Workflow optimization in a clinical laboratory using Lean management principles in the pre-analytical phase

Letelier, Pablo; Guzmán, Neftalí; Medina, Gustavo; Calcumil, Luis; Huencho, Pamela; Mora, Jonathan; Quiñones, F. Rubio; Jara, Jorge; Reyno, Cristóbal; Farías, Jorge G.; Herrera, Belén Lisandra; Brebi-Mieville, Priscilla; Riquelme, Ismael; San, Martín Andrés

doi:10.5937/jomb0-26055

Cited by 15 publications

(7 citation statements)

References 15 publications

(16 reference statements)

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“…Each sample was prioritized based on patient characteristics (e.g., clinical case, health care worker, etc). However, this traditional approach can impact the productivity of the lab and cause prolonged turnaround times ( 15 – 17 ). To streamline the workflow, the workflow was visualized, and opportunities for improvement were identified ( Fig.…”

Section: Resultsmentioning

confidence: 99%

Optimization of the STARlet workflow for semi-automatic SARS-CoV-2 screening of swabs and deep respiratory materials using the RealAccurate Quadruplex SARS-CoV-2 PCR kit and Allplex SARS-CoV-2 PCR kit

Flipse,

Tromp,

Thijssen

et al. 2024

Microbiol Spectr

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The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic triggered the implementation of large-scale screenings in the health care and in the general population. Consequently, medical laboratories have to apply lean laboratory management to design workflows that are able to process large batches within short turnaround times while maintaining flexibility to use different SARS-CoV-2 reverse transcription polymerase chain reactions (RT-PCRs) and to be able to process a variety of clinical samples. We validated two SARS-CoV-2 PCR assays on the STARlet workflow: Allplex SARS-CoV-2 PCR kit and RealAccurate Quadruplex SARS-CoV-2 PCR kit. Furthermore, we optimized and validated the STARlet workflow for semi-automatic screening for SARS-CoV-2 in upper respiratory swabs and deep respiratory materials (sputa, bronchoalveolar lavage, and aspirate). Strikingly, guanidine-containing lysis buffers allow for easy processing and can enhance sensitivity of SARS-COV-2 screening since sampling in these buffers may preserve viral transcripts as evident by the higher copy numbers of the SARS-CoV-2 N gene. Moreover, using the principles of lean laboratory management, several bottlenecks that are typical for medical laboratories were addressed. We show that lean laboratory management resulted in significant reduction of the turnaround times of the SARS-CoV-2 PCR in our laboratory. This report thus describes a useful framework for laboratories to implement similar semi-automated workflows. IMPORTANCE The SARS-CoV-2 pandemic triggered the implementation of large-scale screenings in the health care and in the general population. Consequently, medical laboratories had to adapt and evolve workflows that are able to process large batches within short turnaround times while maintaining flexibility to use different assays and to be able to process a variety of clinical samples. We describe how the need for increased outputs and greater flexibility was addressed with respect to clinical samples and assays (Allplex SARS-CoV-2 PCR and RealAccurate Quadruplex SARS-CoV-2 PCR). Strikingly, we found that upper respiratory swabs collected in guanidine-containing lysis buffers both improved the ease of processing as well as enhanced the sensitivity of the SARS-CoV-2 screening. This report thus describes a useful framework for laboratories to implement and optimize similar semi-automated workflows.

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Section: Resultsmentioning

confidence: 99%

Optimization of the STARlet workflow for semi-automatic SARS-CoV-2 screening of swabs and deep respiratory materials using the RealAccurate Quadruplex SARS-CoV-2 PCR kit and Allplex SARS-CoV-2 PCR kit

Flipse,

Tromp,

Thijssen

et al. 2024

Microbiol Spectr

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“…The study results are comparable with other studies, where a significant positive change in TAT was observed after initiating and implementing the Lean process throughout their laboratory. 2,5,6 However, the impact of the Lean Six Sigma on TAT was reduced due to the significant drop in the number of samples received post implementation.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Effectiveness of Lean Six Sigma Approach for SARS-CoV-2 RT-PCR Turnaround Time (TAT) Improvement at a Hospital-Based Tertiary Laboratory

2023

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Objectives. This study aims to evaluate the effectiveness of the Lean Six Sigma approach in improving procedure for (TAT) of reverse transcriptase polymerase chain reaction (RT-PCR) for SARS-CoV-2 testing at The Medical City. Specific objectives of the study are to determine the following: 1) baseline sigma and average TAT (in hours); 2) post-implementation sigma and average TAT (in hours) 3) compare if there is a significant improvement between baseline and post-implementation sigma and average TAT (in hours) 4) effect on workflow efficiency.Methodology. Lean Six Sigma method for quality improvement was applied using DMAIC: Define, Measure, Improve, and Control. The root causes identified were lack of manpower, equipment, space, and manual and complex processes. Then, process wastes were identified, and corresponding proposed solutions were sustained in the control phase, such as standardization and the use of automation. Measurement of turn-around time and six sigma of the process were performed for evaluation.Results. Results showed a significant improvement in the TAT in RT-PCR results, with most results released within 24 hours. The pre-Lean Six Sigma data on TAT were as follows: 24.88% released within 24 hours; 65.14% released within 24-48 hours; 3.56% released within 48-72 hours, and 6.42% released in more than 72 hours. The post Lean Six Sigma TAT were as follows: 95.32% released within 24 hours; 4.29% released within 24 to 48 hours; 0.13% released within 48-72 hours, and 0.12% released more than 72 hours. The computed sigma post-implementation was increased from 3.56 to 4.82. The p-value was calculated using the chi-square test, and the computed chi-square statistic is 1894.1021. The p-value is <0.00001 and the result is significant at p<.05. Although there is a significant decrease in the volume of samples post implementation due to the changing COVID-19 situation, real time TAT was improved. It also resulted to increased workflow efficiency with the use of lesser manpower with more appropriate utilization. Conclusion.Applying the Lean Six Sigma method to improve quality processes in the laboratory is shown to be practical, cost-effective, and straightforward.

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“…Staff resistance to change is one of the main barriers, along with lack of support from management and financial constraints. On the opposite side, Letelier [ 25 ] et al mentioned that results were achieved with minimum financial investment (except for the structural modifications). Another case study in a tertiary care pediatric hospital in Nova Scotia, Canada, did not require high financial or time investment, as mentioned by Geerlinks et al [ 31 ].…”

Section: Literature Reviewmentioning

confidence: 99%

“…Letelier et al [ 25 ] mentioned that implementation contributed to the emergence of a culture of continuous improvement in the laboratory. Still, analyzing all the selected articles, we can conclude that too little emphasis was placed on the effects that Lean has on organizational culture and on improving relationships within work teams and focused only on quantitative performance measurement, specifically on the analysis of key performance indicators.…”

Section: Literature Reviewmentioning

confidence: 99%

Externalities of Lean Implementation in Medical Laboratories. Process Optimization vs. Adaptation and Flexibility for the Future

Apostu

Vasile

Veres

2021

IJERPH

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Important in testing services in medical laboratories is the creation of a flexible balance between quality-response time and minimizing the cost of the service. Beyond the different Lean methods implemented so far in the medical sector, each company can adapt the model according to its needs, each company has its own specifics and organizational culture, and Lean implementation will have a unique approach. Therefore, this paper aims to identify the concerns of specialists and laboratory medical services sector initiatives in optimizing medical services by implementing the Lean Six Sigma method in its various variants: a comparative analysis of the implemented models, with emphasis on measuring externalities and delimiting trends in reforming/modernizing the method, a comprehensive approach to the impact of this method implementation, and an analysis of available databases in order to underline the deficit and information asymmetry. The results highlighted that in the case of clinical laboratories, the Lean Six Sigma method is conducive to a reduction of cases of diagnostic errors and saves time but also faces challenges and employees’ resistance in implementation.

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Workflow optimization in a clinical laboratory using Lean management principles in the pre-analytical phase

Cited by 15 publications

References 15 publications

Optimization of the STARlet workflow for semi-automatic SARS-CoV-2 screening of swabs and deep respiratory materials using the RealAccurate Quadruplex SARS-CoV-2 PCR kit and Allplex SARS-CoV-2 PCR kit

Optimization of the STARlet workflow for semi-automatic SARS-CoV-2 screening of swabs and deep respiratory materials using the RealAccurate Quadruplex SARS-CoV-2 PCR kit and Allplex SARS-CoV-2 PCR kit

Evaluation of the Effectiveness of Lean Six Sigma Approach for SARS-CoV-2 RT-PCR Turnaround Time (TAT) Improvement at a Hospital-Based Tertiary Laboratory

Externalities of Lean Implementation in Medical Laboratories. Process Optimization vs. Adaptation and Flexibility for the Future

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