George R. Kim

Identifying and categorising patient safety hazards in cardiovascular operating rooms using an interdisciplinary approach: a multisite study

Background Cardiac surgery is a complex, high-risk procedure with potential vulnerabilities for patient safety. The evidence base describing safety hazards in the cardiovascular operating room is underdeveloped but is essential to guide future safety improvement efforts. Objective To identify and categorise hazards (anything that has the potential to cause a preventable adverse patient safety event) in the cardiovascular operating room. Methods An interdisciplinary team of researchers used prospective methods, including direct observations, contextual inquiry and photographs to collect hazard data pertaining to the cardiac surgery perioperative period, which started immediately before the patient was transferred to the operating room and ended immediately after patient handoff to the post-anaesthesia/intensive care unit. Data were collected between February and September 2008 in five hospitals. An interdisciplinary approach that included a human factors and systems engineering framework was used to guide the study. Results Twenty cardiac surgeries including the corresponding handoff processes from operating room to post-anaesthesia/intensive care unit were observed. A total of 58 categories of hazards related to care providers (eg, practice variations), tasks (eg, high workload), tools and technologies (eg, poor usability), physical environment (eg, cluttered workspace), organisation (eg, hierarchical culture) and processes (eg, non-compliance with guidelines) were identified. Discussion Hazards in cardiac surgery services are ubiquitous, indicating numerous opportunities to improve safety. Future efforts should focus on creating a stronger culture of safety in the cardiovascular operating room, increasing compliance with evidence-based infection control practices, improving communication and teamwork, and developing a partnership among all stakeholders to improve the design of tools and technologies.

The Society of Cardiovascular Anesthesiologists' FOCUS initiative: Locating Errors through Networked Surveillance (LENS) project vision.

Peter J. Pronovost, MD, PhD* BACKGROUND Although the methods to measure preventable harm are imprecise and immature, preventable harm is one of the leading causes of death, disability, and increased costs of care. The field of anesthesiology has been recognized for its efforts to improve patient safety, but much work remains to reduce harm to patients having cardiac surgery. Despite significant publicity regarding patient safety and efforts to improve it since the publication of To Err Is Human 10 years ago, there is little empiric evidence that health care is safer. For example, reports of wrong-site surgery continue to increase year after year despite a national patient safety goal* and widespread efforts intended to reduce such events. Although the true increase in wrong-site surgery is debated and may represent reporting bias, we clearly have not eliminated this sentinel event or other events for which there are data. One logically asks why a country that spends more than 2 trillion dollars a year on health care, 17% of its gross domestic product, continues to produce significant preventable harm. Why do wrong-site surgeries and other adverse events continue despite substantial efforts by regulators, hospitals, and professional societies? The problem is complex and implementing solutions has been exceedingly difficult. However, the solution is conceptually simple: we must adequately develop and apply rigorous science to analyzing errors in the delivery of health care. For example, despite there being a national policy to prevent wrong-site surgery, there are little to no data showing the effectiveness of this intervention. Few quick fixes will improve safety. Similar to biomedical science, safety improvements will require a robust and disciplined science that matures over time. Perhaps the greatest barrier to measurable progress in patient safety is the inability to evaluate with scientific rigor whether patient safety interventions are effective. This is the result of insufficient research funding and, paradoxically, the interdisciplinary nature of patient safety. There is sparse research funding for “basic science” in patient safety, especially to develop measures and tools to improve it. As a result, measures are often of poor quality, and the interventions of limited effectiveness, if not harmful. There are many disciplines that inform the science of patient safety, including organizational sociology and industrial psychology, clinical medicine, human factors engineering, health services research, economics, epidemiology, biostatistics, and informatics. Each discipline views the world through a unique “lens” and has a different frame of reference for viewing various aspects of patient safety risks and interventions as compared with others. Unfortunately, these lenses are From the *Departments of Anesthesiology & Critical Care Medicine and Pediatrics, The Johns Hopkins University School of Medicine and the †Department of Health Policy & Management, Bloomberg School of Public Health, Baltimore, Maryland. Accepted for publication October 5, 2009. Supported by the Society of Cardiovascular Anesthesiologists (SCA) Foundation for the LENS Project. Elizabeth A. Martinez was supported by the Agency for Healthcare Research and Quality K08 grant #HS013904-02. The FOCUS Initiative is a collaborative project of the Society of Cardiovascular Anesthesiologists, the SCA Foundation, and the Johns Hopkins University Quality and Safety Research Group. FOCUS is funded exclusively by the SCA Foundation. Address correspondence and reprint requests to Peter J. Pronovost, MD, PhD, The Johns Hopkins University School of Medicine, 1909 Thames St., Second Floor, Baltimore, MD 21231. Address e-mail to ppronovo@jhmi.edu. Copyright

Recasting the RCA: An improved model for performing root cause analyses

The root cause analysis (RCA) process is used to investigate adverse events. However, it may not reduce the risk of recurrence as effectively as intended. The authors propose adapting a risk prioritization and reduction process modeled after the Commercial Aviation Safety Team (CAST). The process involves the following: (a) increasing effectiveness of selected interventions by prioritizing each cause/contributing factor based on its role in the current sentinel event as well as in future events; interventions are then selected based on their ability to remediate the root causes/contributing factors and the likelihood of successful implementation; (b) measuring effectiveness of intervention implementation; and ( c) evaluating effectiveness of the interventions by measuring the rates of event recurrence, near misses, contributing factors, mitigating factors, and staff perceptions of risk. Teams that evaluate intervention effectiveness are independent of those that implement the intervention. This framework seeks to improve the RCA process and provide further insights into advancing patient safety.

Policy statement - Using personal health records to improve the quality of health care for children

A personal health record (PHR) is a repository of information from multiple contributors (eg, patient, family, guardians, physicians, and other health care professionals) regarding the health of an individual. The development of electronic PHRs presents new opportunities and challenges to the practice of pediatrics. This policy statement provides recommendations for actions that pediatricians can take to support the development and use of PHRs for children. Pediatric health care professionals must become actively involved in developing and adopting PHRs and PHR systems. The American Academy of Pediatrics supports development of: educational programs for families and clinicians on effective and efficient use of PHRs; incentives to facilitate PHR use and maintenance; and child- and adolescent-friendly standards for PHR content, portability, security, and privacy. Properly designed PHR systems for pediatric care can empower patients. PHRs can improve access to health information, improve coordination of preventive health and health maintenance activities, and support emergency and disaster management activities. PHRs provide support for the medical home for all children, including those with special health care needs and those in foster care. PHRs can also provide information to serve as the basis for pediatric quality improvement efforts. For PHRs to be adopted sufficiently to realize these benefits, we must determine how best to support their development and adoption. Privacy and security issues, especially with regard to children and adolescents, must be addressed.

Standards for health information technology to ensure adolescent privacy

Privacy and security of health information is a basic expectation of patients. Despite the existence of federal and state laws safeguarding the privacy of health information, health information systems currently lack the capability to allow for protection of this information for minors. This policy statement reviews the challenges to privacy for adolescents posed by commercial health information technology systems and recommends basic principles for ideal electronic health record systems. This policy statement has been endorsed by the Society for Adolescent Health and Medicine.

Technologies in the wild (TiW): human factors implications for patient safety in the cardiovascular operating room

We describe different sources of hazards from cardiovascular operating room (CVOR) technologies, how hazards propagate in the CVOR and their impact on cognitive processes. Previous studies have examined hazards from poor design of a specific CVOR technology. However, the impact of different CVOR technologies functioning in context is not clearly understood. In addition, the impact of non-design hazards in technology devices is unclear. Our study identified hazards from organisational, physical/environmental elements, in addition to design of technology in a CVOR. We used observations, follow-up interviews and photographs. With qualitative analyses, we categorised the different hazard sources and their potential impact on cognitive processes. Patient safety can be built into technologies by incorporating user needs in design, decision-making and implementation of medical technologies. Practitioner summary: Effective design and implementation of technology in a safety-critical system requires prospective understanding of technology-related hazards. Our research fills this gap by studying different technologies in context of a CVOR using observations. Qualitative analyses identified different sources for technology-related hazards besides design, and their impact on cognitive processes.

High Stakes and High Risk: A Focused Qualitative Review of Hazards During Cardiac Surgery

Cardiac surgery is a high-risk procedure performed by a multidisciplinary team using complex tools and technologies. Efforts to improve cardiac surgery safety have been ongoing for more than a decade, yet the literature provides little guidance regarding best practices for identifying errors and improving patient safety. This focused review of the literature was undertaken as part of the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems), a multifaceted effort supported by the Society of Cardiovascular Anesthesiologists Foundation to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. Hazards were defined as anything that posed a potential or real risk to the patient, including errors, near misses, and adverse events. Of the 1438 articles identified for title review, 390 underwent full abstract screening, and 69 underwent full article review, which in turn yielded 55 meeting the inclusion criteria for this review. Two key themes emerged. First, studies were predominantly reactive (responding to an event or report) instead of proactive (using prospective designs such as self-assessments and external reviewers, etc.) and very few tested interventions. Second, minor events were predictive of major problems: multiple, often minor, deviations from normal procedures caused a cascade effect, resulting in major distractions that ultimately led to major events. This review fills an important gap in the literature on cardiac surgery safety, that of systematically identifying and categorizing known hazards according to their primary systemic contributor (or contributors). We conclude with recommendations for improving patient outcomes by building a culture of safety, promoting transparency, standardizing training, increasing teamwork, and monitoring performance. Finally, there is an urgent need for studies that evaluate interventions to mitigate the inherent risks of cardiac surgery.

Policy statement - Health information technology and the medical home

The American Academy of Pediatrics (AAP) supports development and universal implementation of a comprehensive electronic infrastructure to support pediatric information functions of the medical home. These functions include (1) timely and continuous management and tracking of health data and services over a patients lifetime for all providers, patients, families, and guardians, (2) comprehensive organization and secure transfer of health data during patient-care transitions between providers, institutions, and practices, (3) establishment and maintenance of central coordination of a patients health information among multiple repositories (including personal health records and information exchanges), (4) translation of evidence into actionable clinical decision support, and (5) reuse of archived clinical data for continuous quality improvement. The AAP supports universal, secure, and vendor-neutral portability of health information for all patients contained within the medical home across all care settings (ambulatory practices, inpatient settings, emergency departments, pharmacies, consultants, support service providers, and therapists) for multiple purposes including direct care, personal health records, public health, and registries. The AAP also supports financial incentives that promote the development of information tools that meet the needs of pediatric workflows and that appropriately recognize the added value of medical homes to pediatric care.

Personal Health Records

A personal health record (PHR, also known as a personally controlled health record or PCHR) is “an electronic application through which individuals can access, manage and share their health information, and that of others for whom they are authorized, in a private, secure, and confidential environment.”1 PHRs are lifelong summaries of key information from all providers and include data gathered between encounters, and although they may be linked to and share information with electronic health records (EHRs), PHRs are distinct in that the locus of control of information is the patient2 (and in the case of pediatrics, the parent or guardian) instead of a clinician or health care institution.

Electronic prescribing systems in pediatrics

The use of electronic prescribing applications in pediatric practice, as recommended by the federal government and other national health care improvement organizations, should be encouraged. Legislation and policies that foster adoption of electronic prescribing systems by pediatricians should recognize both specific pediatric requirements and general economic incentives required to speed the adoption of these systems. Continued research into improving the effectiveness of these systems, recognizing the unique challenges of providing care to the pediatric population, should be promoted.