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Hematology > Quality Control > Flashcards

Quality Control Flashcards

1
Q

What is a quality management system

A

consists of all the processes that affect the quality of laboratory test results

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2
Q

What are the 12 components of a quality management system

A
  1. Quality improvement
  2. Organization and structure
  3. Personnel management
  4. Information management
  5. Occurrence management
  6. Process control
  7. Service and satisfaction
  8. Assessment
  9. Documents and records management
  10. Equipment management
  11. Purchasing and inventory
  12. Facilities and safety
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3
Q

What is quality assurance

A

all the activities implemented in a quality system so that quality requirements will be fulfilled and to assure the reliability of test results

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4
Q

What are preanalytical variables of quality assurance

A

test ordering, patient preparation and identification, specimen collection, transport of the specimen, handling of specimen prior to analysis

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5
Q

What are analytical variables of quality assurance

A

quality control procedures

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6
Q

What are post analytical variable of quality control

A

turn around time and reporting of results

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7
Q

What is quality control

A

the monitoring of a test procedure to ensure that the results are valid, accurate and precise

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8
Q

What is accuracy

A

reliability, refers to the closeness with which results check with the true value

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9
Q

How is accuracy assessed

A
  1. analysis of specimens containing known amounts of a substance and comparing results with the true value
  2. comparison of results with results from a reference method
  3. comparison with results obtained by a reference laboratory
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10
Q

What is a reference method

A

a method that is specific for the analyte and is very accurate, also referred to as gold standard

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11
Q

What is precision

A

the reproducibility of a method, the closeness with which several repeat results check with each other

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12
Q

How can precision be expressed mathmatically

A

with standard deviation or coefficient of variation

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13
Q

What is standard deviation

A

the measure of variability about the mean

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14
Q

What is the coefficient of variation

A

the expression of the standard deviation as a percentage of the mean

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15
Q

What is a primary standard

A

a reference material that has a known amount of analyte and is used for calibrating an instrument or preparing standard curves

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16
Q

What is a secondary standard

A

a reference material in which the analyte concentration has been determined by reference to a primary standard

17
Q

What is a calibrator

A

a cell suspension whose parameters have been determined by multiple reference laboratories by reference methods in order to certify their assigned values

18
Q

What is the only measurement in heme that is based on a standard

A

hemoglobin (cyan-methemoglobin standard)

19
Q

What are the three requirements of a standard

A
  1. similar in composition to unknown samples
  2. analyzed in the same manner as unknowns
  3. stable
20
Q

How are precision checks done in hematology

A

a specimen is loaded and ran 6 times then the coefficient of variation is determined

21
Q

How are precision checks done in coagulation

A

two patient samples are pooled and then run 10 times the mean, SD and CV% are determined

22
Q

What are computer delta checks

A

the computer compares current results with the most recent previous result. If it is significantly different as determined by pre-set limits then it fails the delta check and is flagged

23
Q

What does a tech need to do in the case of a delta failure

A

check sample stability (ie. clot), labeling and patient history

24
Q

What must a tech do in the case of a critical result

A
  1. Review testing conditions and specimen integrity
  2. Check previous results on the patient to see if previously critical
  3. Confirm the result
  4. Verbally report the results and document report
25
Q

What is bulls moving average

A

used to monitor instrument drift since red cell indices stay relatively constant on average over time in a given population

26
Q

What is a non-conforming event

A

any incident, error or near miss that does not conform to an established policy or procedure which affects lab results or patient care

27
Q

What is an adverse event

A

when an error reaches the patient

28
Q

What is a close call

A

when an error almost reaches a patient but is caught in time

29
Q

What is a hazard

A

an event waiting to happen that has the potential to cause an error

30
Q

What is a systematic error

A

a regularly occurring error that is measurable

31
Q

What is a random error

A

accidental and unmeasurable

32
Q

What type of error effects accuracy

A

standard

33
Q

What type of error effects precision

A

random

Hematology (7 decks)

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