RISK MANAGEMENT
Aspect Purpose
Limitations of isolated review
Integrated approach
Benefits Summary
Combine multiple external analytical signals (lot verification, delta checks, critical result frequency, reference range monitoring) for comprehensive risk oversight.
Separate, uncoordinated reviews may miss cross-indicator patterns and delay detection of systemic issues.
Collate signals in a single process using dashboards, middleware, or structured trackers; risk-stratify findings based on potential patient harm.
Enables earlier detection of analytical bias, stronger root cause evidence, prioritised CAPA, and better resource allocation.
Implementation Assign responsibility, set review schedule, document in QMS, and review in joint laboratory–clinical governance meetings.
Table 4. The benefits of an integrated review of metrics in the laboratory.
isolation, these indicators can identify specific issues, but they may miss patterns or correlations that only become apparent when data are considered together. ISO 15189:2022 requires laboratories to conduct periodic reviews of examinations, and ISO 22367:2020 emphasises the integration of monitoring activities into a comprehensive risk management process.
In many laboratories, these indicators
are still reviewed separately by different staff members or at different times. For example, EQA results may be reviewed by one group, lot verification data by another, and quality indicators such as
critical result reporting compliance by yet another. While this approach can meet minimum compliance requirements, it does not maximise the potential for early risk detection. A more effective approach is to integrate these signals into a single review process, allowing the laboratory to identify links between indicators and prioritise corrective actions according to the overall risk to patient care (Table 4). Advances in laboratory information systems, middleware, and reporting tools – ranging from dedicated quality dashboards to well-structured Excel- based trackers – have made it easier to collate and review multiple indicators
in one place. When these data are risk-stratified, for example by using the severity of potential patient harm as a weighting factor, it becomes possible to focus attention and resources on the most clinically significant issues. This aligns directly with the ISO 22367 principle that risk control activities should be proportionate to the level of risk. Integrating external signals also facilitates a more coordinated approach to corrective and preventive action (CAPA). For example, if a reagent lot change coincides with an increase in critical results and a small shift in patient reference range distributions, these findings together may provide stronger evidence of analytical bias than any one indicator in isolation. By capturing these links, laboratories can act sooner and with more confidence in the root cause analysis. To implement this integrated
approach, laboratories should assign clear responsibility for collating and reviewing all external analytical signals, define a review schedule (often aligned with periodic examination reviews), and ensure that findings are documented in the quality management system. Regular review of these combined indicators in quality or governance meetings ensures that trends are visible to both laboratory
WWW.PATHOLOGYINPRACTICE.COM SEPTEMBER 2025
33
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84
