The Veterans Affairs root cause analysis system in action

BACKGROUND: The patient safety program in the Department of Veterans Affairs (VA) began in 1998, when the National Center for Patient Safety (NCPS) was established to lead the effort on a day-to-day basis. NCPS provides the structure, training, and tools, and VA facilities provide front-line expertise, feedback about the process, and root cause analysis (RCA) of adverse events and close calls. MONITORING THE PROCESS: Facility patient safety managers determine the disposition of adverse events and close calls occurring at their facilities. They use a safety assessment code (SAC) to prioritize the actual and potential severity and frequency of an event. BEFORE-AND-AFTER STUDY: Before the new RCA system was implemented in 2000, the VA used another adverse event reporting system, focused review (FR). A comparison of the two processes indicates that the RCA process has shifted analyses of adverse events toward a human factors engineering approach-entailing a search for system vulnerabilities rather than human errors and other less actionable root causes. CASE EXAMPLES: Two case examples--on hazards in the magnetic resonance imaging (MRI) room and on a cardiac pacemaker malfunction--illustrate how the RCA system works in actual operation. The cases illustrate that broadly applicable, high-impact actions can result from a thorough RCA process. DISCUSSION: NCPS monitors the quality and completeness of RCAs through the immediate review and feedback process. Still to be investigated is the effectiveness of RCA actions addressing the hypothesized root causes and contributing factors of the close calls and adverse events.     

John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety

BACKGROUND: In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. A NOVEL APPROACH: To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. KEY ACTION ITEMS AND RESULTS RELATED TO RCA: NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.     

Vibro-acoustography beam formation with reconfigurable arrays

In this work, we present a numerical study of the use of reconfigurable arrays (RCA) for vibro-acoustography (VA) beam formation. A parametric study of the aperture selection, number of channels, number of elements, focal distance, and steering parameters is presented to show the feasibility and evaluate the performance of VA imaging based on RCA. The transducer aperture was based on two concentric arrays driven by two continuous-wave or toneburst signals at slightly different frequencies. The mathematical model considers a homogeneous, isotropic, inviscid medium. The pointspread function of the system is calculated based on angular spectrum methods using the Fresnel approximation for rectangular sources. Simulations considering arrays with 50 x 50 to 200 x 200 elements with number of channels varying in the range of 32 to 128 are evaluated to identify the best configuration for VA. Advantages of two-dimensional and RCA arrays and aspects related to clinical importance of the RCA implementation in VA, such as spatial resolution, image frame rate, and commercial machine implementation, are discussed. It is concluded that RCA transducers can produce spatial resolution similar to confocal transducers and steering is possible in the elevational and azimuthal planes. Optimal settings for number of elements, number of channels, maximum steering, and focal distance are suggested for VA clinical applications. Furthermore, an optimization for beam steering based on the channel assignment is proposed for balancing the contribution of the two waves in the steered focus.     

Root cause analysis of the fracture of a sonar window caused by hydrostatic,hydrodynamic, and transient forces around a ship

Sonar systems are installed in naval vessels to inspect objects in the sea. When the system is installed at the bulbous bow of the ship, it can be vulnerable to fractures in rough seas due to hydrostatic and hydrodynamic forces, such as fluid-induced forces, and transient forces, such as slamming and collision with submerged foreign objects. In this paper, root causes analysis (RCA) of the fracture of a sonar window of a typical naval vessel was performed. To identify the root causes of the fracture, a numerical analysis was performed of the stress distribution on a sonar window under various extreme conditions. The results of the analysis, together with hypotheses of the causes of the fracture, are presented. The results of the analysis were verified by measuring the stress on the sonar window under typical sailing conditions of ships. The RCA demonstrated that buckling in response to the hydrostatic forces applied under the typical operating conditions of a water management system (WMS), in addition to excessive slamming, can cause a sonar window to fracture. Based on this RCA, corrective actions to prevent sonar window fractures include changing the material of the window and the operating conditions of the WMS.     

Improvement in the incident reporting and investigation procedures using process excellence (DMAI2C) methodology

In 1996, Health & Safety introduced an incident investigation process called Learning to Look to Johnson & Johnson. This process provides a systematic way of analyzing work-related injuries and illness, uncovers root cause that leads to system defects, and points to viable solutions. The process analyzed involves three steps: investigation and reporting of the incident, determination of root cause, and development and implementation of a corrective action plan. The process requires the investigators to provide an initial communication for work-related serious injuries and illness as well as lost workday cases to Corporate Headquarters within 72 h of the incident with a full investigative report to follow within 10 days. A full investigation requires a written report, a cause-result logic diagram (CRLD), a corrective action plan (CAP) and a report of incident costs (SafeCost) all due to be filed electronically. It is incumbent on the principal investigator and his or her investigative teams to assemble the various parts of the investigation and to follow up with the relevant parties to ensure corrective actions are implemented, and a full report submitted to Corporate executives. Initial review of the system revealed that the process was not working as designed. A number of reports were late, not signed by the business leaders, and in some instances, all cause were not identified. Process excellence was the process used to study the issue. The team used six sigma DMAI2C methodologies to identify and implement system improvements. The project examined the breakdown of the critical aspects of the reporting and investigation process that lead to system errors. This report will discuss the study findings, recommended improvements, and methods used to monitor the new improved process.     

Stay on Your Feet Safety Walks Group

The Safety Walks Group is an initiative that evolved from the Stay on Your Feet Program. The strategies used in this program target both behavioural and environmental change and are based on the five areas for action under the Ottawa Charter (WHO, 1986) and Jakarta Declaration (WHO, 1997). The Safety Walks Group addresses the issue of public hazards via the use of a standard checklist covering pedestrian areas, business houses and accommodation. The project provided a forum for seniors to be proactive, working with the authorities to address the issue of public hazards and make the environment safer.     

Metal nanoparticle plasmon-enhanced light-harvesting in a photosystem I thin film

Silver metal nanoparticle (NP) enhanced fluorescence is investigated in thin films of cyanobacterial Photosystem I trimer complexes (PSI) by correlating confocal laser scanning microscopy, dark-field imaging, and fluorescence lifetime measurements. PSI represents an interesting light-harvesting complex with a 20 nm diameter that is not uniformly contained within the surface-localized plasmon field of the NPs. With weak far-field illumination, 5- to 20-fold fluorescence enhancement is observed for PSI complexes adjacent to NPs, arising from efficient nanoparticle light collection and subsequent localized, surface plasmon excitation of PSI. Enhanced PSI fluorescence is detected most prominently near "rafts" of aggregated NPs that more completely fill the confocal field of view. These results demonstrate opportunities to probe energy transfer within photosynthetic complexes using plasmonic excitation and to design nanostructures for optimizing artificial light-harvesting systems.     

Reliability design of a reciprocating compressor suction reed valve in a common refrigerator subjected to repetitive pressure loads

The compressor in a commercial refrigerator was redesigned to improve its reliability. The compressor used in the refrigerator had been failing due to fracturing of the suction reed valve. Failure analysis, accelerated life tests and corrective action plans were used to identify the key control parameters and levels for the mechanical compressor system. The failure modes and mechanisms found experimentally were similar to those of the failed sample in the field. The missing controllable design parameters of the compressor system in the design phase were an overlap with the valve plate, a weak material [SANDVIK 20C 178t], and the sharp edge of the valve plate. After a tailored series of accelerated life tests with corrective action plans, the reliability of the new compressor system is now guaranteed to be 12.6 years with a yearly failure rate of 0.06%.     

Design of a hinge kit system in a Kimchi refrigerator receiving repetitive stresses

Based on field data and a tailored set of accelerated life tests, the hinge kit system of a closing door in a Kimchi refrigerator was redesigned. Using a force and moment balance analysis, the simple mechanical loads from the closing of the door were evaluated. The failure modes and mechanisms found experimentally were similar to those of the failed sample in the field. Failure analysis, accelerated life tests and corrective action plans were used to identify the key control parameters and level for the mechanical hinge kit system. The missing controllable design parameters of the hinge kit system in the design phase included the corner rounding and rib of the housing hinge kit, the oil sealing method of the oil damper, and the material of the cover housing. After a tailored series of accelerated life tests with corrective action plans, the B₁ life of the new hinge kit design is now guaranteed to be over 10 years with a yearly failure rate of 0.1%.     

Hydroxylamine production: will a QRA help you decide?

The recent publication by the US Chemical Safety Board (CSB) concerning its findings on the Concept Sciences Inc. (CSI) incident involving hydroxylamine (HA) has raised issues with regard to safe production of HA. This CSI incident was followed by another incident that destroyed the Nissin Chemical HA plant in Japan, and today BASF is the sole commercial producer of HA. HA is an important solvent in the pharmaceutical industry and is used as an etching agent in the semi-conductor industry.This paper discusses a Quantitative Risk Assessment of a generic HA production plant, which integrates the findings of the CSB report and the knowledge of potential HA reactivity hazards based on research at the Mary Kay O'Connor Process Safety Center. The intent is to highlight safety concerns and major risk factors in the production and handling of HA and to provide risk assessment guidelines for potential manufacturers. These guidelines are also applicable to the production strategies for other hazardous chemicals.     

The Safety Case Management Committee: expanding the avenues for addressing patient safety

BACKGROUND: The greatest gains in patient safety are likely to result from using a multifaceted framework of safety enhancement initiatives. The Safety Case Management Committee, which has been meeting at the VA Ann Arbor Healthcare System since early 1999, is one such initiative; it is directed at broadening organizational involvement in creating a safer clinical environment. The committee's objective is to address fundamental issues related to patient safety and quality of care. The committee aims to develop thematic approaches to improving major systems triggered by unsafe or risky incidents that demonstrate either iatrogenic harm or risk of harm to patients. COMMITTEE STRUCTURE AND FUNCTIONING: Committee members represent top management, middle management, and front-line employees, but membership is weighted toward those in direct patient care roles. The group also includes a consumer representative. Critical issues are addressed through rigorous case discussion, literature review, and expert consultation. RESULTS: In a 3-year period (Feb 1999 through Dec 2001), 85% of the group's 45 recommendations have been implemented. Topics have included reducing medication errors during emergency procedures, enhancing palliative care services, minimizing the risk of missed x-ray findings, optimizing anticoagulation management, reducing the risk of vascular catheter-related infection, and improving pain management. SUMMARY: The Safety Case Management Committee has successfully addressed actual and potential errors and has implemented strategic safety improvements. The dedicated efforts of highly motivated clinicians who serve on such a committee can augment and enhance risk management advances made through other channels.     

Design evaluation of a French refrigerator drawer system subjected to repeated food storage loads

Based on field data and a tailored set of accelerated life tests, the drawer system of food storage in a French refrigerator was redesigned. Using a force balance analysis, the simple mechanical loads of the drawer system were evaluated. The failure modes and mechanisms found experimentally were similar to those of the failed samples in the field. Failure analysis, accelerated life tests and corrective action plans were used to identify the key control parameters and level for the mechanical drawer system. The missing controllable design parameters of the drawer system in the design phase included no corner rounding and rib thickness in the intersection areas between the box and its cover, the right, center support and left rail system. After a tailored series of accelerated life tests with corrective action plans, the B₁ life of the new draw system is now guaranteed to be over 10 years with a yearly failure rate of 0.1%.     

SSM Health Care clinical collaboratives: improving the value of patient care in a health care system

BACKGROUND: In 1998 SSM Health Care (St Louis) began a series of clinical collaboratives modeled after The Institute of Healthcare Improvement (Boston) Breakthrough Series. There are now four collaboratives, with 46 teams in progress, and four additional collaboratives are scheduled. COLLABORATIVE TOPICS AND STRUCTURE: Each collaborative consists of three phases: the prework, active, and the continuous improvement phases. The structure of the collaboratives is quite similar to that of the Institute for Healthcare Improvement Breakthrough Series. However, the SSMHC collaboratives include a continuous improvement phase, which was designed to help maintain gains from the projects and to involve entities not originally involved in the collaborative. RESULTS OF COLLABORATIVES IN PROGRESS: Entity teams participating in multiple collaboratives seem to ascend a learning curve and become progressively more skilled in subsequent collaborative work. In Collaborative 1--Improving the Secondary Prevention of Ischemic Heart Disease--the participating entities showed significant improvement in cholesterol screening and treatment. In Collaborative 2--Improving Prescribing Practices--the collaborative teams also showed significant improvement, with a combined cost savings of approximately $450,000 per year. Collaboratives 3--Using Patient Information to Improve Care and Assure Success-and-4--Enhancing Patient Safety Through Safe Systems--are under way. SUMMARY: The collaboratives accelerate improvement work through sharing of successes and failures and peer influence within a reinforcing environment. Most of the collaborative teams have reached their project goals, and the pace of clinical improvement work has accelerated since the start of the collaboratives. The collaboratives provide an environment for clinicians to constructively participate in improvement of patient care.     

Reliability design and case study of refrigerator parts subjected to repetitive loads under consumer usage conditions

When newly designed refrigerator parts failed due to repetitive loads under consumer usage conditions in the field, a general method for reliability design was proposed. A newly designed refrigerator compressor system that brings greater energy efficiency to side-by-side (SBS) refrigerators was studied. The laboratory failure mode and mechanism of the compressor was a stopping nose due to design flaws. The data on the failed products in the field, accelerated life tests (ALT) and corrective action plans were used to identify the key control parameters for the mechanical compressor system. The missing controllable design parameters of the compressor system in the design phase were the gap between the frame and the upper due to the stator frame shape. After a tailored series of accelerated life tests with corrective action plans, the B₁ life of the new compressor system is now guaranteed to be over 10 years with a yearly failure rate of 0.1%.     

Making medication safety a strategic organizational priority

Since January 1998 the Executive Session on Medical Error and Patient Safety at Harvard's John F. Kennedy School of Government has periodically convened a group of 25 to 30 practitioners (and a few academics) to discuss issues and identify strategies and solutions concerning patient safety. This profile is adapted from a case study presented at the Executive Session.     

专访国家标准化管理委员会副主任 方向(英文)

正方向,研究员,国家标准委副主任。曾担任中国计量科学研究院副院长兼化学计量与分析科学研究所所长,中国标准化研究院副院长。2007年12月任国家标准化管理委员会总工程师、党组成员;2008年9月任国家标准化管理委员会副主任、党组成员。在他30年的职业生涯中,主要从事质谱技术和质谱仪的研究和创新,为推进质谱仪国产化进程做出了突出贡献,拥有多项发明专利,"小型质谱仪关键技     

Synthesis and Stretching of Rolling Circle Amplification Products in a Flow‐Through System

Enzymatic isothermal rolling circle amplification (RCA) produces long concatemeric single‐stranded DNA (ssDNA) molecules if a small circular ssDNA molecule is applied as the template. A method is presented here in which the RCA reaction is carried out in a flow‐through system, starting from isolated surface‐tethered DNA primers. This approach combines gentle fluidic handling of the single‐stranded RCA products, such as staining or stretching via a receding meniscus, with the option of simultaneous (fluorescence) microscopic observation. It is shown that the stretched and surface‐attached RCA products are accessible for hybridization of complementary oligonucleotides, which demonstrates their addressability by complementary base pairing. The long RCA products should be well suited to bridge the gap between biomolecular nanoscale building‐blocks and structures at the micro‐ and macroscale, especially at the single‐molecule level presented here.     

The safety checklist program: creating a culture of safety in intensive care units

BACKGROUND: In 1999 the VA Ann Arbor Healthcare System began a safety checklist program to help build a culture of safety among nurses, respiratory therapists, and unit maintenance providers in the intensive care units (ICUs). Program objectives were to (a) create the opportunity for each participating staff member to view his or her work and unit environment in a broader safety context; (b) establish clear, concise, and measurable standards that staff would identify and value as important safety factors; (c) develop a data collection methodology that would minimize confirmation bias; and (d) correct safety deficits immediately. DATA MANAGEMENT: Staff measure compliance with safety standards twice daily and record results on a form specifically designed for the project. Data are transferred to a spreadsheet, and graphic presentations are posted in each ICU. Staff periodically adjust both standards and data collection procedures. SUMMARY: Staff can articulate how the program is making the ICU a safer environment. Nursing response to a recent major error reflects the growth that has occurred since the program's inception. Safety checks performed by ICU staff are critical in maintaining a constant level of safety. Although the effect on untoward events was not measured, the potential for incidents, including medication and intravenous errors, nosocomial infections, ventilator complications, and restraint complications may be reduced. The program invests bedside clinicians in writing safety standards, creates a partnership between staff and the clinical risk manager, and provides executive leaders an opportunity to demonstrate support of a culture beyond blame.     

Modelling photosystem I as a complex interacting network

In this paper, we model the excitation energy transfer (EET) of photosystem I (PSI) of the common pea plant Pisum sativum as a complex interacting network. The magnitude of the link energy transfer between nodes/chromophores is computed by Forster resonant energy transfer (FRET) using the pairwise physical distances between chromophores from the PDB 5L8R (Protein Data Bank). We measure the global PSI network EET efficiency adopting well-known network theory indicators: the network efficiency (Eff) and the largest connected component (LCC). We also account the number of connected nodes/chromophores to P700 (CN), a new ad hoc measure we introduce here to indicate how many nodes in the network can actually transfer energy to the P700 reaction centre. We find that when progressively removing the weak links of lower EET, the Eff decreases, while the EET paths integrity (LCC and CN) is still preserved. This finding would show that the PSI is a resilient system owning a large window of functioning feasibility and it is completely impaired only when removing most of the network links. From the study of different types of chromophore, we propose different primary functions within the PSI system: chlorophyll a (CLA) molecules are the central nodes in the EET process, while other chromophore types have different primary functions. Furthermore, we perform nodes removal simulations to understand how the nodes/chromophores malfunctioning may affect PSI functioning. We discover that the removal of the CLA triggers the fastest decrease in the Eff, confirming that CAL is the main contributors to the high EET efficiency. Our outcomes open new perspectives of research, such comparing the PSI energy transfer efficiency of different natural and agricultural plant species and investigating the light-harvesting mechanisms of artificial photosynthesis both in plant agriculture and in the field of solar energy applications.     

Active control of the vacuum infusion process

Through infusion experiments, fibrous preforms are shown to have an inherent heterogeneity in the permeability. This heterogeneity can lead to unforeseen, unpredictable and potentially, problematic flow patterns. A new active control system is proposed to address this issue, capable of monitoring the resin flow, identifying flow disturbances and taking an appropriate corrective action in real-time, through computer-controlled injection ports. A simple technique is also proposed for monitoring the resin flow in closed moulding processes such as Vacuum Infusion (VI), where at least one side of the mould is visible. This uses a low cost web-camera to capture images at fixed time intervals during the infusion phase and analyses them to identify flow disturbances. The control system then uses this information to take corrective action in real-time. To demonstrate the potential of the system, it has been implemented and validated through numerical simulations and infusion experiments.