Lecture 2 Flashcards

1
Q

what is risk?
a) the likelihood and impact of some potential outcome
b) effect of uncertainty on objectives
c) the odds that someone will get injured on the job
d) two or more

A

d) the likelihood and impact of some potential outcome
+ effect of uncertainty on objectives

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2
Q

why do laboratories analyze risk?

A

information that we get from the samples impacts the decision making and health of others.

poor information can lead to poor outcomes

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3
Q

we are obligated by standards to reduce risk through:
a) quality control
b) quality assurance
c) quality management
d) quality checks

A

c) quality management

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4
Q

T/F the higher the risk level, the higher the decision level and the lower the risk level, the more delegated the decision level

A

T, if something is high risk, there is more that needs to go in to assessing and making any decisions pertaining to it

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5
Q

what is the purpose of using models of risk analysis?

A

you are able to examine the impact of the risk as well as how to minimize it if possible

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6
Q

what are the steps in quality management?

A
  1. start documentation (policies, processes and procedures)
  2. map processes ( all areas that come in and impact it)
  3. prepare to meet accreditation standards (lab + external)
  4. keep cycle active (plan, do, check, act)
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7
Q

what are change management models?

A

developed on research+experience on the best ways to manage any change

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8
Q

what are change management processes?

A

include sequence of steps or activities that move a change from inception to delivery

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9
Q

what are external bodies that may be in charge of lab accreditation?

A

CLSI - clinical & lab standards institute

IQMH - institute for quality management in healthcare (accreditation canada)

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10
Q

what is the most important component for an effective change management process?

A

communication during all steps

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11
Q

most resistance to change occurs due to?
a) risk associated with allocating budget to something new
b) fear of the unknown
c) lack of skill
d) return on investment risk

A

fear of the unknown

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12
Q

T/F a critical element of planning is providing a clear multi-step process rather than sudden, unplanned sweeping changes

A

T

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13
Q

quality management consists of

A

quality assurance and quality control

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14
Q

______ includes all analytical steps whereas _____ is analytical only

A

quality assessment; quality control

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15
Q

quality assessment

A

protocols to confirm lab meets the needs of clients

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16
Q

quality control

A

emphasizes statistical procedures, linearity checks, temperature monitoring, reagent and standard checks

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17
Q

external quality assessment in Ontario is provided by?
a) CSMLS
b) IQMH
c) CLSI
d) CMLTO

A

b) IQMH

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18
Q

which is not a pre analytical error?
a) centrifuge performance
b) test usage and practice guidelines
c) expired reagent
d) sample collection

A

c) expired reagent

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19
Q

which is not a way that you can eliminate or reduce analytical errors?
a) maintenence of equipment
b) blood collection into correct tube
c) proficiency testing
d) good documentation of methods

A

b) blood collection into correct tube

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20
Q

which of the following is not a post-analytical error?
a) transcription of results
b) reporting delays or errors
c) specimen storage
d) failure to separate fluid from cells

A

d) failute to separate fluid from cells

21
Q

why is specimen storage conditions so important?

A

cannot repeat tests and trust the results if they have been stored improperly, can delay care for patient

22
Q

what is a reference material?

A

material whose property values are sufficiently homogenous and well established to be used for calibration, assessment of measurement method, or assigning values to materials

23
Q

what are reference materials often called? why

A

standard reference materials because they are pure, no interference so it can give you a good baseline

24
Q

what makes something a gold standard reference method/material?

A

minimal interference and sensitive

25
Q

what is a reference method?

A

procedure of the highest analytical quality that other methods are graded against

26
Q

what is calibration material?

A

material or device of known/assigned characteristics used to calibrate, graduate or adjust a measurement procedure to compare the response obtained from test sample

27
Q

what is control material?

A

device, solution or pooled specimen, naturally or artificcialy derived intended for use in QC

gives high + low results meant to mimic patient sample results

28
Q

random errors are caused by

A

unknown and unpredictable changes

29
Q

T/F random error is the precision of the instrument

A

F, it is the imprecision of the instrument

30
Q

T/F technologists can be part of the environmental conditions that cause random error

A

T

31
Q

which of the following is not an example of random error
a) electronic noise in circuit of electrical instrument
b) inability of automated instrument to pipette exact amount of sample or reagent every time
c) the instrument was operated incorrectly by a tech
d) bubbles in the reagent

A

the instrument was operated incorrectly by a tech

32
Q

T/F random errors should have a gaussian normal distribution

A

T

33
Q

systematic error

A

usually come from the measuring instruments, can cause shifts and trends on LJ plot

34
Q

the accuracy of measurements is often reduced by:
a) random error
b) systematic error
c) equally by both
d) none of the above

A

b) systematic error

35
Q

why is the accuracy of measurements reduced by systematic error?

A

accuracy is closeness to true value, and if there is systematic error the results stray away from the true value

36
Q

which of the following is not a cause for systematic error?
a) something wrong with the instrument
b) instrument is used incorrectly
c) error in measurement of temperature
d) power outage occured in the lab

A

d) power outage occured in the lab

37
Q

____ coefficient of variance = _______ precision

A

high; poor

38
Q

1:3s westgard rule
random or systematic? reject or accept?

A

control is +/- 3SD from the mean
(reject, random)

39
Q

1:2s westgard rule
random or systematic? reject or accept?

A

control is +/- 2SD from the mean
(accept, warning)

40
Q

2:2s westgard rule
random or systematic? reject or accept?

A

2 consecutive controls exceed the same +/- 2SD
(reject, systematic)

41
Q

R4s westgard rule
random or systematic? reject or accept?

A

when 1 control exceeds by +2SD and the other by -2SD; within run
(reject, random)

42
Q

4:1s westgard rule
random or systematic? reject or accept?

A

4 consecutive controls exceed same mean +1SD or -1SD
(reject, systematic)

43
Q

10x westgard rule
random or systematic? reject or accept?

A

when 10 consecutive controls fall on one side of mean
(reject, systematic)

44
Q

2of3:2s westgard rule
random or systematic? reject or accept?

A

when 2/3 controls exceed the same mean +/-2SD
(reject, systematic)

45
Q

3:1s westgard rule
random or systematic? reject or accept?

A

when 3 consecutive controls exceed the same +1SD or -1SD
(reject, systematic)

46
Q

7T westgard rule
random or systematic? reject or accept?

A

when 7 controls trend in the same direction
(reject, systematic)

47
Q

T/F it is possible to have a QC chart that is “too perfect”

A

T, control range can be too broad so everything passes

48
Q

what would be an indication that the control is too broad on a QC chart? what should it be instead?

A

100% of data points fall within +/-1SD

should only have about 68% within +-1SD

49
Q

what is the allowable limit of error?

A
  • determined for each run
  • random/systematic error where you can still report out the result
  • reporting a result within the limit of error will not affect the patient or their treatment