The Intersection of a PSO and Health IT

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Slide 1

The Intersection of a PSO and Health IT

By Karen P. Zimmer, MD, MPH, FAAP
Medical Director, ECRI Institute PSO
Medical Director, Patient Safety and Quality, ECRI Institute
September 10, 2012

Image: A photograph of a lighthouse at night is shown.

Slide 2

Agenda

• Patient Safety Organization (PSO).
• Overview of Health Information Technology.
• Use of a PSO in Collaborative Project (i.e., HIT Hazard Manager).
• Preliminary Data highlights received by ECRI Institute PSO.
• Deep Dive using AHRQ Common Format for HIT/Device Adverse Events.

Slide 3

What is a Patient Safety Organization?

Image: The logo for a Listed PSO is shown.

Slide 4

Final Rules Implementing the PSQIA

• In Jan 19, 2009, PSQIA of 2005 became effective.
• First-ever national system for healthcare providers to improve safety by voluntarily reporting medical errors and near misses.
• Assurance of confidentiality and protection from legal discovery (not subject to subpoenas, discovery, or admissible in court of law).
• Allows providers to seek expert help in understanding patient safety events and preventing their recurrence in a protected legal environment.

Slide 5

Goals of the Patient Safety and Quality Improvement Act

• Allows the organizations that collect the data, called Patient Safety Organizations (PSOs), to provide analysis and feedback (share findings and lessons learned) in a protected legal environment.
• PSOs can collect information about events using a standardized language, called common formats, developed by AHRQ.

Images: The cover of an issue of the Federal Register and a page from the Public Law concerning the Patient Safety and Quality Improved Act are shown.

Slide 6

About ECRI Institute PSO

• Component of ECRI Institute.
• Independent, not-for-profit applied research institute.
• Helping the healthcare community to determine the best ways of delivering care.
• Strict conflict of interest rules.
• 43-year history, 375 interdisciplinary person staff
  • Evidence-Based Practice Center.
  • Federally listed PSO since 2008 (amongst 1^st 10 listed PSOs).
  • Support over 800 provider organizations.
  • Specialty PSO activities (e.g., HIT).

Images: A photograph shows the ECRI flag and the American flag on masts outside the ECRI Institute. Another photograph shows medical staff with a patient in a suspended device.

Slide 7

Overview of Health Information Technology

"It is not a single product; it encompasses a technical system of computers and software that operates in the context of a larger sociotechnical system—a collection of hardware and software working in concert within an organization that includes people, processes, and technology."

—IOM "Health IT and Patient Safety: Building Safer Systems for Better Care."

Slide 8

Perpetuating System Issues

Example: Wrong patient/patient identification.

• Nurse noticed the patient's DOB was incorrect on the account. With further investigation, it was discovered that her admission was tied to the patient's deceased spouse's MRI and DOB.
• Care summary showed history of past medical admissions that were not hers, but her deceased husband's.
• Labs were drawn, sent, and transfusion administered under erroneous account.

Slide 9

What Can We Learn from this Incident?

Just being wired (or using health IT) is not a guarantee of improved patient care.

Slide 10

Background

• While interrelationship between delivery of medical care and IT offer significant benefits, it has raised concerns and potential risks to patients.
• Facilities should not implement HIT without fully understanding the operating environment of their systems.

Slide 11

Background

• Many studies emphasize the unintended consequences of HIT.

  -Ash et al (2004).; Koppel et al (2005).

• The impact can be large because HIT affects so many patients.

  -Sittig and Singh (2011).

• FDA conducted a 2-year study in which 260 reports of medical device malfunctions as a result of IT or software issues were submitted of which 44 resulted in injuries and 6 involved deaths. (U.S. FDA).
• The Joint Commission has also called attention to the safety risks of HIT in a Sentinel Event Alert on safely implementing HIT. (Joint Commission).

Slide 12

Background

• The "Other" IOM report: Health IT and Patient Safety: Building Safer Systems for Better Care, 2011: no central repository of data about HIT errors.
• Many HIT systems, such as EHRs, fall outside FDA's oversight.
• Individual healthcare organizations are beginning to collect HIT event data through their event reporting systems, but rarely shared due to legal concerns which in turn limits trending.

Slide 13

Background

• HIT vendors may prevent organizations from sharing information with nondisclosure clauses that prohibit users from sharing product information about HIT-related patient safety risks (IOM).
• IOM's report highlights the important role of federally certified patient safety organizations (PSOs) in collecting and sharing data about HIT-related events in a nonthreatening and protected manner.

Slide 14

ECRI Institute PSO's Role
In Health IT Error Reporting
(The Hazard Manager™)

Slide 15

ECRI Institute PSO's role in collaboration

• Provided PSO Protection for all the study sites who submitted events using The Hazard Manager.
  • The sites signed limited PSO agreements with ECRI for purposes of this study.
  • The protection made it relatively easier to recruit sites.
  • Sites were interested in learning from one another within this protected space.
• Built, programmed, and operated the web-based beta version of The Hazard Manager as a subcontractor to ABT Associates.

Slide 16

Beta Test Findings

Contributory Causes of 495 Beta Test Hazards

Usability and Software Design—frequently both—were common contributors to health IT hazards.

Image: A bar graph shows percent of hazards by causation categories:

• Hardware—3%.
• Implementation—9%.
• CDS—16%.
• Other User Factors - 17%.
• Data Quality—26%.
• Other Organizational Factors—27%.
• Usability—49 %.
• Software Design—52%.

Slide 17

Preliminary HIT Data Highlights from ECRI Institute PSO database prior to the use of the HIT/Device Common Formats

Image: A drawing of woman pointing at a line graph is shown.

Slide 18

ECRI Institute PSO Data

Methodology

• Query of ECRI Institute PSO database performed 11/2009—1/2012.
• 1237 potentially HIT-related reports since 11/2009.
• 610 (49%) reports were excluded (eg. ordered right, hand-picked wrong).
• 627 Reports tagged with a Magrabi's published classification system for HIT safety reports which was also used with the FDA MAUDE database.
  • The MAUDE database is—a collection of thousands and thousands of reports of safety-related events involving medical devices—including some—but not all—HIT devices like PACS.

Farah Magrabi, Mei-Sing Ong, William Runciman, Enrico Coiera. Using FDA reports to inform a classification for health information technology safety problems. J Am Med Inform Assoc 2012;19:1 45-53 Published Online First: 8 September 2011 doi:10.1136/amiajnl-2011-000369

Slide 19

ECRI Institute PSO Data

Image: A chart compares contributing factors for errors for humans and machines. The words "Input" and "Output" are circled in yellow.

Slide 20

ECRI Institute PSO Data

• Near miss (24%) and Incident (76%) reports related to HIT and technology use.
• A number of reports related to:
  • Intersection of human factors and health care information technology.
  • Inadequate system interfaces.
  • Software anomalies.
  • Inattention to change management.
  • Human errors (such as input errors).
  • Errors related to the design of the system or a combination.

Image: A bar graph shows the following data:

• A—14%.
• B—22%.
• C—32%.
• D—9%.
• E—2%.
• F—1%.
• NULL—21%.

Slide 21

ECRI Institute PSO Data

HIT Related Events by Event Type - AHRQ Taxonomy 1.1
(n = 627)

*ECRI-enhanced event types.

Slide 22

ECRI Institute PSO Data

• National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Harm score.

Slide 23

ECRI Institute PSO Data

Top 5 Health IT Safety Problems

Human - Computer

Slide 24

Preliminary Data highlights from ECRI Institute PSO Deep Dive™ on HIT Using AHRQ's Common Formats

Image: A photograph of a scuba diver swimming underwater is shown.

Slide 25

Deep Dive™ Overview

• Hazard Manager captures additional information—IT Vendors as well as implementation teams; and non-human issues.
• The AHRQ Common Formats version 1.1:
  • HIT data was seen throughout all the event types.
  • Many of the technology issues were not captured but mostly human-interface.
  • Focused on issues at the point of patient care only.
• Common formats version 1.2 HIT/Device Forms:
  • Issues are still focused more at point of care.
  • Incorporated more of the human and technology issues that were missed.

Slide 26

Deep Dive™ Overview

• This deep dive is a snap shot.
• Combine focused collection of data with our previous knowledge from earlier reports, we hope to provide focused guidance to address some of these areas.
  • Example: issues regarding the display of information on computer screens; information gets cut off or important information does not show up in the display.

Slide 27

Deep Dive™ Overview

• Last year, the IOM identified the need for more shared learning about events related to the adoption HIT and noted this learning can occur under the protections of PSOs.
• ECRI PSO Deep Dive fosters that shared learning to ensure that healthcare organizations realize the benefits of HIT without jeopardizing patient safety.

Slide 28

Deep Dive™ Overview

Methodology

• Query of ECRI Institute PSO database performed using HIT Taxonomy.
• 199 HIT implicated reports since from 4/16/2012 to 6/19/2012.
• 28 (14%) reports were excluded.
• 171 (86%) reports tagged using a Magrabi's published classification system for HIT safety reports.
  • Farah Magrabi, Mei-Sing Ong, William Runciman, Enrico Coiera. Using FDA reports to inform a classification for health information technology safety problems. J Am Med Inform Assoc 2012;19:1 45-53 Published Online First: 8 September 2011 doi:10.1136/amiajnl-2011-000369
• 211 problem issues were identified.

Slide 29

Deep Dive™ Overview

Human - Computer

Slide 30

# Events by Health IT Device—ECRI PSO Deep Dive

Slide 31

Back to Our Case Study

• Imagine a world in the future where the patient who was registered under her deceased husband's medical record never had such an error.
• Would we accept an error like this from Citibank?

Slide 32

Summary

• Hazard Manager complements the Common Formats and allows for collection of data systematically across the continuum.
• PSOs with their umbrella of protection can promote sharing of information.
• Unintended HIT-related errors are significant and AHRQ responded with a change in the addition of the AHRQ Common Formats.
• With the updated common formats, tools like hazard manager, and the collection and analytic abilities of PSOs, we hope to see more stories about the improvements in care achieved with HIT.