Chapter 60 - Accrediting Simulation Programs

This study was done to evaluate the experience of securing patient safety in hospital operating rooms. Experiential data were collected from 15 operating room nurses through in-depth interviews. The main question was "Could you describe your experience with patient safety in the operating room?". Qualitative data from the field and transcribed notes were analyzed using Strauss and Corbin's grounded theory methodology. The core category of experience with patient safety in the operating room was 'trying to maintain principles of patient safety during high-risk surgical procedures'. The participants used two interactional strategies: 'attempt continuous improvement', 'immersion in operation with sharing issues of patient safety'. The results indicate that the important factors for ensuring the safety of patients in the operating room are manpower, education, and a system for patient safety. Successful and safe surgery requires communication, teamwork and recognition of the importance of patient safety by the surgical team.

Introduction/Background Privileging is the process by which an institution grants permission to a provider to perform patient care activities. When a hospital grants privileges, it “explicitly endows a [provider] with the right to perform that procedure within its physical and administrative confines”.2 The use of simulation-based assessment (SBA) allows providers to practice and be assessed on a predetermined set of procedures in a controlled and standardized setting until acceptable performance is reached.23 As privileging programs shift toward competency-based assessment, simulation is being utilized to both gain and maintain privileges.25 However, the scope of existing privileging programs that utilize SBA and exactly how SBA is incorporated remains unclear. The objective of this study was to survey simulation centers regarding existing and planned privileging programs that incorporate SBA. Methods Ninety two simulation centers were included in the survey. For feasibility, only simulation centers that were accredited by either the American College of Surgeons (ACS) or from the Society for Simulation in Healthcare (SSiH) were included. The survey took approximately 20-30 minutes to complete and was addressed to directors of simulation centers. Survey data was collected from March through April 2013. Results Twenty seven simulation centers responded (29%). The majority of centers were associated with public hospitals (62%); 33% of centers were associated with private hospitals. All were associated with teaching hospitals. A majority of centers had approximately 5,000-10,000 square feet. Regarding the number of full time employees (FTE’s), this ranged widely from 1 – 52. Nineteen procedures were included in the survey; these were determined based on a review of the literature.33 The procedures that were most often selected as having existing SBA privileging programs included central venous catheterization, sedation, laparoscopic surgery and robotic surgery. The procedures that were most often selected for SBA privileging programs in development included GI endoscopy and bronchoscopy procedures. All of the nineteen procedures surveyed had at least one center with either a current or future SBA program in development. Additional procedures centers reported SBA privileging programs included vein graft harvesting and airway management. Reasons for beginning such programs included desire to develop standards, risk management, patient safety, response or cost reduction related to adverse events, targeting of procedures that occur less frequently and cost reduction related to training. The majority of centers required all providers who performed the given procedure to participate in the program (57%). Centers collaborated with human resources (17%), risk management/legal (33%), quality improvement/quality assurance (42%), medical staff office (58%), continuing medical education (42%), and patient safety (25%). A majority of centers utilized their programs for initial privileging of new providers (57%). Top barriers included institutional political support, provider resistance to participate, litigation from providers (i.e. provider sues hospital if denied privileges), and simulation center staffing and equipment. Methods to develop content for SBA privileging programs included internal expert opinion (69%), literature review (54%), and multi-department (46%) or interprofessional (38%) committees. One center reported that they worked with a credentialing committee; no other Methods of choosing criteria were reported. Methods of delivering the SBA privileging program included testing performance on simulation models (77%) and the use of performance-based checklists (62%). None of the centers reported a method for assessing procedural competency. Conclusion It is clear from the Results that simulation centers are developing SBA privileging programs. However, the process is fragmented as centers are developing programs as single institutions. Further research, publication and guidance is needed so that simulation centers can learn from each other regarding best practices when delivering SBA privileging programs.

ObjectiveTo investigate the relationship between ISO 9001 certification, healthcare accreditation and quality management in European hospitals.DesignA mixed method multi-level cross-sectional design in seven countries. External teams assessed clinical services on the use of quality management systems, illustrated by four clinical pathways.Setting and ParticipantsSeventy-three acute care hospitals with a total of 291 services managing acute myocardial infarction (AMI), hip fracture, stroke and obstetric deliveries, in Czech Republic, France, Germany, Poland, Portugal, Spain and Turkey.Main Outcome MeasureFour composite measures of quality and safety [specialized expertise and responsibility (SER), evidence-based organization of pathways (EBOP), patient safety strategies (PSS) and clinical review (CR)] applied to four pathways.ResultsAccreditation in isolation showed benefits in AMI and stroke more than in deliveries and hip fracture; the greatest significant association was with CR in stroke. Certification in isolation showed little benefit in AMI but had more positive association with the other conditions; greatest significant association was in PSS with stroke. The combination of accreditation and certification showed least benefit in EBOP, but significant benefits in SER (AMI), in PSS (AMI, hip fracture and stroke) and in CR (AMI and stroke).ConclusionsAccreditation and certification are positively associated with clinical leadership, systems for patient safety and clinical review, but not with clinical practice. Both systems promote structures and processes, which support patient safety and clinical organization but have limited effect on the delivery of evidence-based patient care. Further analysis of DUQuE data will explore the association of certification and accreditation with clinical outcomes.

Hospitals have made slow progress in meeting the Institute of Medicine's patient safety goals, and implementation of safety systems has been inconsistent. The next logical question is this: What organizational characteristics predict greater implementation of patient safety systems, in terms of both extent of systems and progress over time? To answer this question, a survey was administered to 107 hospitals at two points in time. Data were consolidated into seven latent variables measuring progress in specific areas. Using the overall measure, Joint Commission-accredited hospitals showed statistically significant improvement, as reflected in the sum score (p = .01); nonaccredited hospitals did not show statistically significant improvement (p = .21). Joint Commission accreditation was the key predictor of patient safety system implementation. Management type and urban/rural status were secondary predictors. Several factors may account for the strong association between accreditation and patient safety system implementation. In 2003, the Joint Commission began tying accreditation to patient safety goals. Also, Joint Commission data are now widely available to the public and may stimulate hospitals to address safety issues. Healthcare executives, hospital trustees, regulators, and policymakers should encourage Joint Commission accreditation and reward hospital efforts toward meeting Joint Commission standards. The Joint Commission should continually strive to maintain evidence-based and state-of-the-art standards that advance the aim of providing the best possible care for hospitalized patients.

The objective was to assess the levels of formation and leading components of the patient safety system of the anesthesiology and resuscitation (A&R) service (department) of multidisciplinary hospitals.Materials and methods. Expert assessment of the patient safety system of the anesthesiology and resuscitation service (department) of 235 multidisciplinary hospitals, including the assessment of its level, leading components, and their structure in the overall sample. Expert assessment method. Statistical analysis of data distribution, Student’s t-test for independent samples of different sizes, correlation analysis.Results. It has been established that in the main part (38.3%) of multidisciplinary hospitals, the A&R service is at an average (sufficient) level of ensuring patient safety. 17% are at a high (organized) and highest (system-organized) level in terms of ensuring patient safety. A fairly large part (44.7%) is at a low (insufficient) and minimal (critical, extremely low) level of ensuring patient safety. At the same time, the level of ensuring patient safety in the A&R service of multidisciplinary hospitals is important and has a close but inverse relationship with the level of digitalization. Comparison of the severity of the five leading (main) components (criteria) for ensuring patient safety in the A&R service of multidisciplinary hospitals made it possible to assess the levels of their completeness and their structure and showed that in the general sample, the most pronounced criteria for ensuring patient safety were «Teamwork, staff expertise» and «Availability of medicines».Conclusion. The current state of the patient safety system of the A&R service of multidisciplinary hospitals is characterized by 5 levels and 5 leading (main) components, the expert assessment of which made it possible to distribute the A&R services of hospitals according to the indicated levels, identify the structure of their leading components an determine target areas for improving the patient safety system.

At Yarmouk Primary Health Care Center (PHCC), a continuous quality improvement and patient safety system is in place. \ Health care delivery was explored and paper-based incident reporting was found to compromise patient safety and quality. Induction of electronic reporting of incidents was started and its favorable outcome demonstrated. This was followed by establishing a continuous quality improvement process at the facility. Ethical principles were followed during data collection and analysis. Electronic Incidence reporting was started in January 2022. A substantial increase (16 in paper-based versus 53 in electronic reporting) in Incidence reporting, following introduction of electronic reporting at Yarmouk PHCC was demonstrated. A reduction of time consumption from 35 minutes in paper-based Incidence reporting to 10 minutes in electronic reporting was demonstrated. An improvement in accuracy while using electronic Incidence report (94%) in comparison to that while using Paper based Incidence reporting (85%) was documented. Maximum Incidence reporting was by Pharmacy followed by doctors, administration staff and laboratory. Maximum Incidences were product related followed by investigation related. No sentinel event reporting was found. The majority of reported incidences were in “no harm” and “near miss” categories. Employee satisfaction improved with electronic Incidence reporting. Due to advancement of technology today, it is imperative and strongly recommended to use principles of quality improvement process to improve patient safety and quality of care. Electronic Incidence reporting is found to improve quality and patient safety. Further studies into impact of better utilization of electronic Incidence reporting on health care outcomes is strongly recommended. Key words: Patient safety; Quality Improvement; Electronic Incidence reporting; Paper-based Incidence reporting

It has been well recognized internationally that hospitals are not as safe as they should be. In order to redress this situation, health care services around the world have turned their attention to strategically implementing robust patient safety and quality care programmes to identify circumstances that put patients at risk of harm and then acting to prevent or control those risks. Despite the progress that has been made in improving hospital safety in recent years, there is emerging evidence that patients of minority cultural and language backgrounds are disproportionately at risk of experiencing preventable adverse events while in hospital compared with mainstream patient groups. One reason for this is that patient safety programmes have tended to underestimate and understate the critical relationship that exists between culture, language, and the safety and quality of care of patients from minority racial, ethno-cultural, and language backgrounds. This article suggests that the failure to recognize the critical link between culture and language (of both the providers and recipients of health care) and patient safety stands as a 'resident pathogen' within the health care system that, if not addressed, unacceptably exposes patients from minority ethno-cultural and language backgrounds to preventable adverse events in hospital contexts. It is further suggested that in order to ensure that minority as well as majority patient interests in receiving safe and quality care are properly protected, the culture-language-patient-safety link needs to be formally recognized and the vulnerabilities of patients from minority cultural and language backgrounds explicitly identified and actively addressed in patient safety systems and processes.

In the elderly, use of medications may increase the propensity for adverse drug events due to alterations in pharmacokinetic and pharmacodynamic profiles from normal aging processes. Deprescribing is the planned and supervised process of dose reduction or discontinuation of medications that may lead to harm or are no longer beneficial. While there are studies detailing strategies to deprescribe medications such as benzodiazepines and antipsychotics in nursing homes or for patients with dementia, there is a lack of guidance to safely deprescribe chronic medications, such as antidiabetics, for older patients in the community setting. To evaluate the risk of hypoglycemia and other outcomes of pharmacist-managed deprescribing on selected antidiabetic medications under the guidance of a standardized program compared with usual care within an integrated health care system. This was a retrospective propensity score-matched cohort study. The pharmacist-managed deprescribing group included patients who were enrolled in the deprescribing program between July 1, 2016, and June 30, 2017. The usual care group included eligible patients who did not receive the deprescribing intervention and were matched to the deprescribing group using propensity score matching (PSM). Baseline demographics and clinical variables were used for matching. Patients were followed for 6 months or the end of membership or death, whichever occurred first. Primary outcome was the risk of hypoglycemia. Secondary outcomes included risk of hyperglycemia, proportion of patients at goal (A1c), change in A1c, change in monthly antidiabetic drug cost, and all-cause mortality. Outcomes were analyzed using descriptive statistics and multivariant regression or Cox proportional hazard models when appropriate. After PSM, 685 patients in the deprescribing group and 2,055 patients in the usual care group were similar in age, gender, weight, and comorbidity burden (mean [SD] age 82.4 [5.4] years, 48% female, mean [SD] weight 81.7 [19.2] kg, mean [SD] Charlson Comorbidity Index score 3.2 [1.6]). Compared with the usual care group, the deprescribing group had a lower risk of hypoglycemia (1.5% vs. 3.1%, P < 0.02; adjusted odds ratio 0.42, P < 0.01). As for the secondary outcomes, the deprescribing group had a greater change (SD) in A1c (0.3 [0.6] vs. 0.2 [0.7] P < 0.01) and lower all-cause mortality (2.3% vs 5.6%, P < 0.01; adjusted hazard ratio 0.35, P < 0.01). There were no differences observed in the risk of hyperglycemia, proportion of patients at goal A1c < 7%, and change in monthly antidiabetic drug costs between the 2 groups. There are currently no studies to our knowledge that evaluate the outcomes of a pharmacist-managed deprescribing program targeting antidiabetic medications. The results of our study showed that deprescribing of selected antidiabetics reduced the risk of hypoglycemia and may have mortality benefit in elderly patients with well-controlled type 2 diabetes, who are taking medications that can cause hypoglycemia. Further and longer studies are needed to validate these benefits. No outside funding was provided to support this research study. The authors of this study have no actual or potential conflicts of interest to report. Parts of this study were presented in a nonreviewed resident poster at the Academy of Managed Care Pharmacy Managed Care and Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

National policies and efforts of medical associations have promoted patient safety management systems mainly in acute care hospitals. However, evidence on the long-term impact of these initiatives in Japan remains limited. This study assessed trends in patient safety systems and their implementation in Japanese acute care hospitals. We conducted a secondary analysis of nationwide biennial surveys of patient safety managers from 2015 to 2023. Surveys targeted a stratified random sample of hospitals based on bed size and examined the implementation of systems for detecting and analyzing medical incidents, along with experiences of serious adverse events. Trend analyses by hospital size were conducted using the Cochran-Armitage test. Analyses were conducted as exploratory trend analyses using available-case data. The organizational commitment to patient safety was well maintained, as reflected in the assignment of a safety manager and department. Adverse event reporting systems were widely adopted throughout the period, and systematic reviews of all inpatient deaths rose significantly (25.0% in 2015 to 70.5% in 2023). However, advanced incident analysis methods remained underutilized, particularly in small hospitals (<200 beds). The proportion of hospitals experiencing serious medical accidents increased, especially among large hospitals (≥400 beds). Over the past decade, Japanese acute care hospitals have made notable progress in developing patient safety infrastructures. While foundational systems were widely implemented, adoption of advanced analytical tools remains uneven. The rise in reported serious events may reflect improved detection and identification capabilities, or a simple increase in medical accidents. Sustained policy support and customized strategies for smaller hospitals are essential for continued advancement.

Patient safety continues to be a national challenge not only for providers but for patients and families as well. In an attempt to standardize processes and systems, we have lost opportunities for improvement. For instance, current patient safety reporting systems tend to favor capturing details around events that are classified as highly clinically significant (i.e., sentinel-level and never events); yet little to no effort is spent on capturing information about less evident errors or near misses, nor simply about concerns that are more experiential in nature. As a result, patients' experiences and observations are relegated to the notion of satisfaction, real-time reporting remains illusive, and the ability to learn across incidents remains anecdotal rather than systematic. Herein we propose an alternative, real-time, innovative model that merges syndromic surveillance and patient engagement to embrace patient-initiated reporting of patient safety events and concerns. The result would be a patient safety system where patients are partners, in both the conduct of their care, and in the quality of the healthcare delivered.

To identify and categorize system factors in complex laparoscopic surgery that have the potential to either threaten patient safety or support system resilience. The operating room is a uniquely complex sociotechnical work system wherein surgical successes prevail despite pervasive safety threats. Holistically characterizing intraoperative factors that thus support system resilience in addition to those that threaten patient safety using contextual methodologies is critical for optimizing surgical safety overall. In this prospective descriptive interdisciplinary study, 19 audio/video recordings of complex laparoscopic general surgical procedures were directly observed and transcribed. Using a qualitative systems-based approach, intraoperative human factors with the potential to impact patient safety, either as a safety threat or as a support for resilience, were identified. Adverse events were further assessed for shared threats and supports. Data collection was guided by the Systems Engineering Initiative for Patient Safety 2.0 work system model. A total of 1083 relevant observations were made over 39.8 hours of operative time, enabling the identification of 79 distinct safety threats and 67 resilience supports within the surgical system. Safety threats associated with the physical environment, tasks, organization, and equipment were prevalent and observed in equal measure, whereas supports for resilience were predominantly attributed to clinician behaviors, including proactive team management and skills coaching. Two subclinical adverse events were identified; shared safety threats included suboptimal technology design, whereas shared resilience supports included calm clinician behavior and redundant intraoperative resourcing. Safety threats and resilience supports were found to be systematic in the surgical setting. Identified safety threats should be prioritized for remediation, and clinician behaviors that contribute to fostering resilience should be valued and protected.

All people should always experience the safest, highest-quality, best-value healthcare across all settings. This paper analyses how, in keeping with its vision, The Joint Commission works with healthcare organisations to continuously improve healthcare quality and patient safety. It holds its accredited organisations to the highest standards by inspiring them to excel and achieve zero harm. To effectively help healthcare organisations positively transform, The Joint Commission shares with them its high-reliability framework for achieving zero harm. In addition, it provides strategies on how to reorganise healthcare organisations’ structures to integrate all improvement efforts, including performance improvement, infection control, regulatory, accreditation, patient safety and environmental services. The Joint Commission survey is designed to assess risk and identify potential harm that an identified risk poses to a healthcare organisation’s patients, staff and visitors. Healthcare leaders are provided with valuable tools and data analytics that prioritise risk and identify those areas that are most likely to lead to serious harm. Although all identified areas of risk must be addressed, these tools and analytics allow leaders to prioritise their resources and focus their initial efforts on areas that matter most. These electronic tools are available to healthcare systems regardless of size, and are of benefit to leaders in assessing those organisations that may need greater support and/or more resources to perform better. The Joint Commission has positioned itself as a leader in quality improvement and patient safety solely in order to partner with healthcare organisations to help them advance their improvement efforts while at the same time inspiring organisations to aim to eliminate all forms of harm.

To explore and compare the didactic approaches to practical skills learning at simulation centres in Scandinavian universities and university colleges. Academic simulation centres are an important arena for learning practical nursing skills which are essential to ensure competent performance regarding patient safety and quality of care. Knowledge of didactic approaches to enhance learning is essential in promoting the provision and retention of students' practical nursing skills. However, research on didactical approaches to practical nursing skills learning is lacking. A qualitative comparative design was used. During November and December 2019, interviews were conducted with a total of 37 simulation centre directors or assistant directors, each of whom possessed in-depth knowledge of practical skills in teaching and learning. They represented bachelor nursing education in Denmark, Norway and Sweden. A qualitative deductive content analysis was conducted. The results revealed all five predetermined didactical components derived from the didactical relationship model. Twenty-two corresponding categories that described a variation in didactic approaches to practical skills learning in Scandinavian nursing simulation centres were identified. The didactical components of Learning process revealed mostly similarities, Setting mostly differences and Assessment showed only differences in didactic approaches. Although various didactic approaches were described across the countries, no common approach was found. Nursing educational institutions are encouraged to cooperate in developing a shared understanding of how didactic approaches can enhance practical skills learning. Cross-country comparisons of practical nursing skills learning in Scandinavian countries highlight the importance of educator awareness concerning the impact diverse didactic approaches may have on competent performance in nursing education. Competent performance is pivotal for ensuring patient safety and the provision of high-quality care. No Patient or Public Contribution. This study followed the Consolidated Criteria for Reporting Qualitative Research reporting guidelines.

Objective To Investigate the clinical medicine postgraduates＇ perception on ＂patient safety＂ issues, analyze the potential problem of patient safety education for clinical postgraduates, provide some references and evidences for the further reformation of clinical medicine education system. Methods Total of 154 first-year clinical postgraduate of Jinan University （2012 grade ） were voluntarily surveyed with questionnaire on ＂patient safety＂ issues . Their survey results were divided into three groups： fresh graduates group （group A）, 1-3 year-worked-experience group （group B ） and more than 3 year-worked- experience group （group C） and statistically analyzed with Kruskal-Wallis H／Wilcoxon test . Results The majority of participants agreed that ＂patient safety is chiefly＂ and ＂making errors in medicine is inevitable＂ without being familiar with such perception as ＂definition of latent factors＂, ＂characteristics of a successful error reporting system＂ or ＂the number of preventable adverse events each year in WHO, country and local hospital management department＂. Most of the students were keen to accept effective curriculum and training course on ＂patient safety＂, while over half of them were less reluctant to learn ＂disclosing an error to a patient＂, respondents of different work-experience had some distinction on perception and attitude of ＂patient safety＂ ： students of group A and B agreed that＂ reporting systems can reduce future errors＂ and tend to disclose and investigate ＂ errors＂, but attitude of group C was indifference. Conclusions The perception of clinical medicine postgraduates on patient safety were quite insufficient and superficial. The gap between theoretical education in school and clinical practice is remarkable, furthermore enhancing of the formal curriculum and training system on ＂patient safety＂ for the postgraduate students are urgent, as well as the improving of public health system management such as ＂reporting system of patient safety＂. Key words: Patient safety ; Perception; Clinical medicine ; Postgraduate ; Questionnaire

Risk-based computer system validation is a process many companies developed long before the August 2003 Guidance for Industry document on Part 11 Scope and Application was issued by the US Food and Drug Administration. The main differences between priorexisting risk models and this guidance is the emphasis on patient and product safety, product quality, and record integrity as required in the Part 11 Scope and Application Guidance. When computerized systems are used to collect data on which decisions are made on drug efficacy and patient safety or are used to control the quality of drug during a manufacturing process, the point of focus has to change. This article outlines a consistent and justifiable method for determining the risk of a computerized system with the emphasis on patient and product safety, product quality, and record integrity.