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Difference between revisions of "AdverseEvent FHIR Resource Proposal"

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==Resource appropriateness==
 
==Resource appropriateness==
  
<!-- Does the resource meet the following characteristics?
+
An adverse event is a well-known healthcare concept that is regularly tracked and reported for clinical care, public health and research.
 
 
Must
 
* 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
 
* 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==

Revision as of 14:29, 12 January 2016



AdverseEvent

Owning Committee Name

RCRIM

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

Content sources

Example Scenarios

Resource Relationships

Timelines

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