Patient Safety Evaluation System and Patient Safety Organization Fundamentals

1. Patient Safety Evaluation System and Patient Safety Organization Fundamentals Toolkit Material for Introducing Definitions and Concepts to Your Organization

2. Patient Safety & Quality Improvement Act of 2005 (PSQIA) • Signed into law July 29, 2005 • Final rule released November 21, 2008 • Rule took effect January 19, 2009 • Purpose • To improve patient safety, healthcare quality, and outcomes by sharing data within a protected legal environment nationwide

3. PSQIA (continued) • Authorized the creation of federally certified Patient Safety Organizations (PSOs)that will • Receive protected data from providers • Analyze the data, and • Share recommendations with healthcare providers • Completely voluntary; no federal funding • Limits the use of patient safety information in criminal, civil, and administrative proceedings • Imposes monetary penalties for violations of confidentiality or privilege protections

4. Why Is Federal Protection Needed? • Providers fear that patient safety reports could be used against them • State protections may offer no protections or inadequate protections • Need robust reporting and aggregation of data • Analyze events to effectively identify failure patterns • Identify and share data to reduce the potential risks associated with patient care

5. What Do the New Terms Mean? • Patient Safety Organizations (PSOs) • Entities that meet the requirements of PSQIA • Collect and analyze data from submitted events in compliance with PSQIA • Patient Safety Work Product (PSWP) • Information that is privileged and confidential • Patient Safety Evaluation System (PSES) • The protected space in which PSWP is collected or developed for reporting to, or from, a PSO

6. Patient Safety Organizations (PSOs) • Federally designated by AHRQ • PSOs must comply with a host of requirements • Information reported to or developed by a PSO for the purpose of conducting patient safety activities is protected

7. What Is PSWP? Includes information that: • Could improve patient safety, healthcare quality, or healthcare outcomes and is assembled by a provider for reporting to a PSO, such as: data, reports, memoranda, written or oral statements, analyses (e.g., root cause analyses, FMEAs) • Identifies or constitutes the deliberations or analysis of, or identifies the fact of reporting pursuant to, a patient safety evaluation system

8. PSQIA: Legal Protection • Privilege: • Not subject to subpoena in civil, criminal, administrative proceedings • Not subject to discovery • Not admissible into evidence • Not subject to Freedom of Information Act • Confidentiality: • PSWP cannot be disclosed except as permitted under the Act/regulations; improper disclosure can trigger financial penalties • These protections go beyond state law for some PSOs

9. Sharing PSWPProvider  PSO

10. PSWP Does Not Include • Patient medical records • Billing and discharge information • Other original patient or provider information • Information that is collected, maintained, or developed separately, or exists separately, from a PSES • Information collected to comply with external obligations: • State reporting requirements • FDA MedWatch; NPDB

11. Document PSWP • Document: • Information collected for reporting to a PSO • Date of collection • Prevent inappropriate disclosure by labeling PSWP • “CONFIDENTIAL PATIENT SAFETY WORK PRODUCT. Protected under the Patient Safety and Quality Improvement Act. Do not disclose unless authorized by [name of governing document, office, or body].” • Establish policies and procedures to define PSWP

12. Defining a PSES • The regulations say… “A protected space or system that is separate, distinct, and resides alongside but does not replace other information collection activities mandated by laws, regulations, and accrediting and licensing requirements, as well as voluntary reporting activities that occur for the purpose of maintaining accountability in the health care system.”

13. Defining a PSES (continued) • Collection, management, or analyses of information for reporting to, or by, a PSO • Flexible and scalable to individual operations • Consider • What type of data should be included? • How should existing structures and processes be used? • Should the PSES be centralized or involve multihospital systems?  • Who should have access to PSES data? • How long can the data stay in the PSES before reporting to a PSO?

14. What Is Reportable Data? • Assembled in PSES: • Data or information that promotes a culture of safety and improves patient care • Impressions and/or subjective data that is not available in the medical record • Data that is not required for other reporting • Information that will not be used to make adverse employment decisions

15. Potential PSES Elements *Consider the scope and implications of state law privileges when deciding whether to report peer review information **Report only if facility policy does not consider the videos to be part of the medical record

16. Implementing a PSES • Take inventory, consider who will: • Collect data to be reported to a PSO • Single source or multiple sites? • Single department or organization wide event reporting? • Document within the PSES and include the date the information entered the PSES • Analyze data to be reported to a PSO • Remove data before reporting to a PSO • Submit the data from the PSES to the PSO • Committees or individual authorized to submit

17. Implementing a PSES (continued) • Collect and report data that will improve culture of safety • Patient safety, healthcare quality, and outcome data • Do not include data for adverse employment action or state reporting • Remove data from PSES prior to reporting to a PSO • Peer review information that could lead to disciplinary action • Document the act and date of removal of such information from the PSES

18. Implementing a PSES(continued) • No specific requirements, however consider documenting: • Processes, activities, the physical space, computer systems, and equipment that comprise the PSES • Procedures for entering data and information into the PSES • Personnel who have access to the PSES and how they carry out their duties and the system's operations • Conditions for accessing PSWP that is part of the PSES • Procedures for reporting information to the PSO and receiving feedback from the PSO • Procedures for disseminating information outside the PSES

19. Removing PSWP from the PSES“The Drop Out Provision” For information that enters the PSES under the assembled or developed clause, a provider may voluntarily remove such information from its PSES for any reason provided that: • The provider acts before the information is reported to a PSO • The provider no longer intends to report the information to a PSO • The provider documents the act and date of removal

20. The Drop Out Provision(continued) • Upon removal, the information is no longer PSWP and can be used for other purposes • A “copy” of information that is removed can still be shared with the PSO • Once information has been reported to a PSO, the provider cannot use the drop out provision

21. Removing PSWP from the PSES

22. Managing a PSES • Promote a culture that encourages internal reporting of • Adverse events • Errors • Near misses • Educate the appropriate individuals about the benefits of PSO participation

23. Managing a PSES (continued) • Review process for managing PSWP within the PSES • Ensure staff understands responsibilities of confidentiality and security • Monitor the process that the organization has put in place • Use the information from the PSO to improve the organization’s approach to patient safety and healthcare quality

24. Managing a PSES (continued) • Evaluate and optimize the PSES on an ongoing basis. This should include: • Determine if the PSES is meeting the objective to improve patient safety, quality of care, and patient outcomes • Confirm that the PSES policies and procedures are consistently followed • Evaluate whether the PSES is defined optimally for the organization • Review and revise PSES policies and procedures to ensure that the PSES changes in step with organizational changes

25. Policies and Procedures • Include: • Purposes and scope • Definitions • Description of the PSES • Reporting to PSO • Confidentiality and security • Permissible disclosures

26. Questions!