Observational Study Medicine ® OPEN Predictors of patient safety culture in hospitals in Venezuela A cross-sectional study ∗ Mónica Susana Chirinos Muñoz, MgSca,b,d,e, , Carola Orrego, PhDb,c,d,e, Cesar Montoya, PhDb,d,e, Rosa Suñol, PhDb,c,d,e Abstract An organization’s culture with regard to patient safety is important because it defines the beliefs and practices of the organization, and consequently its efficiency and productivity. Knowing the level of this and the factors that influence or not their dynamic represents a challenge, due to the degree of complexity and specificity of the elements involved. The aim of this study was to analyze predictors of patient safety culture in public and private hospitals and examining the factors that contribute to it, constructing a new and specific theoretical and methodological model. This study was carried out by reviewing medical records, detecting healthcare professionals directly involved in caring (N = 588), for patients in 2 public hospitals and 2 private hospitals in Venezuela (N = 566), conducting an “Analysis of Patient Safety Culture” questionnaire. The results were subsequently analyzed, derived 3 predictors factors and using a Patient Safety Culture Index (PSCI) for specific determination to evaluate patient safety culture level. The analysis showed that all hospitals had a “moderately unfavorable” PSCI (public = 52.96, private = 52.67, sig = 0.90). The PSCI was calculated by assessing the weight of the following factors in the index: occupational factors (factor loading = 32.03), communication factors (factor loading = 11.83), and organizational factors (factor loading = 9.10). Traumatology presented the lowest PSCI of all the care units, falling into the “unfavorable” category (36.48), and Laboratory the highest (70.02) (sig = 0.174), falling into the “moderately favorable” category. When analyzing professional groups, nurses had the highest PSCI, with a “moderately unfavorable” rating (PSCI = 61.1) and medical residents the lowest, falling into the “unfavorable” category (35.2). Adverse event reporting is determined by “management expectations and actions” (sig = 0.048) and “direct interaction with the patient” (sig = 0.049). The use of this theoretical and methodological approach in other contexts may provide a more objective system for identifying more specific needs and factors that influence in patient safety culture, and consequently, opportunities for improvement when constructing a patient safety culture in healthcare institutions. Efforts need to be made to improve safety culture in the hospitals studied, irrespective of whether they are public or private. Abbreviations: AE = adverse events, CF = communication factors, HSOPSC = Hospital Survey on Patient Safety Culture, OF = occupational factors, OrF = organizational factors, PSCI = Patient Safety Culture Index. Keywords: organizational culture, patient safety, patient safety culture, quality in health, quality management, safety management, survey Editor: Ediriweera Desapriya. To the Avedis Donabedian Research Institute (FAD), and its human capital, for their unconditional support. To Dr Ricaurte Salom Gil for being my support and academic father (today a victim of COVID-19). This study is part of the Methodology of Biomedical Research and Public Health programme. Universitat Autonoma de Barcelona, Barcelona, Spain. The authors have no conflicts of interests to disclose. Supplemental Digital Content is available for this article. All data generated or analyzed during this study are included in this published article [and its supplementary information files]. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. a Health Sector Management Program –University of Zulia, Maracaibo, Venezuela, b Methodology of Biomedical Research and Public Health programme. Universitat Autonoma de Barcelona, c Avedis Donabedian Research Institute (FAD), d Research Network on Health Service Chronic Diseases REDISSEC. Barcelona, Spain, e Instituto Universitario de Tecnología de Maracaibo, Venezuela. ∗ Correspondence: Mónica Susana Chirinos Muñoz, Tu salud c.a. 84 Street Av 14 N° 13B-32 Belloso, Maracaibo-Zulia State, Venezuela (e-mail: seguridaddelpaciente.vzla@gmail.com). Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. How to cite this article: Chirinos Muñoz MS, Orrego C, Montoya C, Suñol R. Predictors of patient safety culture in hospitals in Venezuela: A cross-sectional study. Medicine 2021;100:18(e25316). Received: 19 June 2020 / Received in final form: 7 January 2021 / Accepted: 2 March 2021 http://dx.doi.org/10.1097/MD.0000000000025316 1 Mónica et al. Medicine (2021) 100:18 Medicine 1. Introduction variables quantitatively, thereby adding value to the methods and Raising the issue of safety culture presents a challenge for models for assessing patient safety culture already known.[7,8] organizations. Safety culture has been defined as “the product of Further, this study has also been applied to examining how individual and group values, attitudes, perceptions, competen- adverse event (AE) reporting contributes to establishing a positive cies, and patterns of behavior that determine the commitment to, patient safety culture.[6] The overall structure of this manuscript and the style and proficiency of, an organization’s health and text was defined by the CONSORT check list: Introduction, safety management. Organizations with a positive safety culture Methods, Results, Discussion, and Conclusions. are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures.”[1] A safety 2. Design and methods culture should therefore evaluate psychological aspects – in other The study has been conducted within the framework of a research words, how people’s reactions to safety processes vary according project entitled “Identification of Adverse Events in Hospitals in to their values, attitudes, and perceptions; behavioral factors, that the Region of Zulia,” which makes an integrated assessment of 3 is, what people do within the organization regarding safety dimensions of patient safety: culture; and situational factors, referring to what is reported by the organization in terms of its policies, regulations, etc. 1. the individual care process and its repercussion on the patient, One of the main recommendations to help healthcare through the study “Prevalence and Characterization of institutions improve in this area is to develop an organizational Adverse Events”;[20] culture that is centered around patient safety,[2] as this is 2. what the patients observe and perceive regarding the care considered key to ensuring that communication is clear, process, through the criteria “Patient Perception”; and objective, and as flawless as possible.[3–5] 3. the considerations of healthcare professionals, through the Different methodologies exist for analyzing patient safety study “Safety Culture.” culture and its various dimensions,[6–11] and this can sometimes All 3 studies were conducted simultaneously in terms of make it difficult to compare and assess any differences that may population, time, space, and context. exist on an organizational and individual level.[12–15] Such This study uses a cross-sectional design and takes an comparison and assessment is fundamental to developing an epidemiological, observational, and comparative approach. optimum level of safety culture and facilitating decision- The study variables are the analysis of patient safety culture, making.[16] This idea is derived from the need to know the true and its predictors, in public and private hospitals, which will be attitudes, beliefs, and practices of the organization in combina- analyzed, with a theoretical and methodological model based on tion with its human capital, to optimize patient safety. If these calculating a PSCI and examining the factors that contribute to it. factors are not clearly and promptly known, it is difficult to This will be done in 2 steps: improve. This need requires clarification in both developed and developing countries. Studies such as the comparative database 1. To assess safety culture indicators, a version of the AHRQ report,[7] have transformed the experience of assessing safety Hospital Survey on Patient Safety Culture was used that had culture into a tool for continuous improvement. been adapted and validated by the Spanish Ministry of Health In the context of Venezuela, as far as is known, no previous and Consumer Affairs and the University of Murcia.[21,22] The research has been carried out on patient safety culture, survey was administered directly to the healthcare profes- contributing to the lack of major progress in this area and sionals by 2 interviewers; the participants were given a printed justifying the need for new and innovative contributions on this version together with a brief explanation of the objective and subject. In this respect, the decision to conduct the research in the questionnaires were collected after a maximum period of the state of Zulia, aside from the technical feasibility, was 48 hours. because it is a region of great economic importance for the 2. Safety culture index and its predictors are calculated using country, and the 5th largest geographically.[17]Another very factor analysis, which will be described later on. important feature of the Venezuelan healthcare system is that The observation units consisted of 588 healthcare professio- healthcare can be of 2 types – public and private – and we nals, representing doctors, nurses, hemotherapy specialists, therefore considered it relevant to assess patient safety culture nutritionists, laboratory assistants, bioanalysts, radiographers, in both models.[18,19] social workers, post-graduate resident physicians, and adminis- The present study in a global context provides a new and trative staff, all of whom formed part of a convenience sample innovative quantitative methodological tool to the measurements from 2 public hospitals and 2 private hospitals in the region of about the culture of patient safety; because its exposes punctually Zulia, Venezuela. The professionals were selected based on a and objectively the factors according to their nature that predict single criterion: they had to be involved in the individual care of the quality of the culture of patient safety in the organization each of the 566 hospitalized patients over a period of 4 months under study, this allows to guide improvement actions. (April, May, June, and July 2015).[20] Their involvement was For the reasons outlined above, the proposed objective of this detected by verifying their signatures on the patients’ medical research is to analyze patient safety culture and its predictors in records. public and private hospitals. Further, given that there is not just one specific way of measuring patient safety culture in hospitals, 2.1. Data analysis and therefore facilitating the implementation of improvement actions, we propose a new theoretical and methodological model The data analysis techniques applied were as follows: based on calculating a Patient Safety Culture Index (PSCI) and Frequencies, percentages, means, and standard deviations were examining the factors that contribute to it. The aim of using this used as descriptive variables, all of which had a confidence measurement is to be able to connect and compare the different interval of 95%. 2 Mónica et al. Medicine (2021) 100:18 www.md-journal.com In order to assess the relationship between the different Consequently, the PSCI would be the result of the sum of these sections of the survey and safety culture, a quantitative analysis 3 factors, which are determinants within the conditions of this model of patient safety culture was created using the variables study. The index was split into 4 levels: proposed in the Hospital Survey on Patient Safety (HSOPSC) Level 1: Favorable (104–85), published by the AHRQ (Agency for Healthcare Research and Level 2: Moderately favorable (84–65), Quality).[22,23] Level 3: Moderately unfavorable (64–45) and, The first step of the model to be designed was the PSCI, which Level 4: Unfavorable (44–25). was calculated by applying factor analysis, taking into account the 12 dimensions covered in the instrument, socio-professional These ranges were estimated according to the class interval characteristics, and the additional information: calculated using the formula shown below: 1. Score awarded to the degree of patient safety in the service/ ðPSCImax Þ  ðPSCImin Þ unit, and RSCI ¼ 4 2. Number of adverse events reported (see supplementary material, http://links.lww.com/MD2/A102). where: A correlation matrix comprising a low determinant value RSCI: Patient Safety Culture Index Range. (less than 0.05), a Kaiser–Meyer–Olkin (KMO) value above PSCImax: Maximum value obtained in the factorial analysis. 0.75 and Bartlett’s highly significant test for sphericity was used PSCImin: Minimum value obtained in the factorial analysis. to select the indicators that best define the variable (factor loading > 0.5). A univariate ANOVA was applied to evaluate the possibility of The second step was to apply factorial analysis (see significant differences between factors (indicators proposed in the supplementary material, http://links.lww.com/MD2/A102), survey) by care unit and healthcare professional. which resulted in 2 main observations: And finally, logistic regression was applied to adverse event reporting to identify the predictor variables of adverse event 1. The indicators were grouped according to a statistical value – reporting in patient safety culture.[16,24,25] The omnibus test was they had to account for 55% of the variance in the “culture of applied to the model coefficients; and the logistic regression safety” construct and be identified as predictors of safety equation was applied to the prediction. The final regression culture in the study population. Based on this, indicators were model also incorporated the patient support line (if the healthcare then identified that have a greater or lesser statistical weight professional has direct interaction or contact with patients) and (e.g., indicator: years of experience in the hospital = 0.95), all the other aspects of safety culture: safety perception, learning, which determined its predictive value in the safety culture teamwork between units, openness in communication, feedback, analysis. The greater the weight, the greater the predictability reporting, professional expertise, hospital experience, and service and the lesser the weight, the lesser the predictability of a experience (Fig. 1). positive patient safety culture. Logistic regression equation for prediction 2. Consequently, 3 indicator groups were pinpointed and a common characteristic was identified for each mutuality, 1 Y¼ resulting in the indicators being grouped into the following 3 1eð1:827 þ 0:606 Patient classifications: support line  0:512 ExpectationsÞ  Occupational factors (OF): this group refers to those indicators 2.2. Ethical considerations that have work-related characteristics. This study was approved by the ethics committees at the Clinic 0:95 ðyears of experience in the hospitalÞ Hospital of Maracaibo (Act N 07-15), The Rosario Hospital of þ 0:93 ðyears of professional experienceÞ Cabimas (Act N 06-16), our Lady of Chiquinquirá Hospital of þ 0:89ðyears of service experienceÞ: Maracaibo (Act N 0316), General Hospital of the South “Dr Pedro Iurbe” (Act N 25-06-16-1).  Communication factors (CF): these comprise indicators that Patient consent is not required, because the observation units reflect the effect of communication on the relationship between were healthcare professionals. healthcare professionals and the different organizational levels of healthcare and on patient safety culture. 3. Results 0:837ðadverse event reportingÞ þ 0:835ðfeedbackÞ 3.1. General characteristics of the population þ 0:547ðteamwork in units=serviceÞ The response rate of the survey among healthcare professionals þ 0:541ðorganizational learning=continuous improvementÞ: was 68.8% (405 of the 566 professionals who were sent the survey responded), of whom 51% (N = 206) worked in public  Organizational factors (OrF): these comprise indicators hospitals and 49% (N = 199) in private hospitals. relating to aspects that have an impact on the organization. As shown in Table 1, nursing professionals are most strongly represented at both the public and private hospitals studied, 0:681ðexpectationsÞ þ 0:643ðperception of safetyÞ accounting for 36.07% (N = 149), while specialist physicians þ 0:625ðstaffingÞ þ 0:527ðhospital workÞ account for 17% (N = 67) and resident physicians 13% (N = 53). þ 0:515ðmanagement supportÞ: The professions with least representation are pharmacists (N = 5), 3 Mónica et al. Medicine (2021) 100:18 Medicine RESEARCH PROYECT: STUDY SAME POPULATION, TIME, SPACE, AND CONTEXT Study: Adverse Events idenficaon.²⁰ PATIENT SAFETY CULTURE Paent Safety Percepons. Review of paent´s Idenficaon of Health medical records. workers in medical records. *12 dimensions covered in the instrument. hghhhhhhh *Socio-professional Instrument hh characteriscs . *The addional applicaon. informaon. *Factorial Analysis. Data Analysis. *Correlaon Matrix. *Barle´s test for sphericity. Pacient Safety Culture Definitory indicators of Index. paent safety. *Occupaonal factors. Predictors of paent *Communicaonal safety culture. factors. *Organizaonal Factors. Figure 1. Flow diagram of methodology. Studies of patient safety, complementary to this Study. Internal Process sequence. Natural process sequence. Table 1 Population distribution by type of hospital, safety culture index, and predictors of culture. Public hospitals Private Occupational Communication Organizational Healthcare workers (PuH), N % hospitals (PrH), N % Total, N % PSCI factors (OF) factors (CF) factors (OrF) Nursing professionals 57 14.1 92 22 149 36.1 61.1 ± 8.1 39.1 ± 8.41 12.9 ± 0.5 9.2 ± 0.2 Specialist physicians 41 19.9 26 13.1 67 16.5 53.9 ± 3.11 32.9 ± 3.2 11.8 ± 0.7 9.1 ± 0.4 Resident physicians 43 20.9 10 5.0 53 13.1 35.2 ± 2.81 15.1 ± 1 11.0 ± 0.8 9 ± 0.5 Pharmacists 1 0.5 4 2.0 5 1.2 43.6 ± 2.61 17.6 ± 1.7 16.4 ± 9.5 ± 0.8 Dietitians 5 2.4 4 2.0 9 0.5 68.6 ± 6.11 48 ± 4.3 11.1 ± 1.4 9.4 ± 0.7 Technicians (EKG, laboratory, 15 7.3 16 8.0 31 7.7 59.7 ± 3.51 37.8 ± 3.7 12.3 ± 1.2 9.5 ± 0.9 radiology) Administration/management 3 1.5 11 5.5 14 3.5 51.9 ± 2.51 29.2 ± 1.4 12.7 ± 1 9.8 ± 0.4 Other 29 14.1 25 12.6 54 13.3 55.4 ± 4.41 33 ± 2.3 13.2 ± 0.9 9.1 ± 0.6 Patient care assistants 7 3.4 7 3.5 14 3.5 – – – – Pharmacy resident 2 1.0 2 1.0 4 – – – – – – – – – – – – – – – – Unit assistants 3 1.5 2 1.0 5 1.2 – – – – – – – – – – – – – – – Total 206 100 199 100 405 100 F (Sig) 5.36 (0.00) 5.1 (0.00) 5.62 (0.00) 1.39 (0.18) 4 Mónica et al. Medicine (2021) 100:18 www.md-journal.com Table 2 Identification of safety culture factors by type of hospital. Type of hospital Public hospitals (PuH) Private hospitals (PrH) SD Sig SCI average 52.67 52.96 0.11 0.90 Occupational factors (OF) 32.03 SD 30.24 SD 0.71 0.47 Years of experience in the hospital 11.77 0.38 10.22 0.36 1.54 0.12 Years of professional experience 13.21 0.22 12.74 0.3 0.47 0.63 Years of service experience 9.48 0.22 9.62 0.25 0.16 0.87 N 200 199 Communication factors (CF) 11.83 12.86 0.71 0.47 Event reporting 3.71 0.98 4.05 0.86 0.86 0.001 Feedback and communication of errors 3.58 0.92 4.05 0.77 5.23 0 Openness in communication 3.04 0.7 3.04 0.66 1.78 0.07 Teamwork between units/services in the hospital 3.83 0.56 3.83 0.54 0.92 0.35 Organizational learning/continuous improvement 3.48 1.62 3.48 0.76 3.36 0.001 N 206 199 Organizational factors (Orf) 9.1 9.55 0.71 0.47 Management expectations and actions 3.08 0.53 3.13 0.44 0.86 0.38 Perception of safety 3.28 0.65 3.23 0.67 0.75 0.45 Staffing 2.79 0.7 2.95 0.71 2.21 0.027 Teamwork in the unit or service 3.12 0.76 3.29 0.76 3.04 0.003 Hospital management support for patient safety 2.9 0.74 3.41 0.56 7.17 0 N 206 185 SD = standard deviation; Sig = statistical significance; PSCI = favorable (104–85), moderately favorable (84–65), moderately unfavorable (64–45), unfavorable (44–25). resident pharmacists (N = 4), and dietitians (N = 9). A large statistical difference between types of hospitals (PuH OF = 13.21, participation of health workers was included (N = 54, 13.3%), PrH OF = 12.7) and the indicator with the least weight was “years who were not categorized in the instrument, but who participate of service experience” (see Table 2). in the care process. Next, CF are secondary predictors of the culture of patient Table 1 also shows the safety culture index means of all the safety. The indicator “teamwork between units/services in the professionals involved in the process, together with their hospital” had the highest average in this factor (same in both predictors. Nutritionists and dieticians presented the highest types of hospitals CF = 3.83); followed by “adverse event index in both public and private hospitals (PSCI = 68.6) with a reporting” (PuH CF = 3.71, PrH CF = 4.05). The indicator with rating of “moderately favorable,” followed by nursing the least weight in this factor was “openness in communication” professionals (PSCI = 66.1, OF = 39.1). The healthcare person- (PuH CF = 3.04, PrH CF = 3.04). nel with the lowest index at both types of hospital were the Sequentially, communication factors follow occupational resident physicians with a rating of “unfavorable” (PSCI = 35.2, factors, with “teamwork between units/services in the hospital” OF = 15.1). In all cases, the labor factor predominates as having the highest average in the PSCI, with the same score predictors of the safety culture (OF = 39.1 ± 8.4) (see Table 1); recorded for both types of hospitals (CF = 3.83); followed by however, in the case of resident physicians, with little “adverse event reporting” (PuH CF = 3.71, PrH CF = 4.05). The statistically significant difference with respect to communica- indicator with the least weight in the index was “openness in tional and organizational factors (labor: PSCI = 15.1, commu- communication” (PuH CF = 3.04, PrH CF = 3.04). nicational: PSCI = 11, organizational: PSCI = 9). In this Lastly, organizational factors had the least weight within the population group certain indicators such as years of experience, PSCI, and the organizational indicator with the greatest weight years in service, among others, are not determinants because was “perception of safety” (PuH OrF = 3.28, PrH OrF = 3.23); they are new doctors, and they focus their opinion on what they while the indicator with the least weight was “staffing” (PuH receive as part of their training. OrF = 2.79, PrH = 2.95). Finally, remaining in the category of “Moderately Unfavor- As the index did not have a significant difference between both able,” with special relevance, the specialist physicians (PSCI = types of hospitals (sig = 0.9), the information by care units is 53.9), technicians (PSCI = 59.7), and management personnel considered global (see Table 3). (51.9); like the rest, labor factors predominate as the main The highest score is found in the clinical laboratory unit (PSCI: predictors, followed by communicational and organizational 70.02 = moderately favorable). Laboratories usually have quality factors. management systems to streamline their processes, which could As shown in the global value of the PSCI, in the study hospitals, influence a higher level of safety culture and the lowest in the care it was “Moderately Unfavorable” (public hospitals: PSCI = unit of Traumatology and Orthopedics (PSCI: unfavorable = 52.67, private hospitals: PSCI = 52.96) without statistically 36.48). Occupational factors continue to be the primary significant differences between them (0.90, SD = 0.11). predictors of the index. Units that handle a high volume of As shown in Table 2, occupational factors are the primary patients such as internal medicine, ICU, surgery, and pediatrics, determinants of the index (PSCI OF = 48), and consequently the among others, presented moderately unfavorable rates. Likewise, strongest predictor of the culture of patient safety. Among the as in all areas, labor factors persist as the highest predictors of the indicators that compose it, the one with the greatest weight in the index (sig = 0.01); followed by the communication factors and index average was “years of professional experience,” with no then the organizational factors. 5 Mónica et al. Medicine (2021) 100:18 Medicine Table 3 Patient Safety Culture Index (PSCI) by care unit and factor. Gynecology/ Medicine Traumatology Urology obstetrics Neurology Emergencies internal ICU Surgery Pediatrics Nephrology Pharmacy Laboratory. Others Sig F (Sig) SCI 36.48 37.43 41.42 42.15 42.57 46.59 47.32 49.38 50.92 51.54 53.25 70.02 54.46 0.17 2.24 (0.00) Occupational factors 16.57 17.09 20.47 19.58 20.14 25.35 26.15 28.45 29.9 30.26 28.01 47.56 32.36 0.19 2.06 (0.01) Communication factors 11 12.78 11.67 13.01 12.71 12.18 12.4 11.87 11.85 12.4 15.18 12.72 12.74 0.11 1.64 (0.05) Organizational factors 7.55 7.55 9.27 9.55 9.72 9.06 8.76 9.04 9.36 8.88 10.04 9.72 9.2 0.53 1.69 (0.04) F = Anova; Sig = statistical significance of Anova; PSCI: favorable (104–85), moderately favorable (84–65), moderately unfavorable (64–45), unfavorable (44–25). Finally, due to the theoretical importance of the notification of ing a cultural environment with greater awareness of the adverse events, the study highlights this idea and makes a specific problem, increases the skills of human capital, and consequently assessment of this indicator, as shown in Table 4. It shows the improves the quality of the services provided. We consider that indicators that were significant predictors of whether a this contribution nurtures the body of knowledge of the methods professional reported adverse event or not; the highest indicator of analysis of the safety culture. was “management expectations and actions” (Omnibus test sig = Notably, this is the first study that analyzes predictors of 0.048), which acted as a protection factor (ODDS = 0.59), that is, patient safety culture by calculating an index that can be used as a a predictor of reporting. The second highest indicator was “direct control variable to compare and relate other variables.[26] Our involvement with the patient” (sig = 0.049) (see Table 4), proposal is therefore to explore a theoretical and methodological classified as a risk factor (coefficient value for this variable = model that groups together indicators from a previously 0.606, sig = 0.048, and odds ratio = 1.834), that is, that being in validated instrument,[21] and converts them into factors. We direct contact with the patient or the first line of care is in itself a believe that this approach adds to the body of knowledge factor of opportunity and predisposition to report. Nurses, proposed by the AHRQ through the HSOPSC as the tool enabled followed by resident physicians and then specialists, reported us to innovate quantitatively considering that the literature did more than those who had no direct contact with the patient. not document any experiences of this nature,[8] and our method therefore provided an alternative analytical approach. The results presented here transcend the typical description of aspects of 4. Discussion patient safety culture that are already known,[13,15] and reveal After analyzing the results, the Patient Safety Culture Index in another perspective for defining this variable. both the public and private hospitals studied was found to be Much of the literature presents a list of descriptors of patient “moderately unfavorable”; occupational factors were the main safety culture and these have undoubtedly had a significant impact; predictors of patient safety culture in both types of hospitals, however, we consider that healthcare organizations require more followed by communication and organizational factors. Further- functional and operative forms of analysis and interpretation that more, according to the study, adverse event reporting was a can facilitate their understanding of the environment within which predictor of patient safety culture as a result of the patient they operate. In this study, we evidence that another level of culture support line and management expectations and actions. prediction exists, which we consider to be better adapted to the This is the first investigation to analyze the Patient Safety functioning of institutions, as the indicators present a natural Culture by calculating an Index whose usefulness as a control tendency to relate to each other numerically, with the 3 variable is to compare and relate other variables.[26] A new aforementioned predictor groups differentiated, and which, in theoretical methodological model is proposed to analyze and accordance with the statistical values obtained, whether high or measure the level of safety culture and its predictors through low, will define the factor that is considered to have the greatest or resulting factors that contain indicators of a known and validated lowest predictability in the culture of that particular care instrument (HSOPSC).[21] After an institution undergoes this organization, and which can provide information for decision- analysis, the results it provides, in our view, are more objective making. Consequently, the index is proposed as a measure of the and specific than other measurement methods. The use of the relationship between these 3 constructs, thereby enabling a single index and the factors, allows to objectively visualize the culture analysis value to be obtained. measurement of culture, and facilitates the implementation of We believe that this logical approach could help healthcare improvement actions focused on user participation,[27] promot- institutions improve operations and endow them with greater Table 4 Variables explaining adverse event reporting (logistic regression). 95% CI for Exp (B) Variable Log-likelihood Sig. of Standard Exp (B) Step 10 of model change B error Wald Sig Odds Lower Upper Management expectations and 89.723 0.043 0.512 0.301 2.885 0.048 0.599 0.332 1.082 actions regarding safety Direct patient support line 89.646 0.049 0.606 0.362 2.809 0.049 1.834 0.902 3.727 Constant 1.827 0.966 3.573 0.059 6.213 See Section 2 to identify the variables included in the model. 6 Mónica et al. Medicine (2021) 100:18 www.md-journal.com objectivity since it collects information about the culture that can their work, they are susceptible to burn-out syndrome,[36] then be used for decision-making and for improving and where over their professional lives healthcare professionals developing patient safety culture. can start to depersonalize patients, putting their health at risk The theoretical and methodological model is expressed and jeopardizing and undermining the organizational cul- systematically as follows: ture.[12,32] 1. Processing in equal conditions of the results of the 12 aspects Communication factors are also critical in care units as well of patient safety culture as well as additional information on as in their relationship with other hospital settings,[15] due to the any elements of a clearly occupational nature within the multiple interactions that a patient has during a hospital instrument,[21] allowing for replication.[28] stay.[31,37] The indicators of communication such as “team- 2. Application of factor analysis as a model for relating latent work between the units,” “feedback or communication of variables with the variables observed, by constructing factors errors” and “adverse event reporting,”[16,24,25,37] have been and examining them quantitatively; these factors serve as a identified as predictors in other studies,[37,38] where safety general starting point for any safety culture-related inter- culture levels were high or favorable. These findings placed ventions. special emphasis on reporting as an attribute of a positive 3. Creation of an index, as a qualitative and quantitative patient safety culture as it increases awareness of patient safety interpretation of the patient safety culture at the healthcare issues, especially in the first line of medical care.[39] In this case, institutions studied. As described in other studies,[26] index can and coinciding with a study conducted in Lebanon,[37] in the be used as a control variable to compare and relate other study population what determines whether a professional variables. The index gave us a relational perspective of the reports an AE or not, is the level of “management expectations indicators contained in the instrument, enabling us to analyze and actions to promote patient safety”[37,39] and “direct the status of safety culture at the hospital where it was applied. interaction with the patient.” In this sense, these professionals 4. Classification of the indicators into occupational, communi- are exposed to high levels of stress as a result of their proximity cation, and organizational factors, representing a reengineer- to the patient care process,[33] which tends to lead to a greater ing of the typical aspects affecting safety culture within an incidence of AE[11]; however, this premise makes them more institution, which provide a general starting point for safety aware of the need to report.[40,41] culture-related initiatives.[29,30] Nevertheless, it has been noted that although healthcare professionals may be prone to report errors, if these errors persist and are repetitive, their willingness to report diminishes.[41] The 4.1. Analysis and predictors of patient safety culture greater the gap between the perceptions of leaders and Because patient safety culture was determined using an index, it is professionals in the front line of care, the greater the risk of difficult to analyze these results in terms of other research making mistakes.[11] Evidence has shown that communication experiences. However, as presented in this study, the grouping of problems, whether simple or complex, are major contributors to indicators into occupational, communication, and organizational adverse events and may undermine patient safety.[11,24,36] High- factors is representative of the dynamics and orientation of the quality and safe care depends on the ability of suppliers to safety culture in institutions put forward by Vincent,[31] whose communicate well with patients and other healthcare profes- model defines 7 categories of factors that are inherent in the sionals.[16,36] Nursing staff interact directly with patients more system and have an influence on clinical practice, potentially frequently than other professionals and are the main source of leading to problems with patient safety. interception of incidents and events. Nursing staff are also more Our model proposes an interpretation of the safety culture receptive to the implementation of these ways of working and measurement through the value of an index and the factors that therefore report errors more frequently,[32,41] a fact that is determine it; unlike the HSOPSC survey that establishes an supported in this study as the PSCI is higher for these staff than analysis by means of a mean percentage of positive responses on for other professionals.[34] patient safety. On the other hand, the HSOPSC survey makes the Institutions should promote a culture of organizational measurement based on the 12 dimensions of the safety culture, as learning within an environment that provides a safe place for established by the theory; however, our model, although it is the sharing of any information that may lead to improvements nourished by it, proposes 3 factors that are defined each by the and help create a climate of trust.[16] nature of the indicators that compose it, providing knowledge The fact that both public and private sector institutions about this area, showing that the dimensions have a mutual have obtained a moderately low PSCI (see Table 1) may be nature and are not aspects isolated. due to the systematic crisis situation being experienced by An interesting finding is that one of the occupational factors the healthcare sector over the past 15 years, which has that contributed the most to the “moderately unfavorable” score affected both sectors. Healthcare workers in Venezuela tend in the index was related to professionals with over 10 years of to work in both sectors, which partly explains why the experience. Studies show,[12,32] that as people become more healthcare culture is perceived similarly in both sectors, taking experienced they have a greater awareness of safety practices in into account that the lack of resources and precariousness are the institution where they work. However, 2 points stand out: the same in both types of institution, with 3 main clear scenarios: 1. Staff confidence can be an influencer; the risk may be associated with an overconfident, arrogant, and authoritative 1. Policies that limit the importation of materials and equipment. attitude, which tends to be seen more often in individuals with 2. Restricted access to foreign currency for the purchase of more experience.[33–35]. supplies and medication. 2. As professionals are exposed to “continuous” and “extreme” 3. Lack of egalitarian healthcare policies that promote compli- work stress due to the poor conditions in which they carry out ance with standards of quality in the care process. 7 Mónica et al. Medicine (2021) 100:18 Medicine These situations minimize efficiency, opportunity and the added to in order to facilitate and promote the development of availability of therapy and diagnostic techniques, and accessibili- patient safety culture in healthcare institutions. ty to treatment and medication, thereby undermining the The applicability of the analysis proposed is important because healthcare provided in institutions and, consequently, patient by knowing the index of an institution and the predictor factors safety. that comprise it, decision-making can revolve around improving Another finding, as observed in other studies, is that surgical the indicators encompassed by each factor. For example, in this units obtain the lowest patient safety culture scores, due to the study, occupational factors predominate and one of the complexity of processes and an unwillingness to address risks.[8] associated indicators is years of professional experience; efforts This is the case, for example, with traumatology, and these units would therefore be centered on improving this indicator by should therefore be at the forefront of efforts to improve safety implementing measures such as staff rotation and promotions, culture.[42] among others. This would produce efficient, appropriate, and This is also the first study published in Venezuela on patient far-reaching results in terms of constructing a safety culture. safety culture although there are a few studies comparing the Patient safety is an issue that must be worked on more safety culture variable between public and private institutions. forcefully and globally; to make priority representation in This study confirms that private hospitals tend to report 51.6% government agendas to promote quality management systems less than public hospitals in our survey sample (X2 = 17.7, and the culture of patient safety at the institutional level as the P < .05).[19] One explanation is that under-reporting may occur bases to guarantee an efficient and safe service. in private institutions, due to the reasons described in the Studies of this nature in developing countries are really scarce, literature, which include fear, humiliation, and a punitive therefore this manuscript represents a contribution to the response to the error.[39,43] In the case of Venezuela, employment scientific literature, describing the experience of a country that contracts at private institutions allow employers to dismiss is going through a very particular political, economic and social workers more easily than at public hospitals.[44] situation, known worldwide, that could represent an influencing The above-described findings generate a basis for further factor in the Patient Safety Culture. studies with a broader scope and contribute to building a model The contribution to the body of knowledge is relevant and that offers us a different perspective for analyzing patient safety innovative, since this study, through its methodology, showed culture.[37,40] Our research therefore serves to promote more in- that with a previously validated instrument, its indicators were depth research and the reengineering of knowledge to create a studied, grouped and resized into factors, establishing an index proper knowledge base. that qualitatively and quantitatively shows the value predictive of The limitation presented refers to the sample used, which is not each indicator and each factor, within the safety culture of the representative of the reality in Venezuela; although it is institution where the methodology was applied, combining all representative for the state of Zulia, bearing in mind that the organizational, communicational, and professional criteria, region serves as a reference for the whole country due to its highlighting one over the other. This data invites the institutions population and economy.[17] Another limitation presented is the bearers of these results to define more specific strategies with lack of willingness of health workers to openly express the issues greater scope and institutional impact. The application of this and aspects related to the institutional culture on patient safety, methodology makes visible that little-studied connection be- possibly because they consider it an issue that may have punitive tween organizational factors and the factors of the service repercussions. However, they were approached by explaining the provider. research objectives as a group and individually. Future studies derived from this research focus on replicating the analysis methodology of the safety culture predictors in other institutions, comparing results with other measurement instru- 5. Conclusions ments and validating institutional receptivity by knowing the The results presented in this study provide a preliminary indicators and/or factors that influence with more or less weight, contribution to the general observation that patient safety within the index. culture in Venezuela needs to be improved to guarantee a high- The aim of this paper is to enrich the theory and methods on the quality healthcare service. In this respect, the culture and measurement of safety culture so that the institutions choose the environment within which care processes are carried out may most functional option for them. This research shows that there is act as an important barrier to patient safety or, conversely, a little difference in culture between public and private institutions catalyst for this.[10,16] in the country, and it is the people and not the types of financing This study reveals early signs of patient safety culture in that define the culture of patient safety. Strengthening the socio- Venezuela; however, further research is required to validate this labor aspects is the key to a sustainable patient safety culture, data and substantiate the body of knowledge in this area. conducting intervention studies and assessing verifications. Developing the analysis model proposed here would give other hospitals in Venezuela, or globally, the opportunity to begin to Author contributions assess patient safety culture from a more objective perspective, as shown in the results, so that a patient safety culture can be Conceptualization: Mónica Susana Chirinos Muñoz, Carola developed that is more sustainable in time and adapted to this Orrego, Cesar Montoya, Rosa Suñol. particular context. In this regard, as much information as Data curation: Cesar Montoya. possible should be gathered to help support the validity of the Formal analysis: Mónica Susana Chirinos Muñoz, Cesar model and establish how it can be of the most use. Montoya. 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