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Building Safer Systems. Without data, you are just another person with an opinion. Safety. Safety is not a specific thing. In complex organizations, safety is created by people as they do their work. There are strategies and designs that favor safe performance.

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safety
Safety
  • Safety is not a specific thing.
  • In complex organizations, safety is created by people as they do their work.
  • There are strategies and designs that favor safe performance.

ASA

safety is produced by sociotechnical systems
Safety is Produced by SocioTechnical Systems

“The problem is not bad people; the problem is that the system needs to be made safer.”

….“preventing errors and improving safety require a systems approach….”

“….this higher level of quality cannot be achieved by further stressing current systems of care… Trying harder will not work.” IOM 2001

“….healthcare organizations must develop a systems orientation to patient safety….”

“Safety is a characteristic of systems and not of their components. Safety is an emergent property of systems.”

“Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.”

hro s high reliability organizations characteristics
HRO’s: High Reliability Organizations: Characteristics
  • Process auditing and other active searches (eg, equip testing) for possible failures.
  • High quality standards
  • Risk perception: examining even small but unexpected events.
  • Command and control:
    • Fluid decision-making (flex hierarchy)
    • Formal rules and procedures (but flexible)
    • Constant training

Karlene Roberts, 2005

ASA

safety in medicine needed changes
Safety in Medicine: Needed Changes
  • Specify limits to maximum performance. [How many cases should we do?]
  • Decrease individual autonomy:
    • Regulations – the minimum necessary
    • Teamwork
    • specialization
  • Fatigue, overtime, excessive work schedules, staff shortages, stress.

Amalberti R, 2005

ASA

slide8

Some holes due to active failures

hazards

Other holes due to latent conditions (resident pathogens)

losses

This model is being increasingly criticized as an example of how to understand accidents. It is too static; the defects are often transient; and the whole system is more dynamic than the model suggests.

Successive layers of defenses, barriers, and safeguards

ASA

slide9

Sequential accident models inevitably lead to a root cause, which is the basis of the root cause analysis. The search for a root cause (often a human), tends to perpetuate the blame-the-person outcome. It also suggests that eliminating a root cause will solve the problem.

ASA

slide10

Systemic (not sequential) accident model

A detailed inquiry finds multiple parallel factors that led to the event considered to be the root cause.

ASA

systemic accident model
Systemic Accident Model

Before the accident.

ASA

systemic accident model1
Systemic Accident Model

Retrospective analysis might suggest that the outcome of the actions taken was predictable.

We have not completely escaped blame-&-train.

ASA

slide14

Aviation has achieved a 10-6 rate of injurious accidents.

Surgery is said to have a 10-4 rate.

ASA

slide15
Training

Experience

High/low volume

System

Features

“In the medical arena, the most common system failure is in education. The person at the sharp end (eg, the surgeon) did not know enough or was not experienced enough to make the correct judgment or action.”

VA Hernia Trial: 85% of participating surgeons were still climbing the learning curve.

Who is responsible?

ASA

the evolution of aviation safety 1965 2004

25,400

Business as usual

2015

438

1960

Our Goal

The Evolution ofAviation Safety1965 - 2004

Airplanes in service

Departures 2004

17.5 Million

19,077

2004

Hull loss accidentsper year

Accident Rate / Million Departure

Millions of departures

Hull loss accident rate

1965

1975

1985

1995

2005

2015

ASA

Year

Boeing 2004 Statistical Data – May 2005

teams in aviation medicine

System

Features

Teams in Aviation & Medicine
  • Improved safety in commercial aviation, stemmed from better aircraft, better system designs, automation, and rule-making.
  • Work in aviation and medicine is done by teams.
  • Aviation: CRM reduced cockpit hierarchy, and communication improved. Moved on the LOSA & TEM.
  • Medicine is practiced by teams, and team development is now a major issue. That leads to CRM; better communication; and observational studies of surgical work (LOSA).

ASA

importance of teams in surgical performance

System

Features

Importance of Teams in Surgical Performance

Error Management in Pediatric Cardiac Surgery: Carthey, J et al (unpublished)

Multicenter study of neonatal arterial switch operation in GB. 173 ASO’s observed by experts in error management. Errors defined as major or minor, and compensated or uncompensated.

The total number of minor errors in a case, whether compensated or not, was directly related to the chances that a major error would not be corrected, and a serious complication or death would result. Minor errors and uncompensated major errors and deaths were less common with stable teams.

ASA

slide19

High nurse

turnover

Nurse

Dissatisfaction

O.R.

Vicious

Cycle

SPD

dysfunctional

Nurse

less able

Random case

assignments

Equipment

missing

Surgeon

angry

O.R. tension

mounts

Performance

drop

Case more

difficult

Flow

interrupted

Dysfunctional team.

ASA

slide20

System

Features

Hypothetical staffing pattern during a four-hour case. Nurses, surgeon, and anesthesiologists can be a different mix several times per hour. No stable teams; communication affected; information lost.

ASA

o r communication a team activity

Bottom Line:

Seek harmony to preserve teams and avoid unsafe behaviors. How the surgeon acts is key.

System

Features

O.R. Communication – A Team Activity

Lingard L et al. Communication failures in the O.R. Qual Saf Health Care 2004;13:330.

Lingard L et al. Getting teams to talk. Qual Saf Health Care 2004;14:340

Lingard L et al. Team Communications in the O.R.: Patterns and sites of tension. Acad Med 2002;77:232.

ASA

slide22

Loose coupling

Tight coupling

System

Features

An Important Failure Mode: Tight Coupling

Tight coupling connects parts of the system so rigidly that actions at one place are immediately transmitted throughout. Prediction and control become harder, and accidents increase.

In systems-talk, this is “going solid.”

ASA

everyday examples of tight coupling

System

Features

Everyday Examples of Tight Coupling
  • No hospital beds
  • No ICU beds
  • Overbooked IR schedule
  • Shortage of surgical instruments: cases delayed
  • Inadequate resources to staff O.R. cases
  • Lengthy queues for operations. Elective surgery in off hours.
  • Long queues for routine outpatient appointments.

Examples of failing to set production limits that match production capacity.

ASA

the useful concept of gaps
SBAR (or SCAP)

Read-back

Face-to-face

Hand-off IT (van Eaton)

Checklists

Standardized orders

System

Features

The Useful Concept of Gaps

Complexity creates gaps in care, where information can be lost. Every transition in care constitutes a gap. The increasing fragmentation of medical care is producing more gaps.

Information loss at gaps can be decreased by handoff routines and checklists.

HANDOFFS

CHECKLISTS & ETC.

ASA

checklists standardized orders
Pre-op planning

O.R. scheduling

Admission scheduling

Night before checklist

Pre-op checklist (briefing)

Post-op care checklist

Admission and pre-op orders

Postop orders

Transition orders

Discharge orders

Discharge instructions

System

Features

Checklists & Standardized Orders

Orders

Checklists

As many as 11 checklists between evaluation in the clinic and discharge from the hospital.

ASA

slide26

Referring

MD

Surgical Patient Flowchart

Patient

Surgeon

Start

Clinic

Prepare

Nurses

PreOp

O.R. Suite

Nurses

Operation

O.R.

Nurses

O.R.

Nurses

Anesthesia1

R.R.

Surgical

Ward

Nurses

Nurses

System

Features

Anesthesia2

Home

ASA

slide27

Referring

MD

1.

11.

Patient

Surgeon

1.

2.

Clinic

2.

·Eleven handoffs

·Eight procedural subsystems

3.

3.

Prepare

4.

4.

Nurses

5.

PreOp

5.

O.R. Suite

Nurses

Operation

9.&10.

O.R.

Nurses

O.R.

Nurses

6.

6.

Anesthesia1

R.R.

7.

7.

Surgical

Ward

Nurses

8.

8.

Nurses

System

Features

Anesthesia2

Home

ASA

slide28
Communication deficits during the operation -- lost information.

Poorly synchronized multitasking that delayed case progress.

Hand-offs during inappropriate times -- information loss.

Counting protocol delayed case and of questionable quality.

Circulating nurses performed retrieval errands too often.

Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159.

Observational study of O.R. systems

during general surgery cases.

System

Features

ASA

Good work: LW

slide29

Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159.

  • Demonstrates how investigations done in the O.R. by surgeons can detect system faults.
  • And eliminate unsafe practices.
  • And presumably, improve efficiency.
  • The findings of this study could probably be replicated in most large hospitals.
  • As surgeons troubleshoot O.R. systems, surgeons require a share of administrative authority to implement the changes .

System

Features

ASA

conclusions
Conclusions
  • Progress in understanding
    • The systems nature of safety
    • The nature of surgical systems
    • System faults that affect safety
    • And how to fix them
  • Surgeons must be directly involved in 1) O.R. administration and 2) observational studies of the surgical system to bring about the required changes.

ASA

to err is human or is it

“To Err is Human. . . Or Is It?

ACS Efforts – Error Prevention and Patient Safety

Thomas R. Russell, MD, FACS April 20, 2006

ASA

the american college of surgeons
The American College of Surgeons

“Dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment.”

ASA

institutes of medicine
Institutes of Medicine

Three reports, starting with To Err Is Human: Building a Safer Health System, published in 2000.

  • Demonstrate that our current health care system neither controls spending nor ensures access to quality care
  • Clarion call for all to reevaluate their role
    • Quality
    • Cost

ASA

slide37

To Err Is Human

  • Shift from saving lives by preventing errors to implementing evidence-based practices to improve quality
  • Domain of effectiveness of service, test or therapy to create better outcomes – i.e. “statistical lives”

ASA

quality surgical care
Correct Diagnosis

Proper Staging

Proper Risk Assessment

Disease

Treatment

Proper Treatment

Best evidence

Best technology

Best technique

Proper Outcome

Survival

No complications

Disease cured

Symptoms relieved

Function restored

Death with dignity

ACS is working in all these areas

Quality Surgical Care

ASA

quality surgical care1
Quality Surgical Care
  • Structure
  • Process
  • Outcomes

ASA

acgme abms core competencies
ACGME/ABMS Core Competencies

• Medical Knowledge

• Patient Care

• Interpersonal and Communication Skills

• Professionalism

• Practice-based Learning and Improvement

• Systems-based Practice

ASA

slide45

Practice-Based Learning & Improvement

American College of Surgeons Case Logging System

ASA

closed claims project
Closed Claims Project
  • A standardized collection of reviews of claims involving surgical mishaps from records kept by liability insurance companies
  • 461 claims reviewed to date
  • Purpose – to identify common problems and develop best practices and protective systems to improve patient safety

ASA

education1
Education

Program for Accreditation of Educational Institutes

  • Will serve as regional sites where surgeons may learn new procedures, emerging technologies, and rarely performed procedures

ASA

education2
Education

E-FACS.org

  • Content in clinical areas and broad-based subjects of interest
  • Supports e-learning, case logs, and sharing information about their practices
  • Maintain and submit documentation regarding MOC-related activities

ASA

current acs quality improvement programs
Current ACS Quality Improvement Programs
  • Facility Certification Programs
    • Trauma centers
    • Cancer centers
    • Bariatric centers
  • Continuous Quality Improvement
    • ACS National Surgical Quality Improvement Program (NSQIP)
    • American College of Surgeons Oncology Group
  • National Outcomes Data Bases
    • National Trauma DataBank
    • National Cancer Data Base
    • NSQIP

ASA

development of acosog
Development of ACOSOG
  • May 1998: Initial NCI Award
  • March 1999: 1st trial opens
  • September 1999: NCI Site visit in Chicago
  • May 2000: 5 Year NCI Award

ASA

future directions
Future Directions
  • Expand clinical trials to include studies in trauma, burns / critical care, vascular and cardiovascular diseases
  • Expand Center’s programs in Continuing Medical Education to educate surgeons in the performance of new operations and use of new technology

ASA

american college of surgeons data bases
American College of Surgeons Data Bases
  • National Cancer Data Base- NCDB
  • National Trauma Data Base- NTDB
  • American College of Surgeons National Surgical Quality Improvement Program- ACS NSQIP
  • ACS Bariatric Surgery Data Base
  • ACS Individual Fellow Self-Reporting Data Base
  • Collaborations in Progress
    • SAGES
    • STS
    • AAOS
    • SVS

ASA

collaborative efforts
Collaborative Efforts
  • CMS Surgical Care Improvement Project (steering committee) (SCIP)
  • Physicians Consortium for Quality Improvement (AMA)
    • Perioperative Care Work Group (co-chair)
  • National Quality Forum (NQF)
  • Ambulatory Care Quality Alliance (steering committee) (AQA)
    • Subgroup on Surgery and Procedures (chair)
  • Surgical Quality Alliance (chair) (SQA)
    • Developing quality measure priorities and consensus across surgical specialties

ASA

national quality forum
National Quality Forum
  • Cancer Care Quality Indicators
    • Colon Cancer
      • Colonoscopy preoperative or within 6 months
      • At least 12 nodes resected for non-metastatic disease
      • Adjuvant chemotherapy for node positive disease

ASA

membership1
Membership

Expanded membership base

  • RAS-ACS
  • Affiliate Member category

ASA

membership2
Membership

Innovative methods of communicating with membership

  • Journal of the American College of Surgeons now distributed to all ACS Fellows free of charge
  • Surgery News, new monthly newspaper
  • Electronic methods: ACS NewsScope, e-mail alerts, College’s Web site, and Web portal

ASA