working with patient safety organizations (psos) · pdf filecopyright 2009.ecri institute...

Copyright 2009.ECRI InstituteCopyright 2009.ECRI Institute

Working With Patient Safety Organizations (PSOs)Ronni P. Solomon

ECRI Institute

Copyright 2009.ECRI Institute

P2 Policies and Procedures for Institutions

Working with PSOs

Ronni P. Solomon, Executive Vice President and General Counsel, ECRI Institute

Agenda

� Background of Patient Safety Act

� Key concepts

�Reporting to a PSO

� Setting up your PSES

�Questions & Discussion


About ECRI Institute

� Independent, not-for-profit applied research institute, 40-year history

�Helping the healthcare community to determine the best ways of

delivering care� Patient Safety, Quality and Risk Management

� Technology Assessment, Effectiveness

� Medical Product Evaluation, Planning, Procurement

� Strict conflict of interest rules

�Qualified PSO staff; 300 person interdisciplinary staff� Clinical, safety, risk management, healthcare quality, engineering, life sciences,

information technology, statisticians, data analysts

� Federally-certified PSO


Why ECRI Institute is a PSO


Annual Accidental Deaths(from Lucian Leape)


What Should We Do?

• Implement known best practices

• Redesign faulty systems

• Change the culture - from a culture of

blame to a culture of safety

• Congress should pass legislation to protect the

development and analysis of information related to

improving safety and quality.


Why Federal Protection is Needed

• Providers fear that patient safety reports could be

used against them

• State protections vary – may offer no or inadequate

protections (e.g., no protection if data is shared

outside the hospital)

• For improvement, we need robust reporting and

aggregation of data; by analyzing more events,

patterns of failures could be more rapidly identified


Near-miss data for the health care domain

should be analyzed more extensively than is

currently the case. The data provide two types

of information relevant to patient safety – on

weaknesses in the health care system and,

equally important, on recovery processes.


Stories from Pennsylvania


�Near failure to

rescue patient

who arrested

Near Miss – Color Coded Wristbands


Look-Alike Packaging

�Confusingly similar

packaging for insulin

and tuberculin

syringes

�Potential tenfold

overdose of insulin


Discovering the Unexpected

� Medication errors involving incorrect patient weights

� 40% from the ED. Many don’t have scales capable of weighing immobilized or

unconscious patients without removing them from a gurney or stretcher.

� The not-so unusual…

� Patients scheduled for gall bladder removal only to find that the gall bladder

was already removed. Failure to obtain a proper history (patients had

dementia), and all the patients were diagnosed with ultrasound (a non-specific

test) with no further confirmation.

� 200 reports of staff who misunderstood the distinctions between

living wills and DNR orders.

� Many cases involved inappropriate withholding of treatment, failure to rescue.


Frequency, Severity

�Medication Errors

� 22% of overall

� 4% of events involving harm and

1% of events contributing to or

resulting in death.

�Complications related to

Procedures/Treatments/Tests

� 13% of overall

� 43% of events involving harm and

59% of events resulting in or

contributing to the patient’s death.


Share, Learn, Change

• 218 Patient Safety Officers

reported 607 changes in 2008

• Hand hygiene practices

• Wrong site surgery prevention

• Anticoagulation management

• Medication assessment and fall

risk

• Many more…


Collaboratives, Analysis, Tools


The Patient Safety Act

Many Benefits; Know the Details


PSOs and providers are

mutually responsible

Federal Patient Safety Act


Federal Patient Safety Act

�To improve healthcare quality and

patient safety

�To share data within a protected

legal environment

�To identify and reduce the

potential risks associated with

patient care

The Act is voluntary and does not provide

federal funding of PSOs


Legal Protections

�Not subject to subpoena in civil, criminal, administrative

proceedings

�Not subject to discovery

�Not admissible into evidence

�Not subject to FOIA

�Goes beyond state law for some

�Participation with a PSO is voluntary—legal protections

only kick-in if provider participates


What Does It Mean?

�Patient Safety Organizations (PSOs)• Entities that meet the requirements of the Patient Safety Act and Rule

�Patient Safety Work Product (PSWP)• Information that is privileged and confidential

�Patient Safety Evaluation System (PSES) • The protected space in which PSWP is assembled or developed for reporting to or from a PSO

• A provider’s deliberations and analyses within a PSES are confidential and privileged


Collaborative Model


Patient Safety Organizations (PSO)

�Federally designated by

AHRQ

�PSO must comply with a

host of requirements

�Information reported to or

developed by a PSO for the

purpose of conducting

patient safety activities is

protected


Patient Safety Work Product (PSWP)

1. PSWP means any data, reports, records, memoranda, analyses (such as root cause

analyses), or written or oral statements (or copies of any of this material)

i. 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; or

2. Which identify or constitute the deliberations or analysis of, or identify the fact of

reporting pursuant to, a patient safety evaluation system.

H

O

W


What is not PSWP

�Patient medical records, billing and discharge

information, other original patient or provider information

�Information that is collected, maintained, or developed

separately, or exists separately, from a PSES.

�Information collected to comply with external obligations:

e.g., state reporting requirements; FDA Medwatch;

NPDB.


When is PSWP protected?

�Upon collection

�Provider documents that the information was collected

for reporting to a PSO and the date of collection

�Query: How long is too long before submission to the

PSO?


Documenting PSWP

• Label PSWP

• Helps to prevent inappropriate disclosure.

− “CONFIDENTIAL PATIENT SAFETY WORK PRODUCT.

Protected under the Patient Safety and Quality

Improvement Act. Do not disclose unless authorized by

[name of governing document, office, or body].”

• P & Ps


Patient Safety Evaluation System (PSES)

� Defined as: the collection, management, or analysis of information for

reporting to or by a PSO

� Meant to be flexible and scalable to individual operations

� Best practice is to document the PSES


PSES…The regulations say

A protected space or system that is separate, distinct,

and resides alongside but does not replace other

information collection activities mandated by laws,

regulations, and accrediting and licensing requirements

as well as voluntary reporting activities that occur for the

purpose of maintaining accountability in the health care

system.


Keep in Mind…..

PSWP submitted to the PSO is

forever privileged and

confidential and cannot be

disclosed except in limited

circumstances – called

“permissible disclosures”.


Facility may remove PSWP

from PSES before submitting;

no longer PSWP; a virtual

copy can be sent to the PSO;

PSO still treats it as

confidential.

You Can Remove PSWP from the PSES


Internal Use of PSWP

�Is NOT regulated

�“Affiliated providers” may share identifiable PSWP

�May share with practitioners having privileges

�May share de-identified data with non-affiliated

providers


Establishing the PSES

�Take inventory

�Committees, Departments

�Set goals

�Develop recommendation,

Obtain agreement

�Document the PSES

�Implement

�Monitor


Questions to Consider

�Where to start…what types of data?

�How to use existing structures,

processes?

�Centralize the PSES?

�Multi-hospital systems?

�Access to PSES data?

�How long data can stay in the PSES

before reporting to a PSO?

Patient Safety Officer

PSO


Prioritizing Reportable Data

�Prioritize based on criteria:

• Promotes a culture of safety/improves care

• Impressions/subjective data that is not available in the

medical record

• Not required to be reported elsewhere (although there are

permissible disclosures)

• Data will not be used to make adverse employment

decisions


Documenting the PSES

�Some ideas….• Processes, activities, the physical space, computer systems, and

equipment that compose the PSES

• Procedures for entering data and information into the PSES

• Personnel who have access to the PSES and how they carry out their

duties and the system's operations

• Conditions for accessing PSWP that is part of the PSES

• Procedures for reporting information to the PSO and receiving feedback

form the PSO

• Procedures for disseminating information outside the PSES


P&Ps

�Purposes and Scope

�Definitions

�Describe your PSES

�Reporting to PSO

�Confidentiality, Security

�Permissible Disclosures


Resources

�Advisories,

audioconferences

�www.ecri.org

�Best Practices

�Structures

�P&Ps

�Documenting the PSES


Questions

&

Discussion

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