TSANZ/NATA Respiratory Function Laboratory Accreditation Program

The program will be based on TSANZ’s current Standard which has been updated and developed using the ISO 15189:2022 Standard for medical laboratories – requirements for quality and competence.  

As with other NATA accreditation programs, facilities will be assessed through the NATA’s proven peer-review model, giving consumers assurance and confidence to make safe, healthy and reliable choices.   

You can review the new Standard here

The program will contribute to better health outcomes and treatment for patients with respiratory and lung health conditions and will play a critical role in supporting health workers and researchers to prevent, cure and relieve disability caused by lung disease. 

It will also allow laboratories with respiratory, sleep and blood gas services to have one management system covering all three areas, reducing duplication in the implementation and on-going maintenance of the management system.

Why is TSANZ partnering with NATA to run a joint accreditation program? 

The TSANZ Board decided to partner with NATA after an extensive review of the current Laboratory Accreditation service delivered by TSANZ. The Board believes this partnership will enable a better accreditation program for respiratory function laboratories that will deliver better health outcomes for patients. This partnership maximises NATA’s vast experience in accreditation for testing with the current TSANZ standard to be reviewed and updated in line with the international standard ISO 15189: 2022 medical laboratories – requirements for quality and competence.   

What is the benefit of the new TSANZ/NATA Respiratory Function Laboratory Accreditation Program? 

The TSANZ/NATA Respiratory Function Laboratory accreditation Program will contribute to better health outcomes and treatment for patients with respiratory and lung health conditions. The Memorandum of Understanding (MoU) formalises the arrangement and sets out the responsibilities of both TSANZ and NATA in jointly administering the Program. 

Why has the existing standard been reviewed and updated?

The existing TSANZ standard has been reviewed and updated in line with the international Standard ISO 15189: 2022 Medical laboratories – requirements for quality and competence. This allows laboratories with respiratory, sleep and blood gas services to have one management system covering all three areas, reducing duplication in the implementation and on-going maintenance of the management system. 

How will the program be established? 

The joint TSANZ/NATA Respiratory Function Laboratory Accreditation Program has been established by a Steering Committee whose role included providing technical advice, reviewing the TSANZ standard and aligning it to ISO 15189:2022, providing guidance on the scope of testing, guidance on development of technical accreditation criteria, strategic advice on industry or emerging issues and technical assessor matters. 

 When will the TSANZ/NATA Respiratory Function Laboratory Accreditation Program come into effect and what is the transition period? 

The TSANZ/NATA Respiratory Function Laboratory Accreditation Program is expected to come into effect by February 2025. Laboratories accredited under the TSANZ process will be recognised as accredited until their current TSANZ accreditation expires, or the end of 2025 (whichever period is greater).