Ensuring Clinical Safety – HL7 Implementation

The one thing that is missed quite often during deployment and rollout of HL7 (read HL7V2.x) is the “clinical safety” factor. It is not often considered if introducing the messaging is any way compromising the information quality of patient’s data or if it’s introducing any major business changes to the existing clinical workflow in the organisation. Organisations need to stress to the system providers as well as to the system integrators that they ought to consider clinical safety as a major factor in all stages of the rollout including development, deployment and testing.
There are ways to ensure that the introduction of HL7 does not compromise clinical safety. This post discusses a approach for this
Conformance Accreditor: The organisation needs to employ a system integrator or act itself as one (in case it has a internal tech team) to define conformance standards
Conformance Guidelines: The defining of conformance standards need to be based on the following principles

1. Define the message set that is required to be used within the organisation and publish it. The definitive message needs to be based on the requirements to automate and provide seamless data access, subject to access controls.

2. Avoiding optionality and being more specific when defining the messages

3. Identify the use cases and build story boards using every day scenarios of the organisation. Involve the organisations clinical and administrative team in this.

4. Publication of defined code set to be used in the messages

5. Define mapping guidelines to enable system providers to identify the correct data attributes

6. Provide sufficient guidance on message interactions for the messages that need to be sent and received by the systems for different events.

7. Define the expected systems behaviour while processing the message.

The publication of proper definition of code sets and values, message specifications and mapping guidelines ensures that data is not manipulated in a clinically unsafe fashion or mapped to the wrong code compromising patient safety.
(See this for a better understanding of conformance : http://secure.cihi.ca/cihiweb/en/downloads/hl7can_conformance.pdf)
Conformance Tools: Provide simple test harness tools adhering to the proposed conformance standards, for the system providers to check the correctness of their implementation- e.g. message structures, data types, expected code values. Provide ability to view data in the message in a GUI so that they do not have to traverse the message. These tools are expected to be provided by the system integrator
Conformance Testing: The clinical safety testing process involves exhaustive end to end testing to see if the data sent by the sending systems has not hindered the work flow in the receiving system. The testing to defined work flows in system where the data is received and used ensures that safety of the patients is not compromised
Defining Transition: The changes that are brought about by implementing HL7 in an organisation needs to be formally documented. The capabilities and workflows in the organisation that are impacted by the implementation needs to be compared and ensure that the users are aware of the changes through training.

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