dr jim mcculloch thistle qa johannesburg. worked in labs from 1965 experienced and qualified in...
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Dr Jim McCullochThistle QA
Johannesburg
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Worked in labs from 1965 Experienced and qualified in
Microbiology, Chemistry, Statistics and Clinical Chemistry
Msc Medicine, PhD in Clinical Chemistry Setup Thistle QA in 1990
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Started with 1 EQA (PT) in 1990 and with 1 employee, me!
Now... 23 PTs, 12 staff members 2500 labs directly enrolled Data base has results from 60 countries Data base number over 6000
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PICK THE CORRECT ANSWER ISO says we need it SANAS will look for it It helps achieve a quality result
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To determine the performance of individual labs for specific tests
To monitor the continuing performance of labs
An essential component of a good quality system
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Reference values or consensus Defined methods? Outlier detection and removal Statistics to use, robust or not? Size of data base Report issues Customer complaints
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Wild results, bummers, etc Chauvenet’s Criterion Grubb’s Test Robust statistics using ISO 13528: 2005, e.g.
iteration
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(We) will not be participating in cycle three of what you euphemistically call your quality control scheme.
Quaint statistical manipulation and unacceptable transcription errors render your scheme more than a little suspect.
Please note that we do not require reports. I would sooner the paper be saved for a more useful function than cluttering up my waste paper basket.
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Support Teaching material Seminars Extra samples Custom designed reports
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They are mere sets of figures, albeit with useful information
They give you warnings, not facts You can be “out of control” and not have
a non-conformance Things are not always what they seem
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Myth:Mark Twain said:Lies, damned lies and statistics
Truth:Statistics don’t lie – it’s people who lie!
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04/18/23 Thistle QA 12
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04/18/23 Thistle QA 14
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By calculation from formulation CRM RM Consensus from reference labs Consensus from participating labs
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04/18/23 Thistle QA 18
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Analytes used Sodium, measure of osmotic equilibrium Glucose, likelihood of diabetes Bilirubin, an assessment of liver function
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Fitness for purpose – Acceptable Range Sodium 3% Glucose 7.4% Bilirubin 20.0%
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Methodology Each lab’s results for an entire 6-month
cycle Reduced to one single figure, CV,
basically, SD as a percentage of the mean / average result
Reviewed for changes per lab, and overall number of labs within the fitness-for-purpose percentage
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Findings Sodium 99.9% within f-f-p range Glucose 99.3% within f-f-p Bilirubin 99.1% within f-f-p
General IF first cycle out, next one always in f-f-p UNLESS instrument changes
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TSH, thyroid function test, assessment of thyroid stimulation
T4, thyroid function output test PSA, prostate specific antigen
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FFP TSH, 20% T4, 15% PSA, 25%
Methodology As for Chemistry
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TSH, 94.9% within f-f-p T4, 89.9% within f-f-p PSA, 95% within f-f-p
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04/18/23 Thistle QA 26
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PT an essential tool Needs education, interpretation Can assist in complying with quality
standard Detects changes, e.g. Instrument Cannot lead to CQI, rather compliance
with f-f-p