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 the entire rule, the reopening of the comment period signals the beginning of the effort to finalize a permanent standard by OSHA only three months after the agency withdrew the Healthcare ETS. The Healthcare ETS required healthcare organizations to develop a COVID-19 plan for its workplace that included health screening and management, masking, distancing, and support for vaccination. The Healthcare ETS was withdrawn in December 2021 because OSHA determined that its efforts to establish a permanent standard would exceed the six-month time period allowed under the Occupational Safety and Health Act.

The notice reopening the comment period gives stakeholders both an early view into potential regulatory outcomes of the final rule as well as a series of information requests.
Continue Reading OSHA reopens comments on COVID-19 Healthcare Emergency Temporary Standard

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

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 estimates that 46% of the rehab hospital adverse or temporary harm events were clearly or likely preventable, attributable to such factors as substandard treatment, inadequate patient monitoring, and failure to provide needed treatment. One quarter of impacted patients were transferred to an acute-care hospital for treatment.
Continue Reading OIG Examines Adverse Events in Rehab Hospitals

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 that hospitals experience challenges related to:

Continue Reading GAO Examines Hospital Challenges in Implementing Patient Safety Practices

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

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

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

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,”

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

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

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

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

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

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

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

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