GLI GLI Quality Tool
GLI Quality Tool — Version 2.0

Tuberculosis laboratory gap analysis for accreditation readiness

Accreditation readiness for a tuberculosis laboratory comes from recurring evidence, not a polished quality manual alone. For an accredited medical testing service, the central question is whether staff consistently produce safe, accurate and timely results, document their work and act when something goes wrong. For tuberculosis (TB) diagnostics, this means examining the full pathway from specimen receipt and molecular detection through culture, confirmatory testing, drug-susceptibility testing, referral and reporting.

This guide explains how to conduct a TB lab gap analysis against the twelve quality systems essentials before accreditation. Use the GLI Quality Tool as the backbone, treating each Essential as an evidence question: what is required, who owns it, where it is recorded and how performance is shown. The twelve domains are organisation and management; personnel; equipment; safety; documents and records; materials and reagents; laboratory processes; quality control; quality assurance; external quality assessment (EQA); evaluation and continual improvement; and customer satisfaction.

Australian conditions make scope especially important. A central public health laboratory in Melbourne or Sydney may receive specimens from a network including hospital labs, private pathology providers and collection points in Brisbane, Adelaide, Perth and northern Australia. Courier timetables, flight links, power reliability and distance to referral centres can influence turnaround and continuity. The review should also be shaped with Aboriginal and Torres Strait Islander staff and community-controlled health organisations, so access, communication and culturally safe result delivery are treated as quality requirements.

A useful analysis produces a traceable improvement register, not merely a traffic-light score. For each gap, record the criterion, evidence reviewed, risk, owner, corrective action, due date and acceptance check. Address safety and risks to result validity first, then system-wide gaps. Where the TB service falls within its scope, test readiness against the requirements of Australia’s national accreditation body, NATA, and ISO 15189 rather than inferring it from an extensive policy set.

Define the assessment boundary

Start by fixing the assessment boundary. List every TB test, specimen source, shift, satellite site, staff group and shared instrument. Decide whether the review covers only the laboratory or also collection, transport and referral interfaces. Record the intended accreditation date, applicable NATA schedule and the preceding 12 to 24 months of evidence.

Review each Essential against objective evidence: policies and standard operating procedures, dated records, training and competency files, maintenance and calibration logs, validation reports, quality-control data, EQA results, deviation and corrective-action files, meeting minutes and management-review records. Sample several months rather than relying on the newest template. Mark each item compliant, partial, not met or not applicable, and require a written reason for every exception.

Use a consistent scoring rule that combines regulatory or safety risk with the size of the operational gap. Do not average away a serious weakness: an uncontrolled positive TB culture or an untraceable result is critical even if most checklist items are green. The phase-one readiness guide can test whether safety, trained staff, functioning equipment and workable procedures are in place before deeper review begins.

Test operational controls in the real workflow

Safety starts with local risk assessments for aerosol generation, specimen handling, decontamination, waste, transport, sharps, incidents and business continuity. Confirm that containment, procedures and staff practices match current Australian requirements and facility approvals for the organisms and work performed. Review induction, supervision, after-hours cover and a competency matrix for every critical task.

For equipment and reagents, examine calibration, preventive maintenance, service history, environmental monitoring, lot acceptance, cold-chain records, expiry control and contingency arrangements. Check supplier performance and stock lead times. For imported control strains or proficiency material, involve the biosafety and import officers, check customs requirements with Australian Border Force, and confirm any Department of Agriculture, Fisheries and Forestry biosecurity permit before ordering. Allow for permits, biosecurity checks and clearance in the lead time, and record required licences and alternative supply where applicable.

Then trace specimens through the actual workflow rather than only reading procedures. Follow identification, accessioning, rejection criteria, nucleic acid amplification testing, culture, confirmatory identification, drug-susceptibility testing, QC exceptions, critical results, authorised reporting and referral. Australia’s mixed laboratory market means responsibilities may cross public laboratories, hospital units and national private providers such as Sonic Healthcare. Written agreements should assign responsibility for result integrity, notification, EQA and corrective action.

Verify quality assurance and improvement

Documents and records should demonstrate control rather than merely exist. Check version approval, superseded-file removal, links from procedures to forms and training, retention, specimen traceability, access to records and timely closure of nonconforming events. The quality-management system should include document control, deviations, risk management, corrective and preventive action (CAPA), internal assessment, management review and a clear escalation route.

Quality control, quality assurance and EQA must be linked to risk. Confirm that each method has an approved control plan, acceptance criteria, failed-run handling and authorised review. For TB work this includes controls for nucleic acid amplification testing, culture media and susceptibility testing, plus enrolment in relevant proficiency schemes. Review trends, unsatisfactory EQA performance, referral results and the investigation and closure of outliers.

Run internal assessments independently of the person who performs the work. Sample complete specimen and nonconformance cases, not only attractive records, and test whether findings produce funded corrective action. Track turnaround time, contamination, invalid rates, reporting errors, stockouts and complaints. The Phase 4 resources provide templates and guidance for review, improvement and accreditation preparation once operational controls are functioning.

Prioritise gaps and build the action plan

Rank gaps by patient and staff harm, diagnostic validity, accreditation risk, likelihood and the time needed to control exposure. Separate immediate containment from strategic work, and avoid assigning a long system improvement to a critical specimen, safety or quality-control failure.

Convert each accepted gap into an action with one accountable owner, resources, dependencies, due date and objective evidence for closure. Show the work in the management meeting, review overdue actions and test effectiveness after implementation.

Sequence actions so critical findings close first, foundational work follows and system-wide monitoring becomes routine. A 30-, 60- and 90-day view can help managers see dependencies without treating those dates as a substitute for risk-based prioritisation.

Reassess evidence and prepare accreditation

Repeat the full assessment as a mock accreditation exercise. Ask assessors who were not responsible for the original work to sample the twelve Essentials, follow specimen records, observe bench practice and challenge the evidence behind claimed compliance. Include contract or referral interfaces, since failures often occur between organisations rather than inside the laboratory.

Build the evidence pack around the assessor journey: scope and legal identity, organisation and responsibilities, personnel, facilities and equipment, methods, validation and verification, QC, EQA, nonconformance and corrective action, records, management review and improvement. Reconcile this with the current NATA accreditation process and ISO 15189 requirements, including any sector-specific schedule for the TB service.

Before finalising the action register, use the GLI share structured feedback channel to clarify unclear checklist wording or report practical implementation problems. Do not include patient-identifiable or confidential laboratory information. Use the same questions to confirm that local evidence satisfies the relevant Essential, not merely that a local form has been completed.

Begin now by appointing the gap-analysis lead, confirming scope and issuing evidence requests to every operational owner. Circulate the prioritised register at the next management review, verify closure against objective evidence and schedule the mock assessment. This sequence turns the GLI checklist into a managed, demonstrable quality system and gives the TB laboratory a defensible path towards accreditation.