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seen in the context of a business model, the formal structure of quality management has not been widely adopted by medical professionals, but has traditionally been abased more on technical competency than on process.

THE LABORATORY CYCLE The medical laboratory consists of a working area occupied by scientists, technologists, and pathologists who work with specimens, chemicals, reagents, and equipment. In fact, the laboratory and the responsibilities of lab technicians extend throughout the whole of the practice and jurisdiction of healthcare. The medical laboratory process begins and ends with the patient. This more extensive view of the laboratory process is referred to as the ‘laboratory cycle’. The laboratory cycle is traditionally

divided into the pre-analytic, analytic, and post-analytic phases. In ISO 15189, the term ‘examination’ is used in place of ‘analytic’. ISO 15189 recognizes the importance of each phase of the laboratory cycle and stresses that the quality system addresses each one. The pre-examinations phase begins

with the clinical decision to perform a laboratory investigation and includes all aspects of arranging for the test to be done. All aspects of the pre-examination phase can have a profound impact on the quality of the sample that is ultimately submitted for examination. Errors at any step can result in an altered sample and an inaccurate or inappropriate result: ‘garbage in, garbage out’. The examination phase is

characterized by a high degree of organization and many well- established procedures. Studies have

“ISO 15189 is a standard with multiple applications”

demonstrated that existing practices of laboratory quality control and the quality monitoring of reagents, materials, and equipment have made the examination phase the component of the laboratory cycle with the least number of significant errors. The post-examination phase begins

with the process that determines a test result and develops laboratory information from the examination. The creation of an ambiguous or confusing report, or one that fails to convey the significance of an observation, can undo all the time, work, and energy involved in all the preceding phases of the cycle.

APPLICATION WITH AND WITHOUT ACCREDITATION ISO 15189 is a standard with multiple applications. Its primary application, however, is to improve the structure and function of medical laboratories. Laboratory accrediting bodies also find it valuable for use in accreditation. The Collage of American Pathologists recognized ISO 15189 standards to optimize performance in a changing environment, hence initiated CAP 15189 as a key factor in driving efficiencies and performance as laboratories are challenged to do more with less, provide the highest quality of patient care and remain competitive. CAP 15189 promotes sustainable quality by looking beyond individual procedures and discovering ways to continuously improve the structure and function of your laboratory operations. As a management philosophy, CAP 15189 raises the bar on quality as it drives decisions throughout your entire institution. Official recognition in the form of

accreditations can be an important step for a laboratory because it demonstrates in a clear, objective and independent fashion the competence of the laboratory and its personnel. For example, in UAE medical laboratories are requested by law to establish quality management systems that address their specific issues and become accredited in order to be licensed or maintain the license. 


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