25 hours ago The Patient Safety Rule also excludes the following entities: regulatory agencies; organizations that serve as agents of regulatory agencies (e.g., entities that carry out inspections or audits for a regulatory agency); accreditation and licensure entities; and entities that administer a Federal, State, local, or tribal patient safety reporting system to which healthcare providers are required … >> Go To The Portal
The purpose of the Act is to encourage providers to work voluntarily with new organizations, known as Patient Safety Organizations (PSOs), to improve patient safety and to reduce the incidence of events that adversely affect patients.
The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements; and each entity or component organization must comply with several additional regulatory requirements.
However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily.
To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed a Patient Safety Organizations: A Compliance Self-Assessment Guide to suggest approaches for thinking systematically about the scope of these requirements and what compliance may mean for an individual PSO.
Final Report to Congress To Improve Patient Safety Outlines Strategies To Speed Progress. A final report (PDF, 1.16 MB) on strategies to improve patient safety and reduce medical errors has been delivered to Congress by the U.S. Department of Health and Human Services in consultation with AHRQ.
OCR enforces these confidentiality protections. AHRQ lists patient safety organizations pursuant to section 924 of PSQIA and has responsibility for common formats and network of patient safety databases pursuant to section 923. Learn more about the Patient Safety Rule and read the regulations.
The nurse has the professional responsibility to be engaged in the activities that support a patient-centered safety culture.
AHRQ's Patient Safety Network (PSNet) features a collection of the latest news and resources on patient safety, innovations and toolkits, opportunities for free CME and trainings.
The Patient Safety Organization (PSO) program established federally recognized PSOs to work with health care providers to improve the safety and quality of patient care. The program also creates the first and only comprehensive, nationwide patient safety reporting and learning system in the United States.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for Civil Rights (OCR), Department of Health and Human Services (HHS).
The board of directors has ultimate responsibility for maintaining the quality and safety of patient care provided by its healthcare organization.
Two major aspects of health care that employees are responsible for are: 1) keeping patients and themselves safe and 2) providing the proper quality of care.
In general, there are three different levels or types of activity that are required to achieve and sustain excellence in the management of organizational performance: (1) Oversight, (2) Leadership, and (3) Execution.
The Agency for Healthcare Research and Quality (AHRQ) is the lead federal agency charged with improving the quality and safety of America's health-care system.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
U.S. Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication Number 2015-115, (October 2021). NIOSH/OSHA/CDC Toolkit.
AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events— in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.
The legislation provides confidentiality and privilege protections for patient safety information when health care providers work with new expert entities known as Patient Safety Organizations (PSOs). Health care providers may choose to work with a PSO and specify the scope and volume of patient safety information to share with a PSO. Because health care providers can set limits on the ability of PSOs to use and share their information, this system does not follow the pattern of traditional voluntary reporting systems. However, health care providers and PSOs may aggregate patient safety event information on a voluntary basis, and AHRQ will establish a network of patient safety databases that can receive and aggregate nonidentifiable data that are submitted voluntarily. AHRQ has also developed Common Formats —standardized definitions and reporting formats for patient safety events—in order to facilitate aggregation of patient safety information. Since their initial release in 2009, the Common Formats have been updated and expanded to cover a broad range of safety events.
A 2016 article contrasted event reporting in health care with event reporting in other high-risk industries (such as aviation), pointing out that event reporting systems in health care have placed too much emphasis on collecting reports instead of learning from the events that have been reported. Event reporting systems are best used as a way of identifying issues that require further, more detailed investigation. While event reporting utilization can be a marker of a positive safety culture within an organization, organizations should resist the temptation to encourage event reporting without a concrete plan for following up on reported events. A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.
Patient safety event reporting systems are ubiquito us in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. Incident reporting is frequently used as a general term for all voluntary patient safety event reporting systems, which rely on those involved in events to provide detailed information. Initial reports often come from the frontline personnel directly involved in an event or the actions leading up to it (e.g., the nurse, pharmacist, or physician caring for a patient when a medication error occurred), rather than management or patient safety professionals. Voluntary event reporting is therefore a passive form of surveillance for near misses or unsafe conditions, in contrast to more active methods of surveillance such as direct observation of providers or chart review using trigger tools. The Patient Safety Primer Detection of Safety Hazards provides a detailed discussion of other methods of identifying errors and latent safety problems.
A PSNet perspective described a framework for incorporating voluntary event reports into a cohesive plan for improving safety. The framework emphasizes analysis of the events and documenting process improvements arising from event analysis, rather than encouraging event reporting for its own sake.
The spectrum of reported events is limited, in part due to the fact that physicians generally do not utilize voluntary event reporting systems.
A structured mechanism must be in place for reviewing reports and developing action plans. While traditional event reporting systems have been paper based, technological enhancements have allowed the development of Web-based systems and systems that can receive information from electronic medical records.
Any information that is eligible to become PSWP reported to a PSO by a healthcare provider is protected. The definition of PSWP ( Patient Safety Rule Section 3.20) provides important detail on what information is eligible for protection and when those protections apply.
The PSO readmissions Web page contains helpful information and tools that can be used by such hospitals, and PSOs that work with those hospitals, to address the causes of unnecessary readmissions. In fact, any hospital can work with a PSO on any patient safety issue of the hospital's choice.
The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of healthcare providers in patient safety and quality improvement initiatives , such as fear of legal liability or professional sanctions.
The Patient Safety Act and Rule provide protections that are designed to allay fears of providers of increased risk of liability if they voluntarily participate in the collection and analysis of patient safety events.
OCR is responsible for the investigation and enforcement of the confidentiality provisions of the Patient Safety Rule. OCR will investigate allegations of violations of confidentiality through a complaint-driven system.
To implement the Patient Safety Act, the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) published the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs.
The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements; and each entity or component organization must comply with several additional regulatory requirements.
This bill amends the Public Health Service Act to require hospitals to implement and submit to the Department of Health and Human Services (HHS) a staffing plan that complies with specified minimum nurse-to-patient ratios by unit. Hospitals must post a notice regarding ...
Hospitals may not: (1) take specified actions against a nurse based on the nurse's refusal to accept an assignment for such a reason; or (2) discriminate against individuals for good faith complaints relating to the care, services, or conditions of the hospital or related facilities.
A BILL. To amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1.
S. 1567. To amend the Public Health Service Act to establish direct care registered nurse-to-patient staffing ratio requirements in hospitals , and for other purposes.
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Bills and resolutions are referred to committees which debate the bill before possibly sending it on to the whole chamber.
A bill must be passed by both the House and Senate in identical form and then be signed by the President to become law.