PSO Overview for Executives (Presenter) (Date)

Patient Safety and Quality Improvement Act (PSQIA) PSQIA effective July, 2005 with final regulations published November, 2008 Key Provisions of PSQIA: Allows formation of Patient Safety Organizations (PSOs), which are private or public entities that are federally listed by the Secretary of the US Department of Health and Human Services (HHS). Purpose of PSOs: Undertake efforts to improve patient safety and quality of health care Develop and implement processes for voluntary and confidential reporting of adverse events and for providing feedback to participants Participate in a national network of patient safety databases Work with providers to identify and analyze threats to patient safety and other quality of care problems Provides confidentiality to entities and individuals who report to a PSO Provides protection from discovery of work product in legal proceedings (with defined exceptions)

Center for Patient Safety PSO The Center for Patient Safety (CPS) was one of the first ten federally listed PSO’s in the nation effective November 5, 2008 To participate in the CPS PSO: Sign a contract Develop PSO policies (with assistance of CPS staff) to define patient safety evaluation system (PSES) and patient safety work product (PSWP) Form and educate PSES Workgroup Submit data to PSO web-based database You’ll learn more about participation requirements in this presentation

5 Reasons to Participate in a PSO Share good work we are doing as transparency contributes to improved patient safety for all Take advantage of safe haven of federal protection for safety work product Protect patient safety discussions and analysis currently taking place between hospitals and providers, ie EMS re: trauma, STEMI and stroke Future integration with providers who are members of Accountable Care Organizations ACA provision effective January 1, 2017 requires all hospitals with 50 or more beds to have a patient safety evaluation system (or approved alternative) to receive reimbursement from the HIE plans

5 Reasons to Participate in a PSO Position for recommended requirements by the Office of the National Coordinator for Health Information Technology (ONC – HIT) to report patient safety events related to EHRs to a PSO Active participation in PSO provides strong counter-argument to proposed bills requiring mandatory reporting to the state Department of Health, including increased surveys and fines

Patient Safety Evaluation System (PSES) The mechanism by which information can be collected, maintained, analyzed and communicated “The collection, management, or analysis of information for reporting to or by a PSO” Exists whenever the provider engages in patient safety activities for the purpose of reporting to a PSO Exists whenever the PSO engages in these activities for patient safety purposes This is, in essence, a safe place where you can manage and analyze your patient safety work product (PSWP) while preparing to send it to the PSO. The privilege and confidentiality protections attach when the PSWP enters your PSES Documentation of a PSES is not required, but HHS strongly recommends that a provider document their PSES to support identification and protection of Patient Safety Work Product (PSWP). It may provide substantial proof to support claims of privilege and confidentiality The preamble to the final rule gives some guidance as to what providers should consider in documenting their PSES: A designated secure space When and how information would be reported to the PSO How feedback regarding patient safety events is communicated between the PSES and PSO How protected information would be identified and separated from information that is non-PSWP

Patient Safety Evaluation System (PSES) Workgroup PSES workgroup consists of the core individuals/committees who routinely perform patient safety and quality analysis and improvement work. Other individuals with special subject matter expertise may be called upon as deemed necessary for work on specific events or issues. All PSES workgroup members should sign a confidentiality agreement specific to PSWP. Make-up of PSES Workgroup and responsibilities are defined in organization’s PSO policy. Each organization determines who will be in the PSES workgroup, with guidance of the PSO staff

PSQIA Definition of Patient Safety Activities Efforts to improve patient safety and health care quality Collection and analysis of Patient Safety Work Product (PSWP) Development and dissemination of information to improve patient safety Utilization of PSWP to encourage a culture of safety, and provide feedback and assistance to minimize patient risk Maintenance of procedures to preserve confidentiality of PSWP Provide appropriate security for PSWP Use qualified staff Activities related to the operation of a PSES and provision of feedback to participants PSOs encourage patient safety activities – this is the definition in PSQIA

Patient Safety Work Product (PSWP)? Any data, reports, records, memoranda, analyses, or written or oral statements which could improve patient safety, quality improvements or health care outcomes, and which: a provider assembles as part of its reporting to a PSO and which it does report, or reflect the work of the PSES or the fact that information was reported to the PSES PSWP is confidential and should not be disclosed by any member of the PSES Workgroup 42 USC 921b(7) There are some exceptions for disclosures – would only be made by the PSO contact. Refer to PSO Primary Contact Handbook for more details.

Examples of PSWP to submit to PSO Event, near miss and unsafe condition reports Root Cause Analysis, Failure Mode and Effects Analysis, Learning from Defect Analysis or other proactive risk assessments Notes/discussions from patient safety huddles or rounds, telephone calls or hallway conversations Quality outcome reports such as blood utilization, complications or Core Measure variances Minutes from committees/teams where patient safety/quality improvement is discussed, such as Quality, Safety, P&T, Infection Prevention, among others

Patient Safety Work Product PSWP does not include: patient medical records, billing and discharge information or any other original patient or provider information Data and reports generated for submission to external agencies to meet mandatory or voluntary reporting requirements Improvements, process and policy changes, and Action Plans made as a result of work within the PSES or the PSO PSES Workgroup determines whether information developed in the PSES, or reported to it, becomes protected PSWP and what is reported to the PSO.

Putting It All together Sign PSO contract with Center for Patient Safety Establish, define and document a Patient Safety Evaluation System (PSES) Define Patient Safety Work Product (PSWP) that is collected and maintained in the PSES Establish PSES Workgroup, who discusses, analyzes and manages the PSWP to determine: What should be shared with workforce to improve patient safety and quality of care What to submit to the PSO for broader learning Each member of our PSES Workgroup agrees to maintain confidentiality of all PSWP. Hospital submits data and other information to the secure PSO database.

Questions or Assistance CPS Staff who will gladly assist with PSO establishment and answer questions: Alex Christgen – achristgen@ceneterforpatientsafety.org Eunice Halverson – ehalverson@centerforpatientsafety.org Kathy Wire – kwire@centerforpatientsafety.org Center for Patient Safety 573.636.1014 www.emsforward.org www.centerforpatientsafety.org/emsforward