Patient Safety Risks Research Articles

Perception of Patient Safety Risk Factors and Performance Level of Safety Care Activities among Hospital Nurses

Purpose: The purpose of this study was to identify the level of perception of safety risk factors and the degree of performance of safety nursing activities in order to develop an education program to improve the safety of patients. Methods: The subjects were 217 nurses from 3 university hospitals in Incheon. Data were collected with structured questionnaires and analyzed using descriptive analysis, t-test, and ANOVA using SPSS 22.0. Results: The level of perception of patient's safety risk factors and safety care activities was 2.93 and 4.68, respectively. Perception of patient safety risk factors which belonging to the risk type of therapeutic devices, equipment, service and infrastructure all scored below average; also in addition, behavior, performance, and violence risk type and work system, information and communication risk type showed relatively low perception levels. Safety nursing activities showed a low level of performance in accurate communication among medical teams, management of fire and disaster, security management, use of restraints, identification of patients, and correct performance of operations and procedures. Conclusion: Based on these results, it is necessary to improve the safety of patients by taking proper management measures along with education.

Improving Communication to General Practitioners (GPs) Following Day Attendance on an Oncology Admissions Unit

Background: Weston Park Hospital (WPH) is a specialist cancer hospital, within the Sheffield Teaching Hospitals (STH) NHS Trust. It houses its own admissions unit (WAU) where cancer patients are seen by the on-call medical team for assessment. Patients who are receiving treatment for cancer can self refer via the on-call nurse practitioner, be referred by the GP or be referred by the other hospitals for further management. Patients are either discharged from WAU or are admitted to the in-patient wards for further care. Traditionally, no formal discharge letter is required for patients who are discharged directly from WAU but if necessary a hand-written outpatient prescription is given to them with instructions to take a copy to their GP. An electronic discharge letter may be produced but this is at the assessing doctor’s discretion. A datix was recently generated when a patient was prescribed medication on discharge from WAU but this was not subsequently added to their regular repeat prescription. Additionally we found that the nurse practitioner takes a number of calls from patients regarding prescriptions and difficulty obtaining these from their GP. This highlights a clear failure in communication between WAU and the GPs in the community, thus risking patient safety. We found that of 66 WAU reviews in one week, 22 patients were discharged on the same day and only two discharge letters were produced. The aim of this quality improvement project (QIP) is to improve communication to the GP through implementation of a standard operating procedure where all patients discharged on the same day from WAU are given an electronic discharge letter which is also sent to the GP.

UV-vis Imaging of Piroxicam Supersaturation, Precipitation, and Dissolution in a Flow-Through Setup.

Evaluation of drug precipitation is important in order to address challenges regarding low and variable bioavailability of poorly water-soluble drugs, to assess potential risk of patient safety with infusion therapy, and to explore injectable in situ suspension-forming drug delivery systems. Generally, drug precipitation is assessed in vitro through solution concentration analysis methods. Dual-wavelength UV-vis imaging is a novel imaging technique that may provide an opportunity for simultaneously monitoring changes in both solution and solid phases during precipitation. In the present study, a multimodal approach integrating UV-vis imaging, light microscopy, and Raman spectroscopy was developed for characterization of piroxicam supersaturation, precipitation, and dissolution in a flow-through setup. A solution of piroxicam dissolved in 1-methyl-2-pyrrolidinone was injected into a flowing aqueous environment (pH 7.4), causing piroxicam to precipitate. Imaging at 405 and 280 nm monitored piroxicam concentration distributions during precipitation and revealed different supersaturation levels dependent on the initial concentration of the piroxicam solution. The combination with imaging at 525 nm, light microscopy, and Raman spectroscopy measurements demonstrated concentration-dependent precipitation and the formation, growth, and dissolution of individual particles. Results emphasize the importance of the specific hydrodynamic conditions on the piroxicam precipitation. The approach used may facilitate comprehensive understanding of drug precipitation and dissolution processes and may be developed further into a basic tool for formulation screening and development.

Conditions Requiring Emergent Pediatric Interfacility Transport: Analysis of a Statewide EMS System

Background In regionalized health care systems, pediatric patients routinely require interfacility transfer (IFT) from initial emergency care to a second acute care facility to reach definitive care. IFT is associated with patient safety risks, delays in definitive care, and increased cost. This study identifies high-frequency IFT conditions for pediatric patients from a statewide EMS system to help craft a destination decision tool for pediatric EMS patients that minimizes IFT. Objective To determine the diagnosis categories (DxC) mostly likely to require IFT from EDs to another acute care facility, including the most frequent …

Implications of involving pharmacy technicians in obtaining a best possible medication history from the perspectives of pharmaceutical, medical and nursing staff: a qualitative study

ObjectivesIn recent years, the involvement of pharmacy technicians in medication reconciliation has increasingly been investigated. The aim of this study was to assess the implications on professional roles and collaboration...

230 - Investigating and responding to contamination and sterility failures of cell-based therapies

Cell-based therapies and especially autologous therapy processing begin will the starting raw material, often by leukapheresis cell collection. Therefore it is known that intrinsic contamination at the beginning of processing batch is a real risk that must be adequately assessed. The rate or percentage of product contamination events may be similar to that found in the blood or platelet transfusion industry, or perhaps even higher such as in some peripheral blood progenitor stem cell processes. Therefore, process contamination in the manufacturing stream will likely be realized at some frequency requiring an investigation and response in the form of a deviation report with appropriate corrective and preventative action (CAPA). Sometimes the process contamination may stay hidden at undetectable or unobservable levels throughout early processing until after cell culture incubation phases. Proliferation of microbial contaminants that were previously at low-levels become significantly elevated raising additional risks for cross-contamination of other processes, and risks for patient safety, especially if the product is fresh with a short shelf-life. These factors plus risks for extrinsic contamination from the facility environment and operators involved in open processing results in a final cell product that may at times fail the sterility test specification. Therefore a robust, systematic procedure for investigation of, and responding to contamination events, including thorough and repeatable root cause analysis system, is a vital quality system element that should be in place.

Antimicrobial peptides: an effective approach to prevent bacterial biofilm formation in platelet concentrates.

The safety of platelet concentrates (PCs) is a major concern in transfusion medicine due to contamination mainly with skin Gram-positive bacteria. The predominant contaminant, Staphylococcus epidermidis, forms bacterial cell aggregates (biofilms) in PCs posing a safety risk for transfusion patients. Combinations of synthetic antimicrobial peptides (AMPs) have demonstrated bactericidal activity in PCs. Herein, we have evaluated the ability of a mix of AMPs to inhibit biofilm formation and/or eradicate S.epidermidis biofilms. Three synthetic AMPs, the platelet-derived peptide (PD4) and two arginine-tryptophan repeats (RW3 and RW4), were used for bactericidal and antibiofilm experiments in glucose-supplemented trypticase soy broth (TSBg) and PCs spiked with three biofilm-forming strains of S.epidermidis. Time-killing assays were performed to evaluate the bactericidal capability of the peptides. Inhibition of biofilm formation was assayed by seeding S.epidermidis into TSBg or PC cultures supplemented with the AMPs. Biofilm eradication assays were performed after AMP treatment of preformed biofilms with and without mechanical dislodging. Biofilms were measured using a crystal violet assay. Time-killing assays demonstrated that all S.epidermidis strains were eliminated after 24hours of AMP treatment. While inhibition of biofilm formation was observed for all S.epidermidis strains in TSBg and PCs, the AMP treatment was only effective to reduce the bacterial load of mechanically dislodged biofilms. The combination of three synthetic AMPs (PD4-RW3-RW4) can be used to inhibit biofilm formation by S.epidermidis to enhance PC safety. However, further investigation is needed to improve their activity against mature S.epidermidis biofilms.

An Elemental Impurities Excipient Database: A Viable Tool for ICH Q3D Drug Product Risk Assessment

To support the practical implementation of the International Council for Harmonisation (ICH) Q3D guideline, which describes a risk-based approach to the control of elemental impurities in drug products, a consortium of pharmaceutical companies has established a database to collate the results of analytical studies of the levels of elemental impurities within pharmaceutical excipients. This database currently includes the results of 26,723 elemental determinations for 201 excipients and represents the largest known, and still rapidly expanding, collection of data of this type. Analysis of the database indicates good coverage of excipients relevant to real-world drug product formulations and tested element profiles consistent with ICH Q3D recommendations. The database includes the results from multiple analytical studies for an excipient and thus incorporates within it an indication of both excipient supplier and batch-to-batch variability as well as any variability associated with the different testing organizations and methods employed. The data confirm the findings of earlier smaller studies that elemental impurity concentrations in excipients are generally low and when used in typical proportions in formulated drug products are unlikely to pose a significant patient safety risk. The database is now in active use as one line of evidence in ICH Q3D risk assessments.

Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests.

We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and explore medical device requirements applicable to a laboratory environment to design, develop, and validate laboratory developed tests (LDTs). We performed nine interviews with laboratory professionals to explore concerns and challenges regarding the draft, translated the results into operational factors, and surveyed professionals to test the factors that would comprise a regulatory quality management system framework. Nine interviewees and 35 survey respondents shared concerns of risk classification, process validation, patient safety, and general ambiguity regarding the proposed requirements for development of LDTs. Respondents agree that a regulatory quality management system is needed in laboratories that develop LDTs, but the translation and method for design control to a clinical laboratory do not exist. As a result, laboratories are taking the wait-and-see approach.

Neonatal Nurses Experience Unintended Consequences and Risks to Patient Safety With Electronic Health Records.

In this article, we examine the unintended consequences of nurses' use of electronic health records. We define these as unforeseen events, change in workflow, or an unanticipated result of implementation and use of electronic health records. Unintended consequences experienced by nurses while using electronic health records have been well researched. However, few studies have focused on neonatal nurses, and it is unclear to what extent unintended consequences threaten patient safety. A new instrument called the Carrington-Gephart Unintended Consequences of Electronic Health Record Questionnaire has been validated, and secondary analysis using the tool explored the phenomena among neonatal nurses (N = 40). The purposes of this study were to describe unintended consequences of use of electronic health records for neonatal nurses and to explore relationships between the phenomena and characteristics of the nurse and the electronic health record. The most frequent unintended consequences of electronic health record use were due to interruptions, followed by a heavier workload due to the electronic health record, changes to the workflow, and altered communication patterns. Neonatal nurses used workarounds most often with motivation to better assist patients. Teamwork was moderately related to higher unintended consequences including patient safety risks (r = 0.427, P = .007), system design (r = 0.419, P = .009), and technology barriers (r = 0.431, P = .007). Communication about patients was reduced when patient safety risks were high (r = -0.437, P = .003). By determining the frequency with which neonatal nurses experience unintended consequences of electronic health record use, future research can be targeted to improve electronic health record design through customization, integration, and refinement to support patient safety and better outcomes.

Managing Alarms in Acute Care Across the Life Span: Electrocardiography and Pulse Oximetry.

AACN Practice Alert| April 01 2018 Managing Alarms in Acute Care Across the Life Span: Electrocardiography and Pulse Oximetry Crit Care Nurse (2018) 38 (2): e16–e20. https://doi.org/10.4037/ccn2018468 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share MailTo Twitter LinkedIn Tools Icon Tools Cite Icon Cite Get Permissions Citation Managing Alarms in Acute Care Across the Life Span: Electrocardiography and Pulse Oximetry. Crit Care Nurse 1 April 2018; 38 (2): e16–e20. doi: https://doi.org/10.4037/ccn2018468 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentCritical Care Nurse Search Advanced Search Alarm fatigue is a patient safety risk, occurring when clinicians are exposed to excessive numbers of alarms, particularly false and clinically insignificant alarms. This overexposure results in sensory overload and desensitization to alarms. Consequently, response to alarms may be delayed or alarms may be missed altogether. Patients’ deaths have been attributed to alarm fatigue when a serious clinical event was missed because the alarm was not heard or was assumed to be false.1 In recent studies,2,3 from 89% to 99% of electrocardiographic (ECG) monitor alarms were found to be false or clinically insignificant. To date, clinical strategies to reduce alarms and alarm fatigue have been focused on ECG and oxygen saturation (Spo2) alarms. However, evidence for these strategies is limited. Interventions presented here are primarily supported by expert opinion and/or have demonstrated success in quality improvement projects. To reduce false and clinically insignificant alarms... You do not currently have access to this content.

Acute acalculous cholecystitis: A new safety risk for patients with MS treated with alemtuzumab.

To evaluate acute acalculous cholecystitis (AAC) as a potential safety risk for patients treated with alemtuzumab. The Food and Drug Administration Adverse Event Reporting System and the medical literature were searched for cases of AAC in conjunction with alemtuzumab for all clinical indications. Eight spontaneously reported cases meeting the case definition of AAC in close temporal association with alemtuzumab use were identified. Based on established criteria within the Food and Drug Administration Division of Pharmacovigilance for causality assessment, 4 cases were assessed as probable while 4 were possible. All cases occurred in patients with relapsing-remitting multiple sclerosis. Seven of the 8 cases presented with AAC during or shortly after alemtuzumab treatment, thereby suggesting an acute cytokine release syndrome as a putative pathogenic mechanism. The cases identified in this review differ from the typical AAC cases described in the medical literature based on female preponderance, lack of concurrent critical illnesses, inconsistent presence of other risk factors, and resolution with conservative treatment in the majority of cases. AAC represents a new and potentially life-threatening adverse event associated with alemtuzumab use in relapsing-remitting multiple sclerosis. In cases seen to date, early and conservative treatment resulted in good clinical outcome, although the natural history of AAC in this population without critical illness is not well defined. Awareness of this safety risk by general and specialty neurologists is important for prompt recognition and optimal management.

Development of a proof of principle for universal neutralization of antibiotics in cord blood by-products used for sterility testing.

Bacterial contamination of cord blood (CB) represents a safety risk for transplantation patients. CB sterility testing at Canadian Blood Services' Cord Blood Bank is performed using a 1:1 mix of CB-derived plasma and red blood cells (RBCs). Culture bottles of an automated culture system, which lack antimicrobial neutralization properties, are used for bacterial screening of CB. This process is unsuitable for CB-containing antibiotics, potentially resulting in false-negative results. This study was aimed at developing a protocol for antibiotic neutralization in CB used for sterility testing. Phase 1: four neutralizers-penicillinase, ion exchange resins L and A, lecithin + Tween80, and activated charcoal (AC)-were individually tested to neutralize penicillin or gentamicin in cultures of Staphylococcus epidermidis or Klebsiella pneumoniae, respectively, adjusted to 100 colony forming units/mL, in Müller-Hinton broth (MHB). Phase 2: combinations of penicillinase plus resin L or penicillinase plus AC were assayed for the simultaneous neutralization of both antibiotics in MHB. Phase 3: penicillinase plus resin L was used to neutralize both antibiotics in CB sterility testing samples (plasma + RBCs). Phase 1: penicillin was neutralized by penicillinase and resin A, while gentamicin was neutralized by resin L and AC. Phase 2: the antibiotics were simultaneously neutralized by the two neutralizer combinations tested. Phase 3: neutralization of both antibiotics in CB was achieved with penicillinase and resin L. A protocol for antibiotic neutralization in CB sterility testing samples has been successfully developed at Canadian Blood Services' Cord Blood bank. This in-house assay applies to any culture-based CB bacterial screening method.

Magnesium sulphate replacement therapy in cardiac surgery patients: A systematic review

Introduction: Inconsistent clinical practice in medication management contributes to patient safety risks. Currently, the absence of best practice guidelines contributes to variability in medication management of magnesium sulphate (MgSO4) replacement therapy in the care of post-operative cardiac surgical patients.

The use of advanced medical technologies at home: a systematic review of the literature

BackgroundThe number of medical technologies used in home settings has increased substantially over the last 10–15 years. In order to manage their use and to guarantee quality and safety, data on usage trends and practical experiences are important. This paper presents a literature review on types, trends and experiences with the use of advanced medical technologies at home.MethodsThe study focused on advanced medical technologies that are part of the technical nursing process and ‘hands on’ processes by nurses, excluding information technology such as domotica. The systematic review of literature was performed by searching the databases MEDLINE, Scopus and Cinahl. We included papers from 2000 to 2015 and selected articles containing empirical material.ResultsThe review identified 87 relevant articles, 62% was published in the period 2011–2015. Of the included studies, 45% considered devices for respiratory support, 39% devices for dialysis and 29% devices for oxygen therapy. Most research has been conducted on the topic ‘user experiences’ (36%), mainly regarding patients or informal caregivers. Results show that nurses have a key role in supporting patients and family caregivers in the process of homecare with advanced medical technologies and in providing information for, and as a member of multi-disciplinary teams. However, relatively low numbers of articles were found studying nurses perspective.ConclusionsResearch on medical technologies used at home has increased considerably until 2015. Much is already known on topics, such as user experiences; safety, risks, incidents and complications; and design and technological development. We also identified a lack of research exploring the views of nurses with regard to medical technologies for homecare, such as user experiences of nurses with different technologies, training, instruction and education of nurses and human factors by nurses in risk management and patient safety.

Design and evaluation of a safety-centered user interface for radiation therapy

PurposeAs radiation therapy treatment grows more complex over time, treatment delivery has become more susceptible to adverse events and patient safety risks from use error. The radiation therapy monitoring and treatment delivery user interface explored in this study was redesigned using ecological interface design, a human factors engineering method, and evaluated to improve treatment safety. Methods and materialsAn initial design concept was created based on previously completed analysis and informally evaluated in focus groups with radiation therapists. Sixteen newly graduated radiation therapists used both the redesigned and current system in a usability test to determine if the redesigned system better supported detection of errors. ResultsThe redesigned system successfully improved the error detection rate of 2 errors: wrong treatment volume and wrong treatment site (P < .03 and P < .01, respectively). It also improved level 2 and level 3 situation awareness (ie, comprehension of the meaning of the information and the projection of the behavior of the technology: P < .01 and P < .01, respectively) and achieved a higher user satisfaction. ConclusionsThe ecological interface design approach was found to be effective in redesigning a radiation therapy treatment delivery interface. Radiation therapists were able to deliver simulated radiation therapy with a higher rate of error detection and improved higher-level situation awareness, and participants preferred the redesigned interface to the current interface. Overall, the redesigned interface improved the radiation therapists’ system understanding and ability to detect errors that affect patient safety.

Improving Resident Use of Mental Health Resources: It's Time for an Opt-Out Strategy to Address Physician Burnout and Depression (Commentary).

Improving Resident Use of Mental Health Resources: It's Time for an Opt-Out Strategy to Address Physician Burnout and Depression (Commentary).

Delivering safe and effective test-result communication, management and follow-up: a mixed-methods study protocol

IntroductionThe failure to follow-up pathology and medical imaging test results poses patient-safety risks which threaten the effectiveness, quality and safety of patient care. The objective of this project is to:...

Quality and Variability of Patient Directions in Electronic Prescriptions in the Ambulatory Care Setting.

The prescriber's directions to the patient (Sig) are one of the most quality-sensitive components of a prescription order. Owing to their free-text format, the Sig data that are transmitted in electronic prescriptions (e-prescriptions) have the potential to produce interpretation challenges at receiving pharmacies that may threaten patient safety and also negatively affect medication labeling and patient counseling. Ensuring that all data transmitted in the e-prescription are complete and unambiguous is essential for minimizing disruptions in workflow at prescribers' offices and receiving pharmacies and optimizing the safety and effectiveness of patient care. To (a) assess the quality and variability of free-text Sig strings in ambulatory e-prescriptions and (b) propose best-practice recommendations to improve the use of this quality-sensitive field. A retrospective qualitative analysis was performed on a nationally representative sample of 25,000 e-prescriptions issued by 22,152 community-based prescribers across the United States using 501 electronic health records (EHRs) or e-prescribing software applications. The content of Sig text strings in e-prescriptions was classified according to a Sig classification scheme developed with guidance from an expert advisory panel. The Sig text strings were also analyzed for quality-related events (QREs). For purposes of this analysis, QREs were defined as Sig text content that could impair accurate and unambiguous interpretation by staff at receiving pharmacies. A total of 3,797 unique Sig concepts were identified in the 25,000 Sig text strings analyzed; more than 50% of all Sigs could be categorized into 25 unique Sig concepts. Even Sig strings that expressed apparently simple and straightforward concepts displayed substantial variability; for example, the sample contained 832 permutations of words and phrases used to convey the Sig concept of "Take 1 tablet by mouth once daily." Approximately 10% of Sigs contained QREs that could pose patient safety risks or workflow disruptions that could necessitate pharmacist callbacks to prescribers for clarification or other manual interventions. The quality of free-text patient directions in e-prescriptions can vary dramatically. However, more than half of all patient directions sent in the ambulatory setting can be categorized into only 25 Sig concepts. This suggests an immediate, practical opportunity to improve patient safety and workflow efficiency for both prescribers and pharmacies. Recommendations include implementing enhancements to Sig creation tools in e-prescribing and EHR software applications, adoption of the Structured and Codified Sig format supported by the current national e-prescribing standard, and improved usability testing and end-user training for generating complete and unambiguous patient directions. Such quality improvements are essential for optimizing the safety and effectiveness of patient care as well as for minimizing workflow disruptions to both prescribers and pharmacies. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Yang, Ward-Charlerie, Dhavle, and Green are employed by Surescripts. Rupp reported receiving consulting fees from Surescripts during the conduct of this study. No other disclosures were reported. The content in this article is solely the responsibility of the authors and does not necessarily represent the official views of Surescripts and Midwestern University or any of the affiliated institutions of the authors. Study concept and design were contributed by all the authors. Yang and Ward-Charlerie collected the data, and data interpretion was performed by Yang, Ward-Charlerie and Dhavle. The manuscript was primarily written by Yang, along with Dhavle and Green, and revised by Yang, Dhavle, Rupp, and Green.

Evaluation of system mapping approaches in identifying patient safety risks.

While many system mapping approaches (SMAs) have been broadly used in safety-critical industries, few have so far been employed in the healthcare field to assist in the identification of patient safety risks. In this study, we evaluated a set of system modelling approaches to assess their potential contribution to the identification of risks affecting patient safety. The aim was to gain a greater understanding of the practical application of system modelling approaches with the help of the risk categorization framework developed in this study. We conducted this study in a newly established Adult Attention Deficit Hyperactivity Disorder (ADHD) service at Cambridge and Peterborough Foundation Trust. Eight key stakeholders of the chosen service, including clinicians, managers and administrative staff, were individually asked to evaluate a set of pre-defined six SMAs according to their usefulness in identifying patient safety risks through interview-based questionnaires. It was found that each SMA could be useful in the chosen healthcare service in different ways. Further, specific types of diagrams were selected by stakeholders as more useful than others in identifying different sources of risks within the given system. The results of the evaluation showed that the system diagram is the most useful SMA in risk identification within the given system, while limited time, resources and experience of stakeholders with SMAs may present possible obstacles for their potential use in the healthcare field in future.