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

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3. 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

4. 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

5. 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

6. 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

7. 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

8. 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.

9. 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

10. 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

11. 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

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

13. 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

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

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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. Functional Reporting
Authorizing PSO access to specific information in PSES
Contract
Confidential and secure
Identifies when PSO can have access
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24. Drop Out Provision
PSWP can be withdrawn provided not reported and reason and date documented
Cannot be used if information has been reported
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25. After Removal Take disciplinary action Report to external agencies
Use for another purpose
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26. 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
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27. 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
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28. Minutes Executive session for review in PSES Review of specific cases
Analysis of RCA
Monitoring plans
Recommended actions
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29. Sharing & Uses Healthcare systems can share within and across states
Must comply with all external reporting requirements
May be used internally
Shared with attorneys
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30. 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
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31. 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)

32. 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.

33. Interesting but Not Published Cases
Taylor v. Hy-Vee, Inc., 2016 WL – Incident reports held protected by PSQIA in employment discrimination case.
Eaves-Voyles v. Almost Family, Inc., WL – PSQIA provides whistleblower retaliation protection and private right of action.
Grenier v. Stamford Hospital Stamford Health System, Inc., 2016 WL – PSQIA protection extended to documents sought in malpractice EMTALA action.
Johnson v. Cook County, 2015 WL – 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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