Article Preview
TopIntroduction
The concept of quality management in healthcare system remains an evergreen discussion. A study by the Institute of Medicine reports the annual preventable death of 44,000- 98,000 in USA alone Coskun et al., (2010). Among healthcare services, clinical laboratory services remain important as around 70% of the patient related decision are based on the clinical laboratory (Coskun et al., 2010). The total testing procedure is divided into preanalytical, analytical and post-analytical phase. Estimated error rate in the three phases is 30-75% for preanalytical, 4-30% for analytical, and 9-55% for post-analytical phase (Shah et al., 2014). Hence stringent quality control in the testing laboratory will improve patient care.
Six Sigma methodology is a manufacturing strategy first pioneered by Motorola Company in the 1980s, with the goal of decreasing the defect rates in production. It has improved the production efficiency of different industries. To achieve the similar high quality and near zero defect rates in the healthcare system, Six Sigma metrics is being used in many clinical laboratories and diagnostic industry. Six Sigma metrics is used in combination with total allowable error (CLIA ’88 proficiency testing criteria), method imprecision and bias. As a process performance improvement methodology, Six Sigma is viewed today as a disciplined, systematic, measurement-based and data-driven approach to reduce process variation.
The goal is to attain the highest possible sigma scale within the acceptable limits of total allowable error. This article reviews the basic principles of Six Sigma methodology & their practical utility in the Testing Laboratory.
What is Six Sigma?
Six Sigma is a management policy that explores to improve the quality of process outputs by analyzing and abolishing the source of defects (errors) and reducing variability in manufacturing and business practices. It is a precise approach to cut down the existing errors or mistakes in terms of defects per million (DPM).
Six Sigma is a business management approach used to improve the quality and efficiency of operational processes. It aims essentially to make the operation more reliable and accurate through the utilization of statistical methods.
Six Sigma was initially developed by Bill Smith of Motorola in 1986 for eradicating defects in manufacturing. This defect is explained to be a process or product which fails to meet customers’ requirements and expectations.
The term Six Sigma is defined as the near perfect defect rate of 3.4 defects per million opportunities. As a process improvement strategy, a variety of systematic methodologies for identifying, assessing and improving processes have been developed as part of the Six Sigma approach. The Six Sigma improvement model, Define, Measure, Analyze, Improve, and Control (DMAIC) specifies the following sequence of steps for understanding and improving a process: 1) defining the project goals and customer (internal and external) requirements; 2) measuring the process to determine current performance; 3) analyzing and determining the root cause(s) of relevant defects; 4) improving the process by eliminating defect root causes, and 5) controlling future process performance.
In application to Laboratories, Six Sigma provides the manner to make fewer mistakes in all processes (from filling in an order form, to the most complex analytical process and report delivery) by removing errors before they appear.
Introduction To Testing Process In Clinical Laboratory
In clinical laboratories, we traditionally divide the total testing processes into three phases: pre-analytical, analytical, and post-analytical phases. The total testing process is a multi-step process that begins and ends with the needs of patients. It consists of three major phases:
- •
Pre-Analytical Phase: The phase deals with the collection of specimens from patients and submitting them to the lab;
- •
Analytical Phase: This phase involves testing, examination; analysis and interpretation of the investigations;
- •
Post-Analytical Phase: The phase deals with giving the test reports to the clinicians and their patients.