Medical Liability & Patient Safety: Pennsylvania’s Experience

PA - PSRS

NGA Center for Best PracticesHealth Policy AdvisorsSeptember 10, 2004

Medical Liability & Patient Safety:Pennsylvania’s Experience

PA - PSRS

BackgroundBackground

• Institute Of Medicine Reports

– “To Err is Human – Building a safer health system” (1999)

– “Crossing the Quality Chasm” (2001)

– “Patient Safety - Achieving a new standard for care” (2004)

• 44,000 - 98,000 preventable deaths (estimated)

• $29 Billion per year in additional costs

PA - PSRS

“Little Progress Seen Since 1999 IOMReport On Medical Errors”… HealthGrades (2004)

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Why Do Errors Happen?Why Do Errors Happen?

PA - PSRS

Patient Safety Organization…

PA - PSRS

Strategic / Policy DecisionsStrategic / Policy Decisions

Charter

• Statute• Regulation• Executive Order

Funding

• General Funds• Assessment /

Fees• Grant / Other

Oversight

• Independent Agency/Board

• Existing Agency• Licensure Board

Goal

• Learning• Regulatory

Patient SafetyOrganization

PA - PSRS

Reporting ComponentsReporting Components

• Acute Care Hospitals

• Long-Term Care Facilities

• Ambulatory Surgical Facilities

• Free Standing Clinics

• Pharmacies

• Physician’s Offices

• Other Licensed Entities

Who Reports

• Mandatory vs. Voluntary

• Individual Identifying Data

• Data Sharing

• Confidentiality Provisions

Other Considerations

By Definition

– Medical Errors

– Near Misses

– Adverse Events

– Serious Events

Pre-Defined List

– NQF “Never Events”

– JCAHO Sentinel Events

Types of Events

PA - PSRS

Pennsylvania’s Approach

PA - PSRS

The Medical Care Availability and Reduction of Error (MCARE) Act of 2002The Medical Care Availability and Reduction of Error (MCARE) Act of 2002

• Establishes the Patient Safety Authority

• Goal: Reduce and eliminate medical errors by identifying problems and implementing solutions that promote patient safety

• Promulgate new reporting requirements for: Hospitals, Ambulatory Surgical Facilities (ASF’s) and Birth Centers

PA - PSRS

Patient Safety AuthorityPatient Safety Authority

• 11-member Board appointed by the Governor and General Assembly consisting of:

– Physician General (Chair), Physician, Nurse, Pharmacist, Hospital employee, health care worker, non-health care worker, and 4 other PA residents

• Established as an independent entity

• Non-regulatory

PA - PSRS

Funding ModelFunding Model

• Allows for up to $5 Million a year.

• Assessment of $105/unit based on:

– For Hospitals: Licensed Beds

– For ASFs: Licensed Operating Rooms

– For Birth Centers: Licensed Birthing Rooms

• In 2004 and 2005 – assessed $2.5 million or 50% of authorized amount.

PA - PSRS

Reportable EventsReportable Events

• Serious Event (“adverse event”)

– Event that results in patient harm

• Incident (“near-miss”)

– Event that could have injured a patient

• Infrastructure Failure

– Event related to physical plant, facility systems and criminal activity

PA - PSRS

PA - Reporting ComponentsPA - Reporting Components

Acute Care Hospitals

• Long-Term Care Facilities

Ambulatory Surgical Facilities

• Free Standing Clinics

• Pharmacies

• Physician’s Offices

Other Licensed Entities

Who Reports

Mandatory vs. Voluntary

No Individual Identifying Data

• Data Sharing

Confidentiality Provisions

Other Considerations

By Definition

– Medical Errors

Near Misses

– Adverse Events

Serious Events

Pre-Defined List

– NQF “Never Events”

– JCAHO Sentinel Events

Types of Events

PA - PSRS

Reporting System

PA - PSRS

Report IntakeReport Intake

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Report IntakeReport Intake

• 21 Core Questions

– Patient Age / Gender

– Location

– Event type

– Level of harm, contributing factors and root causes

– Recommendation to prevent future occurrence

• Additional Event Detail Questions

– 15 Major categories, 233 sub categories

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Patient Safety Authority - Clinical AnalysisPatient Safety Authority - Clinical Analysis

Analytics

TriagePatient Safety

Review Meeting

Contact with Individual Facilities

Public Advisories and Recommendations

PSA Annual Report

Program Outputs

Incoming Reports

PA - PSRS

Advisory TopicsAdvisory Topics

• Dangerous Abbreviation in Surgery

• Falls Associated with Wheelchairs

• MRI Hidden Risks

• Hidden Sources of Latex

• Use Of Multidose Medication Vials And Latex Allergy

• Use of X-Rays for Incorrect Needle Counts

• Preventing Wrong-Site Surgery

PA - PSRS

Analytical Tools

PA - PSRS

Harm Score TrendHarm Score Trend

ALL Unsafe Conditions: Harm Score A Event, No Harm: Harm Score B1, B2, C, DEvent, Harm: Harm Score E, F, G, H Event, Death: Harm Score I

0

20

40

60

80

Jan-2004 Feb-2004 Mar-2004

# of

Rep

orts

Facility - Harm Score Trends by MonthFacility - Harm Score Trends by Month

Month

PA-PSRS

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Distribution of EventsDistribution of Events

Slice 1 Slice 2 Slice 3 Slice 4

Medication

Adverse Drug Reaction

Equipment / Supplies

Fall

Error related to Procedure /Treatment / Test

Complication of Procedure /Treatment / Test

Transfusion

Other

9%

21%

28%

16%

11%

6%

9%

3%

6%

PA-PSRS

PA - PSRS

Event DistributionEvent Distribution

1. Complication follow ing surgery or invasive procedure

2. Anesthesia Event

3. Emergency Department

4. Maternal complication

5. Neonatal complication

6. Nosocomial Infection

7. Cardiopulmonary arrest outside of ICU setting

8. IV site complication (phlebitis, bruising, inf iltration)

9. Extravasation of drug or radiologic contrast

10. Catheter or tube problem

11. Onset of hypoglycemia during care

12. Complication follow ing spinal manipulative therapy

13. Other (specify)

Complication of Procedure / Test / TreatmentComplication of Procedure / Test / Treatment

29%

10%

8%

2%2%2%4%

2%2%

12%

12%

16%

PA-PSRS

PA - PSRS

Event Details by LocationEvent Details by Location

PA - PSRS

Culture of LearningCulture of Learning

The ultimate success of this reporting system will not be found solely in the data collected. Rather, improved patient safety will be the result of actions taken by individual facilities in response to what they learn through PA-PSRS.

PA - PSRS

PA Patient Safety AuthorityPA Patient Safety Authority

www.psa.state.pa.us