PSO Overview for (name of organization’s) PSES Workgroup (Presenter) (Date)

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. (Name of Organization’s) PSES Workgroup includes: (Insert definition you have determined for your organization) Other individuals with special subject matter expertise may be called upon as deemed necessary for work on specific events or issues. Each PSES workgroup member should sign a confidentiality agreement specific to PSWP.

Patient Safety and Quality Improvement Act (PSQIA) PSQIA effective July, 2005 with final regulations published November, 2008 Key Provisions of PSQIA: Established provision for 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)

Our PSO Participation (Name of Organization) is a contracted participant in the Center for Patient Safety PSO CPS was one of the first ten federally listed PSO’s in the nation effective November 5, 2008, to provide legal protection and processes for reporting, learning and sharing to improve the safety and quality of care provided

5 Reasons to Participate in a PSO Collaborate and learn from one another – share good work that we are doing as transparency contributes to improved patient safety for all Take advantage of safe haven of federal confidentiality and privilege protection for safety work product Afford protection for 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 Be prepared for ACA provision effective January 1, 2017 requiring all hospitals with 50 or more beds to have a patient safety evaluation system in order to receive reimbursement from the HIE plans (or have an approved alternative)

5 Reasons to Participate in a PSO (cont.) 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 builds case to defend against state legislators who have proposed bills requiring mandatory reporting to the state Department of Health, including increased surveys and fines

Patient Safety Evaluation System (PSES) “The collection, management, or analysis of information for reporting to or by a PSO” The mechanism by which information can be collected, maintained, analyzed and communicated 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 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 Speaker – see the Center’s PSO Primary Contact Handbook for suggested guidelines to develop a PSES.

(Name of organization)’s PSES includes: For us, this means…. (Name of organization)’s PSES includes: (Enter what you have determined to be your PSES) This is, in essence, a safe place where you can manage and analyze your 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 Speaker – see the Center’s PSO Primary Contact Handbook for suggested guidelines to develop a PSES.

Patient Safety Work Product (PSWP)? Any data, reports, records, memoranda, analyses, or written or oral statements which could improve patient safety, quality of care 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 (Name of organization)’s PSWP includes: (Enter what you have determined to be your PSWP) Reminder: PSWP is confidential and should not be disclosed by any member of the PSES Workgroup There are some exceptions for disclosures, but would only be made by the PSO contact. Refer to PSO Primary Contact Handbook for more details. (CH) – may need to add something about being able to share within the workforce

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 (Name of organization) can make decisions whether information developed in the PSES, or reported to it, becomes protected PSWP. For any questions, contact Primary PSO contact (May want to enter name/title) 10

Putting It All together (Name of Organization): Is a participant of the Center for Patient Safety’s PSO Has established, defined and documented our Patient Safety Evaluation System (PSES) Has defined our Patient Safety Work Product (PSWP) that is collected and maintained in our PSES PSES Workgroup 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 has agreed to maintain confidentiality of all PSWP.

Questions or Assistance (Enter Organization PSO contact information) Additional Information: Center for Patient Safety 888-935-8272 www.centerforpatientsafety.org