19 hours ago · (3) R EPORT.—The Centers for Disease Control and Prevention shall submit a report to Congress on the findings of the study under paragraph (1) and make recommendations for— (A) increasing the number of children’s hospitals that report to the National Healthcare Safety Network; and >> Go To The Portal
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 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.
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.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for Civil Rights (OCR), Department of Health and Human Services (HHS).
The nurse has the professional responsibility to be engaged in the activities that support a patient-centered safety culture.
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.
Individuals, organizations, and agencies that meet the definition of a covered entity under HIPAA must comply with the Rules' requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information.
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.
A healthcare provider can only obtain the confidentiality and privilege protections of the Patient Safety Act by working with a Federally-listed PSO. Use the categories on the left to filter the list of PSOs or search a PSO name. There are 96 total PSOs listed by AHRQ.
Joe KianiThe organization was founded in 2012 by Joe Kiani and is based in Irvine, California. Over the last 7 years, PSMF has gathered 4,710 hospitals over 46 countries.
The board of directors has ultimate responsibility for maintaining the quality and safety of patient care provided by its healthcare organization.
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.
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.
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.
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.
The spectrum of reported events is limited, in part due to the fact that physicians generally do not utilize voluntary event reporting systems.
Voluntary event reporting systems need not be confined to a single hospital or organization. The United Kingdom's National Patient Safety Agency maintains the National Reporting and Learning System, a nationwide voluntary event reporting system, and the MEDMARX voluntary medication error reporting system in the U.S.
The Patient Safety and Quality Improvement Act of 2005 (PSQIA) establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides Federal privilege and confidentiality protections ...
To encourage the reporting and analysis of medical errors, PSQIA provides Federal privilege and confidentiality protections for patient safety information, called patient safety work product.
The Patient Safety and Quality Improvement Act signifies the Federal Government's commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. Currently, patient safety improvement efforts are hampered by the fear ...
Ineligible organizations include insurance companies or their affiliates. Finally, the Act calls for the establishment of a Network of Patient Safety Databases (NPSD) to provide an interactive, evidence-based management resource for providers, PSOs, and other entities.
It will be used to analyze national and regional statistics, including trends and patterns of patient safety events. The NPSD will employ common formats (definitions, data elements, and so on) and will promote interoperability among reporting systems. The Department of Health and Human Services will provide technical assistance to PSOs.
Often referred to as the Patient Safety Act, the provisions of this law dealing with PSOs are administered by the Agency for Healthcare Research and Quality (AHRQ) and the provisions dealing with its confidentiality protections are interpreted and enforced by the Office for Civil Rights (OCR).
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.
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.
The confidentiality requirements of the Patient Safety Act do not apply to or prohibit a “[d]isclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration .” 42 U.S.C. § 299b-22(c)(2)(D). The final rule implementing the Patient Safety Act regulation at 42 CFR 3.206(b)(7)(i) provides that the confidentiality provisions shall not apply to or prohibit: "Disclosure by a provider of patient safety work product concerning an FDA-regulated product or activity to the FDA, an entity required to report to the FDA concerning the quality, safety, or effectiveness of an FDA-regulated product or activity, or a contractor acting on behalf of FDA or such entity for these purposes.” Subsection (b)(7)(ii) provides that: “Any person permitted to receive patient safety work product pursuant to paragraph (b)(7)(i) of this section may only further disclose such patient safety work product for the purpose of evaluating the quality, safety, or effectiveness of that product or activity to another such person or the disclosing provider.”1
The Patient Safety Act includes a provision at 42 U.S.C. § 299b-22(g)(6), the “FDA Rule of Construction,” which states that “[n ]othing in this section shall be construed . . . to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.” (emphasis added.) The Patient Safety Act added sections 921 to 926 to the Public Health Service Act. The “section” that is referenced in the FDA Rule of Construction is section 922 of the Public Health Service Act, 42 U.S.C. § 299b-22, which includes all of the Patient Safety Act’s privilege and confidentiality protections and exceptions. Thus, the privilege and confidentiality protections in the Patient Safety Act cannot be construed to limit, alter, or affect any requirement for reporting information to the FDA regarding the safety of an FDA-regulated product or activity.
PSOs, and entities that seek to be PSOs, are reminded that an enti ty that is a unit or division of a legal entity, or that is owned, managed or controlled by one or more legally separate parent organizations, and that seeks to be a PSO, must apply as a component PSO. Thus, an entity that would be operating as a PSO and that is part of a larger organization that engages in FDA-regulated reporting activities, or that has a parent organization that engages in FDA-regulated reporting activities must seek listing as a component PSO. In addition, under 42 U.S.C. 299b-24(b)(1)(A), a PSO’s mission and primary activity must be to conduct activities to improve patient safety and the quality of health care delivery. Seeking listing as a component PSO helps to ensure that entities with multiple missions and activities (such as FDA-regulated reporting activities) are in compliance with this statutory requirement. Given the issues identified in this Guidance, AHRQ will also be engaging in additional inquiry of applicants and PSOs to determine whether the entity is organizationally related to an FDA-regulated reporting entity such that it should be listed as a component PSO (i.e., it is a unit or division of a legal entity, or is owned, managed or controlled by one or more legally separate parent organizations.) If the entity should be listed as a component PSO, AHRQ will work with the entity to pursue such appropriate listing.