Common Non-Conformances Found During NATA Assessments of Pulmonary Function Laboratories and How to Avoid Them
Pulmonary function laboratories in Australia face a unique compliance challenge: they must satisfy both clinical best-practice standards and the rigorous accreditation requirements set by the National Association of Testing Authorities (NATA). Non-conformances raised during NATA assessments are not random, they follow predictable patterns. Understanding those patterns, and acting on them before an assessor arrives, is the single most effective strategy for a smooth accreditation cycle.
TL;DR
The most common NATA non-conformances in pulmonary function labs cluster around documentation gaps, calibration records, and reporting deficiencies.
ISO 15189 and ISO/IEC 17025 underpin NATA's expectations; failing either standard typically generates a finding.
Responding to findings incorrectly is itself a common problem, not just having the finding in the first place.
Systematic quality management, including non-conformance tracking, audit trails, and normal values governance, closes most gaps before they become formal findings.
Purpose-built software that embeds accreditation workflows can dramatically reduce the administrative burden of staying compliant.
What Are NATA Non-Conformances and Why Do They Matter for Pulmonary Function Labs?
A NATA non-conformance is a formal finding that a laboratory has failed to meet a specific requirement of an accreditation standard, most commonly ISO 15189 for medical laboratories. In pulmonary function testing (PFT), that means any gap between what the standard requires and what the lab can demonstrate through objective evidence.
Non-conformances are not just administrative inconveniences. According to compliance data published by Secureframe, non-compliance incidents cost organisations significantly more on average than compliant operations, and the reputational and operational consequences extend well beyond any financial penalty. For a hospital respiratory lab, a serious finding can delay report sign-off, disrupt patient services, and erode referring clinician confidence.
What Are the Most Frequently Raised Non-Conformances in Australian Labs?
According to NATA's own published analysis of assessment findings, the most common non-conformances observed across Australian laboratories include:
Reporting deficiencies: Missing minimum report requirements, incomplete identification of the method used, and failure to include uncertainty of measurement where required.
Calibration and equipment records: Incomplete or missing calibration documentation, out-of-date equipment verification records, and failure to link equipment status to test results.
Document control failures: Using superseded versions of procedures, missing review dates, and inadequate version control.
Training and competency gaps: Insufficient evidence that staff have been assessed as competent for the tests they perform.
Internal audit shortfalls: Audits not covering all relevant clauses, or audit findings not being closed out with verifiable corrective actions.
MAS Management Systems identifies calibration records, document control, and staff competency as the top three recurring deficiencies across Australian labs, a pattern consistent with what NATA assessors encounter in PFT settings specifically.
Why Is Reporting Such a Persistent Problem in Pulmonary Function Testing?
Reporting is the output that patients and clinicians rely on, yet it is consistently one of the weakest areas in laboratory assessments. For pulmonary function labs specifically, the complexity is compounded by the need to align reports with evolving clinical guidelines.
The ATS spirometry guidelines 2025 update, for example, revised reference value recommendations and interpretation frameworks. Labs that have not updated their normal values library or reporting templates to reflect current guidance risk generating reports that are both clinically suboptimal and non-conformant with the standards NATA expects labs to follow.
Common reporting failures in PFT labs include:
Failing to state which reference equations were used and why
Omitting the interpretation criteria applied (e.g., lower limit of normal vs. fixed ratio)
Not documenting test quality grades or acceptability criteria met
Missing patient demographic data required to calculate predicted values
Inconsistent report formatting across different operators
How Should Labs Respond to NATA Assessment Findings?
Receiving a finding is not the end of the process. How a lab responds is equally scrutinised. According to NEAS, many labs struggle with responding to NATA assessment findings in a way that satisfies the assessor, even when the underlying corrective action is sound.
A compliant response to a non-conformance requires:
Root cause analysis: Identifying why the gap occurred, not just what the gap was.
Immediate corrective action: What was done to fix the specific instance.
Systemic corrective action: What was changed to prevent recurrence.
Evidence of implementation: Objective proof that the change has been embedded.
Effectiveness review: Confirmation that the action worked.
O'Dwyer Accreditation notes that non-conformance language from assessors can itself be difficult to interpret, with findings sometimes restating the standard rather than clearly identifying the gap. Labs benefit from building internal capability to decode findings and structure responses methodically.
What Documentation Gaps Trigger the Most Findings?
4CPL's analysis of ISO/IEC 17025 audit non-conformities highlights incomplete documentation as the single most common trigger across all laboratory types. For pulmonary function labs operating under ISO 15189, the equivalent problem areas are:
Documentation Area | Common Gap |
|---|---|
Standard Operating Procedures | Outdated versions in use; no evidence of periodic review |
Equipment Logs | Calibration performed but not formally recorded against the device |
QC Records | QC run but not evaluated against Westgard rules or equivalent criteria |
Training Records | Training completed but competency assessment not documented |
Non-Conformance Register | Incidents noted informally but never formally raised or closed |
Audit Records | Audit conducted but findings not linked to corrective action plans |
The pattern here is consistent: the activity happens, but the evidence does not exist. In an accreditation context, if it is not documented, it did not happen.
How Can Pulmonary Function Labs Proactively Avoid Non-Conformances?
Prevention is significantly less resource-intensive than remediation. Practical strategies include:
Conduct internal mock assessments at least six months before a scheduled NATA visit, using the actual assessment checklist.
Maintain a living non-conformance register that captures near-misses and internal findings, not just formal NATA findings.
Schedule equipment calibration reminders in advance and link calibration records directly to the equipment register.
Keep your normal values library current and document the rationale for every reference equation used.
Standardise report templates so that all minimum reporting requirements are structurally embedded, not dependent on individual operator memory.
Assign document ownership so that every procedure has a named reviewer and a scheduled review date.
Platforms like Rezibase are specifically built around these requirements. Its accreditation module covers document management, training records, non-conformance tracking, action plans, internal audits, and quality control according to Westgard methods, all within a single system designed to meet TSANZ/NATA Standards and ISO 15189 requirements. For labs that currently manage these workflows across spreadsheets and shared drives, consolidating into a purpose-built system removes a significant source of compliance risk.
Frequently Asked Questions
What is the most common NATA non-conformance in pulmonary function labs?
Reporting deficiencies and calibration record gaps are consistently the most frequently raised findings, based on NATA's published assessment data.
Does ISO 15189 apply to pulmonary function labs?
Yes. Pulmonary function laboratories seeking NATA accreditation operate under ISO 15189, the international standard for medical laboratories.
How long does a lab have to respond to a NATA non-conformance?
Response timeframes are set by NATA at the time of assessment. Labs must submit evidence of corrective action within the specified period, typically within 30 to 90 days depending on the severity of the finding.
What happens if a non-conformance is not closed out?
Unresolved non-conformances can result in conditions being placed on accreditation or, in serious cases, suspension of accreditation scope.
Can software help with NATA compliance?
Yes. Purpose-built laboratory management systems that embed document control, QC tracking, non-conformance registers, and audit workflows directly reduce the risk of documentation gaps, which are the most common source of findings.
What is the difference between a major and minor non-conformance?
A major non-conformance indicates a systemic failure or a situation where the integrity of results is in question. A minor non-conformance is an isolated gap that does not undermine the overall system. Both require formal corrective action.
Do labs need to update their reporting templates when ATS guidelines change?
Yes. Alignment with current clinical guidelines, including the ATS spirometry guidelines 2025 update, is expected as part of maintaining fit-for-purpose procedures under ISO 15189.
About Rezibase
Rezibase is Australia's most advanced 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, Rezibase includes a dedicated accreditation module that helps labs meet TSANZ/NATA Standards and ISO 15189 requirements, covering everything from non-conformance tracking to QC management and document control. Learn more at rezibase.com.
If your lab is preparing for a NATA assessment or looking to strengthen its quality management systems, Rezibase can help. Visit rezibase.com to explore the platform or book a demonstration with the team.
References
NATA. Top 5 Laboratory Assessment Non-Conformances. https://nata.com.au/news/top-5-laboratory-assessment-non-conformances/
O'Dwyer Accreditation. Anatomy of a NATA Non-Conformance. https://www.odwyeraccreditation.com.au/understanding-nata-non-conformances/
MAS Management Systems. The Top 3 NATA Deficiencies in Labs. https://www.masmanagementsystems.com.au/the-top-3-nata-deficiencies-in-labs/
NEAS. Do You Find Responding to NATA Assessment Findings Challenging? https://neas.com.au/articles/do-you-find-responding-to-nata-assessment-findings-challenging/
4CPL. Common Non-Conformities in ISO/IEC 17025 Audits and Key Strategies. https://www.4cpl.com/blog/common-non-conformities-in-iso-iec-17025-audits-and-strategies-for-compliance/
Secureframe. 130+ Compliance Statistics and Trends to Know for 2026. https://secureframe.com/blog/compliance-statistics