30 hours ago To report PHI to law enforcement when required by law to do so (45 CFR 164.512 (f) (1) (i)). For example, state laws commonly require health care providers to report incidents of gunshot or stab wounds, or other violent injuries; and the Rule permits disclosures of PHI as necessary to comply with these laws. >> Go To The Portal
The authors suggest that State patient safety regulation illustrates ongoing tensions in U.S. health policy, and conclude that State legislation serves an important function as an intermediate step to bring the patient's perspective to the table.
The Patient Safety Act and Rule provide privilege and confidentiality protections to specific types of information developed when a provider works with a PSO, such as the data collected and reported to PSOs by providers and the communications and feedback a provider receives from the PSO.
When responding to an off-site medical emergency, as necessary to alert law enforcement about criminal activity, specifically, the commission and nature of the crime, the location of the crime or any victims, and the identity, description, and location of the perpetrator of the crime (45 CFR 164.512 (f) (6)).
Patient safety event reporting systems are ubiquitous 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.
Congress vested the authority for implementing the Patient Safety Act with AHRQ by incorporating its provisions into AHRQ's authorizing statute. As the lead Federal agency for patient safety research, AHRQ is an appropriate partner for PSOs and healthcare providers.
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.
Patient Safety Reporting (PSR) gives military treatment facility personnel the ability to anonymously report medical events that impact the safety of patients.
Patient Safety Organizations (PSOs) collect and analyze data voluntarily reported by healthcare providers to help improve patient safety and healthcare quality. PSOs provide feedback to healthcare providers aimed at promoting learning and preventing future patient safety events.
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.
Sen. Jim JeffordsThe PSQIA was introduced by Sen. Jim Jeffords [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005, with 428 Ayes, 3 Nays, and 2 Present/Not Voting.
Reporting systems (frequently referred to as reporting and learning systems) capture patient safety concerns, hazards and/or incidents and are meant to trigger action, facilitate communication, response, learning and improvement.
Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention.
The reporting of incidents to a national central system helps protect patients from avoidable harm by increasing opportunities to learn from mistakes and where things go wrong.
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.
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.
In 2002, The Joint Commission established its National Patient Safety Goals (NPSGs) program; the first set of NPSGs was effective January 1, 2003.
The confidentiality provisions will improve patient safety outcomes by creating an environment where providers may report and examine patient safety events without fear of increased liability risk. Greater reporting and analysis of patient safety events will yield increased data and better understanding of patient safety events.
The regulation implementing the Patient Safety and Quality Improvement Act of 2005 (PSQIA) was published on November 21, 2008, and became effective on January 19, 2009. View the Patient Safety Rule - PDF (42 C.F.R. Part 3). PSQIA establishes a voluntary reporting system to enhance the data available to assess and resolve patient safety ...
PSQIA establishes a voluntary reporting system to enhance the data available to assess and resolve patient safety and health care quality issues.
PSQIA provides for the establishment of Patient Safety Organizations ( PSOs) to receive reports of patient safety events or concerns from health care providers and to provide analyses of these events to the reporting providers.
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.
Child abuse or neglect may be reported to any law enforcement official authorized by law to receive such reports and the agreement of the individual is not required (45 CFR 164.512 (b) (1) (ii)). Adult abuse, neglect, or domestic violence may be reported to a law enforcement official authorized by law to receive such reports (45 CFR 164.512 (c)):
Disclosures for law enforcement purposes are permitted as follows: To comply with a court order or court-ordered warrant, a subpoena or summons issued by a judicial officer, or a grand jury subpoena. The Rule recognizes that the legal process in obtaining a court order and the secrecy of the grand jury process provides protections for ...
To a law enforcement official reasonably able to prevent or lessen a serious and imminent threat to the health or safety of an individual or the public (45 CFR 164.512 (j) (1) (i)); or. To identify or apprehend an individual who appears to have escaped from lawful custody (45 CFR 164.512 (j) (1) (ii) (B)).