a Competency Checklist for Molecular TB Techniques

Molecular methods now sit at the heart of tuberculosis diagnostics in Australian pathology laboratories. Techniques such as Xpert MTB/RIF Ultra, line probe assays and laboratory-developed PCR protocols deliver results in hours rather than weeks, but their speed means little if the staff performing them are not demonstrably competent. A well-designed competency assessment checklist bridges the gap between training and trustworthy results, giving supervisors an objective way to confirm that each scientist can prepare samples, run instruments, interpret outputs and respond to invalid runs with confidence.

The GLI Quality Tool offers a four-phase roadmap built around twelve Quality Systems Essentials that laboratories can adapt to local contexts. For Australian teams working under NATA accreditation and AS ISO 15189 expectations, the framework provides a practical starting point for designing checklists that satisfy both international best practice and national requirements. The following sections walk through how to construct, populate and sustain such a checklist for molecular TB work.

Defining the Scope of Your Molecular Testing Programme

Before listing individual tasks, clarify which molecular platforms and assays the checklist must cover. A reference laboratory in Sydney running the Xpert MTB/RIF Ultra and the Abbott m2000 will have very different competency needs from a regional hospital in Cairns or Launceston that relies on a single GeneXpert instrument and sends indeterminate samples south for sequencing. Document the exact instruments, assay versions, sample types (sputum, BAL, CSF, extrapulmonary specimens) and result-reporting pathways in scope.

Mapping staff roles against this scope is equally important. A checklist for a new medical scientist who completed their degree at a Brisbane or Melbourne university will look different from one designed for an experienced technician transitioning from smear microscopy to molecular work. Identify the prerequisite knowledge each person brings, the gaps that training must fill, and the boundaries of what they are authorised to perform independently once assessed.

Australian laboratories should also align the scope with local regulatory touchpoints. The Therapeutic Goods Administration regulates in-vitro diagnostic devices, while the National Pathology Accreditation Advisory Council (NPAAC) sets the standards for laboratory practice. A checklist that explicitly references these requirements signals to auditors that competency is being assessed against the same criteria used for accreditation.

Core Technical Elements to Include in the Checklist

A strong checklist captures the full pre-analytical, analytical and post-analytical chain rather than focusing only on the moment a sample is loaded into a cartridge. Pre-analytical items might include verification of specimen quality, assessment of sample volume, confirmation of appropriate transport conditions, and correct entry of patient identifiers into the laboratory information system. These steps are common sources of error in busy diagnostic labs and are worth assessing just as rigorously as pipetting technique.

The analytical phase requires attention to reagent handling, master mix preparation, nucleic acid extraction, amplification set-up and instrument operation. For PCR-based methods, include checks for proper contamination control, the use of dedicated areas for pre- and post-amplification work, and the correct application of negative and positive controls with each run. For cartridge-based systems such as GeneXpert, the checklist should confirm that the operator can load the correct volume, recognise error codes and perform basic troubleshooting such as checking for cartridge damage or insufficient sample.

Post-analytical competency covers interpretation of qualitative, semi-quantitative and quantitative results, recognition of indeterminate or invalid outcomes, and the steps required to report results to clinicians and public health authorities. In Australia, where TB notification is mandatory under state and territory public health legislation, the checklist should also confirm that staff understand their reporting obligations, including the timeframe and the data fields required by the relevant jurisdictional notifiable diseases register.

Practical Observations and Direct Assessment Tasks

Checklists gain their real value when paired with structured observation of the scientist at work. A useful approach is to observe the full workflow at least twice per assessment cycle: once announced, where the staff member knows they are being watched, and once unannounced, embedded in routine service delivery. Both formats reveal different behaviours, and together they offer a more honest picture of day-to-day competency than a single practical exam.

Tasks should be realistic and representative of the actual workload. Asking a scientist to process a single contrived sample under ideal conditions tells you little about their ability to manage a busy morning run with multiple specimens, urgent requests and competing priorities. Where possible, include samples with known challenging characteristics, such as paucibacillary sputum or specimens delayed in transit, to test adaptability. A helpful framework for structuring these observations is outlined in the GLI practical observations guide.

Record-keeping during observations matters as much as the observation itself. Notes should describe what the scientist did, not what the assessor thought they should have done, and should capture deviations from protocol with enough context to support later remediation conversations. Photographs of worksheet entries or instrument screens, where appropriate and de-identified, can strengthen the audit trail when the checklist is reviewed by NATA assessors or internal quality managers.

Setting Criteria for Acceptable and Unacceptable Performance

Every line on the checklist needs a defined standard. Without explicit pass criteria, assessors fall back on subjective judgement, which creates inconsistency between staff and between assessment cycles. For each task, state what successful completion looks like: the correct volume pipetted within an acceptable range, the number of procedural steps followed in the right sequence, the time taken to recognise and act on an instrument error, and the accuracy of result interpretation against expected outcomes.

Equally important is a clear definition of failure. A single critical error, such as misreporting an MTB-positive result or failing to recognise a contamination event, should trigger immediate re-assessment and supervised practice regardless of how well other items were performed. Less serious deviations, such as occasional transcription errors or minor delays in reagent preparation, can be grouped into categories that determine whether the person passes, passes with conditions, or requires full re-training.

Remediation pathways should be documented in advance so that staff know what to expect if they do not meet the standard. This might include a defined period of supervised practice, targeted refresher training, a follow-up observation within a specific timeframe, and escalation to a senior scientist or laboratory director if performance does not improve. Transparency around these pathways reduces anxiety for the staff member being assessed and supports a culture of continuous improvement rather than blame.

Documentation and Alignment with Australian Standards

Documentation turns a checklist from a piece of paper into evidence of competency. Each completed assessment should be signed and dated by the assessor and the staff member, stored securely in the laboratory's training records, and linked to the specific assay version and instrument serial number used during the observation. This level of detail is what NATA assessors look for during surveillance audits, and it is also invaluable when investigating incidents or reviewing the performance of a particular platform over time.

Alignment with AS ISO 15189 and NPAAC requirements is easier when the checklist is structured around the same Quality Systems Essentials used in the laboratory's quality manual. If your facility already uses the GLI framework as a reference, the user instructions explain how to integrate phase-specific checklists into the wider quality management system, ensuring that competency records sit alongside equipment logs, internal audits and non-conformance reports.

Retention periods for competency records in Australia generally follow the requirements of the relevant professional registration body and the laboratory's own quality policy. A common practice is to retain records for the duration of employment plus a defined period afterwards, often seven years, in line with broader medical record retention guidance. Electronic records should be backed up, access-controlled and version-controlled so that earlier versions can be retrieved if questions arise about historical assessments.

Review Cycles and Sustaining Competency Over Time

A one-off competency assessment is a snapshot, not a guarantee. Skills drift, assays evolve and instruments are replaced, which means the checklist itself must be reviewed on a defined cycle, typically annually or whenever there is a significant change to the test method, reagent formulation or reporting software. Version control becomes essential here: outdated checklists risk reinforcing superseded practices and can undermine audit findings.

Routine proficiency testing adds another layer of assurance. Participation in an external quality assurance scheme for molecular TB testing, whether run domestically or through an international provider, gives staff regular exposure to blinded samples and helps the laboratory benchmark its performance against peers. Results from these rounds should feed back into the competency checklist, highlighting areas where additional focus or refresher training may be needed.

Finally, build a feedback loop that lets staff contribute to the checklist's evolution. Frontline scientists often identify practical gaps that supervisors overlook, and involving them in the review process increases ownership and improves the relevance of the assessment. When a checklist is treated as a living document rather than a static form, competency assessment becomes a genuine driver of quality rather than a box-ticking exercise.

Take the next step by mapping your current molecular TB workflow against the GLI Quality Tool phases and identifying where your existing competency checks could be strengthened. Adapt the structure outlined above to your instruments, your staffing profile and your NATA-accreditation obligations, then trial the checklist with one team before rolling it out across the laboratory. Consistent application, paired with the supporting materials available through the GLI platform, will give your staff the confidence to perform molecular TB testing at the standard Australian patients and clinicians expect.