Safety Critical Systems Case Study

National E-Health Transition Authority (NEHTA)

Software Improvements in association with Hyder Consulting Pty Ltd, was selected by the National E-Health Transition Authority (NEHTA) to provide a consultancy to support development of a Clinical Safety Assessment Program (CSAP) for Clinical Terminologies.  While a comprehensive set of Quality Assurance activities were currently applied to the activities of terminology services within NEHTA, there was a recognition that there was a safety dimension that aligned closely with that in Safety Critical Software Systems.

Specifically, NEHTA’s requirements were to:

• apply the practices that were currently applied in the safety critical software industry to the area of Clinical Terminologies;
• set up a repeatable program to carry out Clinical Safety Assessments; and
• ensure access to trained resources to apply the Assessment Program process when needed.

NEHTA’s goals were to:

• identify safety related issues in Clinical Terminologies products to ensure that healthcare-related software do not introduce unforeseen or uncontrolled hazards and risks;
• reduce non-tolerable risks; and
• increase confidence of users and stakeholders in the Clinical Terminologies products.

In achieving these three goals, NEHTA’s objectives were to:

• incorporate best practices from the Health industry and other related industries;
• benefit from the knowledge and skill that exists within the Safety Critical Software Industry;
• develop a proven and repeatable Clinical Safety Assessment Program; and
• develop a resource pool from NEHTA and an on-demand panel of resources trained to carry out Safety Assessments

An initial assessment of the Australian Medicines Terminology demonstrated the robustness and appliability of CSAP as developed by Software Improvements.

April 2009

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