IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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CLINICAL DIAGNOSTICS A Risk-Management Roadmap for Clinical Laboratories Any IVD device can and will fail under certain circumstances. CLSI EP 23 provides labs with a set of tools to manage and mitigate risk. Manufacturers also stand to beneft from knowledge of the guidelines. BY JAMES H. NICHOLS Risk Management Risk management should not be a new concept to laboratories. Laboratories evaluate the performance of new devices under the expected operating 30 IVD TEC HNOL O G Y | SP RIN G 2013 magenta cyan yellow black ALEXRATHS/ISTOCKPHOTO.COM C linicians often place a great deal of blind faith in the results of IVD medical devices. Staf assumes if a device gives a result, then that result must be correct. Glucose meters, pregnancy tests, blood gas analyzers and coagulation devices are all considered equivalent to central laboratory instrumentation, only faster. Yet, central laboratory testing is conducted under well monitored and controlled conditions, while these point-of-care testing (POCT) devices are subjected to a variety of environments and staf that may inadvertently lead to incorrect results. Tis article will address how laboratories can develop a quality control plan for POCT and laboratory-based devices to reduce the risk of incorrect results and consequent harm based on Clinical and Laboratory Standards Institute (CLSI) guideline EP23: "Laboratory Quality Control Based on Risk Management."1 While risk management is an integral part of the IVD industry, it is not as formal in the clinical laboratory. Te EP23 guideline was developed to introduce risk management principles to clinical laboratories and is directed toward laboratory staf. conditions before using them for patient care. When errors occur, good laboratory practice requires laboratories to troubleshoot and correct the problem. Action is taken to prevent errors from reoccurring. Staf responds to physician complaints and harm is estimated if incorrect results are released. All of these activities are elements of risk management. So, risk management is a systematic process that includes much of what clinical laboratories are already doing each day of operation. Risk management is defned as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971).2 Risk is the potential for suffering or encountering harm or loss and can be estimated through a combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51)3. So, risk is essentially the potential for harm arising out of an error. Errors that occur at higher frequency or present greater harm to the patient create bigger risk. We often think of the patient as the subject of harm from medical errors, but staf performing the test may also be harmed by an error, through exposure to infectious samples, chemicals, electricity, and other hazards in the laboratory. So, risk can arise from any device or process failure or use error that can cause harm to an individual or organization. Risk can never be eliminated entirely. Tere will always be some residual risk. Yet, that risk may be so i v d t e c hnol ogy. com ES237240_IV1305_030.pgs 04.25.2013 02:08 UBM

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