Toward Aggregation of National Data from Patient Safety Organizations, Program Update

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Slide 1

Toward Aggregation of National Data from Patient Safety Organizations, Program Update

William B Munier, M.D., M.B.A., Director
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality

AHRQ Annual Conference
11 September 2012

Slide 2

Program Update

• PSO Program:
  • Office of the Inspector General (OIG) report.
  • Legal challenges.
  • Affordable Care Act.
  • Current status.
• Common Formats.

Slide 3

PSOs & Common Formats

• Patient Safety Organizations (PSOs) provide a major resource for improving quality & safety:
  • Legally-protected privilege & confidentiality.
  • Expert knowledge.
  • Aggregated data that speeds learning.
• Common definitions and formats (Common Formats) provide the opportunity to harmonize measurement throughout the U.S. & reduce reporting burden.

Slide 4

Patient Safety Today

• Despite 12 years of focus after "To Err is Human," there is substantial evidence that patient safety is still a major problem:
  • Events keep occurring at alarmingly high rates.
  • Measurement is labor-intensive & inconsistent.
• Evidence can be found in 10 recent reports from the Office of the Inspector General on adverse events in hospitals.
• The need for PSOs has never been greater!

Slide 5

Nov 2010 and Jan 2012
OIG Reports on Adverse Events

• OIG reported that 13.5% of hospitalized Medicare beneficiaries experienced serious adverse events; an additional 13.5% experienced temporary harm events.
• Hospital staff did not report 86% of events to the hospital's internal incident reporting systems.
• There was inconsistent identification of adverse events & confusion among front line staff regarding what events they needed to report to the hospital.
• AHRQ & CMS should create & promote a list of patient safety events addressing "the full range of harm;" AHRQ Common Formats can be the basis.

Slide 6

Follow-up with CMS

• In August, AHRQ & CMS hosted a Webinar on the Common Formats for all CMS surveyors across the country.
• CMS plans to add information on the Common Formats to their Web site to assist surveyors & others to understand what the Formats are & how they contribute to improving patient safety.
• While CMS surveyors can check on use of the Formats, they are not permitted to view PSO patient safety work product, or PSWP.

Slide 7

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.

Slide 8

PSO Trial Court Decisions

• Other decisions have included:
  • "A state law that conflicts with a Federal law is without effect."
  • Providers must establish that reports are prepared solely for reporting to a patient safety organization & not for another purpose.
• Lessons learned include the importance of:
  • Documentation of PSES, policies, & procedures.
  • Documentation of particulars, including dates, regarding each case, reporting into PSES, & reporting to PSO.

Slide 9

The Affordable Care Act:.A National Driver for PSOs

The ACA contained two provisions that give PSOs new roles & responsibilities:

1. Readmissions: AHRQ is to make available a program for eligible hospitals to improve their readmission rates through the use of Patient Safety Organizations.
2. Health Insurance Exchanges: Qualified Health Plans (QHPs) operating through the new Health Insurance. Exchanges (HIEs) can only contract with hospitals > 50 beds if they have a patient safety evaluation system (PSES)—which means a PSO—as of January 1, 2015.

Slide 10

PSO Program Coming of Age!

• 76 PSOs currently listed.
• 30 states & DC represented.
• 40 PSOs delisted since inception.
• 12 data-use agreements signed with the Privacy Protection Center (PPC).
• Data expected during 2012 to PPC & the Network of Patient Safety Databases.

Slide 11

PSO Profile Data

Count of PSOs by Type of Business
(A PSO may choose more than one type.)

Image: A bar graph shows the following data:

• Association - 17.
• Provider - 14.
• Consulting - 9.
• Liab Insurnce - 3.
• University - 4.
• Sftwr Devel - 2.
• Consumer - 1.
• Other - 13.

Slide 12

PSO Profile Data

Count of PSOs by Type of Event Reports Solicited

Image: A pie chart shows the following data:

• All topics (no specific focus) - 38.
• Multiple topics, but not all - 5.
• Blood or blood products only - 1.
• Medication or other substances only - 2.
• Surgery or anesthesia only - 4.
• Other - 8.

Slide 13

Types of Providers

• Total providers working with PSOs = 2,004:
  • 1,605 Hospital.
  • 20 Long-Term Care.
  • 379 Other.
    Other types of providers include freestanding clinics, ambulance/EMS services, ambulatory surgery centers, home health care.

Slide 14

Hospitals Working With PSOs

Count of Hospitals by Census Region

(Note: there are 4 hospitals in the territories or Other region.)

Size of Area:

• Large Metro
  619 (39%).
• Medium Metro
  303 (19%).
• Small Metro
  290 (18%).
• Micropolitan
  207 (13%).
• Noncore
  186 (11%).

Image: A map of the United States is broken into Census Regions, and the number of hospitals in each is superimposed over that region:

• West - 337.
• Midwest - 450.
• Northeast - 208.
• South - 606.

Slide 15

Hospitals Working With PSOs

Count of Hospitals by Number of Licensed Beds

(Note: PSOs did not submit bed size for 171 hospitals.)

Image: A bar graph shows the following data:

• 1-5 Beds - 0%.
• 6-24 Beds - PSO Affiliated, 4%; U.S., 10%.
• 25-49 Beds - PSO Affiliated, 12%; U.S., 22%.
• 50-99 Beds - PSO Affiliated, 16%; U.S., 21%.
• 100-199 Beds - PSO Affiliated, 18%; U.S., 21%.
• 200-299 Beds - PSO Affiliated, 17%; U.S., 11%.
• 300-399 Beds - PSO Affiliated, 10%; U.S., 6%.
• 400-499 Beds - PSO Affiliated, 9%; U.S., 3%.
• 500+ Beds - PSO Affiliated, 14%; U.S., 5%.

Slide 16

Provider Profile Data

Count of Hospitals by Ownership

(Note: PSOs did not submit ownership information for 383 hospitals.)

Image: A bar graph shows the following data:

• Private, Non-Profit - PSO Affiliated, 68%; U.S., 58%.
• Private, For-Profit - PSO Affiliated, 20%; U.S., 20%.
• Government - PSO Affiliated, 12%; U.S., 21%.

Slide 17

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 goals for national patient safety measurement.

Slide 18

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 19

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's meaningful use.

Slide 20

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 21

Expansion of Settings/Formats

• Readmissions Common Format for hospitals:
  • Dr. Brian Jack (Project RED) providing advice.
  • Beta version pilot test at the VA now completed.
  • Open for comment at the NQF until September 20th.
• Nursing home Common Formats:
  • Beta version available now.
• Ambulatory Common Formats:
  • Scheduled for development soon.

Slide 22

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 23

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 24

Why Work With a PSO? Why Use Common Formats?

• Gain privilege against discovery & lawsuits.
• Join an increasing group using standard measures; share experience (selectively).
• Decrease measurement burden—over time!
• Gain from a growing community of experts who are sharing their experience based on aggregate data representing large numbers of patients.
• Improve patient care!