The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Development of the Harm Prevention Partners Clinical Model: An Academic-Practice Partnership for Prevention of Patient Harm Events.

This innovative academic-practice partnership applied user-centered design, resulting in a new clinical model, the "Harm Prevention Partners Program." The model engaged students working as teams with faculty to intervene on nurse-sensitive indicators by documenting care on a novel smartphone tool and generating an intervention dashboard to visualize impact. Faculty utilized the dashboard to guide postclinical debriefing and highlight students' impact on patient outcomes.

Core Competency Self-Assessment Enhances Critical Review of Complications and Entrustable Activities.

BACKGROUND: The Accreditation Council for Graduate Medical Education has defined six core competencies (CCs) that every successful physician should possess. However, the assessment of CC achievement among trainees is difficult. This project was designed to prospectively evaluate the impact of resident identification of CC as a component of morbidity review on error identification and standard of care (SOC) assessments. The platform was assessed for its reliability as a measure of resident critical analysis of complication causality across postgraduate year (PGY). MATERIALS AND METHODS: A total of 1945 general surgery cases with complications were assessed for error identification and SOC management between January 1, 2016, and December 31, 2018. CC identification was additionally assessed between January 1, 2019, and December 31, 2019, and included 708 general surgery cases. Data were evaluated for error assessments and overall SOC management. PGY4 and 5 residents were compared for number of cases and complications reviewed, severity, error causation, and CC relevance. RESULTS: Study groups were equivalent by Clavien-Dindo scores. Error identification significantly increased in all categories: diagnostic (P < 0.001), technical (P < 0.05), judgment (P < 0.001), system (P < 0.001), and communication (P < 0.001). Overall SOC assessments validated by a supervising surgical quality officer were unchanged. An increased exposure to cases with severe complications, error causation, and CC relevance was noted across PGY. CONCLUSIONS: The addition of CC assessment into morbidity review appears to improve the critical thinking of evaluating residents by increasing the identification of management errors. Used as an element of prospective self-assessment, teaching residents to identify CC principles in cases with complications may assist in learner progression toward clinical competence and critical thinking.

Patient-related factors associated with an increased risk of being a reported case of preventable harm in first-line health care: a case-control study.

BACKGROUND: Patient safety issues in primary health care and in emergency departments have not been as thoroughly explored as patient safety issues in the hospital setting. Knowledge is particularly sparse regarding which patients have a higher risk of harm in these settings. The objective was to evaluate which patient-related factors were associated with risk of harm in patients with reports of safety incidents. METHODS: A case-control study performed in primary health care and emergency departments in Sweden. In total, 4536 patients (cases) and 44,949 controls were included in this study. Cases included patients with reported preventable harm in primary health care and emergency departments from January 1st, 2011 until December 31st, 2016. RESULTS: Psychiatric disease, including all psychiatric diagnoses regardless of severity, nearly doubled the risk of being a reported case of preventable harm (odds ratio, 1.96; p < 0.001). Adjusted for income and education there was still an increased risk (odds ratio, 1.69; p < 0.001). The preventable harm in this group was to 46% diagnostic errors of somatic disease. CONCLUSION: Patients with psychiatric illness are at higher risk of preventable harm in primary care and the emergency department. Therefore, this group needs extra attention to prevent harm.

Testing a Model of Speaking up in Nursing.

BACKGROUND: Speaking up is using one's voice to alert those in authority of concerns. Failure to speak up leads to moral distress; speaking up leads to moral courage. OBJECTIVE: The purpose of this study was to explore the influences of organizational culture, personal culture, and workforce generation on speaking-up behaviors among RNs. METHODS: We distributed a cross-sectional electronic survey to several thousand RNs, resulting in 303 usable surveys. RESULTS: Organizational culture was a strong predictor of speaking-up behaviors; speaking up partially mediated the relationship between organizational culture and moral distress but was not a mediator between organizational culture and moral courage. Workforce generation did not explain speaking up. CONCLUSIONS: The role of organizational culture supports efforts toward healthy work environments. Because not speaking up is related to moral distress, efforts must be escalated to empower nurses to use their voices.

Variation in Physicians' Electronic Health Record Documentation and Potential Patient Harm from That Variation.

BACKGROUND: Physician-to-physician variation in electronic health record (EHR) documentation not driven by patients' clinical status could be harmful. OBJECTIVE: Measure variation in completion of common clinical documentation domains. Identify perceived causes and effects of variation and strategies to mitigate negative effects. DESIGN: Sequential, explanatory, mixed methods using log data from a commercial EHR vendor and semi-structured interviews with outpatient primary care practices. PARTICIPANTS: Quantitative: 170,332 encounters led by 809 physicians in 237 practices. Qualitative: 40 interviewees in 10 practices. MAIN MEASURES: Interquartile range (IQR) of the proportion of encounters in which a physician completed documentation, for each documentation category. Multilevel linear regression measured the proportion of variation at the physician level. KEY RESULTS: Five clinical documentation categories had substantial and statistically significant (p < 0.001) variation at the physician level after accounting for state, organization, and practice levels: (1) discussing results (IQR = 50.8%, proportion of variation explained by physician level = 78.1%); (2) assessment and diagnosis (IQR = 60.4%, physician-level variation = 76.0%); (3) problem list (IQR = 73.1%, physician-level variation = 70.1%); (4) review of systems (IQR = 62.3%, physician-level variation = 67.7%); and (5) social history (IQR = 53.3%, physician-level variation = 62.2%). Drivers of variation from interviews included user preferences and EHR designs with multiple places to record similar information. Variation was perceived to create documentation inefficiencies and risk patient harm due to missed or misinterpreted information. Mitigation strategies included targeted user training during EHR implementation and practice meetings focused on documentation standardization. CONCLUSIONS: Physician-to-physician variation in EHR documentation impedes effective and safe use of EHRs, but there are potential strategies to mitigate negative consequences.

Analysis of Medication Errors and near Misses Made by Nursing Students.

Despite extensive research and technological advancements, errors related to medication administration continue to rise annually. The body of evidence surrounding medication errors has focused largely on licensed practicing nurses. Nursing students can offer a unique perspective regarding medication administration as their foundation for professional psychomotor skills and cognitive abilities are developed. The purpose of this study was to explore the variables related to medication errors made by pre-licensure nursing students. Data were collected from 2013-2015 in a pre-licensure program. Students completed a post-error survey available in Google Forms. One hundred thirteen responses to the error report were completed. By exploring the factors related to medication errors among nursing students, teaching and learning strategies forming the foundations of medication administration can improve professional nursing practice and improve safety and quality of care.

Patient Harm in Cataract Surgery: A Series of Adverse Events in Massachusetts.

Massachusetts state agencies received reports of 37 adverse events (AEs) involving cataract surgery from 2011 to 2015. Fifteen were anesthesia related, including 5 wrong eye blocks, 3 cases of hemodynamic instability, 2 retrobulbar hematoma/hemorrhages, and 5 globe perforations resulting in permanent loss of vision. While Massachusetts' reported AEs likely underrepresent the true number of AEs that occur during cataract surgery, they do offer useful signal data to indicate the types of patient harm occurring during these procedures.

Redesigning Transplant Organ Labeling to Prevent Patient Harm and Organ Loss.

BACKGROUND: In 2012, the Health Resources and Services Administration and the United Network for Organ Sharing launched the "Electronic Tracking and Transportation" (ETT) project, in response to "labeling and packaging issues" being a frequently reported safety incident. This article describes an improvement project conducted as part of this United Network for Organ Sharing project. METHODS: An interdisciplinary team conducted a Process Failure Modes and Effects Analysis, laboratory simulations of organ labeling during procurement, and a heuristic evaluation of a label software application to inform the design of TransNet, a system that uses barcode technology at the point of organ recovery. A total of 42 clinicians and staff from 10 organ procurement organizations and 2 transplant centers in the United States participated. Processes Addressed: Key features of the redesigned labeling system include independent, double entry of label information into the software application, a machine-readable barcode on each organ's label, and a handheld printer for at "point of use" label printing. OUTCOMES: The new labeling system, TransNet, has become mandatory since June 2017. A survey conducted on early adopters (N = 11), after 1 year of use, indicates the process is safer and more efficient. IMPLICATIONS FOR PRACTICE: The findings from this study suggest that the application of quality planning methods, common in other industries, when redesigning a health-care process, are valuable and revelatory and should be adopted more extensively. Future evaluation of TransNet effectiveness to reduce safety incidents is critical.

Technical rationality and the decentring of patients and care delivery: A critique of 'unavoidable' in the context of patient harm.

In recent decades, debate on the quality and safety of healthcare has been dominated by a measure and manage administrative rationality. More recently, this rationality has been overlaid by ideas from human factors, ergonomics and systems engineering. Little critical attention has been given in the nursing literature to how risk of harm is understood and actioned, or how patients can be subjectified and marginalised through these discourses. The problem of assuring safety for particular patient groups, and the dominance of technical forms of rationality, has seen the word 'unavoidable' used in connection with intractable forms of patient harm. Employing pressure injury policy as an exemplar, and critically reviewing notions of risk and unavoidable harm, we problematise the concept of unavoidable patient harm, highlighting how this dominant safety rationality risks perverse and taken-for-granted assumptions about patients, care processes and the nature of risk and harm. In this orthodoxy, those who specify or measure risk are positioned as having more insight into the nature of risk, compared to those who simply experience risk. Driven almost exclusively as a technical and administrative pursuit, the patient safety agenda risks decentring the focus from patients and patient care.

Self-medication among the elderly in Iran: a content analysis study.

BACKGROUND: Self-medication is described as the use of drugs without a physician's prescription to treat self-recognized illness or symptoms, and an important health issue among the elderly. Despite the wide range of different definitions, recognizing all forms of self-medication among older adults, particularly, in developing countries, help healthcare professionals and providers to reduce harmful effects of self-medication. The purpose of this study is to describe the practice of self-medication and its related factors among elderly people in Iran based on the experiences of people who are involved in this phenomenon. METHODS: This qualitative study was conducted using content analysis. Purposive sampling was used to select the participants and continued until saturation. The participants were the elderly, their care-givers, physicians, and pharmacists. Data was collected using semi-structured interviews, and analysis was done using an inductive approach. The theory of planned behavior was used as a framework to explain the role of the emerged factors in the occurrence of self-medication behavior. RESULTS: Based on the expressed experiences of the participants, factors related to the practice of self- medication among the elderly in Iran fit in these 5 categories: "patient's attitudes towards disease, treatment, and physicians", "living with disease", "unfriendly environments", "enabling health system", and "influential others". CONCLUSIONS: Based on the results of this study, self-medication of the elderly in Iran has commonalities with many countries in regard to over-the-counter medications and complementary and alternative medicine; however, self-medication is also seen with drugs that require a prescription but can easily be obtained from pharmacies. Contributing factors, apart from the elderly themselves, include their families, caregivers, and social circle, the physical environment where they live, and the health system from which they receive services.

An analysis of dental patient safety incidents in a patient complaint and healthcare supervisory database in Finland.

OBJECTIVE: Few studies of patient harm and harm-prevention methods in dentistry exist. This study aimed to identify and characterize dental patient safety incidents (PSIs) in a national sample of closed dental cases reported to the Regional State Administrative Agencies (AVIs) and the National Supervisory Authority for Welfare and Health (Valvira) in Finland. MATERIALS AND METHODS: The sample included all available fully resolved dental cases (n = 948) during 2000-2012 (initiated by the end of 2011). Cases included both patient and next of kin complaints and notifications from other authorities, employers, pharmacies, etc. The cases analyzed concerned both public and private dentistry and included incident reports lodged against dentists and other dental-care professionals. Data also include the most severe cases since these are reported to Valvira. PSIs were categorized according to common incident types and preventability and severity assessments were based on expert opinions in the decisions from closed cases. RESULTS: Most alleged PSIs were proven valid and evaluated as potentially preventable. PSIs were most often related to different dental treatment procedures or diagnostics. More than half of all PSIs were assessed as severe, posing severe risk or as causing permanent or long-lasting harm to patients. The risk for PSI was highest among male general dental practitioners with recurring complaints and notifications. CONCLUSIONS: Despite some limitations, this register-based study identifies new perspectives on improving safety in dental care. Many PSIs could be prevented through the proper and more systematic use of already available error-prevention methods.

Who Judges Harm?

The American Medical Association's (AMA's) "Opinion 1.1.7, Physician Exercise of Conscience" attempts to help physicians strike a reasonable balance between their own conscientious beliefs and their patients' medical interests in an effort to minimize harms to both. However, some ambiguity still remains as to whether the severity of harms experienced by physicians and patients is to be assessed externally (by policy makers or by a professional body like the AMA), or internally by the subjects of those harms. Conflicts between conscientious physicians' self-assessments of the moral harm associated with various actions and the AMA's external assessments of such harms are likely to lead to challenges in the implementation of some provisions of its opinion. This commentary argues, however, that provisions (b) and (e) of the opinion, which describe the information physicians should provide about their own scope of practice and about the existence of controversial procedures, are less likely to conflict with physicians' subjective assessments of moral harm, and therefore will face fewer challenges in implementation.

Direct oral anticoagulants: New drugs with practical problems. How can nurses help prevent patient harm?

The safe use of anticoagulants requires a delicate balance between the risk of bleeding and the risk of thrombosis, particularly in drug-sensitive patients, such as older people. Recently-marketed "direct oral anticoagulants" are now being increasingly prescribed and administered in the hospital setting. Direct oral anticoagulants have pharmacological properties that are often unpredictable, and inter-patient variability in drug response is high. Therefore, people often require meticulous review and planning to ensure they receive optimal dosing and monitoring. The multidisciplinary medication management of those receiving these drugs needs to be effectively coordinated to reduce the risk of patient harm. All clinical staff, including nurses, doctors, and pharmacists, should be competent in the pharmacology of these drugs, and know which people require individualized care plans. In this study, we introduced important concepts via the use of case studies developed from commonly-seen scenarios at our quaternary hospital. In particular, the important role of nurses in ensuring patient safety in the periprocedural setting is highlighted.

Turning the Tables.

In bioethics, the concept of vulnerability is applied almost exclusively to research participants and patients. We turn the tables and apply the concept to nurses caring for anorexia nervosa (AN) sufferers. In doing so, and using results from a qualitative research study undertaken in the UK, we show that AN nurses face a significant probability of incurring identifiable harms (inauthentic relationships and nonreciprocal relationships). Some recommendations on how these harms can be avoided or mitigated are given, but further research is needed.

Towards international consensus on patient harm: perspectives on pressure injury policy.

AIMS: To analyse influential policies that inform practice related to pressure injury management in Australia, England, Hong Kong, New Zealand, Scotland and the United States of America. BACKGROUND: Pressure injuries are associated with significant harm to patients, and carry economic consequences for the health sector. Internationally, preventing and managing pressure injuries is a key nursing activity and quality indicator. EVALUATION: Comparative review and synthesis of pressure injury policies that inform practice. KEY ISSUES: The predominant focus of policy is on patient risk assessment, compliance with documentation and pressure relief. Financial penalty for institutions is emerging as a strategy where pressure injuries occur. Comparisons of prevalence rates are hampered by the lack of consensus on data collection and reporting. To date there has been little evaluation of policy implementation and implemented policy strategies, associated guidelines remain founded upon expert opinion and low-level evidence. IMPLICATIONS FOR NURSING MANAGEMENT: The pressure injury policy agenda has fostered a discourse of attention to incidents, compliance and penalty (sanctions). Prevention and intervention strategies are informed by technical and biomedical interpretations of patient risk and harm, with little attention given to the nature or design of nursing work. Considerable challenges remain if this policy agenda is successfully to eliminate pressure injury as a source of patient harm.

How Effective Are Incident-Reporting Systems for Improving Patient Safety? A Systematic Literature Review.

CONTEXT: Incident-reporting systems (IRSs) are used to gather information about patient safety incidents. Despite the financial burden they imply, however,little is known about their effectiveness. This article systematically reviews the effectiveness of IRSs as a method of improving patient safety through organizational learning. METHODS: Our systematic literature review identified 2 groups of studies: (1)those comparing the effectiveness of IRSs with other methods of error reporting and (2) those examining the effectiveness of IRSs on settings, structures, and outcomes in regard to improving patient safety. We used thematic analysis to compare the effectiveness of IRSs with other methods and to synthesize what was effective, where, and why. Then, to assess the evidence concerning the ability of IRSs to facilitate organizational learning, we analyzed studies using the concepts of single-loop and double-loop learning. FINDINGS: In total, we identified 43 studies, 8 that compared IRSs with other methods and 35 that explored the effectiveness of IRSs on settings, structures,and outcomes. We did not find strong evidence that IRSs performed better than other methods. We did find some evidence of single-loop learning, that is, changes to clinical settings or processes as a consequence of learning from IRSs, but little evidence of either improvements in outcomes or changes in the latent managerial factors involved in error production. In addition, there was insubstantial evidence of IRSs enabling double-loop learning, that is, a cultural change or a change in mind-set. CONCLUSIONS: The results indicate that IRSs could be more effective if the criteria for what counts as an incident were explicit, they were owned and ledby clinical teams rather than centralized hospital departments, and they were embedded within organizations as part of wider safety programs.