Patient Safety:Why Bother?

Noel Eldridge, MS for James P. Bagian, MD, PE

Chief Patient Safety OfficerDirector, VA National Center for Patient Safety

February 28, 2007

james.bagian@va.gov & noel.eldridge@va.gov www.patientsafety.gov

(Jimi couldn’t make it today. You got Noel.)

James Bagian, MD, PEDirector, VHA National Center for Patient Safety

Noel EldridgeExecutive Officer, NCPS

VA Statistics (FY 2005) 7.7M enrollees, 5.3M uniques VA Medical Centers (Hospitals): 156 Admissions: 587,000 Community Based Outpatient Clinics: 708 Outpatient Visits: 57.5M Rx Dispensed (30-day equiv): 231M Lab Tests: 215.9M Total FTE: 197,800

Veterans Health AdministrationVeterans Health Administration2211 Veterans Integrated Service Networks Veterans Integrated Service Networks

I J 2002

N ANUARY

W ERE INTEGRATED AND

RENAMED

VISN 13 14

VISN 23

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Patient Safety Background and VA Information on Reporting

Institute of Medicine Goals

1. Safe – “avoiding injuries to patients from the care

that is intended to help them”

2. Timely

3. Efficient

4. Effective

5. Equitable

6. Patient-Centered (from Crossing the Quality Chasm, 2001)

NY Times and W. Post This Week

Medication Reconciliation & Adverse Events– “Unintentional drug poisonings accounted for

nearly 20,000 deaths in 2004, said the CDC, making the problem now the second-leading cause of accidental death in the United States, after automobile accidents.”

• W. Post – 2/27/07– “In August 2006, the Institute of Medicine of the

National Academies released a major study on medication errors in American hospitals that found that adverse drug events harm more than 1.5 million people and kill several thousand a year, costing at least $3.5 billion annually.”

• NY Times – 2/25/07

Where Healthcare Was/Is

Cottage Industry Mentality Virtually Total Reliance on:

– Professional/Individual Responsibility– Individual Perfection– Train and Blame

Little Understanding of Systems Relative to People and Processes– Ignorance vs. Arrogance

Culturally Different!!!!

Where Does a Culture of Safety Exist?

Would you agree to fly on a bankrupt airline to save $100?

Would you agree to get elective surgery at a bankrupt hospital to save $100?

Are your answers different? If so, why? Do you trust the airline “system” of

regulators, managers, pilots, and mechanics in a different way than you trust the healthcare “system”?

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CAN YOU IMAGINE THE EQUIVALENT FOR AN AIRLINE TRIP?

NAVAL AVIATION MISHAP RATE

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NAMP est. 1959RAG concept initiated

NATOPS initiated 1961Squadron Safety program

System Safety Designated Aircraft

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Three Important Questions

1. What Happened?

2. Why Did it Happen?

3. What Should We Do to Prevent it from Happening Again?

Typical Healthcare Approach

New Policies, Regulations,Reporting Systems, Training

Good First Step But…..

– Lack of Systems Insight

– Superficial Solutions (?Answers)

– Inadequate Follow-Up

– Lost Opportunity

Goal Selection Clear

– Not Confused With Tactics

Compelling– Relevance To Those Who Must Take Action

– Early Stakeholder Involvement in Goal Definition

Reinforced By Leadership– Visible Participation

• All levels – not hierarchical

Goal: Prevent Harm

VA Patient Safety Advisory - August 8, 2000

Item: Medtronic Dual Chamber Temporary Pacemaker model 5388

Specific Concerns: The Medtronic Dual Chamber Temporary Pacemaker model 5388 may become inactive if a button is touched while it is in "self test" mode. If this occurs the pacemaker display freezes, will not work properly and displays an error code of 0004. At this point the pacemaker cannot be turned off. In order to correct the situation the battery drawer has to be opened. Only removal of the battery clears the error and turns the pacemaker off. It may then be restarted.

Typical Missing Features

Clear Understanding of Goal

Preventive Approach

Field Understanding & Buy-In

Systems Approach

Sustainability

Trust/Culture of Safety

Safety System Design

High Reliability Organizations

Role of Reporting

– Learning or Accountability?

Systems-Based Solutions

– Patient Centered – DUH!!!!

Importance of Close Calls

VA Patient Safety Data & Feedback

Incidents reported have monotonically increased since reporting to NCPS started in 2000.

VA inpatient mortality down ~35% from 1999 to 2006. – (Remember: “Correlation is not causation.”)

VA Annual Events Reported (including close calls) is Still Going Up

Safety Assessment Code (SAC)Severity & Probability

Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

The Value of Close Calls in Safety

Close calls can provide “sentinel” information without or before the “Sentinel Event.”

Patient Safety System Design

Patient Safety System Design

Most VA Reports are Actual “SAC 1s” (events with little or no harm, or close calls)

Which Events get RCAs?

Many RCAs are done on events that are not Actual 3s.

Numbers are surprisingly constant since 2001.

Is fewer actual SAC3s since 2001 & 2002 good news? Maybe.

RCA Categories (Coded by NCPS)

Selected Event (FY 2005) for Individual RCAs Percent

Fall 13.9%

Delay in Treatment/Diagnosis/Surgery 10.7%

High Alert Adverse Drug Events 10.5%

Unexpected Death 7.2%

Misidentification 6.3%

Missing Patient 4.9%

Hospital Acquired Infections 4.7%

Outpatient Suicide 3.4%

Correct Surgery 3.3%

65.0%

What about the Adverse Events and Close Calls that don’t get “RCAed”?

In VA Aggregated Reviews are performed at the local level, one per quarter on:

1. Adverse Drug Events

2. Missing and Wandering Patients

3. “Parasuicidal” Events

4. Falls– (When they are not “SAC 3” events)

Guiding Principles For Patient Safety System

Learning, Not Accountability SystemReporting System Characteristics

• Non-punitive - Confidential and De-identified• Internal and External

Importance of Close CallReports Should Emphasize Narratives Interdisciplinary Review TeamsAbout Identifying Vulnerabilities NOT

StatisticsPrompt FeedbackOpen to All Comers

What comes from RCAs?

1. Local Fixes and Learning

2. Local Insight into Better Methods for Improvement and the Tractability of Problems (not like the weather)

3. VA-wide Alerts and Advisories

4. Systemwide Learning and Informed policymaking

VA RCA data on Incorrect Surgical Procedures (2001 – 2005)

In-Operating Room: 33% Out-of-Operating Room: 42% Eye Procedures (can be either setting): 25%

What was Wrong? (2001-2005)

26 27

16

10

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5

10

15

20

25

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WrongSide

WrongSite

WrongProcedure

WrongImplant

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EXAMPLES…

Patient: Similar Diagnosis or NameSide: Other Side Similar DiagnosisSite: On Spine or Hand/WristProcedure:Biopsy vs. Cystoscopy Implant: Lens

VA RCA data on Retained Surgical Items, 2000-2005

Sponge, 52

Towel, 5

Other, 8

Human Factors and Strength of Actions

Safety & Human Error: Challenges

Healthcare Views Errors as Failings Which Deserve Blame - Fault

Train and Blame Mentality Blind Adherence To Rules Corrective Actions Focusing on

Individual No Blood No Foul Philosophy

Safety & Human Error:Cornerstones

People Don’t Come to Work to Hurt Someone or Make a Mistake

Must Keep Asking “Why?”

Safety – Human Error

Technical

IndividualTeam

Profession

Institution

Policies/ProceduresAccident

LATENT FAILURES

DEFENSES

Incomplete procedures

Regulatory narrowness

Mixed Messages

Production pressures

Responsibility shifting

Inadequate training

Attention Distractions

Clumsy Technology

Deferred Maintenance

Patient Safety - Strategy Invite People to Play

– Problem Recognition– Remove Barriers (Punitive, Difficulty, Black

Hole Effect)– Learning NOT Accountability System

Importance of Close Call Blameworthy Definition Training (Middle thru Top Management)

Leadership At All Levels Human Factors Approach

– Tools That Guide Behavior

Changing Culture

Tools

Behavior

Attitude

CULTURE!!!

Prioritize

Risk Based– Severity– Probability

Must Make Sense– Business Processes– Regulatory Environment

Systematic

Cause and Effect Human Error Must Have Preceding

Cause Failure to Follow Procedure By Itself Is

NOT a Root Cause Negative Descriptors Aren’t Actionable Failure To Act Is not Cause Without

Pre-existing Requirement To Act Why,Why,Why

Causation/Actions:Who vs.What &Why

Who– ‘Whose Fault Is This?’– Actions focused on correcting individual– ‘Corrects’ only after problem occurs– Limited scope of action and generalizability

What & Why– Actions focus on systems level causation– Widespread applicability– Stronger preventive strategy

Intentionally Unsafe Acts

“…events that result from: a criminal act; a purposefully unsafe act; an act related to alcohol or substance abuse by an impaired provider and/or staff; or events involving alleged or suspected patient abuse of any kind.”

Intentionally Unsafe Acts are off-limits to Patient Safety (RCA) review, everything else is within limits

On Being Human

Behavior Response

When I say “up”, everyone raise your hand as quickly as you can

This was not an aerobic exercise

Demonstrates: “paired associate learning”

Medical Software Correlation

- Pharmacist uses 95% of time.- “Enter” button enters data.

- Pharmacist uses 5% of time. - “Spacebar” enters data.

“Take-away” on Human Factors…

Considering and acting on knowledge regarding human capabilities, limitations, and tendencies when designing and operating devices and systems

Not always “common sense”

Human Factors Engineering and “Actions”

Warnings and labels (watch out!)

Training (don’t do that)

Procedure changes (work around that)

Interlock, lock-in, lock-out, etc (let me design it so you can not do that – forcing functions)

Is there one right action???

Weaker

Stronger

Actions & Interventions

Stronger Actions

Architectural/physical plant changes New devices with usability testing before purchasing

Engineering control or interlock (forcing functions)

Simplify the process and remove unnecessary steps Standardize on equipment on process or caremaps

Tangible involvement and action by leadership in support of patient safety

Intermediate Actions

Redundancy Increase in staffing/decrease in workload Software enhancements/modifications Eliminate/reduce distractions (sterile medical

environment) Checklist/cognitive aid

Eliminate look and sound-alikes Readback Enhanced documentation/communication

Weaker Actions

Double checks Warnings and labels

New procedure/memorandum/policy Training Additional study/analysis

Strong Action: Brake and Automatic Transmission Connection

“Simple” Engineering Solutions at Disneyworld Resorts (Motels)

Simple Engineering Solutions at Disneyworld Resorts (Motels)

Now I need a car roof that’s round!

Blue tubing does not fit here or here…it only fits here

Alert based on “wrong-tube” RCAs Veterans Health Administration Warning System Published by VA Central Office AL06-012 April 6, 2006

– Item: Mix-up (wrong route of administration) of bladder irrigation with intravenous (IV) infusions

– Specific Incidents: Since 2001, VA facilities have reported five cases of accidental infusion into an IV line or PICC line. Amphotericin B (Attachment #1) was given intravenously when it was intended for irrigation of the bladder via a catheter. The same adverse event could occur with Glycine. Amphotericin B and Glycine are both contraindicated in patients with kidney or liver disease and when Amphotericin B is infused via IV line, it can induce serious complications (e.g., kidney failure).

Look-alikes (different “eye-drops”)

Sound-alikes (e.g., Flomax and Flonase)

Redundancy vs. Double-check in Spelunking (Caving)

Two choices of equipment

1. One flashlight batteries checked twice

2. One flashlight and one headlamp

Lawnmower cut-off switch

Experience is an Expensive Teacher

Management Involvement

Formalized, Not Ad Hoc Safety Permeates the Fabric of All

Activities Relentless

Safety System Design 

Action AssessmentAssessment

Characteristics of Actions– Temporary vs. Permanent– Procedural vs. Physical

Action Evaluation– Process– Outcome

Business Case for Patient Safety

Is There A Business Case?

YOU BET!!! Examples:

– “Easy CAP” CO2 Detector

• $154/detected esophageal intubation– RCA/40person-hrs X 12RCA/yr

• 0.25FTEE

Devices to prevent Out-of-OR Esophageal Intubations are Cost-Effective

Description Equation =

Numerator Cost to implement (11,000 [# of codes] x $10)

$110,000

Denominator Number of recognized events (assuming 100% prevention effectiveness)

715

Cost-Effectiveness Measure

$110,000 / 715 $154

InterpretationIt will cost $154 to detect one unanticipated esophageal intubation ($10 per use at a rate of 6.5%)

Benefit-Cost of Patient Safety

National Center for Patient Safety, Regional Patient Safety Officers, Facility Patient Safety Managers, Local RCA teams

~$130k per VA Medical Center (0.1%)

If this is a VA facility’s budget

This is Patient Safety’s Share

Some Interventions have Zero CostUse of Antimicrobial Soap in VAMCs

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Use Non-antimicrobial

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May-04

See Hand Hygiene Tools on www.patientsafety.gov

Summary and Wrap up

Sustainable Systems Approach Problem Identification Clear Goal Definition Involvement Of All Sectors Identify Systems Influences Identify Systems Controls Identify Constraints Critique – Go To Worst Critics Early On Pilot – Volunteers First Then Others Evaluate

Critical Elements

Safe for Reporters/Participants Prioritization Method What is Blameworthy Not About Fault – 3 W’s Human Factors Engineering Tools

– Triage Cards, RCA Method Concur/Not Concur (Mgmt/Leadership) Feedback Dedicated Patient Safety Duties

Closing Thoughts

Not About Errors!!! Counting reports is not the objective,

identifying Vulnerabilities is– Hope they increase

–Analysis, Action, & Feedback are the key

Prevention NOT Punishment Cultural change is the key – takes time

Safety is the Foundation Upon which Quality is Built

Safety as the Foundation? Quality programs can ensure that we use

evidence-based medicine to determine which cardiac patients…– Are prescribed the most appropriate of many

medications, and/or– Get angioplasty with or without drug-eluting or

bare metal stents, and/or– Get CABG surgery

But if they get surgical site and/or urinary tract infections, and/or fall in the hospital…– Can you call this High Quality Care???

Why Bother?

1. The Problem is Real2. You Can Do Things to Make it

Better

“They say that time changes things, but you actually have to change them yourself”

Andy Warhol

Recently we have received a number of questions about whether is it legal to buy facial tissues. At issue is whether or not the facial tissues are considered personal items.

We have discussed this issue with Department logistic and financial staff as well as VHA clinical staff.

The following provides a basis for the decision that was reached: For patient-care areas and areas frequented by those who come in direct contact with patients, facial tissues should be considered similarly to other expendable supplies that VA workers may use as they perform their duties during work hours. For example, VA supplies disposable respirators, gloves, and surgical scrubs and gowns, all of which are employed by staff to protect patients from the spread of infectious agents. This type of expenditure is clearly appropriate. On the second point, recent guidance from the CDC, JCAHO, the National Health Information Center of the Department of Health and Human Services, and the American Lung Association have all included recommendations for using tissues to cover coughs and sneezes to prevent the spread of infectious agents. First among these infectious agents are viruses that cause upper respiratory infections such as cold and flu, but another agent of concern is Staph. aureus (SA), including methicillin-resistant SA (MRSA), either of which can cause skin and wound infections. Various estimates put the percentage of healthcare workers whose nasal passages are colonized with SA at about 30-40%. (The percent colonized by MRSA is not well described and seems likely to vary widely.) SA and MRSA can be expelled from the nose during a sneeze and live for days or weeks on substrates such as clothes, linens, curtains, countertops, and other environmental surfaces where they can be picked up on hands or transferred to other surfaces and eventually patients. Using a tissue to reduce the dispersion of droplets and the gross contamination of hands or clothes is imperfect but is widely recommended as a basic measure to control the spread of infectious agents.

Conclusion: Facial tissues to be used in patient care areas and areas frequented by those who come in direct contact with patients can be purchased with appropriated funds. This memo should not be taken as a mandate

to generate any new requirement to provide tissues in specific locations or at any pre-set density. Decisions on this topic should be made locally and incorporate local circumstances and considerations.

(Agreed upon by: Fiscal, Accounting, Legal, Network Clinical Managers, Public Health, Environment of Care, Infectious Diseases, Patient Safety, in about 3 weeks.)

Are we there yet?

“From a certain point forward there

is no longer any turning back. That

is the point that must be reached”

- Franz Kafka

Have a Safe Trip Home!

San Diego