Tag Archives: Patient Safety

OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard

The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an Emergency Temporary Standard governing occupational exposure to COVID-19 in healthcare settings, codified at 29 C.F.R. § 1910 Subpart U (“Healthcare ETS”). While this reopening reaches certain questions and issues presented by OSHA and not … Continue Reading

CMS Proposes Updated Fire Safety Standards for Dialysis Facilities

CMS has issued a proposed rule that would require certain dialysis facilities participating in Medicare or Medicaid to meet updated fire safety standards.  The proposed fire safety rule, published November 4, 2016, would apply only to dialysis facilities that do not provide one or more exits to the outside at grade level from the treatment … Continue Reading

OIG Examines Adverse Events in Rehab Hospitals

According to a recent HHS Office of Inspector General (OIG) report, about 29% of Medicare beneficiaries experienced adverse or temporary harm events during their rehabilitation hospital stay, based on sample of 417 beneficiaries in March 2012. This rate is similar to the incidence of adverse events in acute-care hospitals and skilled nursing facilities. The OIG … Continue Reading

GAO Examines Hospital Challenges in Implementing Patient Safety Practices

The Government Accountability Office (GAO) has issued a report focusing on the roadblocks hospitals face in implementing evidence-based patient safety practices, such as the use of antiseptics to reduce Central Line-Associated Bloodstream Infection or administration of anti-clotting medications to higher-risk patients to prevent venous thromboembolism. Based on a review of selected hospitals, the OIG found … Continue Reading

OIG Issues 2015 Compendium of Unimplemented Recommendations

The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others: Payment Policies and Practices: Expand the DRG window to include additional days prior to the inpatient … Continue Reading

CMS Launches “Transforming Clinical Practice Initiative”

CMS has announced its newest innovative delivery reform program, called the “Transforming Clinical Practice Initiative,” which will provide up to $840 million over four years to help clinicians share, adapt, and develop quality improvement strategies. CMS intends to make awards for the following two types of systems: Practice Transformation Networks are peer-based learning networks designed … Continue Reading

OIG Assesses Adverse Events Among Medicare Beneficiaries in SNFs

The OIG released a report on March 3, 2014, “Adverse Events in Skilled Nursing Facilities: National Incidence among Medicare Beneficiaries,” that examines the national incidence rate, preventability, and cost of adverse events in skilled nursing facilities (SNFs). This report is an outgrowth of a series of studies about hospital adverse events. For purposes of this report, the … Continue Reading

ONC Seeks Comments on Health IT Patient Safety Action and Surveillance Plan

The HHS Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on its draft “Health IT Patient Safety Action and Surveillance Plan,” a blueprint for using health information technology (IT) to make care safer and to continuously improve the safety of health IT. The draft plan offers a list of actions … Continue Reading

GAO Examines Unsafe Injection Practices in Ambulatory Care Settings

The GAO has issued a report entitled “Patient Safety: HHS Has Taken Steps to Address Unsafe Injection Practices, but More Action Is Needed.” The report examines the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings, and federal oversight and other efforts aimed at preventing unsafe injection practices … Continue Reading

Patient Safety Events: Common Formats for Reporting, Reporting Challenge Announced

The Agency for Healthcare Research and Quality (AHRQ) has published a notice inviting comments on Common Formats–Hospital Version 1.2, which is used for reporting patient safety events to Patient Safety Organizations (PS0s). Separately, the HHS Office of the National Coordinator for Health Information Technology, has launched the “Reporting Patient Safety Events Challenge,” which invites multi-disciplinary … Continue Reading

Fall 2011 Regulatory Agenda (Belatedly) Released

On January 20, 2012, the Obama Administration posted its Fall 2011 Regulatory Agenda, outlining its planned regulatory initiatives in a number of policy areas. Priorities for the Department of Health and Human Services (HHS) include, among many others: Implementing Affordable Care Act (ACA) insurance reforms, including establishing Affordable Insurance Exchanges, establishing risk adjustment criteria for … Continue Reading

OIG Reviews Hospital Incident Reporting Systems

A recent OIG report, "Hospital Incident Reporting Systems Do Not Capture Most Patient Harm,” estimates that hospital incident reporting systems captured only about 14% of the “patient harm events” experienced by Medicare beneficiaries. Because of what the OIG characterizes as an “absence of clear event reporting requirements,” administrators classified the remainder of unreported events as … Continue Reading

OIG Examines Medicare’s Response to Hospital Adverse Events

The OIG has issued a report entitled “Adverse Events in Hospitals: Medicare’s Responses to Alleged Serious Events.” The report assesses the responses of CMS, state survey and certification agencies, and hospitals to complaints alleging serious adverse events. The OIG concludes that Medicare’s hospital oversight system missed opportunities to address patient safety in response to alleged serious adverse … Continue Reading

Congressional Hearings on Health Policy Issues

A number of Congressional panels have held hearings this month on health policy issues, including Senate Health, Education, Labor and Pensions (HELP) Committee hearings entitled “First, Do No Harm: Improving Health Quality and Patient Safety” and “Diverting Non-Urgent Emergency Room Use: Providing Better Care and Lower Costs.” Both the House Energy & Commerce Subcommittee on Health and … Continue Reading

CMS Forum on Home Health Value-Based Purchasing (Feb. 24, 2011)

On February 24, 2011, CMS is hosting a Special Open Door Forum on “Designing A Home Health Value-Based Purchasing Program.” The event is designed to solicit input from interested parties regarding the development of the plan for implementing a value-based purchasing program for home health agencies as mandated by the Affordable Care Act.… Continue Reading

HIT Quality Measures Workgroup Comment Opportunity

The HHS Health Information Technology Policy Committee’s Quality Measures Workgroup is seeking comments on clinical quality measures enabled for use within electronic health record systems. The Workgroup has identified “measure concepts” in the areas of Patient and Family Engagement, Clinical Appropriateness/Efficiency, Care Coordination, Patient Safety, and Population and Public Health. The Workgroup now is requesting detailed examples … Continue Reading

Common Formats for Patient Safety Data Collection/Event Reporting

On October 22, 2010, the Agency for Healthcare Research and Quality (AHRQ) published a notice announcing the availability of a revised common format for reporting Device or Medical/Surgical Supply patient safety data. Specifically, the revised common format, “Device or Medical/Surgical Supply Including HIT Device,” now captures information about patient safety events related to health information technology.… Continue Reading

Patient Safety/Liability Reform Grants

On June 11, 2010, the Agency for Healthcare Research and Quality (AHRQ) announced that it is awarding grants to support state and health system patient safety and medical liability reform efforts. The $25 million HHS Patient Safety and Medical Liability initiative provides grants for planning, evaluating, implementing patient safety and medical liability demonstrations.  (Note that … Continue Reading

GAO Report on Patient Safety Act Implementation

The Government Accountability Office (GAO) has issued a report entitled, “Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot Yet Be Evaluated.” The report seeks to assess the early implementation of the Patient Safety and Quality Improvement Act of 2005, which included provisions to encourage health care providers to voluntarily … Continue Reading

Common Formats for Patient Safety Data Collection and Event Reporting

The Agency for Healthcare Research and Quality (AHRQ) has published a notice announcing an updated version of the common definitions and reporting formats that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events under the Patient Safety and Quality Improvement Act of 2005. The notice also describes AHRQ’s process for continued … Continue Reading

Patient Safety and Quality Improvement Act Penalties

On August 25, 2009, the HHS Office for Civil Rights (OCR) published a direct final rule adjusting for inflation the maximum civil money penalty amounts for violations of the confidentiality provisions of the November 21, 2008 Patient Safety and Quality Improvement Rule. The inflation adjustment is being made to comply with the Federal Civil Penalties Inflation … Continue Reading

Noncoverage of Preventable Surgical Errors

On January 15, 2009, CMS announced three final national coverage determinations (NCDs) to deny Medicare coverage of certain types of serious, preventable surgical errors. Specifically, CMS will no longer cover: (1) wrong surgical or other invasive procedures performed on a patient; (2) surgical or other invasive procedures performed on the wrong body part; or (3) surgical or … Continue Reading

Final Rule Implementing Patient Safety Act

On November 21, 2008, the Department of Health and Human Services (HHS) published a final rule to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). By way of background, the Patient Safety Act is designed to encourage health care providers to voluntarily report patient safety information, medical errors, … Continue Reading

Draft FDA Guidance: Evaluating Drug/Biological Proprietary Names

On November 24, 2008, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.” The document is intended to help prevent medication errors by assisting industry in the submission of complete product information that will enable FDA to evaluate the … Continue Reading
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