GLI GLI Quality Tool
GLI Quality Tool — Version 2.0

Building A Practical TB Lab Nonconforming Event Classification List

A tuberculosis laboratory needs a clear way to recognise, record and review work that has departed from an approved requirement. A nonconforming event may involve a specimen, test method, instrument, result, record, staff practice or safety control. When these events are classified consistently, the laboratory can distinguish an isolated mistake from a recurring system weakness.

A useful classification list should be simple enough for busy staff to apply during routine work and detailed enough to support investigation. It should also show what evidence must be retained, who reviews the event, whether patient results are affected and which corrective action is required. The aim is learning and control, rather than assigning blame.

For laboratories across Australia, the list must work in different settings, from a large metropolitan service in Sydney or Melbourne to a regional facility in Cairns, Darwin or remote Western Australia. It should accommodate referral testing, courier delays, public hospital workflows, private pathology arrangements and local requirements for privacy, work health and safety, and clinical communication.

Why Classification Matters

A nonconforming event is any failure to meet a specified requirement. The requirement may come from a standard operating procedure, test kit instructions, equipment specification, biosafety rule, internal quality indicator or agreed turnaround time. Examples include an incorrectly labelled sputum specimen, a missed temperature check, an expired reagent used in testing, or a result released before required review.

Without a shared classification system, staff may use vague descriptions such as “operator error” or “minor issue”. These labels often hide the real cause. A specimen problem might reflect unclear collection instructions, an unreliable transport arrangement or a poorly designed laboratory information system. Classification should therefore describe the point of failure and its potential impact, rather than simply naming the person involved.

A well-designed list supports risk-based decisions. A transcription mistake caught before reporting needs a different response from a false-negative result issued to a clinician. Both should be documented, but the second may require immediate notification, result correction, clinical risk assessment and a formal review.

Define Event Categories

Start with broad categories that match the laboratory’s workflow and Quality Systems Essentials. Suitable categories include pre-examination, examination, post-examination, equipment, supplies, personnel, safety, documentation, information management and external provider issues. These headings create a common language while leaving room for a short description of the actual event.

Pre-examination events occur before testing begins. They include unsuitable specimens, missing identifiers, incorrect containers, inadequate volume, delayed transport and incomplete request forms. Examination events include failed controls, contamination, incorrect incubation conditions, instrument malfunction, procedural deviation and an invalid molecular assay run. Post-examination events include delayed reporting, incorrect transcription, failure to communicate a critical result and an amended report that was not properly tracked.

Categories should also record the event’s relationship to patient or staff risk. A useful classification may include “no impact”, “potential impact”, “confirmed impact” and “critical or urgent impact”. This avoids treating every deviation as equal. A safety breach involving infectious aerosols, for example, may need urgent escalation even when no patient result was affected.

Set Documentation Requirements

Every entry should contain enough information for another trained person to understand what happened without relying on memory. Mandatory fields commonly include the date and time, location, staff member or role reporting the event, specimen or batch identifier, relevant procedure, category, description, immediate containment and person notified.

The record should distinguish facts from assumptions. “The positive control was outside the acceptable range at 10:15” is stronger than “the run failed because the operator was careless”. Attach objective evidence where appropriate: instrument printouts, control charts, photographs, temperature records, amended reports, email correspondence, training records or maintenance tickets. Sensitive patient information should be limited to what is necessary and protected under the laboratory’s privacy controls.

The event record should also state whether testing continued, whether affected results were withheld or recalled, and whether a clinical service was contacted. For a TB laboratory, this can be especially important when a delayed or corrected result affects isolation, contact investigation or treatment decisions. The documentation process must support traceability while avoiding unnecessary duplication across paper forms, spreadsheets and the laboratory information system.

The quality management framework can help laboratories align the event register with responsibilities for documents, records, assessment, equipment, personnel and continual improvement. The register should be controlled like any other quality document, with an owner, version history, access rules and a defined retention period.

Classification And Evidence At A Glance

A compact classification list can be built around the stage of work and the type of control that failed. The following groups are broad enough for routine use and can be adapted to a laboratory’s test menu:

Each category should be paired with an impact rating and an evidence requirement. A short entry guide prevents staff from creating inconsistent descriptions or selecting a category based on personal preference:

The categories and ratings should be tested against realistic examples. Ask staff to classify a rejected specimen from a remote community, a failed run during a weekend roster, a courier delay between Brisbane and a regional service, and an amended result sent to a hospital ward. If different users choose different classifications, revise the definitions before putting the list into routine use.

Apply The Process In Australian Laboratories

The classification process should begin when the event is discovered, not at the end of a monthly meeting. The person who notices the issue should make the area safe, preserve relevant evidence and notify the designated supervisor. They do not need to determine the root cause immediately. A short initial record is preferable to a delayed account assembled after details have been forgotten.

Local operating conditions deserve explicit attention. Specimens may arrive through hospital transport, commercial couriers, community collection centres or remote health services, and each route can create different risks. In Northern Territory or Far North Queensland services, longer transport distances and extreme heat may affect time and temperature controls. In a Melbourne or Sydney network, high testing volumes, multiple sites and shift handovers may create different risks around identification and result authorisation.

The list should identify escalation points. A failed molecular test may be managed within the section if no report was issued, while an incorrect positive or negative result may require the scientific lead, pathologist, infection prevention team and treating service to be contacted. Where an event involves workplace exposure, follow the organisation’s work health and safety process as well as the laboratory quality procedure.

Training should use the actual forms and systems used by staff. A short induction exercise, a quarterly scenario review and feedback from night or weekend teams can reveal whether the classification list is practical. Laboratories buying reagents, maintenance or courier services through different suppliers should also record external contributors without shifting responsibility away from the local quality system.

Review, Trend And Improve

A register becomes valuable when data are reviewed for patterns. Useful measures include events per number of specimens, repeat events by category, time to containment, time to close an investigation and the proportion with verified corrective action. Monthly or quarterly review can reveal whether a problem is isolated or linked to a process, site, shift, instrument or supplier.

Root cause analysis should be proportionate to risk. A simple “why” review may be sufficient for a contained documentation slip. A recurring specimen rejection trend may require process mapping, staff interviews, review of collection materials and consultation with referring services. Corrective action should address the system cause, such as revising a form, changing a handover step, improving stock rotation or adding a maintenance alert.

Closure should require evidence that the action worked. Training attendance alone does not prove improvement. Better evidence might include three months of compliant temperature records, a lower rejection rate, successful competency observation or documented review of amended reports. The event should remain open until the action owner, due date and effectiveness check are complete.

The phase checklists provide a practical way to compare the event process with broader quality system development. A laboratory can use the findings to update procedures, risk registers, internal audit plans and management review agendas, ensuring that recurring nonconformities influence the wider improvement programme.

A TB laboratory can now draft its list by selecting categories, defining impact levels, assigning mandatory fields and testing the result with real scenarios. Make the register available at the point of work, train every relevant role and review the first month of entries for consistency. A clear, evidence-based system will help staff contain problems quickly, protect patients and strengthen confidence in every result.