As previously discussed, laboratory staff should be apprised of the inspection process and engaged at appropriate times. Within appropriate parameters, a plan and assigned duties can be put into place as the survey window opens or the scheduled visit approaches. This would include the mock survey inclusive of corrective action and follow-up, as well as physical observation and organization of documentation and supply storage.
Other suggested inclusions are:
- Schedule regular discussion sessions with primary administrative players
- Complete the mock survey and initiate corrective action and follow up
- Assign a primary and secondary staff member in each laboratory section or area to work with the surveyor on the day of the survey. The primary individual is usually a part of the management team. The secondary individual would represent either an assistant on inspection day or the individual who would be primary if the assigned primary staff member was not on site that day
- Set up some short sessions to review the inspection process with all staff
- Conduct routine checks as part of Quality Management on documentation review requirements, e.g., look for required signatures, competency assessments, regularly scheduled quality monitors, and completion of proficiency testing events.
The plan may include additional or alternate items as well as the suggestions mentioned above. The plan should be institution-specific and customizable as the preparatory process moves toward the inspection day.
