scholarly journals Sigma Metric Evaluation of Drugs in a Clinical Laboratory: Importance of Choosing Appropriate Total Allowable Error and a Troubleshooting Roadmap

2021 ◽  
Author(s):  
Lokesh Kumar Sharma ◽  
Rashmi Rasi Datta ◽  
Neera Sharma
Keyword(s):  
Quality Control ◽  
Peer Group ◽  
Internal Quality ◽  
Care Hospital ◽  
External Quality ◽  
Total Allowable Error ◽  
Significant Difference ◽  
Allowable Error ◽  
Study Laboratory ◽  
The Impact

Abstract Objectives Stringent quality control is an essential requisite of diagnostic laboratories to deliver consistent results. Measures used to assess the performance of a clinical chemistry laboratory are internal quality control and external quality assurance scheme (EQAS). However, the number of errors cannot be measured by the above but can be quantified by sigma metrics. The sigma scale varies from 0 to 6 with “6” being the ideal goal, which is calculated by using total allowable error (TEa), bias, and precision. However, there is no proper consensus for setting a TEa goal, and influence of this limiting factor during routine laboratory practice and sigma calculation has not been adequately determined. The study evaluates the impact of the choice of TEa value on sigma score derivation and also describes a detailed structured approach (followed by the study laboratory) to determine the potential causes of errors causing poor sigma score. Materials and Methods The study was conducted at a clinical biochemistry laboratory of a central government tertiary care hospital. Internal and external quality control data were evaluated for a period of 5 months from October 2019 to February 2020. Three drugs (carbamazepine, phenytoin, and valproate) were evaluated on the sigma scale using two different TEa values to determine significant difference, if any. Statistical Analysis Bias was calculated using the following formula: Bias% = (laboratory EQAS result − peer group mean) × 100 / peer group mean Peer group mean sigma metric was calculated using the standard equation: Sigma value = TEa − bias / coefficient of variation (CV)%. Results Impressive sigma scores (> 3 sigma) for two out of three drugs were obtained with TEa value 25, while with TEa value 15, sigma score was distinctly dissimilar and warranted root cause analysis and corrective action plans to be implemented for both valproate and carbamazepine. Conclusions The current study evidently recognizes that distinctly different sigma values can be obtained, depending on the TEa values selected, and using the same bias and precision values in the sigma equation. The laboratories should thereby choose appropriate TEa goals and make judicious use of sigma metric as a quality improvement tool.

scholarly journals Assessment of sigma metrics results of serum glucose and lipid profile tested by automated chemistry analyzer in medical city hospitals in Iraq

2017 ◽  
Vol 5 (11) ◽  
pp. 4690
Author(s):  
Ahmed Naseer Kaftan ◽  
Anne Khazal Yaseen ◽  
Zina Hasan
Keyword(s):  
Quality Control ◽  
Lipid Profile ◽  
Six Sigma ◽  
Clinical Chemistry ◽  
Serum Glucose ◽  
Error Rates ◽  
Internal Quality ◽  
Total Allowable Error ◽  
Medical City ◽  
Allowable Error

Background: A major target of quality assurance is the minimization of error rates in order to enhance patient safety, six sigma or sigma metrics were used to assess the analytical quality of automated clinical chemistry, six sigma metrics is used in combination with total allowable error, method imprecision and bias. The goal is to attain the highest possible sigma scale within the acceptable limits of total allowable error. For assessment of sigma metrics results of serum glucose and lipid profile and verification of reference values for these analytes tested by automated chemistry analyzer in Medical City hospitals.Methods: In the present study, internal quality control (EQA) and external quality assessment (EQA) data were analyzed for the period from May to July 2017 using chemistry autoanalyzer (Siemens Dimension RxL Max) at the Teaching Laboratories of the Medical City. Mean, standard deviation, coefficient of variation, bias, total error and sigma metrics were calculated for glucose, cholesterol, triglycerides and HDL.Results: Excellent sigma values (≥6) were elicited for triglycerides (10.9), Satisfactory sigma values (≥3) were elicited for cholesterol (3.4) and HDL (3.4), while glucose performed poorly (2.3) on the sigma scale.Conclusions: Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self-assessment tool regarding the functioning of clinical laboratory. Triglycerides was the best performer when it was gauzed on the sigma scale, with a sigma metrics value of 10.9 and glucose had the least sigma metrics value of 2.5 so there is need for improvement and the method should be controlled with greater attention to ensure quality. 

scholarly journals Impact of Infectious Disease Consultation in Patients With Candidemia: A Retrospective Study, Systematic Literature Review, and Meta-analysis

2020 ◽  
Vol 7 (9) ◽  
Author(s):  
Takaaki Kobayashi ◽  
Alexandre R Marra ◽  
Marin L Schweizer ◽  
Patrick Ten Eyck ◽  
Chaorong Wu ◽  
...  
Keyword(s):  
Infectious Disease ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Care Hospital ◽  
Inclusion Criteria ◽  
Infectious Disease Consultation ◽  
Significant Difference ◽  
The Impact

Abstract Background Morbidity and mortality from candidemia remain unacceptably high. While infectious disease consultation (IDC) is known to lower the mortality from Staphylococcus aureus bacteremia, little is known about the impact of IDC in candidemia. Methods We conducted a retrospective observational cohort study of candidemia patients at a large tertiary care hospital between 2015 and 2019. The crude mortality rate was compared between those with IDC and without IDC. Then, we systematically searched 5 databases through February 2020 and performed a meta-analysis of the impact of IDC on the mortality of patients with candidemia. Results A total of 151 patients met the inclusion criteria, 129 (85%) of whom received IDC. Thirty-day and 90-day mortality rates were significantly lower in the IDC group (18% vs 50%; P = .002; 23% vs 50%; P = .0022, respectively). A systematic literature review returned 216 reports, of which 13 studies including the present report fulfilled the inclusion criteria. Among the 13 studies with a total of 3582 patients, IDC was performed in 50% of patients. Overall mortality was 38.2% with a significant difference in favor of the IDC group (28.4% vs 47.6%), with a pooled relative risk of 0.41 (95% CI, 0.35–0.49). Ophthalmology referral, echocardiogram, and central line removal were performed more frequently among patients receiving IDC. Conclusions This study is the first systematic literature review and meta-analysis to evaluate the association between IDC and candidemia mortality. IDC was associated with significantly lower mortality and should be considered in all patients with candidemia.

scholarly journals Acute kidney injury requiring dialysis in obstetric patients: management and clinical outcome in case series of 30 patients in a tertiary care centre

2017 ◽  
Vol 6 (7) ◽  
pp. 2997
Author(s):  
Molina U. Patel ◽  
Yuvraj Jadeja ◽  
Niket Patel ◽  
Nayana Patel ◽  
Smruti Vaishnav ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Tertiary Care ◽  
Case Series ◽  
Kidney Injury ◽  
Therapeutic Interventions ◽  
Risk Category ◽  
Care Hospital ◽  
Tertiary Care Centre ◽  
Significant Difference ◽  
The Impact

Background: Acute Kidney Injury is a common medical problem affecting approximately 5% of all hospitalized and 30% of critically ill patients. The incidence in obstetric patients ranges from 1 in 2000 to 1 in 25000 pregnancies. In India till date, the impact of AKI on fetomaternal outcome and pertaining therapeutic interventions is only sparsely studied.Methods: It is a retrospective cross-sectional study. All obstetric patients with AKI on dialysis, admitted to Shree Krishna Hospital, a tertiary care hospital in Karamsad village in Gujarat from January 2013 to August 2015. Multivariate statistical analysis of clinical and laboratory parameters was performed using SPSS program to obtain the results.Results: The incidence of dialysis was 1.6%. HELLP syndrome and pre-eclampsia (80%) was found to be the most common etiology of AKI followed by Congestive cardiac failure (34.5%), hemorrhage and sepsis in 30% resp. All patients were admitted to ICU care. No significant difference was found between SAP II and SOFA monitoring system. Mechanical ventilation was done to support 53.3% and inotropic support was needed by 56.7% patients. According to the RIFLE criteria, majority of the patients fall under risk category followed by injury. 18% of the patients developed End Stage Renal Disease.Conclusions: In view of the multifaceted etiologies and complexity of management of AKI, a multi-disciplinary approach involving nephrologist, intensivists, obstetricians and neonatologists is extremely important.

Applicability of various quality-control sera to assay of high-density lipoprotein cholesterol.

1980 ◽  
Vol 26 (7) ◽  
pp. 903-907
Author(s):  
D G Bullock ◽  
T J Carter ◽  
S V Hughes
Keyword(s):  
Quality Control ◽  
High Density Lipoprotein ◽  
Quality Assessment ◽  
High Density Lipoprotein Cholesterol ◽  
External Quality Assessment ◽  
Density Lipoprotein ◽  
High Density ◽  
Lipoprotein Cholesterol ◽  
Internal Quality ◽  
External Quality

Abstract Effective internal quality control and external quality assessment of high-density lipoprotein cholesterol assay is made difficult by analyte instability, and the suitability of quality-control sera for this purpose has not been studied. We have therefore investigated the properties of 25 different control sera from 15 suppliers by estimating within-batch precision for the two precipitation procedures used most widely (phosphotungstate/Mg2+ and heparin/Mn2+ with enzymic measurement of cholesterol. Some sera had properties similar to those of fresh human serum, but others demonstrated poor precision for one or both procedures or contained apparent high-density lipoprotein cholesterol in unphysiological concentrations. A study of six sera indicated that between-batch precision was consistent with the within-batch findings. We found that eight of the 25 batches of quality-control serum we investigated may be used for internal quality control and external quality assessment of high-density lipoprotein cholesterol assay.

scholarly journals An Overview of Determination of Milk Fat: Development, Quality Control Measures, and Application

2018 ◽  
Vol 66 (4) ◽  
pp. 1055-1064 ◽  
Author(s):  
Robert Kala ◽  
Eva Samková ◽  
Lenka Pecová ◽  
Oto Hanuš ◽  
Kęstutis Sekmokas ◽  
...  
Keyword(s):  
Quality Control ◽  
Milk Fat ◽  
Fat Content ◽  
Control Measures ◽  
Internal Quality ◽  
External Quality ◽  
Accurate Analysis ◽  
Important Indicator ◽  
Quality Controls

Milk fat content is an important indicator of milk quality because of nutritional and technological aspects of dairying. In this sense the milk fat determination is important practice procedure. The work goal was to do an effective overview and comparison of reference and routine methods of fat determination during their development. Nowadays, there exist a number of methods for determining milk fat content. Reference methods require accurate analysis in compliance with the International Standard ISO, whereas routine methods perform analysis using routine instrumental techniques for faster and cheaper results with acceptable accuracy. Quality control measures have a significant role for result determination reliability and they include internal quality controls, external quality controls, precision of evaluation, and blank samples. In conclusion, due to continuous development and improvement, routine methods will be used more often.

scholarly journals Effect of analytical run length on quality-control (QC) performance and the QC planning process

1997 ◽  
Vol 43 (11) ◽  
pp. 2149-2154 ◽  
Author(s):  
Curtis A Parvin ◽  
Ann M Gronowski
Keyword(s):  
Quality Control ◽  
Error Detection ◽  
Planning Process ◽  
Performance Measure ◽  
Major Influence ◽  
Expected Number ◽  
Control Error ◽  
Allowable Error ◽  
The Impact ◽  
Error Condition

Abstract The performance measure traditionally used in the quality-control (QC) planning process is the probability of rejecting an analytical run when an out-of-control error condition exists. A shortcoming of this performance measure is that it doesn’t allow comparison of QC strategies that define analytical runs differently. Accommodating different analytical run definitions is straightforward if QC performance is measured in terms of the average number of patient samples to error detection, or the average number of patient samples containing an analytical error that exceeds total allowable error. By using these performance measures to investigate the impact of different analytical run definitions on QC performance demonstrates that during routine QC monitoring, the length of the interval between QC tests can have a major influence on the expected number of unacceptable results produced during the existence of an out-of-control error condition.

The Impact of Hospital Accreditation on the Patients Satisfaction of Haemodialysis Department Services

2018 ◽  
Vol 6 (8) ◽  
pp. 384
Author(s):  
Zuber Mujeeb Shaikh
Keyword(s):  
Patient Satisfaction ◽  
Health Care Quality ◽  
Tertiary Care ◽  
Care Quality ◽  
Care Hospital ◽  
Significant Difference ◽  
Before And After ◽  
The Impact ◽  
Survey Questionnaires

The quality of hospital Haemodialysis Department Service is one of the most relevant items of health care quality perceived by patients and by their families. Patient satisfaction is considered a way of measuring the quality of services provided. Objectives: To study the impact of National Accreditation Board for Hospitals & Healthcare Providers (NABH) Accreditation, India on Haemodialysis Department Service patient satisfaction. Methods: It is a quantitative, descriptive and inferential research based case study in which sample of a population was studied by structured satisfaction survey questionnaires (before and after the accreditation) in a private tertiary care hospital at Secunderabad, Telangana State, India to determine its characteristics, and it is then inferred that the population has the same or different characteristics. Significance of Research: It was observed initially before the accreditation that there was a lower patient satisfaction rate of the hospital Haemodialysis Department Services, which was affecting the study hospitals’ business. Hypothesis: Null Hypothesis (Ho) and Alternative Hypothesis (H1) were used and tested to compare the before and after impact of accreditation by applying to each question in the questionnaire. Study Design: The closed ended questionnaire was developed considering the Haemodialysis Department Services and incorporated the six dimensions of quality Safe, Timely, Effective, Efficient, Equitable, and Patient-centred (STEEP) and tested prior to implementing. Questionnaires were given to the patients' families for completion upon using the Haemodialysis Department Services two months before and two months after the accreditation. The data were collected in order to cover all three shifts of the Haemodialysis Department Services. Study Population: Simple random sampling method was selected, the researcher had involved all conscious patients (clinical conditions) from all age groups. Data Collections: Primary data were collected from the survey questionnaires. Secondary data were collected from relevant published journals, articles, research papers, academic literature and web portals. Conclusion: At the 5 % level of significance, the t-test results indicate that there is a significant difference in the responses between before (M=51.11, SD=21.89) and after accreditation (M=58.56, SD=17.28) with p-value <0.001. The mean satisfaction score has improved from before accreditation compared to after accreditation.

Sign in / Sign up

Export Citation Format

Share Document