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

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DisclaimerThe 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for Health Care Administration (AHCA)Because the laws in many areas can change rapidly, this information can become outdated.Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.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

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What is a Patient Safety Organization?Background

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History of the Patient Safety Acto To Err is Human:

Building a Safer Health System

1999

o Initiated by the Institute of Medicineo 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

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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

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Benefits of Patient Safety Organization Participation

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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.

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What is a Patient Safety Organization?

Participating

Providers

Patient Safety

Organization

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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?

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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

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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.

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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

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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)

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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 enforcement15

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

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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

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Will PSOs pick up steam?Yes, “future state” heavily linked to improvements in patient safety

Developing Case Law

oThe Courts are validating that PSQIA “preempts” state law.

oThe Courts are generally recognizing how broad this protection was intended to be. (ex. The protection can even apply retroactively.)

oThere is/will be some disagreement over key provisions and intended overall scope of protection.

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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

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What does this mean for the Regulatory Environment?(at least in my view)

QUESTIONS?