Laboratory Quality and Compliance
Practical guidance on laboratory quality, compliance, accreditation, and everyday processes that help diagnostic laboratories deliver accurate, reliable, and traceable results.
Making ISO 15189 part of everyday laboratory operations
ISO 15189 works best when its quality requirements are built into everyday laboratory processes, not treated as paperwork for audits. Routine controls such as sample identification, QC, result review, critical communication, and report correction create reliable evidence. Continuous monitoring, traceability, staff competence, and management review help maintain quality and improve laboratory operations.
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Corrected reports audit trails and traceability
Corrected reports preserve the history of changes made to a laboratory report after release. A proper audit trail records what changed, why, when, and who authorised and communicated the correction. Version control and traceability help ensure the updated report is clear, accurate, and safely communicated.
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Sample rejection criteria and their role in patient safety
Specimen quality is essential for producing reliable and accurate laboratory results. Clear rejection criteria help laboratories identify unsuitable samples, manage exceptions, and ensure proper recollection. Tracking rejection trends helps identify recurring problems and improve the overall specimen collection and handling process.
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Critical result communication as a closed loop process
Critical result communication ensures urgent laboratory results reach the correct authorised person accurately and are acknowledged. A closed-loop process includes communication, read-back, documentation, and escalation when contact or acknowledgement fails. Clear procedures and monitoring help laboratories improve patient safety and ensure reliable critical-result reporting.
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Delta checks in laboratory medicine
Delta checks compare a patient’s current and previous results to identify unexpected changes for review. They help detect possible specimen, analytical, identification, or reporting issues without assuming the result is wrong. Proper validation, documentation, and professional review are essential for using delta checks effectively.
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Practical quality indicators for diagnostic laboratories
Quality indicators help laboratories monitor important processes, identify problems, and measure improvement. They cover pre-analytical, analytical, and post-analytical activities with clearly defined measures and responsibilities. Regular trend review helps laboratories investigate issues, take corrective action, and improve overall quality.
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What laboratories should do when QC goes out of control
When QC becomes unacceptable, laboratories must contain, investigate, correct, verify, assess patient impact, and authorise return to routine work. A failed QC does not automatically mean every patient result is wrong—it signals that the analytical system requires documented review and evidence of recovery. A LIMS can support traceability, alerts, corrective-action records, result review, and audit history, while professional judgement remains essential for investigation and patient-result decisions.
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How to read a Levey–Jennings chart and recognise shifts and trends
A Levey–Jennings chart visually monitors QC results against the mean and standard-deviation limits to identify random variation, shifts, and trends. Approved QC rules and professional judgement are used to decide whether a result requires investigation or corrective action.
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QC, calibration and EQAS: how they work together
Calibration establishes the relationship used to produce analytical results, internal quality control (IQC) monitors ongoing stability, and external quality assessment (EQAS) provides independent comparison. Together, they provide complementary evidence of analytical performance and help laboratories identify, investigate, and address potential problems.
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Internal quality control in medical laboratories explained
Internal quality control (IQC) helps medical laboratories monitor the accuracy, consistency, and stability of analytical testing. It uses control materials and defined review processes to detect changes that could affect patient results and supports timely investigation and corrective action.
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