Patient Safety James Pappas, MD, MBA The speaker does not have any relevant financial relationships with any commercial interests

Patient SafetyJames Pappas, MD, MBA

The speaker does not have any relevant financial relationships with any commercial interests

The Wrong Patient (1)(Chassin & Becher. Ann Intern Med 2002;136:826-833)

Joan Morris (a pseudonym) Jane Morrison (a pseudonym)

History: Joan Morris (Joan M) is a 67 y/o woman admitted for cerebral angiography. The patient had been well until several months earlier, when she fell and struck her head. MRI showed two large cerebral aneurysms. She was admitted to the NS service.

History: Jane Morrison (Jane M) is a 77 y/o woman who had been transferred from an outside hospital for workup of cardiac arrhythmias and was waiting for electrophysiologic studies (EPS).

Initial Hospital Course: One aneurysm successfully embolized one day after admission. Second aneurysm needed surgery, so a second admission planned. Patient was transferred to oncology rather than returning to her bed on the telemetry unit (TU).

Initial Hospital Course: Jane M’s EPS procedure had been delayed for two days. She had also been admitted to the telemetry unit. Her EPS was scheduled as the first case for the early morning of the day of Joan M’s discharge (“day 3” below).

Oncology

Day 1 Day 2

Joan M admit TU Embolization

Day 3

0615

EPS nurse (RN1) phoned TU, asked for “patient Morrison”

Note: EPS IS and HIS not connected.

RN1 incorrectly told that Jane M had been moved to

oncology floor.

0620RN1 calls oncology, (where

Joan M is) and is incorrectly told Jane M is there.

0630

Joan M’s nurse (RN2) agreed to transport: 1) no handoff;

2) no order; 3: clinical sense? RN2 assumed

Joan M unsure, nauseated

0645EPS attending: 1) unaware

wrong patient; 2) fear surprises; 3) meds for nausea

0645-0700

RN1 sees no consent (contradicted daily schedule),

pages EPS fellow

Upon fellows arrival: 1) reviews chart; 2) surprised at

lack of info; 3) then “consented” Joan M

0700-0715RN1 pages

Joan M arrives

Jane M admit TU

EPS Scheduled

The Wrong Patient (2)(Chassin & Becher. Ann Intern Med 2002;136:826-833)

Why did this happen?

Day 3 0800

RN4 and EPS att arrive: 1) att never entered room, 2)

fellow initiated procedure

RNCN: 1) noted Joan M not on a.m. log, 2) entered EPS and

asked fellow:RNCN

arrives

0715-0730

RN3 enters: 1) places pt. on table, 2) attaches monitors,

3) discusses procedure. Joan M tells her: “I fainted.”

NS resident: 1) came to EPS lab—”why my patient” 2)

didn’t use her name, 3) after discussion, assumed att Δed.

07300710

0830-0845

RN5 (from TU) phones EPS : 1) why Jane M not in EPS?

2) RN3 took call, talk w/ RN4 3) “bring Jane M at 1000”

Fellow: “This is our patient.”

Procedure at critical stage, so RNCN did not challenge:

assumed patient had been added after advance sched.

0900-0915

IR att finds Joan M’s room empty. Called EPS to ask why Joan M there.

EPS att said that Jane M was on table. RNCN corrected him saying Joan M was in fact on table. EPS att checked chart, found error: PROCEDURE ABORTED.

Agenda• The importance of patient safety• Approach to patient safety

– Just culture and the unsafe acts algorithm– Normalization of deviance– Root cause analysis

How is this working?

• On thinking of different approaches:– Teamwork and communication– Human factors

The Catalyst• To Err is Human• Up to 98,000 preventable deaths.• This was the ‘what.’

• Crossing the Quality Chasm• Quality as a systems issue.• This was the ‘how.’

The Six Aims For Improvement

Safe Effective

Patient-centered Timely

Efficient Equitable

Back to the ‘Wrong Patient’• This case wasn’t one error (or even a few errors) = harm • In fact, there were 17 individual errors documented in this

case—let’s look at one:

Day 1 Day 2

Joan M admit

Cerebral angiogram performed

Day 3

0615




oncology floor.



0630






0645-0700


pages EPS fellow



0700-0715RN1 pages

Joan M arrives

“RN1 failed to verify the patient’s identity against the EPS laboratory schedule when the patient arrived in the EPS laboratory (6:45 a.m.)”

— Is this an error? If no, why not?— If yes, what kind?— Is there negligence? (Policy?)

Defense in Depth, Swiss Cheese, and Harm

e.g., caregivers

e.g., EMR

e.g., P & P

The potentially hazardous things we do

Characteristic of all high risk domains in western society, e.g.:1) Health care2) Nuclear power3) Military and commercial

aviation4) Fire and police

Not doable

Too many

Inadequate training

Fatigue

Patient Harm Novice

The Sharp End: People in direct contact with the safety critical process.

The Blunt End: The people/

organization that creates the

system and support.

When harm occurs, who usually gets the blame?

1.

2.

3. Intact?

4. Line up

Poor design


– Just culture and the unsafe acts algorithm– Normalization of deviance– Root cause analysis



Basic Structure & Function

• Managing the incident report system• Dealing with data• Connecting the c-suite with the front line• Generating frontline activity to improve safety• Dealing with major errors and sentinel events• Qualifications and training of the PSO• The role of the patient safety committee• Engaging physicians in patient safety• Board engagement in patient safety• Research in patient safety

What are we measuring?• The ‘basics’ include:

– Data from voluntary incident report system– Data from trigger tools (and results of chart review)– Real time surveillance: e.g., CLABSI, CAUTI– Key outcome data: e.g., risk-adjusted mortality– Key process/structural data: e.g., CPOE use– NQF serious reportable events– Malpractice claims and payouts– Accreditation/licensing data from areas of concern– Serious patient complaints– Data from M & M conferences– Results from patient experience surveys– Results from safety culture surveys– Data from executive walk-rounds/focus groups

What do I do with data once

I have it?

Not very many people at LLUH

really know how to use data.


– Just culture/unsafe acts algorithm– Normalization of deviance– Root cause analysis



There’s a lot we could talk

about…

These issues are applicable in ANY

organization.

Back to the ‘Wrong Patient’• This case wasn’t one error (or even a few errors) = harm • In fact, there were 17 individual errors documented in this

case—let’s look at one:

Day 1 Day 2

Joan M admit

Cerebral angiogram performed

Day 3

0615




oncology floor.



0630






0645-0700


pages EPS fellow



0700-0715RN1 pages

Joan M arrives

“RN1 failed to verify the patient’s identity against the EPS laboratory schedule when the patient arrived in the EPS laboratory (6:45 a.m.)”

— Is this an error? If no, why not?— If yes, what kind?— Is there negligence? (Policy?)

Error #5

Unsafe Acts Algorithm

Actionsintended?

Consequencesintended?

Yes

Sabotage,malevolent, et

cetera

Yes

Unauthorizedsubstance?

No

Medicalconditions?

YesNo

SubstanceAbuse without

mitigation

No

SubstanceAbuse withmitigation

Yes

Knowinglyviolated SOP?

No

SOP available,workable,

intelligible, andcorrect?

Yes

Possible recklessviolation

Yes

System inducedviolation

No

Passsubstitution

test?

Deficiencies intraining andselection, orexperience?

NoHistory of

unsafe acts?Yes

No

Possible NegligentBehavior

CULPABLE GRAY AREA BLAMELESS

No

System InducedError

Yes

Blameless Error,but training,

counseling areindicated

Yes

BlamelessError

No

James Reason

Just Culture:The Central Issue

“How can you justly deal with the individual who was involved, while also ensuring that your organization learns as much as it can from the event?” Sidney Dekker

How will you balance accountability with learning ?

Learning: Studying harmful events (or near misses) so as to make improvements that lead to a safer healthcare environment.

If you come down hard on people…

• Workers may be more careful.• They will certainly be less

willing to report instances of harm or even near misses

Safety Accountability

Accountability

Safety

However, if you have no sanctions…

• Workers who are in the ‘wrong seat‘ may persist.

• Other employees may believe “anything goes.”

Safety

Accountability






about…


organization.

Why do people not follow policies and procedures?

• Because they… – don’t know them (knowledge deficit)?– can’t find them (P&P not readily available)? – don’t have the time?– can get away with not following them?– are careless and/or reckless?

The Challenger DisasterDiane

VaughanNormalization

of Deviance

Normalization of DevianceDeviation is NORMAL

Unsafe

Ver

y U

nsaf

e

Illegal/illegal(non-acceptable)

Illegal/normal(usual; real life)

60 to 90%‘Legal’ space

(regulations and standards)

Expected safe place

Uns

afe

LowHigh Production Performance

Low

Hig

hIn

divi

dual

Ben

efits

Dianne Vaughn






about…


organization.

Just Culture:The Central Issue

“How can you justly deal with the individual who was involved, while also ensuring that your organization learns as much as it can from the event?” Sidney Dekker

How will you balance accountability with learning ?

Learning: Studying harmful events (or near misses) so as to make improvements that lead to a safer healthcare environment.

If you come down hard on people…

• Workers may be more careful.• They will certainly be less

willing to report instances of harm or even near misses

Safety Accountability

Accountability

Safety

However, if you have no sanctions…

• Workers who are in the ‘wrong seat‘ may persist.

• Other employees may believe “anything goes.”

Safety

Accountability

How do we learn? One way: RCA

A Young Man with Trauma

0748

Pain 8/10abdomen, RLQ& R flank

0600

HR=130, BP=100/68; alertand oriented

1130

Patientambulating;gross hematuria

medchanges

1/8/09

medchanges

BP, O2sat drop

1940

HR=127, BP=74/51; pain 10/10. Abdomendistended, skincold, clammy;trauma paged

New nurse (justoff orientation)

Res A (PGY2)takes, asks resB (PGY1, onduring day) toassist; bothstate no mentionof BP, only ofpain and family

Unit busy; charge nurseoccupied

2212

Nurse paged resA re: pain 10/10,diaphoresis;page did not gothrough

medchanges

BP, O2sat low

continueddeterioration

0003

Res Acontacted

To OR

0116

Expired

around0200

41 year old male, admitted 1/6/09 w/ blunt trauma to chest and abdomenAdmitted to trauma service, unit 8200

1/9/09

Our Gut Reaction?Go straight to the sharp end of the chisel…

Active Failures: • The young nurse

• The surgical team• The surgical residents

…the unsafe acts algorithm!• Do not automatically blame the caregiver.• Thoroughly investigate the incident…• …for example, root cause analysis, or RCA:

– “RCA is a defined process that seeks to explore all of the possible factors associated with an incident by asking what happened, why it happened and what can be done to prevent it from happening again.” (WHO, emphasis mine)

The Hindsight Bias

Before the Event: There is uncertainty. Patient care can take many paths, many of them ill-defined because much of what we do has little evidence to guide us.

After the Event: This is where investigation takes place. We think the sequence of events inevitably led to an outcome. We underestimate the uncertainty people faced.

The ‘Event’

Adapted from Dekker: The Field Guide to Understanding Human Error (chapter 3)

“To Understand Human Error, You

Need to Attain This Perspective.”

“Hindsight means being able to look back, from

the outside, on a sequence of events that led to an outcome you already know about.”

(Sidney Dekker)

The ‘Basics’ of an Effective RCA

Timely investigation.

Start with a timeline.

• Review the EMR.• Interview those involved.

Discuss within the multidisciplinary care team.

Inside

Outside: Knowledg

e of dangers Hindsight

: Knowledge of outcome

Do not settle for easy answers!!• Ask Why!! root causes issues

Easy

End with a list: 1) issue, 2) action, 3) who, and 4) by when.





Trends in adverse events over time: why are we not improving? (Shojania and Thomas)

• Landrigan, et al. (N Eng J Med 2010;363:2124-34)– Retrospective study of a stratified random sample of 10 hospitals in North Carolina.– 2341 admissions using IHI Global Trigger Tool for Measuring Adverse Events – In these NC hospitals, “harms remains common, with little evidence of widespread improvement.”

• Classen, et al. (Health Affairs, 30, No. 4 (2011):581-589)– Though not focused on temporal trends; reported one-third of patients suffered harm at three

tertiary care hospitals noted for their efforts to improve patient safety. Previous studies show event rates in range of 3-16%. “Progress seems sorely lacking [Shojania].”

• Baines, et al. (BMJ Qual Saf 2013;22:290-298)– Adverse event rate among hospitalized patients in the Netherlands increased from 4.1% (2004) to

6.2% (2008). Preventable adverse events did not change.

Shojania KG, Thomas EJ. Quality and Safety in Health Care 2013:22: 273-277

20011999 20052003 20092007 20132011

Landrigan, et al.

Classen, et al

Baines, et al.

Published

All of this effort…

• Managing the incident report system• Dealing with data• Connecting the c-suite with the front line• Generating frontline activity to improve safety• Dealing with major errors and sentinel events• Qualifications and training of the PSO• The role of the patient safety committee• Engaging physicians in patient safety• Board engagement in patient safety• Research in patient safety

According to Shojania and Thomas:

“…the main message of this [Baines] and the two previous ones [Landrigan and Classen] remains: sustained attention to patient safety has failed to produce widespread reductions in rates of harm [in] medical care.”

• Why?– While patient safety has received much attention over the last 10

years, it has received very little investment (compared to biomedical research). For example, the NIH budget is 30X that of the AHRQ.

– Showing progress in safety requires the following three achievements:• Identification of effective interventions• Dissemination of these interventions• Development of a tool to measure improvements

JC Sentinel Events:Root Cause by Event Type

What might be done differently?

75% to

80%





The Importance of Teamwork and Communication: TeamSTEPPS

• Program developed by DOD and AHRQ• LLUMC implementation started in 2008

Designed for hospitals to address teamwork and communication

Duke University train the trainer program. Simulation center In-situ simulation Coaching at POC Didactic lectures

First, a team… Four teachable/

learnable skills

Team EffectivenessTOOLS &

STRATEGIESBrief

Huddle Debrief

STEPCross Monitoring

FeedbackAdvocacy and Assertion

Two-Challenge RuleCUS

DESC ScriptCollaboration

SBARCall-Out

Read-BackHandoff

OUTCOMES

Shared Mental Model

Adaptability

Team Orientation

Mutual Trust

Team Performance

Patient Safety!!

BARRIERSInconsistency in Team

MembershipLack of Time

Lack of Information SharingHierarchy

DefensivenessConventional Thinking

ComplacencyVarying Communication Styles

ConflictLack of Coordination and Follow-

Up with Co-WorkersDistractions

FatigueWorkload

Misinterpretation of CuesLack of Role Clarity

TeamSTEPPSGroup

BriefShort meeting prior to start: essential roles, expectations, anticipate outcomes and contingencies.

HuddleAd hoc planning to reestablish situation awareness; reinforce existing plans

Debrief After action review designed to improve team performance.

Person-to-Person

SBARTechnique for communication of critical information: Situation Background Assessment and Recommendation

HandoffThe transfer of information (along with authority and responsibility) during transitions in care.

Read backProcess of employing closed-loop communication to ensure info conveyed by sender is understood by the receiver;.

Individual

Call outStrategy used to communicate important information simultaneously to all team members; helps anticipation.

CUS I am Concerned; I am Uncomfortable; This is a Safety issue.

A Young Man with Trauma

0748


0600


1130


medchanges

1/8/09

medchanges

BP, O2sat drop

1940





2212


medchanges

BP, O2sat low


0003

Res Acontacted

To OR

0116

Expired

around0200


1/9/09

SBAR

Situation

I am calling about Mr. Smith. I am worried about his vital signs.

Background

He was admitted two days ago with chest and abdominal trauma.

Assessment

He is hypotensive and tachycardic. I think he is going into shock.

Recommendation

I need you to come see him NOW. Are you available?





The “Wheels-up-After-Landing” MishapWorld War II

The Problem: A number of U.S. fighter and bomber pilots were making the mistake of retracting their aircraft’s wheels instead of

the wing flaps after landing, resulting in the equivalent of belly landings.

Alphonse Chapanis

http://blogs.discovermagazine.com/lovesick-cyborg/2014/11/08/the-mystery-of-virgin-galactics-pilot-error/

B17 “Flying Fortress”

“Human error” had turned out to be a cockpit design error.

The U.S. Army Air Force fixed the problem by attaching a small, rubber-tired wheel to the wheel control and a wedge-shaped symbol to the flap control.

Chapanis, a U.S. Army Air Force psychologist at Wright Field in Dayton, Ohio, eventually figured out that the aircraft involved in such cases — the P-47 fighter, B-17 bomber and B-25 bomber — had nearly identical wheel and flap controls sitting side by side in the cockpit.

Human FactorsHuman factors (HF) is about designing systems that are both resilient

and that aid in the reduction of human error.

Domain Sample topics Sample patient safety and related topics

Physical HF

• Lifting/handing tasks• Repetitive movements• Physical workload• (Re)design of physical space

and layout

• Design of patient rooms to reduce falls• Number and placement of sinks to increase

compliance with hand hygiene• Insuring adequate lighting in medication

dispensing areas

There are three domains of specialization within HF!

BMJ Qual Saf 2012;21:347-351

For example: The “wheels-up-after-landing” mishap

Note: Human factors and ergonomics are synonymous terms.

A Clinical Example

This is no different than the WWII example: same principle, different details.

Imagine a trauma patient with SIRS, who is in significant pain.

The patient has three IVs running:1. Norepinephrine for hypotension2. Morphine for pain3. Normal saline (NS) with K+

A lot of things can go wrong. An example:Each bag goes to a separate pump via tubing. Tubes not

labeled, pumps may or may not be.

The patient’s blood pressure decreases. Nurse, as per protocol, attempts to increase norepinephrine drip but accidently increases morphine, thereby exacerbating hypotension.

Human Factors

In other words, HF covers everything…

Domain Sample topics Sample patient safety and related topics

Cognitive HF

• Training program development• Design and evaluation of tools

and technologies• Decision-making under time-

pressure• Mental workload

• Development of a training program to improve safety of care

• Usability testing of smart intravenous pumps• Development of decision support tools to

reduce diagnostic errors

Macro HF

• Coordination• Teamwork• Safety culture• Large-scale organizational change• Participatory approach to

(re)design efforts• Job design (e.g., scheduling,

breaks, nature of tasks)

• Reducing readmissions through improved discharge planning and coordination

• Studying the impact of new health information technologies on work systems, process and outcomes.

A good example of cognitive HF…

0748


0600


1130


medchanges

1/8/09

medchanges

BP, O2sat drop

1940





2212


medchanges

BP, O2sat low


0003

Res Acontacted

To OR

0116

Expired

around0200


1/9/09

We’ve concentrated on person-to-person communication,…

Nurse Physician

…but what happened here?

What Did We Learn?• The importance of patient safety

• Approach to patient safety

– Just culture/unsafe acts algorithm

– Normalization of deviance

– Root cause analysis


• On thinking of different approaches:

– Teamwork and communication

– Human factors

Healthcare is safe for the vast majority of people the vast majority of time, but it could and should be safer.

The vast majority of healthcare harm events are systems issues, not people issues.

• The balance between creating a learning environment and accountability (a ‘just culture’) is difficult to define, create and maintain.

• Normalization of deviance is inevitable human behavior, the ‘path of least resistance.’

• The process for investigating harm (e.g., RCA) must be well-defined and consistent; if it is, people will be more likely accept the result even if they don’t like it.

By the best methods we know of to measure harm (i.e., trigger tools) not well; the fault of intervention, dissemination, or measurement?

Physical, cognitive and macro human factors considered by many to be the number one systematic cause of patient harm.

A root cause of about 80% of harm events at LLUH. Good teamwork and communication cannot be assumed in complex environments.

Documents

Patient Safety James Pappas, MD, MBA The speaker does not have any relevant financial relationships with any commercial interests