Laboratory Information System (LIS)

National standards and specifications 

General requirements

Cyber security 

The software must demonstrate adherence to the ‘Essential 8’ cyber security principles.  

Privacy 

Data collected about an individual by medical software is likely to constitute health information (which is sensitive information, a category of personal information that generally has a higher degree of privacy protection than other personal information) under relevant federal, state and territory privacy legislation. (e.g. Privacy Act 1988 (Cth), Health Records and Information Privacy Act 2002 (NSW) etc).

The software must demonstrate adherence to relevant Federal, State or Territory privacy legislation. 

Applicable Federal legislation is the Privacy Act 1988 (Cth). Details of the relevant State and Territory based legislation is contained in the State requirements section.

Core requirements 

Standards for identification

The software must:  

• integrate Individual Healthcare Identifiers (IHIs) into the local patient record
• allow for the storing of Healthcare Provider Identifier-Organisation (HPI-O) in the local system and associate or link them with locally stored healthcare provider organisation details
• allow for the storing of healthcare provider identifier-individual (HPI-I) in the local system and associate or link them with locally stored healthcare provider individuals’ details. 

Australian Core Data for Interoperability (AUCDI)

The system should support the use of AUCDI Release 2.

Note: Development is continuing to enhance AUCDI to include further elements to support clinical data and will continue to be published over time.

Standards for data sharing 

The software should:  

• support the authoring and consumption of clinical documents in Fast Healthcare Interoperability Resources (FHIR®) formats.
• support HL7 Fast Healthcare Interoperability Resources (FHIR®)-compliant API as the base standard communication process
• support an API compliant with HL7 version 2.4.1 and the ORM specification as a minimum

Standards for terminology, code sets and classifications  

The software must:  

• support Systematised Nomenclature of Medicine-Clinical Terms AU (SNOMED CT-AU)
• support Standardised Pathology Informatics in Australia (SPIA)
• support Logical Observation Identifiers Names and Codes (LOINC®) 

The system should: 

• support person and provider identification in healthcare National Best Practice Data Set 

National Safety and Quality Health Service (NSQHS) Standards:

The system must:

• support compliance to requirements for the retention of laboratory records and diagnostic material
• support compliance to National pathology accreditation standards

Other National Standards 

The system should:  

• comply with the Digital Imaging and Communications in Medicine (DICOM) standards for the storage, display and sharing of any imaging related to tests (such as histology).  

Connections to National Systems 

HI Service:

If the software is expected to deal with healthcare identifiers then it must: 

• be able to discover and validate Individual Healthcare Identifiers (IHI) via the Healthcare Identifier (HI) Service 

My Health Record

The software must:  

• be able to upload a pathology report to the My Health Record system
• be able to respect patient request to upload at a patient and document level when contributing clinical information to the My Health Record system
• support patient instruction not to upload 

Conformance

The software must:  

• have production access to the My Health Record
• have production access to the Health Identifiers Service 

State-based requirements  

 The following state-based requirements should be considered based on your location. 

All requirements must be supported based on location.