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Stop releasing affected results when quality controls are out of range. Record the symptom, check the entire testing process, correct one plausible cause at a time, and verify controls before repeating patient samples. If an equipment defect is possible, remove the instrument from service, assess when the fault began and which results could be affected, and use an approved backup or referral route while qualified technical help is arranged.

What counts as an inconsistent result?

Inconsistency can appear as control or calibrator drift, an unexpected difference between replicates or runs, or an obvious malfunction such as an error code, abnormal noise, leakage, or failure during a function check. A single surprising patient value is a signal to investigate, not proof that the instrument is defective. Review internal-control results and their trend history: gradual movement toward a limit may reveal a process deviation before one patient result makes it visible.

The exact acceptance limits, statistical rules, notification duties, and retesting requirements come from your method validation, instrument instructions, laboratory quality-control procedure, and applicable local requirements. General quality guidance cannot diagnose a particular analyzer, assay, or jurisdiction.

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First decision: can testing continue?

When controls are outside the acceptable range

Treat an out-of-range control as an out-of-control run. Pause testing on the affected method or instrument, investigate and correct the cause, and withhold patient results. The World Health Organization (WHO) quantitative quality-control guidance states: “Patient results must not be reported until the problem is resolved and the controls indicate proper performance.” Do not release a result merely because it appears clinically plausible.

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When controls are in range but results disagree

Keep the discrepancy under investigation and compare the control trend, calibration status, replicate data, sample condition, reagent and control lots, operator, and instrument. A control that passes at one time does not prove that every earlier or later measurement is valid. Follow the laboratory’s rules for holding, adding comments to, or referring questionable results.

Make the status visible

If the instrument may be malfunctioning, label it clearly as out of service and prevent accidental use. WHO equipment guidance says, “Do NOT use faulty equipment! Seek help from the manufacturer or other technical expert.” Record the time, user, method, error messages, control values, and samples involved before settings or parts are changed.

Investigate the whole process, not only the analyzer

Use the manufacturer’s troubleshooting flowchart when one exists. Work from the observed symptom and change one thing at a time so that each check has an interpretable result. The following checklist covers the common causes identified in WHO equipment and quality-control guidance; none is proof of causation by itself.

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Is the problem related to a poor sample?

  • Was the patient correctly identified and was the specimen collected in the required container and volume?
  • Were transport time, temperature, light protection, centrifugation, mixing, and storage conditions within the method’s instructions?
  • Is the specimen hemolysed, lipaemic, icteric, clotted, contaminated, insufficient, or otherwise unsuitable for this method?
  • Could a sample characteristic interfere with the measurement or create a matrix effect? Check the assay instructions and the laboratory’s rejection criteria rather than relying on visual appearance alone.

Reagents, kits, and control material

  • Check expiry dates, open-vial stability, storage temperature, light exposure, contamination, and preparation or reconstitution records.
  • Identify whether a reagent, calibrator, or control lot changed. A new lot may require lot-specific calibration, verification, or a documented comparison before patient testing.
  • Confirm that control material was prepared, mixed, aliquoted, and stored exactly as its instructions and your SOP require. Degraded controls can mimic instrument failure.

Calibration, settings, and maintenance

  • Review calibration status, calibration-curve or verification records, expiry of calibration, and any failed calibration messages.
  • Check method parameters, units, reference settings, sample probes, cuvettes, lamps, sensors, tubing, and software configuration only as far as the instrument procedure permits.
  • Verify that scheduled cleaning, preventive maintenance, function checks, and temperature or pressure checks were completed and documented.

Utilities, environment, and procedure

  • Confirm water quality and pressure, electrical supply, grounding, gas supply, room temperature, humidity, vibration, and other utilities specified by the manufacturer.
  • Check that the current approved method and procedure version was used, including incubation times, dilution instructions, mixing, and result calculations.
  • Look for a recent software update, configuration change, environmental event, power interruption, or move of the instrument.

People and workflow

  • Determine whether the issue follows one operator, shift, site, sample type, reagent lot, or instrument.
  • Review training and competency records, pipetting or loading technique, barcode handling, specimen order, and transcription or interface steps.
  • Use these patterns to organize the investigation, not as a validated diagnostic algorithm. A correlation still requires confirmation under the laboratory’s procedure.

Correct the cause, verify performance, then repeat only when justified

  1. Describe the failure. Capture control levels and trends, replicate differences, error codes, lot numbers, calibration date, maintenance status, operator, sample type, and time of occurrence.
  2. Select one plausible check. Use the symptom and the manufacturer’s flowchart or your SOP. Avoid simultaneous cleaning, recalibration, reagent replacement, and software changes because you will not know which action affected the outcome.
  3. Apply only authorized corrective action. Routine user maintenance may be allowed; repairs, covers, electrical work, or software changes may require an authorized service provider. Warranty or service terms can restrict who may intervene.
  4. Re-check controls. Run the required control levels and any function or calibration verification specified by the method. Document values, acceptance criteria, and reviewer approval.
  5. Repeat patient samples only after controls perform properly. WHO guidance directs staff to identify and correct possible causes, re-check control material, and then repeat patient samples together with another control when controls read correctly. Use the laboratory’s rules for specimen suitability, duplicate testing, result comparison, and authorization.
  6. Close or escalate the event. If controls remain unacceptable, the cause is uncertain, or the symptom returns, keep testing on hold and obtain qualified technical assistance rather than repeatedly rerunning specimens.

Repeated testing without a plausible cause can consume specimens and create a false impression of confirmation. A repeat result is useful only when the process has been shown to be back in control and the repeat is allowed by the method and SOP.

Decide what to do with results already produced

An instrument can output a plausible number while operating incorrectly. If a defect is suspected, protect patients and the laboratory by conducting a documented impact assessment instead of assuming that every result is wrong or that none are affected.

Contain the risk

  • Remove the instrument or affected method from service, identify it visibly, and prevent further use.
  • Preserve logs, raw data, control charts, calibration files, maintenance records, error messages, and service reports.
  • Define the affected tests and the earliest time at which the fault could have existed. The start may precede the first alarm or failed control.

Estimate the scope

Assess the fault, method, direction and size of possible bias, time window, reagent and calibration lots, sample types, and whether the failure was intermittent or continuous. Review control trends and any independent verification available. The laboratory’s technical lead, quality manager, and responsible clinician should determine the approach under local authorization and privacy procedures.

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Trace and decide

Use the information system and worksheets to identify potentially affected accessions. For specimens still retained, determine whether a validated repeat or alternate method is appropriate. If specimens are no longer held, WHO Laboratory Quality Management System guidance says to contact relevant clinicians or patients as applicable; follow your approved communication, privacy, and disclosure process. Document why each group was or was not retested, corrected, amended, or notified.

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Choose the next action by evidence and capability

Situation Immediate action Result status Further route
Controls out of range; cause not yet known Stop the affected testing, hold the run, investigate one cause at a time Do not release results Correct, re-check controls, and escalate if unresolved
Controls recover after an authorized correction Document the correction and verification Release or repeat only under the method SOP Monitor subsequent controls for recurrence
Controls pass but a sample or replicate is suspect Assess sample integrity, method limitations, and identification Hold or qualify the result as required locally Use an approved repeat or alternate method
Evidence points to a defective instrument Label out of service and preserve records Hold affected testing Qualified service, impact assessment, and possible retesting
Instrument unavailable during repair Activate the validated continuity plan Report only through an approved route Use a backup instrument or referral laboratory; notify providers of likely delays

These options depend on whether controls are acceptable, where the evidence points, whether prior results could be affected, what your SOP permits, and whether a validated alternative is available. They are not a universal retest algorithm.

Escalate safely and maintain testing continuity

Do not bypass an interlock, disable an alarm, substitute an unapproved part, or continue using equipment marked faulty. Contact the manufacturer or another qualified technical expert when the fault is unresolved, recurs after authorized checks, involves electrical or mechanical safety, or falls outside user maintenance. Confirm model coverage, service authorization, response arrangements, and documentation requirements before work begins.

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Possible continuity measures include a validated backup instrument, a replacement instrument supplied during repair, or referral of specimens to a nearby laboratory. Confirm method comparability, specimen stability, transport conditions, result units, reference intervals, turnaround time, and authorization before switching routes. Notify appropriate clinicians or service users about likely delays through the laboratory’s approved channel.

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Build records that make the next investigation faster

Use controlled forms or an electronic quality system, not informal notes alone. Record the event, instrument identity, method, operator, symptoms, control and calibration data, reagent and control lots, environmental or utility checks, maintenance and service activity, decisions, approvals, and communication. Keep links between the incident and affected sample accessions so an impact review is reproducible.

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WHO Laboratory Quality Management System guidance recommends an equipment register that can include:

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  • equipment name, type, model, unique laboratory label, and serial number;
  • manufacturer and contact details;
  • purchase date, installation or location, and service provider;
  • condition and criticality to testing;
  • maintenance frequency, previous maintenance, next scheduled maintenance, and remarks.

When equipment with a critical effect on testing is nonfunctional, the same guidance says to put it out of service and arrange repair. A printed maintenance and calibration logbook can help capture these fields, but it does not replace controlled laboratory records, review, or the SOP.

Use standards in the right scope

Clinical and Laboratory Standards Institute document QMS23-Ed2, General Laboratory Equipment Performance Qualification, Use, and Maintenance, was published June 19, 2019. Its official scope covers performance qualification, routine function checks, calibration verification, and preventive maintenance for 20 types of general laboratory equipment, including common equipment such as centrifuges, fume hoods, and pipettes. It does not cover specialized instrumentation exclusive to particular laboratory sections, and its recommendations supplement rather than replace manufacturer instructions.

Use QMS23-Ed2 as a framework for equipment controls and lifecycle records, not as a troubleshooting manual for a specific analyzer or assay. Its stated count—20 types of general laboratory equipment—is not a count of all laboratory instruments.

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A compact incident checklist

  • Identify the symptom and affected method, instrument, samples, operator, lots, and time.
  • Review control values and trends; hold results if controls are unacceptable.
  • Check sample quality, reagents, controls, calibration, maintenance, utilities, environment, procedure version, and technique.
  • Change one factor at a time and document each check.
  • Apply only corrective actions authorized by the SOP or manufacturer.
  • Verify controls and required function checks before any patient repeat or release.
  • If a defect is possible, remove the equipment from service and preserve evidence.
  • Determine when the fault began, trace potentially affected results, and document retesting or notification decisions.
  • Escalate unresolved faults and activate a validated backup or referral route.
  • Update the equipment register, maintenance record, investigation, and corrective-action record.

Frequently Asked Questions

Should I simply rerun a sample that disagrees with the first result?

No. First investigate the discrepancy and check controls. Repeat testing only after an authorized correction and acceptable controls, using the method SOP’s rules for specimen suitability and result authorization.

Does a passing control prove that earlier patient results were valid?

No. A passing control is evidence about the process at that time. If a defect could have been intermittent or started earlier, perform a documented impact assessment covering the fault, time window, tests, lots, and retained specimens.

Who should repair a malfunctioning instrument?

Use the manufacturer or another qualified technical expert when the fault is unresolved or outside authorized user maintenance. Check service documentation and warranty conditions before attempting repair.

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