In the pursuit of Quality- A laboratory perspective
By Dr. Sujay Prasad
Anand Diagnostic Laboratory
Many years ago when I joined Anand Diagnostic Laboratory, the term Quality was used to describe the nature of test result and its utility in diagnosis and treatment. The “result” was used to rule out a disease, rule in a disease, monitor a disease or use it to evaluate the efficacy of treatment. While all of the above is true even today, the word Quality is no longer limited to the result. It encompasses all aspects of laboratory services from the time the patient or sample enters the lab to the time reports are delivered to the right recipient. This means that the lab has done the right test, on the right patient at the right time with the right sample, within reasonable time, and he right result was delivered to right recipient and all of this at a reasonable price. While it appears to be a very nice sentence, it does not capture the essence of quality.
At Anand Diagnostic Laboratory, the essence of Quality is “Absence of Errors” – This short yet powerful definition is perhaps a sentinel for Anand Diagnostic Laboratory whenever there is deviation from documented procedure. If absence of errors is quality, then identifying errors becomes paramount and fundamental to its elimination. Following Identification, errors are recorded so that they can be analyzed and root cause identified. Elimination of root cause of error through corrective action and Preventive action (CAPA) ensures that the error does not recur and thereby the patients experience quality. Being humans, we are aware of the emotional aspects of “fear of Error” which if present, prevents laboratory staff from identifying the error in the first place.
Typical laboratory work is roughly divided into three phases – Pre examination phase, which includes all activity that occurs from the time a patient, walks in to the lab or sample enters the lab till the time it reaches the analytical instrument. This is a crucial phase of the lab as majority (70% in literature and our experience as well) of errors occur in this phase. Test selection, patient preparation, sample collection, transportation, storage, temperature, and many more are sources of possible errors. With so many variables, it is natural that errors are more frequent than examination and post examination.
Examination phase includes all activities associated with analysis of the patient sample. This aspect of quality is highly evolved and laboratorians are aware of such errors and ensure they are rectified before they cause harm to patients. This phase includes activities like Quality control, proficiency testing, precision, accuracy, total error, Sigma metrics. and so on. Anand Diagnostic Laboratory has started the journey of using Sigma metric to monitor its analytical quality. While the concept is very well known in the manufacturing industry, its role in medical laboratory has only begun in recent years. We have successfully applied the concept of Six Sigma to our analytical methods in clinical chemistry. A sigma value of more than 6 is considered world class. Most of our assays and test methods have a sigma of more than 6. Our effort is to ensure the remaining test methods reach 4 if not 6.
Post analytical phase includes all activities that happen after the test results are obtained and till the right recipient receives the report. This phase is second in the frequency with which errors happen. However, with use of IT and Laboratory information systems, this phase is also seeing a marked reduction in errors.
At ADL, we believe “The users of our services are the very reason of our existence” and wecontinuously strive for error free experience of our patients. Our quality motto drives every aspect of our operations “Total quality management is the window through which we communicate and satisfy or users”. This world health day we want to reassure that this journey will continue and we are committed to quality not as a reflection of a parameter to gauge ADL’s services but our commitment to ensuring care in healthcare.
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