Result Reporting & Authorisation
Important
This section should be included in SOPs where results are reported to internal or external stakeholders.
The ‘Result Reporting & Authorisation’ section of an SOP should detail the process for authorising and the subsequent release of results generated during the procedure.
This section may include:
Reporting procedure: Outline the steps for preparing, verifying, and releasing results, including required documentation, approval processes, and communication channels.
Responsibilities: Define who is responsible for each step of the reporting procedure.
Reporting format: Define the standard format for reporting.
- Authorisation: Define how reports are authorised prior to release, specify:
when authorisation is required (e.g. all results or only when a specific result is generated such as the identification of a resistance or pathogenetic mutation);
how authorisation is documented;
what conditions must be met before authorisation can be granted.
Recipients: Define who the intended recipients of the report are e.g. the requesting clinician, outbreak analyst etc.
Laboratory clinical interpretation: Describe how results are interpreted in a clinical or analytical context, including guidance on providing explanatory notes, limitations, or recommendations provided alongside the result(s).
Alert/critical Values: Specify how critical or alert values are identified, documented, and communicated promptly to responsible clinicians or stakeholders. Include escalation pathways and timeframes.
Potential sources of variation: Highlight factors that may influence reported results (e.g. sample quality, instrument calibration, software version, operator variability) and how these are communicated within the report.
Example content:
🧬 Bioinformatics QC Procedure
Example content from a bioinformatics SOP outlining the procedure for assessing the quality of Illumina sequencing data prior to downstream bioinformatics analyses.
Result Reporting & Authorisation
1. Result Reporting
Reports generated by the bioinformatics QC pipeline (e.g., MultiQC and Centrifuge) are produced in HTML format and can be viewed using a standard web browser. Key sample statistics are extracted from these reports and entered into the laboratory’s sample tracking system. Each sample is categorised as either QC PASS or QC FAIL based on defined QC criteria.
2. Authorisation
Results generated by the pipeline are intended for internal use only. As such, formal authorisation of results is not required.
👩🔬 Staff Training Procedure
This section is not relevant for this example.
🌌 Galaxy Training Procedure
This section is not relevant for this example.
🧪 Laboratory Procedure
This section is not relevant for this example.
💻 Code Update & Review Procedure
This section is not relevant for a code update and review procedure as this procedure does not generate results that require reporting.