1. Patient Safety Organizations: Advancing Patient Safety and Health Care Quality An Overview
AHFSA Conference
Austin, TX August 22-24, 2016

2. Objectives
For attendees to learn the objectives of a Patient Safety Organization (“PSO”) from the providers’ perspective
For attendees to understand the basic framework of how a PSO is designed and operates
To highlight the general issues impacting PSO providers’ participants and survey agencies

3. What is a Patient Safety Organization?
Background
Patient Safety & Quality Improvement Act
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 82 certified Patient Safety Organizations, but that number is expected to increase

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6. What is a Patient Safety Organization?
Defined:
An entity or a component of another organization (private or public) that has a mission and primary activity of improving patient safety and the quality of healthcare delivery.

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

8. What is a Patient Safety Organization?
Privilege / Confidentiality
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 fears of liability, fostering candid reporting of actual patient safety events, unsafe conditions, and near misses.

9. Purpose of Patient Safety Organizations
Protections foster “a non-punitive culture of safety”
Protections alleviate fears of liability, fostering candid reporting of actual patient safety events, unsafe conditions, and near misses.
Create a secure environment where providers can collect, aggregate, and analyze data to improve quality.

10. Purpose of Patient Safety Organizations
Protection for Reporters
Who’s Protected & How:
Agents or Employees of Member Providers
Any individual who reports an event to the Provider Hospital or Patient Safety Organization
Will not face retaliation or adverse employment action in response to the actual reporting of the event to the Patient Safety Organization

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

12. Affordable Care Act § 1311(h)
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.
Effective January 1, 2017
Secretary of Health and Human Services may require non-hospital providers and suppliers (physicians) to meet certain requirements as well.

13. What is a Patient Safety Organization
What is a Patient Safety Organization? Patient Safety Organization Activities
Patient Safety Organizations undertake the following patient safety activities:
Efforts to improve patient safety and the quality of health care delivery;
The collection and analysis of patient safety work product;
The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
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;

14. What is a Patient Safety Organization
What is a Patient Safety Organization? Patient Safety Organization Activities
Patient Safety Organizations undertake the following patient safety activities:
The maintenance of procedures to preserve confidentiality with respect to patient safety work product;
The provision of appropriate security measures with respect to patient safety work product;
The utilization of qualified staff; and
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.

15. What is a Patient Safety Organization?
What is / is not Patient Safety Work Product
Patient Safety Work Product is:
“Any data, reports, records, memoranda, analysis or written or oral statements which could improve patient safety, health care quality, or health care outcomes. . .”
Ex: event reports and investigations, patient safety audits, patient safety communications, Root Cause Analysis, unsafe behavior evaluations, quality reviews, patient safety related minutes

16. What is a Patient Safety Organization?
What is / is not Patient Safety Work Product
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.
Info that flows between providers (ex. Hospital) and PSOs, deliberations or analysis about whether and what to report, and the reporting.

17. What is a Patient Safety Organization?
What is / is not Patient Safety Work Product
Patient Safety Work Product is not:
Medical records, billing records, other original patient information
Information collected outside of the Patient Safety Evaluation System or otherwise “separately maintained”
Information necessary to satisfy mandatory state or federal reporting obligations

18. What Sort of Work has Been Popular in a PSO Environment?
Event Reports/Analysis
Root Cause Analysis
Quality/Risk Reviews

19. What is a Patient Safety Organization?
Release of Patient Safety Work Product – Confidentiality
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

20. Impermissible disclosures are subject to a 10K CMP per violation enforced by OCR

21. What is a Patient Safety Organization?
Release of Patient Safety Work Product – Privilege
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

22. Patient Safety Evaluation System (PSES)
Definition
Statute:
Body that manages the collection, management, or analysis of information for reporting to or by a Patient Safety Organization (CFR Part 3.20 (b)(2))
“Protected space or system that is separate, distinct and resides alongside but does not replace other information collection activities…”
Used to determine which data actually becomes Patient Safety Work Product (PSWP) and is sent to the Patient Safety Organization

23. Patient Safety Evaluation System (PSES)
Think of the PSES as an actual office or physical space, like an “information box”
To: Providers / Reporters
Safety Alerts
Best Practices
Training
PSES
PSWP
Data Aggregation
Deliberation & Analysis
Ideas for Prevention & Quality Improvement
From: Providers / Reporters
Events
Raw Data
Medical Records

24. Patient Safety Evaluation System (PSES)
Important to understand the boundary lines of the “protected space” which is the PSES.
Analysis performed & conducted within the PSES cannot then be dropped out.
AHRQ cautions that information in the PSES must be information created for patient safety. In other words, they warn that you cannot “re-label” corporate documents to obtain the protections.
Appropriate staff with access to the PSES/PSWP must enter into a Confidentiality Agreement and understand how to avoid impermissible disclosures.

25. Patient Safety Evaluation System (PSES)
Application
An established PSES:
Committed to written policy
Provides key definitions
Defines scope of work
Outlines “mechanics” of handling PSWP
Addresses importance / steps for protecting confidentiality of PSWP

26. Developing Case Law
The Courts are validating that this federal law provides protection even where state law does not.
The Courts are recognizing how broad this protection was intended to be.
The protection can even apply retroactively.
Battleground has centered on PSWP exceptions

27. Regulatory Agencies & PSOs: General Impressions
Awkward out of the gate
Providers are learning to “crawl, walk, run”
Survey agency knowledge about PSO environment varies widely
CMS has issued 2013 and “Memorandum Summary” addressing PSOs and survey activities (maybe other?)

28. HHS Guidance – May 2016
“Reiterates” provider responsibilities to meet external obligations using non-PSWP
“Reminds” survey agencies that PSWP is privileged and confidential and cannot be disclosed
Encourages proactive engagement between providers and survey agencies on these issues

29. Thoughts on a Path Forward
We have a mutual best interest in PSO advancement
PSO participation can easily be verified by surveyors
Many PSOs have compliance strategies/plans in place already
Constructive dialogue in advance can be very helpful in my experience

30. Questions
B. Page Gravely, Jr.