Use of a Lean Six Sigma approach to investigate excessive quality control (QC) material use and resulting costs

The Eastern Health Clinical Biochemistry Laboratories cater to the province of Newfoundland and Labrador. Over the last ten years, a significant increase in annual expenses on quality control material and calibrator purchases was observed. Two major Clinical Chemistry Laboratories at the Health Sciences Centre (HSC) and St. Clare's Mercy Hospital (STC), St. John's, work as referral centers for the province. The study's design was based on the Six Sigma DMAIC (Define, Measure, Analyze, Improve, and Control) process and involved tests performed on ten automated Abbott Clinical Chemistry (CC) and Immunoassay (IA) analyzers. The cost of purchasing the QC material from Bio-Rad and Randox had increased due to defective QC and analyzer test assignment process design. The processes were modified. An Individualized Quality Control Plan (IQCP) was developed.Modification in quality control processes helped in bringing down the cost and usage of both QC and calibrators. The cost and usage of individual control material were reduced by 25 to 52% depending on the type of quality control. Total annual expenditure on the purchase of different QC materials before modification was estimated as CAD 346,395(2019) which was reduced to CAD 255,267 with annual savings of 91,128 CAD (26%) after modification (2020). The average usage reduction for various calibrators was 40% with the highest reduction in the use of urine calibrators. The annual cost of calibrators was reduced from CAD 30,568.42 (2019-20) to CAD 17,517 (2020-21) with the saving of approximately 13,051 Canadian dollars (43 %) for the laboratory.There is a constant compulsion in every industry to manage costs. Implementation of Lean and Six Sigma methodology in removing Muda of high costs in a Clinical Chemistry Laboratory is the most warranted strategy in developing a cost-effective laboratory framework.