Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds.

Background New moving average quality control (MA QC) optimization methods have been developed and are available for laboratories. Having these methods will require a strategy to integrate MA QC and routine internal QC. Methods MA QC was considered only when the performance of the internal QC was limited. A flowchart was applied to determine, per test, whether MA QC should be considered. Next, MA QC was examined using the MA Generator (www.huvaros.com), and optimized MA QC procedures and corresponding MA validation charts were obtained. When a relevant systematic error was detectable within an average daily run, the MA QC was added to the QC plan. For further implementation of MA QC for continuous QC, MA QC management software was configured based on earlier proposed requirements. Also, protocols for the MA QC alarm work-up were designed to allow the detection of temporary assay failure based on previously described experiences. Results Based on the flowchart, 10 chemistry, two immunochemistry and six hematological tests were considered for MA QC. After obtaining optimal MA QC settings and the corresponding MA validation charts, the MA QC of albumin, bicarbonate, calcium, chloride, creatinine, glucose, magnesium, potassium, sodium, total protein, hematocrit, hemoglobin, MCH, MCHC, MCV and platelets were added to the QC plans. Conclusions The presented method allows the design and implementation of QC plans integrating MA QC for continuous QC when internal QC has limited performance.

Statistical Process Control: No Hits, No Runs, No Errors?

A novel intervention or new clinical program must achieve and sustain its operational and clinical goals. To demonstrate successfully optimizing health care value, providers and other stakeholders must longitudinally measure and report these tracked relevant associated outcomes. This includes clinicians and perioperative health services researchers who chose to participate in these process improvement and quality improvement efforts ("play in this space"). Statistical process control is a branch of statistics that combines rigorous sequential, time-based analysis methods with graphical presentation of performance and quality data. Statistical process control and its primary tool-the control chart-provide researchers and practitioners with a method of better understanding and communicating data from health care performance and quality improvement efforts. Statistical process control presents performance and quality data in a format that is typically more understandable to practicing clinicians, administrators, and health care decision makers and often more readily generates actionable insights and conclusions. Health care quality improvement is predicated on statistical process control. Undertaking, achieving, and reporting continuous quality improvement in anesthesiology, critical care, perioperative medicine, and acute and chronic pain management all fundamentally rely on applying statistical process control methods and tools. Thus, the present basic statistical tutorial focuses on the germane topic of statistical process control, including random (common) causes of variation versus assignable (special) causes of variation: Six Sigma versus Lean versus Lean Six Sigma, levels of quality management, run chart, control charts, selecting the applicable type of control chart, and analyzing a control chart. Specific attention is focused on quasi-experimental study designs, which are particularly applicable to process improvement and quality improvement efforts.

Clinical Validation of Quality Improvements Using the Six Sigma Concept: A Case Study for Deep Brain Stimulation in Parkinson's Disease.

BACKGROUND: The Six Sigma concept allows for the evaluation of quality changes after the implementation of new technical equipment or adjustment of perioperative procedures. Exemplarily, we applied this method for quality assessment in deep brain stimulation surgery (DBS) for Parkinson's disease. METHODS: The medical procedure and possible errors were registered. Then, 6 critical-to-quality characteristics regarding clinical outcome, surgical precision, and the surgical process were measured. The surgical procedure was then optimized in 2 steps, and its measurement, along with the analysis, was repeated twice. RESULTS: By optimizing perioperative settings, the operation time could be reduced, and the precision of the lead placement could be increased. Clinical outcome, as measured by improvement in UPDRS-III, IV, and reduction of medication could also be improved with smaller required stimulation voltage. With directional leads considerable reduction of medication was achieved in 97% of patients (σ-value 3.39) compared to 83.7% (σ-value 2.53) with nondirectional leads. CONCLUSION: This study shows that the Six Sigma concept is a suitable quality tool to analyze and improve treatment quality of complex medical procedures such as lead positioning in DBS surgery in clinical routine. Our results suggest that directional leads in subthalamic nucleus DBS may have a favorable impact on patients' outcome.

Application of Six Sigma for evaluating the analytical quality of tumor marker assays.

CONTEXT: The results of detection assays for the same specimen are usually quite different in different laboratories or when tested with different detection systems. OBJECTIVE: This study was designed to investigate the value of applying sigma metrics derived from different standards for allowable total error (TEa) in evaluating the analytical quality of tumor marker assays. METHODS: Assays were evaluated for these six tumor markers: total prostate-specific antigen (tPSA), carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), carbohydrate antigen 199 (CA199), carbohydrate antigen 125 (CA125), and carbohydrate antigen 153 (CA153). Sigma values were calculated for two concentrations of quality control products to assess differences in quality of tumor marker assays. Improvement measures were recommended according to the quality goal index, and appropriate quality control rules were selected according to the sigma value. RESULTS: The sigma value was highest using the higher biological variation-derived "appropriate" TEa standard: it was sigma ≥6 or higher in 16.7% of tumor markers. Sigma was below 6 for all tumor markers using the other three TEa. CEA, AFP, CA199, CA125, and CA153 required improved precision. The marker tPSA required improve precision and accuracy. According to sigma values by using China's external quality assessment standards, CEA, AFP, CA125, and CA153 require 13s /22s /R4s /41s multirules for internal quality control, CA199 requires use of 13s /22s /R4s /41s /8x multirules, and tPSA requires maximum quality control rules. CONCLUSION: Six Sigma is useful for evaluating performance of tumor markers assays and has important application value in the quality control of these assays.

Organizational issues for the lean success in China: exploring a change strategy for lean success.

BACKGROUND: The purpose of this paper is to explore a change strategy for lean success in hospitals based on a comprehensive review of the Chinese literature. METHODS: The methodology is a systematic review of the Chinese literature which identified 212 case study papers about lean implementation. We did a thematic content analysis of the 212 papers. RESULTS: Lean applications in Chinese hospitals show significant increases and are mainly used in the fields of outpatient services, operating rooms, pharmacy and logistics. Most hospitals applied lean as a single project but some were beginning to use lean as a systemic path for improvement with an emphasis on lean and strategy. The main goals were to increase the operating efficiency and reduce operating costs. Patients were not central to lean applications. Chinese hospitals appear to lack a full understanding of lean. Four factors appear to be critical for lean success - organizational leadership, adequate technology, stakeholder involvement and individual and organizational benefits. The relationship of these factors changes over time. CONCLUSIONS: This is the first paper to provide a comprehensive view of lean application in Chinese hospitals. The findings presented in this paper provide a systemic evidence to the application of lean in healthcare.

Overview of quality management models for inpatient healthcare settings. A scoping review.

PURPOSE: This scoping review aimed to generate an overview of existing quality management (QM) models for inpatient healthcare published in peer-reviewed literature. DATA SOURCES: Peer-reviewed publications published until June 2016 were retrieved from the databases Medline, PubMed, CINAHL and Cochrane Library using search terms related to QM and models. STUDY SELECTION: Publications mentioning a QM model for general application in healthcare or inpatient care in their title or abstract were included. Languages considered were: English, French, German, Italian and Spanish. DATA EXTRACTION: Data extraction was 3-fold. First, publication characteristics were summarized. Second, the frequency of each identified model was documented and the publications were divided into conceptual and implementation publications. Third, relevant QM models were identified and information regarding the model, including content and relationship with other models, was extracted. RESULTS OF DATA SYNTHESIS: Of 925 retrieved publications, 213 were included. The included publications reported on 64 different QM models that were suitable for or used in inpatient care. Seventeen models were identified as being relevant. The 17 models were then categorized into three different levels: conceptual quality improvement models, concrete application models and country specific adaptations. CONCLUSION: This scoping review provides an overview of 17 existing QM models for inpatient care and their relationships with each other. Various types of models with differing aspects and components exist. In searching for QM models, many different concepts like QM system, accreditation or methodologies appeared. For future investigation, concepts of interest should be clarified.

A review of quality procedures in the UK forensic sciences: What can the field of digital forensics learn?

With a reliance on the various forms of forensic science evidence in complex criminal investigations, the measures for ensuring its quality are facing increasing scrutiny. Improvements to quality management systems, to ensure both the robust application of scientific principles and the accurate interpretation and reporting of results, have arisen as a consequence of high-profile rebuttals of forensic science evidence, combined with process improvements driven by evaluation of current practice. These improvements are crucial to ensure validity of results as well as providing assurance for all those involved in the Criminal Justice System. This work first examines the quality management systems utilised for the examination and analysis of fingerprint, body fluid and DNA evidence. It then proceeds to highlight an apparent lack of comparable quality assurance mechanisms within the field of digital forensics, one of the newest branches of forensic science. Proposals are provided for the improvement of quality assurance for the digital forensics arena, drawing on the experiences of, and more well-established practices within, other forensic disciplines.

Quality of randomized controlled trials of new generation antidepressants and antipsychotics identified in the China National Knowledge Infrastructure (CNKI): a literature and telephone interview study.

BACKGROUND: We are witnessing an exponential increase in the number of randomized controlled trials (RCTs) reported from mainland China. The increase is particularly notable in the field of new generation antidepressants and antipsychotics. Several previous studies have raised doubts regarding their quality. However, the quality of most recent RCTs published in China may have improved. METHODS: We searched RCTs that examined new generation antidepressants and antipsychotics published between 2013 and 2016 in the China National Knowledge Infrastructure (CNKI), the largest database of scientific publications in China. We interviewed the authors of a random subset of the identified references. We assessed the methodological rigor of each study based on the published reports and telephone interviews with the authors using six methodological domains adapted from the Cochrane's risk of bias tool. RESULTS: The final sample consisted of 138 studies, for which we interviewed 58 authors; the authors of 51 studies declined the interview, and the authors of 29 studies could not be contacted. The 51 studies with refused interviews were significantly less likely to be reported from university-affiliated hospitals and were less likely to be published in Chinese core journals. Based on the published reports, most of the 58 studies were assessed to be at unclear risk of bias in most methodological domains. After the interview, only 10 studies were assessed to be at low risk of bias for sequence generation and allocation concealment. Assuming that the studies for which the authors declined interviews had an unclear risk, the proportion of RCTs at low risk of bias in both sequence generation and allocation concealment was 9.2% (10/109, 95% confidence interval [CI]: 5.0 to 16.2). The interviews indicated that the studies were at high risk of bias for most of the other domains. CONCLUSION: In general, RCTs that evaluate new generation antidepressants or antipsychotics and are indexed in the CNKI continue to be of low quality. When conducting systematic reviews and meta-analyses in this field, it would be wise to include a specialist from China as a coresearcher to help assess the risk of bias in the identified studies.

The Impact of Applying Quality Management Practices on Patient Centeredness in Jordanian Public Hospitals: Results of Predictive Modeling.

Targeting the patient's needs and preferences has become an important contributor for improving care delivery, enhancing patient satisfaction, and achieving better clinical outcomes. This study aimed to examine the impact of applying quality management practices on patient centeredness within the context of health care accreditation and to explore the differences in the views of various health care workers regarding the attributes affecting patient-centered care. Our study followed a cross-sectional survey design wherein 4 Jordanian public hospitals were investigated several months after accreditation was obtained. Total 829 clinical/nonclinical hospital staff members consented for study participation. This sample was divided into 3 main occupational categories to represent the administrators, nurses, as well as doctors and other health professionals. Using a structural equation modeling, our results indicated that the predictors of patient-centered care for both administrators and those providing clinical care were participation in the accreditation process, leadership commitment to quality improvement, and measurement of quality improvement outcomes. In particular, perceiving the importance of the hospital's engagement in the accreditation process was shown to be relevant to the administrators (gamma = 0.96), nurses (gamma = 0.80), as well as to doctors and other health professionals (gamma = 0.71). However, the administrator staff (gamma = 0.31) was less likely to perceive the influence of measuring the quality improvement outcomes on the delivery of patient-centered care than nurses (gamma = 0.59) as well as doctors and other health care providers (gamma = 0.55). From the nurses' perspectives only, patient centeredness was found to be driven by building an institutional framework that supports quality assurance in hospital settings (gamma = 0.36). In conclusion, accreditation is a leading factor for delivering patient-centered care and should be on a hospital's agenda as a strategy for continuous quality improvement.

Realigning Shared Governance With Magnet® and the Organization's Operating System to Achieve Clinical Excellence.

In 2012, an academic medical center successfully overhauled a 15-year-old shared governance to align 6 house-wide and 30 unit-based councils with the new Magnet Recognition Program® and the organization's operating system, using the processes of LEAN methodology. The redesign improved cross-council communication structures, facilitated effective shared decision-making processes, increased staff engagement, and improved clinical outcomes. The innovative structural and process elements of the new model are replicable in other health institutions.

Development of an interprofessional lean facilitator assessment scale.

High reliability is important for optimising quality and safety in healthcare organisations. Reliability efforts include interprofessional collaborative practice (IPCP) and Lean quality/process improvement strategies, which require skilful facilitation. Currently, no validated Lean facilitator assessment tool for interprofessional collaboration exists. This article describes the development and pilot evaluation of such a tool; the Interprofessional Lean Facilitator Assessment Scale (ILFAS), which measures both technical and 'soft' skills, which have not been measured in other instruments. The ILFAS was developed using methodologies and principles from Lean/Shingo, IPCP, metacognition research and Bloom's Taxonomy of Learning Domains. A panel of experts confirmed the initial face validity of the instrument. Researchers independently assessed five facilitators, during six Lean sessions. Analysis included quantitative evaluation of rater agreement. Overall inter-rater agreement of the assessment of facilitator performance was high (92%), and discrepancies in the agreement statistics were analysed. Face and content validity were further established, and usability was evaluated, through primary stakeholder post-pilot feedback, uncovering minor concerns, leading to tool revision. The ILFAS appears comprehensive in the assessment of facilitator knowledge, skills, abilities, and may be useful in the discrimination between facilitators of different skill levels. Further study is needed to explore instrument performance and validity.

Performance evaluation of a coagulation laboratory using Sigma metrics.

Purpose Two-thirds of medical decisions are based on laboratory test results. Therefore, laboratories should practice strict quality control (QC) measures. Traditional QC processes may not accurately reflect the magnitude of errors in clinical laboratories. Six Sigma is a statistical tool which provides opportunity to assess performance at the highest level of excellence. The purpose of this paper is to evaluate performance of the coagulation laboratory utilizing Sigma metrics as the highest level of quality. Design/methodology/approach Quality indicators of the coagulation laboratory from January 1, 2009, to December 31, 2015, were evaluated. These QIs were categorized into pre-analytical, analytical and post-analytical. Relative frequencies of errors were calculated and converted to Sigma scale to determine the extent of control over each process. The Sigma level of 4 was considered optimal performance. Findings During the study period, a total of 474,655 specimens were received and 890,535 analyses were performed. These include 831,760 (93.4 percent) routine and 58,775 (6.6 percent) special tests. Stat reporting was requested for 166,921 (18.7 percent). Of 7,535,146 total opportunities (sum of the total opportunities for all indicators), a total of 4,005 errors were detected. There were 2,350 (58.7 percent) pre-analytical, 11 (0.3 percent) analytical and 1,644 (41 percent) post-analytical errors. Average Sigma value obtained was 4.8 with 12 (80 percent) indicators achieving a Sigma value of 4. Three (20 percent) low-performance indicators were: unacceptable proficiency testing (3.8), failure to inform critical results (3.6) and delays in stat reporting (3.9). Practical implications This study shows that a small number of errors can decrease Sigma value to below acceptability limits. If clinical laboratories start using Sigma metrics for monitoring their performance, they can identify gaps in their performance more readily and hence can improve their performance and patient safety. Social implications This study provides an opportunity for the laboratorians to choose and set world-class goals while assessing their performance. Originality/value To the best of the authors' knowledge and belief, this study is the first of its kind that has utilized Sigma metrics as a QC tool for monitoring performance of a coagulation laboratory.

Effect of Lean Six Sigma on quality performance in Malaysian hospitals.

PURPOSE: The purpose of this paper is to investigate the effects of Lean Six Sigma (LSS) and workforce management on the quality performance of Malaysian hospitals. This paper also investigates the direct and indirect relationships between top management commitment and quality performance of the healthcare organisations in Malaysia. DESIGN/METHODOLOGY/APPROACH: This study applied stratified random sampling to collect data from 15 different hospitals in Peninsular Malaysia. The self-administered survey questionnaires were distributed among 673 hospital staff (i.e. doctors, nurses, pharmacists, and medical laboratory technologists) to obtain 335 useful responses with a 49.47 per cent valid response rate. The research data were analysed based on confirmatory factor analysis and structural equation modelling by using AMOS version 23 software. FINDINGS: The research findings indicated that LSS and workforce management have a significant impact on quality performance of the Malaysian hospitals, whereas senior management commitment was found to have an insignificant relationship with quality performance. The research findings indicate that senior management commitment has no direct significant relationship with quality performance, but it has an indirect significant relationship with quality performance through the mediating effects of LSS and workforce management. RESEARCH LIMITATIONS/IMPLICATIONS: This research focussed solely on healthcare organisations in Malaysia and thus the results might not be applicable for other countries as well as other service organisations. ORIGINALITY/VALUE: This research provides theoretical, methodological, and practical contributions for the LSS approach and the research findings are expected to provide guidelines to enhance the level of quality performance in healthcare organisations in Malaysia as well as other countries.

Workplace violence prevention standardization using lean principles across a healthcare network.

Purpose The purpose of this paper is to describe the process used to standardize a Workplace Violence Prevention Program (WVPP) within a five-hospital healthcare system in Veterans Health Administration (VHA). Design/methodology/approach A description of the lean process improvement principles, used to bring the WVPP into compliance with Occupational Safety and Health Administration (OSHA) and other agencies through streamlining/standardizing processes. Findings There was significant standardization in both the threat assessment and education arms of the WVPP. Compliance with all major US Department of Labor OSHA requirements, as well as substantial time savings, were realized as part of this process improvement. Originality/value VHA is leading the way in inter/multidisciplinary assessment and mitigation of workplace violence, however, there are significant competing demands on staff time. This first ever use of lean principles to streamline processes around workplace violence prevention freed up clinician time for care while improving internal and external customer satisfaction, representing a major step forward in workplace violence risk mitigation.

Supply chain partnership assessment of a diabetes clinic.

Purpose Diabetes is one of the major healthcare challenges in India. The chronic nature of the disease makes the lifetime cost of the treatment exorbitantly high. The medicine cost contributes a major size of expense in diabetes management. To make healthcare available to poorest of the poor, it is imperative to control the rising cost of diabetes treatment. The earlier research works done in this area focuses more on inventory management techniques to control the cost of healthcare. Less interest is shown in the role of better supply chain partnership (SCP) in reducing the cost of procurement of medicine. The purpose of this paper is to develop and use the SCP assessment framework for a diabetes clinic. The approach is generalized enough to be adopted for other similar organization. Design/methodology/approach This paper adopts self-assessment criteria of the European Foundation for Quality Management (EFQM) business excellence model for analysis of SCP in the supply chain of a private diabetes clinic in Varanasi. The paper uses analytic hierarchy process (AHP) method for calculation of weights of criteria. Findings The EFQM-based framework can be adopted as easy-to-use tool to make an objective assessment of the SCP. The proposed model in the study is a balanced model between enablers and results, which includes multiple assessment dimensions. The supply chain performance score of the diabetes clinic under study was found as the Tool Pusher, which means the effort in direction of SCP is not too good. The organization needs to clearly define the SCP goal and analyze the results to identify the gap areas. Originality/value The study is first of its kind and contributes to the literature by providing non-prescriptive and easy-to-use SCP assessment framework, for chronic disease care. The case study approach provides a procedure for the healthcare organization willing to adopt this approach.

Patient complaints as a means to improve quality of hospital care. Results of a qualitative content analysis / Patientenrückmeldung als Möglichkeit die Versorgungsqualität von Spitalpatienten zu verbessern. Ergebnisse einer qualitativen Inhaltsanalyse

Background: Many hospitals have defined procedures for a complaint management. A systematic analysis of patient complaints helps to identify similar complaints and patterns so that targeted improvement measures can be derived (Gallagher & Mazor, 2015). Aim: Our three-month, nurse-led practice development project aimed 1) to identify complaints regarding communication issues, 2) to systemise and prioritise complaints regarding communication issues, and 3) to derive clinic-specific recommendations for improvement. Method: We analysed 273 complaints of patients documented by the quality management (secondary data analysis). Using content analysis and applying the coding taxonomy for inpatient complaints by Reader, Gillespie and Roberts (2014), we distinguished communication-related complaints. By further inductive differentiation of these complaints, we identified patterns and prioritised fields of action. Results: We identified 186 communication-related complaints divided into 16 subcategories. For each subcategory, improvement interventions were derived, discussed and prioritised. Conclusions: Thus, patient complaints provided an excellent opportunity for reflection and workplace learning for nurses. The analysis gave impulse to exemplify the subject "person-centered care" for nurses.

Using Lean Six Sigma Methodology to Improve Quality of the Anesthesia Supply Chain in a Pediatric Hospital.

Six Sigma and Lean methodologies are effective quality improvement tools in many health care settings. We applied the DMAIC methodology (define, measure, analyze, improve, control) to address deficiencies in our pediatric anesthesia supply chain. We defined supply chain problems by mapping existing processes and soliciting comments from those involved. We used daily distance walked by anesthesia technicians and number of callouts for missing supplies as measurements that we analyzed before and after implementing improvements (anesthesia cart redesign). We showed improvement in the metrics after those interventions were implemented, and those improvements were sustained and thus controlled 1 year after implementation.

Performance assessment of human resource by integration of HSE and ergonomics and EFQM management system.

Purpose The purpose of this paper is to present an integrated framework for performance evaluation and analysis of human resource (HR) with respect to the factors of health, safety, environment and ergonomics (HSEE) management system, and also the criteria of European federation for quality management (EFQM) as one of the well-known business excellence models. Design/methodology/approach In this study, an intelligent algorithm based on adaptive neuro-fuzzy inference system (ANFIS) along with fuzzy data envelopment analysis (FDEA) are developed and employed to assess the performance of the company. Furthermore, the impact of the factors on the company's performance as well as their strengths and weaknesses are identified by conducting a sensitivity analysis on the results. Similarly, a design of experiment is performed to prioritize the factors in the order of importance. Findings The results show that EFQM model has a far greater impact upon the company's performance than HSEE management system. According to the obtained results, it can be argued that integration of HSEE and EFQM leads to the performance improvement in the company. Practical implications In current study, the required data for executing the proposed framework are collected via valid questionnaires which are filled in by the staff of an aviation industry located in Tehran, Iran. Originality/value Managing HR performance results in improving usability, maintainability and reliability and finally in a significant reduction in the commercial aviation accident rate. Also, study of factors affecting HR performance authorities participate in developing systems in order to help operators better manage human error. This paper for the first time presents an intelligent framework based on ANFIS, FDEA and statistical tests for HR performance assessment and analysis with the ability of handling uncertainty and vagueness existing in real world environment.

Reducing patients' falls rate in an Academic Medical Center (AMC) using Six Sigma "DMAIC" approach.

Purpose The purpose of this paper is to evaluate the impact of adopting the Six Sigma define, measure, analyze, improve and control (DMAIC) approach in reducing patients fall rate in an Academic Medical Center, Saudi Arabia. Design/methodology/approach A prospective study design was adopted and this study was conducted at King Fahd Hospital of the University (KFHU) during the year 2014. Based on the historical data of the patients' falls reported at KFHU during the year 2013, the goal was fixed to reduce the falls rate from 7.18 to<3 (over 60 percent reduction) by the end of December 2014. This study was conducted through the five phases of "DMAIC" approach using various quality tools. Three time periods were identified, namely, pre-intervention phase; intervention phase; and post-intervention phase. Appropriate strategies were identified through the process of brainstorming and were implemented to study the potential causes leading to the occurrence of falls. Findings The pre-intervention falls rate was reported as 6.57 whereas the post-intervention falls rate was measured as 1.91 (demonstrating a 70.93 percent reduction) after the implementation of improvement strategies. The adherence rate toward the practice of carrying falls risk assessment and hourly rounding was observed to be high where 88 percent of nurses are regularly practicing it. A control plan was also executed to sustain the improvements obtained. Originality/value The Six Sigma "DMAIC" approach improves the processes related to the prevention of falls. A greater reduction in patients falls rate (over 70 percent) was observed after the implementation of the improvement strategy.

How Kindred Won Nation's Highest Award For Performance Excellence.

A skilled nursing center from rural Idaho makes its mark in history.