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 The Impact of PSOs on the Healthcare Industry & Benefits of Common Formats 4

2 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 HHS Organizational Focus

3 Need for a National Learning Effort to Improve Quality & Safety Quality improvement is still a developing science Quality improvement is still a developing science Adverse events keep occurring Adverse events keep occurring Measurement is a mess Measurement is a mess Barriers to learning remain Barriers to learning remain

4 Barriers to Learning Providers fear that quality & safety analyses & reports could be used against them in court (malpractice suits) or in disciplinary proceedings 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) 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 Quality & safety improvement is hampered by under-reporting & inability to aggregate data across providers & locations

5 The Patient Safety and Quality Improvement Act Authorizes “Patient Safety Organizations” (PSOs) Authorizes “Patient Safety Organizations” (PSOs) Establishes “Network of Patient Safety Databases” (NPSD) Establishes “Network of Patient Safety Databases” (NPSD) Authorizes establishment of “Common Formats” for reporting patient safety events Authorizes establishment of “Common Formats” for reporting patient safety events Requires reporting of findings annually in AHRQ’s National Health Quality/Disparities Reports Requires reporting of findings annually in AHRQ’s National Health Quality/Disparities Reports

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

7 PSO Trial Court Decisions Several lawsuits have been filed challenging the protections offered by the Patient Safety Act 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) 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

8 PSO Program Status There are currently 80 PSOs in 29 states & the District of Columbia There are currently 80 PSOs in 29 states & the District of Columbia Examples of PSOs include components of: Examples of PSOs include components of: – California Hospital Association – ECRI – Hospital Corporation of America – University HealthSystem Consortium – Walgreens (CVS, too)

9 PSO Profile Data Count of PSOs by Type of Business (N=65) (A PSO may choose more than one type)

10 PSO Profile Data Count of PSOs by Clinical Specialty Focus (N=65) (A PSO may choose more than one type)

11 Affordable Care Act Sec 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) 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: There is a two-year phase-in period: Jan 1, 2015 to Jan 1, 2017 Jan 1, 2015 to Jan 1, 2017 This requirement is likely to increase number & utilization of PSOs during the interim This requirement is likely to increase number & utilization of PSOs during the interim

12 PPC PSO NPSD Other Qualified Sources AHRQ National Quality Reports User: Researcher User: PSO User: Provider PSO Data flow: PSOs, Providers, & PSWP Provider

13 Common Formats Common language for patient safety event reporting Common language for patient safety event reporting – Common language & definitions – Standardized rules for data collection Standardized patient safety reports (“apples to apples”) Standardized patient safety reports (“apples to apples”) Developed through a formal, collaborative process Developed through a formal, collaborative process

14 Making the Formats Universal XKCD 927

15 Common Formats Developed with a Federal work group comprising major health agencies ( e.g., CDC, CMS, FDA, ONC, DOD, VA ) Developed with a Federal work group comprising major health agencies ( e.g., CDC, CMS, FDA, ONC, DOD, VA ) Incorporate input from public, industry Incorporate input from public, industry Reviewed by an NQF expert panel, which provides advice to AHRQ Reviewed by an NQF expert panel, which provides advice to AHRQ Promulgated as “guidance” announced in the Federal Register Promulgated as “guidance” announced in the Federal Register Approved by OMB (process & Formats) Approved by OMB (process & Formats)

16 Common Formats Only national patient safety reporting scheme designed to meet all of the following four goals: 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! Designed to decrease data collection burden!

17 Common Formats Common Formats are site-specific (e.g., hospital) Common Formats are site-specific (e.g., hospital) They apply to all patient safety concerns: 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

18 Modular Focus Hospital Version 1.2 Blood & Blood Products Blood & Blood Products Device & Medical or Surgical Supply, Including HIT Device & Medical or Surgical Supply, Including HIT Fall Fall Healthcare-Associated Infection Healthcare-Associated Infection Medication & Other Substances Medication & Other Substances Perinatal Perinatal Pressure Ulcer Pressure Ulcer Surgery & Anesthesia Surgery & Anesthesia Venous thromboembolism Venous thromboembolism All others via generic forms All others via generic forms

19 Event Type Patient Information Level of Harm Hospital Common Formats For all events, CFs assess general information.

20 Hospital Common Formats If the event is covered by an Event-Specific Format, additional information will be requested. Medication Event Type Patient Information Level of Harm

21 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. MedicationDevice Event Type Patient Information Level of Harm

22 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. MedicationDevice Narrative Event Type Patient Information Level of Harm

23 Hospital Common Formats MedicationDevice Narrative User Defined Customization Each institution, vendor, or PSO can add an unlimited number of additional questions of its own choosing. Event Type Patient Information Level of Harm

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

25 Cautionary Note About EHRs EHR-based extraction of information to support patient safety is getting a lot of attention today 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 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 Little work has gone into defining/specifying how actual patient safety events should be recorded in, or measured from, medical records

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

27 The Future Definition of patient safety events (Common Formats) ultimately needs to support operational systems at three levels: 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 Clinical & electronic definitions must be consistent throughout all levels, & be interoperable where appropriate

28 Common Formats on the Web

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 Authentication Layer Patient Safety Evaluation System AHRQ 1.2 XML Export Module Legacy Systems CSV upload AHRQ 1.2 XML Upload 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 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