IVDT_In Vitro Diagnostics Technology

IVD Technology, Spring 2013

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CLINICAL DIAGNOSTICS specimens should be analyzed on receipt of new lots of reagents to verify their performance after shipment in uncontrolled conditions. Clear communication of potential causes of erroneous results and delineation of laboratory and manufacturer roles for how to detect failures and prevent reporting erroneous results is necessary when developing a quality control plan. Expected Outcomes from Implementing EP23 CLSI EP23: "Laboratory Quality Control Based on Risk Management" describes good laboratory practice for developing a quality control plan based on the manufacturer's risk information, applicable regulatory and accreditation requirements, and the individual healthcare and laboratory setting. Information about the measuring system provided by the manufacturer as well as information about the healthcare and test site setting, local regulatory and accreditation requirements and medical use of the test results are processed through a risk assessment to develop a quality control plan. Once implemented, the quality control plan is monitored for efectiveness and updated as new failure modes are identifed or complaints from physicians help to identify hazards that cause greater harm than estimated during the original risk assessment. CLSI EP23 provides a template for laboratories to map their processes, to identify potential hazards, to address each hazard with a control process, to summarize all of the control processes in a quality control plan, and to implement, monitor, and modify their quality control plans as required to maintain risk to a clinically acceptable level. CLSI EP23 provides a number of potential benefts to both laboratories and manufacturers of diagnostic devices. Laboratories will become aware of their own contributions to failures throughout the entire preanalytic, analytic and postanalytic process. Laboratories also will be 32 IVD TEC HNOLO G Y | SP RIN G 2013 magenta cyan yellow black alerted to conditions that could lead to patient/staf harm. CLSI EP23 will encourage an improved manufacturer/laboratory partnership in quality. Laboratories will need more information about device performance and residual risks from the manufacturer and the manufacturer will get better feedback on failure modes and problems resulting from use of their devices. Most importantly, CLSI EP23 will allow laboratories to design a quality control plan that is right for the test based on analytical performance and reliability, the number of patient samples tested and reported between liquid quality control events, and medical application of the test. Some tests may require more frequent analysis of control samples, while other tests may sufce with less frequent control analysis. But, in contrast to the current expectation that two levels of liquid control analysis each day of patient testing will ensure quality laboratory results, a quality control plan based on risk management will be scientifcally founded on objective evidence that supports the quality control plan. Each control measure will be linked to a specifc hazard or hazard cause to maintain the residual risk to a clinically acceptable level and achieve the expected quality of results. CLSI EP23 is only an introduction to risk management principles for clinical laboratories and is not intended to provide a comprehensive description of the details of risk management. Te EP23 guideline contains sections dedicated to an overview of risk management for laboratories, various control processes, constructing a process map, conducting a risk assessment, developing a quality control plan, and implementing and updating quality control plans after implementation. IVD manufacturers can assist laboratories in developing quality control plans through their knowledge of risk and means of managing risk that have been engineered into their devices. Summary Risk management is something that laboratories are already doing to some degree. CLSI EP23 introduces risk management principles to clinical laboratories and formalizes the risk management process. A quality control plan will help ensure test result quality. Each laboratory's quality control plan will be unique based on the device, the laboratory setting, and the risk to patients from inappropriate decisions based on incorrect or delayed test results. CLSI EP23 provides a template for laboratories to map their testing processes, identify weaknesses or hazards in the process map, defne a control process that can detect failures and/or prevent reporting erroneous results, summarize the control processes in a quality control plan, implement and benchmark the efectiveness of their quality control plan, and modify a quality control plan as part of continual improvement. CLSI will be providing educational webinars and guidance in the coming months to help laboratories apply the risk management principles described in EP23. References 1. "Laboratory Quality Control Based on Risk Management: EP23-A" (Wayne, PA: Clinical and Laboratory Standards Institute, 2011). 2. "Medical devices – Application of risk management to medical devices ISO 14971: 2007" (Geneva: International Organization for Standardization, 2007). 3. "Safety aspects – Guidelines for the inclusion in standards ISO/IEC Guide 51: 1999" (Geneva: International Organization for Standardization, 1999) 4. "Clinical laboratory medicine – In vitro diagnostic medical devices – Validation of user quality control procedures by the manufacturer ISO 15198: 2004" (Geneva: International Organization for Standardization, 2004). IVD James H. Nichols, PhD, DABCC, FACB, is director, Clinical Chemistry, Vanderbilt University School of Medicine, Department of Pathology, Microbiology and Immunology, Division of Laboratory Medicine, Nashville, TN. He can be reached at james.h.nichols@vanderbilt.edu. i v d t e c hnol ogy. com ES237409_IV1305_032.pgs 04.25.2013 04:17 UBM

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