RISK
MANAGEMENT IN CLINICAL LABORATORY
In 1999 the Institute of Medicine
(IOM) published a study entitled "To Err Is Human: Building a Safer Health
System." Its estimate of the number of deaths and adverse outcomes caused
by medical errors sent shockwaves throughout the healthcare community as well
as the general population. Perhaps for the first time members of the healthcare
community began to seriously look at the way healthcare is delivered and how
the process could be improved to enhance patient safety.
Thus, one of
the most beneficial results from the IOM study was that hospital workers and
other healthcare providers realized that they urgently needed to fully and more
effectively incorporate "risk" as a crucial component of their
management. It is the goal of this course to present an overview of risk
management with a clinical laboratory point of view and to hopefully show how
risk management can improve the quality of care we give patients.
Definitions of Risk and Risk
Management
A risk is a future event that may
result in loss or injury. In healthcare, the future event specifically refers
to injury to a patient (negative patient outcomes).
Risk management involves the creation
of policies and procedures and the implementation of practices that are aimed
at the prevention of future events that could result in negative patient
outcomes. Basically, risk management is the process of making and carrying out
decisions that will assist in the prevention of detrimental events. It also
describes techniques used in the prevention of adverse consequences or losses
if an unintended or unexpected event does occur. It is important to demonstrate
how to analyze risks and what options a laboratory has in deciding how to deal
with risks. Often, a critical incident that affects patient care is the result of
multiple errors and system flaws that coincide.
Model of Accident Causation
Feasible
Risk: Keep risks as
low as reasonably practical. You can't make any process safer than is
technologically and/or commercially possible.
Comparative Risk: Keep risks as low as other comparable
risks. For instance, if the public accepts the risks of one activity, achieving
that level of risk in another process is also acceptable. For instance, a risk
question could be formulated like this: should healthcare be as safe as
smoking, as safe as driving, or as safe as
flying?
De minimis Risk: Reduce risk until it is trivial. In
safety culture, this goal is set as a probability of 10-6 or better.
Zero Risk: No risk is acceptable. Safety doesn't
exist while there is still a chance of an accident with harmful consequences.
Zero risk doesn't actually exist, of course, but nevertheless it can be adopted
as a goal, and it is an particularly apt goal for certain tasks. For instance,
a zero risk approach for the handling of nuclear weapons and reactors is
probably a necessary one.[2]
Why Manage Risk?
Every director and manager is aware of
that unexpected event are unavoidable at any point of time in a
laboratory.Unfortunately, this negative unexpected events seriously affects on
the effectiveness as well as the financial welfare of the laboratory which
results into decrease output in terms of quality as well as quantity. Some of
these negative events can have such devastating consequences that the sheer
risk of them occuring cannot be left to chance. Occurrence of such event can be
avoided using systematic and professional way of risk management.
The challenge is to assess and analyse
the extent of risk and control risk in an appropriate and cost-effective
manner. By using risk management strategies, the laboratory can approach risk
in a structured and calculated manner.
Risk Reduction through Quality Systems
and Improvement
• External Audits and EQA
• Internal Audits
• Preventive Actions
• Opportunities for Improvement
• Corrective Actions
Introduction to Patient Safety and
Risk Exposures
Laboratory quality management and risk
management plans that address processes in the preanalytic, analytic, and
postanalytic phases of testing are key elements in ensuring patient safety. The
preanalytic phase of testing includes all processes prior to the actual testing
of a specimen. The analytic phase consists of all the processes involved in the
testing of a specimen, and the postanalytic phase includes all the processes
involved after test analysis. Clinical laboratories are engaged in the process
of risk reduction all the time, but characterize it with different vocabulary.
Risk and the Clinical Laboratory
• Worker
risk
– Safety
–
Responsibility
|
• Patient
risk
– Patient Identification
– Specimen
Identification
–
Information
– Analytic
sensitivity and specificity
– Report
interpretation
|
•
Laboratory risk
–
Financial
–
Liability
– Safety
|
Preanalytic Phase
A study that was published in 2002
concluded that 68 - 87% of laboratory errors occur in the preanalytic and
postanalytic stages of the testing process with the majority occurring in the
preanalytic phase.*
Steps in the pre-analytic phase occur
both inside and outside the laboratory, and are performed by both laboratory
and non-laboratory personnel. While the following list is not exhaustive, some
of the most common sources of error in the preanalytic phase include:
Ø
Patient
preparation - Patient not told to be fasting; improper or no instruction to
patient on proper collection of specimen such as clean catch urine.
Ø
Patient
injured during phlebotomy - Development of hematoma resulting in no specimen
obtained for testing.
Ø
Requisition
errors - Patient information missing, illegible, or on wrong patient; wrong
tests ordered.
Ø
Patient
identification - Patient incorrectly identified.
Ø
Labeling
of specimen - Specimen not labeled or incorrectly labeled.
Ø
Preparation
of specimen - Specimen centrifuged too long or not long enough; specimen placed
in improper preservative.
Ø
Storage
of specimen - Specimen not refrigerated or frozen as required or refrigerated
when it should be at ambient temperature.
Ø
Shipment
of specimen - Shipped at ambient temperature when it should have been shipped
frozen; delay in shipment.
Ø
Accessioning
process including preparation for analysis
Ø
Sorted
into wrong batch; incorrect labeling.
Ø
Order
entry - Incorrect data entered during manual entry of a test requisition.
Ø
Specimen
sub-optimal - Not enough specimen for testing; visible hemolysis.
Ø
Contamination
- Inadequate cleansing of venipuncture site resulting in contamination during
blood culture collection.
Analytic Phase
Errors occur much less frequently in
the analytic phase of laboratory testing than in either the preanalytic or postanalytic
phases. The supposition of published studies on the error rate in this category
is that the percentages remain low primarily because of:
Ø
The
qualifications of testing personnel
Ø
Effectiveness
of internal quality control programs and
Ø
External
assessment practices which assist in identifying analytical errors and
detecting possible sources.
Following is a list of examples of
errors that may be encountered during the analytic testing activities. The list
includes both human and instrumentation errors. While random errors (those that
occur independently of the operator) may be encountered during the analytic
phase, primarily listed are systematic errors. That is, errors those bias the
measurement resulting from either instrument malfunctions or human mistakes.
Ø
Errors
in quality control and verification of performance specifications.
Ø
Instrument
malfunctions.
Ø
Calibration
errors causing a direction of bias in results.
Ø
Manual
pipetting errors.
Ø
Reagent
errors.
Ø
Test
interference caused by unsuspected antibodies.
Ø
Specimen
interference i.e. failing to visually see sample was lipemic.
Ø
Math
errors.
Ø
Staff
errors in testing preparation and processing.
Ø
Inadequate
staffing which may precipitate errors caused by fatigue.
Postanalytic Phase
Recently, significant attention has
been focused on errors made during the postanalytic phase of laboratory testing
and the impact errors made during this phase have on laboratory-related patient
outcomes. Similar to the preanalytic phase, the postanalytic phase can be
subdivided into those procedures that are within the laboratory, and those
outside the laboratory; where the physician receives, interprets, and acts on
the laboratory results. The examples listed below are limited to possible
postanalytic errors that may occur within the laboratory and over which the
laboratory has more control:
Ø
Laboratory
results not verified before being reported.
Ø
Improper
data entry or typing mistakes causing erroneous information to be reported.
Ø
Critical
values not reported, or not reported in a timely manner.
Ø
Laboratory
tests not reported or reported to the wrong health provider.(For example, poor
communication to a patient's physician of the results of laboratory tests that
are pending at the time of a patient's discharge.)
Ø
Lack
of timeliness of reporting laboratory results (slow turnaround time).
Ø
Misinterpretation
of an alphabetic flag in the result field (i.e. lower case "l"
interpreted as the number "1".
Oral results misunderstood by
receiving party- no "read back" requested to confirm that data was
correctly received
Possible applications of Risk
Management Procedures in the Medical Laboratory
• Patient Identification Errors
• Accession Errors
• Provision of new tests and services
Introduction to the Risk Management
Process
Viewing risk management as a process
helps set priorities and assists in ensuring a comprehensive risk management
effort. There are several different approaches to the risk management process;
the approach that is proposed in this course includes these five steps:
1. Identify and analyze loss exposure.
2. Consider alternative risk management
treatments.
3. Select what appears to be the best
risk management treatment or combination of treatments.
4. Implement the selected treatment(s).
5. Monitor and improve the risk
management program.
Identify and Analyze Loss Exposure
Risk management is the process by
which the laboratory becomes aware of risk that can cause potential loss
exposure. Loss could result from a variety of circumstances and, depending upon
the circumstances, can be insignificant to catastrophic. Therefore, in addition
to identifying the risk, it is also important to establish the severity of the
risk by determining the probability of loss if the risk is not controlled.
There are a variety of ways the laboratory can identify potential risks. The
following methods are generally considered among the more effective methods.
Ø
Evaluating
complaints from patients and clients
Ø
Reviewing
incident reports
Ø
Evaluating
deficiencies cited by accreditation or governmental
inspections
(external assessments)
Ø
Reviewing
proficiency testing results
However, it is important to be
sensitive to events or trends that may alert you to risk potential. For
example, although continually monitoring the number of phlebotomies that are
performed in a day may not be a normally effective method for evaluating risk,
if there is a sudden staff shortage of phlebotomists or a sudden increase in
hospital census, it may be worth evaluating the number of phlebotomies that are
done because the risk potential may increase if the phlebotomy staff is
overworked.
Failure Mode and Effect Analysis
Root cause analysis (RCA) is a method
of error analysis that involves retrospective investigations. Error analysis,
using a different conceptual strategy, may also involve prospective attempts to
predict error modes.
One of the most commonly used
prospective approaches is failure mode and effect analysis or
FMEA. Root cause analysis is used primarily to examine the underlying
contributors to an adverse event or condition. FMEA differs in that its primary
use is to evaluate a process prior to its implementation. Its purpose is to
identify ways in which a process might possibly fail with the goal being to
eliminate or reduce the likelihood of such a failure (i.e., reduce risk).
In addition to describing a generic
FMEA process, we will use an example specific to healthcare – HFMEATM – the
Health Care Failure Mode Effects Analysis. This is an actual Risk Management
tool that has been put into use in the VA system in 2001.
1. Create a map of the process, and
use that to identify all hazards and harms that can occur at each step (a
hazard is a potential source of harm, and hazards can result in multiple
harms). We strive for a complete catalogue of all the possible hazards and
harms. Typically this involves brainstorming by a team made up of the staff
that actually performs the process.
2. Next, we assign a frequency or probability to each harm –
estimating the likelihood that that any given outcome will occur. In some
cases, this number is a ranking from 1 to 10, with 1 being very rare, and 10
being frequent. In the case of HFMEATM[3], this ranking isn't even a number,
but is a general frequency (remote, uncommon, occasional, frequent):
Root Cause Analysis
Root cause analysis (RCA) is a
structured study that determines the underlying causes of adverse events. RCA
focuses on systems, processes, and common causes that were involved in the
adverse event. It then determines ways to prevent recurrence by identifying potential
improvements in systems and processes that should decrease the likelihood of
repeating the event.
Occurrences that may jeopardize
patient safety must be investigated immediately and appropriate risk-reduction
activities must be implemented. The most serious of these occurrences has been
labeled by the Joint Commission as a sentinel event. A sentinel event is an
unexpected event involving patient death or serious physical or psychological
injury. A root cause analysis must be performed if a sentinel event occurs.
Another serious event that also requires investigation at the level of a root
cause analysis is sometimes referred to as a near miss. A near miss is a
process variation that did not result in patient death or serious injury, but a
significant risk of one of these adverse outcomes was present and could occur
if the same process variation was repeated.
Cause and Effect (Fishbone) Diagram
Example
This type of diagram graphically helps
identify and organize known or possible causes for a specific problem or area
of concern.
In this theoretical example, the
identified problem is a "near miss." Two units of RBCs were taken to
the Dialysis unit for transfusion of two different patients. The first unit was
hung by one clinical person and started just as another clinical person noticed
that the unit that he/she picked up for transfusing another patient had the
wrong identifying information. The blood was stopped immediately on the first
patient.
Some of the benefits of constructing a
"fishbone diagram" are that it:
Ø
Helps
determine root causes using a structured approach.
Ø
Encourages
group participation and utilizes group knowledge.
Ø
Indicates
possible variations in a process.
Ø
Indicates
areas where more data should possibly be collected.
The Fishbone Diagram
Examining Alternative Risk Management
Treatments
Root cause analysis is a process for
identifying factors that cause risks. It focuses primarily on systems and
processes, not on individual performance. The process progresses from identifying
causes to identifying potential strategies that could possibly be implemented
to improve the system or activity (cause and effect). In other words, after
determining what caused the risk in the first place the next step is to
determine what can be done to stop the risk from happening in the future. This
is referred to as loss prevention.
Some examples of risk control treatments in loss prevention might include:
Ø
Staff
education
Ø
Procedure
revisions
Ø
Policy
review
Selecting the best risk management
treatments involves two steps. The first step requires that there be an attempt
to forecast what effect or effects the suggested alternative risk treatments
might have on the desired objective(s). The second step entails implementing
one or more of the alternative treatments that not only meet the desired
objective(s) but also meet the desired objective in a cost-effective manner.
Implement the selected treatment(s)
The selected alternative treatment or
treatments are then implemented. Everyone who might be affected by the selected
treatment(s) must be made aware of the implementation. The pareto chart
is a useful tool during the implementation phase. It graphically summarizes and
displays the importance of the cause or causes that have been identified in the
fishbone chart and helps the laboratory staff determine which
cause to focus on first.
Errors Related to Risk Management
When the need for root cause analysis
arises, it is hoped that the investigative team will be receptive to all
suggestions and proposals in addition to making a systematic analysis. Listed
are three mistakes that commonly afflict the risk management process and
consequently can affect positive outcomes. The risk control that should be
applied is exposure avoidance.
Anchoring
error: This term
refers to the deliberative trap of allowing first impressions to exert undue
influence on the risk analysis.
Confirmation
bias: This is a
tendency to focus on evidence that supports a working hypothesis rather than
looking for evidences that supports an alternative solution.
Anchoring
bias: This
refers to the tendency to hold on to an initial solution even in the face of
disconfirming evidence.
Pre-Employment Screening
Pre-employment screening is not an
invasion of an applicant's private life. In a screening and credential
verification program, the healthcare organization is seeking to confirm what an
applicant has done in his or her professional career such as previous
employment, criminal and civil records, credit history, driving records,
educational credentials, and professional certifications. Potential employers
are entitled to obtain job-related information in order to make the best
possible hiring decision.
Healthcare organizations that fail to
implement a risk management program, which includes pre-employment screening,
could be eventually exposed to lawsuits, workplace violence, sexual harassment
difficulties, theft, property damage, or loss of business. In addition to
limiting these detrimental effects, other benefits of pre-employment screening
may include:
Ø
Discouraging
job applicants with falsified credentials from even applying.
Ø
Eliminating,
to a degree, the uncertainty in the hiring process.
Ø
Demonstrating
that the health care organization has taken reasonable steps in the hiring
process; thus providing some protection in the event of a lawsuit.
Ø
Encouraging
applicants to be op en and truthful on their applications and during the
interview process.
Employee Competence Assessment
It is important that job-related
performance standards be established for each position in the laboratory (e.g.
medical laboratory scientist, medical laboratory technician, phlebotomist, and
laboratory aide). The standards should be distinctly stated and clearly
communicated (both in writing and verbally) to the employee so that the
employee fully understands what is expected.
It is also important to remember that
when performing an employee performance evaluation, an individual's performance
must only be compared to the established performance standard.
If the employee's performance falls
below an established performance standard, it should be clearly articulated to
the employee where he/she needs to improve to meet the standard. The supervisor
should then meet with the employee at established intervals to discuss whether
the employee is making progress toward meeting the established standard.
In addition, it is important that
supervisors understand how to conduct and properly document an evaluation.
Documentation, however, should not be limited just to the annual or biannual
evaluation review. Performance problems for all employees should be documented
regularly. Apply policies consistently to all employees and in all situations;
avoid inconsistent enforcement. Ensure that all personnel documentation is
reviewed only by those individuals who have a "need to know." The
review process is not to be a means for someone to publicly embarrass an
employee.
To Conclude
Clinical laboratories perform many activities to reduce the risk
of error. Most are done as “reactive” preventive activity. In current scenario
clinical laboratories do not use the tools found helpful in risk management and
time and skills of risk managers in incident investigation is not incorporated.
Quality Management systems require application of preventive actions to reduce
the opportunity for significant error. Tools established for assessing
potential opportunities for risk would appear to fit preventive action needs.
Laboratories can develop strategies to incorporate Risk Management techniques
within the Quality Management system to prevent error
References:
1. ISO/DIS 31000 (2009). Risk management — Principles and guidelines
on implementation. International Organization for Standardization.
2. David Hillson; Ruth
Murray-Webster (30 March 2007). Understanding and Managing Risk Attitude. Gower
Publishing, Ltd. ISBN 978-0-566-08798-1.
4.
Safety
aspects – Guidelines for the inclusion in standards ISO/IEC Guide 51: 1999”
(Geneva: International Organization for Standardization, 1999)
5. CLSI. Laboratory Quality Control Based on Risk
Management; Approved Guideline. CLSI Document EP23-A. Wayne, PA: Clinical and
Laboratory Standards Institute; 2011
