Preparing a tuberculosis laboratory for WHO accreditation
Using the GLI Quality Tool to prepare for WHO accreditation gives a tuberculosis laboratory a practical way to turn quality requirements into daily work. The resource is designed for laboratories at different stages of development, including facilities that are strengthening biosafety, introducing molecular testing, or formalizing procedures for external assessment.
The tool follows a four-phase roadmap built around twelve Quality Systems Essentials (QSEs). These essentials cover the complete laboratory quality management system, from organization and personnel to equipment, purchasing, process control, assessment, and continual improvement. This broad structure helps a laboratory prepare for an assessment without treating accreditation as a document-only exercise.
A strong preparation process begins well before an assessor arrives. The laboratory needs reliable records, competent staff, controlled procedures, safe working conditions, and evidence that problems are identified and corrected. The GLI Quality Tool can help teams organize that work while keeping the needs of tuberculosis testing services at the center.
Clarify the accreditation pathway
The phrase “WHO accreditation” can refer to different forms of recognition, depending on the laboratory’s role and program. WHO may publish technical requirements, endorse assessment approaches, or operate programs connected with the quality of tuberculosis and drug-resistance testing. Formal accreditation, however, is generally granted by an authorized accreditation body against a defined standard, such as ISO 15189 or another applicable framework.
Before using the tool, laboratory leaders should identify the exact assessment route. They should confirm the required standard, scope of testing, national regulations, biosafety expectations, and documentation demanded by the relevant authority. A laboratory preparing for national accreditation may need a different evidence package from a facility seeking recognition within a WHO-supported network.
This clarification prevents wasted effort. It also allows the team to compare each QSE with the clauses and technical requirements that assessors will use. The GLI resource should support the accreditation program, not replace the official standard, application instructions, or assessment criteria.
Establish a baseline with the four phases
The four phases provide a staged route from initial organization to an established quality system. Early phases help a laboratory understand its responsibilities, assign leadership, define policies, and identify the procedures needed for consistent testing. Later phases focus on implementation, monitoring, corrective action, and sustained improvement.
A baseline assessment should involve the people who perform, supervise, and support laboratory work. Staff can review each checklist item, record whether it is fully implemented, partially implemented, or absent, and note objective evidence. Useful evidence may include an approved procedure, a training record, an equipment log, a temperature chart, a quality control review, or a documented corrective action.
The purpose is not to achieve a high checklist score immediately. It is to create an honest picture of risk and readiness. A gap that is visible can be assigned, resourced, and monitored; a gap hidden by optimistic reporting may appear during an external assessment when there is less time to respond.
Connect the QSEs to tuberculosis testing
The QSEs are most useful when they are connected to actual testing pathways. For example, personnel requirements should reflect the competencies needed for smear microscopy, rapid molecular testing, culture, drug-susceptibility testing, or specimen referral. Equipment controls should cover installation, calibration, maintenance, verification, decontamination, and downtime arrangements for the instruments in use.
Document control also needs to match laboratory realities. Current versions of testing procedures should be available at the point of use, while obsolete copies are removed or clearly marked. Records should show who performed a test, which lot or kit was used, whether controls were acceptable, and how results were authorized and reported.
Safety requirements deserve particular attention in tuberculosis laboratories. Risk assessments, engineering controls, personal protective equipment, exposure procedures, waste management, and incident reporting should be integrated into the quality system. Accreditation assessors usually look for evidence that safety is practiced consistently, not merely described in a policy.
| Quality area | Evidence to organize | Readiness question |
|---|---|---|
| Organization and leadership | Quality policy, objectives, roles, meeting records | Does management review performance and provide resources? |
| Personnel | Job descriptions, training files, competency assessments | Can each staff member demonstrate competence for assigned tests? |
| Equipment | Inventory, maintenance records, calibration and verification reports | Is equipment fit for purpose and available when needed? |
| Purchasing and inventory | Supplier evaluation, stock records, lot acceptance checks | Can the laboratory prevent shortages and unsuitable materials? |
| Process control | SOPs, internal quality control, result review records | Are testing steps controlled from specimen receipt to reporting? |
| Assessment | Internal audits, EQA/PT results, nonconformity reports | Does the laboratory detect problems and act on them? |
| Continual improvement | Corrective action logs, trend reviews, management decisions | Can the team show that performance improves over time? |
Build an evidence system before the assessment
A laboratory may perform good work and still struggle during assessment if evidence is scattered. The quality manager should create a simple document and record index that shows where each requirement is addressed. This index can cross-reference the GLI checklist, the applicable accreditation standard, and the location of supporting evidence.
Controlled documents should have clear titles, identifiers, version numbers, approval dates, and review intervals. Records need defined retention periods and protection against loss or unauthorized alteration. Electronic systems can be effective, but access permissions, backups, audit trails, and downtime procedures should be addressed.
Evidence should demonstrate implementation across time. One completed checklist or a recently signed policy is rarely enough. Assessors are more likely to accept a system when they can see repeated quality control reviews, regular temperature monitoring, completed competency checks, timely equipment maintenance, and follow-up of earlier findings.
Use audits and corrective action as preparation
Internal audits are a rehearsal for external assessment, but they should be more than a search for missing paperwork. An audit can trace a specimen through the complete process, interview staff, observe testing, inspect records, and compare practice with the approved procedure. Different staff members should participate so that the audit process itself becomes a learning activity.
Findings should be classified according to risk and handled through a defined corrective action process. The laboratory should identify the root cause, select an action, assign responsibility, set a deadline, and verify effectiveness. Rewriting a procedure may not solve a problem caused by inadequate training, poor workflow, insufficient supplies, or unclear authority.
External quality assessment and proficiency testing results should also feed into improvement work. An unacceptable result requires investigation, documentation, and follow-up rather than a one-time explanation. Trends in contamination, rejected specimens, delayed reports, invalid tests, stock-outs, or instrument downtime can reveal weaknesses before they become major accreditation findings.
For laboratories entering the final stage, the phase 4 guidance can help focus attention on maintaining the system and demonstrating continual improvement. The final preparation period should confirm that improvements are embedded in routine practice, not introduced temporarily for the assessment visit.
Keep readiness sustainable after recognition
Accreditation preparation should strengthen the laboratory’s operating model rather than create a short-lived campaign. Management needs to protect time for quality activities, maintain staffing levels, budget for equipment and supplies, and review quality indicators at planned intervals. When responsibilities depend on one individual, the system becomes vulnerable during leave, turnover, or emergency response.
A practical indicator set might include turnaround time, specimen rejection, internal quality control failures, proficiency testing performance, equipment downtime, corrective action closure, stock availability, and incident reports. Indicators should lead to decisions. If a result changes, the team should know who reviews it, what threshold triggers action, and how the response is documented.
The roadmap should also be revisited after major changes. New instruments, revised algorithms, relocated testing areas, staff turnover, changes in biosafety risk, and expanded testing volumes can alter the laboratory’s quality risks. Periodic reassessment with the GLI checklists helps keep the quality management system aligned with service delivery.
Practical priorities for the preparation team
A focused team can make steady progress by giving priority to the activities that produce the strongest evidence of control:
- Define the accreditation scope and map it to the relevant QSEs and standard clauses.
- Complete a documented baseline review with representatives from every major laboratory function.
- Correct high-risk gaps in biosafety, result reporting, equipment control, personnel competence, and quality control.
- Create a searchable evidence index linking procedures, records, audit findings, and corrective actions.
- Schedule an internal assessment and verify that corrective actions are effective before the external visit.
The team should record decisions, owners, deadlines, and resource needs in a quality improvement plan. Short review meetings can then track progress without turning preparation into a separate administrative burden. Senior management involvement is essential when gaps require procurement, recruitment, facility changes, or changes to testing policy.
The GLI Quality Tool is designed to be used by laboratories and programs, so user experience can help improve future guidance. Teams can share observations through the feedback form, particularly when a checklist item is unclear or difficult to apply in a specific resource setting.
A laboratory that starts with an honest baseline, links requirements to routine tuberculosis testing, and preserves objective evidence will be better prepared for assessment and better equipped to protect patients and staff. Begin with the applicable accreditation requirements, work through the GLI roadmap with the laboratory team, and turn each identified gap into a monitored improvement action.