The Diagnostic Semen Analysis Report
Where samples are being assessed for users outside of the laboratory, the laboratory will need to issue a report. There is a move towards electronic reporting of results directly to the referrer or via a third-party software system, however there will remain a requirement to be able to produce hardcopy reports. Regardless of how the report is issued, it must be accurate and meet the needs of the clinical user. Users with a high level of expert knowledge may require little interpretation of the report, those with a potentially lower level (e.g. GP or oncologist) may require a greater level of interpretation.
The report should clearly identify the patient and patient location, and three unique identifiers are considered to be the minimum requirement for identification. Where a report is on multiple pages, these identifiers should be on all pages of the report. We are aware that historically some semen samples were tested under the female partners name, as this made it easier for the referring clinician to match the report to the couple. This should not be permitted by the laboratory. Even where the female partners details are included in the report, the laboratory should ensure that they have given their consent for this inclusion – failure to do so may result in a GDPR breach.
Where needed, the lab should document any patient reported history, but patient histories or any other additional data should not be taken unless they are issued on the report.
The issued report should contain the time and date of sample collection, it is also useful to record the time and date of analysis as this may be relevant to the interpretation of the report. If a sample is not analysed, the reason for this should be stated on the report. The report format should be concise and easy to read. Where appropriate, the units of measurement should be reported in SI units. Biological reference intervals or clinical decision values should be available, and the origin of these should be clearly stated. Where they do not originate from peer reviewed data, the lab should provide validation data for the ranges given. Where needed, the lab should document any patient reported history, but patient histories or any other additional data should not be taken unless they are issued on the report. Comments may be added to aid the interpretation of the report, but care should be taken not to include a diagnosis, as the lab may not have the full clinical history of the couple.
When releasing the report, the lab should have processes in place to ensure that where the quality of the sample may be compromised and could affect the report, this is documented. There should also be a process in place that ensure that the result have been correctly transcribed. For electronic reporting, especially where multiple software providers have been used, this should be an end to end check to ensure that the report remains unchanged throughout the reporting process. The individual responsible for the final checking and release of the report should have the appropriate level of knowledge for this task. This is especially important where comments are being added to the final report.
An example of a semen analysis report can be found here – Model SA report (Birmingham).