Erin Muellenberg Principal emuellenberg@polsinelli.com 310.203.5322 Patient Safety Quality Improvement Act: What Every Medical Staff Professional Should Know Erin Muellenberg Principal emuellenberg@polsinelli.com 310.203.5322

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What does that mean???? AHRQ Agency for Healthcare Research and Quality CHPSO California Hospital Patient Safety Organization HIE Health Insurance Exchange HEN Health Enterprise Network NPSD Network of Patient Safety Databases PSQIA Patient Safety Quality Improvement Act PSO Patient Safety Organization PSES Patient Safety Evaluation System PSWP Patient Safety Work Product QHP Qualified Health Plan QIO Quality Improvement Network

PSQIA 2005 enacted to reduce preventable harm (“To Err is Human”) Effective January 19, 2009 Encouraging peer review and discussions to reduce harm through enhanced privilege and protections when working with PSO AHRQ developed standardized formats for reporting PSO’s analyze and share data to identify opportunities for improvement PSWP is privileged and protected Payments tied to quality incentivize participation

Legislative History PSQIA – July 29, 2005 Final Rule November 21, 2008 Effective January 19, 2009 CMS issued final regulations of the Affordable Care Act March, 2014 All hospitals > 50 beds must have a PSES and be affiliated with a PSO to be part of a QHP participating in a HIE

Legislative History CMS modifies PSES requirement to include alternative for QHP participation Participates in HEN; or Contracted to QIO Privilege and confidentiality only available if participate in PSO

Patient Safety Work Product and Patient Safety Evaluation System Legislative History May 24, 2016 – HHS Releases “Guidance” Patient Safety Work Product and Patient Safety Evaluation System

Patient Safety Evaluation System “Patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a PSO.” 42 USC 299b-21(6); 42 CFR 3.20.

Patient Safety Work Product (PSWP) Information prepared by a provider and reported to a PSO Information developed by a PSO for conduct of patient safety activities The information identifies or constitutes the deliberations or analysis of, or identifies the fact of reporting, pursuant to a PSES HHS Guidance, May 24, 2016

January 1, 2017 – ACA Hospitals of 50 beds or greater Required to have PSES and reporting to a Patient Safety Organization Contracting with Qualified Health Plan

Goal Improve patient safety by encouraging voluntary and confidential reporting of adverse events Patient Safety Act authorized creation of PSOs Improve quality and safety through Collection and analysis of aggregated data PSOs identify patterns of failure and help identify strategies to improve care

Benefit Privilege and confidentiality protections Established common formats for reporting patient safety events Established Network of Patient Safety Databases Requires annual reporting to AHRQ

PSOs Almost any healthcare entity can be or have a PSO PSO is an external objective expert collecting events reported as PSWP to determine cause of events

Patient Safety Events Incidents Near Misses Unsafe Conditions Any event that adversely effects quality, patient safety, or outcomes

AHRQ Common Formats Uniform measure of patient safety events Permits aggregation and analysis Locally, regionally and nationally

Patient Safety Evaluation System Determines what can be PSWP Policies and Procedures Collects data to improve patient safety Reviews data and takes action Analyzes data and makes recommendations Conducts RCA’s, proactive risk assessments, in-depth reviews, audits Reports to PSO

PSES Activities Reported to PSO Medical error investigations, RCAs Risk Management – incident reports, RCA’s, investigation notes Practitioner specific outcome quality data Peer Review Committee minutes related to patient safety activities

Protects Patient safety activities Collection and analysis of PSWP Development and dissemination of information Recommendations, protocols, best practices, etc. Use of PSWP to promote safety PSES activities Security of PSWP Confidentiality of PSWP

Patient Safety Work Product Data assembled and developed by a provider for reporting to a PSO Analysis and deliberations conducted within a PSES Reports Oral and written statements Data Investigative memos

Patient Safety Work Product Medical Error or Proactive Risk Assessments & Actions, Root Cause Analysis Risk – Investigation notes, interview notes, RCA notes, analysis. Patient safety activities within the PSES which are not required to be externally reported. (Incident reports may be protected in some cases) Outcome/Quality Data – Includes practitioner specific Peer Review – information not used for disciplinary action Committee minutes for activities included in the PSES relating to patient quality and reducing risks Other reports, analyses, deliberations relating to patient safety

What is Patient Safety Work Product (PSWP)? Requirements Must be created in PSES Key dates must be documented PSWP Reports Oral and Written Statement Data Records Memoranda Deliberation and Analysis Data which could improve patient safety, health care quality, or health care outcomes Data assembled or developed by a provider for reporting to a PSO and are reported to a PSO Analysis and deliberations conducted within a PSES Data developed by a PSO to conduct of patient safety activities

NOT Patient Safety Work Product Original Records; medical records, billing, etc. Information collected and maintained outside the PSES External reporting Claims data Information not collected for reporting to the PSO PSWP that is dropped out of the PSES Adverse Event report or other mandated reports to state, federal or local agencies Facts

Functional Reporting Authorizing PSO access to specific information in PSES Contract Confidential and secure Identifies when PSO can have access Footer Text

Drop Out Provision PSWP can be withdrawn provided not reported and reason and date documented Cannot be used if information has been reported Footer Text

After Removal Take disciplinary action Report to external agencies Use for another purpose Footer Text

PSWP is Privileged Not admissible in federal or state court or other legal proceeding State licensure proceedings Hospital peer review disciplinary proceedings Requests from CMS or accrediting agencies Footer Text

EC 1157 v. PSQIA EC 1157 PSQIA Limited in scope of covered activities and entities Consistent national standard Does not apply to federal claims Applies to all state and federal proceedings Protection waived when shared outside institution Protections can never be waived PSWP can be shared within health system and include corporate non-provider parent Footer Text

Minutes Executive session for review in PSES Review of specific cases Analysis of RCA Monitoring plans Recommended actions Footer Text

Sharing & Uses Healthcare systems can share within and across states Must comply with all external reporting requirements May be used internally Shared with attorneys Footer Text

Charles v. Southern Baptist Hospital of Florida Feb. 2017 Medical malpractice plaintiffs sought incident reports related to adverse event The hospital reported the incidents to the PSO and declined to produce under PSQIA Court declined to protect because the reports were designed for the purpose of reporting to the state rather than for reporting to PSO No dual purpose protection Footer Text

Published Cases Illinois Dept. of Financial and Professional Regulation v. Walgreens, 970 N.E.2nd 972 (2012) - IDFPR sought incident reports of medication errors. Walgreens declined to produce as they were PSWP. Court agreed. Lee Medical, Inc. v. Beecher, 312 S.W.3d 515 (2010) – Reports of decision not to use vascular access vendor are not PSWP protected under PSQIA. KD ex rel. Dieffenbach v. U.S., 715 F. Supp. 2d 587 (2010) – NIH research protocols held to be privileged. (Compares and contrasts HCQIA and PSQIA)

Published Cases, cont. Sevilla v. U.S., 852 F.Supp.2nd 1057 (2012) – Documents sought in medical malpractice case privileged from discovery in Federal Torts Claims Act case by PSQIA. Tibbs v. Bunnell, 448 S.W.3d 796 (2014) – Protections to PSWP strictly limited and not extended to other documents containing reasoning and analysis. Baptist Health Richmond, Inc. v. Clouse, 497 S.W.3d 759 (Sept. 22, 2016) – PSQIA does not relieve provider of duty to fulfill statutory and regulatory reporting. Southern Baptist Hospital of Florida, Inc. v. Charles, (Jan. 31, 2017) – Adverse incident reports required to be externally reported not PSWP.

Interesting but Not Published Cases Taylor v. Hy-Vee, Inc., 2016 WL 7405669 – Incident reports held protected by PSQIA in employment discrimination case. Eaves-Voyles v. Almost Family, Inc., 2016 WL 4011270 – PSQIA provides whistleblower retaliation protection and private right of action. Grenier v. Stamford Hospital Stamford Health System, Inc., 2016 WL 3951045 – PSQIA protection extended to documents sought in malpractice EMTALA action. Johnson v. Cook County, 2015 WL 5144365 – Defendants required to show that reports sought in discovery were either reported or functionally reported to PSO. What’s Hot and What’s Coming: Medical Staff Litigation, New Federal Compliance Issues for Medical Staffs and Privacy and Data Security | Arent Fox LLP

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