Building a NICU quality & safety infrastructure.

The American Academy of Pediatrics (AAP) Standards for Levels of Neonatal Care, published in 2023, highlights key components of a Neonatal Patient Safety and Quality Improvement Program (NPSQIP). A comprehensive Neonatal Intensive Care Unit (NICU) quality and safety infrastructure (QSI) is based on four foundational domains: quality improvement, quality assurance, safety culture, and clinical guidelines. This paper serves as an operational guide for NICU clinical leaders and quality champions to navigate these domains and develop their local QSI to include the AAP NPSQIP standards.

Effect of interventions to improve safety culture on healthcare workers in hospital settings: a systematic review of the international literature.

BACKGROUND: In an era of safety systems, hospital interventions to build a culture of safety deliver organisational learning methodologies for staff. Their benefits to hospital staff are unknown. We examined the literature for evidence of staff outcomes. Research questions were: (1) how is safety culture defined in studies with interventions that aim to enhance it?; (2) what effects do interventions to improve safety culture have on hospital staff?; (3) what intervention features explain these effects? and (4) what staff outcomes and experiences are identified? METHODS AND ANALYSIS: We conducted a mixed-methods systematic review of published literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search was conducted in MEDLINE, EMBASE, CINAHL, Health Business Elite and Scopus. We adopted a convergent approach to synthesis and integration. Identified intervention and staff outcomes were categorised thematically and combined with available data on measures and effects. RESULTS: We identified 42 articles for inclusion. Safety culture outcomes were most prominent under the themes of leadership and teamwork. Specific benefits for staff included increased stress recognition and job satisfaction, reduced emotional exhaustion, burnout and turnover, and improvements to working conditions. Effects were documented for interventions with longer time scales, strong institutional support and comprehensive theory-informed designs situated within specific units. DISCUSSION: This review contributes to international evidence on how interventions to improve safety culture may benefit hospital staff and how they can be designed and implemented. A focus on staff outcomes includes staff perceptions and behaviours as part of a safety culture and staff experiences resulting from a safety culture. The results generated by a small number of articles varied in quality and effect, and the review focused only on hospital staff. There is merit in using the concept of safety culture as a lens to understand staff experience in a complex healthcare system.

Interplay between leadership and patient safety in dentistry: a dental hospital-based cross-sectional study.

OBJECTIVES: The study aimed to study the association of leadership practices and patient safety culture in a dental hospital. DESIGN: Hospital-based, cross-sectional study SETTING: Riphah Dental Hospital (RDH), Islamabad, Pakistan. PARTICIPANTS: All dentists working at RDH were invited to participate. MAIN OUTCOME MEASURES: A questionnaire comprised of the Transformational Leadership Scale (TLS) and the Dental adapted version of the Medical Office Survey of Patient Safety Culture (DMOSOPS) was distributed among the participants. The response rates for each dimension were calculated. The positive responses were added to calculate scores for each of the patient safety and leadership dimensions and the Total Leadership Score (TLS) and total patient safety score (TPSS). Correlational analysis is performed to assess any associations. RESULTS: A total of 104 dentists participated in the study. A high positive response was observed on three of the leadership dimensions: inspirational communication (85.25%), intellectual stimulation (86%), and supportive leadership (75.17%). A low positive response was found on the following items: 'acknowledges improvement in my quality of work' (19%) and 'has a clear sense of where he/she wants our unit to be in 5 years' (35.64%). The reported positive responses in the patient safety dimensions were high on three of the patient safety dimensions: organisational learning (78.41%), teamwork (82.91%), and patient care tracking/follow-up (77.05%); and low on work pressure and pace (32.02%). A moderately positive correlation was found between TLS and TPSS (r=0.455, p<0.001). CONCLUSIONS: Leadership was found to be associated with patient safety culture in a dental hospital. Leadership training programmes should be incorporated during dental training to prepare future leaders who can inspire a positive patient safety culture.

Regional perspectives on patient safety policies and initiatives: a focus group study with patient safety leaders in the Middle East and Asian regions.

Preventing and reducing risks and harm to patients is of critical importance as unsafe care is a leading cause of death and disability globally. However, the lack of consolidated information on patient safety policies and initiatives at regional levels represents an evidence gap with implications for policy and planning. The aim of the study was to answer the question of what patient safety policies and initiatives are currently in place in the Middle East and Asian regions and what were the main strengths, weaknesses, opportunities and threats in developing these. A qualitative approach using online focus groups was adopted. Participants attended focus groups beginning in August 2022. A topic guide was developed using a strengths, weaknesses, opportunities and threats framework analysis approach. The Consolidated Criteria for Reporting Qualitative Research checklist was used to ensure the recommended standards of qualitative data reporting were met. 21 participants from 11 countries participated in the study. Current patient safety policies identified were categorised across 5 thematic areas and initiatives were categorised across a further 10 thematic areas. Strengths of patient safety initiatives included enabling healthcare worker training, leadership commitment in hospitals, and stakeholder engagement and collaboration. Weaknesses included a disconnect between health delivery and education, implementation gaps, low clinical awareness and buy-in at the facility level, and lack of leadership engagement. Just culture, safety by design and education were considered opportunities, alongside data collection and reporting for research and shared learning. Future threats were low leadership commitment, changing leadership, poor integration across the system, a public-private quality gap and political instability in some contexts. Undertaking further research regionally will enable shared learning and the development of best practice examples. Future research should explore the development of policies and initiatives for patient safety at the provider, local and national levels that can inform action across the system.

Guidelines in Practice: A Safe Environment of Care.

Creating a safe environment for performing surgical procedures is essential to achieve successful patient outcomes and protect the perioperative personnel who are providing care. Numerous factors challenge the provision of a safe environment of care and create a complex setting for perioperative nurses to manage. The updated AORN "Guideline for a safe environment of care" provides perioperative nurses with recommendations for establishing a safe environment for both patients and personnel. This article provides an overview of the guideline and discusses recommendations for implementing fire safety protocols, using warming cabinets, and creating a latex-safe environment. It also includes a scenario describing the care of a patient with an unidentified latex allergy who is undergoing a laparoscopic sleeve gastrectomy and hiatal hernia repair. Perioperative nurses should review the guideline in its entirety and implement recommendations as applicable in operative and other procedural settings.

TeamSTEPPS improves patient safety.

BACKGROUND: Examine how Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) can be used to manage patient safety and improve the standard of care for patients. METHODS: In order to improve key medical training in areas like surgical safety management, blood transfusion closed-loop management, drug safety management and identity recognition, we apply the TeamSTEPPS teaching methodology. We then examine the effects of this implementation on changes in pertinent indicators. RESULTS: Our hospital's perioperative death rate dropped to 0.019%, unscheduled reoperations dropped to 0.11%, and defined daily doses fell to 24.85. Antibiotic usage among hospitalised patients declined to 40.59%, while the percentage of antibacterial medicine prescriptions for outpatient patients decreased to 13.26%. Identity recognition requirements were implemented at a rate of 94.5%, and the low-risk group's death rate dropped to 0.01%. Critical transfusion episodes were less common, with an incidence of 0.01%. The physician's TeamSTEPPS Teamwork Perceptions Questionnaire and Teamwork Attitudes Questionnaire scores dramatically improved following the TeamSTEPPS team instruction course. CONCLUSION: An evidence-based team collaboration training programme called TeamSTEPPS combines clinical practice with team collaboration skills to enhance team performance in the healthcare industry and raise standards for medical quality, safety, and effectiveness.

Nurses' safety climate, quality of care, and standard precautions adherence and compliance: A cross-sectional study.

INTRODUCTION: Investigations about the interrelationships of nurses' safety climate, quality of care, and standard precautions (SP) adherence and compliance remain particularly scarce in the literature. Thus, we tested a model of the associations between nurses' safety climate, quality of care, and the factors influencing adherence and compliance with SPs utilizing the structural equation modeling (SEM) approach. DESIGN: Cross-sectional design complying with STROBE guidelines. METHODS: Using convenience sampling, nurses (n = 730) from the Philippines were recruited. Data were collected between April and September 2022 using four validated self-report measures. Spearman Rho, mediation and path analyses, and SEM were employed for data analysis. RESULTS: Acceptable model fit indices were shown by the emerging model. The safety climate is positively associated with quality of care and factors influencing adherence to and compliance with SPs. Quality of care directly affected factors influencing adherence to SPs. The factors influencing adherence to SPs directly affected SP compliance. Quality of care mediated between safety climate and the factors influencing adherence to SPs. Factors influencing adherence to SPs mediated between safety climate, quality of care, and SP compliance. CONCLUSIONS: The study's variables are not distinct but overlapping nursing concepts that must be examined collectively. Nurse administrators can utilize the emerging model to formulate strategies and regulations for evaluating and enhancing nurses' safety climate, quality of care, and SP adherence and compliance. CLINICAL RELEVANCE: Our findings may impact policymaking, organizational, and individual levels to improve nurses' clinical practice. PATIENT OR PUBLIC CONTRIBUTION: This study had no patient contribution or public funding.

Virological safety of the UK blood supply in the era of individual risk assessments and HIV PrEP.

A more individualised donor selection policy was implemented in the UK in 2021, which replaced the previous 3-month deferral for men who have sex with men (MSM). Other blood services have a variety of policies in place to ensure the virological safety of blood components, ranging from an indefinite ban on MSM, to a defined period of exclusion, or to an individualised risk assessment that is not based on gender or sexual orientation. Justification of these policies should be based on scientific evidence including assessment of lengths of virological window periods, infectious disease epidemiology within donor populations and donation screening assay sensitivities. Developments in molecular technology and assays which can detect both antibodies and antigens in the very early stages of infection have significantly reduced the risk in most developed countries. However, the increasing usage of pre-exposure prophylaxis (PrEP) to prevent acquisition of HIV infection after possible high-risk sexual contact within the UK blood donor population has been recently noted. It has brought with it new diagnostic challenges within blood screening, notably possible non-detection of HIV RNA and serological markers following PrEP use despite potential infectivity. The use of other testing strategies such as detection of HIV DNA and screening for non-declared PrEP usage should be investigated further.

Guía para la gestión de riesgos de los dispositivos médicos para el diagnóstico / Risk management guidance for diagnostic medical devices

Introducción: Los fabricantes de los dispositivos médicos no siempre disponen de experiencia para realizar un proceso de gestión de riesgos que cumpla con la norma ISO 14971:2019 e incluya los requisitos metrológicos necesarios; por tanto, para un mejor uso de estos equipos, especialmente los de diagnóstico, se debe implementar y mantener un proceso de gestión de riesgos basado en las normativas establecidas. Objetivo: Proponer una guía para la gestión de los riesgos indirectos en pacientes con diagnósticos incorrectos o retrasados. Métodos: Se revisaron las normas internacionales aplicables y se analizaron expedientes de gestión del riesgo de dispositivos médicos, entre ellos reactivos para el diagnóstico in vitro. Resultados: La guía ofrece elementos orientadores para cada etapa del proceso de gestión de riesgos en los dispositivos médicos para el diagnóstico: plan de gestión del riesgo, análisis, valoración y control del riesgo, evaluación del riesgo residual global, revisión de la gestión de riesgo y retroalimentación a partir de la información de producción o posproducción. Conclusiones: Esta guía es una herramienta útil para diseñadores, fabricantes, evaluadores de dispositivos médicos para el diagnóstico, asesores en temas de gestión de riesgos y la calidad de los dispositivos y personal médico(AU)

Introduction: Manufacturers of medical devices do not always have the expertise to perform a risk management process that complies with ISO 14971:2019 and includes the necessary metrological requirements; therefore, for better use of these devices, especially diagnostic devices, a risk management process based on established regulations should be implemented and maintained. Objective: To provide guidance for the management of indirect risks in patients with incorrect or delayed diagnoses. Methods: Applicable international standards were reviewed and risk management dossiers for medical devices, including in-vitro diagnostic reagents, were analyzed. Results: The guidance provides guiding elements for each step of the risk management process for diagnostic medical devices: risk management plan, risk analysis, risk assessment, risk evaluation and control, overall residual risk assessment, risk management review, and feedback from production or post-production information. Conclusions: This guide is a useful tool for designers, manufacturers, evaluators of diagnostic medical devices, risk management and device quality assessors, and medical personnel(AU)

Pediatric Providers' Knowledge, Attitudes, Practice, and Barriers to Firearms Safety Counseling.

OBJECTIVES: Firearms-related injuries and deaths are a leading cause of death in children and young adults ages 5 to 24 years. This study evaluated the counseling practices and barriers to providing safe firearms storage education by pediatricians and advance practice providers. METHODS: An online survey was sent to 296 pediatric outpatient providers in Houston, Texas. Pediatric providers were asked about demographics, knowledge, attitudes, and current practices regarding firearms safety counseling. Descriptive and comparative analyses were performed. RESULTS: Survey respondents (N = 76) were 86% women and 87% physicians. Most (86%) agree that they should discuss firearms safety with parents, whereas only 32% report routine counseling. The most frequent barrier to providing education was insufficient time (63%), followed by unfamiliarity with guns (26%). CONCLUSIONS: Pediatric providers are interested in firearms safety counseling, but few incorporate it into their practice. Addressing barriers of time and comfort level around firearms are potential first steps to curbing a leading cause of injury death among children. Further research is needed to develop counseling methods that are time efficient and culturally competent for the pediatric office.

Association of Hospital Public Quality Reporting With Electronic Health Record Medication Safety Performance.

Importance: Despite billions spent in public investment, electronic health records (EHRs) have not delivered on the promise of large quality and safety improvement. Simultaneously, there is debate on whether public quality reporting is a useful tool to incentivize quality improvement. Objective: To evaluate whether publicly reported feedback was associated with hospital improvement in an evaluation of medication-related clinical decision support (CDS) safety performance. Design, Settings, and Participants: This nonrandomized controlled trial included US hospitals that participated in the Computerized Provider Order Entry (CPOE) Evaluation Tool in the Leapfrog Hospital Survey, a national quality reporting program that evaluates safety performance of hospital CDS using simulated orders and patients, in 2017 to 2018. A sharp regression discontinuity design was used to identify the association of receiving negative feedback with hospital performance improvement in the subsequent year. Data were analyzed from January through September 2020. Exposures: Publicly reported quality feedback. Main Outcomes and Measures: The main outcome was improvement from 2017 to 2018 on the Leapfrog CPOE Evaluation Tool, using regression discontinuity model estimates of the association of receiving negative publicly reported feedback with quality improvement. Results: A total of 1183 hospitals were included, with a mean (SD) CPOE score of 59.3% (16.3%) at baseline. Hospitals receiving negative feedback improved 8.44 (95% CI, 0.09 to 16.80) percentage points more in the subsequent year compared with hospitals that received positive feedback on the same evaluation. This change was driven by differences in improvement in basic CDS capabilities (ß = 8.71 [95%CI, 1.67 to 18.73]) rather than advanced CDS (ß = 6.15 [95% CI, -9.11 to 26.83]). Conclusions and Relevance: In this nonrandomized controlled trial, publicly reported feedback was associated with quality improvement, suggesting targeted measurement and reporting of process quality may be an effective policy lever to encourage improvement in specific areas. Clinical decision support represents an important tool in ensuring patient safety and decreasing adverse drug events, especially for complex patients and those with multiple chronic conditions who often receive several different drugs during an episode of care.

Impact of the WHO Surgical Safety Checklist Relative to Its Design and Intended Use: A Systematic Review and Meta-Meta-Analysis.

BACKGROUND: The aim of this study was to identify what parts of the World Health Organization Surgical Safety Checklist (WHO SSC) are working, what can be done to make it more effective, and to determine if it achieved its intended effect relative to its design and intended use. STUDY DESIGN: We conducted a qualitative thematic analysis and meta-meta-analyses of findings in WHO SSC systematic reviews following Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. RESULTS: Twenty systematic reviews were included for qualitative thematic analysis. Narrative information was coded in 4 primary areas with a focus on impact of the WHO SSC. Four themes-Clinical Outcomes, Process Measures, Team Dynamics and Communication, and Safety Culture-pertained directly to the aims or purposes behind the development of the SSC. The other 2 themes-Efficiency and Workload involved in using the checklist and Checklist Impact on Institutional Practices-are associated with SSC use, but were not focal areas considered during its development. Included in the 20 systematic reviews were 24 unique observational cohort studies that reported pre-post data on a total of 18 clinical outcomes. Mortality, morbidity, surgical site infection, pneumonia, unplanned return to the operating room, urinary tract infection, blood loss requiring transfusion, unplanned intubation, and sepsis favored the use of the WHO SSC. Deep vein thrombosis was the only postoperative outcome assessed that did not favor use of the WHO SSC. CONCLUSIONS: The WHO SSC positively impacts the things it was explicitly designed to address and does not positively impact things it was not explicitly designed for.

Learning from patient safety incidents involving acutely sick adults in hospital assessment units in England and Wales: a mixed methods analysis for quality improvement.

OBJECTIVE: Six per cent of hospital patients experience a patient safety incident, of which 12% result in severe/fatal outcomes. Acutely sick patients are at heightened risk. Our aim was to identify the most frequently reported incidents in acute medical units and their characteristics. DESIGN: Retrospective mixed methods methodology: (1) an a priori coding process, applying a multi-axial coding framework to incident reports; and, (2) a thematic interpretative analysis of reports. SETTING: Patient safety incident reports (10 years, 2005-2015) collected from the National Reporting and Learning System, which receives reports from hospitals and other care settings across England and Wales. PARTICIPANTS: Reports describing severe harm/death in acute medical unit were identified. MAIN OUTCOME MEASURES: Incident type, contributory factors, outcomes and level of harm were identified in the included reports. During thematic analysis, themes and metathemes were synthesised to inform priorities for quality improvement. RESULTS: A total of 377 reports of severe harm or death were confirmed. The most common incident types were diagnostic errors (n = 79), medication-related errors (n = 61), and failures monitoring patients (n = 57). Incidents commonly stemmed from lack of active decision-making during patient admissions and communication failures between teams. Patients were at heightened risk of unsafe care during handovers and transfers of care. Metathemes included the necessity of patient self-advocacy and a lack of care coordination. CONCLUSION: This 10-year national analysis of incident reports provides recommendations to improve patient safety including: introduction of electronic prescribing and monitoring systems; forcing checklists to reduce diagnostic errors; and increased senior presence overnight and at weekends.

Home Hazard Removal to Reduce Falls Among Community-Dwelling Older Adults: A Randomized Clinical Trial.

Importance: Falls are the leading preventable cause of morbidity, mortality, and premature institutionalization for community-dwelling older adults. Objective: To test the effectiveness of a behavioral intervention on fall risk among older adults receiving services from an Area Agency on Aging. Design, Setting, and Participants: This randomized clinical trial examined a home hazard removal intervention in the community using a race- and sex-stratified randomization design. Older adults receiving services from the Area Agency on Aging in urban St Louis, Missouri, were assigned to a home hazard removal intervention delivered over 2 weeks with a 6-month booster or usual care control. Eligible participants were adults aged 65 years or older who did not have dementia, were at high risk for falling, and resided in the community. Enrollment occurred from January 2015 to September 2016; 12-month follow-up occurred from February 2016 to October 2017. Data were analyzed from February 2019 to July 2021. Interventions: The intervention was a home hazard removal program delivered by an occupational therapist in the home that included a comprehensive clinical assessment and a tailored hazard removal plan. Usual care control consisted of annual assessments and community referral. Main Outcomes and Measures: The primary outcome was the hazard of a fall over 12 months. Prespecified secondary outcomes included the rate of falls over 12 months, daily activity performance, falls self-efficacy, and self-reported quality of life. Results: A total of 310 participants (mean [SD] age, 75 [7.4] years; 229 [74%] women; 161 Black participants [52%]) were randomized, with 155 participants assigned to the intervention and 155 participants assigned to usual care. Retention was 127 participants (82%) in the intervention group and 126 participants (81%) in the control group. There was no difference for our primary outcome of fall hazard (hazard ratio, 0.90; 95% CI, 0.66-1.27). There was a 38% reduction in the rate of falling in the intervention group compared with the control group (relative risk, 0.62; 95% CI, 0.40-0.95; P = .03). At 12 months, the rate of falls per person-year was 1.5 (95% CI, 1.32-1.75) in the intervention group and 2.3 (95% CI, 2.08-2.60) in the control group. There was no difference in daily activity performance (adjusted difference, -0.20; 95% CI, -0.95 to 0.55; P = .60), falls self-efficacy (adjusted difference, -0.12; 95% CI, -1.25 to 1.01; P = .84), or quality of life (adjusted difference, 0.84; 95% CI, -0.95 to 2.64; P = .35). Conclusions and Relevance: This randomized clinical trial found that a brief home hazard removal program did not reduce the hazard of falls among community-dwelling older adults at high risk for falling. The intervention was effective in achieving a reduced rate of falls, a prespecified secondary outcome. This effectiveness study has the potential for delivery through the national aging services network. Trial Registration: ClinicalTrials.gov Identifier: NCT02392013.

Multisocieties position paper: Microbiological surveillance on flexible endoscopes.

Transmission with endoscopes, particularly duodenoscope, of potential lethal infections prompted different scientific societies to deliver recommendations aimed reducing this risk. Some International societies extended recommendations on microbial surveillance to all the endoscopes and devices used in the reprocessing procedure. Considering the relevance of the topic, 8 Italian scientific societies of physicians, nurses and technical operators prepared a concerted document taking into account Institutional advisories and facilities in Italy. The rules for a correct microbial surveillance on endoscopes were detailed in term of what, how and when to perform the procedure, also suggesting behaviors in case of contamination.

Risk assessment for postoperative outcomes in a mixed hospitalized gynecological population by the Dutch safety management system (Veiligheidsmanagementsysteem, VMS) screening tool 'frail elderly'.

PURPOSE: Frailty is associated with a higher risk for negative postoperative outcomes. This study aimed to determine the association between the screening tool of the Dutch safety management system, Veiligheidsmanagementsysteem (VMS) 'frail elderly' and postoperative complications in a gynecological population. METHODS: This cohort study included women aged 70 years or older, who were scheduled for any kind of gynecological surgery. VMS screening data (including risk for delirium, falling, malnutrition, and functional impairment) were extracted from the electronic patient records. VMS score could range between 0 and 4 patients with a VMS score of one or more were considered frail. Data on possible confounding factors and complications within 30 days after surgery, classified with the Clavien-Dindo classification, were collected. Regression analysis was performed. RESULTS: 157 women were included with a median age of 74 years (inter quartile range 71-79). Most patients underwent prolapse surgery (52%) or hysterectomy (31%). Forty-one patients (26%) experienced any postoperative complication. Sixty-two patients (39%) were considered frail preoperatively by the VMS screening tool. Frailty measured with the VMS screening tool was not independently associated with postoperative complications in multivariable analysis (Odds ratio 1.18; 95% CI 0.49-2.82). However, a recent fall in the last 6 months (n = 208) was associated with postoperative complications (Odds ratio 3.90; 95% CI 1.57-9.66). CONCLUSION: An independent association between frailty, determined by the VMS screening tool 'Frail elderly', and postoperative complications in gynecological surgery patients could not be confirmed. A recent fall in the last 6 months seems associated with postoperative complications.

Development and content validation of the Safe Surgery Organizational Readiness Tool: A quality improvement study.

BACKGROUND: Recent efforts to increase access to safe and high-quality surgical care in low- and middle-income countries have proven successful. However, multiple facilities implementing the same safety and quality improvement interventions may not all achieve successful outcomes. This heterogeneity could be explained, in part, by pre-intervention organizational characteristics and lack of readiness of surgical facilities. In this study, we describe the process of developing and content validating the Safe Surgery Organizational Readiness Tool. MATERIALS AND METHODS: The new tool was developed in two stages. First, qualitative results from a Safe Surgery 2020 intervention were combined with findings from a literature review of organizational readiness and change. Second, through iterative discussions and expert review, the Safe Surgery Organizational Readiness Tool was content validated. RESULTS: The Safe Surgery Organizational Readiness Tool includes 14 domains and 56 items measuring the readiness of surgical facilities in low- and middle-income countries to implement surgical safety and quality improvement interventions. This multi-dimensional and multi-level tool offers insights into facility members' beliefs and attitudes at the individual, team, and facility levels. A panel review affirmed the content validity of the Safe Surgery Organizational Readiness Tool. CONCLUSION: The Safe Surgery Organizational Readiness Tool is a theory- and evidence-based tool that can be used by change agents and facility leaders in low- and middle-income countries to assess the baseline readiness of surgical facilities to implement surgical safety and quality improvement interventions. Next steps include assessing the reliability and validity of the Safe Surgery Organizational Readiness Tool, likely resulting in refinements.