William B. Munier, MDDirector, Patient Safety Organization Program

Center for Quality Improvement and Patient SafetyAgency for Healthcare Research and Quality

Sponsored by Quantros Patient Safety Center22 July 2014

The Impact of PSOs on the Healthcare Industry &

Benefits of Common Formats

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2

NIHBiomedical research to prevent, diagnose & treat diseases

CDCPopulation health & the role of community-based interventions to improve health

AHRQLong-term & system-wide improvement of health care quality & effectiveness

HHS Organizational Focus

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Need for a National Learning Effortto Improve Quality & Safety

Quality improvement is still a developing science

Adverse events keep occurring

Measurement is a mess

Barriers to learning remain

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Barriers to Learning

Providers fear that quality & safety analyses & reports could be used against them in court (malpractice suits) or in disciplinary proceedings

State laws offer inadequate protections (e.g., multi-state providers cannot share information system-wide without risk)

Quality & safety improvement is hampered by under-reporting & inability to aggregate data across providers & locations

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The Patient Safety andQuality Improvement Act

• Authorizes “Patient Safety Organizations” (PSOs)

• Establishes “Network of Patient Safety Databases” (NPSD)

• Authorizes establishment of “Common Formats” for reporting patient safety events

• Requires reporting of findings annually in AHRQ’s National Health Quality/Disparities Reports

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The Patient Safety Act

PSOs provide uniform US national legal protection – that is, privilege & confidentiality for clinicians & entities performing quality & safety activities

Common Formats provide a way of measuring patient safety events in a uniform manner, both clinically & electronically; they permit aggregation & analysis of clinical information locally, regionally, & nationally

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PSO Trial Court Decisions

Several lawsuits have been filed challenging the protections offered by the Patient Safety Act

Most significant to date: IL Dept of Financial and Professional Regulation v. Walgreens (IL 4/7/11)

– In an opinion filed May 29, 2012, an Illinois appellate court upheld a lower court’s decision that patient safety work product is privileged under the Patient Safety Act & therefore is not discoverable

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PSO Program Status

There are currently 80 PSOs in 29 states & the District of Columbia

Examples of PSOs include components of:

– California Hospital Association

– ECRI

– Hospital Corporation of America

– University HealthSystem Consortium

– Walgreens (CVS, too)

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PSO Profile Data

Count of PSOs by Type of Business (N=65)

(A PSO may choose more than one type)

048

121620 19

17

12

5 53 2

11

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PSO Profile Data

Count of PSOs by Clinical Specialty Focus (N=65)

(A PSO may choose more than one type)

All Spe

cialtie

s

Anest

hesio

logy

Emer

genc

y M

ed

Pharm

acy

Gen

eral

Surge

ry

OB/G

YN

Pediat

rics

Radiol

ogy

Vascu

lar S

urge

ry

Nursin

g

Allied

Health

Colore

ctal S

urg

Family

med

icine

Orth

oped

ic Sur

gO

ther

0

10

20

30

40 36

8 6 63 3 3 3 3 3 3 2 2 2

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Affordable Care Act Sec. 1311 Update

All hospitals > 50 beds are required to have a Patient Safety Evaluation System (PSES), which means a relationship with a PSO, to be part of a qualified health plan participating in a Health Insurance Exchange (HIE)

There is a two-year phase-in period:

Jan 1, 2015 to Jan 1, 2017

This requirement is likely to increase number & utilization of PSOs during the interim

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PPC

PSO

PSONPSD

Other Qualified

Sources

AHRQ National Quality Reports

User:Researcher

User:PSO

User:Provider

PSO

Data flow: PSOs, Providers, & PSWP

Provider Provider Provider

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Common Formats

Common language for patient safety event reporting– Common language & definitions

– Standardized rules for data collection

Standardized patient safety reports (“apples to apples”)

Developed through a formal, collaborative process

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Making the Formats Universal

XKCD 927

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Common Formats

Developed with a Federal work group comprising major health agencies (e.g., CDC, CMS, FDA, ONC, DOD,

VA)

Incorporate input from public, industry

Reviewed by an NQF expert panel, which provides advice to AHRQ

Promulgated as “guidance” announced in the Federal Register

Approved by OMB (process & Formats)

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Common Formats Only national patient safety reporting scheme

designed to meet all of the following four goals:

1. Support local quality/safety improvement

2. Provide information on harm from all causes

3. Allow comparisons over time & among different providers

4. Allow the end user to collect information once & supply it to whoever needs it (harmonization) – a long-term goal

Designed to decrease data collection burden!

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Common Formats

Common Formats are site-specific (e.g., hospital)

They apply to all patient safety concerns:– Incidents – patient safety events that reached the

patient, whether or not there was harm

– Near misses (or close calls) – patient safety events that did not reach the patient

– Unsafe conditions – any circumstance that increases the probability of a patient safety event

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Modular FocusHospital Version 1.2

Blood & Blood Products

Device & Medical or Surgical Supply, Including HIT

Fall

Healthcare-Associated Infection

Medication & Other Substances

Perinatal

Pressure Ulcer

Surgery & Anesthesia

Venous thromboembolism

All others via generic forms

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Event TypePatient

InformationLevel of Harm

Hospital Common Formats

For all events, CFs assess general information.

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Hospital Common Formats

If the event is covered by an Event-Specific Format,

additional information will be requested.

Medication

Event TypePatient

InformationLevel of Harm

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Hospital Common Formats

If the event involves more than one type of adverse action, e.g., a

malfunctioning device that administers too much drug, then more than

one event-specific Format will be invoked.

Medication Device

Event TypePatient

InformationLevel of Harm

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Hospital Common Formats

Narratives are collected on all adverse events. While they are not

useful at a national level, they are invaluable at the local level.

Medication Device

Narrative

Event TypePatient

InformationLevel of Harm

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Hospital Common Formats

Medication Device

Narrative

User Defined Customization

Each institution, vendor, or PSO can add an unlimited number of additional questions of its own choosing.

Event TypePatient

InformationLevel of Harm

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Progress to Date WithAdoption of the Common Formats

Institute of Medicine Report on Health IT and Patient Safety, November 2011 – recommends use of the Common Formats, as well as PSOs, for reporting IT-related adverse events

Office of the Inspector General (HHS) – 2010 & 2012 reports on adverse events in hospitals recommend surveyors/accreditors evaluate hospitals regarding their use of the Common Formats

Office of the National Coordinator for HIT – new S&I Framework Initiative focuses on Structured Data Capture of Formats; ONC plans to integrate Common Formats into Meaningful Use criteria

CMS – is educating their surveyors about the Common Formats to encourage their use; ACA requires hospitals > 50 beds to work with PSOs; CMS regulations establish a two-year phase-in period from Jan 2015 to Jan 2017

NLM – is overseeing efforts to expand LOINC to cover patient safety, including adding codes for the Formats

FDA – has been working with AHRQ to align its device-reporting system, MedSun, with Common Formats, as well as MedWatch for drug-reporting

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Cautionary Note About EHRs

EHR-based extraction of information to support patient safety is getting a lot of attention today

Most work regarding EHRs & safety has centered around alerts, reminders, & “triggers” to foster safer care in real time as providers enter data into EHRs

Little work has gone into defining/specifying how actual patient safety events should be recorded in, or measured from, medical records

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Cautionary Note About EHRs

Data that are entered into EHRs today regarding patient safety events are not standardized in any way – & there are thousands of EHRs!

There is much intellectual work to be done to arrive at standard definitions of patient safety events that are used to document their occurrence – and employed universally in EHR products

Event reporting systems, which contain data that should never be recorded in the medical record, will retain their critical role in supporting patient safety

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The Future

Definition of patient safety events (Common Formats) ultimately needs to support operational systems at three levels:

1. Adverse event reporting (not part of medical record)

2. Surveillance (derived from medical records)

3. Use of electronic health records (recording of data directly into EHRs)

Clinical & electronic definitions must be consistent throughout all levels, & be interoperable where appropriate

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Common Formats on the Web

https://www.psoppc.org

Confidential – Do Not Distribute or Copy Without Prior Permission from Quantros 29

Quantros Safety Suite of Solutions

Safety Rx(Pharmacies)

Safety Event Manger

(Hospitals & Clinics)

Patient Safety Organization Manager

Aut

hen

ticat

ion

Laye

r

Patient Safety Evaluation

System

AH

RQ

1.2

XM

L E

xpor

t M

odul

e

Legacy SystemsCSV uploadAHRQ 1.2

XML Upload

Interface

Interface

NPSD

PSOPPC

PSO Data Management Quantros

Patient Safety Center

Confidential – Do Not Distribute or Copy Without Prior Permission from Quantros 30

Quantros PSO Manager

PSO Technology for Protecting Data

• Quantros Patient Safety Manager (PSOM)• Web-enabled Patient Safety Evaluation System (PSES)

• Keeps incident data separate and defensible• Supports Patient Safety Act compliance• Provides ability to remove PSWP from PSES for external use prior to

submission to PSO• Enables you to help demonstrate “intent to submit” requirement for

protection

• Works best with Quantros safety solutions, but can work with any incident reporting system that can export in AHRQ Common Format 1.2-compliant formats

Confidential – Do Not Distribute or Copy Without Prior Permission from Quantros 31

Quantros Safety Suite of Solutions

Quantros Patient Safety CenterThe Quantros Patient Safety Center (QPSC) is a federally listed PSO. With QPSC, participating providers can work openly and collaboratively with peer organizations and experts in a safe environment.

PSO ManagerThe PSO Manager (PSOM) supports seamless submission of data to the Quantros Patient Safety Center or other Patient Safety Organizations.

Safety Event ManagerThe Quantros Safety Event Manager (SEM) application is the core of the Quantros Safety and Risk Management (SRM) platform and allows event reporters to classify safety incidents faster and more precisely.

Safety RxSafety Rx provides an intuitive, Web-based solution for pharmacists and pharmacy staff to report safety and quality incidents.

IRISIRIS is a web-based analytics and reporting solution that aggregates data across you organization’s quality, safety, and billing systems. This data is presented to end users in one place, via a highly configurable, role-based dashboard, and is integrated with Quantros’ Safety Event Manager.

For more information visit www.quantros.com