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Search results for "United States of America"
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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.
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
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.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
Mohr H, Weiss M. Associated Press. November 27, 2018.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
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.
Washington, DC: Department of Veterans Affairs, Office of Inspector General. March 7, 2018. Report No. 17-02644-130.
Systemic weaknesses in the Veterans Affairs health system have resulted in high-profile failures. Highlighting concerns at one medical center that were found to contribute to opportunities for waste, fraud, and poor health care delivery, this report by the Office of Inspector General outlines 40 recommendations to address deficiencies.
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.
Whitson T, Garten B. Indianapolis, IN: Indiana State Department of Health; 2017.
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.