Timely and accurate diagnosis is the cornerstone to good clinical practice and an essential first step to achieving optimal patient outcomes. The occurrence of laboratory errors can severely impair the clinical decision-making process. It is estimated that 2/3rd of patient diagnosis and treatment is dependent on lab results. A recent study concluded that most of us will experience at least one diagnostic error in our lifetime. In order to reduce errors and improve quality of care, laboratory professionals must be made aware of the impact laboratory results have on the patient and on the other hand clinicians must have a thorough understanding of laboratory processes. The practice of patient safety needs to be adopted in laboratory medicine to avoid any harm to patients and to improve the total testing process. Patients can be harmed not only by the issuance of erroneous results but also due to delayed result generation or delayed critical results communication, etc.
India has now recognised the importance of patient safety and is in the process of adopting a patient safety culture and numerous initiatives are being taken to address this issue. In 2015 during the 68th WHO Regional Committee for South-East Asia all Member of the Region, including India, endorsed the Regional Strategy for Patient Safety in the WHO South-East Asia Region aiming to support the development of national quality of care and patient safety strategies.
Laboratory errors can be avoided by adopting quality assurance practices, newer technologies and through continuous education of lab personnel. Medical laboratories must implement effective quality improvement plans to identify and prevent errors in order to guarantee the reliability of laboratory results. Accreditation in compliance with the International Standard ISO 15189 represents the crucial first step. Unfortunately, only ~2 per cent of laboratories in India are accredited. There is no enforcement by the government for laboratories to undergo accreditation. We need to make people aware of quality stamping and which kind of a lab they should be going to get themselves tested.
Another important step in preventing errors and ensuring patient safety is the development of specific educational and training programs addressed to all personnel involved. A wide variety of information can be provided by a robust quality management system (QMS) including the identification of Quality Indicators (QI) that will help identify undesirable events, evaluate the risk to the patient, and call for corrective and preventive actions as and when required.
Risk management constitutes an essential component of the QMS of medical laboratories. Laboratories need to develop a practical tool for risk management that contains five major steps: risk identification, quantification, prioritisation, mitigation, and surveillance. Potential risks identification must include all aspects of testing including preanalytical, analytical and postanalytical phases. Despite the automation of processes, some risks are persistent, and those, if not controlled adequately, could result in a wrong diagnosis, wrong treatment, and ultimately morbidity and mortality. Therefore, identification and mitigation of potential risks associated with laboratory processes should be given prime importance. However, the effectiveness of the QMS depends on the careful analysis of data collected, staff awareness of the importance of laboratory medicine to the healthcare process and continuous monitoring of the quality improvement plan.
In order to safeguard patients’ interest, laboratory professionals must assist clinicians in selecting the right test for the right patient and provide the right report at the right time to facilitate diagnosis and treatment.
The author is Senior Consultant & Head-Hematology and Biochemistry, PathKind Reference Laboratory. Views expressed are personal.
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