How to implement an internal audit program for a TB microscopy centre
An internal audit program gives a tuberculosis microscopy centre a practical way to check whether its procedures work as intended. It examines the complete testing pathway, from specimen reception and smear preparation to staining, microscopy, result reporting, waste management and corrective action. The purpose is improvement and risk control, rather than finding fault with individual staff.
For Australian laboratories, the program should reflect local governance, work health and safety requirements, privacy obligations and the laboratory’s relationship with state or territory public health services. A small regional service in Cairns, Alice Springs or Ballarat may need a different audit schedule from a large metropolitan facility in Sydney or Melbourne, but the underlying quality principles remain consistent.
The GLI Quality Tool can help a centre organise this work through its quality management roadmap and Quality Systems Essentials. A well-designed audit system turns routine observations into evidence: records show what happened, staff can explain why it happened, and managers can demonstrate that identified issues were addressed and checked.
| Audit focus | Typical evidence | Suggested frequency |
|---|---|---|
| Specimen reception and identification | Request forms, labels, rejection records, transport logs | Monthly sampling |
| Smear preparation and staining | Bench observations, reagent logs, control slides | Monthly or quarterly |
| Microscopy and reporting | Positive and negative slides, worksheets, result registers | Quarterly |
| Equipment and maintenance | Service records, temperature logs, microscope checks | Quarterly |
| Safety and waste | PPE observations, incident reports, disposal records | Six-monthly |
| Corrective actions | Action register, root-cause review, effectiveness checks | At every audit cycle |
Set the purpose and scope
Begin by writing a short audit policy that explains why audits are conducted, who authorises them and how findings are managed. The scope should cover the full TB microscopy workflow, including referral specimens, smear-negative and smear-positive reporting, stock control, cleaning, equipment maintenance, staff competency and communication with clinicians or public health teams.
Avoid attempting to audit every requirement at once. A risk-based annual schedule is more achievable. For example, a centre could review specimen identification and result transcription after a near miss, then examine staining quality and microscope maintenance during the next cycle. This approach concentrates attention where errors could delay treatment or affect contact tracing.
The audit criteria should come from approved standard operating procedures, the laboratory’s quality manual, relevant Australian regulations and applicable accreditation expectations. Where the service is seeking or maintaining NATA accreditation against ISO 15189, the audit program should provide objective evidence that documented processes are followed and improved when weaknesses are detected.
Assign responsibilities and train auditors
The laboratory manager or quality coordinator should maintain the audit calendar, approve checklists and track actions. Each audit needs a named lead, a defined scope, a date and a list of records or activities to be sampled. In a small centre, another trained staff member from a partner laboratory, public health unit or regional network may provide useful independence.
Auditors should understand TB microscopy, quality indicators, confidentiality, interviewing techniques and the difference between observation and judgement. They do not need to be external consultants. A senior scientific officer can audit a process they do not routinely perform, while a colleague from another section observes the microscopy workflow. Auditors should not assess their own work where a reasonable alternative exists.
Good audit training includes reviewing a simulated request form, following a specimen through the workflow and writing evidence-based findings. Staff should learn to describe what was seen, identify the relevant requirement and record the risk without attributing blame. A constructive quality improvement team can help turn audit results into practical changes involving scientists, technicians, managers and clinical partners.
Build a usable audit checklist
A checklist should follow the real sequence of work rather than reproduce a lengthy standard clause by clause. Start with specimen receipt: is the patient identifier complete, is the specimen type acceptable, was the collection time recorded and can the transport conditions be verified? Continue through accessioning, smear preparation, staining, slide labelling, microscopy, interpretation, authorisation and notification.
Include questions about controls and records. Check whether staining reagents are labelled with preparation and expiry dates, positive and negative control results are documented, microscopes are cleaned, and staff can locate the current procedure. Review whether rejected specimens are recorded consistently and whether amended reports are authorised and traceable.
Use a mix of document review, direct observation, staff interviews and record sampling. A checklist should include space for objective evidence, a risk rating, the responsible person and a due date. Digital forms can work well in metropolitan laboratories, while a printed version may be more reliable for a remote service with intermittent connectivity. Keep the approved checklist under document control so obsolete versions are withdrawn.
Collect evidence and report findings
Choose samples that represent normal work. Reviewing ten recent specimens, several positive slides and a selection of negative reports may reveal more than inspecting only the easiest records. Include specimens from different shifts, collection sites or transport routes when the centre receives material from hospitals, Aboriginal Community Controlled Health Services or remote clinics.
During observation, avoid interrupting a safety-critical task. Record facts such as “the staining bench record had no lot number for two of five entries” rather than “staff are careless.” Ask staff to explain the process and listen for practical barriers, such as unclear forms, insufficient bench space, delayed courier transport or a microscope shared between sections.
Audit findings can be graded according to local policy, for example as critical, major or minor, with an additional category for opportunities for improvement. A critical finding might involve an unreported positive result or a patient identification risk. A minor finding could be an incomplete cleaning record where the activity was independently confirmed. The report should state the evidence, the requirement, the risk and the agreed response.
Close the loop on corrective action
Every significant finding needs an owner, a realistic completion date and a method for checking effectiveness. A root-cause review may show that a missing stain lot number results from a poorly designed worksheet rather than poor staff discipline. Corrective action could include revising the form, briefing staff, placing a visual prompt at the bench and adding a short follow-up sample to the next audit.
Track open actions in a central register reviewed at quality meetings. If a regional centre relies on shared microscopes, incubators or centrifuges, responsibilities can become unclear; an equipment sign-out system can strengthen traceability for use, cleaning, faults and handover. This is especially valuable when staff rotate between a public hospital laboratory and a satellite service.
Effectiveness must be tested rather than assumed. After a corrective action, repeat the relevant record review or observation after an agreed interval. Compare indicators such as specimen rejection rates, transcription errors, turnaround time, internal quality control failures and overdue maintenance. Share results at routine meetings in a way that protects patient confidentiality and recognises improvements.
Make the program sustainable
An internal audit program should be part of everyday laboratory management, not an annual event prepared for an assessor. Include audit dates in the service calendar, protect time for staff participation and review trends at management meetings. A small centre might complete one focused audit each month, while a larger service can use a rolling schedule across microscopy, safety, documentation and equipment.
Plan for workforce changes. Australian laboratories often manage rotating staff, leave coverage and recruitment across a wide geography. Keep auditor training records, competency assessments and handover notes current. When a new technician joins, explain how findings are reported and how corrective actions are followed up as part of induction.
Use the GLI Quality Tool’s phase-based guidance and checklists to match the program to the centre’s current maturity. Early work may focus on controlled procedures, basic records and clear responsibilities. More established services can examine trend analysis, supplier performance, staff workload, referral pathways and continual improvement. The result should be a proportionate system that works in a busy Melbourne laboratory as well as a remote service supporting communities across the Northern Territory.
Start with one high-risk process, appoint a trained auditor and complete a focused audit within the next quality cycle. Document the evidence, agree on achievable actions and schedule an effectiveness check before the findings lose visibility. With consistent follow-through, internal auditing becomes a practical safeguard for accurate TB microscopy, timely public health action and safer laboratory work.