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IMMUNOLOGY & SEROLOGY > SAFETY AND QUALITY MANAGEMENT > Flashcards

SAFETY AND QUALITY MANAGEMENT Flashcards

1
Q

most significant hazard in the immunology lab

A

obtaining and testing specimen

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2
Q

the manner of how organisms are transmitted is called

A

chain of infection

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3
Q

6 elements in chain of infection

A 
infectious agent
reservoir
portal of exit
means of transmission
portal of entry
susceptible source
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4
Q

infectious agents examples

A

bacteria
fungi
virus
parasite

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5
Q

a place where the infectious agent can live and multiply

A

reservoir

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6
Q

means of transmission

A 
direct contact
droplets
airborne
vehicle
vector
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7
Q

MOT:

host touches contaminated medium

A

direct contact

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8
Q

MOT:

host inhales infected aerosol droplets from px or specimen

A

droplets

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9
Q

MOT:

host inhales dried aerosol particulates circulating on the air current or dust particles

A

airborne

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10
Q

MOT:

host ingests contaminated food or water

A

vehicle

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11
Q

MOT:

animal or mosquito bite

A

vector

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12
Q

In the chain of infection, a contaminated specimen or an infected patient is considered a/an:

A

reservoir

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13
Q

T/F:

Portal of exit and entry can be the same

A

TRUE

mucous membranes of the eyes, nose, mouth,

PEx: + other body fluids

PEn: + breaks in the skin, open wounds

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14
Q

Most susceptible hosts include:

A

Patients with severe diseases, receiving chemotherapy, newborns and infants, elderly, immunocompromised

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15
Q

T/F:

Once the chain of infection is complete, the infected host becomes another source able to transmit the microorganisms to others

A

TRUE

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16
Q

most likely source of infection in serological testing

A

CONTACT with patient specimens

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17
Q

best way to prevent completion of chain of infection

A

prevent transmission

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18
Q

2 main organizations who formulated guidelines to which laboratories must strictly adhere to.

A

Centers for Disease Control and Prevention (CDC)

Occupational Safety and Health Administration (OSHA)

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19
Q

1 prevention of infection

A

handwashing

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20
Q

methods of hand hygiene

A

handwashing

use of alcohol-based antiseptic cleansers

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21
Q

T/F:

use of alcohol-based antiseptic cleansers may be done after contact with spore-forming bacteria

A

FALSE:

alcohol-based cleansers are not recommended for sanitation upon contact with spore-forming bacteria.

Handwashing is necessary.

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22
Q

T/F:

Wearing gloves is a substitute for hand sanitizing

A

FALSE

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23
Q

T/F:

A true latex allergy from gloves can be life threatening

A

TRUE

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24
Q

CDC developed standard precautions by combining recommendations of what procedures?

A 
universal precautions (UP)
body substance isolation (BSI)
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25
Q

All patients were assumed to be potential carriers of bloodborne pathogens.

A

Universal precaution

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26
Q

OSHA stands for:

A

Occupational Safety and Health Administration

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27
Q

T/F:

Each health-care institution is responsible for designing and implementing its own exposure control plan

A

TRUE

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28
Q

Which regulation by OSHA requires all employers to have a written BloodBorne Pathogen Exposure Control Plan?

A

Occupational Exposure to BloodBorne Pathogen Standard

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29
Q

Components of the OSHA Bloodborne Pathogen Exposure Control Plan

A
  • engineering controls
  • work practice controls
  • personal protective equipment
  • medical
  • documentation
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30
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Providing sharps disposal containers and needles with safety devices

A

Engineering Controls

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31
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Requiring discarding of needles with the safety device activated and the holder attached

A

Engineering controls

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32
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Labeling all biohazardous materials and containers

A

Engineering controls

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33
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Requiring all employees to practice standard precautions

A

Work Practice Controls

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34
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Prohibiting eating, drinking, smoking, and applying cosmetics in the work area

A

Work Practice Controls

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35
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Establishing a daily work surface disinfection protocol

A

Work Practice Controls

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36
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Providing laboratory coats, gowns, face shields, and gloves to employees and laundry facilities for non-disposable protective clothing

A

Personal Protective Equipment

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37
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Providing immunization for the hepatitis B virus free of
charge

A

Medical

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38
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Providing medical follow-up to employees who have been accidentally exposed to bloodborne pathogens

A

Medical

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39
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Documenting annual training of employees in safety standards

A

Documentation

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40
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Documenting evaluations and implementation of safer
needle devices

A

Documentation

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41
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Involving employees in the selection and evaluation of new devices and maintaining a list of those employees and the
evaluations

A

Documentation

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42
Q

Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?

Maintaining a sharps injury log including the type and brand of safety device, location and description of the incident, and confidential employee follow-up

A

Documentation

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43
Q

How long before postexposure prophylaxis is initiated upon confirmation of infection in evaluation of a laboratory accident?

A

within 24 hours

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44
Q

most frequent encountered exposure in the laboratory that places laboratorians in danger of contracting viruses

A

needlesticks

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45
Q

In administering postexposure prophylaxis, what tests are conducted in the sample of the patient?

A

HBV, HCV, HIV

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46
Q

For instances of significant exposure, what could replace patient consent to proceed with testing?

A

physician order/court order

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47
Q

In laboratory accidents, when the patient tests positive for HIV, what medications and PEP are given?

A

PEP using zidovudine (ZDV)

one or two additional anti-HIV medications

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48
Q

In laboratory accidents, when the patient tests positive for HIV, when is the employee retested after administration of medication?

A

at intervals of 6 weeks, 12 weeks and 6 months

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49
Q

In laboratory accidents, when the patient tests positive for HBV, what medication or treatment is given for unvaccinated employees?

A

Hepatitis B immune globulin (HBIG)

HBV vaccine

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50
Q

In laboratory accidents, when the patient tests positive for HBV, what medication or treatment is given for vaccinated employees?

A

tested for immunity

PEP

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51
Q

In laboratory accidents, when the patient tests positive for HCV, what PEP is given?

A

No PEP is available

52
Q

In case of needlestick injuries, any exposed employee should be counseled to report any
symptoms related to viral infection that occur within _______ of the exposure.

A

12 weeks

53
Q

T/F:

All biological waste must be placed in appropriate containers labeled with the biohazard symbol

A

FALSE

except urine

54
Q

most commonly used disinfectant for contaminated nondisposable equipment

A

1:10 dilution of sodium hypochlorite

55
Q

what material should bleach be stored in

A

plastic

56
Q

DOT stands for:

A

Department of Transportation

57
Q

IATA stands for:

A

International Air Transport Association

58
Q

Under DOT and IATA regulations, all diagnostic specimens require _________.

A

triple packaging

59
Q

Inclusions in triple packaging

A

primary container (watertight with positive screw-on cap)

primary container wrapped with enough absorbent material

secondary container (leakproof)

60
Q

when was the Needlestick Safety and Prevention Act signed into law?

A

2001

61
Q

When was the Needlestick Safety and Prevention Act revised by OSHA?

A

June 2022

(all blood holders with needles attached should be immediately discarded into sharps container after the device’s safety feature is activated

62
Q

how should acid and water be combined?

A

add acid to water

63
Q

what to do when skin or eye gets in contact with chemicals?

A

flush area with water for 15 minutes then seek medical attention

(do not try to neutralize chemicals spilled on skin)

64
Q

Safety Data Sheet is required for chemicals and reagents containing hazardous ingredients in a concentration of _________.

A

greater than 1%

65
Q

Chemical Hygiene Plan include:

A 
appropriate work practices
SOPs
PPE
engineering controls
employee training requirements
medical consultation guidelines
66
Q

Many kits used in the immunologic testing often contain what preservative

A

sodium azide

67
Q

exposure to radiation is dependent on the combination of what three elements

A

time, distance, shielding

68
Q

disposal of medical radioactive waste is regulated by the

A

Nuclear Regulatory Commission (NRC)

69
Q

actions to be taken once a fire is discovered

A

Rescue
Alarm
Contain
Extinguish/Evacuate

70
Q

Steps in opening a fire extinguisher

A

Pull pin
Aim at the base of the fire
Squeeze handles
Sweep nozzle side to side

71
Q

symbol system for hazardous material and classification

A

NFPA 704

72
Q

Hazardous Materials Classification:

BLUE

A

Health Hazard

73
Q

Hazardous Materials Classification:

RED

A

Fire Hazard

74
Q

Hazardous Materials Classification:

WHITE

A

Specific Hazard

75
Q

Hazardous Materials Classification:

YELLOW

A

Reactivity

76
Q

refers to the overall process of guaranteeing quality patient care

A

Quality Management

77
Q

continual monitoring of the entire test process from test ordering and specimen collection through reporting and interpreting results

A

Quality Management

78
Q

Normally, QA records are maintained for how long?

A

2 years

79
Q

T/F:

A procedure manual may be in the form of paper or digital

A

TRUE

80
Q

provides the basis for all testing in the laboratory

A

procedure manual

81
Q

defined as anything that can be changed or altered

A

variable

82
Q

defined as the amount of time required between the point which a test is ordered by the health care provider and the results are reported to the healthcare provider

A

TAT

83
Q

processes that directly affect the testing of specimens

A

Examination variables

84
Q

Reagents should be checked against how many levels of commercial control solutions on each shift?

A

two

85
Q

When should reagents be checked against commercial control solutions

A

minimum once a day
each shift or;
whenever a new reagent is opened

86
Q

Deionized water used for reagent preparation is quality controlled by checking its ph and purity meter resistance every when?

A

weekly

87
Q

Who is responsible for signing and dating new procedures and all modification of procedures before they are used?

A

laboratory director

88
Q

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

A

Quality control (WC)

89
Q

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

A

QC

90
Q

these controls are used to verify the accuracy and precision of a test

A

External controls

91
Q

the ability to obtain the expected result

A

accuracy

92
Q

the ability to obtain same results on the same specimen

A

precision

93
Q

T/F:

The control material is exposed to the same conditions as the patient samples

A

TRUE

94
Q

referred to as the ability to maintain both precision and accuracy

A

Reliability

95
Q

FDA standards require that control material test negative for _______.

A

HBV, HIV

96
Q

refers to the spread in the values that indicate the ability to repeat the analysis and obtain the same value

A

Gaussian distribution

97
Q

refers to the average of all data points

A

control mean

98
Q

a measurement statistic that describes the average distance each data point in a normal distribution is from the mean

A

standard deviation (SD)

99
Q

SD expressed as a percentage of the mean; this indicates that whether the distribution of values about the mean is ina narrow versus broad range and should be less than 5%

A

coefficient of variation (CV)

100
Q

refers to the limits between which the specified proportion or percentage of results will lie

A

Confidence intervals

101
Q

in plotting control values, changes in accuracy of results are indicated by a ______, defined as the gradual changing in the mean in one direction that may be caused by a gradual deterioration of reagents or deterioration of instruments performance

A

trend

102
Q

in plotting control values, changes in accuracy of results are indicated by a ______, defined as an abrupt change in the mean that may be caused by a malfunction of the instrument or a new lot number of reagents

A

shift

103
Q

In conducting QC procedures, values are plotted on what type of control charts for visualization of control values

A

Levey-Jennings

104
Q

internal controls are also termed as __________.

A

procedural contols

105
Q

are used to monitor the sufficient addition of a patient specimen or reagent, instruments’ and reagents’ interaction and proper migration of samples in test strips.

A

Internal controls

106
Q

These controls verify the functional ability of a testing device, but does not verify the integrity of testing supplies

A

Electronic control

107
Q

the testing of unknown samples received from an outside agency

A

External Quality Assessment (EQA)

108
Q

External Quality Assessment is also called __________.

A

proficiency testing

109
Q

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

A

Post-examination variables

110
Q

most common method for reporting results

A

electronic/automated

111
Q

this organization stipulates that all labs that perform testing on human specimens for the purposes of diagnosis, treatment, monitoring, or screening must be licensed and obtain a certificate form the CMS.

A

Clinical Laboratory Improvement Amendments (CLIA)

112
Q

CMS stands for

A

Centers for Medicare and Medicaid Services

113
Q

three categories of laboratory tests according to CLIA

A

waived
provider-performed microscopy procedures (PPMP)
nonwaived testing

114
Q

Nonwaived testing is separated into the categories of _____ complexity with regard to requirements for personnel performing the tests.

A

High and moderate

115
Q

which CLIA Test classification pertains to tests considered easy to perform by following the manufacturer’s instructions that have little risk of error

A

Waived

116
Q

which CLIA Test classification pertains to microscopy tests performed by a physician, mid-level practitioner or a dentist

A

Provider-Performed Microscopy Procedure

117
Q

which CLIA Test classification pertains to tests that require documentation of training in test principles, instrument calibration, periodic proficiency testing, and on-site inspections

A

Moderate complexity tests

118
Q

which CLIA Test classification pertains to tests that require sophisticated instrumentation and a high degree of interpretation

A

High complexity tests

119
Q

designed to coordinate activities to direct and control an organization with regard to quality and the reduction of medical errors

A

Quality Management System

120
Q

basis of a quality management system (QMS)

A

Quality system essentials (QSEs)

121
Q

how many QSEs are there?

A

12

122
Q

What tool is being utilized by the lean system?

A 
6S:
sort
straighten
scrub
safety
 standardize
sustain
123
Q

focuses on the elimination of waste to allow a facility to do more with less and at the same time increase customer and employee satisfaction

A

Lean System

124
Q

primary goal is to reduce variables and decrease errors to a level of 3.4 defects per 1 million opportunities

A

Six Sigma

125
Q

6 Sigma Methodology

A

Define goals and current processes
Measure current processes and collect data
Analyze the data for cause-and-effect information
Improve the process using the data collected
Control the correction of concerns displayed in the data

IMMUNOLOGY & SEROLOGY (3 decks)

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