PRACTICALAPPLICATION OF SIX SIGMA DMAIC METHODOLOGY IN EVALUATION OF PRE-ANALYTICAL QUALITY INDICATORS IN LABORATORY SETTINGS

The Six Sigma is a global management methodology that empowers clinical laboratories by better understanding of the quality in their laboratories and helps in improving quality and subsequently reducing laboratory costs. The objective of this prospective study was to practically apply Six Sigma on pre-analytical quality indicators i.e. pre-analytical phase errors of “Total Testing Process” in laboratory at PGIMER Satellite Centre, Sangrur (Punjab). In this study Six Sigma DMAIC ( Dene, Measure, Analyse, Improvement and Control) methodology was applied on routine Outpatient Department (OPD) samples received in hematology and biochemistry laboratory from May, 2020 to July, 2020 after institutional ethical committee permission. Pre-analytical phase errors were taken as pre-analytical quality indicators and were broadly classied in to requisition form and sampling errors. Sigma values and frequencies were calculated using Westgard formula present online at (www. westgard.com > six sigma calculators) for pre-analytical phase errors. After that Improvement phase of DMAIC methodology was done by training of laboratory technicians or personell involved in pre-analytical phase by audio-visual aids. Six Sigma values were calculated again after improvement phase. A total of 787 requisition forms and 1105 samples were studied before improvement phase and 889 requisition forms and 1400 samples were studied after improvement phase. Before improvement phase, overall requisition form errors were working at 2.9 sigma and sampling process was working at 3.1 sigma but after improvement phase, requisition form errors were working at 3.3 sigma and sampling process was working at 3.5 sigma. Before and after improvement phase the sample rejection rate in laboratory improved from 1.90% to 0.93% highlighting the benecial concept of six sigma in laboratory in pre-analytical phase leading to increased clinicians and patients'satisfaction and prevents unusual delaying of reports.

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Performance criteria and quality indicators for the pre-analytical phase

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2014-1124 ◽

2015 ◽

Vol 53 (6) ◽

Cited By ~ 9

Author(s):

Mario Plebani ◽

Laura Sciacovelli ◽

Ada Aita ◽

Michela Pelloso ◽

Maria Laura Chiozza

Keyword(s):

Quality Indicators ◽

Performance Criteria ◽

Analytical Quality ◽

Performance Targets ◽

Laboratory Services ◽

Quality Specifications ◽

Analytical Phase ◽

Total Testing Process ◽

The Individual

AbstractThe definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

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Where is my sample? Investigating pre-analytical pathology sampling errors in a psychiatric hospital

BJPsych Open ◽

10.1192/bjo.2021.911 ◽

2021 ◽

Vol 7 (S1) ◽

pp. S348-S348

Author(s):

Emma Scholes-Pearson ◽

Nieves Mercadillo

Keyword(s):

Psychiatric Hospital ◽

Clinical Setting ◽

Negative Impact ◽

Junior Doctors ◽

Sampling Errors ◽

Error Type ◽

Sampling Process ◽

Transit Times ◽

Analytical Phase ◽

Key Steps

AimsErrors in the pathology sampling process can be costly for all stakeholders in any clinical setting; however, this process is often overlooked within psychiatry. Over the space of just a few short months at Hollins Park Psychiatric Hospital (HPH) such errors were reported to be numerous with staff raising multiple issues relating to the pathology sampling process. These issues often had a negative impact on patient care, leading to outcomes such as as re-bleeding of patients and delays in interventions. Here, we aim to identify the predominant sources of error in this process and suggest possible improvements to minimise these errors in the future.MethodInitially, we mapped and analysed each step of the sampling process as it is currently performed in order to identify areas of possible improvement. We then distributed questionnaires to all junior doctors - who are responsible for the handling of samples within the clinical setting – in order to establish error type and frequency. Questions also assessed individual confidence and familiarity with the sampling process.ResultWhen mapping the sampling process, we identified all key steps required when sending samples from HPH to Warrington and Halton Hospitals laboratory. This included one pathway for sending routine bloods, and one pathway for urgent bloods. The process for sending routine bloods required more steps and ultimately took longer for samples to reach the laboratory – as expected. Of the issues identified during mapping of the pre-analytical phase, a majority of 77.7% of clinicians reported samples had gone missing or were unreported – with the reasons for this being undetermined in most cases – and 55.5% reported their samples never reached the lab. While on the whole participants were comfortable with the steps involved in sending samples to the laboratory, 77.7% were not aware of the requirement to log samples as they were being sent.ConclusionThe reasons underlying errors in the sampling process at HPH were multifactorial and included a lack of clinician familiarity with correct procedure, poor sample recording/tracking and lengthy transit times between the patient and laboratory. Here we outline some simple evidence-based recommendations (including education of staff and improved tracking through an electronic requesting system) to help reduce errors and streamline the sampling process in the hopes of improving both efficiency and accuracy, reducing the financial and clinical impact.

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The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

10.4018/978-1-7998-9198-7.ch012 ◽

2022 ◽

pp. 215-229

Author(s):

Antonia Mourtzikou ◽

Marilena Stamouli ◽

Georgia Kalliora ◽

Ioanna Petraki ◽

Christina Seitopoulou ◽

...

Keyword(s):

Risk Assessment ◽

Quality Indicators ◽

Six Sigma ◽

Laboratory Testing ◽

Laboratory Tests ◽

Clinical Laboratory ◽

Iso 15189 ◽

Pareto Method ◽

Analytical Phase

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

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Evaluation of pre-analytical phase performance of emergency laboratory by harmonized quality indicators and six sigma

10.17727/jmsr.2021/9-10 ◽

2021 ◽

Vol 9 (2) ◽

pp. 64-70

Author(s):

Arumalla VK ◽

Chelliah S ◽

Madhubala V

Keyword(s):

Patient Safety ◽

Quality Indicators ◽

Six Sigma ◽

Working Group ◽

Clinical Chemistry ◽

International Federation ◽

Laboratory Errors ◽

The World ◽

Analytical Phase ◽

Analytical Errors

Background: Pre-analytical errors account for up to 70% of all the errors made in laboratory diagnostics which are mostly not directly under laboratory control. Laboratories across the world have been using different Quality indicators (QIs) for identifying and quantification of pre-analytical errors. Objective of the present study is to identify the different pre-analytical errors with their frequency and to assess the pre-analytical phase performance of emergency laboratory by using harmonized Quality Indicators and six sigma metrics. Methods and material: A prospective observational study was conducted from January 2019 to December 2019 to monitor the inappropriateness of samples and test request forms. We have quantified the performance of pre-analytical phase of our emergency laboratory based on the harmonized QIs proposed by The International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety (IFCC- WGLEPS) and six sigma metrics. Results: Emergency laboratory received a total of 55431 samples during Jan- 2019 to Dec- 2019. Number of pre-analytical errors were 1089 which accounted for 1.96% of total samples received. Haemolysed samples, clotted samples and samples with insufficient volume were contributed to 37%, 26% and 15% of the total pre-analytical errors respectively. Conclusions: Pre-analytical phase performance of our emergency laboratory complies with the quality specifications laid by the International Federation of Clinical Chemistry Working Group on Laboratory Errors and Patient Safety (IFCC-WGLEPS). Implementation of harmonised QIs assures the comparability of laboratory findings with different laboratories across the world.

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Quality Indicators for the Performance Evaluation at a Biochemistry Laboratory

International Journal of Reliable and Quality E-Healthcare ◽

10.4018/ijrqeh.2020040102 ◽

2020 ◽

Vol 9 (2) ◽

pp. 18-33

Author(s):

Zoi S. Athanasiadou ◽

Antonia Mourtzikou ◽

Marilena Stamouli ◽

Petros Karkalousos

Keyword(s):

Quality Indicators ◽

Six Sigma ◽

Risk Evaluation ◽

Statistical Data ◽

Statistical Tool ◽

Iso 15189 ◽

Biochemical Laboratory ◽

Pareto Method ◽

Analytical Phase

The use of quality indicators and risk evaluation are valuable tools for maintaining the quality of laboratory tests. There are both requirements of ISO 15189: 2012 and are usually based on common statistical and empirical data. The purpose of the present study was the quality quantification and risk evaluation through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. Statistical data was collected for the period from 1/12/2017 to 28/2/2018, using the LIS of Biochemical Laboratory. QIs were evaluated using the Six Sigma method and the Pareto statistical tool. FMEA risk analysis was performed, while the degree of risk priority with the Pareto method. The results show that in the analytical phase the QIs give us satisfactory values, while those in the pre- and post- analytical phases need further preventive/corrective actions in order to overcome the problems raised by the QIs. Thus, the fully automatization and computerization of the laboratory is needed.

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Six Sigma performance of quality indicators in total testing process of point-of-care glucose measurement: A two-year review

Practical Laboratory Medicine ◽

10.1016/j.plabm.2021.e00215 ◽

2021 ◽

Vol 25 ◽

pp. e00215

Author(s):

Anne Vincent ◽

Donnah Pocius ◽

Yun Huang

Keyword(s):

Quality Indicators ◽

Six Sigma ◽

Point Of Care ◽

Glucose Measurement ◽

Total Testing Process

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A nationwide evaluation of the prevalence of human papillomavirus in Brazil (POP-Brazil study): protocol of data quality assurance and control (Preprint)

10.2196/preprints.31365 ◽

2021 ◽

Author(s):

Jaqueline Driemeyer Correia Horvath ◽

Marina Bessel ◽

Natalia Luiza Kops ◽

Flávia Moreno Alves Souza ◽

Gerson Fernando Mendes Pereira ◽

...

Keyword(s):

Quality Control ◽

Quality Assurance ◽

Quality Indicators ◽

Sampling Errors ◽

Online Data ◽

Monitoring Visit ◽

Multicenter Clinical Trials ◽

Double Entry ◽

And Control ◽

Quality Assurance And Control

BACKGROUND The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. Quality control aims to monitor sampling errors and measurements during the execution of a study and is based mainly on two pillars: planning and standardization of procedures. OBJECTIVE The present article aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. METHODS Quality assurance and control included several phases and processes that were initiated with the planning of the study and continued through the development of the project; thus, all centers were trained in loco. RESULTS The data were through a structured questionnaire and collection of biological samples, both performed by more than 250 trained and certified health professionals. Furthermore, to correct possible inadequacies, all 119 centers (public health units) received at least one monitoring visit, which evaluated the professionals' performance and the process of completing the online data platform. The data were monitored daily and were audited through the double entry of data, performed by the central team. The reliability of data was analyzed through the test-retest method, comparing data from the online platform and a second application of the interview, and conducted through telephone, also by the central team. The agreement between the test and retest was considered good (kappa between 0.59 and 0.74). Large multicenter clinical trials are the basis of medical evidence-based and health-based prevention, so their design, logistics, and quality processes should always be carefully considered. CONCLUSIONS This article presents the processes and quality indicators in the POP-Brazil study that allow other studies to generate reliable data.

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The use of extra-analytical phase quality indicators by clinical laboratories: the results of an international survey

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2016-0770 ◽

2016 ◽

Vol 54 (11) ◽

Cited By ~ 6

Author(s):

Mario Plebani ◽

Maurice O’Kane ◽

Pieter Vermeersch ◽

Janne Cadamuro ◽

Wytze Oosterhuis ◽

...

Keyword(s):

Quality Indicators ◽

International Survey ◽

Clinical Laboratories ◽

Analytical Phase

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Quality Indicators of the Pre-Analytical Phase

Journal of Medical Biochemistry ◽

10.2478/v10011-012-0013-2 ◽

2012 ◽

Vol 31 (3) ◽

pp. 174-183 ◽

Cited By ~ 2

Author(s):

Nada Majkić-Singh ◽

Zorica Šumarac

Keyword(s):

Health Care ◽

Patient Safety ◽

Quality Indicators ◽

Task Force ◽

Improve Patient Safety ◽

Laboratory Data ◽

Sample Collection ◽

Laboratory Errors ◽

Analytical Phase ◽

Total Testing Process

Quality Indicators of the Pre-Analytical PhaseQuality indicatorsare tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force calledLaboratory Errors and Patient Safety (WG-LEPS)with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.

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