Long story short: an introduction to the short-term and longterm Six Sigma quality and its importance in laboratory medicine for the management of extra-analytical processes

2018 ◽  
Vol 56 (11) ◽  
pp. 1838-1845 ◽  
Author(s):  
Cristiano Ialongo ◽  
Sergio Bernardini
Keyword(s):  
Six Sigma ◽  
Control Charts ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
Effective Control ◽  
Full Potential ◽  
Short Term ◽  
Performance Requirements ◽  
Analytical Phase

Abstract There is a compelling need for quality tools that enable effective control of the extra-analytical phase. In this regard, Six Sigma seems to offer a valid methodological and conceptual opportunity, and in recent times, the International Federation of Clinical Chemistry and Laboratory Medicine has adopted it for indicating the performance requirements for non-analytical laboratory processes. However, the Six Sigma implies a distinction between short-term and long-term quality that is based on the dynamics of the processes. These concepts are still not widespread and applied in the field of laboratory medicine although they are of fundamental importance to exploit the full potential of this methodology. This paper reviews the Six Sigma quality concepts and shows how they originated from Shewhart’s control charts, in respect of which they are not an alternative but a completion. It also discusses the dynamic nature of process and how it arises, concerning particularly the long-term dynamic mean variation, and explains why this leads to the fundamental distinction of quality we previously mentioned.

A directed content analysis of viewpoints on the changing patterns of Lean Six Sigma research

2019 ◽  
Vol 31 (4) ◽  
pp. 641-654 ◽  
Author(s):  
Bryan A. Rodgers ◽  
Jiju Antony ◽  
Zhen He ◽  
Elizabeth A. Cudney ◽  
Chad Laux
Keyword(s):  
Continuous Improvement ◽  
Six Sigma ◽  
Design Methodology ◽  
Lean Six Sigma ◽  
Current Status ◽  
Short Term ◽  
Content Type ◽  
Changing Patterns ◽  
Practical Implications

Purpose The purpose of this paper, builds on previous studies that explored the research patterns over 15 years, is to consider the current status of the integration of Lean and Six Sigma. More specifically, this research addresses whether Lean and Six Sigma are stronger together and explores the reasons why Lean researchers and practitioners may be less likely to integrate Six Sigma in their work. Design/methodology/approach The research utilises a survey of 25 established and respected academics and practitioners from 16 countries. The questionnaire is analysed using a direct content approach and coded in NVivo. Findings The findings suggest that challenges may lie in the perception and understanding of statistics as well as short-term rather than long-term focus on improvement. The findings also suggest that academics and practitioners believe that Lean Six Sigma has developed over time and will continue to develop and improve as a methodology rather than being replaced with a new methodology. Research limitations/implications The survey has a sample size of 25, albeit all respondents are established and very experienced practitioners and academics. Practical implications For organisations that are introducing or refreshing their continuous improvement initiatives, this research identifies some of the challenges and provides the opportunity to address them to maximise the opportunities for success and sustainability. Originality/value The value of this paper is that it further addresses the debate over the integration of Lean and Six Sigma for many organisations which still employ Lean alone, but beyond this it explores how they will continue to develop and whether they are a permanent edition to the quality management landscape or a transition to something else.

scholarly journals Using Shewhart p control charts of external quality-assurance program data to monitor analytical performance of a clinical chemistry laboratory

1996 ◽  
Vol 42 (9) ◽  
pp. 1478-1482 ◽  
Author(s):  
D Chesher ◽  
L Burnett
Keyword(s):  
Quality Assurance ◽  
Control Charts ◽  
Clinical Chemistry ◽  
Analytical Performance ◽  
External Quality Assurance ◽  
Chemistry Laboratory ◽  
Quality Assurance Program ◽  
External Quality ◽  
Simple Method

Abstract We have investigated the application of Shewhart's p control charts in our external quality-assurance program to monitor the long-term performance of our laboratory's analytical quality. The p control charts have been able to detect long-term changes in our laboratory's analytical performance that would have been difficult to detect by more-conventional techniques. We have explored methods for interpreting these charts as well as some of their limitations, which include minimum subgroup size and dependence on constant specification limits. These charts may be not only a simple method for the long-term monitoring of analytical performance of a laboratory, but also of use to the organizers of external quality-assurance programs.

Order of blood draw: Opinion Paper by the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE)

2017 ◽  
Vol 55 (1) ◽  
pp. 27-31 ◽  
Author(s):  
Michael Cornes ◽  
Edmée van Dongen-Lases ◽  
Kjell Grankvist ◽  
Mercedes Ibarz ◽  
Gunn Kristensen ◽  
...  
Keyword(s):  
Working Group ◽  
Clinical Chemistry ◽  
Venous Blood ◽  
Laboratory Medicine ◽  
European Federation ◽  
Blood Collection ◽  
Sample Collection ◽  
Blood Draw ◽  
Preanalytical Phase ◽  
Analytical Phase

AbstractIt has been well reported over recent years that most errors within the total testing process occur in the pre-analytical phase (46%–68.2%), an area that is usually outside of the direct control of the laboratory and which includes sample collection (phlebotomy). National and international (WHO, CLSI) guidelines recommend that the order of draw of blood during phlebotomy should be blood culture/sterile tubes, then plain tubes/gel tubes, then tubes containing additives. This prevents contamination of sample tubes with additives from previous tubes that could cause erroneous results. There have been a number of studies recently looking at whether order of draw remains a problem with modern phlebotomy techniques and materials, or it is an outdated practice followed simply because of historical reasons. In the following article, the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) provides an overview and summary of the literature with regards to order of draw in venous blood collection. Given the evidence presented in this article, the EFLM WG-PRE herein concludes that a significant frequency of sample contamination does occur if order of draw is not followed during blood collection and when performing venipuncture under less than ideal circumstances, thus putting patient safety at risk. Moreover, given that order of draw is not difficult to follow and knowing that ideal phlebotomy conditions and protocols are not always followed or possible, EFLM WG-PRE supports the continued recommendation of ensuring a correct order of draw for venous blood collection.

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

2018 ◽  
Vol 57 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Min Duan ◽  
Xudong Ma ◽  
Jing Fan ◽  
Yanhong Guo ◽  
Wei Wang ◽  
...  
Keyword(s):  
Quality Indicators ◽  
Clinical Chemistry ◽  
Turnaround Time ◽  
Laboratory Medicine ◽  
General Information ◽  
Critical Values ◽  
Medical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

Effektive Zielgruppenansprache am Point-of-Sale

2014 ◽  
Vol 55 (3) ◽  
pp. 21-26
Author(s):  
Thorsten Teichert ◽  
Mathias Valentin ◽  
Sabrina Wauker
Keyword(s):  
Six Sigma ◽  
Market Research ◽  
Product Market ◽  
New Product ◽  
Customer Segmentation ◽  
Short Term ◽  
Point Of Sale ◽  
Sales Personnel ◽  
Phase Analyse

Im vorangegangenen Beitrag in Ausgabe 2/2014 wurde die Bedeutung einer Integration von Marketing und Vertrieb für die Einführung neuer Produkte herausgestellt. So scheitern Produktinnovationen oft nicht aufgrund von Fehlern im Produktdesign oder im Markenkonzept, sondern durch suboptimale operative Markteinführung. Diese wird vom Vertrieb in erheblichem Maße beeinflusst. Daher gilt es, Marketing- und Vertriebsabteilung aufeinander abzustimmen und dem Vertrieb das nötige Rüstzeug bereitzustellen, um abstrakte Marketingkonzepte (wie Zielgruppensegmentierungen) im Alltag praktikabel umzusetzen. An einem Praxisbeispiel wird die Integration von Marktforschung und Vertrieb mit Hilfe der Six-Sigma-Methodik vorgestellt. Als Anwendungsfall dient eine Studie im Leuchtmittelmarkt. A structured Six-Sigma process is applied to align Marketing & Sales activities for the market introduction of a new product. Market research is used to establish a Management Cockpit. Measures enable customer segmentation at the PoS and guide sales personnel for targeting customers. Performance implications prove both short-term as well as long-term benefits. Keywords: unternehmensperformance, measure phase, improve phase, define phase, analyse phase

Harmonization in laboratory medicine: more than clinical chemistry?

2018 ◽  
Vol 56 (10) ◽  
pp. 1579-1586 ◽  
Author(s):  
Mario Plebani
Keyword(s):  
Patient Care ◽  
Patient Outcomes ◽  
Biological Samples ◽  
Clinical Chemistry ◽  
Large Body ◽  
Laboratory Medicine ◽  
Analytical Quality ◽  
Clinical Laboratories ◽  
Analytical Phase ◽  
Clinical Chemistry Tests

Abstract The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. “omics”) rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only “good biological samples” can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the “pre-pre-analytical” phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the “post-post-analytical” steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

scholarly journals Six Sigma revisited: We need evidence to include a 1.5 SD shift in the extraanalytical phase of the total testing process

2020 ◽  
Vol 30 (1) ◽  
pp. 149-152
Author(s):  
Abdurrahman Coskun ◽  
Cristiano Ialongo
Keyword(s):  
Six Sigma ◽  
Laboratory Medicine ◽  
Distributed Data ◽  
Process Performance ◽  
Constant Parameter ◽  
World Class ◽  
Six Sigma Methodology ◽  
Analytical Phase ◽  
Total Testing Process ◽  
Normally Distributed

The Six Sigma methodology has been widely implemented in industry, healthcare, and laboratory medicine since the mid-1980s. The performance of a process is evaluated by the sigma metric (SM), and 6 sigma represents world class performance, which implies that only 3.4 or less defects (or errors) per million opportunities (DPMO) are expected to occur. However, statistically, 6 sigma corresponds to 0.002 DPMO rather than 3.4 DPMO. The reason for this difference is the introduction of a 1.5 standard deviation (SD) shift to account for the random variation of the process around its target. In contrast, a 1.5 SD shift should be taken into account for normally distributed data, such as the analytical phase of the total testing process; in practice, this shift has been included in all type of calculations related to SM including non-normally distributed data. This causes great deviation of the SM from the actual level. To ensure that the SM value accurately reflects process performance, we concluded that a 1.5 SD shift should be used where it is necessary and formally appropriate. Additionally, 1.5 SD shift should not be considered as a constant parameter automatically included in all calculations related to SM.

scholarly journals Performance criteria and quality indicators for the post-analytical phase

2016 ◽  
Vol 54 (7) ◽  
Author(s):  
Laura Sciacovelli ◽  
Ada Aita ◽  
Andrea Padoan ◽  
Michela Pelloso ◽  
Giorgia Antonelli ◽  
...  
Keyword(s):  
Quality Indicators ◽  
State Of The Art ◽  
Clinical Chemistry ◽  
Laboratory Medicine ◽  
The State ◽  
Performance Criteria ◽  
Quality Improvement Strategy ◽  
Laboratory Errors ◽  
Analytical Phase ◽  
Over Time

AbstractQuality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase.This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory.Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

scholarly journals Providing Laboratory Medicine Training in a Low-Resource Setting

2020 ◽  
Author(s):  
Roa Harb ◽  
Chiyembekezo Kachimanga ◽  
Musa Bangura ◽  
Sahr Kanawa ◽  
Charles W Stratton ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Short Term ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Long Term Follow Up ◽  
Barriers To Implementation ◽  
Case Presentations

Abstract Objectives We developed and participated in a 1-week laboratory medicine training presented from June 3, 2019, to June 7, 2019. Methods The training was a combination of daily morning lectures and case presentations as well as afternoon practical sessions in the clinical laboratory. The content was selected over months by local organizers and the visiting faculty and further modified on site to reflect local needs. Results Participants identified practice changes that could be realized in the short term but most faced significant barriers to implementation in the absence of structured and long-term follow-up. Conclusions In this report, we review insights learned from our experience and reflect on strategies for realistic, meaningful, and relevant contributions in the setting of laboratory medicine–oriented short-term programs.

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