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
10
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
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
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