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Search results for "Health Care Executives and Administrators"
- Governmental Reporting
- Health Care Executives and Administrators
Journal Article > Study
Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.
Moore TJ, Furberg CD, Mattison DR, Cohen MR. Pharmacoepidemiol Drug Saf. 2016;25:713-718.
According to this study, many adverse drug event reports submitted by drug manufacturers to the Food and Drug Administration were incomplete. The authors advocate for the FDA to update their reporting requirements and compliance policies.
Jewett C. Kaiser Health News. May 3, 2019.
Transparency has been heralded as a cornerstone to improvement in health care. This news article reports on a government alternative summary reporting program that allowed medical device makers to conceal safety events and malfunction reports associated with medical devices. A new program that expands access to information about device-related failures will be put in place.
AHRQ National Scorecard on Hospital-Acquired Conditions Updated Baseline Rates and Preliminary Results 2014–2017.
Rockville, MD: Agency for Healthcare Research and Quality; January 2019.
Hospital-acquired conditions (HACs) represent a significant source of preventable harm to patients. The Centers for Medicare and Medicaid Services financially penalizes hospitals with increased numbers of HACs through the Hospital-Acquired Condition Reduction Program. This policy of nonpayment has prompted hospitals to focus significant resources on preventing HACs. This AHRQ report found a reduction in HACs from 99 per 1000 acute care discharges to 86 per 1000 discharges between 2014 and 2017, representing a decrease in 910,000 HACs and savings of $7.7 billion. Declines in certain HACs such as adverse drug events and Clostridium difficile infections were noted to be more significant as compared to others. A past WebM&M commentary highlighted the clinical significance of HACs and described an incident involving a patient who developed a pressure ulcer while in the hospital.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
Journal Article > Study
Al Mohajer M, Joiner KA, Nix DE. Acad Med. 2018;93:1827-1832.
The Hospital-Acquired Condition Reduction Program (HACRP) was established by the Centers for Medicare and Medicaid Services (CMS) and withholds payment to hospitals for several hospital-acquired conditions deemed to be preventable sources of patient harm. Prior research has shown that teaching hospitals, hospitals caring for more complicated and high-risk patients, and safety-net hospitals may be more likely to experience financial penalties under HACRP compared to nonteaching hospitals caring for less sick patients. These findings raised concerns regarding the possible unintended consequences related to pay-for-performance. Researchers sought to identify factors associated with HACRP performance and penalties. They found that teaching institutions and hospitals with higher case-mix index, length of stay, and those located in the Northeast or Western United States were more likely to receive penalties under the CMS program. A previous WebM&M commentary discussed the unintended consequences associated with publicly reported health care quality measures.
Journal Article > Study
Adverse effects of the Medicare PSI-90 hospital penalty system on revenue-neutral hospital-acquired conditions.
Padula WV, Black JM, Davidson PM, Kang SY, Pronovost PJ. J Patient Saf. 2018 Jul 17; [Epub ahead of print].
The Centers for Medicare and Medicaid Services (CMS) first implemented a policy of nonpayment for specific hospital-acquired conditions (HACs) in 2008. In 2014, they implemented a value-based purchasing program (the Hospital-Acquired Condition Reduction Program) that reduces reimbursement to hospitals with elevated rates of a range of HACs. The program measures HAC rates by a composite Patient Safety Indicator (PSI90), which includes 10 specific PSIs. This study examined HAC rates after implementation of the reimbursement penalty program at a cohort of academic medical centers. Overall, HAC rates declined over the 2 years following implementation of the program, with only rates of pressure ulcers increasing. Another recent study also found declines in HAC rates associated with CMS nonpayment initiatives, and data from AHRQ has also demonstrated significant reductions in HACs over the past 5 years. Nevertheless, concerns persist about the validity of using PSI for patient safety measurement over time, and other studies have found no effect of reimbursement policies on other HACs that are not included in PSI90 (such as specific health care–associated infections). A past PSNet perspective discussed the effect of pay-for-performance and other financial incentives for patient safety.
Journal Article > Study
Serious adverse drug events reported to the FDA: analysis of the FDA Adverse Event Reporting System 2006–2014 database.
Sonawane KB, Cheng N, Hansen RA. J Manag Care Spec Pharm. 2018;24:682-690.
This retrospective study reviewed serious and fatal adverse drug events (ADEs) reported to the Food and Drug Administration between 2006 and 2014. Over the 9-year study period, the number of serious ADEs reported doubled and a small number of medications accounted for a significant number of serious and fatal ADEs.
Defense Health Agency Should Improve Tracking of Serious Adverse Medical Events and Monitoring of Required Follow-up.
Washington, DC: United States Government Accountability Office; April 2018. Publication GAO-18-378.
Adverse event reporting is an important step toward failure reduction. However, weaknesses in feedback, follow-up, and action resulting from incident reports diminish their impact on safety. This publication analyzed reporting activity and action in the Defense Health Agency. The resulting recommendations suggest the need to improve tracking of incident reports and for clarifying reporting requirements.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.
NHS Improvement. London, UK: National Health Service.
Organizational processes to investigate adverse care incidents play an important part in generating the learning needed for improvements. This announcement sought multidisciplinary insights regarding how to revise the Serious Incident Framework (2015), currently used by the National Health Service, to enhance reporting and investigation processes.
St. Paul, MN: Minnesota Department of Health; March 2019.
The National Quality Forum has defined 29 never events—patient safety problems that should never occur, such as wrong-site surgery and patient falls. Since 2003, Minnesota hospitals have been required to report such incidents. The 2018 report summarizes information about 384 adverse events that were reported and found pressure ulcers and invasive procedure events increased, while fall-related deaths decreased. Reports from previous years are also available.
Improved Policies and Oversight Needed for Reviewing and Reporting Providers for Quality and Safety Concerns.
Washington, DC: United States Government Accountability Office; November 2017. Publication GAO-18-63.
Tracking concerns related to individual clinician performance has the potential to uncover opportunities for clinician skill and system safety enhancements. This report highlights weaknesses in the peer reporting processes of Veterans Affairs medical centers and offers recommendations to improve the quality and timeliness of reporting to ensure safety of patients in the VA system.
Rau J. Kaiser Health News. July 6, 2017.
System failures contribute to recurring problems in health care environments. This news article spotlights how lack of follow-up or action related to inspection reports that have uncovered factors in long-term care facilities that contribute to inadequate care can enable poorly performing nursing homes to remain in operation.
Gardner LA. PA-PSRS Patient Saf Advis. June 2016;13:58-65.
Insufficient health literacy is a known patient safety hazard. This article reviews incidents submitted to a state reporting initiative where insufficient patient understanding may have played a role in delayed or missed care and describes a program to encourage adoption of teach-back and other strategies to help patients better comprehend their health care instructions. A past PSNet perspective discussed the role of health literacy in patient safety.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 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.
Leeds, UK: Clinical Support Audit Unit, Health and Social Care Information Centre. December 9, 2015. ISBN: 9781783865697.
The NHS Safety Thermometer is a tool developed by the National Health Service to facilitate staff participation in measuring patient harm in various care environments. This report explores the data collected on four types of health care–acquired conditions (pressure ulcers, falls, catheter–associated urinary tract infections, and venous thromboembolisms) in NHS patients over a 1-year period.
Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records: Empirically Based Use Cases for Validating Safety-Enhanced Usability and Guidelines for Standardization.
Lowry SZ, Ramaiah M, Taylor S, et al. Gaithersburg, MD: US Department of Commerce, National Institute of Standards and Technology; October 2015. NISTIR 7804-1.
Unintended consequences associated with usability of electronic health record (EHR) systems have the potential to negatively affect patient safety. This report outlines standards to enhance safety-related usability of EHRs by identifying root causes of use errors and addressing these weaknesses through human factors design.
Sixth Report of Session 2014–15. House of Commons Public Administration Select Committee. London, England: The Stationery Office; March 27, 2015. Publication HC 886.
Applying evidence generated from complaints submitted to health care services has been promoted as a way to inform improvement. As a follow up to a previous inquiry, this report explores the process of clinical incident investigations at the National Health Service. The authors draw from accident analysis practices in the aviation industry to provide guidance on developing an independent program to investigate health care incidents in the United Kingdom.
Department of Health. London, England: Crown Publishing; February 2015. ISBN: 9781474112116.
The Francis inquiry uncovered numerous problems in the National Health Service and led to many commentaries about improvement strategies. Summarizing achievements in applying recommendations following the inquiry, this report outlines where further work is needed to ensure that advances in safe care delivery are sustained. Companion materials available include an analysis exploring equality considerations and a table revealing the government response and progress for each of the 290 recommendations put forth in the original inquiry.