Quality is a dynamic state associated with products, services, people, processes, and environments that meets or exceeds expectations and helps produce superior value. Nowhere is the impact of quality on human beings as apparent as in healthcare.
Quality of care and patient safety go hand in hand. Patient safety is an important aspect of an effective, efficient health care system where quality prevails, and practices designed to improve patient safety usually lead to an improvement in quality of care.
Quality of care depends on human and financial resources, professional standards, institutional standards and technology standards. WHO defines quality of care as, “a process that must guarantee each patient the combination of diagnostic and therapeutic acts that will ensure the best results in terms of health, based on current medical science, at the lowest cost for the same result, with the lowest iatrogenic risk and for his greatest satisfaction in terms of procedures, results and human contact in the health care system”.
According to WHO’s International Classification for Patient Safety, patient safety is “the reduction of risk of unnecessary harm associated with healthcare to an acceptable minimum.”
According to reports most patients will experience at least one diagnostic error in their lifetime. These errors can occur in all settings of care and contribute to about 10 percent of patient mortality. Laboratory medicine impacts several aspects of patient care including screening, diagnosis, prognosis, appropriate treatment and monitoring. Thus, the information provided by the laboratory has a direct impact on patient safety. An error in any of laboratory strategic, operational and support processes, could affect patients. Laboratory errors can result in delay, incorrect diagnosis, additional and unnecessary diagnostic testing, unnecessary treatment, treatment complications and inadequate treatment and not to undermine the huge financial and emotional bearing it has on patients and their families.
Laboratory processes involve a complex process of various inter dependent, intricately inter woven sub processes and procedures which need to be performed properly to assure accuracy and reliability of testing. This complex process can be broadly divided into Pre-Analytic, Analytical and Post Analytical processes. Errors can happen and should be detected at each sub processes for assurance of quality. With advanced instrumentation and superior quality reagents, the analytical errors in the laboratory have been controlled to an extent and it is the pre and the post analytical phase which contribute to maximum errors in the laboratory. So the greatest impact on quality is achieved by focusing by pre-and post-analytic phases.
An important step in maintaining quality and achieving error rate reduction in laboratory results is the implementation of a reliable quality system covering all phases of the laboratory processes. One of the guiding document for laboratory quality model is ISO 15189 – 2012 which organizes all activities related to maintaining laboratory quality into 25 clauses of which 15 are management requirements and 10 are technical requirements covering all aspects of laboratory functioning. A set of valuable tools which can quantify the quality of all operational processes by comparing it against a defined criterion are Quality indicators (QIs). QIs are used to monitor and evaluate performance throughout the critical aspects of pre-, intra-, and post-analytical processes. QIs data are evaluated, monitored for trends, outliers and deviations are subjected to adequate root cause
analysis, corrective actions and preventive actions. These actions should be incorporated in the continual improvement plan of the laboratory.To ensure that the established standards of quality and care service are met, in addition to continuous and rigorous internal reviews, laboratories should undergo routine assessments and evaluations by external organizations, for eg, CAP, NABL.
At the heart of quality management is dissatisfaction with the status quo. Continual improvement in the laboratory is not only about responding to problems but is also about continually and proactively seeking to learn about customers, processes and behaviours; and to improve upon existing practices, or to innovate in developing processes and practices.
It is important to remember that Quality of Care and Safety do not exist in isolation in any one domain of the health care system. Instead, they emerge from multiple and intricate interdependencies among broad-based forces within and outside the healthcare domains, including the physical work environment, clinical processes followed, the deployment of technology and devices, and prevailing social norms and modes of thought.