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Objective: To improve the number of patients receiving annual computed tomography (CT) scan and tumour markers, who are diagnosed with low-grade mucinous neoplasms (LAMN)., Design: A pre-/post-intervention design was employed using Lean Six Sigma methods to identify gaps in the screening system and to develop and implement solutions for a more robust, auditable screening programme., Setting: The patients diagnosed with LAMN of the appendix referred to the acute hospital and are enrolled in the screening service., Participants: Consultant colorectal surgeons, cancer nurse specialist, colorectal medical team and quality improvement staff., Interventions: Diagnostic tools identified gaps in the current process. A set of improvements were implemented to standardize the pathway for referral and surveillance of patients, provide information on the condition and treatment and standardize and track information received by patients and their referring hospital., Main Outcome Measure(s): Pre and post-intervention outcome measures were taken for the number of patients who receive an annual CT of thoracic, abdomen and peritoneum and tumour markers and number of patients who receive information and contact details., Results: At baseline, of the 28 patients that met the inclusion criteria only 61% had a correct follow-up. Following the implementation of improvements, 78% of patients had correct follow-up and 90% had received information., Conclusions: Gaps in the current cancer screening system were identified and improvements implemented a reduced number of patients having an incorrect follow-up. Findings are applicable across all precancerous screening systems irrespective of the type of malignancy. The methods used empowered patients and fostered an interdisciplinary team approach to care., (© The Author(s) 2019. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: To improve access for hip fracture patients to surgery within 48 h of presentation to the Emergency Department, and to increase the number of patients receiving pre-operative orthogeriatric review, through streamlining an existing hip fracture patient pathway., Design: A pre-post design involving a multi-disciplinary team use of the Define, Measure, Analyse, Improve and Control framework integral to Lean Six Sigma (LSS) methodology, to assess and adapt the existing hip fracture pathway from presentation to Emergency Department to the initiation of surgery., Setting: A 600-bed teaching hospital in Ireland., Participants: Nursing, medical, administrative and physiotherapy staff working across Emergency Medicine, Orthogeriatrics and Orthopaedic Specialities and Project management., Interventions: LSS methodology was used to redesign an existing pathway, improving patient access to ortho-geriatrician assessment, pain relief and surgery in line with the Irish Hip Fracture Data Base Key performance indicators., Main Outcome Measures: Access to pain relief, access to surgery and volume of patients receiving ortho-geriatric assessment., Results: The percentage of patients undergoing surgery within 48 h of presentation to Emergency Department increased from 55% to 79% at 3 months, and to 85% at 6 months. Improvements were also achieved in the secondary performance metrics relevant to quality of patient care. All care pathway changes were cost neutral., Conclusions: Hip fracture surgery within 48 h of presentation to hospital is a recognized standard of hip fracture care associated with decreased length of stay and decreased mortality. With respect to this performance metric, this intervention has contributed to improved patient outcomes., (© The Author(s) 2019. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

For many years the concept of patient-based quality control (QC) has been discussed and implemented in hematology laboratories; however, the techniques have not been widely implemented in clinical chemistry. This is mainly because of the complexity of this form of QC, as it needs to be optimized for each population and often for each analyte. However, the clear advantages of this form of QC, together with the ongoing realization of the shortcomings of "conventional" QC, have driven a need to provide guidance to laboratories to assist in deploying patient-based QC. This overview describes the components of a patient-based QC system (calculation algorithm, block size, truncation limits, control limits) and the relationship of these to the analyte being controlled. We also discuss the need for patient-based QC system optimization using patient data from the individual testing laboratory to reliably detect systematic errors while ensuring that there are few false alarms. The term patient-based real-time quality control covers many activities that use data from patient samples to detect analytical errors. These activities include the monitoring of patient population parameters such as the mean or median analyte value or using single within-patient changes such as the delta check. In this report, we will restrict the discussion to population-based parameters. This overview is intended to serve as a guide for the implementation of a patient-based QC system. The report does not cover the clinical evaluation of the population., (© 2019 American Association for Clinical Chemistry.)

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., (© The Author(s) 2018. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: For quality analysis, we applied the Six Sigma concept to define quality indicators and their boundaries as well as to compare treatment-dependent outcome data of deep brain stimulation (DBS) of the subthalamic nucleus (STN) in patients with Parkinson's disease (PD)., Methods: The Unified Parkinson Disease Rating Scale (UPDRS) III with on medication and on stimulation, the reduction of daily levodopa equivalence doses (LED), and the stimulation amplitude 1 year after surgery were registered. Regarding the results of the EARLYSTIM study, sigma values for applicable studies were calculated and compared. Further, the impact of perioperative conditions on patients' outcomes was analyzed., Results: Forty-one studies with 2184 patients were included. The bleeding risk was 1.36%. In median, UPDRS III on/on improved by 19.9% while the LED was reduced by 45.2%. The median stimulation amplitude was 2.84 V. With the Six Sigma principle, a comparison between different centers was possible. Microelectrode recordings (MER) did not correlate with occurrence of bleedings and did not impact patient outcome., Conclusions: The Six Sigma principle can be simply used to analyze, improve and compare complex medical processes, particularly, the DBS surgery. Based on these data, higher sigma values were reached for clinical improvement in UPDRS III on/on for patients who underwent surgery in local anesthesia with intraoperative test stimulation compared to surgery in general anesthesia. However, the difference was not statistically significant. Application of MER was found to be optional with no increased bleeding risk and no improvement on patient's outcome.

Introduction: Inefficiencies in the command approval process for publications and/or presentations negatively impact DoD Graduate Medical Education (GME) residency programs' ability to meet ACGME scholarly activity requirements. A preliminary review of the authored works approval process at Naval Medical Center San Diego (NMCSD) disclosed significant inefficiency, variation in process, and a low level of customer satisfaction. In order to facilitate and encourage scholarly activity at NMCSD, and meet ACGME requirements, the Executive Steering Council (ESC) chartered an interprofessional team to lead a Lean Six Sigma (LSS) Rapid Improvement Event (RIE) project., Materials and Methods: Two major outcome metrics were identified: (1) the number of authored works submissions containing all required signatures and (2) customer satisfaction with the authored works process. Primary metric baseline data were gathered utilizing a Clinical Investigations database tracking publications and presentations. Secondary metric baseline data were collected via a customer satisfaction survey to GME faculty and residents. The project team analyzed pre-survey data and utilized LSS tools and methodology including a "gemba" (environment) walk, cause and effect diagram, critical to quality tree, voice of the customer, "muda" (waste) chart, and a pre- and post-event value stream map. The team selected an electronic submission system as the intervention most likely to positively impact the RIE project outcome measures., Results: The number of authored works compliant with all required signatures improved from 52% to 100%. Customer satisfaction rated as "completely or mostly satisfied" improved from 24% to 97%. For both outcomes, signature compliance and customer satisfaction, statistical significance was achieved with a p < 0.0001., Conclusion: This RIE project utilized LSS methodology and tools to improve signature compliance and increase customer satisfaction with the authored works approval process, leading to 100% signature compliance, a comprehensive longitudinal repository of all authored work requests, and a 97% "completely or mostly satisfied" customer rating of the process., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2018.)

Background: Policy encourages health care providers to listen and respond to feedback from patients, expecting that it will enhance care experiences. Enhancement of patients' experiences may not yet be a reality, particularly in primary health care settings., Objective: To identify the issues that influence the use and impact of feedback in this context., Design and Setting: A realist synthesis of studies of the use of patient feedback within primary health care settings., Methods: Structured review of published studies between 1971 and January 2015., Results: Eighteen studies were reported in 20 papers. Eleven studies reported patient survey scores as a primary outcome. There is little evidence that formal patient feedback led to enhanced experiences. The likelihood of patient feedback to health care staff stimulating improvements in future patients' experiences appears to be influenced predominantly by staff perceptions of the purpose of such feedback; the validity and type of data that is collected; and where, when and how it is presented to primary health care teams or practitioners and teams' capacity to change., Conclusions: There is limited research into how patient feedback has been used in primary health care practices or its usefulness as a stimulant to improve health care experience. Using a realist synthesis approach, we have identified a number of contextual and intervention-related factors that appear to influence the likelihood that practitioners will listen to, act on and achieve improvements in patient experience. Consideration of these may support research and improvement work in this area., (© The Author 2017. Published by Oxford University Press.)

Quality Problem or Issue: Jacaranda Health (JH) is a Kenya-based organization that attempts to provide affordable, high-quality maternal and newborn healthcare through a chain of private health facilities in Nairobi., Initial Assessment: JH needed to adopted quality improvement as an organization-wide strategy to optimize effectiveness and efficiency., Choice of Solution: Value Stream Mapping, a Lean Management tool, was used to engage staff in prioritizing opportunities to improve clinical outcomes and patient-centered quality of care., Implementation: Implementation was accomplished through a five-step process: (i) leadership engagement and commitment; (ii) staff training; (iii) team formation; (iv) process walkthrough; and (v) construction and validation., Evaluation: The Value Stream Map allowed the organization to come together and develop an end-to-end view of the process of care at JH and to select improvement opportunities for the entire system., Lessons Learned: The Value Stream Map is a simple visual tool that allows organizations to engage staff at all levels to gain commitment around quality improvement efforts., (© The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

Objectives: To develop a business subsystem fulfilling International Organization for Standardization 15189 nonconformance management regulatory standard, facilitating employee engagement in problem identification and resolution to effect quality improvement and risk mitigation., Methods: From 2012 to 2016, the integrated laboratories of the Henry Ford Health System used a quality technical team to develop and improve a management subsystem designed to identify, track, trend, and summarize nonconformances based on frequency, risk, and root cause for elimination at the level of the work., Results: Programmatic improvements and training resulted in markedly increased documentation culminating in 71,641 deviations in 2016 classified by a taxonomy of 281 defect types into preanalytic (74.8%), analytic (23.6%), and postanalytic (1.6%) testing phases. The top 10 deviations accounted for 55,843 (78%) of the total., Conclusions: Deviation management is a key subsystem of managers' standard work whereby knowledge of nonconformities assists in directing corrective actions and continuous improvements that promote consistent execution and higher levels of performance., (© American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

Objectives: Specimen labeling defects within the perioperative environment are a known patient safety risk that carries the potential for adverse outcomes. These outcomes are a result of errors that occur when unsuspecting providers operate within poorly designed processes with little control over the specimen collection context. Many costly outcomes resulting from labeling errors may include patient harm, inappropriate treatments, lengthy investigations, corrective actions, and, at times, legal action., Methods: This improvement initiative to identify and reduce the risk of specimen labeling defects includes the application of a disciplined Lean problem-solving approach with the engagement of employees who actually perform the work., Results: By listening to the voice of our internal customers, we collectively redesigned the workflow by collaboratively linking work teams of the operating room and Pathology Department of Henry Ford Hospital, Detroit, over a 2-year period., Conclusions: We illustrate successful interventions achieved by Lean process management by streamlining, standardizing, and mistake proofing the processes and eliminating waste and inefficiency through systematic problem solving., (© American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Lean Six Sigma (LSS) is a process improvement methodology developed in the manufacturing industry to increase process efficiency while maintaining product quality. The efficacy of LSS application to the health care setting has not been adequately studied. This article presents a quality improvement project at the U.S. Naval Academy that uses LSS to improve the mass immunizations process for Midshipmen during in-processing. The process was standardized to give all vaccinations at one station instead of giving a different vaccination at each station. After project implementation, the average immunizations lead time decreased by 79% and staffing decreased by 10%. The process was shown to be in control with a capability index of 1.18 and performance index of 1.10, resulting in a defect rate of 0.04%. This project demonstrates that the LSS methodology can be applied successfully to the health care setting to make sustainable process improvements if used correctly and completely., (Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.)

Objectives: To support our Lean culture of continuous improvement, we implemented a daily management system designed so critical metrics of operational success were the focus of local teams to drive improvements., Methods: We innovated a standardized visual daily management board composed of metric categories of Quality, Time, Inventory, Productivity, and Safety (QTIPS); frequency trending; root cause analysis; corrective/preventive actions; and resulting process improvements., Results: In 1 year (June 2013 to July 2014), eight laboratory sections at Henry Ford Hospital employed 64 unique daily metrics. Most assessed long-term (>6 months), monitored process stability, while short-term metrics (1-6 months) were retired after successful targeted problem resolution. Daily monitoring resulted in 42 process improvements., Conclusions: Daily management is the key business accountability subsystem that enabled our culture of continuous improvement to function more efficiently at the managerial level in a visible manner by reviewing and acting based on data and root cause analysis., (Copyright© by the American Society for Clinical Pathology.)

Objective: Continuous quality improvement (CQI) methods are foundational approaches to improving healthcare delivery. Publications using the term CQI, however, are methodologically heterogeneous, and labels other than CQI are used to signify relevant approaches. Standards for identifying the use of CQI based on its key methodological features could enable more effective learning across quality improvement (QI) efforts. The objective was to identify essential methodological features for recognizing CQI., Design: Previous work with a 12-member international expert panel identified reliably abstracted CQI methodological features. We tested which features met rigorous a priori standards as essential features of CQI using a three-phase online modified-Delphi process., Setting: Primarily United States and Canada., Participants: 119 QI experts randomly assigned into four on-line panels., Intervention: Participants rated CQI features and discussed their answers using online, anonymous and asynchronous discussion boards. We analyzed ratings quantitatively and discussion threads qualitatively. Main outcome measure(s) Panel consensus on definitional CQI features., Results: /st> Seventy-nine (66%) panelists completed the process. Thirty-three completers self-identified as QI researchers, 18 as QI practitioners and 28 as both equally. The features 'systematic data guided activities,' 'designing with local conditions in mind' and 'iterative development and testing' met a priori standards as essential CQI features. Qualitative analyses showed cross-cutting themes focused on differences between QI and CQI., Conclusions: We found consensus among a broad group of CQI researchers and practitioners on three features as essential for identifying QI work more specifically as 'CQI.' All three features are needed as a minimum standard for recognizing CQI methods.

Purpose: The implementation of a smart-pump continuous quality-improvement (CQI) program across a large health system is described, with an emphasis on key metrics for outcomes analyses and program refinement., Summary: Three years ago, the University of Pittsburgh Medical Center health system launched a CQI initiative to help ensure the safe use of 6000 smart pumps in its 14 inpatient facilities. A centralized team led by pharmacists is responsible for the retrieval and interpretation of smart-pump data, which is continuously transmitted to a main server. CQI findings are regularly posted on the health system's interdisciplinary intranet. Monitored metrics include rates of compliance with preprogrammed infusion limits, the top 20 drugs involved in alerts, drugs associated with alert-override rates of ≥90%, numbers of alerts by infusion type, nurse responses to alerts, and alert rate per drug library update. Based on the collected CQI data and site-specific requests, four systemwide updates of the smart-pump drug library were performed during the first 18 months of the program, reducing "nuisance alerts" by about 10% per update cycle and enabling targeted interventions to reduce rapid-infusion errors, other adverse drug events (ADEs), and pump-programming workarounds. Over one 12-month period, bedside alerts prompted nurses to reprogram or cancel continuous infusions an average of 400 times per month, potentially averting i.v. medication ADEs., Conclusion: A smart-pump CQI program is an effective tool for enhancing the safety of i.v. medication administration. The ongoing refinement of the drug library through the development and implementation of key interventions promotes the growth and sustainability of the smart-pump initiative systemwide.

The Patient Safety Committee of The American Society for Aesthetic Plastic Surgery (ASAPS) has initiated a new patient safety training program. The pilot module of this program will focus on hypothermia prevention, with the goal of decreasing the negative effects of hypothermia for surgery patients. Previous literature has shown that hypothermia can result in a higher incidence of surgical wound infections and longer postanesthesia recovery times, among other adverse effects. Therefore, educating medical personnel on patient safety techniques like hypothermia prevention is important for achieving positive patient outcomes. However, organizational research indicates that implementing and sustaining improvements system-wide requires a "continuous improvement culture." Earlier research has identified concepts such as double-loop learning, problem-solving, error management, and organizational routines as key elements of a continuous improvement culture. Antecedent to the ASAPS training program, a case study analysis of three surgery practices was performed to better understand the relationship between organizational structure, hypothermia domain knowledge, and continuous improvement culture characteristics. The data analysis indicates a positive correlation between hypothermia prevention and elements of a continuous improvement culture. These findings suggest that a patient safety training program, which includes learning objectives directed at improving organizational culture in addition to specific research-based preventative techniques, is more likely to achieve sustained improvements in patient outcomes than training focused on preventative techniques alone.

Purpose: The use of continuous quality-improvement (CQI) processes in the implementation of intelligent infusion pumps in a community teaching hospital is described., Summary: After the decision was made to implement intelligent i.v. infusion pumps in a 413-bed, community teaching hospital, drug libraries for use in the safety software had to be created. Before drug libraries could be created, it was necessary to determine the epidemiology of medication use in various clinical care areas. Standardization of medication administration was performed through the CQI process, using practical knowledge of clinicians at the bedside and evidence-based drug safety parameters in the scientific literature. Post-implementation, CQI allowed refinement of clinically important safety limits while minimizing inappropriate, meaningless soft limit alerts on a few select agents. Assigning individual clinical care areas (CCAs) to individual patient care units facilitated customization of drug libraries and identification of specific CCA compliance concerns. Between June 2007 and June 2008, there were seven library updates. These involved drug additions and deletions, customization of individual CCAs, and alterations of limits. Overall compliance with safety software use rose over time, from 33% in November 2006 to over 98% in December 2009. Many potentially clinically significant dosing errors were intercepted by the safety software, prompting edits by end users. Only 4-6% of soft limit alerts resulted in edits., Conclusion: Compliance rates for use of infusion pump safety software varied among CCAs over time. Education, auditing, and refinement of drug libraries led to improved compliance in most CCAs.

Objective: This article describes the application of quality improvement methodology to implement a measurement tool for the assessment of functional status in pediatric patients with chronic pain referred for behavioral intervention., Methods: The Functional Disability Inventory (FDI), a validated instrument for assessment of pain-related disability, was chosen as the primary clinical outcome measure. Using improvement science methodology, PDSA (Plan-Do-Study-Act) cycles were run to evaluate: (a) regular FDI administration, (b) two administration methods, (c) regular patient feedback, and (d) documentation methods., Results: Within 1 month, psychologists were administering the FDI at least 80% of the time to patients. A high level of reliability using two administration methods (92.8%) was demonstrated. The FDI was feasible to integrate into clinical practice. Modifications to electronic records further enhanced clinician reliability of documentation., Conclusions: Quality improvement methods are an innovative way to make process changes in pediatric psychology settings to dependably gather and document evidence-based patient outcomes.

Objective: Many changes have been initiated in the Dutch hospital sector to optimize health-care delivery: national agenda-setting, increased competition and transparency, a new system of hospital reimbursement based on diagnosis-treatment combinations, intensified monitoring of quality and a multi-layered organizational development programme based on quality improvement collaboratives. The objective is to answer the question as to whether these changes were accompanied by a further development of hospital quality management systems and to what extent did the development within the multi-layered programme hospitals differ from that in other hospitals., Design: Longitudinal data were collected in 1995, 2000, 2005 and 2007 using a validated questionnaire. Descriptive analyses and multi-level modelling were applied to test whether: (1) quality management system development stages in hospitals differ over time, (2) development stages and trends differ between hospitals participating or not participating in the multi-layered programme and (3) hospital size has an effect on development stage., Setting: Dutch hospital sector between 1995 and 2007., Participants: Hospital organizations., Intervention: Changes through time., Main Outcome Measure: Quality management system development stage., Results: Since 1995, hospital quality management systems have reached higher development levels. Programme participants have developed their quality management system more rapidly than have non-participants. However, this effect is confounded by hospital size., Conclusions: Study results suggest that the combination of policy measures at macro level was accompanied by an increase in hospital size and the further development of quality management systems. Hospitals are entering the stage of systematic quality improvement.

Background: Incidents and quality problems are a prime cause why health care leaders are calling to redesign health care delivery. One of the concepts used is lean thinking. Yet, lean often leads to resistance. Also, there is a lack of high quality evidence supporting lean premises. In this paper, we present an overview of lean thinking and its application to health care., Development, Theory and Application of Lean Thinking to Health Care: Lean thinking evolved from a tool designed to improve operational shop-floor performance at an automotive manufacturer to a management approach with both operational and sociotechnical aspects. Sociotechnical dynamics have until recently not received much attention. At the same time a balanced approach might lead to a situation where operational and sociotechnical improvements are mutually reinforcing. Application to health care has been limited and focussed mainly on operational aspects using original lean tools. A more integrative approach would be to pay more attention to sociotechnical dynamics of lean implementation efforts. Also, the need to use the original lean tools may be limited, because health care may have different instruments and tools already in use that are in line with lean thinking principles., Discussion: We believe lean thinking has the potential to improve health care delivery. At the same time, there are methodological and practical considerations that need to be taken into account. Otherwise, lean implementation will be superficial and fail, adding to existing resistance and making it more difficult to improve health care in the long term.

Background: The surgeon's individual performance is a key component of total quality management (TQM) in cardiac surgery. Early mortality as well as postoperative complications can be stratified in order to develop a surgeon performance index (SPI)., Material and Methods: In three consecutive annual periods (3703 patients) data of board-certified cardiac surgeons were compared. Risk-adjustment of early mortality and postoperative complications was performed by logistical EuroSCORE (logES). Early mortality (EM), early rethoracotomy for bleeding (ReTh), sternal rewiring for instability (ReWr), and mediastinitis (Med) were assessed. ReTh, ReWr, and Med were weighted according to empiric data: (ReThx2; ReWrx1; Medx3). Surgeon performance index was computed as follows: SPI=(EM/logES+[((ReTh/logES)x2)+((ReWr/logES)x1)+((Med/logES)x3)]/6)/2. Ideal SPI was considered

Purpose: Factors influencing the bar-code verification by nurses during medication administration in a Dutch hospital were studied., Summary: The use of bar-code verification during medication administration in five medical departments was recorded daily for three weeks. These data were collected via electronic medication administration records. The frequency of bar-code verification was calculated as a percentage of all administrations, corrected for the availability of bar-coded packages. Nurses were asked why bar-code verification was not always used. A total of 23,492 medication administrations were recorded, 15,162 (64.5%) of which required bar-code verification. Bar-code verification was significantly influenced by the medical department, deviation between prescribed and administered times, administration route of the drug, number of nurses available in each department, and age of the nurse. The five most cited reasons for not verifying bar codes were difficulties in scanning bar codes on the medication labels, lack of awareness of bar codes on medication labels, delays in responses from the computerized system, shortage of time, and administration of medication before prescription., Conclusion: Nurses verified the bar codes of only about half of medications administered to patients. Various factors influenced the frequency of bar-code verification by nurses except the number of medications administered. More education regarding medication safety is warranted to increase compliance to a bar-code-enabled point-of-care system.

By adopting a cultural transformation in its employees' approach to work and using manufacturing based continuous quality improvement methods, the surgical pathology division of Henry Ford Hospital, Detroit, MI, focused on reducing commonly encountered defects and waste in processes throughout the testing cycle. At inception, the baseline in-process defect rate was measured at nearly 1 in 3 cases (27.9%). After the year-long efforts of 77 workers implementing more than 100 process improvements, the number of cases with defects was reduced by 55% to 1 in 8 cases (12.5%), with a statistically significant reduction in the overall distribution of defects (P = .0004). Comparison with defects encountered in the pre-improvement period showed statistically significant reductions in pre-analytic (P = .0007) and analytic (P = .0002) test phase processes in the post-improvement period that included specimen receipt, specimen accessioning, grossing, histology slides, and slide recuts. We share the key improvements implemented that were responsible for the overall success in reducing waste and re-work in the broad spectrum of surgical pathology processes.

Objective: to enhance the delivery of services, using continuous quality improvement, and an outreach strategy., Design and Setting: pre and post measurements in a Primary Health Care system in El Salvador. Outcome indicators: women screened for the first time in their lifetime, unsatisfactory samples, turnaround time, and follow-up., Intervention: involvement of policy, service provision and community levels in 4 plan-do-study-act cycles, facilitating linkages between work processes and a quality control group., Results: 3,408 women screened for the first time in their lifetime in 1 year in regular services; unsatisfactory samples reduced by 1/2; turnaround time reduced by almost 1/3; follow-up increased from 24% (22/90) to 100% (196/196) .146 of the 151 women cytologically defined as low and high-grade squamous intraepithelial lesions (L-HSIL) were confirmed on histology as cervical intraepithelial neoplasia (CIN), while 5 showed benign changes. Of the 43 women classified as having high-grade squamous intraepithelial lesion on cytology, 36 were diagnosed with CIN2 lesions, 7 with CIN3 and 2 were confirmed with invasive carcinoma., Conclusion: improvements in delivery of screening can be made with few additional resources in the absence of an organized system. We promoted linkages between detection and diagnosis through enhancement of teamwork and functional coordination, which improved follow-up rates. We restored links between screening and reading processes through minor adjustments, which improved the turnaround time of samples. Trained outreach workers created new links between community and health services, identifying women who had never been screened before in their lives and facilitating their access to regular clinic services.

Background: Peer review groups (PRGs) and quality circles (QCs) commenced in The Netherlands and have grown to become an important method of quality improvement in primary care in several other European countries., Objective: Our aim was to provide an overview of QC/PRG activities and exemplary programmes in European countries., Methods: A survey was performed in three consecutive steps by EQuiP (European Working Party on Quality in Family Practice), which is a representative association of experts from 26 European countries. The national representatives initially completed a structured questionnaire documenting the number and objectives of QCs/PRGs, sources of support and special programmes in their countries (step 1). In step 2, these sources were used to extend and validate the expert statements. Step 3 studied paradigmatic initiatives in depth., Results: Step 1 took place in 2000; the response rate was 100% (26 countries). QCs/PRGs were very active in 10 countries; 16 countries showed little or no activity. Participation ranged from <2 to 86% of all GPs. Step 2 concentrated upon the countries with a high level of activity. Development appeared to be associated with establishment in private practice and the portion of GPs with vocational training. Eight programmes from six countries describing the establishment and the targeting of QC/PRG work are presented as case reports (step 3)., Conclusion: In the last 10 years, substantial development of QCs/PRGs has taken place in The Netherlands, the UK, Denmark, Belgium, Ireland, Sweden, Norway, Germany, Switzerland and Austria. Further evaluation is needed to clarify the impact on quality of care.

Objective: To improve the quality of patient care by supporting the implementation of practice-specific visitatie (external peer review) recommendations., Design: A descriptive evaluation of an intervention strategy (Quality Consultation). Data collection through participatory observation, telephone interviews, and a postal survey., Setting: Twenty-five specialist group practices (67 specialists) from the specialty societies of surgeons, paediatricians, and gynaecologists, supported in their implementation efforts by two experienced management consultants., Intervention: Approximately 20 h of management consultancy. The Quality Consultation took a site-specific multifaceted implementation approach; its tool kit consisted of various management and quality improvement support methods., Main Measures: Choice of recommendations supported; type of interventions offered; degree of implementation; appreciation of implementation results and process; and impact of management consultants as assessed by participants., Results: The level of participation was high and evaluation of the consultants and the impact of their support positive. Most implementation projects were related to strategic issues or the functioning of the specialist group. Every specialist group was offered multiple interventions, both participatory and non-participatory. The degree of implementation was rated 4.0 on a 5-point scale; the scores for the implementation result and process were 6.6 on a 10-point scale., Conclusions: Visitatie seems to inherently enforce the development of management of medical specialist care. This might also be true for other external peer review models. The development of effective specialist groups deserves high priority in order to implement visitatie recommendations successfully. Management consultants can be instrumental in this process.

In order to ensure that a facility is in compliance with the occupational exposure requirements established by regulatory authorities, the measurements and dose assessments specified in the individual monitoring programme need to be reliable. There are two important questions that shall be addressed here: one is how the licensed facilities can demonstrate to their workers and regulatory bodies compliance with the regulatory limits and the reliability of the results of the individual monitoring programmes; the other concerns the mechanisms used to demonstrate to a facility in another country the reliability of the measurement results of an individual monitoring bioassay programme. The accreditation of the bioassay laboratory, according to ISO/IEC 17025, shall be the basic requirement for obtaining the authorisation granted by the national regulatory authority. For the second question, such confidence can be achieved through International Laboratory Accreditation Cooperation (ILAC).

Objective: From a public health perspective, the effectiveness of any prevention program depends on integrated medical and managerial strategies. In this way, quality management methods drawn from organization and business management can help design prevention programs. The aim of this study was to analyze the potential value of these methods in the specific context of preventing falls in hospital., Setting: Medical and Rehabilitation Care Unit of Saint-Maurice National Hospital (France)., Design: In phase 1, two surveys assessed the context in which falls occurred. The first survey (1995) quantified adverse events during a 1-year period (n = 564) and the second (1996-1997) documented the reasons for falls (n = 53). In phase 2, a set of recommendations to prevent falls was elaborated and implemented throughout the hospital., Results: The fall frequency in this unit was 18.3% in 1995. Analysis showed organizational causes in 35 (66%) of the 53 documented falls; 24 of them were associated with individual factors. Even though the two categories of causes are interdependent, their distinction enables specific recommendations. The proposed organizational management changes recommended do not aim to achieve an illusory objective of 'zero falls', but are designed to reduce the number of avoidable falls and to limit the negative consequences of unavoidable falls., Conclusion: Quality improvement methods shed new light on how to prevent falls. An unexploited potential for prevention lies in organization and management of care for hospitalized patients.

Objective: To evaluate the impact of a quality improvement approach to implementing developmentally appropriate pain assessment guidelines for pediatric inpatients. Patient and staff satisfaction with pain assessment and management, and staff documentation were evaluated one year following the implementation of the revised pain assessment guidelines., Design: Quasi-experimental design., Setting: The pediatric hematology/oncology unit of a regional children's hospital. Study participants. A convenience sample of 36 children and 68 staff at time 1 (TI) and 49 children and 82 staff at time 2 (T2)., Interventions: Staff were educated on the use of pediatric pain assessment tools and a standardized pain assessment protocol was put into practice. Children or their primary caregivers were interviewed, using a questionnaire modified from the American Pain Society quality assurance guidelines, regarding their experiences with pain assessment and management on the unit at T1, just prior to the staff education, and one year later at T2. Multidisciplinary unit staff completed a parallel questionnaire at T1 and T2., Main Outcome Measures: Patient and staff satisfaction with pain assessment and management, and chart audit of compliance with pain assessment documentation., Results: Patients, family members, and staff reported increased pain assessment, improved staff responsiveness to patients' pain and greater satisfaction with assessment tools between TI and T2. Increased compliance with the assessment guidelines was confirmed by chart audit., Conclusions: Improved pain assessment and management practices with resultant increase in patient and staff satisfaction can be achieved and sustained over time using quality improvement strategies.

Objective: To develop a brief French-language, generic, self-administered questionnaire to measure inpatient satisfaction., Design: Issues relevant to patients were identified using three open-ended questions designed in accordance with the disconfirmation paradigm. The content of patients' responses was analysed and then supplemented by items taken from published instruments in order to generate a pool of 93 items. Twenty-nine items were selected following a strict procedure. Content validity was judged by comparing the questionnaire to existing instruments. Construct validity was supported by testing specific hypotheses derived from the literature and by performing principal component analysis. Reliability was estimated by calculating Cronbach's alpha., Setting: A 2200-bed French teaching hospital., Subjects: A mail survey was carried out on a random sample of 1000 inpatients within 2-4 weeks of discharge. Eligible subjects were medical, surgical and obstetrics inpatients who had stayed in the hospital for more than 24 hours., Results: The participation rate (71%) and the completion rate (95%) were indicators of acceptability. There were modest differences between the questionnaire and published instruments (financial aspects, amenities). Construct representation by principal component analysis consisted of six scales which accounted for 58% of the variance in total satisfaction scores. The reliability estimates of internal consistency ranged from 0.67 to 0.86., Conclusion: We propose that the self-administered multidimensional inpatient satisfaction questionnaire provided encouraging preliminary psychometric information. This instrument is intended to involve patient feedback in a continuous quality health care improvement strategy.

Objective: To expand on previous reports by illustrating experiences German health services organizitions made in their assessment against the European Foundation for Quality Management (EFQM) Excellence Model. To provide an evaluation of the EFQM method compared to peer auditing and accreditation concepts within health care., Design: To indicate the EFQM method and scoring system and draft the process of self-assessment in health services organizitions. To refer to the experiences of German health care pioneers during their early assessments., Results: Using the EFQM approach, an organizition can earn up to 1.000 points. More than 50% of German hospitals scored 200-300 points and not a single organizition achieved over 450 points. To make a comparison, the best score obtained in an industrial setting was between 650-750 points. In addition to the numbers, this report describes success factors and best practices of self-assessments, as well as limitations, barriers and lessons learned during the implementation phase., Conclusion: The Excellence Model is a systematic quality management approach to gain competitive advantage. It is non-governmental, non-financier driven, and generic enough to address health care issues. Having its foundation in industry, however, it is not specific enough to cover all areas relevant to health care. Integrating the management-smart method of self-assessment with clinical standards as delivered by peer auditing and accreditation systems generates the potential to deliver excellence in health care.

A hospital's change from a traditional, multitiered incident-reporting system for medication errors to a standardized, nonpunitive medication-use variance process is described. After weaknesses were identified in the hospital's system for reporting and evaluating medication errors, a multidisciplinary task force was formed to redesign the hospital's medication error-reporting system. Its guiding principles were as follows: anonymity and freedom from punitive action are essential for increasing the number of reports, rating medication errors facilitates identification of areas for system improvement, potential errors provide valuable insight into the system's vulnerabilities, and timely review of reports enables rapid systematic correction. To support the intended nonpunitive culture, the term medication-use variance was used in lieu of medication error for any unplanned event that deviates from the intended course of prescribing, dispensing, administering, or monitoring medications. A one-page medication-use variance report was developed that prompted the reporter for key data elements, including root causes, patient outcomes, and possible ways to prevent similar incidents. The most difficult decision for the task force was deciding whether the process should be anonymous. After getting the support of the medical-legal counsel and the quality improvement department for an anonymous reporting process, the task force agreed to test it in the department of pharmacy and in three patient units in September 1998. A paper-driven reporting process was selected initially because an electronic system would not be truly anonymous. The number of reports from these units increased compared with historical trends, and for the first time potential errors were reported. The report form was easy to use and improved the interpretation of reports. Despite these positive results, task force members remained divided on the issue of anonymity but ultimately embraced the nonpunitive culture. In the first six months following hospitalwide implementation, the number of events captured increased more than fivefold; it continues to increase. The resulting database serves as a trigger for quality improvement efforts and a measure of their effectiveness. The redesign of the medication error-reporting process served as the impetus for a change in the organizational culture surrounding medication errors.

Because many preventable medication errors occur at the ordering stage, a program for improving the quality of writing inpatient orders and outpatient prescriptions at one institution was developed. To determine whether potential problems existed in the order-writing process for inpatients, all physician orders for a seven-day period in 1997 were reviewed (n = 3740). More than 10% of all orders had illegible handwriting or were written with a felt-tip pen, which makes NCR copies difficult to read. Other potential errors were also identified. Following educational programs for physicians and residents focusing on the importance of writing orders clearly, physician orders were reviewed for a 24-hour period (n = 654). The use of felt-tip pens decreased to 1.37% of all orders, and no orders had illegible handwriting. A similar quality improvement approach was used to evaluate the outpatient prescription-writing process. A review of all new prescriptions for a consecutive seven-day period at a local hospital-owned community pharmacy (n = 1425) revealed that about 15% of the prescriptions had illegible handwriting and roughly 10% were incomplete. Additional data were gathered through a survey sent to 71 outside provider pharmacies requesting information on problems related to prescriptions written by physicians from the institution; 66% responded. Failure to print prescriber name (96%), illegible signature (94%), failure to include DEA number (89%), and illegible handwriting other than signature (69%) were reported as the main problems. Each physician was given a self-inking name stamp to use when writing prescriptions. In addition, educational programs covering examples of poorly written prescriptions and the legal requirements of a prescription were held for physicians and residents. A follow-up survey showed that 72% of pharmacies saw stamps being used; when stamps were not used, however, illegible signatures continued to be a problem. Follow-up reviews of outpatient prescriptions indicate improvements in handwriting and completeness, but continuing educational efforts are needed. The quality of order writing for inpatients and outpatients continues to be monitored on a regular basis. Ongoing educational programs, follow-up reminders, and feedback to physicians have greatly improved the prescription-writing habits of physicians.

A comprehensive, interdisciplinary approach for reducing the number of chemotherapy-related medication errors at the National Institutes of Health Clinical Center, where approximately 8500 doses of chemotherapy agents are dispensed annually, is described. Heightened awareness of the seriousness of chemotherapy-related medication errors prompted formation of an interdisciplinary task force in June 1995 to analyze and improve the hospital's system for ordering, checking, processing, and administering cancer chemotherapy agents. Problems were analyzed and rectified in accordance with the hospital's plan-do-check-act performance-improvement model. Performance monitors for the improvements included a system to record and categorize all chemotherapy-related prescribing errors and a hospital-wide occurrence-reporting system. The task force identified seven major categories in which improvements were needed: protocol development, computer-system enhancements, dose verification, information access, education for health care practitioners, error follow-up, and infusion pumps. Despite the Clinical Center's good safety-net system, 23 modifications were made to the existing system through December 1999. These changes resulted in an overall 23% decrease in prescribing errors and a 53% decrease in serious prescribing errors. The task force membership was recently broadened to include representatives of additional departments where chemotherapy agents are used, and this group recommended more than 20 additional system changes. The changes are being implemented, and their effect on reducing the number of chemotherapy-related errors will be measured. The continuous-improvement process used prospectively by the task force helps ensure that safe chemotherapy practices are instituted uniformly throughout the hospital.

Continuous quality assurance (QA) in health care has necessitated the adoption of statistical methods developed as industrial process monitoring techniques. One such statistical technique is the cumulative summation (Cusum) methodology, which can monitor continuously a production process and detect subtle deviations from a preset defined level of achievement. The method is practical, simple to apply, easy to introduce and has proved popular with trainees in some specialities. This article introduces the concepts of a sequential analysis, deals with the practical steps of setting up a data collection and monitoring performance for procedures in health care.

Objective: To assess guidelines, set by the National Committee for Quality Assurance, for the Health Plan Employer Data and Information Set (HEDIS) 1999 CAHPS 2.0H Survey (formerly the HEDIS 1999 Consumer Survey) in the light of user's needs to monitor health plan performance over time, monitor sick enrollees, and prioritize determinants (drivers) of enrollee experience., Design: A two-wave, cross-sectional/longitudinal panel design, consisting of national surveys mailed to employees of three major USA corporations in 1993 and 1995., Study Participants: Samples included employees selected to represent 23 major managed care and indemnity plans in five regions of the USA. In 1993, 14 587 employees responded and in 1995 9018 employees responded (response rates: 51 and 52%). The longitudinal panel sample included 5729 employees who completed both surveys and stayed in the same plan for both years. STUDY MEASURES: The main 1993 and 1995 surveys consisted of 154 and 116 items, respectively. Panel survey content assessed care delivery, plan administration, functional status, well being, and chronic disease., Results: CAHPS 2.0H's point-in-time, cross-sectional design was unable to detect selection bias and led to an inaccurate view of change in performance. CAHPS 2.0H's use of aggregate samples masked key differences between healthy and sick enrollees; e.g. the sick became less satisfied over time. The association-based, statistical techniques that many survey users will employ to prioritize the 'drivers' of enrollee experience in the absence of CAHPS 2.0H guidelines yielded a less efficient account of change than the multi-method/multi-trait approach developed for this project., Conclusion: Consumer experience of plan performance is best understood when the separate contributions of longitudinal membership and movement in and out of plans are clarified, changes in health are identified, changes for sick and healthy enrollees are compared, and plan performance on satisfaction criteria is probed to give confirmation and detail. Changes to the CAHPS 2.0H approach in HEDIS 1999 will facilitate user application of these principles.

Background: While routine clinical decision-making has a substantial effect on quality, most practising physicians do not routinely examine their outcomes., Objectives: To set up a practical process for identifying problems in hospital practices of primary care physicians, examine their causes, and develop a quality improvement process that intimately involves practising physicians in problem-solving., Design: All hospital admissions to the Primary Care Service were screened over a 14-month period using simple pre-specified criteria. Quality problems were verified by medical record reviews carried out by two physicians. These problems were discussed at monthly meetings of physicians to characterize the problems fully, identify their causes, and document adverse effects on patient outcomes., Setting: One community hospital., Participants: Primary care physicians from three group practices and four solo practices who admit patients to the Primary Care Service., Interventions: Monthly group discussions plus discussions with individual physicians when time did not permit all quality problems to be discussed at group meetings. Certain issues of high sensitivity were also discussed with the individuals rather than in an open forum., Outcome Measures: Missed or delayed diagnoses, inappropriate treatments, and complications and their root causes., Results: Quality problems were identified in 6% of all admissions. Of these, 60% were missed or delayed diagnoses, 22% were iatrogenic complications and 18% were inappropriate treatments. Root cause analysis suggested that physician behaviors led to 75% of problems; systems problems to 20% and inadequate knowledge to 5%. Process improvements included development of a call-in system to reduce delays in obtaining X-ray reports; implementation of an anticoagulation monitoring system in one group practice; and a protocol of regular feedback of errors in diagnosis to emergency room physicians. Participating physicians reported increased awareness of common errors and greater attention to detail in patient evaluations., Conclusions: Knowledge of root causes of quality problems is essential for improving quality of care. A simple routine approach to examining adverse outcomes and how care might be improved in the future was set up. Active participation of practising physicians is essential. Other organizations could use this process for routinely reviewing and improving quality.

Variations research is one important strategy in the quality management movement designed to improve the quality of health care and to control costs. Information systems are being utilized in variations research to provide an array of potential variables, to provide measures of the variability inherent in these variables, and to assist with the study of the linkages of patient and provider characteristics with interventions and outcomes. This article presents a systems model of inputs, processes, and outcomes with explication of factors related to client, provider, and setting as a heuristic strategy for variable specification. The implications of variable specification, the design and measurement of variability, and the key issue of control in variations research are linked with a discussion of the implications for medical informatics.

In this article we discuss a management construct, called Measures of Effectiveness (MOEs), used by executive leadership at the National Naval Medical Center in its performance of its oversight functions. Three case studies are presented illustrating the usefulness of MOEs for planning, for performance measurement, and for making determinations regarding initiation of formal quality improvement efforts.