Healthcare Quality and Hospital Management Program

Level I – Patient Safety

Muhammad Umar Farooq

Diplomate American Board of Healthcare Quality and Utilization Review Physicians
Member American College of Healthcare Executives
 Level I
Contents
1 Healthcare Quality
Concepts

2 Patient Safety and International Patient Safety Goals

(IPSGs)

3 Systems Thinking and Structure, Process, Outcome (SPO)

Paradigm

4 Quality Structure in
Hospitals

5 Sentinel Events and Root Cause

Analysis
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Innovations in Healthcare
Measurable Quality

2014: 22,000 Heart Transplants

 To Err is Human

44,000 to 98,000
people die in US
hospitals from
preventable medical
errors
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We Make Mistakes
To Err is Human

Safe Systems!
 What is Patient
Safety?
Patient Safety: Freedom from
accidental injury caused during
Institute of Medicine medical care
(IoM)
First, do no harm - Hippocratic Oath

Dimension of quality
T7he Power of PowerPoint |
thepopp.com
Patient Safety
Movement
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Patient Safety Movement

Where it all started

1859, Florence Nightingale: Adequate nursing care instrumental in reducing soldier

mortality rates by 32%

1914, Dr. Eric Codman: Hospitals should look at the result of patient care
rendered during patient’s hospital encounter – resulting into American College of
Surgeon’s Evaluation of Hospitals
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• Organized Medical Staff
• Physicians and surgeons are
licensed, competent and ethical
• With the governing body, the
medical staff adopts rules,
regulations, and policies governing
the organization’s professional
work
• Accurate, complete, and
accessible medical records
• Competently supervised diagnostic
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Patient Safety Movement
Where it all started

1951: Formation of The Joint Commission on Accreditation of Hospitals ( JCAH)

American College of Physicians, the American Hospital Association, the American Medical
Association, and the Canadian Medical Association

1965: a hospital meeting Joint Commission accreditation met the Medicare Conditions
of
Participation

1984: the American Society of Anesthesiologists (ASA) had established the

Anesthesia Patient Safety Foundation (APSF). The APSF marked the first use of the
term "patient safety" in the name of professional reviewing organization
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Patient Safety Movement
Where it all started

1999: To Err is Human, Building a Safer Health System

IOM called for a number of recommendations (next slides). The majority of media
attention, however, focused on the staggering statistics: from 44,000 to 98,000
preventable deaths annually due to medical error in hospitals, 7,000 preventable deaths
related to medication errors alone, $29 billion annually in lost income, disability, and
healthcare costs!

Within 2 weeks of the report's release, Congress began hearings and President Clinton
ordered
a government-wide study of the feasibility of implementing the report's
recommendations.
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Patient Safety Movement
Where it all started

Key Recommendations: To Err is Human, Building a Safer Health System

• Establish a national focus to create leadership, research, tools, and protocols to

enhance the knowledge base about safety;
• Identify and learn from medical errors through both mandatory and voluntary
reporting
systems;
• Raise standards and expectations for improvements in safety through the actions
of oversight organizations, group purchasers, and professional groups;
• Implement safe practices at the delivery level.
• Establishment of Center for Quality Improvement and Patient Safety within AHRQ
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The Response: The Joint Commission

(Inter)National Patient Safety Goals: NPSG and IPSG

Leadership: The leaders are responsible for an organization-wide, integrated patient

safety program
Performance Improvement Data on:
• Operative or other procedures placing patients at risk of • patient perceptions on safety and quality

disability or death
• staff perceptions of risks to individuals and suggestions for
• significant discrepancies between pre- and post-operative
improving patient safety,
diagnoses
• effectiveness of fall reduction activities
• adverse events related to deep sedation/anesthesia
• response to change/ deterioration in patient condition
• confirmed transfusion reactions
• significant medication errors and adverse drug reactions
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The Response: Purchasers
Leapfrog Group

Consortium of major companies and other large private and

public healthcare purchasers

These companies agreed to base their purchase of healthcare on four principles

that encourage more stringent patient safety measures:
• Educating and informing enrollees about patient safety and comparing
healthcare provider
performance;
• Recognizing and rewarding healthcare providers for major advances in protecting
patients from preventable medical errors;
• Holding health plans accountable for implementing these purchasing principles;
• Building support with benefits consultants to utilize and advocate for these principles
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The Response: Purchasers
Leapfrog Group

Consortium of major companies and other large private and

public healthcare purchasers

Three safety initiatives (Leaps)

• Computerized Physician Order Entry (CPOE) System
• Evidence-based Hospital Referral (EHR)
• ICU Physician Staffing (IPS)
• Leapfrog Safe Practices Score [4th leap]
Hospital Performance Measurement Initiatives
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The Response: US Government
Where it all started

The Centers for Medicare and Medicaid Services (CMS) began withholding
reimbursement for following hospital-acquired conditions (HACs) if not present
on admission (POA):

• catheter-associated urinary tract infection, • blood incompatibility,

• surgical site infection (CABG • falls and trauma,

mediastinitis, bariatric surgery, • vascular catheter-associated infection,

orthopedic procedures), • deep vein thrombosis

• stage Ill and IV pressure ulcers, (DVT)/pulmonary embolism (PE) with

• foreign object retained after surgery, total knee and hip replacements.
• air embolism,
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The Response: Providers
Where it all started

Actively participating in the appropriate patient safety accreditation

Implementation of NPSGs and IPSGs
Implementation of NQF/Leapfrog efforts
Quality and public reporting
International Patient
Safety Goals
 1 Identify Patients Correctly

2 Reduce Communication Errors

International 3 Safety of High Alert Medications

Patient 4 Safe Surgeries and Procedures

Safety Goals 5 Reduce Healthcare Associated Infections

6 Reduce Risk of Fall

END DAY 1
See you tomorrow!
Patient Safety Program
 Strategy Program Elements Physician Participation

Senior Leadership’s Generic Components of the Specific Ways of Involving

Involvement Program Physicians
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Strategic Initiative

IHI considers leadership to be the critical success factor for an

effective patient safety program, a responsibility that cannot be
delegated.

Senior leaders, including the Board members, CEO, the executives who report to the CEO, and senior
clinical leaders, must:
• Establish the value system
• Set the strategic goal
• Align efforts to achieve the goal
• Provide resources to create, implement, and sustain the program
• Remove obstacles to improvements
• Require compliance
• Ask what happened, not who did it to change culture
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Program Components
Structur
e

One or more designated, qualified individuals or interdisciplinary group

to manage the program

• Mechanisms to ensure that all applicable functions, departments, programs, and services
of the organization are integrated into and participate in the program
• A defined scope of program activities, including ongoing proactive efforts to both identify
and reduce risk, as well as to respond to errors (from patterns of "no harm" errors to
"near misses" to hazardous conditions and sentinel events);
• Procedures for immediate response to system and process failures and sentinel events,
including care of affected patients, containment of risk to others, and preservation of
facts for analysis;
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Program Components
Reporting

Internal and external medical error reporting processes, including definition

and organization-wide communication of sentinel event;

• An occurrence/event/incident reporting process;

• Defined intervention mechanisms, e.g., proactive risk reduction activities (FMEAs),
responses to system or process failures, systematic tracking of identified risks, and
root cause analysis for sentinel events;
• Defined mechanisms for support of staff involved in a sentinel event or a system or
process
failure, including blame-free internal reporting;
• Use and dissemination of information to improve safety; reporting to the governing
body and external adverse event databases.
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Program Components
Other Components

• Policies, procedures, and education mechanisms to reduce and control risk

to patients and staff;
• Mechanisms to participate in patient safety initiatives, e.g., IPSGs, IHI 5 Million
Lives, Leapfrog initiatives;
• Performance measurement, tracking, analysis;
• Improvement activities;
• Documentation and reporting;
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Physician Participation

Physician leader participation in the development and implementation of the patient

safety program as a strategic initiative

Specific ways in which physicians and other practitioners can facilitate patient
safety/clinical
risk management efforts:
• Identify general areas of risk in clinical aspects of patient care/safety;
• Help design programs to reduce risk in clinical aspects of patient care;
• Develop criteria for identifying specific cases with potential clinical and safety risk;
• Evaluate specific cases identified as having potential or real clinical risk
• Participate on teams to correct problems in the clinical aspects of patient care and
safety
identified through performance improvement and risk management
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Related Programs

Employee Safety Program

Emergency Management

Environmental Safety Program

• Security
• Hazardous Material
• Medical Equipment
• Fire Safety
• Utilities
• Environment of Care
Patient Safety Case
Studies
Culture of Safety
Human side of quality
 Culture…that complex whole
which includes knowledge, belief,
art, morals, law, custom and any
other capabilities and habits
acquired by man as a member of
society.

A family, a society, a nation, an

Culture organization – humans group and
a culture start to establish

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 A blend of the values, beliefs,
taboos, symbols, rituals and
myths
Unwritten rules
• National Anthem – we will stand.
• Wearing dress to golf tournament
vs. dress to football game.
Culture

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Organization Culture

Every company or organization has its own unique personality – just like
people have unique personality.

In groups of people who work together, organizational culture is an invisible but

powerful
force that influences the behavior of the members of that group.
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Organization Culture
How can we define
it?

The way we do things here around here

• You’ll have to learn it!

The code, core logic, the software of mind - the mindset

• In the head

What we do when we know no one is looking

• internally driven
• collective values, beliefs and principles of organizational members and is a product of
such factors as history, product, market, technology, strategy, type of employees,
management style, and national culture
Norms, Behaviors
(Visible)

Personal Values,
Attitudes
(Less visible
but talked
about)

Cultural Values
and Assumptions
(Usually not
visible at all,
often held
subconsciously,
rarely questioned)
 Physical Values Beliefs
dress code, office layout, tech foundation of culture based what we believe is right and
wrong
use, etc on Core Values
3Th8e Power of PowerPoint |

Organization Values
thepopp.com

Communication Integrity Respect Excellence

 We actively look to others for
guidance and consciously
imitate them

When we are unsure of how to react

Memetics and to a stimulus or situation, these

theories suggest that we

Social Contagion
• We transmit beliefs, religions,

• As a result of social conditioning

we
adopt certain rules about the world

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Culture
Strategy
Culture
Process
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Process vs. Culture

Reduce the incidence of hospital-acquired infections

• Develop policies
• Move sinks
• Change soaps
• Post signs
• Make alcohol rubs available
the greatest challenge and opportunity in reducing these infections lies in getting clinicians
to wash their hands - While the team may have improved its processes for hand hygiene —
it did not fundamentally change the culture
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Culture of Safety

Originated outside health care, in studies of high reliability

organizations, organizations that consistently minimize
adverse events despite carrying out intrinsically complex and
hazardous work

• High reliability organizations maintain a commitment to safety at

all levels, from frontline providers to managers and executives.
• This commitment establishes a "culture of safety"
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Culture of Safety

acknowledgment of the high-risk nature of organization's activities

• and the determination to achieve consistently safe operations

a blame-free environment
• where individuals are able to report errors or near misses without fear
of reprimand or punishment
encouragement of collaboration
• across ranks and disciplines to seek solutions to patient safety
problems
organizational commitment of resources to address safety
concerns
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Measuring Culture of Safety

Every organization has a culture – wouldn’t it be good to be able

to
manage it?

Plan it instead of leaving it to chance

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Measuring Culture of Safety

The safety assessment helps identify and measure conditions in healthcare

organizations that lead to adverse events and patient harm. It:
• Diagnoses current safety culture and tracks change over time;
• Raises patient safety awareness and helps prioritize quality strategies;
• Provides an opportunity for internal and external benchmarking;
• Is the baseline from which action planning and system/process changes
can begin
Agency for Healthcare Research and Quality (AHRQ) released the Hospital
Survey on Patient Safety Culture in 2004
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Measuring Culture of Safety
Aspects

Feedback about Error

Communication
Openness
Handoffs and Transitions
Frequency of
Error
Non Punitive Reporting
Response to Errors

Organizational
Learning
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Measuring Culture of Safety
Aspects

Overall Perceptions
Patient Safety Teamwork Across
Units
Supervisors Behavior or
Expectations Management Support in
Patient Safety
Staffing
Teamwork within
Units
Let’s Measure It
Medical Errors
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Medical Errors
Unintentional, preventable mistakes in the provision of care that have actual or potential adverse impact on the
patient.

Error Adverse Error

Failure of a planned action to be An injury resulting from a medical
completed as intended or use of a intervention
wrong plan to achieve an aim...
[including] problems in practice,
products, procedures, and systems

Minor Error Serious Error

An error causing harm that is neither An error causing permanent injury or
permanent nor potentially life- transient but potentially life-
threatening threatening harm
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Medical Errors

Near Miss Active Errors

An error that could have caused harm, Those at the "sharp end", occur at
but did not, either by chance or point of contact between a human and
because of timely intervention some aspect of the system (e.g.,
instrument, machine) or patient;

Latent Error Error Chain

Those at the "blunt end", occur The series of events that led to a
through failures of organization, "disastrous outcome", typically
design, or layers of the healthcare uncovered by a root cause analysis
system affecting the human making (RCA)
contact
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 A sentinel event is an
unanticipated occurrence
involving death or serious physical
or psychological injury.
• Serious physical injury specially
includes loss of limb or function.

Sentinel Event • Called sentinel because they signal

the need for immediate
investigation and response.
• Each hospital establishes an
operational definition of a
sentinel event

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 • Special Cause Variation, falling
outside the normal control limits
of the process of care

• The Joint Commission requires a

Sentinel Event “Root Cause Analysis” as the

intensive analysis technique to
be used by the organization

• Also called “Never Events”

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Sentinel Events

death that is unrelated to the natural course of the patient’s illness or

underlying condition

death of a full-term infant

suicide

major permanent loss of function unrelated to the patient’s natural course of

illness or underlying condition

wrong-site, wrong-procedure, wrong-patient surgery

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Sentinel Events

transmission of a chronic or fatal disease or illness as a result of infusing

blood or blood products or transplanting contaminated organs or
tissues

infant abduction

infant sent home with the wrong parents

rape, workplace violence such as assault (leading to death or permanent loss

of function)

homicide (willful killing) of a patient, staff member, practitioner, medical

student, trainee, visitor, or vendor while on hospital property
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Adverse Drug Events
ADEs

An injury from a medicine or lack of an intended medicine.

A medication error is any preventable event that may cause or lead to

inappropriate medication use or patient harm while the medication is in
the control of the health care professional, patient, or consumer.
• These may include errors in prescribing, order communication, product
labeling, packaging, and nomenclature, compounding, dispensing; distribution,
administration, education, monitoring and use
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Adverse Drug Events

Category A: circumstances or events that have the capacity to cause error.

Category B: An error occurred but did not reach the patient e.g. an” error of
omission” does not reach the patient.

Category C: An error occurred that reached the patient but did not cause
patient harm.

Category D: An error occurred that reached the patient and required

monitoring to confirm that it resulted in no harm to the patient.

Category E: An error occurred that may have contributed to or resulted in

temporary harm to the patient and required intervention.
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Adverse Drug Events

Category F: An error occurred that may have contributed to or resulted in

temporary harm to the patient and required initial or prolonged hospitalization

Category G: An error occurred that may have contributed to or resulted in

permanent patient harm.

Category H: An error occurred that required intervention necessary to

sustain life.

Category I: An error occurred that may have contributed to or resulted in

the
patient’s death
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Adverse Drug Reactions
ADRs

Any response to a drug that is noxious, unintended and that occurs at

doses normally used for prophylaxis, diagnosis or therapy, excluding
failure to accomplish the intended purpose

Allergic: Administration of the drug causes an undesirable immunologic

response, i.e., rash, anaphylaxis, which is often unpredictable.

Idiosyncratic: By definition these are unpredicted physiologic or

psychological responses occurring at therapeutic doses. These are unique
to an individual
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Adverse Drug Reactions
ADRs

Detection Mode
• Voluntary reporting by healthcare professionals or patients themselves
• Identified through triggers (drugs used to treat ADRs symptoms like stat dose
of IV steroids, Procyclidine, Antihistamines) and antidotes use (e.g. Flumazenil,
Naloxone, vitamin K, D25W etc)
• Abrupt discontinuation of medications or dose reductions
• Change of level of care (towards special or critical care)
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Adverse Drug Reactions
ADRs

Response
• Committee (usually Pharmacy and Therapeutics) will review all ADRs on
regular basis and discuss and approve strategies in order to curtail the
preventable ADRs
• In the event of a serious ADR the event may also be reported to
the manufacturer and/or DRAP as deemed necessary
Theories Related to Serious Events

The Blame Game Human Factors Tunnel Vision Swiss Cheese

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The Blame Game

Blame / Shame: Whose Fault is This?

Guilt: I screwed up—waiting for hammer to fall

Moving from who did it to why did this happen: Why things
happen
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The Blame Game

“ People make errors, which lead to accidents. Accidents lead to

deaths.
The standard solution is to blame the people involved. If we find out
who made the errors and punish them, we solve the problem, right?
Wrong. The problem is seldom the fault of an individual; it is the
fault of the system. Change the people without changing the system
and the
problems will continue ”
Don Norman, Apple Fellow
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Human Factors

Human factors are those elements that influence the performance of people
operating equipment or systems; they include behavioral, medical,
operational, task-load, machine interface and work environment factors
These elements include both physical and cognitive abilities
To err is human
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Nominal Human Error Rates

Salvendy G. Handbook of Human Factors & Ergonomics, 1997

Activity Probability

Error of commission (misreading a label) 0.003

Error of omission without reminders 0.01

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Human Factors Engineering

Human Factors Engineering: study of designs that are "human-centered"

• Such designs support or enhance a person’s performance

• Contrast this to designs that force the user to stretch or to make an extra effort to
interact
successfully with an interface or device
• Dangerous devices may trick or mislead users into an unintentional error
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Human Factors Principles

Avoid reliance on memory and vigilance

Use protocols and checklists

Simplify processes

Standardize procedures to reduce unintended

variation Use constraints and forcing functions

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Tunnel Vision

Possibility 2
• In reconstructing an event, we may view the
event with hind-sight bias Actual
Outcome
• We look at the event seeing all the options
the staff person could have or should have
done Possibility 1

• We perceive it to be so clear
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Tunnel Vision

Outside the Tunnel Inside the Tunnel

• Outcome determines culpability • Quality of decisions not determined

• “Look at this! It should have been so by outcome
clear!”
• Realize evidence does not arrive as
• We judge people for what they did revelations

• Refrain from judging people for

errors
“ The point of a human error investigation is to understand why actions and assessments that are now
controversial, made sense to people at the time. You have to push on people’s mistakes until they make
sense—relentlessly.”