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Introduction The 2005 Patient Safety and Quality Improvement Act, actualized as a Learning Network (LN), has enabled the Child Health Patient Safety Organization (PSO) to play a vital and novel role in improving the quality and safety of care. This article describes the Child Health PSO and proposes PSOs as a new construct for LNs. Methods A PSOs ability to affect patient care depends on member organizations' integration of PSO output into their individual Learning Healthcare Systems. Therefore, the Child Health PSO developed tenets of an LN to improve member engagement in PSO outputs. Results All Child Health PSO members participate in case-based learning, requiring ongoing and robust participation by all members. The engagement has been strong, with 86% of children's hospitals achieving a case learning activity metric and 60% of children's hospitals submitting cases. From this LNs perspective, 53% of children's hospitals are considered highly engaged. Conclusions In the last 10 years, the Child Health PSO has evolved as a viable LN and, to sustain this, has set a target of 100% of participating children's hospitals being highly engaged. The previously inconceivable notion of sharing information to improve patient safety among hospitals is now an expected result of the formation of trusting relationships under a federally certified PSO. According to participants, collaboration is an essential element that empowers individual children's hospitals to eliminate preventable harm.

Purpose Incident learning is a critical tool to improve patient safety. The Patient Safety and Quality Improvement Act of 2005 established essential legal protections to allow for the collection and analysis of medical incidents nationwide. Methods and materials Working with a federally listed patient safety organization (PSO), the American Society for Radiation Oncology and the American Association of Physicists in Medicine established RO-ILS: Radiation Oncology Incident Learning System (RO-ILS). This paper provides an overview of the RO-ILS background, development, structure, and workflow, as well as examples of preliminary data and lessons learned. RO-ILS is actively collecting, analyzing, and reporting patient safety events. Results As of February 24, 2015, 46 institutions have signed contracts with Clarity PSO, with 33 contracts pending. Of these, 27 sites have entered 739 patient safety events into local database space, with 358 events (48%) pushed to the national database. Conclusions To establish an optimal safety culture, radiation oncology departments should establish formal systems for incident learning that include participation in a nationwide incident learning program such as RO-ILS.

PURPOSE: In the wake of the Patient Safety and Quality Improvement Act of 2005, national attention has increasingly focused on adverse-event reporting as a means of identifying systems changes to improve patient safety. However, physicians and residents have demonstrated meager involvement in this effort. METHOD: In 2008-2009, the authors measured participation in adverse-event reporting by 680 residents at Oregon Health & Science University before and after implementing a quality improvement initiative, which consisted of a financial incentive and multifaceted educational campaign. The primary measure of success was an increase in the average monthly adverse-event reports submitted by residents to greater than 5% of the institution's overall report submissions. RESULTS: The average number of adverse events reported by residents increased from 1.6% to 9.0% of the institution's overall event reports, representing a 5.6-fold increase during the initiative (P < .001). The relative percentage of resident-submitted reports defined as "near-misses" increased from 6% to 27% during the initiative (P < .001). CONCLUSIONS: The novel approach of integrating a retirement benefit and educational campaign to increase residents' involvement in adverse-event reporting was successful. In addition to increasing residents' contributions to adverse-event reporting to levels higher than any documented in the current literature, there was also a remarkable increase in the relative frequency of near-miss reporting by residents.

The Patient Safety and Quality Improvement Act 1 (PSQIA or Act) was signed into law on July 29, 2005. This Act represents the first federal legislative attempt to directly and systematically addres...

Background: The regulation implementing the Patient Safety and Quality Improvement Act of 2005 (PSQIA) was published on November 21, 2008, and became effective on January 19, 2009 (42 C.F.R. Part 3).1 PSQIA establishes a voluntary reporting system to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides federal privilege and confidentiality protections for patient safety information. Purpose: Greater reporting and analysis of patient safety events will yield increased data and better understanding of patient safety events. A PSO9s workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care. Implications: This new legislation provides a vehicle to better understand at a macro level how the clinical laboratory threatens patient safety and how that threat can be better controlled. What is imperative is that the clinical laboratory staff be involved in collecting and analyzing data. If they are not, the probability is high that data being reported by the laboratory will be misunderstood at the PSO and laboratories may be cited as a threat to patient safety because of a lack of understanding of laboratory operations. ABBREVIATIONS:AHRQ – Agency for Healthcare Research and Quality, OCR – Office of Civil Rights, PSO – Patient Safety Organization, PSQIA - Patient Safety and Quality Improvement Act of 2005, PSR – PSR, PSWP – Patient Safety Work Product

Objectives The Patient Safety and Quality Improvement Act (PSQIA) of 2005, inspired by the Institute of Medicine's (IOM) 1999 report To Err Is Human, affords federal protections in exchange for error disclosures. However, the PSQIA is unlikely to be effective unless frontline providers are aware of its existence. In this study, we assessed the quantity of publications regarding this protection within the medical literature. Methods Four reviewers independently evaluated 2060 safety-related articles, identified through a PubMed database search, to determine whether they discussed actual (or proposed) national legal protections for voluntary reporting of medical errors. Using a reviewer method based on a standard Delphi consensus model, agreement was achieved if at least 3 of 4 reviewers agreed with the decision. Results Articles were separated into pre-IOM report (1990-1999) and post-IOM report (2000-2008) literature. No articles were determined to be "on topic" in the pre-IOM period (n = 624). Twenty-seven articles were considered "on topic" in the post-IOM period (n = 1436), constituting 1.8% of the period total (95% confidence interval, 1.2%-2.6%). Of the 27 on topic articles, 7 appeared in practice-related journals, whereas the remaining 20 were in journals with a health policy or health care administration focus. Conclusions Few published studies were found in clinical journals describing the PSQIA. This raises serious concerns and indicates that physicians may not be aware of the new legal protections afforded for error disclosure. If the health care system is to realize the benefits of error reporting systems, greater education of physicians regarding their legal protections may be needed.

Context: Little is known about hospitals’ adverse-event-reporting systems, or how they use reported data to improve practices. This information is needed to assess effects of national patient-safety initiatives, including implementation of the Patient Safety and Quality Improvement Act of 2005 (PSQIA). This survey generated baseline information on the characteristics of hospital adverse-event-reporting systems and processes, for use in assessing progress in improvements to reporting. Methods: The Adverse Event Reporting Survey, developed by Westat, was administered in September 2005 through January 2006, using a mixed-mode (mail/telephone) survey with a stratified random sample of 2050 non-federal US hospitals. Risk managers were the respondents. An 81% response rate was obtained, for a sample of 1652 completed surveys. Results: Virtually all hospitals reported they have centralised adverse-event-reporting systems, although characteristics varied. Scores on four performance indexes suggest that only 32% of hospitals have established environments that support reporting, only 13% have broad staff involvement in reporting adverse events, and 20–21% fully distribute and consider summary reports on identified events. Because survey responses are self-reported by risk managers, these may be optimistic assessments of hospital performance. Conclusions: Survey findings document the current status of hospital adverse-event-reporting systems and point to needed improvements in reporting processes. PSQIA liability protections for hospitals reporting data to patient-safety organisations should also help stimulate improvements in hospitals’ internal reporting processes. Other mechanisms that encourage hospitals to strengthen their reporting systems, for example, strong patient-safety programmes, also would be useful.

The Patient Safety and Quality Improvement (PSQI) Act enacted in July 2005 constitutes the basis for significant opportunity to improve patient safety in the health care system by creating a voluntary error reporting system. The PSQI Act creates an unprecedented opening to prospectively prev

For over a decade, and with renewed intensity since the passage of the Affordable Care Act, there has been heightened awareness and concern about the safety and quality of inpatient hospital care. In this paper, we estimate the impact of investment in quality improvement, as well as change in the policy environment, on patient safety (adverse) events in a 2004-2012 panel of hospitals in the state of Florida. We find hospital quality investment has favorable, but modest, effects on quality. On the other hand, policy change, which brings public attention to the issue, may have stronger effects. On average, we find a 10 percent increase in hospital quality investment leads to a 2 to 6 percent decrease in adverse events. In contrast, passage of the Patient Safety and Quality Improvement Act, in 2005, and the Centers for Medicare and Medicaid’s policy of withholding reimbursement, in 2008, had much larger effects (45 and 10 percent decreases in adverse events, respectively). Thus, reputation and professionalism may be more important than a “business case” for promoting health care quality. We also find evidence of spillover effects of quality investment from large research (“leading”) hospitals to less-resourced hospitals.

Potential reasons for failure to report medical errors include concerns about adverse publicity, fear of litigation and professional sanctions, the burden of reporting, uncertainty about what information is required to be reported, and lack of feedback. The Patient Safety Quality and Improvement Act of 2005 (PSQIA) was passed by the U.S. Congress as a response to these issues. Successful implementation of PSQIA requires changes such as moving toward an incentive-based system or providing continuing education programs for healthcare providers. In addition, the reform of residency programs will help in the implementation of PSQIA by future healthcare providers.

Medical errors may result from lapses in judgment or lack of prudent care by individual physicians, from system errors inherent in the medical-care delivery model or, more frequently, from a combination of the two. Medical error reporting is a sensitive topic for physicians, institutions, and patients. The veil of secrecy that surrounds medical errors deprives health-care practitioners of knowledge that may help prevent similar adverse outcomes for patients in the future. Although reporting individual medical errors to involved patients is obligatory by most professional codes of conduct for physicians, no laws or professional society guidelines mandate widespread reporting of errors to professional colleagues. Furthermore, reports of medical errors in peer-reviewed journals are extremely rare. In 2000, the Joint Commission for Accreditation of Healthcare Organizations described systemic medical errors as "fundamentally an information problem" and called for the development of programs to collect and analyze medical error data. In this review, we define medical errors and detail common motivations and barriers to publication of error reports. We propose a model for confidential error communication and describe US legislation designed to improve patient safety and establish nationwide programs for error disclosure and analysis.

In the wake of news media reports in 2010 of several tragic incidents of radiation error resulting in substantial harm (1), the leadership of American Society for Radiation Oncology (ASTRO) and American Association of Physicists in Medicine (AAPM) testified before congress, and ASTRO initiated the Target Safely program campaign designed to improve the quality and safety of care in radiation oncology. As part of this initiative, ASTRO, with the support of AAPM, committed to a national error reporting system and safety database. On June 19, 2014, this campaign debuted the Radiation Oncology Incident Learning System (RO-ILS). For such a system to be successful, several requirements must be met. First and foremost, the information must be protected in order for an open and honest discussion to occur. Fortunately, there is a mechanism for such protection under U.S. law. It is called the patient safety organization (PSO). PSOs were established in 2005 as part of the Patient Safety and Quality Improvement Act. ASTRO and AAPM have paired with a federally listed PSO, Clarity PSO, to form a specialty-specific PSO. This will provide a nonpunitive environment in which to assemble and analyze data, thereby protecting data from discovery, subpoena, order, or disclosure under the Freedom of Information Act. This is a federal protection, and it was designed specifically to encourage institutions to engage in incident learning. These protections have been tested in Kentucky (Norton Hospitals, Inc. v. Cunningham) and in Illinois (Department of Financial and Professional Regulation v. Walgreen Company). In both cases, the courts found for the institution reporting to the PSO, and PSO protections were upheld.

The American Society of Anesthesiologists, the Anesthesia Patient Safety Foundation, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and the Patient Safety and Quality Improvement Act of 2005 encourage anesthesiology departments to institute systematic improvements in patient safety, including but not limited to integration of new safety technologies. The evaluation and method of use of the reciprocating procedure device in central venous access is presented.

BACKGROUND To avoid errors and improve patient safety and quality of care, health care organizations need to identify the sources of failures and facilitate implementation of corrective actions. Hence, health care organizations try to collect reports and data about errors by investing enormous resources in reporting systems. However, despite health care organizations' declared goal of increasing the voluntary reporting of errors and although the Patient Safety and Quality Improvement Act of 2005 (S.544, Public Law 109-41) legalizes efforts to secure reporters from specific liabilities, the problem of underreporting of adverse events by staff members remains. PURPOSE The purpose of the paper is to develop a theory-based model and a set of propositions to understand the antecedents of staff members' willingness to report errors based on a literature synthesis. The model aims to explore a complex system of considerations employees use when deciding whether to report their errors or be silent about them. The model integrates the influences of three types of organizational climates (psychological safety, psychological contracts, and safety climate) and individual perceptions of the applicability of the organization's procedures and proposes their mutual influence on willingness to report errors and, as a consequence, patient safety. PRACTICE IMPLICATIONS The model suggests that managers should try to control and influence both the way employees perceive procedure applicability and organizational context-i.e., psychological safety, no-blame contracts, and safety climate-to increase reporting and improve patient safety.

59 Background: Incident learning is one of the most effective ways to improve quality care. To facilitate patient safety improvement at a national level, American Society for Radiation Oncology (ASTRO) and American Association of Physicists in Medicine (AAPM) launched RO-ILS: Radiation Oncology Incident Learning System in June 2014. RO-ILS mission is to facilitate safer and higher quality care through a shared learning environment that is secure and non-punitive. Methods: To ensure the security and protection of data, ASTRO contracted with Clarity PSO, a federally-certified patient safety organization that operates under the auspices of the Patient Safety and Quality Improvement Act of 2005. Radiation oncology practices sign a no-fee contract with Clarity PSO to participate in RO-ILS and then enter safety data into a customized web-based portal. Submitted data are analyzed and interpreted by the Radiation Oncology Healthcare Advisory Council (RO-HAC), a multi-professional team. Practices receive aggregate quarterly reports and institutional reports when substantial data are submitted. Results: During the first year, 61 US practices (123) facilities signed contracts. 42 practices entered 1259 events and 619 of these events (49%) were submitted to the national database. Types of events included: 242 (39%) incidents that reached the patient with or without harm; 206 (33%) near-misses; and 171 (28%) unsafe conditions. RO-HAC identified risk-prone processes including ineffective communication, compressed timelines to start treatment, changes to treatment during the course of therapy and junior practitioners’ errors not remedied by experienced staff. Conclusions: Data suggests that quality assurance processes were effective in catching errors; however, continued work needs to address the origin of these errors and suggest robust solutions. To facilitate improved communication, effective protocols and software enhancements are recommended to alert staff to changes in patients’ management. Policies and procedures on patient hand-offs, emergency cases and oversight of junior staff will help error mitigation. While in its infancy, RO-ILS provides useful data and will serve to improve the quality and safety of radiotherapy.

In an ideal health care environment, physicians and health care organizations would acknowledge and factually report all medical errors and "near misses" in an effort to improve future patient safety by better identifying systemic safety lapses. Truth must permeate the health care system to achieve the goal of transparency. The Institute of Medicine has estimated that 44,000 to 98,000 patients die each year as a result of medical errors. Improving the reporting of medical errors and near misses is essential for better prevention of medical errors and thus increasing patient safety. Higher rates of reporting can permit identification of the root causes of errors and create improved processes that can significantly reduce errors in future patient care. Multiple barriers exist with respect to reporting medical errors, despite the ethical and various professional, regulatory, and legislative expectations and requirements generating this obligation. As long as physicians perceive that they are at risk for sanctions, malpractice claims, and unpredictable compensation of injured patients as determined by the United States' tort law system, legislative or regulative reform is unlikely to affect the underreporting of medical errors, and patient safety cannot benefit from the lessons derived from past medical errors and near misses. A new infrastructure for creating patient safety systems, as identified in the Patient Safety and Quality Improvement Act of 2005 is needed. A patient compensation system guided by an administrative health court that includes some form of no-fault insurance must be studied to identify benefits and risks. Most urgent is the development of a reporting system for medical errors and near misses that is transparent and effectively recognizes the legitimate concerns of physicians and health care providers and improves patient safety.

nurses, physicians, and other health care providers reduce the incidence of patient safety events and maintain confidentiality about those events will move into high gear in 2009. On January 19, 2009, the final rule that establishes the roles and activities of these new entities, known as Patient Safety Organizations (PSOs), took effect. Published by the US Department of Health and Human Services (HHS), the rule describes how PSOs can work with health care providers and organizations to collect and analyze data, and reduce the incidence of patient care risks and hazards. The creation of PSOs was called for by Congress as part of the Patient Safety and Quality Improvement Act of 2005. The Agency for Healthcare Research and Quality (AHRQ) has responsibility for PSO operations, whereas the HHS’ Office for Civil Rights enforces confidentiality provisions. Confidentiality about reporting pa tient safety events is important, because according to the Institute of Medicine’s landmark report To Err is Human, clinicians and health care organizations are often fearful about providing information about errors and near misses be cause of the potential for litigation. The confidentiality provisions contained in the final PSO rule apply to both patients and health care providers. Interim guidelines issued shortly before the final rule was published gave the AHRQ the authority to receive applications from qualified entities seeking to be designated as PSOs. As of December 10, 2008, 25 organizations were officially listed as PSOs. PSOS: THEIR ROLE AND RATIONALE Patient Safety Organizations were called for by the Institute of Medicine and established by Congress in the 2005 law. They are intended to address a major stumbling block to sustained quality improvement—a lack of uniform, federal standards for confidentiality of information about patient safety events. Existing state-based legal protections for quality improvement activities, known as peer review protections, do not exist in all states and only cover hospital-based care, not services provided in nonhospital settings. As a result, health care pro viders and organizations have maintained a pervasive fear of legal liability and sanctions. A second related barrier to quality improvement that the rule sought to address is the inability of health care providers to collect and share data about patient safety events with other facilities, both locally and across states. This is because state peer review protections are limited to the specific hospital, which makes it harder for providers and organizations to identify and adopt patterns of practice that have been shown to reduce the risk of medical errors.

The Patient Safety and Quality Improvement "proposed rule" (2008) was published in the Federal Register on February 12, 2008. This "proposed rule," with a comment period extending to April 14, 2008, was created for the purpose of implementing specific facets of the Patient Safety and Quality Improvement Act of 2005; those dealing with the establishment of Patient Safety Organizations (PSOs), confidentiality protection for patient safety activities, and patient safety work product, and reporting by the Secretary of the Department of Health and Human Services (HHS) to Congress regarding successful strategies that have reduced medical errors and have thereby increased patient safety.

On July 29, 2005, President Bush signed into law the Patient Safety and Quality Improvement Act. This long-awaited bill came after considerable debate in the Senate and the House that focused on patient safety highlighted by the Institute of Medicine's (IOM's) report, To Err Is Human . The IOM report brought the significance of patient safety issues to the national forefront and called for congressional action, but it was 6 years after that report before Congress passed legislation in this area. The article explores the development of patient safety legislation and provides a historical review and analysis of the events leading to the passage of the final bill. It provides background about the major issues requiring resolution and compromise, compares the positions of the competing stakeholders, and describes the importance and degree of influence that can derive from input by stakeholders in the passage of legislation.

A medication error is defined by the National Coordinating Council of Medication Error Reporting and Prevention as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer.”1 The Institute of Medicine’s 1999 report estimated that 7,000 deaths result annually from preventable medication errors and established medical errors (up to 98,000 deaths/ year) as one of the leading causes of morbidity and mortality in the United States.2 Since then, national patient-safety organizations and the federal and state governments have implemented numerous measures and passed laws to reduce medication errors, including root-cause analysis and computerized physician order entry,2–12 mandatory adverse event reporting,13 and the 2005 Patient Safety and Quality Improvement Act, which encourages physicians’ voluntary error reporting without incurring any penalties.14 Subsequently, state health care systems have publicly released hospital reports of serious medical errors, sentinel events, and successful outcomes from educational interventions.15–17 In 2002, the sanofi-aventis (then known as Aventis) Health Council was formed. The 16-member panel was headed by the pharmaceutical company’s chief executive officer and included medical directors and human resources and communications managers. It was strictly devoted to the well-being of company employees and their families. The council developed a multidisciplinary medication error committee (MEC) in September 2004, comprising two pharmacists, two physicians, a registered nurse, and a benefits director. This group elected to conduct a survey to assess the causes and extent of medication errors affecting employees and their family members.

New legislation that allows clinicians to disclose mistakes anonymously is expected to increase reporting of medical errors in the United States. The Patient Safety and Quality Improvement Act of 2005 enshrines in federal law what many hospital systems and organizations already have in place, a “

Introduction Sri Lanka is set to adapt electronic medical records (EMR) at an ever increasing rate in the coming decade. However, handling of EMRs pose considerable legal challenge in relation to its privacy and confidentiality, quality of records and tort based liability. While the Sri Lankan legislation recognise electronic records as legally valid in most instances, it does not provide sufficient legal backing when it comes to sensitive personal health data. Methodology This paper adapts a comparative method of legal research. The author believes this to be an appropriate methodology for answering the research questions as it is primarily used for the purpose of “promotion of mutual understanding by acquiring knowledge of foreign legal systems”. Findings The paper recognizes that the existing Sri Lankan legislation does not provide for sensitive personal data such as EMR. However, the Sri Lankan legislation has already established the legal validity of electronic records. The paper discusses various legislations from the US including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, The Patient Safety and Quality Improvement Act (PSQIA) of 2005 and Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 as reference legislation. It also discusses the Data Protection Act of 1998 in the UK and the EU Directives as reference legislation for establishing a legal framework for Sri Lanka that would address the needs of EMRs. Recommendations Following the legal analysis, the paper proposes a way forward in adapting suitable legislations from the ones discussed. Some of these adaptations include defining the criteria in which a valid legal record can be established, the creation of the role data controller, laying down a clear framework in which personal health data can be shared, defining the criteria that should be met when using EMR for research, measures to encourage the adaption of EMRs and the standards set forth and the necessity to amend the Computer Crimes Act to include specific provisions to deal with crimes involving EMRs. Conclusion The paper concludes by stating the need to obtain wider consensus from all relevant stakeholders before such legislation is implemented and that the same should not hinder the IT industry which can promote the efficiency of the country’s health care system.

All medical personnel are concerned with patient safety. Nurses are well positioned, with their constant interaction with patients, to observe for errors and to analyze the systems that led to those errors. The Patient Safety and Information Act, legislation passed in 2005, encourages voluntary reporting of errors without fear of retribution. Data, stripped of identifiers, will be maintained by public or private entities. The analysis of the information collected will be used to improve medical systems and practice.