The NATA-TSANZ partnership is a formal accreditation program that sets the quality standard for respiratory function laboratories across Australia and New Zealand. Under this framework, labs are assessed against both ISO 15189 medical testing requirements and TSANZ clinical standards, creating a unified benchmark for respiratory and sleep lab accreditation requirements. For lab managers and respiratory scientists, understanding how this dual framework operates is essential to maintaining compliance without overwhelming your team.

TL;DR

• NATA and TSANZ signed a Memorandum of Understanding (MoU) in 2023 to jointly accredit respiratory function laboratories.

• The program applies ISO 15189 standards alongside TSANZ clinical criteria, creating a dual-layer accreditation model.

• Accreditation covers a range of respiratory function tests linked to improved patient outcomes.

• Sleep lab accreditation requirements fall within the broader scope of this framework.

• Purpose-built software can significantly reduce the administrative burden of maintaining ongoing compliance.

What Is the NATA-TSANZ Accreditation Program?

The NATA-TSANZ Respiratory Function Laboratory Accreditation Program is a joint initiative between the National Association of Testing Authorities (NATA) and the Thoracic Society of Australia and New Zealand (TSANZ). According to reporting by Hospital Health, the program was announced in October 2023 and is designed to offer accreditation to respiratory function laboratories for a range of tests that contribute to better health outcomes and treatments.

The partnership was formalised through a Memorandum of Understanding (MoU), as confirmed by Lab Online. This MoU brought together NATA's established expertise in laboratory testing accreditation and TSANZ's clinical authority in respiratory medicine, producing a program that addresses both technical quality and clinical relevance.

The Australian and New Zealand Society of Respiratory Science (ANZSRS) has noted that the TSANZ/NATA Respiratory Function Laboratory Accreditation Program will contribute to better health outcomes and treatment for patients with respiratory conditions.

Why Does Dual Accreditation Exist? What Problem Does It Solve?

Single-body accreditation programs historically left gaps. A lab could meet general laboratory quality standards without necessarily demonstrating clinical competency in respiratory testing, and vice versa.

The dual model solves this by layering two frameworks:

This means a lab cannot pass on technical compliance alone. It must also demonstrate that its clinical processes, including how tests are performed, interpreted, and reported, meet the specialty standards set by TSANZ. This is particularly relevant for labs that also carry sleep lab accreditation requirements, as sleep studies intersect with respiratory medicine at both the clinical and administrative level.

What Does the Accreditation Process Actually Involve?

While the specific assessment process evolves as the program matures, the dual framework generally requires labs to demonstrate compliance across several domains:

Quality Management System (ISO 15189):

• Document control and version management

• Staff training records and competency assessments

• Non-conformance tracking and corrective action plans

• Internal audit cycles

• Quality control data management

Clinical and Technical Standards (TSANZ):

• Validated equipment calibration and maintenance records

• Use of appropriate reference ranges and normal values

• Adherence to ATS/ERS guidelines for test performance

• Structured and clinically defensible reporting

For most labs, the documentation burden is the single biggest operational challenge. Keeping all of this current, audit-ready, and accessible is where many teams struggle, not because they lack clinical competence, but because the administrative infrastructure hasn't kept pace with the standards.

How Should Labs Prepare for and Maintain Ongoing Compliance?

Accreditation is not a one-time event. It requires continuous maintenance, and the gap between initial accreditation and the next assessment cycle is where compliance often quietly deteriorates.

Practical steps labs can take:

1. Map your current processes to the standards. Identify which ISO 15189 requirements you already meet and where the gaps are before an assessor does.

2. Centralise your documentation. Scattered files across shared drives, paper folders, and individual inboxes are an audit risk. A single source of truth is essential.

3. Build training into your workflow, not around it. Staff competency records should be updated as training happens, not reconstructed before an audit.

4. Automate quality control tracking. Manual QC logs are error-prone. Westgard-based QC methods, when configured into your reporting system, reduce both effort and risk.

5. Review your normal values library regularly. Standards evolve. Using outdated reference ranges is a compliance risk that is easy to overlook.

6. Don't treat sleep lab accreditation requirements as separate. If your department covers both respiratory function and sleep studies, your quality system needs to address both cohesively.

Where Does Software Fit Into Accreditation Compliance?

The right software does not just help you report results. It becomes the infrastructure your accreditation program runs on.

Rezibase, a cloud-based respiratory and sleep reporting platform built by respiratory scientists, includes a dedicated accreditation module designed specifically around TSANZ/NATA standards, including ISO 15189 requirements. The module covers:

• Document management with version control

• Training records and competency tracking

• Non-conformance logging and action plan management

• Internal audit tools

• Quality control using Westgard methods

Because Rezibase is built by people who have worked in respiratory labs, the accreditation tools reflect how labs actually operate, not how a generic software vendor imagines they might. This matters when you are trying to maintain compliance across a busy department without adding administrative headcount.

Frequently Asked Questions

Who does the NATA-TSANZ accreditation program apply to?
It applies to respiratory function laboratories in Australia and New Zealand seeking formal accreditation for the range of tests they perform.

Is ISO 15189 mandatory for respiratory labs under this program?
ISO 15189 forms the quality management backbone of the NATA component of the program. Labs seeking accreditation need to demonstrate compliance with its requirements.

Are sleep labs covered under this accreditation framework?
Sleep lab accreditation requirements intersect with the respiratory framework, particularly where sleep studies are conducted within a respiratory department. Labs should assess their full scope of services when preparing for accreditation.

How often do labs need to renew accreditation?
Accreditation cycles typically involve periodic reassessment. Labs should refer directly to NATA and TSANZ for current cycle requirements.

Can software genuinely help with accreditation compliance?
Yes, when it is purpose-built for the context. Generic document management tools can help, but platforms designed around the specific standards respiratory labs face reduce the gap between daily operations and audit readiness.

What is the biggest compliance risk for respiratory labs?
Documentation drift, where processes are followed correctly but not recorded consistently, is one of the most common findings in accreditation assessments.

Does the NATA-TSANZ program cover private clinics as well as public hospitals?
The program is designed to be accessible to respiratory function laboratories broadly. Private clinics should check eligibility directly with NATA or TSANZ.

About Rezibase

Rezibase is a cloud-based respiratory and sleep reporting platform built by respiratory scientists for respiratory scientists. Trusted by over 35 sites including NSW Health and the NHS in the UK, the platform covers the full patient lifecycle from referrals and bookings through to reporting and accreditation compliance. Rezibase includes a dedicated accreditation module aligned to TSANZ/NATA and ISO 15189 requirements, making it a practical tool for labs navigating the dual accreditation framework.

Learn more or book a demo at rezibase.com.

References

• Hospital Health. TSANZ and NATA partner for lung health accreditation program. https://www.hospitalhealth.com.au/content/design-in-health/news/tsanz-and-nata-partner-for-lung-health-accreditation-program-1113293670

• Lab Online. TSANZ and NATA sign MoU for new accreditation program. https://www.labonline.com.au/content/lab-business/news/tsanz-and-nata-sign-mou-for-new-accreditation-program-31101637

• ANZSRS. TSANZ NATA Lab Accreditation Program. https://anzsrs.org.au/tsanz-nata-laboratory-accreditation-program/