Author: Darryl Elzie, PsyD, MHA, MLS(ASCP), CQA(ASQ)
Errors Are Technical Events and Organizational Signals
Clinical laboratory errors are often described as technical failures: a specimen was mislabeled,
quality control was not reviewed, an instrument alarm was overlooked, or an incorrect result
was released. For laboratory management, however, each event also represents information
about the system in which employees work. Workload, staffing, communication, technology,
procedure design, supervision, competing priorities, and workplace culture all influence
whether a process is performed reliably.
Laboratory medicine literature has long shown that risk extends across the entire testing
process rather than remaining confined to the analytical phase. Preanalytical and postanalytical
vulnerabilities frequently involve handoffs, communication, identification, data entry, result
interpretation, and other human-dependent processes. These are precisely the areas in which
management systems and behavioral conditions have substantial influence. 1
A developed corrective-action program, therefore, does more than restore normal operations.
It identifies why the event occurred, why existing controls did not prevent or detect it, and
what changes will make the process more reliable over time. This expectation is also reflected
in CLIA requirements for corrective-action procedures and for evaluating whether corrective
actions were effective and whether policies must be revised to prevent recurrence. 2,3 This is
the core of truly continuous quality improvement.
Correction Is Not Corrective Action
A correction addresses the immediate condition. The laboratory may recollect a specimen,
amend a result, repeat a quality-control run, remove expired material, or quarantine an
affected product. These actions may be necessary to protect patients/donors and restore
operations, but they do not necessarily reduce the probability of recurrence.
Corrective action addresses the cause of the nonconformity. Root cause analysis is the
structured process used to identify the technical, behavioral, environmental, and organizational
factors that permitted the event to occur. The distinction matters because laboratories are
often under pressure to resume testing quickly. Once the immediate problem has been
resolved, leaders may experience a premature sense of closure. Without disciplined follow-
through, the investigation can become a documentation exercise rather than a mechanism for
organizational learning. (However, it should be noted that accurate and complete
documentation is always required.)
Why “Human Error” Is an Incomplete Root Cause
Human error is often presented as a causal factor, but it usually describes what happened
rather than why. Reason’s systems approach distinguishes between a person-focused response,
which concentrates on lapses, inattention, or carelessness, and a system-focused response,
which examines the conditions under which people work. The systems approach does not
remove accountability; it recognizes that predictable human limitations must be considered
when designing safe processes. 4
Attention declines during repetitive work. Working memory is disrupted by interruptions.
Fatigue impairs judgment. Confirmation bias can cause staff to interpret information in a way
that supports an initial assumption. Poorly designed screens, excessive alarms, similar labels,
and complex procedures increase cognitive load. When a critical process depends primarily on
vigilance, memory, and perfect compliance, the system has been designed with limited
tolerance for normal human variability.
For this reason, instructions to “be more careful” are weak corrective actions. A stronger
response will include real change, such as barcode verification, bedside label printing,
automated quality-control lockouts, hard stops, simplified workflows, physical separation of
look-alike materials, or independent review of high-risk steps. Training is appropriate when a
genuine knowledge or competency deficit is demonstrated, but it should not be used to
compensate for poor process design.
Psychological Safety Determines What Leaders Learn
Root cause analysis is only as strong as the information available to the investigation team. Staff
are more likely to report errors, near misses, uncertainty, and unsafe workarounds when they
believe they can speak honestly without automatic humiliation, blame, or punishment.
Psychological safety is the shared belief that interpersonal risk-taking, such as admitting a
mistake, challenging a decision, or raising a concern, is acceptable within the team. 5
Research in healthcare has associated psychological safety with speaking up, learning behavior,
and willingness to report errors, although recent reviews also reveal significant complexity in
the relationships between reporting rates and safety outcomes. A higher number of reports
may reflect a less safe environment, or a healthier reporting culture that makes existing risks
visible. Laboratory managers should therefore avoid judging culture solely by the number of
events reported. 6-9
Leadership response is pivotal. When managers react with anger, public criticism, or immediate
disciplinary action, staff learn that reporting carries personal risk, leading to events being
minimized, reframed, or entirely unreported. Near misses may often completely disappear.
Conversely, leaders who begin with curiosity are more likely to obtain an accurate account of
what really happened.
Use Just Culture Without Eliminating Accountability
A just-culture framework helps managers differentiate human error, at-risk behavior, and
reckless behavior. Human error may require process redesign, coaching, or stronger barriers.
At-risk behavior requires understanding why a shortcut appeared reasonable, efficient, and
acceptable. Reckless behavior requires disciplinary action when an individual knowingly
disregards a substantial and unjustifiable risk.
The distinction prevents two management failures: punishing every deviation as misconduct or
excusing every action as a system problem. Effective accountability examines the behavior, the
available choices, the staff’s understanding of risk, and how the organization has responded to
comparable behavior in the past. Consistency is essential. Staff need to believe consequences
are not dependent on hierarchy, popularity, or the outcome of the event.
Conduct Investigations as Learning Processes
The immediate management priority is containment. Potentially affected specimens, reagents,
records, results, or blood products should be identified and controlled. The laboratory must
evaluate patient or product impact, preserve electronic and paper evidence, notify appropriate
leadership, and define the preliminary scope.
The problem statement should describe what occurred without assuming a cause. “Staff failed
to follow the procedure,” prematurely closes the inquiry. A stronger statement identifies what
happened, what should have happened, when and where the event occurred, how it was
detected, and the actual or potential impact.
Investigation teams should review procedures, training records, competency assessments,
instrument data, audit trails, staffing, workload, environmental conditions, previous events, and
system interfaces. Direct observation is particularly important because written procedures
describe work as imagined, while staff may perform work differently in response to real
operating conditions.
Frontline staff should be included as subject-matter experts. Interviews should be structured as
information-gathering conversations rather than interrogations. Questions such as “What
normally happens at this step?”, “What made the correct action difficult?” and “How is this
work completed during high-volume periods?” are more likely to expose meaningful system
weaknesses than asking, “Why didn’t you follow the procedure?”
Select Corrective Actions by Strength
Corrective actions should be proportionate to the risk and directly connected to documented
causal factors. In general, stronger controls reduce dependence on individual memory and
vigilance. The preferred order is to eliminate unnecessary hazards or steps, engineer the error
out of the process, automate or standardize controls, add forcing functions or hard stops,
simplify workflow, improve visual controls, and then support those changes with revised
procedures and targeted education.
Every action plan should identify the causal factor addressed, the action owner, completion
date, required resources, interim controls, implementation evidence, effectiveness measure,
and follow-up date. Completely engage the continuous quality improvement loop.
Measure Effectiveness, Not Completion
A signed training record or revised procedure proves an activity occurred; it does not prove risk
was reduced. Effectiveness checks should determine whether the original problem has
recurred, whether the identified cause is under control, whether the process is followed
consistently, and whether the intervention has created unintended consequences (this
sometimes happens).
Useful measures may include event recurrence, specimen rejection, amended reports, quality-
control failures, system overrides, proficiency-testing performance, audit findings, direct
observation, competency outcomes, or turnaround-time effects. The laboratory should
establish a baseline, a measurable target, an appropriate monitoring period based on event
frequency, and a responsible reviewer.
Managers should be cautious about short monitoring periods. Immediately after an event,
awareness is elevated, and behavior may temporarily improve. Sustainable change is
demonstrated only when the redesigned process performs reliably after the system has
returned to normal operations.
Convert Event Data into Management Intelligence
Individual investigations provide local insight; aggregated data provide organizational
intelligence. Laboratories should trend deviations, complaints, near misses, audit findings, and
corrective actions by category, location, shift, instrument, process, and causal factor. These
trends should be compared with staffing levels, workload, equipment downtime, training
changes, and turnaround-time pressure.
Repeated “isolated” incidents may reveal a common organizational weakness. Multiple
procedural deviations may indicate that the procedure is impractical. Recurring documentation
errors may reflect interface design or divided attention. As mentioned earlier, an increase in
near-miss reports after a leadership initiative may reflect improved transparency rather than
declining performance.
Corrective-action data should inform management review, resource allocation, equipment
selection, software design, competency programs, staffing decisions, and strategic quality
priorities. The World Health Organization’s laboratory quality framework similarly treats
occurrence management, root cause analysis, corrective action, and follow-up as
interconnected elements of a laboratory quality management system. 10
The Laboratory Manager’s Role
Laboratory managers establish the conditions under which corrective action succeeds or fails.
They determine whether staff have time to participate in investigations, whether evidence is
examined before conclusions are reached, whether quality concerns can be raised without
retaliation, and whether stronger controls receive the resources needed for implementation.
The most useful leadership question after an event is not simply, “Who made the mistake?” It
is, “What conditions made this action possible, and what should the system do differently next
time?” That question does not weaken accountability. It strengthens it by assigning
responsibility not only to the employee performing the task, but also to the leaders who design,
resource, supervise, and improve the process.
When laboratory leaders integrate technical evidence, human factors, psychological safety, and
measurable effectiveness, corrective action becomes more than regulatory documentation. It
becomes a management discipline protecting patients and donors, strengthening staff
engagement, improving operational resilience, and enabling the organization to learn before
the next failure causes harm.
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