Management of the Laboratory

& Interpretation of Results

By
F. Chidzwondo
 Expected Outcomes

• Briefly explain the importance of total

quality management of the lab

• Discuss the factors to be considered

when interpreting test results
 Total Quality Management of
the Laboratory
• To obtain results that are reliable, relevant
& reproducible, a quality assurance system
(QAS) is required

• QAS = all systematic actions essential for

providing adequate confidence that the lab
services will satisfy given medical needs for
patient care
 Total Quality Management of the
Laboratory
For QAS, care must be taken in:
• Specimen collection, handling & storage of
sample
– Pre-analytical factors
• Setting methods of standardization &
calibration
– Analytical factors
• Setting methods of quality control &
assessment
– Post-analytical factors
 Pre-analytical Factors

Difficult to control & monitor as they

mostly occur outside the lab:
• Patient’s preparation
• Sample collection
• Sample handling
• Sample storage guidelines
 Patient’s Preparation
Explanations must be given to patients
because various lab tests are affected by:
• Nutritional status & recent meal
• Alcohol, drugs & smoking
• Exercise, stress & sleep
• Posture
 Sample Collection & Handling
Should follow specific guidelines for:
• Collecting sample
• Type of sample required
• Transport
• Standing time before separation
• Aliquoting
 Sample Storage Guidelines

Guidelines should be established for a given

analyte as they may be affected by:
• Evaporation - electrolytes
• Exposure to light – bilirubin
• Refrigeration & freezing - LDH
 Analytical Factors

• Include both systematic & random errors

• Depend on instrumentation & reagents
– Controlled by clinical biochemists

• Clinical biochemists should follow standard

for regular check-up & maintenance of
equipment
 Post-analytical Factors

• Organisation of recording & reporting

• Reporting of Results
• Speed of Reporting
• Automation & Computer-generated patient
reports
 Interpretation of Results
Correct interpretation of results requires
understanding of:
• Physiological variations in normal individuals
– Within-individual variations
– Between-individual variations

• Acceptable analytical reproducibility

– Different labs may use different analytical
methods & assay temperatures
 Physiological Variations
Intra (within)-individual Inter (between)-individual
• Diet • Age
• Exercise • Sex
• Drugs • Race
• Sleep pattern • Genetics
• Posture • Long term health status
• Time of venipucture
• Length of time
tourniquet is applied
Intra (within)-individual Variations

Time of Day – Diurnal Variation of:

• Plasma iron
• Adrenocorticotropic hormone (ACTH)
• Cortisol
 Intra (within)-individual Variations

Diet
• Plasma [triglyceride]
• Response to glucose tolerance tests
• Urinary calcium excretion
 Intra (within)-individual Variations

Muscular Exercise
• Increase plasma creatine kinase activity
• Increase blood [lactate]
• Lower blood pyruvate
 Intra (within)-individual Variations
Menstrual Cycle
• Plasma [iron]
• Plasma concentration of pituitary
gonadotrophins, ovarian steroids & their
metabolites
• Amounts of hormones & their metabolites
excreted in urine
 Intra (within)-individual Variations

Drugs
• Oestrogen-containing oral contraceptives
affect plasma constituents
 Inter (between)-individual Variations

Age
• Plasma [phosphate] & alkaline phosphatase
activity

• Plasma & urinary concentration of

gonadotrophins & sex hormones
 Inter (between)-individual Variations

Sex
• Plasma creatine, iron & urea concentration

• Plasma & urinary concentration of sex

hormones
 Inter (between)-individual Variations

Race
• Plasma [cholesterol] & [protein]

• Diet??

• Environment??
 Analytical Variations
Analytical variation is a function of analytical
performance which can be evaluated by:
• Quality assurance
• Precision & accuracy
• Sensitivity & specificity
• Reference ranges
 Quality Assurance

• A quality control system is a laboratory’s

system that recognises & minimizes
analytical errors
– by comparing quality control samples with
patients’ samples
• to reassure that methods are performing
satisfactorily
 Accuracy
• Accuracy is the degree of agreement
between the measured value & the
accepted true value
– Dependent on some measurement that has a
given limit if certainty

• An accurate result is in close

agreement with the accepted value
 Precision
Precision
• is the degree of agreement between
replicate measurements of the same
quantity
• the closeness of the agreement between
independent measurements obtained
under the same conditions
– Repeatability of a result
– Depends only on distribution of random errors &
does not relate to the true value
 Sensitivity
• Is the ability of a test to correctly identify those
who have a disease
• Measure of the incidence of positive results in
patients known to have a disease ie true
positive
– Ability to show +ve results in patients with particular
disease
• The higher the sensitivity, the greater the
detection rate, the lower the false –ve rate
 Specificity
• Is the ability of a test to correctly identify those
who do not have a disease
• Measures incidence of negative results in a
person supposed to be free of a disease, ie,
true negative
– % of –ve results among people who do not have the
disease
• The higher the specificity, the lower the false
+ve rate
 Ideal Analytical Method
Method provides
• a correct result (accurate)
• that is the same if repeated (precise),
• is able to detect low conc of analyte
(sensitive) &
• is not subject to interference by other
substances (specific)
 Reference Ranges
• Set of results from a particular defined
population

• No clear-cut distinction between normal &

abnormal concentration of any constituent
– Bell-shaped curve
 Interpretation of Results
To interpret results, know:
• Reference range for healthy individuals

• Expected values for patients with disease

• Prevalence of disease in a population

 Interpretation of Results

• Is the result normal?

• Is the result significantly different from
previous results?
• Is the result consistent with clinical findings?