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AMT MT Exam > Review Cards - Lab Operations, Management, & Education > Flashcards

Review Cards - Lab Operations, Management, & Education Flashcards

1
Q

Recognition granted by nongovernmental agency to institutions that meet certain standards; voluntary

A. Certification
B. Accreditation
C. Licensure
D. None of the above

A

B. Accreditation

Examples: AABB, CAP, JCAHO, NAACLS

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2
Q

Recognition granted by nongovernmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing the exam; voluntary

A. Certification
B. Accreditation
C. Licensure
D. None of the above

A

A. Certification

Examples: ASCP, AAB, AMT

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3
Q

Permission granted by the state to individuals/organizations to engage in certain professions/businesses; mandatory

A. Certification
B. Accreditation
C. Licensure
D. None of the above

A

C. Licensure

Examples: states

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4
Q

Technical standards & accreditation of blood banks

A. Food & Drug Administration (FDA)
B. Centers for Disease Control (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)

A

C. Association for the Advancement of Blood and Biotherapies (AABB)

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5
Q

Standards and guidelines primarily related to infection control and safe work practices

A. Food & Drug Administration (FDA)
B. Centers for Disease Control & Prevention (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)

A

B. Centers for Disease Control & prevention (CDC)

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6
Q

Standards on all aspects of lab practice developed through voluntary consensus

A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

B. Clinical Laboratory & Standard Institute (CLSI, formerly NCCLS)

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7
Q

Standards to facilitate international exchange of goods & services; developed through voluntary worldwide consensus; ISO 15189 defines standards for quality management in medical labs

A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

A. International Organization for Standardization (ISO)

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8
Q

Writes regulations for and enforces Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88)

A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

C. Centers for Medicare & Medicaid Services (CMS)

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9
Q

Interprets & implements federal regulations related to healthcare; oversees CDC, CMS, FDA, SAMSHA

A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Department of Health & Human Services (HHS)

A

D. Department of Health & Human Services (HHS)

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10
Q

Regulates packaging, labeling, & transportation of biological products

A. Environmental Protection agency (EPA)
B. Department of Transportation (DOT)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

B. Department of Transportation (DOT)

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11
Q

Regulates disposal of toxic chemical & biohazardous wastes

A. Environmental Protection Agency (EPA)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

A. Environmental Protection Agency (EPA)

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12
Q

Regulates market entry of instruments/reagents & production of donor blood & components; licenses blood banks

A. AABB
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Food and Drug Administration (FDA)

A

D. Food & Drug Administration (FDA)

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13
Q

Licenses labs that use radionucleotides

A. International Organization for Standardization (ISO)
B. Nuclear Regulatory Commission (NRC)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above

A

B. Nuclear Regulatory Commission (NRC)

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14
Q

Regulates employee safety in the workplace

A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)

A

D. Occupational Health & Safety Administration (OSHA)

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15
Q

Certifies laboratories to conduct forensic drug testing for federal agencies

A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)

A

A. Substance Abuse and Mental Health Services Administration (SAMSHA)

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16
Q

Requires employers to inform employees about hazardous substances in workplace & educate them in safe handling

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above

A

B. Hazard Communication Standard (OSHA 1983)

“Right-to-know Law”

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17
Q

Regulates all lab testing (except research) performed on humans in the USA; requirements for personnel & quality assurance determined by test complexity; administered by CMS

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above

A

A. Clinical Laboratory Improvement Amendments of 1988

“CLIA ‘88”

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18
Q

Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)

A

D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)

“Laboratory Standard”

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19
Q

Mandates work practices & procedures to minimize worker exposure to bloodborne pathogens

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above

A

C. Bloodborne Pathogens Standard (OSHA 1991)

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20
Q

Requires monitoring of formaldehyde exposure

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Formaldehyde Standard (OSHA 1992)
D. None of the above

A

C. Formaldehyde Standard (OSHA 1992)

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21
Q

Regulates use & disclosure of protected health information (PHI)

A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Health Insurance Portability and Accountability Act of 1996
D. None of the above

A

C. Health Insurance Portability and Accountability Act of 1996

“HIPAA”

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22
Q

Tests cleared by the FDA for home use; negligible likelihood of erroneous results, or no reasonable risk of harm to patient if performed incorrectly

A

Waived tests

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23
Q

Quality control for waived tests

A

None required other than to follow manufacturers directions

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24
Q

Certain microscopic exams performed by provider during patient’s visit (e.g., direct wet mount, KOH prep, urine sediment)

A

Provider-Performed Microscopy (PPM)

(It is a subcategory of moderate complexity)

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25
Q

Quality control for PPM

A

Required when controls are available; otherwise, reference materials (e.g., photomicrographs) fulfill requirement

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26
Q

Criteria for moderate complexity tests

A

Score </=12 on 7 criteria

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27
Q

Quality control for moderate complexity tests

A

2 levels of external controls per 24 hours

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28
Q

Is proficiency testing required for PPM?

A

PT not specifically required, but labs must verify accuracy of testing twice annually. Can be through PT, split sampling, or blind testing

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29
Q

Testing personnel requirements for PPM

A

Physician, mid level provider, or dentist

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30
Q

Testing personnel requirements for moderate complexity tests

A

High school diploma or equivalent & training for testing performed

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31
Q

Criteria for high complexity tests

A

Score >12 on 7 criteria

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32
Q

Quality control for high complexity tests

A

2 levels of external controls per 24 hours (except coagulation testing, which requires 2 levels every 8 hours, and blood gases, which require 3 levels every 24 hours)

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33
Q

Testing personnel requirements for high complexity tests

A

Associates degree in medical laboratory technology or equivalent

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34
Q

Standard published in 1991 (revised in 2001) to protect healthcare workers from occupational exposure to bloodborne pathogens

A

bloodborne pathogens standard

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35
Q

Primary requirements of the Bloodborne Pathogens Standard (BBPS)

A

Exposure control plan
Universal precautions
Engineering controls
Work practice controls
Personal protective clothing & equipment
Housekeeping
Training
Medical surveillance
Hepatitis B vaccine
Hazard communication
Sharps injury log

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36
Q

Determination of employees risk of exposure & implementation to control exposure; plan must be reviewed & updated annually to reflect new technologies; Documentation of evaluation &adoption of safer devices is required.

A

Exposure control plan (BBPS)

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37
Q

All blood & certain body fluids are to be handled as if known to be infectious for bloodborne pathogens

A

Universal precautions (BBPS)

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38
Q

Control measures that isolate or remove a hazard from the workplace, e.g., sharps containers, self-sheathing needles, plastic capillary tubes, Plexiglass shields

A

Engineering controls (BBPS)

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39
Q

E.g., hand washing, disposal of needles with safety device activated & holder attached, ban on eating/drinking/smoking in lab

A

Work practice controls (BBPS)

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40
Q

E.g., proper disposal of biohazardous waste, decontamination of work surfaces

A

Housekeeping (BBPS)

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41
Q

E.g., lab coats, gloves, face shields
Must be provided by employer.

A

Personal protective equipment & clothing

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42
Q

BBPS training requirements

A

On assignment and annually thereafter

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43
Q

Postexposure evaluation & follow-up at no cost to the employee

A

Medical surveillance (BBPS)

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44
Q

BBPS Hepatitis B vaccine requirements

A

Provided by employer within 10 days of assignment at no cost to employees

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45
Q

E.g., biohazard labels, red bags

A

Hazard communication (BBPS)

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46
Q

BBPS sharps injury log requirements

A

Must include description & location of incident, device involved. Employee privacy must be protected.

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47
Q

Specimens that are potentially infectious

A

Blood
Tissues
Semen
Vaginal secretions
CSF
Synovial fluid
Pleural fluid
Peritoneal fluid
Pericardial fluid
Amniotic fluid
Saliva in dental procedures

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48
Q

Specimens that are usually NOT infectious (unless visibly bloody)

A

Feces
Nasal secretions
Sputum
Sweat
Tears
Urine
Vomitus

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49
Q

Packaging requirements of biologics for shipping

A

Primary container - test tube, vial, etc containing etiologic agent - securely closed, watertight, surrounded by absorbent material and placed in secondary container

Secondary container - watertight, sealed & placed in approved mailing container

Mailing container - made of fiberboard

Labeling - biohazard label on primary & mailing containers

Training - every 2-3 years or when regulations change

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50
Q

Issued by OSHA in1983; written for the manufacturing industry, but courts expanded jurisdiction to clinical labs

A

Hazard Communication Stands (HCS)

(Also known as the “Right-to-Know” law; “HAZCOM”)

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51
Q

Primary requirements of the Hazard Communication Standard

A

1.) written hazard communication plan
2.) inventory of hazardous chemicals on site
3.) hazard labeling
4.) material safety data sheet (MSDS) for each chemical readily accessible to employees on each shift
5.) training on initial assignment & when new hazard introduced

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52
Q

Issued by OSHA in 1990; extension of the hazard communication standard written specifically for labs

A

Occupational Exposures to Hazardous Chemicals in Laboratories Standard

(Also known as “Laboratory Standard”; “Chemical Hygiene Standard”)

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53
Q

Purpose of the Occupational Exposures to Hazardous Chemicals in Laboratories Standard

A

To limit employee exposure to hazardous chemicals to levels at or below permissible levels (PELs)

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54
Q

Purpose of the Hazard Communication Standard

A

To inform employees about chemical hazards in workplace & protective measures

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55
Q

Primary requirements of the Occupational Exposures to Hazardous Chemicals in Laboratories Standard

A

1.) written chemical hygiene plan outlining SOPs for use, storage, exposure control, & disposal of hazardous chemicals
2.) designation of chemical hygiene officer
3.) hazard ID and labeling
4.) MSDS for each chemical
5.) use of PPE
6.) proper maintenance of file hoods & other protective equipment
7.) monitoring employee exposure
8.) medical exams at no cost to employee
9.) training on initial assignment & before assignments involving new exposures

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56
Q

Causes visible destruction of human tissue on contact; can cause injury on inhalation or contact

A

Corrosives (glacial acetic acid, hydrochloric acid, sodium hydroxide)

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57
Q

pH of corrosives

A

Chemicals with pH <2 or >12

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58
Q

Should inorganic acids be separated from organic acids?

A

Yes

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59
Q

What happens when concentrated acids or bases are mixed with water?

A

It can generate large amounts of heat.

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60
Q

Substances that interfere with metabolic processes when ingested, inhaled, or absorbed through the skin

A

Toxic substances (cyanides, sulfides)

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61
Q

What are threshold limit values (TLVs)?

A

Safe level of exposure

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62
Q

Substances capable of causing cancer

A

Carcinogens (Benzidine, formaldehyde)

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63
Q

Mutagens

A

Induce genetic mutations

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64
Q

Teratogens

A

Cause defects in the embryo

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65
Q

Examples of mutagens & teratogens

A

Benzene, lead, mercury, radioactive material, toluene

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66
Q

Ignitables

A

Substances that cause fire

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67
Q

Examples of ignitables

A

Acetone, alcohols, ether, xylene

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68
Q

Lowest temperature that produces ignitable vapor

A

Flashpoint

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69
Q

Flashpoint for flammables

A

<37.7C

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70
Q

Flashpoint of combustibles

A

> =37.7C

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71
Q

Chemicals that cause explosions

A

Reactives (ether, perchloric acid, sodium azide)

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72
Q

Storage of ether

A

Ether forms explosive peroxides on exposure to air or light; store in explosion-proof refrigerator

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73
Q

Storage of perchloric acid

A

It may react explosively with organic compounds; separate from other acids

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74
Q

A reactive that is shock sensitive when dehydrated and more powerful than TNT

A

Picric acid

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75
Q

A solution that can form explosive lead or copper azides in drains

A

Sodium azide

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76
Q

NFPA Hazmat Diamond - Blue
(Left)

A

Hazard: health
0 - no hazard
1 - can cause significant irritation
2 - can cause temporary incapacitation or residual injury
3 - can cause serious or permanent injury
4 - can be lethal

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77
Q

NFPA Hazmat Diamond - Red
(Top)

A

Hazard: Flammability
0 - will not burn
1 - must be preheated for ignition to occur
2 - must be heated or in increased ambient temp to burn
3 - can be ignited under almost all ambient temps
4 - will vaporize & burn at normal temps

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78
Q

NFPA Hazmat Diamond - Yellow
(Right)

A

Hazard: Instability
0 - stable
1 - increased temp makes unstable
2 - violent chemical change at increased temp or pressures
3 - May explode from increased temp or shock
4 - May explode at normal temp & pressures

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79
Q

NFPA Hazmat Diamond - White
(Bottom)

A

Hazard: special hazards

W = unusual reactivity with water
OX = oxidizer
ALK = alkaline

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80
Q

How should acids be stored?

A

Store below counter level or in acid cabinets.
Separate from flammable & combustible material, bases, & active metals (e.g., sodium, potassium, & magnesium).
Separate organic acids from inorganic acids.
Separate oxidizing acids from organic acids.

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81
Q

Is formic acid an organic, inorganic, or oxidizing acid?

A

Organic acid

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82
Q

Is glacial acetic acid an organic, inorganic, or oxidizing acid?

A

Organic acid

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83
Q

Is citric acid an organic, inorganic, or oxidizing acid?

A

Organic acid

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84
Q

Is hydrochloric acid an organic, inorganic, or oxidizing acid?

A

Inorganic acid

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85
Q

Is nitric acid an organic, inorganic, or oxidizing acid?

A

Inorganic acid and oxidizing acid

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86
Q

Is sulfuric acid an organic, inorganic, or oxidizing acid?

A

Inorganic acid and oxidizing acid

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87
Q

Is chromic acid an organic, inorganic, or oxidizing acid?

A

Oxidizing acid

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88
Q

Is perchloric acid an organic, inorganic, or oxidizing acid?

A

Oxidizing acid

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89
Q

How should bases be stored?

A

Separate from acids.

Store inorganic hydroxides in polyethylene containers.

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90
Q

Examples of bases.

A

Ammonium hydroxide, potassium hydroxide, sodium hydroxide

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91
Q

How should flammable chemicals be stored?

A

Limit amount in work area.

Store in approved safety cans or cabinets.

Separate from oxidizing acids & oxidizers.

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92
Q

Examples of flammable chemicals used in the lab

A

Acetone
Alcohols
Xylene

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93
Q

How should oxidizers be stored?

A

Separate from reducing agents (e.g., zinc, alkaline metals, formic acid), flammables & combusting materials

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94
Q

Examples of oxidizers

A

Nitric acid
Perchloric acid
Sulfuric acid
Acetic acid
Potassium chloride
Hydrogen peroxide

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95
Q

How do you store water-reactive chemicals?

A

Keep away from water. Store in a dry, cool place.

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96
Q

Examples of water-reactive chemicals

A

Sodium
Potassium

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97
Q

Class A fire - combustible material

A

Cloth, wood, paper

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98
Q

What extinguisher(s) should be used in class A fires?

A

Pressurized water (A)
Dry chemical (ABC)

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99
Q

Class B fire - combustible material

A

Flammable or combustible liquids

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100
Q

What type of fire extinguisher(s) would you use on a class B fire?

A

Dry chemical (ABC)
CO2 (BC)

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101
Q

Class C fire - combustible material

A

Electrical equipment

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102
Q

What type of fire extinguisher(s) would you use for class C fires?

A

Dry chemical (ABC)
CO2 (BC)

Dry chemical can damage computers, analyzers.

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103
Q

Class D fires - combustible material

A

Combustible metals

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104
Q

What type of fire extinguisher would you use on class D fires?

A

Leave to professional firefighters

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105
Q

Anticoagulant in a lavender tube

A

EDTA

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106
Q

EDTA - mode of action

A

Prevents clotting by chelating Ca2+

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107
Q

EDTA - examples of use

A

CBC
Diff
Sed rate

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108
Q

Why are EDTA (lavender) tubes used?

A

Prevents platelets from clumping.
Minimal morphologic changes to WBCs.

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109
Q

EDTA tube - special requirements

A

Tube should be at least 1/2 full

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110
Q

Anticoagulant/additive in a green tube

A

Heparin

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111
Q

Heparin - mode of action

A

Prevents clotting by neutralizing thrombin

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112
Q

Tube used for most chemistries

A

Green (heparin)

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113
Q

Tube used for osmotic fragility

A

Green (heparin)

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114
Q

Tube used for plasma hemoglobin

A

Green (heparin)

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115
Q

Tube used for blood gases

A

Green (heparin)

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116
Q

Tube used for CBC, diff, and sed rate

A

Lavender (EDTA)

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117
Q

Best anticoagulant for prevention of hemolysis

A

Heparin (green tube)

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118
Q

Why would you NOT use a heparin tube for diffs?

A

Blue background

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119
Q

Anticoagulant/additive in a blue tube

A

Sodium citrate

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120
Q

Sodium citrate - mode of action

A

Prevents clotting by binding Ca2+

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121
Q

Tube used for most coagulation tests

A

Light blue (sodium citrate)

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122
Q

Why should a sodium citrate tube be used for coagulation tests?

A

Preserves labels clotting factors

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123
Q

Sodium citrate tube - special requirements

A

Tube must be full for 9:1 blood-to-anticoagulant ratio or coagulation results will be falsely increased.

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124
Q

How can you ensure that a 9:1 blood-to-anticoagulant has been achieved when drawing a sodium citrate tube using a butterfly?

A

Use a discard tube to clear the air from the tubing

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125
Q

When should you reduce sodium citrate?

A

When hematocrit is >55%

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126
Q

Anticoagulant/additive in a gray tube

A

Sodium fluoride

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127
Q

Sodium fluoride - mode of action

A

Inhibits glycolysis (not an anticoagulant)

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128
Q

Sodium fluoride - examples of use

A

Glucose
Lactic acid
Blood alcohol

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129
Q

How long does sodium fluoride preserve glucose?

A

24 hours

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130
Q

What can be added to sodium fluoride if anticoagulation is needed?

A

K oxalate - binds Ca2+

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131
Q

Order of draw

A

Blood culture (yellow [SPS] or bottle)
Coagulation (light blue)
Serum (red, gold, speckled)
Heparin (green)
EDTA (lavender, pink, white)
Glycolytic inhibitor (gray)

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132
Q

Why should a blood culture be drawn first?

A

Avoids bacterial contamination from the needle that has pierced other stoppers

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133
Q

Why is a coagulation tube (light blue) drawn before other anticoagulant & clot activator tubes?

A

Avoids contamination with additives that can affect coagulation results.

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134
Q

When should a royal blue tube (no additive) be drawn?

A

Before a coag tube (light blue)

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135
Q

Why should a serum tube be drawn before a heparin tube?

A

Avoids contamination with sodium heparin (increased sodium) or lithium heparin (increased lithium).

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136
Q

Why should a serum tube be drawn before a lavender tube?

A

Avoids contamination from K2EDTA (decreased magnesium and calcium; increased potassium)

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137
Q

Why should a serum tube be drawn before a gray top tube?

A

Avoids contamination with sodium fluoride/potassium oxalate (decreased calcium; increased sodium and potassium)

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138
Q

Why should an EDTA tube be drawn before a gray tube?

A

Avoids contamination with oxalate, which alters cellular morphology

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139
Q

Order for filling microcollection tubes from capillary punctures

A

Blood gases - minimizes exposure to air
EDTA - minimizes clumping of platelets
Heparin - fill after EDTA if CBC needed
Other additive tubes - minimizes clotting
Serum tubes - clotting is not a concern

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140
Q

Phlebotomy - IV - course of action

A

Use opposite arm or perform fingerstick, if possible; otherwise, have nurse turn of IV for 2 minutes, apply tourniquet below IV, use different vein (if possible).

Document location of IV & venipuncture, type of fluid.

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141
Q

Phlebotomy - fistula - course of action

A

Draw from opposite arm

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142
Q

Phlebotomy - indwelling lines & catheters, heparin locks, cannulas - course of action

A

Usually it drawn by lab.

First 5 ml drawn should be discarded.

Lab May draw below heparin lock of nothing is being infused.

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143
Q

Phlebotomy - sclerosed veins - course of action

A

Select another site

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144
Q

Phlebotomy - hematoma - course of action

A

Draw below

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145
Q

Phlebotomy - streptokinase/tissue plasminogen activator (TPA) - course of action

A

Minimize venipunctures.

Hold pressure until bleeding has stopped.

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146
Q

Phlebotomy - edema - course of action

A

Select another site

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147
Q

Phlebotomy - scars, burns, tattoos - course of action

A

Select another site

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148
Q

Phlebotomy - mastectomy - course of action

A

Draw from opposite arm

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149
Q

Phlebotomy - patient refuses - course of action

A

Try to persuade. If unsuccessful, notify nurse. Never draw without consent; could lead to charges of assault & battery.

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150
Q

Phlebotomy - unidentified patient - course of action

A

Ask nurse to identify before drawing.

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151
Q

Phlebotomy - fasting

A

Nothing to eat or drink (except water) for at least 8 hours

fasting blood sugar, triglycerides, lipid panel, gastric, insulin

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152
Q

Phlebotomy - chilling

A

Place in slurry of crushed ice & water. Do not use ice cubes alone because RBCs may lyse.

ACTH, acetone, ammonia, gastric, glucagon, lactic acid, pyruvate, PTH, renin

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153
Q

Phlebotomy - warming

A

Use 37*C heat block, heel warmer, or hold in hand

cold agglutinins, cryoglobulins

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154
Q

Phlebotomy - protection from light

A

Wrap in aluminum foil

bilirubin, carotene, erythrocyte protoporphyrin, vitamin A, vitamin B12

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155
Q

Phlebotomy - chain of custody

A

Chain of custody form. Lock box may be required.

any test used as evidence in legal proceedings; e.g., blood alcohol, drug screens, DNA analysis

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156
Q

Phlebotomy - misidentification of patient - possible effect

A

Treatment errors

Transfusion fatality

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157
Q

Phlebotomy - drawing at incorrect time - possible effect

A

Treatment errors if samples for certain tests aren’t drawn at appropriate time, e.g., therapeutic drug monitoring, analytes that exhibit diurnal variation, analytes that are affected by recent eating/drinking

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158
Q

Phlebotomy - improper skin disinfection - possible effect

A

Infection at site of puncture.

Contamination of blood cultures & blood components.

Isopropyl alcohol wipes can contaminate samples for blood alcohol.

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159
Q

Phlebotomy - drawing from edematous site - possible effect

A

Dilution of sample with tissue fluid

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160
Q

Phlebotomy - fist pumping during venipuncture

A

Increased potassium, lactic acid, calcium, phosphorus

Decreased pH

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161
Q

Phlebotomy - tourniquet >1 minute - possible effect

A

Increased potassium, total protein, lactic acid

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162
Q

Phlebotomy - IV fluid contamination - possible effect

A

Increased glucose, electrolytes (depending on IV)

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163
Q

Phlebotomy - expired collection tubes - possible effect

A

Decreased vacuum - failure to obtain a specimen

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164
Q

Phlebotomy - incorrect anticoagulant or contamination from incorrect order of draw - possible effect

A

K2EDTA before serum or heparin tube = decreased calcium and magnesium; increased potassium

Contamination of citrate tube with clot activator = erroneous coagulation results

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165
Q

Phlebotomy - failure to hold bottom of tube lower than top during collection - possible effect

A

Carryover from one tube to another = possible additive contamination

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166
Q

Phlebotomy - short draws - possible effect

A

Incorrect blood:anticoagulant ratio affects some results, e.g., coagulation tests

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167
Q

Phlebotomy - inadequate mixing of anticoagulant tube - possible effect

A

Micro-clots, fibrin, platelet clumping can lead to erroneous results

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168
Q

Phlebotomy - hemolysis from alcohol contamination, “milking” site of capillary puncture, probing with needle, vigorous shaking of tubes, exposure of samples to extremes of temperature - possible effect

A

Increased potassium, magnesium, LD, iron

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169
Q

Phlebotomy - how long should you allow serum & gel separator tubes to clot to avoid fibrin strands?

A

30-60 minutes

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170
Q

What is the timeframe to centrifuge after collection?

A

Within 2 hours

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171
Q

How long and for what RCF should you spin citrate tubes to produce platelet-poor plasma?

A

1500 RCF for 15 minutes

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172
Q

How long to spin most tubes and at what RCF?

A

1,000-3,000 RCF for 10-15 minutes

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173
Q

How do you avoid loss of CO2 , change in pH, evaporation, or aerosol formation during centrifugation?

A

Keep tubes capped

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174
Q

Why should primary tubes not be re-spun?

A

It can cause hemolysis.

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175
Q

What should you do if you must re-Alina primary tube?

A

Transfer serum/plasma to another tube

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176
Q

Why should serum separator tubes not be re-spun?

A

Serum in contact with RBCs under gel can be expressed & increase potassium

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177
Q

What is the timeframe for separating serum or plasma from cells?

A

Within 2 hours of collection (exception: centrifuged gel tubes)

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178
Q

How long can serum/plasma be kept at room temperature?

A

8 hours

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179
Q

How long can serum/plasma be kept at 2-8*C?

A

48 hours

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180
Q

Can whole blood be frozen?

A

No

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181
Q

Tubes are in horizontal position when rotating; produces a tightly packed, flat sediment surface; recommended for serum separator tubes

A

Horizontal-head centrifuge (swinging bucket)

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182
Q

Tubes are at fixed angle (25-40*C) when rotating; capable of higher speeds; produces a slanted sediment surface that isn’t tightly packed; decantation is not recommended

A

Angle-head centrifuge

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183
Q

High-speed centrifuge; capable of 100,000 rpm; refrigerated to reduce heat

A

Ultra centrifuge

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184
Q

Types of glass - high resistance to thermal shock & chemical attack; heavy walls to minimize breakage; used for most beakers, flasks, & pipets; minimal contamination of liquids by elements in glass; can be heated and autoclaved

A

Borosilicate glass (Kimax, Pyrex)

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185
Q

Types of glass - 6 times stronger than borosilicate; better able to resist clouding due to alkali & scratching

A

Aluminosilicate glass (Corex)

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186
Q

Types of glass - used for highly alkaline solutions; alkali resistant; poor heat resistance

A

Boron free

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187
Q

Types of glass - heat, chemical, & electrical tolerance; excellent optical properties; used for high-precision analytic work, optical reflectors, mirrors

A

High silica

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188
Q

Types of glass - soda-lime glass containing oxides of sodium, silicon, & calcium; least expensive but poor resistance to high temperatures & sudden changes of temperature; only fair resistance to chemicals; can release alkali & affect some determinations; used for some disposable glassware

A

Flint glass

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189
Q

Types of glass - amber or red; used to decrease exposure to light, e.g., bilirubin standards

A

Low actinic

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190
Q

Types of plastic - relatively inert chemically; resistant to most acids, alkalis, & salts; can be autoclaved; used for piper tips, test tubes

A

Polypropylene

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191
Q

Types of plastic - relatively inert chemically; resistant to most acids (except concentrated H2SO4), alkalis, & salts; used for test tubes, bottles, disposable transfer pipets, test tube racks; can’t be autoclaved

A

Polyethylene

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192
Q

Types of plastic - stronger than polypropylene & better temp tolerance, but chemical resistance not as good; clear; resistant to shattering; used for centrifuge tubes, graduated cylinders

A

Polycarbonate

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193
Q

Types of plastic - rigid, clear; shouldn’t be autoclaved; will crack & splinter; used for test tubes, graduated tubes

A

Polystyrene

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194
Q

Types of plastic - soft & flexible but porous; frequently used as tubing

A

Polyvinyl chloride

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195
Q

Types of plastic - extremely inert; excellent temp tolerance & chemical resistance; used for stir bars, stopcocks, tubing

A

Teflon

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196
Q

Glassware inscription - Class A; meets high standards for accuracy

A

A

197
Q

Glassware inscription - temp of calibration; temp glassware & solutions should be for maximum accuracy

A

20*C

198
Q

Glassware inscription - to contain; vessel calibrated to hold specified volume (e.g., volumetric flask)

A

TC

199
Q

Glassware inscription - to deliver; vessel calibrated to deliver specified volume (e.g., graduated cylinder)

A

TD

200
Q

Volumetric glassware - wide-mouthed, straight-sided jar with pouring spout; not accurate enough for critical measurements

A

Beaker

201
Q

Volumetric glassware - sloping sides; graduated markings; used to hold liquids, mix solutions, measure noncritical volumes

A

Erlenmeyer flask

202
Q

Volumetric glassware - pear shaped; long neck with single calibration mark; manufactured to strict standards; glassware & solutions should be at RT; used to prepare standards & reagents; shouldn’t be used to store solutions

A

Volumetric flask

203
Q

Volumetric glassware - upright, straight-sided tube with flared base; used for noncritical measurements; most are TD; shouldn’t be used to measure <5mL or <10% of capacity; use graduate closest in size to volume to be measured

A

Graduated cylinder (graduates)

204
Q

Glass pipets - transfer pipet; single calibration mark; calibrated to accurately deliver fixed volume of nonviscous samples & standards; touch off last drop against wall of receiving vessel

A

Volumetric pipet

205
Q

Glass pipets - transfer pipet; similar to volumetric pipet, but bulb closer to tip; etched rings means blowout; used for accurate measurement of viscous fluids, e.g., whole blood; not widely used

A

Ostwald-Folin

206
Q

Glass pipets - graduated or measuring pipet; graduation marks down to tip; etched ring means blowout; can use for serial dilutions & measuring reagents; not accurate enough for measuring samples or standards

A

Serological pipet

207
Q

Glass pipets - graduated or measuring pipet; doesn’t have graduation marks all the way to the tip or frosted band near upper end; delivery is made “point to point;” not widely used

A

Mohr pipet

208
Q

Glass pipets - disposable pipet for volumes ranging from 1-1,000 uL; single calibration mark; filled by capillary action; TC; must be rinsed out with diluent to deliver exact amount; small pipetting bulb is used

A

Micropipet

209
Q

Glass pipet - programmable and used with disposable plastic tips; aliquots of liquid dispensed can range from 0.1 uL to 10 mL or larger; the device aspirates a predefined volume when its plunger is moved through a complete cycle; good for reducing cross-contamination between samples

A

Semiautomatic & automatic pipettes

210
Q

Pipets - verify accuracy & precision on receipt, after service or repair, & on regular schedule; most accurate method for calibration is gravimetric method (weight of distilled water delivered); secondary method is spectrophotometric (absorbance of potassium dichromate or p-nitrophenol delivered).

A

calibration

211
Q

Grades of chemicals - very high purity; meets specifications of American Chemical Society; recommended for qualitative & quantitative analysis.

A

analytic reagent grade

212
Q

Grades of chemicals - spectrograde, nanograde, or HPLC grade; used for gas chromatography, HPLC, fluorometry, & trace metal determination

A

ultra pure

213
Q

Grades of chemicals - spectrograde, nanograde, or HPLC grade; used for gas chromatography, HPLC, fluorometry, & trace metal determination

A

ultra pure

214
Q

Grades of chemicals - limits of impurities not specified; may be acceptable for some lab applications when higher purity chemicals are not available

A

chemically pure

215
Q

Grades of chemicals - for industrial use; not of sufficient purity to use as analytic reagents

A

practical, technical, or commercial grade

216
Q

Grades of chemicals - meet specifications of U.S. Pharmacopeia or National Formulary; not injurious to health; not necessarily of sufficient purity to use as analytic reagents

A

USP or NF grade

217
Q

Purified water - meets CLSI specifications for ionic, microbiological, & organic impurities, particulate & colloid content; pure enough for most routine testing; replaces previously designated type I and type II water; no single purification method can produce water of this quality; purification systems use various combinations of distillation, deionization, reverse osmosis, & filtration; lab must test at regular intervals for resistivity (the higher the resistivity, the lower the ion concentration), microbial content, & total organic carbon (TOC).

A

Clinical laboratory reagent grade (CLRW)

218
Q

Purified water - for applications that require water of different purity than CLRW, e.g., DNA/RNA analysis, trace metals; must meet specifications of assay

A

Special reagent water (SRW)

219
Q

Purified water - feed water for autoclaves & dishwashers; impurities that could contaminate washed labware or solutions in autoclave are removed; replacement for previously designated type III water

A

autoclave & wash water

220
Q

CAP Reagent Labeling Requirements

A

Content
Concentration
Storage requirements
Date prepared or reconstituted
Expiration date
Lot #, if applicable

(Not required - date received, date opened)

221
Q

Brightfield microscopy - least expensive objective; partially corrects for chromatic & spherical aberrations

A

achromatic objective

222
Q

Brightfield microscopy - controls angle & amount of light sent to objective

A

aperture diaphragm

223
Q

Brightfield microscopy - microscope with 2 oculars

A

binocular microscope

224
Q

Brightfield microscopy - used to eliminate yellow color emitted by tungsten

A

blue filter

225
Q

uses transmitted light & lenses; objects appear dark against white background; used for most routine clinical work

A

Brightfield microscope

226
Q

Brightfield microscopy - microscope with 2 lens systems - objectives & oculars

A

compound microscope

227
Q

Brightfield microscopy - focuses light on specimen

A

condenser

228
Q

Brightfield microscopy - distance throughout which all parts of specimen are in focus simultaneously

A

depth of focus

229
Q

Brightfield microscopy - limits area of specimen that can be seen

A

field of view

230
Q

Brightfield microscopy - limits are of illumination to image field

A

field of diaphragm

231
Q

Brightfield microscopy - used to help objective gather light from a wide numerical aperture; provides high resolution; type B (high viscosity) is commonly used.

A

immersion oil

232
Q

Brightfield microscopy - method of focusing & centering light path & spreading light uniformly; ensures optimum contrast & resolution

A

Kohler illumination

233
Q

Brightfield microscopy - magnification of ocular x magnification of objective; 1,000x is highest magnification achievable with brightfield microscope

A

magnification, total

234
Q

Brightfield microscopy - mathematical expression of light admitted by lens

A

numerical aperture (NA)

the higher the NA, the greater the resolution

235
Q

Brightfield microscopy - lenses attached to revolving nosepiece; most commonly used are low power (10x), high power (40x), & oil immersion (50x or 100x)

A

objectives

236
Q

Brightfield microscopy - eye piece, usually 10x

A

ocular

237
Q

Brightfield microscopy - object in center of field at 1 magnification will be in center of field at other magnifications

A

parcentric

238
Q

Brightfield microscopy - object remains in focus from 1 magnification to another

A

parfocal

239
Q

Brightfield microscopy - more expensive objective that corrects for curvature of field; results in flat field with uniform focus

A

planachromatic objective

240
Q

Brightfield microscopy - ability to reveal fine detail & distinguish between 2 close points

A

resolution

241
Q

Brightfield microscopy - light control knob; light intensity should not be regulated by condenser or diaphragms

A

Rheostat

242
Q

Brightfield microscopy - type of bulb used for brightfield microscopy

A

Tungsten-halogen bulb

243
Q

Brightfield microscopy - image seen through microscope; upside down & reversed

A

virtual image

244
Q

Brightfield microscopy - distance between slide & objective; decreases with higher magnification objectives

A

working distance

245
Q

Brightfield microscope with one special condenser; objects appear white against black background

A

Darkfield microscope

246
Q

microscope used in the identification of live Treponema pallidum & other microorganisms

A

Darkfield microscope

247
Q

Brightfield microscope with 2 special filters; fluorescent dyes absorb light of 1 wavelength & emit light of longer wavelength; objects appear green, yellow, or orange against black background

A

Fluorescent microscope

248
Q

microscope used for direct & indirect fluorescent antibody stains in microbiology & immunology

A

Fluorescent microscope

249
Q

Brightfield microscope with special slit aperture below condenser, polarizer, & special amplitude filter (modulator) in back of each objective; gives 3D effect to unstained specimens

A

Interference contrast microscope

250
Q

microscope used for wet mounts

A

Interference contrast microscope

251
Q

Brightfield microscope with phase condenser & phase objectives; subtle differences in refractive index converted to clear-cut variations of light intensity & contrast; good for living cells, unstained specimens

A

Phase contrast microscope

252
Q

microscope used for manual platelet counts, urine sediments (good for hyaline casts)

A

Phase contrast

253
Q

Brightfield microscope with 2 crossing filters - polarizing filter below condenser, analyzer between objective & eyepiece; objects that can refract light (birefringent) appear white against black background

A

Polarizing microscope

254
Q

microscope used in identification of crystals in urine & synovial fluid; confirmation of fat or oval fat bodies in urine sediment

A

Polarizing

255
Q

2 types of electron microscopes

A

Transmission & Scanning

256
Q

Electron microscopes - beam of electrons passes through specimen, focused onto fluorescent screen or photographic plate; magnification >100,000x

A

Transmission electron microscope

257
Q

electron microscope used for virology, cells (organelles)

A

Transmission

258
Q

Electron microscopes - beam of electrons strikes surface of specimen, focused onto photographic film or cathode ray tube; 3D image; magnification >1,000x

A

Scanning electron microscope

259
Q

electron microscope used for virology, cells (surface)

A

Scanning

260
Q

science (information science) of processing data for storage, retrieval, & use

A

informatics

261
Q

the use of computers & information systems to process & communicate information generated in the clinical lab

A

laboratory informatics

262
Q

computerized medical record

A

Electronic medical record (EMR)

263
Q

Information systems - system of hardware, software, connections, & communication protocols to handle all informational needs of the lab, from intake of requests to delivery of results; can provide patient information, test information, collection lists, work lists, test results, financial functions, productivity/workload monitoring, quality management, & interface with other computer systems

A

Laboratory information system (LIS)

264
Q

Information systems - information system to handle all informational needs of hospital, both clinical & administrative

A

Hospital information system (HIS)

265
Q

Information systems - hardware & software that allow for electronic communication between 2 computer systems, even if they use different programming languages; the LIS is typically interfaced to HIS & automated analyzers

A

Interface

266
Q

Information systems - interface that transmits electronic information in 1 direction, e.g., a point-of-care analyzer downloads test results to the LIS

A

unidirectional interface

267
Q

Information systems - interface that transmits electronic information in 2 directions, e.g., the LIS downloads orders from the HIS & uploads results to the HIS

A

bidirectional interface

268
Q

Information systems - interface between the analyzer and LIS; can apply rules to automate processes, e.g., autoverification (automatic release of results without tech review when certain criteria are met).

A

Middleware

269
Q

Information systems - documentation that the LIS functions as expected; required by regulatory agencies

A

system validation

270
Q

Computer networks - computer network that connects computers in close geographic proximity (e.g., building, campus)

A

Local area network (LAN)

271
Q

Computer networks - computer network that connects computers over larger geographic area (e.g., multisite health-care facility, internet)

A

Wide area network (WAN)

272
Q

Computer networks - global system of interconnected computer networks

A

Internet

273
Q

Computer networks - computer network within an organization; access is usually restricted to employees

A

Intranet

274
Q

Computer networks - extension of a private network onto the internet where it can be accessed by authorized clients, suppliers, etc.

A

Extranet

275
Q

Computer networks - common set of signals & rules that network uses for communication

A

Protocol

276
Q

Computer networks - one of the first protocols developed for connecting computers

A

Ethernet

277
Q

Computer networks - transmission control protocol/internet protocol; originally developed as transfer protocol for Internet; adapted for transmission in LANs

A

TCP/IP

278
Q

Computer networks - standardized message protocol that facilitates exchange of medical data among computer systems

A

Health level 7 standard (HL7)

279
Q

Process by which a lab ensures quality results by closely monitoring preanalytical, analytical, & postanalytical stage of testing

A

Quality assessment or quality assurance (QA)

280
Q

Everything that precedes test performance, e.g., test ordering, patient preparation, patient ID, specimen collection, specimen transport, specimen processing.

A

Preanalytical QA

281
Q

Everything related to assay, e.g., test analysis, quality control (QC), reagents, calibration, preventive maintenance

A

Analytical QA

282
Q

Everything that comes after test analysis, e.g., verification of calculations & reference ranges, review of results, notification of critical values, result reporting, test interpretation by physician, follow-up patient care

A

Postanalytical QA

283
Q

All of the lab’s policies, processes, procedures, & resources needed to achieve quality testing

A

Quality system

284
Q

Part of the analytical phase of quality assurance; process of monitoring results from control samples to verify accuracy of patient results

A

QC

285
Q

A sample that is chemically & physically similar to an unknown specimen & is tested in exactly the same manner; Monitors precision of the test system and covers the dynamic linear range of the assay; for non-waived tests, CLIA requires at least 2 levels of controls assayed every 24 hours, provided the manufacturer’s requirements are not greater (except coag requires 2 levels every 8 hours; blood gases requires 3 levels every 24 hours); for qualitative tests, pos & neg controls must be included with each run

A

Control material

286
Q

Testing control material not built into the test system; term also used for QC that extends beyond the lab, e.g., participation in proficiency testing program

A

External QC

287
Q

Electronic, internal, or procedural controls that are built into the test system

A

Internal monitoring systems

288
Q

Statistical parameters describing spread of data about the mean, e.g., standard deviation, coefficient of variation, range; Measurements of precision

A

Measures of dispersion

289
Q

Difference between the highest & lowest values in data set

A

Range

290
Q

Sum of all observations divided by number of observations; average of all observations

A

Mean

291
Q

Statistical expression of dispersion of values around the mean; requires a minimum of 20 values.

A

Standard deviation (SD)

292
Q

Expressed standard deviation as a percentage

A

Coefficient of variation (CV)

CV % = (SD/Mean) x 100

The lower the CV = the higher the precision.

293
Q

The difference between the means of two methods.

A

Bias

The student’s t test is used to determine if bias is significant.

294
Q

QC Statistics - Normal distribution

A

The Gaussian bell-shaped curve:
*68% of values fall within +/-1 SD of mean
*95% of values fall within +/-2 SD of mean
*99.7% of values fall within +/-3 SD of mean

295
Q

The range within which control values must fall for the assay to be considered valid. Many labs use mean +/-2 SD. 1 determination in 20 will fall outside +/-2 SD. This is an anticipated part of normal variation

A

Control Limits

296
Q

A normal distribution curve lying on its side, marked with mean, +/-1, +/-2, +/-3.

A

Levey-Jennings chart

297
Q

A control result outside established limits.

A

Outlier

(May be due to chance or may indicate a problem in the test system. If it occurs more than once in 20 successive runs, an investigation must be carried out.)

298
Q

6 consecutive control values on the same side of the mean

A

Shift

299
Q

Control values increasing or decreasing for 6 consecutive runs

A

Trend

*Often caused by unstable reagent, calibrator, or instrument condition

300
Q

An error that doesn’t recur in a regular pattern, e.g., error due to dirty glassware, use of wrong pipet, voltage fluctuation, sampling error, anticoagulant or drug interference.

A

Random error

301
Q

Indication of random error

A

indicated by a control value significantly different from others on a Levey-Jennings chart, OR violation of the 13S or R4S Westgard rules.

-usually a one time error, & controls and samples can be rerun with success

302
Q

A recurring error inherent in test procedure, e.g., dirty photometer, faulty ISE, evaporation or contamination of standards or reagents; affects all results

A

Error, systematic

303
Q

Indication of a systematic error

A

Indicated by a trend or shift on a Levey-Jennings chart, OR violation of 22S, 41S, or 10x Westgard rules.

-requires an investigation to determine cause

304
Q

Rejection of a run because QC results indicate a problem when none is present.

A

False rejection

305
Q

How can false rejections of runs be minimized?

A

Use of Westgard rules

306
Q

Westgard - 1 control is >+/-2s from mean

A

1:2S rule

307
Q

Westgard rule that is a warning flag of a possible change in accuracy or precision; initiates testing of other rules.

A

1:2S

308
Q

Westgard - 1 control is >+/-3s from the mean

A

1:3S rule (rejection)

309
Q

1:3S rule - type of error?

A

Random error

310
Q

Westgard - 2 consecutive controls >2s from the mean on the same side

A

2:2S rule (rejection)

311
Q

2:2S rule - type f error?

A

Systematic error

312
Q

Westgard - 2 consecutive controls differ by >4s

A

R:4S rule (rejection)

313
Q

R:4S rule - type of error?

A

Random error

314
Q

Westgard - 4 consecutive controls >1s from mean on the same side

A

4:1S rule (rejection)

315
Q

Westgard - 10 consecutive controls on same side of mean

A

10x rule (rejection)

316
Q

4:1S rule - type of error?

A

Systematic error

317
Q

10x rule - type of error?

A

Systematic error

318
Q

Control out of acceptable range - (Step 1) hold patient results until problem is resolved - rationale?

A

if a control value is inaccurate, patient values might be inaccurate.

319
Q

Control out of acceptable range - (Step 2) rerun control (1 time only) - rationale?

A

Value might have been due to expected random error (1 in 20 results will be outside +/-2 SD)

320
Q

Control out of acceptable range - (Step 3) if control is still out after 1 rerun, run a new vial of control or another lot # - rationale?

A

control might have been outdated, improperly stored, or contaminated

321
Q

Control out of acceptable range - (Step 4) if control is still out, look for & correct any problems, then run control - rationale?

A

Consider reagents (low, outdated, improperly stored, contaminated, change in lot #), preventive maintenance (overdue), mechanical problems, clots, etc.

322
Q

Control out of acceptable range - (Step 5) if control is still out, recalibrate, then run control - rationale?

A

calibration may have shifted

323
Q

Control out of acceptable range - (Step 6) If control is still out, get assistance - rationale?

A

Supervisor or service rep may be able to determine the problem

324
Q

Control out of acceptable range - (Step 7) once resolved, document corrective action - rationale?

A

Provides a record for future reference, points out repetitive problems

325
Q

Control out of acceptable range - (Step 8) evaluate all patient results in rejected run & since last run with acceptable QC; repeat tests & issue corrected reports, as needed - rationale?

A

Ensure accuracy of reported results.

326
Q

The process of testing & adjusting analyzer’s readout to establish correlation between measured & actual concentrations

A

Calibration

327
Q

Reference material with known concentration of analyte; programmed into analyzer’s computer for use in calculating concentration of unknowns; formerly called standard.

A

Calibrator

328
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 (validation study)

329
Q

Calibration verification requirements

A
  1. test 3 levels - high, midpoint, & low
  2. every 6 months, when lot # of reagents changes, following preventive maintenance or repair, & when controls are out of range
330
Q

how close a measurement is to its true value

A

accuracy

331
Q

Verification of accuracy

A

lab tests samples of known values (controls, calibrators, proficiency samples, previously tested patient specimens) to see how close results are to known value

332
Q

reproducibility; how close results are when the same sample is tested multiple times

A

Precision

333
Q

Verification of precision

A

lab repeatedly tests the same samples (on same day & different days) to see how close the results are

CV is used to compare the precision of samples.

334
Q

Range of values over which the lab can verify accuracy of the test system; also known as linearity

A

Reportable range

335
Q

Verification of reportable range

A

lab tests samples with known values at highest & lowest levels claimed to be accurate by the manufacturer

336
Q

formerly called normal value; can vary for different patient populations (age, gender, race); established testing minimum of 120 healthy subjects & determining range in which 95% fall (Note: 5% of healthy population falls outside of reference range)

A

Reference interval

337
Q

Verification of reference interval

A

If manufacturer’s or published reference ranges are used, the lab must test specimens from normal subjects to verify ranges; ranges may need to be adjusted to fit the lab’s patient population.

338
Q

same as detection limit; lowest concentration of substance that can be detected by test method

A

Analytical sensitivity

*high sensitivity means decreased false negatives.
*high value desirable in screening tests

339
Q

Verification of analytical sensitivity

A

determined by manufacturer; for unmodified FDA-approved test, verification isn’t required

340
Q

Ability of method to measure only analyte it’s supposed to measure & not other related substances

A

Analytical specificity

*high specificity means decreased false positives and decreased cross-reactivity

*high value desirable in confirmatory tests

341
Q

Verification of analytical specificity

A

determined by manufacturer; for unmodified FDA-approved tests, verification is not required

342
Q

Diagnostic value of a test - True positive (TP)

A

Positive result in a patient who has the disease

343
Q

Diagnostic value of a test - False positive (FP)

A

Positive result in a patient who does not have the disease

344
Q

Diagnostic value of a test - True negative (TN)

A

Negative result in a patient who does not have the disease

345
Q

Diagnostic value of a test - False negative (FN)

A

Negative result in a patient who does have the disease

346
Q

Diagnostic value of a test - Diagnostic sensitivity

A

% of population with the disease that test positive

TP/(TP+FN) x 100

347
Q

Diagnostic value of a test - Diagnostic specificity

A

% of population without the disease that test negative

TN/(TN+FP) x 100

348
Q

Diagnostic value of a test - Positive predictive value (PPV)

A

% of time that a positive result is correct

TP/(TP+FP) x 100

349
Q

Diagnostic value of a test - Negative predictive value (NPV)

A

% of time that a negative result is correct

TN/(TN+FN) x 100

350
Q

Study to verify accuracy of a new method

A

Correlation study

*split patient samples are analyzed by existing method and new method
*requires a minimum of 40 patient samples representing a wide range of concentrations
*reference values (existing method) are plotted on x axis, values from new method are plotted on y axis.
perfect correlation is straight line passing through zero at 45 angle
*the correlation coefficient (r) can be derived mathematically
*values range from -1 to +1
*0 = no correlation between methods
*+1 = perfect direct correlation
*>=0.95 = excellent correlation

351
Q

Schedule of maintenance to keep equipment in peak operating condition

A

Preventive maintenance

*must be documented and follow manufacturer’s specifications & frequencies

352
Q

Procedures specified by manufacturer to evaluate critical operating characteristics of the test system, e.g., stray light, background counts

A

function checks

*must be within manufacturer’s established limits before patient testing is conducted
*documentation required

353
Q

Comparison of patient data with previous results; detects mislabeled specimen & other errors

A

Delta checks

*when limit is exceeded, must determine if due to medical change in patient or lab error

354
Q

Test results that indicate a potentially life-threatening situation

A

Critical values

*patient care personnel must be notified immediately
*Joint Commission requires “read-back” policy
*person receiving critical values must record & read back patient’s name & critical values
*lab must document person who received information & time of notification

355
Q

List tests with critical values

A

Glucose
Sodium
Potassium
Total CO2
Calcium
Magnesium
Phosphorus
Total bilirubin (neonates)
Blood gases

356
Q

CLIA requires documentation of competency assessment on hire, at 6 months, & then annually

A

Personnel competency assessment

357
Q

Testing of unknowns submitted by an outside agency, e.g., CAP

A

PT

358
Q

Set of instructions for methods used in the laboratory; also known as a procedure manual

A

Standard operating procedure (SOP)

359
Q

the right of a patient to have his/her medical information kept private; restriction of access to information to those who have authorization and a need to know

A

Confidentiality

360
Q

all individually identifiable health information, including lab results; HIPAA requires HCP to establish extensive security measures to ensure privacy; unauthorized disclosure of medical information could lead to charges of breach of confidentiality or invasion of privacy

A

Protected Health Information (PHI)

361
Q

the wrongful intrusion into a person’s private affairs, e.g., unauthorized disclosure of confidential medical information

A

Invasion of privacy

362
Q

consent for a medical procedure given by patient after procedure & possible risks have been explained; may be expressed or implied

A

Informed consent

363
Q

written or verbal consent

A

Expressed consent

364
Q

consent that is inferred from action or signs; e.g., a patient sits in phlebotomy chair & extends arm; action implies consent for venipuncture

A

Implied consent

365
Q

patients have a right to refuse medical treatment/procedures

A

Informed consent

366
Q

violation of duty to exercise reasonable skill & care

A

Negligence

367
Q

misconduct or negligence that results in injury to patient

A

Malpractice

368
Q

touching another person without his/her consent; e.g., drawing blood against a patient’s wishes

A

Assault & battery

369
Q

procedure to guarantee integrity of specimen to court, e.g., legal blood alcohol, drug test

A

Chain of custody

*each person handling specimen must sign a chain-of-custody form that accompanies specimen & documents custody of specimen at all times
*specimen may be transported in a locked box to prevent tampering

370
Q

Prefix - Deci-

A

10^-1

371
Q

Prefix - Centi-

A

10^-2

372
Q

Prefix - Milli-

A

10^-3

373
Q

Prefix - Micro-

A

10^-6

374
Q

Prefix - Nano-

A

10^-9

375
Q

Prefix - Pico-

A

10^-12

376
Q

Prefix - Femto

A

10^-15

377
Q

Prefix - Femto

A

10^-15

378
Q

*C to *F

A

F = (1.8 x *C) + 32

379
Q

*F to *C

A

C = (*F - 32)/1.8

380
Q

If the temperature of a refrigerator is 4*C, what is the temperature in *F?

A

F = (1.8 x 4C) + 32 = 39.2

381
Q

If the room temperature is 73*F, what is the temperature in *C?

A

*C = (73 - 32)/1.8 = 22.8

382
Q

Mean formula

A

Mean = Ex/n

E = sum
x = individual values
n = number of values

383
Q

Calculate the mean of the following data set:

2, 6, 7, 8, 9, 10

A
384
Q

Standard Deviation formula

A
385
Q

Calculate the standard deviation of the following data set:

23, 19, 24, 47, 23, 20

A
386
Q

Coefficient of variation formula

A
387
Q

Calculate the coefficient of variation for the following:

A
388
Q

Dilution formula

A

Dilution = (Vol. of specimen)/(Vol. of specimen + vol. of diluent)

389
Q

What is the dilution if 0.1 mL of serum is diluted with 0.4 mL of saline?

A

(0.1)/(0.1 + 0.4) = 0.1/0.5 = 1/5

390
Q

How would you prepare a 1:10 dilution of urine?

A

1 part urine + 9 parts diluent

391
Q

Correcting for a dilution formula

A

Value obtained for diluted specimen x reciprocal of dilution

392
Q

A specimen for glucose is diluted 1:5. The value of the diluted specimen is 100 mg/dL. What value should be reported?

A

100 mg/dL x 5 = 500 mg/dL

393
Q

Ability to apply management process, systematize workflow, make decisions, communicate with coworkers.

A

Organizational skills

394
Q

Understanding theories of human needs & work motivation

A

People skills

395
Q

Effective use of & accounting for a company’s monetary assets

A

Financial skills

396
Q

Skills to transform resources into products/services

A

Technical skills

397
Q

Manager makes all decisions without input from others; quick decision-making; least acceptance & commitment from staff; poorest quality decisions

A

Authoritarian style

398
Q

Manager makes decisions after polling staff; better quality & acceptance; decisions take longer; those in minority might feel ignored.

A

Democratic style

399
Q

Manager tries to get at least partial agreement from all staff; everyone has input; highest quality decisions; good acceptance & commitment; time-consuming

A

Consensus style

400
Q

Manager leaves decision to staff; least effective approach; manager abdicates responsibility

A

Laissez-faire style

401
Q

Manager leaves decision to staff; least effective approach; manager abdicates responsibility

A

Laissez-faire style

402
Q

organization’s purpose

A

mission

403
Q

organization’s broad, long-term ambitions

A

goals

404
Q

directive’s that describe how a goal will be achieved - should be SMART

A

Objectives

SMART
-Specific
-Measurable
-Achievable
-Realistic
-Time-bound

405
Q

establishing goals & objectives, formulating policies to carry out objectives

A

planning

406
Q

coordinating resources to achieve plans; defining working relationships, including line of authority & workflow

A

organizing

407
Q

communicating, motivating, delegating, & coaching; creating a climate that meets the needs of individuals & the organization

A

directing

408
Q

defining standards of performance, developing a reporting system, & taking corrective action when necessary

A

controlling

409
Q

Lab Management - establishes goals & priorities; broad policy making - title and focus?

A

Director
Focus - organizational goals

410
Q

Lab Management - runs organization within framework of policies given to him/her - title and focus?

A

Administrator
Focus - Organizational goals

411
Q

Lab Management - oversees activity to achieve goal or purpose - title and focus?

A

Manager
Focus - Work environment

412
Q

Lab Management - oversees activities of others to help them accomplish specific tasks - title and focus?

A

Supervisor
Focus - People, operations

413
Q

Maslow’s Hierarchy of Needs - Physiological - definition & workplace counterpart(s)?

A

Survival needs - food, water, air, rest
Workplace - Income

414
Q

Maslow’s Hierarchy of Needs - Safety - definition & workplace counterpart(s)?

A

Physical & psychological security
Workplace - Insurance, safe work environment, job security

415
Q

Maslow’s Hierarchy of Needs - Social - definition & workplace counterpart(s)?

A

Sense of belonging, acceptance, affection
Workplace - social relationships with coworkers

416
Q

Maslow’s Hierarchy of Needs - Esteem - definition & workplace counterpart(s)?

A

Respect, independence, appreciation, recognition
Workplace - Job title, privileges, respect of colleagues

417
Q

Maslow’s Hierarchy of Needs - Self-actualization - definition & workplace counterpart(s)?

A

Realization of full potential
Workplace - challenging work, autonomy, professional growth

418
Q

Personnel required in high-complexity labs under CLIA-‘88

A
  1. lab director
  2. technical supervisor
  3. clinical consultant
  4. general supervisor
  5. general supervisor
  6. testing personnel
419
Q

Responsibilities - overall operation & administration of lab

A

lab director

420
Q

Responsibilities - technical & scientific oversight of lab; must be available on as-needed basis to provide on-site, telephone, or electronic consultation

A

technical supervisor

421
Q

Responsibilities - consultation regarding appropriateness & interpretation of tests

A

clinical consultant

422
Q

Responsibilities - general supervisor

A

day-to-day supervision of lab

423
Q

Responsibilities - specimen processing, test performance, & reporting of test results

A

testing personnel

424
Q

Employee performance appraisal - job description

A

basis for evaluation

425
Q

Employee performance appraisal - standards/criteria

A

what is expected; should be objective & measurable

426
Q

Employee performance appraisal - measurement instrument

A

instrument to compare actual performance with desired performance

427
Q

Employee performance appraisal - evaluator

A

person trained in use of instrument, familiar with intricacies of job, time to dedicate to process

428
Q

Employee performance appraisal - feedback mechanism

A

plan for sharing results of review, taking corrective action, planning for future

429
Q

Evaluation errors - everyone is rated toward middle of scale

A

error of central tendency

430
Q

Evaluation errors - an individual is rated lower than justified because of comparison with another exceptional individual. (the opposite may also occur)

A

contrast error

431
Q

Evaluation errors - everyone is rated high (opposite may also occur)

A

error of leniency

432
Q

Evaluation errors - good performance in one are influences evaluation in other areas

A

halo effect

433
Q

Evaluation errors - poor performance in one area influences evaluation in other areas

A

reverse halo effect

434
Q

Evaluation errors - judgments are made based on recent events or unusual incidents

A

recency phenomenon

435
Q

frequency of testing personnel competency assessment

A

Semiannually during 1st year, annually thereafter, & whenever there’s a change in test methodology or instrumentation

436
Q

Lab operating costs - expenses that don’t fluctuate when volume of work changes over short term

A

Fixed costs

-instrument leases, maintenance contracts, computer services, equipment costs, facilities upkeep, management salaries, custodial salaries, employee benefits, depreciation, lease payments, rent, taxes

437
Q

Lab operating costs - expenses that fluctuate directly with change in work load

A

variable costs

-labor costs, supplies, reagents, disposables

438
Q

Lab operating costs - costs associated with performance of a test

A

direct costs

-supplies, reagents, controls, standards, disposables, equipment costs, equipment maintenance contracts, equipment depreciation, technical & supervisory labor

439
Q

Lab operating costs - overhead

A

indirect costs

-administration, plant maintenance, security, utilities, building depreciation, rent, taxes, insurance, housekeeping, purchasing, billing, regulatory expenses, laboratory information system (LIS) expenses

440
Q

Lab operating costs - total of direct & indirect expenses of producing a test result

A

unit cost/cost per test

441
Q

Break-even price per test - formula?

A

(annual fixed costs + variable costs)/test volume

442
Q

Break-even test volume - formula?

A

total fixed costs/(average revenue per test - variable cost per test)

443
Q

Break-even revenue - formula?

A

total fixed costs/[(average revenue per test - variable cost per test)/average revenue per test]

444
Q

Quality management system developed by CLSI to organize all policies, processes, & procedures for preanalytic, analytic, & postanalytic activities; based on 12 quality systems essentials (QSEs); similar to ISO 15189

A

GP26-A4: Quality Management System: A Model for Laboratory Services

445
Q

List the 12 QSEs that form the basis of GP26-A4.

A
  1. Organization
  2. Customer focus
  3. Facilities & safety
  4. Personnel
  5. Purchasing & inventory
  6. Equipment
  7. Process management
  8. Documents & records
  9. Information management
  10. Nonconforming event management
  11. Assessments
  12. Continual improvement
446
Q

Quality management system developed specifically for clinical labs by the ISO; based on ISO 17025 and ISO 9001; accreditation is mandatory in some countries but currently voluntary in the US

A

ISO 15189: Medical laboratories-Particular requirements for quality & competence

447
Q

General requirements for the competence of testing and calibration laboratories - ISO?

A

ISO 17025

448
Q

Quality management systems - Requirements - ISO?

A

ISO 9001

449
Q

System developed by Toyota to improve quality by improving workflow & eliminating waste; focuses on equipment layout, standardization of processes, cross-training, inventory management; turnaround times are improved by grouping automated analyzers in core lab & replacing batch processing with single-piece flow

A

Lean

450
Q

System developed by Motorola to improve quality by determining & eliminating causes of defects/errors & reducing variability in processes; Uses DMAIC methodology to improve processes & statistical methods to measure quality improvements

A

Six Sigma

Six sigma = only 3 errors per million tests

451
Q

DMAIC methodology

A

Define
Measure
Analyze
Improve
Control

452
Q

Quality improvement system that combines principles of Lean & Six Sigma

A

Lean Six Sigma

453
Q

Internal audit tool to evaluate quality of patient care by following a specimen through preanalytic, analytic, & postanalytic phases of testing; used by The Joint Commission (TJC) & CAP as part of acrediation

A

Tracer methodology

454
Q

Sentinel events: TJC

Definition?
Example?
Goals?

A

Definition: unexpected event involving death or serious physical or psychological injury, or risk thereof
Example: Administration of ABO-incompatible blood
Goals: improve patient care

455
Q

Sentinel events: TJC

Requirements?
Reporting?

A

Requirements:
1. Root cause analysis - analysis of why even happened; examines proximate causes, e.g., personnel equipment, environment, leadership, corporate culture, communication, external factors; focuses on systems/processes, not individuals
2. Action plan - establishes risk reduction strategies & measures of effectiveness; should delineate responsibilities for implementation/oversight & establish time lines
3. Implementation
4. Monitoring

Reporting - reporting to TJC is optional but encouraged so that event can be added to database & used as educational tool to help others avoid similar events; confidentiality is maintained

456
Q

POCT - definition?

A

testing performed at site of patient care; also known as decentralized, bedside or near-patient testing

457
Q

POCT - goal?

A

provide rapid results where immediate medical action is required, e.g., emergency department, ICUs

458
Q

POCT - common tests?

A

urine reagent strips
glucose
electrolytes
blood gases
activated clotting time (ACT)
PT
APTT
hemoglobin

459
Q

POCT - regulations?

A

determined by test complexity; may operate under clinical lab’s CLIA certificate or separate CLIA certificate

460
Q

POCT - optimal staffing - director?

A

MLS or pathologist responsible for administrative, financial, & technical decisions

461
Q

POCT - optimal staffing - Point-of-Care Coordinator?

A

oversees testing & responsible for compliance, training, QC, proficiency testing (if required)

462
Q

POCT - optimal staffing - Designated contact/trainer at each testing site?

A

liaison between POCC & testing personnel; assists with training/competency assessment

463
Q

POCT - optimal staffing - testing personnel?

A

qualifications determined by test complexity of testing; usually phlebotomists, lab assistants, nurses, respiratory therapists

464
Q

POCT - considerations?

A

Cost
Performance specifications
Ease of use
Turnaround time
Impact on quality & cost of patient care
Data management
Data connectivity
Data interface capabilities

465
Q

ABCs of writing behavioral objectives

A

A - audience - who?
B - behavior - what?
C - criteria - under what conditions? When? How?
D - degree - expected standard of performance; How many? How much? How well?

466
Q

VAK learning style model

A

Visual - Seeing - reading assignments, pictures, slides, diagrams, drawings, graphs, videos, demonstrations

Auditory - Hearing - lectures, tapes, discussions; stimulated by changes in vocal tone, pitch, pacing

Kinesthetic - Doing - laboratories, role-play, group work

467
Q

Domains of Learning - Cognitive

Elements?
Knowledge level?
Application level?
Problem solving level?

A

Elements - facts, knowledge

Knowledge level - recall & comprehend facts/information

Application level - apply information in concrete situations

Problem-solving level - manipulate information in new situations or contexts; analyze, synthesize, evaluate

468
Q

Domains of Learning - Psychomotor

Elements?
Knowledge level?
Application level?
Problem solving level?

A

Elements - physical skills

Knowledge level - observe & imitate a skill

Application level - practice a skill

Problem-solving level - adapt existing skills to meet new demands or originate new procedures

469
Q

Domains of Learning - Affective

Elements?
Knowledge level?
Application level?
Problem solving level?

A

Elements - attitudes, feelings, values

Knowledge level - receive & respond to information about attitudes/feelings

Application level - assess attitudes/feelings

Problem-solving level - organize & internalize values into system that guides behavior

470
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Knowledge

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: recall specific facts

Examples: cite, define, identify, label, list, match, state

471
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Comprehension

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: grasp meaning of material

Examples: change, describe, explain, give examples, illustrate, interpret, paraphrase, rephrase, summarize

472
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Application

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: use material in new & concrete situations

Examples: apply, classify, compute, demonstrate, predict, prepare, present, show, solve, utilize

473
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Analysis

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: break down material into component parts

Examples: analyze, associate, conclude, determine, diagnose, diagram, differentiate, discriminate, distinguish, examine, infer, outline

474
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Synthesis

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: put elements together to form new whole

Examples: combine, compile, compose, create, design, develop, devise, generalize, invent, modify, originate, plan, propose, project, revise, rewrite, synthesize, theorize

475
Q

Bloom’s Cognitive Taxonomy & Writing Objectives - Level: Evaluation

Ability to?
Examples of verbs for objectives at different levels?

A

Ability to: judge value of material for given purpose

Examples: appraise, assess, compare, conclude, contrast, critique, deduce, evaluate, judge, weigh

476
Q

Testing at Different Cognitive Levels - Recall

Definition?
Example?

A

Recognizing or remembering isolated information

Example: which enzymes are elevated with liver disease?

477
Q

Testing at Different Cognitive Levels - Application

Definition?
Example?

A

Interpreting or applying limited data

Example: 15 nucleated RBCs per 100 WBCs were observed on a differential. The automated analyzer reported the total WBC as 15 x 10^6/L. What is the corrected WBC count?

478
Q

Testing at Different Cognitive Levels - Analysis

Definition?
Example?

A

Evaluating data, solving problems, or fitting together a variety of elements into a meaningful whole

Example: A patient’s RBCs agglutinated in anti-A, but not in anti-B. His serum agglutinated A1 cells & B cells. What might account for these results & how should you proceed?

479
Q

Which anticoagulant is best for the prevention of hemolysis and therefore utilized when analyzing many chemistry analytes?

A. EDTA
B. Heparin
C. Sodium fluoride
D. Sodium citrate

A

B. Heparin

480
Q

Which type of error is recurring and indicated by a trend or shift on a Levey-Jennings chart?

A. Random
B. Linear
C. Systematic
D. Proportional

A

C. Systematic

481
Q

Which type of error is recurring and indicated by a trend or shift on a Levey-Jennings chart?

A. Random
B. Linear
C. Systematic
D. Proportional

A

C. Systematic

482
Q

Which of the following components of a QC program is most useful to detect sample misidentification?

A. Critical limits
B. Delta check
C. Function check
D. Personal Competency Assessment

A

B. Delta check

483
Q

Which measurement can be calculated as TP/(TP + FN) x 100?

A. Sensitivity (Diagnostic)
B. Specificity (Diagnostic)
C. Positive Predictive Value
D. Negative Predictive Value

A

A. Sensitivity (Diagnostic)

484
Q

Attitude, feelings, and judgment refer to which domain of learning?

A. Cognitive
B. Psychomotor
C. Affective
D. Competency

A

C. Affective

485
Q

Performing a calculation to determine the corrected WBC count is an example of which level of cognitive testing?

A. Recall
B. Application
C. Analysis
D. Evidence-based

A

B. Application

486
Q

Which of the following is an example of an indirect cost when calculating costs for laboratory tests?

A. specimen collection supplies
B. abnormal control material
C. labor cost for performing the test
D. insurance

A

D. insurance

487
Q

Under CLIA ‘88, testing personnel with an associate degree and approved laboratory training may perform which level of testing complexity?

A. waived only
B. moderate complexity only
C. waived and moderate-complexity tests
D. waived, moderate, and high-complexity tests

A

D. waived, moderate, and high-complexity tests

488
Q

The goal of POCT is:

A. to reduce the need for quality control
B. to improve sensitivity and specificity over central lab assays
C. to provide rapid test results when immediate medical action is required
D. to reduce the training needed to perform lab assays

A

C. to provide rapid test results when immediate medical action is required

489
Q

Which of the following is true of the “Six Sigma” method?

A. The goal of Six Sigma is to improve test quality by reducing errors
B. Refers to an error rate of only 3 errors per million tests
C. Process consists of five steps (define, measure, analyze, improve, and control)
D. All of the above are true of Six Sigma

A

D. All of the above are true of Six Sigma

AMT MT Exam (12 decks)

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