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- Error Reporting and Analysis
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Baltimore, MD: Centers for Medicare & Medicaid Services (CMS) Office of Public Affairs; May 18, 2006.
This fact sheet provides information regarding the Centers for Medicare and Medicaid Services' initiative to better understand and minimize never events.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-07-00470.
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.
Adverse Events in Hospitals: Care Study of Incidence Among Medicare Beneficiaries in Two Selected Counties.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-08-00220.
The Center for Medicare and Medicaid Services (CMS) no longer reimburses hospitals for the costs associated with certain preventable adverse events, many (but not all) of which are considered never events. This report from the federal Office of the Inspector General (OIG) examines the adverse events in a sample of Medicare beneficiaries. As outlined in a previous report, the OIG chose to evaluate the overall incidence of adverse events, including "no pay for errors" conditions, never events, and all other adverse consequences of hospitalization, including non-preventable adverse events. Therefore, the 15% overall incidence of adverse events found in this study should be interpreted with caution. Less than 1% of patients experienced a never event, and approximately 4% experienced a condition on CMS's no pay for errors list.
Journal Article > Commentary
Clancy CM. Am J Med Qual. 2009;24:166-168.
This commentary describes the Centers for Medicare and Medicaid Services (CMS) nonpayment policy for never events and explores its potential impact on health care.
Journal Article > Study
Metzger J, Welebob E, Bates DW, Lipsitz S, Classen DC. Health Aff (Millwood). 2010;29:655-663.
Computerized provider order entry (CPOE) has provided significant safety benefits in research studies, especially when combined with clinical decision support to prevent common prescribing errors. However, CPOE's "real-world" performance has been mixed, with high-profile studies documenting a variety of unintended consequences. This AHRQ-funded study used simulated patient records to evaluate the ability of eight commercial CPOE modules to prevent medication errors. The overall results were disappointing, as CPOE failed to prevent many medication errors—including fully half of potentially fatal errors, which are considered never events. The individual CPOE products varied significantly in their ability to detect potential errors. Some hospitals did achieve superior performance, which the authors ascribe to greater experience with CPOE and implementation of more advanced decision support tools. Another recent article found that reminders within CPOE systems resulted in only small improvements in adherence to recommended care processes. Taken together, these studies imply that CPOE implementation may not result in large immediate effects on safety and quality in typical practice settings.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2012. Report No. OEI-06-09-00091.
Incident reporting systems are ubiquitous, but their effectiveness as a means of monitoring for patient safety problems is unclear. In a prior report, the Office of the Inspector General (OIG) found that 13.5% of Medicare beneficiaries suffered an adverse event while hospitalized. This follow-up analysis found that incident reports were not filed for the vast majority of these adverse events. Moreover, hospital personnel did not voluntarily report any of the never events identified in the earlier study. The reasons for this lack of reporting likely include confusion about which types of errors needed to be reported, as well as other issues documented in prior studies such as lack of reporting by physicians. Based on these findings, the OIG recommends that the Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services (CMS) create a uniform list of potentially reportable events for dissemination to hospitals, and that CMS should assist accrediting agencies in assessing the adequacy of hospitals' error reporting systems.
Journal Article > Review
Sullivan N, Schoelles KM. Ann Intern Med. 2013;158(5 Pt 2):410-416.
As the patient safety evidence base matures, the focus is shifting from effectiveness (identifying which strategies can prevent errors) to implementation (ensuring that all patients receive effective strategies). Pressure ulcers are considered a never event, but their incidence has been increasing despite effective preventive strategies. This systematic review identifies several promising methods of implementing multicomponent interventions to prevent pressure ulcers and emphasizes the importance of leadership, simplification and standardization of safety strategies, and regular audit and feedback of pressure ulcer rates in ensuring intervention success. This study was funded by the Agency for Healthcare Research and Quality as part of the Making Health Care Safer II report and was published as part of a special patient safety supplement in the Annals of Internal Medicine.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; November 2010. Report No. OEI-06-09-00090.
Hospitalized patients continue to suffer iatrogenic harm, according to this study of Medicare patients completed by the Office of the Inspector General (OIG). Using methodology similar to the landmark Harvard Medical Practice Study, this study found that 13.5% of hospitalized Medicare patients experienced an adverse event, of which nearly half were considered preventable. However, fewer than 2% of patients experienced either a never event or a preventable complication for which hospitals are no longer reimbursed by the Centers for Medicare and Medicaid Services. These results are similar to the OIG's prior 2008 report. Based on these results, OIG recommends further efforts to accurately measure adverse events, and also recommends broadening the "no pay for errors" policy. The challenges of accurately measuring safety problems are discussed in an AHRQ WebM&M commentary.
Web Resource > Government Resource
Centers for Medicare & Medicaid Services.
The Centers for Medicare and Medicaid Services (CMS) provides consumers with publicly available information on the quality of Medicare-certified hospital care through this Web site. The site includes specific information for both patients and hospitals on how to use the data to guide decision-making and improvement initiatives. Most recently, listings from the Hospital-Acquired Condition Reduction Program (HACRP) and data on Department of Veterans Affairs hospitals were added to the reports available.
Journal Article > Review
Miake-Lye IM, Hempel S, Ganz DA, Shekelle PG. Ann Intern Med. 2013;158(5 Pt 2):390-396.
Considered a never event for hospitalized patients, falls that result in serious injury remain relatively common despite increased attention to the issue. This systematic review identified approaches used to successfully implement fall prevention programs and found high-quality evidence that multicomponent interventions—including patient education, discontinuation of harmful medications, and wristband alerts—can significantly reduce inpatient fall rates. Although concerns have been raised that fall prevention programs could have unintended consequences, this review found that potential harms (such as increased use of sedating medications) had not been systematically evaluated. This review was conducted as part of the AHRQ Making Health Care Safer II report, and on the strength of this evidence, fall prevention strategies are considered one of the top ten patient safety strategies ready for implementation now. An institutional approach to fall prevention is discussed in an AHRQ WebM&M perspective.
2013 Annual Hospital-Acquired Condition Rate and Estimates of Cost Savings and Deaths Averted From 2010 to 2013.
Rockville, MD: Agency for Healthcare Research and Quality; October 2015. AHRQ Publication No.16-0006-EF.
Hospital-acquired conditions (HACs), some of which are never events, have been an important focus of patient safety initiatives, with reporting requirements and Medicare nonpayment leading to significant efforts to prevent these conditions. This update to a prior report from AHRQ details and confirms the declining rates in HACs between 2010 and 2013. The analysis indicated that hospitalized patients experienced 1.3 million fewer HACs over the 3 years (2011–2013) than if the HAC rate had remained at the 2010 level. Consequently, the report estimates a $12 billion savings in health care costs and 50,000 fewer hospital patient deaths. These improvements coincided with nationwide efforts to reduce adverse events, such as the Partnership for Patients initiative and Medicare payment reform. The remaining burden of HACs suggests continued investment in this patient safety problem is needed.
National Scorecard on Rates of Hospital-Acquired Conditions 2010 to 2015: Interim Data From National Efforts to Make Health Care Safer.
Rockville, MD: Agency for Healthcare Research and Quality; December 2016.
Medicare nonpayment and reporting requirements have stimulated health care organizations to focus on reducing hospital-acquired conditions (HACs) such as health care–associated infections and never events. The Agency for Healthcare Research and Quality regularly tracks HAC rates, including rates of adverse drug events, catheter-associated urinary tract infections, central line–associated bloodstream infections, falls, obstetric adverse events, pressure ulcers, surgical site infections, ventilator-associated pneumonias, and postoperative venous thromboembolisms. According to data from the AHRQ National Scorecard, HACs have decreased by 21% between 2010 and 2015. This represents a total of 3.1 million fewer HACs contracted by hospitalized patients over 5 years, saving an estimated 125,000 lives and $28 billion. These findings represent substantial progress and support the success of incentives designed to eliminate HACs as a source of patient harm.