Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

4th year 1st Sem Reviewers > Quality Control (Clinical Chemistry) > Flashcards

Quality Control (Clinical Chemistry) Flashcards

References: CC ni Hyacinth Yambao CC ni Rovie Vila

1
Q

3 parts of Pre-analytical phase

A
  • Patient Identification
  • Patient Preparation
  • Phlebotomy
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

The process of verifying a patient’s identity, is the most important step in specimen collection.

A

Patient identification

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Why patient identification is the most crucial part of pre analytical phase?

A

Patient identification is defined as the process of verifying a patient’s identity and is also considered as the most crucial step of specimen collection. It is necessary in the laboratory testing process due to the fact that misidentifying a patient specimen or collecting specimen from the wrong patient can lead to fatal and detrimental repercussions.
Furthermore, if proper patient identification is not followed religiously the results that the laboratory will release cannot be reliable for the proper diagnosis of the patient and this can result and misdiagnosis of disease and the conduct of improper treatment leading to substandard and poor patient outcomes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Guidelines that (Accuracy in Patient and
Sample Identification) recommends having the patient spell the last name.

A

CLSI guideline GP33-A

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is the minimum identifier?

A
  • 2
  • name and birthdate
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Hormone that is being collected while the patient is sleeping

A

Cortisol

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

3-Way IDENTIFICATION

A

1) patient’s verbal ID statement,
2) check of the ID band,
3) visual comparison of the labeled
specimen with the patient’s ID band
before leaving the bedside.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

it is a part of the process management component of the quality system that integrates good laboratory practices to ensure correct patient results

A

Quality control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

it is the process of ensuring that analytical results are correct by testing known samples that resemble patient’s sample and comparing their determined values with their expected values
(control values)

A

Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

it is the process of ensuring that analytical results are correct by testing known samples that resemble patient’s sample and comparing their determined values with their expected values
(control values)

A

Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are objectives of Quality control?

A

• To check the stability of the machine
• To check the quality of reagents
• To check technical errors (personnel)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

process of verification by comparing the accuracy of the measuring instrument against a reference standard

A

Calibration

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

• This are substances with known concentration used
• It is done every 6 months or more frequently if recommended
by the manufacturers

A

Reference Standard

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

2 types of reference standard

A

o Primary Standard
o Secondary Standard

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Is an ultra-high purity grade compound used in analysis involving assay, identification or purity tests
- Reference material

A

Primary standard

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

These are also high purity grade materials which are quantified in relation to primary standards and put to routine use in laboratories.
- most commonly used in the lab

A

Secondary standards

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Characteristic of an ideal QC materials

A

• It should resemble human sample
• Inexpensive and stable for long periods
• No communicable diseases
• No matrix effects/known matrix effects
• With known analyte concentrations
• Convenient packaging for easy dispensing and storage

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

2 Types of quality control

A
  • INTERNAL QUALITY CONTROL (Intralaboratory Quality control)
  • EXTERNAL QUALITY CONTROL (Interlaboratory Quality control)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

• Analyses of control samples together with the patient specimens
• Daily monitoring of accuracy & precision of analytical methods.
• Detection : Random and Systematic error

A

INTERNAL QUALITY CONTROL (Intralaboratory Quality control)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

• It involves the proficiency testing programs that periodically provide samples of unknown concentrations to participate in clinical laboratories
• It is important in maintaining long-term accuracy of the analytical methods

A

EXTERNAL QUALITY CONTROL (Interlaboratory Quality control)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What is the gold standard for clinical laboratory external QC testing?

A

College of American Pathologists Proficiency program

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

2-level os control solutions

A

Clinical Chemistry

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

3-Level Control Solutions

A

Immunology

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

It is the nearness or closeness of the assayed value to the true or target value

A

Accuracy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

accuracy is estimated using three different types of studies:

A
  1. Recovery
  2. Interference Studies
  3. Patient Sample Comparison
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

degree by which a method is easily repeated

A

Practicability

26
Q

ability of the method to maintain accuracy and precision over a period of time

A

Reliability

27
Q

(Imprecision; Indeterminate)
affect the precision of the test system (e.g., pipetting technique)
- Human error
- not preventable

A

Random error

28
Q

(Inaccuracy/ Determinate)
affect the accuracy of the test system
- Preventable
- there is trend

A

Systematic error

29
Q

a sudden upward or downward change that lasts for four or more consecutive values (e.g., equipment malfunction, instrument adjustments)

A

Shift

30
Q

tendency of results to gradually increase or decrease over a period of time (e.g., contamination, reagent deterioration gradual equipment failure)

A

Trend

31
Q

Values: far from the main set of values
Highly deviating values
Random or systematic errors

A

Outliers

32
Q

Degree of flatness or sharpness

A

Kurtosis

33
Q

National reference lab for Clin chem

A

Lung Center of the Philippines

34
Q

National reference lab for Toxicology

A

East Avenue Medical Center

35
Q

What is the most common laboratory tests performed in the external quality control or in clinical chemistry?

A
  • FBS (Glucose)
  • BUN
  • Uric acid
  • Creatinine
  • Cholesterol
  • Triglyceride
  • Total protein
  • Albumin
  • Sodium
36
Q

used to observe values of control materials overtime to determine and detect errors such as inaccuracy and imprecision.

A

QC charts

37
Q

• This plot will give the earliest indication of systematic errors (trend) and can be used with 13s rule.
• Very sensitive to small, persistent errors that commonly occur in the modern, low-calibration frequency analyzer

A

Cumulative sum (CUSUM)

38
Q

It is used to compare results obtained on a high and low control serum from different laboratories

A

Youden/twinplot

39
Q

• Dot chart
• Most widely used system in clinical laboratory
• Allows the laboratorians to apply multiple rules without the aid of a computer
• Easy identification of random and systematic errors.

A

Shewhart-levey jenings chart

40
Q

• Present in all measurement; due to chance
• Basis for varying differences between repeated measurements
• Due to instrument, operator &
environmental conditions.

A

Random error

41
Q

• Is an error that influence
observations consistently in one
direction
• Detected either positive or negative bias.

A

Systemic error

42
Q

What are the random errors?

A

• Pipetting errors
• Mislabeling of samples
• Temperature and Voltage fluctuation
• Improper mixing of samples & reagent
• Dirty optics

43
Q

What are the systematic errors?

A

• Calibration problem
• Deterioration of reagents & control
• Unstable and inadequate reagent blanks
• Contaminated solutions
• Failing instrumentation
• Poorly written procedures
• Incorrect sample & reagent volume

44
Q

A pair of medical decision points that span the limits of results expected for a defined healthy population

A

Reference Interval

45
Q

What are the applications of reference intervals that can be grouped into three
main categories?

A
  1. diagnosis of a disease or condition
  2. monitoring of a physiologic condition
  3. monitoring therapeutic drugs
46
Q

Range of values that include a specified probability, usually 90% or 95%
- we are using the 95% (±2SD)

A

Confidence Interval

47
Q

defines the interval by the mean ±1.96 SDs
= 𝑥 ±1.96 SD

A

Parametric Method

48
Q

the reference interval is determined by
using the central 95% of values; the
reference range is therefore defined by
the 2.5th to the 97.5th percentiles
- usual/most commonly used

A

Non-Parametric Method

49
Q

is the ability of the analytical method to measure the smallest concentration of the analyte of interest
• screening test

A

Analytical Sensitivity

50
Q

is the ability of an analytical method to measure only the analyte of interest
- Confirmatory test

A

Analytical Specificity

51
Q
  • ability of a test to detect a given disease or condition
  • proportion of individuals with that disease who test positively with the test
A

Diagnostic Sensitivity

52
Q
  • ability of a test to correctly identify the absence of a given disease or condition
  • proportion of individuals without a condition who have a negative test for that condition
A

Diagnostic Specificity

53
Q

the predictive value of a positive test refers to the probability of an individual having the disease if the result is abnormal (“positive” for the condition)

A

Positive Predictive Value

54
Q

refers to the probability that a patient does not have a disease if a result is within the reference range (test is negative for the disease)

A

Negative Predictive Value

55
Q

±1𝑆𝐷 =

A

68.3% 𝑜𝑓 𝑜𝑏𝑠𝑒𝑟𝑣𝑎𝑡𝑖𝑜𝑛s

56
Q

±2𝑆𝐷 =

A

95.4% 𝑜𝑓 observations

57
Q

±3𝑆𝐷 =

A

99.7% 𝑜𝑓 𝑜𝑏𝑠𝑒𝑟𝑣𝑎𝑡𝑖𝑜𝑛𝑠

58
Q
  • Used as a rejection or warning rule when one control result exceeds the mean +/- 2SD
  • FOR SCREENING PURPOSE.
  • Considered as a warning rule, but if the company consider it as a rejection rule, it should be a rejection rule.
  • Random error
A

12S rule

59
Q

• If 1 control observation exceeds 𝑥 ± 3s limit
• REJECT THE RUN FOR PROBABLE.
• Random Error

A

13s rule

60
Q

• If 2 consecutive control values are greater than 𝑥 ± 2s
limit
• REJECT THE RUN FOR PROBABLE
• Systematic Error.

A

22s

61
Q

• If the difference between the 2 controls is equal to or greater than 4s.
• REJECT THE RUN FOR PROBABLE.
• Random Error.

A

R4s

62
Q

• If 10 consecutive control values falls on one side of the mean.
• REJECT THE RUN FOR PROBABLE.
• Systematic errors

A

10x

63
Q
  • If 4 consecutive control values are greater than 𝑥 ± 1s limit
  • REJECT THE RUN FOR PROBABLE
  • Systematic Error.
A

41s

4th year 1st Sem Reviewers (5 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions