Original Research Article
Year: 2021 | Month: February | Volume: 11 | Issue: 2 | Pages: 171-176
Characterization of Pre-Analytical Errors Using Six Sigma Metrics and Process Capability Index in a Clinical Biochemistry Laboratory
Tapasyapreeti Mukhopadhyay1, Sudhanshu Shekhar2, Vikas Karamchand Dagar3, Asok Kumar Mukhopadhyay4
1,2,4Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi
2,3Department of Pathology, Armed Forces Medical College, Pune, India
4Department of Pathology, North DMC Medical College & Hindu Rao Hospital, Delhi, India
Corresponding Author: Sudhanshu Shekhar
ABSTRACT
Objective: Pre-analytical errors have been the commonest source of error in the total testing process. Errors of this nature prove to be a burden for the laboratory, misleading for clinicians, disturbing for management of patient, and a serious issue for the hospital administration as sample rejection leads to loss of critical time and adds to the cost of patient care. The aim of the study is to determine the incidence and types of pre-analytical errors leading to sample rejection.
Materials & Method: A prospective observational study was conducted over a period of two months in the Dept. of Laboratory Medicine in a teaching hospital for biochemistry investigations with an aim to determine the incidence and types of pre-analytical errors leading to sample rejection using six sigma metrics and to generate preventive and corrective actions to achieve higher quality laboratory reports. Sigma value for each error was identified and the defects per million (DPM) yield of the process were calculated.
Results: Of the total 19,002 samples received, 401 (2.11%) were rejected due to pre-analytical problems. Level of sample rejection was unsatisfactory with a sigma metric of 3.6. A larger proportion of errors (73.3%) occurred at the time of sample collection as opposed to errors related to patient identification factors (26.6%).The commonest pre-analytical error was detected to be hemolysis (64.0%).
Conclusion: Pre-analytical errors, although preventable, still remains a major cause of poor quality test results and wastage of resources. By standardization and monitoring the steps involved in obtaining a sample, the pre-analytical errors will greatly reduce. Competent administrative bodies teaming up with laboratory physicians can bring a positive change in patient care. Awareness amongst health care providers cannot be overemphasized.
Key words: Pre-analytical error, Process Capability Index, Six Sigma Metrics.