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163 Cards in this Set

  • Front
  • Back

What is quality control?

Process of monitoring results from control samples to verify quality of patient results

What is quality assurance?

Process by which a laboratory ensures quality results by closely monitoring the preanalytical, analytical, and post analytical stages of testing

At what stage of quality assurance does most lab errors occur?

Preanalytical

What is the purpose of quality control?

Monitoring test processes


Detect analytic errors


Prevent reporting incorrect results


Performance monitoring

What is the purpose of a clinical chemistry laboratory?

Perform analytic procedures that yield accurate/precise information and aid in patient diagnosis/treatment

How are reliable results achieved in the clinical laboratory?

Correct use of supplies/equipment


Understanding analytical concepts

What is a reagent?

Substance or compound used in an assay to cause a chemical reaction

What type of chemicals is suitable for most analytic laboratory procedures?

Analytic reagent (AR)

What type of chemicals is used for specific procedures?

Ultrapure

What type of chemical should not be used for reagent preparation?

Pure grade (CP)

What type of chemicals should never be used in the laboratory?

Technical or commercial grade reagent

Which type of chemicals are acceptable to use in the clinical chemistry lab?

Analytic reagent


Ultrapure

What substance is used in clinical chemistry as a reference for assays?

Standards

What is the most frequently used reagent in the laboratory?

Water

What substances uses purified water to be made?

Reagents


Standards

What type of water is the most pure?

Type 1

What are the methods of water purification?

Prefiltration


Distillation


Deionization


Reverse osmosis


Ultrafiltration


Nanofiltration


Ultraviolet oxidation

How does prefiltration act on water?

Removes particulate matter

How does distillation act on water?

Removes most organic materials

What happens to water in distillation?

Becomes boiled and vaporized

How does deionization act on water?

Removal of ions

How does reverse osmosis work?

Water is forced through semi-permeable which removes contaminants

What does ultrafiltration and nanofiltration remove from water?

Particulate matter


Microorganisms


Pyrogens


Endotoxins

What does ultraviolet oxidation do to water?

UV light disinfects water and causes hydroxyl radicals to decompose contaminants

What testing procedures are done to determine the quality of reagent grade water?

Microbiological colony count


pH


Resistivity


Silicate


Organic matter detection

What is the purpose of the colony count for reagent grade water?

Detects bacterial contamination

What is the purpose of resistivity for reagent grade water?

Measures resistance to the passage of electrical current

What are the colligative properties?

Osmotic pressure


Vapor pressure


Freezing point


Boiling point

What is osmotic pressure?

Amount of pressure required to stop osmosis

What is redox potential?

Measure of the ability of a solution to accept or donate electrons

What is a reducing agent?

Molecule that donates electrons

What is an oxidizing agent?

Molecule that accepts electrons

What is a buffer?

Substance that minimizes changes in pH

What does the buffer do?

Keeps pH constant

What equation is used to calculate pH?

Henderson-hasselbach equation

What is the primary application of resistivity in the clinical laboratory?

Assessing the purity of water

How often should the temperature be monitored in a clinical laboratory?

Daily

What temperatures are refrigerators maintained at?

2-8°C

What are the two types of thermometers?

Liquid-in-glass


Electronic

What type of glassware/plasticware is preferred for laboratory application?

Class A

What type of glassware is best for the clinical laboratory?

High thermal borosilicate


Aluminosilicate

Critical measurements are made using what type of labware?

Class A

What is a TC pipette?

To contain; holds a particular volume but does not dispense that exact volume

What is a TD pipette?

To deliver; will dispense the volume indicated

What type of markings does a blowout pipette have?

2 small etched rings near the top of the pipette

What type of pipette forcefully expels the last drop of liquid?

Blowout pipet

How does self draining pipets work?

Drain by gravity

What type of markings does a self draining pipet have?

No markings

What is chromatography?

Particle separation technique based on physical and chemical interactions of compounds in a mixture

What is the mobile phase of chromatography?

All particles dissolved into a mixture

What is the stationary phase of chromatography?

Separation of particles

What is mass spectrometry?

Measurement based on atomic mass of the compounds and sorts molecular ions based on mass-to-charge ratio

What applications is mass spectrometry used for?

Therapeutic drugs


Drugs of abuse


Trace metals


Vitamins

What is an immunoassay?

The use of antigen-antibody complexes to detect the concentration of an analyte

What are the types of immunoassays?

Competitive


Noncompetitive

What is the relative amount of light emitted to the concentration in competitive immunoassays?

Inversely proportional

What is the relative amount of light emitted to the concentration in noncompetitive immunoassays?

Directly proportional

What are the advantages of automation?

Increase test variety


Decrease labor and test cost


Minimum variation in results


Eliminates potential manual errors


Instruments use small samples

What are the driving forces of automation?

Increase test volume


Faster turn around time


Centralized core labs


Accuracy and precision


Competition among manufacturers


Decrease lab budget


Reduce lab errors


Increase safety

What is Beer's law?

Relationship between absorption of light by a solution and concentration of that solution

How does concentration relate to Beer's law?

Directly proportional to the amount of light absorbed

How does transmittance relate to Beer's law?

Indirectly proportional to the amount of light absorbed

What does a higher %T indicate?

Lower concentration of analyte

What does a lower %T indicate?

Higher concentration of analyte

What is linearity?
The range of accurate reportable results that can be measured by an instrument for a given assay
What is the purpose of calibration?
Establishes a means by which patient samples are mathematically calculated against set standards of known concentration
What is the purpose of a spectrophotometer?
Measures the amount of light absorbed or transmitted by a solution
What are the internal components of a spectrophotometer?

Light source


Monochromator


Cuvette


Photodetector


Readout device

What is the purpose of the light source in a spectrophotometer?
Generates the light that will pass through the sample

What is the purpose of the monochromator in a spectrophotometer?

Selects the desired wavelength for the assayed analyte

What is the purpose of the cuvette used for a spectrophotometer?
Vessel that holds the sample as light passes through it
What is the purpose of the photodetector of a spectrophotometer?
Detects the amount of light transmitted through the sample
What is the purpose of the readout device of a spectrophotometer?
Converts the %T into a number for use

What types of light sources are used for a spectrophotometer?

Tungsten


Deuterium


Laser

What is the most widely used light source for spectrophotometry?
Tungsten
What wavelength of light is tungsten used for in spectrophotometry?

Visible light


400-700 nm

What wavelength of light is deuterium used for in spectrophotometry?

UV light


<400 nm

What devices can be used as a monochromator?

Filters


Prisms


Diffraction gratings

What is bandpass?
The range of wavelengths that are produced and emitted from the monochromator
What is the most common device used for a monochromator?
Diffraction grating
How does diffraction grating work?

Wavelengths bend as the pass a sharp corner


Degree of bending depends on the wavelength

How does a prism work?
Separates white light into a continuous spectrum through refraction with shorter wavelengths
What are the advantages of diffraction grating?

Less expensive than prisms


High accuracy


Low light scatter

What materials can cuvettes be made of?

Quartz


Glass


Plastic

Why should the cuvette be wiped clean before its placed in the spectrophotometer?
Scratches or dust can scatter light and will interference with the instruments reading
Why are fiberoptics used in spectrophotometry?
Offers better directional control of the beam of light
What materials can be used as a photodetector?

Photocell


Phototube


Photodiode

How does the photodetector work?
Converts light into an electrical signal by detecting photons that strike its surface
What are the type of readout devices for spectrophotometers?

Digital


Analog

What is blanking the spectrophotometer?

Absorbance reading of a solution that includes all light passing through the sample without analytes

Why is blanking required?
Provides a baseline reading of the solution
What are the types of blanks used on the spectrophotometer?

Water


Serum


Reagent

Why is water used for blank reading?
Used for initial calibration

Why is serum used for blanking?

Takes into account sample color that could interfere

Why is reagent used for blanking?

Takes into account reagent color that could interfere

What is atomic absorption spectrophotometry used for?
Measurement of metals such as calcium, lead, copper, lithium, aluminum and zinc
What is amperometry?
Measurement of current flowing through an electrochemical cell
What is coulometry?
Measurement of the amount of charge passing between two electrodes at fixed potentials
What is potentiometry?
Measurement of voltage change between two different electrodes in a solution
What is fluorometry?
Measurement of substances that contain fluorescent molecules
How does a fluorometer work?
Absorbs light a short wavelength and emits light a longer wavelength
What types of light sources are used for fluorometers?
Gas discharge lamps
What type of gases are used in fluorometry?

Mercury


Zenon

What is the disadvantage of fluorometers?
Sensitive to environmental changes
What is the advantage of fluorometers?
Increased sensitivity and specificity
What is chemiluminescence?
Production of light from a chemical reaction
What chemicals are used for chemiluminescence?

Luminol


Acridinium esters


Dioextanes

How does chemiluminescence work?
Two chemicals react to form an high-energy intermediate which breaks down releasing some of its energy as photons of light
What is the purpose of turbidimetry?
Determines the concentration of particulate matter in a sample
What is nephelometry?
Measurement of light scatter by small particles
What is osmolality?
Measure of the number of dissolved particles in a solution
How does an osmometer measure osmolality?
Colligative properties
Which colligative properties does the osmometer use?

Freezing point depression


Vapor pressure depression

What ion selective electrode membrane is used to measure calcium?
Liquid membrane
What ion selective electrode membrane is used to measure potassium?
Valinomycin
What ion selective electrode membrane is used to measure sodium?
Silicate in glass
pH electrodes are sensitive to what ion?
Hydrogen ion
What are pH electrodes made from?
Silver wire coated with silver chloride
What is electrophoresis?
The migration of charged particles in an electrical field

What types of support medium are used for electrophoresis?

Agarose gel


Cellulose acetate

What is the pH of the medium used in electrophoresis?
8.6
How much sample is needed for electrophoresis?
2-5 microliters
Which rule failures indicate a systematic error?

2-2s


4-1s


10x

Which rule failures indicate a random error?

1-3s


R-4s

What is a trend?
Six consecutive control results gradually move in either a positive or negative direction on the LJ chart

What is a shift?

A sudden change in control results and at least six consecutive results side on either the positive or negative side of the mean

Who sets the gold standard for proficiency testing in the clinical laboratory?
CAP
What is the main reason for QC failures?
Improper preparation and handling of QC material
What are the two types of controls?

Assayed


Unassayed

What is the difference between assayed and unassayed controls?

Assayed control setup by manufacturer


Lab establishes ranges for unassayed

What is the purpose of Levey-Jennings charts?
Graphic representation of observed values of control material over time in context of the upper an lower controls limits in relation to the target value
How are control limits expressed?
The mean plus or minus standard deviation
How does LJ charts aid in quality control?
Detects errors in accuracy and precision over time
What are the two types of analytic errors?

Random


Systematic

What are the three stages of a QC program?

1. Establish QC limits


2. Use limits to evaluate QC data


3. Remedy errors when indicated

What are the Westgard rules?

Decision criteria used to determine if an analytic run is out of control

What can a trend indicate?

Gradual deterioration of equipment


Equipment failures

What can a shift indicate?

Impending equipment malfunction


New lot number

What are the measures of central tendency?

Mean


Median


Mode

What is the mean?
Average
What is the median?
Middle value of a data set
What is the mode?
Most frequently occurring value of a data set
What is the purpose data dispersion?
Represents the relationship of all the data points to the mean
What are the measures of dispersion?

Range


Standard deviation


Coefficient of Variation


Stand deviation index

What is the range?
Largest value in the data set minus the smallest value

What is the most frequently used measure of variation?

Standard deviation

What is standard deviation?

Distribution of all data points around the mean

What is the coefficient of variation used for?
Compares 2 or more analytical methods to determine which has the greatest precision
What does a smaller CV indicate?
More reproducible results
What CV percentage will indicate good precision?
<5%
What are the measures of shape?
Gaussian distribution
What percentage of results will fall within +/- 1SD from the mean?
68%
What percentage of results will fall within +/- 2SD from the mean ?
95%

What percentage of results will fall within +/- 3SD from the mean?

99%

Why would a laboratory select a new method of testing?

Enhanced provider utilization


Reducing costs


Staffing needs


Improving quality of results


Increasing provider satisfaction


Improving overall efficiency

What are some practical considerations when selecting a new test method?

Type and volume of specimen


Turnaround time


Cost


Quality control plan


Personnel requirements


Safety

What are steps of method evaluation?

1. Precision study


2. Accuracy study


3. Comparison of methods


4. Establish reference range

What causes imprecision?
Random analytical error

What information does a precision study provide?

Estimates random error


Detects reproducibility problems

What causes inaccuracy?
Systematic error

What are the three types of accuracy study?

Recovery study


Interference study


Comparison of methods study

How is imprecision determined?
Repeated analysis study

How is inaccuracy determined?

Recovery study


Interference study


Comparison of methods study