1. NNEPQIN as a Patient Safety Organization NNEPQIN Fall Meeting November 14, 2009 Timothy J. Fisher, MD

2. I have no disclosures.

3. Objectives Review background information leading to development of Patient Safety Organizations Define a Patient Safety Organization (PSO) Review rules and regulations pertaining to PSO’s Discuss how NNEPQIN’s PSO will operate and benefit members

4. Background In 1999, the Institute of Medicine (IOM) issued a landmark report entitled, "To Err is Human: Building a Safer Health System," which highlighted critical areas of research and activities needed to improve the safety and quality of health care delivery. One critical area of the IOM report addressed the reporting and analysis of data on adverse events. The IOM report and its findings spotlighted a serious need to capture information that would help to improve quality and reduce harm to patients.

5. Background Addressing this need, Congress passed The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). To implement the Patient Safety Act, the Department of Health and Human Services issued the Patient Safety and Quality Improvement final rule The Patient Safety Act and the Patient Safety Rule authorize the creation of PSO’s to improve quality and safety through the collection and analysis of data on patient events.

6. What is a PSO? PSO’s are organizations that share the goal of improving the quality and safety of health care delivery. Organizations that are eligible to become PSO’s include: public or private entities, profit or not-for-profit entities, provider entities such as hospital chains, and other entities that establish special components to serve as PSO’s. By providing both privilege and confidentiality, PSO’s create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data, thereby improving quality by identifying and reducing the risks and hazards associated with patient care.

7. Requirements The Patient Safety Rule requires an entity to certify that it meets 15 distinct statutory requirements; a component of another organization must attest that it meets another three statutory requirements

8. 8 Required Patient Safety Activities 1.Efforts to improve patient safety and the quality of health care delivery 2.The collection and analysis of patient safety work product (PSWP) 3.The development and dissemination of information regarding patient safety, such as recommendations, protocols, or information regarding best practices 4.The utilization of PSWP for the purposes of encouraging a culture of safety as well as providing feedback and assistance to effectively minimize patient risk

9. 8 Required Patient Safety Activities cont’d 5.The maintenance of procedures to preserve confidentiality with respect to PSWP 6.The provision of appropriate security measures with respect to PSWP 7.The utilization of qualified staff 8.Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system

10. 7 Additional Certifications 1.The mission and primary activity of the entity are to conduct activities that improve patient safety and the quality of health care delivery 2.The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals 3.The entity, within each 24-month period that begins after the date of the initial listing as a PSO, will establish two bona fide contracts, each of a reasonable period of time, with more than one provider, for the purpose of receiving and reviewing PSWP

11. 7 Certifications cont’d 4.The entity is not, and is not a component of, a health insurance issuer 5.The entity shall fully disclose— –any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and –if applicable, the fact that the entity is not managed, controlled, and operated independently from any provider that contracts with the entity 6.To the extent practical and appropriate, the entity collects PSWP from providers in a standardized manner that permits valid comparisons of similar cases among similar providers 7.The entity uses PSWP for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk

12. Excluded Entities A PSO may not be: – a health insurance issuer – an entity that accredits or licenses providers – an entity that oversees or enforces statutory or regulatory requirements governing the delivery of healthcare services (or an agent thereof) – an entity that operates a Federal, State or Tribal patient safety reporting system

13. How is a PSO staffed? There are two requirements relating to PSO staff in the Patient Safety Rule. –PSO’s must have policies and procedures in place to conduct each patient safety activity, for which PSOs are required to use qualified staff. –PSO’s must have an appropriately qualified workforce, including licensed or certified medical professionals It is desirable that the medical experience reflects the type of patient safety events reported to and analyzed by the PSO.

14. Patient Safety Work Product Patient Safety Work Product (42 C.F.R. §3.20) Data, reports, records, memoranda analyses, or written or oral statements which could improve patient safety, healthcare quality or healthcare outcomes and are developed by or reported to a Patient Safety Organization (PSO).

15. Patient Safety Work Product PSWP is privileged and confidential; legally protected by the privilege and confidentiality protections of the Patient Safety Act and Patient Safety Rule. Can be used to identify patient safety events and unsafe conditions that increase risks to patients.

16. What is PSWP? The Patient Safety Act requires PSO’s to collect PSWP from providers in a standardized manner in order to permit valid comparisons of similar cases among similar providers. PSWP may identify both the patient and the providers involved in a patient safety event and/or a provider employee that reported the information about the patient safety event.

17. How may PSWP be used? Aggregation of data to identify and address underlying causal factors of patient safety problems Confidential reporting of adverse outcomes Voluntary reporting to national network of patient safety databases (NPSD) via use of AHRQ Common Formats

18. How does HIPAA fit in? PSWP may contain individually identifiable health information as defined in the HIPAA Privacy Rule. Health care providers that are HIPAA-covered entities must comply with HIPAA as well as with the use and disclosure limitations for PSWP found in the Patient Safety Rule.

19. HIPAA cont’d PSOs are treated as business associates of participating providers. Patient safety activities are deemed to be “health care operations” so providers are not required to obtain patient authorization before disclosing PHI to PSOs PSO must comply with terms of its business associate agreements with providers which require them to notify providers of any impermissible use or disclosure of PHI

20. No Research use As a general rule, PSWP may not be used for research.

21. Common Formats In order to facilitate standardized data collection, the Secretary of DHHS requested AHRQ to coordinate the development of Common Formats for patient safety events. Common Formats delineate definitions, data elements, and reporting formats that allow healthcare providers to collect and submit standardized information regarding patient safety events. The use of the Common Formats is voluntary

22. Common Formats The Patient Safety Act also requires AHRQ to support the development of a network of patient safety databases (NPSD) that will be maintained as an interactive, evidence-based management resource. The Statute directs AHRQ to use data from the NPSD to analyze national and regional statistics, including trends and patterns, regarding patient safety events. Findings are to be made public and included in AHRQ’s annual National Healthcare Quality Report (NHQR).

23. Common Formats

25. What are the benefits of working with NNEPQIN’s PSO? The PSO will serve as independent, external expert who can collect, analyze, and aggregate PSWP to develop insights into the underlying causes of patient safety events and to develop more reliable information on how best to improve patient safety. The uniform Federal protections that apply to a provider's relationship with a PSO are expected to remove significant barriers that can deter the participation of health care providers in patient safety and quality improvement initiatives, such as fear of legal liability or professional sanctions.

26. Why are we here? Mission: To improve perinatal health throughout Northern New England by: Ensuring that consistent quality improvement parameters are available throughout the region. Enhancing timely review of outcomes by institution, service, and by provider using a consistent database. Facilitating external peer review among organizations of like size. Facilitating benchmarking for excellence in care based on patient mix and institution size. Developing best practice guidelines based on benchmarking and tailored for institution size/type. Providing a forum for interaction and collaboration of hospitals in Northern New England which will: –Help institutions interpret their QI parameters –Enhance institution education about the process of continuous quality improvement. –Identify regional QI projects –Coordinate site visits Facilitating timely and accurate system failure reports in participating institutions and provider groups. Facilitating continuing perinatal education in the region.

27. What are the benefits of working with NNEPQIN’s PSO? Implementation of the CPRB and PSO allow us to move forward in fulfilling the mission of NNEPQIN! Contribution of regional data to NPSB Improvement in local processes and outcomes

28. Questions?