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Immunology and Serology [LAB] > Laboratory Activity 2 – Concepts of Quality Control and Safety in Serologic Testing > Flashcards

Laboratory Activity 2 – Concepts of Quality Control and Safety in Serologic Testing Flashcards

1
Q

The [?] of serologic test results are important in the correct diagnosis of diseases.

A

accuracy and reliability

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2
Q

There are various factors in the laboratory function that affect the outcome of serologic testing; these include

A

specimen collection and processing, methodology, test reagents/kits, instrumentation, technologist’s skills, and others.

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3
Q

To ensure the reliability of results, these factors must subscribe to the

A

standards of quality.

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4
Q

The exposure of the technologist to disease causing agents in the laboratory is of [?] concern.

A

primary health and safety

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4
Q

Possible [?] must, therefore, be known and well understood

A

risk factors

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5
Q

Refers to the overall process of guaranteeing quality patient care and is regulated throughout the total testing system

A

QUALITY ASSESSMENT or QUALITY ASSURANCE (QA)

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5
Q

are the variables that occur before the actual testing of the specimen

A

Pre-analytical factors

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6
Q

are the processes that directly affect the testing of specimens.

A

Analytical factors

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7
Q

Pre-analytical factors

A

• Test request
• Patient preparation
• Specimen collection, handling, and storage

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8
Q

Analytical factors

A

• Reagents
• Instrumentation and equipment: instrument calibration and maintenance
• Testing procedure
• Preventive maintenance
• Access to procedure manuals
• Competency of personnel performing the tests

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9
Q

Refers to the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test

A

Quality Control (QC)

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10
Q

are performed to ensure that acceptable standards are met during the process of patient testing

A

QC procedures

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11
Q

Used to verify the accuracy and precision of a test and are exposed to the same conditions as the patient samples.

A

. External quality controls

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12
Q

(ability to obtain the expected result)

A

accuracy

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13
Q

(ability to obtain the same result on the same specimen)

A

precision

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14
Q

is the ability to maintain both precision and accuracy.

A

Reliability

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15
Q

consists of internal monitoring systems built into the test system

A

Internal quality control

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16
Q

monitor the correct addition of a patient specimen or reagent, the instruments/reagents interaction, and test completion

A

Internal or procedural controls

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17
Q

monitor a test system’s electronic or electric components

A

Electronic controls

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18
Q

• The testing of unknown samples received from an outside agency
• It provides unbiased validation of the quality of patient test results

A

Proficiency testing

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19
Q

are processes that affect the reporting of results and correct interpretation of data.

A

Post-analytical factors

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20
Q

How close measurement is to the true value

A

Accuracy

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21
Q

How close results are when the same sample is tested multiple times

A

Precision

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22
Q

Range of values over which laboratory can verify accuracy of a test system

A

Reportable range

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23
Q

Formerly called a normal value

A

Reference interval

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24
Q

Lowest concentration of a substance that can be detected by a test method

A

Analytical sensitivity

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25
Q

Ability of method to measure the only analyte it is supposed to measure and not other related substances

A

Analytical specificity

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26
Q

Process of testing and adjusting analyzer’s readout to establish a correlation between measured and actual concentrations

A

Calibration

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27
Q

Reference material with a known concentration of analyte

A

Calibrator

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28
Q

Testing materials of known concentrations (calibrators, controls, proficiency testing samples, patient specimens with known values) to ensure accuracy of results throughout reportable range

A

Calibration verification

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29
Q

Calibration verification

• Test three (3) levels:

A

high, midpoint, and low

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30
Q

Calibration verification

• Required every [?], when a lot number of reagents changes, following preventive maintenance or repair, and when controls are out of range

A

six months

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31
Q

Positive result in a patient who has the disease

A

o True Positive (TP)

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32
Q

Positive result in a patient who does not have the disease

A

o False Positive (FP)

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33
Q

Negative result in a patient who does not have
the disease

A

o True Negative (TN)

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34
Q

Negative result in a patient who has the disease

A

o False Negative (FN)

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35
Q

% of the population with the disease that tests positive

A

o Diagnostic sensitivity

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36
Q

% of the population without the disease that tests negative

A

o Diagnostic specificity

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37
Q

% of the time that a positive result is correct

A

o Positive predictive value (PPV)

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38
Q

% of the time that a negative result is correct

A

o Negative predictive value (NPV)

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39
Q

Other Components of the QA Program

A

o Correlation study
o Preventive maintenance
o Function checks
o Delta checks

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39
Q

Study to verify the accuracy of a new method

A

o Correlation study:

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40
Q

Schedule of maintenance to keep equipment in peak operating condition

A

o Preventive maintenance:

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41
Q

Procedures specified by the manufacturer to evaluate critical operating characteristics of a test system

A

o Function checks:

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42
Q

Comparison of patient data with previous results

A

o Delta checks:

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43
Q

Source: Infectious agents

A

Biological

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44
Q

Source: Needles, lancets, and broken glass

A

Sharp

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45
Q

Source: Preservatives and reagents

A

Chemical

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46
Q

Source: Equipment and radioisotopes

A

Radioactive

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47
Q

Source: Ungrounded or wet equipment and frayed cords

A

Electrical

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48
Q

Source: Bunsen burners and organic chemicals

A

Fire/explosive

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49
Q

Source: Slippery floors, heavy boxes, and patients

A

Physical

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50
Q

Possible Injury: Bacterial, fungal, viral or parasitic infections

A

Biological

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51
Q

Possible Injury: Cuts, punctures, or bloodborne pathogen exposure

A

Sharp

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52
Q

Possible Injury: Exposure to toxic carcinogenic or caustic agents

A

Chemical

53
Q

Possible Injury: Radiation exposure

A

Radioactive

54
Q

Possible Injury: Burns or shock

A

Electrical

55
Q

Possible Injury: Burns or dismemberment

A

Fire/explosive

56
Q

Possible Injury: Falls, sprains, and strains

A

Physical

57
Q

Denotes infectious materials or agents that present a potential health risk

A

BIOHAZARD/Biological Health Hazard

58
Q

Chain of infection and safety practices related to the biohazard symbol

A

BIOHAZARD/Biological Health Hazard

59
Q

Concern over exposure to blood-borne pathogens resulted in the drafting of guidelines and regulations by the [?] and the [?] to prevent exposure.

A

Centers for Disease Control and Prevention (CDC)
Occupational Safety and Health Administration (OSHA)

60
Q

The [?] describe four levels of biosafety depending upon the biological agents isolated or studied.

A

National Institutes of Health guidelines

61
Q

The Biosafety levels are based on the [?] of the agents and the availability of effective [?]

A

virulence
treatments and vaccines

62
Q

laboratories handle agents that have no known potential for infecting healthy people.

A

Biosafety Level 1

63
Q

laboratories are those laboratories that work with microorganisms associated with human diseases that are rarely serious and for which preventive or therapeutic interventions are often available.

A

Biosafety Level 2

64
Q

is recommended for materials that may contain viruses not normally encountered in a clinical laboratory and for the cultivation of mycobacteria. Working with mycobacteria requires the use of N95 HEPA filter respirators.

A

Biosafety Level 3

65
Q

is required for work with dangerous and exotic agents that pose a high risk of aerosol-transmitted laboratory infections and life threatening disease for which effective treatments are limited.

A

Biosafety Level 4

66
Q

Exposure risks

A

• Accidental punctures with needles
• Spraying (aerosols) or spilling infectious materials onto desktop or floor
• Cuts or scratches from a contaminated object
• Centrifuge accidents: aerosols, broken tubes, etc

67
Q

all patients are considered to be possible carriers of blood-borne pathogens

A

Universal Precautions (UP)

68
Q

The Universal Precautions (UP) recommends wearing [?] when collecting or handling blood and body fluids contaminated with blood and wearing [?] when there is a danger of blood splashing on mucous membranes and when disposing of all needles and sharp objects in puncture-resistant containers

A

gloves
face shields

69
Q

The CDC excluded [?] not visibly contaminated by blood from UP, although many specimens can contain a considerable amount of blood before it becomes visible

A

urine and body fluids

70
Q

guidelines are not limited to bloodborne pathogens; they consider all body fluids and moist body substances to be potentially infectious

A

Body Substance Isolation (BSI)

71
Q

According to BSI guidelines, personnel should wear gloves at all times when encountering

A

moist body substances.

72
Q

A significant disadvantage of BSI guidelines is that they do not recommend [?] following [?] unless visual contamination is present

A

handwashing
removal of gloves

73
Q

Assume that everyone is potentially infected or colonized with an organism that can be transmitted in the healthcare setting

A

Standard Precaution

74
Q

Includes guidelines describing personnel protective practices

A

Standard Precaution

75
Q
  1. Requiring all employees to practice [?]
A
  1. UP/Standard Precautions
76
Q
  1. Providing laboratory coats, gowns, face and respiratory protection, and gloves to employees and laundry facilities for[?]
A
  1. non-disposable protective clothing
77
Q
  1. Providing sharps disposal containers and prohibiting [?] of needles
A

recapping

78
Q
  1. Prohibiting eating, drinking, smoking, and applying cosmetics, lip balm, and contact lens in the
A

work area

79
Q
  1. Labeling all [?] material and containers
A

biohazardous

80
Q
  1. Providing free immunization for
A

HBV

81
Q
  1. Establishing a [?] for work surfaces; an appropriate disinfectant for bloodborne pathogens is ____________________
A

daily disinfection protocol

82
Q
  1. Providing [?] for employees who have been accidentally exposed to bloodborne pathogens
A

medical follow-up

83
Q
  1. Documenting [?] in safety standards for employees
A

regular training

84
Q

Any [?] to a possible blood-borne pathogen must be immediately reported

A

accidental exposure

85
Q

Evaluation of the incident must begin right away to ensure appropriate

A

post-exposure prophylaxis (PEP)

86
Q

Preventive measures are taken when a person is exposed to infectious disease

A

Post-exposure prophylaxis

87
Q

Post-exposure prophylaxis Procedure:
1. Draw a baseline blood sample from the employee and test it for [?]
2. If possible, identify the source patient, collect a blood sample, and test it for HBV, HCV, and HIV. Patients must usually, give [?] for these tests, and they do not become part of the patient’s record.
3. Testing must be completed within [?] for maximum benefit from PEP.

A
  1. HBV, HCV, and HIV.
  2. informed consent
  3. 24 hours
88
Q

General procedures/ policies that mandate measures to reduce or eliminate exposure to hazard

A

Work practice controls

89
Q

Safety features built into the overall design of a product

A

Engineering controls

90
Q

Work practice controls

A

o Hand washing after each patient contact
o Cleaning surfaces with disinfectants
o Avoiding unnecessary use of needles and sharps and not recapping
o Red bag waste disposal
o Immunization for hepatitis
o Job rotation to minimize repetitive tasks
o Orientation, training, and continuing education
o No eating, drinking, or smoking in the laboratory
o Warning signage

91
Q

Engineering controls

A

o Puncture-resistant containers for disposal and transport of needles and sharps
o Safety needles that automatically retract after removal
o Biohazard bags
o Splash guards
o Volatile liquid carriers
o Centrifuge safety buckets
o Biological safety cabinets and fume hoods
o Mechanical pipetting devices
o Computer wrist/arm pads
o Sensor-controlled sinks or foot/knee/elbow-controlled faucets

92
Q

Barriers that physically separate the user from a hazard

A

Personal protective equipment (PPE)

93
Q

Personal protective equipment (PPE)

A

o Non-latex gloves
o Gowns and laboratory coats
o Masks, including particulate respirators
o Face shields
o Protective eyewear (goggles, safety glasses)
o Eyewash station
o Chemical-resistant gloves; subzero (freezer) gloves; thermal gloves

94
Q

All biological waste, except urine, must be placed in appropriate containers labeled with the

A

biohazard symbol.

95
Q

This includes both specimens and the materials with which the specimens come in contact

A

biological waste

96
Q

The waste is then decontaminated following institutional policy:

A

incineration, autoclaving, or pickup by a certified hazardous waste company.

97
Q

Disinfection of the countertops and sink using a [?] of sodium hypochlorite should be performed daily.

A

1:5 or 1:10 dilution

98
Q

can be divided into three phases (i.e., pre-analytical, analytical, and post-analytical). These phases of the total testing process can be targeted individually for improving quality.

A

Laboratory practice

99
Q

However, presence of [?] adversely affects the quality of the testing process.

A

laboratory errors

100
Q

• Guideline describing personnel protective practices

A

Standard Precaution

101
Q

o Present a serious biological hazard, particularly for the transmission of blood-borne pathogens

A

SHARP HAZARDS

102
Q

Specimens that are POTENTIALLY infectious

A

o Blood
o Pus and purulent fluids
o Semen
o Vaginal secretions
o Cerebrospinal fluid
o Pleural fluid
o Peritoneal fluid
o Pericardial fluid
o Amniotic fluid
o Breast milk

103
Q

Specimens that are usually NOT infectious (unless visibly bloody)

A

o Feces
o Nasal secretions
o Sputum
o Sweat
o Tears
o Urine
o Vomitus

104
Q

is a law monitored and enforced by OSHA.

A

Occupational Exposure to Blood-Borne Pathogens Standard

105
Q

Focus: Process; Defect Prevention

A

Quality Assessment

106
Q

A pro-active process – avoiding errors before the actual process; prevention

A

Quality Assessment

107
Q

o Should be appropriate and error free
o Job for the management

A

Quality Assessment

108
Q

ALL THINGS ABOUT SAMPLE
PREPARATION

A

Pre-analytical factors

109
Q

 Test request
 Patient preparation
 Specimen collection, handling, and storage

A

Pre-analytical factors

110
Q

indicating the days of testing for markers after exposure

A

Test kits with specifications

111
Q

o Folded papers inside test kits; instructions

A
112
Q

o Primary reference – from manufacturers

A

Package inserts

113
Q

o Contains calibrating procedures

A

Package inserts

114
Q

indicates a certain time before the detection of ABs and AGs

A

Package inserts

115
Q

 Reagents
 Instrumentation and equipment: instrument calibration and maintenance
 Testing procedure
 Preventive maintenance
 Access to procedure manuals
 Competency of personnel performing the tests

A

Analytical factors

116
Q

– detection of presence or absence of marker

A

Qualitative Tests

117
Q

– determining concentrations of unknown; positive or reactive patients

A

Quantitative Tests

118
Q

– Test for Analytical Sensitivity

A

Screening Tests

119
Q

– Test for Analytical Specificity

A

Confirmatory Tests

120
Q

Focus: Product or Results; Defect identification

A

Quality Control (QC)

121
Q

A reactive process – defects identified are corrected

A

Quality Control (QC)

122
Q

Should be high in order to avoid false negative reactions

A

Analytical sensitivity

123
Q

Should be high in order to avoid false positive reactions

A

Analytical specificity

124
Q

Formerly known as the STANDARD

A

Calibrator

125
Q

– techniques or tests

A

Analytical

126
Q

– results

A

Diagnostic

127
Q

Delta checks are used for checking:

A
  1. Mixed up samples – wrong sample tested
  2. Technical errors – human or machine error; duplication of test to rule out problem
  3. Patient response to therapy – expected response is not achieved; may be due to changes on patient condition
128
Q

most common biological agent among lab workers

A

Hepa B virus

129
Q

viruses can survive in blood spills for

A

10 to 14 days

130
Q

Establishing a daily disinfection protocol for work surfaces; an appropriate disinfectant for blood-borne pathogens is

A

5.25% NaCl in H2O (1:10)

131
Q

10% common household bleach inactivates
o HBV for
o HIV for

A

o HBV for
o HIV for

131
Q

10% common household bleach inactivates
o HBV for
o HIV for

A

o HBV for
o HIV for

131
Q

10% common household bleach inactivates
o HBV for
o HIV for

A

o HBV for 10 mins
o HIV for 2 mins

Immunology and Serology [LAB] (16 decks)

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