Is a PSO required to engage with additional experts if the PSO adjusts its activities or areas of focus? Which agencies within the Department of Health and Human Services (HHS) implement the Patient Safety Act? A PSO should periodically assess whether its qualified workforce is appropriate for the services it performs to maintain listing. Yes, a PSO may meet this aspect of the appropriately qualified workforce requirement by contracting with individuals as long as the individuals are workforce members, meaning they are under the direct control of the PSO. Learn more information here. Frequently asked questions and definition of terms used in the Patient Safety Act or Patient Safety Rule are summarized here solely for convenience; always rely on the actual text of the Patient Safety Act or Patient Safety Rule in making any determination. Administrative Assistant Department: Quality and Patient Relations / Patient Engagement Status: Temporary full-time for approx. When is an individual considered a member of a PSO's workforce? HHS interprets a PSO's requirement to have an appropriately qualified workforce to mean that a PSO is expected to maintain workforce members that have sufficient expertise to be able to perform patient safety activities, such as the analysis of patient safety work product, and other services offered as a PSO. comply with the other certifications the component PSO has made pursuant to section 3.102(c)(2) with respect to: conducting the mission of the PSO without creating conflicts of interest. The term "surveillance" in this context refers to the improved detection of events and calculation of adverse event rates in populations reviewed that will facilitate collection of comparable performance data over time and across populations of patients. There is also a CFER designed for community pharmacies (CFER-CP) and development of a CFER for Diagnostic Safety (CFER-DS) is underway. Both the mission and the primary activity of the entity (or component) must be to conduct activities to improve patient safety and the quality of healthcare delivery (Patient Safety Rule Section 3.102(b)(2)(i)(A)andPatient Safety Rule Section 3.102(b)(2)(ii)). Currently, there are CFER that include several event-specific modules for hospitals (CFER-H) and nursing homes (CFER-NH). Search All AHRQ The maximum dollar amount of the CMP that can be imposed is updated annually, as described insection 3.404 of the Patient Safety Rule, in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. Drug Shortages: Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability. Insight P olicy Research, Inc. Tap here to review the details. The Patient Safety Rule establishes in Subpart B the requirements that an entity must meet to seek listing, and remain listed, as a PSO. If so, is the PSWP protected? The Joint Commission has been in the business of health care quality for more than 60 years. Telephone: (301) 427-1364. As Required by the Patient Safety and Quality Improvement Act of 2005 Public Law 109-41, Section 922(j) U.S. Department of Health and Human Services . When OCR is unable to achieve an informal resolution of an indicated violation through voluntary compliance, theHHSSecretary has the discretion to impose a civil money penalty (CMP) against any PSO, provider, or responsible person for each knowing and reckless disclosure that is in violation of the confidentiality provisions. A component PSO may onlydisclose PSWP toits parent organization (emphasis added) if permitted by an applicable exception to confidentiality in section 3.206 of the Patient Safety Rule. Is a PSO required to have licensed or certified medical professionals as part of its workforce? 4 WHAT IS QUALITY ASSURANCE Quality assurance as making sure that the View the Patient Safety Rule - PDF (42 C.F.R. The Patient Safety Act promotes the goal of improving patient safety and reducing medical errors by establishing a system in which health care providers can voluntarily collect and report information related to patient safety, health care quality, and health care outcomes to PSOs. The CFS is a set of event descriptions used in retrospective review of medical records to identify whether certain patient safety events occurred. WHAT IS QUALITY ?. The Common Formats are also available in the public domain to encourage their widespread adoption. At this time, any comments on the Common Formats versions that are active for reporting can be submitted through the support@psoppc.org email. An entity does not need to be listed as a PSO or working with one to use the Common Formats. AHRQ then finalizes the Common Formats draft and releases it through the PSOPPC. Learn how working with the Joint Commission benefits your organization and community. AHRQ has received many questions regarding the implementation of the Patient Safety Rule and about PSOs. 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. 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). Submitted to . To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed aPatient Safety Organizations: A Compliance Self-Assessment Guideto suggest approaches for thinking systematically about the scope of these requirements and what compliance may mean for an individual PSO. sections 299b-21 to 299b-26). PSOs can receive reports on quality and safety from any health care provider, including hospitals, doctors' offices, nursing homes, and ambulatory surgery centers. Patient safety culture in assisted living: staff perceptions and association with state regulations. Now customize the name of a clipboard to store your clips. Entities submitting certifications for listing need to attest that they meet the requirement that both their mission and their primary activity are to conduct activities to improve patient safety and the quality of healthcare delivery (Patient Safety Rule Section 3.102(b)(2)(i)(A)andPatient Safety Rule Section 3.102(b)(2)(ii)). L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. The diagram shows the flow of protected information, to be handled as PSWP. The Patient Safety Act amended Title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety by authorizing the creation of patient safety organizations (PSOs). 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 to report by law or regulation (seePatient Safety Rule Section 3.102(a)(2)). Posting #2023-913644. Content last reviewed August 2022. The PSOPPC is developing a tool on their website that any member of the public can use to submit comments. A Notice of Availability to comment on the draft Common Formats is published in the Federal Register, and the draft is posted on thePSO Privacy Protection Center's (PSOPPC) website. PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005 VerDate 14-DEC-2004 11:17 Aug 05, 2005 Jkt 039139 PO 00041 Frm 00001 Fmt 6579 Sfmt 6579 E:\PUBLAW\PUBL041.109 APPS10 PsN: PUBL041 . PSWP analyzed by the PSO forms the basis of protected recommendations from the PSO to the provider. The disposition requirements for PSWP preempt any conflicting state requirements for disposition of information. Since 1951 weve accredited or certified nearly 21,000 health care organizations and programs. When it started just 3 yrs ago there were six main planks now 10. The Patient Safety Rule permits a healthcare provider, such as a hospital, to work with more than one PSO. What are the privacy and confidentiality protections for PSWP? Subpart C of the Patient Safety Rule establishes the confidentiality provisions and disclosure permissions for patient safety work product and the enforcement procedures for violations of confidentiality pursuant to section 922 of the statute. DR. N. C. DAS, At present no one player or country has the expertise let alone funding and research capabilities to tackle the full range of patient safety issues. The Patient Safety Act requires the Secretary of the Department of Health and Human Services (HHS), in consultation with the Director of AHRQ, to prepare a report on effective strategies for reducing medical errors and increasing patient safety. The final rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged The amount, as updated, is published at45 CFR Part 102. See how our expertise and rigorous standards can help organizations like yours. An official website of the Department of Health and Human Services. If individuals or units of the parent organization serve as PSO workforce, they may only use or disclose the PSWP in their capacity as component PSO workforce members. Patient Safety and Quality Improvement Tools to support and improve antibiotic prescribing in ambulatory practices Calibrate Dx: A Resource To Improve Diagnostic Decisions A tool to provide clinicians with guidance for evaluating and calibrating diagnostic performance for the purposes of learning and improvement. Background: 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 (42 C.F.R. Gain an understanding of the development of electronic clinical quality measures to improve quality of care. Incidents: patient safety events that reached the patient, whether or not there was harm involved. If the nature of services or subject matter of patient safety work product collected and analyzed by a PSO changes, a PSO is required to ensure that its qualified workforce is appropriate for such changes. An example of a licensed medical professional being appropriately qualified for the work of the PSO would be a PSO specializing in pediatric safety events that has a currently licensed medical professional with relevant knowledge, expertise, and experience in pediatrics as a workforce member. In this part: (1) HIPAA confidentiality regulations. In addition, hospitals can compare their data to others and analyze trends on a community, regional, and national level. the The Alliance aims to bring together the knowledge and resources that have been developed from patient safety work form around the world in the last decade. 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. If the same PSO specializing in pediatric safety events maintains a geriatrician as the only workforce medical professional, the PSO would have an insufficiently qualified workforce. A shared staffing agreement, executed between the component PSO and the individual(s) or unit(s) from the parent organization, must require that: If the entity seeking listing is a component of another organization, the entity must also certify that it is, and will be in compliance with, three additional requirements specified in the Patient Safety Rule: Every entity seeking to be a PSO must certify to AHRQ that it has policies and procedures (seePolicies and ProceduresTopics to Address; PDF File, 76 KB) in place to perform the eight patient safety activities specified in thePatient Safety Rule. We can make a difference on your journey to provide consistently excellent care for each and every patient. Where can I find more information and the current versions of the Common Formats? What is the relationship between the Patient Safety Rule and the HIPAA Privacy Rule? In general, a component PSO may not share staff with its parent organization (i.e., utilize individuals or units from its parent organization in the work of the PSO) if the parent organization is ineligible for PSO listing as an excluded entity (i.e., one of the types of entities listed in section 3.102(a)(2) of the Patient Safety Rule).