Preanalytical variables and its impact on total quality management of clinical biochemistry laboratory- A tertiary referral rural hospital study

Introduction: Advances in science and Technology have led to transformation of laboratory diagnostics from manual, cumbersome testing methods to fully automated science, ensuring accuracy and speed. Quality is the core issue for all laboratories and this requires total quality management in the laboratory process in the preanalytical, analytical and post analytical phases. Objectives: To study and evaluate the types, frequency and magnitude of errors in our tertiary health care clinical Biochemistry Laboratory in the preanalytical testing process and its overall impact on Total Quality Management System of our laboratory. Materials and Methods: A prospective observational study, samples received for analysis between Jan 2015 to Dec 2015 in the clinical biochemistry section was evaluated for various preanalytical errors. We evaluated the frequency and types of preanalytical errors found in our laboratory by monitoring specimes requested for laboratory analyses from both inpatient and outpatient divisions and statistically analyzed. Results and Discussion: Of the total 1,38,275 analytical requests, 6446 (4.66%) samples were rejected due to various errors in preanalytical variables. For the inpatient samples, preanalytical error rate was 4.20% (4107 samples), the preanalytical variable with highest frequency of occurrence was specimen hemolysis/ Lipemic sample (1.00%) 980 samples. For the outpatient sample preanalytical error rate was 5.75% (2339). The variable with highest frequency was requisitions with incomplete patient treating physician information 1.37% (559). Preanalytical errors in laboratories are very common and play a very important role in patient care and treatment. Lipemic/hemolytic samples are known to affect the parameter to be analysed and incomplete patient information leads to error in reporting the patient's results, which means the post analytical error becomes unavoidable and incomplete treating physician information leads to delayed reporting of critical values. Conclusion: Our study observation showed each preanalytical variable to occur at different frequency and plays a very important role in the Total Quality Management system of the diagnostic lab which needs to be addressed on priority.