GLI GLI Quality Tool
GLI Quality Tool — Version 2.0

Developing A TB Lab Corrective Action Flowchart

A nonconforming tuberculosis result can affect treatment, infection control, contact tracing and public confidence within hours. A corrective action flowchart gives laboratory staff a consistent route from detection to containment, investigation, reporting and verification. It turns a potentially confusing event into a sequence of controlled decisions, with clear points for escalation.

The flowchart should be practical enough for a busy metropolitan service and adaptable to a small regional laboratory. It needs to cover molecular testing, smear microscopy, culture, identification, drug susceptibility testing and reporting activities, while fitting within the laboratory’s quality management system. The best design is simple at the point of use, supported by detailed procedures elsewhere.

Define What Counts As Nonconforming

Start by describing a nonconformance as any departure from an approved requirement that could affect the validity, timeliness, confidentiality or interpretation of a result. This includes an invalid or failed internal control, an unsuitable specimen, a transcription error, a contaminated culture, an instrument failure, a reagent issue, an incorrect patient identifier or a report released with the wrong interpretation.

The flowchart should distinguish between a testing event and a result that has already reached a clinician or public health unit. A failed assay caught before reporting may require containment and repeat testing. A false-negative or incorrect drug resistance result that has been reported requires immediate clinical notification, amended reporting and a documented risk assessment.

Use a consistent incident classification, such as critical, major or minor. A critical event might involve a result that could delay treatment for infectious TB or misclassify rifampicin resistance. A major event could affect a batch or several specimens, while a minor event may be confined to a controlled documentation error with no impact on patient care.

Capture The First Decision Points

The first box should ask whether the result or process is reliable enough to release. If the answer is no, the next action is to place the result on hold and prevent further reporting from the affected run, instrument or specimen group. Staff should record the event in the laboratory’s nonconformance system rather than relying on an informal email or a note beside the analyser.

The second decision should ask whether a patient result has already been issued. If it has, the flowchart must direct staff to notify the authorised supervisor, review the clinical urgency and contact the relevant clinician or public health service. In Australia, this may involve communication with a state or territory TB control program, especially when a result could alter isolation, contact investigation or notification arrangements.

The user instructions for the GLI Quality Tool can help laboratories align this process with a broader quality management approach. They are particularly useful when different staff members need to understand how checklists, evidence and improvement activities fit together.

Separate Containment From Root Cause

Containment is the immediate response that limits harm while the cause is still being examined. Depending on the event, it may include quarantining reagents, stopping an assay, preserving raw data, repeating testing from the original specimen, requesting a new specimen or reviewing all results produced since the last acceptable quality control run.

A root cause investigation should follow containment rather than delay it. Ask what happened, when it began, which specimens and staff were involved, and which controls should have detected the problem. A simple five-whys review can be effective, but complex events may require a fishbone analysis covering people, equipment, methods, materials, environment and information systems.

Avoid assigning blame to the person who noticed the error. A result may be wrong because a procedure was unclear, a barcode workflow permitted an override, a maintenance task was overdue or a handover between shifts was incomplete. The investigation should identify system weaknesses and produce evidence that can be checked later.

Build Branches For Common TB Events

A useful flowchart has separate branches for pre-analytical, analytical and post-analytical problems. For pre-analytical events, include specimen labelling, collection volume, transport temperature, leakage, delay and patient eligibility. A sputum specimen that arrives from a remote community clinic after an extended transport period may require a documented suitability decision rather than an automatic rejection.

Analytical branches should address failed controls, unexpected contamination, instrument flags, discordance between smear and molecular findings, and susceptibility results that do not fit the organism or clinical picture. The pathway should specify when to repeat the test, use an alternative method, consult a reference laboratory or refer material to a specialised service.

Post-analytical branches need clear rules for amended reports, corrected comments and communication records. When a result changes, the original report should remain traceable in the laboratory information system, while the amended report clearly identifies what changed and why. Staff should document the date, recipient, advice given and person responsible for the communication.

The GLI Quality Tool’s Phase 1 resources provide a useful foundation for laboratories beginning to formalise quality policies, responsibilities and essential processes. This is relevant to Australian services where a central reference laboratory may support smaller facilities in regional Queensland, Western Australia or the Northern Territory.

Assign Authority And Evidence

Every decision box should identify who can act and who must be consulted. A medical scientist may place testing on hold, preserve materials and begin a preliminary assessment. A senior scientist or laboratory manager may authorise a corrected report, initiate a wider look-back or approve a deviation from routine testing. A clinical microbiologist, pathologist or TB specialist may be needed for interpretation and clinical escalation.

The flowchart should point to controlled documents rather than reproduce every technical instruction. Link each action to the relevant standard operating procedure, specimen acceptance policy, equipment response procedure, incident form and communication template. Include version control so that staff are not following an obsolete pathway printed months earlier.

Australian laboratories should map the flowchart to their accreditation and governance environment. NATA assessment requirements, NPAAC guidance, state or territory public health arrangements and applicable work health and safety duties can influence how incidents are handled. Privacy obligations under the Privacy Act 1988 also matter when reports, patient identifiers and investigation records are shared electronically.

Verify Effectiveness And Learn

Closing a corrective action means more than completing a form. The laboratory should define an effectiveness check, such as acceptable controls across a specified number of runs, completion of competency assessment, a successful equipment challenge, reduced contamination rates or an audit showing that amended reports contain the required information.

Set realistic timeframes according to risk. A potentially incorrect infectious TB result may need same-day containment and communication. A recurring documentation issue may allow a longer improvement period, provided interim controls are in place. The flowchart should display escalation points when an action is overdue or evidence does not demonstrate improvement.

Trend nonconformances across months and locations. A service in Sydney or Melbourne may identify patterns across high-volume instruments, while a regional network may see delays related to courier schedules, public holidays or limited access to specialist testing. Reviewing these trends during management meetings can support investment decisions, staff training and changes to specimen referral arrangements.

Practical Design Rules For The Flowchart

Keep the visible pathway short, use unambiguous decision wording and test it with the people who will use it during a busy shift. A printable version may be valuable in a containment area, while an electronic version can link directly to procedures and forms.

A flowchart should reflect real working conditions. Staff in Australia may move between a central laboratory and satellite collection sites, use courier networks affected by distance and weather, or manage specimens during roster gaps and weekend services. Designing the pathway around these realities makes compliance more achievable than creating a document that assumes unlimited staffing and immediate access to every test.

Once approved, introduce the flowchart through short scenario-based training. Use examples such as a failed molecular control, a contaminated culture batch and an amended rifampicin resistance report. Ask staff to follow the pathway without coaching, then revise unclear wording, missing contacts or unrealistic timeframes before the next controlled release.

A TB laboratory can now turn the draft into a controlled document: map each decision to its procedure, nominate accountable roles, test the pathway against recent incidents and approve it through the quality system. Make the final flowchart accessible at every relevant workstation, review its performance through audits and trend reports, and update it whenever methods, instruments, regulations or referral arrangements change.