Checklist Phase 3 - Process Management

Has the maximum allowed turnaround time been determined for each examination performed in the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the quality manual of the laboratory?

Activity

Is a table with the maximum allowed turnaround times for each examination included in the SOP on Reporting and Archiving of Results?

Activity

Does the SOP on Reporting and Archiving of Results include the procedure that the requester is immediately informed if the TAT of an examination is exceeded and this can compromise patient care?

Activity

Are staff members aware of the procedure for immediately informing the requester if an examination is exceeding the turnaround time when this can compromise patient care?

Activity

Is the turnaround time monitored on a continuous basis for each examinations?

Activity

Is the result of turnaround time assessment included in the Quarterly Reports?

Activity

Are corrective and preventive actions implemented in an attempt to decrease the percentage of samples exceeding the turnaround time to a minimum?

Activity

When sudden increases are seen in the percentage of samples exceeding turnaround time, is an analysis performed to identify the cause and implement corrective and preventive actions?

Activity

Is the efficacy of corrective and preventive actions to minimize/counteract increase of samples exceeding turnaround time determined in subsequent turnaround time assessments?

Activity

Has the laboratory standardized the procedure of validation of examination methods and equipment in an SOP?

Activity

Has the laboratory validated all the examination methods performed in the laboratory?

Find evidence by asking for the validation reports.

Activity

When the laboratory, through validation, identified the need to change an examination method, was this change made (including adaption of the SOP for that method)?

Activity