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Clinical laboratories are healthcare facilities providing a wide range of laboratory procedures which aid the physicians in carrying out the diagnosis, treatment, and management of patients. These laboratories are manned by medical technologists (clinical laboratory scientists) who are trained to perform various tests to samples of biological specimens collected from its patients. Most of the clinical laboratories are situated within or near hospital facilities to provide access to both physicians and their patients.Classifications of clinical laboratories indicated below reveal that these facilities can provide quality laboratory tests that are significant for addressing medical and public health needs. The list below should not be used as a fixed guide for classifying clinical laboratories because of new areas continually arising in the field of laboratory medicine.
Laboratory networks were developed across countries and states to foster proper coordination and collaboration among clinical laboratories within the specified geographic areas.[3] Quality management systems within these laboratories have also become significant issues recently, including the standardization of laboratory services, strengthening of laboratory systems[4] and the development of new and rapid diagnostic tools. These issues are continually addressed by local and international health authorities and technical experts using the framework of a patient-centered approach.
Providing high-quality, diagnostic testing is the goal of all clinical laboratories. To attain this goal, several issues and problems are needed to be addressed which ultimately underline the need for improving laboratory capacity. Addressing human and financial resources, training and supervision, planning and budgeting, quality assurance, logistics and supply, biosafety and equipment management and other relevant laboratory aspects were found to be necessary to optimize laboratory services provided to patients.
Accreditation for clinical laboratories became common recently with the emergence of international laboratory standards. Several guidelines for laboratories have been developed to regulate laboratory test procedures and maintain its quality.[9] An example of laboratory accreditation is the ISO 15189 provided by the International Organization for Standardization (ISO) which focuses on meeting the requirements for quality and competence of medical laboratories.[10] Another example is biosafety guidelines around microbiological agents such as bacteria, viruses, parasites, and other agents and microbiological products.[11]
The need for risk management in clinical laboratories was highlighted to maintain the accuracy and reliability of laboratory tests. The Clinical Laboratory Standards Institute (CLSI) developed a guideline to introduce the principles of risk management specifically in the clinical laboratory.[12] From risk assessment to risk analysis, evaluation and control down to the process of continuous quality improvement, the clinical laboratory should and must be able to minimize errors along its path of the workflow (i.e., pre-analytic, analytic and post-analytic phases). Such significant risks identified, for instance, in specimen collection and handling and the disposal of laboratory wastes must be taken into consideration by all clinical laboratories. 2b1af7f3a8