Exploring the role of managers in the development of a safety culture in seven French healthcare facilities: a qualitative study.

BACKGROUND: Numerous studies have been conducted over the past 15 years to assess safety culture within healthcare facilities; in general, these studies have shown the pivotal role that managers play in its development. However, little is known about what healthcare managers actually do to support this development, and how caregivers and managers represent managers'role. Thus the objectives of this study were to explore: i) caregivers and managers' perceptions and representations of safety, ii) the role of managers in the development of safety culture as perceived by themselves and by caregivers, iii) managers' activities related to the development of safety culture. METHODS: An exploratory, multicentre, qualitative study was conducted from May 2014 to March 2015 in seven healthcare facilities in France. Semi-structured interviews were conducted with managers (frontline, middle and top level) and caregivers (doctors, nurses and nurse assistants) and on-site observations of two managers were carried out in all facilities. A thematic analysis of semi-structured interviews was performed. Observed activities were categorised using Luthans' typology of managerial activities. RESULTS: Participants in semi-structured interviews (44 managers and 21 caregivers) expressed positive perceptions of the level of safety in their facility. Support from frontline management was particularly appreciated, while support from top managers was identified as an area for improvement. Six main categories of safety-related activities were both observed among managers and regularly expressed by participants. However, caregivers' expectations of their managers and managerial perceptions of these expectations only partially overlapped. CONCLUSIONS: The present study highlights current categories of managerial activities that foster safety culture, and points out an important gap between caregivers' expectations of their managers, and managerial perceptions of these expectations. The findings underline the need to allow more time for managers and caregivers to talk about safety issues. The results could be used to develop training programs to help healthcare managers to understand their role in the development of safety culture.

Improving the safety climate in hospitals by a vignette-based analysis of adverse events: a cluster randomised study.

OBJECTIVE: To assess the impact of a vignette-based analysis of adverse events (AEs) on the safety climate (SC) of care units. DESIGN: Prospective, open, cluster (a unit) randomised controlled trial. SETTING: Eighteen acute care units of seven hospitals in France. PARTICIPANTS: Healthcare providers who worked in the units. INTERVENTION: Vignette-based analyses of AEs were conducted with unit's providers once per month for six consecutive months. The AEs were real cases that occurred in other hospitals. The hospital risk manager conducted each analysis as follows: analysis of the immediate and root causes of the AE; assessment of the care unit's vulnerabilities and existing barriers in the occurrence of an identical AE and search for solutions. MAIN OUTCOME MEASURE: SC was measured using the French version of the Hospital Survey on Patient Safety Culture questionnaire. The primary outcome was the difference in the 'Organisational learning and continuous improvement' dimension score, from before to after the analyses. RESULTS: Median participation rate in the analyses was 20% (range: 7-45%). Before intervention, the response rate to the SC survey was 80% (n = 210) in the intervention group and 73% (n = 191) in the control group. After intervention, it was 59% (n = 141) and 63% (n = 148), respectively. The dimension score evolved differently for the groups from before to after intervention (intervention: +10.2 points ±8.8; control: -3.0 points ±8.5, P = 0.04). Side effects were not measured. CONCLUSIONS: Vignette-based analysis was associated with the improvement of the perception of participants regarding their institution's capacity for organisational learning and continuous improvement.

Impact of an Original Methodological Tool on the Identification of Corrective and Preventive Actions After Root Cause Analysis of Adverse Events in Health Care Facilities: Results of a Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to assess the effectiveness of a new methodological tool for the identification of corrective and preventive actions (CAPAs) after root cause analysis of health care-related adverse events. METHODS: From January to June 2010, we conducted a randomized controlled trial involving risk managers from 111 health care facilities of the Aquitaine Regional Center for Quality and Safety in Health Care (France). Fifty-six risk managers, randomly assigned to two groups (intervention and control), identified CAPAs in response to two sequentially presented adverse event scenarios. For the baseline measure, both groups used their usual adverse event management tools to identify CAPAs in each scenario. For the experimental measure, the control group continued using their usual tools, whereas the intervention group used a new tool involving a systemic approach for CAPA identification. The main outcome measure was the number of CAPAs the participants identified that matched a criterion standard established by eight experts. RESULTS: Baseline mean number of identified CAPAs did not differ between the two groups (P = 0.83). For the experimental measure, significantly more CAPAs (P = 0.001) were identified by the intervention group (mean [SD] = 4.6 [1.7]) than by the control group (mean [SD] = 2.8 [1.2]). CONCLUSIONS: For the two scenarios tested, more relevant CAPAs were identified with the new tool than with usual tools. Further research is needed to assess the effectiveness of the new tool for other types of adverse events and its impact on patient safety.

[Not Available]. / Sécurité du circuit du médicament : état des lieux dans 21 pharmacies à usage intérieur en Aquitaine (Projet SECURIMED).

BACKGROUND: Failures may occur in each part of the medication use process. This study aimed to evaluate the barriers existing in hospital pharmacies in order to prevent medication errors and to help institutions to make improvement actions. METHODS: Within the framework of the SECURIMED project, risk assessment visit (interviews, observations, analysis of adverse event scenario by professionals…) were conducted in volunteer hospital pharmacies. A restitution meeting, after visit in each pharmacy permitted exchanges between visitors and professionals on barriers and weaknesses and then on solutions to reduce identified risks. RESULTS: Twenty-one hospital pharmacies participated. Despite presence of safeguards in some pharmacies, many weaknesses were retrieved (multiplicity of process, lack of resources…) and clinical pharmacy was not enough developed. CONCLUSION: This project has led to an overview of the situation in Aquitaine, and created a regional dynamic to improve the medication system safety.

[Security in medication use process: state-of-play report in 21 hospital pharmacies in Aquitaine (France)]. / Sécurité du circuit du médicament: état des lieux dans 21 pharmacies à usage intérieur en Aquitaine (Projet SECURIMED).

BACKGROUND: Failures may occur in each part of the medication use process. This study aimed to evaluate the barriers existing in hospital pharmacies in order to prevent medication errors and to help institutions to make improvement actions. METHODS: Within the framework of the SECURIMED project, risk assessment visit (interviews, observations, analysis of adverse event scenario by professionals...) were conducted in volunteer hospital pharmacies. A restitution meeting, after visit in each pharmacy permitted exchanges between visitors and professionals on barriers and weaknesses and then on solutions to reduce identified risks. RESULTS: Twenty-one hospital pharmacies participated. Despite presence of safeguards in some pharmacies, many weaknesses were retrieved (multiplicity of process, lack of resources...) and clinical pharmacy was not enough developed. CONCLUSION: This project has led to an overview of the situation in Aquitaine, and created a regional dynamic to improve the medication system safety.

Patient safety incidents are common in primary care: A national prospective active incident reporting survey.

BACKGROUND: The study objectives were to describe the incidence and the nature of patient safety incidents (PSIs) in primary care general practice settings, and to explore the association between these incidents and practice or organizational characteristics. METHODS: GPs, randomly selected from a national influenza surveillance network (n = 800) across France, prospectively reported any incidents observed each day over a one-week period between May and July 2013. An incident was an event or circumstance that could have resulted, or did result, in harm to a patient, which the GP would not wish to recur. Primary outcome was the incidence of PSIs which was determined by counting reports per total number of patient encounters. Reports were categorized using existing taxonomies. The association with practice and organizational characteristics was calculated using a negative binomial regression model. RESULTS: 127 GPs (participation rate 79%) reported 317 incidents of which 270 were deemed to be a posteriori judged preventable, among 12,348 encounters. 77% had no consequences for the patient. The incidence of reported PSIs was 26 per 1000 patient encounters per week (95% CI [23‰ -28‰]). Incidents were three times more frequently related to the organization of healthcare than to knowledge and skills of health professionals, and especially to the workflow in the GPs' offices and to the communication between providers and with patients. Among GP characteristics, three were related with an increased incidence in the final multivariable model: length of consultation higher than 15 minutes, method of receiving radiological results (by fax compared to paper or email), and being in a multidisciplinary clinic compared with sole practitioners. CONCLUSIONS: Patient safety incidents (PSIs) occurred in mean once every two days in the sampled GPs and 2% of them were associated with a definite possibility for harm. Studying the association between organizational features of general practices and PSIs remains a major challenge and one of the most important issues for safety in primary care.

[Adverse events in general medicine, the national primary care study]. / Événements indésirables en médecine générale, enquête nationale en soins primaires.

Carried out in France in 2013, the national primary care study on adverse events enabled the average frequency of such events in outpatient care to be estimated. General practitioners identified an occurrence of an adverse event every two days, without consequence for the patients in three quarters of the cases.

Acceptability of Health Care-Related Risks: A Literature Review.

OBJECTIVES: Risk management aims at reducing risks associated with hospital care to an acceptable level, both in their frequency and their impact on health. The social acceptability of risk on the part of the general population and of the health-care professionals, faced with regular information about adverse events, is undoubtedly evolving rapidly.In contrast to risk acceptability, the concept of risk perception is of limited interest to risk managers because it does not inform on the behaviors and actions resulting from these perceptions. The aim of this work was to define the concept of social acceptability of risk through an in-depth examination of a wide-ranging and multidisciplinary literature. METHODS: A 1990-2010 English and French literature review was carried out in medical, epidemiological, and human and social sciences online databases, gray literature, and books. RESULTS: Of the 5931 references retrieved, 203 met the inclusion criteria. We identified contributions from 5 major research fields: economic, sociocognitive, psychometric, sociological/anthropological, and interactionist. When assessing risks, individuals use a variety of psychological and social processes that include their perception not only of a given risk but also of their own personal and social resources. This global perception has a direct impact on the responses and actual behavior of individuals and groups, enabling them to cope with the risk and/or manage it. CONCLUSIONS: Social acceptability includes perceptions related to risks and the stated intentions of individual behavior. This concept may therefore be relevant for defining local and national patient safety priorities.

Development of a safety culture: initial measurements at six hospitals in France.

A cross-sectional and descriptive survey of a safety culture (SC) was conducted in 20 clinical units in France. A self-administered questionnaire measuring 12 dimensions of safety culture was given to healthcare professionals. The overall response rate was 65%. The poorly developed dimensions of safety culture that were identified were nonpunitive response to error, staffing, management support for patient safety, handoffs, and transitions.

Prospective assessment of hospital-acquired bloosdstream infections: how many may be preventable?

OBJECTIVE: To determine the proportion of preventable hospital-acquired bloodstream infections (HA-BSIs), the authors prospectively examined consecutive cases in a large university hospital over an 18-month period. PATIENTS AND METHODS: Medical charts were assessed with the physician in charge of the patient within 4 days after HA-BSI diagnosis to determine whether the infection was healthcare-related. Preventability was assessed using a validated tool. Results of 378 HA-BSIs (incidence rate, 1.00 per 1000 patient-days), 341 were first HA-BSI episodes in a patient, and 272 (79.8%) were secondary to an identifiable source, of whom 196 (57.5%) were related to medical management. These 196 HA-BSIs were related to an invasive procedure (n=163), a non-invasive medical management (n=30) or both (n=3). RESULTS: Of the 272 patients with HA-BSIs from identifiable sources, 55 (20.2%) had no underlying disease, 115 (42.3%) had an ultimately fatal underlying disease, 99 (36.4%) had a rapidly fatal disease, and three (1.1%) were not evaluated. Of the 196 iatrogenic HA-BSIs, 66 were considered preventable (most of them being related to an intravascular catheter), 84 were of uncertain preventability, and 46 were not preventable. In total, 66 of the 341 HA-BSIs (19.4%) were considered preventable, and 191 (56.0%) were not preventable. CONCLUSION: Although evaluation of the preventability of hospital-associated adverse events has been reported to be difficult and of limited reliability, our simple method may help to identify wards or HA-BSI types that warrant in-depth evaluation.

French national survey of inpatient adverse events prospectively assessed with ward staff.

OBJECTIVES: To estimate the incidence of adverse events in medical and surgical activity in public and private hospitals, and to assess the clinical situation of patients and the active errors. DESIGN: Prospective assessment of adverse events by external senior nursing and doctor investigators with ward staff. SETTING: Random three-stage stratified cluster sampling of stays or fractions of stay in a 7-day observation period for each ward. PARTICIPANTS: 8754 patients observed in 292 wards in 71 hospitals, over 35,234 hospitalisation days. MAIN OUTCOME MEASURES: Number of adverse events in relation to number of days of hospitalisation. RESULTS: The incidence density of adverse events was 6.6 per 1000 days of hospitalisation (95% CI 5.7 to 7.5), of which 35% were preventable. Invasive procedures were the source of half the adverse events, of which 20% were preventable. Adverse events related to the psychological sphere and pain were mostly considered as preventable. Ward staff found it difficult to assess the role of care management in the occurrence of adverse events: 41% of adverse events were expected because of the disease itself, and could have occurred in the absence of the related medical management. CONCLUSION: At the national level in France, every year 120,000-190,000 adverse events during hospitalisation can be considered as preventable. Areas such as perioperative period and geriatric units should receive closer attention. As adverse events occurred more commonly in vulnerable patients, who are not specifically targeted by clinical guidance, practising evidence-based medicine is not likely to prevent all cases. Therefore clinical risk management should prioritize empowerment of local staff, provision of favourable conditions within the organisation, and staff training based on simple tools appropriate for ward-level identification and analysis of adverse events.

Comparison of three methods for estimating rates of adverse events and rates of preventable adverse events in acute care hospitals.

OBJECTIVES: To compare the effectiveness, reliability, and acceptability of estimating rates of adverse events and rates of preventable adverse events using three methods: cross sectional (data gathered in one day), prospective (data gathered during hospital stay), and retrospective (review of medical records). DESIGN: Independent assessment of three methods applied to one sample. SETTING: 37 wards in seven hospitals (three public, four private) in southwestern France. PARTICIPANTS: 778 patients: medical (n = 278), surgical (n = 263), and obstetric (n = 237). MAIN OUTCOME MEASURES: The main outcome measures were the proportion of cases (patients with at least one adverse event) identified by each method compared with a reference list of cases confirmed by ward staff and the proportion of preventable cases (patients with at least one preventable adverse event). Secondary outcome measures were inter-rater reliability of screening and identification, perceived workload, and face validity of results. RESULTS: The prospective and retrospective methods identified similar numbers of medical and surgical cases (70% and 66% of the total, respectively) but the prospective method identified more preventable cases (64% and 40%, respectively), had good reliability for identification (kappa = 0.83), represented an acceptable workload, and had higher face validity. The cross sectional method showed a large number of false positives and identified none of the most serious adverse events. None of the methods was appropriate for obstetrics. CONCLUSION: The prospective method of data collection may be more appropriate for epidemiological studies that aim to convince clinical teams that their errors contribute significantly to adverse events, to study organisational and human factors, and to assess the impact of risk reduction programmes.