Quality assurance in a large reference laboratory.

Abstract

The success of a quality assurance system is contingent on close adherence to each protocol, from preparation of the patient to issuance of the final result. In the event that the system experiences failures at any point, the quality of laboratory data may be jeopardized. Again, the system requires support not just from management and personnel employed at the technical level, but from the entire organization. It requires a complete commitment to quality and to the provision of a high level of service. Such quality assurance programs have been highly successful in the manufacturing industry. For an example, one need look no further than the domination of certain world markets by Japanese industries. Their commitment to quality and their system-wide quality control efforts have been essential to the success and growth of their organizations. Currently, systems that provide high levels of quality assurance are under scrutiny in an effort to reduce costs. As more effort is placed into monitoring an organization's quality, the expenditure of non-revenue producing dollars increases. A large organization should question these expenditures. However, when evaluating such a program, it should be realized that the costs associated with the pursuit of quality are often offset by savings realized through improved processes. Further, quality is a salable commodity. Its lack may be costly. According to Westgard et al., costs of quality can be grouped into prevention costs, appraisal costs, and failure costs. Prevention costs include those costs incurred through the development of sound analytic procedures and adequate training of technical personnel. Appraisal costs comprise those costs incurred as a result of challenging the analytic procedure as well as the entire system. Failure costs represent the dollars spent when out-of-control assays have to be repeated. An important step in evaluating potential savings produced by a quality control program is assigning a dollar value to the cost of repeating an assay. In general, as the quality of an organization's product increases, the expense of providing the product decreases. Likewise, as productivity increases, the cost of testing decreases. Increased quality and productivity provide a higher percentage of profit. As the profitability of an organization increases, the additional resources required to investigate new methods, themselves a valuable contribution to quality assurance, are provided.(ABSTRACT TRUNCATED AT 400 WORDS)