Cause Of Adverse Events Research Articles

Nurses documentation of falls prevention in a patient centred care plan in a medical ward

Objective: To evaluate the consistency of nurses’ documentation in the falls prevention assessment tool, and to ascertain whether patients identified as high risk of falling had falls preventative strategies implemented. Background: Falls are one of the leading causes of adverse events for patients in the hospital setting. The current practice of implementing falls prevention strategies for patients has not been able to be sustained, which remains a challenge for healthcare providers. Among the falls prevention strategies, falls risk assessment tools have been identified as a crucial element in falls prevention so as the number of falls are minimised. Study design and methods: A retrospective chart audit, with the auditing of falls assessment documentation on the Patient Centred Care Plan. Results: The Patient Centred Care Plan audit revealed that 60.8% of patients (n=508) were identified as high risk of falls by the principal investigator. For the cohort of patients identified by the nurses as having a high risk of falling (53.4%), 53.7% of patients had falls prevention strategies implemented, and only 17.5% of patients were engaged with their falls prevention plan. The strategies that were documented by the nurses on the care plan for the high-risk cohort were not implemented for 16.8% of the patients, and 29.5% of high risk of falls patients did not have documentation on the plan indicating their falls status. Discussion: The findings show that there is a significant gap in the identification of high falls risk patients and the documentation and implementation of falls prevention strategies, between nursing staff records on the Patient Centred Care Plan and the audit conducted by the principal investigator for patients who are identified as high falls risk. As part of the audit patient engagement in their falls prevention plan revealed that patients were not informed of their falls risk status by the nursing staff. Conclusion: The outcome from this audit signifies that not all high falls risk patients were identified as a high falls risk, and most of the high falls risk patients were not engaged in their falls prevention plan. Implications for research, policy and practice: Understanding the current practices of falls prevention and raising nursing staff awareness of the identified variance in the implementation of falls prevention strategies will improve the quality, efficiency of healthcare and the patient safety What is already known about the topic? Nurses’ do not always document patient assessment and associated nursing care. There are multiple factors which impact on nurses’ documenting assessment findings and implementation of nursing care. What this paper adds: At times nurses rely on a falls risk assessment made on the previous day when not able to conduct a current falls assessment. Patients are not engaged in their falls prevention plan, even though they are identified as being of risk of falls. Patients are not aware of the implemented falls prevention strategies which are part of their care.

Current state of opioid stewardship.

The opioid epidemic continues to result in significant morbidity and mortality even within hospitals where opioids are the second most common cause of adverse events. Opioid stewardship represents one model for hospitals to promote safe and rational prescribing of opioids to mitigate preventable adverse events in alliance with new Joint Commission standards. The purpose of this study was to identify the prevalence of current hospital practices to improve opioid use. A cross-sectional survey of hospital best practices for opioid use was electronically distributed via electronic listservs in March 2018 to examine the presence of an opioid stewardship program and related practices, including formulary restrictions, specialist involvement for high-risk patients, types of risk factors screened, and educational activities. Among 133 included hospitals, 23% reported a stewardship program and 14% reported a prospective screening process to identify patients at high risk of opioid-related adverse events (ORAEs). Among those with a prospective screening process, there was variability in ORAE risk factor screening. Formulary restrictions were dependent on specific opioids and formulations. Patient-controlled analgesia was restricted at 45% of hospitals. Most hospitals reported having a pain management service (90%) and a palliative care service providing pain management (67%). The absence of opioid stewardship and prospectively screening ORAEs represents a gap in current practice at surveyed hospitals. Hospitals have an opportunity to implement and refine best practices such as access to pain management specialists, use of formulary restrictions, and retrospective and prospective monitoring of adverse events to improve opioid use.

Patient Safety Over Power Hierarchy: A Scoping Review of Healthcare Professionals' Speaking-up Skills Training.

Communication failures in healthcare constitute a major root cause of adverse events and medical errors. Considerable evidence links failures to raise concerns about patient harm in a timely manner with errors in medication administration, hygiene and isolation, treatment decisions, or invasive procedures. Expressing one's concern while navigating the power hierarchy requires formal training that targets both the speaker's emotional and verbal skills and the receiver's listening skills. We conducted a scoping review to examine the scope and components of training programs that targeted healthcare professionals' speaking-up skills. Out of 9,627 screened studies, 14 studies published between 2005 and 2018 met the inclusion criteria. The majority of the existing training exclusively relied on one-time training, mostly in simulation settings, involving subjects from the same profession. In addition, most studies implicitly referred to positional power as defined by titles; few addressed other forms of power such as personal resources (e.g., expertise, information). Almost none addressed the emotional and psychological dimensions of speaking up. The existing literature provides limited evidence identifying effective training components that positively affect speaking-up behaviors and attitudes. Future opportunities include examining the role of healthcare professionals' conflict engagement style or leaders' behaviors as factors that promote speaking-up behaviors.

Adverse drug reactions in primary care: a scoping review

BackgroundMedication-related adverse events, or adverse drug reactions (ADRs) are harmful events caused by medication. ADRs could have profound effects on the patients’ quality of life, as well as creating an increased burden on the healthcare system. ADRs are one of the rising causes of morbidity and mortality internationally, and will continue to be a significant public health issue with the increased complexity in medication, to treat various diseases in an aging society. This scoping review aims to provide a detailed map of the most common adverse drug reactions experienced in primary healthcare setting, the drug classes that are most commonly associated with different levels/types of adverse drug reactions, causes of ADRs, their prevalence and consequences of experiencing ADRs.MethodsWe systematically reviewed electronic databases Ovid MEDLINE, Embase, CINAHL Plus, Cochrane Central Register of Controlled Trials, PsycINFO and Scopus. In addition, the National Patient Safety Foundation Bibliography and the Agency for Health Care Research and Quality and Patient Safety Net Bibliography were searched. Studies published from 1990 onwards until December 7, 2018 were included as the incidence of reporting drug reactions were not prevalent before 1990. We only include studies published in English.ResultsThe final search yielded a total of 19 citations for inclusion published over a 15-year period that primarily focused on investigating the different types of adverse drug reactions in primary healthcare. The most causes of adverse events were related to drug related and allergies. Idiosyncratic adverse reactions were not very commonly reported. The most common adverse drug reactions reported in the studies included in this review were those that are associated with the central nervous system, gastrointestinal system and cardiovascular system. Several classes of medications were reported to be associated with adverse events.ConclusionThis scoping review identified that the most causes of ADRs were drug related and due to allergies. Idiosyncratic adverse reactions were not very commonly reported in the literature. This is mainly because it is hard to predict and these reactions are not associated with drug doses or routes of administration. The most common ADRs reported in the studies included in this review were those that are associated with the central nervous system, gastrointestinal system and cardiovascular system. Several classes of medications were reported to be associated with ADRs.

Does telehealth improve anticoagulation management in patient service centers (PSC)? A pilot project.

Anticoagulation Management Services (AMS) are known to improve warfarin management in the outpatient setting. The guideline recommendations are well established and indicate that patients who receive a Vitamin K antagonist (VKA) should be under the care of an experienced and specialized anticoagulation clinic (Lip et al. in Chest 154(5):1121-1201, 2018). Warfarin, a VKA, is considered a high risk medication and one of the most common causes of adverse events with poor patient outcomes. Anticoagulation care is assessed by measuring the percent of Time in Therapeutic Range (TTR) in patients receiving a VKA. Evidence shows that a 10% improvement in TTR has been associated with a 10% reduction in adverse event rates. Optimal management over usual medical care should prevent 7 myocardial infarctions, strokes, major bleeds, or deaths per 100 patients/year (Bussey et al. in Pharmacotherapy 9(4):214-219, 1989). Telehealth or telemedicine can be defined as the use of electronic information along with telecommunication technologies to provide medical services to individuals that are in remote locations from each other (Perednia in JAMA 273(6):483-488, 1995; Gray et al in J Thromb Thrombolysis 2019(48):690-693, 2019). This technology allows a provider located at a distant site to use two-way audio visual electronic communication to deliver clinical health care services to a patient who is located at an originating site (Kristian et al. Int J Technol Assess Health Care 28(1):44-51, 2012; Testa and Zimmermann in Telemedicine for managing patients on oral anticoagulant, 2011; Telehealth Services in CMS Manual System Pub 100-04 medicare claims processing, 2019). The goals of the Telehealth Anticoagulation Management Service are to: (1) increase patient satisfaction (2) reduce turnaround time for results by providing the INR (International Normal Ratio) results in real time (3) increase patient compliance to INR testing and (4) improve system wide anticoagulation care by increasing cTTR (center Time in Therapeutic Range) metrics to high quality metrics of65% and above. The overarching goal of our health system Telehealth program was to develop a collaborative care telemedicine INR model in collaboration with core laboratories (Patient Service Centers or PSCs) in order to improve patient quality metrics on warfarin. In this model, the Tele-ACTS Center (Telehealth Anticoagulation and Clinical Thrombosis Service) team was able to provide distant care for the outpatient population on warfarin maintenance therapy using a virtual telemedicine INR model located in a distant location to the PSC. Using this model, we were able to improve center-based TTR by 45.73%.

Nurses’ Psychological Feelings About the Application of Gibbs Reflective Cycle of Adverse Events

Subject: To investigate the psychological feelings of nurses about the application of Gibbs Reflective Cycle during nursing adverse events. Methods: 13 cases were interviewed in depth by semi-structured interviews, and the interview data were analysed and summarized. Result: After the occurrence of adverse events, nurses on duty have negative emotions, especially in the event of big adverse events, the psychological feeling of depression is more intense, and even leading to the new nurses on duty doubt about their careers. The nurses think that the Gibbs Reflective Cycle is helpful for the growth, especially for nursing staff with low seniority. However, it is difficult to determine the specific cause when analyzing the cooperation and participation of adverse events. Nurses also worry that a reflective diary could become a bad record for the rest of their careers. Conclusion: Gibbs reflection Cycle's theoretical approach can help nurses develop clinical nursing thinking in the process of dealing with adverse events and deepen nurses' understanding of the causes of adverse events. At the same time, nursing managers should pay attention to nurses' negative psychological state and eliminate their concerns about poor work records. Using Gibbs reflection Cycle to reflect on the causes of adverse events is a way to develop nurses' clinical thinking, which is an effective way to continue medical education and training.

An equipment qualification framework for healthcare

Manufacturing, in regulated industries, has developed systematic practices, protocols and tools for equipment acceptance testing, described by the term Equipment Qualification. This paper, in drawing parallels between requirements of manufacturing equipment and medical equipment, hypothesizes that the protocols, practices and tools of Equipment Qualification can be adapted for application in healthcare. In manufacturing, where the quality of output is of critical concern, the scope of Equipment Qualification is building confidence that the equipment can produce product to specification. In healthcare, where patient safety is the critical concern, the identification and control of potential causes of adverse events is of central importance in establishing confidence that the equipment is “ready for its intended use.” This paper details the development of an Equipment Qualification framework for healthcare to guide healthcare practitioners in best practice tools, techniques and considerations for the identification and control of potential causes of adverse events. The Equipment Qualification framework presented in this paper synthesizes existing knowledge in the domains of risk management, quality, safety, reliability, maintenance, calibration, human factors engineering and lean methods with empirical findings of benchmarking case studies in manufacturing companies and requirements analysis case studies and questionnaire in healthcare. The framework is written in the systems engineering modeling language IDEFØ.

Association Between Immune-Related Adverse Events During Anti–PD-1 Therapy and Tumor Mutational Burden

Immune checkpoint inhibitors (ICIs) that target the programmed death 1 receptor (anti–programmed cell death 1 [PD-1] therapy) have ushered in a new era of cancer therapy. However, their application has been curtailed by serious immune-related adverse events (irAEs), such as colitis, pneumonitis, and myocarditis, that remain largely unpredictable. Although the use of tumor mutational burden (TMB) as a biomarker for expected therapy response has been advocated,1 a similar parameter for irAEs is lacking. In an attempt to fill this clinically relevant knowledge gap, we investigated the association between irAEs reported during anti–PD-1 therapy and TMB by comparing large-scale surveillance data of irAEs with the median TMB across multiple cancer types. Methods We retrieved postmarketing data of adverse events from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from July 1, 2014, to March 31, 2019. According to the ethics committee policy of the EKOS (Ethikkommission Ostschweiz, Switzerland), this study was exempt from ethical review because all analyzed datasets are deidentified and publicly available. We considered only reports for which the anti–PD-1 agents nivolumab or pembrolizumab were the suspected cause of adverse events. Anti–PD-1 and anti-cytotoxic T-lymphocyte–associated protein 4 combination treatment was excluded. Closely related indications were aggregated to unified terms; for example, “malignant melanoma” was aggregated to “melanoma.” To limit our analysis to irAEs, we filtered terms to match broadly accepted diagnoses that were outlined in peer-reviewed irAE management guidelines. The median TMB in tumor tissue was obtained from previously published comprehensive genomic profiling.2,3 Lastly, we only considered cancers for which there were at least 100 cases of adverse events during anti–PD-1 therapy reported in FAERS. To assess the risk of a patient developing any irAE, we estimated reporting odds ratios (RORs) by comparing the odds of reporting these irAEs rather than others for the anti–PD-1 agents with the odds for all other drugs in the database, which represents standard practice for quantitative analyses of data in FAERS and similar databases.4 Results Our search strategy identified a total of 47 304 adverse events (AEs) in 16 397 patients reported as treated with anti–PD-1 monotherapy for 19 different cancer types. Of these patients, 3661 had at least 1 irAE (22.3%; 95% CI, 21.7-23.0). The comparator group comprised 16 411 749 AE reports from 5 160 064 patients. Our analysis revealed a significant positive correlation between the ROR of reporting an irAE during anti–PD-1 therapy and the corresponding TMB across multiple cancer types, with a higher ROR of irAE associated with a higher median number of coding somatic mutations per megabase of DNA (Figure; Pearson correlation coefficient R = 0.704; P < .001). The correlation coefficient suggests that 50% of the differences in the irAE risk across cancer types may be attributed to the TMB. Discussion Our analysis indicates that cancers with a high TMB, such as melanoma and non–small cell lung cancer, are associated with a higher irAE ROR during anti–PD-1 therapy, strongly suggesting that these cancers are associated with a higher risk of irAEs than cancers with a low TMB. A possible explanation for this finding may be the different neoantigenic load across cancer types. Additionally, studies have shown that T cells that react against a neoantigen can crossreact against the corresponding wild-type protein.5 Another contributing mechanism may be antigen spreading, where tumor cell death releases antigens, including neoantigens, that prime lymphocytes against the wild-type antigens in healthy tissue. Given the results of the analysis, we propose that the association between irAEs and improved response to anti–PD-1 treatment are linked via an underlying neoantigenic potential that stems from a high TMB. A limitation of the study is the use of spontaneous reports for indirectly measuring the risk of irAE. Furthermore, patients with cancers with a high TMB may receive a longer course of anti–PD-1 treatment. However, most irAEs reported during anti–PD-1 therapy develop within the first few weeks of treatment.6 This finding suggests that therapy duration is unlikely to influence the statistical outcome. In conclusion, a high TMB may be a useful biomarker for assessing patients’ risk of irAEs during anti–PD-1 therapy, which has particular relevance for vulnerable patient groups.

How to undertake intravenous infusion calculations.

This article provides a step-wise, practical approach to undertaking intravenous (IV) infusion calculations. It also explores the evidence base behind medication errors in relation to calculations. REFLECTIVE ACTIVITY: 'How to' articles can help to update your practice and ensure it remains evidence-based. Apply this article to your practice. Reflect on and write a short account of.

How to undertake oral medicines calculations

Rationale and key pointsThis article provides a step-wise, practical approach to undertaking oral medicines calculations for tablets, capsules and liquid preparations. It also explores the evidence base behind medication errors in relation to calculations.• Medication errors have been identified as one of the most frequent types of patient safety incident that occur, and they are the most common, single preventable cause of adverse events.• Undertaking a medicines calculation can reduce the risk of an incorrect medicines dose being administered to the patient, which would result in a suboptimal therapeutic benefit or possible harm to the patient.• Nurses must ensure that they practise undertaking medicines calculations, while healthcare organisations have an important role in ensuring this skill is developed and maintained among their staff.Reflective activity‘How to’ articles can help to update your practice and ensure it remains evidence-based. Apply this article to your practice. Reflect on and write a short account of:1. How this article might improve your practice when undertaking oral medicines calculations.2. How you could use this information to educate nursing students or your colleagues on the appropriate methods for undertaking oral medicines calculations.

A Hazard Analysis of Class I Recalls of Infusion Pumps.

BackgroundThe adverse event report of medical devices is one of the postmarket surveillance tools used by regulators to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. However, with the development of the related technologies and market, the number of adverse events has also been on the rise, which in turn results in the need to develop efficient tools that help to analyze adverse events monitoring data and to identify risk signals.ObjectiveThis study aimed to establish a hazard classification framework of medical devices and to apply it over practical adverse event data on infusion pumps. Subsequently, it aimed to analyze the risks of infusion pumps and to provide a reference for the risk management of this type of device.MethodsThe authors define a general hierarchical classification of medical device hazards. This classification is combined with the Trace Intersecting Theory to form a human-machine-environment interaction model. Such a model was applied to the dataset of 2001 to 2017 class I infusion pump recalls extracted from the Food and Drug Administration (FDA) website. This dataset does not include cases involving illegal factors.ResultsThe proposed model was used for conducting hazard analysis on 70 cases of class I infusion pump recalls by the FDA. According to the analytical results, an important source of product technical risk was that the infusion pumps did not infuse accurate dosage (ie, over- or underdelivery of fluid). In addition, energy hazard and product component failure were identified as the major hazard form associated with infusion pump use and as the main direct cause for adverse events in the studied cases, respectively.ConclusionsThe proposed human-machine-environment interaction model, when applied to adverse event data, can help to identify the hazard forms and direct causes of adverse events associated with medical device use.

Examining Causes and Prevention Strategies of Adverse Events in Deceased Hospital Patients: A Retrospective Patient Record Review Study in the Netherlands.

To improve patient safety and possibly prevent mortality from adverse events (AEs) in hospitals, it is important to gain insight in their underlying causes. We aimed to examine root causes and potential prevention strategies of AEs in deceased hospital patients. Data on 571 AEs were used from two retrospective patient record review studies of patients who died during hospitalization in the Netherlands. Trained reviewers assessed contributing factors and potential prevention strategies. The results were analyzed together with data on preventability of the AE and the relationship of the AE with the death of the patient. In 47% of the AEs, patient-related causes were identified, in 35% human causes, in 9% organizational causes, and in 3% technical causes. Preventable AEs were caused by technical, organizational, and human causes (78%, 74%, and 74%, respectively) more often than by patient-related causes (33%). In addition, technical factors caused AEs leading to preventable death (78%) relatively often. Recommended strategies to prevent AEs were quality assurance/peer review, evaluation of safety behavior, improving procedures, and improving information and communication structures. Human failures played an important role in the causation of AEs in Dutch hospitals, because they occurred frequently and they were frequently the cause of preventable AEs. To a lesser extent, latent organizational and technical factors were identified. Patient-related factors were often identified, but the preventability of the AEs with these causes was low. For future research into causes of AEs, we recommend combining record review with interviewing.

Adverse events in prehospital emergency care: a trigger tool study

BackgroundPrehospital emergency care has developed rapidly during the past decades. The care is given in a complex context which makes prehospital care a potential high-risk activity when it comes to patient safety. Patient safety in the prehospital setting has been only sparsely investigated. The aims of the present study were 1) To investigate the incidence of adverse events (AEs) in prehospital care and 2) To investigate the factors contributing to AEs in prehospital care.MethodsWe used a retrospective study design where 30 randomly selected prehospital medical records were screened for AEs each month in three prehospital organizations in Sweden during a period of one year. A total of 1080 prehospital medical records were included. The record review was based on the use of 11 screening criteria.ResultsThe reviewers identified 46 AEs in 46 of 1080 (4.3%) prehospital medical records. Of the 46 AEs, 43 were classified as potential for harm (AE1) (4.0, 95% CI = 2.9–5.4) and three as harm identified (AE2) (0.3, 95% CI = 0.1–0.9). However, among patients with a life-threatening condition (priority 1), the risk of AE was higher (16.5%). The most common factors contributing to AEs were deviations from standard of care and missing, incomplete, or unclear documentation. The most common cause of AEs was the result of action(s) or inaction(s) by the emergency medical service (EMS) crew.ConclusionsThere were 4.3 AEs per 100 ambulance missions in Swedish prehospital care. The majority of AEs originated from deviations from standard of care and incomplete documentation. There was an increase in the risk of AE among patients who the EMS team assessed as having a life-threatening condition. Most AEs were possible to avoid.

Epidemiology of infection in mechanical circulatory support: A global analysis from the ISHLT Mechanically Assisted Circulatory Support Registry.

Despite advances in device technology and treatment strategies, infection remains a major cause of adverse events (AEs) in mechanical circulatory support (MCS) patients. To characterize the epidemiology of MCS infection, we examined the type, location, and timing of infection in the International Society for Heart and Lung Transplantation Registry (ISHLT) for Mechanically Assisted Circulatory Support (IMACS) over 3 years, 2013 to 2015. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) definitions were used to categorize AE infections occurring in MCS patients within IMACS. The IMACS infection variables were mapped to ISHLT definitions for infection where feasible. Three categories of MCS infection were defined as ventricular assist device (VAD) specific, VAD related, and non-VAD. There were 10,171 patients enrolled from January 2013 through December 2015. Infection was the most common AE, with 3,788 patients (37%) experiencing ≥ 1 infection, and 6,758 AE infections reported overall. Non-VAD infection was the largest category, 4,501: 34.0% pneumonias, 30.6% non-VAD-related bloodstream infections (BSIs), 24.15% urinary tract infections (UTIs), and 10.2% gastrointestinal infections. VAD-specific infection was the second largest category, 1,756: 82.9% driveline, 12.8% pocket, and 4.3% pump/or cannula infections. VAD-related infection was the smallest category, 501: 47.5% BSIs, 47.5% mediastinitis, and 5.0% mediastinitis/pocket infections. All 3 categories were more frequently reported ≤ 3 months after implant. Non-VAD infection, including pneumonia, BSI, UTI, and gastrointestinal infection, was the leading category of infection in MCS patients and the most frequently reported ≤ 3 months after implant. These results provide evidence to support resourcing and strengthening infection prevention strategy early after implantation in MCS.

Assessment of Incorrect Surgical Procedures Within and Outside the Operating Room

Reducing wrong-site surgery is fundamental to safe, high-quality care. This is a follow-up study examining 8 years of reported surgical adverse events and root causes in the nation's largest integrated health care system. To provide a follow-up description of incorrect surgical procedures reported from 2010 to 2017 from US Veterans Health Administration (VHA) medical centers, compared with the previous studies of 2001 to 2006 and 2006 to 2009, and to recommend actions for future prevention of such events. This quality improvement study describes patient safety adverse events and close calls reported from 86 VHA medical centers from the approximately 130 VHA facilities with a surgical program. The surgical procedures and programs vary in size and complexity from small rural centers to large, complex urban facilities. Procedures occurring between January 1, 2010, and December 31, 2017, were included. Data analysis took place in 2018. The categories of incorrect procedure types were wrong patient, side, site (including wrong-level spine), procedure, or implant. Events included those in or out of the operating room, adverse events or close calls, surgical specialty, and harm. These results were compared with the previous studies of VHA-reported wrong-site surgery (2001-2006 and 2006-2009). Our review produced 483 reports (277 adverse events and 206 close calls). The rate of in-operating room (in-OR) reported adverse events with harm has continued to trend downward from 1.74 to 0.47 reported adverse events with harm per 100 000 procedures between 2000 and 2017 based on 6 591 986 in-OR procedures. When in-OR events were examined by discipline as a rate, dentistry had 1.54, neurosurgery had 1.53, and ophthalmology had 1.06 reported in-OR adverse events per 10 000 cases. The overall VHA in-OR rate for adverse events during 2010 to 2017 was 0.53 per 10 000 procedures based on 3 234 514 in-OR procedures. The most common root cause for adverse events was related to issues in performing a comprehensive time-out (28.4%). In these cases, the time-out either was conducted incorrectly or was incomplete in some way. Over the period studied, the VHA identified a decrease in the rate of reported adverse events in the OR associated with harm and continued reporting of adverse event close calls. Organizational efforts continue to examine root cause analysis reports, promulgate lessons learned, and enhance policy to promote a culture and behavior that minimizes events and is transparent in reporting occurrences.

Analysis on the risks of severe adverse events in rabies post-exposure prophylaxis and appropriate decision-making procedure

ABSTRACT Severe adverse events (AEs) following post-exposure rabies vaccination had been occasionally described in previous studies. Once AEs occurred, immediate medical treatment and appropriate change of vaccine and vaccination schedule were of significance. It was also important and challengeable to determine the relationship among adverse reactions, vaccines residues and laboratory tests for patients, to choose a proper vaccine in resumed vaccination, to avoid the reoccurrence of AEs and to ensure adequate immune response. Here, we present steps about how to cope with AEs by giving an example with a two-year-old girl who was identified as category II exposure to rabies, suffered from anaphylaxis after first dose administration with human diploid rabies vaccine (HDCV) so vaccination was temporarily suspended. Dexamethasone was prescribed to her in anti-allergy therapy. Allergy tests indicated that the patient was not sensitive to allergens and heterologous proteins. Vaccine test report showed that residual kanamycin existed in that batch of vaccines. This reminded us to provide her antibiotic skin sensitivity test which found she was allergic to kanamycin. Thus, we could conclude it was the cause of AEs. Then, 0.5 mL lyophilized Purified Vero Cell Rabies Vaccine (PVRV) without any residues was enrolled in the resumed vaccination. To ensure successful immunization, immunogenicity test was also provided which showed adequate immune response (RVNA ≥ 0.5 IU/mL) starting from day14. Besides, no further AEs occurred afterward. This study emphasized the importance of in-depth survey, analysis and implied the necessity to scientifically and properly choose the optimal vaccine for patients and appropriately provide treatments if AEs occurred.

Standardization of Oncology Resident Handover Notes in Order to Improve Patient Safety

Communication errors are a leading cause of adverse events in healthcare. Resident handover notes are not standardized. This resident led quality improvement project aimed to produce a standardized patient handover note with goal of 100% compliance at 12 months. We implemented a standardized handover note using Advancing Safety for Patients in Residency Education (ASPIRE) sessions. In the first session the residents reviewed sample weekend and holiday handover notes with the ASPIRE attending. This was followed by take home project where the residents reviewed data elements that are crucial to a safe handover note. In the following ASPIRE session the residents used consensus based recommendations regarding data elements that were deemed essential in a handover document. The standardized handover document was distributed to all staff and off service residents. The intervention was evaluated by reviewing compliance over the first 10 months. Compliance with the standardized handover note was 75% in the first three months of implementation. Compliance was 100% in the most recent three months. The average compliance is 90% in the first 10 months. Patient code status was addressed on average 48% of the time. Patient location was stated on average 79% of the time. Using ASPIRE sessions we were able to produce a standardized handover note. Our aim was to reduce communication errors and improve patient safety. Compliance increased in the first 10 months. Code status and patient location can be further optimized. This project can be adapted at other programs to improve patient safety.

Medication Errors Associated With Adverse Drug Reactions in Iran (2015-2017): A P-Method Approach.

Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using national data and valid statistics are required. The primary objective of this study was to provide a national ‘characteristic profile’ of medication error-associated adverse drug reactions (ADRs), which are also known as preventable ADRs (pADRs). A retrospective study of pADR reports submitted to the national pharmacovigilance center (PCV) within Iran’s Food and Drug Administration was conducted over a 2-year period (2015-2017). Preventability Method (P-Method), which is a standardized tool developed and recommended by the World Health Organization (WHO), was used for preventability assessment. The results of the analyses revealed that while the number of pADRs increased from year one to two (601 to 630), their proportion out of all ADRs per year decreased (7.32% to 6.44%). The percentage of pADRs was higher in females (61.01%) and adults (83.27%), and the highest number of reports were received by nurses (71.57%). Having ‘a documented hypersensitivity to an administered drug or drug class’ was the most common preventable factor in both years (61.23% and 54.29% respectively), and ‘anti-infectives used systemically’ were the medication class which primarily contributed to both serious (53.29%) and non-serious pADRs (39.19%). The specific characteristics of medication errors associated with ADRs from this study, especially the preventable criteria which led to their occurrence, can help devise more specific preventative policies.

Half Of Postoperative Deaths After Hepatectomy Are Preventable: Results Of The Root-Cause Analysis Of A Prospective Multicenter Cohort

Background: Mortality after hepatectomy has not decreased over the past decade at specialized HPB-centers (4.7%) or nationally (5.8%). Prognostic models inaccurately predict mortality. Sensitizing HPB-centers to their outcome also fails to improve the postoperative course. A root-cause analysis, a method employed outside medicine to retrospectively explore and overcome the causes of adverse events, of postoperative mortality was performed. Study design: The study population was a prospective cohort of hepatectomies performed at 13 HPB-centers between 10/2012 and 12/2014. Of the 1906 patients, 90 patients died within 90-days (4.7%). The root-cause analysis was performed independently by a senior HPB-surgeon and a HPB fellow. The aims were to assess if: (1) the cause of death had been identified by the attending surgeons; (2) the patient had been managed according to International guidelines; (3) the intra and post-operative management had been inappropriate; (4) the death was preventable; (5) a typical root-cause of postoperative death could be identified. Results: The cause of death was identified by the index surgeon and by the root-cause in 84% and 88% of the patients. The root-cause was intra-operative in 33% (technical error, 24%; inappropriate judgement, 22%) or related to delayed postoperative management (23%). Guidelines were not followed in 57%. Overall, 47% of deaths were preventable. The typical cause of death was a patient operated for a malignancy, with insufficient evaluation (tumor stage or progression), in whom a larger than expected procedure was performed. Conclusion: Compliance with guidelines and team communication if an unplanned operative finding occurs should be strictly implemented.

Impact of the communication and patient hand-off tool SBAR on patient safety: a systematic review

ObjectivesCommunication breakdown is one of the main causes of adverse events in clinical routine, particularly in handover situations. The communication tool SBAR (situation, background, assessment and recommendation) was developed to...