HL7 NRLS Harmonisation Project

HL7 Patient Safety Special Interest Group (PSSIG)

Mission and Charter

To err is human

To cover up is unforgivable

To fail to learn is inexcusable

Sir Liam Donaldson (2004)

Author:Chris Foye, NPSA

Approved by:

Date:16 March 2005

Version1.1

I. Contents

I. Contents

II. Introduction

III.Mission Statement

IV.Charter

V.Patient Safety / Patient Safety Incident Definitions

VI. International Collaboration

VII.Assumptions

VIII.PSSIG Decision Tree......

IX.Prioritisation

X. Conclusion

XI.Glossary

XII.Endnotes

II. Introduction

This document outlines a revised mission statement, charter and approach to message development for PSSIG. It also captures the Group’s priorities and provides a decision tree for assessing new project requests.

For those readers who wish to appreciate the context of this paper please refer to the scoping paper[1], which reviewed the Group’s remit and made a number of recommendations with regard to its future scope and direction.

III. Mission Statement

Note: this statement is in accordance with HL7 Policies and Procedures for the establishment of a SIG.[i]

IV. Charter

• Construct Domain Information Models (DIMs), Refined Message Information Models (RMIMs), and messages that can be communicated between HL7 v3 compliant systems that serve patient safety related requirements from a broad perspective.
• Create scenarios to identify the requirements for identifying and reporting patient safety incidents and other related information.
• Identify the set of trigger events to initiate the transmission of such data.
• Develop the required messages, message segments, and data fields necessary to support the reporting of patient safety incidents.
• Create clinical documents for collecting and reporting patient safety incidents.
• Identify and promote the required terminology to support the collection and reporting of patient safety incidents.
• Coordinate and cooperate with other groups to promote the reduction or prevention of patient safety incidents via the effective use of decision support mechanisms. PSSIG will work alongside the Clinical Decision Support Technical Committee and other groups to achieve this.
• Coordinate and cooperate with other groups interested in using these documents and messages
• Enable and promote the use of these standards and make the standard as widely available as possible.
• Ensure PSSIG work products are harmonized with each other.

V. Patient Safety / Patient Safety Incident Definitions

The mission statement and charter use the following definitions for ‘patient safety’ and ‘patient safety incident’.

VI. International Collaboration

At the time of writing the PSSIG scoping paper, the World Health Organisation had just established a Patient Safety Alliance. PSSIG agreed, at the HL7 AGM, to periodically review the Alliance’s activities to see whether there were any opportunities for collaboration. NPSA and ARHQ will conduct this review as they are both active members of the Alliance.

VII. Assumptions

The PSSIG scoping paper listed a set of principles based on an analysis of “An organisation with a memory” and “To Err is Human”. These principles were then converted into a set of patient safety messaging assumptions for PSSIG to adhere to. These assumptions are listed below.

1. PSSIG will create, where necessary, multi-level standardised messaging structure(s) for the exchange of patient safety data / information. The scope of the messages must include all patient safety incident types including near misses. Once specified, the messaging structure will allow for relevant organisations to collect and share patient safety information. It will accommodate the more granular information needs of specialist agencies as well as those of patient safety related organisations, which may only need high-level incident information. The structure will allow for anonymous reporting to satisfy the legal requirements / national policies of certain jurisdictions. To ascertain what is in scope refer to the patient safety / patient safety incident definitions (see section V).
2. PSSIG will develop messages capable of complementing national / international programs. Patient safety message standardisation will be encouraged to allow for information sharing across realms e.g. UK & US. The message structure will allow for information sharing between relevant organisations, encourage better analysis at a national level and make analysis and cross-comparisons at an international level easier.
3. PSSIG should actively collaborate with patient safety related organisations and, if possible, pursue collaborative work with the WHO’s Patient Safety Alliance. PSSIG feels that to operate disconnected from other related organisations could result in an unnecessary duplication of effort. The Group is therefore keen to ensure that there is adequate international representation to prevent this from happening and to ensure that PSSIG messages do not become unduly biased towards a particular country / organisation’s requirements.
4. PSSIG will leverage all known information sources (inside / outside HL7) that could facilitate or impact the analysis of patient safety information. PSSIG acknowledges that creating messages for incident reporting or facilitating RCA / investigative analysis is not sufficient in itself. Such reports will need to be complemented with other data / information sources. For complementary HL7 messages, the Group will consider embedding triggers to ensure they are routed to the appropriate patient safety organisation. An example of this might be denominated data like mortality rates.

Note: the area of triggers and decision support needs further discussion.

1. Ensure that message information allows for the education of frontline staff as well as providing stakeholders with a holistic view of patient safety.
2. PSSIG messages will be in a standardized format to facilitate the analysis of patient safety information. The message will allow for data to be transmitted in a de-identified/anonymous format.
3. PSSIG recognises the need to take into account external factors e.g. a country’s legal requirements during message development, but this will not necessarily override the need to develop messages that can be leveraged globally.
4. Message developers will be mindful of the reporting burden on the clinician’s workflow.
5. PSSIG needs to be adaptable to the work of the patient safety community by helping them to decide whether and how to embed their safety solutions (e.g. alerts, decision support and guidance) within a HL7 v3 message. This could include support to groups like the clinical decision support group and will require greater co-ordination with other groups.
6. An effort will be made to create generic messages to support global implementation of PSSIG products.
7. Ensure that PSSIG’s work is not overly biased towards notification reporting and does consider post-incident investigations / root cause analysis.
8. PSSIG will provide realm-independent implementation / conformance guidance for its messages. PSSIG recognises that a standard message format does not necessarily mean that implementation will be consistent. Therefore, written implementation / conformance guidance will be provided for PSSIG messages.
9. PSSIG will promote and offer guidance to relevant organisations to implement the messages developed by the PSSIG.

VIII. PSSIG Decision-Making Practices

The PSSIG decision-making practices will be in accordance with established HL7 policies and procedures. The PSSIG decision-making practices document is available for review by accessing the PSSIG website. Additionally, PSSIG has developed a decision tree that is intended to help members to determine when a request from a third-party is in scope. The decision tree has four branches, indicative of the four possible types of request that the Group may receive, and then set criteria must be satisfied in order for any given request to be considered within scope. It is envisioned that this diagram will evolve over time. The decision-making tree is available on the PSSIG website.

IX. Prioritisation

PSSIG will promulgate a priority status document, which will be distributed to all PSSIG list server members before each PSSIG meeting.

1. Individual Case Safety Reporting (ICSR)

The immediate focus of PSSIG is the ICSR model, which is nearing normative status. The group will continue to support the development of the ICSR until it attains normative status.

1. Patient Safety: Generic Incident Notification (GIN)

PSSIG will initiate a programme of work (lead by the NPSA and AHRQ), which will allow for the capture, analysis and prevention of patient safety incidents. The NPSA has already established the National Reporting and Learning System, which will provide a good basis for creating the GIN. PSSIG members are expected to contribute by critiquing the model and advising message developers.

1. Patient Safety: Root cause and Underlying factors Message (RUM)

PSSIG will investigate whether the GIN reporting structure is suitable for post-incident investigations i.e. could a flag be set in the message to indicate whether this is a notification report or an investigation? If the flag was set to investigation then the reporter would be allowed to provide more detailed information.

An analysis of the first three work strands will determine the feasibility of this approach.

1. Sub-Domain Development

Once PSSIG are satisfied that the GIN model is robust and stable, members will investigate the viability of developing sub-domain information models e.g. hospital acquired infections and blood bank incidents. Such work will require a message sponsor and developer.

1. Decision Support

PSSIG will collaborate with other groups to ensure that, where appropriate, patient safety decision support mechanisms are embedded into their messages e.g. medication warnings to prevent iatrogenic disease.

1. Complementary Information

Once PSSIG has a clearer idea as to the potential data analyses that can be performed the Group will investigate augmenting this information with other sources of pertinent information.

X. Conclusion

This paper reflects the agreed position of PSSIG and the relevant sections of this document i.e. the mission statement and charter will be formally adopted at the Working Group Meeting in January 2005.

Chris FoyePage 116/03/05

Private and Confidential

XI. Glossary

AHRQAgency for Healthcare Research and Quality

APSFAustralian Patient Safety Foundation

FDAFood and Drugs Administration

GINPatient Safety: Generic Incident Notification

HL7Health Level 7 - International health messaging standard

ICSRIndividual Case Safety Report

NPSA National Patient Safety Agency

PSI Patient Safety Incident

PSSIGPatient Safety Special Interest Group

RCARoot Cause Analysis

R-MIMRefined Message Information Model

RUMPatient Safety: Root cause and Underlying factors Message

XII. Endnotes

Chris FoyePage 124/05/2019

[1]

[i] Pol. 09.02.02 A Special Interest Group (SIG) may be established for the purpose of focusing on a particular aspect of the standard or on a particular user requirement. The purpose of a SIG is to make sure the Standard meets the need of an identified group. A SIG must have a parent Technical Committee (TC).