Quality laboratory testing applies to all specialty areas of the medical laboratory. The overarching
quality management system creates the framework. All phases of testing are included within this framework.
- In the laboratory, this applies not only to specimen testing but to all phases of the laboratory process. This includes specimen collection, storage, transportation (pre-examination), testing/examination (examination), and the evaluation of results and subsequent reporting to appropriate individuals (post-examination).
Although sometimes confusing and used interchangeably in conversation, the following two terms have very different meanings within the quality management system:
- Quality Assurance: Refers to a set of all actions and activities taken to ensure that the organization delivers products that meet performance requirements while adhering to standards and procedures.
- Quality Control: Refers to the set of activities or procedures designed to monitor the specific test measurement procedure and results to ensure all quality requirements are being met (eg, proper test system performance, uniformity, and minimization of errors).
In greater detail:
Quality control (QC) is a system used to maintain a determined level of accuracy and precision.
- Proper quality control helps ensure that reported results of patient laboratory testing are correct.
- Quality control includes testing control samples, charting the results, and performing statistical analysis.
- Quality control test performance lies within the manufacturer's defined specifications. (Otherwise, corrective action must be taken.)
- Quality control statistics may be calculated manually or by using special software - either contained on the laboratory's computer or onboard the laboratory analyzer itself.
- Not only must quality control statistics be obtained, they must be reviewed.
In this course, the focus will be on basic quality control ideas as they pertain to the examination (testing) phase. In addition, most ideas presented will refer to quantitative testing.
