There are a range of activities within QMS that relate directly to the processes that ensure reliable laboratory results and prevention of errors. Process control consists of the technical activities required to produce a test result and includes the preanalytical handling of samples for testing, the steps for testing, and the ascertainment of a valid run. The use of control materials is a fundamental component for conducting the analytical phase of testing, and both internal (kit) controls and external reagents that serve as positive or negative controls are utilised for validation and to monitor test performance. Quality control (QC) refers to those measures that must be included in each assay to verify that the test is working properly.
Laboratory quality assurance (QA) is the overall programme that encompasses specimen collection, testing processes (including quality control), and the accurate interpretation of results and timely reporting. QA is a systematic approach to define the best practices for all processes associated with the functioning of the laboratory that can affect the reported results. The goal of QA is to prevent errors and assure that procedures are performed consistently. QA establishes procedures to review performance and procedures and directs both proactive and corrective proactive measures to improve laboratory quality. Documentation of QA activities not only leads to improved accuracy but are important to demonstrate the quality of the results generated by the laboratory.
Periodic review of procedures and processes drive continual improvement. By following procedures that have been established to minimize errors and generate the appropriate documentation for subsequent review and critical evaluation of laboratory processes, the laboratory can achieve the highest possible accuracy.
It is becoming more common for risk management principles to be applied to clinical laboratory environments [3,4]. The testing process is mapped as individual steps and any possible weaknesses or hazards are identified and processes are formulated to avoid errors or inconsistencies at each step. This analysis of the process, from pre-analytical to post-analytical phase, is the most important feature and is customized for the particular laboratory test. The potential source of error or hazard at each step is identified and a plan is formulated to mitigate the risks of error.