Root causes and preventability of unintentionally retained foreign objects after surgery: a national expert survey from Switzerland.

BACKGROUND: Retained foreign objects (RFO) after surgery are rare, serious patient safety events. In international comparisons based on routine data, Switzerland had remarkably high RFO rates. The objectives of this study were to 1) explore national key stakeholders' views on RFO as a safety problem, its preventability and need for action in Switzerland; and 2) to assess their interpretation of Switzerland's RFO incidence compared to other countries. METHODS: A semi-structured expert survey was conducted among national key representatives, including clinician experts, patient advocates, health administration representatives and other relevant stakeholders (n = 21). Data were coded and analyzed to generate themes related to the study questions following a deductive approach. RESULTS: Experts in this study unequivocally emphasized the tragedy for individual patients affected by RFOs. Productivity pressure and the strong economization of operating rooms were perceived as detrimental to safety culture, which was seen as essential for RFO prevention, specifically by those working in the OR. RFOs were seen as "maximally minimizable" but not completely preventable. There was strong agreement that within country differences in RFO risk between Swiss hospitals existed. On the systems level and compared to other safety issues, RFO were having less urgency for most experts. The international comparison of RFO incidences raised serious skepticism across all groups of experts. The validity of the data was questioned and the dominant interpretation of Switzerland's high RFO incidence compared to other countries was a "reporting artifact" based on high coding quality in Swiss hospitals. While most experts thought that the published RFO incidence warrants in-depth analysis of the data, there was little agreement about who's role it was to initiate any further activities. CONCLUSIONS: This investigation offers valuable insights into the perspectives of significant stakeholders concerning RFOs, their root causes, and preventability. The findings demonstrate how international comparative safety data are perceived, interpreted, and utilized by national experts to derive conclusive insights.

Are cross-sectional safety climate survey results in operating room staff associated with the surgical site infection rates in Swiss hospitals?

OBJECTIVES: The aim of this study was to investigate the association between surgical site infections (SSIs), a major source of patient harm, and safety and teamwork climate. Prior research has been unclear regarding this relationship. DESIGN: Based on the Swiss national SSI surveillance and a survey study assessing (a) safety climate and (b) teamwork climate, associations were analysed for three kinds of surgical procedures. SETTING AND PARTICIPANTS: SSI surveillance data from 20 434 surgeries for hip and knee arthroplasty from 41 hospitals, 8321 for colorectal procedures from 28 hospitals and 4346 caesarean sections from 11 hospitals and survey responses from Swiss operating room personnel (N=2769) in 54 acute care hospitals. PRIMARY AND SECONDARY OUTCOMES: The primary endpoint of the study was the 30-day (all types) or 1-year (knee/hip with implants) National Healthcare Safety Network-adjusted SSI rate. Its association with climate level and strength was investigated in regression analyses, accounting for respondents' professional background, managerial role and hospital size as confounding factors. RESULTS: Plotting climate levels against infection rates revealed a general trend with SSI rate decreasing as the safety climate increased, but none of the associations were significant (5% level). Linear models for hip and knee arthroplasties showed a negative association between SSI rate and climate perception (p=0.02). For climate strength, there were no consistent patterns, indicating that alignment of perceptions was not associated with lower infection rates. Being in a managerial role and being a physician (vs a nurse) had a positive effect on climate levels regarding SSI in hip and knee arthroplasties, whereas larger hospital size had a negative effect. CONCLUSIONS: This study suggests a possible negative correlation between climate level and SSI rate, while for climate strength, no associations were found. Future research should study safety climate more specifically related to infection prevention measures to establish clearer links.

Preventing Surgical Site Infections: Are Safety Climate Level and Its Strength Associated With Self-reported Commitment To, Subjective Norms Toward, and Knowledge About Preventive Measures?

OBJECTIVES: Surgical site infections (SSIs) represent a major source of preventable patient harm. Safety climate in the operating room personnel is assumed to be an important factor, with scattered supporting evidence for the association between safety climate and infection outcome so far. This study investigated perceptions and knowledge specific to infection prevention measures and their associations with general assessments of safety climate level and strength. METHODS: We invited operating room personnel of hospitals participating in the Swiss SSI surveillance program to take a survey (response rate, 38%). A total of 2769 responses from 54 hospitals were analyzed. Two regression analyses were performed to identify associations between subjective norms toward, commitment to, as well as knowledge about prevention measures and safety climate level and strength, taking into account professional background and number of responses per hospital. RESULTS: Commitment to perform prevention measures even when situational pressures exist, as well as subjective norm of perceiving the expectation of others to perform prevention measures were significantly ( P < 0.05) related to safety climate level, while for knowledge about preventative measures this was not the case. None of the assessed factors was significantly associated with safety climate strength. CONCLUSIONS: While pertinent knowledge did not have a significant impact, the commitment and the social norms to maintain SSI prevention activities even in the face of other situational demands showed a strong influence on safety climate. Assessing the knowledge about measures to prevent SSIs in operating room personnel opens up opportunities for designing intervention efforts in reducing SSIs.

Addressing Patient Safety Hazards Using Critical Incident Reporting in Hospitals: A Systematic Review.

INTRODUCTION: Critical incident reporting systems (CIRS) are in use worldwide. They are designed to improve patient care by detecting and analyzing critical and adverse patient events and by taking corrective actions to prevent reoccurrence. Critical incident reporting systems have recently been criticized for their lack of effectiveness in achieving actual patient safety improvements. However, no overview yet exists of the reported incidents' characteristics, their communication within institutions, or actions taken either to correct them or to prevent their recurrence. Our main goals were to systematically describe the reported CIRS events and to assess the actions taken and their learning effects. In this systematic review of studies based on CIRS data, we analyzed the main types of critical incidents (CIs), the severity of their consequences, their contributing factors, and any reported corrective actions. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we queried MEDLINE, Embase, CINAHL, and Scopus for publications on hospital-based CIRS. We classified the consequences of the incidents according to the National Coordinating Council for Medication Error Reporting and Prevention index, the contributing factors according to the Yorkshire Contributory Factors Framework and the Human Factors Classification Framework, and all corrective actions taken according to an action hierarchy model on intervention strengths. RESULTS: We reviewed 41 studies, which covered 479,483 CI reports from 212 hospitals in 17 countries. The most frequent type of incident was medication related (28.8%); the most frequent contributing factor was labeled "active failure" within health care provision (26.1%). Of all professions, nurses submitted the largest percentage (83.7%) of CI reports. Actions taken to prevent future CIs were described in 15 studies (36.6%). Overall, the analyzed studies varied considerably regarding methodology and focus. CONCLUSIONS: This review of studies from hospital-based CIRS provides an overview of reported CIs' contributing factors, characteristics, and consequences, as well as of the actions taken to prevent their recurrence. Because only 1 in 3 studies reported on corrective actions within the healthcare facilities, more emphasis on such actions and learnings from CIRS is required. However, incomplete or fragmented reporting and communication cycles may additionally limit the potential value of CIRS. To make a CIRS a useful tool for improving patient safety, the focus must be put on its strength of providing new qualitative insights in unknown hazards and also on the development of tools to facilitate nomenclature and management CIRS events, including corrective actions in a more standardized manner.

Development and Psychometric Evaluation of the Speaking Up About Patient Safety Questionnaire.

OBJECTIVE: Speaking up about safety concerns by staff is important to prevent medical errors. Knowledge about healthcare workers' speaking up behaviors and perceived speaking up climate is useful for healthcare organizations (HCOs) to identify areas for improvement. The aim of this study was to develop a short questionnaire allowing HCOs to assess different aspects of speaking up among healthcare staff. METHODS: Healthcare workers (n = 523) from 2 Swiss hospitals completed a questionnaire covering various aspects of speak up-related behaviors and climate. Psychometric testing included descriptive statistics, correlations, reliabilities (Cronbach α), principal component analysis, and t tests for assessing differences in hierarchical groups. RESULTS: Principal component analysis confirmed the structure of 3 speaking up behavior-related scales, that is, frequency of perceived concerns (concern scale, α = 0.73), withholding voice (silence scale, α = 0.76), and speaking up (speak up scale, α = 0.85). Concerning speak up climate, principal component analysis revealed 3 scales (psychological safety, α = 0.84; encouraging environment, α = 0.74; resignation, α = 0.73). The final survey instrument also included items covering speaking up barriers and a vignette to assess simulated behavior. A higher hierarchical level was mostly associated with a more positive speak up-related behavior and climate. CONCLUSIONS: Patient safety concerns, speaking up, and withholding voice were frequently reported. With this questionnaire, we present a tool to systematically assess and evaluate important aspects of speaking up in HCOs. This allows for identifying areas for improvement, and because it is a short survey, to monitor changes in speaking up-for example, before and after an improvement project.

Patient Safety Threats in Information Management Using Health Information Technology in Ambulatory Cancer Care: An Exploratory, Prospective Study.

BACKGROUND: Cancer care is complex, involving highly toxic drugs, critically ill patients, and various different care providers. Because it is important for clinicians to have the latest and complete information about the patient available, this study focused on patient safety issues in information management developing from health information technology (HIT) use in oncology ambulatory infusion centers. OBJECTIVE: The aim was to exploratively and prospectively assess patient safety risks from an expert perspective: instead of retrospectively analyzing safety events, we assessed the information management hazards inherent to the daily work processes; instead of asking healthcare workers at the front line, we used them as information sources to construct our patient safety expert view on the hazards. METHODS: The work processes of clinicians in three ambulatory infusion centers were assessed and evaluated based on interviews and observations with a nurse and a physician of each unit. The 125 identified patient safety issues were described and sorted into thematic groups. RESULTS: A broad range of patient safety issues was identified, such as data fragmentation, or information islands, meaning that patient data are stored across different cases or software and that different professional groups do not use the same set of information. CONCLUSIONS: The current design and implementation of HIT systems do not support adequate information management: clinicians needed to play very close attention and improvise to avoid errors in using HIT and treat cancer patients safely. It is important to take the clinical front-end practice into account when evaluating or planning further HIT improvements.

Registration and Management of "Never Events" in Swiss Hospitals-The Perspective of Clinical Risk Managers.

BACKGROUND: In Switzerland, there is no mandatory reporting of "never events." Little is known about how hospitals in countries with no "never event" policies deal with these incidents in terms of registration and analyses. OBJECTIVE: The aim of our study was to explore how hospitals outside mandatory "never event" regulations identify, register, and manage "never events" and whether practices are associated with hospital size. METHODS: Cross-sectional survey data were collected from risk managers of Swiss acute care hospitals. RESULTS: Clinical risk managers representing 95 hospitals completed the survey (55% response rate). Among responding risk and quality managers, only 45% would be formally notified through a designated reporting channel if a "never event" has happened in their hospital. Averaged over a list of 8 specified events, only half of hospitals could report a systematic count of the number of events. Hospital size was not associated with "never event" management. Respondents reported that their hospital pays "too little attention" to the recording (46%), the analysis (34%), and the prevention (40%) of "never events." All respondents rated the systematic registration and analysis of "never events" as very (81%) or rather important (19%) for the improvement of patient safety. CONCLUSIONS: A substantial fraction of Swiss hospitals do not have valid data on the occurrence of "never events" available and do not have reliable processes installed for the registration and exam of these events. Surprisingly, larger hospitals do not seem to be better prepared for "never events" management.

What do double-check routines actually detect? An observational assessment and qualitative analysis of identified inconsistencies.

OBJECTIVES: Double checking is used in oncology to detect medication errors before administering chemotherapy. The objectives of the study were to determine the frequency of detected potential medication errors, i.e., mismatching information, and to better understand the nature of these inconsistencies. DESIGN: In observing checking procedures, field noteswere taken of all inconsistencies that nurses identified during double checking the order against the prepared chemotherapy. SETTING: Oncological wards and ambulatory infusion centres of three Swiss hospitals. PARTICIPANTS: Nurses' double checking was observed. OUTCOME MEASURES: In a qualitative analysis, (1) a category system for the inconsistencies was developed and (2) independently applied by two researchers. RESULTS: In 22 (3.2%) of 690 observed double checks, 28 chemotherapy-related inconsistencies were detected. Half of them related to non-matching information between order and drug label, while the other half was identified because the nurses used their own knowledge. 75% of the inconsistencies could be traced back to inappropriate orders, and the inconsistencies led to 33 subsequent or corrective actions. CONCLUSIONS: In double check situations, the plausibility of the medication is often reviewed. Additionally, they serve as a correction for errors and that are made much earlier in the medication process, during order. Both results open up new opportunities for improving the medication process.

[Patient safety hazards resulting from information technology usage in outpatient oncology infusion centers: A prospective analysis of information management]. / Patientensicherheitsgefährdungen durch die Nutzung von IT in onkologischen Ambulatorien: eine prospektive Analyse des Informationsmanagements.

OBJECTIVES: Thorough management of patient information is crucial in cancer care in order to avoid errors. Clinicians need complete, up-to-date information to be able to develop an adequate mental model of the patient's situation. The aim of the present study was to identify patient safety hazards coming with the use of health information technology (HIT): patient safety hazards in three outpatient oncology infusion centers were assessed and priority topics identified. Additionally, the number of information sources clinicians have to use in order to get an idea of the patient's situation was systematically assessed. Interviews and observations were conducted with one nurse and one doctor of each ambulatory infusion center. PRINCIPAL RESULTS: Information management-related patient safety hazards were omnipresent in daily care: eleven topics were identified from 125 assessed patient safety hazards. Three of them were particularly relevant to the clinicians' development of an adequate mental model about the patient: patient-related information was not stored in one place but often fragmented in different HIT systems; despite the introduction of HIT, paper documentation remained in place for certain information, making access difficult and increasing the number of relevant sources; the lack of usability of the HIT systems made it difficult to retrieve patient information in a timely manner. Clinicians needed to use between 5 and 11 sources of information to get a more complete picture of a patient's situation. MAJOR CONCLUSIONS: Overall, it has been shown that the design of the HIT systems is not sufficiently adapted to the work processes and does not support clinicians in being fully informed about a patient. The topics identified point to future system design and areas for improvement. In this process, it is very important to align the real work requirements with the design of the HIT and to evaluate and monitor the actual implementation and use of HIT.

Oncology nurses' beliefs and attitudes towards the double-check of chemotherapy medications: a cross-sectional survey study.

BACKGROUND: Double-checking medications is a widely used strategy to enhance safe medication administration in oncology, but there is little evidence to support its effectiveness. The proliferated use of double-checking may be explained by positive attitudes towards checking among nurses. This study investigated oncology nurses' beliefs towards double-checking medication, its relation to beliefs about safety and the influence of nurses' level of experience and proximity to clinical care. METHODS: This was a survey of all oncology nurses in three Swiss hospitals. The questionnaire contained 41 items on 6 domains. Responses were recorded using a 7-point Likert scale. Multiple regression analysis was used to identify factors linked to strong beliefs in the effectiveness of double-checking. RESULTS: Overall, 274 (70%) out of 389 nurses responded (91% female, mean age 37 (standard deviation = 10)). Nurses reported very strong beliefs in the effectiveness and utility of double-checking. They were also confident about their own performance in double-checking. Nurses widely believed that double checking produced safety (e.g., 86% believed errors of individuals could be intercepted with double-checks). In contrast, some limitations of double-checking were also recognized, e.g., 33% of nurses reported that double checking caused frequent interruptions and 28% reported that double-checking was done superficially in their unit. Regression analysis revealed that beliefs in effectiveness of double-checking were mainly associated with beliefs in safety production (p < 0.001). Nurses with experience in barcode scanning held less strong beliefs in effectiveness of double-checking (p = 0.006). In contrast to our expectations, there were no differences in beliefs between any professional sub-groups. CONCLUSION: The widespread and strong believe in the effectiveness of double-checking is linked to beliefs about safety production and co-exists with acknowledgement of the major disadvantages of double-checking by humans. These results are important factors to consider when any existing procedures are adapted or new checking procedures are implemented.

Medication Safety in Oncology Care: Mapping Checking Procedures From Prescription to Administration of Chemotherapy.

PURPOSE: To increase medication safety in oncology, checking procedures are increasingly applied by nurses, physicians, and pharmacists. However, little is known about the number, types, and consistency of implemented checks. The aim of the study was to assess the number and types of different checking procedures that are performed along the lifecycle of a chemotherapy prescription across three hospitals, different care settings, administration routes, and professional groups. METHODS: A scheme to evaluate checking procedures and a mapping approach to illustrate the checks along the phases of the medication process were developed. Checking procedures were assessed on the basis of analysis of internal guidelines and interviews with nurses and physicians who work on wards and in ambulatory infusion units of three hospitals. RESULTS: There were considerable differences in number and type of checking procedures among administration routes, professional groups, wards and ambulatory infusion units, and hospitals. During the prescribing phase, the lowest number of checks was performed. In internal guidelines, checking procedures were documented poorly, though the pharmacy process was an exception. CONCLUSION: In contrast to the pharmacists, nurse and physician clinician checking procedures are less standardized within and across hospitals. The results point to different checking habits for the professional groups; for example, physicians would rather perform plausibility reviews than checks. Our evaluation scheme to categorize checks and the visualized mapping approach was feasible and understandable for practitioners.

Implementation status of morbidity and mortality conferences in Swiss hospitals: a national cross-sectional survey study.

OBJECTIVE: To determine the implementation status and current practice of morbidity and mortality conferences (M&MCs) in Switzerland. DESIGN: A national cross-sectional online survey was conducted in spring 2017. The questionnaire focused on overall goals, structure and procedures of hospital M&MCs. Further topics included satisfaction, perceived effectiveness and support requirements. SETTING: A total of 913 chief physicians of surgery and internal medicine, and specialist fields of obstetrics and gynaecology, anaesthesiology and intensive care from Swiss acute care hospitals were invited to the survey. 321 completed the questionnaire, resulting in a 35.2% response rate. PARTICIPANTS: Chief or senior physicians in charge of the M&MCs in their department. INTERVENTION: No intervention. MAIN OUTCOME MEASURES: Numbers and percentages of M&MCs within the surveyed disciplines fulfilling certain characteristics and procedural features. RESULTS: Among 321 respondents, the majority are conducting M&MCs in their departments. Within and between the medical disciplines considerable heterogeneity was found in structural and procedural features of M&MCs. Only a small part of the reported M&MCs is following a systematic approach and meeting recommended procedural features. Although the respondents are satisfied and perceive the M&MCs as an efficient tool, they agree that there is a need for professionalization and standardization. CONCLUSION: M&MCs are widely used to promote medical education, patient safety and quality improvements. However, the term M&MC seems to cover different types of meetings. Although the overall goals are similar, various types of M&MCs are used in practice and different objectives are pursued. Tools such as checklists, guidelines and templates are considered helpful.

Medication double-checking procedures in clinical practice: a cross-sectional survey of oncology nurses' experiences.

BACKGROUND: Double-checking is widely recommended as an essential method to prevent medication errors. However, prior research has shown that the concept of double-checking is not clearly defined, and that little is known about actual practice in oncology, for example, what kind of checking procedures are applied. OBJECTIVE: To study the practice of different double-checking procedures in chemotherapy administration and to explore nurses' experiences, for example, how often they actually find errors using a certain procedure. General evaluations regarding double-checking, for example, frequency of interruptions during and caused by a check, or what is regarded as its essential feature was assessed. METHODS: In a cross-sectional survey, qualified nurses working in oncology departments of 3 hospitals were asked to rate 5 different scenarios of double-checking procedures regarding dimensions such as frequency of use in practice and appropriateness to prevent medication errors; they were also asked general questions about double-checking. RESULTS: Overall, 274 nurses (70% response rate) participated in the survey. The procedure of jointly double-checking (read-read back) was most commonly used (69% of respondents) and rated as very appropriate to prevent medication errors. Jointly checking medication was seen as the essential characteristic of double-checking-more frequently than 'carrying out checks independently' (54% vs 24%). Most nurses (78%) found the frequency of double-checking in their department appropriate. Being interrupted in one's own current activity for supporting a double-check was reported to occur frequently. Regression analysis revealed a strong preference towards checks that are currently implemented at the responders' workplace. CONCLUSIONS: Double-checking is well regarded by oncology nurses as a procedure to help prevent errors, with jointly checking being used most frequently. Our results show that the notion of independent checking needs to be transferred more actively into clinical practice. The high frequency of reported interruptions during and caused by double-checks is of concern.

Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

BACKGROUND: National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? METHODS: A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. RESULTS: The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. CONCLUSIONS: To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts.

Motivational antecedents of incident reporting: evidence from a survey of nurses and physicians.

QUESTIONS UNDER STUDY: Underreporting is a major issue when using incident reporting systems to improve safety in hospitals. Based on a psychological framework, this study investigated the motivational antecedents of the willingness to report into incident reporting systems in healthcare. Individual, organisational and system-related influences on the willingness to report incidents were investigated in a survey of physicians and nurses from five Swiss hospitals. METHODS: The motivational antecedents were tested using structural equation modelling. The sample consisted of 818 respondents, 546 nurses and 230 physicians; the response rate was 32%. The willingness to report was assessed by using a self-report scale, validated with the self-reported number of reported incidents during the previous year. RESULTS: The most important influence on the willingness to report was the transparency of the incident reporting system procedures to potential users, such as. knowing how and what kind of events to report. At the individual level, the perceived effectiveness of reporting was a relevant antecedent. At the organisational level, management support positively influenced the willingness to report. Different antecedents were found to be relevant for nurses and physicians. CONCLUSIONS: Implications are discussed that open up alternatives for the design and implementation of incident reporting systems in healthcare. For example, the results of the study point to opportunities for making incident reporting systems more transparent and participatory and to allow for experience of how they actually improve patient safety.

[Patient safety culture in hospitals: experiences in planning, organising and conducting a survey among hospital staff]. / Patientensicherheitsklima im spital: erfahrungen mit der planung, organisation und durchführung einer mitarbeitervollbefragung.

This article presents the first hospital-wide survey on patient safety climate, involving all staff (medical and non-medical), in the German-speaking area. Its aim is to share our experiences with planning, organising and conducting this survey. The study was performed at the university hospital in Zurich and had a response rate of 46.8% (2,897 valid questionnaires). The survey instrument ("Patientensicherheitsklimainventar") was based on the Hospital Survey on Patient Safety Culture (AHRQ). Primarily it allowed for assessing the current patient safety climate as well as identifying specific areas for improvement and creating a hospital-wide awareness and acceptance for patient safety issues and interventions (e.g., the introduction of a Critical Incident Reporting System [CIRS]). We discuss the basic principles and the feedback concept guiding the organisation of the overall project. Critical to the success of this project were the guaranteed anonymity of the respondents, adequate communication through well-established channels within the organisation and the commitment of the management across all project phases.

Psychometric properties of the Hospital Survey on Patient Safety Culture for hospital management (HSOPS_M).

BACKGROUND: From a management perspective, it is necessary to examine how a hospital's top management assess the patient safety culture in their organisation. This study examines whether the Hospital Survey on Patient Safety Culture for hospital management (HSOPS_M) has the same psychometric properties as the HSOPS for hospital employees does. METHODS: In 2008, a questionnaire survey including the HSOPS_M was conducted with 1,224 medical directors from German hospitals. When assessing the psychometric properties, we performed a confirmatory factor analysis (CFA). Additionally, we proved construct validity and internal consistency. RESULTS: A total of 551 medical directors returned the questionnaire. The results of the CFA suggested a satisfactory global data fit. The indices of local fit indicated a good, but not satisfactory convergent validity. Analyses of construct validity indicated that not all safety culture dimensions were readily distinguishable. However, Cronbach's alpha indicated that the dimensions had an acceptable level of reliability. CONCLUSION: The analyses of the psychometric properties of the HSOPS_M resulted in reasonably good levels of property values. Although the set of dimensions within the HSOPS_M needs further scale refinement, the questionnaire covers a broad range of sub-dimensions and supplies important information on safety culture. The HSOPS_M, therefore, is eligible to measure safety culture from the hospital management's points of view and could be used in nationwide hospital surveys to make inter-organisational comparisons.

Assessing hospitals' clinical risk management: Development of a monitoring instrument.

BACKGROUND: Clinical risk management (CRM) plays a crucial role in enabling hospitals to identify, contain, and manage risks related to patient safety. So far, no instruments are available to measure and monitor the level of implementation of CRM. Therefore, our objective was to develop an instrument for assessing CRM in hospitals. METHODS: The instrument was developed based on a literature review, which identified key elements of CRM. These elements were then discussed with a panel of patient safety experts. A theoretical model was used to describe the level to which CRM elements have been implemented within the organization. Interviews with CRM practitioners and a pilot evaluation were conducted to revise the instrument. The first nationwide application of the instrument (138 participating Swiss hospitals) was complemented by in-depth interviews with 25 CRM practitioners in selected hospitals, for validation purposes. RESULTS: The monitoring instrument consists of 28 main questions organized in three sections: 1) Implementation and organizational integration of CRM, 2) Strategic objectives and operational implementation of CRM at hospital level, and 3) Overview of CRM in different services. The instrument is available in four languages (English, German, French, and Italian). It allows hospitals to gather comprehensive and systematic data on their CRM practice and to identify areas for further improvement. CONCLUSIONS: We have developed an instrument for assessing development stages of CRM in hospitals that should be feasible for a continuous monitoring of developments in this important area of patient safety.