GLI GLI Quality Tool
GLI Quality Tool — Version 2.0

Creating a Reliable TB Reference Material Log

A tuberculosis laboratory reference material handling and reconstitution log provides a controlled record of what arrived, how it was stored, who prepared it, and whether it remained suitable for use. It supports quality control, staff training, troubleshooting, stock management, and traceability across the entire life of a material.

A well-designed log should be simple enough for routine use and detailed enough to withstand an internal review or NATA assessment. Australian laboratories may be working in major facilities in Melbourne, Sydney, Brisbane, Perth, or Adelaide, as well as smaller regional services where deliveries, staffing, and equipment access are less predictable. A consistent record helps maintain the same standard in every setting.

Purpose And Scope

Define the materials covered before creating the form. The register may include non-infectious controls, commercial molecular assay controls, proficiency testing samples, prepared reference suspensions, inactivated organisms, and other materials used to verify TB testing. If infectious or potentially infectious material is included, the log must align with the laboratory’s approved biosafety and transport procedures.

The record should follow a material from receipt through storage, reconstitution, aliquoting, use, and disposal. It should also show when a batch was quarantined, rejected, or removed from service. A single log can cover several material types if the fields clearly distinguish them, although high-risk or complex materials may need a separate worksheet.

Set a retention period in the laboratory document control system. The period should reflect accreditation requirements, manufacturer instructions, contract conditions, and the risk associated with the testing process. Electronic records need access controls, audit history, and backup arrangements; paper records need legible entries, protected storage, and a method for correcting errors without obscuring the original information.

Designing The Log

Start with a unique log number or electronic record ID. Link it to the supplier, product name, catalogue or lot number, certificate of analysis, purchase order, and date received. Record the quantity, format, concentration where applicable, and assigned expiry date. If a supplier provides a revised certificate, retain the original document and record the reason for the update.

Include a clear status field such as pending inspection, accepted, quarantined, released, expired, or discarded. This prevents staff from using material that has arrived damaged or has not yet been checked. A barcode or QR code can reduce transcription errors, particularly in large laboratories, but it should supplement rather than replace the essential written information.

Keep the layout practical for a busy bench. Staff should be able to record the event without searching through several systems. Use drop-down selections for repeated entries in an electronic form, while preserving a free-text area for unusual observations, deviations, corrective actions, and follow-up decisions.

Receiving And Storing Materials

At receipt, compare the delivery with the purchase order and expected temperature conditions. Inspect the packaging for leakage, broken seals, wet insulation, damaged labels, or evidence of thawing. Record the delivery date and time, courier condition, temperature indicator result if supplied, and the name or initials of the person who performed the check.

Australian deliveries can involve long distances and hot conditions, particularly when materials travel from a supplier in Sydney or Melbourne to a regional laboratory in northern Queensland or Western Australia. A cold-chain excursion may occur during a depot delay, public holiday, or extreme summer heat. The log should therefore capture the evidence available at receipt rather than simply stating that the shipment was “okay”.

Storage entries should identify the exact location, such as freezer number, refrigerator, shelf, rack, box, and position. Record the storage temperature or monitoring result when the material is placed into storage. Follow the manufacturer’s instructions and local risk assessment rather than relying on a general assumption that every control belongs at 2–8 °C or frozen.

Use stock rotation based on expiry and opened-date limits. In Australia, laboratories may need to coordinate deliveries around Christmas and New Year closures, public holidays, or reduced courier services. Recording minimum stock levels and expected lead times helps prevent urgent substitutions that have not been verified.

Recording Reconstitution

The reconstitution entry should identify the material, lot, vial or aliquot number, and the procedure used. Record the diluent name, lot number, volume added, target concentration, date and time, operator, and equipment used. If the procedure requires a specified mixing technique, waiting period, or temperature equilibration, provide a checkbox or field confirming that each step was completed.

Do not rely on memory for calculations. The worksheet can include the stated concentration, intended final concentration, total volume, dilution factor, and number of aliquots. Where a calculation is performed electronically, protect the formula and validate it before release. Where it is calculated manually, require a second-person check for higher-risk materials or unusual dilutions.

Record observations such as incomplete dissolution, unexpected colour, clumping, broken vial, low volume, or a label that does not match the accompanying paperwork. The operator should stop and quarantine the material when the result is questionable. A supervisor or authorised scientist can then assess whether it may be accepted, reprocessed, returned, or discarded.

Applying Safe Handling Controls

The log is one part of the control system, not a replacement for a standard operating procedure, risk assessment, or competency record. Staff must use the approved biological safety cabinet, personal protective equipment, disinfectant, spill response process, and waste stream for the material being handled. Record any required cabinet identification, decontamination status, or equipment check in the relevant supporting record.

Surface cleaning needs to be specific to the material and disinfectant. The laboratory can use this surface decontamination job aid to support a clear, task-based instruction for staff handling reference materials. The log may reference the job aid or procedure number without reproducing every cleaning step.

Australian laboratories must consider applicable state or territory Work Health and Safety legislation, local biosafety requirements, and institutional policies. A facility in New South Wales may use a different form or approval pathway from one in Victoria or Western Australia, but the underlying controls should remain equivalent. Waste handling, incident notification, and exposure response must be consistent with the organisation’s authorised arrangements.

Transport documentation also matters when materials move between sites. Confirm the classification, packaging, labelling, and courier requirements before dispatch. Do not assume that a reference material is exempt from transport controls because it is used for quality control; classification depends on the material’s properties and condition.

Managing Deviations And Disposal

Create a deviation number whenever a material is received warm, arrives late, has damaged packaging, is reconstituted with the wrong diluent, exceeds its open-vial stability period, or is stored outside the specified range. The log should state what happened, when it happened, who identified it, and what immediate containment action was taken.

A useful investigation distinguishes the event from the decision. For example, the event may be a freezer alarm overnight; the decision may be to quarantine affected aliquots pending temperature review and control testing. Record the evidence considered, the authorised person who approved release or rejection, and any impact on patient testing, quality control results, or proficiency testing.

Disposal records should include the date, quantity, reason, waste stream, and person responsible. If material is discarded because of expiry, link the entry to stock rotation or ordering data. If it is discarded after a spill or suspected contamination, link it to the incident report. This creates a traceable record without placing confidential incident details in a widely accessible stock log.

When a supplier issues a recall or safety notice, use the lot number and aliquot identifiers to locate affected material quickly. A precise register can prevent unnecessary disposal of unrelated stock and supports timely notification to relevant testing areas.

Reviewing Trends And Improving Practice

Review the log at a defined frequency, such as monthly for active materials and at each batch review for lower-volume services. Look for recurring temperature excursions, incomplete entries, repeated calculation corrections, expired stock, or delays between reconstitution and release. These patterns may indicate a training gap, an unsuitable storage layout, or a purchasing problem rather than individual carelessness.

Use the findings in the laboratory’s quality meeting and corrective action process. The continual improvement guidance can help connect log findings with monitoring, assessment, corrective action, and sustained improvement activities. A change might involve revising a form, adding a second-person check, changing a supplier, or setting a reminder before a stability period ends.

Trend data is especially useful for laboratories serving dispersed populations. A regional service may discover that small orders create excessive freight delays, while a metropolitan laboratory may find that shared freezers lead to misplaced aliquots. Both findings can support practical changes based on evidence from the local workflow.

Review the form itself after incidents, audits, equipment changes, and updates to manufacturer instructions. Remove fields that are never used, clarify ambiguous wording, and keep the approved version number visible. Staff should be trained on the revised form and old versions withdrawn from benches and shared drives.

Practical Fields And Review

A compact log can still capture the information needed for traceability. Build the minimum dataset around receipt, storage, preparation, use, and disposal, then add fields required by the material’s risk assessment or supplier instructions.

Record at receipt

Record during preparation and follow-up

Make the log available where the work occurs, while controlling access to electronic records. A tablet at the preparation area may be useful in a large Brisbane laboratory, whereas a controlled paper form may be more reliable during intermittent connectivity at a remote service. Either format is acceptable when entries are timely, protected, retrievable, and linked to approved procedures.

A reference material handling and reconstitution log becomes valuable when it reflects real work rather than adding administrative burden. Validate the draft with the staff who receive, prepare, store, and use the materials, then approve it through document control. Put the final version into routine use, monitor completion, and act on the evidence it produces.