B-032 Total lab Automation Validation/Verification Protocol: First Step of Process Excellence Journey in Smart Core Lab in Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute, Mumbai, India
Authors: Das B , Bhat L , Patil R , Tawde V , Kamath S , Pal P 
Published: September 2023

Abstract

Background
The total laboratory automation (TLA) involves the integration, automation, consolidation and digitalization of pre-examination, examination, and post-examination processes. It is far simpler to introduce TLA in a lean, highly standardized smart core lab setting than it is to replicate complex procedures based on manual workflows, therefore harmonization/standardization is a requirement. In this era of modern clinical laboratory, a very important step with respect to the quality of the entire process is method validation/ verification. Hence, it is fundamental to verify/validate TLA process flow, new techniques, new methods and new test parameters.During laboratory accreditation process, the most frequently cited deficiency involves inappropriate PQ (Performance Qualification) and verification protocol. The main principles to the PQ laboratory test validation or verification protocol are Accuracy, Precision, Reference Interval, Detection Limit (LOD), Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR), etc. Hence a clinically appropriate turnaround time is guaranteed via validation, which also provides accurate and precise readings.

Methods
Around 250 parameters, of biochemical and immunoassay for samples like serum/plasma/cerebrospinal fluid/urine have been validated/verified on this automated system. Clinical Laboratory Standards Institute (CLSI) and best practise checklist as per international and national accreditation bodies served as the foundation for verification. Following are the steps for verification. Analytical Accuracy: Run samples by both methods to evaluate bias. Verify Precision: Run 5 replicates per run for 5 days, at all levels of control sera. Check Reference Intervals: Representative 20 healthy individuals are selected. Verify LOB and LOD Values: Run 20 blank (zero calibrator) or low patient samples. Pneumatic System Verification Protocol: 20 samples carried manually by health care assistants and 20 samples transported via the pneumatic system. We have done sigma metrics of 250 parameters in the lab.

Results
With particular reference to Thyroid Stimulating Hormone (TSH), we have obtained the following results: For the Reference interval study, out of 353 volunteers recruited, 8 volunteer data were excluded (7 outliers, 1 abnormal TPO values). We obtained the reference interval of 0.53–4.489 μIU/mL, which is within the range specified by the manufacturer's reference range. A good level of analytical accuracy is demonstrated between the two instruments with r2 = 0.9938 having a coefficient of variation of 4.32%. The coefficient of variation values of precision for inter laboratory method comparison for lower and high-level values is 1.39% and 1.76% respectively, which is comparable with the manufacturers claims values. The coefficient of repeatability is 1.3442 is higher than 0.7 and hence considered as the two instruments having a good retest reliability. We observed more than six sigma performance of TSH. Based on Operational Specification (OPSpecs) Chart and Method Decision Chart sigma values of all the parameters are evaluated and quality control strategies have been defined.

Conclusion
Thus, validation of all biochemistry & immunoassay parameters in TLA set up of the smart core laboratory promotes an environment, emphasizing patient safety and quality patient care.