Six sigma for clinical lab

BACKGROUND: Six Sigma is a popular quality management system that enables continuous monitoring and improvement of analytical performance in the clinical laboratory. We aimed to calculate sigma metrics and quality goal index (QGI) for 17 biochemical analytes and compare the use of bias from internal quality control (IQC) and external quality assurance (EQA) data in the calculation of sigma metrics. METHODS: This retrospective study was conducted in Marmara University Pendik E&R Hospital Biochemistry Laboratory...

Electroencephalograms can capture brain oscillatory activities during sleep as a form of electrophysiological signals. We analysed electroencephalogram recordings from full-night in-laboratory polysomnography from 100 patients with Down syndrome, and 100 age- and sex-matched controls. The ages of patients with Down syndrome spanned 1 month to 31 years (median 4.4 years); 84 were younger than 12 years, and 54 were male. From each electroencephalogram, we extracted relative power in six frequency bands or rhythms (delta, theta, alpha, slow sigma, fast sigma, and beta) from six channels (frontal F3 and F4, central C3 and C4, and occipital O1 and O2) during five sleep stages (N3, N2, N1, R and W)-180 features in all...

INTRODUCTION: Clinical laboratories serve a critical role in increasing the efficiency of patient care. Choosing the right test, getting trustworthy results and appropriate interpretation are of utmost importance in improving the patient's well-being. Quality management strategies should be applied in routine patient care because laboratory errors have a major impact on the quality of patient care. In sigma metrics, errors identified are quantified as percentage errors or defects per million (DPM)...

Six Sigma Foundations is a statistical standard that indicates an exceptionally high level of quality, along with a customer satisfaction management approach that intends to lower error rates and boost process efficiency. The Define, Measure, Analyse, Improve, and Control (DMAIC) approach is a fundamental component of Six Sigma and provides an organised framework for process improvement. In contrast to conventional techniques that are more manual-based, Six Sigma emphasises and focuses on making decisions based on facts and evidence...

Introduction This study was conducted to assess the analytical performance of biochemical tests using Six Sigma methodology and to assess the underlying causes of unsatisfied performance of analytes with a sigma value of less than 4 using quality goal index (QGI) and root cause analysis (RCA). Methodology Daily data for internal quality control (IQC) for both level 1 (L1) and level 2 (L2) and monthly data for external quality assessment for a period of six months were recorded. The coefficient of variation (CV), bias, and total allowable error (TEa) were calculated to analyze the sigma (σ) values for 19 biochemical analytes...

A zero defects goal was implemented in the clinical laboratory settings using a six-sigma model. Daily Internal Quality Control (IQC) and external quality control data from April-September 2023 was extracted to calculate the sigma metrics of 21 biochemical analytes based on Total Error Allowable (TEa), % bias and co-efficient of variation percent (CV%). A retrospective comparative study was conducted in the department of Clinical Biochemistry at Kanva Diagnostic Services Pvt. Ltd, Bengaluru, India. The analytical performance of the 21 biochemical analytes was tested on Cobas 6000 and C311 analyzers...

Introduction Blood tests are essential for detecting and treating hospitalized individuals with diseases. Laboratory blood tests provide doctors with critical information required to treat their patient's illnesses. The most common sources of error in clinical laboratories are pre-analytical errors. Although quality control measures can remediate analytical errors, there is a requirement for stringent quality checks in the pre-analytical sector as these activities are performed outside of the laboratory...

OBJECTIVE: To determine the sigma value of immunoassay parameters which are within the 2Z score on external quality control (EQC). STUDY DESIGN: A cross-sectional study. Place and Duration of the Study: Department of Chemical Pathology and Endocrinology (AFIP),non-ability ity consecutive  from June to November 2022. METHODOLOGY: Ten immunoassay parameters were selected on the basis of the internal quality control (IQC) and external quality control (EQC) programs...

BACKGROUND The cognitive impact of estradiol (E2), a sex steroid hormone, particularly its unique characteristics mediated through different estrogen receptors (ERs), is garnering research interest to optimize estrogen replacement therapy (ERT) and mitigate adverse effects. However, a systematic bibliometric investigation elucidating the connection between E2/ERs and cognition is lacking. This study examines 3502 Web of Science Core Collection publications using CiteSpace to unveil trends in this research field...

AIM OF THE STUDY: We evaluated and compared blood gas analysis (EGA) non-conformities (NC) considered operator-dependent performed in Point-Of-Care (POC) analyzer as quality indicators (IQ) of the pre-analytical phase. To this end, four different NC registered in the resuscitation departments of the Hospital Polyclinic Bari from the beginning of the pandemic (March 2020) until February 2022 were evaluated. The results obtained were compared with those recorded in the pre-COVID period (March 2018-February 2020) to check if there were differences in number and type...

BACKGROUND: We evaluated analytical and Sigma performance for 6 next generation chemistry assays on the Abbott Architect c8000 system. METHODS: Albumin with bromocresol purple or green, amylase, cholesterol, total protein, and urea nitrogen were analyzed using photometric technology. Analytical performance goals were defined based on Accreditation Canada Diagnostics (ACD) and Clinical Laboratory Improvement Amendments (CLIA). Precision study consisted of testing 2 quality control concentrations and 3patient serum sample pools, twice a day in quintuplicate over 5 days...

BACKGROUND: We developed an efficient online automated quality control (AUTO QC) system and tested its feasibility on automatic laboratory assembly lines. METHODS: AUTO QC is based on developed quality control software (Smart QC) and designed adaptable consumables before. We applied the system to two assembly lines in our laboratory. Using third-party quality control samples, we evaluated the impact of the online AUTO QC system on out-of-control rate, biosecurity risk, turnaround time (TAT) and cost...

When increasing the quality in clinical laboratories by decreasing measurement uncertainty, reliable methods are needed not only to quantify the performance of measuring systems, but also to set goals for the performance. Sigma metrics used in medical laboratories for documenting and expressing levels of performance, are evidently totally dependent on the "total permissible error" used in the formulas. Although the conventional biological variation (BV) based model for calculation of the permissible (or allowable) total error is commonly used, it has been shown to be flawed...

OBJECTIVES: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become a common technique in clinical laboratories in recent years. Because most methods are laboratory-developed tests (LDTs), their reproducibility and quality control (QC) have been controversial. In this study, Westgard Sigma Rules were used to evaluate the analytical performance and establish an individualised internal QC (IQC) strategy for these LDTs. METHODS: Taking the LC-MS/MS LDT method for homocysteine (Hcy) as an example, the 'desirable specifications' from the Biological Variation Database were used as quality goals...

PURPOSE: 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 standardized preanalytical code (SPREC) aggregates warm ischemia (WIT), cold ischemia (CIT), and fixation times (FIT) in a precise format. Despite its growing importance underpinned by the European in vitro diagnostics regulation or broad preanalytical programs by the National Institutes of Health, little is known about its empirical occurrence in biobanked surgical specimen. In several steps, the Tissue Bank Bern achieved a fully informative SPREC code with insights from 10,555 CIT, 4,740 WIT, and 3,121 FIT values...

OBJECTIVE: Measurement of cardiac biomarker troponin T plays a vital role in the diagnosis of myocardial infarction. A quick turnaround time (TAT) for cardiac troponin T is crucial in managing patients in the emergency department and critical care unit. The goal of the study was to implement Lean Six Sigma methods to improve stat troponin T TAT compliance rate (the time specimen received in the laboratory to the reporting of results through the laboratory information system [LIS]) from 86% to 95% in an 8-month period...

We describe the optimization and validation of six DNA isolation protocols from fresh leaves of the rare tree Acacia pachyceras . The first four protocols employed three commercial kits (Sigma, Nucleospin1, Nucleospin 2, Promega) whereas the remaining two were based on the traditional sodium dodecyl sulfate (SDS) and cetyltrimethylammonium bromide CTAB methods. Each protocol provided significantly different results concerning DNA concentration ( p  < 0.032), yield ( p  < 0.000), contaminant carry over, protocol duration, cost per sample, and comprehensive cost...

Processes to enhance customer-related services in healthcare organizations are complex and it can be difficult to achieve efficient patient-focused services. Laboratories make an integral part of the healthcare service industry where healthcare providers deal with critical patient results. Errors in these processes may cost a human life, create a negative impact on an organization's reputation, cause revenue loss, and open doors for expensive lawsuits. To overcome these complexities, healthcare organizations must implement an approach that helps healthcare service providers to reduce waste, variation, and work imbalance in the service processes...

Introduction: The aim of the study was to determine the current state of laboratory's extra-analytical phase performance by calculating preanalytical and postanalytical phase quality indicators (QIs) and sigma values and to compare obtained data according to desired quality specifications and sigma values reported by The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group - Laboratory errors and Patient Safety. Materials and methods: Preanalytical and postanalytical phase data were obtained through laboratory information system...