PSO Membership

1. PSO Membership Building a Culture of Safety

2. Presenters: Lisa Corbett, Peggy Binzer, and Dr. Susan Saik Peebles

3. North Carolina’s Background • North Carolina has several statutes that create peer review processes and provide protection for that information. • State facilities struggled with forming true peer review committees, and following procedures.

4. In 2009, in a Tort Claim case against a State Facility, Plaintiff’s counsel requested root cause analyses going back for a period of YEARS in a document production request. • The State objected on grounds that the information was protected under State peer review laws.

5. The Deputy Commissioner ordered the Facility to produce the records to him for review, and ultimately released them to plaintiff’s counsel. • The facility and its staff thereafter did not want to engage in any type of peer review activities due to the concern that they would not be protected in litigation.

6. Other events • In 2007, North Carolina moved from having an internal P & A, the Governor’s Advocacy Council for Persons with Disabilities, (GACPD) to having an external P & A. • Prior to 2007, GACPD did not request peer review or root cause analysis information.

7. Federal Litigation • On November 18, 2011, DRNC filed an action in NC’s Middle District. DRNC v. Moses Cone, 1:11-cv-812. • Moses Cone has a behavioral health unit, and a client of that unit died within an hour of having been restrained. • DRNC initiated an investigation and requested records, including the medical record, peer review and root cause analysis documents.

8. Moses Cone produced the medical record but refused to produce peer review or root cause analysis, citing the peer review protection by law. • Moses Cone filed a motion to dismiss which was denied. • DRNC filed a motion for judgment on the pleadings, which was granted.

9. The Court followed the law from other Circuits and ruled that DRNC was entitled to peer review under the federal law. • DRNC will use the information to make its determination of whether or not abuse or neglect occurred. • Result: a chilling effect on peer review processes.

10. Patient Safety and QualityImprovement Act • The purpose of the PSQIA is to create a culture of safety by providing legal protection for quality information while permitting the sharing of best practices and other information to continuously improve the quality of patient care. • Many states’ peer review protections have been eroded, the protections do not cross state lines, and are generally inadequate for the purpose of sharing information among unrelated entities.

11. Elements of a PSO • Patient Safety Organization (PSO): A means of furthering the ability to accelerate the identification of, understanding of, and implementation of evidence-based solutions for preventable harm. • Patient Safety Evaluation System (PSES): The collection, management, or analysis of information for reporting to or by a PSO. • Clinical Prospective: Where clinicians can share information about medical errors and how to prevent them to bring lesson learned to the bed-side. • Legal Prospective: Identifies protected information and protected space.

12. Elements of a PSO • Patient Safety Work Product (PSWP): • Any quality data and analysis, oral statements – assembled or developed by a provider for reporting to a PSO and are reported to the PSO – that could improve quality of patient care or which constitute the deliberations or analysis of a PSES. • Patient Safety Work Product that is collected and developed in the PSES must be reported for the protections to attach: • Actually reporting • Representative reporting • Functional Reporting • Analysis, conversations and deliberations in PSES are protected without reporting to the PSO.

13. PSQIA PROTECTIONS • Privilege: • Information is not subject to subpoena, discovery, or admission into evidence • Federal privilege preempts state tort laws but not reporting laws • Federal privilege does not preempt state laws that provide stronger peer review protections • Provides federal liability protections to providers: • Federal privilege and confidentiality protections cross state lines • Federal privilege preempts state tort laws but not state reporting laws (e.g., shield for event reports) • Establishes a federal peer review privilege for all providers (e.g., nurses, EMT, pharmacists) • Preempts use of protected information in federal cases (e.g., racial discrimination) • Confidentiality – The Act places a statutory requirement on providers not to disclose “Patient Safety Work Product,” except under certain circumstances and imposes penalties of up to $10,000 per violation against any person or principal who knowingly or recklessly violates the confidentiality provisions.

14. PSQIA PROTECTIONS • PSO cannot be compelled: A patient safety organization shall not be compelled to disclose information collected or developed under this part whether or not such information is patient safety work product unless such information is: • Identified, • Is not patient safety work product, and • Is not reasonably available from another source. • Providers have additional defenses: Providers must exert the privilege and have the burden of proof

15. What Cannot be PSWP • Patient Safety Work Product is NOT: • Any document required to be reported by law • Information collected, maintained or developed separately, or which exists separately, from a PSES (medical record, billing information). • Corrective Actions • Information that is dropped out of the PSES

16. Disclosures and Uses of PSWP • “Disclosure is the release of information outside of the entity for which a specific disclosure permission must be applicable.” • May voluntarily disclose nonidentifiable information, best practices, clinical protocols and other nonidentifiable information. • “Use” is defined in the preamble to the regulation. “Use” means “the sharing of PSWP for any purpose within a legal entity (health system, hospital), • A provider may use PSWP for any purpose within its hospital or health system with two caveats, confidential information should be treated as being confidential; be careful of personnel actions.

17. CMS and Other Surveyors • Survey and licensure bodies are not accrediting bodies and are not treated as such under 42 C.F.R. 3.206. Thus, such entities are not entitled to receive patient safety work product voluntarily from providers. • Presently working with CMS to determine what other information can be provided to satisfy the conditions of participation. CMS wants to see that events are being reporting, analyzed, systematic changes are being made, and hospital leadership is engaged. • We recommend educating your regulatory body concerning the PSQIA. • If a facility wants to share protected information, such as an RCA, all providers must agree via contract, the information shared must be marked as PSWP, and the Surveyor must be informed that the information is protected.

18. How Providers Are Using the National Privilege • Gone beyond filling gaps in state peer review statute • Allowing providers to talk to each other about barriers • Peer to Peer/Case Study Collaborative Programs • Health Systems and specialties creating learning systems and “systemizing” care • Using data to be predictive and lowering malpractice operational costs • Solving what keeps you up at night.

19. DSOHF 14 State Operated Facilities • 3 Psychiatric Hospitals • 3 Alcohol and Drug Treatment Centers • 3 ICF/IID Centers • 3 Skilled Nursing Facilities • 1 PRTF • 1 School Adult admissions, Long-term, Forensics, Medical Unit, Child/Adolescent, Geropsychiatry, Deaf, Psychiatric Intensive Care, Acute Substance Abuse Treatment, Rehabilitative Substance Abuse Treatment, Pre-trial, Residential/Respite/Crisis ICF/IID, Residential SNF Patients and Residents served have high levels of complexity

20. Working to Build Safety Culture • Ablame-free environment whereindividuals are able to report errors or near misses without fear of punishment • Encouragement of collaborationacrossranks and disciplines to seek solutions to patient/resident safety problems • Organizational commitmentof resources to address safety concerns AHRQ Patient Safety Primer http://psnet.ahrq.gov/primer.aspx?primerID=5

21. Safety Culture Hines S, Luna, K, Lofthus J, et al. Becoming a High Reliability Organization: Operational Advice for Hospital Leaders. (Prepared by the Lewin Group under Contract No. 290-04-0011.) AHRQ Publication No. 08-0022. Rockville, MD: Agency for Healthcare Research and Quality. April 2008

22. PSES • Provides a safe place for honest dialogue and discussion. • Space that allows for open and free discussion - to speak up without fear of retaliation. • In this environment, system failures are identified and minimized as a result of the reporting and analysis of safety events.

23. The North Carolina Quality Center PSO • Was the first designated federally certified PSO in North Carolina and the 25th in the nation • Collects data on serious patient safety events as well as near misses and unsafe practices • Encourages participating facilities to share their serious reportable events, learn with others about how to prevent these events and thus improve healthcare quality • Current participation: 99 Facilities from 3 states • Program is designed to be applicable for the entire continuum of care. In the NCQC PSO there are Hospitals, SNF facilities (10), Home Health providers, Ambulatory Surgery Centers, and Hospital Owned Physician practices.

24. Improvements and Actions PSES Ad Hoc Involved staff Event Review Committee Tracking and F/U Interfacility Event Reviews RCA PSWP Physician Peer Review Unit Manager Review Mortality Review Undesirable Trends Committee analyses Ad Hoc Involved Staff DSOHF PSES

25. Event Review Committee* (Includes ad hoc) Root Cause Analysis Team** (Includes CD, CNO, CEO as standing members) Clinical Management Team Action Plan All Category F through I Selected Category A through E at Risk Manager discretion Executive Leadership Committee Follow-up on Action Plans Risk Management Complete event QA Related Hospital Committees • Falls • P&T • QCC • Patient Safety Committee • Medication Safety • Video Review • Others Corporate Clinical Quality Council CCQC Traditional process per facility policy Category A through E events Patient/resident Safety Events Incident Reports * If Event Review Committee or RCA Team discovers a Physician Specific Peer Review issue, refer to Medical Staff Peer Review process. ** Includes RCA, Sentinel Events, Death Reviews, Other event reviews

26. Our Approach to Implementation • Face to face initial meetings with each facility • Policies and Procedures describing the PSES • PSWP – disclaimers and security Training • Alignment of committees and responsibility

27. Our Approach to Implementation Developed a corporate policy that would serve as a template for individual facilities. • Due to uneven staffing and org structures, developed system that was based on functions rather than specific positions • Met with each facility and produced flow chart of how protected information and work product would flow through each organization • Tried to use existing committees/processes and modify them • Patient Safety Event Review Committee • Sensible access to incident reports • Work closely with Attorneys • Generated a “To-Do” List Our biggest challenge and how we have addressed it – • Developing an understanding of the difference between PI data that does not need to be part of the PSES and Patient Safety information that does. • How the facility interfaces with our corporate entity