Development of the Medicare Patient Safety Monitoring System Susan L. Abend, MD, FACP David R. Hunt, MD, FACS Gaston Mbateng, Ph.D. Nancy Safer, RN, MSN.

Development of the Medicare Patient Safety Monitoring

System

Susan L. Abend, MD, FACP David R. Hunt, MD, FACSGaston Mbateng, Ph.D. Nancy Safer, RN, MSN

Janet P. Tate, MPHNancy R. Verzier, RN, MSN, CPHQ

Background and Development Team

• DHHS Patient Safety Task Force

• CMS– David R. Hunt, MD, FACS

• Qualidigm– Connecticut Quality Improvement Organization

• Active Collaborators– Federal Agency Work Group

• AHRQ, CDC, FDA, VA– Technical Expert Panel– Computer Science Corporation (Central Data Abstraction Center)

Goal

To determine the incidence of To determine the incidence of specific, clearly defined, specific, clearly defined,

hospital-acquired adverse hospital-acquired adverse events within the Medicare events within the Medicare

populationpopulation

Purpose

• Baseline data for CMS national quality improvement initiatives– Surgical Care Improvement Project

• Annual data to the National Healthcare Quality Report

• A method for repeated assessment of events (tracking and trending) for safety improvement activities within healthcare organizations

Design

• Retrospective Cohort Study

• 25,000- 40,000 randomly-selected discharges/year from the Hospital Payment Monitoring Program – Data obtained from medical charts and

Medicare Part A claims database

• HPMP cases– randomly selected cases from 50 states, D.C.,

Puerto Rico, U.S. Virgin Islands– sent to CDAC’s to check coding accuracy

MPSMS Definition of Adverse Event

“An unintended patient harm, injury, or loss more likely associated with an interaction with the health care delivery system than

from an attendant disease process.”

• Patient centered– Focuses on patient experience– Does not presume to assign severity

• Detects an untoward outcome• Requires defined healthcare exposure• Not dependent on cause

– Process malfunction (error, negligence)– Imperfect technology

Measure Development Process

• Event and exposure defined

• Boolean algorithm developed to detect exposure-related event

• Alpha test

• Beta test

• Clinical review

• Production

Measure Selection Measure Selection CriteriaCriteria

• Findable/FeasibleFindable/Feasible• Adverse event(s) very likely to be Adverse event(s) very likely to be

associated with exposureassociated with exposure• Common (burden on Medicare Common (burden on Medicare

population)population)• Responsible for serious morbidity Responsible for serious morbidity

and mortalityand mortality• PreventablePreventable

Adverse Event Rates’02 and ‘03 Medicare Inpatients

Post-Operative Pneumonia 2.5 + 0.3

Post-Operative Venous Thromboemboli 0.6 + 0.1

Post-Operative Urinary Tract Infection 3.7 + 0.3

Knee Replacement Adverse Events 7.2 + 1.3

Hip Replacement Adverse Events 11.4 + 1.8

Rate (%) + 95%CI

Adverse Event Rates’02 and ‘03 Medicare Inpatients

Ventilator Associated Pneumonia 11.9 + 1.8

Hospital-Acquired Bloodstream Infection 0.30 + 0.05

CVC-Associated Bloodstream Infection 1.4 + 0.3

CVC-Associated Insertion Site Infection 2.6 + 0.4

CVC-Associated Mechanical Adverse Events

2.3 + 0.3

Rate (%) + 95% CI

Average Length of Stay ’02, ‘03 Medicare Patients With Invasive

Surgical Procedures

Error bars indicate 95% CI

0

5

10

15

20

25

30

Post OpPneumonia

Post Op VTE Post Op UTI

DA

YS

with event

no event

Inpatient Mortality Rate’02, ‘03 Medicare Patients With Invasive

Surgical Procedures

Error bars indicate 95% CI

0

5

10

15

20

25

Post OpPneumonia

Post Op VTE Post Op UTI

%

with event

no event

Phase II MeasuresOne Year of Data Pending

• Postoperative Cardiac EventsPostoperative Cardiac Events

• Adverse Drug EventsAdverse Drug Events– Anticoagulant-related hemorrhagic eventsAnticoagulant-related hemorrhagic events– Insulin/oral hypoglycemic agent-related hypoglycemic Insulin/oral hypoglycemic agent-related hypoglycemic

eventsevents– Antibiotic-associated C. Difficile infectionAntibiotic-associated C. Difficile infection

• Pressure UlcersPressure Ulcers

Phase III Measures In Development

• In- Hospital Falls

• Angiography-Related Adverse Events– Contrast nephropathy– Adverse events related to femoral artery

puncture

• Urinary Tract Infections Associated with Bladder Catheterization

Reliability

Agreement Rate of Reported MPSMS Variables

0

10

20

30

40

50

60

70

80

90

100

>=95% >=90% and < 95% >=80% and < 90%

%t

dichotomous

categorical

Kappa Statistic for Reported MPSMS Variables

15%

30%55%

> 0.8

0.61 - 0.8

<= 0.6

Limitations

• Validation– No true gold standard yet defined for

determining sensitivity and specificity

• Data source issues– Retrospective– Depends on consistent documentation of

exposures and events in medical record

• Events are relatively infrequent• Limited capability for risk adjustment

Policy Implications

• Complements reporting efforts– Able to detect denominator– No reporting bias

• Complements indicators derived from administrative data alone– Potential for improved sensitivity– Richer database of variables

Policy Implications cont’d

• Standard definitions– trackable over time

• Allows hospitals to use common, standard benchmarks

• Potential for post-discharge surveillance of events

• Usable in paper or electronic health records– Potential for concurrent or prospective use in error

trapping or event avoidance.

Summary

• The MPSMS is a reliable tool for measuring adverse events in hospitalized patients

• Can measure the outcome of errors, suboptimal systems and/or technologies

• Uses standardized, patient-oriented definitions of adverse events

• Development is transparent and consensus-driven – strong collaboration between public and private stakeholders

Conclusion

The MPSMS is a valuable tool for hospitals and health care organizations

to use in making transformational changes to create a safe healthcare

environment.

This material was prepared by Qualidigm, the Medicare Quality Improvement Organization for Connecticut, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. Pub. # QUALCT-PSMS-200501