Quality control and quality assurance.

Abstract

The office laboratory's need for quality is no different from that of any other clinical laboratory. If patients are to receive the benefit of physician's office testing, reliable, high-quality laboratory results are essential. To achieve this, the physician's office laboratory must have an adequate quality assurance program. Several fundamental components of such a program have been addressed in this article: procedure manuals, record-keeping, maintenance logs, quality control charts, participation in proficiency testing, and laboratory inspection. If your state's regulations do not yet require these activities in the physician's office laboratory, they soon will! A successful laboratory's quality assurance program will provide the following assurances. (1) Quality practices are established and followed by all personnel involved with the testing in the laboratory. (2) The technologist performing the test will know when systems and instruments are working properly and the patients' results are reliable. (3) High-quality information needed by the physician interpreting or evaluating patient laboratory results will be generated. (4) A set of written records is available demonstrating to the inspector that uniform and acceptable protocols have been established and are practiced in the laboratory. One short article cannot provide all the specifics for a laboratory's quality assurance program. The manufacturers and suppliers of instruments and reagents should be able to provide support in the following areas: calibration, type of controls to be used, development of a control chart, required maintenance procedures, establishment of accuracy and precision, and troubleshooting. If they cannot or will not, your laboratory should, perhaps, consider an alternative vendor to supply instrumentation and/or reagents. Additionally, resources such as the professional organizations, consultants, other clinical laboratories, and the inspectors or certifying agencies should also be considered in developing a comprehensive quality assurance program.