General Lab Principles, QA

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General Lab Principles, QA
2013-06-09 15:35:29
General Lab Principles QA

General Lab Principles and QA
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  1. What types of chemicals meet the specifications established by the American Chemical Society (ACS) and are used in most analytical lab procedures?
    Analytical reagent (AR) grade
  2. What reagents have undergone additional processing that makes them suitable for special procedures such as atomic absorption, chromatography, molcular diagnostics, etc...?
    Ultrapure reagents
  3. What water is of the higest quality and is used in test methodologies where minimum interference and maximum precision and accuracy are needed?
    CLRW (Clinical Laboratory Reagent Water)
  4. Who established the specifications of CLRW (clinical laboratory reagent water)?
    CLSI (Clinical and Laboratory Standars Institute)
  5. What is required in preparation of reagent grade water (CLRW)?
    • Prefilters: glass or cotton microfibers that remove 98% of the particulate matter
    • Activated carbon: removes organic matter and chlorine
    • Submicron filter: removes all particles or microorganisms larger than the membrane pore size
    • Reverse osmosis: removes 95-99% of bacteria and organic and other particulate matter
    • Ion exchange: system of resin cartiridges or tanks connected in series that removes cations and anions to make deionized water
  6. What type of water is used in sterility specification for tissue or organ culture, nucleic acid content for DNA testing, metal content for trace metal analysis, etc...?
    Special reagent water (SRW)
  7. What water is used for internal instrument rinsing, making dilutions, etc... and needs to meet manufacturer's specifications?
    Instrument feed water
  8. What water is purified to contain only lo levels of organics, inorganics, and particulate matter so it does not leave residue on glassware or contaminate solutions and media in autoclaves?
    Water for laboratory diswashers and autoclaves
  9. What standards are highly purified chemicals that are weighed or measured to produce a solution with an exact concentration?
    Primary standards
  10. What standard are solutions who values are determined by repeated analyses, using a reference method?
    Secondary standards
  11. Who provides standard reference material for purchase, such as:
    Standard reference materials (SRMs)
    Certified reference materials (CRMs)
    National Institute of Standards and Technology (NIST)
  12. Name the types of glass used in the lab environment
    • Flint glass: inexpensive, used in making disposable glass, made from soda-lime glass
    • Borosilicate glass: resistant to heat, corrosion, and thermal shock
    • Pyrex and Kimax: can withstand high temps
    • Corex: 6x's stronger than borosilicate, used for thermometers
    • Vycor: used for extremely high temps (up to 900 degrees celcius) and resists heat shock
  13. Name the types of plasticware used in the lab environment
    • Polyolefins: generally resistant to acids, alkalis, and salt solutions
    • Polycarbonate: May be used for centrifuge tubes
    • Fluorocarbon resins: Used for temps from -270 to 255 degrees celcius, used for stir bars and tubing
  14. What pipette:
    Have the bulb closer to the center
    Accurately deliver a fixed volume of aqueous solution
    Drain by gravity and should NOT be blown out
    Volumetric pipettes
  15. What pipette:
    Have the bulb closer to the delivery tip because they deliver viscous fluids
    Deliver an accurate volume by being "blown out" using a pipetting bulb
    An etched ring or pair of etched rings near the top of the pipette indicates the need to "blow out"
    Ostwald-Folin pipettes
  16. What pipettes:
    Are calibrated to the tip and must be "blown out" to deliver entire volume
    Need to blow out is indicated by the etched rings at the top of the pipette
    Serologic pipettes
  17. What pipettes:
    Calibrated between marks
    Cannot be blown out
    Mohr pipettes
  18. How should centrifuge speed be checked periodically?
    With a tachometer
  19. What class of weights is used to check analytical balances for proper calibration?
    Class S weights
  20. What class of weights has the quality of a primary standard and are used to check the accuracy of other weights?
    Class M weights
  21. What type of variation occurs according to sleeping and waking times?
    Diurnal variation
  22. How does stress change the labs?
    • Increase cortisol
    • Increase total cholesterol
    • Decrease hormone production of pituitary hormones and aldosterone
  23. How can stasis caused by tourniquet use, repeated fist clenching, and improper drawing techniques change lab results?
    • Increase potassium
    • Increase proteins
    • Increase metabolic by-products
    • Increase hemolysis of RBCs
  24. What tests are most affected by hemolysis and how?
    • Increase potassium
    • Increase LD (lactate dehydrongenase)
    • Decrease sodium
  25. What does a Red top blood tube contain and why is it used?
    • No additives
    • Used for routine chemistries, therapeutic drug levels, immunohematology, and serology
  26. What does a lavender top blood tube contain and why is it used?
    • Contains K3 EDTA (ethylenediaminetetraacetate) as an anticoagulant
    • Used in hematology procedures, special chemistry assays, and immunohematology (blood bank)
  27. What does a pink top blood tube contain and why is it used?
    • K2 EDTA (thylenediaminetetraacetate) as an anticoagulant (removes ionized Ca)
    • Used in immunohematology (blood bank)
  28. What does a blue top blood tube contain and why is it used?
    • Sodium citrate as an anticoagulant (1:10 ratio) (removes ionized calcium)
    • Used for coagulation studies
  29. What does a green/mint top blood tube contain and why is it used?
    • Heparin as an anticoagulant (inactivates thrombin)
    • Used for chemistry and cytogenetic testing
  30. What does a speckled, tiger, or marbled top SST blood tube contain and why is it used?
    • Separator is a thixotropic gel that forms a barrier bwetween the cells and serum during centrifuging
    • Used in chemistry
  31. What is the correct order of draw for routine tests?
    • Sterile (blood cultures)
    • C Spot He Eats Oranges
    • C: Citrate (blue)
    • S: SST
    • H: Heparin (green/mint)
    • E: EDTA
    • O: Oxalate
  32. What is the term for material of known concentration that is used to calibrate an instrument or develop a standard curve?
  33. What is the term for data-driven, business approach to performance improvement and oriented toward process identification and process improvement?
    Six Sigma
  34. What is the term for an improvement trend to make work faster by providing ways to streamline through the removal of waste?
    Lean principles
  35. What were established by the International Organization for Standardization as a series of 4 standards for quality management?
    ISO 9000 Standards
  36. What is the middle value in a set of numbers that are arranged according to their magnitude?
  37. What is the most frequently obtained value in a set of numbers?
  38. What reflects the variation of data values around the mean?
    Standard Deviation (s)
  39. What reflects dispersion around the mean and is the square of the standard deviation?
    Variance (s2)
  40. What reflects random variation of analytical methods in units that are independent of methodology, because it is a percentage comparison of the standard deviation divided by the mean?
    Coefficienct of variation (CV)
  41. What is the percentage of individuals without the specific disease that are correctly identified or predicted by the test as having the disease?
    Sensitivity of the test
  42. What is the percentage of individuals without the specific disease that are correctly identified or predicted by the test as NOT having the disease?
    Specificity of a test
  43. What is the minimum number of specimens needed to determine a reference interval?
    Minimum of 20 specimens from healthy individuals
  44. What is the acceptable control range within?
    Mean +-2 standard deviations
  45. What Westgard multirules detect random error?
    • 13S
    • R4S
  46. What Westgard multirules detect systematic error?
    • 22S
    • 41S
    • 10X
  47. What is Westgard multirule 12S?
    • 1 Control value exceeds the mean +-2 standard deviations
    • Warning rule - results reportable
  48. What is Westgard multirule 13S?
    • 1 Control value exceeds the mean +-3 standard deviations
    • Detects random error
  49. What is Westgard multirule 22S?
    • 2 Consecutive control values exceed the same 2 standard deviations limit (both 2 above or 2 below)
    • Detects systematic error
  50. What is Westgard multirule R4S?
    4 Consecutive control values are recorded on one side of the mean and exceed either above or below the mean (4 above or 4 below one standard deviation)
  51. What is the Westgard multirule of 10X?
    • 10 Consecutive control values are recorded on one side of the mean (above or below)
    • Detects systematic error
  52. What is a graphical technique for analyzing interlaboratory data when each laboratory has made two runs on the same analyte or one run on two?
    Youden plot
  53. What term refers to a program where a clinical lab contracts with an agency (CAP or American Association of Bioanalysts) to receive and assay samples, the concentration of which is unknown to the participating clinical labs to estblish target values and ranges of accepability?
    External quality control
  54. What is the consequence for failure to comply with proficiency testing?
    Can result in sanctions, including a complete closure of the lab