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FEATURE Quality standards


including medical laboratories. However, there are fundamental differences between medical laboratories and traditional testing-and calibration laboratories. By definition, medical laboratories are not calibration laboratories and while medical laboratories can be considered a type of testing laboratory, many aspects of ISO 17025 such as the requirements for test reports and the types of services provided to clients, are inappropriate. When originally proposed in


1995, ISO 15189 was intended to internationally harmonize quality management procedures or regulations


“The examination phase is characterized by a high degree of organization and many well-established procedures”


for medical laboratories. Only a few countries had medical laboratory management and the need for a harmonized approach to medical laboratory care was increasingly evident. As patients and their samples moved across borders, the need for harmonization and consistency became more apparent. Medical laboratories exhibit special characteristics related to medical emergencies requiring urgent examinations and reporting, collection of samples from patients, acceptable turnaround times, education and training of healthcare staff, and contribution to medical audits. Thus, there were sound reasons for the development of a new international standard to address the specific quality management and technical issues of medical laboratories. In developing ISO 15189, ISO/TC


212 working group used existing quality management documents and standards for the medical laboratory field, as well as ISO 9000:1994 and ISO 9001: 2000. ISO 15189 also draws upon ISO/ IEC 17025:1999 general requirements for the competence of testing and calibration laboratories that serve as a good model for a laboratory quality management system.


MedLab Issue 2 2011 35


MEDICAL LABORATORIES: FUNCTIONS AND ISSUES Medical laboratories rely on experience and expertise to provide vital medical services. Medical laboratories and the scientists that operate them, determine which test can and should be made available, provide advice and assistance on the selection of tests, establish the optimal mode for collecting and transporting samples, and determine the most effective and efficient methods for examining specific parameters. Having generated the information, medical laboratories are responsible for the generation of accurate meaningful, interpretive reports. The service that lab technicians provide completes as full testing process that begins and ends with the patient. Often the laboratory scientists are valuable expert consultants who provide an interpretation of results


in the context of the individual patient. Medical laboratories often serve


diversity of clients. In most medical situations, the clinician who has ordered or requested the test is seen as the primary client of the laboratory, but the patient from whom the specimen is derived is also a client. The medical laboratory often provides information to public health officials, insurers, and medical-legal services, which are also clients. These auxiliary services are becoming more obvious in the growing Middle East markets and the demand will increase rapidly in the next few years. Quality issues for medical laboratories include examinations of quality control, proficiency testing (also referred to as external quality assessment), and such quality indicators as turnaround time and report retention time. While many laboratories are 


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