Patient Safety Organizations: Advancing Patient Safety and Health Care Quality An Overview Florida Society for Healthcare Risk Management & Patient Safety – Agency for Health Care Administration JOINT TRAINING - April 24, 2015

2 Disclaimer The information contained in this presentation is for general educational purposes only. Any views or advice offered in this presentation are those of its authors and should not be construed as the position of the Florida Society for Health Care Risk Management and Patient Safety (FSHRMPS) or the Agency for Health Care Administration (AHCA) Because the laws in many areas can change rapidly, this information can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.

o Patient Safety & Quality Improvement Act (42 U.S.C. § 299b-21et seq.)  Congress identifies a strong need for a comprehensive “learning environment” free from fear of litigation and disciplinary consequences  Signed by President George W. Bush in 2005  Regulations to Implement Act – January 19, 2009  Creates Patient Safety Organizations, which allow providers to conduct patient safety activities on a privileged/confidential basis  Currently approximately 85 certified Patient Safety Organizations, and that number is expected to increase 3 What is a Patient Safety Organization? Background

4 History of the Patient Safety Act o To Err is Human: Building a Safer Health System  1999 o Initiated by the Institute of Medicine o Concluded:  Majority of medical errors caused by faulty systems, processes, and conditions that lead to mistakes or failure to prevent adverse events o Recommended:  Designing health care system to improve safety  Broader protection for the entire spectrum of patient safety improvement work

5 History of the Patient Safety Act o PSO participation is voluntary  Choosing to form a component PSO or participate in a PSO is a significant commitment to patient safety

o Opportunity to learn, improve patient safety, and share valuable information o Increased reporting of safety concerns o And better sharing of patient safety tools and lessons o Further enhances focus on patient safety process o Increased engagement and collaboration with medical staff 6 Benefits of Patient Safety Organization Participation

7 o Any entity, public, private, profit, or not for profit o Health insurance issuers and regulatory/accreditation entities that oversee health care providers cannot be listed o Must be certified and listed by AHRQ PSO What is a Patient Safety Organization?

o Patient Safety Organizations are:  Independent and external resources that collect, analyze, and aggregate “patient safety work product” (e.g., Root Cause Analysis, event reports) to develop insights into the underlying causes of patient safety events. 8 What is a Patient Safety Organization? Participating Providers Patient Safety Organization

9 Hospital #1 Patient Safety Organization Hospital #2 Hospital #3 Hospital #4 Hospital #5 Analyses & Reports to Improve Patient Safety What is a Patient Safety Organization?

10 o Patient Safety Organizations  Afford both privilege and confidentiality protection to patient safety work product (e.g., Root Cause Analysis, event reports), subject to exceptions.  Create a secure environment where providers can collect, aggregate, and analyze data to improve quality.  Alleviate fear of liability, fostering candid reporting of actual patient safety events, unsafe conditions, and near misses. What is a Patient Safety Organization? Privilege / Confidentiality

11 o Patient Safety Organizations undertake the following 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; 3.The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices; 4.The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk; 5.The maintenance of procedures to preserve confidentiality with respect to patient safety work product; 6.The provision of appropriate security measures with respect to patient safety work product; 7.The utilization of qualified staff; and 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. What is a Patient Safety Organization? Patient Safety Organization Activities

o Patient Safety Work Product is:  “Any data, reports, records, memoranda, analyses, written or oral statements...”  Which could improve patient safety, health care quality, or health care outcomes; and  (A) Which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, which includes information that is documented as within a patient safety evaluation system for reporting to a PSO, and such documentation includes the date the information entered the patient safety evaluation system; or  (B) Are developed by a PSO for the conduct of patient safety activities;  Which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system. 12 What is a Patient Safety Organization? What is / is not Patient Safety Work Product

o Patient Safety Work Product examples:  Event reports and investigations, patient safety audits, patient safety communications, Root Cause Analysis, unsafe behavior evaluations, quality reviews, patient safety related minutes 13 What is a Patient Safety Organization? What is / is not Patient Safety Work Product

o Patient Safety Work Product is not:  Medical records, billing records, other original patient information  “Information which is collected, maintained or developed separately or which exists separately from a patient safety evaluation system”  Required state or federal reports (ex. Code 15) 14 What is a Patient Safety Organization? What is / is not Patient Safety Work Product

o Patient Safety Work Product is confidential and shall not be disclosed.  Exceptions to Confidentiality:  Ex:  Disclosure for Patient Safety Activities  Disclosure for research authorized by the Secretary  Disclosure to Food and Drug Administration  Voluntary disclosure to accrediting body  Disclosure for business operations i.e. to attorneys, accountants, etc.  Disclosure to law enforcement 15 What is a Patient Safety Organization? Release of Patient Safety Work Product – Confidentiality

 Patient Safety Work Product is privileged  Not subject to discovery  Civil Subpoena or Order (ex., 3rd party subpoena or discovery request)  Discovery in administrative proceedings (ex., Board Of Medicine request)  State/Federal Freedom Of Information Act requests  Cannot be admitted as evidence  In federal or state civil or criminal proceedings, administrative rule-making or any professional disciplinary proceeding 16 What is a Patient Safety Organization? Release of Patient Safety Work Product – Privilege

ex. Affordable Care Act § 1311(h) ex. Hospitals with 51 or more beds must in essence participate in a Patient Safety Organization in order to contract with insurers that sell Qualified Health Plans in Exchanges.  Statutory deadline postponed January 1, 2017 Secretary of Health and Human Services may require non-hospital providers and suppliers (physicians) to meet certain other requirements as well. ex. State PSO participation requirements ex. Movement toward “High Reliability Organization” environment 17 Will PSOs pick up steam? Yes, “future state” heavily linked to improvements in patient safety

Developing Case Law o The Courts are validating that PSQIA “preempts” state law. o The Courts are generally recognizing how broad this protection was intended to be. (ex. The protection can even apply retroactively.) o There is/will be some disagreement over key provisions and intended overall scope of protection. 18 So, What do the Courts think so far?

o A new opportunity to partner in patient safety improvement o Regulatory Oversight Agencies (ex., CMS & state licensing agencies)  Requires a new conversation and cooperative effort  PSO Awareness is all over the board 19 What does this mean for the Regulatory Environment? (at least in my view)

QUESTIONS?