Search results for "Regulation"

Requirements are needed to manage risks associated with health information technology systems. This final rule provides a framework for government review of technologies certified by the ONC Health IT Certification Program. The rule also covers certification guidance for testing laboratories. The regulations go into effect December 19, 2016.

Patient Safety Organizations (PSOs) were formed with provisions to protect voluntarily submitted incident data to enhance transparency and learning from medical error. Despite those expectations, PSOs still have obligations to report certain situations to external organizations. This guidance aims to clarify what and when external reporting should take place for PSOs to remain in compliance with federal requirements while appropriately protecting incident data.

This website disseminates information regarding an AHRQ-funded initiative to implement and evaluate medical liability reform improvements that support safe patient care.

This proposed rule suggests updates to the government requirements hospitals must comply with to participate in Medicare and Medicaid. Changes include emphasis on the role of leadership engagement and safety culture as ways to generate improvements in areas such as reducing hospital-acquired infections and readmissions. Comments on the proposed rule are due August 15, 2016.

Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.

This announcement alerts prescribers to differences in two oral formulations of the same medication that can lead to dosing errors. The FDA suggests that clinicians specify dosage form, strength, and frequency on prescriptions for this drug to reduce the risk of patient harm and recommend that pharmacists follow up with prescribers if such information is missing.

The practice of using multi-dose insulin pens, meant for single patient use only, among multiple patients has been linked to health care–associated infections. This announcement outlines federal labeling requirements to raise awareness of the risks associated with this practice to prevent misuse of the devices.

This national action plan aims to align the efforts of multiple federal programs committed to reducing patient harms related to adverse drug events. The three initial high-priority targets of the action plan are anticoagulants, diabetes agents, and opioids. These medication classes were chosen due to their common usage and their very high potential to cause clinically significant, preventable, and measurable adverse events. The action plan outlines a four-pronged approach: surveillance, prevention, incentives and oversight, and research. The full report delves into detailed tactics for each of these areas, as well as for the three drug classes. Focusing on specific high-risk drug classes, rather than pursuing the commonly advocated approach of universal drug safety, was also recommended by a recent systematic review of medication errors.

This Web site provides a selection of materials and discussion groups to help hospital-based pharmacists improve medication safety.

The National Quality Forum originally defined 27 health care "never events"—patient safety events that pose serious harm to patients, but should be considered preventable—in 2002. The 2011 update now consists of 29 events, organized into surgical events (e.g., wrong-site surgery), device events (e.g., air embolism), care management events (e.g., death or disability due to medication errors), patient protection events (e.g., patient suicide), environmental events (e.g., fires), radiologic events, and criminal events. One notable addition to the original list is that serious harm associated with failure to properly follow up on test results is now considered a never event. Since the development and dissemination of this list, many states have mandated that health care facilities report all instances of these events. When such an event occurs, many institutions mandate performance of a root cause analysis.

This final rule prohibits federal reimbursements to states for costs associated with health care–acquired conditions. The regulations are effective as of July 1, 2011.

This online toolkit provides sample documents, policies, and Web site links related to the 27 states that have implemented adverse event reporting initiatives.

This Congressional testimony summarizes a 2008 investigation and responds to its findings. It suggests that prioritization of effort, data consistency, and data compatibility are needed to improve health care–associated infection reduction efforts.

This fact sheet discusses the role of the Food and Drug Administration (FDA) in reducing medication errors and describes examples of such errors for consumers.

This report from the United Kingdom is intended to guide Primary Care Trusts in implementing never events policies for 2009-2010.

The Tax Relief and Health Care Act of 2006 mandated that the Office of Inspector General (OIG) report to Congress the incidence of "never events" among Medicare beneficiaries, payment by Medicare for services in connection with such events, and the process used to identify events and deny payments. This report addresses that mandate by providing a descriptive analysis of the key issues to understanding hospital-based adverse events. The report is focused around discussion of seven critical issues that are explored in detail. Of note, OIG expanded the study of never events to the broader topic of adverse events in their analysis.

This report shares the results of the British National Patient Safety Agency effort to reduce medical error and found that safety wasn't always given the priority necessary to drive change and that data collection efforts could still be improved.

This article reports on a new Centers for Medicare and Medicaid Services (CMS) rule mandating that Medicare will no longer pay for treating certain preventable errors starting in 2008, including some hospital-acquired infections, decubitus ulcers, and retained foreign bodies. The policy is generating considerable discussion in patient safety circles, with some expressing concerns regarding the economic impact on hospitals and the increased efforts it is likely to create for hospitals to document certain patient problems present at the time of admission.

This government report found that the clinical laboratory survey process is flawed, allowing safety requirements to be bypassed.

This Webcast presents a panel discussion on the development of patient safety organizations as stipulated by the Patient Safety and Quality Improvement Act of 2005 and other developments in the safety movement. Panelists include several patient safety leaders, including Agency for Healthcare and Research Quality (AHRQ) director, Carolyn Clancy.