AHRQ's Work in Quality Measurement for Patient Safety: Common Formats

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Slide 1

AHRQ's Work in Quality Measurement for Patient Safety: Common Formats

William B Munier, MD, MBA, Director
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality

AHRQ Annual Conference
10 September 2012

Slide 2

The Measurement Issue

• Highlighted by the Partnership for Patients:
  • No way to know precisely how many patient safety events have occurred or are occurring in the U.S.
  • No way to measure actual performance nationally.
  • Sampling & extrapolation only way to establish a baseline & subsequently establish national trends.
• Without measurement, it is virtually impossible to know if progress is being made.

Slide 3

Common Formats

• Authorized by Patient Safety Act in 2005 → PSOs.
• Developed with a Federal work group comprising major health agencies (e.g., CDC [Centers for Disease Control and Prevention], CMS [Centers for Medicare & Medicaid Services], FDA [Food and Drug Administration], DoD [Department of Defense], VA [Veterans Administration]).
• Incorporates input from public, industry.
• Reviewed by an NQF [National Quality Forum] expert panel, which provides advice to AHRQ.
• Promulgated as "guidance" announced in the Federal Register.
• Approved by OMB [Office of Management and Budget] (process & Formats).

Slide 4

Common Formats

• Only patient safety reporting scheme designed to meet three goals:
  • Provide information on harms from all causes.
  • Support local quality/safety improvement.
  • Allow the end user—to collect information once & supply it to whoever needs it (harmonization).
• Designed to serve IOM [Institute of Medicine] goals for national patient safety measurement.

Slide 5

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.

Slide 6

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.

Slide 7

Hospital Common Formats (CFs)

For all events, CFs assess general information.

Image: Three boxes are captioned Event Type, Patient Information, and Level of Harm.

Slide 8

Hospital Common Formats

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

Image: Three boxes are captioned Event Type, Patient Information, and Level of Harm. A fourth box has been added above the first two, captioned Medication.

Slide 9

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.

Image: Three boxes are captioned Event Type, Patient Information, and Level of Harm. A fourth box captioned Medication sits above the first two. A new box, captioned Device, has been added above Patient Information, and Level of Harm.

Slide 10

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.

Image: A sixth box, captioned Narrative, has been added to the five boxes described in the previous slides, completing a pyramid.

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Hospital Common Formats

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

Image: A seventh box, captioned User Defined Customization, has been added atop the box captioned Narrative. An arrow points to this new box, with the note, "Each institution, vendor, or PSO can add an unlimited number of additional questions of its own choosing."

Slide 12

Harmonization Issues

• Current Medicare HACs & PSIs—administrative data.
• Partnership for Patients HACs.
• CDC's NHSN.
• FDA's MedSun.
• NQF Serious Reportable Events (SREs).
• State reporting system requirements.
• Event reporting vs. surveillance.
• EHRs & ONC/CMS meaningful use.

Slide 13

National Drivers for 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.
• Office of the Inspector General (HHS)—2011 and 2012 reports on adverse events in hospitals recommend surveyors/accreditors evaluate hospitals regarding their use of the Common Formats.
• CMS—is working with AHRQ to align CMS programs, including survey & certification, with the Common Formats.
• FDA—has been working for nearly two years with AHRQ to align its device-reporting system, MedSun, with Common Formats.
• Office of the National Coordinator for HIT—requested challenge award proposals for adverse event reporting using Common Formats & PSOs; plan to integrate Common Formats in stage 3 Meaningful Use criteria.

Slide 14

Event Reporting vs. Surveillance

• The Common Formats are currently designed as a concurrent event-reporting system:
  • Contain information in the EHR & more.
  • Do not include denominators.
• The Formats are being adapted to be used as a retrospective surveillance system—Safer Care:
  • Will include denominators; will generate rates.
  • Will not address near misses & unsafe conditions.

Slide 15

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.

Slide 16

Common Formats on the Web

To view sample reports, event descriptions, user guide, and programming instructions for electronic implementation visit: https://www.psoppc.org/web/patientsafety