Donated Analyser and Heat-Exposed Malaria RDTs
A county hospital laboratory receives two donations in one week. First, a used automated haematology analyser from a private hospital, with no installation records, no service history, and a printout showing a calibration performed 14 months ago. Second, 40 boxes of malaria rapid diagnostic tests from a programme, delivered in an open pickup and stored for two days in a room where the thermometer recorded 37.4 °C; the kit box says store at 2–30 °C. The laboratory manager asks you to “start using both on Monday because the workload is high”. The hospital has a quality manual but no written verification protocol for donated equipment, and the RDT lot is not yet in the stock register. The next external quality assessment malaria panel is due in three weeks.
1. What must happen before the donated haematology analyser is used for patient samples?
Read the worked answer
The analyser must not be used for patient testing until it has been installed, verified and formally authorised. A 14-month-old calibration printout and no service history are not evidence of current performance.
A defensible process has four stages:
- Installation and safety: confirm the electrical supply, environment, biosafety and space requirements; obtain the service history and any outstanding faults; check that the manufacturer or a qualified engineer confirms the instrument is fit for use.
- Operational verification: check background counts, precision, carryover, and the analyser’s internal calibration and settings. Calibrate or verify calibration with traceable materials as specified by the manufacturer.
- Performance verification: run within-run and between-day precision using appropriate control material; compare patient results with the current method or a referral laboratory across the clinically important range, including low and high values; review flags, differentials and reference intervals; check sample carryover. A comparison of at least 20–40 samples, depending on the parameter, is reasonable, but the acceptance criteria must be set in advance.
- Authorisation and training: document the results, have the laboratory manager or quality officer review and sign off, train staff, and add the analyser to the equipment inventory and maintenance schedule.
Until then, the laboratory should continue with its existing method or refer samples. External quality assessment panels are not a substitute for pre-use verification.
2. Should the malaria RDT lot be accepted? What testing, if any, would justify using it?
Read the worked answer
Do not accept the lot into routine use yet. The kits were exposed to 37.4 °C for two days, above the labelled upper limit of 30 °C. Heat exposure can degrade antibodies and produce false-negative results, which is particularly dangerous in malaria diagnosis.
Actions:
- Quarantine the boxes and label them “do not use – temperature excursion”.
- Record the thermometer reading, delivery conditions, duration and number of boxes.
- Contact the manufacturer or supplier for stability data and written advice on the specific lot. If the manufacturer states the lot is compromised or cannot confirm stability, reject it and request replacement.
- If the manufacturer permits further assessment, run the kit’s internal control and external positive and negative controls, and test a small panel of known positive and negative samples, including low parasite density positives. Use the results against pre-set acceptance criteria.
- Do not rely on the upcoming EQA panel as the verification exercise; EQA is an external quality assessment tool, not a pre-use check, and its results arrive too late.
- Enter accepted kits in the stock register, apply first-in-first-out, and store them within 2–30 °C with temperature monitoring.
If no replacement kits are available and malaria diagnosis depends on RDTs, the laboratory should inform clinicians and use microscopy where possible. The safest default is rejection unless the manufacturer provides evidence that the lot remains stable.
3. What documentation and governance should the laboratory put in place before either donation is used?
Read the worked answer
The laboratory needs a written verification and acceptance procedure that covers donated equipment and reagents, with named responsibilities and acceptance criteria set before testing begins.
Documentation for the analyser: donation agreement and asset record; service history and engineer’s report; installation record; calibration and verification records; precision and comparison data; staff training records; authorisation signature; maintenance schedule; and a statement of limitations.
Documentation for the RDTs: delivery note; temperature excursion record; manufacturer’s written advice; control and panel results if applicable; acceptance or rejection decision; stock register entry; storage conditions; and disposal or return record for rejected kits.
Governance: the laboratory manager authorises use after review; the quality officer checks the records; staff are trained on the new method; the procedure is added to the quality manual; and the hospital’s procurement or donations committee is informed of the risks. The laboratory should also tell clinical staff about any delay or change in service.
Finally, the laboratory should review why it accepted donations without a pre-delivery assessment. A simple donation checklist, covering service history, temperature-controlled transport and documentation, would prevent a repeat. The pressure to “start on Monday” is understandable, but using unverified equipment or heat-damaged RDTs would transfer risk directly to patients.