Baseline review meeting

Before the intervention proper begins it is necessary to establish the baseline, that is to define the existing level of safe behaviours, against which improvements can be measured. To do this, observations are taken and the safety performance measure is calculated for a period of some four weeks before any feedback is given by the observer. This baseline safety performance measure is the average safe behaviour for the complete four-week period. At this point, when the baseline measure has been established, we would normally hold a review meeting with the observers. This has a number of purposes ... 

Consequently, for a system that is in operational use and does not meet the criteria for retrospective validation, the approach should be to establish documented evidence that the system does what it purports to do. To do this, an initial assessment is required to determine the extent of documented records that exist. Existing documents should be collected, formally reviewed, and kept in a system history file for reference and to establish the baseline for the validation exercise. From the document gap analysis the level of redocumenting and retesting that is necessary can be identified and planned. 

---