Internal Lab Evaluation

POLS qualified staff will schedule an internal lab evaluation with the lab before the CAP(this was the only mention of CAP – will that confuse?), COLA or state evaluations to insure all requirements are met. This can take one to two days, based on the size of the laboratory. If there is corrective action needed, this will be discussed with the supervisor on site at the end of the evaluation. A written evaluation will be sent to the lab with-in a month of the on-site visit.

Review of Laboratory and Documentation

Organization Facility
Laboratory Director Responsibilities Personnel
Proficiency Testing - Regulated Analyte PT - Unregulated
PT - Failures PT - General
Lab Information Systems Pre - Analytic
Procedure Manual Storage & Labeling - Reagents, Standards & Controls
Environmental Conditions Maintenance
Verify Performance Specs Establish Performance Specs
Performance Specs General Calibration
Quality Control Individualized Quality Control Plan
Equivalent Quality Control Waived Testing (if any)
Mass Spectrometry Post Analytic
Quality Assessment