As part of maintaining UKAS accreditation to ISO 15189:2022, PureLab UK evaluates measurement uncertainty where relevant to the examinations we perform. Measurement uncertainty reflects the potential variation associated with a result and helps the laboratory understand factors that may influence the reliability and interpretation of laboratory findings.
The level of uncertainty associated with a laboratory result is influenced by a combination of pre-examination, examination and post-examination factors. The sources and significance of uncertainty vary between laboratory disciplines and individual examinations.
PureLab UK evaluates and monitors relevant factors through its quality management system, internal quality control processes and external quality assurance programmes to support the quality and reliability of patient results. Information relating to measurement uncertainty for specific examinations is available on request.
Factors Affecting Measurement Uncertainty
- Specimen collection and sample quality, including the adequacy and suitability of the material received.
- Specimen identification and clinical information supplied with the request.
- Transportation, storage, preservation and fixation of specimens before examination.
- Time between specimen collection and examination, where this may affect sample integrity.
- Quality and performance of reagents, consumables and preparation materials.
- Performance, maintenance and calibration of laboratory equipment and instruments.
- Variation within examination methods and laboratory processes, including specimen preparation, processing, sectioning, staining and analytical procedures.
- Distribution or heterogeneity of cells, tissue components or analytes within a specimen.
- Analytical interferences and examination-specific limitations that may influence the result.
- Technical competence, training and experience of laboratory staff.
- Interpretation and reporting of results, including the application of appropriate reporting criteria, reference information and clinical context.
- Referral of specimens or examinations to other laboratories, where applicable.