This wiki has undergone a migration to Confluence found Here
<meta name="googlebot" content="noindex">

Difference between revisions of "AdverseEvent FHIR Resource Proposal"

From HL7Wiki
Jump to navigation Jump to search
(Created page with "{{subst::Template:FHIR Resource Proposal}}")
 
(migrate to Confluence)
 
(18 intermediate revisions by 2 users not shown)
Line 1: Line 1:
−
 
+
Current version: https://confluence.hl7.org/display/FHIR/AdverseEvent+FHIR+Resource+Proposal<div class="messagebox cleanup metadata">
−
<div class="messagebox cleanup metadata">
 
 
<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
 
<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>
 
<div style="background:#F0F0F0">
 
<div style="background:#F0F0F0">
Line 13: Line 12:
  
  
−
=PutProposedResourceNameHere=
+
=AdverseEvent=
  
 
<!-- Resource names should meet the following characteristics:
 
<!-- Resource names should meet the following characteristics:
Line 23: Line 22:
 
* Unique
 
* Unique
 
* Avoid non-universal abbreviations (e.g. URL would be ok)
 
* Avoid non-universal abbreviations (e.g. URL would be ok)
−
* Be expressed as a noun
+
* Be expressed as a nounAdv
 
* Be consistent with other similar resources
 
* Be consistent with other similar resources
 
  -->
 
  -->
  
−
==Owning committee name==
+
==Owning Committee Name==
  
 
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
 
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
−
[[YourCommitteeName]]
+
[[Regulated Clinical Research Information Management| RCRIM WG]] and [[Patient Care WG]]
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
  
 
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
 
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
−
* Work Group Name
+
*Patient Care, Pharmacy, CDS, PHER, EC
−
* or link
 
−
* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
Line 45: Line 42:
 
==Scope of coverage==
 
==Scope of coverage==
  
−
<!-- Define the full scope of coverage for the resource. The scope must be clearly delineated such that it does not overlap with any other existing or expected resource. The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"
+
Based on TANSI/HL7 V3 ICSRP1, R2-2012 HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 (revise and partition ANSI/HL7 V3 RRCS, R1-2005)1/31/2012
 +
 
 +
ICSR Part 1 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266
 +
ICSR Part 2 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267. (medicinals only)
 +
 
 +
To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.
  
−
Scope should consider numerous aspects of breadth of scope, including:
+
The adverse event resource will address the exchange of the following types of information:
−
* Subject: Human vs. non-human vs. non-patient (e.g. lab bench medicine)
+
1) Individual Case Safety Report (ICSR): framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances.  The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device.
−
* Disciplines: Environmental Health, Palliative, Respiratory, Psychology, Maternity, Clinical Research
+
2) (Not in current standard) – Individual Occurrence Report (IOR): the identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.
−
* Delivery environment (Community, Geriatric, Home care, Emergency, Inpatient, Intensive, Neonatal, Pediatric, Primary)
 
−
* Locale: Country, region
 
  
−
As a rule, resources should encompass all of these aspects.
+
Does the concept of sentinel event need to be included?
−
  -->
+
Can system triggers for alerts be addressed in the resource?
 +
 
 +
C-CDA for hospital acquired infections.  NHS safety network under CDC.  – possible sources of other data elements
  
 
==RIM scope==
 
==RIM scope==
  
−
<!-- Identify the formal RIM mapping for the root concept of the resource. The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
+
1. InvestigationalEvent: Class Code INVSTG
  
−
==Resource appropriateness==
+
2. Causality: ? Code based on event vs. associations 
 +
 
 +
3. Report: Class Code CACT (can have multiple reports)
 +
 
 +
'''Common data elements for ICSR'''
 +
 
 +
*Identifiable patient (Note that this may be restricted by regulation and can be masked using "Privacy" or initials. However, for product problems there may or may not be an identifiable patient.)
 +
 
 +
*Identifiable reporter
 +
 
 +
*Date of Event
 +
 
 +
*Description of the event or problem
 +
 
 +
*Substance or Product name
 +
 
 +
'''Common data elements for IOR'''
 +
 
 +
*Identifiable patient (Note that this may be restricted by regulation and can be masked using "Privacy" or initials. However, for product problems there may or may not be an identifiable patient.)
 +
 
 +
*Identifiable reporter
 +
 
 +
*Date of Event
  
−
<!-- Does the resource meet the following characteristics?
+
*Description of the event or problem
  
−
Must
+
==Resource appropriateness==
−
* Represents a well understood, "important" concept in the business of healthcare
 
−
* Represents a concept expected to be tracked with distinct, reliable, unique ids
 
−
* Reasonable for the resource to be independently created, queried and maintained
 
  
−
Should
+
An adverse event is a well-known healthcare concept that is regularly tracked and reported for clinical care, public health and research.
−
* Declared interest in need for standardization of data exchange</span>
 
−
* Resource is expected to contain an appropriate number of "core" (non-extension) data elements (in most cases, somewhere in the range of 20-50)
 
−
* Have the characteristics of high cohesion & low coupling – need to explore whether coupling is good some places, not elsewhere – layers from Bo’s document
 
−
-->
 
  
 
==Expected implementations==
 
==Expected implementations==
  
−
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
+
Adverse event documentation and reporting of an adverse event is an integral part of any care setting, research setting or public health reporting entity.
  
 
==Content sources==
 
==Content sources==
  
−
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
+
Existing ISO/HL7/CEN  standards as well as examples of health care institution occurrence reporting systems.
 +
Will also review data elements in the CDC National Health Safety Network.
  
−
Are there any source specifications that you wish to consult but are concerned about access to or expertise to consider? -->
+
==Example Scenarios==
  
−
==Example Scenarios==
+
*1.  During the course of a clinical trial, a research subject develops an adverse reaction to a research drug.  Documentation of this observation is reporting to the drug sponsor and the US Food and Drug Administration.
  
−
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
+
*2.  A patient slips and falls on spilled water in the health care institution bathroom.  The patient suffers no ill effects but the nurse documents the fall in the hospital occurrence reporting system to document the fall and to alert hospital administration.
  
 
==Resource Relationships==
 
==Resource Relationships==
  
−
<!-- What are the resources do you expect will reference this resource and in what context?
+
AllergyIntolerance, Condition, Procedure, Risk Assessment, Medication Statement, Immunization, Observation
−
 
 
−
What resources do you expect this resource reference and in what context?
 
−
 
 
−
Note: These may be existing resources or "expected" resource
 
−
 
 
−
Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 
−
-->
 
  
 
==Timelines==
 
==Timelines==
  
−
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
+
DSTU 2.1 - DRAFT
  
 
==gForge Users==
 
==gForge Users==
  
−
<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->
+
Lloyd McKenzie, Elaine Ayres

Latest revision as of 14:59, 31 October 2019

Current version: https://confluence.hl7.org/display/FHIR/AdverseEvent+FHIR+Resource+Proposal

OpenHotTopic.GIF

This page documents a Pending FHIR Resource Proposal



AdverseEvent

Owning Committee Name

RCRIM WG and Patient Care WG

Contributing or Reviewing Work Groups

  • Patient Care, Pharmacy, CDS, PHER, EC

FHIR Resource Development Project Insight ID

Scope of coverage

Based on TANSI/HL7 V3 ICSRP1, R2-2012 HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 (revise and partition ANSI/HL7 V3 RRCS, R1-2005)1/31/2012

ICSR Part 1 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266 ICSR Part 2 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267. (medicinals only)

To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.

The adverse event resource will address the exchange of the following types of information: 1) Individual Case Safety Report (ICSR): framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances. The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device. 2) (Not in current standard) – Individual Occurrence Report (IOR): the identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.

Does the concept of sentinel event need to be included? Can system triggers for alerts be addressed in the resource?

C-CDA for hospital acquired infections. NHS safety network under CDC. – possible sources of other data elements

RIM scope

1. InvestigationalEvent: Class Code INVSTG

2. Causality: ? Code based on event vs. associations

3. Report: Class Code CACT (can have multiple reports)

Common data elements for ICSR

  • Identifiable patient (Note that this may be restricted by regulation and can be masked using "Privacy" or initials. However, for product problems there may or may not be an identifiable patient.)
  • Identifiable reporter
  • Date of Event
  • Description of the event or problem
  • Substance or Product name

Common data elements for IOR

  • Identifiable patient (Note that this may be restricted by regulation and can be masked using "Privacy" or initials. However, for product problems there may or may not be an identifiable patient.)
  • Identifiable reporter
  • Date of Event
  • Description of the event or problem

Resource appropriateness

An adverse event is a well-known healthcare concept that is regularly tracked and reported for clinical care, public health and research.

Expected implementations

Adverse event documentation and reporting of an adverse event is an integral part of any care setting, research setting or public health reporting entity.

Content sources

Existing ISO/HL7/CEN standards as well as examples of health care institution occurrence reporting systems. Will also review data elements in the CDC National Health Safety Network.

Example Scenarios

  • 1. During the course of a clinical trial, a research subject develops an adverse reaction to a research drug. Documentation of this observation is reporting to the drug sponsor and the US Food and Drug Administration.
  • 2. A patient slips and falls on spilled water in the health care institution bathroom. The patient suffers no ill effects but the nurse documents the fall in the hospital occurrence reporting system to document the fall and to alert hospital administration.

Resource Relationships

AllergyIntolerance, Condition, Procedure, Risk Assessment, Medication Statement, Immunization, Observation

Timelines

DSTU 2.1 - DRAFT

gForge Users

Lloyd McKenzie, Elaine Ayres

Retrieved from "https://wiki.hl7.org/w/index.php?title=AdverseEvent_FHIR_Resource_Proposal&oldid=166862"