Rates Of Safety Events Research Articles

Building a High-Reliability Organization: One Systemʼs Patient Safety Journey

With a focus on the elimination of all preventable harm, Ascension has been on a journey of continuous improvement in quality and patient safety since 2002. Our bold national system goals have been aligned to form core components of transformative initiatives such as the Journey to Zero and Healing Without Harm, as well as programs conducted in partnership with the Centers for Medicare & Medicaid Services (CMS), such as the Partnership for Patients and Leading Edge Advanced Practice Topics.Improving patient safety is a continuous process at Ascension, the nation's largest nonprofit healthcare system, with sites of care in 24 states and the District of Columbia. Central to this process is the universal adoption of the principles of high reliability (HR). The goal in adopting these principles is to foster a behavior-based model and evolve into a high-reliability organization (HRO). An HRO is defined by Weick and Sutcliffe (2007) as an entity that avoids catastrophes in an environment where accidents are normally expected as a result of risk factors and complexity.In 2011, Ascension committed to becoming an HRO system-wide and has trained more than 100,000 associates and providers, board members, and all senior leaders on the principles of HR. During this journey, we have had 19,000 fewer mortalities than would have occurred at our historic maximum rate, and we have identified significant reductions in the rates of serious safety events and associated severity of harm. Areas with the greatest gains, as measured by our work as a Hospital Engagement Network with the CMS Partnership for Patients, include reductions in injurious falls, surgical site infections for abdominal hysterectomies and colon surgeries, early elective deliveries, catheter-associated urinary tract infections, and venous thromboembolism.INSIGHTS FROM OUR H I G H - R E LI AB I LI T Y JOURNEYWhile Ascension cannot yet claim full achievement of our Journey to Zero, we continue to advance our safety principles at all points of care. Along the way, we have learned significant lessons. One central lesson is the understanding that healthcare leaders at all levels must be adamant in creating a safe environment for care delivery. Four other key insights from our journey to HR are shared here.Insight 1: Complacency Lurks Around Every CornerCountermeasure: Provide every executive, leader, provider, and associate with basic knowledge and set expectations to ensure continued organizational commitment and knowledge.Organizations pursuing HR often show an initial increase in adverse event reporting following HR training, but sustained behavior change is far more challenging to achieve. At Ascension, we saw an increase in reporting of serious safety events and near misses, suggesting adherence to the HR principle of preoccupation with failure.Nevertheless, we still find evidence of underreporting. Stabilization in the rate of reported safety events may reflect the emergence of a safer care environment-or it may be a sign of complacency in event reporting and a loosening of the safety culture. Complacency may lurk in seemingly minor choices. For example, is a wrongsite surgery a permanent or a temporary harm? A temporary harm may go unreported or uninvestigated. If a nurse administers a reversal agent to counteract respiratory depression due to oversedation, is it reported as an event, or and not reported because no harm resulted? Each of these events is preventable, and in an HRO, neither event should be normalized but, rather, fully investigated, with the learning harvested and disseminated for behavior and practice changes. Discussing such situations can help leaders and providers understand how well HR principles have been inculcated into the culture-or where complacency is lurking. When complacency is found, a process should be defined to determine what countermeasures can help sensitize providers to potential patient harm and identify learning opportunities. …

The Association of Nursing Workloads, Organizational, and Individual Factors with Adverse Patient Outcome

Introduction: Adverse patient outcomes have become a big concern in the quality of healthcare. Different factors can have an impact on the variety and rate of adverse patient outcomes. Objectives: The present study aimed at determining the rate of patient safety during events and evaluating nursing workloads as well as identifying the main factors that affect the incidence rate of patient safety events among nurses. Methods: This cross-sectional study was conducted on 293 nurses working in 24 wards of Baqiyatallah hospital in Tehran, Iran, in 2016. The sampling method was stratified random sampling. Data were collected using a self-administered questionnaire, which was classified into 4 subtitles: Individual and organizational characteristics, perceived subjective, objective workloads, and some patient safety events during the past 6 months. Binary and multiple regressions were used to survey the relationship between variables using the SPSS Version 23 software. Results: Bloodstream infection, pressure ulcer, and patient falls were the most reported adverse outcomes during the past 6 months with 76.1%, 66.2%, and 59%, respectively. At least one of the 6 adverse outcomes was reported by nurses within the range of 45%-77%. Of all individual characteristics, the only significant relationship occurred between work experience and bloodstream infection (P value = 0.28 and 0.32). No significant relationship was detected between adverse patient outcomes and objective workloads. Regression models revealed that the subjective workload of adverse patient outcomes increased with making adjustments in the individual and organizational characteristics. The incidence rates of adverse outcomes were 5.69-9.78 times more than the fixed shifts in all rotational shift works. Conclusions: The nurses reported a high incidence rate of all patient safety events, and the results revealed that the objective workload could not be a predictor for patient adverse events. According to the findings, subjective workload and work shift were significantly related to the incidence rate of adverse patient events. In conclusion, good regulation of sleep-wake cycles can be an important factor for decreasing the rate of adverse patient events.

Safety Performance in the Construction Industry: Quasi-Longitudinal Study

AbstractSafety remains a major challenge in the construction industry throughout the world, yet there are very few longitudinal or quasi-longitudinal studies in this domain. This paper demonstrates how a quasi-longitudinal study can provide insight into safety performance. A comparison is made between two cross-sectional studies: 911 questionnaires collected from construction workers between 2004 and 2006, and 802 collected between 2014 and 2015 in Ontario, Canada. The data comprised demographic factors, 13 safety climate factors, and three safety outcome categories. Rates of injury, stress, and safety events reduced overall since 2004, although the change was significant only for events. Findings show improved consistency in safety awareness among participants independent of employers, suggesting that regionwide safety programs have been effective. Safety climate factors accounted for 15–20% of the variance in safety outcomes, down from 2004. Interpersonal conflict at work is strongly related to all safe...

Consumer Rankings and Health Care: Toward Validation and Transparency

Differences between the Centers for Medicare & Medicaid Services (CMS)-measured rates of safety events for Rush University Medical Center (RUMC; Chicago) and the U. S. News & World Report (USNWR)-deter mined patient safety score were evaluated in an attempt to validate the USNWR patient safety score-based ranking. The USNWR findings for Patient Safety Indicators (PSIs) were compared with findings derived from RUMC internal billing data, and sensitivity analyses were conducted using a simulated data set derived from the Healthcare Cost and Utilization Project (HCUP) state inpatient data sets. Discrepancies were found for PSIs 3 (Pressure Ulcer Rate), 9 (Perioperative Hemorrhage or Hematoma Rate), and 11 (Postoperative Respiratory Failure Rate)-an excess of 0.72, 0.63, and 0.26 cases/1,000 admissions, in USNWR versus RUMC, respectively). The sensitivity analysis, which included missing present on admission (POA) flags and dates, resulted in an increase of rates by 1.83 (95% confidence interval [CI] = 1.10-2.56) cases/1,000 hospital- izations, 2.72 (CI = 0.00-5.90) cases/1,000 hospitalizations, and 3.89 (CI = 1.60-6.20) cases/1,000 hospitalizations for PSI 3, 9, and 11, respectively. Regression modeling showed that each 1% increase in transfers was associated with an in- crease of 0.06 cases of PSI 3/1,000 admissions; each 1,000 increase in admissions was associated with an increase of 0.04 cases of PSI 9/1,000 admissions. The USNWR data set produced inaccurate PSI rates for RUMC, and false-positive event rates were more common among high-transfer and high-volume hos- pitals. More transparency and validation is needed for con- sumer-based benchmarking methods. In response to these findings and concerns raised by others, in 2016 USNWR made changes to its methodology and data sources and reported them in announcing its 2016-17 Best Hospitals.

Adverse inpatient outcomes during the transition to a new electronic health record system: observational study

Objective To assess the short term association of inpatient implementation of electronic health records (EHRs) with patient outcomes of mortality, readmissions, and adverse safety events.Design Observational study with difference-in-differences analysis.Setting...

Stroke : Highlights of Selected Articles

In this study, von Kummer et al present the results of the DIAS-4 trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke [phase 4]), as well as results of a pooled analysis from the DIAS-3 and 4 and DIAS-Japan trial. The DIAS trials were double-blind, randomized, placebo-controlled trials testing the safety and efficacy of 90 μg/kg of intravenous desmoteplase administered 3 to 9 hours after symptom onset in patients with occlusion or high-grade stenosis in proximal segments of the middle, anterior, or posterior cerebral arteries; DIAS-4 was terminated prematurely after the results of DIAS-3 revealed lack of efficacy. In DIAS-4, despite a statistically significant 23% absolute difference in recanalization, only an insignificant 6% difference in the proportion of patients with modified Rankin Scale score of 0 to 2 was observed. In the pooled analysis, a total of 795 patients with a median time to treatment of ≈7 hours were included. A similar pattern of results emerged: despite a significant absolute …

Assessing the impact of safety monitoring on the efficacy analysis in large Phase III group sequential trials with non-trivial safety event rate

ABSTRACTIn Phase III clinical trials for life-threatening conditions, some serious but expected adverse events, such as early deaths or congestive heart failure, are often treated as the secondary or co-primary endpoint, and are closely monitored by the Data and Safety Monitoring Committee (DSMC). A naïve group sequential design (GSD) for such a study is to specify univariate statistical boundaries for the efficacy and safety endpoints separately, and then implement the two boundaries during the study, even though the two endpoints are typically correlated. One problem with this naïve design, which has been noted in the statistical literature, is the potential loss of power. In this article, we develop an analytical tool to evaluate this negative impact for trials with non-trivial safety event rates, particularly when the safety monitoring is informal. Using a bivariate binary power function for the GSD with a random-effect component to account for subjective decision-making in safety monitoring, we demonstrate how, under common conditions, the power loss in the naïve design can be substantial. This tool may be helpful to entities such as the DSMCs when they wish to deviate from the prespecified stopping boundaries based on safety measures.

Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study

Chronic hepatitis C virus (HCV) infection in patients with stage 4-5 chronic kidney disease increases the risk of death and renal graft failure, yet patients with hepatitis C and chronic kidney disease have few treatment options. This study assesses an all-oral, ribavirin-free regimen in patients with HCV genotype 1 infection and stage 4-5 chronic kidney disease. In this phase 3 randomised study of safety and observational study of efficacy, patients with HCV genotype 1 infection and chronic kidney disease (stage 4-5 with or without haemodialysis dependence) were randomly assigned to receive grazoprevir (100 mg, NS3/4A protease inhibitor) and elbasvir (50 mg, NS5A inhibitor; immediate treatment group) or placebo (deferred treatment group) once daily for 12 weeks. Randomisation was done centrally with an interactive voice response system. An additional cohort of patients who were not randomised received the same regimen open-label and underwent intensive pharmacokinetic sampling. The primary efficacy outcome was a non-randomised comparison of sustained virological response at 12 weeks (SVR12) after the end of therapy for the combined immediate treatment group and the pharmacokinetic population with a historical control. The primary safety outcome was a randomised comparison between the immediate treatment group and the deferred treatment group. After 4 weeks of follow-up (study week 16), unmasking occurred and patients in the deferred treatment group received grazoprevir and elbasvir. The primary efficacy hypothesis was tested at a two-sided significance level (type I error) of 0·05 using an exact test for a binomial proportion. Safety event rates were compared between immediate treatment and deferred treatment groups using the stratified Miettinen and Nurminen method with baseline dialysis status as the strata. The study is registered at ClinicalTrials.gov, number NCT02092350. 224 patients were randomly assigned to the immediate treatment group with grazoprevir and elbasvir (n=111) or the deferred treatment group (n=113), and 11 were assigned to the intensive pharmacokinetic population. Overall, 179 (76%) were haemodialysis-dependent, 122 (52%) had HCV genotype 1a infection, 189 (80%) were HCV treatment-naive, 14 (6%) were cirrhotic, and 108 (46%) were African American. Of the 122 patients receiving grazoprevir and elbasvir, six were excluded from the primary efficacy analysis for non-virological reasons (death, lost-to-follow-up [n=2], non-compliance, patient withdrawal, and withdrawal by physician for violent behaviour). No patients in the combined immediate treatment group and intensive pharmacokinetic population and five (4%) in the deferred treatment group discontinued because of an adverse event. Most common adverse events were headache, nausea, and fatigue, occurring at similar frequencies in patients receiving active and placebo drugs. SVR12 in the combined immediate treatment group and intensive pharmacokinetic population was 99% (95% CI 95·3-100·0; 115/116), with one relapse 12 weeks after end of treatment when compared with a historical control of 45%, based on meta-analyses of interferon-based regimens used in clinical trials of patients infected with HCV who are on haemodialysis. Once-daily grazoprevir and elbasvir for 12 weeks had a low rate of adverse events and was effective in patients infected with HCV genotype 1 and stage 4-5 chronic kidney disease. Merck Sharp & Dohme Corp.

Multicenter randomized controlled trial on Duration of Therapy for Thrombosis in Children and Young Adults (the Kids‐DOTT trial): pilot/feasibility phase findings

Randomized controlled trials (RCTs) on pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. The Kids-DOTT trial is a multicenter RCT investigating non-inferiority of a 6-week (shortened) versus 3-month (conventional) duration of anticoagulation in patients aged <21years with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1year and anticoagulant-related, clinically relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded-endpoint, parallel-cohort RCT design. No eligibility violations or randomization errors occurred. Of the enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in prespecified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1year was 82%. Interobserver agreement between local and blinded central determination of venous occlusion by imaging at 6weeks after diagnosis was strong (k-statistic=0.75; 95% confidence interval [CI]0.48-1.0). The primary efficacy and safety event rates were 3.3% (95%CI0.3-11.5%) and 1.4% (95%CI0.03-7.4%). The P/F phase of the Kids-DOTT trial has demonstrated the validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention and endpoint rates to inform the fully powered RCT.

Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs

ObjectivesBiological disease-modifying antirheumatic drugs (bDMARDs) have shown diminished clinical response following an inadequate response (IR) to ≥1 previous bDMARD. Here, tofacitinib was compared with placebo in patients with an IR...

Differences in the rates of patient safety events by payer: implications for providers and policymakers.

The reduction of adverse patient safety events and the equitable treatment of patients in hospitals are clinical and policy priorities. Health services researchers have identified disparities in the quality of care provided to patients, both by demographic characteristics and insurance status. However, less is known about the extent to which disparities reflect differences in the places where patients obtain care, versus disparities in the quality of care provided to different groups of patients in the same hospital. In this study, we examine whether the rate of adverse patient safety events differs by the insurance status of patients within the same hospital. Using discharge data from hospitals in 11 states, we compared risk-adjusted rates for 13 AHRQ Patient Safety Indicators by Medicare, Medicaid, and Private payer insurance status, within the same hospitals. We used multivariate regression to assess the relationship between insurance status and rates of adverse patient safety events within hospitals. Medicare and Medicaid patients experienced significantly more adverse safety events than private pay patients for 12 and 7 Patient Safety Indicators, respectively (at P < 0.05 or better). However, Medicaid patients had significantly lower event rates than private payers on 2 Patient Safety Indicators. Risk-adjusted Patient Safety Indicator rates varied with patients' insurance within the same hospital. More research is needed to determine the cause of differences in care quality received by patients at the same hospital, especially if quality measures are to be used for payment.

Independent brachytherapy plan verification software: Improving efficacy and efficiency

Background and purposeTo compare the pre-treatment brachytherapy plan verification by a physicist assisted by custom plan verification software (SAV) with those performed manually (MV). Materials and methodsAll HDR brachytherapy plans used for treatment in 2013, verified using either SAV or MV, were retrospectively reviewed. Error rate (number of errors/number of plans) was measured and verification time calculated. All HDR brachytherapy safety events recorded between 2010 and 2013 were identified. The rate of patient-related safety events (number of events/number of fractions treated) and the impact of SAV on the underlying errors were assessed. ResultsThree/106 errors (2.8%) were found in the SAV group and 24/273 (8.8%) in the MV group (p=0.046). The mean ±1 standard deviation plan verification time was 8.4±4.0min for SAV and 11.6±5.3 for MV (p=0.006). Seven safety events out of 4729 fractions delivered (0.15%) were identified. Four events (57%) were associated with plan verification and could have been detected by SAV. ConclusionsWe found a safety event rate in HDR brachytherapy of 0.15%. SAV significantly reduced the number of undetected errors in HDR treatment plans compared to MV, and reduced the time required for plan verification.

Optimization of drug-drug interaction alert rules in a pediatric hospital's electronic health record system using a visual analytics dashboard.

To develop and evaluate an electronic dashboard of hospital-wide electronic health record medication alerts for an alert fatigue reduction quality improvement project. We used visual analytics software to develop the dashboard. We collaborated with the hospital-wide Clinical Decision Support committee to perform three interventions successively deactivating clinically irrelevant drug-drug interaction (DDI) alert rules. We analyzed the impact of the interventions on care providers' and pharmacists' alert and override rates using an interrupted time series framework with piecewise regression. We evaluated 2 391 880 medication alerts between January 31, 2011 and January 26, 2014. For pharmacists, the median alert rate prior to the first DDI deactivation was 58.74 alerts/100 orders (IQR 54.98-60.48) and 25.11 alerts/100 orders (IQR 23.45-26.57) following the three interventions (p<0.001). For providers, baseline median alert rate prior to the first round of DDI deactivation was 19.73 alerts/100 orders (IQR 18.66-20.24) and 15.11 alerts/100 orders (IQR 14.44-15.49) following the three interventions (p<0.001). In a subgroup analysis, we observed a decrease in pharmacists' override rates for DDI alerts that were not modified in the system from a median of 93.06 overrides/100 alerts (IQR 91.96-94.33) to 85.68 overrides/100 alerts (IQR 84.29-87.15, p<0.001). The medication serious safety event rate decreased during the study period, and there were no serious safety events reported in association with the deactivated alert rules. An alert dashboard facilitated safe rapid-cycle reductions in alert burden that were temporally associated with lower pharmacist override rates in a subgroup of DDIs not directly affected by the interventions; meanwhile, the pharmacists' frequency of selecting the 'cancel' option increased. We hypothesize that reducing the alert burden enabled pharmacists to devote more attention to clinically relevant alerts.

Ohio Children's Hospitals' Solutions for Patient Safety: A Framework for Pediatric Patient Safety Improvement.

Building upon their previous collective success and a clinical imperative for rapid improvement, the eight tertiary pediatric referral centers in Ohio sought to dramatically decrease the most serious types of harm that occur to hospitalized children by collectively employing high reliability methods focused on safety culture. With the support of the hospitals' executives, the Ohio collaborative obtained legal protection and built will by clearly identifying types and frequency of harm events that occur in each participating hospital and across the state. The improvement efforts were divided among task forces designed to incorporate the principles of high reliability organizations into the work of all employees, focusing primarily on the consistent application of error prevention behaviors. Between January 2010 and October 2012, the serious safety event rate among the participating hospitals decreased by 55%, equating to 70 fewer children per year who experienced this most severe type of event in the participating hospitals. Between January 2011 and October 2012, all events of serious harm were decreased by 40%, meaning 18 fewer children per month suffered serious harm. Rapid and significant improvement in pediatric patient safety is possible through collaboration of children's hospitals dedicated to the application of high reliability principles and the noncompetitive sharing of outcomes and best practices.

Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis. The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation. One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria. There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n= 72) and effective orifice area of 1.50 ± 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases. The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.

Long term follow-up from amplatzer cardiac plug European multicenter post market observational study

Purpose: The AMPLATZER® Cardiac Plug (ACP) is a percutaneous transcatheter device intended to prevent thrombus embolizations from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AF). The objective of this prospective, open-label study is to evaluate safety and performance of the ACP device in closure of the LAA and report the initial long-term follow-up results out to two years. Methods and results: We report safety results on a total of 40/161 (24.8%) patients who have been followed for two years post ACP implantation at ten investigative centers in Germany, Spain, United Kingdom, Ireland and the Czech Republic. Study follow-up included rigorous neurological and echocardiographic assessments at baseline, 1, 6, 12 months and 2 years post implant, as well as after a suspected stroke, TIA or systemic embolism. The study is being 100% monitored. An independent Data Monitoring Board is utilized and adjudicates seriousness and relatedness of all the safety events. In comparison to previously presented studies on ACP and other percutaneous LAA closure devices, this cohort was older and had a higher incidence of comorbidities. The majority of reconsented patients (50.9%) had a history of permanent AF, mean age was 70.48±12.54, mean CHA2DS2VASc score 3.27±1.55, and mean HAS-BLED score 2.857±1.15. Prior stroke or TIA was reported in 20.7% of reconsented patients. 100% of subjects with reported 2 year follow up TOE's reported closure of the LAA. Closure is defined as absence of flow or flow of < 3 mm jet into the LAA as assessed by transoesophageal echocardiography (TOE). From implant to six months, two ischemic strokes were adjudicated as unrelated to the device or procedure in a subject population of 204. With 40 subjects completing 6 months to 2 year follow-up, one new ischemic stroke occurred at 256 days post implant in a patient with a risk factor of prior ischemic stroke. Long term follow-up data revealed a total of 19 safety events occurring after the 6 month follow-up period in 9/40 (22.5%) patients. There have been no reported hemorrhagic strokes in any subjects post implant. There have been no reported thrombus on the device or device embolization after 6 months. Conclusion: The ACP device is a good alternative for high risk patients based on the reported excellent closure status. One out of five re-consented patients had a history of prior stroke/TIA and current long-term follow-up data revealed only one new stroke occurring after 6 months. The rate of safety events compares favorably with other LAA closure devices.

A Comprehensive Patient Safety Program Can Significantly Reduce Preventable Harm, Associated Costs, and Hospital Mortality

To evaluate the effectiveness of a hospital-wide initiative to improve patient safety by implementing high-reliability practices as part of a quality improvement (QI) program aimed at reducing all preventable harm. A hospital wide quasi-experimental time series QI initiative using high-reliability concepts, microsystem-based multidisciplinary teams, and QI science tools to reduce hospital acquired harm was implemented. Extensive error prevention training was provided for all employees. Change concepts were enacted using the Institute for Healthcare Improvement's Model for Improvement. Compliance with change packages was measured. Between 2010 and 2012, the serious safety event rate decreased from 1.15 events to 0.19 event per 10 000 adjusted hospital-days, an 83.3% reduction (P<.001). Preventable harm events decreased by 53%, from a quarterly peak of 150 in the first quarter of 2010 to 71 in the fourth quarter of 2012 (P<.01). Observed hospital mortality decreased from 1.0% to 0.75% (P<.001), although severity-adjusted expected mortality actually increased slightly, and estimated harm-related hospital costs decreased by 22.0%. Hospital-wide safety climate scores increased significantly. Substantial reductions in serious safety event rate, preventable harm, hospital mortality, and cost were seen after implementation of our multifaceted approach. Measurable improvements in the safety culture were noted as well.

SAT0267 Safety of Ustekinumab from the Placebo-Controlled Periods of Psoriatic Arthritis and Psoriasis Clinical Developmental Programs

ObjectivesTo describe safety of UST during double-blind, PBO-controlled portion of the PsA & PsO programs.MethodsSafety for PsA were pooled from a Ph2(n=146)& 2 Ph3(PSUMMIT I[n=615], PSUMMIT II[n=312]) studies in pts...

Memorial Hermann: High Reliability from Board to Bedside

In 2006 the Memorial Hermann Health System (MHHS), which includes 12 hospitals, began applying principles embraced by high reliability organizations (HROs). Three factors support its HRO journey: (1) aligned organizational structure with transparent management systems and compressed reporting processes; (2) Robust Process Improvement (RPI) with high-reliability interventions; and (3) cultural establishment, sustainment, and evolution. The Quality and Safety strategic plan contains three domains, each with a specific set of measures that provide goals for performance: (1) "Clinical Excellence;" (2) "Do No Harm;" and (3) "Saving Lives," as measured by the Serious Safety Event rate. MHHS uses a uniform approach to performance improvement--RPI, which includes Six Sigma, Lean, and change management, to solve difficult safety and quality problems. The 9 acute care hospitals provide multiple opportunities to integrate high-reliability interventions and best practices across MHHS. For example, MHHS partnered with the Joint Commission Center for Transforming Healthcare in its inaugural project to establish reliable hand hygiene behaviors, which improved MHHS's average hand hygiene compliance rate from 44% to 92% currently. Soon after compliance exceeded 85% at all 12 hospitals, the average rate of central line-associated bloodstream and ventilator-associated pneumonias decreased to essentially zero. MHHS's size and diversity require a disciplined approach to performance improvement and systemwide achievement of measurable success. The most significant cultural change at MHHS has been the expectation for 100% compliance with evidence-based quality measures and 0% incidence of patient harm.

It's a Crime to Risk Patient Safety

Professional Issues Poster Presentation Purpose for the Program Patient safety was defined by the Institute of Medicine as “the freedom from accidental injury due to medical care or from medical error.” Creating a culture of safe patient care is leading the healthcare industry in terms of quality of care, medical reimbursement, patient outcomes, patient satisfaction, and nursing education. The purpose of this innovative education is to enhance the critical thinking skills of perinatal direct care nursing staff on patient safety hazards with the intent to decrease adverse patient outcomes. The Crime Scene Investigation (CSI) education program was implemented to improve an overall safe environment that reduces the rate of adverse obstetric safety events. Proposed Change Traditional nursing education includes self‐study packets, written examinations, online learning modules, and didactic oral presentations. As nurses we routinely use psychomotor skills; however, traditional nursing education fails to address how we perform and critically think. A CSI room was created to have the direct care nurses physically identify safety hazards in an obstetrics’ patient room. Implementation, Outcomes, and Evaluation A patient's room was simulated into a crime scene with a low fidelity mannequin and more than 35 patient safety hazards with various maternal education competencies, including invasive lines, wound care, sepsis, respiratory, blood administration, medication safety, and falls. Neonatal patient safety hazards included patient identification, safe sleep, and radiant warmer equipment. The nurses received information about the crime scene through a case study and then entered the room to investigate for patient safety hazards. The investigating enhanced critical thinking skills and awareness of patient safety hazards. Direct care nurses engaged in communication about the safety hazards and discussed process and flow in the patient's room. Direct care nurses were able to identify areas of risk on the obstetric unit and implement ideas for process improvement. Implications for Nursing Practice The CSI project affected nursing care because it created a new type of learning environment that enhanced critical thinking skills and psychomotor skills. Minimal cost was associated with the project as everything was preformed on the unit during the staff's scheduled shift. This CSI education project is adaptable to any health professional education. Avoiding preventable injuries to mother and neonates improves a patient's outcomes and is on the forefront of staff education and awareness.