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The Impact of PSOs on the Healthcare Industry & Benefits of Common Formats

William B. Munier, MD Director, Patient Safety Organization Program Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality Sponsored by Quantros Patient Safety Center 22 July 2014

HHS Organizational Focus

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NIH

Biomedical research to prevent, diagnose & treat diseases

CDC

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

AHRQ

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

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Need for a National Learning Effort to Improve Quality & Safety

 Quality improvement is still a developing science  Adverse events keep occurring  Measurement is a mess  Barriers to learning remain

Barriers to Learning

4  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 and Quality 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

PSO Trial Court Decisions

7  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

PSO Program Status

8  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) 20 15 10 5 0 19 17 12 5 5 3 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) 40 35 30 25 20 15 10 5 0 36 8 6 6 3 3 3 3 3 3 3 2 2 2 28

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

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Data flow: PSOs, Providers, & PSWP

Provider Provider Provider

AHRQ National Quality Reports

PSO

User: PSO

PPC NPSD PSO

User: Provider

PSO

Other Qualified Sources User: Researcher

Common Formats

13  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

Making the Formats Universal

14 XKCD 927

Common Formats

15  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 Focus Hospital 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

Hospital Common Formats

For all events, CFs assess general information.

19 Event Type Patient Information Level of Harm

Hospital Common Formats

If the event is covered by an Event-Specific Format, additional information will be requested.

20 Medication Event Type Patient Information Level of Harm

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.

21 Medication Event Type Patient Information Device Level 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.

Narrative Medication Event Type Patient Information Device Level of Harm

Hospital Common Formats

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

User Defined Customization Narrative Medication Event Type Patient Information Device Level of Harm

Progress to Date With Adoption of the Common Formats

      24

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

Cautionary Note About EHRs

25  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

enter data into EHRs as providers  Little work has gone into defining/specifying how actual patient safety events should be recorded in, or measured from, medical records

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

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) 27  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

Quantros Safety Suite of Solutions Patient Safety Organization Manager Safety Rx

(Pharmacies) Interface

Safety Event Manger

(Hospitals & Clinics) Interface

Legacy Systems CSV upload AHRQ 1.2 XML Upload Patient Safety Evaluation System PSO Data Management NPSD PSOPPC Quantros Patient Safety Center

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

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 30

Quantros Safety Suite of Solutions Quantros Patient Safety Center

The 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 Manager

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

Safety Event Manager

The 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 Rx

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

IRIS

IRIS 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

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