your fair dealing or fair use rights, or other applicable copyright exceptions and limitations; o The author's moral rights; o Rights other persons may have either in the work itself or in how the work is used, such as publicity or privacy rights. Notice For any reuse or distribution, you must make clear to others the license terms of this work.

2 Central Questions How do these views of the work fit together? Allergies and Intolerances DAM Allergies and Intolerances CMET (Logical Model) C-CDA Templates for Allergies and Intolerances Can we identify the disconnects?

3 C-CDA Templates for Allergies and Intolerances 1. The purpose of the template(s) 2. The structural representation and relationships 3. The vocabulary bindings for concepts

4 Section Templates Two Allergy and Intolerance Sections one requires entries, one does not Entries Optional Progress Note History and Physical Consultation Note Discharge Summary Procedure Note Entries Required Continuity of Care Document (CCD)

5 Allergy and Intolerance Section This section lists and describes any medication allergies, adverse reactions, idiosyncratic reactions, anaphylaxis/anaphylactoid reactions to food items, and metabolic variations or adverse reactions/allergies to other substances (such as latex, iodine, tape adhesives) used to assure the safety of health care delivery. At a minimum, it should list currently active and any relevant historical allergies and adverse reactions. Regardless of how the Allergy Problem Act template and/or Problem Concern Act template are ultimately used in a given C-CDA document, it is an absolute requirement of all CDA documents that the section narrative text completely capture all the information represented in the structured elements within the section. Brian Weiss

6 Entry Templates Allergy Problem Act Allergy-Intolerance Observation Inherits from Substance or Device Allergy-Intolerance Observation Allergy Status Observation Deprecated in C-CDA R 2.0 Severity Observation This Severity Observation has been identified as the Criticality Observation Reaction Observation Severity Observation Medication Activity Procedure Activity Procedure

7 Structural Relationships Note: this is a template that is not used by any document. The template doesn t appear to support representation of devices. DSTU Comments have been made about this template. (#58, #78 C-CDA R1.1) Inherits from Substance or Device Allergy-Intolerance Note: the name of this template changes to Allergy Concern Act in C-CDA R2.0 Note: Allergy Status Observation is Deprecated as of C-CDA R2.0 Note: This Severity Observation has been identified as really being the Criticality Observation Note: Medication Activity and Procedure Activity Procedure are complex structures To see the underlying structures of these two entry parts, refer to the base Procedure Activity Procedure entry defined under the Procedure Section and the Medication Activity entry defined under the Medications Section. Note: Medication Activity is an endless loop.

8 Template Name Purpose Allergy Problem Act Allergy-Intolerance Observation This clinical statement act represents a concern relating to a patient's allergies or adverse events. A concern is a term used when referring to patient's problems that are related to one another. Observations of problems or other clinical statements captured at a point in time are wrapped in a Allergy Problem Act, or ""Concern"" act, which represents the ongoing process tracked over time. This outer Allergy Problem Act (representing the ""Concern"") can contain nested problem observations or other nested clinical statements relevant to the allergy concern. This clinical statement represents that an allergy or adverse reaction exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a manufactured material participant playing entity in the allergy observation. While the agent is often implicit in the alert observation (e.g. ""allergy to penicillin""), it should also be asserted explicitly as an entity. The manufactured material participant is used to represent natural and non-natural occurring substances. NOTE: 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. Substance or Device Allergy- Intolerance Observation This clinical statement represents that an allergy or adverse reaction to a substance or device exists or does not exist. The agent that is the cause of the allergy or adverse reaction is represented as a participant in the observation.

9 Template Name Purpose Allergy-Intolerance Observation Severity Observation Reaction Observation This clinical statement represents the gravity of the problem, such as allergy or reaction, in terms of its actual or potential impact on the patient. The Severity Observation can be associated with an Allergy Observation, Reaction Observation or both. When the Severity Observation is associated directly with an Allergy it characterizes the Allergy. When the Severity Observation is associated with a Reaction Observation it characterizes a Reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity. This clinical statement represents an undesired symptom, finding, etc., due to an administered or exposed substance. A reaction can be defined with respect to its severity, and can have been treated by one or more interventions.

10 Template Name Purpose Reaction Observation Severity Observation Medication Activity This clinical statement represents the gravity of the problem, such as allergy or reaction, in terms of its actual or potential impact on the patient. The Severity Observation can be associated with an Allergy Observation, Reaction Observation or both. When the Severity Observation is associated directly with an Allergy it characterizes the Allergy. When the Severity Observation is associated with a Reaction Observation it characterizes a Reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity. This medication activity is intended to contain information about medications that were administered in response to an allergy reaction. Procedure Activity Procedure This procedure activity is intended to contain information about procedures that were performed in response to an allergy reaction.

11 Template Name Code Value Notes Allergy Problem Act " " Allergies, adverse reactions, alerts or - CONC n/a Allergy-Intolerance Observation ASSERTION Allergy/Adverse Event Type Value Set Severity Observation "SEV Problem Severity Reaction Observation The value set for this code element has not been specified. Implementers are allowed to use any code system, such as SNOMED CT, a locally determined code, or a nullflavor. Problem Value Set Severity Observation "SEV Problem Severity The allergen is expressed in the consumable participation. Modeling of the Criticality Observation needs to be developed Medication Activity MAY contain zero or one [0..1] code n/a The particular medication is expressed in the consumable participation. Medication Clinical Drug Procedure Activity Procedure This code in a procedure activity SHOULD be selected from LOINC (codesystem ) or SNOMED CT (CodeSystem: ), and MAY be selected from CPT-4 (CodeSystem: ) or ICD10 PCS (CodeSystem: ) (CONF:19207). n/a

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13 The allergen is expressed in the consumable participation SHOULD contain zero or one [0..1] participant (CONF:7402) such that it SHALL contain exactly one Consumable (CodeSystem: HL7ParticipationType STATIC) (CONF:7403). SHALL contain exactly one [1..1] participantrole (CONF:7404). This participantrole SHALL contain exactly one Manufactured Product (CodeSystem: RoleClass STATIC) (CONF:7405). This participantrole SHALL contain exactly one [1..1] playingentity (CONF:7406). This playingentity SHALL contain exactly one Manufactured Material (CodeSystem: EntityClass STATIC) (CONF:7407). This playingentity SHALL contain exactly one [1..1] code (CONF:7419). This code SHOULD contain zero or one [0..1] originaltext (CONF:7424). The originaltext, if present, SHOULD contain zero or one [0..1] reference (CONF:7425). The reference, if present, SHOULD contain zero or one (CONF:15952). This SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section ) (CONF:15953). This code MAY contain zero or more [0..*] translation (CONF:7431). In an allergy to a specific medication the code SHALL be selected from the ValueSet Medication Brand Name DYNAMIC or the ValueSet Medication Clinical Drug DYNAMIC (CONF:7421). In an allergy to a class of medications the code SHALL be selected from the ValueSet Medication Drug Class DYNAMIC (CONF:10083). In an allergy to a food or other substance the code SHALL be selected from the ValueSet Ingredient Name DYNAMIC (CONF:10084).

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17 Question How can we make these two worlds make sense together? Can we list the issues?