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Errors fall into predictable patterns

Communication
Planning
Execution

Human Factors

Examines activity by way of component tasks


and considers it in terms of:
Physical demands:fatigue, illness, substance
abuse, stress
Skill requirements:inexperience, fear,
procedural shortcuts
Mental workload:boredom, cognitive
shortcuts, reliance on memory
Team dynamics: stress, shift work
Device design:equipment/programs
Environment:
fixed: lighting, heat, unnatural workflow space
controllable: noise, interruptions, motion,
clutter
Human Factors Principles

Avoid reliance on memoryseven digits is our


max
Decrease reliance on vigilance
Increase verbal feedback/structured
communication
Standardize what you can, and only that; use
protocols & checklists wisely
Use constraints and forcing functions to create
a safety net to save you from yourself
Reduce handoffs and standardize content
How to Respond to Errors?

Report themWUSM Employees use the WUSM Event Reporting


System http://ers.wusm.wustl.edu
BJC Employees use the BJC System (icon on desktops)
SAFElineCall7-SAFE (7233) and leave a message
Submit cases to Departmental QI or M&M process

Transparency with each other safely telling lessons learned


Ask What happened not Who did it?
Give a full explanation to patients/families of adverse events
Ask Who else can learn from this?generalize lessons
Involve patients and families in safety efforts
Culture of Safety

Focuses on creating a safe system in which to


work
Strikes a balance between flattening
hierarchy and effective teamwork with a
recognized leader
Strives for high reliability with members
preoccupied with failure
Creates an environment where both
patients, physicians, staff are treated with
dignity and respectRight thing to do
Keeps patients safer
Communication of Adverse Events to Patients

When harm occurs:


Consult with all those involved to establish
facts
Give family a prompt explanation of what
occurred
Express regret and compassion for what they
are experiencingsay sorry
Discuss the medical needs going forward
short and long term effects of injury

If error contributed to harm:


Give a compassionate & truthful explanation
and say you are sorry
Tell them what you are doing to prevent it
from happening again
Identify who will be their contact for future
discussions
Document the error and the discussions in the
record
The report proposes six aims for
improvement in the healthcare system: (1)
safe, (2) effective, (3) patient-centered, (4)
timely, (5) efficient, and (6) equitable (Institute
of Medicine Committee on Quality of
Health Care in America, 2001).
The most common medication errors were:
drug to
wrong patient, wrong dose of medication, drug
overdose, omitted drug, wrong drug and
wrong administration time.

The most commonly reported causes for these


errors were:
failure to follow checking procedures, written
miscommunication, transcription errors,
prescriptions misfiled and calculation errors.
Donchin et al. (1995) estimated a rate of 1.7
errors per ICU patient per day
A human factors analysis showed that most
errors could be attributed to poor
communication between physicians and
nurses.
Suggestions for reducing errors in ICUs are multiple, such as improving
communication between nurses and physicians (Donchin, et al., 1995);
improving access to
information (L.L. Leape, et al., 1995); providing timely appropriate care
(Bracco, et al.,
2000); and integrating various types of computer technology, including CPOE
(Varon & System-related human errors seem to be
Marik, 2002). particularly
prevalent in ICUs.
Cimino et al. (2004) examined medication prescribing
errors in nine pediatric ICUs. Before the implementation of various
interventions, 11.1% of
the orders had at least one prescribing error. After the
implementation of the interventions
(dosing assists, communication/education, and floor stocks), the rate
of prescribing errors
Another high-risk care process is transition of
care
Each transition requires the transfer of all
relevant information
from one entity to the next, as well as the
transfer of authority and responsibility

Transitions may be influenced by poor


communication and inconsistency in care
Transitions involving medication changes from
hospital to long-term care have been shown to
be a likely cause of adverse drug events
Patients prescribed long-term medication
therapy with warfarin
were found at higher risk for discontinuation of
their medication after elective surgical
procedures
Despite the increased attention towards
patient safety, it is unclear whether we are
actually
making any progress in improving patient
safety (Charles Vincent, et al., 2008). Several
reasons for this lack of progress or lack of
measurable progress include: lack of reliable
data
on patient safety at the national level (Lucian
L. Leape & Berwick, 2005; Charles Vincent,
et al., 2008) or at the organizational level
(Farley, et al., 2008; Shojania, 2008; Charles
Vincent, et al., 2008), difficulty in engaging
clinicians in patient safety improvement
activities (Hoff, 2008; Charles Vincent, et al.,
2008), and challenges in redesigning and
improving complex healthcare systems and
processes
which distinguishes between latent and active
failures

Latent conditions are the inevitable resident


pathogens within the system that arise from
decisions made by managers, engineers,
designers and others

Active
failures are actions and behaviors that are directly involved in an accident: (1) action slips or
lapses (e.g., picking up the wrong medication), (2) mistakes (e.g., because of lack of
medication knowledge, selecting the wrong medication for the patient), and (3) violations or
work-arounds (e.g., not checking patient identification before medication administration).
organizational accident model
This model defines 7 categories of
system factors that can influence clinical
practice and may result in patient safety
problems:
(1) institutional context, (2) organizational and
management factors, (3) work environment,
(4) team factors, (5) individual (staff) factors,
(6) task factors, and (7) patient characteristics.

Five HRO principles influence mindfulness: (1)


tracking small failures, (2) resisting
oversimplification, (3) sensitivity to operations,
(4)
resilience, and (5) deference to expertise
The levels of system design are organized
hierarchically as follows: physical
devices, physical ergonomics, individual
behavior, team and group behavior,
organizational
and management behavior, legal and
regulatory rules, and societal and cultural
pressures.
a team at Boston Medical Center redesigned the hospital discharge process by
improving information flow and coordination. Three components of the discharge process
were changed: (1) in hospital discharge process, (2) care plan post-hospital discharge, and
(3) follow up with patient by pharmacist. Changes in the inhospital redesigned discharge
process included: communication with the patient (i.e. patient education and information
about follow up care), organization of post-discharge services and appointments for followup
care, review of medication plan and other elements of the discharge plan, and
transmission of discharge summary to appropriate parties (e.g., primary care provider of the
patient). At the time of discharge, the patient was provided with a comprehensive written
discharge plan. Post-discharge, a pharmacist followed up with the patient. This system
redesign effort considers all important steps of the discharge process involved in the
transition of care and the many interactions that occur in the discharge process (see Figure
3).
Patients who received the intervention were less likely to be re-admitted or to visit the
emergency department 30 days post-discharge. They were also more likely to visit their
primary care provider. Survey data showed that patients involved in the redesigned
discharge process felt more prepared for the discharge.
Some of the barriers to the widespread
dissemination of this knowledge in healthcare
organizations include: lack of recognition of
the importance of systems design in various
aspects of healthcare, technical jargon and
terminology of human factors and systems
engineering, and need for development of
knowledge regarding the application of human
factors and systems engineering in
healthcare.
Numerous books provide information on human factors methods (Salvendy, 2006;
Stanton,
Hedge, Brookhuis, Salas, & Hendrick, 2004; Wilson & Corlett, 2005). Human factors
methods can be classified as: (1) general methods (e.g., direct observation of work), (2)
collection of information about people (e.g., physical measurement of anthropometric
dimensions), (3) analysis and design (e.g., task analysis, time study), (4) evaluation of
human-machine system performance (e.g., usability, performance measures, error
analysis,
accident reporting), (5) evaluation of demands on people (e.g., mental workload), and
(6)
management and implementation of ergonomics (e.g., participative methods). This
shows
the diversity of human factors methods to address various patient safety problems. In
this
section, we described selected human factors methods that have been used to
evaluate highrisk
care processes and technologies.
FMEA
(Failure Modes and Effects Analysis) is one
method that can be used to analyze, redesign
and improve healthcare processes to meet the
Joint Commissions National Patient Safety
Goals. The National Patient Safety Center of
the VA has adapted the industrial FMEA
method to healthcare (DeRosier, Stalhandske,
Bagian, & Nudell, 2002). FMEA or other
proactive risk assessment techniques have
been applied to a range of healthcare
processes,
such as blood transfusion (Burgmeier, 2002),
organ transplant (Richard I. Cook, et al.,
2007), medication administration with
implementation of smart infusion pump
technology
(Wetterneck, et al., 2006), and use of
computerized provider order entry (Bonnabry,
et al.,
For instance, a review of literature by Karsh
(2004) highlight
the following principles for technology
implementation to promote patient safety:
top management commitment to the
change
responsibility and accountability structure
for the change
structured approach to the change
training
pilot testing
communication
feedback
simulation
end user participation.
Error analysis tools: Plan-Do-Study-Act (PDSA)

The purpose of PDSA quality improvement efforts is to establish a functional or


causal relationship between changes in processes (specifically behaviors and
capabilities) and outcomes. Langley and colleagues51 proposed three questions
before using the PDSA cycles: (1) What is the goal of the project? (2) How will it be
known whether the goal was reached? and (3) What will be done to reach the
goal? The PDSA cycle starts with determining the nature and scope of the
problem, what changes can and should be made, a plan for a specific change, who
should be involved, what should be measured to understand the impact of
change, and where the strategy will be targeted. Change is then implemented and
data and information are collected. Results from the implementation study are
assessed and interpreted by reviewing several key measurements that indicate
success or failure. Lastly, action is taken on the results by implementing the
change or beginning the process again.51
Six Sigma

There are two primary methods used with Six Sigma. One method inspects process
outcome and counts the defects, calculates a defect rate per million, and uses a
statistical table to convert defect rate per million to a (sigma) metric. This method is
applicable to preanalytic and postanalytic processes (a.k.a. pretest and post-test
studies). The second method uses estimates of process variation to predict process
performance by calculating a metric from the defined tolerance limits and the
variation observed for the process. This method is suitable for analytic processes in
which the precision and accuracy can be determined by experimental procedures.
One component of Six Sigma uses a five-phased process that is structured,
disciplined, and rigorous, known as the define, measure, analyze, improve, and
control (DMAIC) approach.53, 54 To begin, the project is identified, historical data are
reviewed, and the scope of expectations is defined. Next, continuous total quality
performance standards are selected, performance objectives are defined, and
sources of variability are defined. As the new project is implemented, data are
collected to assess how well changes improved the process. To support this analysis,
validated measures are developed to determine the capability of the new process.
Toyota Production System/Lean Production
System
Steps in the Lean methodology involve maximizing value-added activities
in the best possible sequence to enable continuous operations.58 This
methodology depends on root-cause analysis to investigate errors and
then to improve quality and prevent similar errors.

Physicians, nurses, technicians, and managers are increasing the


effectiveness of patient care and decreasing costs in pathology
laboratories, pharmacies,5961 and blood banks61 by applying the
same principles used in the Toyota Production System. Two reviews of
projects using Toyota Production System methods reported that health
care organizations improved patient safety and the quality of health
care by systematically defining the problem; using root-cause analysis;
then setting goals, removing ambiguity and workarounds, and clarifying
responsibilities
Root Cause Analysis

Root cause analysis (RCA), used extensively in engineering62 and similar


to critical incident technique,63 is a formalized investigation and
problem-solving approach focused on identifying and understanding the
underlying causes of an event as well as potential events that were
intercepted. The Joint Commission requires RCA to be performed in
response to all sentinel events and expects, based on the results of the
RCA, the organization to develop and implement an action plan
consisting of improvements designed to reduce future risk of events and
to monitor the effectiveness of those improvements

An RCA is a reactive assessment that begins after an event, retrospectively outlining the
sequence of events leading to that identified event, charting causal factors, and
identifying root causes to completely examine the event.66 Because it is a labor-
intensive process, ideally a multidisciplinary team trained in RCA triangulates or
corroborates major findings and increases the validity of findings
HFMEA. Developed by the VAs National Center for Patient Safety, the health failure
modes and effects analysis (HFMEA) tool is used for risk assessment. There are five
steps in HFMEA: (1) define the topic; (2) assemble the team; (3) develop a process
map for the topic, and consecutively number each step and substep of that
process; (4) conduct a hazard analysis (e.g., identify cause of failure modes, score
each failure mode using the hazard scoring matrix, and work through the decision
tree analysis);79 and (5) develop actions and desired outcomes. In conducting a
hazard analysis, it is important to list all possible and potential failure modes for
each of the processes, to determine whether the failure modes warrant further
action, and to list all causes for each failure mode when the decision is to proceed
further. After the hazard analysis, it is important to consider the actions needed to
be taken and outcome measures to assess, including describing what will be
eliminated or controlled and who will have responsibility for each new action.79

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