Section 1 Flashcards
1
Q
What is an accreditation?
A
Recognition granted by nongovernmental agencies to institutions that meet certian standards
2
Q
What are some examples of accreditations?
A
AABB
CAP
Joint Commission
NAACLS
3
Q
What is a certification?
A
Recognition granted by nongovernmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing exam
4
Q
What is an licensure?
A
Permission granted by state to individuals/organizations to engage in certain professions/businesses.
Mandatory
5
Q
What is the Association for Advancement of Blood and Biotherapies (AABB)?
A
Technical standards and accreditation of blood banks
6
Q
What is the Center for Disease Control and Prevention (CDC)?
A
Standards and guidelines primarily related to infection control and safe work practices
7
Q
What is the Clinical Laboratory and Standards Institute (CLSI)?
A
Standards on all aspects of lab practice developed through voluntary consensus
8
Q
What is the Internaltion Organization for Standardization (ISO)?
A
Standards to facilitate international exchange of goods and services. Developed through voluntary worldwide consensus
9
Q
What is the center for Medicare and Medicaid Services (CMS)?
A
Writes regulations for and enforces Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88)
10
Q
What is the Department of Health and Human Services (HHS)?
A
Interprets and implements federal regulations related to health care.
- over sees CDC, CMS, FDA, SAMSHA
11
Q
What is the Department of Transportation (DOT)?
A
Regulates packaging, labeling, and transportation of biological products
12
Q
What is the Enviromental Protection Agency (EPA)?
A
Regulates disposal of toxic chemicals and biohazardous waste
13
Q
What is the Food and Drug Administration (FDA)?
A
- Regulates market entry of instruments/reagents and production of donor blood and components
- Licenses blood banks
14
Q
Nuclear Regulatory Commission (NRC)?
A
Licenses labs that use radionucleotides
15
Q
What is the Occupational Safety and Health Administration (OSHA)?
A
Regulates employee safety in the workplace
16
Q
What is the Substance Abuse and Mental Health Services Administration (SAMSHA)?
A
Certifies laboratories to conduct forensic drug testing for federal agencies
17
Q
What is the Hazard Communication Standard (OSHA 1983)?
A
- Requires employers to inform employees about hazardous substances in workplace and educate them in safe handling
- Right-to-know law
18
Q
What is the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988)?
A
- Regulates all lab testing (except research) performed on humans in U.S. Requirements for personnel and quality assurance determined by test complexity
- administered by CMS
19
Q
What is the Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)?
A
- Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs
- Laboratory Standard
20
Q
What is the Bloodborne Pathogens Standard (OSHA 1991)?
A
Mandates work practices and procedures to minimize worker exposure to bloodborne pathogens
21
Q
What is the Formaldehyde Standard (OSHA 1992)?
A
Requires monitoring of formaldehyde exposure
22
Q
What is the Health Insurance Portability and Accountability Act of 1996 (HIPAA)?
A
Regulates use and disclosure or protected health information (PHI)
23
Q
Described the waived complexity
A
- tests cleared by FDA first home use, negligible likelihood of erroneous results or no reasonable risk of harm to patient if performed incorrectly
- No control, just follow manufactures directions
- proficiency test in not required
- Qualifications - none
24
Q
Describe the provider-performed microscopy complexity (PPM)?
A
- certain microscopic exams performed by provider during patients visit.
- example = direct wet mount, KOH prep, urine sediment
- controls required if available
- Proficiency testing not specifically required but lab must verify accuracy of testing annually
- personnel = physician, midlevel practitioner, and dentist
25
Describe moderate complexity
- score less than or equal to 12 on 7 criteria
- 2 levels of external controls per 24 hours
- proficiency testing required
- qualification = high school diploma or equivalent and training for testing performed
26
Describe high complexity
- score greater than or equal to 12 on criteria 7
- 2 levels of external controls per 24 hours
- proficiency testing is required
- qualification = associate degree in medical laboratory science or equivalent
27
What is the purpose of Bloodborne Pathogens Standard?
- To protect health-care workers from occupational exposure to bloodborne pathogens
- HIV, HBV, and HCV
28
What are the primary requirements for Bloodborne Pathogens Standard?
- exposure control plan
- university precautions
- engineering controls
- work practice controls
- personal protective clothing and equipment
- housekeeping
- training
- medical surveillance
- HBV vaccination
- hazard communication
- sharps injury log
29
What are potentially infections specimens?
- blood
- tissues
- semen
- vaginal secretions
- CSF
- synovial fluids
- pleural fluid
- peritoneal fluid
- pericardial fluid
- amniotic fluid
- saliva in dental procedures
30
What specimens are usually not infectious?
- Feces
- Nasal secretions
- Sputum
- Sweat
- Tears
- Urine
- Vomitus
31
Describe primary container
- test tubes, vials
- containing etiologic agent
- must be securely closed
- watertight
- surrounded by absorbent material
- placed in secondary container
32
Describe a secondary container
- must be watertight
- sealed
- placed in approved mailing container
33
Describe a mailing container
Must be made of fiberboard
34
Descibe labeling
- biohazard label required on primary and mailing container
35
Describe training of employees
Employees must be trained and retrained every 2-3 years or when regulations change,
36
What are the primary requirements of HCS?
- written hazard
- inventory of hazardous chemicals on site
- hazard labeling
- MSDS for each chemical readily accessible to employers on each shift
- training on initial assignment and when new hazard introduced
37
What are the primary requirements for OSHA?
- written chemical hygiene plan outlining standard operating procedures for use, storage, exposure control, and disposal of hazardous chemicals
- designation of chemical hygiene officer
- hazard ID and labeling
- Safety data sheet for each chemical readily accessible to employees on each shift
- use of PPE
- proper maintenance of fume hoods and other protective equipment
- monitoring of employee exposure to hazardous chemicals
- medical exams at no cost in cases of suspected overexposures
38
Describe corrosives
- examples = glacial acetic acid, hydrochloric acid, sodium hydroxide
- effect = visible destruction of human tissue on contact , can cause injury on inhalation or contact
39
Describe Toxic Substances
- examples = cyanides and sulfides
- effect = interfere with metabolic processes when ingested, inhaled, or absorbed through skin
40
Describe carcinogens
- example = benzidine and formaldehyde
- effect = capable of causing cancer
41
Describe mutagens and tetraogens
- example = Benzene, lead, mercury, radioactive material, toluene
- effect = mutagens induce genetic mutations. Tetraogens cause defects in embryo
42
describe ignitables
- example = acetone, alcohols, ether, xylene
- effect = fire
43
Describe reactives
- example = ether, perchloric acid, picric acid, and sodium azide
- effect = explosions
44
Describe Health on the NFPA Hazmat Diamond and levels
- symbol = blue diamond (left)
- 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
45
Describe flammability on the NFPA Hazmat Diamond and levels
- symbol = red diamond (top)]
- 0 = will be burn
- 1 = must be preheated for ignition to occur
- 2 = must be heated or in increase ambient temp to burn
- 3 = can be ignited under almost all ambient temps
- 4 = will vaporize and burn at normal temp
46
Describe instability of the NFPA Hazmat Diamond
- symbol = yellow diamond (right)
- 0 = stable
- 1 = increase temp makes unstable
- 2 = violent chemical change at increase temp or pressure
- 3 = may explode from increase temp or shock
- 4 = may explode at normal temp and pressures
47
Describe special hazards of the NFPA Hazmat Diamond
- symbol = white diamond (bottom)
- W = unusual reactivity with water
- OX = oxidizer
- ALK = alkaline
48
Describe acid storage
- store below counter level or in acid cabinets
- separate from flammable and combustible material, bases and active metals
- separate organic acids from inorganic acids
- separate oxidizing acids from organic acids
49
What are some examples of acids?
- organic = Formic, glacial acetic, citric
- inorganic = hydrochloric, nitric, sulfuric
- oxidizing = chronic, nitric, perchloric, sulfuric
50
Describe the storage of bases
- separate from acids
- store inorganic hydroxides in polyethylene containers
51
What are some examples of bases?
- ammonium hydroxide
- potassium hydroxide
- sodium hydroxide
52
Describe storage of flammables
- limit amount in work area
- sore in approved safety cans or cabinets.
- separate from oxidizing acids and oxidizers
53
What are some examples of flammables?
- acetone
- alcohols
- xylene
54
Describe storage of oxidizers
- separate from reducing agents , flammable, and combustible materials
55
What are examples of oxidizers?
- nitric acid
- perchloric acid
- sulfuric acid
- acetic acid
- potassium chloride
- hydrogen peroxide
56
Describe storage of water reactive chemicals
- keep away from water
- store in a dry, cool place
57
What are examples of water-reactive chemicals?
- sodium
- potassium
58
Describe Class A fire
- cloth, wood, paper
- extinguisher = Pressurized water (A) and Dry chemical (ABC)
- do not use water on electrical fires or burning liquids
59
Describe Class B fire
- flammable or combustible liquids
- extinguisher = Dry chemical (ABC) and CO2 (BC)
60
Describe Class C fire
- electrical equipment
- extinguishers = dry chemical (ABC) and CO2 (BC)
- Never use water
- Dry chemical may damage electrical equipment
- CO2 leaves no residue
- good choice for computers and analyzers
61
Describe Class D fire
- combustible metals
- leave to the professionals
62
Describe EDTA
- lavender top
- prevents clotting by chelating calcium
- prevents platelets from clumping
- minimal morphological change to WBCs
- Tube should be atleast half full
- used for = CBC, sed rate, differentials
63
Describe Heparin
- green top
- prevent clotting by neutralizing thrombin
- best anticoagulant for prevention of hemolysis
- don’t use for diffs.
- used for = many chemistries, osmotic fragility, plasma hgb, and blood gases
64
Describe Sodium citrate
- blue top
- prevents clotting by binding calcium
- preserves labile clotting factors
- tube must be full for 9:1 ration
- used for = most coagulation tests
65
Describe sodium fluoride
- gray top
- inhibits glycolysis (not an anticoagulant)
- preserves glucose for 24 hours
- combined with potassium oxalate if anticoagulation needed
- oxalate binds calcium
66
What is the correct draw order for evacuated and filling tubes from a syringe?
- Yellow top/blood culture bottles (Blood culture)
- Light blue (coagulation {citrate})
- Red/gold/speckled (serum)
- Green (heparin)
- Lavender/pink/white top (EDTA)
- Gray (glycolytic inhibitor)
67
What is the order of draw for micro collection tubes from capillary punctures?
- blood gases = minimize exposure to air
- EDTA = minimizes clumping of platelets
- Heparin = should be filled after EDTA if CBC needed
- other addictive tubes = minimize clotting
- serum tubes = clotting is not a concern
68
What should be done when the patient has an IV?
- use opposite arm or perform finger stick if possible
- otherwise, have nurse turn off IV for 2 minutes
- apply tourniquet below the IV
- use different vein
- document location of IV and venipuncture and type of fluid
69
What should be done if the patient has a fistula?
- draw from opposite arm
70
What should be done if the patient has indwelling lines and catheters, heparin locks and cannulas ?
- usually not drawn by lab
- first 5 mL is discarded
- Lab may draw below heparin lock if nothing is being infused
71
What should be done if the patient has sclerosed veins?
Select another site
72
What should be done if the patient has a hematoma?
- draw below
73
What should be done if the patient was given streptokinase or time plasminogen activator (TPA)?
- minimize venipunctures
- hold pressure until bleeding stops
74
What should be done if the patient has edema for a blood draw?
Select another site
75
What should be done if the patient has scars, burns, and tattoos for blood draw?
Select another site
76
What should be done if the patient has had a mastectomy for blood draw?
Draw from the opposite arm of the mastectomy
77
What should be done if a patient refuses a blood draw?
- try persuade
- notify nurse
- never draw without consent
- could lead to charges of assault or battery
78
What should be done if a blood draw needs to be done on an unidentified patient?
- ask nurse to ID before drawing
79
Describe the special test requirements: fasting
- nothing to eat or drink (except water) for atleast 8 hours
- example = fasting blood sugars, triglycerides, lipid panel, gastric and insulin
80
Descibe the special test requirement: chilling
- place in slurry of crushed ice and water
- don’t use ice cubes alone because RBCs may lyse
- examples = ACTH, acetone, ammonia, lactic acid, PTH, glucagon
81
Describe the special test requirement: warming
- use 37C heat block, heel warmer, or hold in hand
- examples = cold agglutinins and cyroglobulin
82
Describe the special test requirement: Protection from light
- wrap in aluminum foil
- examples = bilirubin, carotene, RBC protoporphyria, vitamin A and B12
83
Describe the special test requirement: Chains of custody
- chain of custody form
- lock box may be required
- example = any test used as evidence in legal proceedings
84
What could occur if a patient was misidentified?
- treatment error
- possible fatal transfusion
85
What can occur if blood is drawn at the incorrect time?
- treatment error
86
What could occur if improper skin disinfection is done?
- infection at site of puncture
- contamination of blood cultures and blood components
- isopropyl alcohol wipes can contaminate samples for blood alcohol
87
What can occur if blood is drawn from an edematous site?
- dilution of sample with tissue fluid
88
What can occur if the patient pumps their fist during venipuncture?
- increase in potassium, lactic acid, calcium and phosphorus
- decrease in pH
89
What can occur if the tourniquet is on longer than 1 minute?
- increased potassium, total protein, lactic acid
90
What can occur if there is a IV fluid contamination during venipuncture?
- increase glucose and electrolytes
91
What can occur if the wrong anticoagulant tube is used or contamination from wrong order draw?
- K2EDTA before serum or heparin tube = decreased calcium, magnesium and increased potassium
- contamination of citrate tube with clot activator = erroneous coag results
92
What can occur if expired tubes were used for venipuncture?
- decreased vacuum
- failure to obtain specimen
93
What can occur if the tube is NOT held by bottom of tube lower than top during collection?
- carryover from one tube to another
- possible additive contamination
94
What can occur if the tubes are short fills?
- incorrect blood
- anticoagulant ratio affects some results
95
What can occur if there is inadequate mixing of the tube?
- micro clots
- fibrin
- platelet clumping can lead to erroneous results
96
What can occur if there is alcohol contamination, milking, probing wit needle, vigorous shaking, exposure to extreme temps when collecting blood?
- increase in potassium, magnesium, lactate dehydrogenase (LD) and iron
97
Why should collection tubes be kept vertical?
To promote clotting
98
How long should serum and gel separators tubes sit before centrifugation, and why?
- 30-60 minutes
- to avoid fibrin clotting
99
What should most tubes be centrifuged at? And why?
- 1,000-1,300 RCF for 10-15 minutes
- citrate tubes should be spun at 1,500 RCF for 15 minutes
- to produce platelet-poor plasma
100
Why are tubes cappped when the are centrifuged?
- avoid loss of CO2, change of pH, evaporation or aerosol formation
101
What should tubes not be re-spun?
- can cause hemolysis
- if necessary, transfer serum to another tube
- serum separators = serum in contact with RBCs under gel can be expressed and increase potassium
102
What is the window of time a specimen should be centrifuged from collection?
- within 2 hours of collection
103
Describe centrifugation of Lipemic specimens
- ultracentrifugation at 10^5 X g to remove Chylomicrons (triglycerides)
104
What temp should separated serum be stored at
-Room temp for 8 hours
OR
-At 2-8C for 48 hours
- for longer = freeze at -20C
105
What should never be frozen?
Whole blood
106
What is relative centrifugal force (RCF)?
- force acting on sample being centrifuged
- gravities (g)
- function of RPM and radius
- RCF = 1.12 x 10^5 x r x rpm^2
107
What is RPM?
- revolutions per minute
- speed of centrifugation
- determined by a tachometer
108
What is radius (r)?
- distance in cm from center of rotation to bottom of tube when rotating
109
Describe the horizontal-head centrifuge (swinging-bucket)
- tubes are in a horizontal position when spinning
- produces a tightly packed, flat sediment surface
- recommended for serum separator tubes
110
Describe the angle-head centrifuge
- Tubes are at fixed angle (25-40 degrees) when rotating
- capable of higher speeds
- produces a slanted sediment surface that isn’t tightly packed
- decantation is not recommended
111
Describe the ultracentrifuge
- high speed
- capable of 100,000 RPM
- refrigerated to reduce heat
112
What are reasons to reject a specimen?
- missing/inadequate labeling
- collected at wrong time
- collected in wrong tube
- insufficient specimen
- inadequate volume of blood in anticoagulant tube
- exposure to temp extremes
- prolonged transit
- clots in CBC tube
- hemolysis
- lipemia
113
Describe borosilicate glass
- example = Kimax and Pyrex
- high resistance to thermal shock and chemical attack
- heavy walls to minimize breakage
- used for most beakers, flasks, and pipers
- minimal contamination of liquids by elements in glass
- can be heated and autoclaved
114
Describe aluminosilicate class
- example = Corex
- 6 times stronger than borosilicate
- better able to resist clouding due to alkali and scratching
115
Describe boron free glass
- used for highly alkaline solutions
- alkali resistant
- poor heat resistance
116
Describe high silica glass
- heat, chemical, and electric tolerance
- excellent optical properties
- used for high-precision analytic work, optical reflectors , mirrors
117
Describe flint glass
- soda lime glass containing oxides of sodium, silicon, and calcium
- least expensive but poor resistance to high temp and sudden changes of temp.
- only fair resistance to chemicals
- can release alkali and affect some determinations
- used for some disposable glassware
q
118
Describe low actinic glass
- amber or red
- used to decrease exposure to light
119
Describe polypropylene plastic
- relatively inert chemically
- resistant to most acids, alkalis, and salts
- can be autoclaved
- used for pipet tips and test tubes
120
Describe Polyethylene plastic
- relatively inert chemically
- resistant to most acids, alkalis and salts
- used or test tubes, bottles, disposable transfer pipet, test tube racks
- can not be autoclaved
121
Describe polycarbonate plastic
- stronger than polypropylene and better temp tolerance, but chemical resistance not a good
- Clear
- resistant to shattering
- used for centrifuge tubes and graduated cylinders
122
Describe polystyrene plastic
- rigid, clear
- should not be autoclaved
- will crack and splinter
- used for test tubes and graduated cylinder
123
Describe polyvinyl chloride plastic
- soft and flexible but porous
- frequently used as tubing
124
Describe teflon plastic
- extremely inert
- excellent temp tolerance and chemical resistance.
- used for stir bars, stopcocks, and tubing
125
Describe the “A” inscription on glassware
- class A
- meets high standards for accuracy
126
Descibe the inscription “20C” on glassware
- temp of calibration
- temp of glassware and solutions should be at this temperature for maximum accuracy
127
Describe the inscription “TC” on glassware
- to contain
- vessel calibrated to hold specified volume
- example = volumetric flask
128
Describe the inscription “TD” on glassware
- to deliver
- vessel calibrated to deliver specified volume
- graduated cylinder
129
Describe a beaker
- wide mouthed
- straight-sided jar with pouring spout
- not accurate enough for critical measurements
130
Describe Erlenmeyer flask
- sloping sides
- graduated markings
- used to hold liquids, mixed solutions and measure non critical volume
131
Describe Florence flask
- spherical base with long cylindrical neck
- single calibration mark
- only for noncritical measurements
132
Describe the volumetric flask
- pear shaped
- long neck with single calibration mark
- manufactured to strict standards
- glassware and solutions should be at RT
- used to prepare standards and reagents
- shouldn’t be used to store solutions
133
Describe the graduated cylinder
- upright, straight-sided tube with flared based
- used for noncritical measurements
- most are TD
- shouldn’t be used to measure <5 mL or <10% of capacity
- used graduate closest to size to volume to be measured
134
Describe the volumetric pipet
- transfer pipet
- single calibration mark
- calibrated to accurately deliver fixed volume of non-viscous samples and standards
- touch off last drop against wall of receiving vessel
135
Describe the Ostwald-Folin pipet
- transfer pipet
- similar to volumetric pipet but bulb closer to tip
- Etched ring means blowout
- used for accurate measurement of viscous fluids
- not usually used
136
Describe the serological pipet
- graduated or measuring pipet
- Graduation marks down to tip
- Etched ring means blowout
- can use for serial dilutions and measuring reagents
- not accurate enough for measuring samples or standards
137
Describe the Mohr pipet
- graduated or measuring pipet
- Does not have graduation marks to the tip or frosted band near upper end
- delivery is made “point to point”
- not widely used
138
Describe the micropipet
- 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 pipet bulb is used
139
Describe the semiautomatic and automatic pipets
- programmable and used with disposable plastic tips
- aliquots of liquid dispensed can range from 0.1 uL to 10 mL or larger
- than device aspirates a predefined volume when it’s plunger is moved through a complete cycle
- good for reducing cross contamination between samples
140
Describe the calibration pipet
- verify accuracy and precision on receipt, after service or repair and on regular schedule
- most accurate method for calibration is gravimetric method (weight of distilled water delivered)
- secondary method is spectrophotometric
141
Describe Analytic reagent grade chemicals
- very high purity
- meets specification of American Chemical Society
- recommended for qualitative and quantitative analysis
142
Describe Ultra pure grade chemicals
- spectrograde, nanograde, or HLPC grade
- used for gas chromatography, HPLC, fluorometry, and trace metals determinations
143
Describe the chemically pure grade chemicals
- limits of impurities not specified
- may be acceptable for some lab applications when higher purity chemicals are not available
144
Describe the practical, technical, or commercial grade chemical
- for industrial use
- not of sufficient purity to used as analytic reagents
145
Describe USP or NF grade chemical
- meet specifications of U.S. pharmacopeia or National Formulary
- Not injurious to health
- not necessarily of sufficient purity to use as analytic reagents
146
Describe Clinical Laboratory reagent grade water (CLRW)
- meets CLSI specifications of ionic, microbiological and organic impurities, particulate and colloid content,
- pure enough for most routine testing
- no single purification method can produce water of this quality
- used combinations of distillation, deionization, reverse osmosis and filtration.
- lab must test at regular intervals for resistivity, microbial content and total organic carbon (TOC)
147
Describe special reagent water (SRW)
- for applications that require water of different purity than CLRW
- must meet specifications of assay
148
Describe autoclave and wash water
- feed water for autoclaves and dishwashers
- impurities that could contaminate washed labware or solutions in autoclave are removal
- replacement for previously designated type III water
149
what are the CAP reagent labeling requirements?
- content
- concentration
- storage requirements
- date prepared or reconstituted
- expiration date
- lot #, if applicable
150
What are not requirements for CAP reagent labeling?
- date received
- date opened
151
What is an achromatic objective?
- Least expensive expensive objective
- Partially corrects for chromatic and spherical aberrations
152
What is an aperture diaphragm?
Controls angle and amount of light sent to objective
153
What is a binocular microscope?
One with 2 oculars
154
What a blue filter for microscopes?
Used to eliminate yellow color emitted by tungsten
155
What is a Brightfield scope?
- used transmitted light and lenses
- objects appear dark against white background
- used for most routine clinical work
156
What is a compound microscope?
- one with 2 lens systems: objective and oculars
157
What is a condenser?
Focuses light on specimen
158
What is depth of focus?
Distance throughout which all parts of specimen are in focus simultaneously
159
What is a field diaphragm?
Limits area of illumination to image field
160
What is a field of view?
- area of specimen that can be seen
161
What is immersion oil?
- used to help objective gather iight from a numerical aperture
- provides high resolution
- type B (high viscosity) is commonly used
162
What is Koehler illumination?
- method of focusing and centering light path and spreading light uniformly
- ensures optimum contrast and resolution
163
What is magnification, total?
- Magnification of ocular x magnification of objective
- 1,000 x is highest magnification achievable with brightfield microscope
164
What is numerical aperture (NA)?
- mathematical expression of light admitted by lens
- the higher the NA, the greater the resolution
165
What are objectives of a microscope?
- lenses attached to to revolving nosepiece
- most commonly used are low power (10x), high power (40x) and oil immersion (50x or 100x)
166
What is an ocular?
- eye piece
- usually 10x
167
What is parcentric?
- objective in center of filed of 1 magnification will be in center of field at other magnification
168
What is parfocal?
- object remains in focus from 1 magnification to another
169
What is a planachromatic objective?
- more expensive objective that corrects for curvature of field.
- Results flat field with uniform focus
170
What is resolution?
- ability to reveal fine details and distinguish between 2 close points
171
What is rheostat?
- light control knob
- light intensity shouldn’t be regulated by condenser or diaphragms
172
What is a tungsten-halogen bulb?
- type of bulb used for brightfield microscopy
173
What is a virtual image?
- image seen through microscope.
- upside down and reverse
174
What is working distance of a microscope?
- distance between slide and objective
- decreases with higher magnification objectives
175
What is a darkfield microscope?
- brightfield microscope with special condenser
- objects appear white against black background
- application: ID of live treponemal pallidium and other microorganisms
176
Whta is a fluorescent microscope?
- brightfield microscope with 2 special filters
- fluorescent dyes absorb light of 1 wavelenght and emit light of longer wavelength
- objects appear green, yellow, or orange against black background
- direct and indirect fluorescent antibody stains in microbiology and immunology
177
What is an interference contrast microscope?
- brightfield microscope with special slit aperture below condenser, polarizer and special amplitude filter (modulator) in back of each objective
- gives 3D effect to unstained specimens
- wet mounts
178
What is a phase contrast microscope?
- brightfield microscope with special slit aperture below condenser and phase objective
- subtle differences in refractive index converted to clear-cut variations of light intensity and contrast
- good for living cells, unstained specimens
- used for manual platelet counts, urine sediments (good for hyaline cast)
179
What is a polarizing microscope?
- brightfield microscope with 2 crossing filters - polarizing filter below condenser, analyzer between objective and eyepiece
- objects that can refract light (bifringent) appear white against black background
- used for ID of crystals in urine and Synovial fluid, confirmation of fat or oval fat bodies in urine sediment
180
What is a transmission microscope?
- Beam of electrons passes through specimen
- focused onto fluorescent screen or photographic plate
- magnification >1,000 x
- used for virology, organelles
181
What is a scanning microscope?
- beam of electrons strikes surface of specimen
- focused onto photographic film or cathode ray tube
- 3D image
- magnification > 1,000x
- used for virology of cell surfaces
182
What is informatics?
- information science
- science of processing data for storage, retrieval and use
183
What is laboratory informatics?
- used of computers and information systems to process and communicate information generated in clinical lab
184
What is electronic- medical record (EMR)?
- computerized medical record
185
What is Laboratory information system (LIS)?
- system of hardware, software, connections, and communication protocols to handle all informational needs of lab, form intake of requests to delivery of results
- can provide patient information, test information, collection lists, work lists, tests results, financial functions, productivity/workload monitoring, quality management and interface with other computer systems
186
What is Hospital information system (HIS)?
Information system to handle all informational needs of hospital, both clinical and administrative
187
What is an interface?
- hardware and software that allow for electronic communication between 2 computers systems, even if they use different programming languages
- the LIS is typically interfaced to HIS and automated analyzers
188
What is a bidirectional interface?
- interface that transmits electronic information in 2 directions
- example = the LIS downloads orders from the HIS and uploads results to the HIS
189
What is a unidirectional interface?
- interface that transmits electronic information in 1direction
- example = POC analyzer, downloads test results to LIS
190
What is middleware?
- interface between an analyzer and LIS
- can apply rules too automate processes (autoverification)
191
What is system validation?
- documentation that LIS functions as expected
- required by regulatory agencies
192
What is computer area network (LAN)?
- computer network that connect computers in close geographic proximity (building, campus)
193
What is a wide area network (WAN)?
- computer network that connects computers over larger geographic area (multi site healthcare facility, internet)
194
What is the internet?
- global system of interconnected computer networks
195
What is the intranet?
- computer network within an organization
- access is usually restricted to employees
196
What is the extranet?
- extension of a private network onto the internet where it can be accessed by authorized clients, suppliers, etc
197
What is protocol?
- common set of signals and rules that network uses for communication
198
What is the Ethernet?
- one of the 1st protocols developed for connecting computers
199
What is TCP/IP?
- Transmission Control Protocol/internet protocol.
- adapted for transmission in LANs
200
What is Health 7 standard (HL7)?
- standardized message protocol that facilitates exchange of medical data among computer systems
201
What is Quality assessment or quality assurance (QA)?
-process by which lab ensures quality results by closely monitoring preanalytical, analytical, and postanalytical stages of testing
202
What is preanalytical QA?
- everything that precedes test performance
- examples = test ordering, patient preparation, patient ID, specimen collection, specimen transport, and specimen processing
203
What is analytical QA?
- everything related to assay
- example = test analysis, quality control (QC), reagents, calibration, preventive maintenance
204
What is postanalytical QA?
- everything that comes after test analysis
- example = verification of calculations and reference ranges, review of results, notification of critical values, result reporting, test interpretation by physician, follow up patient care
205
What is a quality system?
- all of the labs policies, processes, procedures, and resources needed to achieve quality testing
206
What is Quality Control (QC)?
- part of analytical phase of quality assurance; process of monitoring results from control samples to verify accuracy of patient results
207
What is control material?
- sample that is chemically and physically similar to unknown specimens and is tested in exactly the same manner
- monitors precision of 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
208
What is external QC?
- testing control material not built into test systems
- term is also used for QC that extends beyond the lab (participation in proficiency testing program
209
What is internal monitoring systems?
- electronic, internal, or procedural controls that are built into test system
210
What measures of dispersion?
- statistical parameters describing spread of data about mean
- example = Standard deviation, coefficient of variation, range.
- measurement of precisions
211
What is range?
Differences between highest and lowest values in data set
212
What is the mean?
- sum of all observations divided by number of observations
- average of all observations
213
What is Standard Deviation (SD)?
- statistical expression of dispersion of values around mean. Requires a minimum of 20 values
214
What is coefficient of variation (CV)?
- expresses standard deviation as percentage
- the lower the CV, the higher the precision
215
What is bias?
- the difference between the means of two methods
- the student’s t test is used to determine if bias is significant
216
Describe Normal Distribution of quality control statistics?
- the Gaussian bell-shaped curve:
- 68% of values fall within +/- 1 SD of mean
- 95% of values fall within +/- 2 SD of mean (95% confidence interval)
- 99.7% of values fall within +/- 3 SD of mean
217
Describe control limits
- range within which control values must fall for assay to be considered valid
- many labs use mean +/- 2SD
- 1 determination in 20 will fall outside of +/- 2SD
- this is anticipated part of normal variation
218
What is a Levy-Jennings chart?
- normal distribution curve lying on its side, marked with mean, +/- 1, +/- 2, +/- 3
219
What is an outlier when referring to quality control?
- a control result outside established limits
- may be due to chance or may indicate problem in test system
- if it occurs mre than once in 20 successive runs, investigation must be carried out
220
What is a shift?
- 6 consecutive control values on same side of mean
221
What is a trend?
- control values increasing or decreasing for 6 consecutive runs
- often caused by unstable reagent, calibrator or instrument condition
222
What is a random error?
- error that doesn’t recur in regular pattern
- indicated by control value significantly different from others on Levy-Jennings chart or violation of 1-3S or R-4S Westgard rules
- usually a 1 times error and controls and samples can be rerun with success
223
What is a systematic error?
- recurring error inherent in test procedures
- affects all results
- indicated by trend or shift on Levy-Jennings chart, or violation of 2-2S, 4-1S, or 10-x Westgard rules
- requires investigation to determine cause
224
What is a false rejection?
- rejection of run because QC results indicate problem when none is present
- Used Westgard rules minimizes false rejections
225
What is the 1-2S Westgard rule?
- 1 control > +/- 2S from the mean
- warning flag of possible change in accuracy or precision
- initiates testing of other rules. If no violation of other rules, run is considered in control
226
What is the 1-3S Westgard rule?
- 1 control > +/- 3S from mean
- random error
- rejection rule
227
What is the 2-2S Westgard rule?
- 2 consecutive controls >2S from the mean on the same side
- systematic error
- rejection rule
228
What is the R-4S Westgard rule?
- 2 consecutive controls differ by >4S
- random error
- rejection rule
229
What is the 4-1S Westgard rule?
- 4 consecutive controls >1S from mean on the same side
- systematic error
- rejection rule
230
What is the 10-x Westgard rule?
- 10 consecutive controls on the same side of the mean
- systematic error
- rejection rule
231
What are some actions a tech should do when controls are out of acceptable range?
- hold patient result until problem resolved
- rerun control (1 time only)
- if control is still out, run a new vial of control or another lot #
- if control is still out, look of and correct any problems, then run controls
- if control is still out, recalibrate, then run control
- if control is still out, get assistance
- once resolved, document corrective action
- evaluate all patient results in rejected run and since last run with acceptable QC. Repeat tests and issue corrected reports, as needed
232
What is calibration?
- process of testing and adjusting analyzers readout to establish correlation between measured and actual concentrations
233
What is a calibrator?
- reference material with known concentration of analyte
- programmed into analyzers computer for used in calculating concentration of unknowns
- formerly called standard
234
What is calibration verification?
- testing materials of known concenconcentrations (controls, calibrators, proficiency testing samples, patient specimens with known values) to ensure accuracy of results throughout reportable range
- test 3 levels - high, midpoint, and low
- required every 6 months, when lost # of reagent changes, following preventive maintenance or repair and when controls are out of range
235
What is accuracy?
- how close measurement is to true value
- verification = lab tests samples of known values to see how close results are to known value
236
What is precision?
- reproducibility
- how close results are when same sample is tested multiple times
- a procedue can be precise but it accurate
- verification = lab repeatedly test samples
237
What is reportable range?
- range of values over which lab can verify accuracy of test system
- also know as linearity
- verfication = lab tests samples with known values at highest and lowest levels claimed to be accurate by manufacturer
238
What is a reference interval?
- formerly called normal value
- can vary for different patient populations
- established by testing minimum of 120 healthy subjects and determine range in which 95% fall.
- lab must use manufacturers reference ranges or published reference range, if appropriate for their patient population
- verifcation = if manufacturers or published reference ranges are used, lab must test specimens from normal subjects to verify ranges, range may to be adjusted to fit labs patient population
239
What is analytical sensitivty?
- same as detection limit
- lowest concentration that be detected by test method
- increased sensitivity means decreased false negs.
- high value desirable in screening tests
- verification = determined by manufacturer. For unmodified FDA-approved tests, verification isn’t required
240
What is analytical specificity?
- ability of method to measure only analyte it’s supposed to measure and not other related substances
- increased specificity means decreased false POs.
- decreased cross- reactivity
- high value desirable in confirmatory tests
- verification = determined by manufacturer. For unmodified FDA approved tests, verification isn’t requried
241
What is a true positive (TP)?
- positive result in patient who has the disease
242
What is a false positive (FP)?
- positive result in patient who doesn’t have the disease
243
What is a true negative (TN)?
- Negative results in patient who doesn’t have the disease
244
What is a false negative (FN)?
- Negative result in patient who does have the disease
245
What is the diagnostic/clinical sensitivity?
- % of population with the disease that test positive
- TP/(TP+FN) X 100
246
What is diagnostic/clinical specificity?
- % of population without the disease that test negative
- TN/(TN+FP) x 100
247
What is a positive predictive value (PPV)?
- % of time that a positive result is correct
- TP/(TP+FP) x 100
248
What is a negative predictive value (NPV)?
- % of time that a negative result is correct
- TN/(TN+FN) x 100
249
What is correlation study?
- study to verify accuracy of method
- split patient samples are analyzed by existing method and new method
- requires a minimum of 40 patients samples representing wide range of concentrations
- reference values are plotted on X axis, values from new method on y axis
- perfect correlation is straight line passing through zero at 45 degree angle
- the correlation coefficient can be derived mathematically
250
What is preventative maintenance?
- schedule of maintenance to keep equipment in peak operating conditions
- Maintenance must be documented and follow manufacturers specifications and frequencies
251
What are function checks?
- procedures specified by manufacturer to evaluate critical operating characteristics of test system (stray light, background counts.
- Must be within manufacturers established limits before patient testing is conducted
- documentation required
252
What are delta checks?
- comparison of patient data with previous results
- detects mislabeled specimen and other errors
- when limit is exceeded, must determine if due to medical change in patient or lab error
253
What are critical values?
- test results that indicate a potentially life-threatening situation
- list typically includes glucose, sodium, potassium, total CO2, calcium, magnesium, phosphorus, total bilirubin, blood gases
- patient care personnel must be notified immediately
- joint commission requires read-back policy
254
What is the “read-back” policy?
- person receiving critical value must record and read back patients name and critical values
- lab must document person who received information and time of notification
255
What is personnel competency assessment?
- CLIA requires documentation of competency assessment of hire, at 6 months, and then annually
256
What is proficiency testing (PT)?
- testing of unknowns submitttd by outside agency (CAP)
- unknowns must not receive preferential treatment
- results reported to agency, which compares them to results from other labs
- CLIA requires all labs performing nonwaived tests (moderate or high complexity) to participate in PT
257
What is standard operating procedure (SOP)?
- Set of instructions for methods used in the laboratory.
- Also known as procedure manual
258
What are the CLIA requirements for procedure manuals?
- requirements for patient preparation, specimen collection, labeling, storage, preservation, transportation, processing, referral, and criteria for specimen acceptability and rejection
- procedures for microscopic examinations, including test calculations and interpretation of results
- preparation of slides, solutions, calibrators, controls, reagents, stains and other material used in testing
- calibration and calibration verification procedures
- reportable range for patient test results
- control procedures
- corrective action when calibrator or control result fail to meet labs criteria for acceptability
- limitations in methodology, including interfering substances
- reference intervals
- imminently life-threatening laboratory results (critical values)
- pertinent literature references
- system for entering results in patient record and reporting
- action to take if test system becomes inoperable
259
What is confidentiality?
- the right of patient to have their medical information kept private
- restriction of access to information to those who have authorization and a need to know
260
What is protected health information (PHI)?
- all individually identifiable health information, including lab results.
- HIPAA requires health-care providers to establish extensive security measures to ensure privacy
- Unauthorized disclosure of medical information could lead to changes of breach of confidentiality or invasion of privacy
261
What is invasions of privacy?
- the wrongful intrusion into a persons private affairs (unauthorized disclosure of confidential medical information)
262
What is informed consent?
- consent for a medical procedure given by patient after procedure and possible risks have been explained
- may be expressed or implied
263
What is expressed consent?
Written or verbal consent
264
What is implied consent?
- consent that is inferred from action or signs
265
What is informed refusal?
- patients have right to refuse medical treatment/procedures
266
What is negligence?
- violation of duty to exercise reasonable skill and care
267
What is malpractice?
- misconduct or negligence that results in injury to patient
268
What is assault and battery?
- touching another person without their consent
- Darwing blood against a patients wishes could lead to charges of assault and battery
269
What is chain of custody?
- procedure to guarantee integrity of specimen to court
- each person handling specimen must sign chain of custody form that accompanies specimen and documents custody of specimen at all times.
- specimen may be transported in locked box to prevent tampering
270
What is a Deci-?
10^-1
271
What is a Centi-?
10^-2
272
What is a milli-?
10^-3
273
What is a micro-?
10^-6
274
What is a nano-?
10^-9
275
What is a pico-?
10^-12
276
What is a femto-?
10^-15
277
What is the formula to convert temperature from celsius to farenheit and vice Versa?
F = (1.8 x C) + 32
278
What are organizational skills?
- ability to apply management process, systematize workflow, make decisions, communicate with coworkers
279
What are people skills?
Understanding theories or human needs and work motivation
280
What are financial skills?
- effective use of and accounting for companies monetary assets
281
What are technical skills?
- skills to transform resources into products/services
282
What is an authoritarian style?
- manager makes all decisions without input from others.
- Quick decision-making. Least acceptance and commitment from staff
- poorest quality decision
283
What is a democratic style?
- manager makes decisions after polling staff
- better quality and acceptance
- decisions take longer
- those in minority might feel ignored
q
284
What is a consensus style?
- manager tries to get at least partial agreement from all staff
- everyone has input
- high quality decisions
- good acceptance and commitment
- time consuming
285
What is a Laissez-faire?
- manager leaves decisions to staff
- least effective approach
- manager abdicates responsibility
286
What is a mission?
Organizations purpose
287
What are goals?
- organizations board, long-term ambitions
288
What are objectives when referring to foundations?
- directives that describe how a goal will be achieved
- should me SMART
—specific
—measurable
—achievable
—realistic
—time-bound
289
What is planning?
Establishing goal and objectives, formulating policies to carry out objectives
290
What is organizing?
- coordinating resources to achieve plans
- defining working relationships, including line of authority and workflow
291
What is directing?
- communicating, motivating, delegating and coaching.
- creating a climate that meets the needs of individuals and the organization
292
What is controlling?
- defining standards of performance, developing a reporting system, and taking corrective action when necessary
293
What is a director?
- establishes goals and priorities
- broad policy making
- organizational goals is focus
294
What is an administrator?
- runs organization within framework of policies given to him/her
- organizational goal is focus
295
What is a manager?
- oversees activity to achieve goal or purpose
- work environment is focus
296
What is a supervisor?
- oversees activities of others to help them accomplish specific tasks
- people, operations is focus
297
What are physiological needs?
- survival needs.
- foods water, air and rest
- workplace counterparts = income
298
What are safety needs?
- physical and psychological security
- workplace counterparts = insurance, safe work environment, job security
299
What are social needs?
- sense of belonging, acceptance, and recognition
- workplace counterparts = social relationships with coworkers
300
What are esteem needs?
- respect, independence, appreciation, and recognition
- job titles, privileges, respect of colleagues
301
What are self-actualization needs?
- realization of full potential
- workplace counterparts = challenging work, autonomy, professional growth
302
What is a laboratory director?
- overall operation and administration of lab
303
What is technical supervisor?
- technical and scientific oversight of lab
- must be available on as-needed basis to provide on-site, telephone, or electronic consultation
304
What is a clinical consultant?
- consultation regarding appropriateness and interpretation of tests
305
What is a general supervisor?
- day-to-day supervision of lab
306
What is testing personnel?
- specimen processing, test performance, and reporting of test results
307
What is a job description?
Basis for evaluation
308
What are standards/criteria?
- what is expected
- should be objective and measurable
309
What is a measurement instrument?
- instrument to compare actual performance with desired performance
310
What is an evaluator?
- person trained in use of instrument, familiar with intricacies of job, time to dedicate to process
311
What is a feedback mechanism?
- plan for sharing results of review, taking corrective action, planning for future
312
What is error of central tendency?
- everyone is rated toward middle of scale
313
What is a contrast error?
- an individual is rated lower than justified because of comparison with another exceptional individual. ( The opposite may also occur)
314
What is an error of leniency?
- everyone is rated high (the opposite may also occur)
315
What is the halo effect?
- good performance in one area influences evaluation in other areas
316
What is the reverse halo effect?
- poor performance in one area influences evaluation in other areas
317
What is recency phenomenon?
- judgements are made based on recent events or unusual incidents
318
What are fixed costs?
- expenses that don’t fluctuate when volume of work changes over short term
- examples = instrument lease, maintenance contracts, facilities upkeep, rent
319
What is variable costs?
- expenses that fluctuate directly with change in work load
- example = labor costs, supplies, reagents, and disposables
320
What is a direct cost?
- costs associated with performance of a test
- example = supplies, controls, disposables, equipment costs
321
What is indirect cost?
- overhead
- examples = administration, security, insurance, rent, taxes
322
What is the unit cost/cost per test?
- total of direct and indirect expenses of producing a test result
323
What is a sentinel event??
- unexpected event involving death or serious physical or psychological injury or risk thereof
- goal = to improve patient care
324
What are the requirements when a sentinel event occurs?
1. Root cause analysis: analysis of why event happened. Examines proximate causes. Focuses on systems/processes, not individuals
2. Action plan: establishs risk reduction strategies and measures of effectiveness. Should delineate responsibilities for implementation/oversight and establish time lines
3. Implementation
4. Monitoring
325
What is Point-of-Care testing (POCT)?
- testing performed at site of patient care
- also known as decentralized, bedside, or near-patient testing
- goal = to provide rapid test results where immediate medical action is required
