Quality is vital to all laboratory operations. Components of laboratory quality include accuracy, reliability, and timeliness of reported test results. While accuracy is the primary component that comes to mind, it is equally important for every individual test result to be reliable. Reporting all results in a timely manner is a vital component of providing quality test results. A Quality Management System (QMS) does not guarantee that laboratory operations will be error-free, but rather helps to detect errors as well as implement changes to correct errors and any resulting consequences.
Clinical Laboratory and Standards Institute (CLSI) has organized twelve (12) quality essentials into a framework that will follow a path to obtaining quality operations in the laboratory. 13
Each laboratory must have a system for managing and overseeing the total quality operation within the laboratory. The QMS must encompass all aspects of laboratory operations. This should include:
- The organizational structure as well as all testing processes and procedures.
- The quality system must be inclusive of the three phases of testing: pre-analytical, analytical, and post-analytical.
- Processes and procedures must be carried out correctly and in appropriate order to provide the accuracy and reliability necessary to produce quality in all aspects of laboratory operations.
- Errors or omissions of the quality essentials at any phase of testing may produce a laboratory result that is inaccurate or unreliable.
