savc presentation

8/2/2019 SAVC Presentation

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Bronwyn Claudia Cloete


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The effect of haemolysis on the quality of

results in the Biochemistry laboratory

y Its all about Quality

y A process is a collection of activitiesthat converts inputs into outputs

or results - Gryna, Chua & DeFeo (2007:195)

yA collection of processes is a

system

y ISO 9001:2008 advocates the

Process Approach


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C

offee Making Process:

y Specific requirement: Morning Cuppa

y Specific inputsy Specific steps

y Evaluate outcome

y Determine improvement needs

y Improve

QUALITY IS APPLICABLE TO EVERYTHING


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ISO 9001:2008y What the customer wants is what the customer gets

y Process Approach:

Inputs Outputs

y Based on customer requirements

y Without customer, there will be no need for Quality

y Overview of ISO 9001:2008

PROCESS


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SANS 17025: 2005

y Identical implementation to ISO/IEC 17025:2005

y Overview of ISO 17025:2005y ISO/IEC 17025:2005 is based on ISO 9001

y No compliance to ISO/IEC 17025 without complianceto ISO 9001

y New standard due soon


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Improvement = Object ofStudyy Quality Improvement needs to add practical value

y Research Design: Primarily scientific with elements ofsocial science methodology

y Structure of research design: Action research in thepositivistic paradigm

y Experimentation for data collection

y Protocol analysis and Observation data collection

yAu fait with study environment


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Indentify Customer Requirements

y Research Objective: Determine exact values of

acceptable levels of haemolysis when accepting bloodsamples for trace mineral analysis.

y Primary Research Question: What is the maximumhaemolysis level acceptable, as measured in terms of

optical density using a spectrophotometer at 540 nmwavelength, in order to accept samples for Tracemineral analysis?


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Literature Reviewy Saibaba (1998: online) states presence of substance in a sample having effect which changes correct value of the result must be

corrected to ensure quality (Saibaba, 1998: online)y Thomas (2010: online) contends that haemolysis is an important interference factor (Thomas, 2010: online)y Guder. (1986: online) asserts: Haemolysis is defined as the breakdown of red blood cells and the release of haemoglobin and

intracellular contents into the plasma and Plasma concentrations exceeding 300mg/L, results in the haemolysis of red bloodcells being observable to the naked eye. (Gruder, 1986: online)

y Lippi, (2009: online) states major worldwide concern for all clinical laboratories is in vitro haemolysis affecting test results and

seriously impacts on patient care and the laboratorys reputation. (Lippi, 2009: online)y Ong, Chan, Lim (2009: online) conducted studies finding that a cost saving occurred with a reduction in sample hemolysis

(Ong et al., 2009: online)y Henry, Cannon, and Winkelman, asserts that Spectrophotomic methods can be used to read hemoglobin levels. (Henryet al.,

1974 (6))y Spectrophotometers are standard research tools, used in chemistry laboratories, utilizing the relationship absorption of light

and colour as principle for the way it works. (Hoydt, n.d.: online)y To achieve impact from research, the research environment is examined from holistic perspective. Ruiz-Marrero (2009: online)

contends the holistic view, is an interdisciplinary vision conceiving every natural system as an integrated whole, which cannotbe understood if broken down into its constituent components (Ruiz-Marrero, 2009: online)

y In additional to holistic consideration the research environment Jiju Mike, Andreas, (1998: 169 - 176) contends the use of

statistical quality control techniques is an essential part of the search for effective quality control and can lead to qualityimprovement id applied correctly. (Jiju et al, 1998: 169 - 176)y According to The Quality Assurance Project,(QAP), (n.d.: online) quality improvement involves applying methods most

appropriate in order to close the gap between expected levels of quality and current levels of quality.y Gate to Quality (n.d.: online) asserts that Any tool or technique that can be used for improving the process/product quality,

help in analyzing the current situation, help in gathering information or help in bringing small or big change (towardsimprovement) in the organization can be called a Quality tool or technique. (Gate to Quality, n.d.: online)


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Identify and Examine Processy Quality engineers toolbox

y 7 Basic Quality Tools (B7)

y PDCA cycle

yAdditional: 7 New Quality Tools for projectmanagement (N7)


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Plan Phase : Background ResearchBased on research objective the following were examined

in the research environment:

y QMS

y Equipment resources

y Reagents and methods

y Staff component

y Other Process Inputs: Samples


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Ishikawa Root Cause Analysis

y Ishikawa Diagram

y Sample pie chart


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Existing Process Map


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PDCACycle

y PLAN, DO, CHECK and ACT

y Cycles for continuous improvementyAlso known as PLAN, DO, STUDY and ACT (PDSA)


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Dr William Edwards Deming

1900 - 1993

y Statistician, professor and author

y

Considered the Father of Qualityy Renowned for work conducted post

World War II and credited for the Japanese IndustrialMiracle

y

Along with Juran, launched Total Quality Management

Learning is not compulsory ...neither is survival Dr. William E. Deming


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Do Phase : Conduct an Experiment

y Sample group of ten ewes, nonpurposively sampled.

y

Four samples of blood collected in red top serum tubesfrom each ewe on fortnightly basis.

y One tube from each animal centrifuged immediately,serum removed from clot.

yArtificial manipulation remaining three tubes, bloodstored in 25oC incubator and every third day a tube wascentrifuged and serum removed.

y Samples stored in 4oC fridge until analysis.


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Do Phase : Conduct an Experiment

y Procedure repeated for ten replicates over a twenty

week period.y Thus: Ten sets of data collected for each animal in the

sample group.

yAll samples were spectrophotometrically measured.

y Each data set contained measurements of thefollowing trace elements: Cu, Zn, Ca, Mg, Phos and Fe.

y Measurements were taken of Fresh samples, Day three,Day six and Day nine samples.


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Check Phase : Analyse the datay Raw data analysed with statistical quality tools

y SPC : Control charts, ANOVA hypothesis testing andregression and correlation

y Check sheets, scatter diagrams

y CUSTOMISE THE BOUQUET OF QUALITY TOOLSFOR YOUR OWN PURPOSE


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Average Spectrophotometric

Measurements

00.2

0.4

0.6

0.8

1

1.2

1.41.6

103 104 114 117 119 120 123 124 129 141

Average HaemolysisReadings

Fresh Day 3 Day 6 Day 9

0

0.2

0.4

0.6

0.8

1

1.2

Fresh Day 3 Day 6 Day 9

Average HaemolysisReadings

Series1


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Copper (Cu)

Mean copper mineral levels were significantly out of recommended normalrange, as expected due to known environmental factor of soil copper levels inthe Stellenbosch area being traditionally low. Copper levels were elevated withthe upward progression of haemolysis in samples. This elevation wasdetrimental to result quality output even though it was within recommendednormal range.


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Zinc (Zn)

Mean zinc mineral levels stayed within recommended normal range,however a trend was observed whereby the mean zinc levels wereelevated due the upward progression of haemolysis levels. Thus it canbe said that uncontrolled haemolysis in samples would have adetrimental effect to result quality output.


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Calcium (Ca)

Mean calcium trace mineral levels were initially found to be within therecommended normal range, however with the upward progression ofhaemolysis, the mean calcium levels were found to significantly decrease. Thusuncontrolled haemolysis in samples would have a detrimental effect to resultquality output. Group 9 mean calcium levels were out of recommended normalrange.


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Manganese (Mg)

Mean magnesium trace mineral levels stayed within recommended normalrange, however an upward trend was detected in relation to the upwardprogression of haemolysis.


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Phosphorous (Phos)

The mean phosphorous trace mineral level s of the fresh group was found tobe within recommended normal range, however with the upward progressionof haemolysis the mean trace mineral value steadily moved upwards andsignificantly out of recommended normal range.


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Iron (Fe)

The mean iron trace mineral level of the fresh group was only slightly out of

recommended normal range. It was determined that this could also be as aresult of environmental factor impacting on research, however the significantobservation to be made during interpretation, is considered to be the steadyand marked upward trend of mean iron levels with the upward progression ofhaemolysis occurrence in samples. Mean iron levels of groups Day 3, 6 and 9are considered to be significantly out of recommended normal range.


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ANOVA and Questionnaire Analysis

y With the exception of the trace element Zn an ANOVA

f test conducted tested the hypothesis that thehaemolysis effect on the results of all the other traceelement was significantly different.

y Protocol analysis and observation studies were

conducted. Statistical analysis of feedback from staffmembers provided a scale for a colour chart.


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Quality Improvement Areas


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Act Phase : Resultsy QMS in Biochemistry section at WC PVL is good.

y Inadequate samples have detrimental effect on result quality.

y Haemolysis influences trace mineral levels of samples.y Invalidates normal reference values.

y A linear relationship between haemolysis levels and all tracemineral levels researched.

y A linear positive relationship exist between time beforecentrifugation takes place and haemolysis level.

y Extent of the relationship is different from trace elements totrace element.

y Haemolytic impact found to be progressive over time in all cases.


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Conclusion : Recommendations

y Samples for trace element analysis must be screened

for suitability for analysis.yA colour chart to be used as a practical measure in

order to screen samples received for trace mineralanalysis at WCPVL.

y If uncertainty prevails over acceptability of a particularsample, a spectrophotometric test may be done toestablish that the sample does not exceed themaximum acceptance level of 0.377nm.


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Colour Chart

Henry, Cannon, and Winkelman, assert that spectrophotomic methodscan be used to read hemoglobin levels. (Henryet al., 1974:6)


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Modified Process Map


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