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THE ROLE OF SIX SIGMA IN A MODERN
QUALITY MANAGEMENT STRATEGY
From Randox Laboratories Ltd
“To err is human…” - a phrase commonly used to attest to the
inherent fallibility of humankind. People make mistakes, and
often those mistakes have consequences; large and small.
The healthcare industry is no different. In their 1999
report, To Err is Human, Kohn and colleagues estimated that
up to 98,000 deaths per year could be directly attributed to
medical errors 1 . This fact, coupled with evidence that around
60-70% of all medical decisions are made based on laboratory
results 2 , shows that consistently accurate laboratory outputs are
of paramount importance in reducing risk to patients.
The clinical laboratory plays a crucial role in patient care, and
this role is increasingly being shown the recognition it deserves.
Consequently, laboratories are becoming busier than ever before,
and with increased workloads, it stands to reason that the rate of
error will also increase. Coskun and colleagues maintain that this
increased probability of error should be offset with new,
innovative solutions aimed at decreasing the risk of error 3 .
However, before we can develop strategies to reduce the risk of
error, we must first understand the potential sources of error.
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Sources of Error
When it comes to laboratory testing, errors are not
restricted to the laboratory itself, as they can occur at nearly
any stage. The ‘total testing process’ is a multistep clinical
process which begins and ends with the needs of the patient 4 .
It consists of 9 steps:
1. Test selection and submitting a laboratory test request
2. Sample collection (serum, plasma, urine, CSF, etc.)
3. Identification
4. Transport of the sample to the laboratory
5. Sample preparation
6. Sample analysis
7. Reporting test results
8. Interpretation of test results
9. Action
Each of these steps has the potential for error, and some
steps are more prone to error than others due to increased
human involvement 5 . These steps can be further broken down
into 5 phases; Pre-Pre Analytical Phase (Step 1), Pre-Analytical
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